Social, Technological and Health Innovation: Opportunities and Limitations for Social Policy, Health

SOCIAL, TECHNOLOGICAL AND HEALTH INNOVATION: OPPORTUNITIES AND LIMITATIONS FOR SOCIAL POLICY, HEALTH POLICY, AND ENVIRONMENTAL POLICY

EDITED BY : Andrzej Klimczuk, Magdalena Klimczuk-Kochańska and Jorge Felix

PUBLISHED IN : Frontiers in Public Health, Frontiers in Political Science, Frontiers in Sociology and Frontiers in Psychology

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ISSN 1664-8714 ISBN 978-2-83250-513-7 DOI 10.3389/978-2-83250-513-7

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SOCIAL, TECHNOLOGICAL AND HEALTH INNOVATION: OPPORTUNITIES AND LIMITATIONS FOR SOCIAL POLICY, HEALTH POLICY, AND ENVIRONMENTAL POLICY

Topic Editors: Andrzej Klimczuk, Warsaw School of Economics, Poland Magdalena Klimczuk-Kochańska, University of Warsaw, Poland Jorge Felix, University of São Paulo, Brazil

Citation: Klimczuk, A., Klimczuk-Kochańska, M., Felix, J., eds. (2022). Social, Technological and Health Innovation: Opportunities and Limitations for Social Policy, Health Policy, and Environmental Policy. Lausanne: Frontiers Media SA. doi: 10.3389/978-2-83250-513-7

Table of Contents

05 Editorial: Social, Technological and Health Innovation: Opportunities and Limitations for Social Policy, Health Policy, and Environmental Policy Andrzej Klimczuk, Magdalena Klimczuk-Kochańska and Jorge Felix

PART I

SOCIOECONOMIC CHALLENGES IN THE DEVELOPMENT OF SOCIAL, TECHNOLOGICAL AND HEALTH INNOVATION

09 “One Health” Approach for Health Innovation and Active Aging in Campania (Italy)

Vincenzo De Luca, Giovanni Tramontano, Luigi Riccio, Ugo Trama, Pietro Buono, Mario Losasso, Umberto Marcello Bracale, Giovanni Annuzzi, Rosa Zampetti, Francesco Cacciatore, Giannamaria Vallefuoco, Alberto Lombardi, Anna Marro, Mariarosa Anna Beatrice Melone, Cristina Ponsiglione, Maria Luisa Chiusano, Giancarlo Bracale, Gaetano Cafiero, Aurelio Crudeli, Carmine Vecchione, Maurizio Taglialatela, Donatella Tramontano, Guido Iaccarino, Maria Triassi, Regina Roller-Wirnsberger, Jean Bousquet and Maddalena Illario

20 Delivering High-Quality, Equitable Care in India: An Ethically-Resilient Framework for Healthcare Innovation After COVID-19 Ahmad Ozair and Kaushal Kishor Singh

27 Why Is Rehabilitation Assistance Policy for Children With Disabilities Deviated in Supply-Demand? A Case Study in Mainland China

Cai Yun Qi and Yuan Wang

40 Research on Financing Mechanism of Long-Term Care Insurance in Xiamen, China: A System Dynamics Simulation Liangwen Zhang, Sijia Fu and Ya Fang

51 Minimizing the Risk of Catastrophic Health Expenditure in China: A Multi-Dimensional Analysis of Vulnerable Groups

Jiahui Wang, Xiao Tan, Xinye Qi, Xin Zhang, Huan Liu, Kexin Wang, Shengchao Jiang, Qiao Xu, Nan Meng, Peiwen Chen, Ye Li, Zheng Kang, Qunhong Wu, Linghan Shan, Daniel Adjei Amporfro and Bykov Ilia

PART II

INNOVATION IN THE CONTEXT OF REGULATORY FRAMEWORKS OF SOCIAL POLICY, HEALTH POLICY, AND ENVIRONMENTAL POLICY

72 Reimagining Innovation Amid the COVID-19 Pandemic: Insights From the WISH Innovation Programme

Maha El Akoum and Mahmoud El Achi

79 Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic

Petra Maresova, Lukas Rezny, Lukas Peter, Ladislav Hajek and Frank Lefley

92 Social, Legal and Economic Implications for the Implementation of an Intelligent Wound Plaster in Outpatient Care

Peter Enste and Alexander Bajwa Kucharski

102 Implementation of Assistive Technologies and Robotics in Long-Term Care Facilities: A Three-Stage Assessment Based on Acceptance, Ethics, and Emotions

Annette Franke, Elmar Nass, Anna-Kathleen Piereth, Annabel Zettl and Christian Heidl

115 Philippine Mental Health Act: Just an Act? A Call to Look Into the Bi-directionality of Mental Health and Economy

Nicholle Mae Amor Tan Maravilla and Myles Joshua Toledo Tan

PART III

THE IMPLEMENTATION OF SOCIAL, TECHNOLOGICAL AND HEALTH INNOVATION: SELECTED EXAMPLES

121 Promoting Responsible Research and Innovation (RRI) During Brazilian Activities of Genomic and Epidemiological Surveillance of Arboviruses

Marta Giovanetti, Luiz Carlos Junior Alcantara, Alfredo Souza Dorea, Qesya Rodrigues Ferreira, Willian de Almeida Marques, Jose Junior Franca de Barros, Talita Emile Ribeiro Adelino, Stephane Tosta, Hegger Fritsch, Felipe Campos de Melo Iani, Maria Angélica Mares-Guia, Alvaro Salgado, Vagner Fonseca, Joilson Xavier, Elisson Nogueira Lopes, Gilson Carlos Soares, Maria Fernanda de Castro Amarante, Vasco Azevedo, Alícia Kruger, Gustavo Correa Matta, Laisa Liane Paineiras-Domingos, Claudia Colonnello, Ana Maria Bispo de Filippis, Carla Montesano, Vittorio Colizzi and Fernanda Khouri Barreto Nicholle Mae Amor Tan Maravilla and Myles Joshua Toledo Tan

125 The Association of Social Capital and Self-Rated Health Between Urban Residents and Urbanized Rural Residents in Southwest China

Tianpei Ma and Bo Gao

134 An Innovative Approach for Decision-Making on Designing Lifestyle Programs to Reduce Type 2 Diabetes on Dutch Population Level Using Dynamic Simulations

Teun Sluijs, Lotte Lokkers, Serdar Özsezen, Guido A. Veldhuis and Heleen M. Wortelboer

150 Analysis of Three Potential Savings in E-Working Expenditure

Michal Beno

TYPE Editorial

PUBLISHED 29September2022

DOI 10.3389/fpos.2022.1020110

OPENACCESS

EDITEDBY LesliePaulThiele, UniversityofFlorida,UnitedStates

REVIEWEDBY SiYingTan, National Universityof Singapore,Singapore

*CORRESPONDENCE

AndrzejKlimczuk klimczukandrzej@gmail.com

SPECIALTYSECTION

Thisarticlewassubmittedto Politics ofTechnology, asectionofthejournal FrontiersinPoliticalScience

RECEIVED 15August2022

ACCEPTED 08September2022

PUBLISHED 29September2022

CITATION

KlimczukA,Klimczuk-KochanskaM and FelixJ(2022)Editorial:Social, technologicalandhealthinnovation: Opportunitiesandlimitationsforsocial policy,healthpolicy,and environmentalpolicy. Front.Polit.Sci. 4:1020110. doi:10.3389/fpos.2022.1020110

COPYRIGHT © 2022Klimczuk, Klimczuk-KochanskaandFelix.Thisis anopen-accessarticledistributed underthetermsofthe Creative CommonsAttributionLicense(CCBY) Theuse, distributionorreproduction inotherforumsispermitted,provided theoriginalauthor(s)andthecopyright owner(s)arecreditedandthatthe originalpublicationinthisjournalis cited,inaccordancewithaccepted academicpractice.Nouse,distribution orreproductionispermittedwhich doesnotcomplywiththeseterms.

environmentalpolicy

AndrzejKlimczuk1*,MagdalenaKlimczuk-Kocha ´ nska2 and JorgeFelix3

1 DepartmentofPublicPolicy,CollegiumofSocio-Economics,SGHWarsawSchoolofEconomics, Warsaw,Poland, 2 FacultyofManagement,UniversityofWarsaw,Warsaw,Poland, 3 UniversityofSão Paulo,SãoPaulo,Brazil

KEYWORDS

digitalhealth,healthinnovation,integratedinnovation,multisectoral policy,public policy,publichealth,socialinnovation,technologicalinnovation

EditorialontheResearchTopic

Social,technologicalandhealthinnovation:Opportunitiesand limitationsforsocial policy,healthpolicy,andenvironmentalpolicy

Overview

Innovationisprogressivelyneededinrespondingtoglobalchallenges.Moreover, theincreasingcomplexityofchallengesimpliesdemandfortheusageofmultisectoral andpolicymixapproaches.Wickedproblemscanbetackledby“integratedinnovation” thatcombinesthecoordinatedimplementationofsocial,technological,andhealth innovationco-createdbyentitiesofthepublicsector,theprivatesector,thenongovernmentalsector,andtheinformalsector(cf. MeissnerandKergroach,2021).

ThisResearchTopicfocusesonfillingtheknowledgegapsabouttheselectedtypesof innovation.First,regardingsocialinnovationthatcanbeunderstoodasnewstrategies, concepts,products,services,andorganizationalformsthatallowthesatisfactionof humanneeds(Murrayetal.,2010).Second,atechnologicalinnovationthatrefersto neworremarkably improvedproducts,goods,orservicesintermsoftheirtechnical specifications,components,materials,software,design,orotherfunctionalfeatures (Celietal.,2015).Third,healthinnovationthatfocusesonnovelorenhancedhealth policies,systems,products, technologies,services,andcaredeliveryschemestoimprove people’shealth(WHO,2021).Finally,thisResearchTopichighlightsattemptsto developintegratedinnovationthatcanaddvaluetosocialpolicy,healthpolicy,and environmentalpolicybyimprovingefficiency,effectiveness,quality,sustainability,safety, andaffordability(Figure1).

Editorial:Social,technological andhealthinnovation: Opportunitiesandlimitationsfor socialpolicy,healthpolicy,and

FIGURE1

Proposed understandingofrelationshipsbetweenselectedtypesofinnovationinthecontextofsocialpolicy,healthpolicy,andenvironmental policy.Source:ownelaboration.

ThemainideabehindtheResearchTopic“Social, Technological andHealthInnovation:Opportunitiesand LimitationsforSocialPolicy,HealthPolicy,andEnvironmental Policy”comesfrompreviousstudiesofco-editorsonthe rolesofinnovationinselectedpublicpolicies(Klimczukand Klimczuk-Kocha´nska,2019; Klimczuk andTomczyk,2020; FelixandKlimczuk,2021).Fournewgoalsunderpinned workonthis ResearchTopic:(1)toidentifyandsharethe bestcurrentpracticesandinnovationsrelatedtosocial, environmental,andhealthpolicies;(2)todebaterelevant governancemodes,managementtoolsaswellasevaluation andimpactassessmenttechniques;(3)todiscussdilemmasin thefieldsofmanagement,financing,designing,implementing, testing,andmaintainingthesustainabilityofinnovativemodels ofdeliveringsocial,healthandcareservices;and(4)torecognize andanalyzesocial,technologicalandhealthinnovationthathas emergedorhasbeenscaled-uptorespondtocrisessuchasa COVID-19pandemic.

Thepresentedcollectionincludes14articlespreparedin totalby100authors.Italsocontainsfivetypesofarticles covering:eightoriginalresearcharticles(Beno; Maresovaetal.; QiandWang; Sluijsetal.; EnsteandKucharski; Wangetal.; Ma andGao; Zhang etal.),twoperspectivearticles(ElAkoumandEl Achi; Ozairand Singh),oneconceptualanalysisarticle(Franke etal.),onereviewarticle(DeLucaetal.),andtwoopinion articles(Giovanettietal.; MaravillaandTan).Thepapers comprisingthisset areorganizedaccordingtothreethemes.

DeLucaetal. analyzetheregionalinnovationecosystem inCampania,Italy, whichfocusesonideasofhealthyaging, the“silvereconomy,”digitalization,usageoflocalassets,and

ThemeI:Socioeconomicchallenges inthedevelopmentofsocial, technologicalandhealthinnovation

alife-course approach.Inthenextpaper, OzairandSingh showadvancesincreatinganinclusiveandethicallyresilient frameworkforhealthcareinnovationinIndia.Thesubsequent studiesfocusedonChinacontinuethediscussion. QiandWang provideanexampleofatargetedrehabilitationassistancesystem forchildrenwithdisabilitiesinwhichtheparticipants’behaviors existinadynamicinteractionwiththeregulatory,normative, andcognitivecontextsthatgenerateinclusionandexclusion errorsunderlyingtheinaccuratepolicyimplementation.The teamof Zhangetal. investigatedtrendsinlong-termcare insurancefundsand factorscrucialforestablishingasustainable long-termcareinsurancefinancingmechanisminChina.The finalpaperby Wangetal. concentratesonthestatistical estimationofcatastrophichealthexpenditurebasedondata fromChina’sNationalHealthServiceSurvey.Thestudy recommendsdevelopingtargetedandmultidimensionalpolicies tosupportidentifiedtypesofhouseholdsandvulnerablegroups.

ThemeII:Innovationinthecontext ofregulatoryframeworksofsocial policy,healthpolicy,and environmentalpolicy

ElAkoumandElAchi explorehowhealthcareinnovations canreducethe costsandtimeassociatedwithresponsestothe COVID-19pandemic.Thepaperanalyzesapplicationsreceived ininnovationcompetitionsorganizedbytheWorldInnovation SummitforHealth.Inthesubsequentstudy, Maresovaetal. investigatehowmedicaldevicedevelopersrespondtoregulatory frameworkrequirementsintheEuropeanUnion.Ontheother hand, EnsteandKucharski presentsocial,legal,andeconomic challengesimplied bytheintroductionofintelligentwound plasterandtheteamof Frankeetal. discussdiverseeffects ofassistive robotsusageinlong-termcarefacilities.Finally, MaravillaandTan arguetheneedformentalhealtheconomics andpoliciesthatinfluencenotonlythequalityoflifebutalsothe levelsofproductionandconsumption.

Also, Sluijsetal. focusontargetedintervention.Theirstudy investigates thereductionoftype2diabetesbasedona cost-benefitanalysisofvariouslifestyleprogramsthrough dynamicsimulations.Thelaststudyofthiscollection,by Beno,analyseshowpotentialfinancialbenefitsfore-workers differinvarious countriesandwhetherthesecanincreaseeworkers’earnings.

Conclusion

TheresultsoftheanalyzespresentedinthisResearchTopic allowtheformulation ofthreecollectivelessonsderivedfrom thesestudies.Theseare:(1)integratedinnovationcombining social,technologicalandhealthinnovationneedsahighlevel ofcooperationandcoordinationbetweenvariousentities andespeciallywell-organizedknowledgetransfersbetween researchandpractice;(2)governance,publicmanagement, andorganizationalmanagementofintegratedinnovationneed anin-depthunderstandingofmultilevel,multistakeholder, andmultisectoralapproaches;and(3)policymixrelatedto integratedinnovationshouldcover,amongothers,investment inresearchanddevelopment,supportservicesandimprovement ofinnovationcompetenciesofpolicyactors,andthecreationof newmarkets.

Moreover,thearticlesincludedinthiscollectionsuggest fourdirectionsforfurtherresearch.Theseare:(1)featuresof emergingeconomicsystemsbasedonintegratedinnovation suchasthesilvereconomy,longevityeconomy,socialeconomy, circulareconomy,greeneconomy,andsharingeconomy;(2) functionsofco-design,co-creation,andco-productionschemes inthedevelopmentofintegratedinnovationintheareas ofsocialpolicy,environmentalpolicy,andhealthpolicy; (3)disruptionsandchallengesforintegratedpublicpolicies andprogramsonsocial,environmental,andhealthissues relatedtodeliveringservicesgoingbeyonddigitalinnovation; and(4)opportunities,criticism,andethicalcontroversies relatedtoexamplesofintegratedinnovationsuchasdigital socialinnovation,e-health,plant-basedinnovation,food innovation,artificialintelligence-basedsolutions,socialand servicerobotics,smartenvironments,gerontechnology,and welfaretechnology.

Authorcontributions

Giovanettietal.,intheirarticle,describehowtheGenomic andEpidemiologicalSurveillanceofArbovirusesinBrazil wascombinedwiththedisseminationofbestpracticesof emergingmovementssuchastheOpenScienceandthe ResponsibleResearchandInnovation.Inthenextpaper, MaandGao provideevidencethatthereisaneedto stimulatesocialcapitalthatmaydifferentlyinfluenceselfratedhealthindistincttypesofcommunitiesinChina.

AKoutlinedanddraftedtheeditorial.MK-KandJF contributedbyreviewing andrevisingthemanuscriptof editorialandleadingeditorialworkonallmanuscripts includedinthisResearchTopic.Allauthorsofthepapers listedhavemadeasubstantial,direct,andintellectual contributiontotheworkaswellasapprovedtheirpapers forpublication.

ThemeIII:Theimplementationof social,technologicalandhealth innovation:Selectedexamples

10.3389/fpos.2022.1020110

Acknowledgments

Wewantto thankalltheauthorsandthereviewers whocontributedtothepresentedarticlecollectionfortheir dedicationtoourtopicsandtotheirreadinesstosharetheir knowledgeandtime.Wealsogivethankstothealwayshelpful Frontiersteam,whoseorganizationalskillsandunderstanding madethisResearchTopicpossible.

Conflictofinterest

Theauthorsdeclarethattheresearchwasconductedin theabsence ofanycommercialorfinancialrelationships

References

Celi,M.,Deserti,A.,andRizzo,F.(2015). Report onExistingFormsofSocial InnovationAcrossEurope–PartI:SIProcessesandBusinessModels.Gelsenkirchen: InstituteforWorkandTechnology.

Felix,J.,andKlimczuk,A.(2021).“Socialentrepreneurshipandsocialinnovation inaging,”in EncyclopediaofGerontologyandPopulationAging,edsD.GuandM. E.Dupre(Cham:Springer).

Klimczuk,A.,andKlimczuk-Kocha´nska,M.(2019).“Neweconomy,food,and agriculture,”in: EncyclopediaofFoodandAgriculturalEthics,edsD.M.Kaplanand P.B.Thompson(Dordrecht:SpringerNetherlands).

thatcouldbeconstruedasapotentialconflict ofinterest.

Publisher’snote

Allclaimsexpressedinthisarticlearesolelythose oftheauthorsanddonotnecessarilyrepresentthose oftheiraffiliatedorganizations,orthoseofthepublisher, theeditorsandthereviewers.Anyproductthatmaybe evaluatedinthisarticle,orclaimthatmaybemadeby itsmanufacturer,isnotguaranteedorendorsedbythe publisher.

Klimczuk,A.,andTomczyk,L.(2020). PerspectivesandTheoriesofSocial InnovationforAgeingPopulation. Lausanne:FrontiersMedia.

Meissner,D.,andKergroach,S.(2021).Innovationpolicymix:mappingand measurement. J.Technol.Transf. 46,197–222.doi:10.1007/s10961-019-09767-4 Murray,R.,Caulier-Grice,J.,andMulgan,G.(2010). TheOpenBookofSocial Innovation. London:NESTA.

WHO(2021). WHOCompendiumofInnovativeHealthTechnologiesforLowResourceSettings2021:COVID-19andOtherHealthPriorities.2021.Geneva: WorldHealthOrganization.

published:11May2021 doi:10.3389/fpubh.2021.658959

Editedby: AndrzejKlimczuk, WarsawSchoolofEconomics,Poland

Reviewedby: NoelCarroll, NationalUniversityofIreland Galway,Ireland FrancescoSchiavone, UniversityofNaplesParthenope,Italy MichaelFriebe, OttovonGuerickeUniversity Magdeburg,Germany MariaJacobs, TilburgUniversity,Netherlands KunioShirahada, JapanAdvancedInstituteofScience andTechnology,Japan

*Correspondence: MaddalenaIllario illario@unina.it

Specialtysection: Thisarticlewassubmittedto PublicHealthPolicy, asectionofthejournal FrontiersinPublicHealth

Received: 26January2021 Accepted: 18March2021 Published: 11May2021

Citation: DeLucaV,TramontanoG,RiccioL, TramaU,BuonoP,LosassoM, BracaleUM,AnnuzziG,ZampettiR, CacciatoreF,VallefuocoG, LombardiA,MarroA,MeloneMAB, PonsiglioneC,ChiusanoML, BracaleG,CafieroG,CrudeliA, VecchioneC,TaglialatelaM, TramontanoD,IaccarinoG,TriassiM, Roller-WirnsbergerR,BousquetJand IllarioM(2021)“OneHealth” ApproachforHealthInnovationand ActiveAginginCampania(Italy). Front.PublicHealth9:658959. doi:10.3389/fpubh.2021.658959

“OneHealth”ApproachforHealth InnovationandActiveAgingin Campania(Italy)

VincenzoDeLuca 1,GiovanniTramontano 2,LuigiRiccio 3,UgoTrama 3,PietroBuono 3 , MarioLosasso 4,UmbertoMarcelloBracale 1,GiovanniAnnuzzi 5,RosaZampetti 6 , FrancescoCacciatore 7,GiannamariaVallefuoco 8,AlbertoLombardi 9,AnnaMarro 10 , MariarosaAnnaBeatriceMelone 11,CristinaPonsiglione 12,MariaLuisaChiusano 13 , GiancarloBracale 14,GaetanoCafiero 15,AurelioCrudeli 16,CarmineVecchione 17 , MaurizioTaglialatela 18,DonatellaTramontano 19,GuidoIaccarino 20,MariaTriassi 1 , ReginaRoller-Wirnsberger 21,JeanBousquet 22 andMaddalenaIllario 1*

1 DipartimentodiSanitàPubblica,UniversitàdegliStudidiNapoli“FedericoII,”Naples,Italy, 2 UnitàOperativaSemplice RicercaeSviluppo,AziendaOspedalieraUniversitariaFedericoII,Naples,Italy, 3 DirezioneGeneraleperlaTuteladellaSalute eilCoordinamentodelServizioSanitarioRegionale,Naples,Italy, 4 DipartimentodiArchitettura,UniversitàdegliStudidi Napoli“FedericoII”,Naples,Italy, 5 UnitàOperativaSempliceMicroinfusorietecnologieinnovative,AziendaOspedaliera UniversitariaFedericoII,Naples,Italy, 6 AziendaSanitariaLocaleSalerno,Salerno,Italy, 7 DipartimentodiScienzeMediche Traslazionali,UniversitàdegliStudidiNapoli“FedericoII,”Naples,Italy, 8 AziendaSanitariaLocaleNapoli2Nord, Frattamaggiore,Italy, 9 AziendaSanitariaLocaleBenevento,Benevento,Italy, 10 AziendaSanitariaLocaleAvellino,Avellino, Italy, 11 DipartimentodiScienzeMedicheeChirurgicheAvanzateeCentroInteruniversitariodiRicercainNeuroscienze, UniversitàdegliStudidellaCampaniaLuigiVanvitelli,Naples,Italy, 12 DipartimentodiIngegneriaIndustriale,Universitàdegli StudidiNapoli“FedericoII,”Naples,Italy, 13 DipartimentodiAgraria,UniversitàdegliStudidiNapoli“FedericoII,”Naples, Italy, 14 MediterraneanFederationforAdvancingVascularSurgery,Naples,Italy, 15 UnionedegliIndustrialidiNapoli,Naples, Italy, 16 Federterme,Rome,Italy, 17 DipartimentodiMedicina,ChirurgiaeOdontoiatria,UniversitàdegliStudidiSalerno, Salerno,Italy, 18 DipartimentodiNeuroscienzeeScienzeRiproduttiveedOdontostomatologiche,UniversitàdegliStudidi Napoli“FedericoII,”Naples,Italy, 19 DipartimentodiMedicinaMolecolareeBiotecnologieMediche,UniversitàdegliStudidi Napoli“FedericoII,”Naples,Italy, 20 DipartimentodiScienzeBiomedicheAvanzate,UniversitàdegliStudidiNapoli“Federico II,”Naples,Italy, 21 DepartmentofInternalMedicine,MedicalUniversityofGraz,Graz,Austria, 22 MACVIA-France,Fondation PartenarialeFMCVIA-LR,Montpellier,France

ThisarticledescribeshowinnovationsareexploitedinCampania(Italy)toimprove healthoutcomes,qualityoflife,andsustainabilityofsocialandhealthcareservices. Campania’sstrategyfordigitalizationofhealthandcareandforhealthyagingisbased onaperson-centered,life-course,“OneHealth”approach,wheredemographicchange isconsideredcapableofstimulatingagrowthdynamiclinkedtotheopportunities ofcombiningthe“SilverEconomy”withlocalassetsandthespecifichealthneeds ofthepopulation.Theend-users(citizens,patients,andprofessionals)contribute totheco-creationofproductsandservices,beinginvolvedintheidentificationof unmetneedsandtest-bedactivity.TheCampaniaReferenceSiteoftheEuropean InnovationPartnershiponActiveandHealthyAgingisaflexibleregionalecosystemto addressthechallengeofanagingpopulationwithalife-courseapproach.Thegood practices,developedinthecontextofresearchandinnovationprojectsandinnovative procurementsbylocalstakeholdersandcollaborationswithinternationalnetworks, havebeenallowingthetransferofinnovativesolutions,knowledge,andskillstothe stakeholdersofsuchamulti-sectoralecosystemforhealth.

Keywords:healthpolicy,digitalhealth,activeandhealthyaging,healthinnovation,futurehealthandhealthcare, informationandcommunicationtechnologies,silvereconomy

INTRODUCTION

Worldwidedemographicchangewithincreasinglyaging populationsposesachallengetosocieties.TheAgingEurope reportpublishedbytheEuropeanCommissionin2019 highlightedthatthepopulationofolderadults(65yearsor more)intheEuropeanUnion(EU)willincreasefrom101 millionin2018to149millionby2050.Thenumberofpeople intheEU-28aged75–84yearsisprojectedtoexpandby60.5%, andthoseaged65–74yearstoincreaseby17.6%,with9.6% fewerpeopleagedunder55yearslivingintheEU-28by2050 (1).ThecurrentCOVID-19pandemicbringsanadditional challengefor thissegmentofpopulation,relatedtotheincreased riskofadverseoutcomeincaseofinfection(2).Furthermore, thedeteriorationin thequalityoflifeoftheolderadultsasa consequenceoflonelinessandinsufficienttreatmentresulting fromthepandemicimposeshealthchallengesofunknown dimension.Duetothepandemic,healthconditionsofolder adultsworsen,andmortalityincreases,especiallyamongthe vulnerablesubgroupsofpopulations,settingacountrybackon itspathofhumandevelopment,andincreasingtheeconomic pressureongovernments(3).Theadditionalburdensofhigh unemploymentrates amongtheworking-agepopulationand migrationwillputastrainonhealthcareandwelfaresystemsin southernandeasternEuropeanregions(4).TheUnitedNations 2030AgendaforSustainableDevelopment(5)callsforaglobal alliancetoaddressthesocialchallengesthatallcountriesare facing,withafocusonhealthandtraining,andinrelation totheinequalitiesthatpreventsustainabledevelopmentfor theglobalsociety.AccordingtoWorldHealthOrganization (WHO)DecadeforHealthyAging,iflivinglongerisdominated bypoorhealth,socialisolation,ordependencyoncare,the implicationsforolderpeopleandsocietyarenegativeinterms ofsustainabilityanddevelopment.Poorhealthforolderadults makesthemlessproductive,earnless,retireearlier,andbe ingreaterneedforhealth,care,andsocialservices(6).The impactof socialinequalitiesonpopulationhealthandmortality hasbeenwell documented,aswellasthefactthatinmany westernindustrializednations,thereisagradientbetweensocial classposition(employment,education,and/orincome)and theriskofdeath(7).Thishasconsequencesforindividuals, industry,publicauthorities,healthandcareorganizations,policy makers,andinvestmentcommunities(8).Theterm“health inequality”referstothehealthdifferencesbetweenindividuals orgroups(9)thatarepreventableandunnecessary:allowing themtopersistisunfair.Differencesbetweensocialgroupsare consideredhealthinequalitiesbecausetheyreflectanunfair distributionofhealthrisksandresources.Infact,tobetruly effective,healthservicesmustbeabletomanagethehealth oftheentirepopulationandnotonlythosewhoneeditfor specifichealthconditions.Theagingprocessisnotthesamefor allindividuals(10):thelossofabilitytypicallyassociatedwith agingdiffers andisdevelopedthroughoutaperson’slife-course. Disabilityanddependencyarenotaninevitableconsequence ofaging,andthereisalotwecandototransformitintoan opportunity,bysupportingandstimulatingactiveandhealthy trajectoriesofagingalongtheentirelife-course.TheWHO

indicatesthreekeyapproachestoalignhealthsystemstothe needsofolderpopulations:

1.Developingandensuringaccesstoservicesthatareperson centeredandintegrated; 2.Orientingsystemsaroundintrinsiccapacity;and 3.Ensuringthereisasustainableandtrained healthworkforce.

Inthisperspective,thereisaneedtostrengthenhealth promotionanddiseasepreventionalongtheentire life-course,whileaddressingtheneedsofanaging populationbysupportingindependentlivingathome, self-managementofage-relatedconditions,andreduction ofisolation.

OPPORTUNITIESFROMTHE INTERNATIONALIZATIONOFTHE REGIONALHEALTHSYSTEMS

TheCampaniaRegionfollowstheindicationsoftheWHO “OneHealth”approachfortheimplementationofsustainable developmentgoalsacrossallpolicies,inaninter-sectoraleffort (health,environment,educationandtraining,research,and tourism),includingdifferentstakeholdersalongthequadruple helixofinnovation(11, 12).Thisinnovationecosystemis basedon theapproachintroducedbytheEuropeanInnovation PartnershiponActiveandHealthyAging(EIPonAHA),a stakeholder-driven,voluntaryinitiative,launchedin2012to fosterinnovationanddigitaltransformationinactiveandhealthy agingacrosscountriesandregionswithintheEU(13 15).The EIPonAHAbringstogetherpublicauthorities,healthandcare providers,researchers,industry,andcivicsocietyorganizations within,andacross,regionstoaddressthechallengesofan agingpopulationthroughthedevelopment,implementation, andscaling-upofevidence-basedinnovativesolutions,digital technologies,andmodelsofhealthandcare.Oneofthe biggestchallengesfortheEIPonAHAismovinginnovative solutionstowidespreadapplication,beyondprojectsortest bedenvironments.TheEIPonAHAhasbeensupporting thedevelopmentandadoptionofinnovationatscale,either withinaregion,acrossacountry,orbytransferringto otherregionsandcountries.TheEIPonAHAReference Sites(RS)areregionalecosystemsthatbringtogetherlocal quadruplehelixpartnersfromindustry,civilsociety,academia, andgovernmentauthoritiestofocusonacomprehensive, innovation-basedapproachtoactiveandhealthyaging.They areleadingregionalorganizationscommittedtoinvestingin innovationforactiveandhealthyagingandsupportingtheir transferandscaling-upacrossEurope(16).TheReferenceSite “quadruplehelix” structureinvolvesallthestakeholderstowork collaborativelyandeffectivelyindefiningandunderstanding need;co-creatingandco-designingnewsolutions;offering suitabletestbedenvironments;andevaluatingandmeasuringthe impactofinnovationonpatient,serviceuser,andsustainability. TheEuropeanCommission(EC)awardedtherecognitionof “ReferenceSite”toCampaniaforthefirsttimein2012,to

theResearchandDevelopmentUnitofFedericoIIUniversity Hospital,asthereferentforCampaniacluster(Table1). TheRSsubsequentlyobtainedafirstregionalrecognition (RegionalResolutionn.622/2012),whichestablishedaspecific coordinationgroupforachievingtheobjectivesoftheEIP onAHA.TheFedericoIIUniversityHospitalresubmittedthe applicationtotheECin2016,obtainingtherecognitionof “3starsRS.”TheRegionalResolutionn.221/2017establishedan interdisciplinarygroupforthecoordinationandmanagement oftheRS.Thelatest“4starsRS”awardwasobtainedin2019, supportedbytheDepartmentofPublicHealthofFedericoII University.Thescale-upofvalidatedinnovativesolutionsisat thecoreactivityofthestakeholdersoftheCampaniaRSofthe EIPonAHA(17).CampaniaRScoalitionisalsoconnectedto theProMIS(Programma MattoneInternazionaleSalute),the ItalianMinistryofHealthnetworkforinternationalizationof regionalhealthsystems(RHS).RepresentativesofallItalian regionsparticipateinProMIS,toaddressthecurrentand emerginghealthneedsoftheItalianpopulation,sharingand exploitingtheopportunitiesprovidedbyinnovativegood practices(18).

TheHealthInnovationDivisionoftheCampania Regioncoordinatedandsupportedthestakeholdersof theRHSinthedevelopmentoftheProMISregional Network(ProMIS@Campania),includingpublichealthcare organizationsofCampania,duringthe2017–2020timeframe. ProMIS@CampaniaandCampaniaRScollaborativelydesigned strategicobjectives,through:

1.Periodicdedicatedmeetings,fortherecognitionoftheneeds inherentinprocedures,tools,andtechniquesusefulfor innovationinhealthcare(FocusGroups);

2.InvolvementintheactivitiesofthenationalProMISnetwork, withparticularreferencetoEuropeaninitiatives,projects,and workinggroups;and 3.Thematicworkshops.

The SupplementaryMaterials providemoredetails ontheactivitiescarriedoutintheframeworkofthe ProMIS@Campanianetwork.

Thismultidisciplinary,inclusive,andcollaborativeapproach highlightedanasymmetricalprogressofthedifferentgroups, duetothedifferentlevelsofmaturityofthesharedgood practices,andtotheheterogeneityoftheskillsexpressedbythe involvedorganizations.

Thesystematicapproachdescribedforthestrengthening oftheProMIS@Campaniaregionalnetworkhasbeen identifiedthroughadecision-makingandconsensus processintegratingevidencegatheredfrompreliminary studies,andanempiricaldatacollectionwithlocoregional stakeholdersthatwasdevelopediterativelyduringa3-year timeframe.Thisprocesshasallowedtheidentificationof someprioritythematicareasfortheregionalstrategies, withrespecttowhichithasbeenpossibletotake advantageoftheparticipationinspecificEuropean-funded projects,inlinewithwhatwasdevelopedwithinthe ProMIS@Campanianetwork.

CAMPANIA’SSTRATEGICOBJECTIVES

Theresultsemergingfromtheactivitiesofthe ProMIS@Campanianetworkindicate,asastrategicobjective,the repositioningoftheofferofserviceswithinaperson-centered healthecosystem,throughtheadoptionofinnovativeapproaches thatallowtheimplementationofproactiveinterventions,anduse validatedinnovativegoodpractices.Campaniahasimportant researchassets,akeyelementforthedevelopmentofan economybasedonknowledge,aslongastheresearchresultsare transferredtothemarket.“Healthisthegreatestwealth,”and itisoneoftheinvestmentsectorswiththestrongestdrivefor innovation.Healthhasahighturnoverofknowledge,anditis oneofthemostimportantmarketsforinnovationinapublic healthcontext.ThisisparticularlytrueinCampania,where theRHSisleavingfromrepaymentplanandisinvestingin theenhancementofserviceprovisiontocitizens,toimprove healthoutcomesandthesystemsustainability.Aproactive, innovation-drivenapproachtranslatesintoopportunitiesfor regionaleconomicgrowththatcanbetriggeredbydigital transformation,enablingcross-sectorallinks.Theinnovation oftheCampaniaecosystemforhealthstimulatesmultisector andmulti-actorcollaborations(19).Thedigitaltransformation strengthenspatient empowerment,increasingtheaccessibility ofservicesforsegmentsofthepopulationwithspecifichealth needs,suchastheolderadultsandpeoplewithdisabilities.The ProMIS@Campaniastrategyforinnovationisalignedwiththe objectivesoftheNationalHealthPlan(20)andthenewregional Health Plan(21),aimedatcapacitybuildingoftheregional stakeholdersfromthesocialandhealthsystems,strengthening cross-sectoralcollaborationsatthelocoregional,national,and internationallevels.Inthisregard,thedigitaltransformationof healthandcareofferstheopportunitytotransformsocialand healthchallenges,suchastheagingofthepopulationandhealth inequalitiesintoopportunitiesforsustainabledevelopment, andmightbeoneofthepriorityareasforinvestmentsaimedat bridginginfrastructuralgapsanddigitaldivide(22).

EMERGINGPRIORITYLINES OF INNOVATIONNEEDS

ThestrategicobjectivesoftheProMIS@Campanianetwork providedasharedvision,facilitatingtheidentificationofhealth needsandsupportingtheagreementofthelocalstakeholders onthepossiblewaystoenhancethegoodpracticesprovided bythecollaborativeactivitieswithininternationalandnational projects.ThevisionofProMIS@Campaniawasalignedwiththe prioritiesoftheEuropeanCommission,allowingthealignment offinancialinstrumentsattheregional,national,andEuropean levelsforthedevelopmentoflong-terminvestmentplans,to producestructuralchanges.

Figure1 representsthedirectoriesresultingfromtheactivities carriedoutwithintheProMIS@Campanianetwork,onwhichthe stakeholdersofCampaniaRShavebeenfocusingon,coherently

withthefourprioritiesoftheEuropeanBlueprintforthedigital transformationof healthandcarefortheagingsociety(23, 24).

THEGOODPRACTICES FORHEALTH INNOVATIONINCAMPANIA

CampaniaparticipationintheEIPonAHAcommunity broadenedtheadoptionofdigitalsolutionsinhealthand care,exploitingthegoodpracticesavailable(25)through twinningactivitieswithdifferentEuropeanregions(Table2). ThetwinningsrepresentedanopportunityprovidedbytheEC toexchangeknowledgeandinnovativegoodpracticeswithhigh potentialforreplicabilityandscalingup(26).

Theparticipationto internationalcollaborativeactivitiesalso providedtheopportunitytobeinvolvedininternationalresearch projectstodesign,test,implement,andmonitortheimpactof innovativegoodpractices.Suchprojectswerecoherentwiththe prioritydirectoriesidentifiedbytheregionalfocusgroups.

Figure2 providesalistoftheEuropeanprojectsthatwere awardedtothestakeholdersofCampaniaRSecosystemthat weresubgroupedaccordingtothestrategiclinesoftheProMIS regionalnetworkandhavefosteredthestakeholders’engagement atdifferentlevelsinthematicworkinggroups.

INNOVATIVEPROCUREMENTS

Amongthefinancialinstrumentsfortheresearchand developmentofdigitalsolutions,akeyenablerhasbeen representedbyinnovativeprocurements.TheECintroduced

twoformsofpublicprocurementtopromoteinnovationinthe publicsector:publicprocurementforinnovativesolutions(PPI) andpre-commercialprocurement(PCP).PPIisaprocurement processinwhichpublicauthoritiesactascustomersforthe launchofinnovativegoodsandservicesthatarenotyetavailable onalarge-scalecommercialbasis.PCPisaboutpurchasing researchanddevelopment(R&D)servicesratherthanready-tomarketproducts,involvingindustryplayersasfuturesuppliers atallstagesofsolution’sdevelopment,fromresearchtofinal product,influencingthemarketfromthedemandside,andby stimulatingsupplierstodevelopsolutionsthatrespondtowellidentifiedunmetneedsofendusers(27, 28).Thestakeholders ofCampania RScommunityhavebeentakingadvantageofthe opportunityrepresentedbyinnovativeprocurementbyjoining differentconsortia,andbecomingoneoftheleadinggroupsin Europe.Innovativeprocurementsupportstheimprovementof thematchmakingbetweensupplyanddemandofinnovation withtheaimofreducingmarketfragmentation,andpromoting acollaborativeapproachtoincreasetheknowledgesharingand thecapacityoftheRHStoexpressitsneedforinnovationin awaythatallowsinterestedpartiestoprovideadequateand sustainablesolutions.Byparticipatinginsevenpre-commercial procurements(PCP)(Table3),thestakeholdersofCampania RShavebeensteeringthemarkettowardinnovativehealthcare solutionsandthedevelopmentofdemand-drivenproducts(29). Each PCPofferstheopportunityforstakeholdersandsuppliers todevelopspecificrequirementsforinnovativesolutions,to contributetoclinicalpilotsinhealthcaresettings,andtooffer vendorsthepossibilitytoexploittheresultsofthepilotsforthe developmentofnewready-to-marketsolutions.

FIGURE1| EmergingdirectoriesofthehealthinnovationecosysteminCampania.

TABLE1| Thestakeholders ofCampaniaRSalongthefourhelixesofinnovation.

Government/HealthprovidersResearchandacademia Industry Civilsociety

•Campaniaregion, •Localhealthagency Napoli1 Centro, •LocalhealthagencyNapoli2Nord, •LocalhealthagencyNapoli3Sud, •LocalhealthagencyBenevento, •LocalhealthagencyCaserta, •LocalhealthagencyAvellino, •LocalhealthagencySalerno, •Cardarellinationalrelevance Hospital, •PascalenationalcancerInstitute, •AziendadeiCollinationalrelevance Hospital, •FedericoIIUniversityHospital, •VanvitelliUniversityHospital, •SanGiovannidiDioeRuggi d’AragonaUniversityHospital

•FedericoIIUniversityofNaples(departmentof publichealth,departmentofadvanced biomedicalscience,departmentof architecture,departmentofindustrial engineering,departmentofagricultural science,departmentofclinicalmedicineand surgery,departmentoftranslationalmedical science,departmentofpharmacy, departmentofmolecularmedicineand biotechnologies,departmentofneuroscience, CEINGEadvancedbiotechnologyresearch center,CIRFF–Interdipartimentalresearch centerforpharmacoeconomicsanddrug utilization),

•ParthenopeUniversityofNaples(department ofphysicalactivities),

•UniversityofSalerno(departmentofmedicine andsurgery,departmentofcivilengineering),

•SuorOrsolaBenincasaUniversityofNaples, •VanvitelliUniversityofNaples(departmentof medical,surgicalanddentalspecialties)

•L’OrientaleUniversityofNaples(department ofhumansciences)

•Digitalinnovationhubcampania (Unioneindustrialicampania), •Federterme(Italianfederationof thermalandhealingwater industries), •ConfcooperativeSanitàCampania (Confederationof cooperatives–healthdivision)

•Ancelkeysinstitute,

•E.Ferrarivocationalhighschool, •Mediterraneanfederationfor advancingvascularsurgery,

•ItalianassociationAlzheimer disease(AIMA),

•Italiancancerassociation(ANT),

•ProgettoALFAassociation(Health Literacy),

•Campussalute(Healthpromotion),

•FedericoIIUniversityemeritus professorsassociation,

•Saluteincollinaassociation(general practitioners),

•CosmicNet(smallandmedium municipalitynetwork)

Centerforgastrology-Belgium/The Netherlands EIP-AHAscaleupstrategy-EC MASK-ARIA Preventionandmanagementofallergicrhinitis MACVIA-FranceRS EIP-AHAscaleupstrategy-EC Telerevalidatie PromotionofadaptedphysicalactivityinNCCDspatientTwenteRS EIP-AHAscaleupstrategy-EC Listeo+ Managementofwaitinglistandpre-op recommendations AndaluciaregionRS

DigitalhealthEuropeCSA Myprescription PolytherapymanagementandprescriptionadherenceAndaluciaRegionRS DigitalhealthEuropeCSA

RomagnaRegion,andvalidatedinCampaniabytheSalerno

collaborationwiththeUniversityofSalerno.Theorganizational modelforcollectiveandindividualinterventionsisunder development(30).

Thesolutionconsistsofasharedcareplanallowingboth patientsandprofessionalstoenterdatasuchasglucose measurements,whilegivingeachofthemspecificrightsto dosoandintegratingdatacaptureddirectlyfromdevices. Measurementofparametersusedbyhealthprofessionalsand patientstomanagethediseasearetransferabletothemain ProEmpowersolution,includingautomaticdatatransferfrom device.Thesolutionis,furthermore,abletodelivermessages tothepatient,includingmessagesformulatedbyaprofessional andthoseautomaticallygeneratedthroughdataanalysis— notificationsofdeviationfromgoals,tipsforbettermanagement, etc.(31).

IntegratedHomeCareforSubjectsWith

Multi-Morbidity,Including Lowand MediumIntensityofCare(BeyondSilos)

BeyondSilosisaninnovativepracticethatconsistsofanICTbasedhomemonitoringsystemprovidedasaservicebyaprivate homecarecompany,whichallowshospitalstafftofollowup patientsathome,asifthepatientwasstillinthehospital(32, 33).

TheBeyondSilos GoodPracticewillberecalibratedandusedas abasisforthepilotphaseoftheEuropeanVIGORproject.

ReviewofthePolypharmacyRegimens (“MedicationReview”and “De-prescribing”)

The“FRIENDD”studywasimplementedtoidentifycases ofprescriptiveinappropriatenessandreportthemtothe generalpractitionersconnectedtoamultispecialistteamfor de-prescribing.Thestudycurrentlyinvolvesexpertsfrom differentmedicalareas(pharmacology,geriatrics,neurology, gastrointestinal,andendocrinology)(34).

AMultisectoralPathfor RhinitisandIts Multimorbidity

TheMASK-ARIAinitiativeaimstodevelopaninterprofessional caremodel(pharmacists,generalpractitioners,andspecialists) foranintegratedmanagementofpatientswithallergicrhinitis. MASK-ARIAinCampaniaisdevelopedthroughasmartphone

appthatallowsforrhinitisassessmentandusesaclinicaldecision supportsystem(CDSS)(35 38).

TheGastrological ApproachtoMalnutrition

Thegastrologicalapproachtomalnutritionisaprimary preventionapproachtomalnutritionincasesofspecific nutritionalneeds,inallhealthcaresettings(39).Thefocusof thegastrologicalapproachistheimplementationofpersonalized ICT-supportednutritionalinterventionsthatleveragevalidated screening,assessment,andmonitoringtools,recognizinga coherentsetofactivitiesaimedatimprovingfoodintakein frailindividuals.

EarlyIdentificationofMildCognitive DeclinetoEnableTargetedInterventions

AmulticenterstudywascarriedoutinCampaniatovalidatethe ItalianversionoftheQuickMildCognitiveImpairment(QMCII)toolandtoobtainnormativedata.FurtherstudiesonItalian patientswithMCI(mildcognitiveimpairment)areunderwayto investigatethediagnosticpropertiesofQMCI-I,andtousethe multidomainstructureofthetooltoclassifythevarioussubtypes ofMCIandindicateinterventions,includingmemorytraining supportedbydigitaltools(40, 41).

PERsonalizedICTSupported Servicefor IndependentLivingandActiveAging

PERSSILAAservicesareofferedtoolderadultsthroughliving labsorganizedinlocalcommunities,andareintegratedwith

FIGURE2| InternationalprojectsinvolvingCampania’sstakeholders.

TABLE3| Pre-commercialprocurementsinCampania.

Project Aim Funding(e)Fundingscheme Beneficiary

ProEmpower Self-managementandmonitoringofdiabetestype2750,000.00EuropeancommissionFedericoIIUniversityHospital HSMonitor Earlydetectionandmanagementofhypertension924,000.00EuropeancommissionFedericoIIUniversityHospital eCARE Earlydetectionandmanagementoffrailtyinolder adults 980,000.00EuropeancommissionBeneventolocalhealthagency

ADCARE ICTsupportedintegratedservicesformultimorbidity management 2,008,125.00ItalianministryofresearchFedericoIIUniversityHospital

IngegneriaBioMedicaICTsupportedmanagementofmedicaldevices1,347,500.00ItalianministryofresearchFedericoIIUniversityHospital INCAREHEART Self-managementandmonitoringofchronicheart failure 930,000.00EuropeancommissionFedericoIIUniversity

TIQUE Integratedapproachtochronicheartfailure management 1,476,358.33EuropeancommissionAvellinolocalhealthagency Total 8,415,983.33

healthcareservices.Thisnewmultimodalservicemodel,focused onnutritional,physical,cognitive,andsocialdimensions,is supportedbyaninteroperableICTserviceinfrastructureand byalevelofgamification.Anextensionofthepilot,aimed atCampaniaruralareas,iscurrentlyintheplanningand implementationphase(42, 43).

ICTSupportedAdapted PhysicalActivity

TheTelerevalidatie.nl R platformsupportsthephysicalactivityof sedentarypatientsattheirpremises.ItprovidesICT-supported personalizedtrainingprogramwithtutorialvideosandatthe sametimeallowstotracktheiruseoftheplatform(44). TheFedericoII UniversityHospitalhasactivatedaclinicfor thephysicalactivityonprescription(PAP),toensurethat patientsdischargedbyarehabilitationpathwayareenrolledin apersonalizedphysicalactivityprogram.Tothisaim,patients whoareenrollingintheprogramaresubjectedtophysicalneed assessments,performedaccordingtotheguidelinesforexercise testingandprescriptionoftheAmericanCollegeofSports Medicine(45).Telerevalidatie.nl R isanexampleofsuccessful transferofaninnovationtocurrentpractice.Thesolutionwas initiallydevelopedintheframeworkofthePERSILAAproject. Itstransferwassupportedbytwointernationaltwinningsthat supportknowledgetransferandadaptationsthatresultedinthe finalintegrationoftheprogramforadaptedphysicalactivityinto serviceprovisionoftheFedericoIIUniversityHospital.

EarlyIdentificationofFrailtyinPrimaryand SecondaryCareSettings

TheSUNFRAILtoolenablesearlyidentificationoffrailty-risk domainsintheelderly,inordertopreventfunctionaldecline andadversehealthoutcomes.Thetooliscurrentlybeingused inpilotsatthethematicfocusgroupoftheProMIS@Campania network(46).

TRANSFERABLEELEMENTS

NewSkills forNewJobs

Tacklingthechallengeofanagingpopulationrequiresmoving fromareactiveapproachtodiseasetoaproactiveonefor

healthandwell-being.TheCampaniaRSapproachcontributed totheconnectmultidisciplinaryskillsandknowledge,placing thecitizenatthecenterofhealthcareservices,improving theirqualityandaccessibility.AsCOVID-19emergency demonstrated,digitalliteracyandtrainingwillbeessential amongprofessionalsacrosssectors,fore.g.,forsecondaryuse ofdata,hence,theneedtomakedigitaltoolsandsolutions accessibletothesegroups(47),fosteringtechnologicalskills. Furtherstrengtheningofhumanresourcesinaregionalhealth systemispivotaltodevelopcapacitybuilding,integratingthe enrollmentofnewprofessionalsinacontinuoustrainingcourses, asafundamentaltoolformaintaininghigh-qualitystandards intheprovisionofhealthandsocialservicesandprotecting individualandcollectivehealth.

InnovationtoMarketinCampania

TheCampaniaRSecosystemhasbeenmakingeffortsto implementtheEIPonAHAInnovationtoMarket(I2M)strategy byestablishingadialoguewithindustrialstakeholders,such astheDigitalInnovationHubofCampania(DIH)andthe HealthTechInnovationHub.CampaniaDIHistheregional networkofprivatecompaniesengagedininnovationanddigital transformationprojects,notonlyinthehealthsector.The HealthTechInnovationHubistheresultofthecollaboration betweentheFedericoIIUniversityofNaplesandMedtronic Italy,withtheaimofcombiningacademicandindustryskills togeneratenewsolutionsinhealthcare.Thesharedobjectiveis toocontritetothedevelopmentofthe“DigitalHealth”market inresponsetothehealthneedsofcitizens.Thiscollaborative andcross-sectorialapproachfollowstheimplementationof theEuropeanplanfor“Innovationtomarket”(I2M)(48)in Campaniaandbroadens thecommitmentoflocalstakeholders intheactivitiesandfurtherprogressoftheI2Mplan.The RScancontributetotheorganizationofactivitiesaimedat enrichingandextendingtheimpactoftheI2Mplanatthe regionallevel.Thealignmentbetweentheobjectivesofinterested stakeholdersstrengthensthestrategyofthedigitalmarketand extendstheprioritiesofdigitaldevelopmentinCampaniatothe healthsector.Throughthissynergy,CampaniaRSwillstimulate andpromotethedemandforinnovationinthehealthcare

system,improvingthelevelofmultidisciplinaryknowledge andincreasingtheawarenessoftheopportunitiesofferedby digitalizationtoindustryandpromotingtheadaptationand large-scaleadoptionofvalidatedgoodpractices.

Health,Accessible,andSustainable Tourism

Healthisanimportantsectoroftheeconomy,andhealthtourism isgrowingrapidlyacrossEurope.Healthtourismreferstoany formoftourismdevelopmentrelatedtohealthcreationthat includeshealthpromotion,specifichealthservices,orservices addressinghealthneedsrelatedtospecificconditions(49). Aneffectiveapproachneedsintegrationbetweenhealth,social, andtourismservicestomaketouristdestinationsaccessible, addressingthedifferentpatternofneeds:frailty,dependency, health-specificneedsthatdeterminespendingprioritiesof significantpartsofthegeneralconsumereconomy,suchasthe “SilverEconomy”(47).TheCollaborationbetweenItalianand EuropeanReferenceSites,inthecontextofthenationalProMIS networkandtheEIPonAHAReferenceSitesCollaborative Network(RSCN)(50)ledtosynergicactionsinthefieldof health, tosupportthedevelopmentofaccessibleandsustainable tourism.Thisisthroughsharingvalidatedandinnovative experiencesthatstrengthenaccessibilitytohealthservices intheregional,national,andinternationalcontexts.Broad, collaborativeactivitieswillallowtheidentificationofshared strategiesandpriorityimplementationareastofurtherdrivethe developmentofthisemergingsector.

Bottom–UpApproach

Often,theregionsadoptatop–downstrategytothedevelopment ofthelocalnetworkforinnovation,withacentralizeddefinition ofpriorities,andsubsequentcollectionofgoodpracticeson theground.ProMIScarriedoutanassessmentfocusingonthe methodologyforthedevelopmentofthelocalnetworkforthe implementationofregionalpoliciesinAHA(51).Inthisstudy, forexample,thestrategyofFriuliVeneziaGiuliaRSisbased ontheimplementationofaregionalprogramforthepromotion ofhealthyaging,withmanyareasofinterventions,suchas civilcommitment,culture,andsocialtourism,theaccessto newtechnologies,information,andservices.Aspecificpanel hasbeencreatedtoimplementandmanageallthoseareasof intervention.LiguriaRScreatedapublic–privatepartnership foractiveagingthatcollectssomeoftheexcellencesactivein theregionintermsofresearchandinnovation(University), socialsector,ITcompanies,traininginstitutions,regionalhealth agencies,andlocalinstitutions.LombardyRSisbasedonthe connectionbetweentheregionalDirectorateforWelfareand theLombardyClusterforTechnologiesinlifeenvironments thatisamultidisciplinarytechnologicalcluster,fundedby theDirectorateforProductiveActivitiesandResearch.Inthe frameworkof“SilverConstellationforHealth,”PiedmontRS developedanoperationalsettingofinterlacedgoodpracticeson AHA,importantexperiencescontributingtothehealthpolicy, addingnewprofessionalandcommunityskills.TheEmilia–RomagnaRSiscomposedofawiderregionalcoordinationteam involvingtheDepartmentofHealthandSocialPolicies,the

DepartmentofProductionTradeandTourismandASTER,the technologicalclusteroftheEmilia–RomagnaRegion.

CampaniaisfollowingKotter’seight-stepchange managementmodeltorealizethevisionofthe“OneHealth” approach(52, 53).Theinnovationecosystem,throughCampania EIPonAHARSandProMIS@Campanianetwork,engageda groupofstakeholdersintheidentificationanduptakeofgood practicesintheregionandbeyond(Step1–2).Sharingknowledge andopportunitiesofcollaborationamongstakeholdersallowed thedevelopmentofasharedvisionandstrategythatwere appropriatelycommunicatedthroughnewsletters,conference presentations,andscientificpublications.Thisapproach empoweredotherstoactonthevision(Step3–4).The involvementofstakeholdersintheregional,national,and Europeanlevelactivitiesempoweredandstimulatedother stakeholders(Step5).Thegeneratedgoodpracticesrepresent short-termwins(Step6),forwhichitisnecessarytoconsolidate theresultsandproducemorechanges(Step7).Thewider implementationandthecontinuousmonitoringoftheresults willconnectthesolutionstogetherinasingleprocessofchange andanchorinnovativeapproachestothelocalcultureand context(Step8).

BOTTLENECKS

Innovationofhealthandcareposesmanychallengesthatcannot beaddressedtimelybyanisolatedapproach,i.e.,financeand insurance,technologicalstandards,degreeofinteroperabilityof solutions,issuesarounddatasecurity,andsolutionsfordata analytics/datamining,lackofICTliteracy,lackofcontinuity betweendifferentresearchmaturitylevel(e.g.,TLR1to9).

LimitedInternationalCollaborations

Thequadruplehelixofinnovationforthedigitaltransformation ofhealthandcareincludesalsoresearch,andindeed, inCampania,aneffortwascarriedouttostrengthen interdisciplinaryapproachesinexpertgroups,inallprojectsand twinnings,butfurtherdevelopmentsarenecessarytoensurethat horizontalactivitiessucceedinfacilitatingthemainstreaming alonginternationalopportunities,forexample,connecting withinternationalnetworks.Thiselementispivotaltoreduce fragmentationintheprocurementofinnovativesolutionsfor healthservices.Strengtheningcollaborationsatinternational levelsisakeyenablertofosternationalalliances,facilitate peer-to-peerlearningandtransferofinnovative,validatedgood practices.Withinthisapproach,networksplayacatalyticroleto facilitatecapacitybuilding.

AbsenceofDigitalServicesinStandard CarePathways

Ensuringappropriatenessispivotaltousedigitalsolutionsin healthcareservicesnotatadiscretion,astheyareincludedin thestandardcarepathways(PercorsiDiagnostico-Terapeutico eAssistenziali–PDTA),adaptedtothespecificneedsofthe person(PianoAssistenzialeIndividuale–PAI),hence,theefforts ofthenationalhealthsystemtoestablishanomenclatureof digitalservicesanddefinenewPDTA(healthandsocial)forthe integratedmanagementofdiseasesintheterritory,whenthey

areavailableasIT-supportedservices,hence,theintroductionof essentiallevelsofdigitalhealthcareinthenewMinimumService Level(LivelliEssenzialidiAssistenza–LEA),withreimbursement arrangementsspecificfordigitalservices,ispivotal(54).

LowDigitalLiteracy

Large-scaleadoptionofadigitalsolutionforhealthandcare needstoreachhighlevelsofdigitalliteracyforendusers (professionals,patients,andcitizens)andtoconsiderhowdigital toolsandsolutionscanbemadecompletelyaccessibletothese groups(47).Onlybystartingfromtheanalysisoftheneeds expressed bycitizensandinstitutionswillwebeabletoenhance themarketofinnovativesolutions,respondingtoconcrete unmetneedsofolderadultsandremovingtheorganizational, technological,andbehavioralobstaclesthatinfluencelarge-scale adoptioninthelocoregionalcontext.

FragmentedApproachtoStructural Reform

Healthinnovationneedsstronginstitutionscapableof implementinghealthreform,withaccompanyingclear programmingobjectivesandsuccessfulprojects.Manyof thegapsidentifiedarelinkedtostructuralreformissuesthat aredifficulttoaddressthroughproject-basedfunding.Stronger capacityandtechnicalexpertisetoimplementanddesign reformscancomplementthecapacitytodevelophigh-quality policiesandprojects(55).

CONCLUSIONS

Thegovernance approachofCampaniaRStoaddressthe needsofanagingpopulationtranslatesinstrengtheningdisease preventionandhealthpromotionintheentirelife-course throughempowermentanddigitalsolutions,andinsupporting independentlivingathomeandincommunity,strengthening self-managementofage-relatedconditionsandreducing isolation.Suchproactive,user-centeredsystemempowers citizensandinformalcaregiverstotakegreaterresponsibilityfor healthandwell-being,byprovidinginformationandadvisingon healthylifestyles,tostayactiveandhealthyaslongaspossible (56 58).Similarly,age-friendlyenvironmentsarebeneficialto individualsandsociety throughouttheentirelife-course(59)and areenabled bydigitalsolutions.A“SilverEconomy,”deployed intheframeworkofalife-courseapproach,couldstimulate sustainablegrowthinCampania,creatingopportunitiesand jobs,throughdigitalinnovationandacrosssectorssuchas

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transportation,constructions,andbuiltenvironment,aswell assupportingpatientsandolderadultstoremainindependent, active,andlivelongerintheirhomesandcommunities,while increasingtheefficiencyandeffectivenessofhealthandsocial caresystems(47).Endusersareatthecenterofsuchapproach, toacceleratethedesignofuser-friendlyproductsandservices, sharingexperienceswithnewgenerations,andbeinginvolvedin test-bedactivities(60).

AUTHORCONTRIBUTIONS

MIconceived thepresentedideaanddraftedthetableof contents.MI,VDL,andGTwrotetheentiremanuscript.LR, UT,andPBcontributedtotheAbstractandthesectionStrategic Objective.ML,MLC,GB,DT,andACcontributedtotheAbstract andthesectionHealth,Accessible,andSustainableTourism. GA,UMB,RZ,FC,andMTacontributedtothesectionsThe GoodPracticesforHealthInnovationinCampania,Emerging PriorityLinesofInnovationNeeds,andInnovativeSolutions AvailableinCampania.GI,AL,andAMcontributedtothe sectionsInnovativeProcurementsandTheopportunityofAging inCampania:newskills,newjobs.GVandMMcontributed tosectionOpportunitiesFromtheInternationalizationofthe RHS.CPandMTrcontributedtothesectionLong-Term SustainabilityofInvestmentsinDigitalTransformation.CV andGCcontributedtothesectionInnovationtoMarketin Campania.RR-WandJBcontributedtosectionsIntroduction andConclusionsandcriticalreading.Allauthorscontributedto thearticleandapprovedthesubmittedversion.

ACKNOWLEDGMENTS

TheauthorswouldliketothanktheUNESCOChairfor HealthEducationandSustainableDevelopmentofFederico IIUniversity,theProgrammaMattoneInternazionaleSalute, theProMIS@CampaniaNetwork,MaurizioCaiazzo,Annamaria Colao,KeomaColapietro,AlessandraComo,SaraDiamare, RosannaEgidio,MariaGaldi,RosaAnnaGiordano,Carmine Lauriello,LisaLeonardini,AntonioMaritati,LuigiNicolais,and MariaRosariaRomano.

SUPPLEMENTARYMATERIAL

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ConflictofInterest: Theauthorsdeclarethattheresearchwasconductedinthe absenceofanycommercialorfinancialrelationshipsthatcouldbeconstruedasa potentialconflictofinterest.

Copyright©2021DeLuca,Tramontano,Riccio,Trama,Buono,Losasso,Bracale, Annuzzi,Zampetti,Cacciatore,Vallefuoco,Lombardi,Marro,Melone,Ponsiglione, Chiusano,Bracale,Cafiero,Crudeli,Vecchione,Taglialatela,Tramontano, Iaccarino,Triassi,Roller-Wirnsberger,BousquetandIllario.Thisisanopen-access articledistributedunderthetermsoftheCreativeCommonsAttributionLicense(CC BY).Theuse,distributionorreproductioninotherforumsispermitted,provided theoriginalauthor(s)andthecopyrightowner(s)arecreditedandthattheoriginal publicationinthisjournaliscited,inaccordancewithacceptedacademicpractice. Nouse,distributionorreproductionispermittedwhichdoesnotcomplywiththese terms.

published:18February 2021 doi:10.3389/fpubh.2021.640598

Editedby: MagdalenaKlimczuk-Kochanska, UniversityofWarsaw,Poland

Reviewedby: AdetayoEmmanuelObasa, StellenboschUniversity,SouthAfrica GilbertoPerez, MackenziePresbyterian University,Brazil

*Correspondence: AhmadOzair ahmadozair@kgmcindia.edu

† ORCID: AhmadOzair orcid.org/0000-0001-6570-4541 KaushalKishorSingh orcid.org/0000-0002-6457-0606

Specialtysection: Thisarticlewassubmittedto PublicHealthPolicy, asectionofthejournal FrontiersinPublicHealth

Received: 11December2020

Accepted: 19January2021 Published: 18February2021

Citation: OzairAandSinghKK(2021) DeliveringHigh-Quality,EquitableCare inIndia:AnEthically-Resilient FrameworkforHealthcareInnovation AfterCOVID-19. Front.PublicHealth9:640598. doi:10.3389/fpubh.2021.640598

DeliveringHigh-Quality,Equitable CareinIndia:AnEthically-Resilient FrameworkforHealthcareInnovation AfterCOVID-19

AhmadOzair*† andKaushalKishorSingh †

FacultyofMedicine,KingGeorge’sMedicalUniversity,Lucknow,India

Developingcountriesstruggletoprovidehigh-quality,equitablecaretoall.Challenges ofresourceallocationfrequentlyleadtoethicalconcernsofhealthcareinequity.To tacklethis,suchdevelopingnationscontinuallyneedtoimplementhealthcareinnovation, coupledwithcapacitybuildingtoensurenewstrategiescontinuetobedeveloped andexecuted.TheCOVID-19pandemichasmadesignificantdemandsofhealthcare systemsacrosstheworld—toprovideequitablehealthcaretoall,toensurepublichealth principlesarefollowed,tofindnovelsolutionsforpreviouslyunencounteredhealthcare challenges,andtorapidlydevelopnewtherapeuticsandvaccinesforCOVID-19. Countriesworldwidehavestruggledtoaccomplishthesedemands,especiallythe lattertwo,consideringthatfewnationshadlong-standingsystemsinplacetoensure processesforinnovationwereon-goingbeforethepandemicstruck.Thecrisis representsacriticaljuncturetoplanforafuture.Thisfutureneedstoincorporatea visionfortheimplementationofhealthcareinnovation,coupledwithcapacitybuilding toensurenewstrategiescontinuetobedevelopedandexecuted.Inthispaper,thecase ofthemassiveIndianhealthcaresystemisutilizedtodescribehowitcouldimplementthis vision.Aninclusive,ethically-resilientframeworkhasbeenbroadlylaidoutforhealthcare innovationinthefuture,therebyensuringsuccessinboththeshort-andthelong-term.

Keywords:globalhealth(MeSH[H02.403.371]),healthpolicy,healthplanning[MeSH],publichealth,community medicine,digitalhealth(eHealth),digitalhealth

INTRODUCTION

“Thereseemstobenolimittothepossibilitiesofscientificmedicine,andwhilephilanthropistsare turningtoitastothehopeofhumanity,philosopherssee...asciencefromwhichmaycome...peace overalltheearth(1).”Verily,whatfaithinmodernmedicinehadbeenexpressedbySirWilliam Osler in1902,isbutreflectedintheheroicdemandsmadeofittoday—totouchmorelivesthan everbefore.Suchdemandswarrantinnovationatscaleandinallaspectsofhealthcare.Nowhere aretheymorevisibletoday,thanintheworldwidecall-to-armstoprovidebreakthroughtreatments andvaccinationforCOVID-19(2).

Medicinehashadalonghistoryofbothscientificandsocialinnovation.Thelatter,forinstance, isevidentintheachievementsofpublichealth,includinginthecurrentpandemic.Therefore, whilerankinginnovationswiththegreatestimpactonhealthcare,theDeloitteCenterforHealth Solutionsusedthefollowing,wide-rangingdefinition:

“Anycombinationofactivitiesortechnologies,thatbreaks existingperformance trade-offsintheattainmentofanoutcome, inamannerthatexpandstherealmofthepossible;defined inhealthcareasproviding‘moreforless’—morevalue,better outcomes,greaterconvenience,access,andsimplicity;allfor lesscost,complexity,andtimerequiredbythepatientandthe provider,inawaythatexpandswhatiscurrentlypossible(3).”

Attainmentof thesepresumedendpointsiswhatisexpected ofhealthcaresystemsacrosstheworld,bothindevelopingand developednations,andbothinthecurrentcrisisandbeyond. Thisattainmentmaybeeitherevolutionary,broughtonby gradualadvances,orrevolutionary,whichiscreative,disruptive, anddiscontinuous.Suchendpointsrequireonetohave,firstly, ashort-termstrategyfortranslatinginnovativestrategiesinto practice;andsecondly,along-termvisionandphilosophyfor futureinnovation.

Analysisofasinglehealthcaresystem,inthecontextof itsuniquechallenges,providesafoundationtodrawlessons from.Inthiscommentary,abroadframeworkofinnovation forthehealthcaresysteminIndiahasbeendescribed,which isinclusive,ethically-resilient,andincorporateslearningpoints frompatientcareexperiencesatthelargestresidentialhospitalin SouthAsia,bothbeforeandduringtheCOVID-19pandemic(4) (Table1).Asdiscussedbelow,rectifyinghealthdisparities,which havebeenexposedbythepandemic,andensuringuniversal healthcareaccessmustbecomeIndia’sguidinglightsforhealth policymovingforwards.

Before theCOVID-19pandemic,thebiggestkillersinIndia, aspertheWorldHealthOrganization,indecreasingorderof frequency,hadbeenischemicheartdisease,chronicobstructive pulmonarydisease,stroke,diarrhealdisease,lowerrespiratory infection,pretermbirthcomplications,andtuberculosis(12). What bindstogetherthetopthreeinthislist,togethercausinga thirdofalldeaths,arethechronicnatureoftheirriskfactors,i.e., diabetes,hypertension,dyslipidemia,smoking,visceralobesity, etc.Allofthesearemodifiableorpreventable,andthuswellpositionedtobethearenaofhealthcareinnovators.

SHORT-TERMSTRATEGIESFOR INNOVATION:THECURRENTBIGIDEAS

THECHALLENGEININDIA

EvenbeforeCOVID-19struck,themajorityoftheIndian populationwasyettohaveaccesstohealthcareinitsentirety,let aloneanexcellentone.Thepublicsectorwasalreadycontributing merely30%tothecosthere,incontrastto84%in,forinstance, theUnitedKingdom(5).Out-of-pocketexpendituremadeup over60%of totalhealthcareexpenses,inanationhaving273 millionlivingbelowtheinternationalpovertylineofUS$1.90per personperday(6).Coupledwiththeaveragepublicspending onhealthcarepercapita,ameagerINR3/-perday,thescale oftheeconomicchallengebecomesclear(5).Unfortunately,the abovechallengehasonlybeenaccentuatedbythepandemic, withestimatesallowingforapossibilityofdoublingofpoverty (7, 8).Issuesofunavailabilityofcriticalmedicalequipmentand unaffordabilityoftheprivatesectorhavealsobeenbroughttothe fore—issuesthatcanbetackledbyinnovationandreformaswell (9, 10).

Anationthatranksamongstthelowestworldwidefor thepercentageofitsgrossdomesticproduct(GDP)spenton healthcare,therefore,requires“frugalinnovation,”drivenby prioritizedanalysisofpopulation-levelhealthcareneeds.The intenttoimplementinnovationmustbewitharazor-sharpfocus onensuringthatbenefitsflowtothebottomofthepyramid.In planningforIndia’sfuture,itmustberememberedthateven emergencycareremainsanelusiveentityformost,letalone annualhealthcheck-ups(11).

Short-termstrategiesforinnovationinIndiamustemploy bothtop-downandbottom-upapproachestosucceed,merely onedoesnotsucceedalone.Thetop-downstrategyneeds alargernumberofmoreenhancedstreamlinedpublicprivatepartnerships,alongwithagreaterpublicinvestment inbiomedicalresearch.Whilethelatterhasbeenseenin therecentfundingprovidedfordevelopingtherapeuticsand vaccinesagainstCOVID-19,thissupportneedstobesustained, directed,andunconditional,similartohowtheIndianspace andaeronauticsagencieswereprovidedintheirearlydays. Thusforhealthcare,thisfundingmustnotmerelybecontingent onproducingaregularstreamofpublications.Thebottomsupstrategy,forinstance,needsourfinestmedicalgraduates steppingforwardforbiomedicalinnovation—thevastmajority ofthemcurrentlypursueclinicalpracticealoneormigrateto greenerpastures,wheresignificantincentivesforbiomedical researchexist.

Notably,thetwenty-firstcenturyisblessedwithvaststores ofimmense,deep,accessible,andever-growingknowledge, i.e.,bigdata,whichcanbeutilizedwithgreatimpactin medicine(13).Withtheexplosionofmonitoringdevicesand electronichealthrecordsglobally,asresearchersgetaccess toconsiderablymorepatientdatathaneverbefore,many conclusionsareyettobedrawnbypredictiveanalytics.If crunchedwithpatternrecognition,bigdatacanprovidespecific, especiallyregional,epidemiologicalinformation,anddifferential therapeuticresponses(14).

Tectonicplatesunderneathclassicalhealthcarehave longbeenshifting;COVID-19hasgreatlyaccentuatedtheir movement.Particularly,thetechnologiesoftelehealth,remote patientmonitoring,andconsultingbymobiletechnology (mConsulting),hadbeenleisurelychuggingonprior—theyhave nowbeenthrustintofullviewbecauseofnecessity(15, 16).In ourinstitution,an ElectronicCOVIDCareSupport(ECCS) system,whereamultidisciplinaryteamofpulmonologists, intensivists,andinternistswereavailableroundtheclockto adviseandguideintensivecareunitsacrosstheprovincein managingcomplexCOVID-19patients,especiallythosewith multi-organdysfunction.Thiswasofcrucialvalueinour province,wherefellowship-trainedintensivecarephysiciansare butahandfulandthattoonearlyallintheprovincialcapital. Similarly,thecityadministrationconstructedacallcenterfor

TABLE1| Broadaction itemsandstrategiesforhealthcareinnovationinIndiaafterCOVID-19.

Short-termstrategies

Greaterpublic investment Bigdata andartificial intelligence

Public-private partnership

Deeplearningand Machinelearning

Telehealthandremote patientmonitoring

Targetedtherapyor Precisionmedicine

“Local”medicaldevice manufacturing

Utilizingavailable devices(smartphones) forhealthcaredelivery

Pillar1:creationof ecosystemsandincentives

Simplifyingregulationsand easingcreativecollaborations

Developinginnovationcenters, bio-incubators,andmed-tech park

Ensuringadequate compensationforbiomedical researchers

Creatingculturesof innovation—lesshierarchy, morecommunication

medicalqueriesfromthegeneralpublicwhichjuniordoctors fromourinstitution staffed,resultinginsignificantbenefittothe generalpublicwithregardstomanagingmildCOVID-19cases athome.Consideringhowusefulsuchtechnologieshaveproved, eveninIndiawherethesmartphonepenetrationratehasbeen rapidlygrowing,usageofthesetechnologieswilllikelycontinue afterthepandemicaswell(16).

Usingmachinelearning(ML),advancedimage-processing capabilitiesenhancedbyartificialintelligence(AI),convolutional neuralnetworks(CNN),deeplearning(DL),naturallanguage processing(NLP),manyclinically-proventechnologieshavebeen described,someapprovedbyregulatorybodies,andanumber arerapidlyforthcoming(17).Couplingimageprocessingwith ML/DLhasbeenespeciallyusefulinvisual-heavyfieldslike dermatology,pathology,ophthalmology,andradiology(18).For instance, ArterysCardioDL,thecloudanalyticssoftwarerecently approvedbytheU.S.FoodandDrugAdministration(FDA), helpsinterpretcardiacMRI,reducestheworkloadofradiologists, andthussignificantlydecreasestheneedforspecialists(19).

HowwillthesetechnologiesbeimplementedinIndia? Considerause-casescenarioofthe“CheXNeXt”algorithm (20).ThisCNN-basedtechnologyutilizeschestx-rays,themost commonimaging toolacrosstheworld.Builtbyresearchersat StanfordUniversity,ithasbeenproventodiagnosepneumonia insuspectedcasesbetterthanradiologistsofthesameinstitution, historicallylong-consideredoneofthetop-tenbestradiology trainingcentersintheUS(21).India,ontheotherhand,withits immenseburdenof infectiousdiseases,sorelylacksradiologists, especiallyatprimaryandsecondaryhealthcarecenters.However, x-raydiagnosticfacilitiesareoftenavailableatcommunityhealth centers.Therefore,imagestakenheremaybeuploadedonline foranalysisbythealgorithmresultinginguidancefortherural physician.Thiswillallowrapidconfirmationofthediagnosis innon-complexcases,themajority,byabasicmedicaldoctor leadingtoanearlystartofempirictreatmentandbetterpatient outcomes.Suchinnovations,byradicallyreducingthenumberof specialistsrequired,holdimmensehopeforhealthcaredeliveryin

Long-termstrategies

Pillar2:manageable risk-taking

Pillar3:capacitybuilding andbiomedicaleducation

Runningofmultiplepilot projects Enhancementsinstandard pedagogy

Decentralizationofresearch funding Engagingprofessionalmedical societies

Allowingpersonaland organizationalfailureswithout immediateshutdown

Promotingsocialinnovation andentrepreneurship

PhysicianScientist (MBBS-PhD)andmastersin biomedicalinnovation programs

Creatingmedicalschools havingpurposefulaimof biomedicalinnovation

themostremotevillages.Technologyherecomplementsclinical competency,withthealgorithmdiagnosingthemajorityofcases andflaggingthechallengingonesforreviewandresolution bytheexpert.Thus,implementingCheXNeXtinanation whereovertwo-thirdsliveinvillagescanhaveasignificant impact(22).Unfortunately,supportforthistechnologywasnot available inthecurrentpandemicinthemajorityofIndia,where doctorsinruralareascouldhavebenefittedbygettingX-raysof suspectedCOVID-19pneumoniacasesevaluatedbyaradiologist oracounterpart.

Furthermore,aspartofhealthcareinnovation,AIcannot onlydiagnosediseaseundersupervisionasabove;ithasbeen proventoworkwithouttheneedforasupervisingdoctor, inselectedcases.Thisgainsspecialrelevanceinanation havingoneofthepoorestphysician(allopathic)topatient ratiosworldwide.ConsiderIBM’sWatsonforOncology,whose independenttherapeuticdecision-makingforbreastcancercases hada93%concordancewithamulti-disciplinarytumor-board (23).Similarly,“IDxDr,”thefirstFDA-approvedAI-based diagnosticsystem forscreeningofdiabeticretinopathy,alsodoes notrequireanophthalmologistforitsoperation(24).Thus,it isofvaluetosecondaryhealthcarecentersininaccessibleareas, inIndia,permittingthemtoscreenalargenumberofdiabetics (25).Thisiscrucialforacountryhavingover70milliondiabetics (26),andacurrentepidemicofretinopathy(27).Anotherwork, publishedin 2020,promisessimilarsignificancebydetecting fundalpapilledemawithover96%sensitivity(28).

Anadditionalbulwark ofanapproachwouldbetheleveraging commonlyavailabledevicesforhealthcaredelivery,whose built-intechnologieswouldalsobeutilizedforpoint-of-care (POC)diagnostics.Forinstance,verifiedsmartphoneapps,using AI,canactaspersonalized,patientadvisors:answeringtheir unmetneeds,helpingadheretoprescribedmedications,and encouragingthemtoimplementlifestylechanges(29).This technology hasalreadybeenutilizedbyretailindustries.Here, thisfreesupthespecialist,especiallyinoverloadedpublic hospitals,tomanagecasesofhighestacuity.Inthecurrent

pandemic,whileanappwaslaunchedbythefederalgovernment forresponding toqueriesoftheusers,atthebackenditrequired significantmanpowertorespondtothequeries.Innovations usingcurrentlyavailabletools,asusedsuccessfullypriorby suicidepreventionhotlinesusingtheubiquityoflandlines,will provecriticalinIndia,havingover300millionsmartphone users(30).

Similarly,“AliveCorKardiaband,”therecentlyFDAapprovedsensor(31),deliversamedical-gradesix-leadECG, inconjunctionwithasmartwatch.TheREHEARSE-AFRCT proveditsclinicalutilitybyshowingthatitwasbetterable todetectincidentatrialfibrillation,comparedtoroutine care(32).Astheelectronicsindustryevolves,appliancecosts fall.Webelievethataspricesofsmartwatchescompatible withthistechnologywilllikelycomedown,itwillleadtoits greateradoptionbylargepartsofurbanIndia,withface-to-face consultationexpendituressavedandpatientoutcomesimproved.

THECASEFORMOREFORLESS

Thereadermayreturnnowtooneofthesectionsinthe definitionofhealthcareinnovation,usedpreviously,of“morefor less.”InnovationinIndia,therefore,mustalsoincludeeffortsto reducethecostsofexistingtechnologiesthatarecurrentlyeither inaccessibleorposeaconsiderablechallengetothefundingof publichospitals,suchasroboticsurgery,biosensors,3D-printed prosthetics,etc.Hospitalsherelackreliablealternativesfrom localmanufacturersforequipmentsuchasevenendoscopes,let alonesurgicalrobots,andhavetopurchasetheseatapremium fromforeignmanufacturers.Thisdearthofhigh-quality, medical-grademanufacturingcapacityhasbeenfeltacutelyin theventilatorshortageduringtheCOVID-19pandemicaswell, withlocalmanufacturersscramblingtodevelopcapacity(33). HadIndianmedicalcorporationsbeenmanufacturingventilators withsignificantlyhighenoughoutputanduptakeinmajor hospitals,aperiodofdifficultymayhavebeenaverted,wherea shortageofventilatorswasfelt.

WhatisrequiredisanIndianmedicalequipmentindustry, functioningatthelevelofglobalstandards,suchasthe economicalJaipurfootthatcangivetheoriginal“SACHfoot” arunforthemoney(34, 35).Suchanindustrywillalso helpmakeaccessiblenewPOCtestingforcancer,stroke,etc., thusgreatlyassistingintheirtestinginrural,remote,and disprivilegedpopulationsinIndia,leadingtotheirdetection and/orearlymanagement.Onecanenvisionthissimilartothe worldwiderevolutionbroughtaboutbythewidespreadaccess toPOCpregnancytests(36).Lessonsmustbelearntfrom howempoweringis theavailabilityofmedicalequipmentin ruralareas,evidentinthesuccessof“foldscope”indiagnosing parasiticdiseasesinresource-limitedsettings(37).Verily,this wasa challengeinthecurrentpandemicconsideringthatthe reversetranscriptase-polymerasechainreaction(RT-PCR)based testingforCOVID-19couldonlybecarriedoutincertain laboratories,whichweregeographicallylimitedintheinitialparts ofthepandemic.Ourowninstitutionperformedthemaximum numberoftestscarriedoutatanysinglecenterinIndia.

Movingawayfromaone-size-fits-allapproachwillbeanother innovationstrategy.AnNHSreportsuggeststhatupto70% ofpatientsdonotbenefitfromtheconventionaltreatment pathwayusingmass-manufacturedmedications(38).Notably, thecostof gene-basedstudieshasbeenrapidlyfalling.Low cost,widely-availablenext-generationsequencing(NGS)and genotypingwillenabletheprescriptionofpersonalizeddrugs leadingtolesstherapeuticfailuresandmoreconsistentresponses (14, 39).Earlyrecognitionofandinterventioninhigh-risk groupsalsopreventssignificantcostslaterinlife.Thiscosteffectivenesshasbeen,forinstance,well-demonstratedinfamilial hypercholesterolemiacasestreatedwithevolocumab(40).As notedina cost-effectivenessworkthatlookedatuniversalgenetic screeningforBRCA1/2mutations,bringingdownthetestcostto below250$resultedintheratioofcostperquality-adjustedlifeyear(QALY)reaching53,000$/QALY,well-underthecommonly citedUS-basedthresholdof100,000$/QALY(41).Asimilar hopeisenshrinedinthe3D-printingofprostheticstailoredto thepatient(42).Inthecurrentpandemic,severalpromising drugcandidateswerelookedat,suchashydroxychloroquine, remdesivir,etc.butthenlargelyabandonedduetothemajority ofstudiesdemonstratingalackofefficacy.Itisusefultoconsider theideaofwhethergenotype-basedanalysescouldhavehelped selectpatientswhofoundhavebenefittedfromspecificagents.

Optimismisalsowell-placedineconomicalbiosensors.These wouldideallyallowforcontinuous,painless,andnon-invasive monitoringofvitalparameters,andhelpguidebothprevention andtreatment.Unfortunately,veryfewdeviceslikethefingertip pulseoximeterexist,whichdidhavetheaboveattributesand wasavaluabletoolinthecurrentpandemicbothinthehomebasedandthein-hospitalmanagementofCOVID-19cases. Thesedevicesareespeciallyusefulinpatientswherelong-term monitoringisrequired.Unfortunately,inIndia,alargenumber ofsuchpatientsareunabletoremaininregularfollow-upatthe oftendistanttertiarycarecenterduetotheissuesofcost,time, andlostincometherein.Here,suchsensorscanprovidedatafor remotefollow-upandallowforgreatertimebetweenphysical visits.Forinstance,the“Lumee”biosensorallowsforlong-term monitoringoftissueoxygenlevels,helpinginthefollow-upof peripheralvasculardisease,whichtendstoalsobeneglectedin ruralareas(43).

ISINDIAEQUIPPED TOIMPLEMENT THESESTRATEGIES?

Itisimportanttonotethetwomajorbottlenecksfortheseshortterminnovationstrategies.Theseare,first,possessionofstrong computerscienceandmedicaltechnologyindustries,andsecond, deepabilitytocarryoutlargeclinicaltrialstoproveefficacy. WhileIndia’shistoricalcompetencyinthetechnologyarena createsabedrockofmedicalinnovationtobedonein-house, itsmassivepopulationallowsforlarge-scalecarefulstudiestobe conductedatamuchlowercostforthelatter,withoutsacrificing anyqualityparadigms.Thisisexemplifiedbythelargestclinical trialeverintheworld,conductedinIndiainovertwomillion children(44, 45).

Otherlimitationstoimplementingthesestrategiesinclude thepolitical willtodevotesupportandmanpowertoenhancing healthcareandincreasingthepercentageofGDPspentonthis sector.Discussionofhowtotacklethisandhowtoimprove financingintointerventionstoimprovesocialdeterminantsof healtharebeyondthescopeofthisarticle.

Thus,Indiaisuniquelypoisedtodeliverrapidbreakthroughs initshealthcaredelivery,provideditsresearchinstitutionsand innovatorsarespecificallytaskedwithandincentivizedtosolve thisproblem.Developingsuch“disruptiveinnovation”isvital,as originallydescribedbyBowerandChristensen,sinceitrepresents astratagemdifferentfromincrementalenhancementsingood healthcareforthosewhoalreadyhaveit(46).Asapartofamultifacetedapproachtoinnovation,itgivesaccessiblehealthcareto thosewhoentirelylackit.

THELONG-TERMGAME-PLAN

Ingrapplingwithstrategiestotranslatestrategiesforinnovation intopractice,itisimperativetohaveaparallelapproachto developingasystemthatfosterstheirriseandprovidesthem withastructuretoleanonto. Three pillarswillneedtobe erected,uponwhichhopefullytheedificeofinnovationwill transpire(Table1).

Thefirstpillarmustbethecreationofecosystemsand incentivesthatpromotecreativecollaboration.Disruptiveideas ofthefuturewillemergeattheinterfaceofdifferentfields, ashasoccurredbefore,forinstance,inthedevelopment oftheCTscanner(47).Thiswillrequirecross-pollination ofvaried conceptsandprocessesofthought,possibleonly whencollaborationbetweeninstitutions,hospitalsandindustry happensininterdisciplinaryareassuchasdatacaptureand analytics,patientengagement,andnaturalsciences,exemplified bythedevelopmentofCRISPRforgeneediting(48).During thepandemicin India,anexampleofthiswasshowninthe developmentandusageofthepaper-basedrapiddiagnostic testingforCOVID-19utilizingCRISPR,namedFELUDA(49). Tonote, suchcross-pollinationcanbefacilitatedbythecreation ofinnovationcenters,bio-incubators,andmed-techparks,some ofwhichhaverecentlybeenset-up(50).

Whatelse canbedonetoensurethesecreativecollaborations?

Simplifyingandstreamliningslow,bureaucratic,regulatory,and administrativeprocesses,allofwhichhindercollaborativework iscritical.Toillustrate,considerthechallengesencountered indoingmulticentricstudiesinIndia—forinstance,each participatingcentermustseparatelyapplyforandcompletethe entireinstitutionalreviewboard(IRB/IEC)approvalprocess, aspercurrentregulations.Thus,nocentercanutilizethefact thatastudyhasbeenalreadyapprovedbyanothergovernmentaccreditedIRB/IEC,soastohaveafasterreviewattheirown IRB/IEC.Thiswasamajordifficultyfacedbyourinstitutionand otherswhenconductingmulticentricclinicaltrialsinatimesensitivemannerforevaluatinginterventionsforCOVID-10. Hindrancessuchasthesesloweddownthepaceofbiomedical researchinaperiodofurgencyandcontributedtothedelayin gettingmedicationsapprovedandtothebedside.Besidesthis,a

rectificationofthestrict,pervasive,andall-sustainingcultureof hierarchyinmedicineinIndiawouldalsohelp.Ithashistorically stifledcollaboration,preventedvoicesfromspeakingup,and overemphasizedtheroleofchairpersonsanddirectorsatthe costoftheteammembers.Furthermore,cognizancemustbe takenofthefactthatthefinestachievementsofmedicinein thecurrentcenturyhavebeenduetobreakthroughsinbiology andbiotechnology.Scientistsofthesefieldsmustbebetter incentivizedandrecognizedfordoingbiomedicalresearchin India.Institutionsheremustalsofurthersubjectthewisdomof theirtraditionaltextstorigorousresearch,asexemplifiedbythe Nobel-prize-winningdiscoveryofArtemisinininChina(51).

Thesecond pillarmustbetheespousalofaphilosophy thatallowsforahostofpilotprojectstorun.Ouranecdotal experiencesuggeststhatsenior,establishedinvestigatorsare heavilyrewardedwithgrantsinIndia,whileearlycareer researchersfailtogetanythingsignificant.Arisk-aversebehavior, ashasbeenhistoricallytheIndianperspective,mustbereplaced withconductionofsmall-scalepilotprojectswith“manageable risks,”allowingalargenumberofinstitutionstohavefunds toexperimentandtodemonstrate“proof-of-concept.”Greater decentralizationofresearchfundingwouldhelpthisaswell. Herein,thoughtmustalsobegiventosocialinnovationand entrepreneurshipinmedicine,asdemonstratedbythesuccess of“SwachhBharat”withregardstosanitationandhygiene (52).Similarly,consideringtheprevalenceofdomesticabuse, malnutrition,andnutritional anemiainIndianwomen,strategies thatempowerfinanciallywomenalsoindirectlycontributeto theirhealthcare,liketheworkdonebySakhaConsultingWings (53).Theseareoftenhardertoimplementbutproducefarmore long-lastingimpact.

Thethirdpillarmustbecapacitybuildingandreformin medicaleducation.Firstly,pedagogicteachingofsubjectsin Indianmedicalschoolstodaylacksbothfocusandrelevance, sincemuchofitis“teachingtothetest.”Thistestis typicallyeitherthemedicalschoolexaminationorpost-graduate medicalentranceexamination,bothofwhichstronglyfocuson rotememorization.Thisadverselycontributedtothecurrent pandemicsincefinalyearmedicalstudentsherecouldnot bewell-utilizedtocareforCOVID-19patientssincestudents inIndiadonotmanagepatientsundersupervisiontilltheir internshipyear.Itisalsowell-documentedthatthecontent ofeducationimpartedmoldsitselftothetestingthereafter, aphenomenonreferredtoasthe“washback”or“backwash” effect(54, 55).Improvementsintestingmethodologywill, therefore, likelyresultintheenhancementofmedicaleducation asabackwasheffect.Thus,torealizetheintentofimparting scientificcuriosityandaspiritofinnovation,examinationsmust becometailoredtotestrelevantissues,coupledwithadeliberate attemptatgradualmodernizationoftheentirecurriculum(55). Professional medicalsocietiesinIndiamustbecomeengagedin thismodernization,inadditiontohavingthemconnectingwith andacademicallymentoringtheirfuturetrainees,similartotheir counterpartsintheUSandUK.

Furthermore,itwouldbehelpfultostartjointphysicianscientist(MBBS-PhD)programs,similartothemedicalscientist trainingprograms(MSTP),alsoknownasMD/PhDprograms,

intheUS.Otherwise,anMBBS(Honors)oranMBBSwith anintercalatedresearch-basedBSc(asiscommonintheUK) programmaybecreatedatapexmedicalschools.Certainpremier medicalschoolsofIndiamayalsobedesignatedasthosehaving anovelcurriculummergingclassicalmedicaltrainingwith biomedicalinnovation.Noneofthesefouroptionscurrently existsinIndia.Similarly,anincreaseisalsowarrantedinthe numberofinstitutionsofferingmastersprogramsinmedical innovation,currently,therebeingfewsuchinthecountry,for instance,thequitesuccessfulMastersinMedicalScienceand Technology(MMST)programatIndianInstituteofTechnology Kharagpur,whichsolelytakesinmedicalschoolgraduates(56).

Alloftheseprogramsmustpurposefullyaimtocreatefuturereadygraduatesinfieldsofinnovation,interdisciplinaryresearch, technologyadvancements,dataanalytics,statisticalcapabilities, etc.Theseprogramswouldmandateadditionalcourseson computerscience,molecularbiology,rapidprototyping,and/or medicalmaterialscience,coursesthatarenotpartofthecurrent medicalschoolcurriculuminIndia.Finally,theseprogramsmust

alsobein-linewiththeaspirationsofourmedicalgraduates andthehealthneedsofthecountry,deliberatelyfocusingon “frugalinnovation.”

CONCLUSION

HealthcareinnovationinIndiawillbebroughtaboutby amultiprongedapproach:early-attainable,specificobjectives ofimplementingefficaciousnewstrategiesforthepriority healthcareneedsofthepopulation,i.e.,frugalinnovation;and along-termvisionforfosteringtheculturethatpromotessuch advancements;orelseworthyintentionswillkeepgettinglost intranslation.

AUTHORCONTRIBUTIONS

AOconceptualized,drafted,andeditedthemanuscript.KSedited themanuscript.Bothauthorscontributedtothearticleand approvedthesubmittedversion.

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ConflictofInterest: Theauthorsdeclarethattheresearchwasconductedinthe absenceofanycommercialorfinancialrelationshipsthatcouldbeconstruedasa potentialconflictofinterest.

Copyright©2021OzairandSingh.Thisisanopen-accessarticledistributed underthetermsoftheCreativeCommonsAttributionLicense(CCBY).Theuse, distributionorreproductioninotherforumsispermitted,providedtheoriginal author(s)andthecopyrightowner(s)arecreditedandthattheoriginalpublication inthisjournaliscited,inaccordancewithacceptedacademicpractice.Nouse, distributionorreproductionispermittedwhichdoesnotcomplywiththeseterms.

published:07April 2021 doi:10.3389/fpubh.2021.666333

Editedby: MagdalenaKlimczuk-Kochanska, UniversityofWarsaw,Poland

Reviewedby: VictorPeñeñory, UniversityofSanBuenaventura Cali,Colombia YaninaBesstrashnova, AlbrechtFederalScientificCentreof RehabilitationoftheDisabled,Russia HannaLopatina, BerdyanskStatePedagogical University,Ukraine

*Correspondence: YuanWang wywy19840502@jlu.edu.cn

Specialtysection: Thisarticlewassubmittedto PublicHealthPolicy, asectionofthejournal FrontiersinPublicHealth

Received: 10February2021 Accepted: 12March2021 Published: 07April2021

Citation: QiCYandWangY(2021)WhyIs RehabilitationAssistancePolicyfor ChildrenWithDisabilitiesDeviatedin Supply-Demand?ACaseStudyin MainlandChina. Front.PublicHealth9:666333. doi:10.3389/fpubh.2021.666333

WhyIsRehabilitationAssistance PolicyforChildrenWithDisabilities DeviatedinSupply-Demand?ACase StudyinMainlandChina

CaiYunQiandYuanWang*

DepartmentofLaborandSocialSecurity,SchoolofPhilosophyandSociology,JilinUniversity,Changchun,China

Childrenwithdisabilitieshavemostpotentialforsalvagerehabilitation,andtheir rehabilitationresultsareconcernedwiththeirentirelifeprocess.Although,theChinese statehasestablishedatargetedRehabilitationAssistanceSystemforDisabledChildren andhasexpandedtheprovisionofrehabilitationservices,aseveredeviationbetween supplyanddemandremains.Existingstudieshavefocusedrelativelymoreonpolicy contentandlessonthepolicycontext,atthemacro-structurallevel.However,using thecaseoftheZWRehabilitationCenterinCityJ,thisstudydividedthedeviationinto exclusionerrorsandinclusionerrors,andusedthepolicycontextapproachtoexplorethe reasonsforthedeviation.Wefoundthatthebehaviorsoftheparticipantsinrehabilitation servicesexistinadynamicinteractionbetweentheregulatorycontext,thenormative context,andthecognitivecontext.Thejointforcesofthethreecontextsproduceboth exclusionerrorsandinclusionerrors,whicharetheunderlyingreasonsfortheinaccurate executionofthetargetedpolicy.Theresultsofthisresearchcanprovideenlightenment forimprovingrehabilitationpolicy.

Keywords:rehabilitationassistancesystemfordisabledchildren,supply-demanddeviation,policycontext, exclusionerror,inclusionerror

INTRODUCTION

Currently,thereare85.02millionpersonswithdisabilitiesinMainlandChina–themaximum numberpernationintheworld.Rehabilitationhasbecomeoneofthemostimportantways torestoreorcompensatefordisabledpeople’sbodyfunctionsandimprovetheirqualityoflife, andChinaispayingincreasedattentiontosuchrehabilitationefforts.Since1988,thestatehas integrateditsrehabilitationprogramforpersonswithdisabilitiesintonationaleconomicandsocial developmentplanstoprotectthoseindividuals(1).Recently,abriefgovernmentdocumentalso notedthatanewtargetedrehabilitationprogramhadbeenimplemented(2).Indeed,“targeted” isahot wordinpresent-dayChina,havingbeenderivedfromtheterm“targetedpoverty alleviation,”whichauthoritiesfirstproposedin2013.Targetedrehabilitationreferstotheprovision ofrehabilitationservicesonthebasisoftheactualneedsanddifficultiesofeachdisabledindividual, throughaccuratediagnosisandscientificevaluation(3).

Inthe fullplanforrehabilitationofpersonswithdisabilities,rehabilitationforchildrenisthe startingpoint,andisconcernedwiththechildren’sentirelifeprocess.Studieshaveshownthat themostsuccessfultimefortherehabilitationisbetween0and6yearsofage,becauseduring thatperiodthebrainhasthebestflexibility,withthebestcompensatoryeffects,forrestoring

aninjuredbrain’sstructureandfunction(4).Forchildren, graspingtheopportunityofearlysalvagerehabilitationcan effectivelyavoidordecreaselatercomplicationsandsequelae, thus,creatingopportunitiesfortheireducation,employment, andsocialintegrationinthefuture.Currently,thereare1.678 millionchildrenwithdisabilitiesinthisagerangeinChina (5).Mostofthosechildrenarefacedwithdifferentkinds ofrisks,including poverty,malnutrition,poorhealth,lackof familyprotection,andsoon(6),andmanyhaveextensive demandsfor medicalrehabilitationandcare.Tosatisfythose demands, theCPCCentralCommittee andthe StateCouncilon PromotingtheDevelopmentoftheCauseofDisabledPeople(2008) statedtheopinionthatsalvagetreatmentandrehabilitation forchildrenwithdisabilitiesshouldbegivenpriorityand thatsalvagerehabilitationprojectsforpoordisabledchildren bytheChinaDisabledPersons’Federation(CDPF)wereto becarriedout.Beginningin2018,guidedbytheconceptof targetedrehabilitationandoverseenby theStateCouncilonthe EstablishmentofaRehabilitationAssistanceSystemforDisabled Children, rehabilitationserviceshavebeenprovidedforchildren aged0–61 yearswhohaveadisabilityofvision,hearing,speech, limb,intelligence,orwhohaveautism.Thecontentofthe servicesincludesoperations,assistivedevicesconfiguration,and rehabilitationtraining,withthegoalsofreducingdysfunction, improvingfunctionalstatus,andraisingtheindividual’sability forself-careandsocialparticipation(7).

Theinteractions betweenserviceprovidersandserviceusers, reportedfromtheirexperiencesofprovidingandobtaining welfare,canestablisharelationalunderstandingofpolicy(8). Fromthe positionofserviceproviders,theRehabilitation AssistanceSystemforDisabledChildren(RASDC)isaninclusive policythatisbasedoncivilrights,anditcaneffectivelyaddress therehabilitationbarriers.However,fromthepositionofservice users,thisservicehasnothadastronglypositiveeffect.The rehabilitationprovisionrateislow,remainingfarfromthegoalof targetedrehabilitation.Surveydatahaveidentifiedthatafterthe implementationofthepolicy,thesupplyrateoftheserviceisonly 20.33%,whereas,thedemandrateisapproximately27%(9).After Chinahasprovidedagenerousrehabilitationservicefordisabled children,whyistherestillaseveresupply-demanddeviation?

Toanswerthatquestion,thisstudydistinguishedbetween twokindsofdeviationsandinvestigatedthemusingthe perspectiveofthepolicycontext.Specifically,studiesevaluating theeffectivenessofsocialwelfareprogramshavefoundthat twodeviationscommonlyoccurinattemptsto“target”public expendituresforpoorpeopleinpovertyreductionpolicies.One isan“exclusionerror”(alsocalled“undercoverage,”or“failureto reachtheprimeobjective”),inwhichsomesubjectsareeligible toreceivebenefitsbutdonotreceivethem,andtheotherisan “inclusionerror”(alsocalled“leakage,”or“excessivecoverage”),

1Itshould benotedthatages0–6yearsarenottheabsoluteagelimit.Infact,China’s 31provinces(districts,municipalities)andXinjiangProductionandConstruction CorpshaveintroducedlocalRASDCaccordingtolocalconditions,andamong thoseprovinces,17provinces(districts,municipalities)havewidenedtheagelimit foreligibleapplicantstovaryingdegrees(datafrom2019),suchas,ages0–15years inBeijingand0–17yearsinShanghai.CityJ,theplaceforinvestigationinthis paperalsoextendedtheeligibleagesto0–17years.

inwhichthosewhoreceivebenefitsarenoteligibletoreceive them(10, 11).Intryingtoclassifythesupply-demanddeviation inrehabilitationsservices,attentionhastendedtofocusonone errorandtooverlooktheother,andthatsingle-errorfocushas ledtoanarrowunderstandingofthesupply-demanddeviation. Inourresearch,wetoofoundtheexistenceofthesetwoerrors intheimplementationprocessofthetargetedRASDC.However, relevantextantresearchonthisareaisscarce.Toexplorethe reasonsforexclusionerrorsandinclusionerrors,weusedthe policycontext,andspecificallytheregulatory,normative,and cognitivecontexts,asanewperspective.Thatapproachgivesa muchmorecomprehensiveframeworkthatcancapturevarious aspectsoftheideology,politicalinterests,culturalnorms,social knowledge,rulesandregulations,andotherfeaturesthatcould haveaconsiderableimpactontheadministrativeprocess(12, 13). Thisstudy,conducted inthelocalenvironmentofpresent-day MainlandChina,soughttorevealthesupply-demanddeviation oftheRASDCinChina,andtoenrichtheacademiccommunity’s understandingofhowthelocalpoliticalandculturalcontexts changetheestablishedgoalsofpolicy.

LITERATUREREVIEW

InChina,theresearchonrehabilitationhasbeenconducted mainlyinthefieldofmedicine,andstudiesontherehabilitation policiesfordisabledchildrenhavebeencarriedoutonlyrecently. TheproposalinChinaoftheRASDCin2018wasanimportant watershedevent,andthetopicgraduallybecameahotbutton inacademiccircles.Although,somescholarshaveconducted ongoingresearchontheissuesofrehabilitationservicesfor disabledchildren,mostofthemhavefocusedononlytheservice content.Fromthatapproach,thefindingshaveshownthatthe inaccurateimplementationoftheRASDChasbeencausedby ideas,methods,andspecificcontentsofprovision.

Thefirstaspectofimplementationisinregardtotheideaof provision,ofputtingthechildfirst,andmaximizingthebenefits forthechild,butatpresentinChinathatideaisnotmetwith consensusamongall,andtheprinciplethatthestateisthe supremeguardianandprotectorofthechildisnotestablished. Asaresult,theRASDCeffortshavemainlybeensurvivororiented,andhavebeenlackingininclusiveanddevelopmentorientedpolicies(14).Studieshaveshownthat,althoughstate fiscal expendituresareincreasing,alackoffunds,theuseof strictcriteriaforrehabilitationassistance,andtheproblemof rehabilitationdemandsnotbeingincludedintheRASDCarestill majordilemmas(15).

Second, regardingthemethodsforprovision,medical rehabilitationservicesforchildrenwithdisabilitiesarecurrently providedbydesignatedagencies,mainlyintheformof “governmentprocurementservices.”Amongthoseservices, imperfectserviceskillsinagenciesarethemostimportant factor,andthatproblemproducesanexclusionerror.Poor rehabilitationservicenetworks,lackofprofessionalstaff, lowprofessionallevels,andslowupdatingofrehabilitation technologieshaveallaffectedtheeffectivenessofprovisionof rehabilitationservices(16 18).

Finally,someresearchhassuggestedthattheRASDCpolicy lackssupporting policies(19).TheRASDCismainlyaimedat helpingpoorhouseholdstosolvetheproblemofexcessivecosts inmedicalcareandrehabilitationforchildrenwithdisabilities. However,thosehouseholdsarefacedwithmoresevereparental pressuresintheprocessofrehabilitation,comparedwith householdswithdisabledpeopleofotherages(20, 21).The long-termcare needsofdisabledchildrengraduallyincrease thephysicalandemotionalburdenswithinfamilies,andthose burdenscannotbesolvedbyinsufficientsupportservices.That increasingpressure,inturn,canleadtherecipientstovoluntarily abandonrehabilitationservices(22).Additionally,thoseservice providersmake medicalrehabilitationthemainfocus,andthey ignoretheuniversaldemandsofcommunity-basedandfamilybasedrehabilitation(23, 24).

Thosereviews havedemonstratedthatmanyexclusion errorsoccurfromtheideas,methods,andspecificcontents ofrehabilitationprovision.Asaresult,alargenumberof rehabilitationdemandsofchildrenwithdisabilitiesarenot satisfiedeffectively,andthatoutcomeisfarfromthegoalof targetedrehabilitation.Thecausesofexclusionerrorsinclude suchmaincharacteristicsasinsufficientgovernmentfinancial support,alowsupplyofrehabilitationservices,poorqualityof rehabilitationservices,unevendistributionofservices,lackof equipment,largegapsinrehabilitationprofessionals,inadequate supportsystems,andsoon(19, 25 27).Tosolvethosebarriers, governmentresponsibility shouldbeclarified–thatis,the statedgoalshouldincludesuchitemsastheprovisionof additionalservicesbyincreasinggovernmentfiscalspending, mobilizingsocialforces,andexpandingtheparticipationspaceof volunteers(28, 29).Itisalsoimportanttoimproverehabilitation technology andincreasethedeliveryofsupportservices,such as,medicalscreening,exerciserehabilitation,medicaland educationalintegration,community-basedrehabilitation,and caresupport,amongothers(30 33).

Thediscoveriesmadethroughtheservicecontentapproach haveattractedwidespreadattentionfromscholars,butthatisa smallportionofthepolicycontext,anditcanonlyfindexclusion errors.Inaddition,theexistingliteratureoveremphasizes exclusionerrorscausedbythepolicymakersanddirect providers.Inreality,however,policyimplementationisalways theinteractionbetweenindividualfactorsandenvironmental factors,andthatinteractionisexactlywhatthepolicycontext approachemphasizes.Fromthepolicycontextapproach,we foundtwotypesoferrors–exclusionerrors(withadditional, differentexpressionscomparedwiththoseintheexisting research)andinclusionerrors–bothofwhichhaveledto inaccurateresultsfromtheRASDC.

Furthermore,thetwouniversallyadoptedresearchmethods arelimited.Existingstudieshavemainlyappliedquantitative methodstomeasurerehabilitationneeds(9, 26, 34),alongwith a fewin-depth interviews(18).Inregardtothequantitative methods, fieldresearchhasfoundthatalargenumberof childrenwithdisabilitiesandtheirparentsareinapassive stateofacceptance,andtheyarenotclearlyinformedabout rehabilitationpoliciesandtheirownneeds,sothataccurate statisticscannotbeobtainedbyquestionnaire.Inregardtothe

in-depthinterviews,thestudieshavefocusedonlyonhouseholds thathavechildrenwithdisabilitiesandhavenotreallyoutlined theentireprocessofimplementationandidentifiedareaswhere theerroroccurred.Inresponse,thisstudy,byusingacase studymethod,analyzedbehavioralcharacteristics,andwelfare choicesofwelfareprovidersandusersinspecificfields,toanswer thequestionofhowthepolicycontextcauseswell-targeted rehabilitationprogramstobeimplementedinaccurately.

THEORETICALFRAMEWORKAND METHOD

TheoreticalFramework

Socialpolicy’s“goal-result”isnotasimplelinearrelationship, andcomplexmechanismsofintermediatephases–policy implementationsystems–cannotbeignored.Someseemingly unrelatedeventsinimplementationcaninterferewiththe expressionofpolicyobjectives,resultinginanimperfect correspondencebetweenthepoliciesandtheservicesactually provided.Whatfactorscanaffectpolicyimplementation?From PressmanandWildavsky’sresearchin1973(35),variousscholars haveinvestigatedthequestionofinfluentialfactorsonpolicyin differentways,includingfactorsinsociety,economy,technology, andthepoliticalenvironment,amongothers(36).Hilland Hopeoffereda detailedexplanation,pointingoutthatthe dependentvariablesthataffecttheoutcomeofimplementation includepolicycharacteristics,policyformation,verticalpublic administration,influencesonimplementationagencyresponses, horizontalinter-organizationalrelationships,theimpactof responsesfromthoseaffectedbythepolicy,andtheenvironment orpolicycontext(37).Instudyingpolicyimplementationinthe thirdworld, thesefactorsareresummarizedastwoelements: thecontentoftheplanandagivenpolitical-socialcontext (13).Variousscholarshaveallrevealedandaffirmedthat contextssuchas,thelegalsystem,culture,socialnorms,and thevaluesofanorganizationhaveafar-reachinginfluenceon policyimplementation.However,instudiesontheexecution oftheRASDC,environmentalfactorshavebeenignored,either intentionally,orunintentionally.

Researchershaveemployeddifferentwaystoconceptualize andoperationalizethecontextinwhichindividualsand organizationsexist.Parsonswasconcernedwithsocialnorms (38),whereasMarchandSimonexaminedcognitiveand normativestructures (39).Furthermore,Scott’sclassicstudy suggested thatregulative,normative,andcultural-cognitiveare thekeyfeaturesofanationalcontext(40).Thattheoretical frameworkhasgroundbreakinglyintegratedthreebasicelements asthemaincompositionoftheinstitution.AfterScott,scholars havegivenmoreattentiontothemicroapplicationsofthismacro theory.Amongthosescholars,Kostovaeffectivelyovercame thelimitationsofpastworkandconstructedacomprehensive frameworkoftheexternalenvironmentwithwhichtostudythe specificphenomenonofqualitymanagementofpublicservices betweendifferentcountries(12).Inherpaper,“regulatory component” referstothemandatorylawsandregulationsina particularnationalenvironmentthatpromoteorrestrictcertain

typesofindividualandorganizationalbehaviors.“Normative component”consists ofsocialnorms,socialresponsibility,values, beliefs,andassumptionsabouthumannatureandhuman behaviorthataresociallysharedandarecarriedbyindividuals andorganizations.“Cognitivecomponent”comprisessocial knowledgeandcognitivecategoriesthatarewidelysharedina country,includingthecognitiveprogramsthatpeopleusewhen choosingandinterpretinginformation(12).Although,Kostova studiedthe particularissueofqualitymanagement,theapproach thatsheappliedisgeneralizableandcouldbeusedinvarious studiesconcernedwithotherissues.

Well-targetedrehabilitationprogramsfordisabledchildren willnotachievetheirgoalsbecauseofaspecificpolicycontext. Thisstudy,drawingonthetheoreticalframeworkofpolicy contextandtakingChineselocalknowledgeintofullaccount, anchorsthesethreefactors–theregulatorycomponent,the normativecomponent,andthecognitivecomponent–into aninvestigationoftheprovisionissuesoftheRASDC.We focusedonthecomplexinteractionsoflocalgovernments, serviceagencies,andchildrenwithdisabilities,throughtheir maintenanceofthepoliticalpower,emphasisonself-interest, andreinforcementofthenegativeroleofthedisabled,andwe constructedasupplementaryandcomprehensiveperspectivefor understandingpolicyimplementation.Wearguethatthepolicy contextapproachextendsbeyondthedualismofthesupplyorientedmodelandthedemand-orientedmodel,andweseek toprovideadequateevidenceregardinghowtheseinteractions producebothanexclusionerrorandaninclusionerrorin connectionwiththetargetedRASDC.Although,eachsubcontext involvestheparticipationofmultiplesubjects,inChina’s political-socialcontext,theRASDChasbeenimplemented via

theprocessofthestatedistributingtasksthroughtop-down ordersandtherehabilitationagenciesprovidingtheservices. Inthatlight,wedefinetheregulatorycontextasmainlythe lawsandregulationsoforganization,distribution,constraints, andincentivesbythelocalgovernmentsthatareresponsiblefor implementingtheRASDC.Thenormativecontextisembodied inthevaluesofsocialnormsandsocialresponsibilitythat rehabilitationagenciesfollowwhenallocatinganddelivering specificresources.Thecognitivecontextreferstothelong-termdisabledcultureinChina,andthefactthatindividualcognition andsocialcognitionoftheRASDCbyfamilieswithdisabilities andthepublichaveavitalimpactonbehavioralchoices.

Theresearchconceptforthisstudyisshownin Figure1 IntheimplementationstageofthetargetedRASDC,thethree subelementsofregulatorycontext,normativecontext,and cognitivecontextcoexistandhaveavitalimpactonthebehavior ofrelatedindividualsandorganizations.Theseleadtotwo kindsofimplementationresults:(a)preciseimplementation–inotherwords,achievingthepolicygoals,and(b)deviant implementation,orfailuretoachievethepolicygoals.Thereare twoformsofdeviation,calledexclusionerrorsandinclusion errors.Tosolvethem,itisnecessarynotonlytoadjustthe inappropriatepolicyobjectives,butalsothroughvariousways tochangeanyexistingunfavorableenvironmentofpolicy implementation.Thistwo-prongedapproachisthekeyto theproblem-solving.

Methods

WeusedaqualitativestudymethodandselectedZWinCity Jasthemainresearchsite.Wecollectedethnographicdataby

FIGURE1| Thepolicycontext anditsdeviationsinRASDCimplementation.

participatoryobservation,in-depthinterviews,andareviewof governmentdocuments,statisticalyearbooks,andotherfiles.

FieldAccessandSampling

CityJ,theprovincialcapitalofProvinceJ,issituatedinarich coastalareaofeasternMainlandChina.Duetopoliticalfactors, CityJisoftenthefirstpilotareaforthepolicypracticeby theCDPF.In2013,thecitylaunchedasalvagerehabilitation programforchildrenwithdisabilities.Thiscity,overtime,has movedintotheforefrontofallofChina’scities,andithasrich practicalexperience.

Thefieldworkportionofthestudystartedinthesummer of2020.Whilevisitingtherehabilitationagency,theauthors gainedaccesstoalistofthenamesandbasicinformationfor51 designatedagenciesinCityJfortheRASDCthathadbeennewly establishedin2018.Amongthe51agencies,49wereprivate non-enterpriseunits(non-profitorganizations).TheZWChild RehabilitationCenterandZWChineseMedicineClinic(really oneagency,withdifferentservices;hereinafterreferredtoas “ZW”)wastheonewiththelargestnumberofdisabledchildren initsservices,thelargestnumberofdifferentkindsofdisabled children(70withautism,90withmentaldisability,and20with cerebralpalsy),andthemaximumagerangeofdisabledchildren (aged0–17years).Itwasalsothefirstdesignatedrehabilitation assistanceserviceagency,approvedin2013,andithasarich levelofexperience.Therefore,weselectedZWastheprimary researchsite.

ThefounderoftheZWorganization,afterabusinessfailure in2003andwithnoaccesstoconvertingtoBuddhism,decided tomakeuseofhisowntraditionalChinesemedicineskills todosomethinggoodforthecountryandthepeople,so heestablishedZWin2006.TheZWorganizationdeveloped rapidlybymakingfulluseofthecharacteristicelementsof Chinesemedicine:acupuncture,massage,medicinaldiet,and othertraditionalChinesemedicinetherapies.Atpresent,ZW isarehabilitationcenterforcerebralpalsy,mentaldisability, autism,hyperactivitydisorder,hemiplegia,andparaplegia,for whichitintegratesrehabilitation,education,andfamily-based rehabilitationguidance.Itisnowengagedprimarilyinexercise training,homeworktraining,speechtraining,sensorytraining, physicaltherapy,musictherapy,guidededucation,special education,socialwork,medicinalmeals,medicinebaths,aspa, massage,acupuncture,near-infraredbrainfunctionimaging technology,andothertreatmentitems.Theagencyissituated inarelativelymarginalareaofanurbanzoneinDistrictB, CityJ,withconvenienttrafficandlowrent,anditcovers anareaof2600squaremeters.Currently,ithastwoChinese medicalrehabilitationspecialists,30therapists,and22teachers forspecialeducation.

Atpresent,ZWcanhold180childrenwithdisabilities.InJuly andAugust,2020,whenwedidtheresearch,therewereonly 139childrenatZW(becauseofCOVID-19,somefamilieshad limitedmovement).Theorganizationprimarilyreceiveschildren withdisabilitieswholiveinDistrictB,butsomechildrenfrom otherprovinces,cities,anddistrictsarealsoattractedbyits reputation.Thechildrenrangeinagefrom0to17years,and theyhavedifferenttypesanddegreesofdisability.Theirfamily

backgroundsalsodifferfromeachother,buttheyhaveonething incommon—allarechildrenwithdisabilities.

DataCollectionandDataAnalysis

WiththehelpoftheheadofZW,wecollectedethnographic datainJulyandAugust2020.Weusedthreedifferentmethods: participatoryobservation,in-depthinterviews,andareviewof governmentdocuments,statisticalyearbooks,andotherfiles.

Tobegin,thefirstauthorhadanearlyone-monthlongintenseparticipatoryobservationperiodwithintheZW organization,closelyobservingeachstep,includingprojectsetting,implementation,assessmentandadjustment,andsoon, intheRASDC.Participatingasauniversityvolunteer,theauthor wasresponsiblefortheentireworkoftheRASDC,chiefly handlingtheissuesforparentsofdisabledchildreneligiblefor assistanceandalsogettinganopportunitytodockwiththe localDisabledPersons’Federation.Duringthattime,threestaff membersintheadministrativeofficesharedwiththeauthor theirworkingexperiences,feelings,andattitudestowardthe implementationoftheRASDC.Datafromthoseinterviewsalso wereenteredintofieldrecordsofparticipatoryobservation,asan importantwayofdatacollection.

Next,weconducted15in-depthinterviews,eachranging from30mintoanhour.Ourintervieweesweredividedinto twocategories:threemembersinthemanagementteam, includingthefounderandheadofZW,onetherapistandthe directoroftheadministrativeoffice,and12primarycaregivers offamilieswithchildrenwithdisabilities.Thecaregivers wereselectedafterconsiderationoffactorssuchas,gender, age,householdregistration(Hukou),children’sage,children’s disabilitytype,andwillingnesstobeinterviewed.Owingto CityJ’sextendedageforrehabilitationservicesto17years, ourresearchwasnotlimitedtochildren0–6yearsoldbut alsoincludedintervieweeswhosechildrenwithdisabilitieswere aged7–17.Beforetheinterviews,weprovidedtheinterviewees withgeneralinformationrelatedtoourresearch,including thepurpose,subjects,process,durationofthestudy,and theresearchschedule.Theentireresearchprocessfollowed theproceduresoftheinstitutionalreviewcommitteeandtook intoaccountseriousrequirementsforconfidentiality,non-harm, andinformedconsentofparticipants.Moreinformationabout theintervieweescanbefoundin Tables1 3.Theauthors completedalltheone-on-oneinterviewsinMandarinordialects, convertedalloftheinterviewrecordingsintoChinese,wordby word,andselectivelytranslatedsomeinformationintoEnglish asrequiredinordertopresentthefindings.Forconfidentiality, allidentifyinginformationwasanonymizedduringtranslation andtranscription.

Finally,wealsostudiedgovernmentdepartmentsguidelines, statisticalyearbooks,workingdocuments,andotherfiles relatedtotheRASDC,tosupplementourfielddata.Inthis investigation,weselectedinformationfrommultiplesourcesto improvevalidity.

Wecodedtherespondents’narrativesintwostages:one ofopencodingandoneoftheoreticalcoding.Guidedby qualitativeanalysistechniques(41),weintegratedrawdata fromdifferent sourcestogenerateconsistentthemes,toreveal

TABLE1| Descriptionofresearchparticipants–caregivers.

Case Roleofinterviewee Age Child’sage Child’sgender Child’sdisabilitytype Hukou (DistrictB)

Case1 Mother 30 5 F Mentaldisability Non-local

Case2 Mother 47 11 F Mentaldisability Non-local

Case3 Father 38 12 M Autism Local

Case4 Uncle 36 15 M Mentaldisability Local

Case5 Grandfather 65 6 M Autism Non-local

Case6 Father 32 6 F Mentaldisability Non-local

Case7 Mother 36 4 M Autism Local

Case8 Mother 31 6 F Cerebralpalsy Non-local Case9 Mother 50 14 F Mentaldisability Local

Case10 Father 37 7 M Autism Non-local Case11 Mother 49 10 M Mentaldisability Local Case12 Mother 29 4 M Autism Local

TABLE2| Generalcharacteristicsof theresearchparticipants(N = 12).

Variables N (%)

Children’sage 0–6 58.3% 7–17 41.7%

Children’sgender Male 58.3% Female 41.7%

Children’sdisabilitytype Mentaldisability 50% Autism 41.7% Cerebralpalsy 8.3% Hukou Local 50% Non-local 50%

TABLE3| Descriptionofresearchparticipants–managers.

CaseAgeGenderEducational attainment JobtitleYearsworking inZW

Case1350MUniversityFounder&head16 Case1438 MUniversityTherapist 14 Case1535FUniversityDirector 10

theprocessofimplementingtheRASDC,andtoidentify themultipledeviationsandtheircontextualcausesinthis process.Ourpurposewastoformulateanextendedcase studywiththeoreticalandpracticalmeaning(42),thatcould extendthe understandingfromtheexistingliteratureonthe supply-demanddilemmaforrehabilitationservicesandcould providesomesuggestionsforpolicypracticeslater.Thecentral administrativeworksysteminChinahasahighdegreeof thecharacteristicof“IsomorphicResponsibility,”sothecases selectedinthisresearchhadacertainexpansibility.Wetry ourbesteffortstoreducetheimpactofthelimitationsof thecasemethodontheresultstoimprovereliabilityand validity(43).

FINDINGS

The RASDCtakesplaceinaspecificfield,embeddedinlocal institutionalsituationsandconstrainedbyhabitus.Theresults ofourempiricalsurveyindicatethatintheprocessofdelivering targetedservicesforchildrenwithdisabilities,thereiswide interactionamonglocalgovernments,rehabilitationagencies, andfamilies.Thatinteractionexistsinaperpetual,dynamic tensionbetweentheregulatorycontext,normativecontext,and cognitivecontext.Inthefollowingparagraphs,wewilldiscuss (1)theconstrainedandincentiverulesproducedbyChinese localgovernmentsintheregulatorycontext,(2)thestrong normsandweaksocialresponsibilityofrehabilitationagencies inthenormativecontext,and(3)theidentitycultureofchildren withdisabilitiesandtheirfamiliesinthecognitivecontext. Additionally,wewillpresentouranalysisofhowthethree contextsgeneratederrorsofexclusionandinclusion,whichthen ledtoaninabilitytoexecutetheRASDCaccurately.

RegulatoryContext:SpecialExecutive RulesoftheChineseLocalGovernment

InthetargetedRASDCsysteminpresent-dayChina,thelocal governmentplaysacrucialroleinprovidingservices,supervising theoperationsofagencies,andguidingpolicymanagementwith officialdiscourses.TheRASDCadoptsmanykindsoflocal executiverules,fromwhichthetargetmanagementresponsibility system,theadministrativesubcontractsystem,andpromotion tournamentsarethekeystoexecutingpolicyandarealsotheroot causeofdeviantbehaviorsintheregulatorycontext.

ExclusionofTypesintheTargetManagement ResponsibilitySystem

Chinaassignsandexecutestasksthroughitstargetmanagement responsibilitysystem,whichisasystemformcreatedina highlycentralizedenvironment.Itsconcretemanifestationisto decomposeandrefinethegeneraladministrativegoalsstepby step,formingasetoftaskssystemsasthebasisformanagement, rewards,andpunishmentsoforganizationsatalllevels(44).

TABLE4| AllocationofrehabilitationassistancetasksforchildrenwithdisabilitiesinCityJ(2018).

District Tasks Othertasks Total

Ages0–9

Hearing&speechdisabilityMentaldisabilityCerebralpalsyAutism

Ages10–17Corrective surgery Lowvisionsurgery

A 8 29 26 260 0 0 30119

B 17 70 18 4324 0 0 20192

C 15 50 20 18 0 0 0 10113

D 14 30 12 1312 0 0 1596

E 20 53 24 2420 4 1 10156

F 15 20 15 1510 3 0 583

G 17 44 40 821 0 0 8138

H 13 15 16 115 6 0 066

I 19 30 20 45 1 0 079

J 15 30 8 846 0 0 0107

K 7 19 13 64 0 0 1059

L 8 45 46 112 1 0 0113

Total 168 435 258177159 15 1 1081,321

Indeed,ourstudyshowedthattherehabilitationexperiences ofchildren withdisabilitieswereextremelycloselyrelatedto theirlocalDisabledPeople’sFederation,whichhorizontallyis anexecutiveinstitutionthatisresponsiblefortheformulation andimplementationofallmattersconcerningpersonswith disabilities,andwhichverticallyiscomposed,fromthetop down,bytheChinaDisabledPerson’sFederation(CDPF), theProvincialDisabledPerson’sFederation,theMunicipal DisabledPerson’sFederation,andtheDistrictDisabledPerson’s Federation.Underthetargetmanagementresponsibilitysystem, aftertheDisabledPeople’sFederationhasobtainedthetasksof theRASDCfromthehigherlevel,thenthetasksarerefinedand assignedtothelowerlevelandfinallytorehabilitationagencies, accordingtothetop-downstructure.Forspecifictasks,see Table4.WefoundthattheDisabledPeople’sFederationinCity Jdividesrehabilitationservicesintofourtaskindexes,thereby assigningtheservicestochildrenwithautism,withlimbdisability (cerebralpalsy),withintelligencedisability,andwithhearing andspeechdisability.Forvisualdisability,onlylow-vision surgerycanbeprovided,andlong-termrehabilitationservices forchildrenwhocannotrecovertheirvisionarelacking.That limitationofservicesdepriveschildrenwithvisualdisabilities ofaccesstotargetedrehabilitationservices,thus,leadingtoan exclusionerror.

Inaddition,thecapacityandpreferencesoftherehabilitation agenciesproducealargenumberofexclusionerrors.Thetasks assignedbythetargetmanagementresponsibilitysystemare basednotonthenumberofchildrenwithdisabilitiesfrom DistrictAtoL,butonthecapacityofrehabilitationagenciesto receivechildren.Thatis,thecapacityiscalculatedbyjudging thegrossbuildingarea,numberoftherapists,curriculumtype, andotherfactors.Thenumbersfortotaltasksin Table4 arethe sumsofthecapacityofeachagencyinCityJ.However,having arisenonlyrecently,privatenon-profitrehabilitationagencies inChinadonothavethecapabilitytocoverallofthechildren

withdisabilities.In2018,1,321childrenreceivedrehabilitation services,whereasthenumberofchildrenwithdisabilitiesinCity Jexceeded5,000.Evenmoreseriousisthefactthat,according tothematerialsof51rehabilitationagencies,withtheexception ofgeneralchildrehabilitationhospitals,mostoftheprivatenonprofitrehabilitationagenciesfocusonchildrenwithautismand mentaldisability,whileignoringothertypesofdisabilities.

ExclusionofRegionsintheAdministrative SubcontractSystem

AnotherimportantruleinChina’sregulatorycontextisthatofthe administrativesubcontractsystem.Itisaproductofthesoulof the“contractsystem”placedunderthehierarchicalshell,andin it,tasksassignedbythesuperiorsaretobeaccomplishedthrough administrativepowerdistributionandeconomicincentives (45, 46).IntheprocessofcontractingouttheRASDC’stasks, geographicregions serveastheboundaries.Decisionsabout whichregionchildrenwithdisabilitiesandtheirfamiliesshould obtainthesourceoftheirservicesaremadethroughtheunique householdregistrationsystem(hukousystem),inwhichone canonlyreceivetheserviceswiththelocalhukou,andthe locationofthehukouisbasedontheperson’spersonalidentity card.InChina,theflowingpopulationis245millionpeople, withinwhichthecross-provincialflowingpopulationis85.88 million(47).Despitealackofdataonthemigrantpopulation ofchildren withdisabilities,itispossibletoidentifyasignificant numberofsuchgroups.Thecombinationoftheadministrative subcontractandthehukousystemresultsinanexclusionerror basedongeographicpositionintheapplicationoftheRASDC, whenindividualsandfamilieswhoseplaceofresidenceand locationofhukouareinconsistent.Theparticipantofcase11 leftadeepimpressionontheinterviewerbecauseshecriedin theinterview.SheandherfamilyhadlivedinTianjinProvince forseveraldecades.Thefamily’srehabilitationservicewasselffinancedduringthefirst3years,becausetheirhukouwasinCity

J.Inthe4thyear,aftertheylearnedaboutthefreerehabilitation assistanceinCityJ,themotherrentedaroomnearZWwithher disabledchild,whichmeantthatsheandthechildlivedalong distancefromherhusbandandeldestson.

Unfortunately,theboundariesofdifferentservicesvary. Rehabilitationservicesforchildrenwithdisabilitiesusethe provinceastheboundary,whereas,educationservicesusethe cityoreventhedistrictastheboundary.Childrenwithdisabilities whoreceiverehabilitationinZW(DistrictB)alsofaceurgent educationalneeds,whichrequirenon-DistrictBfamiliestogo backtotheirlocalspecialeducationschool.Asaresult,some familiesmustchoosebetweeneducationandrehabilitation.The latestrehabilitationmethodfortheintegrationofrehabilitation andeducationexcludeschildrenwhoseplaceofresidence isdifferentfromtheirlocationofhukou,thus,creatingan exclusionerror.

Hecannotdorehabilitationnextyear.Hehastogotoschool.The specialeducationschoolinourhometownhadbeencallingussince lastyear.Hewillbeoldtogotoschool(case10).

WasteofSourcesinPromotionTournamentSystem

Peopledonotunderstandwhyrehabilitationservicesfor disabledchildrenaged0–6yearsdifferamongagegroups indifferentprovincesandcities.Theavailableservicesare determinednotonlybythelocaleconomicdevelopment,but alsoarecloselyrelatedtopromotiontournaments,thethird anddistinctlyinformalruleintheregulatorycontext.Inorder toencourageeachunitwithinthefivemanagementlayersin Chinatoworkeffectively,acompetitionmechanismhasbeen formedinwhichthecompetitiondependsonaperformance measurement.DistinguishingitfrommanyWesterncountries, China’sperformancemeasurementoftheunitisactuallyan evaluationoftheprincipalpersoninchargeoftheunit (48),meaningthatleadersoflocalorganizationswithgood performancein theRASDCgreatlyenhancetheirchancesof politicaladvancement.TheCDPF’sleadersatalllevelsare motivatedtogainacompetitiveadvantagebyincreasingthe numberofbeneficiariesoftheRASDC.

TheDisabledPeople’sFederationinCityJhasbroadenedthe policycriteriaforoutstandingperformanceintheassessment process.First,therestrictionsonthefinancialconditionsof theapplicant’sfamilyhavebeencanceled,andfullcoverage isavailableforallchildrenwithdisabilities.Second,theage foreligibilityof0–6yearshasbeenbroadenedto0–17years. However,asthedirectoroftheadministrativeofficeinZW hasdemonstrated,thebesttimetorehabilitatechildrenwith disabilitiesisduringtheagerangeof0–6years,withchildren abovetheageof7notexperiencingasgreataneffectfrom rehabilitationtrainingaschildrenaged6yearsandunderdo. Therefore,extendingtheageforeligibilityleadstoaninclusion error,andtosomeextentresultsinawasteofresources. Nevertheless,thisconclusiondoesnotmeanthatrehabilitation servicesfordisabledchildrenaged7–17shouldbecanceled. Theauthors’viewpointfavorsprovidingtheolderchildrenwith servicesthataremoreresponsivetotheirspecificneeds,andthus, realizinganoptimalallocationofresources.

Forchildrenwithdisabilitiesaged10-17,tobehonest,theirrecovery inrehabilitationwillbemuchworse.Actually,manyhavegiven uptherehabilitation.Butsomeparentsthinkthatsinceitisafree service,theyshouldenjoyit,atleastthechildrencanhaveaplace toplay,withtheteachercaring[for]them.Butthey’recrowdingout otheryoungerchildren’s resource(case15).

NormativeContext:StrongNormsand WeakSocialResponsibilityin

RehabilitationAgencies

Thenormativedimensioncomprisesthesocialnormsandsocial responsibilitiesnecessaryforimplementationoftheRASDC. Socialnormsdictatehowthepolicyimplementationshould becompletedanddeterminethelegalmethodsrequiredto achievethepolicyobjectives,whereas,socialresponsibilityrefers tothepreferredvaluesinpolicyimplementationandthe attitudetowardtheobligationsthatareinvolved.Thenormative dimensionillustratesthevaluesoftherehabilitationagenciesas thebasicpolicyproviderforchildrenwithdisabilities.

DoubleErrorsinStrongNorms

TheCommunistPartyofChina’sCentralCommitteeandthe StateCouncilpaygreatattentiontotheRASDCandprovide astrongandwidelysharednormforrehabilitationagencies, whicharethefirstlineserviceproviders.Inpresent-dayChina, privatenon-enterpriseunits,ornon-governmentalorganizations (NGOs),areoftennotspontaneousgrassrootsorganizations butinsteadareheavilyinfluencedbyChina’spolicysupport andfinancialsupport,andtherefore,tendtobebureaucratic. Thatsystemresultsinrepeated,organized,andinstitutional normsthatemphasizepolicyoutcomes,andsuchanemphasis createsstrongexternalpressureontheagencies–whichare highlydependentonexternalresourcesandhavetheprimary taskofrespondingtotherequirementsofthoseexternal organizations.Thatsystemicpressureisnotalwaysrealisticor effective–onthecontrary,inmanycases,itonlycompletes thepurposeof“ritual”withoutreallymeetingtheusers’needs. Inparticular,differentrehabilitationagenciesfacedifferent pressures,andthetypesofdeviationsthatresultarealsodiverse. Ourfindingsrevealedthatthechildren’shospitalhadthelargest demandsandcouldonlycompleteitsvestedtasksthrough formalorinformalmethods,suchas,modifyingstandards, screeningclassifications,andlimitingqueuing,thus,producing anexclusionerror.However,thedemandsofbackwardareas ornewlyestablishedrehabilitationagenciesareoftensmall,and theyhavetofulfilltheirofficialtasksbyreducingthecriteriafor eligibilityandattractingadditionalchildren,thus,generatingan errorofinclusion.Onemanagerweintervieweddescribedthe phenomenonandherideasabouttheRASDC.

Freerehabilitationassistanceinchildren’shospitalsislimitedon quotas.Thequotaisnow6monthsaway.Thechildrenwillbe givenonlychargeditemsaftertheyarediagnosedatthechildren’s hospital.Someparentsknowthattheycangotootheragencies,but thosewhodon’tknowhavetogohome(case15).

SelectiveNeglectinSituationsofWeakSocial Responsibility

Although, rigidnormshavebeentheguidelinesforpolicy implementation,thecriteriaforcomparingandevaluating thebehavioroftheRASDC’simplementorshavebeen insufficient,andthatdeficiencyhascausedrehabilitation agenciestolacksocialresponsibility.Rehabilitationservices forchildrenwithdisabilitiescurrentlyareprovidedbya formof“governmentprocurementservices.”Theentitiesthat undertakethegovernmentpurchasingservicesaremostly NGOs,whichbydefinitionaresocialorganizationsorganized byenterprises,socialgroups,andothersocialforces,aswellas individualcitizens,usingnon-state-ownedassetstoengagein non-profitsocialserviceactivities.AsNGOs,thosenon-profit organizationsstillhavea“for-profit”needtomaintainthe operationoftheorganization.InZW,“90%oftherevenue comesfromthesupportoftheRASDCprogram.”Managers complainedmorethanonceinourinterviewsaboutfunding challenges,suchas,insufficientgovernmentmoneyandunclear governmentrequirements.

Onelessonfrom2020hasmadetheheadofZWvery cautiousthisyear.Thatyear,anewmodel,“institution + family + community”rehabilitation,wasintroducedfor childrenwhoaremoreseriouslydisabledandunableto leavetheirhome.Inordertoobtainadditionalpublicfunds, ZWcooperatedwithaspecialeducationschooltorender rehabilitationservicesinchildren’shomes.However,themoney failedtobedeliveredattheendoftheyear,because3-month centralizedinstitution-basedrehabilitationhadbeenlacking (thecriteriawereemphasizedatthetimeoftheassessment). Now,ZWhasgivenupthatgroupofchildrenreluctantly. Clearly,theeconomicdemandsoftheagencyfarexceededthe levelofsocialresponsibilityoftherehabilitationservices.The primaryaimoftheagencywastoobtain,asfaraspossible, childrenwithdisabilitieswhowereeasilyrehabilitatedand couldacquirethefundsfromtheRASDC.Forotherchildren withhigherdegreesofdisability,andinabilitytoprovide themwithinstitution-basedrehabilitation,andanattitudeof neglect,havebeenadoptedtowardthem.Inpractice,this behaviorthattheagenciesengagedintofurthertheirown interestswasobviouslyinconsistentwiththeoriginalpurpose ofthewell-targetedRASDCandhasledtonumerouscasesof exclusionerrors.

Inaddition,nocriteriahavebeendevelopedforevaluating policyimplementationfromtheperspectiveofthedisabled childrenandtheirhouseholds.Ontheonehand,thelocal government’smanagementstrategies,fromincentivesto penalties,stillseemfocusedonshapingtherehabilitation agenciesintodisciplinedandefficientimplementorsofofficial discourseandhavenotofferedmuchautonomyorflexibilityfor thefamilieswithdisabledchildren.Ontheotherhand,influenced bydifficultieswithsocialsupervision,inadequatedevelopmentof citizens’participationinpolitics,andanegativedisabilityculture, fewpeoplehavetheopportunityandwillingnesstopayattention totheRASDC’simplementation.Theabsenceofsupervision fromserviceusersandthepublichasfurtherreducedthelevel ofsocialresponsibilityinrehabilitationinstitutions,andthat

situationfostersanexclusionerror.Thedirectevidencefromthe managers’narrativesrevealsthat:

Nowitismainly[upto]theDisabledPersons’Federation, orathird-partyorganizationinvitedbytheDisabledPersons’ Federation,tosupervise.Theydon’tunderstandatall,filloutthe formandthey’redone(case14).

CognitiveContext:IdentityCulturein FamiliesofDisabledChildren

IntraditionalChinesesociety,referringtosomeoneas“canji”or “canfei”meansthepersonisdisabledandcannotdoanything. Thesewordshaveobviousderogatoryanddiscriminatory implicationsanddonotplacethedisabledandtheabledon equalfooting(49).Thisnotionofinequalityaboutpersonswith disabilitiesfurtherinfluencesattitudesonprocreationandcare, andinsodoingleadstoanotherimplementationdeviationof theRASDC.

TheExclusiveEffectofStigmatizationofChildren WithDisabilities

InancientChina,personswithdisabilitiesdidnotpossess thequalificationstoenjoycompleterights.Forexample,a personwithadisabilitywasnotallowedtoentertheancestral hallandnotallowedtobeanofficial—rulesthattreated personswithdisabilitiesdifferentlyfromotherpeople(50). Furthermore, theChinesewordsdescribingdisability,such as,“xiazi”(visualdisability),“longzi”(hearingdisability), “yaba”(speechdisability),“quezi”(physicaldisability),“shazi” (intellectualdisability),and“fengzi”(mentaldisability),arecited ineverydaylanguageasacceptablematerialforteasing,blaming, andreviling,eventothepresentday.Thesewordsarelabelsthat carryseriousstigmaandcreatepsychologicalobstaclesinthe parents.Welfarerecipientsareoftenculturallystigmatized;thus, theyarenotwillingtoadmitthattheirchildrenaredisabledand theyarereluctanttoreceiverehabilitationservicesthatidentify thechildrenasbeingdisabled.Theseconceptsleadtosubjective exclusionbyservicerecipients.

In[our]village,onlymychildreceivesrehabilitationservice.Others donotandtheirparentsrejectrehabilitation,becausetheydon’t admitthattheirchildisdisabled.Theytakeittobenaturalwhen thechildcannotspeakatthree(case5).

Thechildofmywife’sclassmateisalsoautis[tic].Mywifetoldher totakeherchildforrehabilitationinCityJ,sayingthatourchildis gettingbetterintheZW.Mywifetoldheronceortwice,andlater she[wa]sobviouslyoutoftouchwithus,withoutcomingtoour homeortalkingtousontheway.Shefeelsthatwelookdownon herbyalwayssayingthatherchildisdisabled(case6).

Oneconditionbywhichchildrenwithdisabilitiescanobtain freerehabilitationservicesistohaveadisabilitylicense,which isanofficialdocumentforpeoplewithdisabilitiescomposed oftheirIDnumberandtwoothernumbersthatrefertotheir gradeofdisabilityandtheirtypeofdisability.Inthatnegative environment,someparentsrejectthedisabilitylicense,whichis obtainableafterastrictmedicaldiagnosis.Evenwhentheyhave

thedesiretogetrehabilitationassistancefortheirchildren,they canbepersuadedtoquitbecauseofthispaperidentification,thus, causinganexclusionerror.

Hisfatherisnotwillingtohavethedisabilitylicense,sayingthatthe childwillcomplainwhenhegrowsup.Hefeelsthatthedisability cardisachild’slifeshame(case7).

Inothercases,familymembersacceptthefactthattheirchildren aredisabled,butcorrespondingly,thatkindofdisabilityculture fostersasenseofinferiorityandshameinthosefamilies. Afamily’sinteractionswithotherswithoutdisabilitiesplaya significantroleinconstructingthefamilymembers’disabled identitiesandfacilitatingtheirnegativeperspectivetowardtheir lives.Femaleparents,especially,expressfearorangeratthe eyesofstrangersintheirworkplace.Theyalwaysrejectparties withfriendsorrelatives,feelingthattheyare“inferior”and “worsethanothers.”Underthisself-cognition,theirgoalof rehabilitationfortheirchildrenistohavenormalchildrenor childrenwhoappeartobenormal.Ifthefamilymemberssee nohopeofrecoveryforthedisabledchild,theywillrefuseto receiverehabilitation.

Thereisnohopetorecovery.Itistootir[ing].Wewanttosendher toacarecenter.Oncesheisthere,wecanleaveitaloneandjustgo toseeheronceamonth(case9).

ChoiceofCareintheTraditionalConceptof Procreation

Theconceptofprocreation,underthenation’sfamilyplanning policy,iscloselylinkedtotheideathatpersonswithdisabilities areincompleteandinferior.Afamilyplanningpolicyhasbeen carriedoutinChinafrom1982tothepresent.From1982to2015, aone-couple-one-childpolicy,oronechildinonecouple,was strictlyenforced.Insomespecialcases,however,twochildren wereallowed,andonesuchspecialcasewaswhenthefirstchildof thecouplewasdisabled.Since2016,aone-couple-two-children policyhasbeenadopted,andinsomespecialcasesthreechildren areallowed,includingthecaseinwhich“thecouplegivesbirthto twochildren,withoneofthemidentifiedasbeinghandicapped whocannotgrowintoanormallaborforceaccordingtolaw” (51).Withtheexceptionofsomehouseholdsthatareafraidof havinganotherchildwithadisability,mostcouplesdochooseto haveanotherchildandhopethathe/sheisnormal.Otherwise,the familyisnotconsideredperfect.

InChinesesociety,thefamilyplaystheessentialrolein providingwelfarefordisabledchildrenintheirlivingsituation andtheirspirituallife.Throughoutthenation’slonghistorical development,theChinesefamilysystemhasalwayspreserved greatinternalstabilityandformedasolidfamilycaremodel(52). Researchfindingshavepointedoutthatthefixedcycle,beginning with“raisingchildren”andendingwith“caringfortheold,” ismaintainedandreproducedintergenerationally.Ofthetwo parents,themotherisusuallythecaregiverduringthestageof raisingthechildren.Inourstudy,incases5,6,and10,other familymembersundertookcaregivingdutiesonlybecausethe mothersweredisabled.Furthermore,ingeneral,afterthebirth

ofthefamily’ssecondorthirdchild,themother,asthemajor caregiver,cannotmaintainabalanceintakingcareoftwooreven morechildren,oneofwhomisdisabled.Then,shemustchoose betweentwooptions.

Thefirstchoiceistovoluntarilyabandonthedisabledchild andtogiveadequatecaretothehealthyone,thus,resultinginan exclusionerror.

Theeldestbrotheris23nowandisgoingtogetmarriedsoon.I cannotstayhereallthetime.Sonextyear,weplantogiveup rehabilitation.We’llseewhetherwecansendhimtoaspecial educationschoolsothatI’llhavetimetomanagemyfamilymatters (case11).

Thesecondoptionistodependonthesystemofurgentlyneeded careagenciestoprovidecareforthechildwithadisability. Whencareagenciesandprofessionalcareworkersarescarceand expensive,suchfamiliesareforcedtotransferthecarepressureto rehabilitationagencies,whereinchildrencanhaveclassesevery day.Inthatway,thecareburdenofthefamilycanbealleviated, thus,resultinginaninclusionerror.

Thischildis15now.Tobehonest,hecannotmakeanyprogress here.Hecomesjusttoplay.Hismotherandfatherarebothworking withoutanytimetotakecareofhim.Isendhimhereeveryday. There’sateacherinclass,andwedon’thavetotakecareofhim everyminute(case4).

DISCUSSIONANDCONCLUSIONS

Thisresearch,basedonacasestudyofZW,inMainlandChina, startedwithathree-dimensionaltheoreticalframeworkforpolicy contextandconductedasystematicanalyticinvestigationinto supply-demanddeviationsintheimplementationoftheRASDC, aswellasthereasonsbehindthosedeviations.Thestudy’s majorfindingrevealedthatthefailureoftherehabilitation policywasnotduetojustthepolicycontentitselfbutwas alsoduetothecontextofpolicyimplementation,withspecial aspectsoftheChineseenvironmentaffectingthefinalresult ofimplementingtheRASDC,whichhaveanegativeimpact ontheirhealth.Theempiricaldatawecollectedpresented exclusionerrors,inwhichthosewhoshouldenjoytheservices didnotreceivethem,andalsoinclusionerrorsofwasted resources.Tobeconcrete,intheregulatorycontext,thelocal government’simplementationoftheRASDCpolicywasaffected byformalandinformalrules,suchas,thetargetedmanagement responsibilitysystem,theadministrativecontractingsystem,and promotiontournaments,allofwhichcausedbarrierssuchas, theexclusionofdisabilitytypes,exclusionduetoinconsistent serviceavailabilityintheregionofthefamily’sresidence,and inclusionerrorsofextraservicesbeinggiventothosewho didnotneedthem.Inthenormativecontext,thebehavior andactivityofrehabilitationagencieswerelimitedbystrong normsandweaksocialresponsibility.Prioritywasgivento accomplishingthegovernment’stasksformally,notvirtually,by showingpreferencetothosewithmilddisabilitiesandneglecting thosewithseveredisabilities.Finally,inthecognitivecontext,

TABLE5| Contextsandtypes ofdeviations.

Contexts CharacteristicsofcontextsTypesofdeviations

RegulatorycontextTargetmanagement responsibilitysystem

Exclusion error

Administrativesubcontract system Exclusionerror

PromotiontournamentsystemInclusionerror NormativecontextStrongnorms Exclusionerror, inclusionerror WeaksocialresponsibilityExclusionerror, inclusionerror

CognitivecontextStigmatization Exclusionerror Traditionalconceptsof procreation&care Exclusionerror, inclusionerror

childrenwithdisabilitieswereconsideredasaspecialgroup, andwereconceived ofasbeingdifferentfromhealthypeople. Householdswithdisabledchildrenfeltashamedandinferior. Thosekindsofattitudespreventedthefamiliesfromactively acquiringtheservices,orforcedthemtorelinquishtheservices, orpressuredthemtotransferthedisabledchild’scareinthe dynamicofcontinuingtohaveotherchildren.Thesefindingsare summarizedin Table5

Thisresearchcanprovideinspirationandsuggestionsfor improvingtheprecisionofimplementingtheRASDCpolicy’s servicesforchildrenwithdisabilities.TheWorldHealth Organization(WHO)istryingtodesigninternationalstandards forrehabilitationservicesthatcanbeusedeverywhere,oneof whichis theWHOGlobalDisabilityActionPlan2014-2021: betterHealthforAllPeoplewithDisability.Theactionplanputs forward7actionstoachievethegoalof“strengthenandextend rehabilitation,habilitation,assistivetechnology,assistance andsupportservices,andcommunity-basedrehabilitation”: providingleadershipandmanagement,providingadequate financialresources,developingandmaintainingasustainable workforce,establishingahealthcaresystemmechanismfor effectivecoordination,makingavailableappropriateassistive technologies,promotingaccesstoarangeofassistanceand supportservices,supportingandbuildingthecapacityof personswithdisabilities,andtheirfamilymembersand/or informalcaregivers(53).Accordingtothefindingsofthisarticle, combinedwith theinternationalreformplan,rehabilitation policyinMainlandChinaneedstobeoptimizedandreduceboth exclusionerrorsandinclusionerrors,soastorealizethevision ofaccuraterehabilitationforallpersonwithdisabilities.This actionplanspecificallyincludes:

Proposedaction1:Revisepolicies,standards,and implementationmanagements.First,thegovernmentshould strengthenpolicies,strategiesandplansonhabilitation, rehabilitation,assistivetechnology,supportandassistance services,community-basedrehabilitation,andrelatedstrategies basedontheactualnumberandneedsofdisabledchildren. Secondly,thegovernmentshouldbreakgeographicalboundaries andprovideadequatefinancialresourcestoincreasecoverage andaccesstorehabilitationservicesfornon-localchildren withdisabilities.Finally,theevaluationindicatorsofthe DisabledPersons’Federationsatalllevelsshouldbereformed

bycomprehensivelyevaluatingtheactualservicedemandand servicequality,ratherthanthepolicytextsandsupplyquantity.

Proposedaction2:Enhancethesocialresponsibilityof rehabilitationagencies.Tobeginwith,arehabilitationassistance networkshouldbebuilttoexchangeinformationbetween differentrehabilitationagenciesand,whenappropriate,to providereferralservicesinordertobalancethedifferentpressure ofrehabilitationagencies.Moreover,third-partysupervisionand bottom-uppublicsupervisionshouldbestrengthenedtoimprove rehabilitationagencies’socialresponsibilityandtoachievea rationalallocationofrehabilitationresources.Inaddition,it isimportanttotrainhealthpersonnelforearlyidentification, assessment,andreferralofchildrenwithdisabilities,especiallyin undevelopedareas.

Proposedaction3:Fosteranenvironmentofequality,social acceptance,andintegrationforchildrenwithdisabilities.We needtointernallyandculturallychangetheminds,feelings,and acquireddispositionsofthepublicandfamilieswithdisabilities, or,inBourdieu’sword,theirhabitus.Duringthetransformational process,itwillbeimportanttobuildsocialconsensusby publicizingrehabilitationthroughnetworksandthemedia,by popularizingtheNewConcepttowardPersonswithDisabilities, andbyenhancingpeople’ssocialsenseofresponsibility.Wealso mustincreasecommunicationwithfamilieswhohavechildren withdisabilitiesandconvincethemthatthosechildrenarenot justadragonthefamily–thatinstead,theirchildrencan returntotheirfamiliesandsocietythroughproperrehabilitation treatments.Psychologicalsupportprovidedforparentswith disabledchildrenwillimprovethequalityofcaretheygiveto theirchildrenandconsequentlyincreasethequalityoflifeof childrenandfamily(54).

Thisresearchhadthreemainlimitations.First,itwasdifficult toobtainmuchinformationfromthepastresearch,because thiswasthefirstqualitativeresearchdiscussingimplementation deviationoftheRASDC,andthereasonsforit,fromthe perspectiveofpolicycontext.Second,theRASDCwasanew policy,andtherewerefluctuationsinthetaskindexesand evaluationmethodsthatmighthaveaffectedthecredibilityof thedata.Last,thisresearchwasbasedonasinglecasestudy, butChina’spopulationstructure,itsurbanandruralstructures, anditsbureaucraticstructurearequitecomplex,meaningthat theRASDCdiffersindifferentprovincesandcities.Asaresult, theapplicabilityofthisstudy’sconclusionstootherregions andsituationsneedsfurtherdiscussionandreflection.Inthe future,additionalqualitativeandquantitativeresearchshouldbe conductedtoextendthecredibilityofourexistinganalysis.

DATAAVAILABILITYSTATEMENT

Theoriginalcontributionspresentedinthestudyareincluded inthearticle/supplementarymaterial,furtherinquiriescanbe directedtothecorrespondingauthor/s.

ETHICSSTATEMENT

Thestudiesinvolvinghumanparticipantswerereviewedand approvedbyAcademicCommitteeofJilinUniversity.The

patients/participantsprovidedtheirwritteninformedconsentto participateinthisstudy.

AUTHORCONTRIBUTIONS

CQ:conceptualization,methodology,investigation,writing theoriginalmanuscript,revisingthemanuscript,and administration.YW:conceptualization,investigation,writingthe originalmanuscript,andrevisingthemanuscript.Allauthors: contributedtothearticleandapprovedthesubmittedversion.

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ConflictofInterest: Theauthorsdeclarethattheresearchwasconductedinthe absenceofanycommercialorfinancialrelationshipsthatcouldbeconstruedasa potentialconflictofinterest.

Copyright©2021QiandWang.Thisisanopen-accessarticledistributedunderthe termsoftheCreativeCommonsAttributionLicense(CCBY).Theuse,distribution orreproductioninotherforumsispermitted,providedtheoriginalauthor(s)and thecopyrightowner(s)arecreditedandthattheoriginalpublicationinthisjournal iscited,inaccordancewithacceptedacademicpractice.Nouse,distributionor reproductionispermittedwhichdoesnotcomplywiththeseterms.

published:16August 2021 doi:10.3389/fpubh.2021.714044

Editedby: MagdalenaKlimczuk-Kochanska, Faculty ofManagemen,Universityof Warsaw,Poland

Reviewedby: SunWei, ShenzhenSecondPeople’s Hospital,China MingshengChen, NanjingMedicalUniversity,China

*Correspondence: YaFang fangya@xmu.edu.cn

Specialtysection: Thisarticlewassubmittedto PublicHealthPolicy, asectionofthejournal FrontiersinPublicHealth

Received: 24May2021 Accepted: 14July2021 Published: 16August2021

Citation: ZhangL,FuSandFangY(2021) ResearchonFinancingMechanismof Long-TermCareInsuranceinXiamen, China:ASystemDynamics Simulation. Front.PublicHealth9:714044. doi:10.3389/fpubh.2021.714044

ResearchonFinancingMechanism ofLong-TermCareInsurancein Xiamen,China:ASystemDynamics Simulation

LiangwenZhang 1,2,3 ,SijiaFu 1,2 andYaFang 1,2*

1 StateKeyLaboratoryofMolecularVaccinologyandMolecularDiagnostics,SchoolofPublicHealth,XiamenUniversity, Xiamen,China, 2 KeyLaboratoryofHealthTechnologyAssessmentofFujianProvinceUniversity,SchoolofPublicHealth, XiamenUniversity,Xiamen,China, 3 SchoolofEconomics,XiamenUniversity,Xiamen,China

Objective: Thisstudyaimedtopredictthechangingtrendoflong-termcareinsurance (LTCI)fundsbyclarifyingthelinkagebetweenrevenueandexpenditureanditsinfluencing factorsandtoprovideevidencefortheestablishmentofasustainableLTCIfinancing mechanisminChina.

Method: WehavetakenXiamenasanexample,basedonthedatafromXiamen SpecialEconomicZoneYearbookandfieldsurvey.ThechangingtrendofLTCIfunds ispredictedfrom2020to2030basedonthesystemdynamicsmodel(SDM)oftheLTCI financingsystem.Also,throughliteratureresearchandexpertconsultation,wefoundthe interventiongoalsandanalyzedtheirimpactonthebalanceofLTCIfunds.

Results: Inthecurrentsituation,accordingtotheforecast,therevenueandthe expenditureoftheLTCIfundswillincreaseyearbyyearfrom2020to2030inXiamen, anincreaseofabout3.7timesand8.8times,respectively.After2029,theexpenditure willexceedtherevenueoftheLTCIfundsandthebalancewillturnintoadeficit.From theperspectiveoffundrevenue,byadjustingtheindividualpaymentrate,government financialsubsidies,andenterprisepaymentrate,theproportionofLTCIfundscanbe increasedtoalleviatethebalancedeficitundertheoriginalforecast.Onthecontrary, fromtheperspectiveoffundexpenditure,increasingtheproportionofreimbursement andtherateofseveredisabilitywillleadtoanincreaseinfundexpenditure.Inthiscase, thebalanceofthefundswillturnintoadeficit,7yearsinadvance.Inaddition,itwas foundthattheseveredisabilityratehasthegreatestimpactonthebalanceoffunds.

Discussion: TheSDMcanobjectivelyreflectthestructureandthebehavioroftheLTCI financingsystemandhasgoodapplicability.Byincreasingtheindividualpaymentrate, governmentfinancialsubsidies,andenterprisecontributionrate,reasonablesettingof thereimbursementratioofnursingservices,especiallyforthepreventionofdisability amongtheelderly,tomaintainthesustainabilityofthefunds.Thisstudyprovidesstrong evidenceforpolicymakerstoestablishasustainableLTCIsysteminChina.

Keywords:long-termcareinsurance,financingmechanism,systemdynamicmodel,sustainability,modelingand simulation

INTRODUCTION

Chinahasenteredaperiodofrapiddevelopmentofpopulation aging,facingtheseverechallengeofdeepaging.Attheendof 2019,254millionpeoplewereagedover60years,accountingfor 18.1%ofthetotalpopulation,accordingtotheNationalBureau ofStatisticsofChina(1).Itisprojectedthattheproportionof elderlypeoplewill reachone-thirdby2050,exceedingthatof mostEUcountries(2).Asthepopulationages,thenumberof disabled peoplealsoincreases(3).Withtheincreasingdemand forprofessionalnursingcarefortheelderly,traditionalhomebasedcareisunsustainable.Thelong-termcareinsurance(LTCI) systemhasemergedasanimportantmeasuretorespondtothe needsofsocialcarecausedbytheagingofthepopulationand toreducetheeconomicandcareburdenontheindividualsand theirfamilies(4).Underthebackgroundofthechangeoffamily structureandtheweakeningoftraditionalsupportfunctions, itiscriticaltoestablishanLTCIsystemthatsuitsthenational conditionsofChina.

LTCIinChina

Atpresent,theChinesegovernmentisactivelyimplementingthe LTCIpolicy.InJune2016,theChinesegovernmentpublished the“GuidanceonPilotCitiestoLaunchLong-TermCare Insurance.”AttheendofJune2019,theLTCIschemehas beenpilotedin15cities,covering88.54millionpeople,and benefiting426,000people(5).InSeptember2020,theNational MedicalSecurityAdministrationpublishedthe“Guidanceon ExpandingthePilotCitiesoftheLong-TermCareInsurance” toexpandthepilotprogramoftheLTCI;14newLTCIpilot citieshadbeenplannedtobeaddedtotheoriginal15pilot cities.Thepilotperiodwillbe2years(6).Itcanbeseenthat theestablishmentandimprovementoftheLTCIsystemarethe inevitablechoicesforChinatocopewiththeagingpopulation. EnrolmentinLTCIislinkedtothemedicalinsurancestatusof individuals.Chinacurrentlyhastwomedicalinsuranceschemes, namely,theurbanemployeemedicalinsurance,coveringurban residentswithformalemployment,andmedicalinsurancefor urbanandruralresidents,coveringruralandurbanresidents withoutemployment.TheinsuredofLTCImustbetheinsured oftheurbanemployeeinsuranceorthemedicalinsurancefor urbanandruralresidents(7).Inaddition,accordingtothe disability assessmentcriteriasetbyeachpilotarea,mostofthe pilotareasguaranteethelong-termcare(LTC)needsofthe severelydisabled.Themaintypesofcarearehomecareand institutionalcare,andthestandardofinsurancepaymentisabout 50–70%.TheoperationofLTCIinvolvesmanyaspects,such asfinancing,evaluation,service,andsupervision.Amongthem, financingisthecoreoftheLTCIsystemandisthefoundation fortheformationofinsurancefunds,whichreflectstheinternal mechanismoffinancing.Howtobuildafair,reasonable,and sustainablefinancingmechanismistheprimaryproblemwhen establishinganLTCIsystem(8).

PreviousResearch

At present,theresearchabroadhasanearlystartinwhich theoreticalresearchandempiricalstudieshaveachievedfruitful

results.Previousstudiesmainlyfocusedonthefinancing model(9, 10),equity(11),andsustainabilityoffinancing (12),advantagesanddisadvantagesofpublicandprivateLTCI financing(13, 14),andcomparisonoffinancingmechanisms (15 17).Thequantitativestudiesonthefinancingmechanism ofLTCIhaveawiderangeofcontentsandmaturemethods. Theresearchcontentincludesbasicnursingdemandforecasting (18, 19),insurancepricing(20),policysimulation(18, 20),and costcontrol(21),amongothers,andthesystemdynamicsmodel (SDM)is introducedtooptimizethepensionsecuritysystem (22, 23).TheseresultsprovideareferenceforChinesescholars.

Atpresent,somedomesticscholarsfocusonanalyzing andsummarizingtheLTCIfinancinginOECDcountriesand domesticpilotcities(24, 25)andgraduallyexpandingto financingchannels(26),financingmodels(6),financialsupply anddemandforecasts(7, 27, 28),LTCIcontributionrate(29, 30)andotheraspects.Theresearchmethodsmainlyfocuson thetraditionallogistic regression,actuarialmodel,International LaborOrganizationfinancingmodel,andsoon.Fewstudieshave analyzedthefinancingmechanismofLTCIfromasystematic perspective.LTCIfinancingsysteminvolvescomplexsocial demography,healthmanagement,economics,andothermultidimensionalvariables.ResearchshowedthatSDMiswell-suited toaddressthedynamiccomplexityofhealth-relateddelivery systems(31).ThisstudyconsideredXiamenasanexampleto constructanSDMoftheLTCIfinancingsystem.Asoneofthe fivespecialeconomiczonesinChina,Xiamenisfacingtherisks andchallengesbroughtbytheagingpopulation,suchasthehigh agingrateandtheaveragelifeexpectancyofthepopulation,andit isurgenttomaintainthebalancebetweenthesupplyanddemand ofnursingservicesfortheelderly(32),whichisrepresentative andtypical.

Therefore,fromtheperspectiveofequity,efficiency,and sustainability,thisstudyconstructstheSDMofLTCIfinancing inXiamenunderthebackgroundofaging,makesamediumandalong-termpredictionofLTCIfinancing,whichmakesthe predictionresultsmorescientificandaccurate,andobserves thechangingtrendofLTCIfundsinthefuture.Then,by adjustingthekeypolicyindicators,suchasindividualpayment rate,theinfluenceofinterventiongoalsonthefinancingsystem ofLTCIwasanalyzedtoprovideevidenceoftheneedforthe establishmentofasustainablefinancingmechanismformultiple financialsupplies.

MATERIALSANDMETHODS

DataSources

Dataforthisstudyaretakenfromfieldresearch,expert consultation,theyearbookofXiamenSpecialEconomicZone, andpublishedresearchliterature.Basedontheprincipleof typicalsampling,fourrepresentativeLTCIpilotcities(Jiaxing, Shanghai,Chengdu,andJingmen)wereselectedfromtheeast, middle,andwestofChinatoconductthefieldresearch.The surveycontentmainlyinvolvestheinsuredpopulation,the methodandleveloffinancing,andpaymenttoreflecttheoverall constructionoftheLTCIsystem.Themaindatasourcesarelisted in Table1

TABLE1| Summary ofmaindatasources.

Parameters ValueUnit Source

Insuredpopulationofurbanemployees

273.8810,000peopleXiamenSpecial EconomicZoneYearbook2020

PercapitaGDP 142,739Yuan XiamenSpecialEconomicZoneYearbook2020

Percapitadisposableincomeofurbanresidents 55,870Yuan XiamenSpecialEconomicZoneYearbook2020

Insuredpopulationofurbanandruralresidents 14810,000peopleXiamenSpecialEconomicZoneYearbook2020

Percapitainstitutionalcarecostsb 30,000Yuan Surveydata

Percapitahomecarecostsb 18,000Yuan Surveydata

Changerateofinsuredpopulationofurbanemployeesa 6%Yuan XiamenSpecialEconomicZoneYearbook(2011-2020)

Changerateofinsuredpopulationofurbanandruralresidentsa 5.9%Yuan XiamenSpecialEconomicZoneYearbook(2011-2020)

ChangerateofpercapitaGDPa 5%DimensionlessXiamenSpecialEconomicZoneYearbook(2000-2020)

Governmentpercapitasubsidystandardb 0.04%DimensionlessAssumedvalue

Changerateofpercapitadisposableincomeofurbanresidentsa 8%DimensionlessXiamenSpecialEconomicZoneYearbook(2015-2020)

Enterprisecontributionrateb 0.04%DimensionlessAssumedvalue

Individualpaymentrateb 0.06%DimensionlessAssumedvalue

Severedisabilityrateb 0.3%DimensionlessHistoricalliterature(33)/Surveydata

Proportionof choosingtheinstitutionalcareb 3%DimensionlessHistoricalliterature(34)

Proportionof choosinghomecareb 97%DimensionlessHistoricalliterature(34)

Reimbursement ratiob 70%DimensionlessAssumedvalue

aCalculatedbyusingdatafromXiamenSpecialEconomicZoneYearbook. bAccordingtotheactualoperationandinvestigationofLTCI,thebaseofseveredisabilityrateisthetotal numberofinsuredpeople.Thebaseofindividualpaymentrateisthepercapitadisposableincomeofurbanresidentsin2019;andtheenterprisecontributionrateandgovernmentper capitafinancingstandardbasepercapitaGDPin2019.

KeyAssumptions

Atpresent,XiamendoesnotimplementtheLTCIsystem. Therefore,accordingtopublishedresearchliterature,combined withthefieldresearch,thekeyassumptionsofthisstudyare asfollows:(a)XiamenimplementedLTCIin2019,andthe forecasttimeofthemodelis2020-2030.(b)Atpresent,the enrollmentinLTCIislinkedtothemedicalinsurancestatus ofindividuals’inpilotcities.Toensurethefairnessofthe implementationofthesystem,itisassumedthatthosewho participateinLTCIareinsuredofallmedicalinsurance,andthose whoenjoythebenefitsofLTCIaretheseverelydisabledpeoplein theinsuredpopulation.(c)FundsforLTCImainlycomefrom premiumpayments,withouttakingintoaccounttheinvestment andoperationincomeofinsuranceinstitutions.(d)Xiamen implementsacompulsorysocialLTCIsystem,whichraises fundsthroughvariouschannelssuchasindividual,enterprise contributionandfinancialsubsidiesandestablishesadiversified financingmechanism,whichisnotattachedtothemedical insurancefunds.(e)Theeconomicdevelopmentisrelatively stable,andthepercapitaGDPandwagelevelsmaintainacertain growthratewithoutmajorfluctuations.

ModelConstruction

SystemAnalysis

ThemodelingprocessofSDMmainlyincludes:(a)System subjectanalysis:Throughcollectingandanalyzingthepolicy documentsandliteraturerelatedtotheLTCIfund,thisstudy identifiesthestakeholdersoftheLTCIfinancingsystem.On thisbasis,thesystemanalysismethodisusedtodetermine themainbodyofthesystem:individuals,enterprises,andthe government.(b)Drawingofthecausaldiagram:IntheSDM,

thesystemstructureiscomposedofthefeedbackloop,which showstherelationshipbetweenvariablesandtheactionpath. Basedonthepurposeofthestudyandtheactualoperationof LTCIfinancing,thisstudymakesaloopanalysisontherevenue subsystemandtheexpendituresubsystemoftheLTCIfunds. Thevariablesofthetwosubsystemsandeachsubsystemare interrelatedandrestrictedandultimatelyaffectthebalanceof theLTCIfunds(Figure1).Inthisfigure,thearrowrepresents therelationshipamongvariables,andthedirectionofeachline showsthedirectionoftheeffect.Thesign“+”dictatesthat thevariableschangeinthesamedirection,whilethesign“–”dictatesthatthevariableschangeintheoppositedirection. (c)Modelconstruction:Accordingtothecausalitydiagram, withthehelpofaliteraturereviewandsystemanalysistheory, therelationshipsbetweenvariablesinthemodelaredefined (Figure2).TherevenuesubsystemofLTCIfundsincludesthe revenueofurbanemployees,retirees,andurbanandrural residents.TheexpendituresubsystemofLTCIfundsisaffected bythetotaldemandandreimbursementratioofLTCexpenses. Throughdrawingthesystemflowdiagramandestablishing thestructuralequation,theinitialvalueofvariablesrefersto officialstatistics,andthefunctionalrelationshipbetweenthe variablesaredeterminedbythesocialinsuranceactuarialmethod andtheregressionanalysismethod.(d)Simulationandpolicy optimization:BasedontheoperationofLTCI,combinedwith fieldsurveyandsensitivityanalysis,thisstudyselectsfivekey variablesthataffecttherevenueandtheexpenditureoftheLTCI fundforscenariosimulation.

SensitivityAnalysis

Sensitivityanalysisdeterminestheinfluencedegreeofparameters onthemodelbychangingtheparametersandcomparingthe

FIGURE1| Causalitydiagramof LTCIfinancingsystem.

FIGURE2| Flowdiagramof LTCIfinancingsystem.

outputofthemodel.BasedontheLTCIoperationsituation, combinedwith fieldinvestigations,weselectedfivekeyvariables thataffecttherevenueandtheexpenditureoftheLTCI fundsforsensitivityanalysis,namely,individualpaymentrate, governmentfinancialsubsidiesandenterprisecontributionrates, reimbursementratioofnursingservices,andseveredisability

rate,toverifytheinfluenceofparametersonthebalanceof LTCIfundstoachievesensitivityanalysis.Wesetthenumber ofverificationsto200andusedrandomuniformdistributionto verify.TheresultsshowthattheLTCIfundbalancehaschanged significantlybyadjustingtheparameterrange(Figure3),which providesareferenceforpolicyintervention.

HistoricalTest

Themodelhaspassedthedimensionalconsistencytest,the structuraltest,andthehistoricaltest.Accordingtothedata availabilityandthehistoricaltests,thenumberofinsuredmedical insurancebyurbanemployeesinpopulationfactorsandthe percapitadisposableincomeofurbanresidentsineconomic factorsareselectedforthesimulationdata.Bycomparingthe dataofthemedicalinsuredpopulationofurbanemployeesand percapitadisposableincomeofurbanandruralresidentsin theyearbookofXiamenSpecialEconomicZone(2012-2019), thehistoricaltestofthemodelwascarriedout.Theaverage errorbetweentheactualdataandthesimulationdatais0.67% (Table2).Withinareasonablerange,themodelishighlyfitting, effective,andreasonable.

RESULTS

TheSDMcanobjectivelyreflectthestructureandthebehavior oftheLTCIfinancingsystemandhasgoodapplicability.Inthis section,first,weanalyzethechangesintherevenue,expenditure, andbalanceoftheLTCIfundinthecurrentsituationand,second, weanalyzethefuturetrendofthefundbychangingthefivekey variablesthataffectthebalanceoftheLTCIfund.Finally,by comparingtheimpactofthesevariablesonthefundbalance,the correspondingconclusionsaredrawn.

AnalysisoftheCurrentSituation

Figure4 and Table1 showtherevenue,expenditure,andbalance oftheLTCIfundsfrom2020to2030.Therevenueandthe expenditureoftheLTCIfundsshowanincreasingtrendyearby year,anincreaseofabout3.7timesand8.8times,respectively. After2029,theexpenditureoftheLTCIfundswillexceedthe revenueoffunds,andthebalanceoffundswillincreasefirstand thendecrease;itwillreach– 34.05millionin2030.

PolicyIntervention

BasedontheoperationofLTCI,combinedwithfield investigation,thisstudyselectedfivekeyvariablesaffecting therevenueandtheexpenditureofLTCIfunds,including

individualpaymentrate,reimbursementratioofnursing services,therateofseveredisability,governmentfinancial subsidies,andenterprisecontributionrates.Keyvariableswere adjustedtoconductscenariosimulations,andthechanging trendsofLTCIfundsrevenues,expenditures,andbalanceswere comparedunderdifferentinterventionprograms.

AdjustIndividualPaymentRate

Toensurethefairnessoftheimplementationofthesystem, thebaseoftheindividualpaymentratesofurbanemployees andurbanandruralresidentsisthepercapitadisposable incomeofurbanresidents.Also,todecreasetheburdenofthe individualpayment,accordingtothepracticeofthepilotarea, theproportionofsimulatedsetvaluewassetbetween0.06and 0.1%,whichisabout 30–55(basedonthepercapitadisposable incomeofurbanresidentsin2019).

Test1-1:individualpaymentrate = 0.06%

Test1-2:individualpaymentrate = 0.08%

Test1-3:individualpaymentrate = 0.1%

TheresultsshowthatincomparisonwithTest1-1,therevenueof theLTCIfundsofTest1-3increasedby 416millionto 1.819 billion,andthebalanceincreasedby415.75millionto 381.7 million.Test1-1willturnintoadeficitinthebalanceofthe LTCIfundsin2030,andafterraisingtheindividualpaymentrate (Test1-2andTest1-3),thebalanceoffundsdidnotturnintoa deficitinthesimulatedyears(Figure5).Therefore,theincrease inindividualpaymentratescanincreasetherevenueoftheLTCI fundsanddelaytheyearwhenthebalanceoffundsturnsinto adeficit.

AdjusttheReimbursementRatioofNursingServices

Allofthepolicydocumentspointedout“differentiatedtreatment guaranteepoliciesareformulatedaccordingtothelevelofcare andservicedeliverymethods,andthepaymentleveloffunds isgenerallycontrolledatabout70%forLTCIexpenditurethat meetstherequirements.”Accordingtothepracticeinthepilot area,thereimbursementratioofnursingservicesisabout50–90%.Therefore,thisstudysetsthesimulationvalueofthe reimbursementratioas50,60,70,80,and90%.

Test2-1:Reimbursementratio = 50%

Test2-2:Reimbursementratio = 60%

Test2-3:Reimbursementratio = 70%

Test2-4:Reimbursementratio = 80%

Test2-5:Reimbursementratio = 90%

Theresultsshowedthat,withtheincreaseinthereimbursement ratioofnursingservices,theexpenditureofLTCIfundsalso increased.IncomparisonwithTest2-1,theexpenditureofthe LTCIfundsinTest2-5increasedby 822millionto 1.848 billionin2030,andthebalanceoffundsturnsintoadeficitearlier thaninothersituations(Figure6).Therefore,theincreaseofthe reimbursementratiowillincreasetheexpenditureoftheLTCI fundsandacceleratethedeficitofthebalance.

FIGURE3| Sensitivityanalysisdiagram

TABLE2| Historicaltest.

Year Medicalinsuredpopulationofurbanemployees

Actualdata/10,000 people Simulation data/10,000people

Percapitadisposableincomeofurbanresidents

Errorrate/%Actualdata/10,000 people Simulation data/10,000people Errorrate/%

2012 182.15 180.7244 0.78265 37,576 38382.08 2.1452

2013 192.26 191.4216 0.43608 41,360 36,772 11.09284

2014 203.64 199.4962 2.03487 39,625 39539.296 0.216288

2015 212.23 209.7704 1.15893 42,607 42923.712 0.74333

2016 223.16 228.185 2.251748 46,254 46417.632 0.35377

2017 242.75 241.956 0.32709 50,019 50484.128 0.9299

2018 257.4 257.4472 0.018337 54,401 51847.36 4.694105

FIGURE4| Therevenue, expenditure,andbalanceofLTCIfunds.

FIGURE5| Therevenue andbalanceofLTCIfunds.

AdjustGovernmentFinancialSubsidiesand EnterpriseContributionRates

To ensurethefairnessoftheimplementationofthesystem, thebaseofgovernmentfinancialsubsidiesandenterprise contributionratesarebothpercapitaGDP,andthetwovalues areequal.Theproportionofthesimulationsetvalueisbetween 0.04and0.07%,thatis,about 55–100(basedonthepercapita GDPin2019).

Test3-1:governmentfinancialsubsidiesandenterprise contributionrates = 0.04%.

Test3-2:governmentfinancialsubsidiesandenterprise contributionrates = 0.05%.

Test3-3:governmentfinancialsubsidiesandenterprise contributionrates = 0.06%.

Test3-4:governmentfinancialsubsidiesandenterprise contributionrates = 0.07%.

TheresultsshowedthatincomparisonwithTest3-1,therevenue oftheLTCIfundsofTest3-4increasedby 584millionto 1.87 million,andthebalanceincreasedby 584.45millionto 550.4 million.Test3-1showedadeficitinthebalanceoftheLTCIfunds in2030.Afterraisingtheenterprisecontributionrateandthe percapitafinancingstandardofthegovernment(Test3-2,Test33,andTest3-4),thebalanceoffundsdidnotturnintoadeficit inthesimulatedyears(Figure7).Itcanbeseenthatraisingthe financingstandardofenterprisesandgovernmentsubsidiescan increasetherevenueoftheLTCIfundsandpostponetheyear whenthebalancebeginstodecline.

AdjusttheRateofSevereDisability

AllofthepolicydocumentspointedoutthattheLTCIsystem takestheinsuredwhohasbeeninastateofdisabilityfora longtimeastheprotectionobject,focusingonthebasiclife careofseverelydisabledpeopleandthemedicalcareclosely relatedtobasiclifeandotherexpenses.Atthebeginningofthe system,limitedresourcesshouldbeusedonthepeoplewhoare mostinneedofprotection,whichnotonlydoesnotcausea wasteofresourcesbutalsodoesnotcauseexcessivepressure onenterprisesandindividualstopayfees(35).Atpresent,the beneficiaries oftheLTCIinpilotcitiesofChinaaremainly

severelydisabledelderly,andtheassessmentcriteriafordisability aremainlybasedontheBarthelindex.Accordingtothepractice inthepilotarea,duetotheslightlydifferentselectionofdisability assessmentcriteria,themeasuredvalueandrealvalueofthe severedisabilityrateareabout0.3and0.5%.Therefore,inthis study,thesimulationvalueoftheseveredisabilityrateissetto 0.3,0.4,and0.5%.

Test4-1:Therateofseveredisability = 0.3%.

Test4-2:Therateofseveredisability = 0.4%.

Test4-3:Therateofseveredisability = 0.5%.

TheresultsshowedthatthetotalexpenditureofTest4-3is 958 millionhigherthanthatofTest4-1to2030,reaching 2.395 billion(Figure8).Increasingtherateofseveredisability,the balanceoftheLTCIfundsturnsintoadeficitinadvance.Itcan beseenthatthelowertheseveredisabilityrateis,thelowerthe expenditureofLTCIfundscanbereduced,andtheyearwhenthe balancepresentsdeficitcanbedelayed.

ComparisonofInterventionEffect

Furtheranalyzethedifferencesintheimpactofadjusting individualpaymentrates,reimbursementratioofnursing services,severedisabilityrates,enterprisecontributionrates, andgovernmentpercapitafinancialsubsidiesonfundbalances. TakingthebalanceoftheLTCIfundsastheobservation index,theindividualpaymentrate,reimbursementratio, enterprisecontributionrate,andgovernmentpercapitafinancial subsidiesincreaseby10%undertheconditionofother conditionsunchanged.

Itcanbeseenfrom Table3 thatwhentheindividualpayment rateincreasesby10%,thechangerangeofthebalanceofthe LTCIfundsfrom2020to2030is ∼8.91–54.37%;whenthe proportionofreimbursementincreasesby10%,thechangerange offundbalancefrom2020to2030is ∼-311.42to 10.16%;when theenterprisecontributionrateandthegovernmentpercapita financialsubsidiesincreaseby10%,thechangerangeofthefund balancefrom2020to2030is ∼-144.37to1.13%;finally,when theincreaserateofseveredisabilityis10%,thechangerange offundbalancefrom2020to2030is ∼-653.94to 21.39%.It canbeseenthattheeffectsofthefourinterventiongoalsonthe

FIGURE6| Theexpenditure andbalanceofLTCIfunds.

FIGURE7| Therevenue andbalanceofLTCIfunds.

FIGURE8| Theexpenditure andbalanceofLTCIfunds.

balanceofLTCIfundsaredifferent.Theeffectsonthebalanceof theLTCIfundsfromhightolowaretherateofseveredisability, thereimbursementratio,therateofenterprisecontribution, thegovernmentpercapitafinancialsubsidies,andtherateof individualpaymentrates.

DISCUSSION

ThefinancingsystemofLTCIinvolvescomplexsocial demography,healthmanagement,economics,andothermultidimensionalvariables.Regardingitasalargesystem,itsmain bodyincludesthegovernment,enterprises,insuredpersons,and nursinginstitutions,amongothers,whichalsocontainsmultiple subsystemsandtheirinfluencingfactorsthataffectandrestrict eachother.ThisstudyisbasedontheSDMofXiamenLTCI financingtosimulatepolicyinterventionstrategies.Withoutany intervention,therevenueandtheexpenditureoftheLTCIfunds showanincreasingtrendyearbyyear,anincreaseofabout3.7 timesand8.8times,respectively.After2029,theexpenditure oftheLTCIfundsexceedstherevenue,andtheaccumulated balancewillturnintoadeficit,reaching– 34.05millionin2030, atwhichtimetheLTCIfundswillbeinsolvent.Theresultsshow that,ifnointerventionmeasuresaretaken,therevenueandthe

expenditureoftheLTCIfundswillfacetheriskofimbalance.By predictingthefuturedevelopmenttrendofLTCIfunds,itreflects thenecessityandurgencyofimprovingtheLTCIfinancing systemandestablishingaunifiedLTCIfinancingmechanism.

ThisstudyintroducedtheestablishedLTCIfinancingSDM asanexperimentalplatformtosimulatepolicyinterventions andjudgedtheeffectsandimpactofvariousstrategiesby observingchangesinsystembehavior.Aimingatthekeyvariable ofLTCIfunds,first,bysettingtheindividualpaymentrateof LTCIparticipantsat0.08–0.1%,itwasfoundthatincreasing theindividualpaymentratecandelaythebalanceoffunds turnintoadeficit;second,theenterprisecontributionrateand governmentpercapitafinancingstandardareadjustedto0.04–0.07%.Theresultsshowedthatthebalanceoffundsdoesnot turnintoadeficitinthesimulationperiodwhenthegovernment financialsubsidiesandenterprisecontributionrateareincreased. Byadjustingthepoolingfundsandpersonalaccountsofbasic medicalinsurance,theLTCIfinancingmechanismundertaken byindividuals,enterprises,andgovernmentscanbeconstructed, withoutincreasingthesocialsecuritypaymentburdenofthe enterprisesandindividuals(36).Withtheexplorationand improvementof thesystem,itwasrecommendedtoincrease thepaymentcapacityoftheLTCIfundspromptlyandfurther

TABLE3| Percentagechange ofthelong-termcareinsurancefundsbalance underdifferentinterventionschemes(%).

YearBasedontheoriginalresearchhypothesis,increase10%, respectively

Individual paymentrates Governmentfinancial subsidies,and enterprisecontribution rate

Reimbursement ratio Severe disability rate

20198.91 1.13 10.16 21.39 2020 9.85 0.18 12.12 25.46 202111.06 1.09 14.7 30.8 202212.79 2.84 18.23 38.21 202315.36 5.27 23.31 49.01 202419.36 9.32 31.56 66.3 202526.69 16.64 46.73 98.17 202644.55 34.58 83.84 176.08 2027154.37 144.37 311.42 653.94 202895.96 105.97 207.69 436.09 202935.29 45.26 81.94 172.04 203021.12 31.12 52.61 110.43

increasethegovernmentfinancialsubsidiesforurbanandrural residentsin LTCI.Atthisstage,thepeoplewhoenjoythe LTCIaretheelderlygroup.Toensuretherationalityand fairnessofthesystem,itisrecommendedtoimplementapaying policyforurbanretiredemployees.Withoutcausingpressure onthepaymentofretireesandthegovernment,thepaymentof premiumsbyretiredemployeescanincreasetherevenueofthe LTCIfundsandmaintainitsstabilityandsustainability(37).

Inaddition,thepolicydocumentsallpointedout “differentiatedtreatmentguaranteepoliciesareformulated accordingtothelevelofcareandservicedeliverymethods,and thefunds’paymentlevelisgenerallycontrolledatabout70%for LTCIexpenditurethatmeetstherequirements(5, 6)”.According tothe practiceofpilotareas,thereimbursementratioofnursing servicesisadjustedtobeabout50–90%.Theresultsshowed that,asthereimbursementratioincreased,theexpenditureof theLTCIfundsalsoincreased,acceleratingthedeficitinthe balanceoffunds.Therefore,tomaintainthesustainabilityofthe funds,theinitialpaymentstandardofnursingserviceshould notbetoohighandshouldbereasonablydeterminedaccording totheprincipleof“determiningexpenditurebyrevenue.”In theinitialstageoftheimplementationofthesystem,through timelyanalysisoftheservicecontentandpaymentstandards formulatedinthepreviousperiod,theactualapplicationof theservicecontentandpaymentstandardsarecontinuously adjustedaccordingtotheactualsituation.Inthelaterstageofthe implementationofthesystem,passiveprotectionaftertheevent canbetransformedintoanactivecomprehensiveprotection of“prevention + compensation,”whichnotonlyguarantees thesustainabilityofsystemoperationbutalsohelpstobuilda healthyagingsociety(38, 39).

Finally,accordingtothepracticeofpilotareas,duetothe slightlydifferentselectionofdisabilityassessmentcriteria,the adjustedseveredisabilityrateisabout0.3–0.5%.Theresults

showthatincreasingtheseveredisabilityratewillleadto thedeficitoftheLTCIbalanceoffundsaheadoftime.In comparingtheeffectoffourinterventiontargetsonthebalance ofthefund,itwasfoundthattheseveredisabilityratehasthe greatestimpactonthefundbalance.Atpresent,thedomestic assessmenttoolsfordisabilitylevelsaremainlybasedonthe Barthelindex,whichmeasuresbasicdailylivingability.The contentofthedisabilityassessmentisrelativelysingle,only measuringself-careability,andthedisabilityassessmentisnot comprehensiveenough.IfonlyasingleBarthelindexscaleis usedfordisabilityassessment,itmayleadtoahighdisability rate,whichisnotconducivetomaintainingthestabilityand sustainabilityoftheLTCIfunds.Therefore,combinedwith thecurrentpracticeinpilotareas,itissuggestedthatthe followingpointsshouldbeconsideredintheconstructionof disabilityassessmenttool:(a)atpresent,Chinahasnotyet formedaunifiednationalLTCIsystem,andtheselectionof disabilityassessmentcontentshouldmatchwiththelocalLTCI servicedeliverycapacityandscientificallyjudgethedegreeof disability;(b)developingthecorrespondingdisabilityassessment informationmanagementsystemandusingtheinformation systemtocompletetheassessmentwork,whichcanavoid subjectiveandhumanfactorsintheassessment;and(c)relying onthelocalmedicalinstitutionsatalllevelsandestablishinga databaseofevaluationexpertstoensurefairnessandjusticein theevaluation(40).

Underthe currentsocialbackground,foreignexperience showsthatitisurgenttobuildanLTCIsystemwithsocial insuranceasthemainbody,financialsubsidiesasthesupport, andcommercialinsuranceasthesupplement.Atthesame time,policymakersshouldestablishamulti-dimensionaland dynamicfinancingmechanismsharedbyindividuals,enterprises, andgovernment(41).AsfarasChinaisconcerned,ithas becomea trendtodesignLTCIasanindependentfinancing insurance,whichisparalleltoothersocialinsurance.However, fewstudieshaveanalyzedthefinancingmechanismofLTCI fromasystematicperspective.Therefore,basedonthefield research,thisstudyconstructsthefinancingmechanismof theindividuals,enterprises,andthegovernment,whichcan providethebasisforthefurtherimplementationandsustainable developmentofthesystemandalsothereferenceforother developingcountriestoestablishasustainableLTCIsystem (42).Partofthedataisbasedonfieldinvestigationandexpert consultationconducted infourrepresentativeLTCIpilotcities, Jiaxing,Shanghai,Chengdu,andJingmen,whichincreasedthe reliabilityofthemodelandenrichedthequantitativeresearch ontheLTCIsystem.Itprovidestheoreticalsupportforthe constructionandoptimizationoftheXiamenLTCIfinancing mechanism.However,therearestillsomelimitationstoour study.First,duetothelackofrelevantdata,theparameters aresetusingtheestimationmethodandlackofdynamic, suchasseveredisabilityrate,whichmayaffecttheaccuracy ofthemodelprediction(43).Second,thisstudymainlytakes Xiamenas anexample,lackingacomprehensivestudyon thenationalLTCIsystem,butitprovidesideasforthestudy ofthenationalLTCIfinancingmechanism.Therefore,inthe future,wewillcarryoutresearchnationwideandsetsome

parametersaccuratelytoprovideamorevaluablereference forthe developmentandimprovementoftheLTCIsystem inChina.

CONCLUSIONS

Insummary,theSDMcanobjectivelyreflectthestructure andthebehavioroftheLTCIfinancingsystemandhas goodapplicability.Theresultsshowthattherevenueandthe expenditureoftheLTCIfundsdisplayanincreasingtrend yearbyyear.Byincreasingtheindividualpaymentrate, governmentfinancialsubsidies,andenterprisecontributionrate, reasonablesettingofthereimbursementratioofnursingservices, especiallythepreventionoftheelderlydisability,tomaintain thesustainabilityofthefunds.Therefore,first,itispossible tobuildanLTCIfinancingmechanismbornebyindividuals, enterprises,andgovernment,tofurtherincreasethegovernment financialsubsidiestourbanandruralresidents,toimplement thepaymentsystemforretiredemployees,toincreasethe revenueofLTCIfunds,andtoimprovethepaymentability ofthefundsinthefuture.Second,policymakersshouldbuild afairandeffectivedisabilityassessmentsystemaccordingto theactualsituationofthepilotareastoscientificallyjudgethe degreeofdisability.Inaddition,areasonablestandardsystemof treatmentprotectionshouldbeconstructedinaccordancewith theprinciple“expenditureisdeterminedbyrevenue,thebalance betweenrevenueandexpenditure”tomaintainthestabilityand sustainabilityoftheLTCIfunds.

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DATAAVAILABILITYSTATEMENT

Theoriginalcontributionspresentedinthestudyareincluded inthearticle/supplementarymaterial,furtherinquiriescanbe directedtothecorrespondingauthor/s.

AUTHORCONTRIBUTIONS

LZcontributedtothestudyconception,design,and draftedthemanuscript.SFparticipatedinthestatistical analysisanddraftedthemanuscript.YFsupervisedand revisedthemanuscript.Allauthorsreadandapprovedthe finalmanuscript.

FUNDING

ThisstudywassupportedbytheNationalNaturalScience FoundationofChina(GrantNo.81973144)andtheChina PostdoctoralScienceFoundation(GrantNo.2020M671949).The funderswhosupportedthisstudyhadnoroleinstudydesign, datacollection,andanalysis,decisiontopublish,orpreparation ofthemanuscript.

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TheauthorswouldthanktheYearbookofXiamenSpecial EconomicZone,foritssupportwiththedata.Wearealsograteful totheexpertswhoparticipatedinthesurvey.

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published:06August 2021 doi:10.3389/fpubh.2021.689809

Editedby: JorgeFelix, University ofSãoPaulo,Brazil

Reviewedby: AmjadMohamadiBolbanabad, KurdistanUniversityofMedical Sciences,Iran AndrzejKlimczuk, WarsawSchoolofEconomics,Poland

*Correspondence: QunhongWu wuqunhong@163.com LinghanShan linghanshan@126.com

†Theseauthorshavecontributed equallytothisworkandsharefirst authorship

Specialtysection: Thisarticlewassubmittedto PublicHealthPolicy, asectionofthejournal FrontiersinPublicHealth

Received: 01April2021

Accepted: 06July2021 Published: 06August2021

Citation: WangJ,TanX,QiX,ZhangX,LiuH, WangK,JiangS,XuQ,MengN, ChenP,LiY,KangZ,WuQ,ShanL, AmporfroDAandIliaB(2021) MinimizingtheRiskofCatastrophic HealthExpenditureinChina:A Multi-DimensionalAnalysisof VulnerableGroups. Front.PublicHealth9:689809. doi:10.3389/fpubh.2021.689809

MinimizingtheRiskofCatastrophic HealthExpenditureinChina:A Multi-DimensionalAnalysisof VulnerableGroups

JiahuiWang 1,2† ,XiaoTan 3† ,XinyeQi 1,2 ,XinZhang 1,2 ,HuanLiu 1,2 ,KexinWang 1,2 , ShengchaoJiang 1,2 ,QiaoXu 1,2 ,NanMeng 1,2 ,PeiwenChen 1,2 ,YeLi 1,2 ,ZhengKang 1,2 , QunhongWu 1,2*,LinghanShan 1,2*,DanielAdjeiAmporfro 1,2 andBykovIlia 1,2

1 CentreofHealthPolicyandManagement,HealthManagementCollege,HarbinMedicalUniversity,Harbin,China, 2 DepartmentofSocialMedicine,SchoolofPublicHealth,HealthManagementCollege,HarbinMedicalUniversity,Harbin, China, 3 ShenzhenHospitalofGuangzhouUniversityofTraditionalChineseMedicine(Futian),Shenzhen,China

Background: InmovingtowarduniversalhealthcoverageinChina,itiscrucialto identifywhichpopulationsshouldbeprioritizedforwhichinterventionsratherthanblindly increasingwelfarepackagesorcapitalinvestments.Weidentifythecharacteristicsof vulnerablegroupsfrommultipleperspectivesthroughestimatingcatastrophichealth expenditure(CHE)andrecommendinterventionpriorities.

Methods: DatawerefromNationalHealthServiceSurveyconductedin2003,2008,and 2013.AccordingtotherecommendationofWHO,thisstudyadopted40%astheCHE threshold.AbinaryregressionwasusedtoidentifythedeterminantsofCHEoccurrence; aprobitmodelwasusedtoobtainCHEstandardizedincidenceunderthecharacteristics ofsingleandtwodimensionsin2013.

Results: ThetotalincidenceofCHEin2013was13.9%,whichshowsageneral trendofgrowthfrom2003to2013.Familiesinwesternandcentralregionsandrural areasweremoreatrisk.Factorsrelatedtosocialdemographyshowthathouseholds withafemaleoranunmarriedheadofhouseholdorwithalowsocioeconomicstatus weremorelikelytoexperienceCHE.Householdswitholderadultsaged60andabove had1,524timeshigherlikelihoodofexperiencingCHE.Amongthehealthinsurance schemes,theparticipantscoveredbytheNewRuralCooperativeMedicalSchemehad thehighestriskcomparedwiththeparticipantsofallbasichealthinsuranceschemes. Householdswithseveralmembersseekingoutpatient,inpatientcareorwithnoncommunicablediseasesweremorelikelytoexperienceCHE.Householdswithmembers notseeingadoctororhospitalizeddespitetheneedforitweremorelikelytoexperience CHE.Characteristicssuchasahouseholdheadwithcharacteristicsrelatedtolow socioeconomicstatus,havingmorethantwohospitalizedfamilymembers,rankedhigh. Meanwhile,thecombinationofhavingilliteratehouseholdheadsandwithbeingcovered byotherhealthinsuranceplansorbynonerankedthefirstplace.Cancernotablycaused arelativelyhighmedicalexpenditureamonghouseholdswithCHE.

Conclusion: InChina,considering thevulnerabilityofthepopulationacrossdifferent dimensionsisconducivetothealleviationofhighCHE.Furthermore,peoplewithmultiple vulnerabilitiesshouldbeprioritizedforintervention.Identifyingandtargetingthemtooffer helpandsupportwillbeaneffectiveapproach.

Keywords:catastrophichealthexpenditure,financialprotection,universalhealthcoverage,China,insurance

INTRODUCTION

Throughoutthe40yearsof“reformandopeningup”of China,thecountryhasprogressedremarkablyintermsof socioeconomicdevelopment.ItsGDPhasincreasedfrom368 billionyuan(USD53billion)in1978to83trillionyuan(USD 13trillion)in2019,witnessinganaverageannualgrowthrate of15%(1).Inadditiontoitseconomicprogress,Chinahas alsoaccelerateditsgoalofimproveduniversalhealthcoverage (UHC).Notably,Chinasetupthebiggestmedicalinsurance safetynetsintheshortesttimesoastocoverasmanypeople aspossible.Since2003,Chinahaslaunchedandimplemented aseriesofbasicmedicalinsuranceschemes,includingUrban EmployeeBasicMedicalInsurance(UEBMI),launchedin1998, whichwasprovidedmandatorilyforemployeesinurbanareas (alsoincludingretiredandrural-to-urbanmigrantworkers), whosepremiumistobebornebyboththeemployerandthe employee,withacombinedindividualaccountandasocially pooledfund;individualaccountsaremainlyusedforgeneral outpatientservicesortopurchasedrugsinthedrugstores.New RuralCooperativeMedicalScheme(NCMS)waslaunchedin 2003asavoluntarysystemofmutualassistancethroughrisk poolingtomitigateunaffordablehealthservicesandafinancial burdeninruralareas.Thefundingisfromthecontributionof anindividualandthegovernment;theUrbanResidentBasic MedicalInsurance(URBMI),launched4yearsafterNCMS, wasdesignedforurbanresidentsnotcoveredbyUEBMIor NCMS,includingprimaryandsecondaryschoolstudents,young children,andotherunemployedurbanresidents.Itisona voluntarybasisatthehouseholdlevel,andissponsoredby thegovernmentandanindividual.DifferentfromUEBMI,the individualaccountsforURBMIorNCMSparticipantscould notbeusedinthedrugstores.Subsequently,integrationof basicmedicalinsurancesystemswasconductedinsuccession alloverthecountry;thepatternsofintegratingURBMIand NRCMS(2)orintegratedUEBMI,URBMI,andNRCMSwere chosenaccordingtotheirlocalconditions(3).Currently,the coveragerate ofbasicmedicalinsuranceismorethan95%(4). GreatprogressofChinahasalsoattractedinternationalattention; areportpublishedinthejournal“TheLancet”evaluatedand affirmedtheprogressofChinainbroadeninginsurancecoverage, statingthatChineseinsuranceisthemostextensiveinsurance programglobally(5).Thebroadcoverageofbasichealth insuranceplayeda greatroleinalleviatingthemajorfinancial barrierhinderingsmoothaccesstohealthservices.Theproblem ofseekingmedicalservice,whichChineseoftensay,“Seeinga doctorishard”hasbeenimprovedtosomeextent(6).However, thestrong performanceinachievingextensivecoveragewasnot

sufficienttorealizeUHC,astheissueofaffordability—“seeing adoctorisexpensive”—stillexists.UHCaimstoensurethatno individualsuffersfinancialhardship(7)whenaccessingquality health services.A2010WorldHealthOrganization(WHO) reportinterpretedUHCalongthreedimensions(8):breadthof coverage, thatis,theproportionofthepopulationthatenjoys socialhealthprotection;depthofcoverage,namely,therange ofessentialservicesnecessarytoeffectivelyaddresshealthneeds ofpeople;andheightofcoverage,whichreferstotheportion ofhealth-carecostscoveredthroughpoolingandprepayment mechanisms(9).

Financialprotection isoneofthemajoraimsofhealthsystems (10)andhasbeen,ingeneral,capturedbyawell-established indicatorcalled“catastrophichealthexpenditure”(CHE)(11, 12) andalso,by theeffectsofout-of-pocketpaymentsonpoverty (13).AccordingtoWHOmethodology,CHEisdefinedasoutof-pocket(OOP)spending forhealthcarethatexceeds40%of acapacityofahouseholdtopay(CTP)(14, 15).TheCHE proportioninChinahasbeenatahighlevel;astudycovering 133countriesrevealedthatChinaandsomecountrieswith inadequatehealthinsurancecoverageorinpovertywereall listedatthemostseriouslevel(16).Unlikecountries,such asMexico, Thailand,andVietnam,whoseCHEratehasbeen fallingwithanincreaseintheproportionofthepopulationwith insurancecoverage,thesituationinChinahasnotchangedinthe expecteddirectiondespitethelaunchofthethreebasicmedical insuranceschemesandthecontinuousexpansionofcoverage (16).AccordingtothefindingsofthenationalsurveyinChina, theCHErate wasupto13%in2008androseto14.57%in2012 (17, 18).

Sincethe healthsystemreformwasinitiatedin2009,the Chinesegovernmenthasmadenumerousefforts,increasingits investmentinhealthcarefrom929.5billionyuanin2013to 1445.1billionyuanin2017,withanincreasedrateof55.5% (19).Amongthese,subsidiesformedicalinsuranceofurbanand ruralresidents increasedfrom328.2billionyuanto491.9billion yuan,atanaverageannualgrowthof10.6%(19).Aseriesof policiesto alleviateCHEincidencewerealsolaunched,including zeromarkuppolicyondrugsales;morespecifically,thispolicy aimstocancelthe15%drugmarkupwhenpatientspurchase drugsdirectlyfromhospitalsandreducethemedicalburdenof patients(20),andestablishingcriticalillnessinsurance.Despite thesituationhasimproved,albeitnotsignificantly,considering thelimitedavailablehealthresources,itiscrucialtoidentify whichpopulationsshouldbeprioritizedforwhichinterventions andconsequentlydevelopappropriateapproachestoreachthese targetedpopulations,aswellasensureappropriateallocation ofresourcesandsupport,ratherthanblindlyincreasingwelfare

packagesorcapitalinvestment.Besides,theactualsituationof these vulnerablegroupsismaskedbytheaveragerate.Itis difficulttoaddresstheeconomicburdenofthevulnerablegroups solelybasedonageneralizedsystemofpreferences.Beingthe mainsourceofhighCHE,improvingthefinancialprotection ofvulnerablegroupsisthekeytorealizeUHC,especiallyfor developingorlow-incomecountries(21).

Manystudies haveconductedresearchonCHEinChina; however,onlyafewhavereportednationalrepresentative estimatesforthewholepopulation(17, 18, 22, 23).Anindepthanalysis ofvulnerablepopulationswithhighCHEriskis limitedaswell.Currently,Chinahasjustcompletedthetaskof eliminatingabsolutepoverty,whilethepreciseandquantitative identificationofthemechanismofmarginalgroupsthatare pronetofallintopovertyduetoillnessisstillinsufficient, withpolicymakersandthegeneralpubliceagertoknowthe progressofeliminatingtheriskofCHEinChinaandwhere itsweaknesslies(24, 25).Thisstudyexaminedtheprogressof Chinainenhancingfinancialprotection,identifyingthemain characteristicsofthehigh-riskpopulationthatneedtobefilled tofullyachieveUHC.Theresultswouldalsocontributeto thedevelopmentofhealthcaresystemsinothernationswith similarsituations.

MATERIALSANDMETHODS

StudyDesign

Thisstudyconductedacomparativeanalysisbetween2003and 2013toobtainthetrendofCHEincidenceandthechanges ofhealthcareneedsandhealthserviceutilizationovertime. Anin-depthanalysiswasconductedonthefifthNHSSin 2013,identifyingthefactorswithhighriskandlockingthe characteristicswithoneriskfactor,twooverlappingriskfactors afterstandardized.

DataSource

MostdatawereobtainedfromthefifthNationalHealthService Survey(NHSS),whichwasconductedin2013.Additionally,the datafromthethirdandfourthNHSSwereusedforsupplement. NHSSisanationallyrepresentativesurveyorganizedbythe Chinesegovernmentevery5years.Amultistage,stratified randomsamplingmethodwasadoptedintheNHSStoensurea representativesample.Alltheparticipantswereinterviewedfaceto-facebytrainedinvestigators;ultimately,57,023householdsin thethirdNHSS,56,456householdsinthefourthNHSS,93,613 householdsinthefifthNHSSwereincludedinthesurvey(26 28).Afterdatacleaning,57,023householdsinthethirdNHSS, 56,433householdsinthefourthNHSS,and93,570householdsin thefifthNHSSwererespectivelyusedinthisstudy.

QualityControl

TheresponserateofthefifthNHSSoftheadultrespondents was82.1%.Thetest-retestreliabilityofthequestionnairereached 97.7%.Inreferencetothe2010SixthNationalPopulationCensus data,theresultsshowthatthereisnodifferenceinthefamilysize andtherural-to-urbanhouseholdratiobetweenthesampleof thefifthNHSSandthewholecountry;however,theproportion

ofolderadultswashigherinthesamplethaninthegeneral population(26);thedataofthethirdandfourthNHSSalso showgoodconsistency inhouseholdsizebetweenthesurveyed populationandthegeneralpopulation(27, 28).

Measurement

Catastrophic HealthExpenditure

AccordingtotheWHOdefinition,CHEoccurswhenthetotal OOPhealthpaymentsofahouseholdequalorexceed40%of CTPofthehousehold(15).OOPisthenetafterreimbursement underanytype ofinsurance,includingconsultingfeesofdoctors, drugpurchases,andhospitalizationexpenses,whileexcluding health-relatedtransportationfeesandspecialnutritionexpenses. TheCTPofthehouseholdisdefinedasthenon-subsistence effectiveincomeofthehousehold.Thenon-subsistencespending ofthehouseholdwasusedasaproxyforCTP,and,when foodexpenditurewaslessthansubsistencespending,CTPwas definedastotalexpenditureminusfoodexpenditure(15),while householdsubsistencespendingwascalculatedasthepovertyline multipliedbystandardhouseholdsize.Thepovertylineisdefined asthefoodexpenditureofthehouseholdwhosefoodexpenditure shareoftotalhouseholdexpenditureiswithinthe45thand55th percentilesofthetotalsample(15).

Variables

Thedependent variableiswhetherahouseholdexperienced CHE.Theindependentvariablesincludedattributesconcerning thehouseholdhead,suchasgender,educationlevel, maritalstatus,employmentstatus,andinsurancetype; sociodemographiccharacteristicsofhouseholds,suchas region,economicquintiles(annualhouseholdconsumption expenditurewasrankedintoquintilesafteradjustmentfor standardhouseholdsize),familysize,andhavingfamilymember over60yearsoryoungerthan5years;andindicatorsonneed andutilizationofhealthservicesamonghouseholdmembers, suchasthenumberofpeoplewithnon-communicablediseases (NCDs)inthelast6months,orthenumberofpeopleadmitted inhospitalsinthepreviousyear;apreferredinstitutiongrade forcommondiseasesandwithmembersnotseeingadoctor orhospitalizeddespitetheirneedforit;thevariablesandtheir codesaredetailedin Table1

DataAnalysis

Descriptivestatisticswereusedtorevealthebasiccharacteristics oftherespondentsandtheirhealthcareneedsandservice utilization.Atimetrendapproachwasconductedtoanalyze theCHEincidencetrendfrom2003to2013.Alogistic regressionmodelwasusedtoidentifythedeterminantsof CHE.Themetricsforhealthcareneedsandserviceutilization andfamilypopulationstructurewerestandardizedinthe comparativeanalysisoftheincidenceofCHEacross31 provinces,asingle-dimensionfactor,andtwo-dimensionfactors, othervariableswereusedascontrolvariables.Aprobitmodelwas usedtostandardizethehealthcareneedsandserviceutilization (24, 29, 30).Allstatisticalanalyseswereconducted,usingSTATA 11.0.Statisticalsignificancewassetatthe5%level.

TABLE1| Basicinformation ofrespondentsinthefifthNHSS.

Variable Variable value

Dependentvariable

ExperiencingCHEornot

Independentvariable

Genderoftheheadofhousehold

Number(households)Percentage(%)

0 = No 80,565 86.10 1 = Yes 13,005 13.90

0 = Female 23,744 25.40 1 = Male 69,826 74.60

Maritalstatusoftheheadofhousehold 0 = Married 78,751 84.20 1 = Others 14,819 15.80

Educationalleveloftheheadofhousehold 1 = Illiterate 9,904 10.60 2 = Primaryschool 26,556 28.40 3 = Juniorhighschool 33,742 36.10 4 = Seniorhighschoolandtechnicalschool 11,800 12.60 5 = Technicalsecondaryschoolandabove 11,568 12.40

Employmentstatusoftheheadofhousehold 1 = Employed 64,026 68.40 2 = Retired 16,164 17.30 3 = Unemployedandstudents 13,380 14.30

Medicalinsurancetypeoftheheadofhousehold 1 = UEBMI 23,919 25.60 2 = URBMI 6,847 7.30 3 = NCMS 43,362 46.30 4 = Integration 12,060 12.90 5 = Mixture 4,811 5.10 6 = Othersandnone 2,571 2.70 Region 1 = Eastern 31,201 33.30 2 = Central 31,186 33.30 3 = Western 31,183 33.30

Location 0 = Urban 46,798 50.00 1 = Rural 46,772 50.00

Householdsize 1 =≤2 41,633 44.50 2 = 3–4 39,289 42.00 3 =≥5 12,648 13.50

Householdwithmembersagedsixtyandabove 0 = No 52,792 56.40 1 = Yes 40,778 43.60

Householdwithmembersagedfiveoryounger 0 = No 77,239 82.50 1 = Yes 16,331 17.50

Numberofpatientswithchronicdiseases 1 = 0 52793 56.40 2 = 1 30,316 32.40 3 =≥2 10,461 11.20

Numberofhospitalizedmembers 1 = 0 74,641 79.80 2 = 1 16,795 17.90 3 =≥2 2,134 2.30

Preferredinstitutiongradeforcommondiseases 0 = Primaryhospital 75,833 81.00 1 = Non-primaryhospital 17,737 19.00

Whetherthereisamembergotoclinicin2weeks0 = No 75,006 80.20 1 = Yes 18,564 19.80

Membernothospitalizeddespitetheneedforit 0 = No 89,516 95.70 1 = Yes 4,054 4.30

Membernotseeingadoctordespitetheneedforit0 = No 66,440 71.00 1 = Yes 27,130 29.00

RESULTS

BasicInformationRegardingRespondents oftheFifthNHSS

Mosthouseholdheadsweremale(74.60%),married(84.20%), juniorhighschoolgraduates(36.10%),andemployed(68.4%). TheNCMSwasthemostcommonmedicalinsuranceamong householdheads(46.9%).Nearlyhalfofthehouseholdshad membersover60yearsoldandmemberssufferingfromNCDs inthelast6months;meanwhile,44.5%ofthehouseholdshadno morethantwofamilymembers(Table1).

CatastrophicHealthExpenditureIncidence

From2003to2013

Table2 showstheCHEincidencesin2003,2008,and2013, whichwere,respectively11.7,13.2,and13.9%.Theresult ofthetimetrendapproachindicatesthat,from2003to 2013,theCHEincidenceshowsageneraltrendofgrowth overtime(χ 2 = 150.724, P < 0.001),althoughthegrowth rateslowed.

TABLE2| Catastrophichealth expenditureincidencesin2003,2008,and2013. TotalHouseholdswithCHE χ 2 P-value N N (%)

200357,023 6,649(11.7) 150.724 <0.001 200856,433 7,445(13.2) 201393,57013,005(13.90)

HealthcareNeedsandServiceUtilization andHospitalizationExpenses From2003to 2013

Wecomparedthehealthcareneedsandserviceutilizationof therecentthreeNHSSconductedin2003,2008,and2013.The resultsshowthatthehealthcareneedsincreasedovertheyears; theprevalenceofNCDswas33.1%in2013,whichwasdouble thanthatin2003(15.1%).Thenon-admissionrate,definedas thepercentageoftherespondentswhohadnotbeenadmitted toinpatientcareinthepastyeardespitebeingadvisedbya doctor,decreasedfrom29.6%in2003to17.1%in2013.Thenonattendancerate,definedasthepercentageofthepatientswho wereillbutdidnotseekmedicaltreatmentinthepast2weeks, decreasedfrom48.9%in2003to27.3%in2013.

Althoughthehealthcareneedsofresidentshavebeenmet,this hasresultedinhighermedicalexpenses.Expendituredatafor 2008and2013areadjustedformovementsintheconsumerprice indexandtaken2003asthebasicyear.Afteradjustment,through comparingtheaveragehospitalizationexpensesofthethree NHSS,itwasfoundthattheaveragehospitalizationexpenses increasedovertheyears,fromUSD616(3,815yuan)in2003 toUSD1,273(8,520yuan)in2013,withanannualgrowth rateof19.9%.Furthermore,overthepastdecade,theaverage hospitalizationcostincreasedby106.6%(Figure1).

MultidimensionalAnalysisBasedon CharacteristicsofCHERiskHouseholds

TheDistributionofCHERateAmongRegionsand Provinces

TheCHEproportioninthefifthNHSSwas13.9%.Froma regionalperspective,theproportionofCHEinruralareasis

FIGURE1| Comparison of health-careneedsandserviceutilizationin2003,2008,and2013.$:USD,UnitedStatesDollar.Accordingtotheexchangerateof6.1932 yuantoUS$1.00.

TABLE3| Univariateanalysisof factorsassociatedwithCHE.

Characteristicsoftherespondents

Total CHE Standarderror χ 2 P-value N (%) N (%)

Incomequintilea 766.742 <0.001

Quintile 1 18,714(20.00)3,703(19.80) 0.0029 Quintile2 18,714(20.00)2,643(14.10) 0.0025 Quintile3 18,714(20.00)2,369(12.70) 0.0024

Quintile4 18,714(20.00)2,020(10.80) 0.0023

Quintile5 18,714(20.00)2,270(12.10) 0.0024

Householdsize

≤2 41,633(44.50)8,350(20.10) 0.0020 3 4 39,289(42.00)3,466(8.80) 0.0014 ≥5 12,648(13.50)1,189(9.40) 0.0026

2,379.113 <0.001

Region 33.961 <0.001

Eastern 31,201(33.30)4,046(13.00) 0.0019 Central 31,186(33.30)4,489(14.40) 0.0020 Western 31,183(33.30)4,470(14.30) 0.0020

Location 136.568 <0.001

Urban 46,798(50.00)5,886(12.60) 0.0015

Rural 46,772(50.00)7,119(15.20) 0.0017

Gender 24.709 <0.001

Male 69,826(74.60)9,476(13.60) 0.0013

Female 23,744(25.40)3,529(14.90) 0.0023

Maritalstatusoftheheadofhousehold 550.394 <0.001

Married 78,751(84.20)10,039(12.70) 0.0012 Others 14,819(15.80)2,966(20.00) 0.0033

Educationalleveloftheheadofhousehold

2,327.951 <0.001 Illiterate 9,904(10.60)2,548(25.70) 0.0044

Primaryschool 26,556(28.40)4,691(17.70) 0.0023

Juniorhighschool 33,742(36.10)3,867(11.50) 0.0017

Seniorhighschoolandtechnicalschool 11,800(12.60)1,120(9.50) 0.0027 Technicalsecondaryschoolandabove 11,568(12.40) 779(6.70) 0.0023

Employmentstatusoftheheadofhousehold 2,635.196 <0.001

Employed 64,026(68.40)6,593(10.30) 0.0012 Retired 16,164(17.30)2,889(17.90) 0.0030

unemployedandstudents 13,380(14.30)3,523(26.30) 0.0038

Medicalinsuranceoftheheadofhousehold 404.361 <0.001

UEBMI 23,919(25.60)2,779(11.60) 0.0021

URBMI 6,847(7.30) 986(14.40) 0.0042

NCMS 43,362(46.30)6,816(15.70) 0.0017

IBMIUR 12,060(12.90)1,774(14.70) 0.0032

Mixedmedicalinsurance 4,811(5.1%) 374(7.80) 0.0039

Othertypesandnone 2,571(2.7%) 276(10.70) 0.0061

Householdsincludingmembersagedabove60years

No 52,792(56.40)4,192(7.90) 0.0012 Yes 40,778(43.60)8,813(21.60) 0.0020

3,593.430 <0.001

Householdsincludingmembersagedbelow5years 395.525 <0.001

No 77,239(82.50)11,534(14.90) 0.0013 Yes 16,331(17.50)1,471(9.00) 0.0022

Numberofpatientswithchronicdiseases

0 52,793(56.40)4,048(7.70) 0.0012

4,182.198 <0.001

TABLE3| Continued

Characteristicsoftherespondents

Total CHE Standarderror χ 2 P-value N (%) N (%)

1 30,316(32.40)6,175(20.40) 0.0023

≥2 10,461(11.20)2,782(26.60) 0.0043

Numberofhospitalizedmembers

0 74,641(79.80)6,711(9.00) 0.0010

1 16,795(17.90)5,415(32.20) 0.0036

≥2 2,134(2.30) 879(41.20) 0.0107

7,552.608 <0.001

Preferredinstitutionalgradeforcommondiseases 26.674 <0.001

Primaryhospital 75,833(81.00)10,754(14.20) 0.0013 Non-primaryhospital 17,737(19.00)2,251(12.70) 0.0025

Whetherthereisamembergotoclinicin2weeks 1,254.815 <0.001

No 18,564(19.80)8,930(11.90) 0.0024 Yes 75,006(80.20)4,075(22.00) 0.0015

Membernothospitalizeddespitetheneedforit 1,443.631 <0.001

No 89,516(95.70)1,382(34.10) 0.0016 Yes 4,054(4.30)11,623(13.00) 0.0053

Membernotseeingadoctordespitetheneedforit 1,875.437 <0.001 No 66,440(71.00)5,850(21.60) 0.0016 Yes 27,130(29.00)7,155(10.80) 0.0019

aQuintile 1isthepoorest,20%,andquintile5isthewealthiest,20%.

1.2timeshigherthanthatinurbanareas;thecentral(14.4%) andwesternregions(14.3%)showahigherCHEratecompared withtheeasternregion(12.9%)(Table3).Ofthe31provinces, 17exceededthenationalaverageleveloftheCHErate,and mostofthemwereconcentratedinthecentralandwestern regionswithlower percapita GDP.Thenumberofhouseholds whosufferedfromCHEinthewesternregionwaslargerthan thatintheeasternandcentralregions.Fewcitiessuchas BeijingandprovincessuchasShandonghadafairlyhighCHE incidence(Figure2).

CHEIncidenceCrossDifferent CharacteristicsofHouseholds

Table3 showstheCHEincidencesamonghouseholdsacross differentcharacteristics.Theunivariateanalysisresultsshow statisticallysignificantrelationshipsbetweenCHEandfactors relatedtothehouseholdhead,demographics,andhealthservice needsandutilization(Table3).

DeterminantsofHouseholdsDroppingInto CHEin2013inChina

Intheresultofthemodel, R2 = 26.9%,andtheHosmer–Lemeshowtestshowedthatthemodelfitswell(p81> 0.05), thelogisticregressionanalysisrevealedseveraldriversofCHE. Householdsinwhichtheheadwasmale(OR = 1.200,95%CI = 1.138–1.264),unmarried(OR = 1.191,95%CI = 1.124–1.263), orilliterate(OR = 1.191,95%CI = 1.124–1.263)hadahigher riskofCHEthanothergroups.Comparedwithhouseholdsinthe fifthquintile,householdsinQuintile1(OR = 1.483,95%CI = 1.374–1.600)andQuintile2(OR = 1.241,95%CI = 1.153–1.337)

hadahigherCHErisk.Comparedwiththehouseholdheadwith aneducationleveloftechnicalsecondaryschoolandabove,the groupswithaneducationlevelofilliterate(OR = 2.351,95%CI = 2.114–2.616),primaryschool(OR = 1.779,95%CI = 1.616–1.957),juniorhighschool(OR = 1.510,95%CI = 1.377–1.657), andseniorhighschoolandtechnicalschool(OR = 1.342,95%CI = 1.208–1.491)weremorelikelytofaceCHE.Additionally,the bettertheemploymentstatusofthehouseholdhead,thelower theriskofCHEinthehousehold:comparedwithunemployed orstudenthouseholdheadgroups,employed(OR = 0.522,95% CI = 0.493–0.552)andretiredgroups(OR = 0.756,95%CI = 0.695–0.823)hadalowerriskofCHE.Householdswithout inpatientmembers(OR = 0.123,95%CI = 0.111–0.136)oronly oneinpatientmember(OR = 0.580,95%CI = 0.523–0.643)were atalowerriskthanthosewithmorethantwoinpatientmembers. ComparedwithhouseholdswithmorethantwoNCDmembers, thosewithnoNCDmembers(OR = 0.509,95%CI = 0.473–0.548)andonlyoneNCDmember(OR = 0.842,95%CI = 0.793–0.894)wereatalowerriskofCHE.Householdswithoutpatient membershadahigherCHEriskthanthereference(OR = 1.507, 95%CI = 1.433–1.584).Householdsinruralregionshadahigher risk(OR = 1.062,95%CI = 1.007–1.119)thanurbanhouseholds, whilethoseinwestern(OR = 1.079,95%CI = 1.023–1.138)and centralregions(OR = 1.052,95%CI = 0.998–1.109)hadahigher riskthanthoseintheeasternregion.Householdscoveredby UEBMIhadthestrongestabilitytoresisttheeconomicburden ofdisease.ComparedwithUEBMI,othertypesofinsurance revealedahigherriskofCHE,and,amongthesegroups,the riskofNCMSwashighest(OR = 1.508,95%CI = 1.382–1.646). Notably,householdswithmembersnotvisitingadoctor(OR =

1.325,95%CI = 1.256–1.396)ornot hospitalizeddespitetheneed forit(OR = 1.757,95%CI = 1.625–1.899)hadahigherriskof experiencingCHE(Table4).

TheCHEStandardizedRateUnderthe CharacteristicsofSingleDimension

Figures3, 4,respectively,showtheCHEstandardizedrate underthesingledimensionofdemographicfactorsand healthserviceneedsandutilizationfactors.Regardingthe demographicfactors,thetopthreefactorswiththehighestCHE riskwereilliteratehouseholdhead(23.06%),unemployedor studenthouseholdhead(22.43%),andthepooresthousehold economicstatus(20.11%).Regardingthefactorsofhealth serviceneedandutilization,thetopthreefactorswiththe highestriskwerehavingtwoormorehospitalizedpatients (20.53%),havingtwoormorechronicdiseasepatients(15.93%), andhavingmemberswhoshouldbehospitalizedbutare not(14.76%).

CHERiskCharacteristicsUnderDifferent LocationLevels,RegionLevelsand

EconomicQuintileLevelsofHouseholds, andHealthInsuranceLevelsofHousehold Heads

Figures5 8,respectively,showthatCHEriskcharacteristics liedunderdifferentlocationlevelsandregionlevelsand

economicquintilelevelsofhouseholds,andhealthinsurance levelsofhouseholdheads.Regardingthelocationlevelofthe household,theCHEratesofruralhouseholdswerehigherthan urbanhouseholdsingeneral.Urbanhouseholdswithilliterate householdheadshavethegreatestrisk,withastandardizedrateof 22.30%,followedbyruralhouseholdswiththepooresteconomic status(21.40%).Inruralhouseholds,thosewithunemployedor studentstatushouseholdheadrankedfirst(24.50%);thosewith anilliteratestatusalsohadaconsiderableCHErisk(23.45%).

Regardinghouseholdregion,eastern,central,andwestern householdswithilliteratehouseholdheadswereallthemost vulnerable.Inaddition,unemployedorstudentstatuswasalso ariskcharacteristicforhouseholdsfromthreeregions.The CHErisksofeasternandwesternhouseholdswithmorethan twohospitalizedmemberswerequitehighat22.10and21.15%, respectively.Thepooresthouseholdslocatedineasternand centralregionsalsoneedtobepaidattentiontomeanwhile.

Regardingeconomicstatus,thepooresthouseholdswith differentcharacteristicsshowhigherCHEratesthanother economicgroupsatover20%.Inthepooresthouseholds, thosewithilliteratehouseholdheadsrankedfirst(27.20%), followedbythosewithunemployedorstudenthouseholdheads (27.09%).Forhouseholdswithsub-pooresteconomicstatus, thosewithhouseholdheadswhowereunemployedorstudents werethemostvulnerable(22.70%).Notably,therichestgroup withunemployedorstudentstatushouseholdheadalsohada considerablyhighCHEincidence(21.36%).Withtheexception

FIGURE2| Theincidenceof CHEacross31provincesinChina.

TABLE4| Determinantsof CHE,usinglogisticregression. Sig. Exp(B) 95.C.I.

Lower Upper

Incomequintile

Quintile1vs. 5 0.000 1.483 1.374 1.600

Quintile2vs.5 0.000 1.241 1.153 1.337 Quintile3vs.5 0.125 1.058 0.984 1.137 Quintile4vs.5 0.008 0.907 0.844 0.974

Householdsize

≤2vs. ≥5 0.000 4.000 3.682 4.344

3–4vs. ≥5 0.000 1.854 1.712 2.008

Region

Centralregionvs.Easternregion

0.061 1.052 0.998 1.109

Westernregionvs.Easternregion 0.006 1.079 1.023 1.138 Ruralvs.Urban 0.025 1.062 1.007 1.119

Genderoftheheadofhousehold: Femalevs.Male 0.000 1.200 1.138 1.264

Maritalstatusoftheheadofhousehold: Othersvs.Married 0.000 1.191 1.124 1.263

Educationalleveloftheheadofhousehold

Illiteratevs.Technicalsecondaryschoolandabove 0.000 2.351 2.114 2.616

Primaryschoolvs.Technicalsecondaryschoolandabove 0.000 1.779 1.616 1.957

Juniorhighschoolvs.Technicalsecondaryschoolandabove 0.000 1.510 1.377 1.657

SeniorhighschoolandTechnicalschoolvs.Technicalsecondaryschoolandabove 0.000 1.342 1.208 1.491

Employmentstatusoftheheadofhousehold

Employedvs.unemployedorstudent 0.000 0.522 0.493 0.552 Retiredvs.unemployedorstudent 0.000 0.756 0.695 0.823

Medicalinsuranceoftheheadofhousehold

URBMIvs.UEBMI 0.000 1.293 1.171 1.427 NCMSvs.UEBMI 0.000 1.508 1.382 1.646

Integratedmedicalinsurancevs.UEBMI 0.000 1.316 1.195 1.448

Mixedmedicalinsurancevs.UEBMI 0.337 0.938 0.823 1.069

Othertypesandnonevs.UEBMI 0.003 1.256 1.080 1.459

Havingmembersaged ≥60years: Yesvs.No 0.000 1.524 1.448 1.605

Havingmembersaged ≤5years: Yesvs.No 0.162 0.949 0.882 1.021

Memberswithchronicdiseases

0vs. ≥2 0.000 0.509 0.473 0.548 1vs. ≥2 0.000 0.842 0.793 0.894

Inpatientsmembers

0vs. ≥2 0.000 0.123 0.111 0.136 1vs. ≥2 0.000 0.580 0.523 0.643

Preferredinstitutionalgradeforcommondiseases

Non-primarymedicalinstitutionvs.primarymedicalinstitution 0.065 1.059 0.997 1.126

Whetherthereisamembergotoclinicin2weeks: Yesvs.No 0.000 1.507 1.433 1.584

Membersnothospitalizeddespitetheneedforit: Yesvs.No 0.000 1.757 1.625 1.899

Membersnotseeingadoctordespitetheneedforit: Yesvs.No 0.000 1.325 1.256 1.396

ofgroupsinQuintile1,economicgroupswithmorethantwo hospitalizedmembershadconsiderablyhighCHErisk.

Regardingthehealthinsurancelevel,householdswithUEBMI ormixedmedicalinsurancehadalowerCHEriskthan householdswithotherinsurancetypes.Householdheadscovered byURBMIwithanunstablemarriedrelationshipwerethe mostvulnerablegroup(22.44%),followedbythosewhowere

illiterate(21.92%).ForNCMShouseholds,householdheads whowereunemployedorstudents(25.00%)rankedfirst, andilliteratehouseholdheads(23.57%)rankedsecond.For IBMIURhouseholds,thosewithmorethantwohospitalized membershadthehighestCHErate(24.46%),andtheintegrated insurancecategoryshowsalowerCHEratethanURBMIor NCMS;thelowerratewaslargelyduetothelowerCHErate

FIGURE3| TheCHEstandardizedrateunderthecharacteristicsofsingledimensionrelatedtodemographicfactors.

FIGURE4| TheCHEstandardizedrateunderthecharacteristicsofsingledimensionrelatedtohealthserviceneedandutilizationfactors.

amongurbanresidents,asthevalueamongruralresidentswas higher.For thosewithotherinsurancetypesorthosewithout medicalcoverage,thetoptworiskcharacteristicswerehaving anilliteratehouseholdhead(29.71%)andhavingmorethantwo hospitalizedmembers(27.51%).

TopFiveCharacteristicsofSingleorTwo DimensionsinOccurringCHE

Inordertodeterminetargetedinterventions,ouranalysis listedthetopfivecharacteristicsofhouseholdswithasingle riskfactorandtwocombinedCHEriskfactors.Inthe topfivecharacteristicsofhouseholdswithoneriskfactor, wefoundthathouseholdswhosehouseholdheadswere illiterate,unemployedorstudents,whosenumberofinpatient memberswasnomorethantwooccupyingthetopthree (23.06,22.43,20.53%).Nextwerehouseholdswiththepoorest economicstatusandhouseholdheadsinunstablemarriages. Regardingthetopfivecharacteristicsofhouseholdswithtwo combinedriskfactors,thosewithanilliteratehouseholdhead andwhowerecoveredbyotherhealthinsurancetypesor notcoveredrankedfirst,followedbyhouseholdsizewas

nomorethantwo,combinedwiththehouseholdheads, whowereilliterate,andhouseholdsizewasnomorethan twoandthehouseholdheadswereunemployedorstudent status(Table5).

Top10DiseasesofTotalHospitalization ExpensesofHouseholdsWithCHE

Thisstudyanalyzedthetop10diseaseswiththehighest totalhospitalizationexpensesforhouseholdsexperiencingCHE. Therewerefourdiseasesforwhichthetotalhospitalization expenseexceeded1,766.14USDandthehighestbeing2,099.08 USDforamalignanttumor,congenitalheartdiseaseorother congenitalabnormalities,andNCDIs.Notably,amongthetop fourdiseases,thenumberofCHEcasescausedbyamalignant tumoristhehighest(768households),followedbyinjuryand poisoning(753households)(Table6).

DISCUSSION

TheunrelentinglyhighCHErateinChinahasnotimproved despitetheeffortsoftheChinesegovernment.Itisdifficult

FIGURE5| Factorsaffecting CHEbydifferentlocationsofhouseholds.

FIGURE6| TheCHEstandardizedratebydifferenteconomicquintilegroups.

FIGURE7| TheCHEstandardizedratebydifferentareas.

FIGURE8| TheCHEstandardizedratebydifferenthealthinsurancesystems.IBMIUR:Integrationinsurancereferstootherbasicmedicalinsurancetypes,which integrateeitherURBMIandNCMSorUEBMI,URBMI,andNCMS.Mixturemedicalinsurance:Itreferstoparticipantscoveredbybasicmedicalinsuranceand commercialinsuranceatthesametime.

TABLE5| Top5familycharacteristicsrelatedtoCHEwithasingleriskfactorandtwocombinedCHEriskfactors.

Order Topfivetypesoffamilieswithoneriskfactor

CHEstandardizedrate(%)

1 Illiteratehouseholdhead 23.06

2 Household headwithunemployedandstudentstatus 22.43

3 Householdwith2ormorehospitalizedmembers 20.53

4 Pooresthouseholds 20.11

5 Householdheadwithunstablemarriage 19.72

Order Topfivetypeswithtwocombinedriskfactors

CHEstandardizedrate(%)

1 Illiteratehouseholdheadcoveredbyotherhealthinsurancetypesornot covered 29.71

2 Householdsizewasnomorethan2andthehouseholdheadwasilliterate 29.59

3 Householdsizewasnomorethan2andthehouseholdheadwasunemployedorastudent 29.25

4 Householdwithmorethantwoinpatientmembersandthehouseholdsizewasnomorethan2 28.76

5 Householdheadwasilliterate,unemployed,orastudentorhouseholdhadmorethan2inpatient membersandanunemployedorstudenthouseholdhead 27.92

toachievetheexpectedeffectbyincreasingwelfareand compensationpoliciesindiscriminately,withoutconsidering populationtargeting.ThisstudyestimatedtheCHErateat thegeographiclevels(national,regional,andprovincial),in addition,exploringfactorsrelatedtodemography,disease, healthserviceneed,andutilizationtodelineatethekeyrisks andvulnerablepopulationsthatwouldhelpdevelopdynamic andeffectiveresponsesaimedatthosefamiliesexperiencing CHE.TheanalysisshowsthatthetotalCHEratein2013 (13.9%)was6.92%higherthanthatofthepreviousNHSSin 2008;however,thegrowthratewaslowerthanthatbetween 2003and2008.Householdslocatedinruralareas,inthe westernregion,withmemberswhoareNCMSparticipants, withmembersovertheageof60,withafemalehousehold headorahouseholdhead,withlowsocioeconomicstatus orunstablemarriedrelationship,andwithsmallerhousehold size,morehospitalization,outpatient,andNCDmemberswere morevulnerabletoCHE.Intherankingofsingleriskfactors forCHE,thetopfivefactorsleadingtothehighestCHE incidencewereprimarilyconcentratedinhouseholdswith lowsocioeconomicstatusorhavingmorethantwoinpatient members.Meanwhile,intheoverlappingriskfactorsforCHE, thecombinationofhavingilliteratehouseholdheadsandbeing coveredbyotherhealthinsuranceplansorbynoneranked thefirst.

Comparedwithotherdevelopingcountries,theCHE incidencerateinChinaisrelativelyhigh(31).Aseriesof estimatesfrom othercountriesaround2013applied40%asthe CHEthresholdandfoundthattheCHEincidencesofMongolia andKenyawerelowerthanthatofChina,at1.1%(31)and4.52% (32),respectively;meanwhile,CHEincidenceofNepalissimilar tothatofChinaat13.8%(33),whilethatofIndiaishigherthan thatof Chinaat18.2%(34).

Theincreasingeconomicburdenwasattributedtoseveral aspects;ontheonehand,theagingpopulationandits healthserviceneeds,especiallytheprevalenceofchronic NCDs,increasedrapidly,leadingtoarapidgrowthofhealth expenditure(35).Ontheotherhand,theimprovementof

TABLE 6| Top10diseaseswiththehighesttotalhospitalizationexpensesof householdswithCHE.

OrderDisease

Number (households) Total hospitalization expenses(USD)

1Malignanttumor 768 2,099.08

2Congenitalheart diseaseor othercongenitalabnormalities 18 2,099.08

3Benigntumor,tumor insitu 204 1,776.14

4Injuryandpoisoning 753 1,776.14

5Urogenitalsystemdisease 516 1,291.74

6Mentaldisease 60 1,178.71

7Infectiousdisease 101 1,130.27

8Diseaseofbloodandblood formingorgan 74 1,130.27

9Neurologicaldisease 174 1,114.13

10Otherdiseases 146 1,106.05

USD,UnitedStatesdollar,accordingtotheexchangerateof6.1932yuantoUSD1.00.

economicstatus, thedevelopmentofmedicaltechnology,andthe universalcoverageofthemedicalinsurancesystempromotedthe utilizationofhealthservices.Inourstudy,thehospitalization rateroseto9%,andtheproportionofpeoplegivingup treatmentorhospitalizationforfinancialreasonsdecreased to7.6and7.4%,respectively.Inthecaseofsurginghealth serviceneeds,healthinsurance,inturn,largelystimulated theutilizationofhealthservices,therebyleadingtohigher CHE(whichoccurswhenhealthinsurancedoesnotprovide adequatefinancialprotection).Thus,theimprovementofthe benefitspackage,reasonablereimbursementstandardsetting, andeffectivepaymentmechanismtocontrolhealthexpenditure wereespeciallycrucialtoalleviatetheriskofCHEandachieve UHC.Thisstudyaimedtoidentifythevulnerablegroupsand providetargetablestrategiesthatshouldbeprioritized.Thestudy conductedananalysisofthecharacteristicsofmultiplevulnerable groupsacrossthefollowinglevels.

HouseholdsLocatedintheWestern Region,Livingin theRuralAreas,Were MoreEasilytoDropIntoCHE,theHigh CHERate,OwingtoOverutilizationin DevelopedRegionsShouldBePaidMore Attention

Fromtheperspectiveoftheregion,thecentralandwestern regionshadhigherCHEincidenceriskthantheeasternregion, with13.4and13.3%,respectively.Itisworthnotingthat,in thecaseofnostatisticaldifferencebetweenthecentraland westernregionsontheCHErate,thehospitalizationratein thecentralregion(8%)islowerthanthatinthewestern region(8.6%),buttheaveragehospitalizationexpenseswere higherinthecentralregion(SupplementaryMaterial1)(26). Thisillustrates theregionaldifferencesinthedesignofmedical insuranceschemesleadtodifferentpatternsofaneconomic burden.ThroughtheanalysisofCHEproportionin31provinces distributedintheeastern,western,andcentralregions,wefound thattheCHErateofmostprovincesintheeasternregionwas belowthenationalaverageandwasalsogenerallylowerthan thatofthecentralandwesternregions,reflectingthatabetter economiclevelcontributedtoresistingCHE.However,another findingindicatedthatthereexistsomeeasternprovinceswith highGDP percapita withconsiderablyhighCHErates,such asBeijing,Shanghai,andTianjinProvince,revealingthat,when theeconomicdevelopmentreachesacertainextent,itresults inhigherCHEincidenceinstead,owingtoutilization(oreven overutilization)ofhealthservices.Moreover,ahighdegreeof agapinfinancialprotectionbetweenruralandurbanresidents stillexists.OurstudyshowsthattheCHErateinruralareasis associatedwithahigherCHEproportion,andruralresidents had1.062timeshigherriskthanurbanresidents.Anotherstudy alsoconfirmedthattheresidentsinruralareassufferedagreater financialburdenfromhealthexpenditures;thepercentagewas 2.4timeshigherthanthatoftheurbanresidentsin2013(36).

HouseholdsWithSmaller HouseholdSize andUnstableMarriedRelationshipsWere Vulnerable;MedicalandNursingServices fortheOlderPeopleWouldIncrease SeveralTimesRiskofCHEforTheir Families

Ourstudyshowsthatthelargerthehouseholdsizewas,thelower thepossibilityofCHEriskwas;thelikelihoodofexperiencing CHEinthehouseholdswithlessthantwomemberswas ∼4times comparedwiththehouseholdswithmorethanfivemembers. Morefamilymembersimpliesbetterrisk-sharingabilityand moreworkingmembersenteringthelabormarket,and,inturn, thisreducestheriskofthehouseholdexperiencingCHE.A recentstudyshowsthat,asthenumberofhouseholdmembers increases,theriskofimpoverishmentbymedicalexpensesis reducedby1.5%points(37).Atthesametime,wefoundthat marriageis aprotectivefactor,illustratingthatexistenceof stablemarriedrelationshipsinahouseholdismoreconducive toreducingthepossibilityofCHE.Theresultsalsoindicateda significantlyhigherprobableconnectionbetweenCHEincidence

andhouseholdswitholderadults(OR = 1.524,95%CI = 1.448–1.605),asreportedinotherstudiesinChina(17, 22, 38);thisis consistentwith theresultsreportedbyYardimetal.inTurkey (39)andKavosietal.inIran(40).Thereasonsforhighmedical expensesamong olderadultswerelistedasfollows:first,most olderpeoplesufferfromNCDsofvaryingdegrees;however, healthservicesanddrugscoveredbyhealthinsurancepolicies forNCDinclinicswerelimited(41);thus,theyeitherpaidhigh proportionOOPspending foritorseekinginpatientservice, whichneednothavebeencarriedout,justforreimbursement (42, 43).Inaddition,duringaperiodofrecuperationorselftreatmentat home,self-purchaseddrugsfromdrugstoresarea crucialsupportforolderpeople.Assuchpurchasesweremade outsidemedicalinstitutions,mostfamiliescoveredbyinsurance otherthanUEBMIhavetobearthispartofthehighcostsalone. Outsidemedicalservices,additionalnursingexpendituresfor olderadultsarealsoaconsiderableeconomicburden,andthis isanincreasingproblemforvulnerablehouseholdssupporting olderadultsinChina(44).Infact,thesecostsdonotbelong tothe scaleofOOP;thus,thefinancialriskofhouseholds withelderlymemberswasconservativelyundervaluedinour study.AlthoughtheChinesegovernmenthasestablishedlongterminsuranceforthosewithcareneeds,thescopeofpolicy implementationislimitedtopilotareas,andthepolicyremains inthepilotstage.SimilarinmanywaystoChina,Kenyahas alsoestablishedsupplementaryinsurancetobettereconomically protecttheelderly,althoughthiscoverageisrelativelylimited (45).Apreviousstudyoncalculatingalong-terminsurance pilotindicated thatimplementinglong-termcareinsurancemay effectivelyreducehospitalizationandoutpatientexpenses.Thus, pilotprojectsshouldbeacceleratedandextendedtothewhole populationassoonaspossible.

Meanwhile,wemustseriouslyconsidertheagingpopulation, thelevelofaging,untilthisstudywasconducted,hadreached 202million,andthenumberisprojectedtodoubleby2040 (343.8million)(46, 47).Itisestimatedthatthehealthcare expenditureforChineseolderadultswillalmostdoubleover thenextthreedecades,whichwillbeupto263billionCNY in2050(48).Thus,thestrategicandtacticalreservefordealing withtheagingsocietyshouldbecompletedinthisperiod.On onehand,weshouldimplementapositivepopulationpolicy, promotingrelevanteconomicandsocialpoliciestomatchthe currentfertilitypolicytodelaytheagingprocess,and,onthe otherhand,wemuststrengthenthehealthmanagementforolder adultsbyestablishinghealthrecordsandprovidingfreephysical examinationeveryyeartocontrolordelaythedevelopment ofdiseases.

reducetheoddsofexperiencingCHEand viceversa,whichhas beencomprehensivelyproveinmanystudies(17, 22).Ourstudy notably foundthatonlythepoorest(OR = 1.483)andthesubpoorest(OR = 1.241)groupsshowsignificantlyhigherriskthan therichest,whilesomepreviousstudiesfromlow-andmiddleincomecountriesshowadifferentassociationbetweenCHErisk andeconomicstatus.InIndia,thepooresthouseholdstendto forgohealthcarethatmightbringthemfinancialhardship,and, thus,relativelypoorhouseholdsareassociatedwithahigher incidenceofCHE(33).InThailand,essentialhealthservices aresufficientlycovered bysocialinsurance,andtheutilization ofprivatehigh-levelhealthservices,resultinginthehighCHE rateismorelikelytooccurinhighincomepopulations(49, 50).Onthecontrary,inChina,thereisanestablishedhealth insurancesystem,covering morethan95%ofthepopulation. Healthserviceaccess,especiallyamongthelow-incomegroup, hasgreatlyimproved;however,thereimbursementrateisnot sufficientlyhightoprotectpeoplefromhighOOPpaymentsfor essentialhealthservices(17).Inthiscontext,theparticipantsdid nothavetoforgohealthcareservices,butasthereimbursement ratesoftheirinsurancesystemswerenotsufficient,thelowerincomegroupsweremorelikelytobeassociatedwithahigher incidenceofCHE.

Inaddition,wefoundthathouseholdswithhousehold headswhowereilliterateorunemployedorstudentsalways rankedthehighestineachlevel.Thisillustratedthat,although providingsubsidiescouldalleviatetemporarypoverty,long-term andradicalplanningshouldpaymoreattentiononimproving educationorprovidingbetteremploymentopportunities,asit istheonlywaytohindertheintergenerationaltransmissionof poverty(51).

alargergapinfinancialprotection(53, 54),andthedisparity wascausedbyalackofconsiderationforthepropensity ofruralresidentsinmedicalinsurancefinancingandhealth serviceutilization.

Undertheintegratedinsurance,formerfixed-pointmedical institutionswereunifiedunderabiggermanagementscope, and,hence,improvementinconvenientoff-sitemedicalbilling ofintegratedinsurancemayincreasecasesofruralpatients goingtourbanhospitals.Increasinghospitalizationratesin tertiarymedicalinstitutionsanddecreasinghospitalizationrates inprimaryandsecondaryinstitutionswerewitnessedinwestern Chinaafterintegration,whichsupportsthefindingsofthis study(55).Furthermore,high-qualitymedicalresourcesare mostlyconcentratedin urbanareas(56, 57),evenasrural residentsare promptedtousehealthservicesand,therefore, enormouslyincreasetheirmedicalcosts.Amongthenationwide financingmodesofintegratedinsurance,mostofthemhavenot transformedseveralfinancinglevelstoonlyonefinancinglevel. Theproblemwithsettingseveralfinancinglevelsisthatrural residentstendtochoosealowerfinancinglevel,whetherlimited byincomeorinfluencedbypasthabits(58, 59).However,urban residentstended toreceivemorehealthservicesandenjoybetter welfare.Thisleadstoareversesubsidy(60, 61)and,thus,results inanew inequality.Therefore,inareaswithalargegapinurban andruraleconomicdevelopment,thefinancingsubsidyshould beprovidedforruralresidents.

Ourstudyshowsthatinallmedicalinsurancetypes—URBMI, NCMS,andintegratedinsurance—theparticipantsshowhigher CHEincidencethanUEBMI,whichare1.1,1.2,and1.0times higher,respectively,thanthenationallevel.Theparticipantsof NCMSwerethemostvulnerable,followedbythosecovered underURBMI,whiletheintegratedinsuranceparticipantsshow alowerratethanthoseofURBMIorNCMS,indicatingthat theintegratedsocialhealthsystemwasprobablyconduciveto providemorefinancialprotectiontothebeneficiary.However, theintegratedinsuranceparticipantsdonotseemtoshowgreater advantagesintermsofreducingCHEriskasexpected.Asof thisstudy,afewdistrictsinChinapioneeredtheintegrationof theruralandurbanschemesand,inanevensmallernumber ofdistricts(DongguanandZhongshan),directlymergedthe UEBMI,URBMI,andNCMS(52).

Meanwhile,we foundthattheintegratedreformonly benefitedurbanresidents,whereastheCHEoccurrenceamong ruralresidentsunderintegratedinsuranceishigherthannonintegratedinsurance.Severalstudiesalsoprovedthat,underthe integratedinsurance,theurbanandruralparticipantsexperience

Demandandutilizationofhealthserviceswerethenecessary conditionsforhealthexpenditure.Ourresultsindicatedthat householdswithNCDmembersfacedahigherCHErisk.Our analysisofthetop10diseasesforwhichpeopleinhouseholds withCHEwerehospitalizedrevealedthatthehouseholdswith memberswithamalignanttumororcongenitalheartdisease orothercongenitalabnormalitiessufferedthehighestexpenses (2,099.08USD);however,themajorityofhouseholds(768) experiencedCHEduetoamalignanttumor.Malignanttumors werefoundtobeahugechallengenotonlybecausetheycan belife-threateningbutalsobecausetheyhavehighlikelihoodof leadingtoCHE(62).Acalculationofcancercostsindifferent countriesshowsthat,intheUS,theproportionofhousehold expensesforcancerpatientswasonly20.9%,whileinChina itwasashighas78.8%(63).Manyanticancerdrugswerenot coveredinthereimbursementscopeorthereimbursementratio wasnotsohigh,andthesewerethemainreasonsforhigh medicalcosts.Since2018,theChinesegovernmenthasgradually includedanticancerdrugsinitsmedicalinsurancecatalog throughnegotiation;however,barriersrelatedtoanticancer drugsarrivingathospitalsremainandmustbeovercometosolve theimbalanceinthedemandandsupplyofdrugs(64)andenable patientstoenjoy thebenefitsofthepolicy.Meanwhile,support forchronicdiseasepreventionandcancerscreeningmustalso bestrengthened.

HouseholdsCovered byNCMSHadthe HighestCHERisk;theIntegrationReform ofBasicHealthInsuranceWasConducive toImproveItsFinancialProtection

StrengthenFinancialProtectionforCancer PatientsandEnsureInsuranceCoverage ofCommonlyUsedAnticancerDrugsand TheirAccessibility

PayMoreAttentiontoHouseholdsWith SeveralPatientsand Removethe

ObstaclestoTreatmentDelay

Severalpreviousstudieshaveshownthathavinginpatientor outpatientmembersinthehouseholdincreasedtheprobability ofCHE(65).Inourresult,havingmorethantwohospitalized memberswasthehighestCHEriskfactorofthehealthservice andutilizationfactors.Itisnecessarytoestablishafamily-based identificationmechanismforvulnerablegroupsinthemedical systemandprovidetargetedadditionalfeerelieforsubsidies forthem.

Asurprisingfindingwasthathouseholdmemberswho shouldseeadoctororbehospitalizedbuthadnotdone soexperienced1.757-or1.325-timeshigherrisk,respectively, comparedwiththereferencegroup.Onepossibleexplanation wasthat,becauseofforgoingmedicalservicesthattheyshould havebeenreceived,thetreatmentopportunitywasgreatly delayed,therebyincreasingfuturemedicalexpenses.Although thevaluein2013ismuchlowercomparedwiththelastsurvey in2008,theproportionofthosenothospitalizedduetofinancial reasonsreachednearly50%(SupplementaryMaterial2).Thus, thegovernmentshouldmakeeffortstoensurethatallthe povertygroupsarecoveredbybasicandcatastrophichealth insuranceschemes,appropriatelydecreasethedeductible, increasethecaponhospitalizationreimbursementexpenses,and increasethereimbursementproportionwithinthepolicyscope. Furthermore,thegovernmentshouldtakestepstoenhance medicalassistancetothepovertygroups,suchasdecreasing thethresholdsofmedicalassistanceandexpandingthemedical assistancebenefitsscope(66).Itisnecessarytostrengthen theirregular monitoringtopreventthemfromreturning topoverty.

PriorityInterventionTargetsand Suggestions

Theanalysisofcharacteristicsofhouseholdswithsingle dimensionriskfactorsforCHEshowedthatfamilieswith factorsrelatedtolowsocioeconomicstatusrankedahigh place;householdswithmorethan2hospitalizedmembersand thosewithunstablemarriageswerealsoamongthetopfive characteristics.Therefore,thesethreecategoriesofvulnerable groupsinthelowsocioeconomic-statusgroupareprimary concerns.Highcostsofhospitalizationaremainlydueto excessivemedicaltreatmentandunreasonablehospitalization behavior(24).Thus,measuresshouldbetakenforreforming paymentmechanismandimprovingthemedicalinsurance policyforout-patientcaretocontrolhospitalizationpayments, especiallyforNCDs.Increasinginvestmentinpreventionof NCDsandmanagementofNCDpatientsshouldalsobe seriouslyconsidered.Itisdifficultforhouseholdswithan unemployedhouseholdheadtoresisttheriskofCHE,and, thus,policysupportiscrucialforthem.Whentworiskfactors— illiteratehouseholdheadandlackofhealthinsurance—are combined,theCHEincidenceincreasedtonearly30%.This isfollowedbythecombinationsofhouseholdsize ≤2and illiteratehouseholdhead,householdsize ≤2andemployed

householdhead.Thedisadvantagedgroupstendtohave multiplevulnerabilities.Identifyingthegroupswithmultiple vulnerabilitiesandtakingrelevantmeasureswouldbeanideal approachtoaddressthepersistentlyhighCHErate.However, capturingthegroupswithmultiplevulnerabilitiesdependson thedegreeofrealizationofhouseholdinformationaswellas filinganddatasharingamongdifferentdepartmentsatthe nationallevel.

Thedisadvantagedgroupstendtohavemultiple vulnerabilities.Identifyingthegroupswithmultiple vulnerabilitiesandtakingrelevantmultifacetedmeasureswould constituteanapproachtoaddressthehighCHErate,which hasbeenhighforalongtime.However,capturingthegroups withmultiplevulnerabilitieswasuptotherealizationdegree ofinformationfilinganddatasharingofhouseholdsamong differentdepartmentsatthenationalleveltoalargeextent.

Thestudyhadtwodistinctivestrengths.First,thedataused inthisstudywereobtainedfromanationallyrepresentative surveyorganizedbytheChinesegovernment.Thissurvey,which includedalarge-scalesampleundertakenwithamultistage, stratifiedrandomsamplingmethod,reflectsthesituationof CHEincidenceandexpenditureaccurately.Additionally,we conductedastandardizedcalculationontheCHErateunder singledimensionandtwodimensionsriskcharacteristicsof Chinesehouseholds.Themetricsforhealthcareneedsandservice utilizationandpopulationstructureofafamilywerestandardized inthecomparativeanalysisoftheincidenceofCHEacross 31provinces,asingle-dimensionfactor,andtwo-dimension factors.Therewerealsoseverallimitationsinourstudy.First, thiswasacross-sectionalstudy;thus,thecausalrelationship betweenpredictorsandCHEisnotreflected.Second,thedata wereself-reportedbytherespondents,andtheremayberecall biasintheresponses.Third,owingtosomerespondentsbeing unabletoaffordhealthservicepayment,itmightleadtothe underestimationofCHEtosomeextent.Fourth,thedatausedin thisstudyhavetheirlimitationastheyrestrictthisstudybefore 2013,owingtothelackofdataavailabilityafterthat.Fifth,the CHEratewasestimated,usingonlytheATPapproachwiththe thresholdof40%.Usingthedefinitionof10%ofanincome(orits proxies)thresholdastheSDGusewouldbemorecomprehensive.

CONCLUSIONS

ThisstudyinvestigatedandidentifiedthehighCHEincidence groupfromtheperspectiveoftheregion,familystructure, socioeconomicstatus,medicalinsurance,andneedsand utilizationofhealthservices.Wefoundthatfrom2003to 2013,theCHEincidenceshowsageneraltrendofgrowthover timeandtheincidencein2013wasalsohigherthanmost developingcountries.Householdslocatedinwesternregions andruralareasweremorevulnerable,andseveralprovinces locatedintheeasternregionsalsohadaconsiderablyhighCHE incidence,owingtooverutilization.Householdswithsmaller size,lowersocioeconomicstatus,unstablemarriedrelationship ofhouseholdheadsormembersagedover60hadhigherCHE risk.HouseholdheadscoveredbyNCMShadthehighestrisk

ofCHE,and,whiletheintegratedinsurancewasconduciveto providemorefinancial protection,itperformedworseamong ruralresidents.HouseholdswithmoreNCDmembersor inpatientmembershadhigherCHErisk.And,amongthese typesofNCDs,thenumberoffamilieswithCHEdueto cancerwasthelargest,andtheirtotalmedicalexpenditureis thehighest.Householdswithhospitalizedmembersorwith membersnotseeingadoctor/hospitalizeddespitetheneed foritincreasedthelikelihoodofCHE.Householdswith characteristicsrelatedtolowsocioeconomicstatus,having morethantwohospitalizedfamilymembers,werethemost vulnerablegroupsthatneedimmediateattention.Whenthe factorofhavingmorethantwoinpatientmemberscombined withthecharacteristicsrelatedtolowsocioeconomicstatus, householdsize ≤ 2,theCHErateofthesefamiliesincreased dramatically.Thosehouseholdheadswithcharacteristicsof multiplevulnerabilitiesshouldbethepriorityinterventiontarget, andrelatedstakeholdersshouldcooperatetoestablishafamily informationsharingplatformandinterveneintheissuebased oncooperation.

DATAAVAILABILITYSTATEMENT

Thedataanalyzedinthisstudyissubjecttothefollowing licenses/restrictions:Datasetsusedinthisstudyareavailable fromCentreofHealthStatisticsandInformation,National HealthCommissionofthePeople’sRepublicofChina.The dataarenotpubliclyavailableduetotheconfidentialpolicy. Requeststoaccessthesedatasetsshouldbedirectedtothewebsite ofNationalHealthCommissionofthePeople’sRepublicof China:http://www.nhc.gov.cn/.

ETHICSSTATEMENT

Thestudyinvolvinghumanparticipantswerereviewed andapprovedbyethicsclearancewasobtainedfromthe MedicalEthicsCommitteeatHarbinMedicalUniversity.The patients/participantsprovidedtheirwritteninformedconsentto participateinthisstudy.

AUTHORCONTRIBUTIONS

JW,XT,andQWdesignedthestudy.LScontributedtodata processing.JW,XQ,andHLcontributedtoresultanalysis.JW andXTdraftedthemanuscript.XZ,KW,SJ,QX,NM,andPC assistedwiththecollectingliteratureandprovidingsuggestions forthismanuscript.QW,YL,andZKrevisedthepaper.DAand BIprovidegreathelpwithprovidingsuggestionsandcollecting theliteratureduringtherevision.Allauthorscontributedtothe articleandapprovedthesubmittedversion.

FUNDING

ThisworkwassupportedbytheNationalSocialScience FundofChina(GrantNo.19AZD013)andNationalNatural ScienceFoundationofChina(GrantNos.71804036,71403073, 71874045,and72074064).

SUPPLEMENTARYMATERIAL

TheSupplementaryMaterialforthisarticlecanbefound onlineat:https://www.frontiersin.org/articles/10.3389/fpubh. 2021.689809/full#supplementary-material

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Copyright©2021Wang,Tan,Qi,Zhang,Liu,Wang,Jiang,Xu,Meng,Chen, Li,Kang,Wu,Shan,AmporfroandIlia.Thisisanopen-accessarticledistributed underthetermsoftheCreativeCommonsAttributionLicense(CCBY).The use,distributionorreproductioninotherforumsispermitted,providedthe originalauthor(s)andthecopyrightowner(s)arecreditedandthattheoriginal publicationinthisjournaliscited,inaccordancewithacceptedacademicpractice. Nouse,distributionorreproductionispermittedwhichdoesnotcomplywiththese terms.

published:07June2021 doi:10.3389/fpubh.2021.678768

Editedby: AndrzejKlimczuk, WarsawSchoolofEconomics,Poland

Reviewedby: SweilemBaseemAlRihani, TabulaRasaHealthcare,UnitedStates FrancescoDiCarlo, UniversityofStudiesG.d’Annunzio ChietiandPescara,Italy JunlinXu, HunanUniversity,China

*Correspondence: MahaElAkoum melakoum@qf.org.qa

Specialtysection: Thisarticlewassubmittedto PublicHealthPolicy, asectionofthejournal FrontiersinPublicHealth

Received: 24March2021 Accepted: 20April2021 Published: 07June2021

Citation: ElAkoumMandElAchiM(2021) ReimaginingInnovationAmidthe COVID-19Pandemic:InsightsFrom theWISHInnovationProgramme. Front.PublicHealth9:678768. doi:10.3389/fpubh.2021.678768

ReimaginingInnovationAmidthe COVID-19Pandemic:InsightsFrom theWISHInnovationProgramme

MahaElAkoum* andMahmoudElAchi

WorldInnovationSummitforHealth,QatarFoundation,Doha,Qatar

TheWorldInnovationSummitforHealth(WISH)hoststwoinnovationcompetitions aspartofitsbiennialhealthcareconference.DuringtheCOVID-19pandemic,WISH receivedmorethan350applicationsforbothcompetitions,ofwhich31wereshortlisted toshowcaseattheWISH2020virtualsummit.Ofthe31showcasinginnovations, 11(35.5%)hadsuggestedanalternativeusetotheirinnovationasacontributionto theglobalfightagainstCOVID-19.Assuch,thisarticleexplorestheapparentand urgentneedfortherepurposingofhealthcareinnovationstoreducethecostsandtime associatedwiththeconventionalapproach,inordertobestrespondtothedemandsof theglobalpandemic.

Keywords:innovation,healthcareinnovation,costefficiency,publichealth,competition

INTRODUCTION

TheworldiscurrentlyfacingoneofthegreatestsocialandeconomicchallengessinceWorld WarII(1).ThekeytoovercomingtheCOVID-19pandemicliesinfindinginnovativeand effectivetreatmentsforthedisease,furtheremphasizingtheneedforanoutside-inapproach tohealthcareinnovation(2).Thelengthy,conventionalpathtothediffusionofinnovation hasbeen complemented,andinsomecasesreplaced,withanultrafastapproachthatfocuses ontherepurposingofknowledge,ideas,andavailabletechnologiesinordertoproviderapid solutionstothecrisesathand(3).Inthiscontext,weexplorehowexistingstartupsandventures haverespondedtothelackofavailableresourcesandincreasedpressureonhealthcaresystems worldwidebyreimaginingtheirinitialpurposetonavigateCOVID-19.Throughthethorough examinationofapplicationsreceivedandshortlistedfortheWorldInnovationSummitforHealth (WISH)InnovationProgramme,weconsidertheinnovativetechnologiesthathaveevolvedtoreact efficientlyandeffectivelytothisglobalhealthemergency.

WISHINNOVATIONPROGRAMME

AboutWISH

WISHisabiennialglobalgatheringofhealthcareleaders,policymakers,academics,andinnovators basedinDoha,Qatar,andchargedwithbuildingahealthierworldthroughglobalcollaboration. Aswellaspresentingpaneldiscussionsandpresentations,WISHcommissionsandundertakes

researchandalsooffersaplatformforshowcasinginnovationin health. Atthecoreoftheaimofshowinghealthinnovationare twoinnovationcompetitions,opentoentrepreneurstowardthe startoftheirproductdevelopmentjourney.

WISHInnovationCompetition2020

InMarch2020,daysbeforethecoronavirusoutbreakwas declaredapandemicbytheWorldHealthOrganization (WHO),WISHlaunchedtworebrandedhealthcareinnovation competitions:the“SparkCompetition”and“Booster Competition.”Thesecompetitionsprovidedtalentedand strivingentrepreneurswithaplatformtopromoteideasand productsaimedatimprovingthedeliveryandqualityof healthcare.Applicationstothecompetitionsremainedopen untilJuly31,2020.

TheWISHInnovationSparkCompetitionwasaimedat entrepreneurswhowereseekingtosolvehealthcarechallenges bydevelopingandvalidatingascalableproject.Thesewere typicallyearly-stageinnovationsorstartups.TheWISH InnovationBoosterCompetitionwasaimedatalreadyexisting healthcaresolutionswithinnovatorsthatwerelookingto scaleupandgrow.Thecompetitionswereopentolocaland internationalapplicants,aligningwithWISH’smissiontobuild ahealthierworldthroughglobalcollaboration.Successful applicantsforbothcompetitionswererequiredtomeet certaincriteria,suchasanevidence-basedmarketneedforthe proposedinnovation,anddemonstratedpotentialforsustainable futuregrowth.

Thepanelofjudgesincludedhealthcareinnovationexperts, investors,innovationhubrepresentatives,andscientists.

AmongitslocalpartnersareQatarFoundation’sQatar ScienceandTechnologyPark,HamadBinKhalifaUniversity InnovationCenter,QatarBusinessIncubationCenterfoundedby QatarDevelopmentBankandQatarResearch,Developmentand InnovationCouncil.GlobalhubsincludetheUnitedKingdom–basedBMJNewVentures;theHAGGroup,aBrazilian innovationcenter;PortugueseinnovationcenterBeta-I;andThe HelixCentreintheUnitedKingdom.

METHODS

WeexaminedtheapplicationsreceivedfortheWISHInnovation Programmetoidentifywhichoftheapplicantshadsuggested analternativeuseoftheirinnovationforCOVID-19diagnosis ortreatmentofsymptoms.Thisinvolvedthesortingand filteringofapplicationsthroughthereportfunctionofApplyby SurveyMonkey,exportingthistoMicrosoftExcelandfiltering againmanuallybymentionof“COVID.”Upondetailedreview, twoinnovationswereexcludedastheapplicanthadnot mentionedanalternativeuseorpotentialuseoftheproduct forCOVID-19.Teninnovationsthatwerecreatedforthe solepurposeofCOVID-19werealsoexcludedsoastofocus onthethemeofinnovativerepurposing.Forthepurpose ofthisarticle,onlytheshortlistedinnovationsshowcasedat WISHandthathadhighlightedandprovidedevidencefora potentialuseforCOVID-19eitherthroughtheonlineapplication

portalorthroughpersonalcommunicationafterthesummit wereconsidered.

RESULTS

Atotalof350applicationswerereceivedviatheapplication portalandthroughemailcommunication.Ofthose350,49 (14%)hadsuggestedapotentialforuseforCOVID-19.Of the31innovationsthatwereshortlistedtoshowcaseatWISH 2020,11(35.5%)hadreportedanalternativepotentialuse forCOVID-19.Theinnovationsweresplitintosixdifferent categoriesbasedontype,function,andmodeofcareor servicedelivery.Thesecategoriesincludedartificialintelligence (AI)solutions,digital/app-basedsolutions,medical/scientific equipment,community-based/socialsolutions,educationand training,andtelemedicine. Table1 listsanddescribesthese innovationsinsomedetailandexplorestheiroriginalfunction orpurpose,andhowtheywererepurposedorcouldpotentially berepurposed,toprovidesolutionstodifferentaspectsofthe COVID-19pandemic.Webpagelinkshavebeenprovidedfor eachoftheinnovationsformoreinformation.

Themostcommoncategoryorfieldofinnovationsand technologicalsolutionstosuggestanalternativeuseforCOVID19wasAI,where4ofthetotal11listedinnovationswereAIbased.Thesecondmostcommoncategorywasmedical/scientific equipment(3of11),withtheremainingfourcategoriesincluding oneinnovationeach.

DISCUSSION

TheCOVID-19pandemicisthefirstcoronaviruspandemicto haveaglobaleffect(4).Thenovelty,speed,andseverityofthe virus,alongwiththelackoftimeandresourcesavailableforan effectiveandtimelyresponse,haveallbeencontributingfactors behindtheracetofindinnovativetherapiesandtechnologies thatnotonlyimprovehealthoutcomes,butalsosoftenthe socialandeconomicimpactsofthepandemic.COVID-19has alsorevolutionizedthewayinwhichsolutionsarefound, developed,anddeployed,redefiningwhatitmeanstoinnovate. Theconventionalapproachofextensivetestingandtrialing ofnewtechnologies,drugs,andprocesseshasbeenreplaced withamore“frugal”andefficientresponsethatisfocusedon repurposingtechnologiesandideasthatalreadyexist(2, 3).

ThishasbeenevidentintheoutcomeoftheWISH innovationcompetitionswherebymorethanathirdofthe shortlistedapplicantshavedemonstratedpotentialfortheir innovationtobeusedinthefightagainsttheCOVID-19 pandemic.Thisreemphasizesthenotionthatsolutionsto somecomplexproblemsmayarisefromratherunconventional sources—especiallyinthemiddleofaglobalcrisis.Given thesizeofthecrisisathand,itisimperativethatwe removeregulatorybarriersandfacilitatethiscost-effective andtimesavingapproachtohealthcaredelivery.Inorderto encouragethis,anopeninnovationculturemustbeadopted wherebytheinnovationprocessinvolvespurposiveknowledge flowbetweenorganizationalboundaries(5).

TABLE1| Shortlistedinnovationsand theirpotentialtohelpwithCOVID-19pandemic.

Nameof innovation Descriptionofitsmainpurpose

Artificialintelligence

KalyaTM Kalyaisan artificialintelligencesolutionfocusedon non-pharmacologicalinterventionssuchasphysicalinterventions, psychologicalinterventions,nutritionalInterventions,anddigital interventions.Thishelpsaddressthemajorhealthchallengesoftoday andtomorrow(cancer,diabetes,aging,strengtheningtheimmune system,lifestyle).Kalya’sexpertiseenablesthedesignofdedicated digitalsolutionsfromtheindexingofscientificliteraturetothe explorationandanalysisofdatatosupportthedecisionsofhealth professionals.

iLoFTM: cloud-based libraryofdisease biomarkersand biologicalprofiles

iLoFisacloud-basedlibraryofdiseasebiomarkersandbiological profilesbasedinOxford,UnitedKingdom.ItusesAIandphotonicsto buildacloud-basedlibraryofdiseasesandtheirbiomarkersand biologicalprofiledtodrasticallyreducethecostandtimeofdrug discoveryanddrugrepurposing.SupportedbytheUniversityofOxford andMicrosoftVentures,iLoFisbeingusedtofindsolutionsforoneof thebiggestepidemicsofourtime,Alzheimerdisease.Itisalsobeing usedtofindpotentialtreatmentsfordigestivecancers,stroke,and infectiousdiseases.

BotkinTM Botkin.AIisasoftwareplatformbasedonartificialintelligence technologiesfortheanalysisofdifferenttypesofradiologicalstudies. Mainpurposesincludeearlydetectionoflungmalignantneoplasms, earlydetectionofbreastcancer,detectionoflungnon-oncological pathologies(tuberculosis,pneumonia,etc.),andCOVID-19detection. Botkin.AIhascommercialandpilotintegrationsinfourcountriesand possessesthebestresultintermsoflungoncologydetectioninthe world.

PandexitTM Pandexitisasoftwarethatusesanalgorithmtopredicttheevolutionof anypandemicweeksinadvance.Therevolutionaryalgorithmisusedto buildahigh-granularitymodelofanypandemicforanentirecountry. Thesoftwarethengeneratesthepoliciesneededtofightandendthe pandemic,bothsavinglivesandprotectingtheeconomy.

COVID-19implication

Complementary,non-pharmacologicalinterventionsprovideddigitally areextremelyrelevantinthetreatmentcontextofCOVID-19.Especially astheavailabilityofnewresearchfindingsoninterventionsfor COVID-19isbeingupdatedalmostdaily,Kalyacanhelpusethesenew emergingdatatohelpsupportthedecisionsoffrontline workers—savingthemtimeandprovidingthepatientswiththebest possiblecare.

AnindicatedalternativepotentialuseforiLoFisthatitcanbeusedto generateclinicaloutput,operatingasaforecasttoolthatpredictsthe severityofsymptomsforCOVID-19patients.

Digital/app-based

Dorothy.appTM Dorothy.appisamonitoringsystemcreatedfordementiapatients. Dorothy.apptransformsastandardwalkerintoanaugmented reality-basednavigationassistantforthosewithdementiausingatablet computer.Itallowsfamilytobothcommunicatewithandremotely checkthewell-beingoftheirlovedone.Dorothytransmitsreal-time locationdatatofamilymembersallowingeasycommunication, maximizingsocialnetworks,andcarecollaboration.Itcandetect deteriorationingeneralhealth.

Medical/scientificequipment

AMSUTM:The AirwayMedical SuctionUnit

AMSUlookslikeasportsbottle.ItincorporatesaVenturithatturns positivepressurefromasmallcanofchlorofluorocarbon-friendlygas intonegativepressure(suction).Throughcarefulselectionofgas (positive)pressureandVenturisize,itispossibletoincorporatean effectivelaryngealsuctiondeviceintothecapofthe“sportsbottle.”Itis usedtoclearblockedairwaysinanemergency.Italsohelpsclear sputumorvomitusonaregularbasisinpeoplewithchronicbraininjury conditions.

BotkincanbeusedfordetectionofCOVID-19throughradiological analysis.Botkin.ai’sX-RayAnalysisfunctionisintendedtoprovide assistancetoaradiologistinordertohelpfindpathologicalchangesin chestx-rays.Earlydetectionofmedicallyactionablepathological changescanpotentiallyleadtoearlyhospitalizationandtreatmentand, inturn,adecreaseinmortalityrate.

Pandexithassuccessfullybeendeployedinthreecountries;ithasbeen usedbythespecialteamsinchargeoffightingtheCOVID19pandemic tosimulatescenarios,modelanumberofpolicies,discovertheireffects onthespreadofthepandemicinsidethepopulation,andselectthe mostefficientwaytosavelivesandlimitthedamagestotheeconomy. Atthevaccinerolloutstageofthepandemic,Pandexitallowsthe decisionmakerstomodelanincreasingnumberofvaccinatedpeople inspecificcategoriesofthepopulationandtakenewvariablesofthe virusintoaccount.Pandexitmodelsareincreasinglyaccuratedueto theemergingdataonCOVID-19anditsvariants.Itcanevaluatethe efficiencyofanimplementedcurfewandalockdownandcanpredict andrecommendtheexactnumberofdaysneededtoreacha specifictarget.

Dorothyincreasestheindependenceofthosewithdementiawhilealso beingabletorevolutionizehowsupportandmonitoringaredelivered.It alsosupportsthe“recovery”phaseoftheCOVID-19response, particularlyinoftenquarantinedfacilities.Aslanguageisalsooften impaired,thetelemetrydatacaninitiallyinformfamilyandclinicians aboutactivityandprovidealertswhenchangesinsuchdatasuggest andeteriorationingeneralhealthallowingformoreholisticremotecare.

CAMSUTM,theCOVID-19AirwayMedicalSuctionUnit,isa wall-mountedsuctionunitthatwasdevelopedaspartofthepandemic response.ItcanbeusedtoclearsomeCOVID-19symptomsby preventingsputumfromincubatinginthelaryngealareaandtraveling tothelungcavity.This,inturn,wouldimproveoutcomesandprevent someICUadmissionsforsedation/intubation/ventilation,savingmoney andfreeinguphospitalbeds.

TABLE1| Continued

Nameof innovation Descriptionofitsmainpurpose

WecaresolarTM

Solarsuitcaseis acompactsolarelectricsystemthatprovidespower generationandmedicalappliances.Someofitsfeaturesinclude high-efficiency,water-resistant,long-lasting(70,000h)LEDlights designedforsurgicalprocedures;12-VDCand5-VDCpowerportsfor mobilecommunication;anelectronicfetalheartratemonitor;an electronicinfraredthermometer,tablets,ande-readersequippedwith educationalmaterials.

COVID-19implication

Theno-touchinfraredthermometerhasbeenusedinCOVID-19 assessments.Improvedphonechargingensuresthatemergency referralshappenwhenneeded,especiallygiventhatthetarget populationisrural,improvisedcommunitiesinAfricaandSoutheast Asia.

QABYbiotechTM

QABYisaQatar-basedbiotechstartupthatencompassesnovel antibodies,innovativeassays,uniquebiomarkers,andthe evidence-basedknowledgeonhowtotackleneurodegenerative diseases.QABYcanfacilitatetheearlydetectionofneurodegenerative diseases,assesstreatmentresponses,andmonitordisease progression.

QABY’skeyactivitiesincluderesearchanddevelopmentoftoolsand assaysanddiscoveryofnewdiseasetargets,providingservices throughparticipationinclinicaltrials,andsellingantibodiesandkits directlytoendusers.

Educationandtraining

Medics.AcademyTM Medics.Academyisatechnology-enhancedlearningandeducation platform.Itusesadvancedtechnologiestoscaleprogramsacross countriesandtoreachlarge-scaleaudiencesofhealthcareworkers.

Communitybasedsolution

CharlyTM Charlyisaspeechassistant/speechrecognitiondevicethatwas designedtopromoteindependentcommunicationbetweenpeople withhearingimpairments.Charlyrecognizesspeechandconvertsit intotext.

Telemedicine

BleepaTM Bleepaisasecureclinicalmessagingappthatfacilitatesremote image-basedcommunicationbetweenclinicians.Itallowsmedicalstaff toviewanddiscusshigh-qualitymedical-gradeimagingonmobile devices.

RepurposinginthePharmaceutical Industry

Inthe pharmaceuticalindustry,drugrepurposinghasbeen practicedforyears.While denovo drugdevelopmentrequires substantialfinancialinvestmentsandyearsofexperimentation, drugrepurposingallowsdeveloperstocuttime,cost,and riskbyusingAIandcomputationalbiologytofindadditional therapeuticusesofdrugsthathavepreviouslybeenthrough theserigoroussafetytrialsandarealreadyonthemarket(6 8). Traditionalmethodsofdrugdevelopmentrequiresometimesup to15years’worthofpreclinicalresearch,clinicalstudies,safety reviews,USFoodandDrugAdministration(FDA)review,and post-marketmonitoring.Manyrepurposeddrugshavealready beenapprovedbytheFDAsavingbothtimeandmillionsof dollars(9, 10).Therehavebeenseveralsuccessfulexamplesof drugsthathavebeenrepurposedacrossdifferentfieldssuch asdiabetesandoncology(11).InthecaseoftheCOVID-19 pandemic,asvaccinedevelopmentandrollouttakemonths, differentdrugsarebeingrepurposedinordertohelpalleviate symptomsandpreventdeaths.Theefficacyofthesedrugsin

QABYreceivedaninnovationgrantfromHamadbinKhalifaUniversity InnovationCentertodevelopaserologytestforCOVID-19.Theblood testwassuccessfullycompletedwithin6months,andthedataare stronglycorrelatedwithdatageneratedusingotherwell-established technologies,furthervalidatingtherobustnessandusefulnessofthe in-housekit.Currently,theinnovatorisalsofinalizingthedevelopment ofanthertestforCOVID-19,namedneutralizationassaytobeadded totheQABYportfolio.

Medics.AcademywascommissionedbytheWHOtohelpdeliveran educationandtrainingprogramtosupporttheWASHagendaaspart oftheCOVID-19response.

CharlyhasbeenhelpingpeoplewithdisabilitiesattheEmployment CenterinMoscowtofindjobsafterhavinglostthem(insomecases duetoCOVID-19).Thishasproventobecheaper,faster,andmore efficientthanhavinganinterpreter.Thefoundersarealsolookingat waystomakeCharlymoreusefulfordistantworking.Examplescould includehelpwithuniversitylecturesforstudentsstudyingremotelydue totherestrictionsbroughtaboutbytheCOVID-19pandemic.

SincetheonsetofCOVID-19,Bleepahasbeenhelpingsenior consultantstoguidefrontlinestaffandmanagecasesremotelyand safelywithoutface-to-faceinteraction.

achievingfavorableoutcomesinpatientswithCOVID-19isstill beingstudied(12 15).

RepurposinginHealthcareandService Provision

SimilartowhathasbeenwitnessedfromtheWISHinnovation competitions,otherexamplesofhealthcareinnovationsbeing repurposedanddeployedintheglobalbattleagainstCOVID19havebeenrecentlyrecordedintheliterature.Oneexample fromtheUnitedNationsDevelopmentProgrammeAccelerator LabincollaborationwiththeRwandanMinistryofICTand Innovationincludedthedeploymentoffiveantiepidemicrobots toaidfrontlineworkerstofightspreadoftheCOVID-19virus (16).TheserobotsprovidedsupportindetectionoftheCOVID19cases,includingcitizensreturningfromtravel,aswellas providingotherservicesinthehospitalsetting.

Anotherlarge-scaleexamplecomesfromIndiawhererailway coacheswereconvertedtoisolationwardsforCOVID-19 patientstomeettheincreasedandunmetdemandforhospital beds(17).Suchinnovativeandresourcefultacticshavebeen

practicedbylow-andmiddle-incomecountriesforyearsandare generallypraisedfor expandingaccesstocare,whilefosteringa uniquelycompetitiveenvironmentforcreatingsolutionsthatare increasinglysustainable(18).

Hospitalsin theirentiretyhavealsobeenreshapedand repurposedinthefightagainsttheCOVID-19pandemic,where aroundtheworldwehavewitnessedmanymitigationstrategies deployedatahealthcaresystemlevelandwithinthehospital setting.ExamplesfromSouthKoreaincludestratificationof patientcare,theestablishmentofCOVID-19hospitalsand dedicatedCOVID-19emergencycenters,theestablishmentof dedicatedcommunityfacilitiesandemergencycenters,andthe assignmentofrespiratorycaresplithospitals(19).Thesewereall appliedeffectivelyandhavebeenkeyintacklingthecrisisathand giventhestrainonhealthcareresources.

TheUseofAIDuringCOVID-19

Healthsystemsarecopingwiththeexplosivedemandthrough thelarge-scaleadoptionofAIanddigitaloperatingmodels (20, 21).AIcanbeusedinanumberofsignificantapplications inthe fightagainsttheCOVID-19pandemic.Theseapplications rangefromearlydetectionanddiagnosis,treatmentmonitoring, contacttracing,projectionofcasesandmortality,development ofvaccinesanddrugs,decreasinghealthcareworkers’workload, anddiseaseprevention(22).

Oneexample ofAIbeingusedfordetectionanddiagnosis purposesincludesProvidenceSt.JosephHealthsysteminSeattle, wherebyinpartnershipwithMicrosoft,Providencedeveloped anonlinescreeningandtriagesolution.Thistoolcouldhelp detectanddifferentiate,atarapidrate,thedifferencebetween apatientwithCOVID-19andapatientwithanother,less threateningailment(20).Thissamepartnership,togetherwith Universityof BritishColumbia,hasalsoprovidedotherAIdrivensolutionstomonitorthecomplianceandeffectiveness ofsocialdistancingmeasures,aswellaspersonalprotective equipment(PPE)usage(23).

Similarto“Pandexit”mentionedin Table1,another innovationthathasalsobeendeployedintheuseofvirus trackingisMetabiota.Metabiota,acompanythatprovides servicesfortheUSDepartmentofDefenseandintelligence agencies,hasbeenusedtodetecttheriskofspreadofdisease, calculatingitspredictionsfromfactorssuchassymptoms, availabilityoftreatment,andmortality(24).

TheRiseof TelehealthDuringthe COVID-19Pandemic

Theuseoftelehealthortelemedicinetechnologiestocombatthe currentCOVID-19crisis,aswellastheoverallmanagementof communicablediseasesasawhole,isideal.Telehealthsolutions decreasetheneedforperson-to-personcontact,soforCOVID19patients,orpatientswhoareconcernedaboutgettinginfected, telehealthcanprovideaneffectivealternativesolutionforremote assessmentanddeliveryofcare(25, 26).

Otheradvantagesoftelehealthincludeincreasedaccess andavailabilitytospecialistsandsubspecialists.Thesecan sometimesbedoctorsindifferenthospitals,providingcare indifferentregions.TheMountSinaisystem,forexample,

leveragesspecialistsacrosseighthospitalstoprovideemergency consultationsandmakereferralswhereneeded(27).The limitationof thesetypesofsolutionsisusuallyrelatedto issuestodowithpayment,staffing,andcredentialing.Itis alsoarguedthatnurses,medicalassistants,andphysician assistantsallcontributetotheoverallexperienceofin-person careprovision,andtelemedicinecouldnotpossiblyreplicate this(27).

Telemedicinecan alsotaketheformatofamessagingapp betweendoctorstofacilitatediscussionsandsharedexperiences andrecommendationswhenitcomestomorechallenging medicalcases.Suchisthecaseof“Bleepa,”oneoftheWISH2020 shortlistedinnovatorsmentionedin Table1.Herethechallenge isavoidingtheleakofconfidentialandsensitiveinformation, suchasthepatient’sconditionandmedicalhistory.

LessonsFromOtherIndustries

Otherindustries,sometimeswithnoclearlinkstothe healthcareindustry,arealsofollowingsuit.Severalfirms, forexample,haveexaptedtheircapacitiesandcapabilities toproducePPE(28).Inaddition,anumberofcosmetic brandshavestartedmanufacturinghandsanitizerstomeet theincreaseindemand.Thesebrandsincludethelikes ofL’OrealandNivea(29).AnotherexampleisDyson,a producerofhouseholditemssuchasairpurifiers,vacuum cleaners,andhairdryers.DysonannouncedinMarch2020 thatithadinitiatedthedesignandproductionprocessof 10,000ventilators,followingtheUnitedKingdom’sNational HealthServices’predictionsofanincreaseddemandfor ventilatorsamidtheCOVID-19pandemic(30).Thistype ofinnovative cross-industrycollaborationtorespondtothe globaldemandforhealthcareisanapproachtobeapplauded andencouraged.

CONCLUSION

ItiswithoutadoubtthattheCOVID-19pandemichas emphasizedtheneedforanaccelerated,cross-sectorial,and frugalapproachtohealthcareinnovation.Theinnovation competitionsatWISHfurtheremphasizedthisneedthrough directresponse,wheremorethanathirdoftheapplicants suggestedanalternateusefortheirinnovation.While repurposingproductsisapracticethathasbeengoingon foryearsbeforetheonsetofthecurrentpandemic,ithas beenmostlybeenpracticedbyotherindustriessuchasdrug development.SolutionsthatmakeuseofAIanddigital-based technologiesfordeliveryofservicesandcareareespecially helpfulduringaglobalcrisissuchasthisonewheresocial distancingplaysagreatroleinstoppingthespreadofthe virus.Itisalsoevidentthatnotallsolutionsmustbehigh-tech inorderforthemtoprovidesufficientanswersanddeliver impact.InnovationssuchasAMSU,mentionedin Table1, providerelativelylow-tech,yethighlyeffectivesolutions. Finally,itisimperativethatlessonsarelearnedfromthis pandemicatagloballevelandthatthisfastandfrugalmethod ofrespondingtoanincreaseindemand,especiallyinthe timeofcrisis,becomesmainstreamandrunsinparallelto

themoretraditionalapproachtoinnovationandproduct development.In orderforrepurposingtobecomemainstream practiceinhealthcareinnovation,thereisaneedforsystems worldwidetofacilitatethisthroughtheadoptionofopen innovationmechanisms.

DATAAVAILABILITYSTATEMENT

Therawdatasupportingtheconclusionsofthisarticlewillbe madeavailablebytheauthors,withoutunduereservation.

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AUTHORCONTRIBUTIONS

MahaEwrotethedraftwithinputfromMahmE.Bothauthors contributedtothearticleandapprovedthesubmittedversion.

FUNDING

SupportedandfundedbytheWorldInnovationSummit forHealth(WISH),QatarFoundation.OpenAccessfunding providedbytheQatarNationalLibrary.

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15.Abd-ElsalamS,ElkadeemM,GlalKA.Chloroquineas chemoprophylaxisforCOVID-19:willthiswork? InfectDisord DrugTargets. (2020)20:1–2.doi:10.2174/18715265206662007262 24802

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28.LiuW,BeltaguiA,YeS.Acceleratedinnovationthroughrepurposing: exaptationofdesignandmanufacturinginresponsetoCOVID-19. RD Manag. (2021).doi:10.1111/radm.12460.[Epubaheadofprint].

29.TheEconomicTimes. L’OrealJoinsFightAgainstCoronavirus,toDeliver FreeHandSanitisertoHospitals&Pharmacies.(2020).Availableonline at:https://economictimes.indiatimes.com/magazines/panache/loreal-joinsfight-against-coronavirus-to-deliver-free-hand-sanitisers-to-hospitals-andpharmacies/articleshow/74863953.cms(accessedJanuary12,2021).

30.BashirN,CNNBusiness.JamesDysondesignedanewventilatorin 10 days.He’smaking15,000forthepandemicfight. TheMercuryNews (2020, March26).

ConflictofInterest: Theauthorsdeclarethattheresearchwasconductedinthe absenceofanycommercialorfinancialrelationshipsthatcouldbeconstruedasa potentialconflictofinterest.

Copyright©2021ElAkoumandElAchi.Thisisanopen-accessarticledistributed underthetermsoftheCreativeCommonsAttributionLicense(CCBY).The use,distributionorreproductioninotherforumsispermitted,providedthe originalauthor(s)andthecopyrightowner(s)arecreditedandthattheoriginal publicationinthisjournaliscited,inaccordancewithacceptedacademicpractice. Nouse,distributionorreproductionispermittedwhichdoesnotcomplywiththese terms.

published:28April 2021 doi:10.3389/fpubh.2021.666453

Editedby: MagdalenaKlimczuk-Kochanska, UniversityofWarsaw,Poland

Reviewedby: AliceRavizza, PolitecnicodiTorino,Italy RamayahThurasamy, UniversitiSainsMalaysia (USM),Malaysia IngridMajerova, SilesianUniversityinOpava,Czechia WadimStrielkowski, UniversityofCalifornia,Berkeley, UnitedStates

*Correspondence: PetraMaresova petra.maresova@uhk.cz

Specialtysection: Thisarticlewassubmittedto PublicHealthPolicy, asectionofthejournal FrontiersinPublicHealth

Received: 10February2021 Accepted: 25March2021 Published: 28April2021

Citation: MaresovaP,ReznyL,PeterL,HajekL andLefleyF(2021)DoRegulatory ChangesSeriouslyAffecttheMedical DevicesIndustry?EvidenceFromthe CzechRepublic. Front.PublicHealth9:666453. doi:10.3389/fpubh.2021.666453

DoRegulatoryChangesSeriously AffecttheMedicalDevicesIndustry? EvidenceFromtheCzechRepublic

PetraMaresova 1*,LukasRezny 1,LukasPeter 2,LadislavHajek 1 andFrankLefley 1

1 DepartmentofEconomics,UniversityofHradecKralove,HradecKralove,Czechia, 2 DepartmentofCyberneticsand BiomedicalEngineering,TechnicalUniversityofOstrava,Ostrava,Czechia

Background: WithintheEU,someofthechallengesandperceivedrisksnowfacing medicaldevice(MD)developersresultfromchangesintheregulatoryframework, emphasizingsafety.Therefore,medicaltechnologycompaniesmustadoptstricterquality assurancemeasuressothatindividualdevicescanbespeedilytrackedandretrievedin emergencysituations.

Objectives: WehighlightthechallengesandrisksfacedbytheEuropeanmedical devicesindustry,particularlythosefacedbySMEsintheCzechRepublic.Weaddress twoimportantresearchquestions:Q1.Doadvantagesfromincreasedregulation outweightheadditionalexpenses?Q2.AsmanyMDdevelopersareSMEs,willthenew regulatoryregimeresultinsomeofthosecompaniesgoingoutofbusinessandtherefore impedefutureinnovation?

Methods: Thepaperfocusesonasinglecasestudy,withthesituationandoutcomes discussedinthecontextofthefinancialresultsofafurther50medicaldevice manufacturersmarketingintheCzechRepublic.

Results: Ourfindingssuggestthatthenewlegislationwillresultinimprovedsafety, facilitateproductrecalls,butthecostandadministrativeburdenmaybehigh.The evidencealsoindicatesthatsomeSMEsmaybeforcedtodiversifyto“non-medical” products,withtheinevitablelossofinnovativeMDsbeingmadeavailabletopatientsand healthcareproviders.

Keywords:risk,patientsafety,regulation,innovation,SME,medicaldevices

INTRODUCTION

TheEuropeantradeassociationforthemedicaltechnologyindustry(MedTech)statethat“medical technologiescansavelives,improvehealth,andcontributetosustainablehealthcare”(1).The medicalhealthliterature(2)states,“Medicaldevicesareusedforthediagnosis,monitoring, andtreatment ofvirtuallyeverydiseaseorcondition,andincludefamiliarobjectssuchas simplebandagestohigh-endMRIscanners”regulatedbyCouncilDirective(3, 4).European manufacturersnowfacethenewRegulation(EU)2017/745tobeintroducedin2021.Thisnew legislationnotonlypresentsissuesconcerninghealthandriskbutalsoforsocietyingeneral.

Attitudestowardregulationsareperceiveddifferently.Concernhasbeenexpressedinthe literaturethatthecurrentregulatoryregimeformedicaldevices(MDs)isinadequate,biasedtoward commercialinterests,thatinnovationoutpacesthedevelopmentofregulatorycontrols,resultingin

socialandpatientriskimplications(5 7).deMol(8)argues(p. 735)that“medicaldevicesareconsideredtobeacornerstone ofmedicaltechnologyandtoenableprogressinhealthcare formillionsofpatients.”Thecurrentregulatoryregime may,however,beputtingpatientsatrisk(9).Withrespect toinnovation theories,astrictinterpretationofthePorter hypothesisimpliesthatchallengingfactorsintheformof heavyregulationscaninduceinnovationbecauseestablished technologiesgettobereplacedbynewer,moreeffectiveandsafer alternatives(10).Thismaybeparticularlytrueofthemedical devicemarket,whichishighlyregulated,andnewentrantsmust fulfillmanyconditions.Theseconditionsinvolvemainlysafety regulationsbutalsoenvironmentalprotectionrequirements,and theyaffectmultipleaspectsofthedevelopmentprocess:technical, clinical,aswellasbiological.Whilethedemandingconditions maybeseenasanobstacle,theymayalsoprovestimulatingfor innovation(11).

Thisindustry’s characteristicsaretheexceptionallyhigh innovationpotential(11),theabove-averagenumberof innovationssuccessfullyappliedtothemarket,thehigh addedvalueofproducts,andthehighexportpotential(12). Themanufacturersofmedicaltechnologieshavehigh-level researchanddevelopmentcapacities.Theyarealsovocalin expressingtheirexpertiseandknowledgetowardthecontinuous developmentofinnovativeandaccelerateddevelopment(13).As aresult, suchdevelopmentactivitiesintheCzechRepublicoften resultinproductswithuniqueproperties,whichareconsidered innovativeglobally.Theresearch,development,andproduction ofMDshavealongtraditionintheCzechRepublic(14).In additiontothepositiveimpactontheeconomicdevelopment oftheCzechRepublic,thedevelopmentandproductionofMDs alsohaveadirectpositiveimpactonothersectors,especiallythe healthservicessector(13).

ThemainchangeunderthenewMDRregulationsfocuses onsafetyandriskreduction,whichistobeachieved bystrictprocessesthatleadtomarketauthorization(15). Medicaltechnologycompaniesmustadoptmorestringent qualityassurancemeasuressothatindividualdevicescanbe speedilytrackedandretrievedinemergencies.Amongthenew requirementsintroducedbytheMDRiscreatingaunique positiontobefilledbyacandidatewithproofofexperiencein medicaldeviceregulations.Thispersonistobeentrustedwith managingallmattersrelatedtoregulatoryrequirements(16). ForSMEsintheCzechRepublic,itcanbechallengingtofind anemployeewithsuchexpertise.Moreover,“toobtainMDR authorizationforclassIII,implantabledevicesandhigh-riskclass IIb,MedTechcompanieswillberequiredtopresentanotified bodywithalargevolumeofclinicaldatathatsupportstheir products’clinicalperformance”(17).

However, fromanSMEperspective,thenewEuropean legislation(highlightedinthispaper)mayresultinasignificant proportionalincreaseincostsandanincreasedadministrative burned,resultingintheimpossibilityforsomecompanies tocontinuedevelopingnewproductsand,therefore,restrain innovationforthedevelopmentofMDs.

Thispaperaimstohighlightthechallengesandrisksfacedby theEuropeanmedicaldevicesindustryduetorecentlegislation

changes,particularlythosefacedbySMEsintheCzechRepublic. Weaddresstwoimportantresearchquestions:

Q1.Doadvantagesfromincreasedregulationoutweighthe additionalexpenses?

Q2.AsalargeproportionofMDdevelopersareSMEs, willthenewregulatoryregimeresultinsomeofthose companiesgoingoutofbusinessandthereforerestrict futureinnovation?

Itisessentialtohighlightandbringtotheliteraturetheperceived risks(asaresultoftheproposednewlegislation)facingSME companiesthatcurrentlydevelopinnovativeMDs.

Firstly,sectoranalysisprovidesanoverviewofthemedical devicemarketandMDcompanies’structureintheCzech Republic.Secondly,thecasestudyofanSMEcompanydescribes andanalysesthesituationfromthepointofviewofregulation andtheimpactonthefunctioningofthiscompany.Regardlessof thecompany’ssize,theseproblemsorrequirementswillhaveto besolvedbyeverycompany.

THEORETICALBACKGROUND

Theimportanceofinnovationinthemedicaldevicemarketand theactualimpactonsociety,themarketandtheeconomyisoften linkedtoregulationsatnationalandgloballevels.Itisessential tostatethecontextofthecurrentlegislativeconditionsinforce andtoacquaintthemwiththeirpossibleimpacts,which,for example,someauthorshavementionedinthepast,bothnegative andpositive.

R&D,Innovation,andRegulationinthe FieldofMedicalDeviceDevelopment

Successinmedicaldevicedevelopmentisdeterminedbythe variablesofinnovativeness,financialanalysisandplanning,user inputinthedevelopmentprocess,andcompanyemployees’ engagementinthenewproductdevelopment(NPD)goals.It followsthatsuccessfulproductdevelopmentandplacementon themarketdependsonacomplexinterplayoffactorsrelating equallytobusinessstrategies,technologicalsolutions,human resources,andend-userinvolvement.Additionally,asurvey foundthatnewglobalinnovationsaccountedforonly4.4percent ofNPDprojectsinlargercompaniesand9.3percentofNPD projectsinSMEs(18).

Themedical devicesectorisarapidlydevelopingindustry(19) subjected topressuresfromallsides.Newtechnologiesemerge infastsuccession.Theyarewidelypublicized,whichresultsin patientsincreasingdemandsforthelatestinventionsthatare stillintheearlystagesofdevelopmentandmayrequireyearsof honingandtestingbeforetheycanbeintroducedtothemarket. Therefore,theever-increasingchallengeofsmallhigh-techfirms (HTSFs)istokeepupwiththelatestbreakthroughsandcomeup withwaystoleveragetheirpotential(20).

HourdandWilliams(21)conductedacasestudyonasample of14UK-basedSMEsoperatinginthemedicaldevicesector. Theresearcherscomparedtheindividualcompanies’business strategiesandpracticestodeterminethefactorsmostimportant

fortheseenterprises’success.Itwasfoundthateachstageof thedevelopment processpresentsitspeculiarchallengesand thatallthestagesareequallyessentialtotheoverallsuccess. Thisinvolvesobtainingfunding,securingpartners,recruiting staff,andsettingupdevelopmentmilestonesinthepreparation stage.Furtheron,successdependsonconductingclinicaltrials, obtainingapprovals,launchingtheproductandconductingpostmarketsurveillance.

Numerousobstaclescanhinderthesuccessoftheenterprise. Theseincludeexternalcost-relatedissues,suchaslackof funding(22),highimplementationcost(22, 23)andthecost ofverification orcertification(22).Furthermore,barriersmay presentthemselvesintheformofunethicalregulatoryauthorities (24)andthedifficultyofobtaininginformation(22).

TheImportanceof Regulationfor Innovation

ThemanufacturersofMDscooperatewithclinicalworkplacesto researchanddevelopnewdevicesandthenintheapplication phase.Thisco-operationisessentialforahighlevelof medicalandnursingcare.Therefore,modernMDsrepresenta fundamentalandirreplaceableareaforcontemporarymedicine, whichneedstobefurtherdevelopedandinnovated(25).An essentialprerequisite fortheuseofinnovativeMDsforincreasing thelevelofthehealthcareprovidedistocreate,inparticular, optimallegislativeconditionsfortheirmarketlaunching.

Itisdifficulttodrawanydefinitiveconclusionswhenit comestotherelationshipbetweenregulationandinnovation. Theassociationisahighlycomplexone,andtheimpactof regulationoninnovationisnotalwaysimmediatelyapparent. Thisimpactmaybemanifestedindirectlyandgradually,such asinsubtleshiftsinmarketstructureincompetition,business strategiesandinvestmentpriorities(11).

Thenewlegislation’skeygoal,highlightedinthispaper, istoprovideamoretransparent,efficientand“consumeroriented”approachandincreasepatientsafety.Theeffectsof regulationonproductqualityhavebeenfrequentlyresearched inthepast.Whilemanytheoreticalmodelsillustratethe relationshipsbetweenproductquality,competitiononthe market,andpriceregulation,onlyafewstudiesdescribe therelationshipbetweenregulatorypoliciesandtechnological innovation.However,apositiverelationshipbetweenheavy regulationandinnovationwasestablishedinthePorter hypothesis(10),whichproposedtheinnovationeffectof introducinginnovative environment-friendlyprocessesasa resultofheavyenvironmentalregulations.Simultaneously, innovativetechnologiesarecost-efficient,compensatingforany costsincurredinachievingcompliancewithnewregulations. Furthermore,innovationsstimulatedthroughregulationscanbe furtherutilizedthroughpatenting,whichultimatelyservesasa competitiveadvantageovercompaniesthatarenotsubjectedto suchstrictregulations.

Incontrast,studiesthatillustrateanegativeimpactof regulationsoninnovation(26)highlightthathospitals’ regulatory obligationssignificantlysloweddownthespread ofCTscans,whicheventuallybecamemoreprevalentin

individualphysicians’officesthaninhospitals.Peltzman(27), researchingtheeffectsofnewFDAregulationsonthedrug industry,reportsthattheregulationsledtoasignificantdrop inthenumberofnewdrugsintroducedinthemarketand thatthecostsexceededanypotentialsavings.Finally,some studies(28, 29)confirmthatthenewFDAregulationsresulted incompanies cuttingdowninvestmentsininnovation,hence decreasingthenumberofnewdrugsintroduced.

Whatwillbethepossibleconsequencesofthenewmedical deviceregulations[(MDR)2017/745]?Willitsupportor hinderinnovation?

Regulatory

Medicaltechnologiesarecharacterizedbyaconstantflow ofinnovation,resultingfromahighlevelofresearchand developmentwithintheindustryandco-operationwithusers. Newproductdevelopmentcantakefrom1to2yearsinterms oftheirriskclass.HealthmeansaredividedintoclassesI,IIa, IIb,III.Theplacingonthemarketofaneworinnovatedproduct dependsonthecomplexityofmeetingtheessentialrequirements and,aboveall,ontimerequiredfortheconformityassessmentby thenotifiedbody(NB).

Thefollowingriskclassificationsanddescriptionsaretaken from(17).

Class I [I(low-risknon-sterile),Is(sterile),Im(measure), Ir(reusable)]–Providedsterile“and/orhaveameasuring function(low/mediumrisk)orreusablelow-riskClassIdevices placedonthemarketinasterilecondition,haveameasuring functionorarereusablesurgicalinstruments:assessmentofthe technicaldocumentationrelatingonlytothosespecificfeatures ofthedevice,suchassterility,measurement,orreprocessing” [seealso(30)].

Class IIa (mediumrisk)“ClassIIadevices:Assessmentofthe technicaldocumentationforatleastonerepresentativedevicefor eachcategoryofdevices”[seealso(31)].

Class IIb (medium/highrisk)ClassIIb“implantabledevices (exceptsutures,staples,dentalfillings,dentalbraces,tooth crowns,screws,wedges,plates,wires,pins,clips,andconnectors) andClassIIbactivedevicesintendedtoadministerand/or removeamedicinalproduct:Assessmentofthetechnical documentationfor”[seealso(32)].

Class III (highrisk).ClassIIIdevices:“Assessmentofthe technicaldocumentationforeverydevice.”

WithintheEuropeanUnion,themedicaldeviceindustry, fromdevelopmentthroughmanufacturingtodistribution,is subjecttoEUdirectivesandregulations.Thedifferencebetween thetwoisthatdirectivesmustbeembeddedineachmember state’snationallegislativesystem,whereasregulationsapply directly.Legislationconcerningmedicaldevices(intheCzech Republic,whereourstudyisbased)isspreadacrossanumber ofdifferentdirectives,decreesandlawsissuedbytheMinistry ofHealthoftheCzechRepublic.Thesedocumentsapplyto medicaldevicesingeneralortospecifictypesofdevices,such asactiveimplantsor invitro diagnosticdevices.Asanexampleof legislativeconditions,theEuropeanmanufacturersfacethenew Regulation(EU)2017/745(33)oftheEuropeanParliamentand theCouncil on MedicalDevices(MDR).Currently,MDsinthe

CzechRepublicareregulatedbyActNo.268/2014Coll.Likethe nationallawsof theothermemberstatesoftheEuropeanUnion, thislawincorporatesCouncilDirective93/42/EEC(MDD)on MDs(34).

Afterplacing onthemarket,MDsmustbemonitored,and theirclinicalbenefitand,whereappropriate,therisksarising fromtheirusemustbecontinuouslyevaluated.Accordingto Article10oftheMDR,themanufacturermustsetupasocalledproactivewaytoestablish,document,implement,and periodicallyupdatetheriskmanagementsystemorconduct aclinicaltrialundertherequirementsofArticle61ofthe MDR,includingpost-marketclinicalfollow-up(PMCF)(35). ThePMCF isarequirementincludedinthecurrentMDD, allowingmanufacturerstostartPMCFstudiesbeforetheend oftheMDD.Theclinicaldatafromthesestudieswillbeused forMDRclinicaltrials,thuspartiallyavoidingcostlyclinical trials.However,manufacturersoftenhaveonlyapost-market surveillance(PMS)process,whichtheyunderstandasasummary ofsalesandproduction;thecollectionofclinicaldataisonly marginallyincludedhere.Forthisreason,manufacturerslack clinicaldatathattheycouldrelyonintheirMDRclinical trials,whichcanmeanhighfinancialdemands,notonlyforthe implementationofclinicaltrials.

ThefactorsmentionedabovehighlighttheEuropeanMDs industry’schallengesduetorecentlegislationchanges,especially bySMEs.MDRwasduetocomeintoforceinMay2020,but duetotheCOVID-19situation,ithasbeenpostponeduntilMay 2021.Thisgivesmanufacturersmoretimeandtheopportunity tostarttakingstepstofacilitatethetransitiontoMDR.Even thoughthecertificatewillbeissuedandsupervisedaccordingto theMDDuntiltheendofthetransitionalperiod,manufacturers willalreadybeobligedtomeettherequirementsoftheMDR.

GeneralViewoftheMedicalDevice Industry,SpecificallyinEurope

Thedevelopmentofanewmedicaldevicetypicallystartsin asmall,innovation-drivencompany.Smallcompaniestendto standatthebeginningoftechnologicalprogressinmedical devicesforseveralreasons(36).Small-sizedcompaniesmove forwardfasterbecausetheyareeasiertomanagethanlarge corporates.Theinventorandinnovatorisoftentheleaderand decision-maker,unlikeinlargercompanies,whereresearch, leadership,andmanagementformdifferentlevels.Withthe innovatorandexecutiveinoneperson,itissignificantlyeasier tomakeinformeddecisionsandassesspossiblerisks.

Thisfactisalsosupportedbythenumberofcompaniesand thestructureofthemarketinEurope.Thereare25,000MedTech enterprisesinEurope,95percentofthembeingSMEs(37, 38). Theseenterprisesareatthegreatestriskofexitingthemarket becauseadministrativecostsareoftentoohighforthem.

TheCzechmarketisstillrelativelysmallcomparedtoother Europeanmarkets.DemandformedicaldevicesintheCzech Republicin2016-2020isrelativelyconstant.In2016,market growthwas1.3%.In2019itwasestimatedat2%.Demand formedicaldevicesintheCzechRepublicbytypeofdeviceis highestinareas:Catheters,cannulaeandneedles,orthopedic

andfractureappliances,Medicalfurniture,Electro-diagnostic equipment,andmedicalinstrumentsandappliances(39).

TheCzechmarket’sopportunitieslieintheagingpopulation connectedwithchronicdiseases;thereisalsodemandfor innovativeproductsthatimproveefficiencyandhealthoutcomes, suchasmini-invasivesurgerysystems,digitalimageprocessing, orhome-careequipment(40).

RESEARCHMETHODOLOGY

This paperispartlybasedonasinglecasestudy,consideringthat a“Casestudyisthestudyoftheparticularityandcomplexityofa singlecase,comingtounderstanditsactivitywithinimportant circumstances”(41).Thepopularityofcasestudyresearchis increasing,especiallyincorporateresearch,ascasestudies canprovideinsightsthatmightnotbeachievedwithother approaches.However,“Theimportantissueistohaveaclear objective,involvetherightpeopleandhaveaccesstotheright information”(42).Casestudiescanfocusonasinglecaseor severalcases.Therearenoformalrequirementsinamulticasestudyastoaminimumnumberofcasesrequired,and neitheristherearequirementofarandomselectionofcases (43).Therefore,acasestudymaynotberepresentativesince theresearchersimplyexaminessuchmaterialasisavailable. Althoughgeneralizationsfromasinglecasestudymaybelimited, thisdoesnotdistractfromtheirimportance.“Casestudiescan beusedtoexplain,describeorexploreeventsorphenomenain theeverydaycontextsinwhichtheyoccur”(44).Analyzinga particularcaseindetailmayprovetobehelpfulindiscovering anddescribingcause-and-effectrelationshipsandeventually estimatingpossibletendenciesthatmayapplytosimilarcases. Thisresearchfollowsthemainstepsinpreparingandconducting acasestudy,includingsuccessivelyidentifyingaspecificcase, collectingdata,interpretingdata,anddrawingconclusions(45). Ontopof that,wehaveperformedtheindustryanalysisinthe CzechRepublictoassesshowrepresentativeisthecaseofthe selectedcompanyinquestion,medicaldeviceproducers,which furtherenhancetheusabilityoftheperformedcasestudy.

Design

Ourresearchisbasedonasinglecasestudysupportedbydata fromafurther50companies.ThecasestudySMEcompanyis arepresentativeofCzechmanufacturers,listedintheRegister ofMedicalDevices,whichsince2015isaunifiedsystemfor comprehensivedatamanagementinmedicaldevicesinthe CzechRepublic(46).WechoseanSMEcompanyfocusing onthe productionofseveraltypesofMDclassIIb,including pacemakers.Thefactthatmanystudiesconfirmtheimportance ofSMEcompaniesplayedaroleinselectingthecompanyfor ourdetailedcasestudy.Initially,welookedattheregisterof theAssociationofManufacturersofMedicalTechnology(47), thetotal numberof140companiesavailable.Weexcluded in vitro Diagnostic(IVD)manufacturers(thesecompaniesarenot affectedbytheexaminedchangeinlegislation)anddistributors. Sixty-eightcompaniesremainedforfurtheranalysis.Inthenext step,economicdatawerefoundinthedatabaseofAlbertina companies’Economicdata(48)(profit,revenuesandnumberof

TABLE1| Numberof MDmanufacturersbysizeofcompany.

Company category Numberof companies Theaveragenumberofactive MDsintheregistry

Micro 13 19.25

Small 18 44.75

Medium-sized 16 63,62 Large 6 57

employees)werenotavailableforallcompanies.Ourfinalset contains53 companiesintotal (Table1) Generally,ourstudywasperformedinthefollowingsteps:

• Sectoranalysisbasedondataofmedicaldevicecompaniesin theCzechRepublicto;

◦ AlistofMDcompanieswasusedfromtheregisterofthe AssociationofManufacturersofMedicalTechnology.

◦ Foreachcompanyinformationoftheproductionofmedical devicesaccordingtotheriskclassesavailableinthedatabase theNationalRegisterofMedicalDevices(availableat: https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/)ClassIIIIwereincluded;

◦ Fortheincludedcompanies,economicdatawereadded usingtheAlbertinadatabase(48),andeconomicanalysis wasdone;

• Casestudyelaborationtoshowpossiblescenariosofthe impactofnewlegislation.

Data

Weobtainedasizabledatasetfromaccountingstatements andinternalcompanyinformationobtaineddirectlyfromthe company’srepresentative.Ourdatasetcoverstheperiodof2002–2018,containingatotalof36variables.Informationabout companyrevenuescorrespondingtothevariousproductclasses orservicesispresent,alongsidecostcategories:salaries,material costs,andspecificcostsdirectlyrelatedtoMDdevelopments andtheircontinualmarketapproval(certificationcosts).Total revenues,costs,andgrossprofitarealsoincluded.

Thedatasetis,however,notwithoutitslimitations.Sinceit coversarelativelylongtimeperiod,manyaccountingstandards changedovertheanalyzedperiod;namely,themethodfor reportingemployeenumbers(givenbyfull-timevs.part-time contrastsinreporting)changedthreetimes.Thismadeitdifficult toobtaincomparabledatafortheentireperiod.

Thecompanyrepresentativewasrepeatedlyinterviewed, andtheselectedfinancialvariables(Table2)wererefinedand interpreted.Additionally,aninterviewwasconductedinMay 2019todeterminethecompany’sstrategyinthereportingperiod.

WeusedIBMSPSSversion24wastoforecastthemain variablesforthefuturecompanydevelopmentscenario.SPSS TimeSeriesModelerwasusedtoselectthemostappropriate method(exponentialsmoothing,univariateautoregressive integratedmovingaverageandmultivariate)basedonthebestfit tothehistoricaldata(49).

RESULTS

Innovation inthefieldofMDsisundertakenbySMEcompanies. Therefore,sectoranalysiswhichshowsthemedicaldevicemarket intheCzechRepublic,isdone.Thenpossiblescenariosofthe impactofnewregulationsareshowninasinglecasestudy.

Analysis–Part1-MedicalDeviceIndustry intheCzechRepublic

ThemajorproblemofMDRimplementationisinthefield ofinnovation.Specifically,mostinnovativeresearchinMDsis notundertakenbybigcompaniesbutbySMEs(37, 38).“Such companies usually focusontheproductionofasmallnumber ofproducts,meaningtheirmargindoesnotallowthemtopay forallthenecessarycostsconnectedwithMDRcompliance” (11).TheestimatedcostsforSMEstolaunchanewclassIII MDwillbebetween EUR1–4millionorEUR7–28millionif thedevicemustfulfillthecentralizedpre-marketauthorization procedurerequirements.Aspecificexpertestimateassociated withthelegislativeconditionsisgivenin Table3.

TheabovedataareanoverallestimatefortheMDmarket. However,therearenodataavailableontheimpactof newlegislationonbusinessresults(50).Therefore,wehave preparedourspecificationbasedonseveralsources.Wehave selectedcompanieslistedasmembersofthetwoMDproducer associationsintheCzechRepublicforouranalysis.Ourfinallist consistsof50companieswhosedatawererelevantandavailable. SeesectionDesignfordetailedinformation.Dataaredisplayed in Table4

Increasesincertificationcostsforconformityassessmentwere quantifiedbyadomainexperttobeapproximately2.5points multipleofthecurrentcosts,excepttheMDofsafetyclassI, wheretherearenoincreasesexpected.

Weusedacombinationofdataregardingrevenues,profit,and thenumberofMDsineachcompany’ssafetyclasses.Estimates oftheincreaseincertificationcostswereobtainedbymultiplying thenumberofMDsineachrespectivesafetyclassbytheexpected riseincertificationcostsforthatclass.Forcompanieshaving multipleMDinthesamesafetyclass,coefficientswereused tolowerestimatedcertificationcostsreflectingthefactthat producersoftencertifyMDinlargerbatches(coefficientsused were0.17forsafetyclassI;0.26forclassIIa;0.27forclassIIb and0.3forclassIII).Estimatedcertificationcostincreaseswere furthercomparedwithtotalrevenuestoobtainapercentageshare inrevenuestocreateareasonableestimateofthesignificanceof thisincreaseforthecompany.Column5in Table4 displaysthese resultsforthegroupsofcompaniesinourset.

Resultsshowclearlythattheestimatedburdenofcertification costincreasesfallsdisproportionatelyonsmallandmicrocompanies.Thisisbecausetheyhavearelativelyhighshare ofMDsinhighersafetyclasses,IIbinparticular,forwhich certificationcostsarequiteconsiderable,buttotalrevenues arerelativelysmall.Ontopofthat, Table4 showsthatprofit marginsareincreasinginlinewiththecompanysize.The smallestcompanies,onaverage,areevenrecordinglosses.The redcurvein Figure1 depictsthedecreasingestimatedincreasein certificationcostsasthepercentageofrevenues.Itishigherthan

TABLE2| Monitoredvariables.

Revenuefromtheresaleofconsumable material

Salesofsafetytechnicalcontrol(STC)

NumberofperformedSTC

Purchaseofmaterial

Purchaseofmaterialforresale

Cashflow

Foreignsources(“debt”)

Purchaseofmaterialforproduct Goods(stockofproductsforsaleandmaterialforresale)

Revenueforproduct Averageadjustedemployeecount Stockofmaterial

Numberofsoldpieces(product) Employeewagestotal

Salesofownproductsandservices

Revenuefortotalsales

Purchaseofservices,total

Totalvalueofstoredstocks(productsandmaterial)

NetCapital

Purchaseofservices,productcertificationSubsidygrantedbytheMinistryofIndustryandTradeforthe developmentofacardiostimulator

Purchaseofservices,systemcertificationSubsidygrantedbytheMinistryofIndustryandtradeformarketing Profitbeforetaxes Totalcosts

Totalrevenues

TABLE3| Approximate costsrelatedtothedevelopmentofMDs(EUR).

Costsofmarketingactivitiesandinternationalexhibitions(fairs)

InactiveActive Active/implantsComments

IIIIa IIb III

Timeofdevelopment[year]112 2 2

EmployeesHW 017,77135,54235,54235,542Withasalaryof1,500EURpermonth SW 017,77135,54235,54235,542Withasalaryof1,500EURpermonth other3554217,77171,08571,08571,085Withasalaryof1,500EURpermonth

Sterilizationvalidation 001,8511,8511,851

Measurementvalidation 01,8511,8511,8511,851

Testsel.Security 03,7025,5535,5535,553Notforimplantableones(joints,forstimulators) EMC 01,8513,7023,7023,702EMCisnotimplantable(joints,itisastimulator),but againtheyhaveahigherpriceforbiologicalevaluation Biologicalevaluation 1,8511,8515,5535,5535,553BasedontypeofMD Clinicalevaluation 7407401,8513,7023,702Iftheclinicaltrialisbasedonaclinicaltrial,evenmillions Typetest 74074037025,5535,553

CEConformityDeclaration007,4059,25611,107Abroad:notifiedbody:itisIIa-20thousand e;IIb-25 thousand e,III-30thousand e,plussupervisionevery yearabout5thousand e.AccordingtotheMDR,itis expectedthatitshouldbeupto25%more.

QMS 5,5535,5535,5535,5535,553

PMCF Afterplacingaproductonthemarket,thecostdependsonthetypeofproduct,itsuseandthecomplexityofthestudyitself (largepricerange);estimateforIIbispartoftheAppendix.

Total 44,42869,60417,9193184,746186,598

theprofitmarginsforthelowerthreegroupsofcompanies(1–19 employees,16 companiestotal)witharelativelysmallestimated impactonthelargercompanies(20–199employees,27intotal) andnegligibleimpactontheevenlargercompanies(200–999 employees,7)whereitdeclinessignificantlytobelowonepercent ofrevenues.Onlythegroupofcompanieswiththenumberof employeesintherangeof100–199showaslightdivergencefrom thetrend.Thiscanbeexplainedbythefactthatcompaniesin thisgrouphavethehighestaverageamountofregisteredMD’s (34)concentratedinthesafetyclassesIIbandIII.

Analysis–Part2-CaseStudy

OurcasestudyisbasedonanSME(Mediatrade–pulse generators)operatingandregulatedintheCzechRepublic.Inthe contextofthechangeinlegislativeconditionsintheEuropean

Union,thecompany’scrucialconcernisrelatedtoitseconomic developmentunderthenewlegislativeconditions.

CompanyCharacteristicsandStrategy

Thecompany’sprimaryfocus,whichwasestablishedin1994, isexternalpacemakers’EPG10productionandmedical devicesofriskclassIIb.However,itisrelativelynewtothe MDindustry,havingenteredthefieldin2012.Secondary activitiesincludethesaleofmaterialsforusageinthe areasofgastroenterology,speciallybootsetsforendoscopic stents(guiding,integralandpusher),disposableinjector varices;doubleandtriplelumencatheterforERCP,endoscope catheters,guidewires,Nazo-biliarcatheters.Inareaofcardiology itproducedevice,cardiostimulationcatheter,loadersets, accessories,neurostimulation.

TABLE4| MedicaldevicemarketintheCzechRepublic–MDtype,production,economicindicators.

Numberof employees Number offirms

Averagenumberof activeMDinthe nationalMDlist

I*IIa*IIb*III*Averageweightedprofit shareinrevenues[%of revenues]

Expectedincreaseof certificationcostsas percentageofrevenues

1,500–1,9991 9 9 10.50% 0.03

1,000–1,4991 34 34 11.31% 0

250–499 3 14 53.50.81.3 14.04% 0.1

200–249 2 9 1,50.570 15.52% 0.25

100–199 8 34 120.88.15.8 5.42% 1.16 50–99 6 20.2 8,85.72.73 9.96% 0.86 25–49 9 21 170.91.90.8 6.04% 0.78

20–24 4 9.25 3.30.53.81.5 4.69% 2.02

10–19 5 14.5 3.21.25.60 2.12% 5.63

6–9 7 10 62.11.40.9 16% 5.3 1–5 4 9.25 01.353.3 169% 10.13

*Averagesum(count)ofMD’sinagivensafetyclassandgroupofcompanies.

Innovationplaysalargepartinitsproductdevelopment strategy.Since thecompany’sinception,itlaunchedthefirstgenerationanalogproducts,whichitinnovatedintodigitalform in2013,launchingitssecond-generationpacemaker.Basedon marketdemand,thethird-generationproductwithbiphasic stimulationimpulsewaslaunchedin2017.

Gradually,withincreasedproduction,thedomesticmarket waslargelysaturated(inparticular,regionalhospitalswerefully securedbyMediatrade).Thecompanyalsoprovidesservicefor eachdeviceintheformofanannualsafetycheck(thehistorical revenuetrendisshownin SupplementaryFile1B.Expansionto foreignmarketshaspartiallybeenachieved.

Intheirbusinessactivities,variousdevelopmentproblems relatingtocertificationandlegislativehavebeenaddressed. Thecompanyalsofacedcomplicationsinproducttestingor testinginlaboratoriesforcompliance.Anotherchallengewas thecompilationofdocumentationforthenewproducttobe satisfactoryintheCzechRepublic’slegislation.Thesolutionto theseproblemswaspartiallyachieved,intheearlyyears,through certificationusingexternalassistance.Inlateryears,professional activitieswerealsodealtwithbyrecruitingexternalexperts.

Theproduct’spricewasdeterminedbasedonthemarket competitionwiththemaximumtargetpriceofCZK40,000.This wasbecausehospitals,ifinterestedintheproduct,didnothave

FIGURE1| Certificationcosts.

TABLE5| Economicindicators in2017.

Debt77.41percent

Theshareofreceivablesincurrentassets144.00percentReturnonEBIT1.31percent

Inventoryturnovertime55.00days Currentliquidity0.37

Increase/decrease insalesin 13.74percent Receivablesturnovertime859.00daysReturnonequity0.53percent Averagemonthlysalary1,519EUR/month

Convertedatthehistoricalratesforthegivenyears;dataarefromhttps://www.kurzy.cz/kurzy-men/historie/EUR-euro/2008/.

toissueatenderfortheproductuptoandincludingCZK40,000. Thisresultedinreducedadministrativecostsforhospitals.

EconomicIndicatorsoftheCompany

Mediatrade’sfinancialresultsshowlong-termgrowthbetween 2002and2018,withpartialdeclinesin2007,2012,and2017. TherevenuesfollowthedevelopmentGDPfrom2011to 2017.Despitetheeconomiccrisisbetween2007and2009,the companyregisteredrisingrevenues(SupplementaryFile1C Thiscorrespondstothehealthcareandpharmaceutical industries’performanceintheCzechRepublic,whichdidnot showadeclineintheaddedvalueoverthissameperiod.

Thecompanyhasahighdebtratioandalongturnover ofinventoryandreceivables.Itscurrentliquiditypointstothe abilitytorepayitsshort-termliabilities(Table5).Mediatradehas avaluethatismoretypicalforimmediateliquidity,thatis,very low.Theprofitabilityoflessthanhalfapercentagepointand otherindicatorsaddstoanunfavorableeconomicprospectunder thecurrenteconomicandlegislativeconditions.

ExpectedDevelopment

Toassessthecompany’spossiblefuturedevelopment,wehave definedfourscenariosbasedontheforecastsofthreekey variables–revenuesforconsumptionmaterial,amountof performedpacemakersafety–technicalcontrols(STC),andthe numberofproductssold.Theanalysisofconsumptionmaterial revenueswithexponentialsmoothingandthepredictionof growingrevenuesresultedinEUR114,708,EUR120,760,and EUR126,813for2020,2021,2022,respectively.Thisisbasedon thehistoricaldataforthesamevariablewithobservedgrowth ofroughly150%inthelast10yearsandrepresentsasimple trendextrapolation,i.e.,analystestimate.Thelevelofuncertainty concerningthisestimateisquiteconsiderable,ataround50% oftheforecastedmeanvalue(Upperconfidencelimitof148 118EUR,lowerconfidencelimitof81298EURonthe95% confidencelevelfortheyear2020).Basedonhistoricaldata fortheamountofperformedSTC’s(usuallyperformedoncea yearforeachdevicetoverifythatitfunctionscorrectly,i.e., outputsignalprecisioniswithindefinedbounds),theSPSSTimeseriesmodelerselectedARIMA(0,0,0)wasusedforthisdata series,whichequalsaninterpolationdataseriesintermsofits meanvalue.Intermsofmodelfit,R-squaredwasnegligible.The predictiondoesnotseemhelpful,andconsequently,itwasnot usedforfurtheranalysis.Fortunately,weknowthattheamount ofperformedsafety–technicalcontrolseachyear–isdetermined bythetotalnumberofpacemakersintheCzechRepublic hospitals.Mediatradealreadyreachedacapof270active pacemakersinCzechhospitals,sotheconstantforecastofthe342 performedSTCisrelevantfortheCzechmarket,givencurrent

safetyregulationsregardingthisMD’smaintenance.Forthelast variable,thenumberofsoldpacemakers,thesimpleexponential smoothingmethodwasused,withaconstantpredictedvalue of48piecessoldeachyear.Thisagaincorrespondsrelatively welltoourexpectationsbecauseMediatradehasalreadycaptured theCzechmarket,andanyfurthergrowthinproductsalesmay havetocomefromforeignmarkets.Itisnecessarytopoint outthatthetrajectoriesmentionedaboveofthethreeprimary sourcesofrevenueforthecompanydonotrepresentexact statisticalprojectionsbutmoresoanalystestimates,basedon theknowledgeofthecompanyinnerworkingsandprocesses accompaniedbyanunderstandingoftheCzechmarketforthis particularkindofMD.Costswerecalculatedusinghistorical dataforthecorrespondingcategories;fordetails,pleaseseethe collecteddataonMediatradein SupplementaryFile2.

Thefirstscenarioisthebusiness-as-usualscenario(BAU), inwhichtherearenosignificantchangesregardingthecosts relatedtoMDcertificationandthesalesvolumeisbasedon theforecastsexplainedinthepreviousparagraph.Inthesecond scenario,thecompanyisfacedwithincreasedcertification expenditures(CERT)tomaintainitsMDsalesontheCzech medicalmarket.Twofollowingscenariosarebasedonpossible mitigationstrategiesthecompanycouldadopttooffsetimpacts ofCERTscenario–CERT+EXPbasedonapro-exportcompany orientation,whereitexpandsonforeignmarketswiththehelp ofincreasedmarketingexpenditures,andCERT+PRIC,where ittriestomitigatetheincreasedcertificationcoststhroughan increaseof15percentinthepriceofitsservicesandproducts. WeassumeinelasticdemandfortheMD,sothepredicted volumesoftheunitssoldandservicecheck-upsdecreaseby 7.5percentoverall.Theresultsofthisexerciseareshown in Figure2

UndertheBAUscenario,thecompanygeneratesasmall profitoverthe3-yearforecastperiod.However,oncethe increasedcertificationexpendituresareincludedintheCERT scenario,thefirmincursasignificantloss,whichfurther impairsitsfinancialstanding(EUR195,160indebtin 2016).Thefirstmitigationstrategy,CERT+EXP,somewhat improvesthesituation.However,thecompanystillincursa loss,astheincreasedvolumeofsalesabroadrequireshigher marketingexpensesandslightlyhigheremployeecosts.Thelast strategy,CERT+PRIC,istheclosesttozero,withasmallloss ofEUR2,444.

Regardingidentifieduncertaintyaroundforecastedsalesof consumptionmaterial,theriskisdisproportionallyskewedto thedownsideoftheforecastedmeanvalueinthepostCOVID19world.Alowerconfidencelimitforthefirstforecastedyear representsadeclineofEUR27,649,enoughtowipeoutthewhole profitintheBAUscenarioandsignificantlydeepenthelossesin

FIGURE2| Cumulativeprofit/loss.

FIGURE3| Developmentof revenuesandcostsunderthesimulatedscenarios.

therestofthescenarios.Alsoimportantisthedistributionof theresultsovertimeduetocashflowconsideration;thetemporal distributionisdepictedin Figure3

Thefirst3yearsarebasedonthehistoricaldataobtainedfrom financialstatements,andthesimulationresultsarepresentedfor 2020–2022.Inallscenarios,lossesareconcentratedinthefirst simulationyear,butinthetwofinalscenarios,thefirmgenerates aslightprofit,exceptfortheBAUscenario.

DISCUSSION

Previousstudies[see,forexample,(7)]highlighttheneedfor regulatorychange.Thecurrentregimeappearstobebiased towardMDproducersandnottheendusers’safetyandrisk assessment.KentandFaulkner(5)argue(p.189),“thatthere areweaknessesintheregulationofmedicaldevicesandthat commercialinterestshavedominatedregulatorypolicy,”and

(p.191),“Theprocessesofinnovationoutpacethedevelopment ofregulatory controls.”Therehasalsobeenconcernexpressed abouttheincreasingnumberofMDrecalls(2).LeiterandWhite (6)arguethat“medicaldevicesareincreasinglybeingimplanted inhumanbodies,constitutingmanufacturedrisks.”

Oneofthebiggestproblemsforcompaniesappearstobe inacquiringclinicaldata,whichwillenablethemtosucceed intheconformityassessmentorcertificationprocess,according toMDR2017/745.Untilnow,MDD93/42/ECrequirements wereperceiveddifferently;theMEDDEVrecommendations specifiedthem.However,theywerestillrecommendations. WithintheMDR2017/745,itisnolongerarecommendation butaregulation.Thus,thereisanobligationformanufacturers todemonstrateclinicaldata.However,itisnotentirelyclear whetherclinicaldatafromclinicaltrialsordatafromPMCF studieswillsuffice.Manufacturersbelievethatawell-designed PMCFprocesswillprovidethemwithsufficientqualityclinical datatodemonstratetheirproduct’sclinicalsafety.However, therightlysetPMCFprocessisaninterventioninthe economicsituationofthecompany.Itistherighttimefor manufacturerstodecidewhatchangestheywillmaketotheir processesandbusinessmodeltoavoidthefinancialimpacton theirbusiness.

Asthenewregulationscomeintoeffect,2021willbea challengingyearformanycompaniesintheMDmarket. ThelegislativechangesaimtomakeMDssaferforpatients throughouttheirlifetime.Forcompanies,thismeansadditional controlcosts,evenafteranMDhasbeenlaunchedandalsonew clinicaltrialsforMDswithalowerriskclassthaninthepast.

Fromourresearch,itisclearthatSMEswillbemost affectedbythechangeinlegislation.Largercompaniesare betterpositionedtoadapttolegislationchangesbecausethey alreadyhavearegulatorydepartmenttomonitorandupdate thelegislativerequirementsfortheircurrentlymanufactured medicaldevices.Article15ofMDR2017/745specifiesthata manufacturerisrequiredtohaveatleastonepersonwithinhis organizationdemonstratinghisexpertiseinregulatoryaffairs, butatthesametimeadmitsthatsmallfirmsmayhavesuch apersonemployedexternally.Fromthispointofview,the responsetolegislativechangesinsmallcompanieswillnotbe asdynamicasincompaniesthathaveestablishedaninternal regulatorydepartment.Thesecompanieswillbeforcedtomake manychangesthatwillimpacttheireconomicindicators.

Ourmarketanalysisshowsthatthelargerthecompanythe lowerthepercentagechangeinincreasedcostscausedbythe MDRnewrequirements.Inourdataset,itwasalsoapparent that,ingeneral,micro-capcompaniesarespecializedinthe productionofafewMDsinhighersafetyclasses.Therefore,they willbedisproportionatelyaffectedbynewregulations,estimates ofincreasesincertificationcostsas%ofrevenuesareheight. Largercompaniesfocusonthelarge-scaleproductionofclassI MD’swhereitishardertocompetebysmallcompaniesduetothe economiesofscale.ThatleadstospecializationonMD’sinmore demandingsafetyclasses,whichwill,unfortunately,beharder hitbyincreasestocertificationcosts.Theabove-mentionedleads toapotentiallythreateningsituationforSME’s.Theperformed sectoralanalysisfurthershowedthattheresultsobtainedinthe

casestudyofMediatradearerelevantintheCzechRepubliccase, asmicro-capcompanies(see Figure1)sharemanyofthesame characteristicsingeneral.

Overall,thereisanotherprobleminthemedicaldevice market,corruption.AccordingtoTransparencyInternational’s Index,theCzechRepublicisoneofthecountrieswithahigher levelofcorruption.IntheCRareidentifiedillegalandnonstandardmethodsoftenderingandvendorlock-inCompetitive ProceduresWithoutNegotiation(CPWN).Itallowstogetthe contracttoasinglebidderwithoutacompetition(Act134/2016 Coll.,§63).Initsreports,theSupremeCourtrepeatedlydraws attentiontoCPWN’spracticesinsecuringpublicprocurement, includingatthelevelofministersandinstitutionsresponsible forthepurchaseofmedicaldevicesandequipment.Inthe years2011-2016,theshareofthesecontractsrangedfrom31 to62%oftheirtotalvolume.Acommonproblemwithnonstandardmethodsinthehealthsectoristhevendorlock-in, itmeansproprietylock-inorcustomerlock-inthatmakesa customerdependentonavendorforproductsandservices.Then thecontractingauthorityoftentendstocompeteforlong-term contractsinclosedprocedures,forhigherpricesontheaccount ofpublicfunds.Oneofthespecificexamplesinthefieldof healthcareisthecreationofacartelforthesupplyofmedical equipmentandmoderntechnologiestotheCzechhospitals(50). Thereisalso pressurefromthepharmaceuticalandmedical deviceindustrytowardtheuseofmoreprofitableproducts. Thereisnodefinitionofthestandardhealthcarecoveredby theinsuranceasguaranteedbythelaw.Ithappenedinthepast thattheregulationwas ad-hoc andusuallyevenretrospective (51).ThisfatisconfirmedbytheEuropeanResearchCentre forAnti-Corruptionand State-Building(ERCAS),theCzech RepublichasbeenoneofthemostsuccessfulCentreandEastern Europeancountriesinthefightagainstcorruptioninallareas, includingthehealthcaresector.Nowadays,itsadministrative simplicityandtransparencyarecomparabletoEuropean standardsasaresultoftheharmonizationoflawswithinthe EuropeanUnion(52).

CONCLUSIONS

Concerningthe developmentofMDs,theEUregulations’ changespresentmanychallengestotheMDindustry.Thenew stricter(heavy)regulationsaimtoimprovepatientsafetythrough morerigorousqualityassurancemeasures,butthereisconcern thatthismayadverselyaffectSMEs.

ThePorterhypothesisimpliesthatheavyregulationinduces innovationwhile,ontheotherhand,thereisacontraryviewthat heavyregulationisabarriertoinnovation.Withinthecontext ofthenewMDdevelopmentregulationsdiscussedinthispaper, itwouldappearthat,withrespecttoSMEs,heavyregulation maybeabarriertotheinnovationofnewMDs.Incontrast, withregardtolargerorganizations,suchregulationmayprove tostimulateinnovation.However,whilesomeSMEsmaymove awayfromMDdevelopmenttonon-MDproducts,theymay transfertheirinnovativeskillstotheseproductstothemedical profession’sdetriment.

RegardingresearchquestionQ1,ourresearchshowsthatthe newregulations shouldensureimprovedMDsafety.However, theeconomicloadmaybeexcessivebothtotheproducerand healthcareprovider.Aproblemisnotonlythepriceofthe conformityassessmentprocess,whichintheCzechRepublic varieswithregardtothetypeandriskclassofMDintherange ofCZK150–600thousandwithintheassessmentaccordingto MDD93/42/EECbutanotherdifficultyforthemanufactureris theobligationtosubmitclinicaldataforconformityassessment. ObtainingclinicaldatathatcanbeusedforMDs’clinicaltrials andsubsequentlysettingupthePMCFsysteminclinicaltrials mayalsobebeyondsmallcompanies’power.Theevidencealso indicatesthatsomeSMEsmaybeforcedtodiversifyto“nonmedical”products,withtheinevitablelossofsomeinnovative MDsbeingmadeavailabletopatientsandhealthcareproviders. Q2haspartlybeenansweredunderQ1,butasthenumber ofMDdevelopersreducessowillthenumberofinnovative MDs,thusrestrictingfutureMDinnovation.Followingthe introductionofthenewregulations,furtherresearchshouldbe undertakentoverifyourfindingsandperceivedimplicationsfor thedevelopmentofMDsbySMEs.Onamorepositivenote,due totheeffectofCOVID-19,theimplementationoftheregulations hasbeendelayeduntil2021,givingcompaniesthechanceto managethetransitionmorepositivelyandevenseekoutbenefits throughtheopportunityofacompetitiveadvantage.

Limitationsregardingourstudymayarisefromtwo perspectives;(i)thepaperdealsonlywiththeproductionofMDs subjecttoMDD93/42/EC,resp.MDR2017/745anddoesnot, therefore,includeMDsinclassIVD,and(ii)itisbasedmainly onasinglecasestudy–Mediatrade.Duetothespecificsofthe selectedcompany,namelyitsuniquebusinessmodel,previously receivedstatesubsidiesandhistoricalchangesintheCzech accountingpracticesdisallowexactreplicationofthiscasestudy. Wehaveaddressedthisissuebysupportingourresearchwitha comprehensiveanalysisofthewholeindustry,whichconfirms theresultsobtainedfromMediatrade.Nevertheless,webelieve thatthepaperprovidesavaluablecontributiontotheliterature concerningtheinnovativedevelopmentofmedicaldevices.

Webelievethepaperistimelyinthatitaddressesan importantcurrentissueregardingtheMDindustry’sfuture. Infurthersupportofthetimelyrelevanceofourpaperisthe

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DATAAVAILABILITYSTATEMENT

Therawdatasupportingtheconclusionsofthisarticlewillbe madeavailablebytheauthors,withoutunduereservation.

AUTHORCONTRIBUTIONS

PM,LP,andFLcontributedtoconceptionanddesign ofthestudy.LRperformedthestatisticalanalysisand graphicaloutputs.PMandLHwrotethefirstdraft ofthemanuscript.PM,FL,LH,LR,andLPwrote sectionsofthemanuscript.Allauthorscontributed tomanuscriptrevision,read,andapprovedthe submittedversion.

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ConflictofInterest: Theauthorsdeclarethattheresearchwasconductedinthe absenceofanycommercialorfinancialrelationshipsthatcouldbeconstruedasa potentialconflictofinterest.

Copyright©2021Maresova,Rezny,Peter,HajekandLefley.Thisisanopen-access articledistributedunderthetermsoftheCreativeCommonsAttributionLicense(CC BY).Theuse,distributionorreproductioninotherforumsispermitted,provided theoriginalauthor(s)andthecopyrightowner(s)arecreditedandthattheoriginal publicationinthisjournaliscited,inaccordancewithacceptedacademicpractice. Nouse,distributionorreproductionispermittedwhichdoesnotcomplywiththese terms.

published:08July2021 doi:10.3389/fpos.2021.694132

Editedby: AndrzejKlimczuk, WarsawSchoolofEconomics,Poland

Reviewedby: AdrianaGrigorescu, NationalSchoolofPoliticalStudies andPublicAdministration,Romania SurendraPatel, AllIndiaInstituteofMedicalSciences Jodhpur,India

*Correspondence: PeterEnste enste@iat.eu

Specialtysection: Thisarticlewassubmittedto PoliticsofTechnology, asectionofthejournal

FrontiersinPoliticalScience

Received: 12April2021 Accepted: 14June2021 Published: 08July2021

Citation: EnstePandKucharskiAB(2021) Social,LegalandEconomic ImplicationsfortheImplementationof anIntelligentWoundPlasterin OutpatientCare. Front.Polit.Sci.3:694132. doi:10.3389/fpos.2021.694132

Social,LegalandEconomic ImplicationsfortheImplementationof anIntelligentWoundPlasterin OutpatientCare

PeterEnste*andAlexanderBajwaKucharski

InstituteforWorkandTechnology(IAT),Department:HealthIndustriesandQualityofLife,WestphalianUniversityofApplied Sciences,Gelsenkirchen,Germany

Background: Thecareofchronicwoundsisoneofthecoretasksofinpatientand outpatientcare.Thecorrecttimingofchangeshasasignificantimpactonthepositive courseofwoundhealing.TheVulnusMONprojectdevelopedanintelligentwoundplaster todeterminetheoptimumtimetochangetheplasterinhospital.Againstthebackgroundof implementingthesolutionalsointheoutpatientsector,thisarticlefocusesonthefollowing researchquestions:Whatisthelegalframeworkforwoundcareinoutpatientcare?What arethedifferencesinwoundcarebetweeninpatientandoutpatientcare?Whatobstacles andbarriersarisefortheVulnusMONprojectwhenitisimplementedintheoutpatient sector?Caninitialeconomicestimatesbemadeforthetransfertotheoutpatientsector?

Method: Duetothecomplexityofthedifferentresearchquestions,amixedmethod designwasused.Thequalitativepartofthestudyincludesbothfocusgroupsandexpert interviews.Aspartofthequantitativeanalysis,adatasetonoutpatientwoundcarewas analyzed(n 463).

Results: Insummary,itcanbestatedthattheprojectVulnusMONanditsintelligentwound plaster,whichaimstodeterminetheidealtimetochangeawoundplasterisviewedvery positivelybytheprofessionals.However,thereareanumberofbarriersthatinhibitthe potentialtransferofthenewdigitalsolutiontotheoutpatientsetting.Fromaneconomic pointofview,implementationintheoutpatientsectormakessense,astraveltimescanbe reduced.However,thestudyalsopointsoutimportantsocialimplications,thatpose severalchallengesfortheactualtransferoftheplastertotheoutpatientsector.

Keywords:outpatientcare,digitalhealth,ELSI,woundmanagement,healthcare

INTRODUCTION

Thecareofchronicwoundsisoneofthecoretasksofinpatientandoutpatientcare.Thecorrect timingofchangeshasasignificantimpactonthepositivecourseofwoundhealing.Especiallyinthe outpatientsetting,infectioncontrolisaparticularchallengebecausetheenvironmentdoesnot providethesamehygienicconditionsthatexistinahospital(PayneandPeache2021).Inaddition, severalstudiesshowthatthetreatmentofchronicwoundsisahereditarycostfactorinthehealth systemthatisveryoftenunderestimated.Atthesametime,thestudiespointtoanurgentneedfor actionintheoptimizationofwoundcaresothat,ontheonehand,thequalityoflifeofpatientsis

improvedand,ontheotherhand,thecostsintheareaofwound caredonotincreaseuncontrollablyinthefuture(Olssonetal., 2019; Nussbaumetal.,2018; Bates2020).Againstthis backgroundthreemainfactorscanbeidentifiedthrough whichbetterwoundmanagementcanbeachieved:Shortening thewoundhealingtime,optimizingthefrequencyofdressing changesandreducingthepreventionofwoundinfections.By achievingthesegoals,thequalityoflifeofpatientscanbe improvedontheonehandandthecostsinthecontextof woundcarecanbesignificantlyreducedontheother (LindholmandSearle2016).

Around3.4millionpeoplelivinginGermanyneedcare services.Threequartersofthesearecaredforathome.Alarge partofthecarefortheapproximately830,000peopleinneedof careisprovidedbytheapproximately14,100outpatientcare services.Thisdoesnotincludepeoplewhoonlyreceivehomecare accordingtotheFifthBookoftheGermanSocialCode(SGBV). Afurther820,000peopleinneedofcarearecaredforinthe 14,500nursinghomeslicensedunderSGBXI(FederalStatistical Office,2018,2019).Thequalityofinpatientfacilitiesand outpatientcareisassessedandrecordedthroughregular systematicevaluation.Accordingtothis,6.6%ofthoseinneed ofcareinnursinghomesand7.3%inoutpatientcaresufferfrom chronicwounds,suchasdiabeticfootulcers,decubitusulcersor vascularlegulcers(MedizinischerDienstdesSpitzenverbandes BundderKrankenkassen,2017).

Woundmanagementisunderstoodtobemuchmorethanjust woundcare.Infact,woundcareisapartofwoundmanagement. Thespectrumrangesfromuniformdiagnostics,the determinationofwoundtypes,healingandtreatment,pain managementtowounddocumentation.Expertsfromvarious medicalprofessionsareinvolved,includingnurseswithspecial training,theso-calledwoundmanagersorwoundexperts.

Effectivewoundmanagementisanenormouschallengeandis basedonthecompletedocumentationofthehealingprocessby thewoundexpertsandenablesappropriatetreatmentadaptedto therespectivestageofthewound.Rapidinterventionandtransfer tosafetreatmentpathwaysincreasesthechancesofaccelerating woundhealing,preventscomplications,reducespainand improvesthequalityoflifeofthoseaffected.Adistinctionis madebetweenacuteandchronicwounds.Inthecaseofthelatter, bothwoundcareandsupportforwoundhealingareconsiderably morecomplex.Woundsaredescribedaschroniciftheypersist formorethaneightweekswithouttherapyordonothealwithin onetothreemonthswiththerighttherapy(Storcketal.,2019; Dissemondetal.,2017).

Againstthisbackground,itisclearthatdigitalproductscan makeasignificantcontributiontoimprovingthequalityofcarein thehealthsector(Haggerty2017; Alamietal.,2017; Krausetal., 2021).However,itisalsoevidentthatthedigitaltransformationin thehealthsectorhasstartedlaterthaninotherindustriesandhas toovercomeanumberofbarriersandacceptanceproblems (Herrmannetal.,2018).Theevidenceondigitaltransformation incarecanbedescribedasratherabstractatthispointintime, becauseinthecontextofreviews,trendsareusuallyparaphrased thathavelittleempiricalevidence,arebasedonexpertopinions,or donotsystematicallycorrelatesubjectiveassessmentsandobjective

outcomeeffects(Johnsonetal.,2019; Robert2019).Studiesthat examinetheperspectivesofprofessionalnursesontheuseofdigital technologyintheworkprocessfocusinparticularontheaspectsof attitudes,acceptanceandsetting-specificreadinessfortechnology. Theresultsvary.Whilethespectrumofattitudesamongcaregivers rangesfromskepticismtointerest,morein-depthquestionswitha viewtoconcreteobstaclestouserevealproblemsincompletely differentareas:Forexample,thetechnologicalinfrastructuresand possibilitiesforusearenotalwaysavailable,especiallyinelderly carefacilities,andatthesametimetheageofthecaregiverplaysa centralrole(Papadopoulosetal.,2018; Rantanenetal.,2018;Coco etal.,2018; Hülsken-Giesleretal.,2019).Inthiscontext,ELSI researchcanmakeanimportantcontributiontoidentifying problemsandbarriersalreadyinthedevelopmentprocessand todevelopingsolutionstrategiesforthefurthercourseofthe project.(Goldenbergetal.,2019; Parkeretal.,2019).

ThispaperdescribespartoftheELSIresearch,i.e.,focusingon thesocial,legalandeconomicimplications,usingaconcrete example.AspartoftheVulnusMONproject,anintelligent woundplasterwasdevelopedthatusessensorsaspartof continuousmonitoringtodeterminetheoptimaltimewhen theplastershouldbechangedtooptimizethewoundhealing process.Forthispurpose,parameterssuchastemperature,pH value,impedanceandhumidityarecontinuouslymeasuredand analyzed.Thedatafromthelocalwoundsensorsareprocessed withfurtherinformationanddatafromthepatient’ s file.Inthis way,thewoundhealingprocessandthetherapyareoptimally supported.ThepatchwasusedinaGermanhospitalaspartofthe project.Theaimofthispaperistoreviewtheframework conditionsthatdescribethepotentialuseofthedeveloped woundplasterintheambulatorycaresector.Withthisin mind,thispaperdescribestheframeworkthatcharacterizes theimplementationofinpatientuseintheoutpatientsector.A practicalimplementationdidnotoccurduringtheprojectperiod. Therefore,noconclusionsaboutpatientacceptancecanbemade atthistime.Fortheambulatorycaresectortherearesomespecial features,sothatatransferandtheassociatedrequirementshave totakecertainaspectsintoaccount:Legalframeworkconditions thatregulatetheprescriptionofdressingmaterials,theplaceof useinthepatient’shousehold,whichrequires flexibilityin standardizedcareprocesses,andasometimesnotyethigh levelofdigitalizationintheareaofoutpatientservices, combinedwithadifferentformofworkorganization,present newchallengesfortheexpansionoftheVulnusMONproject.

Fortheoutpatientsector,therearetwooptions,whichare describedbelow:

• OptionI:Measurementanddatatransmissiontakeplace continuouslyinthepatient’shousehold.Forthispurpose, boththetransmitterandreceiverofthedataareinstalledin thepatient’shousehold.Thetimeofchangeisdeterminedin realtime.

• OptionII:Thetransmissionofdataisdonebyadevicethat theoutpatientcareservicecarrieswiththem.Accordingly, thecareprovidermustbeonsitetotransferthedata.The determinationoftheoptimaltimeofchangecantherefore bedelayedundercertaincircumstances.

TABLE1| Researchdesign.

Topic Method

Legalframework

Differencesinwoundcarebetweeninpatientandoutpatient

QualitativeLiteraturereview

Focusgrups

Obstaclesandbarriers Focusgroups

Economic QuantitativeDataanalysis

Inordertodeveloptargetedsolutionstrategiesingoodtimeso thatimplementationintheoutpatientsectorcansucceed,the overarchingmainquestionofthepapercanbeformulatedas follows:WhatcontributioncanELSIresearchmaketosupportan implementationofadigitalapplicationinambulatorycare?This raisesthefollowingquestions:

• Whatisthelegalframeworkforwoundcareinoutpatient care?

• Whatarethedifferencesinwoundcarebetweeninpatient andoutpatientcare?

• WhatobstaclesandbarriersarisefortheVulnusMON projectwhenitisimplementedintheoutpatientsector?

• Caninitialeconomicestimatesbemadefortransfertothe outpatientsector?

METHODS

Duetothecomplexityofthedifferentresearchquestions,itwas decidedtouseacombinationofdifferentresearchmethods.The methodologicalapproachisbasedontheprinciplesofmixed methods,inwhichbothquantitativeandqualitativeresearch methodsareused.

Thisraisesthequestionofwhatgoalispursuedbypursuing theresearchquestionwithbothquantitativeandqualitative methods,ifthisresultsinaconsiderableadditional expenditureoftimeandnotinfrequentlyalsomaterialand financialresources.Thereisagreementintheresearch landscapethatthecombinationofthetwoapproachesshould balanceouttherespectivestrengthsandweaknesses(Creswell 2014;BaurundBlasius2014; Kelle2014).

Inthisstudy,too,themainquestionisthereforetheadded valueofcombiningmethodstoanswerthequestion.Ifone orientsoneselftothe fivebasicfunctions(validation, complementarity,initiation,developmentandextension)to whichamixedmethodsapproachcanbeassigned,the functionofextensionisidentifiedforthepresentexpertize. Thisfunctionischaracterizedbythefactthatthequantitative andqualitativeapproachrefertotwodifferentareasin connectionwithoneobject(SchreierandOda ˘ g).Thesubject matterisambulatorywoundcare,thequantitativeapproach referstoeconomicissueswhilethequalitativeapproachrefers totheexperiencesandevaluationsbythenursingstaff.This researchdesigncanbecalledConvergentParallelMixedMethods (Creswell2014)andcanbepresentedasdisplayedin Table1.

Inthe firststepofthestudy,aliteraturereviewwasconducted, whichtookintoaccountboththestateoftheartinoutpatient

woundcareandthelegalbasisinGermany.Thequalitativepart ofthestudyincludesfocusgroupsaswellasexpertinterviews.A totaloftwofocusgroupswereconducted.Inthe firstfocusgroup, aspecialfocuswasplacedonoutpatientwoundcareandthe associatedchallengesforthewoundpatch.Thefocusgroup consistedofeightwoundexpertswhoworkinambulatory care.Thesecondfocusgroupdealtwithgeneralquestions aboutdigitalizationintheoutpatientcaresector.Thisfocus groupconsistedofmanagementandnursingstaffaswellas peoplefromthetechnicalsector.Furthermore, fiveexpert interviewswereconductedwithmanagersofoutpatientcare. Thecontentofthefocusgroupswasasfollows:Atthebeginning, theprocessofwoundcareinoutpatientwoundcarewas addressed(onlyinfocusgroup1);inthefurthercourse,the impactofdigitalizationontheoutpatientsectorwasdiscussed.In thelastpart,thedigitalsolutionwaspresentedinordertodiscuss questionsofpotentialpracticabilityandacceptance.Theexpert interviewsincludedthesamethematicaspectsandservedto sharpenthecontentoftheresults.

Theinstrumentofqualitativecontentanalysiswaschosen astheevaluationmethod.Itstandsasanevaluationmethod fordatathataccruedwithintheframeworkofqualitative researchprojectsandischaracterizedbythefactthatitis alsoabletohandlelargedatavolumesandtostructure themthrougharule-guidedprocedure( MayringandFenzl 2014).Withintheframeworkofthequantitativeanalysis,a datasetonoutpatientwoundcareofanoutpatientnursing servicewasanalyzed.Descriptivemethodswereusedforthe analysis,allcalculationswerecarriedoutwiththestatistical softwareSPSS.

RESULTS

TheLegalFrameworkforOutpatientWound Care

Successfultreatmentofchronicwoundsoftentakesplacewiththe involvementofseveralmedicalprofessionalgroupstoensure properwoundcare.Thetreatmentusuallyextendsoveralonger periodoftime.Professionalassessmentandtreatmentofwounds iscrucialforwoundhealingandcanbecarriedoutbydoctorsas wellasbyqualifiednursingstaff,theso-calledwoundmanagers. Thedoctorisinitiallyresponsiblefordiagnosis.Whendeciding ontherapy,whichisalsopartofhisorherareaofresponsibility, heorshedecideswhetherandtowhatextenttreatmentcare activitiesshouldbedelegatedtonursingstaff(Reibnitzand Skowronsky2018).

Shoulditprovemedicallynecessaryfromthedoctor’spointof view,heorshecanreferthepatienttoaspecialistorevento hospitalforinpatienttreatment.Woundsaretreatedwith dressingsspeciallydevelopedforwoundcare,whichcanbe redeemedbyaprescriptionfromthedoctoratapharmacy andamedicalsupplystore.Aswithmedicines,thestatutory co-paymentapplieshereforeachdressingprescribed.

Thedressingsarechangedataprescribedintervalaccordingto theinstructionsoftheattendingphysician.Thedoctorcanissuea prescriptionfortheoutpatientnursingservice.Asarule,the woundmanagersareresponsiblehere,whosegoalistopromote thequalityoflifeoftheaffectedpersonthroughappropriate woundcare,tosupportwoundhealingandtopreventa recurrenceofthewound.Ifnecessary,woundmanagerscan alsoinstructpatientstotakeoverwoundcareindependently inthelongterm.Dressingchangesbyanambulatorycareservice areaserviceofhomehealthcareandaresubjectto reimbursement.Ingeneral,theexpensesforthenecessary measuresforwoundcareareprescriptiveaccordingto§31 SGBVandarecoveredbythehealthinsurancefunds.The professionalwoundandphotodocumentationispartofthe nursingdocumentationandthereforefallsunderthe responsibilityofthewoundmanagers.Thephysician’staskis todocumentthecourseoftreatmentinthemedicalrecords (DeutschesNetzwerkfü; ReibnitzundSkowronsky2018).

Inordertosuccessfullycarryoutwoundhealing,further medicalproducts,so-calledaids,maybenecessaryincertain cases.Aidstosupportthehealingprocessofwoundscanalsobe prescribedbythedoctor.Thesecanbeobtainedfromamedical supplystore.

Whenprescribingservicesandproducts,thedoctorisbound bytheprincipleofeconomicefficiencyaccordingto§12Para. OneSGBV,i.e.,theservicesmustbesufficient,appropriateand economicalandmustnotexceedwhatisnecessary.Forthis reason,notallavailableservicesandproductsarereimbursable forwoundtreatmentandcanonlybereimbursedafterprior individualapprovalbythehealthinsurancefund.Iftheyarenot includedinthecatalogofbenefitsofthehealthinsurancefunds, theymustbe financedbythepatientsthemselves.

Outpatientwoundcareissubjecttospecificcoursesofaction andlegalframeworkconditionsthatmustbetakenintoaccount fortheappropriatecareofpatients,butalsofortheprotectionof serviceproviders.Thelegalandcontractualstipulationsinthe SocialCodeBookXIandSocialCodeBookVdefinetherangeof servicesofoutpatientcarethatareavailableinGermanyforthe managementofproblemsituationsinconnectionwithillnessand theneedforcareinthehomeenvironment.TheFederalJoint Committeehasexpandedthespecificationsforthecareof patientswithchronicanddifficult-to-healwoundsinthearea ofhomecarein2019.Accordingtothis,thecareofchronicand difficult-to-healwoundsshouldprimarilytakeplaceinthe householdoftheinsuredpersonor,accordingto§2,inother suitableplaceswheretheinsuredpersonfrequentlyspendstime.

Ifthisisnotlikelytobepossibleintheinsuredperson ’ s homeduetothecomplexityofthewoundcareorthe circumstancesinthehome,thewoundcareshouldthentake placeinspecializedfacilities.However,thismustbeevident

fromtheregulation.Forthecareofchronicanddif fi cult-tohealwounds,theserviceistobeprescribedaccordingtothe proceduresforno.31a.Accordingto§3,everyhomenursing measurerequiresamedicalprescription.Theserviceproviders whocarryoutthemeasureswithintheframeworkofhome nursingcareare fi rstboundbytheprescriptionandthenbyitif approvalisgiven.

Accordingto§7,thecareproviderreportstothetreating contractualdoctoronchangesinthehomecaresituation,in particularhomenursingcare,oruponrequestbythedoctor,if necessaryalsobytransmittingextractsfromthecare documentation.Thedoctordecidesonthenecessarymeasures resultingfromthis(GemeinsamerBundesausschuss2019). Accordingly,thelegalframeworkclearlyspecifiesthatthe prescriptionfortreatmentismadebythegeneralpractitioner. FortheVulnusMonproject,thismeansthat,especiallyinthe outpatientsector,GPsmustbeincludedinthesupplychainand theymustalsohavethenecessaryinfrastructure.

DifferencesinWoundCareBetween InpatientandOutpatientCareSettings

Inthefocusgroupdiscussion,theordinaryprocessofwoundcare isdiscussed.Theusualcareprocessisasfollows:Awoundexpert goesouttothepatientandlooksatthewoundandtakesaphoto. Theexpertthencontactstheprimarycarephysicianbecauseheor shemustissuetheprescription.Thewoundexpertmakesa recommendationonhowtotreatthewound.Thedoctorthen makesthedecisiononhowtotreat.Ideally,thereissubsequently regularcontactwiththefamilydoctor’sofficewithphoto documentationofthewoundhealing:

“Normally,ifthewounddeteriorates,contactismade withtheprimarycarephysicianorthephysicianspecifies atimeperiodwherethestatusofthewoundshouldbe reported.Iftherearechangesordeterioration,an alternativetreatmentmethodcanbediscussed ”

Mostwoundsthatoccurarepressureulcertreatments,leg ulcers,unhealedsurgicalwounds,andwoundsrelatedtofalls.In thisregard,thewoundmanagersnotethatthereisaspecific treatmentmethodforeachwound.Thisalsomeansthatthereare differentdressingmaterialsandcertainmaterialsare contraindicatedforcertainwounds.Thisresultsinawide rangeofpatientswithdifferentages.Ingeneral,theaverage ageofpatientswithwoundcareonlytendstobelowerthaninthe outpatientsetting.Therearemanypatientswithwoundhealing disordersaftersurgery.Asalreadydescribedabove,theseare usuallypatientsforwhomonlythewoundistreatedandwho, afterhealing,arenolongerpartofthenursingservice’sclientele. Regardingthetaskofwoundexperts,however,itmustbenoted thattheirdutiesdonotexclusivelyincludethecareofwounds. Thenursemustalsoperformtheothertasksofcare.Ineveryday life,itcanalwaysbethecasethatothernursingstaffwhoarenot sowellversedinwoundcareconsultthewoundexperts.

Thegroupclearlystatesthatthereisnosuchthingas “ typical woundcare” inoutpatientcare.Thecareprocessesaremuchless

standardizedherethanininpatientcare,becausethenurses havetoadapttothehomesituationandtheassociated environment.

Woundcareintheoutpatientsettingisverydifferentfrom careintheinpatientsetting.Thereissignificantlylesstime available:Forexample,therearewoundirrigationsolutions thataresupposedtosoakinfor15min.Inoutpatientcare, thereisnotimeforthis.Onaverage,dressingchangesin outpatientcaretake8min.Inthissituation,thenursemust thereforeassesswhethertoreducetheexposuretimeandthus acceptthatthesolutionwillnotachieveitsfulleffect,orwhether thespecifiedtimewillnotbeadheredto,whichcan,however, resultintheentiretimeandtourschedulebeingdisrupted.In general,itisnotedthatthetimeallowanceisamajorproblem:if thepreparationtimeoftheworkplace,thecarefuldisinfection andthechangingintoappropriateprotectiveclothingare included,thereiseffectivelyverylittletimeleftfortheactual assessment,documentation,andcareofthewound.

Therearealsosignificant fluctuationsintheamountofwound carethatisprovidedtopatients:Therearetimeswhenthereare veryfewpatientswithwoundstocarefor,butthenitcanalso happenthat fivenewpatientswithwoundcareareaddedinone fellswoop.Veryoftenitisthecasethatonlythewoundneedsto betreatedandnofurthernursingcareisprovided.Typical examplesofthisarewoundcareafteroperationsorsecondary woundhealing.Forthenursingstaff,thismeansthattheymust constantlyadapttonewsituationsandenvironments.

Regardingtheactualcareprocess,thefocusgroupnotesthat therearemanydifferencescomparedtowoundcareinthe inpatientarea.Intheinpatientsetting,theentireprocesscan beobservedwithbetteraccuracy,becausethereisconstant contactandexchangewiththepatients.Inoutpatientcare,for example,dressingchangesareprescribedthreetimesaweek,and thepatientisthenvisitedonthesedays.However,nursesoften areunawareofwhatishappeningontheotherdays.Ifthepatient isunabletoreportifsomethingiswrongwiththedressing,the woundhealingprocesscanbeadverselyaffected.Suchproblems anddifficultiescanoccurrepeatedly.Therefore,outpatientnurses mustbepreparedtoreactvery flexibly.

Theactualworkprocessisalsoinfluencedbythesituationon site.Itveryoftenhappensthatthehygienicconditionsarenotthe sameasinthehospital:

“Thatdoesn’tevenmeanthathouseholdsare particularlydirty.Ofcourse,thathappens,too,but that’sacompletelydifferentissue.Therearejust thingsthatarejustdifferentthaninthehospital. Thereisn’talwaysaclosetwherewecanstorethe material.Inmanyhouseholds,therearealsopets,so youhavetopayspecialattention.Ininpatientcare,if youdon’thaveenoughmaterialorneedsomethingelse, youcangotothematerialstorage.Inoutpatientcare, however,youhavetomakedowithwhat’sonhand. That’swhereimprovisationisoftenneeded.”

Thegroupgoesontosaythatinmanycasestheworkspaceis significantlylimited,andonemustimprovisebecausethework

surfaceismuchsmallerthaninthehospital.Inaddition,the lightingconditionsarenotalwaysoptimal. Averycentraldistinctionfrominpatientcareistheroleofthe caregiver,whichistakeninoutpatientcare:

“Theroleofthenurseisalsodifferent.Youareaguestin someone ’shomeandifapatientwantssomethingdonea certainway,eventhoughitdoesn’tmakesensefroma professionalpointofview,youdoitthewayheorshe wantsitdone.Thatmaysoundmoredramaticthanitis. Generally,therearefewproblems,butyouhavetokeep remindingyourselfthatyouareinvadingtheirprivacy muchmoreintensivelythanyouwouldininpatient care. ”

Thisaspectappliesnotonlytowoundcare,buttotheentire nursingprocessandisverycloselylinkedtoadherencetospecific times.Thegroupstatesthatasteadyroutineofcareisvery importantformanypatients:

“Manypatientsareusedto fixedtimeswhenwevisit them.Theyadjusttothisandsetuptheirdailyroutine thatway.Ifwethencomeatothertimesbecausethereis apostponement,becauseanemergencyhascomeupor thetourhadtobechanged,somebecomeimpatient quickly. ”

Inthefocusgroupitemergedthatinseveralcasesthereare problemswiththecommunicationwithprimarycarephysicians. Althoughallparticipantsinthefocusgrouphavefurthertraining aswoundmanagers,incertaincasestheyfeelthattheyarenot takenseriouslyinthediscussionwiththeprimarycarephysician whenthetreatmentprocessiscoordinated:

“Doctorsneverdiscusswithusateyelevel,butmany doctorshavenoideaaboutwoundcare.”

Problemsalwaysarisewhenprimarycarephysicians prescribetreatmentthatisoutofdateandnotconduciveto thewoundhealingprocess.Insuchasituation,thewoundexpert isallowedtosayifheorshedoesnotagreewithatreatmentand canrefusetoperformit.Acontinuingeducationprogram ensuresthatwoundexpertsarealwaysawareofthelatest advancesincare.Theyusuallyhaveasigni fi cantknowledge advantageoverprimarycarephysicians,althoughsome practicesnowhavewoundexperts.Additionally,avery commonproblemisprescribinghigh-costmaterialsbecause itimpactstheprimarycarepractice’sbudgeting.Ingeneral,one hastobemuchmoreeconomicalwithmaterialsinoutpatient carebecausemuchlessisprescribedandonealwayshasto obtainanewprescriptionfromthepractice,combinedwiththe dif fi cultiesjustdescribed.Veryoften,thesedisputesarefought outat the expenseofthepatients,becausetheydonotreceivethe mosteffectivecare:

“Inonespecificcase,adoctorrefusedtoprescribe dressingmaterial,thiswasalldocumentedandthe

woundactuallyworsenedconsiderably.Itwasthen suggestedtothepracticethatthepatientshouldbe transferredtoawoundoutpatientclinic,andthat ultimatelyhappened ”

Relativesalsoplayaveryimportantroleintheoutpatient caresetting.Thisdoesnotonlyapplytowoundcare,butitalso ratherreferstotheentirecareprocess.Sometimesrelatives makealotofeffort,butsometimestheydon ’ t.Forexample,they applyointmentsthatdon ’ thelpatallandsometimeseven contributetoworseningthewound.Thisisoftenwellintentionedonbehalfoftherelativesbecausetheywantto supportthenursingstaffintheir work.Veryoften,however,the exactoppositeisachieved,asthewoundhealingprocessis halted.Inthissituation,itisverydif ficultfornursesto fi nd thecorrectwordssoasnottooffendtherelatives.Some relativesalsowanttoobserveanddocumenteverystepof theprocess.Thenursingstaffconsiderthistobevery disturbing,becausetheycannotconcentrateontheirwork andaredistracted:

“IthasalsohappenedseveraltimesthatIhaveordereda relativeoutoftheroombecausehewasdisturbingtoo much.Ofcourse,heisoffendedat first,butyouhaveto findtherightwordsandmakeitclearthatyoucan’tdo yourjobproperlylikethat. ”

ObstaclesandBarriers

Thefocusgroupagreesthatdigitizationhasnotyetmademuchof animpactonoutpatientcare.Thecaredocumentationthatis carriedoutatthecareservice,forexample,isstilldone handwritten.Thegroupknowsthatitisalreadydifferentat otherservices.Theystatethatinafewyears,complete documentationwillcertainlybedonedigitally.However,the groupcannotjudgewhenadigitaltransitionwilltakeplace. However,aconversiontodigitaldocumentationrequiresalotof timeandrequiresacompletereorganizationinmanyprocesses. Aboveall,thedocumentationisviewedverycritically:

“Adigitalcareplanisveryinflexible,youcan’treactas flexiblytochangesasyoucanwithhandwritten documentation.Itlacksalltheindividualityofthe patients.Itismuchtoorigid.Wounddocumentation inparticularhastohappenveryindividually.Ihave greatdoubtsastowhetherdigitaldocumentationcan reflectthisindividuality. ”

However,someprocessesarealreadybeingdonedigitally today.Tourplanningisalreadydonedigitallytoday.Acentral PCcreatestheplan,whichisthentransferredtothenurse’scell phone.Inaddition,thephotofunctionofthecellphoneisused fordocumentation,especiallyforwoundcare,becausethisallows thehealingprocesstoberecordedatregularintervals:

“Inrarecases,itevenhappensthatthedoctorshavethe woundhistorysenttothemviaWhatsApp.Theycan thenrespondwiththeirprescriptionsandadjustthe

materialifnecessary.However,thisdoesnothappen veryoften. ”

Thefocusgroup findsitverydifficulttomakeageneral assessmentofwhetherdigitizationhasapositiveornegative impactonoutpatientcare.Inmanycases,dataprotectionhinders workinoutpatientcare(e.g.,fetchingprescriptions).Alot dependsonhowuser-friendlytheprogramsare.Thegroup describestheimpressionthatmanyfunctionsarenotalways useful.Inaddition,therearealsofearsanddoubtsamongthe patients:

“Onthestreet,everyoneisjustwalkingaroundwithacell phone.Nowthenursesalsocomewithcellphonesand startclickingaround ”

Inthefurthercourseofthefocusgroupdiscussion,the VulnusMonproject,i.e.,theintelligentwoundplaster,is presentedtotheparticipantsanditisdiscussedwiththem howsensibleitistouseitinoutpatientcare.Thegroupnotes thatmanypatients finddigitaldevicesveryimpersonal.Thereare alsodoubtsastowhetherpatientsagreetotheirdatabeing transmitted:

“Manypatientsseethisasanintrusionontheir autonomyanddonotwanttorelinquishcontrolover theirbodiesinthisway.Theywillcertainlyfeelakindof surveillance.”

Anotherproblemisthatcellphonesalreadyhavemanygapsin coverageinmanyregions.Whethersmoothdatatransmissionis guaranteedinallhouseholdsishighlydoubted.IfaWi-Fi connectionhastobeavailableinthehousehold,thereare furtherproblems,becauseatthepresenttimemanypeopledo notyethaveWi-Fiintheirhomesanddonotintendtoacquire thistechnology.Thisisespeciallytrueforseniorhouseholds.In addition,the fixeddailystructureofthepatientsmentionedabove isseenasapossiblebarriertoimplementation:

“Thepatientneedscommunication.Itisdifficultnotto beabletotellthepatientexactlywhenyouwillbeback. These fixedappointmentsplayanimportantrole.”

Theexpertsfurthernotethatthepatient’sconditionplaysan importantroleinwhethersuchasystemcanbeused.Thereare veryoftenrestlesspatientswhomovearoundalot,sothedressing canslipduetoscratchingormovement.Thegroupissurethat theseeffectswillcertainlyinfluencethemeasurement.Onsize andmaterial,theexpertsnotethatthereareverydifferentsized wounds.Andondressingmaterial,ithasalreadybeensaidabove thatthereisdifferentmaterialforcertaintypesofwounds:

“

Oneforalldoesnotwork!”

Manywoundsarealsodressedwithcompression,sothe plastermustalsobeabletowithstandpressureandmustnot negativelyaffectthewoundintheprocess.Thisaspectmust

TABLE2| Totalnumberofpatientsandpatientswithwoundcare.

NumberShare

Totalnumberofpatients463100%

Patientswithwoundcare7516.2% PatientsONLYwithwoundcare214.5%

definitelybetakenintoaccountinfurtherdevelopment,asthe woundoftenremainsunseenforseveraldays,especiallyinthe outpatientarea.Ifthetransmissiondoesnotworkandthesensor causesunnecessarypressurepoints,thiscanhaveserious consequencesforthewoundhealingprocess.

Determiningtheidealtimetochangedressingsisseenasvery useful,althoughitisassociatedwithdifficultieswhen implementedinoutpatientcare.However,itwouldbe conceivableforthedatatogodirectlytotheprimarycare physician.Thisrelievesthenursingserviceandreduceserrors inthetransmissionofinformation.

EconomicEstimationsforOutpatient WoundCare

Duringtheexpertinterviewswithmanagersofoutpatientcare services,theaspectoftheeconomicdimensionwasaddressed: “

Itcanbeassumedthat,fromaneconomicpointof view,purewoundcareisnotlucrativeforthenursing service.Youtraveltothepatienteveryotherdaytotreat thewound,regardlessofwhethertheplasterneedstobe changedornot.Thenursespendsalotoftimeinthe car,whichcannotbebilled.”

Thisstatementwillbeverifiedinthefollowingusing quantitativemethods.Forthispurpose,thepatientdatasetof thenursingserviceinvolvedintheprojectwillbeused.Thedata setcontainsallpatientswhoreceivednursingcarein2017. Accordingly,theprojectdoesnotcollectitsowndatamaterial, butratherconcentratesontheanalysisofsecondarydata material.Thedatasetincludesinformationongender,age, typeofcare,anddurationofcare.

In2017,atotalof463patientswerecaredforbytheoutpatient nursingservice(Table2).Ofthese,75patientsreceivedwound care,whichcorrespondstoashareof16.2%.Ananalysisofthe datashowsthatalargeproportionofpatientswhoreceivewound carealsoreceiveothernursingservicesfromthenursingservice. Thisisthecasefor54patients,consequently21patientsreceived onlywoundcarefromtheambulatorycareservicein2017.More than70%ofthepatientswhoreceivewoundtreatmentalso receiveothernursingcare.Theproportionofpatientswhoare caredforexclusivelybytheoutpatientnursingserviceforwound careisthusjustunder fivepercent(4.5%).

Ifwelookattheagestructureofthepatients,thefollowing pictureemerges:Theaverageageofpatientsreceivingonly woundcareis69.8years(SD15.88).Forpatientswhoreceive othernursingservicesinadditiontowoundcare,thevalueis 78.9years(SD11.01).Thedifferenceissignificant(t(63) 2.710,

TABLE3| Agestructureofthepatients.

AgePatientswithwoundcare (%) Patientsonlywith woundcare(%)

Under6078 60 69years1419 70 79years 19 24 80yearsandolder 60 49

TABLE4| Averagedurationofcareservicesinminutes.

AvgMinMax

Totalnumberofpatients10.95.120 Patientsonlywithwoundcare12.56.620 Patientswithwoundcare10.25.118.3

p 0.009). Table3 showshowtheproportionsaredistributed withintheagegroups.

Theagestructureofallpatientswithwoundcareshowsthat themajorityofpatientscanbeattributedtothegroupofthevery old(80yearsandolder):With60%,clearlymorethanevery secondpatientwithwoundcareis80yearsandolder.One fifthof thepatientsformthegroupofpersonswhoarebetween70and 79years(19%).Withdecreasingage,theproportionbecomes smaller:14%ofthepatientscanbeassignedtotheagegroup 60 69years.Only7%ofthepatientsareyoungerthan60years.If onelooksattheagestructureofpatientsforwhomonlywound careisperformed,theassumptionthatthesepatientsareyounger thanpatientsforwhomadditionalnursingservicesareperformed isconfirmed:Theproportionofpersonsyoungerthan60years increasesbyonepercentagepoint.Theincreaseinthenextage groupisalreadyclearer:with19%,thesharevalueintheage group60 69yearsisclearlyhigherthaninthepatientsforwhom anursingmeasureisalsocarriedoutinadditiontowoundcare. ToassessthecorrelationCramerVwascalculated.Thereisa mediumcorrelationbetweenthevariablesagegroupandwound care(V 0.396).

Inthefollowing,itwillbeshownhowlonganinterventionatthe patient’shomeusuallytakes.Here,adifferentiationismade betweenpatientswithadditionalnursingcareandpurewoundcare.

From Table4 itcanbededucedthatthereisaslightdifference intheaveragedurationofcare:Whiletheaveragedurationofcare forpatientswithonlywoundcareis12.5min,itisslightlyshorter at10.2minforpatientswhoreceivecareinadditiontowound care.Atthesametime,bothtypesofcareshowaverywiderange. Ifwelookatwoundcarealone,theminimumis6.6min, comparedtoamaximumof20min.Thedifferenceis significant(t(61) -2.806, p 0.007).

Inafurtherstep,itwillnowbeexaminedwhicheconomic statementscanbemadeaboutoutpatientwoundcareonthebasis ofthepatientdata.Forthispurpose,thefollowinghypothesisis formulated:H1:Purewoundcareisnoteffectiveforthenursing servicefromaneconomicpointofview.

Thefollowingkey figureswillbeusedforthispurpose:

TABLE5|

• Numberofpatients

• Numberofoperations

• Revenueperoperationandtotal

• Totaloperatingtimesinhours

• Totaltraveltimeinhours

• Totalcosts

Asseenin Table5,itcanbeconcludedthatthepurecareof woundsinoutpatientcarewithoutadditionalnursingservicesis associatedwithde ficitsforthenursingservicepresentedhere. Thesede ficitscanbeexplainedaboveallbythehightime expenditureoftravel:Inoneyear,767missionsweremade inwhichonlywoundcarewasadministeredtothepatient.This correspondstoatimeexpenditureof286h.Ofthese,128hwere spentinthecaralone,whichcorrespondstoashareofalmost 45%.Thedrivingtimeisnotbillableforthenursingservice,soa largepartoftheworkingtimeincurredisnotbillableforthe nursingserviceviathehealthinsurance.Theother55%ofthe totaltimeisspentonwoundcareinthepatient ’ shome.Here, oneserviceisremuneratedat €14.19.Ifthecostsforthenursing servicearecalculatedusinganhourlyrateof €45,whichincludes materialandoverheadcostsinadditiontopersonnelcosts,this resultsinatotalde ficitofalmost €2,000peryear.Theresults clearlyshowthatthehypothesisformulatedatthebeginningis agreedwith.

Againstthebackgroundofthiscalculation,itbecomesclear thattheintroductionofthedigitalwoundplastermakessense fromaneconomicpointofview.Theareaofwoundcarehasso farbeenrunningatade ficit.Withthedeterminationofthe optimaltimeforchangingtheplaster,traveltimescanbe reduced,asitcanbeassumedthatthenumberof interventionswillalsobereduced.Thiscalculationassumes thatthewoundhealingprocessisbetterwiththeuseof thedigitalwoundplasterthanwithconventionalwound treatment.

DISCUSSION

Inthissection,theidentifiedbarriersarenowdiscussedwith possiblesolutionsforasuccessfulimplementationinthe outpatientsetting:Thecentralpersoninoutpatientcarein woundcareisthewoundmanager,whocontactsthegeneral practitionerafterinspectingthewound.Hemakessuggestions

fortreatment,the finaldecisionismadebythegeneralpractitioner. Thegeneralpractitionerthenissuestheprescriptionforthewound treatment.Thisprocessdoesnotrunsmoothlyinpractice.Inmany cases,communicationwiththegeneralpractitionerisnotonan equalfooting,sothatthewoundmanager’srecommendationisnot alwaysputintopractice.TheGPsarenotalwaysuptodatewiththe latestdevelopmentsinwoundtreatment.Inaddition,low budgetingforreimbursementoftenleadstotreatmentstepsnot beingprescribedinatimelymanner.Forthisreason,afollow-up projectisrecommendedinwhichtheinpatientsolutionis transferredtotheoutpatientsector.Inthisfollow-upproject,a networkofnursingservices,generalpractitionersandspecialists shouldbecreated,inwhichajointtrainingcanbeimplemented andevaluated.

Itshouldalsobenotedthatthereisaspecifictreatment methodforeachtypeofwound,combinedwiththe correspondinglydifferentdressingmaterials.Thesensorsmust thereforebeappliedtodifferentdressingmaterials.Analternative wouldbetoseparatethesensorsandtheplastermaterialsothat bothcanbecombinedindividuallyforthecorrespondingwound type.Anumberofwoundsaretreatedwithcompression bandagesthatapplypressuretothewound.Thematerialof thesensorsmustbechosenso flexiblythatnopressurepointscan develop.

Inoutpatientcare,woundtreatmentsoftenoccurwhereonly thewoundistreated,andnoothernursingservicesare performed.Veryoften,thepatientsareyoungeronaverage thantheotherpatientsinoutpatientcare.Manyelderlypeople donotyethaveaWi-Fi-connectioninthehouse.Amobile solutionthatthecareservicebringswiththemislesssuitable becausethedatacannotbepassedoncontinuously.Aspartofa follow-upproject,thehouseholdsshouldbeequippedwiththe technicalinfrastructure.Inthecourseoftheincreasing digitalizationofhouseholds,however,thisbarrierwillbecome smallerinthenearfuture.

Theworkprocessesinwoundcareinoutpatientcarediffer signi fi cantlyfromtheprocessesininpatientcare:Thesituation aloneofbeingaguestinthepatient ’ shouseholdisachallenge forthenursingstaff.Furthermore,theworkingconditions (cleanliness,hygiene,material,workplace)arenotatthe samelevelasininpatientwoundcare.Theuserequiresa rethinkingintheentireareaofoutpatientcare:Thisapplies totheoperativelevelaswellastotheplanningand managementlevel.Whenusingthedigitalsolution,the nursingstaffmustbeabletoreact fl exiblywhenadressing changeisindicated.

Ingeneral,theeffectsofdigitalizationonthe fi eldof outpatientcareareperceivedasratherdif fi cult:Experiences withdigitaldocumentationhavenotprovidedanyrelief;rather, ithasnotbeenabletomapthecomplexityandindividualityin outpatientcare.Atthesametime,itisalsoevidentthatthere hasbeenverylittleexperiencewithdigitalproductsin outpatientcaresofar.TheoverallgoaloftheVulnusMON projectispositivelyreceived,butthehighdegreeof digitalizationandfurtherbarriers(e.g.,plastermustbeable totreatdifferenttypesandsizesofwounds)ensurethattheuse ofthedigitalwoundplasterincareisassessedasratherunlikely

atthepresenttime.Theeffectivenessoftheapplicationmustbe provenbyclinicalstudies.Thiswillmakethebene fi tsmore transparentfornursingstaffandpatients.Furthermore,a participatorymethodshouldbechosenwithinthe frameworkofaresearchprojectforimplementationinthe outpatientsector,sothatnursingstaffanddoctors ’ practices areinvolvedinthedevelopmentandadaptationprocessatan earlystage.

Insummary,theintegrationofELSIquestionsinthecontext ofanexploratorystudyturnsouttobeveryuseful.Thus, barriersandobstaclescouldbeidenti fi edataveryearly stage,whichcanbetakenintoaccountinfurtherproject planning.Ithasbeenshown,forexample,that implementationwillleadtomajorchangesinestablished workprocesses.Asaresult,thequali fi cationprocess,which isabsolutelynecessaryforsuccessfulimplementation,should includenotonlynursingstaffbu talsophysiciansandpatients, becausetheirroutineswillalsochangesigni fi cantly.Atthe sametime,itshowsthatitmakesalotofsensetolookatall aspectsofELSIresearchtogetherinordertopointoutapparent contradictionsandtodevelopmeasuresintimethatcanresolve thecontradictions.Theexampleoftheintelligentwound plaster,forexample,hasshownthatimplementationmakes sensefromaneconomicpointofview,butthatsocial

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DATAAVAILABILITYSTATEMENT

Theoriginalcontributionspresentedinthestudyareincludedin thearticle/SupplementaryMaterial,furtherinquiriescanbe directedtothecorrespondingauthor.

AUTHORCONTRIBUTIONS

PEwasresponsiblefortheresearchdesign.PEwasalso responsiblefordatacollectionandanalysis.Thewritingofthe manuscriptwasdoneincollaborationbetweenPEandAK.

FUNDING

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ConflictofInterest: Theauthorsdeclarethattheresearchwasconductedinthe absenceofanycommercialor financialrelationshipsthatcouldbeconstruedasa potentialconflictofinterest.

Copyright©2021EnsteandKucharski.Thisisanopen-accessarticledistributed underthetermsoftheCreativeCommonsAttributionLicense(CCBY).Theuse, distributionorreproductioninotherforumsispermitted,providedtheoriginal author(s)andthecopyrightowner(s)arecreditedandthattheoriginal publicationinthisjournaliscited,inaccordancewithacceptedacademic practice.Nouse,distributionorreproductionispermittedwhichdoesnot complywiththeseterms.

published:26August2021 doi:10.3389/fpsyg.2021.694297

Editedby: MagdalenaKlimczuk-Kochanska, UniversityofWarsaw,Poland

Reviewedby: ClaudeFerrand, UniversitédeTours,France SandroRamaFiorini, IBM(Brazil),Brazil SusanneFrennert, MalmöUniversity,Sweden ZhaohuiSu, TheUniversityofTexasHealth ScienceCenteratSanAntonio, UnitedStates

*Correspondence: AnnetteFranke a.franke@eh-ludwigsburg.de

Specialtysection: Thisarticlewassubmittedto HealthPsychology, asectionofthejournal FrontiersinPsychology

Received: 12April2021 Accepted: 04August2021 Published: 26August2021

Citation: FrankeA,NassE,PierethA-K, ZettlAandHeidlC(2021) ImplementationofAssistive TechnologiesandRobotics inLong-TermCareFacilities: AThree-StageAssessmentBasedon Acceptance,Ethics,andEmotions. Front.Psychol.12:694297. doi:10.3389/fpsyg.2021.694297

ImplementationofAssistive TechnologiesandRoboticsin Long-TermCareFacilities: AThree-StageAssessmentBasedon Acceptance,Ethics,andEmotions

AnnetteFranke1* ,ElmarNass2 ,Anna-KathleenPiereth3 ,AnnabelZettl4 and ChristianHeidl3

1 LudwigsburgProtestantUniversityofAppliedSciences,Ludwigsburg,Germany, 2 CologneUniversityofCatholicTheology, Cologne,Germany, 3 SRHUniversityofAppliedSciences,Fuerth,Germany, 4 YOUSEGmbH,Berlin,Germany

Assistivetechnologiesincludingassistiverobots(AT/AR)appeartobeapromising responsetotheincreasingprevalenceofolderadultsinneedofcare.Anincreasing numberoflong-termcarefacilities(LTCFs)trytoimplementAT/ARinordertocreate astimulatingenvironmentforagingwellandtoreduceworkloadforprofessional carestaff.Theimplementationofnewtechnologiesinanorganizationmayleadto noticeableculturalchangesintermsofsocialinteractionsandcarepracticesassociated withpositiveornegativeemotionsfortheemployees.Thisappliesespeciallyfor LTCFswithhighratesofvulnerableresidentsaffectedbyincreasingcareneeds andspecificethicsinnursingandculturalruleswithinthesetting.Thus,systematic considerationinleadershipmanagementofemotionsandethicalaspectsisessential forstakeholdersinvolvedintheimplementationprocess.Inthisarticle,weexplicitly focusontheemotionsoftheemployeesandleaderswithinLTCFs.Werelateto directconsequencesfortheorganizationalwell-beingandculture,whichisofcourse (indirectly)affectingpatientsandresidents.Whileaspectsoftechnologyacceptance suchassafetyandusefulnessarefrequentlydiscussedinacademicliterature,thetopic ofemotion-managementandethicalquestionsduringtheorganizationalimplementation processinLTCFsreceivedlittleattention.Emotionalcultureentailsaffectivevalues, ethicalnormsandperceptionsofemployeesandfurtherinvestigationisneededto addresstheimportanceoftransformationalleadershipduringimplementationprocess. Forthispurpose,wedevelopedathree-stagedassessmenttoolforimplementation ofAT/ARinlong-termcareinstitutions.Acceptance(A),ethicalacceptability(A)and emotionalconsequences(E)areconsideredascomprehensiveassessment,inwhich emotionalconsequencescomprisemanagementaspectsoftransformationalleadership (T),emotion-management(E)andorganizationalculture(O).BasedonAAEandTEO, thispaperpresentsanintegratedframeworkillustratedwithaillustrativeexample andaimstocombineestablishedapproacheswithethicalinsightsinordertounfold potentialsofAT/ARinLTCSs.

Keywords:assistivetechnologies,assistiverobotics,carehomes,long-termcare,ethics,organization,emotion management,qualityoflife

INTRODUCTION

Digitalization4.0andassistivetechnologyincludingassistive robotics(AT/AR)evokecertainaspirationsinhealthcarewith regardtowell-beingandeconomicarguments(MagsamenConradandChecton,2014).InMarch2018,theWorldHealth Organization(WHO)promotedtheaccesstoAT/ARforall memberstates:

“Theimpactofassistivetechnologygoesfarbeyondthebenefits ofhealthandwell-beingtoindividualusersandtheirfamilies. Italsohassocioeconomicbenefits,byreducingdirecthealth andwelfarecosts(suchashospitaladmissionsorstatebenefits), enablingamoreproductivelaborforce,andstimulatingeconomic growth”[WorldHealthOrganization(WHO),2018,p.3].

AT/ARembracevariousdimensionsofinterestingproducts, aids,devicesorsoftwarewhichenablepersonswithfunctional losses,e.g.,communicationboards,screenreaders,positioning devicesorservicerobots1 [InternationalFederationofRobotics (IFR),2021].In2019,themarketforprofessionalservicerobots increasedby32%[InternationalFederationofRobotics(IFR), 2020].Growingpotentialcanbeassumed,whenmorerobots couldovercometheprototypestage(Bedarfetal.,2015; Hersh, 2015; ScassellatiandVázquez,2020).

Withinthelastdecadesinformation,communicationand assistivetechnologiesseemtofindtheirunstoppablewayinto (health-)carefacilities,evenwhenmanyinstitutionsinresidential care—comparedtotechnologicalpioneersinlong-termcarelike Japan—arestillstrugglingwithgeneralpreconditionsfornew technologies(e.g.,accesstowirelessinternet)(Moyleetal.,2018; Seifertetal.,2020; Grüneberg,2021; Tanetal.,2021).

Especiallyfordecisionmakersinlong-termcarefacilities (LTCFs)2 AT/ARsuggestsnewopportunitiesrelatedto preservingactivitiesandpersonalwell-beingforresidents, lowerhealthcarecosts,reducedworkloadforprofessional caregiversandsolutionsfornursingshortage(Sharkeyand Sharkey,2012; Bonaccorsietal.,2016; ScassellatiandVázquez, 2020; Tanetal.,2021).

Robotsaresupposedtobeusedinlong-termcarefordifferent purposes:tosolvelogisticalchallenges,assupportiveaidforbasic needs,forsafeguardingandmonitoring,andforinstrumental taskslikecleaningorsocialinteraction(Tanetal.,2021).At thesametime,LTCFsrepresentparticularchallengingsettings includingself-imageofcareandspecificvulnerableclients.In Germanyforexample,aboutaquarterofallpersonsinneedof carearelivinginLTCFs,ofwhommorethan70%sufferfrom severeimpairmentofindependence(Destatis,2020).

Inthisrespect,AT/ARmayleadtofundamental organizationalchangesinLTCFsandthequestionisnotif orwhen,but“howbesttoshapeanddirectoureffortsto optimizethedevelopmentandapplicationofnewtechnologies” (Schulzetal.,2015,p.725).

AT/ARalreadyposedacontroversialdiscussionaboutsafety, socialjustice,usefulnessandappropriatenessinlong-termcare. Inaddition,discussionsaroseonquestionsofeconomicviability, customeracceptance,co-designanduserimpact(e.g.,stresslevel) (Berkowskyetal.,2017; Chuetal.,2017; Kwon,2017; Meyer andFricke,2017; Diefenbach,2018; MerkelandKucharski,2019; PeineandNeven,2020).Alltheseaspectshavealreadybeen exploredincurrentresearchliterature,eventhoughadeeper understanding,forexample,ofambivalentuseracceptanceis stillneeded(Hersh,2015).Inthisrespect, Kricketal.(2019), provideasystematicreviewonthreecoreoutcomedimensions concerningdigitaltechnologiesforallparticipantsinvolvedinthe caresectorsbyfocusingon acceptance,effectivenessandefficiency (AEE)ofnewtechnologies.

WhilethesedimensionsofAT/ARinlong-termcareare frequentlydiscussedinacademicliterature, emotionalandethical acceptanceandacceptability,andthe roleofleadership within organizationsreceivedlittleattentionsofar.Eventhough somestudiesunderlinetheimportanceofimplementation circumstancesandmanagementpractices(e.g.,furthereducation ofemployees)(Tanetal.,2021),deeperinvestigationsare requiredintermsofmanagementapproachesas Melkasetal. (2020,p.5)pointout: “Roboticresearchhassofarfocusedon technicalimplementation,technologydevelopment,andclinical applications,buttherehasbeenlimiteddiscussiononsocialand managerialissuesthatmightbeequallyimportantforsuccessful robotuse.”

1Definedasarobot“thatperformsusefultasksforhumansorequipmentexcluding industrialautomationapplications.”Servicerobotscanbecategorizedasmedical robots,logisticrobotsorfieldrobots(ibid).Furthercategorizationsofrobot-based servicesdifferbetween(1)assistiverobotsprimarilyusedforphysicalapplications, (2)socio-emotionalrobotsforcompanionshipand(3)robotsforhealthandsafety monitoring(SharkeyandSharkey,2012; Prabuwonoetal.,2017; Meyeretal., 2020).

2Definedas“afacilitythatprovidesroomandboard,aswellasmanagementof chronicmedicalconditionsand24-hassistancewithADLsinpatientswhoare physicallyand/orcognitivelyimpaired”(Kleinetal.,2013; Sanfordetal.,2015: p.182).

Theaimofthisarticleistoaddressstakeholdersand managementstaffinLTCFsintheirstrategicleadershiprole intheAT/ARimplementationprocess.Fromourperspective, itisimportantforthistargetgrouptoexamine“emotionmanagement,”whichmeanstherecognitionofethicsand emotions(explicitlyfromstaffandimplicitlyfromLTCresidents)withintheorganization(Thieletal.,2012).Asthe majorityofLTC-residentsexperiencemultimorbidity,cognitive impairments,functionaldeclineanddecreasingqualityoflife (e.g.,lowerlevelsofloneliness)(Boggatz,2020),LTCFsrepresent aspecificworkplaceenvironment,wherethedemanding conditionsofresidentsandsocialnormsframemultiple dimensionsofemotionality(Bolton,2001).Fulfillmentof professionalcaretaskslikeconversations,liftingorwashingby differentkindsofrobots,hasemotionalandethicalconsequences forbothpatientsandstaffincarehomes.Thisappliesin particularinconsiderationofnursingvalueslikeautonomy, beneficence,justiceandnon-maleficence(Beauchampand Childress,2001; SharkeyandSharkey,2012; HaddadandGeiger, 2020Tanetal.,2021).Inaddition,anxietyandskeptical expressionsofnursingstaffcanbeassumedinthefearto becomereplacedbytechnology(Feil-Seiferetal.,2007; Broekens etal.,2009; WolbringandYumakulov,2014; Cocoetal.,2018; Mitzneretal.,2018).Fromapracticalperspective,thismeans thatstrategicplanningandunderstandingofsignificantaffects

andemotionsarecriticaltotheongoingsuccessofamodern organizations(Thieletal.,2012).

Wethereforecombine Bolton(2005) ideaof“emotionmanagement”andtheconceptof“transformationalleadership” accordingto BassandAvolio(1994).Boltondevelopeda multidimensionalapproachtoemotionalityinorganizationswith specificfocusonnurses,incriticalengagementwith Hochschild (1989) distinctiononemotionalworkandemotionallabor. ForBolton,feelingsandmotivationsarecentralininteractions withinanorganization,whereactors(leadersaswellasworkers) areabletochannelemotionsintheirworkplacetoachieve organizationalgoals.Workersarepurposiveagentsoftheir emotions,butconstrainedbyorganizationalemotionrulesand embeddedinbroaderculturalbeliefsandvalues.Boltonprovides atypologyoffourdimensionsofemotion-management,from whichwedepict“prescriptiveemotion-management”asmost relevantforourtopic(=emotion-managementaccordingto organization/professionalrules).Thismeans,thatorganizational powerisrelatedtoemotionalrules,as Bolton (2005,p.8)labels “nursesasmulti-skilledemotionmanagers”(seealso Cranford andMiller,2013).Theapproachoftransformationalleadership wereferto,underlinestherolemodelfunctionofleaders,setting attractivegoalsandfosteringmotivationandstimulationfor employees(BassandAvolio,1994).Leadersandmanagement staffexpressthemselvesthroughaspectssuchasinspiration, visionorpersonalrolemodelactionandthusdeliberatelyappeal toemotionsoftheiremployees.

Drawingonbothconcepts,twoquestionsariseasrelevant forthispaper:(1)Howcanemotion-managementand transformationalleadershipfruitfullycontributetoAT/AR implementationwithinLTCFs?(2)Howcanaholisticassessment ofemotionalandethicalaspectsbedesignedaspartofthechange managementprocessforAT/ARimplementationinLTCFs withoutneglectingtheacceptance-perspective?

Toaddressthesequestions,weapplytheAEEsystemby Kricketal.(2019) asanassessmenttoolanddevelopitfurther withregardtoethicsandemotionalityinorganizations.First, wepresentanideal-typical,butconcreteillustrativeexample ofsuchtechnology,whichweseeasthecentralthreadof ourpresentation(2).Afterthatweoutlinegeneralpractical consequencesofAT/ARimplementationinthecaresectorfor organizationalcultureinviewofourillustrativeexample(3).In thefollowingsection,wesystematicallyillustrateourassessment criteriawithregardtoemotionsandethics(4,5),andapply ittotheillustrativeexampleinthreestages(6).Weconclude withalookatourcontributiontothediscussion,followed byanoutlook(7).

ILLUSTRATIVEEXAMPLE

Somehurdlesandopportunitiesofnegativeemotionsand concernsofacceptanceandacceptabilityaretypicalchallenges forAT/ARimplementationprocesses(Diefenbach,2018).An inpatientLTCFsisplanningonimplementingthe“CareAssist Robot”(CAR, Figures1, 2; Toyota,2021).Thefacilityhas61 bedspaces,ofwhich21patientsarecognitivelyimpairedandin

FIGURE1| CareAssistRobot(Source: FutureofOccupation,2015).

FIGURE2| CareAssistRobot(Source: FutureofOccupation,2015).

needofseverecare,andpredominantlyrequire24-hassistance. CARistobeusedforpeoplewithmultimorbiddiseasesaswellas physicallimitationsduringearlyandlateduty.As Figures1, 2 show,itwillbeusedinworkprocessessuchastransfersand lifting,e.g.,frombedtowheelchair,orinpersonalhygiene processesfromthewheelchairtothebathtub.CARisthereby operatedbyacaregiver.Nursingstaff,nursingassistantsandcare assistantsaretobesupportedandrelieved(and,amongother things,skeletalandmusculardisordersonthepartofthenursing staffaretobereducedpreventively),becauseliftingandtransfer servicesarephysicallyverystrenuous(FutureofOccupation, 2015).

Theorganizationalsoexpectsasignificantreductionincosts andcompensationfortheexistingshortageofnursingstaff throughtheuseofCAR.Furthermore,theimplementationis supposedtoincreasethequalityofworkandthejobsatisfaction oftheemployees.Therobotisexpectedtobeimplementedwithin thenextmonths.

Employeesinmanagementpositions(nursingservice managementandresidentialareamanagement)wereincluded intheselectionprocessaswellasinthediscussionwiththe company,whichmanufacturedCAR.Indoingso,theywereable toconsiderthesuitabilityintermsofcontentandfunctionon thebasisofacatalogofcriteriaaswellastheprice-performance ratio.TheacquisitioncostsforthreeCARamountto€28,600.

Theimplementationprocess,whichisgoingtotakeabout 3months,willbesupportedbythemanufacturer,whowill holdaworkshopevery6weekstoinformemployeesabout theuseoftherobot,howtohandleit,howtodocument data,andhowtochangeprocessesandworkflows.Four weeksaftertheimplementationthemanufacturerwillholdan additionalworkshop.

Severalemployeesreportanxiety,anger,bewildermentand disappointment.Whilesomeofthemarefrustratedandwillnot acceptthatmanagementisbuyingrobotsinsteadofcreatingnew jobs,othersareconcernedaboutbeingreplacedbyarobot,with potentialjobloss.Inaddition,somenursesareafraidoftheir patientswithdementia,whocouldpossiblybeconfusedbyCAR andperceiveadditionalstresscausedbytechnology-generated overloadforsensoryandmotoricfunctions(hearing,collision withCARintheroom).

ForsomenursesCARappearslikeadystopianscenerywith hybridandblurringboundariesbetweenhumansandmachines (“Whoistakingcareofaperson?Therobotortheperson,whois pushingthebutton?Andwhatcomesnext?”).Evenwhensome personsarealsocuriousandexcitedtotryCAR,theyhesitate whethertheycanoperatethemachine.

Theconsequence,orpossibleunexpectedreactionsof staff,couldbethatmorenegativeemotionsarisewithinthe organizationandthiscouldresultin,forexample,adisturbed relationshipoftrustwiththehome’smanagementandleaders, increasedillness-relatedabsenceorevenincreasedstaffturnover. Ontheotherhand,however,someothercolleaguesreporta ratherpositiveattitudetowardrobotsandarelookingforward topossiblyhavingmorejoyandmeaninginperforming theirtasksagain.

Withourexample,wetriedtopointoutthepossible dynamicsofemotionality,whichareimportantforourfurther argumentation.Forthenextstep,wehavetofocuson organizationconsequencesofAT/ARimplementationincare homestogetabroaderpictureandbetterunderstandingofthe upcomingassessmentpart.

orcontextualfactorscanbeobservedinconnectionwiththe implementationofdigitaltechnologiesinprofessionaleveryday (health-)care:

Granjaetal.(2018) examinedintheirsystematicreviewmajor facilitatorsandbarriersofeHealth-implementationinatotalof 221includedstudies.Ontheoneside, “Qualityofhealthcare” turnedouttobethemostrelevantcategorycontributingto thesuccessofeHealthinterventionsinclinicalpractice.This embraces interalia bettercommunicationwiththepatient, improveddiagnosisandprovidedpatient-centeredcare.The determinant “workflow”—i.e.,themannerpeopleinteractwith theirwork,otherpeopleandcommunicationpathways—playsa criticalroleinaffectingtheadoptionatthispoint.Itisimperative tomoldthenewworkprocessesaftertheinterventionina waythatincreasedworkload,workflowdisruption,undefined roles,underminedface-to-facecommunicationaswellasstaff turnoverareprevented(Granjaetal.,2018).However, “costs” was thecategorymostmentionedaddingtothefailureofeHealth interventionsduetothefactthattheshortageoffinancial resourcesinhibitstheATadoptionorratherimplementation.It becomesclearthatanationalpolicyforinvestmentineCareTechnologies—especiallyestablishingfinancialmechanismsto supportorganizationalchanges—isrequiredforsuccessful productlaunches(Granjaetal.,2018,p.4–5).

Kruseetal.(2018) analyzed30articlesandidentified33 differentbarriersofwhichthemostoccurredandimportantran asfollows:“technicallychallengedstaff,”“resistancetochange,” “cost,”“reimbursement,”“ageofpatient,”aswellas“levelof educationofpatient.”Againstthisbackdrop,thereviewers cometoconclusionthatindividualtrainingandorganizational change-managementtechniquesareessentialtoovercomethe outweighingtechnology-specificbarriers(Kruseetal.,2018,p.4).

Papadopolousetal.(2020) exploredimplementation-enablers and-barriersinasystematicreviewforthefieldofsocially assistivehumanoidrobotsinhealthandsocialcare.The12in theanalysisincludedstudiessuggestthat “personalization” and “enjoyment” seemtobecrucialadoption-enablers.Incontrast, “technicalproblems” andthe “limitedcapabilitiesoftherobots” weresummarizedasthetwomostimportantobstacles.It shouldbenotedthattheevidenceofinvestigatedstudieswas limited,wherebyageneralizationoftheseinitialfindingsis excluded(ibid.).

CONSEQUENCESOFAT/AR IMPLEMENTATIONFOR ORGANIZATIONALCULTUREINTHE CARESECTOR

Inpracticalimplementations,ithassofarmostlybeenassumed thatAT/AR“onlyneedstobeactivated”inordertohave apositiveeffect(Beimbornetal.,2016; GallistlandWanka, 2019; MerkelandKucharski,2019).However,manyhurdles withregardtoindividualcharacteristics,participatorydesign

Melkasetal.(2020) identifiedsixtypesofimpactsoncare personnel(fivetypesofimpactsoncareresidents)concerning theuseof“Zora,”acarerobotforpersonalcognitiveand socialassistance.Foremployeeschangeshavebeenexperienced intermsof“workatmosphere,” “meaningfulness,” “workload,” “professionaldevelopment,” “competences,” and“workethics” andtheauthorsunderlinetheimportanceoforganizational leadershipandinformationpolicywithintheorganization(ibid.).

Thestudyof Mitzneretal.(2018) alsofocusedonthe perceptionofprofessionalcaregiverswithamobilemanipulator roboticassistant.Theparticipantsreportedsomepositive experiencesofAR,e.g., “timeefficacy” and “productivity,” butat thesametimeskepticismintermsof “reliability,”“appropriate tasks” forindividualdifficulties,andthequestioniftherobot “mightbeahazard” forsomepatients.

Attitudesofhealthcarestaffwhichcomeintoconflictwiththe ATandAR-adoptionpotentiallyresultinskepticism,frustration, negativethoughtsandbadfeelings(Magsamen-Conradand Checton,2014; Melkasetal.,2020).Slightlyorstronglynegative emotionsofpatientsandhealthcareprofessionalsappearas underestimatedbarriersresultingintheAT/ARnevercompletely integratedintotheworkflow,wherebytheimplementationfails overall(NielsenandMathiassen,2013; Søllingetal.,2014).

Asawayofsummarizing,electedkeyimplementation dimensionsbeingbasedontheillustratedarticlesaresynoptically organizedbytheperspectivesofpatients,healthcareprofessionals aswellashomeandnursingmanagementstaff(Table1).

Notably,notmerelytheorganizationalenvironment influencesthedeployment(atbest,inapositiveway)but theimplementationitselfaffectstheinstitution.Inthislight, Kuziemskyetal.(2016) investigatedinasystematicreviewthe phenomenonofsocalled “unintendedconsequences” (UICs)as wellasorganizationalandsocialissuesrelatedtotheseeffects.

ThetermUICswasestablishedascrucialfactors,whichcan bebeneficialand/oradversewithalackofpurposefulaction ofcausation.Althoughtherelationshipbetweencollaborative teamsandindividualprovidersweredeterminedasthemain sourceofUICs,thereisaneedtostudyandsubstantiatethe reasonandmanneroftheiroccurrence.Besidethis,theUICs arecontributingtodiverseorganizationalandsocialsub-themes, namely:processchangeandevolution,individual-collaborative interchange,contextofuseaswellas(proactive)approachesto model,study,andunderstandUICs(Kuziemskyetal.,2016).

AparticularhighlightwastherealizationthatUICsgobeyond errorsandalsoincludechangesinworkflow,communication andemotions(Ashetal.,2007; Boryckietal.,2012).Moreover, UICscanbeneficiallyelicitpositiveprocessesandthusimprove caredelivery(Ashetal.,2007; MelbyandHellesø,2014).For thispurpose,UICsshouldbebetterexploredtoanticipatethe consequencesandthentospecifically,proactivelyusetheminthe phaseofpre-implementationonthemicroandmesolevelofa careinstitution(Kuziemsky,2015).

Insummary,itcanbeemphasizedthatthenursingstaff inmanagementpositionsshouldconstantlybeawareofthe potentialdevelopmentofUICsduringAT/ARimplementation. Onthataccountitisimportanttoknowwhichenablersor obstaclesaredecisiveforanaccomplisheddeployment.Inthis wayinthecaseofsuboptimalorfalteringimplementation progresseshighprioritycategories(i.e.,thecategory“workflow”) canbeparticularlyanalyzedandinfluencedbyorganizationaland emotionalaspects.

ORGANIZATIONSASEMOTIONAL

ARENASFORTRANSFORMATIVE LEADERSHIP

Oneofthemostprominentperceptionsofemotionalityand managementleadstoadistinctdividebetweenprivateandpublic spheres,whereemotionsmayoccur.Forexample, Hochschild (1989) distinguishesbetweenunpaid“emotionwork”andpaid “emotionallabor.”Sheargues,thatemotionworkcanbedefined

asaperson’smanagementofherorhisinternalfeelings,with theaimtoevokeaspecificemotionalreactionfromanother person(privatecontext).Translatedintoaprofessionalcontext, forexamplewhenleadersasktheiremployeestodo“emotion work”incontactwiththeirclients,this“emotionwork”turns into“emotionallabor.”Ingeneral,Hochschild’sconceptrefersto serviceactivitiesoractivitiesrelatedtopeople.Emotionallabor forexampleentailsfrequenttelephoneorpersonalcontactwith clientsorcustomersandrequiresacertainemotionalexpression towardthem.However,iffeelingsaresuppressedsystematically andforalongerperiodoftimeoremployeeandclientindicate differentfeelingsandunequalexchangeofemotions,thisleadsto negativeeffectsonmentalhealthoftheemployeesandimpaired organizationalwell-being.

Fineman(1993) placesemotionsexplicitlyintheworkplace. Hedenotesorganizationsas“emotionalarenas.”Everyday dissatisfactionsanddisillusions,aswellasdevotionandpassion, suchasboredom,envy,fear,love,anger,guilt,infatuation,etc., bringaboutthepotentialtounite,butalsotoseparatethe workforce.Theydetermine,howrolesareappropriatedand implemented,howpositionsofpowerareexercised,trustislived, acceptanceandcommitmentisdevelopedandhowjudgments aremadeinaway,thattheycannotsimplybeexcludedfrom organizationalprocesses(ibid.).

Withherconceptof“emotion-management”primarilybased ongynecologicnursingpractice, Bolton(2005) underlinesthe difficultiestoseparateprivateandpublicemotionaldimensions ininteractionsbetweenemployees.Indoingso,shecriticizes Hochschild’sdistinctionofemotionworkandemotionallabor:

“Emotionisalived,interactionalexperiencewithtrafficrulesof interactionframinghowitisexpressedandshared.Employees drawonbothprofessional,organizationalandcommercialcodesof conductandsocialfeelingrulesintheirinteractionswithothers.

Thefragileaccomplishmentofsocialinteractioniscontinually maintainedthrough,notonlyformalexchanges,butalsothrough episodesofcompassionandsharedlaughter” (Bolton,2005,p.2).

Theapproachassumesthatemotionsdonotsimply“happen” inorganizations,butaretheresultofcontrolledprocessesin whichemployeesaredepictedasactiveagents.Accordingly, managingemotionsdoesnotmeanimposingunauthentically emotions,butrathercreatingthepossibilityforemotional compliance.Bolton’smodelof“emotion-management”isbased onfourcategories:

• “presentational” (emotionsarehandledaccordingtosocial rules),

• “philanthropic” (emotion-managementasa“donation”),

• “prescriptive” (withregardtoorganizationorprofessional rules),

• “pecuniary” (emotion-managementiscommercialized).

DrawingonemployeesinLTCFs,emotion-managementis framedbyspecificsocialnormsonacceptanceandacceptability ofAT/AR.“[I]nthiswaynursesareportrayedasmultiskilledemotionmanagerswhobothcomplywithandresistthe organizationalconstraintswhichexistaroundthem.”(Bolton, 2005,p.8).Asideorganizationalrules, CranfordandMiller(2013)

TABLE1| ElectedkeydimensionsinfluencingthesuccessorfailureofAT-implementationbyperspective(ownelaboration).

Perspective

OutcomePatientsHealthcareprofessionalsHomeandnursingmanagementstaff

Success Patientempowermentandself-management Enjoyment Personalization

Failure Age

Levelofeducation(esp.ATliteracy) Privacyandsecurity

Qualityofhealthcare Usability Familiarization

Technically-challengedstaff Resistancetochange Workflow Perceptionofimpersonalcare

underlinetheroleoforganizational“signals”asimportantfor personsinneedofcare.

Forexample, SmollanandSayers(2009) focusonthe affectiveorganizationalculture,whichshapeshowemotionsare experiencedandexpressed.Theresultsoftheirstudyshowan interconnectionofculturalchangeandemotions:thegreater thecongruencebetweenthevaluesoftheemployeesandthe organization,themorepositivearereactionsoftheemployees withregardtochange.Iftheemotionsofemployeesaretreated withrespectandappreciationduringanorganizationalculture changeprocess,employeeswillparticipatemoreinthechange process(ibid.). Kaplanetal.(2014) developedatheoreticalmodel whichhighlightseightspecificcategoriesofleaderemotionmanagementbehaviorlikeinteractingandcommunicatingin aninterpersonallytactfulmanner,demonstratingconsideration andsupportforemployeesorstructuringworktaskswith considerationforemployees’emotions(ibid.).Inaddition,the authorsaddressdimensionsthatincludeknowledge(e.g.,selfawareness,knowledgeofemotionsandtheirconsequences,etc.), skills(e.g.,emotionrecognition,perspectivetaking,etc.)aswell asproximaloutcomes(psychologicalsafety,satisfactionwiththe leader,etc.),andultimateoutcomes(cohesion,satisfactionand organizationalcommitment).

Alsothestudyfrom Höldetal.(2020) shows,thatcooperation withtheteamandsupervisorsisoneofthemostsignificant aspectsofjobsatisfactionamongprofessionalnurses.Agood teamcancreateprofessionalandidealsupportfornursesand improvetheirprofessionaldevelopmentandqualityofcare. Thesepositiveaspectsofjobsatisfactionshouldbeintegrated inemotion-managementandplayasignificantroleinthe implementationofAT/AR.Inthisrespect,leadersarerequested, whoareabletoperceiveemotionsinatargetedmannerwithin theframeworkoftheirmanagementbehavior,whoareableto showtheseemotionsandtoevoketheminemployees.Amutual exchangeorimplementationofemotionswithinemotionmanagementforprospectivechangemanagementprocessesis thereforedesirable.

Ifwenowfocusonleadershipwithintheorganization andspecificallyontheoriesofleadership,itbecomesapparent thatemotionsalsoplayasignificantrolehere(Kaplan etal.,2014; ScheinandSchein,2018).Stakeholdersand managementstaffhavetoshapetheimplementationprocess inawaythatitmatchestheassumptionsandvaluesof theemployees,theirorganizationalculture,toensuretheir

Costs Privacy Dataandeffectivenesspolicies Successfulchangemanagement

Costs/reimbursement Privacy/confidentiality Datasecurity Effectiveness

acceptance.Emotionsareinterwoveninleadershiptheories andareattheheartofmanyleadershipmechanisms,such asinspiredemployees,sustainableinterpersonalrelationships andinvestmentinemployeedevelopment,performanceand satisfaction,etc.(MacGregorBurns,2007; Littleetal.,2016).As aresult,alargenumberofacademicsunderstandpersonsin leadershiprolesasmanagersofgroupemotions(Brotheridgeand Lee,2008; AshkanasyandHumphrey,2011; Littleetal.,2016).

“Transformationalleadership”accordingto BassandAvolio (1994) providesamodelforemotion-managementbasedonfour principles:

(1)“Idealizedinfluence” representstherolemodelfunctionof leaders.Aclearorientationofvalues,whichisreflected intheattitudeoftheleader,providesorientationfor employees.Furthermore,theauthorsemphasizethatin thisformofleadership,managersputtheirowninterests behindthoseoftheorganizationasawhole.Such leadershipbehaviortriggersrespect,admirationandtrust amongemployees.

(2)“Inspirationalmotivation” isaboutmotivatingemployees throughchallengingandattractivegoals.Themeaning ofthesegoalsmustbemadeclear.Bypursuinga commongoal,teamspirit,optimismandcommitment canbefostered.

(3)Theapproachalsoemphasizestheroleof“intellectual stimulation” ofemployees.Creativityandproblem-solving skillsofemployeesshouldbepromoted.Inthelongterm, employeesshouldacquiretheabilitytocriticallyquestion outdatedassumptions,routinesandhabitsandfindnew approachestosolutions.

(4)Withintheframeworkof“individualizedconsideration,” employeesshouldbeindividuallysupportedaccording totheirpersonalstrengths,weaknessesandexpectations. Theleaderactsasakindofcoachandpromotesthe developmentoftheprofessionalperspectivesandpotentials oftheindividualtoahigherlevel(ibid.).

Transformationalleadersexpressthemselvesthroughaspects suchasinspiration,visionorpersonalrolemodelactionand thusdeliberatelyappealtoemotionsoftheiremployeesinorder tosupportthemaswellasconsecutivelyraisetheiracceptance, aspirations,motivesandgoals(Bolton,2005).Transformational leadershipbehaviorisintendedtogenerateoptimism,confidence

andbeliefintheiremployeesbysuggestingtothemthatalthough theirchallengesseemimmense(Bass,1985; Yukl,2012).

TheimplementationofnewtechnologiesinanemotionalsensitivesettinglikeLTCFsrequirespecificleaderbehavior inrespectoftheidentityandstabilityofthecarepersonnel. Followingtheapproachesofemotion-managementand transformationalleadership,thesuccessfulimplementationand realizationofprofoundchangeandinnovationprocessescan bedecisivelysupportedbyshapinganemotionalrelationship betweenleadersandthoseled(TichyandUlrich,1984).Inlight oftheaforementionedconcepts,anintegratedacceptancemodel couldbeuseful,whichcompriseskeydimensionsforassessment ofAT/ARimplementationinlong-termcareinstitutions.

acertainbehavior,stillengagesinitifheorsheassumesthat someonepersonallyimportantapprovesofit.

Venkateshetal.(2003) developedtheUnifiedTheoryof AcceptanceandUseofTechnology(UTAUT)byintegrating severalotherconceptssuchasTAM,theoryofplannedbehavior (TPB)ortheoryofreasonedaction(TRA).Theconcept underlinestheimportanceofsocialinfluenceandfacilitating conditionsinacceptanceoftechnologieswhereasvariablesasage, genderorexperienceonlyhaveamoderatingeffect.Themost importantvariableforbehavioranduseoftechnologyrepresents theownperformanceexpectancyofaperson.IntheTAM3Model, VenkateshandBala(2008) focusedontheperceived easeofuse,whichisinfluencedbyfactorssuchascomputer self-efficacy,computeranxietyorresultsdemonstrability.

AMULTI-PERSPECTIVEMODELOF ACCEPTANCE,ETHICAL ACCEPTABILITYANDEMOTIONAL CONSEQUENCES

Followingtheworkof Kricketal.(2019),whichusedthethree outcomedimensionsacceptance,effectivenessandefficiency (AEE)intermsofAT/ARevaluation,wepresentamodified approachbasedonthethreeperspectives acceptance(A), ethical acceptability(A) and emotionalconsequence(E).Together,they formtheacceptabilityandemotionalconsequences(AAE)model accordingtoourperspective.Inasubsequentstep,weapplythis modeltoourillustrativeexampleanduseittoarriveataholistic evaluationoftheimplementationfortheorganizationalculture.

Acceptance(A)

Whenaddressingtheissueoftechnologyacceptance,itis importanttoconsidertheneedsandcharacteristicsofpotential users.PersonsinLTCFsaremorefrequentlyconfrontedwith experiencedfunctionallossesanddecreasedcoordinativeand sensoryabilities.Thesedifficultiescauseindividualstoperceive, useandaccepttechnologydifferently.

Oneofthemostprominentconceptsisthe“Technology AcceptanceModel(TAM)”by Davis(1986).Thismodel highlightstheusefulnessofatechnology(degreetowhicha personbelievesthatusingaparticularsystemwouldenhance herorhisperformance)andtheperceivedeaseofuse(degreeto whichapersonbelievesthatusingaparticularsystemwouldbe freeofeffort)whichtogetherwithexternalfactorsinfluencethe attitudetowardusingandthebehavioralintentiontouse(ibid., 320).Criticalarguments,however,addressthelimitedpractical implicationsofthisapproachandtheinfluenceofprofessionalor occupationaluseofasystem(KingandHe,2006).

ThefurtherdevelopedTAM2-Model(VenkateshandDavis, 2002)considersthesocialandcognitiveinstrumentalfactors influencingtheperceptionofusefulnesssuchasnorms,image, jobrelevanceandvoluntariness.Thus,TAM2underlinesthat both,socialandcognitive-instrumentalvariables,haveanimpact ontechnologyacceptanceanduse.Inthiscontext,themodel issufficient,whenaperson,evenifheorshedoesnotsupport

AllTAM-modelsintheirmodificationareconsideredtohave beenempiricallytestedmanytimes.However,thesemodels havehardlybeenappliedinrelationtopersonsinneedofcare orincarehomes.

IntheAlmeremodel, Heerinketal.(2010) usedtheitems oftheformerUTAUTquestionnaireadaptivelywithregardto animal-likesocialroboticsandolderpersonsastheirusers. Insteadofexpectedperformancesandexpectedeffort,theauthors renamedthevariableswith“perceivedusefulness”and“perceived easeofuse.”Inadditiontotheexistingassumptionsthat usefulnessandvoluntarinessplayasignificantroleinhowa personacceptsAR,Almerealsoemphasizestheimportanceof affectiveandcognitiveattitude.Thus,acceptancevariableshave beenaddedtotheUTAUTmodellikeperceivedenjoyment, confidence,orperceivedadaptability.Intotal,12different dimensionsdeterminetechnologyacceptancesuchasanxiety (forusingsocialrobotics),(positiveornegative)attitudetoward technology,facilitatingconditions(adequateintroductionin functionsoftherobot),intentiontouse,perceivedadaptiveness (oftherobotwithregardtospecificneedsofthepatient), perceivedenjoyment,perceivedeaseofuse,perceivedsociability, perceivedusefulness,socialinfluence(relatedtotheacceptanceof others),socialpresence(asperceivedsocialinteractionwiththe robot)andtrust(integrityandreliabilityoftherobot).Centralto themodelisthusnotonlytheindividualperspective,butalsothe ideathatacceptanceisembeddedinsocialcontexts,likeinour exampleinanorganizationalsetting.

Insummary,theseprominentandempiricaltestedmodelsfor technologyacceptancefocusedonvariousaspectsofacceptance suchasperceivedusefulness,easeofuse,orvoluntaryinuse. Intheprominenttriangleofcaregivers,carerecipientsand technology,organizationalcultureandethicswere,however, mentionedonlyinpassing.

EthicalAcceptability(A)

Foranethicalevaluationacceptancealoneisnotasufficient criterion.Ahumaneperspectivedoesnotfirstaskaboutthe usefulnessofatechnologyforsolvingconcretepracticalproblems oramereacceptance.Itasksaboutacceptabilityagainstthe backgroundoftheconsequencesofatechnology’suseforthe imageofhumanityandcoexistence.Firstofall,AT/ARincare contextsareundoubtedlysomethinggood,ifwhattheyhelpto achieveinturnproducessomethinggoodintheend.

Justice,self-determination,privacy,etc.,andthecriteriafor nursingformulatedby BeauchampandChildress(2001) like justiceandautonomyareonlyafirstapproachhere.Goingtothe rootoftheethicalquestion,self-determinationisbynomeansthe fulfillmentofone’sowndesires.WithImmanuelKant,autonomy means:reason,freefromegoisticwilling,recognizedwhata personshoulddo.Ifapersonmakesthisoughther/hisought, she/heisultimatelyautonomousandfree.Butthishaslittleto dowiththecommonunderstandingofself-determination;for itistheobligatedfreedominresponsibility.Thus,thereisa significantneedtosemanticallyfilltheethicalgeneralitiesand tosubstantiallyquestion,evaluateandresponsibleimplement theuseoftechnologytoavoidunintendedconsequences.The possiblereferencetothedistinctionthatrobotscanonlyachieve predeterminedgoalsbutcannotsetgoalsforthemselvesisno longersufficientwhenalgorithmsinspireandcontroleachother evenwithouthumanintervention(MatsuzakiandLindemann, 2016).Isthecarerobotseenasacolleagueorisitevenallowedto determineworkprocessesofhumanemployees?This,however, contradictsournotionofhumanumandalsoimplieshighly complexliabilityissuesincaseofroboterrors(Kaplan,2004; Bartnecketal.,2019; Nass,2020).Whowilltakeresponsibility forthis?

Wefirsttakealookatalreadyexistinginstrumentsofethical evaluationofAT/ARbeforewesharpenandproposeourposition. Anethicalevaluation-modelpopularinthecontextofAmbientAssisted-Living(AAL)istheMEESTAR-Model(Modelforthe EvaluationofSocio-TechnicalArrangements)(Weber,2015, 2020).Ittakesanexplicitethicalviewontheconsequencesof AAL-adoptionsandinterventionslikeprivacy,securityorjustice andtriestobalanceresponsibilityandabilityinthiscontext. Theseaspectsareremarkablynecessarywithregardtoclients withcognitiveimpairmentsinordertoprovideappropriate informationandtoolsforasensitiveadoptionoftechnology.In thecourseoffurtherdevelopment,less“practical”approaches andmorequestionsofattitude,participation,trustandvalues haveflowedintothedevelopmentofthemodel.However,from apsychologicalandethicalpointofview,someessentialaspects arestilldisregardedaspositiveornegativeaffection,authenticy, autonomyorresonance(Beimbornetal.,2016; Rosa,2019). AndMEESTARisaproceduralmodel,whichdoesnotrepresent itsownethicalposition,butonlybringsdifferentonesinto discussionwitheachother.

Beyondproceduralethics,wehavetorefertomodels withastrongconceptofacceptability(JaenschandNass, 2019),likeforexampleaKantianoraChristianperspective— equallylegitimateintermsofscientifictheorytostartfrom secularorreligiouspostulates.Therefore,wechooseforthe criterionofacceptabilityasasemanticallysubstantialposition withatransparenthumanisticviewofdignity.Thefocuslies independentlyofeconomicallymeasurableacceptance,onthe consequencesfortheimageofman,responsibilityandsocial coexistence.Againstalegalpositivistviewinwhichlawsand ethicscoincide,wedonotderiveourethicalargumentsfromlegal provisions,which,moreover,alsovarywidelyinternationally.Itis preciselythisperspectivethatenablesacriticalevaluationofrules andlawsaswell.

Accordingtothisview,theuseoftechnologyisacceptableifit enableseveryhumanbeingtoliveuptotheresponsibilitygiven toher/him(byGodorbyreason)beforeherself/himself,before eachother(andbeforeGodorbeforereason).Theunconditional humandignityasthebasisofhumanityandthusofethicsisthen justified,forexample,intheideaoftheimageofGodinman (Christianity),theideaofthesubstitutionofGodbyman(Islam) orinthenecessitiesofreason(Kant).Autonomyunderstoodin thiswayisthusalwayslinkedtogiventasksorduties,which couldbejustifiedinKantianorreligiousterms(Westphal,2016; Frick,2019).Equaldignitybelongstoeveryhumanbeing,but nottomachines,virtualrealities,cyborgsorthelike.Theuseof technologyincaremustthenalwaysbeaservicevalueforthe developmentofhumanbeingsintheirindividuality,socialityand tripleresponsibility.Suchhumanityshouldabsolutelyframethe logicofself-referentialtechnology.

EmotionalConsequenceandthe TEO-Model(E)

Drawingontheideaofemotion-managementandtransformative leadership,organizationalchangesasAT/ARimplementationin LTCFsareemotionalchallenges,whichcantriggeruncertainty, mistrustorfearwithinthesetting.Thecompetenceofthenurse toestablishasafeandhealingconnectionwiththepersoninneed ofcaresymbolizesacentralethicalandemotionalcontentofthe careprofession.Ontheotherhand,theeffectsoftechnologyuse couldfacilitatethedailyworkroutine/processofnurse-skilled employeesandpromoteapleasantorganizationalculture.

Ifcertainemotionsaresuccessfullyfostered(not manipulated!)byleadersinthelongterm,thecorporateculture mayalsochangeinthisdirectionovertimeandcontributeto individualandorganizationalwell-being.Forleadersinthe caresectoritisamatterofacceptingandreflectingonexisting emotionswithintheworkforce,butalsoofcreatingframework conditionsthatpositivelysupportthechangeprocessonan emotionallevel(Golemanetal.,2002; Bolton,2005).

Asdescribedinsection“Acceptance(A),”severalmodels ontechnologyacceptanceembracefactorsasattitudeand behaviorshapedbystructuralandcognitivefactors.Purchasing behaviorandpositiveemotionsaboutAT/ARimplementation are,however,susceptibletomanipulationandmisinformation. Concerningthelegitimacyandemotionalconsequencesforthe imageofcaregiversashumanbeings,thismeansconcretelythat theuseoftechnologyisonlylegitimateifitdoesnotleadto theisolationoranonymizationofhumancontacts.Iftechnology replaceshumaninteractionandfeelingsofbelongingandagency, thesocialnatureofhumanbeingsismisled.

Collectiveemotionsarepartofthecorporatecultureand generallytoaccept.Thismaymeanthatinanorganizationwhere cautious,protectivebehaviorhasreliablyledtosuccessinthe past,implementationshouldbeundertakeninparticularlyslow steps,staffshouldbeabletotryoutthenewsolutionfirstintest settings,wheremistakesdonotmeanseriousconsequencesand wheretheyhavetheopportunitytoexpressconcernsopenly.

Furthermore,leaders—asdistinctrolemodels—shouldbe awareoftheirownemotionsregardingthechangeandreflect

emotionsthatnewtoolsandpracticestriggerinthem,even beforetheactualimplementation.However,emotionssuchas satisfactionoranticipationarenaturallymoreconducivetothe implementationprocessthanfear,angerorsadness.Therefore,it ishelpfultocreateframeworkconditionsthatpromotepositive emotionsregardingthechangeofnursingpractice.Thiscanbe, forexample,thepossibilityofco-determinationinthechoiceof technologyortheco-designoftheadaptationofworkprocesses, butitcanalsoinitiallymeangivingspaceforthearticulationof negativeemotionsontheirworkflow.

SinceAT/ARisaddedasasupportingfactor,theformer dyadic“two-wayrelationship”betweencarereceiverandcare giverbecomesa“three-wayrelationship”(see Figure3).Wecall thisframework“TEO”fortheintegrationof transformational leadership, emotion-managementand organizationalcultureas diagnosisanditerativeassessmentinstrumentofthedimension “emotionalconsequence.”

In Figure3,measuresinTEOarepresentedthatare significantforemotion-managementinorganizations.Itshould bedesignedlikeleadershiparoundAT/AR,e.g.,withregard tothequestion,howemotionscanbecreatedaroundthe technology,liketrust,joy,peace,harmonyetc.Itisalso necessary,thattheemployees/nursingstafffeelacceptedand creative.Theethicalaspectsshedlightontheiterativeprocessof implementingatechnicalassistancesystemfromthebeginning. TheaspectsofAT/ARimplementationarestructuredby theleader/organizationmanagementwithintheframeworkof transformationalleadershipandincludetheessentialaspectsof theorganizationalculture,management,thepersonnelinLTCFs andimplicitlyalsothepersonsinneedofcare.Apossible toolforimplementationareworkshopsinwhichleadersand organizationmanagementspecificallyaddresshowthecaretasks maybechangingandredistributedwithintheframeworkof changemanagement.

Tosummarize,measuresforanAT/ARimplementation shouldaddressthefollowingkeyquestions:

1.Whatistheemotional statusquo beforerunningthe changemanagementprocesswithintheorganizationor

amongemployeeswehavetoconsiderinordertocreatea correspondingemotionalculture?

2.Whatchanges—especiallyinthecaregivingrelationship, communicativebehavior,andhealthstatus—couldeach resultfromtheuseoftechnology?

3.Towhatextentmaythesepositive/negativeeffectsinfluence workflowandjobsatisfactionofthenursingstaffaswell astheorganizationalcultureandthuspromote/impairthe implementation?

Underthisassumption,anintendedimplementation wouldnecessarilyhavetotakeintoaccountthepatient-nurse relationship,generalethical-humanassessmentcriteria,and theirinteractions.

AAE-APPLICATIONTOTHEPRACTICAL EXAMPLE

HavingpresentedourspecificassessmenttoolofAAE,wenow wouldliketoillustratethismodelalongtheillustrativeexample introducedearlier:ALTCFandtheimplementationofthe“Care AssistRobot”(CAR).

Acceptance(A)

Accordingtoimportantmodelsofuseracceptance[seesection “Acceptance(A)”],thisdimensionrepresentsthewillingnessof theemployeestoincludeCARintheirdailyroutines.AstheTAM modelanditsmodificationsortheAlmeremodelindicate,the acceptancedependsforexampleonthetasks,CARisdesigned for—inthiscontextphysicalassistanceincarework—andits perceivedusefulnessandhoweasyCARcanbeoperated.Inthis case,greateracceptancecanbeassumed,asCARissupposed toreducephysicalburdenforcaregiversandthereforperforms animportantcaretasksthatdoesn’treplacesocialoremotional interactionsbetweencaregiverandcarereceiver(as,forexample, itwouldpossiblybethecasewithsocialassistiverobots).

Nursingstaff’sconcernsaboutinsufficientfunctions(like takingtoomuchtimeformovingapatient)orlossof controlcouldbeaddressedintermsofspecificworkshops forintroductionandpeer-to-peer-education,whichrelatesto specificusercharacteristics,realisticscenariosandthesocial contextinwhichtherobotisused.Theopportunitytotryout CARanditsfunctionsinaworkshopsetting(andnotinurgent situations)allowsemployeesaprevention-orientedculturein respectofshortcomingsbutalsoasarenasforexperiencedselfefficacyandconfidence.Inaddition,itisimportanttoconsider thevoluntarinesstouseCARandifresistance(byemployees butalsobyresidents)againsttherobotisacceptableforleaders. Possibilitiesofparticipationintheimplementationprocess(as mentionedinthisexample)andtransparentinformationpolicy bytheleadersarealsocrucialtoavoidnegativeattitudesand perceptionsofreplacement.

EthicalAcceptability(A)

EthicalacceptabilityinourexampleismorelikelyasCAR providesphysicaltaskstoreducephysicalimpairmentsand

FIGURE3| Implementationoftechnicalassistanceandtransformational leadershipwithemotion-managementinnursingpractice—TEO(own elaboration).

mobiledifficultiesforthepersonsinneedofcare.However,staff membersinourexampleareconcernedaboutthepossibilityto becomeremovedbyCARintheirpersonalassistance.

Inrespecttoethicsinnursingsocialinteractionsandnonmaleficenceofpatientsareroles,whichcannotbecompensated byaAT/AR.However,conflictsbetweenpatientsandcarestaff intheethicalevaluationofCARusemayarise,forexample, wherepatientsprefertheuseoftechnologytoahumannursing service,whilenursesseethisspecificserviceasessentialtotheir jobdescriptionandidentity.Or,viceversa,anursemaywant togetridofunpleasantcareservicesthatthepatientprefersto seeprovidedbyahuman.Suchconflictshaveconsequencesfor organizationalculturewhennurses’issuesofconscienceaffect theirmotivation,jobsatisfaction,andidentificationwiththeir work.ThecriterionofethicalacceptabilityofCARusedoesnot requiresmoothingoutallsuchconflicts.Iftheuseoftechnology withallitsconsequencesleadstothefactthattherebythe humanrelationshipbetweenthemandpatientswins,thenitis acceptable.Theconcreteevaluationinindividualcasesdepends onthesemanticsoftheideaofhumanity,whichcanbeshaped differentlyforculturalorideologicalreasons.

Inourexample,itispossiblethatpatientsinspecificcare contextsprefertheuseofCARtocarebyhumans,forexample outofshame,andthereforeregardthisarrangementasmorally preferable.Fortheself-imageofnursingstaff,theuseofCARcan thenalsobeseenasafacilitation,becauseencounterswithshame canbeavoided.Suchasubstitutionofhumancarebyrobotics isacceptableinprinciple,ifitisalwaysclearthatanethical evaluationontheuseofCARdoesnotitselfattributeamoral qualitytothisconcreterobotics.Theusemaybeacceptable,but theroboticsitselfisnevermorallygoodorbad.Otherpositions areconceivablehere,forexampleinanimism(Kaplan,2004; Hornyak,2016).

WhoisCARincomparisontothenurseandother employeesintermsofhumanimageandnursingethics?How isresponsibilityincaretasksattributedbetweenstaffandCAR? Oncesuchquestionshavebeenclarifiedintheorganization(clear limitshavebeensetfortheuseofrobots;thereisnoreplacement ofhumancommunication;machinesarenotcolleaguesand questionsofliabilityhavebeenclarified),theuseofCARcould beethicallysupportedinprincipleundertheseconditionsifit actuallyrelievestheworkloadofthescarcenursingstaffandif thisroboticsiseasytooperate.

EmotionalConsequences(E)

Inourillustrativeexampleemployeesreportedvariousemotions withregardtoCAR:anxiety,anger,confusionbutalsocuriosity. Whilesomeofthemarefrustratedanddisappointed,becausethe managementisbuyingrobotsinsteadofcreatingnewjobs,others areworriedaboutbeingreplacedbyaCARwiththepossible lossoftheirjob.Possibleunexpectedreactionscouldariseonthe partbygeneratingevenmorenegativeemotionsamongthestaff, developingadisturbedtrustrelationshipwiththemanagement, leadingtoforexampleincreasedsickdaysorstaffturnover.

TheapplicationofTEO(includingtransformativeleadership, emotion-managementandorganizationalculture)inits practicalfeasibilitymeansthatleadershipisassociatedwithan

emotionalreactionoftheemployeesandhascorresponding emotionaleffectsthathavepresumablyhardlybeenperceivedin leadershipmanagement.

IntheillustrativeexampleofaLTCF,knowingexactlywhat contributestoaprofessionalworkflowandsatisfactionofcare staffintheirjob,aresignificantstepstomovetogetherpositively inthedirectionofchangemanagement(e.g.,implementation ofAT/AR).Inthecaseoftheexistingnegativeemotionswith regardtoCAR,itisimportantthatthemanagerpromotes positiveemotionsandhasacalmingeffectwithlessintensity, satisfactionandserenityandthattheirrolemodelfunction againexemplifiestrustthroughauthentic,honestandbeneficial communicationprocessesaswellastheemphasisonjoint positiveperformances,sothatachangefromnegativecanbe convertedintopositiveemotions.

Withthefocusparticularlyon emotion-management, timingandemotionsmustbethoughttogether.Thechange managementprocessinourexamplestartsalongtimebefore theimplementationprocessoftheAT/AR(e.g.,planning budgetforCAR,negotiationwiththemanufacturers).In workshops(asalreadymentionedwithregardto Acceptance) thetransformationalleadershiphastocreateanemotional visionofCARimplementation.Caregiverswanttobeinformed andactivepartoftheprocessandtransparent,authenticand communicativeinformationpolicybytheleadingmanagement. Thismeanstocreateemotionsaroundtherobot,liketrust,joy, peace,harmonyetc.,werecaregiversfeelaccepted,creativeand areabletoflourish.

Theapplicationofourthree-stagesystemfortheintroduction oftheCareAssistRobothasshownthatacceptance, ethicalacceptabilityandemotionseachmakecriteriaforan implementationtransparent,whichallowaholisticevaluation alsoinahumanperspective.Thesecriticalcriteriacannowbe easilymerged.Theyarethecompassforthemanagementof LTCFtodesignaresponsibletransformationalchangeprocessin responsetoAT/ARimplementations.

DISCUSSIONANDOUTLOOK

Inthefuture,residentialcarewillincreasinglyfacethe challengeofsuccessfullyimplementingdigitaltechnologies. ThiscanespeciallybeexpectedforLTCFs,asmultiple assistivetechnologiesandrobotspromisenewpossibilities formaintainingthequalityoflifeofvulnerableresidentsas wellasfacilitationforprofessionalcaregiversintheirdaily work.Severalstudiesunderlinedtheimportanceofdifferent acceptancedimensionsinthecaresectorandspecificoutcomes fordifferentusergroups.

Fromourperspective,successfulimplementationby organizationalleadersalsohastotakeintoaccountthe existingorganizationalcultureandtosupportemployeesinthese changesbeyondtraditionalconceptsoftechnologyacceptance, especiallyonanemotionallevelandinrespectofethicalvalues innursing.Comparedtootherindustries,theimplementationof AT/ARinLTCFshastoconsiderspecificemotionalconditions incaresettingsintermsofvulnerableresidentswithdailycare

needs,shortageofprofessionalcaregiversandethicalsocialrules innursing.Inthecontextoffacilitatorsandbarrierscontributing totheAT/ARdeployment,thestakeholder-entitiesaredecisive too:TheaimofAT/ARimplementationisfrequentlytoevoke positiveemotionalityinpatientsandemployeesandthusto supportthehealthbalanceofolderorcognitivelyimpaired people.Ideally,thesegeneratedeffectswouldhaveanequally positiveeffectonprofessionalcaregiversand,inabroadersense, theentireorganization,includingtheprevailingworkculture.

Thus,wearguehereforamoreethicalandemotionledleadershipandmanagementstrategiesincareinstitutions toenablemodernorganizationstoadoptaconstructiveand reflexiveattitudetowardtechnologywithout,however,being manipulative.Weofferahumanisticcompasswiththeevaluation criterionofAAE(acceptance,ethicalacceptabilityandemotional consequences),whichincludestheideaofhumanityandsocial coexistenceforthesolutionofconcreteindividualquestionsin carepractice.Indoingso,weavoidapaternalisticnarrowing,as localnormsandorganizationalculturesshouldbeconsidered.

Toavoidunpredictable/unintendedresultsandresistance, employeesshouldbestimulatedbychangeandinvolvedin aparticipativeway.Inthisrespect,anintentionalutilization offactorswhichfosterfacilitator-categoriesisverybeneficial fortheentireinstitution.Whiletheconceptof“emotionmanagement”exploreshumanemotionsattheworkplaceand conceptualizeanewmanagementapproach(Bolton,2005), “transformationalleadership”underlinestherolemodelfunction ofleaders,attractivegoalsandmotivation,orstimulationfor employees(BassandAvolio,1994).Wehavetranslatedthe emotionalconsequencesintheAAEapproachintoathreeperspectiveheuristicmodel“TEO”thatintegratesprevious prominentapproachesontransformativeleadership,prescriptive emotion-managementandorganizationalcultureontheissueof technologyimplementation.Emotionalconsequencescaptured bytheperspectiveofTEOcanpotentiallysupportorganizations indevelopingappropriateimplementationguidelinesand provideideasforacommonvaluediscussion.Inaddition, adaptedtotherespectiveinstitutionalframeworkconditions, itcanrepresentaninitialdiagnosticorratheriterative assessmentblueprintforunderstandingandimprovingchange managementduringtheholeimplementationprocess.For

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ConflictofInterest: AZwasemployedbythecompanyYouseGmbH.

Theremainingauthorsdeclarethattheresearchwasconductedintheabsenceof anycommercialorfinancialrelationshipsthatcouldbeconstruedasapotential conflictofinterest.

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published:21July2021

doi:10.3389/fpsyg.2021.706483

Editedby: MagdalenaKlimczuk-Kochanska, UniversityofWarsaw,Poland

Reviewedby: SheilaDow, UniversityofStirling,UnitedKingdom PiersMichaelGooding, TheUniversityofMelbourne,Australia

*Correspondence: MylesJoshuaToledoTan mj.tan@usls.edu.ph

†Theseauthorshavecontributed equallytothisworkandsharefirst authorship

Specialtysection: Thisarticlewassubmittedto HealthPsychology, asectionofthejournal FrontiersinPsychology

Received: 07May2021

Accepted: 22June2021 Published: 21July2021

Citation: MaravillaNMATandTanMJT(2021)

PhilippineMentalHealthAct:Justan Act?ACalltoLookIntothe Bi-directionalityofMentalHealthand Economy.Front.Psychol.12:706483. doi:10.3389/fpsyg.2021.706483

PhilippineMentalHealthAct:Justan Act?ACalltoLookIntothe Bi-directionalityofMentalHealthand Economy

NicholleMaeAmorTanMaravilla 1† andMylesJoshuaToledoTan 2,3*†

1 CollegeofMedicine,CebuDoctors’University,Mandaue,Philippines, 2 DepartmentofNaturalSciences,UniversityofSt.La Salle,Bacolod,Philippines, 3 DepartmentofChemicalEngineering,UniversityofSt.LaSalle,Bacolod,Philippines

Keywords:Philippines,mentalhealthact,mentalhealth,happinessandwell-being,NorthwesternEurope,mental healtheconomics,economy,psychology

INTRODUCTION

Itmayseemintuitivetosaythatahealthyeconomymakespeoplehappy,butlittleissaidabout theconverseofthisstatement.Perhaps,weshouldlookintohowhappypeoplemakeaneconomy healthy.Thenatureofhappinesshasbeendebatedonbyphilosophersforthousandsofyears,but abenchmarkforitthathasbeenacceptedbymanysocialandbehavioralscientistsinthepastfew decadeshasbeenDiener’sSubjectiveWell-being(SWB)(Diener,2009).Studiesthatemploythe useofSWB showthatindividualswhoreporthighlevelsofittendtolivelongerwithhealthier lives,havehealthiersocialrelationships,andworkmoreproductively(Montagnoli,2019).Hence, higherlevelsofSWBcouldmeangoodmentalhealthamongindividuals. Polietal.(2020) described goodmental healthas“astateofwell-beingthatallowsindividualstocopewiththenormal stressesoflifeandfunctionproductively.”However,thedefinitionof goodmentalhealth mayvary amongcultures,valuesandtraditions.Cultureaffectshowpeoplemanifestsymptoms,expressthese symptoms,dealwithpsychologicalproblems,anddecidewhethertoseekcare(EshunandGurung, 2009).Becauseofthesedifferences,thebestwaytoenrichourunderstandingof mentalhealth mightbetoevaluatethedifferentperspectivesofmentallyhealthypopulationstowardit(Vaillant, 2003).Furtherunderstandingofmentalhealthissignificantbecauseitgreatlyaffectstheeconomy aseconomiesappeartocruciallydependonthepopulation’smentalhealth.Andso,goodmental healthissignificantforeconomicgrowth.Accordingto KnappandWong(2020),theeconomyhas abi-directionalrelationshipwithmentalhealth.Economicdeclinemayleadtoagreaterlikelihood ofmental-illnessduetoexposuretoriskfactorssuchassocialexclusion,pooreducation,treatment costs,unemployment,andpoverty.Mentalhealthproblemsmayalsoleadtoasignificantdeclinein economicactivitythatresultsfromproductivitylossesandlimitedresourcesfortreatment.Thus, thestudyofeconomics,particularlymentalhealtheconomics(MHE),issignificantinidentifying waystoimprovementalhealthandmentalhealthcareproductionandconsumption.Unfortunately, tothebestofourknowledgeandunderstanding,therearecurrentlynoexistingstudieswrittenon PhilippineMHE.AndsotohelpaddresstheeconomicandmentalhealthcrisesinthePhilippines, wehopetosparkdiscussionsthatwillpromotethestudyofMHEforthegoodofallFilipinos.

THESTATEOFMENTALHEALTHINTHE PHILIPPINES

ThePhilippinesisanarchipelagoofover7000islands,withover 120languages,andnumerousreligions.Thecountryhasbeen occupiedandcolonizedbymanyforeignpowerssince1545and itonlygainedfullindependencein1946.Thiscolonialhistory hascontributedtotheuniqueFilipinoculture,yetthecountry remainspoorlyunderstoodbecauseofitslateindependenceand ofitbeingoneofonlytwoChristian-majoritycountriesinthe FarEast(Lallyetal.,2019).TheculturalbeliefsofFilipinos varyinalmost everyrespect.Oneofthepopularbeliefsisthat depressionandanxietyarenon-existent,andthatmentalillnesses aresomethingtobeashamedof.Aqualitativestudyconducted by Tanakaetal.(2018) showedthatthisstigmaisconsideredto beaneffectofthepublicbeliefaboutmentaldisorderswhich consistofthreethemes:Firstis familialproblems,whereinthe familyrejectsordisownsthefamilymemberwhosuffersfrom amentaldisorderbecausetheybelievethatitcanbeinherited. Secondis unrealisticpessimismandoptimism abouttheseverity ofthedisorder,whereinthementallyilleitherwouldcertainly sufferfromseverefunctionalimpairmentorwouldbeableto overcomeanypsychologicalsufferingbythemselves.Lastisthe oversimplifiedchroniccourse,whereinpeoplewithoutmental illnessesapplyanacuteillnessmodeltothoseill,andexpectfull recoveryintheshortterm.

Becauseofthisstigma,mentalhealthhasbeengivenvery littleattentionbythePhilippinegovernmentandpublicsectors. EvenafterthecountryhasrecentlypasseditsfirstMentalHealth ActandUniversalHealthCareLaw,only5%ofthehealthcare expenditureisdirectedtowardmentalhealth.Also,thereare only7.76hospitalbedsand0.41psychiatristsper100,000 people(WorldHealthOrganization—AssessmentInstrumentfor MentalHealthSystems,2007;DepartmentofHealth,2018). ThisratiowasknowntobelowerthanotherWesternPacific countrieswithsimilareconomicstatuses,likeMalaysiaand Indonesia(Lallyetal.,2019).ThePhilippinegovernmentdoes noteven provideeconomicsupportfororganizationsthathave beeninvolvedintheformulationandimplementationofmental healthpoliciesandlegislation(WorldHealthOrganization— AssessmentInstrumentforMentalHealthSystems,2007). Consequently,mental illnesshasbecomethethirdmostcommon disabilityinthePhilippines,whereinsixmillionFilipinoslive withdepressionandanxiety.Becauseofthis,thecountryhas thethirdhighestrateofmentaldisordersintheWestern Pacific(Martinezetal.,2020).Also,thePhilippineWorld Health Organization(WHO)SpecialInitiativeforMentalHealth conductedin2020showedthat ≥3.6millionFilipinossuffer fromatleastonekindofmental,neurological,orsubstance usedisorder(DepartmentofHealth,2020).Suicideratesare reportedtobe at3.2per100,000populationwithhigherrates amongmales(4.3/100,000)thanfemales(2.0/100,000).However, thesenumbersmaybeunderreportedbecausesuicidecasesmay sometimesbemisclassifiedas“undetermineddeaths”(Lallyetal., 2019;Martinezetal.,2020).TheWHOestimatedthat154million Filipinossuffer from depression,1millionfromschizophrenia,

FIGURE1| Aninfographicthat summarizesthestateofmentalhealthin thePhilippines.

and15.3millionfromsubstanceusedisorders,while877,000 diedueto suicideeveryyear(DepartmentofHealth,2018). Thus,mental disorderscouldgreatlyaffectemploymentand levelsofeducation,mostespeciallyinages25to52years (Hakulinenetal.,2019).Itwasfoundinastudyby Hakulinen etal.(2020) thatindividualswithaseverementaldisorderhad notably lowerlevelsofemploymentbefore,andmoreespecially after,thediagnosisoftheirdisorder.Theiroverallincomescame primarilyfromtransferpayments,andthemostaffectedwere thosediagnosedwithschizophrenia.Afterreceivingamental disorderdiagnosis,morethanhalfoftheseindividualsreceived noemploymentearnings.

Filipinosaregenerallyunhappynotonlybecauseofpoor economicconditions(unemployment,lowsalary,etc.),butalso becauseofpressuresarisingfromhighexpectationsfromfamily andsociety.Inthestudyby Palaganasetal.(2017),itwasshown that24% ofmidwives,29%ofdoctors,51%ofnurses,and61% ofphysicaltherapistsdesiredtomigratetotheUnitedStates, Canada,Australia,andtheUnitedKingdomtoworkashealth professionals.Theirmigrationsresultedinshortagesofhealth workers,reductionsintheprovisionofhealthservices,poor qualityofhealthcareserviceprovision,longerwaitingtimesfor patients,andincreasedworkovertime.Theirdecisionstomigrate weremainlyinfluencedbythegreaternumberofemployment opportunitiesandhighsalariesabroadwheretheyaregiven morerespectandqualityofpractice,whichgreatlydevelop theirwellbeing.

ThestateofmentalhealthinthePhilippinesinsummarizedin Figure1 (WorldHealthOrganization—AssessmentInstrument forMental HealthSystems,2007;DepartmentofHealth,2018; Tanakaetal.,2018;Martinezetal.,2020).

AHAPPYNORTHWESTERN EUROPE

Here,wetalkabouttheconditioninNorthwesternEuropean countriestoestablishabasiswithwhichtocomparethatin thePhilippines.

Mentalhealthisassociatedwitheitherhappinessor unhappiness,andissignificanttoNordiclife.Agoodreasonwhy Nordicsarehappyistheirsystemthatprovidessecurity,free education,andareasonablebalanceofworkandpersonaltime (AndreassonandBirkjaer,2018).Humanitarianismistherootof theirculturethathasledtoeconomicgrowthandreconversion ofcities.Innovationanddevelopmentwerealsoattributed totheirkindnesstowardthemulticulturalneighborhoodsof theircountry(EuropeanEconomicandSocial European,2016). Asidefromculture,thegovernmentalsoplaysanimportant roleindevelopingthesecountries.Sincethelate19thcentury, independentcourtsystemsthathandlecorruption-related mattershavebeendistinctivefeaturesofNordiclegalsystems. Thesehavemadetheirgovernmentsmoretrustworthyand reliable,andhavegiventheircitizenstheassuranceofeffective reformsthatfulfilltheirpurpose(WorldHappinessReport, 2021).ThisexplainswhyNorthwesternEuropeancountrieshave amongthe highestscoresintheWorldGovernanceIndicator. Moreover,theyusedigitaltoolstooptimizemanagement, servicedelivery,andoverallstatecapacity.Nationalwebsites areestablishedtoallowcitizens’participationinpolicymaking

andtoprovidefeedbackonpublicservices.Thus,the collaborationbetweengovernmentsandtheircitizensisableto strengthenresearch,monitoring,andtheevaluationframework ofpolicymaking.Italsopromotestransparencyandtrustbetween them(WorldHealthOrganization,2018b).Inaddition,health hasalways beentheirtoppriority.Therefore,publicservices suchashealthcareanddisabilityservicesaresupportedbythe government(WorldBankGroup,2021).

THEPHILIPPINESAND NORTHWESTERN EUROPE—ACOMPARISON

The WorldBankGroup(2021) hasemphasizedthatmental health ispartofthestrategytoimprovedisadvantaged economies.Inordertoachievethis,peopleshouldbeinpositive mentalandemotionalstatesofenjoymentandcontentment, id est “happiness”(Richardsetal.,2015).However,accordingto Hartetal.(2018) and Wahlbeck(2015),socioeconomicfactors likepoverty,poor education,unemployment,andhighdebt, whicharemostlyexperiencedbyFilipinos,affecthappiness.

Economiccrisescanproducesecondarymentalhealtheffects thatleadtoincreasedsuicideandsubstanceabusemortalities (WorldHealthOrganization—EuropeanRegion,2020).The Philippineshasfacedmultiplefinancialcrisessincethe1980s. Infact,the1980sand1990ssawadramaticdeclineinthe country’sbankingsystemthatcausedFilipinosandfinancial intermediariestolosetrustinit.Thishasbeenknownasthe lostdecade forthewholePhilippineeconomy.Fortunately,bank earningsrecoveredinthe2000sduetotheeconomic,financial, andstructuralreformsthatwereimplemented.Thisprovideda strongeconomicfoundationforthecountry,especiallyduring the2009GlobalFinancialCrisis.Thecountryalsocontinuedto carryoutpolicyreformsthatfurtherenhancedthevarioussectors oftheeconomy.However,severeandshiftingweatherpatterns, anddisease,haveincreasinglybecomeasourceofdownsiderisks tothefinancialsystem(BangkoSentralngPilipinas,2020).Inthe studybyMontagnoliand Montagnoli(2019),itwasshownthat financialcrises bringaboutmicro-andmacroeconomicchanges incountriesthataffectSWBandleadtomajorandlong-lasting psychologicallosses.However,theselossescanbecounteracted bysocialwelfareandotherpolicymeasures(WorldHealth Organization—EuropeanRegion,2020).Thus,measuresofthe samenatureshouldbecarriedouttocounteracttheeffectsof financialcrisesinthePhilippinesandinturn,alleviatetheplight oflow-wageearnerswhoaremorepronetopsychologicaldistress (Kronenbergetal.,2017).Thesemeasurescanbeachievedby investinga greaterdealinhealthandeducation.

However,Filipinosmigratetoothercountriesbecauseof thepersistenteconomiccrisesandunemployment. Palaganas etal.(2017) showedthatthedecisionoftheworkerstomigrate ismainlyinfluenced bytheirjobdissatisfactionwithincome, workload,andinfrastructure.However,increasingthewagesof low-wageearnerswouldnotentirelyenhancetheirmentalhealth (Kronenbergetal.,2017).Accordingto Martinezetal.(2020), although Filipinosenjoymoreopportunitiesandhigherwages abroad,mentalhealthissuesstillexistamongOverseasFilipino Workersduetolanguagebarriers,immigrationstatus,lackof

insurance,anddiscrimination.Thismaybeexplainedbythe happiness-income paradoxpresentedby Easterlinetal.(2010) Accordingto them,“atapointintimebothamongandwithin nations,happinessvariesdirectlywithincome,butovertime, happinessdoesnotincreasewhenacountry’sincomeincreases.” Thisisevidenceoftheincompletenessoftheunidirectional perspectiveoftheeffectsoftheeconomyonhappiness,andin turn,mentalhealth.Whilethereistruthinthisperspective,the perspectiveintheotherdirection,i.e.thattheeffectofmental healthontheeconomy,isprobablyequallyasimportant.

Beingthatmentalhealthissueshavebeenwidelyneglected inthePhilippinesandmigrationhasresultedinthelossof investmentsinhumancapital(Palaganasetal.,2017),itwould bebest totakestepstoattempttoadoptthementalhealth promotionstrategyofEuropeasnineofthe10happiest countriesintheworld—Finland,Denmark,Switzerland,Iceland, Netherlands,Norway,Sweden,Germany,andAustriaarein NorthwesternEurope(WorldHappinessReport,2021).This isperhapsbecauseoftheirgoodeconomicstatusandquality healthcare.Mentalhealthpromotioninthesecountriesproved tobemoreeffectivebecauseitwasintroducedintothepolitical agendausingadifferentapproach.Neithertheprevalenceof mentalillnessnortheneedforresourceswasemphasized. Instead,mentalhealthwashighlightedasafundamental componentofpublichealth,andashavingasignificanteffect onindividualcountriesandtheirhuman,social,andeconomic capital(Wahlbeck,2015).IftheDepartmentofHealthinthe Philippineswould usethisapproach,thegovernmentwould viewthebottomlineoftheeconomiccrisisinadifferentlight. Realizingthiswouldprovideanewperspectivetomanaging theeconomy.

However,theunresponsivegovernancehasmadeFilipino peopleofallsocio-demographicprofilesdistrustthegovernment. Thisleadstoadisunitybetweenthetwogroups.According to Montagnoli(2019),uncertaintyanddistrustinfinancial andpolitical institutionscausedbyfinancialcrisesmayresult inpsychologicallossesthatshapedecisionmaking.These crisesexacerbatedisapprovalanddistrustinthePhilippine government.ThisiscontrarytotheexperiencesinNorthwestern Europe,whereindividualstrustandsociallyinteractwiththeir neighborhoods.Finland,forinstance,whichrankedhigheston measuresofmutualtrust,enjoysthesentimentthattheirlives andlivelihoodsareprotectedevenduringtimesofthepandemic (Hartetal.,2018;WorldHappinessReport,2021).

AsregardspsychiatricservicesprovidedinNorthwestern Europeancountries,thereare39to130psychiatricbedsper 100,000inhabitantsandover80,000psychiatrists.Ofthese countries,thosewiththehighestnumbersofpsychiatristswere Germany(27per100,000inhabitants),Finland(24per100,000), theNetherlands(23per100,000),andSweden(23per100,000) (Eurostat,2020).However,suicideandmentaldisordersstill existinthesecountries.In2015,itwasreportedthatthere were56,000deathsduetosuicideintheEuropeanUnion.And, amongNorthwesternEuropeancountries,Belgiumrecordedthe highestsuiciderate(17per100,000population)whileDemark recordedthelowest(10per100,000)(Eurostat,2018).The prevalence ofmentaldisordersarealsoveryhighinEurope, whereFinland(18,800per100,000)andtheNetherlands(18,600

per100,000)rankedthehighestinthecontinent.InallEuropean countries,especiallyinNorthwesternEurope,themostcommon mentalhealthproblemisanxietydisorder(25millionpeople), followedbydepressivedisorders(21million),alcoholanddrug usedisorders(11million),bipolardisorders(5million),and schizophrenia(1.5million)(OECD/EuropeanUnion,2018).It certainly appearsthatmentalhealthproblemsaresignificantly moreprevalentinNorthwesternEuropeancountriesthaninthe Philippines.However,thisisprobablybecausementaldisorders gounderdiagnosedinthePhilippinesowingtolackofmental healthprovidersandfacilitiesinthecountry.

Moreover,theeconomicandsocialburdenofmentalillnesses, unemployment,andworkerproductivitylossesamountto over600billionEurosor4%ofthegrossdomesticproduct (GDP)across28Europeancountries.Thegovernmenthas alreadyspentaroundthree-quartersofitshealthfunds,andthe country’snationalbudgetmaybeaffectediflargehealthcare spendingcontinues.Therewouldalsobechallengesonthe fiscalsustainabilityofhealthandlong-termcaresystems. Forthesereasons,healthsectorshavemademajorstridesto promotegoodmentalhealthandtopreventmentalillnesses. Moreover,manymoreEuropeancountrieshaveensuredthe implementationofcomprehensiveplansandpoliciesthataddress mentalhealthpromotionandsuicideprevention.TheEuropean MentalHealthActionPlan2013-2020isstrongevidenceofthis (OECD/EuropeanUnion,2018)andthefruitsoftheseeffortsare manifestedby theirfavorableSWBscores(DeNeveandSachs, 2020)and bythefindingsofthe WorldHappinessReport(2021) ThearchitectsofthementalhealthprogramoftheWHOin Europe,itsmemberstates,andtheirpartnersworkedtogether todevelopandimplementmentalhealthpoliciesandlegislations thatreflectthevisionoftheWHOthatthereis“nohealthwithout mentalhealth”(WorldHealthOrganization—EuropeanRegion, 2018).If thePhilippineswerealsotoendeavortowardthissense ofsolidarity, there,too,wouldbeimprovementsinthehealthcare systemthatwouldsendripplesthroughouttheeconomy.

Althoughtherewereyearsofslowhealtheconomicgrowth acrossEuropefollowingtheeconomiccrisisin2008,nearlyall Europeancountrieswereabletoriseinrecentyears.Yet,there arevariationsobservedinthelevelandgrowthofhealthspending acrossEurope.Forinstance,high-incomeEuropeancountries, suchasLuxembourg,Norway,andSwitzerland,havethehighest healthexpenditurespercapitaatEUR4,713(approximately USD5715intoday’sexchangerates),whileRomania(EUR 983orUSD1,192)andBulgaria(EUR1,234orUSD1,496) havethelowest(OECD/EuropeanUnion,2018).Nevertheless, themental healthexpenditurepercapitainEuropeishigher thanallothercountriesatEUR17.89(USD21.70).Also,77% ofthecountriesinEuropehavestand-alonementalhealth laws,while64%ofthemhaveupdatedtheselegislationssince 2013.Meanwhile,inthePhilippines,mentalhealthandother economicproblemsarehardlyaddressedbecauseofundeveloped mentalhealthlegislations,plansandpolicies(WorldHealth Organization, 2018a),andannualnetfiscalloss(Department ofFinance,2021). Eventhoughthecountry’sCurrentHealth Expenditure(CHE) reached792.6billion(USD16.5billion)in 2019,10.9%higherthan714.8billion(USD14.9billion)in 2018,thetotalmentalhealthexpenditureperpersonisonly

12.19(USD0.25).Thisisonly1/87thatofEurope.Moreover, only0.22%of thegovernment’stotalexpenditureisallottedto mentalhealth.ThebulkoftheCHEwasspentonhospitals (43.6%),followedbypharmacies(30.3%),andprovidersofhealth caresystemadministrationandfinancing(7.4%).Therearealso stand-alonelawsandpoliciesformentalhealthinthecountry buttherearenoreportsthatmonitortheirimplementation. Neitherarethereauthoritiesthatassessthecomplianceofmental healthlegislationsinthePhilippineswithinternationalhuman rights(WorldHealthOrganization—AssessmentInstrumentfor MentalHealthSystems,2007;PhilippineStatisticsAuthority, 2020).Evidently,mentalhealtheconomistsareneededtobest resolvethementalhealthissuesofthecountry. Mentalhealthisnotwell-establishedinthePhilippines becauseofthedearthofinvestmentschanneledtowardresearch. Thus,Filipinomentalhealthworkerscannotfullyutilizetheir skillsduetooutdatedpracticeguidelinesandinappropriate curricula(Palaganasetal.,2017)unlikeinEuropewhereguidance oneconomic crisesandmentalhealtharebasedoncarefully reviewedresearch(Carrascoetal.,2016).Theimplementationof communitymental healthservicesarealsobasedonempirical clinicalevidence.Throughthis,theyareabletorecognizegaps thatexistbetweentheneedsofthepopulationandactual serviceprovision(Semrauetal.,2011).Thiscommitmenthas ledtotechnologicalinnovationssuchase-MentalHealthafter evaluatingtheefficacyofdeliveringmentalhealthservices (Gaebeletal.,2020).

DISCUSSION

Thusfar,thePhilippineMentalHealthActhasbeennothing morethan“justanact.”Nonetheless,thereisstillhopethat theprovisionofmentalhealthcarewillberecognizedasa significantneedtoamelioratelifeandeconomy.However, gradualchangeshouldbeginwithnormsingrainedinculture beforegovernmentalreformscouldbeenjoyed,asthese,too,are productsofsocialnormsthemselves.Moreover,socialstigmaand discriminationarethetoxictraitsthatmisshapeFilipinoculture.

Furthermore,thisisthetimetodroptheromanticizationof FilipinoresiliencybecausethetruthisthattheaverageFilipino isnotgenuinelyhappy.ApictureofasmilingFilipinodoesnot equatetoahappyFilipinobecausethementallyillknowhowto smiletoo.ThePhilippinesisadevelopingcountrythatstruggles toobtaineconomicstabilitybecauseofoutdatedwaysthatresult ingapsinmentalhealthpromotion,whichinturn,bleedinto theeconomy.Theincreasingprevalenceofmentalillnessesbears agreatimpactonhuman,social,andeconomiccapital.This maybetruenotonlyinthePhilippines,butalsoinother developingcountries.Moreover,depressionandanxietyshould berecognizedasdisorders,notmereillusions.Familiesmust belistenersandcomfortersofthementallyill,notcastigators. Filipinosmustalsounderstandthatthereisacomplexprocess inmanagingmentalhealthissuesandfullrecoverycouldnotbe achievedoverashortperiodoftime.

ThisarticleisacallforFilipinostoviewmentalhealthissues inadifferentlightandtoimpelgovernmentandpublicsectorsto

prioritizethemandtosetthePhilippineMentalHealthActinto motion.Belowisaprescriptionfortherealizationofamentally healthyPhilippines.

First,mentalhealthprofessionalsmustbemobilizedto educatefamiliesaboutmentalhealthandmentaldisordersto eliminatestigmaanddiscrimination.Theymustparticipatein andcontributetothedevelopmentofmentalhealthpolicyand servicedeliveryguidelines.Andveryimportantly,“familygroup conferencing”skillsshouldbeincludedinthetrainingand practiceofpsychiatry.

Second,sincementaldisordersusuallybegininadolescence, muchattentiononthementalhealthofindividualsinthis agegroupmustbegiven.Suicideintervention,prevention,and responsestrategieswithparticularattentiontotheconcernsof theyouthshouldbeimplemented.

Third,thequalityofmentalhealthservicesshouldbe basedonthefindingsofmedicalandscientificresearch.By doingso,acomprehensiveandeffectivementalhealthcare systemcouldbedevelopedandestablishedtoprovidethe psychological,psychosocial,andneurologicneedsoftheFilipino. Familymembersshouldalsobeencouragedtoparticipate inresearch,informulatinganddevelopingmentalhealth policies,andinpromotingmentalhealthintheworkplace andcommunities.

Andfinally,becausesuicideandsubstanceabusecontinueto beprevalentinthecountry,itwouldbebestforlegislatorsto reviewtheMentalHealthActinordertoidentifyanylapsesin thelawforitsimprovement.

Throughtheseefforts,wehopethatthePhilippineMental HealthActwouldbeabletoeffectuatehappiness,contentment, andhealthiersocialrelationships.Thesewillbegoodnotonlyfor thementalhealthoftheindividual,butalsoforthosearoundhim orher.ThementallyhealthyFilipinopopulationthatemerges throughthesechangescouldreversetheeffectsoffinancialcrises, unresponsivegovernanceandunproductivityinthecountry.The economywillcontinuetogrow,employmentandsalarieswill increase,andFilipinoswillnolongerneedtomigrateabroadto seekgreenerpastures.

Asearliermentioned,MHEisasubjectthatcriesoutfor explorationinthePhilippines.Alas,here,mentalhealthandthe economyareconsideredtobetwoseparateconceptsthatappear toexcludeeachother.Bethatasitmay,wehopethatthisarticle sparksconversationsthatwilldrawtheindubitableconnection betweenthesecorrelatedconceptsinacademe,government,and industry.Wehopethatitbecomesadisciplineinitselfand investigationsinthedisciplinearecarriedoutforthegood ofthecountry.Wehopethatthispaperwouldinterestfuture researcherstolookintoverifyingtheconverseoftheseemingly intuitiveideathatahealthyeconomymakespeoplehappyasitis ourbeliefthathappypeoplewillmakeoureconomyhealthy.

AUTHORCONTRIBUTIONS

Conceivedthework:MTandNM.Draftedthearticle:NM. Criticallyrevisedthemanuscript:MT.Bothauthorsreadand approvedthefinalmanuscript.

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ConflictofInterest: Theauthorsdeclarethattheresearchwasconductedinthe absenceofanycommercialorfinancialrelationshipsthatcouldbeconstruedasa potentialconflictofinterest.

Copyright©2021MaravillaandTan.Thisisanopen-accessarticledistributed underthetermsoftheCreativeCommonsAttributionLicense(CCBY).Theuse, distributionorreproductioninotherforumsispermitted,providedtheoriginal author(s)andthecopyrightowner(s)arecreditedandthattheoriginalpublication inthisjournaliscited,inaccordancewithacceptedacademicpractice.Nouse, distributionorreproductionispermittedwhichdoesnotcomplywiththeseterms.

published:01July2021 doi:10.3389/fpubh.2021.693743

Editedby: AndrzejKlimczuk, WarsawSchoolofEconomics,Poland

Reviewedby: FilipeVieiraSantosDeAbreu, InstitutoFederaldeEducação,Ciência eTecnologiaDoNortedeMinas Gerais(IFNMG),Brazil VeikkoIkonen, VTTTechnicalResearchCentreof FinlandLtd,Finland

*Correspondence: LuizCarlosJuniorAlcantara luiz.alcantara@ioc.fiocruz.br

FernandaKhouriBarreto fernanda.khouri@hotmail.com

†Theseauthorshavecontributed equallytothiswork

Specialtysection: Thisarticlewassubmittedto PublicHealthPolicy, asectionofthejournal FrontiersinPublicHealth

Received: 11April2021

Accepted: 07June2021 Published: 01July2021

Citation: GiovanettiM,AlcantaraLCJ, DoreaAS,FerreiraQR, MarquesWdA,JuniorFrancade BarrosJ,AdelinoTER,TostaS, FritschH,IaniFCdM,Mares-GuiaMA, SalgadoA,FonsecaV,XavierJ, LopesEN,SoaresGC,Castro AmaranteMFd,AzevedoV,KrugerA, CorreaMattaG, Paineiras-DomingosLL,ColonnelloC, BispodeFilippisAM,MontesanoC, ColizziVandBarretoFK(2021) PromotingResponsibleResearchand Innovation(RRI)DuringBrazilian ActivitiesofGenomicand EpidemiologicalSurveillanceof Arboviruses. Front.PublicHealth9:693743. doi:10.3389/fpubh.2021.693743

PromotingResponsibleResearch andInnovation(RRI)DuringBrazilian ActivitiesofGenomicand EpidemiologicalSurveillanceof Arboviruses

MartaGiovanetti 1,2†,LuizCarlosJuniorAlcantara 1,2*†,AlfredoSouzaDorea 3 , QesyaRodriguesFerreira 4,WilliandeAlmeidaMarques 1,JoseJuniorFrancadeBarros 5 , TalitaEmileRibeiroAdelino 2,6,StephaneTosta 2,HeggerFritsch 2 , FelipeCamposdeMeloIani 2,6,MariaAngélicaMares-Guia 1,AlvaroSalgado 2 , VagnerFonseca 2,JoilsonXavier 2,ElissonNogueiraLopes 2,GilsonCarlosSoares 2 , MariaFernandadeCastroAmarante 7,VascoAzevedo 2,AlíciaKruger 8 , GustavoCorreaMatta 9,LaisaLianePaineiras-Domingos 10,ClaudiaColonnello 11 , AnaMariaBispodeFilippis 1,CarlaMontesano 12,VittorioColizzi 12 and FernandaKhouriBarreto 4*

1 LaboratóriodeFlavivírus,InstitutoOswaldoCruz,FundaçãoOswaldoCruz,RiodeJaneiro,Brazil, 2 LaboratóriodeGenética CelulareMolecular,InstitutodeCienciaBiologica(ICB),UniversidadeFederaldeMinasGerais,BeloHorizonte,Brazil, 3 InstituiçãoBeneficenteConceiçãoMacedo,Salvador,Brazil, 4 InstitutoMultidisciplinaremSaúde,UniversidadeFederalda Bahia,VitóriadaConquista,Brazil, 5 LaboratóriodeVirologiaMolecular,InstitutoOswaldoCruz,FundaçãoOswaldoCruz,Rio deJaneiro,Brazil, 6 LaboratórioCentraldeSaúdePública,FundaçãoEzequielDias,BeloHorizonte,Brazil, 7 Laboratóriode DesenvolvimentodeVacinas,UniversidadedeSãoPaulo,SãoPaulo,Brazil, 8 DepartamentoNacionaldeIST/AIDS/Hepatites Virais,Brasília,Brazil, 9 EscolaNacionaldeSaúdePúblicaSergioArouca,InstitutoOswaldoCruz,FundaçãoOswaldoCruz, RiodeJaneiro,Brazil, 10 DepartamentodeFisioterapia,InstitutodeCiênciasdaSaúde,UniversidadeFederaldaBahia, Salvador,Brazil, 11 LaboratoriodiScienzedellaCittadinanza,Rome,Italy, 12 DepartmentofBiology,UniversityofRomeTor Vergata,Rome,Italy

Keywords:responsibleresearchandinnovation,Horizon2020,publichealth,technologicalinnovation,education

Scientificadvanceshavebeenaccompaniedbygreatachievementsandalsogreatsocietal expectationswithrespecttoresearchandinnovation.Infact,thescientificscenarioisreconfiguring itself.Ifresearchwaspreviouslylimitedtoacademy,nowitispresentincompaniesandhasadirect relationshipwitheconomicsandpolitics,playinganimportantroleonsocialissuessuchasgender, accessibility,andopportunities(1).

Inthis sense,someworldmovementsareemerging,astheOpenScienceandtheResponsible ResearchandInnovation(RRI)(2, 3).Thesemovementsaretransformingscientificpractice, integratingand aligningtheinterestsbetweenscienceandtechnology,societyandenvironment. Themainaimistoexpandthenumberofagentsthatthinkandexecutetheseideas,inadditionto promotinggreateraccessibilitytotheresultsofscientificresearchand,consequently,performinga morepopularscience(4).

TheEuropean CommissiondefinesRRIas“aprocessforbetteraligningresearchandinnovation withthevalues,needsandexpectationsofsociety.Itimpliesclosecooperationbetweenall stakeholdersinvariousstrandscomprisingscienceeducation,accesstoresearchresultsandthe applicationofnewknowledgeinfullcompliancewithgenderandethicsconsiderations.”In practice,theRRIsearchfor“sciencewithandforsociety”andisguidedbyeducationasapromoter ofscientificpropagation(5).Actually,theinformationitselfisnotthesameofausefulandcritical knowledge.Tobecomeknowledge,itisnecessarytodisseminatetheinformation,alwaysbasedon openaccess.Inthissense,continuedtrainingandthedisseminationoftechnologyareessentialfor

agrowingrangeofprofessionalstobringresearchandinnovation toplaceswhereopportunitiesareusuallyscarce.Inaddition,the popularizationofscienceandtechnologyprovidesanincreasein interestinissuesthatareusuallyawayfromroutine,suchasthe genomicandepidemiologicalsurveillance(1, 4).

Currently,the genomicandepidemiologicalsurveillanceof arbovirusesseemstoplayacrucialroleinBraziliancontext. Seasonallyoutbreaksofdengue,chikungunya,zika,andyellow feveroccursinBrazil,disproportionatelyaffectingthepoorest populationandoverwhelmedthepublichealthsystem(6). Couplinggenomicdiagnosticsandepidemiologytoinnovative digitaldiseasedetectionplatformsallowedanopen,global anddigitalviralpathogensurveillancesystem(7 10).Inthis context, consideringviralpathogensurveillanceinmind,realtimesequencing,bioinformaticstoolsandthecombinationof genomicandepidemiologicaldatafromviralinfectionscan giveessentialinformationforunderstandingthepastandthe futureofanepidemic,makingpossibletoestablishaneffective surveillanceframeworkontrackingthespreadofinfections toothergeographicregions.Theseactionscanbeevenmore relevantifcarriedoutinconjunctionwitheducationalactions, suchastechnologytransferandtrainingcourses.

Inthissense,inordertoassisttheBrazilianMinistryofHealth (BMoH),wecarryoutareal-timegenomicmonitoringofthe arboviruscirculatingandco-circulatinginBrazil,duringthe 2016–2020epidemics,applyingtheRRIconcepts.Theseconcepts involvefiveprincipalkeys:(i)Gender;(ii)OpenAccess;(iii) Education;(iv)PublicEngagement;and(v)Ethics.Thefollowing strategieswereestablished:(i)ateambasedonachievinggender equality(theteamcomprised24peopleofwhich12maleand 12female);(ii)anopenaccessdatabasetomakedataavailable assoonastheywereproduced;(iii)technologytransferand capacitybuildingforthehealthworkerstotrackthespreadof emergingviralpathogens;(iv)thepublicationsoftheobtained resultsinlocalandinternationalopenaccessjournalstomake availablefinaldataforthescientificcommunityandthegeneral population;and(v)allstepswerecarriedoutbasedonthe applicationoffundamentalethicalprinciplesandlegislationto scientificresearch(Figure1).Ourreal-timegenomicactivities startedin2016whenBrazilandtheAmericasexperienced theemergingofanewinternationalconcerntheZikavirus infection.AtthattimeincollaborationwithNationaland Internationalinstitutionswestartedoursequencingmissionin NortheastBrazil.Duringthisproject,calledZiBRA(Zikain BrazilRealTimeAnalysis),wewerecapacitatedontheuseof thenanoporesequencing,togetmoreinsightregardingthe dispersiondynamicsofthisemergingviraltreatinBrazil.Usinga mobilelabin15workingdayswegenerateasubstantialnumber ofcompleteandnearcompleteZIKVgenomesandalldatawere alsosharedinrealtimeonafreeonlinewebsiteplatform(http:// www.zibraproject.org)(11).

Consideringthe successobtainedusingthisnoveltechnology wedecidedtoextendthoseactivitiestotracktheemergence andthere-emergenceofotherviralpathogenscirculatingin BrazilandAmericas(https://www.zibra2project.org).Forthis purpose,welunchedthesecondphaseofthosereal-timegenomic activities,calledZIBRA-2project,wherewecharacterizedallthe

arbovirusescurrentlycirculatingandco-circulating,including ZIKV,chikungunyavirus(CHIKV),denguevirus(DENV)and yellowfevervirus(YFV).

WeinvestigatedthespreadoftheCHIKV— East/Central/South/Africangenotype(CHIKV-ECSA)in differentBrazilianregions(North,SoutheastandSoutheast),as wellaswefollowedthespreadofZIKVintheAmazonregion (12 14).Between2016and2018wewerealsofullydedicated totrack there-emergenceofYFVinSoutheast,Brazil.In thiscontext,weextendedourreal-timegenomicsurveillance activitiestounderstandtheoriginsofthisoutbreakfirstly detectedinthestateofMinasGeraisandthenfollowtheYFV spreadinginothersoutheastern(RiodeJaneiro,EspíritoSanto, andSãoPaulo)andNortheastern(Bahia).Thoseactivitiesgave usthepossibilitytogenerate200completeand/ornearYFV completegenomesequencesfromthoseregions,andhighlighted theimportanceofgenomics-basedmethodstoinfectiousdisease surveillanceandcontrol(9, 15).Duringtheseactivitieswe alsoappliedtheRRIconcepts,bytargetingpublichealthand higher-educationinstitutions.Wegenerateandanalyzemostof thedatainreal-timewithintrainingprograms,andweprovide aproof-of-conceptoftheuniqueopportunitiesthatportable sequencingtechnologiesofferforlocalcapacitybuilding.

In2019,wetakeadvantageoftheexperiencesobtainedand innovateduponsuchfieldsurveillanceinitiativesbyincluding real-timetrainingsessionsinthesurveillancescheduleunder 2formats:inthefield,usingamobilenanoporesequencing laboratoryinsideamotorhomefor17daysintheMidwest, trainingpersonnelfromlocalpublichealthlaboratories;and intheclassroom,undera2weekworkshop(BeloHorizonte city,Southeast)attendedbyalargenumberofparticipantsfrom publichealthlaboratoriesfromacrossLatinAmerica.

Thecoursehad62studentsfrom34nationalandinternational institutions(agerangeofparticipantsbetween25and50 ofwhichhalfofthemweremaleandhalffemale).In additiontopost-graduatestudents,courseparticipantsincluded laboratorytechniciansandhealthpractitionersinuniversities andlaboratoriesfromseveralinstitutionsresponsiblefor laboratory-basedsurveillanceofemergingandreemerging diseases,suchastheCentralPublicHealthLaboratoriesofthe BrazilianstatesfromtheBMoH’snetworkandpublichealth laboratoriesfromParaguay,Argentina,Panama,Chile,Mexico, Uruguay,CostaRica,andEcuador.Inbothformats,training includedallsurveillancetasks,fromsequencingtocomputational analysesandresearchwriting.Employinggenomicsurveillance inthefieldandintheclassroom,wegeneratedandanalyzed227 novelcompletegenomesequencesofDengue1–2(16).

Inorderto disseminatethoseexperiencesinourinstitution (FIOCRUZ),attheendof2019wepromotedthemeeting “StructuralTransformationsforResponsibleResearchand Innovation.”Duringthiseventwehadtheopportunityto discusswithresearchersandgraduatestudentswaystoapply theRRIconcepts,inadditiontoemphasizingtheneedof promotestructuralchangeinthisfield,inresearchinstitutions. ConsideringthatFiocruzismainlyinvolvedinproducing, disseminatingandsharingknowledgeandtechnologies,we hadnoproblemsinproposingmeasurestodisseminateRRI

conceptsintheinstitution.People,researcher,studentsinvolved werereally receptivetotrytocometogethertomakethose structuralchangeshappen.Itisimportanttonotethat,part oftheFiocruz’smission,asstatedbefore,ispromotingthe scientificdisseminationtothegeneralpopulation.Inthissense, weusedtoshareinnearlyrealtimealltheobtainedresults withthegeneralpublic,usingsocialmidia(videoandtelevision platforms)including:(i)YouTube,(ii)Twitter,and(iii)Brazilian openTVchannels(moredetailscanbefoundhere:https://www. zibra2project.org/zibra-press/).

Overall,thesurveillanceoutputsandtraininginitiativecarried outduringthoseactivitiesalsoservedasaproof-of-concept fortheutilityofreal-timeportablesequencingforresearch andlocalcapacitybuildinginthegenomicsurveillanceof emergingviruses.Morerecently,inMarch2020,theCoronavirus Disease2019(Covid-19)pandemic,causedbytheSevere AcuteRespiratorySyndromeCoronavirus2(SARS-CoV-2)virus, wasdeclaredbyTheWorldHealthOrganization(WHO).In February,theBrazilianMinistryofHealthconfirmedthefirst caseinthecountryandinApriltheLACENfromMinasGerais stateworkedincollaborationwithourteamtosequenceand analyze40completeSARS-CoV-2genomes(17).Thisworkcan beseenasanexampleoftheRRIimpactontheinteractions betweenscienceandsocietyinBrazilanddemonstratesthe importanceoftheRRIconceptsapplicationduringallresearch activitiesforsocialandhealthpolicy.Asimilarprojectof sequencingSARS-CoV2genomeshasbeenrequiredbythe MinistriesofHealthoftheRepublicofChadandoftheRepublic ofCameroon(CentralAfrica).Twooftheauthors(M.G.e V.C.)arereadytomovetoCentralAfricaforcapacitybuilding,

viralsequencesandbioinformaticstraininginthecontextofthe RRIapproach.

CONCLUSION

Thedatapresentedherereinforcetheneedforreal-timeand continuedgenomicsurveillancestrategiestobetterunderstand andpreparefortheepidemicspreadofemergingviralpathogens andfortifythatthisisonlypossiblethroughthespreadof scienceandtechnologycombinedwithsocialandenvironmental awareness.Thisimpliesharmreductionandintensificationof benefitsforsociety,theeconomyandtheenvironment,in additiontoequippingthescientificcommunitytoactmore quicklyintimesofcrisis.

TheparticipationinStructuralTransformationtoAttain ResponsibleBIOSciences(https://starbios2.eu),aEuropean projectthatreceivedfundingfromtheHorizon2020andaimsto implementtheRRIapproachinresearchinstitutions,provided uswiththeidealenvironmenttoreflectourresearchprojects,as wellasfacilitatesthepracticalinsertionofRRIintobioscience. Wehopethatthisreportcanhelpthescientificcommunityto promotestructuralchangesintheirresearch,inordertopractice anddisseminatetheResponsibleResearchandInnovation.

AUTHORCONTRIBUTIONS

MG,LA,andFB:conceptionanddesignanddraftpreparation. MG,LA,AD,QF,WM,JJ,TA,ST,HF,FI,MM-G,AS,VF, JX,EL,GS,MC,VA,AK,GC,LP-D,CC,AB,CM,VC,and

FIGURE1| llustrativediagramrepresentingthestrategyusedtoimplementRRIconceptsduringreal-timegenomicsurveillanceactivitiesofcirculatingarboviruses carriedoutinBrazil. (A) Timelineshowingthestrategysteps. (B) TheRRIprinciplesappliedduringtheresearch.

FB:methodology.LA:resources.Allauthorscontributedtothe articleandapproved thesubmittedversion.

FUNDING

ThisresearchwasfundedbyEuropeanUnion’sHorizon 2020,grantnumber709517(STARBIOS2).Allactivitieswere supportedbyDecit,SCTIE,BrazilianMinistryofHealth, ConselhoNacionaldeDesenvolvimentoCientífico-CNPq (440685/2016-8),CoordenaçãodeAperfeiçoamentodePessoal deNívelSuperior-CAPES-(88887.130716/2016-00),innovation ProgrammeunderZIKAllianceGrantAgreementno.734548and byPan-AmericanHealthOrganization(SCON2018-00572).MG andLAwassupportedbyFundaçãodeAmparoàPesquisado EstadodoRiodeJaneiro(FAPERJ).TheLaboratóriodeFlavivirus wassupportedbyFaperj(FundaçãoCarlosChagasFilhode AmparoàPesquisadoEstadodoRiodeJaneiro)undergrant

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ConflictofInterest: Theauthorsdeclarethattheresearchwasconductedinthe absenceofanycommercialorfinancialrelationshipsthatcouldbeconstruedasa potentialconflictofinterest.

Copyright©2021Giovanetti,Alcantara,Dorea,Ferreira,Marques,JuniorFrancade Barros,Adelino,Tosta,Fritsch,Iani,Mares-Guia,Salgado,Fonseca,Xavier,Lopes, Soares,CastroAmarante,Azevedo,Kruger,CorreaMatta,Paineiras-Domingos, Colonnello,BispodeFilippis,Montesano,ColizziandBarreto.Thisisanopen-access articledistributedunderthetermsoftheCreativeCommonsAttributionLicense(CC BY).Theuse,distributionorreproductioninotherforumsispermitted,provided theoriginalauthor(s)andthecopyrightowner(s)arecreditedandthattheoriginal publicationinthisjournaliscited,inaccordancewithacceptedacademicpractice. Nouse,distributionorreproductionispermittedwhichdoesnotcomplywiththese terms.

published:25August 2021 doi:10.3389/fpubh.2021.718793

Editedby: MagdalenaKlimczuk-Kochanska, UniversityofWarsaw,Poland

Reviewedby: YanjunRen, LeibnizInstituteofAgricultural DevelopmentinTransitionEconomies (LG),Germany XiaoNongZou, CancerFounationofChina,China Bao-JieHe, ChongqingUniversity,China

*Correspondence: BoGao gaobo15@126.com

Specialtysection: Thisarticlewassubmittedto PublicHealthPolicy, asectionofthejournal FrontiersinPublicHealth

Received: 01June2021

Accepted: 04August2021 Published: 25August2021

Citation: MaTandGaoB(2021)The AssociationofSocialCapitaland Self-RatedHealthBetweenUrban ResidentsandUrbanizedRural ResidentsinSouthwestChina. Front.PublicHealth9:718793. doi:10.3389/fpubh.2021.718793

TheAssociationofSocialCapitaland Self-RatedHealthBetweenUrban ResidentsandUrbanizedRural ResidentsinSouthwestChina

TianpeiMa 1,2 andBoGao 2*

1 LaboratoryforAgingandCancerResearch,NationalClinicalResearchCenterforGeriatrics,WestChinaHospital,Sichuan University,Chengdu,China, 2 DepartmentofHealthRelatedSocialandBehavioralScience,WestChinaSchoolofPublic HealthandWestChinaFourthHospital,SichuanUniversity,Chengdu,China

Chinahasseenanacceleratedprocessofurbanizationinthepast30years.The influenceofurbanizationonhealthiscomplexandprimarilyinfluencedbychangesin socialcapital.Thepurposeofthisresearchwastocomparethesocialcapitalbetween urbanresidentsandurbanizedruralresidentsofsouthwestChinaanditsrelationship withself-ratedhealth.Itisofgreatsignificancetostudythedifferenceofsocialcapital betweenurbanandurbanizedruralresidentstohelpurbanizedruralresidentsimprove theirsocialadaptabilityandhealth.Datawascollectedfrom1,646residentsbetween NovemberandDecemberof2017inChengdu.Threelogisticregressionswereused toinvestigatetheassociationbetweensocialcapitalandself-ratedhealthbycontrolling fordemographicvariables,lifestylesfactors,andhealthstatusfactors.Weobservedthat urbanresidents’self-ratedhealthhadahigherproportionof“good”thanthatofurbanized ruralresidents(P = 0.017).Aftercontrollingforfactorssuchashealthstatusand demographiccharacteristics,participantswithhighersocialcapitalhadbetterself-rated health.Urbanizedruralresidentswithhighercommunitytrustandbelonginghadbetter self-ratedhealth(OR = 0.701,95%CI = 0.503∼0.978),howeverurbanresidentswith higherpersonalsocialnetworksandfamilyrelationshipshadbetterself-ratedhealth (OR = 0.676,95%CI = 0.490∼0.933andOR = 0.666,95%CI = 0.450∼0.987, respectively).Differenttypesofcommunitiesshouldfocusonthetypesofsocialcapital fromdifferentsources,soastotakemoretargetedmeasurestoimprovethesocial supportofresidentsandimprovetheirhealth.Improvingresidents’socialtrustand senseofbelongingmayhelpurbanizedruralresidentsbetteradapttothenewliving environmentandhelpthemcompletetheidentitytransformation.

Keywords:socialcapital,self-ratedhealth,urbanization,urbanizedruralresidents,SouthwestChina

INTRODUCTION

Inthepast30years,Chinahasseenanacceleratedprocessofurbanization(1).Ingeneral, urbanization isaformofmigrationofacountry’spopulationfromruraltourbanareas(2).The expansionof Chinesecitieshasbeendramatic.In2011,theproportionoftheurbanpopulation (51.3%)exceededthatoftheruralpopulationforthefirsttimeinhistory(3).In2020,China’s

urbanizationratehasreached63.9%.Duetotherapidityof urbanization, inmanyruralareasthathavebecomeurban districts.Theimpactofurbanizationonindividualhealth outcomeshasbothpositiveandnegativeconsequences.Onthe onehand,changesinlivingenvironmentandlifestyleareall relatedtotherapidgrowthofurbanization(4).Manyfactors, suchasdeterioratingairquality,increasedhigh-calorieintake, andreducedsocialinteractionwithneighbors,affectthehealth oftheresidents.Ontheotherhand,peopletendtohavebetter accesstoqualityhealthservicesandothercommunityresources, includinghealthinformation(5).Theinfluenceofurbanization onhealthiscomplexandprimarilyinfluencedbychangesin reciprocityandtrust,socialstructureandnetworks,whichare mentionedinmostdefinitionsofsocialcapital(6).

Socialcapitalhasbeendefinedas“thosefeaturesofsocial organizationthatfacilitatecooperationformutualbenefit,such astheextentofinterpersonaltrustbetweencitizens,normsof reciprocity,anddensityofcivicassociations”(7, 8).Moreand moreresearcheshavebeenconductedontheroleofsocialcapital onpersonalhealthinthesetwodecades(9).Astudybasedon datafrom 39statesinUSfoundthatlackofsocialcapitalwas stronglycorrelatedwithhighertotalmortality,deathrateofheart diseaseandinfantmortality(10).Moreover,areviewillustrates thattheassociationbetweensocialcapitalandpersonalhealth outcomemaydifferdependingonthespecificaspectsofsocial capitalbeingexplored(11).

Therearemany indicatorsforevaluatingthehealthof thepopulation,includingphysicalhealth,mentalhealthand diseasestatus.Variousassessmentsofhealthstatusfrequently askrespondentstoratetheiroverallhealthwiththecategories ofexcellent,good,fair,andpoor(12).Self-ratedhealthappears tohaveasignificant,independentassociationwithmortality risksinnumerousstudies,whenincludedmedical,behavioral, orotherhealth-relatedindicators(13).Ouetal.foundthat poorself-ratedhealthwasrelatedtoprematuremortalityand chronichealthconditions(14).Inaddition,self-ratedhealth issusceptible tomanyexternalfactors,suchasmaterial, psychosocial,behavioral,workplaceenvironmentalandsocial capital(15, 16).Asubstantialbodyofliteratureassessedon theassociationofsocialcapitalonindividuals’self-ratedhealth indevelopedcountries.Forinstance,Kawachiandcolleagues detectedacontextualeffectoflowsocialcapitalontherisk ofpoorself-ratedhealthamongUSresidents,aftercontrolling forcertainindividual-levelfactors,suchaslowincome,low education,smoking(7).Snelgroveshowedthataprotective relationshipwithcurrentself-ratedhealthandsocialtrustafter adjustingforindividualcharacteristics,baselineself-ratedhealth andindividualsocialtrustinBritain(17).Nevertheless,afew researchespaidattentiontotheinfluenceofsocialcapitalonselfratedhealthamongChineseresidents.Usingmultilevelanalysis, Mengetal.foundthattrustinsocialcapitalindicatorswas beneficialtoself-ratedhealthinChina(6).ResearchbyZhuet al.showed thatthereisinequalityinobjectivehealthoutcomes betweenthefloatingpopulationandlocalhypertensivepatients, butthereisnoinequalityinsubjectivehealthoutcomes(18). These studieshaveexaminedtherelationshipbetweensocial capitalandself-ratedhealthinurbanorruralareas.Takinginto

accounttheparticularityofChina’surban-ruraldualstructure, comparisonsbetweendifferentgroupsofpeoplemayhelpus betterunderstandtheimpactofsocialcapitalonChina’sselfratedhealth.

InthecontextofChina’surbanizationpolicy,thegovernment collectivelycollectsthefarmlandthatwasoriginallycultivated byruralresidentsinthevillagesaroundthecity.Theseresidents wereconcentratedintheapartmentcommunityandtheir householdregistrationstatuswasconvertedfromruraltourban (19).Thesearecalledurbanizedruralresidents(3).Theyleft theoriginal land andfacedtheproblemofre-establishinga livingcircle.Thelivesofthesepolicyimmigrantshavechanged inmanywayscomparedtotheiroriginallives.Therearethree mainchanges:first,theircareerswerenolongerfarmers.But becauseoftheirlowlevelofeducationandlackofnecessary workskills,thiscreatedaseriouseconomicburden.Second,the typeofsocialmedicalinsurancehadchanged.Thereweresome differencesinthepaymentstandard,reimbursementratioand reimbursementscopebetweenruralresidents’medicalinsurance andurbanresidents’medicalinsurance.Third,theirlivingspace changedfromscatteredbrickhousetosingle-familyhigh-rise apartments.Urbanizedruralresidentsmayexperiencechallenge duetochangesintheirlivingenvironmentandlifestyle.Asruralto-urbanmigrationmayinfluencemigrants’healthorwell-being byexposingtonewenvironmentalriskandbenefits,stimulating changesinpatternsofbehaviorandconnectionofsocialnetwork, andprovidingaccesstoresourceswhichwereunavailableatthe originalplace(20, 21).Inthenewlivingenvironment,howto helpthem establishnewsocialconnectionsandsocialsupport andimprovetheirhealthlevelhasbecomeanurgentproblemto besolved.

However,inthebackgroundofChina’surbanization development,empiricalevidenceontherelationshipbetween socialcapitalandself-ratedhealthisverylimited(22).This studymainlyaddressestwoobjectives:first,tostudythehealth statusofurbanizedruralresidentsandthedifferencesamong urbanizedruralresidentsandurbanresidents.Second,toexplore thedifferencesintherelationshipbetweensocialcapitaland self-ratedhealthofthesetwogroups?

MATERIALSANDMETHODS

StudySetting

Ourcross-sectionalstudywasconductedbetweenNovemberand Decemberof2017.Theface-to-facequestionnairesurveywas conductedinthecommunityofChengdu,whichisoneofthe mostdevelopedcitiesinSouthwestChina.Astheurbanization speedofChengducitycontinuestoaccelerate,alargenumber ofurbanizedruralresidentsswarmintothecity,whichposes manychallengestourbanmanagement.Meanwhile,italso providesagoodopportunityandconditionsforustostudy itssocialcapitalandhealthstatus.Since2004,Chengduhas transferredanaverageofnearly200,000farmerstocitiesand townseachyear,andthecityhasbuiltatotalof630farmers’ concentratedresidentialareasandnewruralcommunities,witha totalareaofmorethan28millionsquaremeters(23).Urbanized ruralresidents areimportanthumanresourceintheprocessof

urbanization.Establishingandimprovingpublicservicessuchas education,culture,andmedicalcare,andtheold-agesecurity andemploymentsecuritysystemsareofgreatsignificanceto helpurbanizedruralresidentsbetterintegrateintourbanlife andpromotesocialequity.Chengdu’sreformexperiencehas importantimplicationsforurbanizationdevelopmentpoliciesin otherregionsofthecountry.

StudyParticipants

Theselectioncriteriafortherespondentswere:(1)15yearsof ageandolder;(2)residentswholivedintheselectedcommunity forhalfayearormore(toexcludesometemporarilyrented residents);(3)nomentalillnessandhearingimpairment,ableto expressthemselves;(4)respondentsmustanswerthequestions themselves;(5)urbanizedruralresident:theirlandwerelevied becauseoftheurbanizationpolicyandtheirruralhukou(official registration)wereconvertedintourbanhukouwithin15years. Urbanresidents:theirurbanhukouperiodweremorethan15 yearsbecauseofurbanplanning.

SamplingandSampleSize

Thesurveyusedamulti-stagestratifiedrandomsampling method.First,Chengduwasdividedintocentralurbanareas andsuburbsaccordingtoeconomiclevel,andonedistrictwas randomlyselectedinthecentralurbanareaandthesuburbs. Then,werandomlyselectedanurbanresidentialcommunity andanurbanizedruralresidentialresettlementcommunityin eachdistrict,anduniformlycodesthebuildingsintheselected community.Accordingtothefamily,wesurveyedalleligible familymemberspresentineachhousehold.

Wecalculatedthesamplesizeusingthefollowingformula: n = [µ2α/2π (1-π)]/δ2 (24),where π = 33.2%[which was2weekprevalencerateinthepopulationaged15andoverinthe fifthNationalHealthServiceSurveyofSichuanProvincein2013 (25)], δ = 1.5%(δ isthe allowableerror,determinedbythe researcherbasedonpreviousexperience), α = 0.05, µ2α/2 = 1.96.Basedonthisformula,thesamplesizewascalculatedto be1,739.Atotalof1,740communityresidentsweresurveyed face-to-facebytrainedinvestigators.Excludingquestionnaires withtoomuchmissinginformation,1,646validquestionnaires werefinallyobtained,andtheeffectiveratewas94.6%.Thestudy protocolwasapprovedbytheInstitutionalReviewBoardof SchoolofPublicHealth,SichuanUniversity.Informedconsent wasobtainedfromeachparticipantfollowingadetailexplanation aboutthepurposeofthestudy.

Variables

Thequestionnaireincludedthreeparts,(a)demographic characteristics,health-relatedfactors,andhealthstatus,(b)social capital,(c)self-ratedhealth.

DemographicCharacteristics,Health-Related Factors,andHealthStatus

Demographiccharacteristicsmainlyincludedgender,age, maritalstatus,education,income,andemploymentstatus. Health-relatedfactorswasconsideredtoincludethesequestions, “Areyoucurrentlysmoking?,”“Areyoucurrentlydrinking

alcohol?,”and“Howmanytimeshaveyouexercisedonaverage everyweekforthepast6months?.”Healthstatusofparticipants wasmeasuredbytwoindices,thepast2weeksofanydiseases, anddiagnosisofchronicdiseases(0 = No,1 = Yes).History ofchronicdiseasesincludedhypertension,diabetes,chronic bronchitis,chronicgastritis,coronaryheartdisease,rheumatism andotherdiseases.

SocialCapitalMeasurement

Thereisanongoingdebateabouthowtomeasuresocialcapital. Onthebasisofalargenumberoftheoreticalstudiesonsocial capitalintheearlystage,wereferredtodomesticandforeign measureinstruments(26, 27),andformedthissocialcapitalscale throughtheDelphimethod.Thequestionnaireofsocialcapital (see SupplementaryTable1)has23items,dividedintofive domains,PersonalSocialNetwork(SC1,4items),Interpersonal Support(SC2,4items),FamilyRelationship(SC3,5items), CommunityParticipation(SC4,3items),CommunityTrustand Belonging(SC5,7items).SC1mainlymeasuresthenumberof peoplewhoareclosetoeachotherindailylifeandeconomics, andthenumberofsocialactivitieswiththem.SC2represents thesupportofothers,forexample,“whenyouaresickor uncomfortable,canyoualwaysgetthecareofothers?”SC3 indicateswhetherfamilyrelationshipsareharmonious,including relationshipswithspouses,parents,andchildren.SC4measures theindividual’scommunityparticipation,suchas“Thenumber oftimesyouhaveparticipatedinacommunityactivityinthe lastyear.”SC5representstheindividual’ssenseofbelonging tothecommunityandthetrustofthecommunityresidents. Forexample,“Ifyouhavetomoveawayfromwhereyou livenow,doyoufeeluncomfortable?”(Specificitemsforthe SocialCapitalScaleandscoringmethodsareprovidedin SupplementaryTable1.)Theanswersconsistedof2-,4-,and 5-pointLikertscales,withthehigherscoreindicatingahigher levelofsocialcapital.Thesumofthescoresforallitemsin eachdomainwasthescoreforthatdomain.Eachrespondent’s SC1,SC2,SC3,SC4,andSC5scoresweredichotomizedbythe cutoffpointofthemedianofthecorrespondingsocialcapital scores:scoreslowerthanmedianscoresmeantlowsocialcapital. Thereliabilityofthisscalecanbeacceptable(Cronbach’salpha 0.681,SC1 = 0.539,SC2 = 0.602,SC3 = 0.609,SC4 = 0.411 andSC5 = 0.788).

Self-RatedHealth

Weusedanitemtoreflecttheself-ratedhealthofthe respondents:wouldyousaythatingeneralyourhealthis excellent,verygood,good,fair,orpoor?Fromthisquestion,we createdadichotomousoutcomemeasure(0 = excellent,very good,orgood;1 = fairorpoor)(7).

DataQualityControl

Duringthedatacollectionphase,undergraduateorgraduate studentswithamedicalbackgroundwereselectedas investigators,andtheyweretrainedintensivelybeforethe survey.Afterthedailysurvey,theinvestigatorcross-checked thequestionnaireonthatdayandsignedandconfirmedit.At

TABLE1| Characteristicsofthe participants.

Total(%)Urbanresidents(%)Urbanizedruralresidents(%) χ 2 P

Gender 18.498 <0.001**

Male 511(31.0) 315(35.6) 196(25.8)

Female 1,135(69.0) 570(64.4) 565(74.2)

Age(years) 23.089 <0.001**

<45 214(13.0) 147(16.6) 67(8.8)

45–54 422(25.6) 215(24.3) 207(27.2)

55–64 389(23.6) 209(23.6) 180(23.7) 65+ 621(37.7) 314(35.5) 307(40.3)

Maritalstatus 35.017 <0.001**

Single 100(6.1) 69(7.8) 31(4.1)

Married 1,294(78.6) 713(80.6) 581(76.3)

Divorced 35(2.1) 22(2.5) 13(1.7) Widowed 217(13.2) 81(9.2) 136(17.9)

Education 240.193 <0.001**

Primaryschoolandbelow 635(38.6) 218(24.6) 417(54.8)

Secondaryschool 473(28.7) 243(27.5) 230(30.2) Highschool 297(18.0) 219(24.7) 78(10.2) Collegeandabove 241(14.6) 205(23.2) 36(4.7)

Personalmonthlyincome(CNY)

<2,000 965(58.6) 348(39.3) 617(81.1)

2,000∼ 230(14.0) 174(19.7) 56(7.4)

3,000∼ 184(11.2) 141(15.9) 43(5.7)

4,000+ 267(16.2) 222(25.1) 45(5.9)

297.404 <0.001**

Employmentstatus 223.205 <0.001**

Employed 470(28.6) 309(34.9) 161(21.2) Retired 464(28.2) 341(38.5) 123(16.2) Unemployed 712(43.3) 235(26.6) 477(62.7) **

thedatacollationandanalysisstage,theverifiercleanedupthe databaseanddeletedmissingrecords.

StatisticalAnalysis

ThedatabasewassetupwithEpiData3.0(Denmark).Descriptive statisticswereusedtoillustratedemographiccharacteristics ofparticipants.Andweusedchi-squaretesttoundertakean analysisofparticipants’socialcapitalbyeachindicatorof demographiccharacteristics.Logisticregressionwasusedto describetherelationshipbetweensocialcapitalandself-rated healthbycontrollingfordemographicvariables.Inthefirst model(Model1),oddsratios(ORs)and95%confidenceintervals (95%CIs)werecalculatedfortherelationshipoffivedimensions ofsocialcapitalandself-ratedhealth.Model1onlyincluded fivedimensionsofsocialcapitalasindependentvariables.In thesecondmodel(Model2),theOR(95%CI)wasadjusted bycontrollingfordemographicvariables,includinggender,age, education,maritalstatus,income,employmentstatus.Thethird model(Model3)controlledthehealth-relatedfactorsandhealth statusbasedonModel2,includingsmoking,drinking,physical exercise,thepast2weeksofanydiseases,andchronicdiseases. Weusedtheforwardmethodtofiltervariables.Thesocialcapital contentswerealsoconsideredinModel2andModel3.We usedtheforwardmethodtofiltervariables. Tables3, 4 showed

thevariablesthateventuallyenterthemodel.Thegoodnessof fitaboutthesemodelswereestimatedbyHosmer-Lemeshow test(see SupplementaryTable5).Allstatisticalanalyseswere performedwithIBMSPSS21.0.P<0.05wasconsideredto indicateastatisticallysignificantdifference.

RESULTS

CharacteristicsoftheParticipants

Thedescriptiveinformationof1,646participantswerepresented in Table1.Therewere885urbanresidents(53.8%)and761 urbanizedruralresidents(46.2%).Theaverageageofurban residentsandurbanizedruralresidentswas55.6years(SD = 16.9)and58.7years(SD = 14.9).Morethanhalfofthe respondentswerewomen.Thevastmajorityoftheparticipants weremarried(80.6and76.3%,respectively).Urbanizedrural residentsreportedlowereducationlevelsandincomethanurban residents.Morethanhalfoftheurbanizedruralresidentswere unemployed(62.7%).

TheDistributionofHealth-RelatedFactors, Self-RatedHealthandSocialCapital

Thecurrentsmokinganddrinkingbehaviorwerenot significantlydifferentbetweenthetwogroupsofparticipants

TABLE2| Thedistributionof health-relatedfactors,self-ratedhealthandsocial capitalbetweenurbanresidentsandurbanizedruralresidents. Urban residents (%)

Urbanized ruralresidents (%)

χ 2 P

Currentsmoker

0.2620.626 No 698(78.9)608(79.9) Yes 187(21.1)153(20.1)

Currentdrinker 1.0280.322 No 701(79.2)618(81.2) Yes 184(20.8)143(18.8)

Exercise/week(times) 6.6350.036* 6+ 550(62.1)518(68.1) 1∼5 153(17.3)105(13.8) <1 182(20.6)138(18.1)

Chronicdisease 4.1470.045* No 587(66.3)468(61.5) Yes 298(33.7)293(38.5)

Illwithinthepast2 weeks 3.9450.047* No 604(68.2)484(63.6) Yes 281(31.8)277(36.4)

Self-ratedhealth 5.8230.017* Good 626(70.7)496(65.2) Bad 259(29.3)265(34.8)

SC1 0.9230.348 High 443(50.1)399(52.4) Low 442(49.9)362(47.6) SC2 1.6270.213 High 484(54.7)440(57.8) Low 401(45.3)321(42.2) SC3 5.5890.019* High 520(58.8)403(53.0) Low 365(41.2)358(47.0) SC4 2.4540.125 High 475(53.7)379(49.8) Low 410(46.3)382(50.2)

SC5 15.131 <0.001** High 408(46.1)424(55.7) Low 477(53.9)337(44.3) * P < 0.05, ** P < 0.001.SC1:PersonalSocialNetwork,SC2:InterpersonalSupport, SC3:FamilyRelationship,SC4:CommunityParticipation,SC5:CommunityTrustand Belonging.Usethemedianasacriterionfordividinghighandlowgroupofsocialcapital.

(P > 0.05),whileitseemedbetterforurbanizedruralresidents toparticipateinphysicalexerciseeveryweek(P = 0.036).It canbeseenfromthechronicdiseaseand2-weekillnessthatthe healthstatusofurbanresidentswasbetterthanthatofurbanized ruralresidents(Table2).Thedistributionofself-ratedhealth wasdifferentbetweenurbanresidentsandurbanizedrural residents(P = 0.017).Theself-ratedhealthofurbanizedrural residentswasworsethanthatofurbanresidents.Bycomparing thefivedimensionsofsocialcapital,itshowedthattheurban residentshadbetterfamilyrelationships(P = 0.019).However,

thecommunitytrustandsenseofbelongingofurbanizedrural residentswashigher(P < 0.001).

AssociationsBetweenSocialCapitaland Self-RatedHealth

Thelogisticregressionmodelswereestablishedwithself-rated healthasthedependentvariable,socialcapital,demographic characteristicsandhealthstatusfactorsasindependentvariables. Aftertesting,theVIFvaluesbetweensocialcapitalandother socio-economicfactorswere <10,andtherewasnocollinearity betweenthevariables.Therelationshipsbetweensocialcapital andself-ratedhealthindifferentlogisticregressionmodelsare presentedin Tables3, 4 amongurbanizedruralresidentsand urbanresidents.Forurbanizedruralresidents,higherSC5was significantlyassociatedwithself-ratedhealthinModel2and Model3(OR = 0.676,95%CI = 0.491∼0.931andOR = 0.701,95%CI = 0.503∼0.978,respectively).Forurbanresidents, SC1wassignificantlyassociatedwithself-ratedhealthallthree models.PeoplewithhigherSC1hadbetterself-ratedhealthin Mode1(OR = 0.683,95%CI = 0.505∼0.923),Model2(OR = 0.669,95%CI0.487∼0.918),andModel3(OR = 0.676,95%CI = 0.490∼0.933).Inaddition,SC3wasalsoprotectivefactorsafter controllingvariablesofdemographiccharacteristicsandhealth status(OR = 0.598,95%CI = 0.407∼0.878inModel2andOR = 0.666,95%CI = 0.450∼0.987inModel3).

DISCUSSION

Thisresearchisdedicatedtoexploringsocialcapitalamong urbanresidentsandurbanizedruralresidentsofWestChinaand itsrelationshipwithself-ratedhealth.

Inthepast10years,China’surbanizationprocesshasbeen veryrapid,andChengduisalsoundergoingaprocessofrapid urbanization.Chengdu,thecapitalcityofSichuanProvince, hasapopulationof17millionpermanentresidents,ofwhich nearly2millionaremigrants.Atpresent,theurbanizationrate inChengduis71.9%(28).Urbanizedruralresidentsdonothave urban hukouorhaveobtainedurbanhukouinrecentyears. Theurbanhealthservicefacilitiesandsubsidizedhealthcare werebetterthantheruralareasundertheurban-ruraldual structure(29).Wefoundthaturbanresidentsandurbanized ruralresidents havestatisticallysignificantdifferencesin2weekillness,chronicdisease,andself-ratedhealth.Thehealth statusofurbanresidentswasbetterthanthatofurbanizedrural residents.Andurbanizedruralresidents’self-ratedhealthhad alowerproportionof“good.”Manyliteratureshavereported thatsocioeconomicstatus(30),healthstatus(31),health-related behaviors(32),socialcapital(33)andotherfactorsmayhave animpact onself-ratedhealth.Thedifferencesbetweenthese twotypesofresidentsmaycausedifferencesintheirown healthassessments.

Byinvestigatingthesocialcapitalofresidents,wefoundthat thecommunitytrustandbelongingofurbanizedruralresidents werebetterthanthoseofurbanresidents.Itshowedthatthese participantshadmaintainedtheoriginalcommunitycontact, andtheresettlementcommunitywasmostlyanacquaintance.

TABLE3| Associationsofsocial capitaltoself-ratedhealthamongurbanizedruralresidents.

Model1 Model2 Model3

OR95%CI P OR95%CI P OR 95%CI P

SC1(Low)

High 1.0830.792,1.4810.6171.0560.770,1.4480.7361.0850.781,1.5070.626

SC2(Low)

High 0.8210.598,1.1280.2230.7740.560,1.0680.1190.7780.557,1.0880.142

SC3(Low)

High 0.7750.568,1.0560.1070.8720.627,1.2120.4130.9510.674,1.3410.775 SC4(Low)

High 1.1150.821,1.5150.4871.1130.816,1.5190.4971.1190.810,1.5470.495 SC5(Low)

High 0.7400.542,1.0120.0600.6760.491,0.9310.017*0.7010.503,0.9780.036* Age(<45)

45-54

1.6910.872,3.2800.1201.3520.688,2.6570.381 55∼64 2.7021.393,5.2390.003*1.6390.824,3.2610.159 65+ 2.4531.297,4.6410.006*1.4200.729,2.7670.303

Illwithinthepast2weeks(No)

Yes

1.9041.328,2.731 <0.001* Chronicdisease(No)

Yes 2.2041.521,3.194 <0.001*

SC1:PersonalSocialNetwork,SC2:InterpersonalSupport,SC3:FamilyRelationship,SC4:CommunityParticipation,SC5:CommunityTrustandBelonging.Model1onlyincludedfive dimensionsofsocialcapitalasindependentvariables.Model2controlledtheinfluenceofdemographiccharacteristics(gender,age,maritalstatus,education,income,andemployment status),andModel3adjustedforriskfactors(2-weekillness,chronicdiseases,smoking,drinking,andphysicalexercise)basedonModel2.Usethemedianasacriterionfordividing highandlowgroupofsocialcapital. * P < 0.05.Thecontrolgroupismarkedinbrackets.

However,thefamilyrelationshipofurbanizedruralresidents wasnotsoclose,whichwasreflectedintherelationship withparentsandtherelationshipbetweenhusbandandwife waslowerthanthatofurbanresidents.Intheurbanization process,theresidentialmodeofcentralizedresettlementchanged theformercourtyard-styledecentralizedlivingmode,which ledtothedecompositionoftheoriginaljointfamilyintoa nuclearfamily,whichmayalsoweakentheintergenerational relationship.Inaddition,urbanizedruralresidentsfacednewlife issuesarisingfromurbanization,includingemployment,medical care,educationfortheirchildren,etc.Duetothepressureoflife, theirtimespentwiththeirspousesandparentshaddecreased, leadingtofamilytensions(34).Thissuggeststhatpoliciesshould paymoreattention tovarioussocialinsuranceissuesofurbanized ruralresidentstoalleviatetheirlivingpressureandpromotethe stabilityoftheirfamilyrelationships.

Ourstudyshowedthatasignificantpositiveassociation betweensocialcapitalandself-ratedhealth.Aftercontrolling forfactorssuchashealthriskfactorsanddemographic characteristics,participantswithhighersocialcapitalhadbetter self-ratedhealth.Thesocialcapitalfactorthataffectstheselfratedhealthofurbanizedruralresidentswasmainlythesense ofcommunitytrustandbelonging.Intheformerrurallife inChina,theneighborhoodrelationshipbetweentheresidents wasveryclose,andtheneighborsoftenexchangedorhelped eachother.Inurbanizedcommunities,mostresidentsinthe samesettlementwereformerneighbors,sotheircommunity belongingandtrustwerestillsignificantlyrelatedtoself-reported health.However,modernurbanlifemayreconstructtheirsocial

networksaftertheymovedin.Theseurbanizedruralresidents maytendtodecreasesocialinteractionandfeellonelyorisolated astheymovedintomodernorhigh-riseapartment(35).It shouldbenoted thattheproportionofurbanizedruralresidents whoareover65yearsoldreaches40.3%.Mostofthemdo nothaveformalandstablework.Theirfocusoflifeismainly inthecommunitieswheretheylive,sotheyhaveastrong dependenceonthecommunityenvironment.Asalargemarginal populationconcludingonunemployedruralmigrantshasbeen created,theurbancommunityareawillbecomeanimportant resourceofsocialcapitalfortheminprovidingneighborhoodbasedmutualhelporjobinformation(36).Thelackof neighboring relationshipsandlong-termisolation,loneliness, thepressureoflifemayaffecttheirassessmentofhealth(37, 38).Schultzetal.foundthatsocialcapitalmeasures,suchas informalsocializing, formalgroupinvolvement,organizedgroup interactionandvolunteeractivity,werethesignificantpredictor ofself-ratedhealth(39).Evidencefromanurbanrenewal schemein HongKonghasshownthattheestablishmentof goodcommunitypolicingandaffinityneighborhoodcommittees cangreatlyenhanceresidents’trustandwell-beinginthe community(38).Bycarryingoutvariousmeaningfulcommunity activities,enhancingtheemotionalexchangesbetweenresidents, increasingthecommunityparticipationofresidents,andcreating afamilyatmosphereforthem,theycanfeelmoresocialsupport andsocialtrust,reducethepressureonlife,andthusenhance individualhealth(17).

However, wefoundthatthesocialcapitalfactorsthataffectthe self-ratedhealthofurbanresidentswereprimarilypersonalsocial

TABLE4| Associationsofsocial capitaltoself-ratedhealthamongurbanresidents.

Model1 Model2 Model3

OR95%CI P OR95%CI P OR 95%CI P

SC1(Low)

High 0.6830.505,0.9230.013*0.6690.487,0.9180.013*0.6760.490,0.9330.017* SC2(Low)

High 0.7450.548,1.0130.0600.8120.588,1.1210.2050.8040.579,1.1160.192

SC3(low)

High 0.7570.559,1.0270.0730.5980.407,0.8780.009*0.6660.450,0.9870.043* SC4(low)

High 1.1740.866,1.5930.3021.1050.800,1.5260.5451.0810.778,1.5010.642 SC5(low)

High 1.0060.747,1.3540.9710.8320.604,1.1460.2600.8300.599,1.1500.262

Gender(male)

Female 1.4791.039,2.1060.030*1.4581.019,2.0860.039*

Age(<45)

45–54

0.5160.301,0.8830.016*0.4730.274,0.8180.007* 55–64 0.4490.237,0.8530.014*0.3470.179,0.6710.002* 65+ 0.7650.410,1.4270.4000.5320.278,1.0180.057

Maritalstatus(no)

Yes 1.9911.231,3.2200.005*1.9811.216,3.2290.006*

Employmentstatus(employed)

Retired 2.5091.446,4.3540.001*2.2571.293,3.9400.004* Unemployed 2.0151.040,3.9020.038*1.9090.980,3.7190.057

Income(<2,000)

2,000∼

2.1101.209,3.6850.009*1.9951.133,3.5120.017*

3,000 1.1660.645,2.1100.6111.1210.614,2.0460.711 4,000+ 1.4000.783,2.5030.2571.3020.724,2.3390.378

Illwithinthepast2weeks(No)

Yes 1.4651.030,2.0840.034* Chronicdisease(No)

Yes 1.9511.337,2.8470.001*

SC1:PersonalSocialNetwork,SC2:InterpersonalSupport,SC3:FamilyRelationship,SC4:CommunityParticipation,SC5:CommunityTrustandBelonging.Model1onlyincludedfive dimensionsofsocialcapitalasindependentvariables.Model2controlledtheinfluenceofdemographiccharacteristics(gender,age,maritalstatus,education,income,andemployment status),andModel3adjustedforriskfactors(2-weekillness,chronicdiseases,smoking,drinking,andphysicalexercise)basedonModel2.Usethemedianasacriterionfordividing highandlowgroupofsocialcapital.

* P < 0.05.Thecontrolgroupismarkedinbrackets.

networksandfamilyrelationships,whichreferredtoindividuallevelsocialcapital.Differentfromurbanizedruralcommunities, residents’neighborhoodrelationshipswererelativelystablein theurbancommunity.Mosturbanresidentswereforcedto putmostoftheirenergyintotheirwork,andrarelyhadtime tocommunicatewiththeirneighbors.Theirsourcesofsocial supportandsocialnetworksweremoreextensivefromfamily, friends,andassociates,butlessonsocialcapitalatthecommunity level(40).Thefindingsfromthecurrentmultivariateanalysis showedthattherelationshipbetweenindividualsocialcapital andhealthoutcomehadbackingfromotherstudies(41).For example,an analysisfromolderAmericansfoundthatsocial networkswereassociatedwithalowerpresenceofdepressive symptoms(42).Verhaegheetal.suggestedtherewasapositive relationship between networksocialcapitalandself-ratedhealth, andsocialconnectionsfromdifferentclassesprovidedpeople

differentsetsofresources.Networksocialcapitalfromstrong tieswasmoreimportanttoself-ratedhealththannetworksocial capitalfromweakties(43).Generally,urbanresidentshad higher socioeconomicstatus,andsocialcapitalatindividual levelsuchaspersonalsocialnetworksandfamilyrelationships, wasstrongersocialcapitalforthem.Theirself-ratedhealth wasmorestronglyaffectedbyindividualsocialcapital.In addition,wefoundthat,aftercontrollingforotherfactors, maritalstatus,employmentstatus,andincomeofurbanresidents weresignificantlyassociatedwithself-ratedhealth,whilethis relationshipwasnotsignificantforurbanizedruralresidents. Thisalsoimpliedthatsocioeconomicfactorshadanimportant impactonself-ratedhealthofurbanresidents.

Themainlimitationofthisstudyisthatitisacross-sectional survey,itdoesnotvalidatethecausalrelationshipbetween socialcapitalandself-ratedhealth.Therefore,prospective

researchesareneededtoconfirmourfinding.Inaddition, thequestionnaire formeasuringsocialcapitalwasnotan internationalquestionnaire,whileitwasdevelopedtofitthe Chineseculturalbackground.Also,thisstudydidn’tconsiderthe interactionofsocialcapitalandothersocio-economicfactors.

CONCLUSIONS

Thisresearchfoundasignificantpositiverelationshipbetween self-ratedhealthandsocialcapital.Inthecaseofcontrolling factorssuchashealthstatusanddemographiccharacteristics, participantswithhighersocialcapitalhadbetterself-ratedhealth. Atthesametime,weobservedthaturbanizedruralresidents withhighercommunitytrustandbelonginghadbetterself-rated health,howeverurbanresidentswithhigherpersonalsocial networksandfamilyrelationshipshadbetterself-ratedhealth. Theinfluenceofsocialtrustandsenseofbelongingonthehealth ofurbanizedruralresidentscannotbeignored.Intheprocess ofurbanization,improvingresidents’socialtrustandsenseof belongingwillhelpurbanizedruralresidentsbetteradapttothe newlivingenvironmentandhelpthemcompletetheidentity transformation.Inthefutureresearchonsocialcapital,different typesofcommunitiesshouldfocusonthetypesofsocialcapital fromdifferentsources,soastotakemoretargetedmeasuresto improvethesocialsupportofresidentsandimprovetheirhealth.

DATAAVAILABILITYSTATEMENT

Therawdatasupportingtheconclusionsofthisarticlewillbe madeavailablebytheauthors,withoutunduereservation.

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ETHICSSTATEMENT

Thestudiesinvolvinghumanparticipantswerereviewed andapprovedbyInstitutionalReviewBoardofSchoolof PublicHealth,SichuanUniversity.Thepatients/participants providedtheirwritteninformedconsenttoparticipatein thisstudy.

AUTHORCONTRIBUTIONS

TMandBGconceptualizedtheidea.TMcollectedthedata, performedthestatisticalanalyses,andwrotethefirstdraftofthe manuscript.BGcriticallyrevisedthemanuscript.Alltheauthors checkedandapprovedthefinalmanuscript.

FUNDING

ThisresearchwasfundedbyNationalNaturalScience FoundationofChina,grantnumber71603176.

ACKNOWLEDGMENTS

Wewishtoacknowledgealltheinvestigatorsfortheirassistance withdatacollectionandalltherespondentsfortheircooperation.

SUPPLEMENTARYMATERIAL

TheSupplementaryMaterialforthisarticlecanbefound onlineat:https://www.frontiersin.org/articles/10.3389/fpubh. 2021.718793/full#supplementary-material

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published:29April 2021

doi:10.3389/fpubh.2021.652694

Editedby: MagdalenaKlimczuk-Kochanska, UniversityofWarsaw,Poland

Reviewedby: TamkeenKhan, AmericanMedicalAssociation, UnitedStates NanetteSteinle, UniversityofMaryland,Baltimore, UnitedStates

*Correspondence: TeunSluijs teun.sluijs@tno.nl

Specialtysection: Thisarticlewassubmittedto PublicHealthPolicy, asectionofthejournal FrontiersinPublicHealth

Received: 12January2021 Accepted: 22February2021 Published: 29April2021

Citation: SluijsT,LokkersL,ÖzsezenS, VeldhuisGAandWortelboerHM (2021)AnInnovativeApproachfor Decision-MakingonDesigning LifestyleProgramstoReduceType2

DiabetesonDutchPopulationLevel UsingDynamicSimulations. Front.PublicHealth9:652694. doi:10.3389/fpubh.2021.652694

AnInnovativeApproachfor Decision-MakingonDesigning LifestyleProgramstoReduceType2

DiabetesonDutchPopulationLevel UsingDynamicSimulations

TeunSluijs 1*,LotteLokkers 2,SerdarÖzsezen 1,GuidoA.Veldhuis 3 and HeleenM.Wortelboer 1

1 DepartmentofMicrobiologyandSystemsBiology,NetherlandsOrganisationforAppliedScientificResearch(TNO),Zeist, Netherlands, 2 MethodologyDepartment,SchoolofManagement,RadboudUniversity,Nijmegen,Netherlands, 3 Department MilitaryOperations,NetherlandsOrganisationforAppliedScientificResearch(TNO),TheHague,Netherlands

Thenumberofindividualssufferingfromtype2diabetesisdramaticallyincreasing worldwide,resultinginanincreasingburdenonsocietyandrisinghealthcarecosts.With increasingevidencesupportinglifestyleinterventionprogramstoreducetype2diabetes, andtheuseofscenariosimulationsforpolicysupport,thereisanopportunitytoimprove populationinterventionsbaseduponcost–benefitanalysisofespeciallycomplexlifestyle interventionprogramsthroughdynamicsimulations.Inthisarticle,weusedtheSystem Dynamics(SD)modelingmethodologyaimingtodevelopasimulationmodelforpolicy makersandhealthprofessionalstogainaclearunderstandingofthepatientjourneyof type2diabetesmellitusandtoassesstheimpactoflifestyleinterventionprogramson totalcostforsocietyassociatedwithpreventionandlifestyletreatmentofpre-diabetes andtype2diabetesinTheNetherlands.Systemdynamicsdescribesunderlyingstructure intheformofcausalrelationships,stocks,flows,anddelaystoexplorebehaviorand simulatescenarios,inordertoprescribeinterventionprograms.Themethodologyhas theopportunitytoestimateandsimulatetheconsequencesofunforeseeninteractions inordertoprescribeinterventionprogramsbasedonscenariostestedthrough“what-if” experiments.First,theextensiveknowledgeofdiabetes,currentavailabledataonthe type2diabetespopulation,lifestyleinterventionprograms,andassociatedcostinThe Netherlandswerecapturedinonesimulationmodel.Next,therelationshipsbetween leveragepointsonthegrowthoftype2diabetespopulationwerebaseduponavailable data.Subsequently,thecostandbenefitsoffuturelifestyleinterventionprogramson reducingdiabetesweresimulated,identifyingtheneedforanintegratedadaptivedesign oflifestyleprogramswhilecollectingtheappropriatedataovertime.Thestrengthsand limitationsofscenariosimulationsofcomplexlifestyleinterventionprogramstoimprove the(cost)effectivenessoftheseprogramstoreducediabetesinamoresustainableway comparedtousualcarearediscussed.

Keywords:systemdynamicmodel,type2diabetes,lifestyle,cost-benefit,patientjourneymodeling,decision supportmodel

INTRODUCTION

Diabetes mellitus(DM)isacomplexdisorder(1 3),and thenumberof individualssufferingfromDMisdramatically increasingworldwidefromover360millionindividualsin2015, expectedtobe500millionindividualsin2030(3 5).Nineout of10individuals ofthetotalDMpopulationsuffersfromtype 2diabetes(T2DM)(6),whichischaracterizedbyasystemic metabolic disorderofwhichfastingbloodglucoseconcentration slowlyincreasesoveryears(1),andamajorcauseofslowhealing footulcers, kidneyfailure,blindness,heartattacks,stroke,and lowerlimbamputation(3).T2DMcanbetreatedandprevented, andas such,itsconsequencescanbeavoidedordelayedbymeans ofdiet,physicalactivity,medication,aswellasregularscreening andtreatmentforcomplications(7).Withouteffectivelifestyle interventionprograms, DMresultsinanincreasingburdenon societyandasubstantialriseinhealthcarecosts(8, 9).

AlsoinTheNetherlands,thereistalkofanemerging epidemic,asovertheyears,thetotalpopulationofDMpatients increasedfrom3.9%in2007to6.6%in2019(10, 11).Today, witha populationof ∼18.2millionpeople,1.2millionpeople (6.6%)areestimatedtosufferfromdiabetes,anditisestimated thatthisprevalencewillincrease ∼30%by2030(12, 13).In latestcalculations,thedirectcarecostsofDMaccumulatedto astaggering1.6billioneurosin2017,accountingforaround 1.8%ofthetotalhealthcarebudgetofTheNetherlands(6, 14). Thereisan urgentneedtoexplorehowthisrisingsocietalburden canbereduced(cost)effectively.Recently,nutritionandlifestyle interventionprogramsfocusingontreatmentandespecially reversingT2DMpatientstoahealthystatehavebeendescribed intheliterature(3, 15 17).Nevertheless,despitehavingaccess tointervention programsandknowledgeoflifestyleonthe onsetandprogressionofT2DMandontotalcost,onlylimited long-termpoliciesonearlypreventionofpre-diabetesorT2DM patientsarebeingimplementedintheDutchhealthcaresystem. Aclearunderstandingofthe“T2DMpatientjourney,”our denominationofthejourneyfrombeinghealthytobecoming pre-diabeticandeventuallybecomingdiabeticovertimeand possiblyrecoveringfromT2DMcouldsupportdecisionmakers tooptimizecurrentpolicyincludingweigh-offsinsocialcost thatisinferredthroughtheaccumulationofthis(pre)diabetic populationovertime.Aneasilyaccessiblesimulationtoolto bridgethegapbetweenallthesedimensionsandtosimulate interconnectedeffectsofdifferentprogramsontheoutcome priortotheimplementationofinterventionstrategiesappearsto behardlyexistentintheliterature.

Currentlyavailablesimulationmodelsforcosteffectiveness orcost–benefitanalysisofinterventionprogramsondiabetes areoftenbaseduponMarkov-typesimulationsofhealthcare costs(18, 19).However,theseMarkov-typesimulationsdonot offeranopportunity toestimatetheconsequencesofunforeseen dynamicinteractionsovermultipleyearsintheprescriptionof actions/interventionsbasedonscenariostestedthrough“whatif”experiments(20).Assuch,dynamicsimulationmodeling couldbea moreeffectivemethodfordesigningespeciallyhighleveragepolicypopulationlifestyleprogramsinthecontextof acomplexproblemsuchastype2diabetes.Asmallnumber

ofsystemdynamics(SD)modelssimulatingtheonsetand progressionofdiabetesonpopulationlevelovertimehavebeen described(21, 22).However,theseSDmodelsfocusonthe UnitedStatesandthereforelackspecificparametersforThe Netherlands.Themodelswereconstructedforthepurposeof explainingtheprogressionofthenumberofpatientswithtype 2diabetesanddidnottakeintoaccountanyformofdynamic simulationofthecostsandbenefitsoflifestylepolicies.

Therefore,inthepresentstudy,weaimtodevelopanSD modeloftheT2DMpatientjourneyvisualizingandexploring theconsequencesvia“what-if”scenarios.Toachievethis,we aimtosimulatethecostsandbenefitsoflifestyleprograms overtimeviacouplingthreeinterconnectedelements,i.e.,(1) thedynamicjourneyfromhealthy(normoglycemic)totype2 diabetesatpopulationlevel,(2)theeffectoflifestyleprograms focusingoneitherprevention,treatment,and/orreversing T2DM,and(3)theirassociatedtotalcostforsociety.The resultingsimulationmodeldoesnothavetheaimtobe100% accurateinpredictingthefuture,asthiswillnotbepossible. Itaimstosupportthedecision-makingonT2DMpre-and interventionstrategiesbysocietyandpolicymakersbymeansof ascenario-simulationtoolofthecostandbenefitanalysesoftype 2diabeteslifestyleprograms.

TodevelopaT2DMpatientjourneySDmodel,athorough understandingofthecoreconceptsoftheonsetandprogression ofthediseaseandassociatedcostsofthiscomplexsocial issueiscrucial,whichisdescribedinsectionBackground.The Methodssectionelaboratesonthemethodsusedtocollectthe appropriatedata,modelbuilding,andaddressestheroleof feedbackgoverningthesystem’sbehavior.TheResultsection providesanoverviewoftheT2DMpatientjourneymodel, followedbythevalidationprocessofthemodelandtheresulting scenarios.TheDiscussionsectiondescribesthelimitationsof thestudyandsummarizesthemostimportantinsightsresulting fromthepresentstudy,followedbysectionConclusion.

BACKGROUND

TheT2DMPatientJourney

T2DMisacomplexdisease,slowlyevolvingandbothgenetic andlifestylerelated(1, 3).Theindividualisdiagnosedwith T2DMwhen fastingbloodglucoseor2-hpost-loadbloodglucose reachesvalues ≥ 7.0and ≥11.1mmol/L,respectively(23).The individualisreferredtoas“pre-diabetic”or“havingpre-diabetes” whenthefastingbloodglucoseor2-hpost-loadbloodglucoseis higherthanthebloodglucoselevelsofhealthyindividualsbut lowerthanthestandardsettoreceivethediagnosisDM(2, 24, 25).ResearchershaveshownthatT2DMandpre-diabetesresults fromaninteractionofheritableriskfactorsandnon-heritable riskfactors(2, 5, 26 28).Thenon-heritableriskfactorsindicate thepossibility ofT2DMpatients,anddiagnosedpre-diabetes patientscouldbereversedtohealthyindividuals.

Inlinewiththisinteraction,LoosandJanssens(29) arguedthatmostindividualsdevelopT2DMasaconsequence ofsufferingfromametabolicsyndromeorobesity,which predominantlyoccursduethecombinationofanunhealthy

lifestyleandageneticsusceptibilityforgainingweight.InThe Netherlands,theHeartFoundationandtheRotterdamRcohort studysuggestthatoneoutofthreeobeseDutchindividualswill developT2DMovertime(30).ThenumberofDMpatients inThe Netherlandshasincreasedfrom160,000individualsin 1990to1.2millionin2018(12).Inmorerecentyears,Dutch healthcareisseeminglyregainingcontrolovertheT2DMdisease. StatisticsNetherlands(31)haspublisheddataconcerningthe numberofT2DMpatientsofthetotalDutchpopulationfrom 2014to2018showingasteadychangefrom3.7%in2014to 4.0%in2019.Afasterrateofincreasewasobservedinthetwo decadesbefore(from1990to2011),thenumberincreasedfrom 160,000to830,000(10, 31),whichis1%toaround4.9%ofthe totalpopulation (31).Aunifiedscientificexplanationforthisis notyetpresent;however,explanationsmightbefoundinmore awarenessofunhealthylifestyleviamediaandsuccessratesof theinstallmentoflocalintegratedlifestyleprogramsandbariatric surgeryforespeciallyobeseT2DMpatients(32).Nevertheless, thenumberof T2DMandpre-diabetespatientsisforeseento grow(25, 33),largelyasaresultoftwofactors.Besidestheeffect ofincreasingobesity(29, 33),anincreasingagingpopulationalso resultsin anincreasingT2DMpopulation,asinsulinresistance increasewithobesity(34)andage(35).Currently,51%ofthe Dutch populationabove20yearsoldareoverweight,ofwhich 15%areobese.Bothpopulationshaveincreasedoverthepast 5years(31),andwiththeknowledgethatoneofthreeobese peopledevelops T2DM,thesenumbersindicatethatcombined (cost)effectivelifestyleprogramsmayhaveextensivepositive implicationsforsociety.

TreatmentofT2DMandLifestylePrograms

AimingtoReverseT2DM

InTheNetherlands,T2DMtreatmentisperformedin compliancewiththeguidelinesoftheNHG-standard(de NederlandseHuisartsenGenootschapStandaardinDutch). PatientswithT2DMareprimarilytreatedinprimarycareby generalpractitioners(GPs)andtheirpracticestaff,including practicenurses(PNs).Aftermedicaltreatmentandlifestyle advice,every3–6months,routinediabetesconsultationsare performed,includingphysicalexaminations,bloodglucose checks,andotherlaboratorytests,andtheresultsdiscussed withpatients.BothGPsandPNsperformmedicalandlifestyle counselingaccordingtogenerallyacknowledgedcriteria(36, 37). Besides treatment,researcherssuggestthatnon-heritablerisk factorsaremodifiable,andhence,assumingthatindividualsare abletomakesustainablelifestylechanges,T2DMpatientscould behelpedtopermanentlylowertheirbloodglucoselevelsto normallevels.Thisprocessisreferredtoas“reversingtheT2DM patient”(2).However,toachieveanactualreversalofT2DM patients,long-termbehavioralchangesareneededtorestore normal,sustainablebloodglucoselevels(2, 3, 38 40).Reversal programsofT2DMarefocusedonprovidingtreatmentwith limiteduseofinsulin,asearlyroutineuseofinsulintherapy canhavenegativeconsequencessuchasincreasedmortality, weightgain,increasedrisksofcancer,andhypoglycemia(41). Inthe beginning,T2DMinterventionprogramsrangedfrom

programsfocusingonimprovingcurrenttreatmentprograms inTheNetherlands,asapprovedbytheNHG-standard,by re-evaluatingthescreeningprocessresultinginthepossibility tointerveneearlier(10).Asknowledgeincreased,otherT2DM programswere developedfocusingonchanginglifestylefactors, suchaspersonalizednutrition(40, 42),enhancingphysical exercise(43),orafterbariatricsurgeryforindividualswithsevere obesity(32, 44).

Treatmenteffectiveness,however,ishighlydependenton thepatient’sintrinsicmotivationtodeliberatelymakelifestyle changes.Long-termcoachingisoftenoutsideoftheGP’srole, withthedevelopmentofseveralcoachingtoolsasaresult (45).Additionally,throughcurrentadvancementsoftechnology, thepossibilityofdeterminingpre-diabetesgivestheabilityto reducethecausesearlierinsteadoffightingtheconsequences. Overweightandobesityforinstanceareverywell-knownto increasetheincidenceofT2DM(34).Earlyreversalsareto reducethe potentiallong-termcostduetothedevelopmentofthe T2DMpopulation.Hence,thepresentstudyarguesthatlifestyle programsshouldfocusonthepre-diabetespopulationaswell.

TheConstructionandCalculationofTotal CostArisingFromT2DM

ThetotalcostassociatedwithT2DMarecostsresultingfrom individualssufferingfromundiagnosedpre-diabetes,diagnosed pre-diabetes,andT2DM.Thesecontributionsinhealthcarecost areabatableand/orevenpreventable,asresearchsuggeststhat non-geneticobesityisrelativelypreventableintheassumption thatindividualscanmakesustainablelong-termbehavior changes(46).Therearemultipletypesofcoststhatarise fromT2DM.

First,asTheNetherlandsisawelfarestate,thepublic authoritiesprovideunemploymentbenefitstothedisabled(47). IncaseofaT2DMpatientbecomingdisabled,theindividual mayclaimforbenefitsaccordingtotheWorkandIncome Act(WIA).Withintheinvalidityscheme(theWIAscheme), adistinctionismadebetweenfull,permanentdisability(in Dutch“InkomensvoorzieningVolledigArbeidsongeschikten,” IVAbenefit)andpartialdisability(inDutch“Werkhervatting GedeeltelijkArbeidsgeschikten,”WGAbenefit).

Second,theemployerdevelopscostarisingduetolabor productivitylossoftheindividualsufferingfromT2DM, whicheventuallymayresultinabsenteeismoftheT2DM patient(9).Additionally,thecostresultingfromanobligatory salarypaymentfor disabledemployeesisconsidered.When anemployeeisdeclaredpartiallyorfullydisabledinThe Netherlands,theemployerisobligatedtopaythesalaryofthe employeeupto2yearsasregulatedintheEmployeeInsurance Agency(47).

Lastly,everypersonisinsuredundertheHealthcareInsurance Act(ZVW)andtheLong-TermCareAct(Wlz).Bothmedical aswellasnon-medicalcostariseduetotheneedforprimary care,hospitalization,andmedicalsupport.Thepresentstudy, therefore,recognizesmedicalcostsresultingfromambulatory care,hospitalization,physiotherapy,toolsanddevicesuse, generalpractitionercare,andmedicaltreatment(thelatter

beingseparatedfortheelderlyasinsulininanelderlybody adjustsdifferently andthereforeneedsadditionaltreatment). Furthermore,costarisingfromcomorbiditiesofT2DM(48 51)aretakenintoaccount.Additionally,costsarisingfrom managingorganizationsconcernedwithT2DMbyT2DM patients’foundationassociationsareincluded.

ConnectingtheElements

Toexploretheeffectivenessofpolicyinterventions,thesethree interconnectedelements(thedevelopmentoftype2diabetes, lifestyleprogramsfocusedonreversingT2DM,andassociated cost)needtobecoupledtoeachothertoprovideaholistic viewonthelikelydevelopmentofinterventionsontheT2DM stockandsubsequentcostovertime.Thepossibilityofreversing type2diabetesandreducingitssubsequentnumberofpatients, theevidenceoftheeffectivenessoflifestyleprograms,andthe subsequentcostforsocietyshouldbetreatedasacombination ofdirectandindirectcosts.Additionally,thesepre-and interventionprogramsarefinanciallyheavyandrequirelongtermcommitmentof(health)professionalsandpatients.Toput alltheseaspectsinacomputermodel,simulatingthedynamics ofthefuturetrendoftype2diabeticsandassociatedcostcould possiblyguidethewayforamoreinformeddecision-makingas towhichprogramsdecisionmakerscanconsiderimplementing inacertaincontextforoptimalresult.

METHODS

ChoosingSDforComputationalModeling

TomodeltheT2DMpatientjourneyinTheNetherlands,an SDmodelingapproachwasappliedforthefollowingreasons. In2016,Aloukietal.reviewedthatmanyofthepublic healthinterventionsfallshortoftheirlargergoals,asthese interventionsusuallyarebaseduponlinearprojectionsof retrospectdata(52).Currenteconomicevaluationmethodsare ofteninsufficientto simulatedynamicsofcomplexphenomena involvedandtovisualizetheoutcomeof“whatif?”experiments. Environment,behavior,andpopulationchangeovertime,where riskfactors,statesofuncertainty,healthcareprofessions,and interventionresourcesarecontinuouslyinteractingwithone another.Whenthelatterphenomenaresultinchronicproblems, thesecanbedefinedas“wickedproblems”(53, 54).Toaddress wickedproblemsto anextentinwhichtheymightbecome manageable,thisresearcharguestheneedofaholistic,integral approach,easilyaccessibleforstakeholders,thatcapturesnonlinearbehaviorofthecomplexsystemovertime.SDmodelingis well-suitedtoaddressthiscomplexityandanappropriatemethod foridentifyingimportantleveragepointsandexaminationof possibleinterventionsincomplexproblemsinadvanceofreallifeimplementationandsubsequentevaluation,whichwould otherwisebetoocostly(21, 55).Therefore,withtheultimate aimtodevelopasimulationtool,SDwasusedtobuildafirst versionofanSDmodeltogaininsightsinthedevelopmentof theT2DMpatientjourneyinTheNetherlandsunderthecurrent policy,underlifestyleprogramsasseveralinterventionpolicies, andunderprogramsthatcombinelifestyleinterventionpolicies.

BasicsofSDMethodologyExplained

SDmodelingsimulatescomplexdynamicbehaviorovertimeand workswithinterrelationships,whicharerepresentedinmultiple linkeddifferentialequations(56 59).Themethodpredominantly makesuse ofstocksandflows.Asimplifiedpopulationmodeland itsrespectivebehavior,illustratingstocksandflows,arepresented in Figure1A.Astock,indicatedwithasquare,representsa (accumulationofa)quantityatacertainpointintime.Aflow, however,indicatedwithadouble-linedarrow,modelsthechange inastockovertime(andtherefore“flows”inoroutofthestock). Variables,indicatedbywordsprecedingsinglearrows,adddetail totherelationsbetweenstocksandflows.Thesevariablesmostly areendogenizedwithinthesystem.Ultimately,theinteraction andfeedback(knownas“loops”)betweenmultipleendogenous variables,stocks,andflowscreatethedynamicsovertime (Figure1B).

BuildingtheT2DMPatientJourneyModel

AparticipatoryprocesswasusedtodeveloptheSDmodel,as illustratedin Figure2,anddescribedbelow.

ThecurrentSDmodelfindsitsoriginsinthesystemic analysisofdiabetesperformedbytheCenterforDiseaseControl andPreventionintheUSA.Theaimofthisresearchby Homeretal.wastomodelthekeydriversofpopulation flowsandinputsamenabletopolicyintervention(21).Ina furtheradaptationofHomer’swork,Jonesetal.(22)redefined themodelto a“patientjourney.”Alargefocuspointin thestudyofJonesetal.wasthedivisionofcomplicated anduncomplicateddiabetes,andnoattentionwaspaidto associatedcosts.Inthecurrentstudy,wechosetofocusonthe impactoflifestyleinterventionprograms,whichhasthemost impactonearlypreventionandreversalofdiabetes,andas such,wedidnotdistinguishbetweencomplicatedT2DMand uncomplicatedT2DMbutfocusedonfouradditionalfactors affectingtheearlyonsetandactualemergenceofT2DM.The factorswere(1)theeffectofanagingpopulation(indicated inthemodelasElderlyfractionofadultpopulation),(2) theeffectofobesityontheemergenceofT2DM(indicated inthemodelasObesefractionofadultpopulation),(3) theeffectofpopulationgrowth(indicatedinthemodelas Adultgrowthrate),and(4)theT2DMdeathratecompared todeathrateofthenormoglycemicpopulation(indicated inthemodelasDeathratesfordiabetic-andnon-diabetic population,respectively).Multipleimprovementsweremadedue tonewinformationavailableontheeffectofpreventionand lifestyleinterventionprogramschangingtherecoveryratesof thesubpopulationsduetofurtherevidenceofreversingT2DM patientsbynutritionandlifestyle.ThestructureoftheT2DM modelwasparameterizedtowardthecurrentsituationanddata availableinTheNetherlands.

DataCollectiontoBuildtheFinalT2DM

PatientJourneyModel

Tocollecttheappropriatedata,expertswereiteratively interviewedtoelicittheirknowledgeonT2DMandlifestyle interventionprogramsandtovalidatetherelationshipspresented inthepreliminarymodel,asdescribedbyVennix(57).

FIGURE1|(A) Simplifiedpopulation modeland (B) itsrespectivebehavior.Thestockisrepresentedasasquare;theflowsarerepresentedasdouble-linedarrows. Themorepeoplethereare,thehigherthebirthrateisovertime;areinforcingloop(R1).Givenafixedcarryingcapacity,themorepeoplethereare,themorepeople willdie;acounteractingreinforcingloop(R2).Ifthebirthrateremainslargerthanthedeathrate,wewillexperiencepopulationgrowth.Populationgrowth,however, hasitslimitsduetoallkindsoffactor.Therefore,abalancingstructureisbuiltin,indicatedbylimitingvariable“carryingcapacity.”Thecloserthepopulationgetstoits respectivecarryingcapacity,themoredeathswilloccur(asecondcounteractingreinforcingloop(R3),eventuallystabilizingpopulationgrowthwheretheamountof deathsequalstheamountofbirths.

Accordingly,interviewswereheldwithfivescientificexperts workingatTheNetherlandsOrganisationforAppliedScientific Research(TNO).Allexpertshaddetailedscientificknowledge and/ortogethermorethan40-yearexperienceonT2DMaswell asitslifestyleprogramsinTheNetherlands.Backgroundofthe expertswereinbiomedicalsciences,healthsciences,molecular biology,economics,andsocialhistorywithafemale/maleratio

of2/3.Theexpertinterviewswereconductedaccordingto aninterviewguideapproach,audio-recordedandanalyzedfor overallthemes,asdescribedbyVennix(57, 60).Duringthe expertinterviews, somechangesinthepreliminarymodelwere suggested.Forexample,incontrastwithJonesetal.(22), anoutflow fromtheT2DMpopulationtothenormoglycemic populationwassuggested,asexpertsarguedthepossibility

FIGURE2| Overviewofthe participatoryprocessofbuildingasystemdynamic(SD)modelfordecision-makingondesigninglifestyleprogramstoreducetype2 diabetesonDutchpopulationlevelusingdynamicsimulations.

ofreversingbothpre-diabeticsandT2DMpatients.After crosscheckingwiththerelevantliteraturereviewandbackground informationasdescribedthemodules TheT2DMPatient Journey,TreatmentofT2DMandLifestyleProgramsAiming toReverseT2DM,and TheConstructionandCalculationof TotalCostArisingFromT2DM,thepreliminarymodelwas modifiedaccordingly.Thereafter,themodifiedpreliminarySD modelwasvalidatedbytheexperts.Finally,afterseveralcritical discussions,afinalstructureofthemodelwasgenerated andinsertedinStellaArchitectsoftwareversion2.0.1(iSee Systems,2020).Forparameterizingthemodel,datawere extractedfromscientificliterature,WorldBank,andDutch databasesofStatisticsNetherlands(CBS),DutchHealthcare Authority(NZa),TheNationalHealthCareInstitute(ZIN), NetherlandsInstituteforHealthServicesResearch(NIVEL), NationalInstituteforPublicHealthandtheEnvironment (RIVM),DutchDiabetesResearchFoundation(DiabetesFonds), DutchDiabetesAssociation(DVN),andtheNetherlands OrganizationforAppliedScientificResearch(TNO).Based onthesedata,themodelwasadjustedtorepresentthe baselinescenario.Detailsofthedatausedaregivenin SupplementaryData

RESULTS

TheConstructionoftheT2DMPatient

JourneyModel

TheT2DMpatientjourneymodeldisplaysthejourneyof individualsdevelopingT2DMandthepossibilitiestoreduce T2DMviainterventionsprograms,coupledtothecosts associatedwithT2DMandthesesubsequentprogramsin TheNetherlands(Figure3).Themoretype2diabetics,the higherthecostforsociety.Detailsofthemodelaregivenin SupplementaryData

Themodel,aspresentedin Figure3,isconstructedviathe followingrationale.Theinitialstockisthe“Normoglycemic population”ofTheNetherlands,consistingofallindividuals abletodevelopT2DM.Thatis,thetotalDutchpopulation minustheT2DMpopulationasT1DMpatientsareableto developinsulinresistance(61).Individualsarerecruitedtothis populationbecauseofbeingborn,migration,andpassingaway (formedasanexogeneousvariabletokeepthescopeoffocuson T2DMdevelopment:thevariable“Dutchpopulationtrend”).A smallfractionofthisstockisalreadydiabetic,whereasasmallbut growingfractiondevelopsT2DMovertime.Therefore,theinitial valuesofthenormoglycemicpopulationplustype2diabetic populationmustequalthenumberofcitizensinTheNetherlands atthemodel’sinitialstartingtime.Underthecircumstancewhen theDutchpopulationgrowthisequaltothegrowthprojections ofCBS,themodelportraysthefollowingbehavior:themore diabetics,thelargerthegroupofdiabeticsbecomes,andthemore thestockofnormoglycemicpopulationdepletes;areinforcing (+)relationship.Ontheotherhand,themoretype2diabetic peoplerecover(ordifferentlysaid,thestock“type2diabetics” reduces),thelargerthenormoglycemicgroup:abalancing(–)relationship.Toreducetheamountoftype2diabetics,one

can“adjust”theseflowswithinterventionstrategies.Wecan reducetheamountoftype2diabeticsbyeitherimplementing apreventionprogram,whichwillreducetheamountofpeople becomingdiabetic(slowdownthereinforcingstructure)orwe canacceleratethetype2diabeticrecoveriesbyimplementing interventionstrategies(increasethebalancingstructure).From normoglycemictodiabetic,mostindividualsundergogenerally thefollowingprocess:first,onebecomesoverweightoreven obese(outliersarerepresentedas“non-obese”)andbecomes apre-diabetic.Eitherthepersongetsdiagnosedordoesnot, representedasthe“Diagnosedpre-diabetics”and“Undiagnosed pre-diabetics”stocks.Overtime,asmallfractionofbothstocks “reverts”andflowsbacktotheNormoglycemicpopulationstock. Hence,individualswhosufferedfromeitherpre-diabetesor T2DMareagainrecruitedtothenormoglycemicpopulation through“recovery.”However,alargepartofthesegroups becomestype2diabetic,flowingintothe“Type2diabetics”stock. Apercentageofthistype2diabeticspopulationcanbereversed, flowingbacktothe“Normoglycemic”stock.Theaccording differentialequationscanbefoundinthe SupplementaryData; theequationsfollowtherational:

(1)Diabetespopulation = (fractionofdiagnosedpre-diabetics thatbecomediabetic/timeittakestobecomediabeticfor diagnosedpre-diabetics + fractionofundiagnosedprediabeticsthatbecomediabetic/timeittakestobecome diabeticforundiagnosedpre-diabetics).

(2)Normoglycemicpopulation = [initialnormoglycemic population + (fractionoftype2diabeticsthatrecovers/time ittakestorecover)].

Pre-diabetics

Individualsexperiencingsymptomsofpre-diabetesperdefinition firstdevelopundiagnosedpre-diabeticandarethusrecruited tothe“Totalpersonsthatbecomepre-diabetics.”Theseprediabetespatientseithercanseeageneralpractitionerandreceive eitherthediagnosisimpairedfastingglucose(IFG)orimpaired glucosetolerance(IGT)(diagnosedpre-diabetespopulation, depictedin Equation2),orleavethediagnosistorest.The diagnosisrate(IFGandIGT)isdeterminedbycombining thefractionincidence(IFG)andthefractionincidence(IGT). IndividualssufferingfromeitherIFGorIGTarerecruitedfrom thetotalpre-diabetespopulationtothediagnosedpre-diabetes populationwhenreceivingthediagnosisIFGorIGT.Both individualswhoarediagnosedandundiagnosed(orwhoare notvisitingageneralpractitioner)canexperiencesymptomsof T2DM,asthediseaseprogressesovertime.Fractionsofboththe diagnosedandundiagnosedpre-diabetespatientsrecoverfrom pre-diabetesandisrecruitedtothenormoglycemicpopulation again;thelatterhasasmallerpercentageofreturningaspeople simplydonotknowtheyhavepre-diabetes.

ReversingtheT2DMPopulation

IndividualsarerecruitedovertimetotheT2DMpopulation fromtheundiagnosedanddiagnosedpre-diabetespopulation (IFG/IGT).T2DMpatientsleavetheT2DMstockintwoways: first,passingawayduetoT2DMwhenreachingtheaverage

FIGURE3| TheT2DMpatient journey.Boxesarestocksthataccumulateovertime,doublearrowsarein-oroutflowsthateithergiveinputortakeoutputofthe stock.Circlesarevariablesthataffectthein-oroutflows,containingparametervalues.Cloudsareoutputsthat“flowoutofthesystem”likedeaths.Theprocessis visualizedfromgreen(healthy)toorange(likelytodevelopT2DM)tored(developedT2DM),withmultiplepossibilitiestobouncebackinthesystemto“healthy”(green arrows).ThesystemcontainsthedifferentialequationsasdescribedinsectionTheConstructionoftheT2DMPatientJourneyModel.

lifeexpectancyofaT2DMpatient;second,byrecoveringfrom T2DM.ThefractionthatrecoversfromT2DMdeterminesthe recoveryrateoftheT2DMpopulationandthusthenumber ofpeoplerecruitedagaintothenormoglycemicpopulation. Furthermore,afractionofT2DMpatientsthatarereversedtoa stateinwhichtheydonotneedanymedicineexperiencearelapse intothetype2diabetesstock.Thispercentageisaround65%and

heavilyaffectsthefollow-throughofthesuccessratesofacertain lifestyleprogram(48).Withabariatricsurgery,however,this relapsepercentageisonly5%(62).AsCBSonlyprovidesdataof T2DMfrom 2011onwards,theinitialvalue(t = 0)isdefinedby theDutchpopulationtrendmultipliedbythefractionofT2DM overthetotalpopulationin2011.Followingtheequations,the resultingSDmodelcanbefoundin Figure3

TABLE1| Modelvaluesused thatdeterminethetimeandfractionofindividuals totransitfromonestocktoanother.

Transition Average time (years)

FromstockATostockB

Normoglycemic population (non-overweight)

Normoglycemic population (overweight)

Diagnosed pre-diabetics

Fractionofstock fromAtoB,divided byaveragetime(DT)

Totalpersons that becomepre-diabetics 2 0.01

Totalpersonsthat becomepre-diabetics 3 0.33

Type2diabetics4 0.70

example,thehighertheT2DMpopulation,themorepeopleto treat)and,inturn,providesafeedbackfortheT2DMpopulation dynamics(themoreeffectivethelifestyleprogram,themore peoplerecoverfromT2DM).

Submodule1:InterventionandPrevention Programs

Undiagnosed pre-diabetics

Normoglycemic population 2 0.30

Type2diabetics7 0.90 Diagnosed pre-diabetics

Undiagnosed pre-diabetics

Normoglycemic population 4 0.10

Type2diabeticsNormoglycemic population 3 0.01

NoMedicine necessary Type2diabetics2 0.65 NoMedicine Necessary Type2diabetics (BariatricSurgery) 100.05

Dataarebaseduponassumptionsmadefromtheliterature,reports,anddiscussion withexperts.Fractionsofstocksareindicatedbetween0and1,inwhich1indicates 100%.Dataarebaseduponassumptionsmadefromtheliterature,reportsanddiscussion withexperts.

DynamicsOverTime

AsSDmodelingisamethodtocapturebehaviorovertime,these differentialequationsareconstructedaccordinglybydividing thedifferenceoveracertaintimestep(dt)inthisstudyin months.IntheSDmodel,certaintimefactorsarecrucialfor thebehaviorofthemodel,namely,thetimeapersontakeson averagetobecomepre-diabetic,theaverageonsetandrecovery timesfrom(un)diagnosedpre-diabeticstoeithertype2diabetic ornormoglycemicpopulation,andtherecoverytimeforatype 2diabetictoreverttoanormoglycemicperson.Thetimeand fractioninwhichonetransitionsfromonestocktoanother(in years)arerepresentedin Table1.

Submodules

Inordertoperform(cost)effectivenessanalyseswiththeSD model,twotypesofsubmodulesweredevelopedandconnected tothedynamicsoftheT2DMpopulation:thesubmoduleon effectivenessofthelifestyleinterventionprogramsonreducing thepre-diabeticandT2DMpopulationandasubmoduleonthe costsandbenefitsofthelifestyleinterventionprograms.The submodulesrunsimultaneouslyofeachotherandcomplement themselveswithelementsofthe“larger”T2DMmodel.The T2DMmodelformsmerelyaninputforthecostforsociety(the morepatients,themorethecost,andthemoreprogramcost, themoretotalcost).Theeffectivenessofthelifestyleprograms, however,enjoysitsinputthroughtheT2DMpopulation(for

Thestructureenablingtheimplementationofintervention programsispresentedinthe SupplementaryData.Thismodule servesasaninputforapossiblehigherrecoveryrateofT2DM patients(preventionprograms)aswellasaloweronsetrate fromthenon-glycemictopre-diabeticstock.Therationaleisas follows.Assumingthatindividualsareabletomakesustainable lifestylechanges,thepresentstudyarguesthatT2DMpatients (eitherIFGorIGT)caneitherrecoverwithoutintervention program(normalrecoveryrate)andwiththesupportof one(recoveryrateinterventionprogram).Therecoveryrate interventionprogramisdeterminedbytheprogramrecruitment rateandtheprogramsuccessrate.Thenumberofindividuals recruitedtoparticipateinacertaininterventionprogramis determinedbythepotentialrecruitmentrateortheindicated recruitmentrate,asitisinitializedwiththespecial-function MIN.Thepotentialrecruitmentratecanonlybedetermined bythemaximumpatientsabletoreceivetreatmentovertime. Furthermore,theindicatedrecruitmentraterepresentstheactual numberofT2DMpatientswhoarerecruitedtoparticipateinthe certainprogram,whichisdeterminedbyinvestments.Thereafter, themodelwithimplementationofacertainlifestyleintervention programisconnectedtotheassociatedcostsandbenefits.

Submodule2:TotalCostofType2Diabetes

Thetotalcostoftype2diabetesinTheNetherlandsconsistof costsfortheDutchauthorities,thehealthinsurer,theemployer, and,moreimplicitlytoacertainextent,thepatient.In Figure4, aschematicandstaticoverviewisgivenofthecosts,asthey havebeenincorporatedinthemodelandtheirrespective mathematicalrelationships.Thetotalaccumulativecostsare representedinthe SupplementaryData.Inordertocouplethe coststothedevelopmentandscenariosettingofT2DMand lifestyleprogramsovertime,itisrequiredtocoupleelementsas theT2DMdevelopmentovertime(thetype2diabeticsstock)to thesestaticequations.

ModelValidation

InSDmodeling,modelvalidationisacombinationofa social,qualitativeprocessaswellasformaltesting(63). Therefore, itisarguedthatmodelvalidityshouldbejudged consideringthemodel’spurpose(63).Accordingly,theT2DM patientjourneymodel’svaliditywasjudgedconsideringits purposebyconductingseveralstructuretestsandstructurebehavior-orientedtestsasdescribedearlier(26, 64).Within structuralbehaviortesting,anextremeconditiontestwasused toexaminewhetherthemodelstillrationallyportraystheright behaviorwhenbeingputtoextrememeasures.Inthemodel, thenormoglycemicpopulationwassettoboth0and100 million,whereasthemodeladequatelyportrayedrealityinfor examplecost:0T2DMpatientsresultedin0costs,100million

FIGURE5| DutchT2DMPopulation between2013and2019,basedupon StatisticsNetherlands(CBS)data(31)asreferencemode(blackline)and simulatedchange usingtheT2DMpatientjourneymodel(blueline).

T2DMpatientsresultedinafewbillioneurosincosts.By conductingbehaviorsensitivityanalysis,allexogenousvariables wereexaminedbasedontheirimpactonthemodel’sbehavior (59).Whenconductingbehaviorsensitivityanalysison Fraction IndividualsDevelopingPre-diabetes (see SupplementaryData), forexample,thesimulationsshowedthatallfivepopulationsare verysensitivetochangesinthefraction.Themodelappearstobe verysensitiveforchangesregardingthefractionofindividuals determiningthenumberofoverweightandobeseindividuals whodevelopdiabetes[FractionOverweightDevelopingPrediabetes(BMI)].Furthermore,thebehaviorreproductiontest examinedthemodel’sabilitytoreplicatethereferencemode ofbehavior(59)onCBSpublisheddataonthenormoglycemic populationandtheT2DMpopulationfrom2013to2019(31). Whencomparingthemodel’sbehaviorandtheCBSdata,roughly thesamebehaviorwasobserved(Figure5).Hence,themodelis abletoreplicatethereferencemodeofbehavior.

ScenarioSimulationoftheCostand BenefitsofFutureLifestylePrograms

TheT2DMpatientjourneymodelissimulatedfora45-year timeperiodfrom1990to2035toenablecomparisonwithresults presentedintherelevantliterature(10).Followingthecurrent policy,simulationshowsthatthetotalcostsofT2DMincrease asaresultofanincreaseinthetype2diabeticsstock,asshown bytherelationshipbetweentheT2DMpopulationandthetotal costsforsocietyT2DMpopulation.Asalltheelementsare interconnectedandvalidatedto“sufficientlycorrectwithreality,” policyleversareimplementedinthemodeltoexaminedynamic cost–benefitinteractionsinthemodel.Thecurrentpolicylevers arefive-fold:First,onecanchooseto“activate”acertainprogram, eitherpreventionoranintervention(pre-diabetesprogramand T2DMprogram).Second,onecandeterminethesuccessrateof theprogram.Realistically,thisisusuallyatradeoffwithcost: themoreitiseffective,themorepeopleareneededsothemore cost,whichisanotherpolicylever(costmultiplier).Thepotential amountofpeoplethatwillbefocusedoncanalsobedetermined with“potentialpatientstorecruitinprogram.”Aprogramcan

choosetoeitherfocusonasmallgroupandmakethisextremely efficientordrawittoawidergroupwiththeriskofbeing lessefficient.

Usingdifferent“what-if?”experiments,thedevelopmentof theT2DMpopulationandthetotalcostsforsocietyofT2DM weresimulatedunderhypothesizedmultiplepolicyscenario runs:currentpolicy(“Nolifestyleprogram”)andpolicyoptions 1–4(activatedintheyear2020),astobeseenin Table2,followed bytheoutcomesoftheseparticularpolicyparameterizationsto totalcostforsocietyofalltheinterventions(Figure6A)andits subsequentT2DMpopulation(Figure6B).

ScenarioRun1:NoInterventionPolicy

Inthe“nointerventionpolicy”situation,wesimulatethat noadditionallifestyleprogramisyetinstalled.Therefore,the programactivationsremain0.Themodelshowsthattheinflows diabetesonsetratefromundiagnosedandpre-diabetes,diabetes onsetratefromdiagnosedpre-diabetes(IFG/IGT)continuously exceedtheoutflowsrecoveryrateT2DMpopulationandrecovery rate(un)diagnosedpre-diabetes,resultinginasteadilyincreasing T2DMpopulation.Thetotalcostforsocietyassociatedwith T2DMfollowthetrendoftheT2DMpopulationandresult incurrentsettingtoacostforsocietyintheNetherlandsthat increasesto13billioneurosin2035.

AdditionalInterventionPolicies

Whenanadditionalinterventionprogramisimplemented,itwill alwaysincuranextracost.However,T2DMpatientscanalso fullyrecoverviaalifestylechangewithoutthesupportofany additionallifestyleprograms(currentpolicy),althoughrare.To determine(cost)effectivenessofadditionallifestyleprogramsas offsetunderincreasedcost,severalpolicyscenarios(different lifestyleprograms)arerunontheframeworkoftheT2DM patientjourneyanditssubsequentsocietalcosts.Multipleaspects arebeingtakenintoaccountinalltheseadditionallifestyle interventions:thesuccessrateofaprogram,thechoiceofa focused(T2DMpopulationonly)oranintegratedprogram(both T2DMandpre-diabetespopulation),thepotentialamountof patients(eitherT2DMonlyorT2DMandpre-diabetes)that canberecruitedintheprogram,andthecostperpersonofthe program.Alllifestyleprogramscontaintrade-offs.Forexample, tohavealifestyleprogramwithsuccessratewhilestill“keeping itcheap,”oneneedsafocusedapproachwithaselectivegroupas personalizedcareisexpensive.Anotherexampleisthetrade-off ofhavinganintegratedapproachthatcoversmostofthesociety; inordertonotmakethelifestyleprogramtooexpensive,one needstomaketrade-offsinthesuccessandrecruitmentratesof theprogram.

ScenarioRun2:BariatricSurgery

Scenariorun2isonewhereabariatricsurgeryisperformedon patients.ThesuccessratesarebasedonYskaetal.(44),and thecostfor thissurgeryisbasedonRIVMdata(62).Inthis policy,anadaptationontherelapserateandtimefromthe“no medicinenecessary”stockismade.Theparametervaluesforthis grouparesetonrelapserateof5%(0.05ascomparedto0.65) withadelayof10yearsinsteadof2.Thecostofthisbariatric

TABLE2| Hypothesizedinterventionscenarios andtheirparametervaluesusedinscenariosimulation.

Simulatedintervention scenarios T2DMprogram

Pre-diabetesprogram

Yes/noFraction recruited Success rate Cost multiplier Yes/noFraction recruited Success rate Cost multiplier

NoInterventionpolicyNo No

Policy1 “BariatricSurgery” Yes 0.28 0.95 17 No Policy2 “ReverseDiabetes2Now” Yes 0.002 0.28 1 No

Policy3 Yes 0.3 0.3 1.0 No Policy4 Yes 0.45 0.3 2.0 Yes 0.3 0.3 1.0 Policy5 Yes 0.6 0.5 3.0 Yes 0.4 0.5 3.0

Parametervaluesareindicatedbetween0and1,inwhich1indicates100%.Dataarebaseduponassumptionsmadefromliterature,reportsanddiscussionwithexperts.

surgery,however,accumulatestoaround17timestheamountof alifestyle intervention,rangingfrom15,000to20,000euros(62). Thesuccessrateofthispolicyisseton95%.Sinceonlypeople withBMIabove35areeligibleforbariatricsurgeryduetoDutch careregulations,thepercentageofpeoplerecruitedissetto28%, whichroughlyaccountsforthepercentageofpeoplewhohave aBMIabove35.Thepolicyportraysthat,howeverextremely effective,thisisaveryexpensivepolicyoptionwhenitisdeployed overthelargerpopulation(Figure6,run2).

ScenarioRun3:The“ReverseDiabetes2Now” program

Inscenariorun3,theprogramof“ReverseDiabetes2now”is simulatedwithitscurrentsuccessrates(40)andgradually increased inpopulationtreatmentover10years.Theprogram

currentlyhasasuccessrateof28%wherenomedicineis necessary,andaround2,500peoplearetreatedyet(roughly 0.002%ofT2DMpopulationin2020).Pricingisassumedtobeset on“average.”Themodelsimulates,whenthetreatedpopulation isgraduallyincreasedover10yearsto30%oftheentireT2DM population,thatthetype2diabetespopulationwillstagnateand subsequentlyitscost(Figure6,run3).

ScenarioRun4:PolicyOption1

Policyoption1isamoderatelysuccessfuladditionallifestyle program(successrateoftheprogramis30%,or0.3)but merelyfocusesontheT2DMpopulation.Tokeepthecostdown (averagecost),theprogramcanonlyfocuson30%oftheT2DM population.Asaresult,theprogramturnsouttoleveloffthe costsintheyear2025(foracloserlook,simulationofthe

FIGURE6| Simulatedchange in (A) thetotalcostforsocietyassociatedwithT2DMpopulationand (B) thetotalT2DMunderfivedifferentscenariostested,whichare activatedin2020(detailsofscenariosindicatedin Table2).

costforsocietyofthepolicyrunispresentedin Figure6, run 4).AlthoughitpracticallylevelsoffthegrowthoftheT2DM population,theprogramisstillahighsocietalburdeninterms ofcost.

ScenarioRun5:PolicyOption2

Policyoption2isafairlysuccessfuladditionalintegrated program(successrateoftheprogramis45%or0.45forboth T2DMpatientsaswellas30%or0.3forpre-diabetesbillionby2) forT2DMpatientsandstandard(1.0)forpre-diabetespatients. Asaresult,theprogrambringsdowntheT2DMpopulationtoa farextentandisarelativelysmallinvestmentforthebenefitit brings(Figure6,run5:asmallbumpin2020,whichisbeing correctedthroughanextensivelylowerT2DMpopulationand thusadecreaseintotalcostforsocietyofaroundtwobillioneuros in7years).Thecombinationturnsouttobesuccessfulfortotal costforsocietyinthelongrunwhileensuringthatonlyasmall investmentneedstobemadeforthesocietytoimplementthis integratedprogram.

ScenarioRun6:PolicyOption3

Policyoption3isanexpensive(pricingmultipliedby4)yetvery successfuladditionalprogramfocusedontheT2DMpopulation (successrateoftheprogramis60%or0.6forT2DMpatients). Asmentioned,personalizedcareisexpensive,hencefourtimes thestandardcosts.OnecanseeadrasticdecreaseintheT2DM population.Intermsoflong-termgain,thisisthemostsuccessful optionforbothreductioninT2DMpopulationastotalcost,but morepractically,thiscomesataprice.Thestakeholdersneedto preinvestasmuchas1billioneurosinthisprogram(Figure6, run6:alargebumpin2020of1billioneuroscomparedtocurrent policy)togetthisresult,whichlikelywillresultinlargeresistance ofstakeholders.

DISCUSSION

Thisstudywasperformedtodemonstratehowdynamic simulationscanbeusedtoexploretheconsequencesofpolicies inordertodesignlifestyleinterventionprogramsofacomplex diseaselikeT2DMbasedonscenariostestedthrough“whatif”experiments.Atfirst,understandingofthepatientjourney fromanormoglycemicand/orobesehealthstatetowardprediabetestowardtype2diabetes,andviceversa,wasbasedupon literaturedata,databases,andexpertinterviews.Thereafter,a detailedstudytocaptureavailablecostforsociety,currentpolicy, andavailableT2DMinterventionprogramswerecollected.The combinationofliteratureandempiricaldata,discussionswith knowledgeexperts,andseveralpubliclyaccessibledatasourcesin TheNetherlands,appearedtobesuccessfulfordevelopingafirst versionofanSD-basedsimulationtoolfocusingonthepatient journeyoftype2diabetesasacomplexreversaldisease,andthe associatedtotalcostforthesociety.Theanalysespresentedin thisstudydemonstratetheinsightsandconclusionsonecould drawfrombuildinganSDmodelanduseitforsimulation experiments.Theexperimentsimprovedunderstandingofsome characteristicdynamicsofthesimulateddiabetespopulation inTheNetherlands:(1)obesityisamajorfactordrivingthe

growthofpre-diabetesandassuchT2DMprevalence;(2)the inabilityofthecurrentpolicytoreduceT2DMprevalencein thelongterm;(3)lifestyleinterventionprogramsfocusingon T2DMalonereduceT2DMpopulationonshorttermbutisless effectiveoverlongertime;and(4)thesignificantdelaysbetween primarypreventioneffortsanddownstreamimprovementsin diabetesoutcomes.Theseresultsindicatetheneedforadditional interventionprogramsfocusingonpre-diabetics.

Theparticipatoryprocessofbuildingsimulationmodelscan helpimproveourunderstandingofacomplexchronicdisease dynamicsliketype2diabetes.Inaddition,itcanalsoidentifythe missingdataneededtoimprovethemodelandourknowledge andmayenhancethecommitmentofcollaborativeparticipatory actionresearchtocollectlongitudinaldataforevaluationof theinterventionprograms.Asaconsequence,thismayresult inmorecost-effectivelifestyleinterventiondesigns.However, allsimulationmodelshaveseveralinherentlimitations.All modelsremainincompletesimplificationsofthereality,andtheir conclusionsareaffectedbothbystructuralboundariesandby theuncertaintiesofthedatawithwhichtheyarecalibrated(59). Techniquessuchasboundarycritiqueandsensitivitytesting (59, 64)canbeusedtoassesstheextenttowhichmodelsmay beaffectedbythesesimplificationsanduncertainties.Inthe caseofthetype2diabetespatientmodel,sensitivitytesting suggeststhatthemagnitudesofitssimulatedfutures,suchas thoseseenin Figure1,aresubjecttosomeimprecisionbecause ofuncertaintiesaboutinputparametersbutthatthedirections ofchangeandthusourgeneralfindingsareunaffectedby theseuncertainties.

Limitations

Tocalibratethemodel,accessibledatabasesinTheNetherlands of,amongothers,CBS,KPMG,NederlandseZorgautoriteit, NIVEL,RIVM,andTNOwereused.Forsomeconcepts,data estimatesandassumptionsintrendsandratehadtobemade duetolimiteddataavailabilityorconflictingdatasets.No distinctioninagegroupswasmade,asspecificdataforall othervariablesperagegroupwerescarce.Ageisconsidered tohavealimitedeffect,asthefractionofindividualsbelow theageof20yearsoldsufferingfromT2DMiscloseto0 (31).Theaveragelifeexpectancyofahealthyindividualin TheNetherlandsis81.7years(31).Assumingthatundiagnosed individualsunawareof theirT2DMconditionpassawaysooner thanindividualsawareoftheircondition,ashortenedlifespan of10and8yearswasconsideredfortheundiagnosedprediabetespopulationandthediagnosedpre-diabetespopulation, respectively.FortheT2DMpopulation,ashortenedlifespanof9 yearswasassumed.

Publiclyaccessibledataonsustainablerecoveryratesarenot availableyet.Itisassumedthatalreadyrecoveredindividuals andnormalhealthyindividualsdevelopT2DMatthesamepace. Forbothdiagnosedpre-diabetespopulations,asthediseasehas notyetprogressedasmuch,itisassumedthatthemotivationto recoverofdiagnosedpre-diabetespatientsufferingfromIFGor IGTispresent,andthus,therecoveryfractionfortheIFG/IGT diagnosedpre-diabetespopulationwassetat10%.Furthermore, itwasassumedthatundiagnosedpre-diabetespatientsare

unawareoftheirconditionandthusaretheleastmotivatedto recoveror simplydonotknowabouttheirdiseaseuntilitis toolate.Therefore,therecoveryforundiagnosedpre-diabetes populationwassetat5%.

Inthesubmoduletotalcostforsociety,somecostswere determinedforthetotalDMpopulationinaccordancewith therelevantliterature,thecostsfortheT2DMpopulationwere determinedbytakingtheproductofthetotalcostforsociety ofthetotalDMpopulationandthefractionthat9outof10 DMpatientssufferfromT2DM(6, 31).Additionally,itwas assumedthatallT2DMpatientsandallpre-diabetespatients areemployed.

SuggestionsforFutureWork

ForthefullpotentialoftheT2DMpatientjourneymodel,itis clearthatextralongitudinaldataneedtobecollectedtoimprove theprognosticvaluefordecision-makingondesigninglifestyle programstoreducetype2diabetesonDutchpopulationlevel. However,basedupontheavailabledata,themodelshowedthat comparedwiththecurrentsituation,thepolicyoptions3and 4areobservedtobethemosteffectiveintermsofdecrease inT2DMpopulationandreductionintotalcostforsociety. Thisisduetothesepolicyoptionshavingthehighestreference frame—theseprogramsapplytotheentirediabetespatient journey.Therefore,webelievethatfutureresearchshouldfocus onidentifyingthemostoptimalpolicyoptionsunderasimilar approach.Thatis,conductingscenarioanalysiswithindividual policysuccessratespergroupinthepatientjourneyinacertain contexttakingconstrictionsintoaccount,whilecollectingthe dataasindicatedin Table2 overtimetoevaluatethelifestyle programwhileimprovingtheT2DMpatientjourneymodel.

Thepresentstudyarguesthatbothcreationofawareness onpre-diabetes,combinedlifestyleprograms,andcollective actionsareimportanttoreduceT2DM,asbesidesthecurrent expenditureofbillionsofeurosthatarelargelyavoidable, itcouldcontributetopositivesocietalchangeandreverse obesogenictendenciesinDutchsociety.Policyshouldnotonly focusonmedicationorlifestyleinterventionprogramsinthe caseofseveresymptomsbutalsofocusonearlyprevention programsbysupportingsustainablechangetowardahealthy diet,exercise,sleeppattern,andreductioninchronicstress,for afullremissiontowardahealthystate.Currently,individuals deliberatelyneedtomakelifestylechangestomanagetheirblood glucoselevels,whereasamoresupportiverolefromsociety andpublicauthoritiestoreduceunhealthystressorswouldbe beneficial.Overtheyears,somechangeshavebeenmade,such aspromotingdailyexerciseandinstallingbikelanes.Atthesame time,however,grocerystoressellunhealthyproductsateyelevel, andtoooften,stairsareinstalledbehinddoorswhileelevators areprominentlyplacedatthemainentranceofofficebuildings. Dutchcitizensarethereforereceivingcontradictoryprompts fromtheirsocialenvironment,andatensionappearstoexist betweenincentivesthatpromotehealthyandunhealthylifestyles.

Toparameterizethemodeltoreality,assumptionshadtobe made.Inaccordancewith(65),eachassumptionisexplicitly stated in the SupplementaryData andopenforcriticism. Therefore,futurestudiesshouldbefocusedondiscussionof

theseassumptionsbygainingknowledgeandlongitudinaldata onthedevelopmentof(un)diagnosedpre-diabetesandthe recoveryprocessof(un)diagnosedpre-diabetespatients.This willalsoresultinlessparametersensitivityinthebehavior sensitivityanalysis.

Additionally,whenassessingtheeffectivenessofthepolicy options,theunderlyingassumptionisthatthatallindividualsare abletomakesustainablelifestylechangesthatcontinuebeyond thetimeframeofthemodel.However,futurestudiesshouldfocus onincludingtheeffectofthisassumptionfortworeasons.First, themajorityofT2DMpatientsareelderly(35).Consequently, thoseindividuals havepracticedunhealthylifestylesforalong periodoftime.Hence,itcouldbearguedthatthislimitsthe successofadoptinganewlifestyle.Second,asT2DMismore progressedthan(un)diagnosedpre-diabetes(1),itisarguable thatit ishardertomakebehaviorallifestylechangesforT2DM patientsthanfor(un)diagnosedpre-diabetespatients.Another assumptionthatshouldbechallengedinfutureresearchisto measuretheeffectofstakeholders’budgettoinvestmentin lifestyleprograms.

Moreover,futurestudiesshouldincludetheeffectofgender, educationlevel,socialstatus,migrationbackground,andculture, asresearchsuggeststhefactorstobeofsignificantinfluence inthedevelopmentofT2DM(66, 67).Withmoreaccurate dataof thelocalsituation,themodelhasthepotentialto supportlocalpolicymakerswithnewinsightsandhypotheses exante implementationofpreventionandlifestyleintervention programsformoresustainable(cost)effectivenessintheirown region.However,evenwiththeirinevitableimprecisionand incompleteness,simulationmodelscanenhancelearningand decision-making,whichistheirprimarypurpose(59).

CONCLUSION

Inthe presentstudy,weusedSDmodelingtobuildaprototype modeltobeimplementedintoasimulationtooltogainaclear understandingofthetype2diabetesmellituspatientjourney andtoassesstheimpactoflifestyleinterventionprogramson totalcostforsocietyassociatedwithdeveloping,preventing, andlifestyletreatmentofpre-diabetesanddiabetes.Wewere abletocapturetheextensiveknowledgeofdiabetes,current availabledataonbothpopulationlevel,lifestyleintervention programs,andassociatedcostforsocietyinTheNetherlands intoonesimulationmodel.Themodelwasabletovisualize andmeasuretherelationshipbetweenleveragepointsonthe differentoutcomesoflifestyleprograms.Whenassessingthe policyoptions’effectivenessintermsoftheirtotalcostfor societyreductions,themodelshowsthatsimulationruns5and 6provetobemosteffectiveintermsoflong-termsocietal costreductionandsimulationrun1istheleasteffectiveone. Asthesystemicapproachshows,thisisduetofocuspoints inthemodel:Simulationruns2–4aremerelyfocusedonthe reductionincurrentT2DMcases,whichislargelyincreasingcost aspersonalizedcareisexpensive.Simulationruns5and6takethe entireclientjourneyintoaccountandaddressesapersonalized optiontobothpre-diabeticsandT2DM.Inthisway,more

individualswithdiversifiedproblemsgettreated,preventingthe numberof individualsdevelopingT2DMtoalargeextentand thus,withmorefocusedeffort,lowercostforsociety.However,a crucialremarkonpracticalityshouldbemadeintheassessment. Insimulationruns2and6,althoughmoreeffectivefortheT2DM populationaswellascostinthelongrun,largesumsofmoney arerequiredtoinitiateandmaintaintheprograms.Simulation run5,however,althoughlowerinsuccess,requiresafarlower initialinvestmentandisstillveryeffectiveintermsofreduction intheT2DMpopulation.Simulationrun5(orPolicyoption4)is therefore,inapracticalsense,consideredthemosteffectivepolicy optionthatispresentedinthisstudy.

Toourknowledge,thisisthefirstintegratedsimulationmodel ofthetype2diabetespatientjourneyinTheNetherlandsfrom thenormoglycemictothediabetespopulation.Webelievethat throughscenariosimulationsofcomplexlifestyleintervention programsinanearlystageofdesignandimplementationprocess, the(cost)effectivenessoflifestyleinterventionprogramsfor diabetesscanbeimproved.

DATAAVAILABILITYSTATEMENT

Thedatasetspresentedinthisstudycanbefoundinonline repositories.Thenamesoftherepository/repositoriesand accessionnumber(s)canbefoundbelow:WorldBank,Dutch databasesofStatisticsNetherlands(CBS),DutchHealthcare Authority(NZa),TheNationalHealthCareInstitute(ZIN), NetherlandsInstituteforHealthServicesResearch(NIVEL), NationalInstituteforPublicHealthandtheEnvironment (RIVM),DutchDiabetesResearchFoundation(DiabetesFonds),

DutchDiabetesAssociation(DVN)andtheNetherlands OrganizationforAppliedScientificResearch(TNO).

AUTHORCONTRIBUTIONS

TSandLL:frameworkandmodel.HW,LL,andTS:literature review.TS,GV,andLL:methodology.SÖ:input.HW: supervision.TS:results,graphs,analysis,andconclusion.TS andHW:discussionandfinaledits.HW,GV,andSÖ: review.Allauthorscontributedtothearticleandapprovedthe submittedversion.

FUNDING

ThisresearchwasfundedbyTNOinternalresearchsources.

ACKNOWLEDGMENTS

Dr.S.Wopereis,Dr.B.vanOmmen,Dr.J.J.W.Molema, andMscS.Deutenaregreatlyacknowledgedfortheir intellectualinputontheT2DMpatientjourneymodel. WethankProf.Dr.E.vandenAkker-vanMarlefrom LeidenUniversityMedicalCenter(LUMC)fordiscussionson healthcarecosts.

SUPPLEMENTARYMATERIAL

TheSupplementaryMaterialforthisarticlecanbefound onlineat:https://www.frontiersin.org/articles/10.3389/fpubh. 2021.652694/full#supplementary-material

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Copyright©2021Sluijs,Lokkers,Özsezen,VeldhuisandWortelboer.Thisisan open-accessarticledistributedunderthetermsoftheCreativeCommonsAttribution License(CCBY).Theuse,distributionorreproductioninotherforumsispermitted, providedtheoriginalauthor(s)andthecopyrightowner(s)arecreditedandthatthe originalpublicationinthisjournaliscited,inaccordancewithacceptedacademic practice.Nouse,distributionorreproductionispermittedwhichdoesnotcomply withtheseterms.

published:07May2021 doi:10.3389/fsoc.2021.675530

Editedby: AndrzejKlimczuk, WarsawSchoolofEconomics, Poland

Reviewedby: MohitNayal, NationalMaritimeFoundation, India ElizabethShen, FudanUniversity,China

*Correspondence: MichalBeno beno@mail.vstecb.cz

Specialtysection: Thisarticlewassubmittedto SociologicalTheory, asectionofthejournal FrontiersinSociology

Received: 03March2021 Accepted: 23April2021 Published: 07May2021 Citation: BenoM(2021)AnalysisofThree PotentialSavingsinEWorkingExpenditure. Front.Sociol.6:675530. doi:10.3389/fsoc.2021.675530

AnalysisofThreePotentialSavingsin E-WorkingExpenditure

MichalBeno* InstituteofTechnologyandBusinessinCeskeBudejovice,CeskeBudejovice,Czechia

Theaimofthisresearchstudyistocontributetothesustainabilityofe-workinginitiatives, speci ficallybyexploringthreeemployee- financialimpacts.Thestudyadoptedatwo-step methodologicalapproach: firstly,acomprehensivereviewoftheexistingliteraturewas doneand,secondly,secondarydataanalysiswascarriedout.Thestudyanalyseshow threepotential financialbenefitsfore-workersdifferinvariouscountriesandwhetherthese canincreasee-workers ’ earnings.Itwasfoundthattherearesignifi cantbenefits. Regardingtheaffordabilityofahome,e-workingpresentsausefultooltomovetoless costlyregions.Thisreducesthestrugglewithhousing.Asidefromhousing,commutingis oneofthelargesttimeandcostconsumingexpenses.Basedonourcalculations,all employeescansavecommutingtimeandmoneybyusingpublictransportortheirown vehicles.Importantconsiderationsherearethecosts,suchasfuel,insurance,tolls,time, healthandenvironment.Makingcappuccinoorcoffeeathomeisausefulwaytodecrease expensescomparedtobuyingthematacafé.Generally,theresultsindicatethatan increaseofe-workingtendstodecreaseselectedexpensesofemployees.Thispaper pointoutsthat,onthebasisofaveragecostings,e-workingdecreasesselectedexpenses ofemployees.The findingsalsoindicatethatmorelong-termandcomprehensivestudies areneeded,especiallyinrelationtootherbene fits,suchaslunch,childcareandclothing. Thisstudyhascontributedtohighlightingthee-working financialbenefitsfore-workersby notcommutingtowork.

Keywords:E-workingexpenditure,affordabilityofhome,commuting,cappucino,coffee

INTRODUCTION

E-working(teleworking,telecommuting),inbrief,workingfromhome,isnotanewconcept.The ILOhasestimatedthat7.9%oftheglobalworkforce(5.6%menand11.5%women)workfromhome (thisincludesface-to-displayworkers)onapermanentbasis(ILO,2021).WiththeCovid-19 pandemic,thenumberofemployeesworkingfromhomehasincreaseddramatically,especiallyinthe white-collarworkers’ sector(Belzunegui-ErasoandErro-Garcés,2020),butpeoplewiththelowest incomesandeducationalattainmenthavebeendisproportionatelyaffected(Lundetal.,2020). Recentresultsofasurveyfrom Argentina showthat80%oftheworkforcewasengagingintelework asapolicyofsocialisolation(SanchézZinny,2020).

Sincethepandemicoutbreak,therehavebeensomeattemptstodeterminetheteleworkability potential. Sosteroetal.(2020) estimatethat37%ofdependentemploymentintheEUiscurrently teleworkable. DingelandNeiman(2020) foundthatintheUnitedStatesthesamepercentageofjobs isperformedentirelyathome.Additionally,Saltiel’s(2020)resultsshowthatonly13%ofworkersin developingcountriescouldworkfromhome,yetthissharerangesfrom5.5%inGhanato23%in

Yunnan(China).InAustralia,almost40%ofalljobscanbedone fromhome(UlubasogluandOnder,2020).

Intheliterature,agreatdealofattentionispaidtothe potentialbenefitsofe-workingfromtheemployee’ s perspective(BernardinoandBen-Akiva,1996; Mokhtarianand Salomon,1997; Mokhtarianetal.,1998; KitouandHorvath,2003; Shafizadehetal.,2007).

Theobjectofthisresearchistocontributetothesustainability ofe-workinginitiatives,specificallybyexploringtheemployeefinancialimpacts.Theimpactofthecostsforemployeesvaries. Employeescansaveconsiderablybye-commutingbut,other costsforemployees,so-calleddirectcosts(fuel,electricityandairconditionuse,mobilephones),increase.Theimpactofe-working isnotequallydistributedamongdifferenttypesofemployees, employersandcountries.Toachievetheobjectofthisresearch, wesetouttounderstandthisimpactbyanalyzingsecondarydata ofvariables,namelyhousing,commutingandcappuccino/coffee. Theaffordabilityofhousinghaslongbeenaglobalproblem (Makridis,2019; Eurostat,2021).Secondly,commutinghasalso beentiedtoincreasesinlaborcostsandlossesinproductivity (GrinzaandRycx,2020).Finally,coffeeisatypicalemployee habitduringanordinaryworkingday(CoffeeandHealth,2017) andincreasestheexpenses(SoPure,2019)ofdifferent generations,gendersandindustrysectors(PBFY,2019).This analysiswillshowtheincreaseddisparitybetweene-workersand intensiveface-to-faceworkerswhoaregenerallypaidless.

Themainresearchquestionsinthisstudywere:

• toanalyzehowthreepotential financialbenefitsfor e-workersdifferinvariouscountries and

• whetherthesecanincreasee-workers’ earnings.

Thenextsectionpresentsaliteraturereview.Inthesecond part,themethodologyisintroduced.Theresultsofthestudyare presentedinthefollowingsection.Thefourthsectionisthe discussion,andthelastpartconcludeswithasummary.

THEORETICALBACKGROUND

Inthepre-Covid19period,Europeancountrieswerereluctantto implemente-working(BenoandHvorecky,2021).Bute-working hasbeenagrowingphenomenonintheadvancedworldcompared todevelopingcountries(AnsongandBoateng,2018).Thisis revealedinrecentstudies,whereitisshownthatnearly100 millionworkersin35advancedandemergingcountriescould beathighriskbecausetheyarenotabletoworkremotely.The poor,theyoungandwomenaremostatrisk(Brussevichetal., 2020). DingelandNeiman(2020) indicatethatthedeveloped worldhasalowprevalenceofjobsthatarecompatiblewith workingfromhomecomparedtotheadvancedworld. Saltiel (2020) estimatedthatonly13%ofemployeesfromten developingcountriescouldworkfromhome. Delaporteand Pena(2020) evaluatedtheshareofindividualsworkingfrom

homefrom7%inGautemalato16%intheBahamas.Thisis causedbyoccupationalstructures[higher-skilledvs.lower-skilled jobs(Watson,2020)],age,genderandeducation(Brussevichetal., 2020),andincomelevel(ILO,2020).

Telecommuting,virtualofficeandteleworkareafewofthe termsusedtodescribethesamephenomenon(SihaandMonroe, 2006).Simply,e-workersarethoseworkerswhoareworking outsidetheorganisation’spremisesusingmoderntechnology. Be ˇ noandFeren ˇ cíková,(2019) believethate-workingisatriplewinoption.

Workingfromhomehasvariousbenefits.Accordingtodata from Citrix(2019),potentialUnitedStateseconomicgainsfroma flexibleworkingculturecouldamounttoapproximately$2.36 trillionperannum.Possibleemployeebenefitscanbebrought aboutbyemployersencouragingtheiremployeestodotelework (Deloitte,2011).E-workingcanreducecostsforbothemployer andemployee(Madsen,2003).But Bernardino(1996) suggested thattheexpectedperceivedsavingsandtheactualsavingsmay differ.Inthisstudy,the financialbenefitshavebeenexamined.

Accordingto RiswadkarandRiswadkar(2009),employeescan derivearangeofcostsavingsthroughteleworking. Listerand Harnish(2011) reportthate-workingsavesemployeestimeand money.Theseauthorsalsosaythatteleworkcouldsave employeesbetween$250and$2700ayear(Listerand Harnish,2013).

Someoftheemployees’ workrelatedexpensesdecrease (Kanellopoulos,2011),e.g.,travelorprofessionalworkoutfits (RiswadkarandRiswadkar,2009),officeclothingandlunches (FordandButts,1991).Anotherstudyshowedthatoverhalfof theparticipants(57.1%)indicatedsomewhatofareductionin monthlyexpenses(BaardandThomas,2010).Savingmoneyis possiblebydispensing with thecommutetotheoffice(Wienclaw, 2020, p.2).Additionaly,savingsarederivedfromareductionin fuelandwearandtearofthevehicle(FordandButts,1991)or costsforparkingandothertransport(Wienclaw,2020).This confirmstheILOpaper(ILO,2016)thatteleworkerscanreduce allthesecosts,includinginsurance.Accordingtodatacollectedby GargandvanderRijst(2015),employeescouldsaveanaverageof 822.06randspermonthiftheydonottraveltowork.Dell employeeswhoonaverageworkremotely10daysamonth saveabout$350ayearincommutingcosts(Sahadi,2016). Furthermore,workingremotelyonaverage2.4daysper workingweekwouldamounttocostsavingsof$44.4billion oncommutingspentonticketsorfuel(Citrix,2019). Swink (2008), p.862alsoaddsthathomeworkingemployeesmayenjoy reducedexpensesforworkattire,lessstressandreduced transportationexpenses.Another financialbenefit,especially forthesandwichgeneration(middle-agedadultswhoare caringfortheirelderlyparentsandtheirownchildren),isthe decreasedcostforbabysitting/kindergartens/nurses(Lupu,2017) andafter-schoolactivities(Wienclaw,2020).

METHODOLOGY

Inthispaper,atwo-stepmethodologicalapproachhasbeenused. Firstly,acomprehensivereviewoftheavailableexistingliterature

onthe financialbenefitsofe-workingisdonebecausea substantiveandthoroughliteraturereviewisthebasisforany goodresearchproject(BooteandBeile,2005).

Next,asecondarydataanalysiswasimplementedtocreatea startingpointforfutureanalysis.Inthisstudy,secondarysources wereusedtoanswertheresearchquestionbecausetheyoffera goodcollectionofexistingdata.Furthermore,sincethematerial beinginvestigatedcomprisesalargestudyingunit,itis impracticaltostudyitdirectly.Sourcesofsecondarydata includedjournals,newspapers,websitesandgovernmentand otherorganizationrecords.Thisincludestherelationship betweenvariablesandthecauseofaparticularvariablein relationtoe-working.Followingtheexigenciesofsettled researchquestions,inquiriesweremadeaboutappropriate existingarchivalsources.Theresearchquestionswere “the dictatorshipoftheproblem” (Vogt,2008).

Onthebasisofresearchquestions,weidenti fi edappropriate secondarydatainthesesteps:identi fication,selection, examination,conductinganalysesandinterpretingresults.In contrasttoprimarydata(individual/teamofresearchers designs,collectsandanalysesdata),analysisofdatacollected byotherswasalsoused.TheUnitedStatesdollar,astheworld ’ s leadingcurrency,wasusedforthecalculations.Inorderto performcommutinganalyses,itisnecessarytoconsiderthe amountandpatternoftravelofthepopulationinthecities surveyed.InLondon,27%ofworkerstypicallytraveledtowork bycar,44%byrail,13%bybus,9%onfootand5%bybicycle (GOV.UK,2019).The2011HongKongpopulationcensus showsthattherewasmoremasstransport,70.1%(busand train),thantravelbycarandtaxi,10.5%( Census,2011 ).Hong Konghasalwaysbeenlesscar-dependentthanothercities (CullinaneandCullinane,2003; Dawdaetal.,2019). Moreover,tobeef ficient,availableandproductive( Dawda etal.,2019),acommutingsystemmustservedifferent requirementsintheformofmultimodaltransportation modes,e.g. Kuhnimhofetal.(2006) foundthatmultimodal individualsinGermanytendtousecarsseveraltimesperweek andusepublictransportlessregularly,preferringtocommute. Nobis(2007) presentedanextensiveoverviewofmultimodality (car/bike,car/publictransport,bike/publictransport,car/bike/ publictransport). HeinenandBohte(2014) pointtopublic transport(railorunderground)andcyclingasresulting multimodalgroups.Cyclingasamultimodaloptionis affectedbypositiveweatherconditions( Heinenetal.,2011). TheCityofLondonhasalongtraditionofamultimodal integratedsystem( Dawdaetal.,2019).

Theutilizationofavailabledatatoanswerresearchquestions hasseveralbenefits(lesstimeandresourcesarerequired,accessis obtainedtolargeandwide-rangingdatasets).Somelimitations dooccur,includingalackofknowledgeoftheexistenceofrich datasetsandhowtoobtainandevaluatethecontents,insufficient oroutdateddata,andlackoffundstohirestafftoassistwiththe work(Dunnetal.,2015).

Thisanalysisstrategyisgearedtowardproducingactionable findings.Furthermore,these findingsalsoprovideinformation forfurtherresearch.

FINDINGS

Recentarticlesdrawtheattentiontothemostcostlyelementsof e-working.Forexample,remoteworkwillcostbusinessinJapan morethan1.3trillionyen(Nakafuji,2020). Munk(2020) stresses thatdespitethepotentialsavings(commuting,dry-cleaningbills, shoppingforworkattire),therearesomehiddenexpenses,such aselectricitybills,phonedataplans,suppliesforthehomeoffice andwearandtearofpersonaldevices.Interestingly,arecent CreditCards.comsurveyshowsthatworkingfromhomedueto thepandemiccostshouseholdsabout$108morepermonth (Segal,2020).

Housing

Themainbenefitofe-workingisthatoneworksfromhomeor anotherlocationinsteadofworkinginacubicle.Arecentstudyby Redfinrevealedthataquarterofparticipantsmoveforreasonsof affordability,andalmost60%saidtheirabilitytoaffordnonhousingexpensesandleisureactivitiesimprovedaftertheir relocation(Katz,2020).Thelatestdatarevealthat14millionto 23millionAmericansareplanningtobenefitfrome-workingby seekinghousinginmoreaffordablemarkets,withthebiggestoutmigrationoccurringinmajorcities(Upwork,2020).

Generally,peoplechoosewheretoliveonthebasisoftheir workplaceandtrytoavoidlongcommutes.Buttimeshave changedduetothehighhousingpricesaroundtheworld. BasedonaDemographiaInternationalHousingAffordability Survey,the10leastaffordableinternationalhousingmarkets rankedbyhousepricetoincomeratiowereHongKong, Vancouver,Sydney,Melbourne,LosAngeles,Toronto, Auckland,SanJose,SanFranciscoandLondon(Coxand Pavletich,2020).Notably,NewZealand,HongKong,the UnitedStates,theUnitedKingdomandAustraliaarethetop regionsdoingbusiness(WBG,2020),buttheyareatthetopof thosewiththeleastaffordablehousing.Throughe-working, doingbusinessremotelyoffersemployeestheopportunityto participate/workwithoutbeingpresent.Conversely,baby boomers,onaccountoftheirageandchildren,were consideringdownsizingandmovingbackintocitieswhere walkabilityandurbanlivingaremoreappealing.E-working seemstobethecatalyst(Schreiber,2016).Thisisin accordancewiththelifecourseratherthaneconomicmotives inresidentialrelocationdecisions(Nijkampetal.,1993).As technologycontinuestoimproveandthesehousingtrends increase,moreemployeeswillrecognizethebenefitsof workingremotely.Theempiricalevidenceindicatesthatusing thehomeasaworkplacehasbecomeasubstantialfeatureoflabor marketsinmanywesterneconomiesandthatthishasincreased significantlyinrecentyears(DolingandArundel,2020).

Commuting

Oneofthebenefitsofe-workingisthedecreaseoftraffic congestionandlowercarbonemissions(KitouandHorvath, 2003; Shafizadehetal.,2007).Buttransportcostshavea significantimpactonthestructureofeconomicactivitiesas wellasoninternationaltrade.Empiricalevidenceunderlines

TABLE1| Commuting(London).

CommutingdaysTicketsperweekMonthlyticketpublic transport

5 10 $179.40

MonthlysavingsAnnualsavings

$0 $0

4 8 $143.52 $35.88 $430.56 3 6 $107.64 $71.76 $861.12 2 4 $71.76 $107.64 $1291.68 1 2 $35.88 $143.52 $1722.24 0 0 $0 $179.40 $2152.80

Source,Author’sowncalculationbasedon DeutscheBank,2019

TABLE2| Commutingbycar(HongKong).

CommutingdaysAveragedistancekma

5 308.40

Monthlysavingsspent onfuelb,c

Monthlysavingsspent onparkingd

$0 $0

4 246.72 $147.91 $138.44

3 185.04 $295.82 $276.88 2 123.36 $443.73 $415.32 1 61.68 $591.93 $553.76 00 $739.54 $692.20

aAveragedistance15.42km(Numbeo,2021). b20workingdays.

cAveragecostpergallonoffuel$2.40(GPP,2021).

dDailyparkingcost$34.61(Spacer,2021).

Source,Author’sowncalculation.

thatraisingtransportcostsby10%reducestradevolumesby morethan20%(RodrigueandNotteboom,2020).

Commutingisseenasoneofthelargesttime-consuming (trafficorwaitingfordelayedpublictransportmodes)and recurrigexpenses(fuel,parking,tolls,montlytransitpasses) thatmankindfaces.Onestudypresentedthebestandworst commutecitiesamong74worldwidecities(ExpertMarket,2019). In Table1,cost-savingcalculationsshowthatLondon‘smonthly ticketpublictransportisthemostexpensiveone,andalsoshow thatbesideslongcommutesandbarriers,costsavingscouldbe thereasonforfurthere-workingexpansion.Researchersfound thatanextraminuteofcommutingtimereducesbothjoband leisure-timesatisfaction,butincreasesstrainandworsensmental healthforworkers.Additionally,20minofcommutingtoand fromworkeachworkingdayhavethesameeffectonjob satisfactionasa19%reductioninpersonalincome(UWE, 2017).RecentlyitwasfoundthatLondonerscommute74min eachday(NE,2020)andspend$179.40eachmonthforaticket pass(DeutscheBank,2019).

Basedonthiscalculation,Londonerswhochoosehybrid working(partlyathomeandpartlyincubicles)atleast2days couldsave$71.76monthlyand$861.12annually,comparedto $2152.80annuallybyworkingremotelyfull-time,analmost threefolddifference(seehighlighteddatain Table1).

Bycommuting,driversincuranumberofcosts.In Table2, calculationsofoverallsavingsforHongKongarepresented.

Commutersspendonaverage42.42min(Numbeo,2021)a daycommuting-14hamonthor170hperyear-whichisalmost comparabletotheUnitedStatesrate(Vasel,2015).Theaverage

HongKongcommuterdriverspendsover$739.54monthlyon fueland$692.20monthly(ashighlightedin Table2)ondaily parking(28%ofmen’smonthlyincomeand37%offemale’ s monthlyincome(Stotz,2021)),or$352onamonthlybasis (Spacer,2021)onparkingalone(14%ofmen’smonthly incomeand19%offemales’ monthlyincome(Stotz,2021)), whichcouldbesavedinitsentiretybye-working,butonly 3.12%ofemployeesinHongKongworkfromhome (Numbeo,2021).Savingmoneyoncostcomponentssuchas fuel,insurance,tolls,time,healthandtheenvironmentshouldbe furtherconsidered.

Coffee

Coffeeiscelebratory.Itsconsumptionisuncommon,andits uncommonnessimbuesitwithauniquemystiqueassociatedwith awealthy,refinedandintellectuallyevolvedclass.Coffeeis predominantlyanoutsidedrink,itderivesitsutilityfroma social,estheticandemotionalrole(Verma,2013).Coffeehas becomeanimportantpartofsocietalnormsacrosstheglobe (Waxman,2004; Almqvistetal.,2007; Moretti,2017).

Millennialsspend$2008ayearatcoffeeshops(Mckenzie, 2020),andtheaverageAmericanspendsabout$1100ayearon coffee(Acorns,2020).Furthermore,thedatahighlightthat41% ofthemadmittedtospendingmoreoncoffeeinthepastyearthan theyhadinvestedintheirretirementsavings(Mckenzie,2020).

Generally,wesavemoneybymakingthingstoeatortodrink athome(Thorpe,2012). McCleanetal.(2020) foundthat somethingassimpleasmissingone’sregularmorningcupof coffeecancausethatemployeetobegintheworkdaylesscalmand

TABLE3| Morningcappuccinoandcoffee.

CommutingdaysMonthlycappuccinoata

5 $126.00 $0 $124.80 $0 4$100.80$2.00$99.84$0.80 3$75.60$4.00$74.88$1.60 2$50.40$6.00$49.92$2.40 1$25.20$8.00$24.96$3.20 0$0$10.00$0$4.00

Source,Author’sowncalculation.

morementallyexhausted.Thecostsforcoffeeorcappuccinovary fromcountrytocountryandfromcontinenttocontinent(CCM, 2019; DeutscheBank,2019).AcappuccinoinCopenhagencosts $6.30(DeutscheBank,2019),andacoffeecosts$6.24inDoha (CCM,2019).Wehavecalculatedthatmakingmorning cappuccinoathomecosts$0.50andcoffeecosts$0.20.As shownin Table3,makingmorningcappuccinoandcoffeeat homeischeaperthanbuyingit.AnemployeeinCopenhagenwho drinksonemorningcappuccinoon5daysaweekspends$126per month,butwhene-workingfull-timehe/shesaves$116monthly and$1392annually.Furthermore,whendrinkingonemorning coffeeanemployeespend$124.80permonth,butwhen e-workingfull-timehe/shesaves$120.80monthlyand $1449.60annually.Makingone’sowncappuccinoorcoffeeis clearlyawaytosavemoneywithworkingremotely,whetheritis full-timeornot.

DISCUSSION

E-workingcanhelptoreducetheemployee’sexpenses,asshown inthisstudy.Isitpossiblefore-workingtoaffecthousingchoices? Theriseofe-working(developingeconomiesadaptmoreeasily (Banaetal.,2020))enablesemployeestoliveandworkawayfrom theorganisation’spremises,evenalongwayaway.Thedatain thisstudyconfirmthattheshifttoworkingremotelyhaschanged andwillcontinuetochangehousingpatterns.Aworldinwhich e-workersworkathomemaynotonlyaffecttheformandchoices ofhousing,butalsoimpliesapotentialtransformationofthe physicalstructureofcities,thedistributionofpropertyvaluesand thebroaderlaborandhousingmarketsthemselves(Dolingand Arundel,2020).Whilethepandemicmayhavemadeofficesless accessible,hybridworking,co-workingande-workingwillbe muchappreciatedinthefuture. Wilsker(2008) statesthatthe averagefull-timee-worker,regardlessofsalaryscale,receivesthe equivalentofanannualsalaryincreaseof$8400duetothe reducedexpensesthatresultfrome-working(vehicle,clothing, parking,foodandinsurancecosts).Someoftheseexpenseswere examinedinthisstudywithpositivepotentialsavingsfor employees.Whatdoesitmeaninthelongterm?Asalso showninthisstudy,sometrendsarealreadyemerging. E-workersaremorelikelythancommuterstoresideinmore peripheralareas,suchasurbangreensettingsortownandrural areas,asstatedinananalysisfromtheNetherlands(Muhammad etal.,2007),wheretherateofe-workingisveryhigh.

CONCLUSION

Inthepre-Covidera,veryfewemployeesworkedfromhome(and thiswasusuallyonacasualbasis).Suddenly,e-workingexploded evenindevelopingcountries.Toworkfromhomesituationis expectedtocontinue.Theimpactofe-workingisnotequaldivided aroundtheglobeamongdifferenttypesofemployeesincluding age,gender,education,skillsandoccupationalstructures.

Inthisstudy,wediscussedandanalyzedthree financial benefitsofe-working.Threedependentvariableswereused: housing,commutingandcappuccino/coffee.Thestudywas conductedintwostages.The firststageinvestigatedthe financialbenefitsfore-working.Inthesecondstage, dependentvariableswereanalyzed.

Themainresearchquestioninvestigatedinthispaperis: Howthreepotential financialbenefitsfore-workersdifferin variouscountriesandwhetherthesecanincreasee-workers’ earnings? Ouranalysisconsidersbothquantifiableandnonquantifiableconsiderations.Itisclearthate-workerscan reducetheirexpensescomparedtoregularcommuters,evenin hybridorfull-timeworkfromhome.Wesetouttoresearchhow, intermsofcostsandbenefits(housing,commutingand cappuccino/coffee)apermanentincreaseinworkingfrom homewouldinfluenceoverallemployeeexpenses.Itwasfound thatincreasingtheperiodofworkingfromhomeisdrivenbycost savingsforemployees.Thistranslatestoareductionofthe struggleforhousing,lesscommutingandsavingmoneyby drinkingacappuccino/coffeeathome.However,inthose countrieswithagreatershareofinformaleconomyandalow prevalenceofremotejobs,theresultcanbethereverse.

Asmoderntechnologycontinuestoimprove,housingtrends willaccelerate,commutingwillbecomemoreexpensiveandtime consuming,andpriceswillincrease.Moreemployeesarelikelyto recognizethesavingspotentialthatcomesfromworkingfrom homeinsteadofcommutingtowork.Offeringa flexiblework cultureincludinge-workingcanbeaprofitablelong-term strategy.Ifcostscontinuetobelowerthanthoseforonlocation,moreemployerswillincreaseat-homework.The latestdataofonestudyindicatethatwhenworkersexperience higherWFHefficiency,theyhaveahigherpreferenceforWFH evenafterthepandemic.Additionally,femaleworkerspreferred WFHtwiceperweek,whilethemaleworkersmoreoften preferredWFHonceperweek.Finally,workersfromthe managementandtheself-employedlevelsdemonstrateda lowerpreferenceforWFH,comparedtothefront-lineand

middle-gradeworkers(Wongetal.,2020).Obviously,however, somejobsstillhavetobecarriedoutonsite.

Thelimitationsofthestudyarisemainlyfromnottakinginto considerationmitigating,location-culturalspecificexpensesin relationtodependentvariablesexploredinthisstudy(e.g.,air conditioning,electricity,freesnacksorlunches).Moreover,the modalityofgroupsdescribedinthemethodologygiveriseto furtherlimitations. Nobis(2007) notesthatmostadolescentsare multimodal,and Kuhnimhofetal.(2006,2012) determinedthat singlepeoplearemultimodal.

FURTHERRESEARCH

ThelabormarketimpactofCovid-19stillneedtobeexamined. Aspectsnotcoveredbythisresearcharetheanalysisoflunch, childcareandclothingvariables.Theseissuescouldbedealtwith infutureresearch.Thisisneededinordertounderstandhow additionaldatacanthrowfurtherlightone-workingasa

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DATAAVAILABILITYSTATEMENT

Theoriginalcontributionspresentedinthestudyareincludedin thearticle/SupplementaryMaterial,furtherinquiriescanbe directedtothecorrespondingauthor.

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MBconceivedofthepresentedidea,wasengagedinthe investigation,literaturesearchandselection,verifiedthe analyticalmethods,writingoriginaldraft,preparation,and finishingthelastversion.

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