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Preventive Care Guidelines: Too Much of a Good Thing?

Researchers suggest it might be time for some ‘de-intensification’

Editor’s note: The following is fourth in a series about changes occurring among primary care physicians.

Does anybody actually oppose the concept of preventive medicine for kids and adults? Ask yourself: How many

people do you know who believe that regular blood pressure checks at the pediatrician’s office or annual well-woman visits are bad?

Yet in a research report and accompanying editorial in JAMA Internal Medicine this fall, clinicians from the University of Michigan and elsewhere raised a red flag: They ask, Have we reached a point where providers have too many guidelines to keep track of, including those pertaining to preventive care? When professional societies or governmental agencies add recommendations to their guidelines, do they remove others of lesser value? Is it time to “de-intensify” preventive care guidelines?

“Much of health care involves established, routine, or continuing use of medical services for chronic conditions or prevention,” write the authors of “Identifying Recommendations for Stopping or Scaling Back Unnecessary Routine Services in Primary Care.” “Stopping some of these services when the benefits no longer outweigh the risks (e.g., owing to older age or worsening health) or when there is a change in the evidence that had previously supported ongoing treatment and monitoring, presents

45% of people with diabetes 45% of people with diabetes 45% of people with diabetes 45% of people with diabetes who have had a lower extremity who have had a lower extremity who have had a lower extremity who have had a lower extremity amputation pass away within 5 years1 amputation pass away within 5 years amputation pass away within 5 years1 amputation pass away within 5 years 1 1

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• In a randomized controlled trial,2 the effects of use of a MediHoney • In a randomized controlled trial,2 the effects of use of a MediHoney • dressing were studied in patients with Type II diabetes and Wagner Grade dressing were studied in patients with Type II diabetes and Wagner Grade In a randomized controlled trial,2 the effects of use of a MediHoney • In a randomized controlled trial,2 the effects of use of a MediHoney 1 and 2 diabetic foot ulcers (DFUs) over a 16-week period. 1 and 2 diabetic foot ulcers (DFUs) over a 16-week period. dressing were studied in patients with Type II diabetes and Wagner Grade dressing were studied in patients with Type II diabetes and Wagner Grade 1 and 2 diabetic foot ulcers (DFUs) over a 16-week period. 1 and 2 diabetic foot ulcers (DFUs) over a 16-week period. • Mean duration of healing time was 31 days (± 4 days) in the MediHoney • Mean duration of healing time was 31 days (± 4 days) in the MediHoney • group vs 43 days (± 3 days) in the control group. group vs 43 days (± 3 days) in the control group. Mean duration of healing time was 31 days (± 4 days) in the MediHoney • Mean duration of healing time was 31 days (± 4 days) in the MediHoney group vs 43 days (± 3 days) in the control group. group vs 43 days (± 3 days) in the control group. • Total Contact Casting is recognized by clinicians as the Gold • Total Contact Casting is recognized by clinicians as the Gold • Standard and Preferred method for off-loading DFUs.3, 4 Standard and Preferred method for off-loading DFUs.3, 4 Total Contact Casting is recognized by clinicians as the Gold • Total Contact Casting is recognized by clinicians as the Gold

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1. Moulik PK, Mtonga R, Gill GV. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care. 2003;26(2):491-494. 1. Moulik PK, Mtonga R, Gill GV. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care. 2003;26(2):491-494. 2. 1. Kamaratos AV, Tzirogiannis KN, Iraklianou SA, Panoutsopoulos GI, Kanellos IE, Melidonis AI. Manuka honey-impregnated dressings in the treatment of neuropathic diabetic foot ulcers. Int Wound J. 2012;9:1-7. 2. Kamaratos AV, Tzirogiannis KN, Iraklianou SA, Panoutsopoulos GI, Kanellos IE, Melidonis AI. Manuka honey-impregnated dressings in the treatment of neuropathic diabetic foot ulcers. Int Wound J. 2012;9:1-7. Moulik PK, Mtonga R, Gill GV. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care. 2003;26(2):491-494. 1. Moulik PK, Mtonga R, Gill GV. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care. 2003;26(2):491-494. 3. 2. Fife CE, Carter MJ, Walker D, Thomson B, Eckert KA. Diabetic foot ulcer off-loading: The gap between evidence and practice: Data from the U.S. Wound Registry. Advances in Skin and Wound Care. 2014;27(7):310-316. 3. Fife CE, Carter MJ, Walker D, Thomson B, Eckert KA. Diabetic foot ulcer off-loading: The gap between evidence and practice: Data from the U.S. Wound Registry. Advances in Skin and Wound Care. 2014;27(7):310-316. Kamaratos AV, Tzirogiannis KN, Iraklianou SA, Panoutsopoulos GI, Kanellos IE, Melidonis AI. Manuka honey-impregnated dressings in the treatment of neuropathic diabetic foot ulcers. Int Wound J. 2012;9:1-7. 2. Kamaratos AV, Tzirogiannis KN, Iraklianou SA, Panoutsopoulos GI, Kanellos IE, Melidonis AI. Manuka honey-impregnated dressings in the treatment of neuropathic diabetic foot ulcers. Int Wound J. 2012;9:1-7. 4. 3. Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care. 2001;24(6):1019-1022. 4. Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care. 2001;24(6):1019-1022. Fife CE, Carter MJ, Walker D, Thomson B, Eckert KA. Diabetic foot ulcer off-loading: The gap between evidence and practice: Data from the U.S. Wound Registry. Advances in Skin and Wound Care. 2014;27(7):310-316. 3. Fife CE, Carter MJ, Walker D, Thomson B, Eckert KA. Diabetic foot ulcer off-loading: The gap between evidence and practice: Data from the U.S. Wound Registry. Advances in Skin and Wound Care. 2014;27(7):310-316. 4. Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care. 2001;24(6):1019-1022. 4. Armstrong DG, Nguyen HC, Lavery LA, van Schie CH, Boulton AJ, Harkless LB. Off-loading the diabetic foot wound: a randomized clinical trial. Diabetes Care. 2001;24(6):1019-1022.

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a challenge for both clinicians and patients and is rarely done successfully even when evidence favors cessation.”

Personalize preventive care

“If we don’t work to get healthier as a nation, we will not be able to afford our healthcare,” says Eva Chalas, M.D., FACOG, FACS, president of the American College of Obstetricians and Gynecologists. “The steady and rather dramatic rise in healthcare cost is unsustainable.

“Prevention is truly worth a pound of cure,” she says. “Unfortunately, most Americans take better care of their cars and pets than their health. The obesity epidemic – which is responsible for the development of many other conditions, including hypertension, heart disease, type 2 diabetes, cancer and musculoskeletal diseases, amongst others – continues to be on the rise. We must convince our populations to engage in healthier lifestyles, and that medications are not a substitute for lifestyle changes.”

Preventive care guidelines can help, but “we should not practice ‘one size fits all’ medicine,” says Chalas. “I believe that preventive care should be personalized and as such, based on each patient’s risk factors to develop a particular condition.” In this, she agrees with the JAMA researchers, who advise against performing annual cardiac testing in individuals at low risk for cardiovascular disease.

“Gaps in health care of our patients continue to exist, and we need to find ways to engage them in their healthcare to minimize risk of development of chronic diseases, such as obesity, type 2 diabetes, hypertension, heart disease and cancers related to inherited deleterious mutations. Because obstetricians and gynecologists care for their patients across their lifespan, we are uniquely positioned to predict the risk of development of these conditions, since many initially occur in pregnancy, and help patients mitigate these risks.

“I believe that in the future, we will be using genetic information to identify risk factors for chronic diseases at birth, and working with parents and pediatricians on mitigation strategies,” she says.

Preventive care should be personalized and as such, based on each patient’s risk factors to develop a particular condition.

‘Clear and unambiguous’

Suzanne Berman, M.D., a pediatrician in Crossville, Tennessee, and chair of the American Academy of Pediatrics’

Section on Administration and Practice Management, agrees with the JAMA authors that subtracting one preventive care guideline for every new one that’s added isn’t a bad idea. But it’s not always possible, particularly with pediatrics. It’s difficult to characterize any pediatric preventive-care guidelines as non-essential, as they may add decades – not merely months or years – of healthy living to kids’ lives, she says.

But like the JAMA authors, Berman believes that guidelines – whether for prevention or therapy – must be clear and unambiguous. “A guideline that says ‘Avoid use of drug X for condition Y’ is too vague,” she says. “What does ‘avoid use’ mean?” Does it mean never use the drug for that condition, or does it mean only use it under certain circumstances? And are those circumstances clearly defined?

AAP policy-writers of the organization’s Bright Futures preventive care guidelines strive for precision, she points out. First launched in 1994 and updated regularly, Bright Futures offers a schedule of recommended preventive services for children, and it forms the basis for Medicaid’s Early and Periodic Screening, Diagnostic and Treatment (EPSDT) program.

Berman points out one more difficulty associated with guidelines: It can take a long time – years, in fact – for new ones to become standard practice. For example, a study may show incontrovertibly that early supplementation of iron for babies with anemia improves outcomes, yet years may pass before the majority of pediatricians are onboard. Perhaps it’s force of habit on the part of physicians or even insurers, or simply the fact that it takes time for the majority of clinicians to become aware of new guidelines, let alone integrate them into their practices.

At the same time, years may pass before the majority of doctors finally abandon practices that have been discredited. “We sometimes shake our heads and ask, ‘How can people still be doing that?’” she says. “After all, we are supposed to learn how to continually evaluate medical evidence.” But doctors are busy, they have their families and friends, or they may simply fail to stay current with certain protocols if they rarely see patients to which they apply.

Evidence-based medicine

“Preventative care is an integral and important part of family medicine,” says Amy Mullins, M.D., medical director for quality and science, American Academy of Family Physicians. “Screening for disease, then altering the course of that disease if needed, is life-changing for patients and ultimately saves the health care system dollars.

AAFP supports the use of evidence-based medicine, she adds. “This involves all aspects of medicine and is necessarily complex, complicated, and requires the use of many different guidelines.”

The AAFP reviews recommendations put forth by the United States Preventive Services Task Force (USPSTF) and the CDC’s Advisory Committee on Immunization Practices (ACIP), and either chooses to agree or disagree with their recommendations, says Mullins. “We also review guidelines from other medical organizations and either endorse, provide an affirmation of value, or do not endorse.

“Guidelines are routinely updated, and some are retired, as are the quality measures that are typically developed using the guidelines. The USPSTF and ACIP recommendations are also routinely updated. The AAFP utilizes a specific methodology for developing clinical practice guidelines based on available evidence and patient preferences.”

Preventive care guidelines: Resources

ʯAdvisory Committee on Immunization

Practices (ACIP), Centers for Disease Control and Prevention, www.cdc.gov/vaccines/acip/ index.html ʯ Bright Futures, American Academy of Pediatrics, https://brightfutures.aap.org/Pages/ default.aspx ʯ Clinical Preventive Services Recommendations,

American Academy of Family Physicians, www.aafp.org/family-physician/patient-care/ clinical-recommendations/clinical-practiceguidelines/clinical-preventive-servicesrecommendations.html ʯ Comparative Guideline Tables, American

College of Physicians, www.acponline.org/ clinical-information/guidelines/comparativeguideline-tables. (Summaries of recommendations from a variety of U.S. and international organizations regarding controversial topics in screening, prevention and management.

Available to ACP members.) ʯ Women’s Preventive Services

Initiative (WPSI), American College of Obstetricians and Gynecologists, www.womenspreventivehealth.org/about ʯ U.S. Preventive Services Task Force, www.uspreventiveservicestaskforce.org/uspstf

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Hand hygiene is the primary measure for providing safer care in healthcare facilities.1 Although substantial

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Proper hand hygiene is more than just washing and sanitizing regularly. If healthcare personnel (HCP) have dry or cracked skin, they are not only compromising their first line of defense against illness, they are also less likely to wash or sanitize hands because it is uncomfortable to do so. Choosing products that are formulated with mild and effective ingredients available offers HCP protection against skin damage and is a critical foundation for a hand hygiene program.

Product formulation can also greatly influence the overall antimicrobial efficacy of alcohol-based hand rubs (ABHRs), the preferred method of hand hygiene when hands are not visibly soiled. It is more of an important factor than alcohol concentration alone. Product formulation

can also influence the amount of ABHR needed to achieve efficacy. When formulated properly, ABHRs containing 70% ethanol have been proven to meet global standards when tested at volumes more representative of normal product use in healthcare environments.2 Almost all previous studies evaluating the efficacy of ABHR products have used application volumes of 3-5 mL or more.3 However, such large volumes are seldom used in clinical practice in U.S. healthcare settings. Two studies in which HCP were given the opportunity to select the volume of ABHR to apply to their hands during routine nursing activities, the mean volume of product applied ranged from 0.73-1.09 mL per application.4,5 These findings suggest that HCP apply variable amounts of ABHR to their hands at much lower volumes than the recommended product application for efficacy. HCP are prone to do this to achieve short dry times that allow them to return quickly to their duties.

[HCPHW]) and European Norm (EN) 1500 global standards. Additionally, using ASTM E1174, the efficacy of these formulations was compared head-to-head against 7 representative commercially available ABHRs and 2 World Health Organization (WHO) recommended formulations containing alcohol concentrations of 60% to 90%. These tests used an application volume of 2mL, which is a more realistic volume used by healthcare workers. The two ABHR products based on 70% ethanol, in a gel and foam format, met U.S. Food and Drug Administration (FDA) efficacy requirements when tested at a volume of 2 mL. In contrast, the 7 additional ABHR products and 2 WHO-recommended formulations failed to meet the same efficacy standard, suggesting that the majority of ABHRs used in U.S. hospitals may have substandard efficacy at realistic volumes. The two 70% ethanol ABHR formulations were also evaluated at dispenser output of 1.1mL, the mean product outputs for 8 commercially available Given the fact that HCP prefer ABHR product/dispenser combinations. Given the fact that HCP prelower volumes, they are also fer lower volumes, they are also less less likely to actuate a dispenser likely to actuate a dispenser more than once to save time. If the ABHR more than once to save time. If in the dispenser isn’t formulated properly, HCP are not achieving the ABHR in the dispenser isn’t proper efficacy with a single dose of product. Both the gel and foam test formulated properly, HCP are not products met FDA efficacy requireachieving proper efficacy with a ments at both the first and the tenth application. This is the first report single dose of product. to demonstrate that well-formulated ABHR can meet FDA efficacy requirements at a volume achievable with a single-dispenser actuation. Efficacy in the real world In conclusion, these studies collectively demonstrate The fact that HCP prefer to use low volumes of ABHR that when formulated properly, ABHRs can meet effiquestions the efficacy of product in use. Can an ABHR cacy standards at volumes that accurately reflect actual meet efficacy at real world dosing standards? Two novel use in clinical settings. Our results demonstrate the ABHR formulations containing 70% ethanol were evalu- importance of careful ingredient selection and proper ated according to American Society for Testing and Mate- formulation when developing ABHRs to maximize rials (ASTM) E1174 (Health Care Personnel Handwash antimicrobial efficacy.

1. Centers for Disease Control and Prevention. Guidelines for hand hygiene in health-care settings—2002. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR 2002;51 (RR-16):1-45. 2. Edmonds, Macinga, Comparative efficacy of commercially available alcohol-based hand rubs and World Health Organization-recommended hand rubs: Formulation matters 3. Rotter ML. Hand washing and hand disinfection. In: Mayhal CG, ed. Hospital Epidemiology and Infection Control. 4th ed. Philadelphia: Lippincott Williams & Wilkins, 2011:1365-1383. 4. Leslie RA, Donskey CJ, Zabarsky TF, Parker AE, Macinga DR, Assadian O. Measuring alocohol-based hand rub volume used by healthcare workers in practice. Antimicrob Resist Infect

Control 2015;7:P295. 5. Acquarulo BA, Sullivan L, Gentile AL, Boyce JM, Martinello RA. Mixed-methods analysis of glove use as a barrier to hand hygiene. Infect Control Hosp Epidemiol 2019;40:103-5.

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