Standardization Pro and Con

Neerav Goyal, MD, MPH, and Ellen S Deutsch, MD, MS PAO-HNS Patient Safety Committee

Patient care is complex and often involves managing conflicting goals, such as balancing potential risks vs benefits of a treatment or providing the best care for an individual patient vs conserving resources for society. The PAO-HNS Patient Safety Committee has decided to tackle specific patient safety principles with the same appreciation for nuanced understanding that you face in making clinical recommendations.

We present a “point-counterpoint” discussion about a patient safety / healthcare quality principle, and conclude with areas of agreement, which we hope will provide the foundation for the optimal application of safety and quality principles.

PRO: STANDARDIZATION IS GOOD

We rely on many standardized processes, some of which are so embedded in our culture that we may not even recognize their power.

Standardization informs our expectations;1 when information about a patient is presented to us, we know that first we’ll hear a high-level summary (e.g., this is a 5 year old boy who underwent tonsillectomy 7 days ago) and then relevant details in a predictable sequence that allows us to understand the patient’s condition.

Similarly, the documentation of patient care starts with history, proceeds through examination, incorporates an assessment, and concludes with a plan. While the details may vary, the familiar structure helps us find the information we seek. Standardized processes underpin handoffs, often based on an SBAR format (situation, background, assessment, recommendation), operative reports and other informational resources.

Standardization allows us to generate evaluation and treatment processes that ensure completeness and consistency; indeed, creating an informed algorithm requires review and integration of current knowledge. These processes provide stable guidance to improve the care of individual patients by providing direction for technical processes such as surgical procedures as well as non-technical processes such as obtaining a complete patient history.

Standardization also supports our efforts to move beyond analysis based on anecdotal information to evidence-based medicine. Some knowledge may only be revealed through analyzing collective experiences over many patient encounters. Effective treatment algorithms should be based on meaningful data; to accomplish this, data must be aggregated in a standardized manner. This knowledge is then disseminated in a standardized format: healthcare publications use an “IMRAD” (introduction, methods, results, analysis, discussion) structure, again to make it easier for readers to find the information we seek.

Standardization helps us in the direct provision of care. Standardized roles help us distribute responsibilities during routine patient care and enhance our responses during crises; we know what capabilities to expect from the different personnel in our healthcare teams.

Standardization allows predictability, which decreases anxiety, and anticipation, which improves planning and responses. When managing a patient in the operating room, shared expectations of responsibilities and understanding of each healthcare provider’s skill set allow us to respond effectively to, for example, an airway crisis.

Studies of standardization have demonstrated decreased costs, increased compliance with guidance, decreased hospital length of stay, and improved timeliness of healthcare delivery, among other benefits.2

In summary, standardization contributes to efficient, thorough care processes. CON: STANDARDIZATION IS BAD

Standardization has its roots in eliminating variation with a goal of simplifying processes and making them more efficient and safer. The concept is employed in industries that require high reliability such as manufacturing, aviation, and healthcare.

However, it is also important to understand that standardized algorithms in healthcare often come from administrators and managers and not clinicians,2 and represent “work as imagined” rather than “work as done.”3 This disconnect can lead to well-intended processes contributing to worse patient outcomes. For example, to reduce the rate of catheter associated urinary tract infections (CAUTI), many hospitals have implemented algorithms for earlier catheter removal as a triggered nursing task. The result is an increased number of catheter removals on post-operative day 0 or 1. Interestingly, in select populations the policy has been associated with increases in urinary retention and re-catheterization without decreasing the rate of CAUTIs.4,5

Standardization can oversimplify complex processes, especially when applied to a heterogenous population. In contrast to industries like manufacturing or aviation, healthcare must accommodate the significant variations introduced by different comorbidities, diagnoses, necessary management, and preferences of each individual patient.

In chasing efficiency and standardization, we can lose sight of the individual and collective expertise that clinicians can bring, and instead suggest that all members of a discipline have equivalent skills. For example, considering all floor level beds to be equivalent can lead to an increased availability of beds for admitted patients and improve hospital efficiency and available capacity. However, it negates the unique expertise specialized hospital units could bring when taking care of patients with tracheotomies, nasogastric tubes, or free flap reconstructions. Having less experienced teams care for complex patients can lead to more patient safety events. For otolaryngologists this can be especially concerning for patients such as laryngectomees, who have undergone relatively low volume procedures that result in complex, critical airway needs and require allied clinicians with specific expertise.

Standardization can lead to diffusion of responsibility, and complacency; we have all witnessed recitations of pre-operative site verifications that are conducted in a perfunctory thoughtless manner.

As we have seen with responses to COVID-19, variations such as resource limitations, technologic advances and disease evolution require flexibility and adaptability. Standardization, even when based on proven principles and processes, is inherently fixed in the past; rigid adherence can create a brittle system that prevents innovation.

In summary, standardization can be detrimental to patients with unique needs and limit a system’s ability to adapt. Continued on page 10

Continued from page 9

AREAS OF AGREEMENT ABOUT STANDARDIZATION

Standardization can be helpful but must be thoughtfully applied to optimize patient outcomes while reducing unnecessary variation in care. Implementing standardized protocols, such as with “evidence-based medicine,” helps to provide a floor, a minimum standard, for care, but not necessarily a ceiling for optimal care. Standardization may be most useful in stable activities with predictable resources; and may provide a starting point for novices or newly formed teams, or for participation in infrequently performed processes. The development and implementation of standards should include and incorporate the expertise of front-line clinicians as well as other stakeholders.

Healthcare delivery is a complex adaptive system, and the consequences of many patient care processes in this dynamic environment are not completely predictable. Creating standards that are goal- rather than process-oriented supports customization and optimization for specific applications. Decisions about when standardization is a help or a hindrance requires balancing potential shortcomings and benefits, based on a combination of objective data and expertise-based judgment.

References 1. Bilmes J. Charles R. Berger and James J. Bradac, Language and Social Knowledge: Uncertainty in interpersonal relations. london: Edward arnold, 1982. pp. viii + 151.

Language in Society. 1984;13(1):87-90. doi: 10.1017/S004740450001592X.

2. What is the impact of standardisation on hospital efficiency. Standardisation in healthcare. https://static.healthcare.siemens.com/siemens_hwem-hwem_ssxa_websites-contextroot/wcm/idc/groups/public/@global/documents/download/mda4/nzy0/~edisp/standardization_in_healthcare-05852743.pdf. Accessed 14Sep, 2020.

3. Hollnagel E, Wears R, Braithwaite J. From safety-I to safety-II: A white paper. 2015.

4. Tam V, Lutfi W, Morgan K, et al. Impact of enhanced recovery pathways and early urinary catheter removal on post-operative urinary retention.

The American journal of surgery. 2020. doi: 10.1016/j.amjsurg.2020.06.057.

5. Chai J, Pun T. A prospective randomized trial to compare immediate and 24-hour delayed catheter removal following total abdominal hysterectomy. Acta obstetricia et gynecologica Scandinavica. 2011;90(5):478-482. doi: 10.1111/j.1600-0412.2011.01104.x.

Announcing the upcoming addition of MEDSTRO!

SOUNDINGS | Fall 2020

During the new membership year, members will be able to interact via our virtual message boards.

Ishita Srivastava, BS Jasmine Miravitlles, BS George R. Gardner, BS Nithin D. Adappa, MD

Introduction Chronic rhinosinusitis (CRS) is a complex inflammatory disease that is caused by a combination of factors, and leads to local inflammation in the paranasal sinuses and a significant decrease in quality of life. This disease presents as one of two phenotypes: chronic rhinosinusitis with nasal polyps (CRSwNP) and without nasal polyps (CRSsNP). Both types are currently managed by medical and surgical treatments. The surgical treatment, namely endoscopic sinus surgery (ESS), is highly effective in decreasing inflammatory burden and improving the efficacy of long-term medical therapy. One such method of long-term control is the steroid nasal spray.

Topical steroids are effective due to their ability to reach a higher concentration of local tissue without increased bioavailability and subsequent reduction of side effects characteristic of systemic steroids. Typical spray delivery systems tend to be both low pressure and low volume. This results in a majority of the medication being delivered to the anterior nasal cavity and inferior turbinates, as opposed to the paranasal sinuses1,2. This has been proven to be the case regardless of whether surgery was performed. This poor delivery to the paranasal sinuses is worsened with the presence of common CRS symptoms, such as large polyps or stenosed sinuses. Another method of long-term therapy is irrigating with steroids. As opposed to steroid sprays, steroid irrigations have a high volume and high pressure delivery system3. When performed correctly, such irrigations allow for effective treatment of all of the mucosal surfaces, especially following ESS in which the sinus cavities have been opened. Despite the effectiveness of this method, this treatment poses its own disadvantages as a significant amount of the steroid medication is quickly evacuated from the sinuses along with the rinse. An alternative steroid delivery system that can be used as a medical therapy for longterm control of CRS is the novel exhalation delivery system-fluticasone (EDS-FLU). This FDA-approved treatment for nasal polyps is the OptiNose® exhalation delivery system that has been on the market since 2018. This nasal spray combines a patient-initiated exhalation through a mouthpiece which is connected to a steroid reservoir. This allows for the elevation of the soft palate against the posterior nasopharyngeal wall, which separates the nasal cavity from the oropharynx. Thus, the steroid is confined to the nasal cavities and paranasal sinuses, as opposed to being wasted in untargeted areas4. We examined the evidence for the use of EDS-FLU, particularly in the management of chronic rhinosinusitis with and without nasal polyps.

Data During the FDA-approval process, four large-scale studies were performed to assess the efficacy of EDS-FLU as an adjunctive treatment for sinonasal inflammation: Navigate I5, Navigate II6, Exhance-37, and Exhance-128. The first two studies were part of a prospective, double-blind, randomized controlled phase 3 trail. The strongest level of evidence is shown in the CRSwNP patient population in both of the Navigate studies. Each had four treatment arms: placebo, 93, 186, and 372 mcg delivered twice daily through EDS-FLU for a total of 16 weeks. By the end of the study, all of the patients transitioned to 372 mcg twice daily. Compared to the placebo group, patients showed statistically significant improvements in nasal congestion/ obstruction, facial pain/pressure, rhinorrhea, and hyposmia/anosmia. There was a notable lack of improvement in facial pain/pressure at 93 mcg and anosmia at 186 mcg. In regard to the Sino-Nasal Outcome Test-22 (SNOT-22), there was a significant 7-9 point increase compared to the placebo group5. via endoscopic examination. In Navigate I, there was greater than one point polyp grade improvement in 66% of patients receiving 186mcg EDS-FLU and 72% of those receiving 372 mcg EDS-FLU5. In Navigate II, there was greater than one point polyp improvement in 68% of patients receiving 93 mcg EDS-FLU, 63% of patients receiving 186 mcg EDS-FLU, and 69% of patients receiving 372 mcg EDSFLU. Navigate II also showed significantly different polyp elimination in at least one nostril in 16% more patients as compared to the placebo cohort6.

Smaller scale studies that have utilized the data from the Navigate I and II studies have found significant improvements in quality of life. One such study found that EDS-FLU patients missed significantly fewer days of work due to CRS as compared to the placebo group9. Another study used the Standard Form-36 survey and found that EDS-FLU patients had a three-fold improvement in general quality of life and health status after 16 weeks of treatment, as compared to the placebo group10.

The other two studies mentioned earlier, Exhance-3 and Exhance-12, examined the effects of 372 mcg EDS-FLU7,8. Exhance-3 enrolled 705 patients (603 with CRSsNP) and lasted for 3 months7, while Exhance-12 enrolled 224 patients (189 with CRSsNP) and lasted for 12 months8. Both studies found that the mean SNOT-22 scores improved regardless of CRS phenotype, with Exhance-3 patients showing a 24 point increase7 and Exhance-12 patients showing a 21 point increase8. Upon examination of nasal polyps, polyp elimination in at least one nostril was observed in 48% of Exhance-3 patients7 and 54% of the Exhance-12 group8. Notably, 83% of the Exhance-12 cohort also showed greater than one point polyp grade improvement8. Additional evidence of effectiveness was also found in subjective measures such as patient reports of symptomatic improvement.

777 East Park Drive PO Box 8820 Harrisburg, PA 17105

PRSRT STD US POSTAGE PAID HARRISBURG PA PERMIT NO 922

Outcomes data for the new fluticasone exhalation delivery system

Continued from page 11

Conclusion EDS-FLU has been shown to be an effective alternative steroid delivery system, as demonstrated by the results of the multiple double-blinded and randomized controlled trials in patients with CRS. The novel combination of a patient-initiated exhalation mouthpiece and steroid reservoir allows for more effective medication delivery to the nasal cavities and paranasal sinuses, especially when considering the drawbacks of traditional topical steroid methods. The data shown in Navigate I, Navigate II, Exhance-3, and Exhance-12 demonstrate how EDS-FLU can lead to significant improvement for patients in numerous areas, from sinonasal symptoms to enhanced quality of life.

Conflicts of Interest Dr. Nithin Adappa is a consultant for OptiNose®. References 1. Harvey RJ, Goddard JC, Wise SK, Schlosser RJ. Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation. Otolaryngol Neck Surg 2008; 139: 137 - 142

2. Djupesland PG, Skretting A. Nasal deposition and clearance in man: comparison of a bidirectional powder device and a traditional liquid spray pump. J Aerosol Med

Pulm Drug Deliv 2012; 25: 280 - 289. 3. Harvey RJ, Schlosser RJ. Local drug delivery. Otolaryngol

Clin North Am 2009; 42: 829 - 845

4. Kovacs AJ, Goshtasbi K, Kuan, EC. What is the evidence for fluticasone exhalation delivery system in chronic rhinosinusitis?. Current Op in Otolaryngol & Head and

Neck Surg 2020; 28: 14-17

5. Sindwani R, Han JK, Soteres DF, et al. NAVIGATE I: randomized, placebo-controlled, double-blind trial of the exhalation delivery system with fluticasone for chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy 2018; 33: 69 - 82

6. Leopold DA, Elkayam D , Messina JC, et al. NAVIGATE II: randomized, double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis. J

Allergy Clin Immunol 2018; 143: 126 - 134.e5. 7. Sher MR, Mair EA, Messina J, et al. EXHANCE-3: a Phase 3, three-month study of safety and efficacy of fluticasone propionate exhalation delivery system (FLU-EDS) in patients with chronic rhinosinusitis with (CRSwNP) and without nasal polyps (CRSsNP). J Allergy Clin Immunol 2017; 139: AB66.

8. Palmer JN, Jacobson KW, Messina JC, et al.

EXHANCE-12: 1-year study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis.

Int Forum Allergy Rhinol 2018; 8:869 - 876.

9. Velez FF, Sacks H, Messina JC, et al. Impact of EDS-FLU on work productivity: results from two phase III trials,

Navigate 1 and 2. Poster presentation at American

Rhinologic Society Spring Meeting, April 19 - 20, 2018,

National Harbor, MD.

10. Velez FF, Mahlis EM, Messina JC, et al. EDS-FLU improves quality of life and health status: pooled analysis of phase 3 trials Navigate I and II. J Allergy Clin Immunol 2018; 141: AB163.