Editorial

Revisiting Structure, Process, and Outcome Scott M. Gilbert, MD, MS

Nearly 4 decades after first describing the structure-process-outcome framework for assessing quality in health care, Dr. Avedis Donabedian outlined some of the shortfalls in his own care during an interview published in Health Affairs.1,2 Treated earlier in his life for prostate cancer, Donabedian was diagnosed with bladder cancer years later after worsening urinary symptoms and episodes of urinary obstruction, infections, and renal failure led to the detection of a tumor in his bladder. Urine cytology, commonly used to evaluate a patient for bladder cancer, was performed at some point before the diagnosis but went unchecked for months (James Montie, MD, oral communication). The results were abnormal. Donabedian ultimately had his bladder removed, and he lived the remaining few years of his life with “lots of permanent tubes and pouches.”2 He died on November 9, 2000 of metastatic cancer.3 In the 14 years since Donabedian’s death, the quality landscape has changed markedly and has moved from a more general awareness of quality chasms in health care to broader policy efforts designed to proactively assess quality and improve care.4-8 Central to these efforts, the best way to measure quality is as pertinent a question today as it was in 2000. Resoundingly, however, structure, process, and outcome measures that evaluate the context and setting of care, the way in which care is delivered, and the effects of that care have become the main linchpins in quality assessment and improvement programs. To date, the National Quality Forum has vetted and endorsed more than 460 quality indicators,9 many of which underpin high-profile quality improvement programs such as the Physician Quality Reporting System and the Hospital Inpatient Quality Reporting Program of the Centers for Medicare & Medicaid Services.10,11 Within the realm of urology, National Quality Forum–endorsed quality measures have been limited mainly to urinary incontinence and prostate cancer thus far.9 Bladder cancer quality indicators have been proposed by some groups, but they have not yet been adopted or implemented into actionable measures at a national level.12,13 In this issue of Cancer, Chamie et al14 further probe quality gaps in the management of bladder cancer. Leveraging the Los Angeles Surveillance, Epidemiology, and End Results cancer registry and supporting information abstracted from operative and pathology reports, they critically evaluate and link a meaningful and probably inarguable measure of quality—the presence of muscle on endoscopic biopsy/resection—to outcome, in this case, mortality, on a relatively large scale. Adequate muscle sampling at the time of transurethral bladder tumor resection has been examined in a number of prior studies and linked to an increased risk of understaging and higher rates of disease recurrence.15,16 As a result, ensuring adequate muscle sampling during bladder tumor resection has become a standard principle across bladder cancer guidelines, particularly in the setting of invasive high-grade disease without muscle in the specimen.17,18 Among 1865 bladder cancer patients treated in the Los Angeles area between 2004 and 2005, Chamie et al report that muscle was absent in 30% and was not mentioned in 18% of pathology reports. The absence or lack of a mention of muscle, moreover, was independently associated with worse survival, implicating understaging and a missed opportunity for more aggressive treatment in a large group of patients. Using hierarchical models to account for clustering among providers (surgeons and pathologists), the authors found that the risk of mortality was nearly 50% greater for cases in which muscle was absent (hazard ratio, 1.48; 95% confidence interval, 1.00-2.18) and 91% greater for cases in which muscle was not mentioned in the pathology report (hazard ratio, 1.91; 95% confidence interval, 1.12-3.24) in comparison with cases for which muscle was present in the bladder resection/biopsy specimen. Corresponding 5-year mortality rates also differed markedly between groups: 7.6% when muscle was present, 12.1% when muscle was absent, and 18.8% when muscle was not mentioned. This points to concerning and potentially widespread quality gaps among patients treated for bladder cancer.

Corresponding author: Scott M. Gilbert, MD, MS, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612; Fax: (813) 7458494; [email protected] Genitourinary Oncology Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida; Health Outcomes and Behavior Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. See referenced original article on pages 379-85, this issue. DOI: 10.1002/cncr.-29070, Received: September 4, 2014; Accepted: September 8, 2014, Published online October 22, 2014 in Wiley Online Library (wileyonlinelibrary.com)

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Editorial/Gilbert

Although eye-opening, these results may overestimate the proportion of cases in which muscle is not sampled or present, at least to some degree. In the context of the endoscopic management of bladder cancer, judging quality on the basis of a single procedure fails to account for the recognition of and response to a lack of muscle on the initial resection through repeat and restaging procedures. A more practical and inerrant quality measure would almost certainly include a repeat procedure in such cases. This multiprocedure approach would not only more closely parallel treatment guidelines and more properly define what should be done (ie, high-quality care) but would also likely engender greater buy-in from clinicians. Still, the authors’ approach—linking process to outcome—is apt, and their chief finding of a grade in outcome counters pedants who might argue that a muscle-present/absent quality measure that does not include repeat transurethral resection within an inclusive process is not illustrative. As mentioned in their discussion and described by others,19 restaging procedures are discordantly low among patients with bladder cancer, and higher mortality with understaged or inadequately staged cancers at the initial resection should not be ignored. The lack of mention of muscle in the resection specimen (whether muscle is present or absent) seems to be a clearer quality issue. Although pathology reporting standards exist,20 a standardized approach to reporting diseasespecific factors, such as the presence or absence of muscle or lymphovascular invasion within bladder transurethral resection specimens, is not currently in place. Pathology reports may also fail to uncover other potential quality problems such as inconsistencies in interpretation. The results described herein closely mirror an oft cited report in which not only was muscle absent in 51% of urothelial carcinomas but interpretive discrepancies were noted among pathologists in 24% of cases.21 Although these finding suggest that deficiencies in pathology reporting may be problematic, we do not know the extent to which they persist today. Although updated guidelines clearly delineate the clinical importance of obtaining and examining muscle during endoscopic procedures for bladder cancer, the data from Chamie et al’s study14 date to 2004-2005. More recent information is necessary to determine whether the needle gauging this particular quality question is stuck or has moved during the last 10 years. Nevertheless, the study’s findings are a sounding board, and accordingly, these authors propose a rational and potentially useful modification of the American Joint Committee on Cancer staging criteria whereby a trailing “x” would denote an absence of muscle (eg, pT1x for urothelial carcinoma invading the lamina propria without muscle present in the specimen). Cancer

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Quality issues in bladder cancer have gone largely overlooked outside urology, even though it is one of the most common and costly cancers.22,23 Perhaps it is a lowpriority disease. Perhaps we (physicians who take care of bladder cancer patients) have not raised enough awareness. We likely have also been poor stewards and have failed to adopt proven processes of care that translate, on average, into better patient outcomes.24 If physicians do not actively embrace treatments that move care forward, how do we expect quality to follow? There are several ways forward. First, the urologic community and other stakeholders vested in improving the quality of bladder cancer care need to push quality assessment and improvement efforts further so that they reach broader forums. Second, the identification of quality deficits, such as performance gaps in key processes of care and an absence of supporting structural components of care, needs to be translated into action items that link to better care and better outcomes. This latter point should not be understated. Focusing only on provider performance risks missing a tantamount problem: the current lack of resources (eg, communications networks, clinical alert systems, and decision aids) necessary to meaningfully move quality improvement in the right direction. Donabedian recognized that improving health care only begins with quality assessment and that process and structure need to be linked. His surgeon and later my mentor, Dr. James Montie, emphasized this point often and referred to Donabedian’s case not only as a cautionary lapse in follow-up but more so as a remediable example of systemwide shortcomings in communication. For him, improving care hinges on improving communication networks and system-level resources (structure), tools that enable clinicians to routinely provide the right care (process). Donabedian summarized the importance of linking quality assessment to action plainly. In his last book, published posthumously, he wrote that “there is no one method that in and of itself is uniformly effective or ineffective. Therefore, it seems to me that the secret to success is neither in the method itself [quality measurement], nor entirely the circumstances within the method is implemented [quality improvement]. The secret, rather, is perhaps the interaction between the circumstances and the method; it is the fit between the two.”25 FUNDING SUPPORT No specific funding was disclosed.

CONFLICT OF INTEREST DISCLOSURES The authors made no disclosures. 329

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REFERENCES 1. Donabedian A. Evaluating the quality of medical care. Milbank Mem Fund Q. 1966;44:166-206. 2. Mullan F. A founder of quality assessment encounters a troubled system firsthand. Health Aff (Millwood). 2001;20:137-141. 3. Frenk J. Obituary for Avedis Donabedian. Bull World Health Organ. 2000;78:1475. 4. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001. 5. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. N Engl J Med. 2003;348: 2635-2645. 6. Centers for Medicare & Medicaid Services. Welcome to the Partnership for Patients. http://partnershipforpatients.cms.gov. Accessed September 2, 2014. 7. Centers for Medicare & Medicaid Services. Premier Hospital Quality Incentive Demonstration. http://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/HospitalQualityInits/HospitalPremier. html. Accessed September 2, 2014. 8. Centers for Medicare & Medicaid Services. Pioneer ACO Model. http://innovation.cms.gov/initiatives/Pioneer-ACO-Model/index.html. Accessed September 2, 2014. 9. National Quality Forum. http://qualityforum.org/Home.aspx. Accessed September 2, 2014. 10. Centers for Medicare & Medicaid Services. Physician Quality Reporting System. http://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/PQRS. Accessed September 2, 2014. 11. Centers for Medicare & Medicaid Services. Hospital Inpatient Quality Reporting System. http://www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment-Instruments/HospitalQualityInits/HospitalRHQDAPU. html. Accessed September 2, 2014. 12. Montgomery JS, Miller DC, Weizer AZ. Quality indicators in the management of bladder cancer. J Natl Compr Canc Netw. 2013;11:492-500. 13. Cooperberg MR, Porter MP, Konety BR. Candidate quality of care indictors for localized bladder cancer. Urol Oncol. 2009;27:435-442.

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14. Chamie K, Ballon-Landa E, Bassett JC, et al. Quality of diagnostic staging in patients with bladder cancer: a process-outcomes link. Cancer. 2015;121:379-385. 15. Herr HW. The value of a second transurethral resection in evaluating patients with bladder tumors. J Urol. 1999;162:74-76. 16. Shoshany O, Mano R, Margel D, Baniel J, Yossepowitch O. Presence of detrusor muscle in bladder tumor specimens—predictors and effects on outcomes as a measure of resection quality. Urol Oncol. 2014;32:40.e17-e22. 17. Hall MC, Chang SS, Dalbagni G, et al. Guidelines for the management of nonmuscle invasive bladder cancer (stages Ta, T1 and Tis): 2007 update. J Urol. 2007;178:2314-2330. 18. Babjuk M, Burger M, Zigeuner R, et al. EAU guidelines on non– muscle-invasive urothelial carcinoma of the bladder: update 2013. Eur Urol. 2013;64:639-653. 19. Goldsmith JD, Siegal GP, Suster S, Wheeler TM, Brown RW. Reporting guidelines for clinical laboratory reports in surgical pathology. Arch Pathol Lab Med. 2008;132:1608-1616. 20. Skolarus TA, Ye Z, Montgomery JS, et al. Use of restaging bladder tumor resection for bladder cancer among Medicare beneficiaries. Urology. 2011;78:1345-1349. 21. Maruniak NA, Takenzawa K, Murphy WM. Accurate pathological staging of urothelial neoplasms requires better cystoscopic sampling. J Urol. 2002;167:2404-2407. 22. American Cancer Society. Cancer Facts & Figures 2014. http:// www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2014/. Accessed September 2, 2014. 23. Mossanen M, Gore JL. The burden of bladder cancer care: direct and indirect costs. Curr Opin Urol. 2014;24:487-491. 24. Cookson MS, Chang SS, Oefelein MG, Gallagher JR, Schwartz B, Heap K. National practice patterns for immediate postoperative instillation of chemotherapy in nonmuscle invasive bladder cancer. J Urol. 2012;187:1571-1576. 25. Donabedian A. An Introduction to Quality Assurance in Health Care. New York, NY: Oxford University Press; 2003.

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Revisiting structure, process, and outcome.

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