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Journal of Clinical Oncology, Vol 25, No 34 (December 1), 2007: pp. 5348-5349 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2007.13.6184
Moving Beyond Guidelines to Improve the Quality of Care for Men With Prostate CancerDepartment of Urology, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, CA Androgen deprivation therapy (ADT) was described more than 60 years ago as an effective treatment for reducing morbidity in men with metastatic prostate cancer.1 Over time, the increasing proportion of newly diagnosed men with localized disease2 (a consequence of ad hoc screening) motivated research into possible benefits of ADT for these men. Urologic oncologists now have robust data supporting specific indications for the use of ADT in men with localized disease. Men with high-risk disease undergoing radiation therapy derive a survival benefit from neoadjuvant ADT,3 whereas men undergoing radical prostatectomy do not.4 No robust data support ADT as being beneficial in primary therapy for localized prostate cancer, compared with other available modalities including watchful waiting. These observations have been codified into national practice guidelines, such as those promulgated by the National Comprehensive Cancer Network,5 to promote evidence-based oncologic care. As inquiries into ADT's potential for benefit have delivered some answers, data have also accumulated describing the potential harms of ADT. Men receiving ADT as primary therapy for prostate cancer have lowered vitality scores, increased physical discomfort, and diminished sexual function compared with watchful waiting.6 Generally, ADT is associated with fatigue, hot flashes, decreased libido, decreased muscle mass, increased adiposity, and decreased quality of life scores.7,8-10 Other significant health effects include osteoporosis with a subsequent increased risk for fracture11 as well as a likely increased risk of diabetes and heart disease.12,13 Given these potential morbidities, ADT as primary treatment of low-risk prostate cancer may increase overall mortality in some men. In light of the documented risks of ADT, it seems logical that its use should be restricted to clinical settings in which a clear benefit has been demonstrated. However, in a previous study, Shahinian and colleagues14 used linked Surveillance, Epidemiology and End Results (SEER)-Medicare data to demonstrate that the identity of the particular urologist who treats a patient with prostate cancer is a more important determinant of that patient's likelihood of receiving ADT in the clinical setting. In this issue of the Journal, Shahinian and colleagues15 further characterize one element of the quality problem documented in their initial article. They ask the question, "If the identity of the urologist is a critical determinant of this form of cancer treatment, are particular urologists delivering care that has no basis in evidence?" They again turn to linked SEER-Medicare data in a retrospective, observational cohort study. Using the American Medical Association Physician Masterfile, Shahinian et al identified a cohort of men with incident prostate cancer in the SEER-Medicare linked data set and identified a variety of urologist characteristics that might predict practice consonant with evidence-based use of ADT. The primary hypothesis was that urologists who are strongly academically affiliated and those who are board certified would provide more evidence-based cancer care. In the overall cohort, patients of nonacademically affiliated urologists were more likely to receive ADT as part of their care. To bring the quality issue into focus, they divided the cohort of men into two groups: those with a clear, evidence-based indication for ADT use (locally advanced or high grade tumors in men undergoing radiation therapy) and those with no evidence-based indication (use of ADT as primary therapy for moderate- or low-grade localized disease). They found that urologists lacking academic affiliation were 1.7 times more likely to use ADT in a clinical scenario where harm may well outweigh benefit. Lack of board certification was not significantly associated with nonevidence-based usage, potentially due to problems with the statistical power of the study (only approximately 6% of urologists in the sample were not board certified). Reassuringly, board certification and academic affiliation did not change odds for receipt of ADT in the setting for which good evidence supports its use. Interestingly, in a time trend analysis, nonacademically affiliated urologists were more likely to use ADT in the evidence-based setting at the end of the time period under study. This may be due to financial incentives to use ADT, which was well-reimbursed at the time and could have had higher impact on nonacademic practices. Several hypotheses could be forwarded to explain some of the differences seen in this study, but it is important to note that even among academically affiliated or board-certified urologists, nearly one in three patients received ADT in the setting for which there was no proven benefit. Only about four in 10 patients of these urologists got ADT when it would likely have improved their survival. Shahinian et al cannot account for patient preferences for treatment with this data set; some patients may simply refuse ADT or, conversely, demand it for reasons of their own. However, other community-based work has documented widespread use of ADT in settings for which no benefit has been demonstrated, such as neoadjuvant use before radical prostatectomy or as primary therapy for localized disease.16 Shahinian et al15 suggest that targeted continuing medical education or discretionary referral to board certified physicians may improve the evidence-based use of this potentially harmful treatment. While these may be logical proposals, the patterns of care observed here are symptoms of a systematic quality control issue in American health care. This problem has been described for decades—unwarranted variation in treatment of similar patients, comprised of a mix of failure to deliver needed care and delivery of inappropriate care.17 Despite nearly $2 trillion in health care expenditures and a legal system which provides substantial penalties for medical malpractice, many Americans do not receive recommended, effective care. In a landmark study, McGlynn et al18 demonstrated that in national sample of adults receiving physician services, recommended care was delivered 54% of the time for patients with colorectal cancer and 76% for patients with breast cancer. In a population-based study of patients with breast and colorectal cancer, Malin et al19 found that adherence was less than 85% for 18 of 36 breast cancer quality measures and 14 of 25 colorectal cancer measures. In another population-based study, Miller et al20 found that quality of care for prostate cancer varied by treating physician specialty; more quality indicators were met during the care of patients undergoing radiation therapy than during the care of patients undergoing radical prostatectomy. Evidently, nationally promoted guidelines for use of ADT in men with prostate cancer are insufficient to create consistently high quality care in this clinical setting at the national level. Patients with prostate cancer may be paying the price for this failure of their health care system in the form of avoidable complications (increased fractures, reduced vitality, reduced sexual health, or an increased risk of heart disease and diabetes) or reduced survival after radiotherapy. Evidence from studies such as these has motivated the Centers for Medicare and Medicaid Services (CMS) and private payers to push for changes in the way physicians are compensated, in the hope that reimbursement "carrots" (or "sticks") will prove effective at improving the quality of care where guidelines have not. They also hope that better quality care will result in less expensive care, which is a highly debatable hypothesis. Several multistakeholder groups, including the Ambulatory Quality Alliance, the Surgical Quality Alliance, and the Cancer Quality Alliance, are actively operationalizing quality indicators which might be used for measurement and new reimbursement systems. CMS has selected prostate cancer as a condition for inclusion in its 2008 "more-pay-for-simply-reporting-your-performance" program, known as the Physician Quality Reporting Initiative (PQRI). The American Urological Association partnered with the American Medical Association to identify and develop prostate cancer quality measures (in a multistakeholder consensus process), for inclusion in the 2008 PQRI. One of the proposed indicators measures the "percentage of high-risk prostate cancer patients receiving external beam radiotherapy who were prescribed adjuvant hormonal therapy," which Shahinian et al15 have identified as an area ripe for improvement. Can a system-wide effort to improve quality solely by changing physician compensation be effective? How will this increased compensation be financed, or will the paradigm shift to reduction in reimbursement for low quality care in short order? Will there be unintended consequences for patients? How will we define high quality oncologic care in the absence of level I evidence? These are major, unanswered questions facing proponents of these efforts. As data presented by Shahinian et al15 joins the burgeoning literature describing quality of care problems in oncology, oncologists are likely to learn the answers to these questions. AUTHOR'S DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. REFERENCES 1. Huggins C, Stevens RE, Hodges CV: Studies on prostate cancer. II. The effects of castration on advanced carcinoma of the prostate gland. Arch Surg 43:209-233, 1941 2. Crawford ED: Epidemiology of prostate cancer. Urology 62:3-12, 2003 (suppl 1)[Medline] 3. Bolla M, Collette L, Blank L, et al: Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): A phase III randomised trial. Lancet 360:103-106, 2002[CrossRef][Medline] 4. Aus G, Abrahamsson PA, Ahlgren G, et al: Three-month neoadjuvant hormonal therapy before radical prostatectomy: A 7-year follow-up of a randomized controlled trial. BJU Int 90:561-566, 2002[CrossRef][Medline] 5. Baker LH, Hanks G, Gershenson D, et al: NCCN Prostate Cancer Practice Guidelines: The National Comprehensive Cancer Network. Oncology 10:265-288, 1996 (suppl)[Medline] 6. Potosky AL, Reeve BB, Clegg LX, et al: Quality of life following localized prostate cancer treated initially with androgen deprivation therapy or no therapy. J Natl Cancer Inst 94:430-437, 2002 7. Joly F, Alibhai S, Galica J, et al: Impact of androgen deprivation therapy on physical and cognitive function, as well as quality of life of patients with nonmetastatic prostate cancer. J Urol 176:2443-2447, 2006[CrossRef][Medline] 8. Holzbeierlein JM, Castle E, Thrasher JB: Complications of androgen deprivation therapy: Prevention and treatment. Oncology (Williston Park) 18:303-309, 2004[Medline] 9. Boxer RS, Kenny AM, Dowsett R, et al: The effect of 6 months of androgen deprivation therapy on muscle and fat mass in older men with localized prostate cancer. Aging Male 8:207-212, 2005[CrossRef][Medline] 10. Lubeck DP, Grossfeld GD, Carroll PR: The effect of androgen deprivation therapy on health-related quality of life in men with prostate cancer. Urology 58:94-100, 2001 (suppl 1)[CrossRef][Medline] 11. Diamond TH, Higano CS, Smith MR, et al: Osteoporosis in men with prostate carcinoma receiving androgen-deprivation therapy: Recommendations for diagnosis and therapies. Cancer 100:892-899, 2004[CrossRef][Medline] 12. Keating NL, O'Malley AJ, Smith MR: Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol 24:4448-4456, 2006 13. Saigal CS, Gore JL, Krupski TL, et al: Androgen deprivation therapy increases cardiovascular morbidity in men with prostate cancer. Cancer 110:1493-1500, 2007[CrossRef][Medline] 14. Shahinian VB, Kuo YF, Freeman JL, et al: Determinants of androgen deprivation therapy use for prostate cancer: Role of the urologist. J Natl Cancer Inst 98:839-845, 2006 15. Shahinian VB, Kuo YF, Freeman JL, et al: Characteristics of urologists predict the use of androgen deprivation therapy for prostate cancer. J Clin Oncol 25:5359-5365, 2007 16. Cooperberg MR, Broering JM, Litwin MS, et al: The contemporary management of prostate cancer in the United States: Lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry. J Urol 171:1393-1401, 2004[CrossRef][Medline] 17. Schuster MA, McGlynn EA, Brook RH: How good is the quality of health care in the United States? Milbank Q 76:517-563, 1998[CrossRef][Medline] 18. McGlynn EA, Asch SM, Adams J, et al: The quality of health care delivered to adults in the United States. N Engl J Med 348:2635-2645, 2003 19. Malin JL, Schneider EC, Epstein AM, et al: Results of the National Initiative for Cancer Care Quality: How can we improve the quality of cancer care in the United States? J Clin Oncol 24:626-634, 2006 20. Miller DC, Spencer BA, Ritchey J, et al: Treatment choice and quality of care for men with localized prostate cancer. Med Care 45:401-409, 2007[CrossRef][Medline] Related Article
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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