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© 2003 American Society for Clinical Oncology
Taking Stock of Volume-Outcome StudiesMemorial Sloan-Kettering Cancer Center, New York, NY OVER THE last several years, a large body of work has emerged investigating the association between hospital volume and surgical outcomes, primarily short-term operative mortality.1 While many diseases are represented in this literature, both heart disease and cancer have received particularly extensive scrutiny. Although not all studies have demonstrated a statistically significant volume-outcome trend, the overall pattern in the results is overwhelmingly consistent.2 High-volume hospitals demonstrate lower mortality rates, with the magnitude of the trend varying considerably by procedure. For cancer surgery, trends for pancreatectomy and esophagectomy are especially pronounced. Indeed, esophagectomy is one of five procedures for which the Leapfrog coalition of health care purchasers has instituted a volume standard for patient referrals.3 The Leapfrog initiative echoes recommendations by the Institute of Medicine after a broad review of the system of cancer care.4 These volume standards are, however, not without their critics.5,6 Many common procedures have low surgical mortality rates, and so even if a volume-outcome trend exists, it may be difficult to demonstrate convincingly in observational studies, and it may be of limited clinical relevance. For these procedures, morbidity outcomes represent the end points of primary clinical relevance. As a result, a volume-outcome literature is beginning to emerge in which the focus of attention is on perioperative or postoperative events that have an important bearing on the quality of life of the patient. This includes, for example, issues such as the frequency of continence-impairing procedures for colon cancer (ileostomy or colostomy) or rectal cancer (abdominoperineal resection).7,8 Morbidity is especially important regarding prostate cancer surgery, which is a common procedure with low operative mortality but with a substantial risk of various adverse outcomes, notably urethral anastomotic strictures, urinary incontinence, and long-term loss of erectile function in addition to postoperative surgical and anesthetic complications. In the article by Hu et al9 in this issue of the Journal of Clinical Oncology, the investigators have made use of the 5% national sample from Medicare from the years 1997 and 1998 to explore the relationship of both hospital volume and surgeon volume to in-hospital complication rates, length of stay, and the frequency of subsequent anastomotic strictures. Their analysis involves 2,292 patients receiving radical prostatectomy. Although trends favoring high-volume hospitals and surgeons are observed for all comparisons, they remain statistically significant in a joint analysis including both volume indicators only for the effect of surgeon volume on in-hospital complications and length of stay, a result that leads the authors to conclude that "surgeon rather than hospital volume determines short-term radical prostatectomy outcomes." A few other groups have examined these issues using various data sources such as the National Inpatient Sample (not restricted to elderly medicare recipients),10 the entire Medicare database from 1991 to 1994,11 a population sample in Northern England,12 and the Surveillance, Epidemiology, and End Results–Medicare linked database from 1992 to 1996.13 The first three of these studies limited attention to hospital volume and demonstrated significant trends for mortality, complications, and length of stay in all studies in which these end points were evaluated, which is not inconsistent with the unitary analyses of hospital volume presented by Hu et al.9 In our recently published study,13 trends were observed for postoperative complications and late urinary complications (primarily strictures) for both hospital and surgeon volume. The magnitudes of the trends were more modest, and indeed, the nearly 50% reduction in complications among high-volume surgeons observed by Hu et al9 may be simply the result of the relatively small sample size in this category in their study. Subsequent detailed analyses (not included in our earlier publication) support the conclusion of Hu et al9 that surgeon volume is a more important predictor of these outcomes than hospital volume. Also, our detailed analysis of variations in surgeon-specific outcome rates indicated the existence of considerable between-surgeon variation in outcomes, even among surgeons with similar volumes. Thus, although the magnitudes of the volume-outcome trends are modest, there may be considerable variation in outcomes that is not captured in the volume metric, perhaps caused by variation in surgical technique or skill. For professional medical societies, these studies indicate a need for more attention to the effects of surgical technique on variations in outcomes.5,6 Are such variations the result of differences among surgeons in inherent technical skill or differences in experience or education? If the latter, what educational programs would effectively improve technique? The rapid introduction of minimally invasive surgical procedures over the last decade has reawakened interest in surgical technique, attracting practicing surgeons to formal educational programs focused on technique. Efficient and effective educational programs are essential to minimize the learning time for new techniques. Because some outcomes after radical prostatectomy are not apparent for months or years, technical recommendations should be coupled with documentation of long-term results. Certainly most surgeons can learn to perform better, and professional education sponsored by surgical societies has a central role to play in improving outcomes. Can professional surgical organizations do more? Radiation oncologists sponsored national patterns of care studies14 to document morbidity and cancer control outcomes. These studies confirmed the importance of dose in local control of prostate cancer and of high-energy linear accelerators in reducing morbidity. Over time, the quality of radiation therapy improved across the country.15 Similarly, for surgery, the Veterans Administration Quality Improvement Program monitored outcomes for key surgical procedures and was associated with reductions in morbidity and mortality over time.5 Neither of these efforts addressed variation among individual surgeons. Should the American Urological Association or the American College of Surgeons sponsor a surgical patterns of care center, collecting data confidentially and providing benchmark feedback to members? To date, concerns about cost and about misuse or misinterpretation of the data have inhibited a national effort to document outcomes. Under pressure from managed care, hospitals have used this approach to reduce costs and shorten hospital stays while maintaining or improving patient satisfaction.16 With little enforcement, surgeons altered their practice when informed how lengths of stay and costs for their patients varied from their peers, and the means for the whole group improved.17 For morbidity and cancer control outcomes after radical prostatectomy, a similar approach is being tested in at least one academic medical center, where the urology service has instituted a so-called report card for each surgeon. The data are protected from legal discovery through the quality assurance system. We await evidence that overall outcomes are improved significantly by this approach. For individual surgeons, these studies confirm once again the age-old wisdom that quality of care and quality of surgical technique have consequences. Although not proven by any of the studies, the implication is that good technique can be learned, with subsequent improvements in outcomes. Conscientious surgeons, aware of these studies, may be motivated to assess their own outcomes and use educational opportunities to improve performance. Finally, the volume-outcome studies confirm the suspicions of many patients: For major cancer operations, it matters who performs their procedure. But how should patients be advised to select a surgeon? The data provide few clear answers. In general, busier surgeons will probably have better outcomes. But there seems to be enough variation among busy surgeons that volume alone is an insufficient guide. We are left with little more than word of mouth from family and friends and the subjective recommendations of personal contacts within the medical community. REFERENCES
1. Halm EA, Lee C, Chassin MR: Is volume related to outcome in health care? A systematic review and methodologic critique of the literature. Ann Intern Med 137:511–520, 2002
2. Birkmeyer JD, Siewers AE, Finlayson EVA, et al: Hospital volume and surgical mortality in the United States. N Engl J Med 346:1128–1137, 2002 3. Birkmeyer JD, Finlayson EVA, Birkmeyer CM: Volume standards for high-risk surgical procedures: Potential benefits of the Leapfrog initiative. Surgery 130:415–422, 2001[CrossRef][Medline] 4. Hewitt M, Simone JV: Ensuring Quality Cancer Care. Washington, DC, Institute of Medicine, National Academy Press, 1999 5. Khuri SF: Invited commentary: Surgeons not General Motors should set standards for surgical care. Surgery 130:429–431, 2001[CrossRef][Medline] 6. Russell TR: Invited commentary: Volume standards for high-risk operations: An American College of Surgeons view. Surgery 130:423–424, 2001[CrossRef][Medline]
7. Schrag D, Cramer LD, Bach PB, et al: Influence of hospital procedure volume on outcomes following surgery for colon cancer. JAMA 284:3028–3035, 2000 8. Schrag D, Panageas KS, Riedel E, et al: Hospital and surgeon procedure volume as predictors of outcome following rectal cancer resection. Ann Surg 236:583–592, 2002[CrossRef][Medline] 9. Hu JC, Gold KF, Pashos CL, et al: The role of surgeon volume in radical prostatectomy outcomes. J Clin Oncol 21:XXX–XXX, 2003 10. Ellison LM, Heaney JA, Birkmeyer JD: The effect of hospital volume on mortality and resource use after radical prostatectomy. J Urol 163:867–869, 2000[CrossRef][Medline]
11. Yao SL, Lu-Yao G: Population based study of relationships between hospital volume of prostatectomies, patient outcomes, and length of hospital stay. J Natl Cancer Inst 91:1950–1956, 1999 12. Thorpe AC, Cleary R, Coles J, et al: Deaths and complications following prostatectomy in 1400 men in the Northern Region of England. Br J Urol 74:559–565, 1994[Medline]
13. Begg CB, Riedel ER, Bach PB, et al: Variations in morbidity after radical prostatectomy. N Engl J Med 346:1138–1144, 2002 14. Hanks GE, Leibel SA, Krall JM, et al: Patterns of care studies: Dose-response observations for local control of adenocarcinoma of the prostate. Int J Radiat Oncol Biol Phys 11:153–157, 1985[Medline] 15. Gerber RL, Smith AR, Owen J, et al: Patterns of care survey results: Treatment planning for carcinoma of the prostate. Int J Radiat Oncol Biol Phys 33:803–808, 1995[CrossRef][Medline] 16. O’Brien JA, Jacobs LM, Pierce D: Clinical practice guidelines and the cost of care: A growing alliance. Int J Technol Assess Health Care 16:1077–1091, 2000[CrossRef][Medline] 17. Liebman BD, Dillioglugil O, Abbas F, et al: Impact of a clinical pathway for radical retropubic prostatectomy. Urology 52:94–99, 1998[CrossRef][Medline]
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Copyright © 2003 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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