Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
REVIEW ARTICLE Hospital and Physician Volume or Specialization and Outcomes in Cancer Treatment: Importance in Quality of Cancer Care By Bruce E. Hillner, Thomas J. Smith, and Christopher E. Desch Purpose: To conduct a comprehensive review of the health services literature to search for evidence that hospital or physician volume or specialty affects the outcome of cancer care. Methods: We reviewed the 1988 to 1999 MEDLINE literature that considered the hypothesis that higher volume or specialization equals better outcome in processes or outcomes of cancer treatments. Results: An extensive, consistent literature that supported a volume-outcome relationship was found for cancers treated with technologically complex surgical procedures, eg, most intra-abdominal and lung cancers. These studies predominantly measured in-hospital or 30-day mortality and used the hospital as the unit of analysis. For cancer primarily treated with low-risk surgery, there were fewer studies. An association with hospital and surgeon volume in colon cancer varied with the volume threshold. For breast cancer, British studies found that physician specialty and volume were associated with improved long-term outcomes, and the single American report showed an association between hospital volume of initial surgery and better 5-year survival. Studies of nonsurgical cancers, principally lymphomas and testicular cancer, were few but consistently showed better long-term outcomes associated with larger hospital volume or specialty focus. Studies in recurrent or metastatic cancer were absent. Across studies, the absolute benefit from care at high-volume centers exceeds the benefit from break-through treatments. Conclusion: Although these reports are all retrospective, rely on registries with dated data, rarely have predefined hypotheses, and may have publication and self-interest biases, most support a positive volumeoutcome relationship in initial cancer treatment. Given the public fear of cancer, its well-defined first identification, and the tumor-node-metastasis taxonomy, actual cancer care should and can be prospectively measured, assessed, and benchmarked. The literature suggests that, for all forms of cancer, efforts to concentrate its initial care would be appropriate. J Clin Oncol 18:2327-2340. © 2000 by American Society of Clinical Oncology. ECAUSE OF A GROWING lack of public confidence in the United States health care system, the National Cancer Policy Board undertook a comprehensive review on the effectiveness of cancer services and their delivery.1 At the Board’s request, we initiated a comprehensive review of the health services literature looking for evidence that characteristics of providers, facilities, or delivery systems affect the quality of cancer care. The scope of this review is limited to what was found to be the largest body of evidence for an association with quality of cancer care: the relationship between outcomes and hospital or physician volume or specialty. The higher volume– better outcome association was first described 20 years ago by Luft et al.2 A succinct definition of quality of care, prepared by the Institute of Medicine, is as follows: “quality of care is the degree to which health services for individuals and populations increase the likelihood of desired outcome and are consistent with current professional knowledge.”3 The three classic components of quality of care are structure, process, and outcome and can be assessed using process data, outcome data, or both.4,5 The least satisfactory assessments are implicit reviews, usually of the medical record or secondary data (insurance claim or registry), in which no prior standards or agreement about good or better care exists. Preferred are evaluations that use explicit process criteria, ie, whether a breast cancer patient had an estrogen receptor assay performed, whether its results were recorded, and the result expressed as the proportion of criteria that were met. This last step requires setting targets or benchmarks. Almost all cancer studies are implicit reviews that seldom demonstrate where target levels for specific process B From the Massey Cancer Center and Department of Internal Medicine, Medical College of Virginia at Virginia Commonwealth University, Richmond, VA. Submitted July 8, 1999; accepted February 15, 2000. Supported in part by the following grants: Faculty Research Award from the American Cancer Society, Atlanta, GA (B.E.H.), Faculty Scholar Award, Project on Death in America, Open Society, New York, NY (T.J.S.), grant no. RFP CO 94388-63 from the Office of Cancer Communications, National Cancer Institute, Bethesda, MD (T.J.S.), grant from the National Cancer Policy Board of the Institute of Medicine, Washington, DC, and grant from the Virginia Commonwealth University Outcomes Research Center, Richmond, VA. Address reprint requests to Bruce E. Hillner, MD, FACP, Virginia Commonwealth University, Box 980170, Richmond, VA 23298-0170; email [email protected]. © 2000 by American Society of Clinical Oncology. 0732-183X/00/1811-2327 Journal of Clinical Oncology, Vol 18, No 11 (June), 2000: pp 2327-2340 2327 2328 Table 1. HILLNER, SMITH, AND DESCH Framework of Factors Affecting Treatment Processes and Outcome Patient Treatment processes and outcome Education Income Comorbidity Insurer Access Coordination of services Barriers to referral Geography Location Distance from treatment Physician provider Specialty training or focus Case volume Research focus Medical center Size and scope of services Case volume Academic Multidisciplinary Table 2. Conceptual Overview of Support for Volume-Outcome in Cancer Care Therapy Intent and Outcome Time Frame Principal Treatment Modality Surgery Chemotherapy Radiation Curative Short-Term Curative Long-Term Palliative Large None None Modest Modest None N/A None None Abbreviation: N/A, not applicable. subsequently narrowed the focus to the relationship of volume and outcome. Excluded were reports related to screening or early detection and surveys of physician attitudes or practices based on hypothetical patients. We used the following MEDLINE terms: disease management, epidemiology, medical audit, outcome assessment, outcome and process assessment, physician practice patterns, quality assurance, health care quality indicators, quality of health care, registries, standards, and treatment outcome. These terms were combined with individual cancer terms. The bibliography of each article was reviewed for other potentially relevant citations. Quality Assessment components or outcomes were assessed. The optimal assessment is to show an association between achieving the targets or ordinal descriptions (poor, fair, or good) and subsequent outcome. Studies in other conditions have found various nontreatment factors associated with better outcomes (Table 1). Patient factors are the most obvious and the most studied in cancer. Patients with less education or lower income and/or comorbidity commonly have poorer outcomes.6 A patient’s insurer may affect access to care and coordination of services by creating barriers to referral. Geographic variation in care, especially surgery (specifically, radical prostatectomy [RP] and mastectomy), is well known.7,8 Physician characteristics, such as specialty training focus, research interest, and case volume, should convey that the physician’s management is state-of-the-art. The same is true for hospitals or medical centers where the size and scope of services, case volume, presence of multidisciplinary clinics, and academic affiliation are associated with high quality. These characteristics should translate into processes that physicians know or believe to be associated with better outcomes. These processes include the following: adopting new beneficial therapy early, delivering higher rates of well-established, effective therapy, improving delivery of therapy, and providing superior coordination of care. METHODS Information Sources We reviewed the published literature cited in MEDLINE from 1988 to 1999 that was potentially related to quality of cancer care, and we Identified papers were reviewed for their completeness in controlling for potential biases. 9,10 Only studies that stratified or adjusted for clinical stage were included. In addition, each was assessed regarding whether it identified and controlled for case mix by adjusting for differences in demographics and/or comorbidity. The studies that included adjustments for comorbidity were specifically highlighted. All studies were classified by type (process or outcome), data sources, units of analysis, country, and attribute assessed. RESULTS The review found numerous methodology limitations in almost all studies. All but one report used retrospective data. The vast majority were not hypothesis-driven. Almost all used convenience samples and had no preplanned statistical power or effect-size estimates. Reports that considered processes of care focused on variation between groups or sites of care, not on variation from specific targets. Comorbidity was usually inferred from administrative claims, not specific clinical indices or databases. An overview of the results is shown in Tables 2 and 3. Table 2 categorizes the results by the principal treatment modality, therapeutic intent, and time frame. The vast majority of studies, which will be discussed subsequently in detail, focused on the short-term outcomes of cancers for which the primary mode of therapy was surgery performed with curative intent. Long-term outcomes of these surgical therapies were substantially fewer. There were fewer than 10 studies of cancers for which the principal treatment was chemotherapy. The specific processes that lead to or that are associated with the superior outcomes in specific hospitals or physician specialties have not been deciphered. No 2329 VOLUME/SPECIALIZATION AND CANCER CARE OUTCOMES Table 3. Pancreas Hospital volume Acute Long-term Hospital specialty Physician volume Physician specialty Overview of Positive Volume-Outcome Effects for Nine Common Cancer Categories Other GI Surgery Lung Colorectal Breast Ovary ** ** ** **,⌽ * * * *** * * Symbols: *** Five or more studies; ** two to four studies; * one study; ⌽ Testes ** ** * * ** * ** two or more studies not showing volume-outcome effect. studies were found of hospital or physician characteristics related to outcomes, such as level of pain control or patient/family satisfaction, after radiation therapy in which the goal was palliative,. Table 3 lists the numbers of studies found for each of nine common cancers, stratified by four characteristics: hospital volume, hospital specialization, physician volume, and physician specialization. The only paired characteristic and cancer category that had five or more studies that supported the volume-outcome hypothesis was hospital volume and surgery for pancreatic cancer. Cancers Associated With High-Risk Surgery The quality of cancer care might be superior in terms of its association with physician specialty or hospital volume in cases in which the primary therapy is a high-risk surgical intervention. Cancers that fit this category are non–smallcell lung cancer (NSCLC) and pancreatic, esophageal, and gastric cancer. The unit of analysis has principally been the hospital, with little evaluation of the effect of specific surgeon volume. Pancreatic. Numerous studies show a consistent trend toward hospital case volume predicting better outcome in pancreas surgery. These studies offer the most compelling Table 4. Lymphoma * ** ** * Prostate support of the hospital case volume– better outcome hypothesis because of their size and diversity of study designs. Glasgow and Mulvihill11 in California and Lieberman et 12 al in New York performed similar studies (Table 4) in which statewide hospital discharge records were used to evaluate hospital volume for major pancreatic resections. In both states, centers with higher volume had better profiles in mortality, costs, and length of hospitalizations. Of 298 hospitals in California from 1990 to 1994, 88% treated an average of two or fewer patients per year with pancreatic resection. The risk-adjusted mortality in hospitals that treated an average of one or less cases per year was 14.1%, compared with 3.5% at hospitals that averaged more than 10 per year. In New York state between 1984 and 1991, approximately 25% of hospitals averaged one surgery per year and approximately 75% of hospitals averaged fewer than seven per year. In New York, the logistic regression model that adjusted for hospital volume, comorbidity, clinical variables, and time trends did not find that individual physician volume was a predictor of better outcome. Janes et al13 evaluated and compared the national patterns of care for pancreatic cancer for the period from 1983 to 1990 using the National Cancer Database of the American College of Surgeons. Unadjusted operative mortality was Pancreatectomy In-Hospital Mortality and Hospital Volume in Two States Average Annual Volumes of Pancreatic Resections ⱕ1 No. California, 1990-1994 (n ⫽ 1,705) Hospitals Patients Risk-adjusted mortality New York, 1984-1991 (n ⫽ 1,972) Hospitals Patients Risk-adjusted mortality % ⬎ 1-10 Range (%) 263 No. % ⬎ 10 Range (%) 33 53 8 3.5 6.9-8.7 58 24 18.9 % 2 38 9.6-14.1 124 No. 2 57 19 11.8-12.9 5.5 NOTE. Some categories were collapsed to allow direct comparison. Therefore, ranges of risk-adjusted mortality rates are shown. Data adapted from Glasgow and Mulvihill11 and Lieberman et al.12. 2330 HILLNER, SMITH, AND DESCH Table 5. Procedure Pancreatectomy Esophagectomy Pneumonectomy Hepatic resection Pelvic exenteration Thirty-Day Mortality for Selected Cancer Surgeries in the Elderly, 1984 to 1993 No. of Incident Cases Surgeries Performed (%) 1-5 Cases 6-10 Cases 11⫹ Cases 19,205 6,782 103,425 126,395 185,305 3.9 7.4 1.3 0.6 0.9 12.9 17.3 3.7 5.4 3.7 7.7 3.9 14.1 3.5 3.2 5.8 3.4 10.7 1.7 1.5 Hospital Volume and 30-Day Mortality (%) NOTE. Data adapted from Begg et al.18 7.7% for hospitals in which fewer than five patients per year were treated for this disease and 4.2% for those in which 20 or more patients per year were treated. A series of papers from Johns Hopkins addressed the effects of regionalizing this procedure. Gordon et al,14 using hospital discharge reports, compared the hospital mortality, length of stay, and costs for the period from 1988 to 1993 between Johns Hopkins and the rest of Maryland (a total of 38 hospitals). The results were striking: in-hospital mortality was 2.2% versus 13.5% (relative risk [RR], 6.1; 95% confidence interval [CI], 2.9 to 12.7), and mean length of stay (23 v 27 days) and mean total charges were 20% greater outside Johns Hopkins. A follow-up study attributed the decline in the Maryland in-hospital mortality for pancreas surgery from 17.2% in 1984 to 4.9% in 1995 (a 61% decrease) to the increase in share of discharges at the high-volume provider, Johns Hopkins.15 A second follow-up report for the period from 1990 to 1995 considered correlations between the effect of hospital case volume and that of the individual surgeon (⬍ five, five to 50, and ⬎ 50 patients for 5 years).16 No independent effect of surgeon volume was observed, but only four surgeons were classified as high-volume surgeons, each of whom practiced at Johns Hopkins, and 27 were medium volume. Birkmeyer et al17 showed that hospital volume is also associated with an improved late survival in the elderly who are undergoing pancreaticoduodenectomy. He assessed a retrospective cohort of all 7,229 patients in the United States older than 65 years who had undergone this procedure and stratified hospitals by annual averages of less than one, one to two, two to five, and five or more cases per year. Overall, 3-year survival was 37% at the high-volume centers and 25% to 29% at the lower volume centers. The RR ratio after adjusting for case mix was 0.69 (95% CI, 0.62 to 0.76). Esophageal, gastric, and hepatic resection. Begg et al18 recently assessed 30-day mortality and hospital volume in the elderly using linked Medicare/Surveillance, Epidemiology, and End-Results (SEER) databases for the period from 1984 to 1993. The study was the only one that was identified as having an a priori hypothesis, although the size of anticipated differences was not given. The linked databases identified precise details of the surgical procedures, comorbidity, and stage for a variety of surgical procedures (Table 5). These procedures were chosen because they “involve preoperative judgement, diagnostic accuracy, meticulous surgical technique, and demanding postoperative care.”18 Curative surgery is rarely performed for these cancers in the elderly. Table 5 shows that for all incident cancers over the 10-year period, the number of procedures within 2 months of diagnosis (excluding hepatic resection) ranged from approximately 1% to 7%. Yet, within this small subset of patients undergoing surgery, a distinct trend of decreasing mortality with increasing volume was observed for all conditions except for pneumonectomy. There was no difference in the relative comorbidity across hospitals and no evidence that high- (or low-) volume centers operated on a lower risk set of patients. The only other study that addressed esophagectomy used California discharge abstracts from 1990 to 1994 of 273 hospitals and 1,561 patients.19 Eighty-eight percent of hospitals averaged two or fewer cases per year, which accounted for 50% of all patients treated. Annual crude and risk-adjusted hospital mortality rates all decreased in the period from 1990 to 1994. Hospital volume was the largest independent variable that affected mortality: average mortality at a center in which more than 30 cases were treated was 4.8%, compared with 16% at those that treated fewer than 30 cases. The Johns Hopkins group addressed hepatic resection in-hospital mortality using the identical method that they used for pancreatic surgery. Johns Hopkins performed almost one half of all hepatic resections in Maryland. Approximately one half of these resections were for metastatic cancer and 18% for primary liver cancer. Comorbidity was not different between high- and low-volume centers. In-hospital mortality at Johns Hopkins was 1.5%, compared with 7.9% in the remainder of Maryland.20 NSCLC. Despite NSCLC being the leading cancer cause of death in the United States, only three studies of it were found, all of which addressed its surgical care. 2331 VOLUME/SPECIALIZATION AND CANCER CARE OUTCOMES Table 6. California Postoperative Mortality With Lung Cancer Surgery, 1983 to 1986 Annual Hospital Volume for All Lung Cancer Procedures Lesser resections Total procedures within category, no. Adjusted mortality, % Adjusted odds ratio 95% CI Pneumonectomy Total procedures within category Adjusted mortality (%) Adjusted odds ratio 95% CI ⬍9 9-16 17-24 ⬎ 24 2,588 5.2 1.0 2,945 4.1 0.7 0.6-1.0 2,553 3.5 0.6 0.5-0.8 2,822 3.4 0.6 0.4-0.8 365 13.6 1.0 374 11.4 0.8 0.5-1.2 377 11.7 0.8 0.5-1.3 413 9.7 0.6 0.4-1.0 NOTE. Data adapted from Romano and Mark.23 Numerous surveys of physician attitudes concerning optimal care were found, but they were excluded because actual care was not described. Surgical resection continues to be the preferred treatment for early-stage NSCLC. Despite improved imaging techniques, approximately one third of all patients with NSCLC have an initial surgical procedure. Expected perioperative mortality varied with the extent of the surgery: pneumonectomy, ⬃6%; lobectomy, ⬃3%; segmental resection, ⬃1%, and age, stage, and comorbidity.21 These mortality estimates are typical of university center reports. However, Whittle et al22 found a 17% 30-day mortality rate after pneumonectomy in a national sampling of Medicare claims from the early 1980s. Romano and Mark23 assessed 12,439 hospital discharges from 499 hospitals from the state of California who underwent pulmonary resections in the period from 1983 to 1986. The mean age was 62 years for pneumonectomy and 65 years for lesser procedures. A multivariate regression model that included demographic data and clinical comorbidity found no difference in the risk of in-hospital death associated with teaching hospitals. Table 6 shows a consistently lower operative mortality rate at higher volume centers. The effect of individual surgeon volume was not addressed. A more recent study by Silvestri et al24 used a South Carolina statewide severity-adjusted database to compare general with thoracic surgeons. From 1991 to 1995, 1,720 resections were performed, of which 90% were lobectomies. General surgeons performed approximately one half of all procedures. No differences were observed in demographics or comorbidity in patients by physician specialty. Lobectomy mortality was higher among patients treated by general surgeons: 5.3% v 3.0%, P ⬍ .05. Seventy percent of thoracic surgeons performed more than 10 resections per year, whereas 75% of general surgeons performed fewer than 10. The third study by Begg has been described previously. For pneumonectomy, the 30-day mortality rates showed a non–statistically significant trend of higher volumes (P ⬍ .29). No studies were identified that addressed variation in the process of care for NSCLC associated with physician specialty or hospital type. Specifically, no studies addressed referral patterns to medical or radiation oncologists, staging, especially for stage III disease, the types and quantity of radiation therapy, the use of first- or second-line chemotherapy, or the effectiveness in end-stage symptom control. Common Cancers With Low Surgical Risk The hypothesis that hospital or physician volume leads to better outcome has been studied in colon, breast, prostate, and ovarian cancers. For each of these cancers, the perioperative risks associated with the primary therapy are low. Given the high incidence of these cancers and the high frequency of multimodal postsurgical therapies, each condition could provide insights into volume-outcome benefits from superior coordination of care. In addition, colon cancer– and breast cancer–associated procedures are predominantly performed by generalist surgeons. Therefore, the physician volume– outcome hypothesis is also the most threatening to general surgeons. Colon cancer. Measurable, modest improvements in overall and stage-specific survival that have occurred in the past 30 years, which are attributed to improvements in surgical technique by reducing perioperative mortality and the addition of adjuvant chemotherapy, are unlikely to be confounded by significant stage migration. Benefits associated with physician specialization and hospital volume have been inconsistently observed, possibly because of a difference in the volume thresholds used. When found, these have been observed predominantly in rectal cancer. Most studies focused on short-term operative mortality, and none addressed preoperative evaluation, adjuvant chemotherapy in 2332 Table 7. HILLNER, SMITH, AND DESCH Colorectal Resection by Surgeon and Hospital Volume Association With In-Hospital Mortality in 9,739 Resections in Maryland, 1992 to 1996 Surgeon Annual Volume* ⬍5 % of group % of all cases Average annual case volume Crude mortality, % Adjusted relative risk 80 36 1.8 4.5 1.00 ⬎ 10 5-10 14 37 7.0 6 27 14.0 3.3 0.79 2.6 0.64 Hospital Annual Volume* Total — — 3.1 3.5 — ⬍ 40 58 32 21.5 4.7 1.00 40-70 28 36 50 3.0 0.79 ⬎ 70 14 32 89.9 3.0 0.78 Total — — 39 3.5 — NOTE. Data adapted from Harmon et al.29 *Numbers in each group were 812 surgeons and 50 hospitals. stage III disease, or actual (v survey) patterns of follow-up care. Numerous British studies have not consistently found volume or specialty effect. An older Scottish report by McArdle and Hole25 from 1974 to 1979 found a four-fold variation in survival and complications based on a surgeon’s specialty volume and interest in colorectal disease. Subsequently, Kingston et al26 evaluated the care of 578 patients by 12 community surgeons interested in colorectal cancer compared with university care and found no benefit from university care. The audit of Mella et al27 of short-term outcomes of 3,221 patients diagnosed in 1992 to 1993 in Wales and Scotland found no effect for surgeon volume (using ⬍ 10 or ⬍ 30 cases per year) or specialty interest. Overall, 30-day mortality was 7.6%. Kee et al28 reviewed a cohort of 3,217 new patients in Northern Ireland diagnosed between 1990 and 1994. After a median follow-up of 4.5 years, they found no long-term benefit associated with surgeon or hospital volume. Seventy-one surgeons operated at 19 hospitals. Only 20% of cases were managed by surgeons who averaged ⱕ 10 cases per year. Neither in-hospital nor 30-day mortality was reported. Harmon et al29 from Johns Hopkins conducted the best American study, in which they performed a cross-sectional analysis of all colorectal cancer surgery using Maryland state discharge data from 1992 to 1996. This study was unique in that it was large enough to examine the independent effect of surgeon and hospital volume. Table 7 shows the distribution of case volume by surgeon and hospital and the observed in-hospital mortality rates and RRs. In contrast to the 20% in Northern Ireland, 74% of cases were managed by surgeons who averaged fewer than 10 cases per year. Seven hospitals, including Johns Hopkins, were defined as high-volume. We estimate that the proportion of surgeons to population was approximately three-fold greater in Maryland than in Northern Ireland. Higher surgeon volume was associated with significant improvement in in-hospital death, length of stay, and costs. Medium-volume surgeons achieved results equivalent to those of high-volume surgeons when they operated at high-to-medium–volume hospitals. All other American studies before and after 1988 have addressed all forms of colorectal resection, not just those performed for colorectal cancers. This is an important distinction because the case-volume thresholds are not directly comparable. Khuri et al,30 as part of the Veteran Affairs National Surgical Quality Improvement Program, assessed eight commonly performed surgeries of intermediate complexity, including partial colectomy. This was the only identified study that used prospectively collected data. They found no differences in risk-adjusted 30-day mortality between 1994 and 1998 at 125 hospitals among 13,000 patients based on volume, but the average crude mortality rate was high at 6.9%. Rosen et al31 compared six colorectal specialty surgeons with 33 other surgeons for the period from 1986 to 1994 at two university-affiliated hospitals in Pennsylvania. The hospitals had accredited colon and rectal and general surgery training programs. Before and after the adjustment for comorbidity, specialty surgeons had lower in-hospital mortality in 2,805 patients: 8-year mean, 1.4% v 7.3% (P ⬍ .0001). This benefit was primarily observed in the 54% of patients with higher comorbidity. Studies limited to rectal cancer are few, but all show a volume or specialty effect. Porter et al32 addressed care between 1983 and 1990 at five Edmonton, Canada, hospitals of 683 patients with rectal cancer treated by 52 surgeons, of whom five had specific training in colorectal surgery. Local recurrence is an especially strong indicator of surgical technique. Multivariate analysis showed that local recurrence and disease-specific survival were both worse if treated by a non–specialty trained (RR 2.5; 95% CI, 1.35 to 2.40) or low-volume surgeons (⬍ 21 cases in 7 years; RR 1.8; 95% CI, 1.35 to 2.40). Holm et al32a found in 1,399 patients within the clinical trial setting that patients at higher volume (⬎ 10 cases per year) or university hospitals had a 2333 VOLUME/SPECIALIZATION AND CANCER CARE OUTCOMES lower incidence of risk-adjusted local recurrence and deaths from rectal cancer. Breast cancer. Given its high incidence and long history of patient advocacy, breast cancer has generated the most concern about the quality of its care. In the United States, research has primarily focused on factors associated with breast-conserving surgery (BCS) but not on physician or hospital factors associated with better long-term outcomes or processes. Two British studies addressed surgeon characteristics. Sainsbury et al33 evaluated 12,861 women by geographic district and individual surgeon between 1979 and 1988 in Yorkshire. They found a benefit in cases in which a surgeon’s volume averaged more than 30 cases per year (RR, 0.85; 95% CI, 0.77 to 0.93). These surgeons provided care for approximately 50% of the cases. A multivariate analysis found an absolute 8% survival benefit that was attributed to greater use of chemotherapy. Gillis and Hole34 performed a similar assessment in western Scotland between 1980 and 1988. Specialist surgeons were defined as those who were involved in a dedicated breast clinic or clinical trials and who kept separate records of patients with breast cancer. Such specialists provided care for approximately 25% of 3,786 cases. They found absolute benefit in survival rates of 9% and 8% for groups at 5 and 10 years, respectively, and an adjusted RR of death of 0.84 (95% CI, 0.75 to 0.94). The benefit was seen for all patient clinical and social subgroups. Bonett et al35 evaluated the 5-year survival by hospital type in South Australia of 2,589 cases from 1980 to 1986. After adjusting for stage, no significant differences were found between large public (n ⫽ 4), large private (n ⫽ 5), and smaller hospitals (n ⫽ 71). Only two outcome studies from the United States were found. These addressed hospital factors associated with breast cancer survival. The most prominent and disturbing was by Roohan et al,36 which used New York state hospital discharge summaries that were linked to the state cancer registry. From 1984 to 1989, 47,890 women with presenting summary stage (in situ, local, regional, or metastatic) were hospitalized at 266 hospitals. Cases were stratified by initial summary stage and risk-adjusted for age at diagnosis. An association of higher hospital volume with better 5-year survival was seen in all stages. Table 8 shows the risk ratios for all causes of mortality after 5 years, after adjusting for comorbidity, socioeconomic status, and stage. The highest volume hospitals provided only approximately 22% of the care but were associated with a 19% to 60% improvement in survival.36 The other prominent, but flawed, study by Lee-Feldstein et al37 evaluated 5,892 white women from 1984 to 1990 treated at Southern California hospitals that Table 8. Five-Year Breast Cancer Survival by Hospital Volume in New York State, Diagnosed in 1984 to 1989 Hospital Annual Volume Patients treated over 5 years No. % Relative risk of death at 5 years 95% CI ⬍ 10 10-50 958 2 1.60 14,440 30 1.30 22,230 10,262 47 22 1.19 1.00 1.42-1.81 1.22-1.37 1.12-1.25 NOTE. Data adapted from Roohan et al. 50-150 ⬎ 150 36 were stratified into the following categories: small community, census fewer than 200; large community, census more than 200; Health Maintenance Organization, average census not reported; or teaching hospitals. Because lymph node involvement was unknown in 15% of patients and comorbidity was not included in the multivariate survival analysis, all of the results are suspect. For example, women with local or regional disease treated by mastectomy compared with BCS with radiation had a 1.45 RR of death, which is inconsistent with all other reports. The literature regarding the process of breast cancer care has principally focused on factors and temporal trends associated with the use of BCS versus total mastectomy. Hospital characteristics associated with the greater use of BCS, such as teaching affiliation, larger size, on-site radiation therapy, and urban location, have been relatively consistent across studies. These factors may not be predictive today. In a recent, 1993 to 1995 cross-sectional comparison of care, Guadagnoli et al38,39 evaluated BCS and other indicators of process of initial care in more than 2,500 women at 18 randomly selected Massachusetts hospitals and 30 Minnesota hospitals. They found that practice was generally consistent with the results of national consensus conferences. They also found that only teaching hospitals in Massachusetts were associated with greater BCS use but were less likely to perform axillary node dissection. In contrast to type of surgery, the use and type of adjuvant therapy does make a difference in survival. Although the SEER registry shows a temporal increase in adjuvant therapies since the mid-1980s, only one report was found that addressed physician factors. Johnson et al40 found a marked increase in the use of adjuvant therapy in nodenegative patients seen by a medical oncologist after the May 1998 National Cancer Institute (NCI) Clinical Alert. However, a detailed multivariate analysis of other patient characteristics was not presented; therefore, a spectrum bias is possible. Important differences in radiation therapy processes of care or treatment planning associated with physi- 2334 HILLNER, SMITH, AND DESCH Table 9. Hospital Volume and Radical Prostatectomy Events in Medicare Enrollees, 1991 to 1994 Hospital Annual Volume Mean 30-day mortality % Range Relative risk 30-day mortality Range Readmission rate Range Serious complication Range Low (⬍ 39) Medium Low (39-74) Medium High (75-140) High (⬎ 140) 0.63 0.53-0.73 0.59 0.49-0.68 0.56 0.47-0.66 0.39 0.31-0.46 1.53 1.25-1.77 1.30 1.21-1.39 1.43 1.37-1.48 1.43 1.17-1.69 1.16 1.07-1.25 1.25 1.19-1.25 1.41 1.16-1.68 1.08 0.99-1.17 1.09 1.03-1.15 1.00 1.00 1.00 NOTE. 15.5% of cases were performed at teaching hospitals. 86.7% of cases were performed by urologists. Relative risk adjustments included age, race, surgeon specialty, hospital teaching status, and year of diagnosis and comorbidity. Data adapted from Yao.43 cian volume or facility characteristics were either not identified or not presented in the two breast cancer–specific American College of Radiology Patterns of Care studies.41,42 Breast cancer–specific processes of care associated with physician or hospital factors were sought but not found. These included detailed evaluations related to the reporting and use of estrogen receptor status, the use, extent, and complications of axillary node dissection, and the duration of hormonal therapy and the type of chemotherapy. No studies were found that were related to physician, hospital, or health system predictors of evaluation and treatment for advanced breast cancer. In particular, no reports were found that addressed predictors of type of first- or second-line treatment or stopping rules for metastatic disease. Prostate cancer. There is no consensus on the optimal therapy for early- or late-stage prostate cancer, and care patterns have markedly changed over the last 15 years. For early-stage disease, there has been a marked increase in the RP rate, which seems to have crested since 1992. The impact of hospital and physician volumes on perioperative mortality is just beginning to be addressed. An important report by Yao and Lu-Yao43 describes a 1991 to 1994 Medicare claims analysis of 101,604 men who underwent RP that addressed 30-day mortality and complication rates related to hospital volume. This analysis was unusual in that hospital teaching status and surgeon specialty were factors included in the risk adjustment model. Although the absolute differences in 30-day mortality were small (0.39% to 0.65%), a clear gradient effect of hospital volume by quartiles and outcomes was observed (Table 9). A study by Karakiewicz et al45 with similar design but broader time frame that included 4,997 RPs in Quebec from 1988 to 1996 found a lower 30-day mortality of 0.45% at academic centers, which treated 37% of the total cases, versus 0.72% at community centers. Ovarian cancer. Assessments in ovarian cancer have focused on the effect of the type of surgeon. Nguyen et al44 performed the most prominent but oldest of the studies found, in which they used detailed hospital data from more than 900 hospitals of 25 consecutive cases at each hospital of 5,156 patients from 1983 and 7,160 patients from 1988. An exploratory surgical procedure was performed in the initial management of 96% of patients. The breakdown by surgeon’s specialty was 20% general surgeons, 20% gynecologic oncologists, and 45% general gynecologists. Approximately one half of patients of gynecologists had stage III or IV disease, compared with two thirds of patients of gynecologic oncologists or general surgeons. Appropriate surgical staging, completeness of debulking, and median survival all correlated with specialty. Table 10 shows that the stage-stratified 5-year survival rates varied by clinically meaningful amounts. Two British studies also showed an association between surgical specialty and survival. Kehoe et al46 assessed approximately 1,200 patients in central England between 1985 and 1987. Patients who were treated by general surgeons had more advanced disease compared with those treated by gynecologists. A multivariate model found care by a general surgeon to be an independent prognostic factor, with a 5-year RR of death of 1.34 (95% CI, 1.07 to 1.51). Woodman et al47 found similar results in a study of 691 women diagnosed in 1991, in which those treated by general surgeons, compared with those treated by gynecologists, had an adjusted RR of death of 1.58 (95% CI, 1.19 to 2.10). In this study, a surgeon’s volume was not predictive of survival, but referral to a medical oncologist was strongly predictive (RR, 0.54; 95% CI, 0.43 to 0.68). 2335 VOLUME/SPECIALIZATION AND CANCER CARE OUTCOMES Table 10. Stage I II III IV Ovarian Cancer Survival by Physician’s Specialty, Diagnosed in 1983 No. of Patients 1,377 448 1.355 1,080 5-Year Survival (mean ⫾ SD, %) GYO OBG GS 88.6 ⫾ 2.5 62.6 ⫾ 5.9 25.2 ⫾ 2.6 10.4 ⫾ 2.6 89.6 ⫾ 1.1 60.9 ⫾ 3.1 29.2 ⫾ 1.9 16.8 ⫾ 1.8 87.8 ⫾ 2.1 47.4 ⫾ 5.5 16.8 ⫾ 2.0 10.9 ⫾ 1.6 NOTE. Data adapted from Nguyen et al.44 Abbreviations: GYO, gynecologic oncologist; OBG, general gynecologist; GS, general surgeon. Only two studies addressed hospital factors. Junor et al48 audited 479 of the 533 new cases in Scotland in 1987. Patients first seen or operated on by a nongynecologist had worse mortality (RR 1.34 and 1.37, respectively; 95% CI, 1.05 to 1.77). Twenty-seven percent of patients were referred postoperatively to a multidisciplinary referral clinic. After the adjustment for clinical factors and the use of platinum chemotherapy (given to approximately 50% of patients aged ⬍ 65 years), patients referred to the specialized center had a 0.73 RR of death. Munoz et al49 retrospectively assessed processes of care in 785 women in 1991 who were identified from SEER registries. Only 10% of women with presumptive stages I and II disease, 71% with stage III disease, and 53% with stage IV disease received recommended staging and treatment. The only physician or organizational feature assessed was whether the reporting hospital had a gynecology residency program, and this feature was associated with an increased odds ratio (1.9) for appropriate care. No studies addressed the effect of provider specialty in advanced ovarian cancer, such as physician specialty effects on the use and patterns of chemotherapy, survival, and elements of palliative care. Cancers Principally Treated Nonsurgically Lymphomas. Because chemotherapy and/or radiation therapies are the primary treatments for lymphoma, they should provide the best opportunity to find practice variation and infer quality differences in nonsurgical cancer care. However, after an extensive search of the literature, no studies were found since 1988. This is especially disappointing in light of the report of Davis et al,50 which contrasted survival in 3,607 patients with Hodgkin’s disease registered by SEER (community care) with 2,278 patients treated at one of 21 comprehensive cancer centers, all of whom were diagnosed between 1977 and 1982. Modest differences in age, histology, and stage distributions were adjusted for in the multivariate comparison. The rate of death among patients initially treated at SEER hospitals was higher (RR, 1.5; 95% CI, 1.3 to 1.7) than at comprehensive centers and was consistently observed for all stages, histologies, and ages. Testicular cancer. Only one American study of testicular cancer was found. An indirect, retrospective survival comparison was performed by Feuer et al51 of patients with metastatic testicular cancer treated at the Memorial SloanKettering Cancer Center (n ⫽ 133) and of cases identified from five SEER registries (n ⫽ 172) from 1978 to 1984. Although 89% of the SEER cases received chemotherapy and 95% of these used cisplatin, the 3-year survival was markedly better at the Memorial Sloan-Kettering Cancer Center. This benefit in the latter group compared with the former was more striking for patients with minimal or moderate disease (94% v 73%) than for those with advanced cases (52% v 40%, respectively). The authors speculated on numerous potential sources for the better outcomes, including differences in chemotherapy regimen, dose-intensity, salvage therapies, and institutional factors. Three European studies have addressed hospital volume primarily within participating centers in clinical trials. Because hospitals that participate in clinical trials are likely to be a self-selected group that are commonly expected to have higher volume than nontrial hospitals, these are a particularly compelling set of studies. Harding et al52 performed a population-based audit of 440 men diagnosed between 1977 and 1989 with nonseminomatous germ cell tumors in western Scotland. All but 11 patients were treated at tertiary referral centers: 235 at a single unit and 194 at four other units. Independent prognostic factors included extent of tumor, 5-year period of diagnosis (1975 to 1979 v 1985 to 1989), and treatment unit (unit 1 v units 2 through 5). Unit 1 had the best survival rates, treated the most patients (53%), and had the majority of patients (70%) with the worst prognosis. Ninety-seven percent of patients at unit 1 versus 61% at units 2 through 5 were treated on a nationally agreed protocol. After adjustment for prognostic factors and for those treated on protocol, the risk of death was much higher for patients outside of unit 1 (RR, 2.8; CI, 1.5 to 5.2). Collette et al53 analyzed 380 patients treated at 49 hospitals that participated in a European Organization for Research and Treatment of Cancer trial of poor-prognosis germ cell tumors. Patients who were treated in the 26 centers that each entered fewer than five patients and who 2336 HILLNER, SMITH, AND DESCH represented 14% of all patients had an RR of death of 1.85 (95% CI, 1.16 to 3.03) and a 2-year survival rate of 62% versus 77%, compared with the other 23 centers. Aass et al54 noted a similar effect in an earlier, smaller study in which 193 patients were studied who participated in clinical trials at 14 Scandinavian centers between 1981 and 1986. A multivariate analysis found that patients treated at the institution with the highest volume (46%) after adjustment for prognostic factors had a lower risk of death compared with those treated at the other institutions (RR, 0.72; 3-year survival rate, 84% v 60%, respectively). Leukemia. The only study of acute leukemia care, excluding those that considered transplantation, was of 879 adolescents and young adults diagnosed between 1984 and 1994 in regions of England and Wales that kept and maintained leukemia registries.55 No differences in survival were observed that were associated with treatment on a national clinical trial, care at a teaching hospital, or hospital annual case volume. The International Bone Marrow Transplantation Registry addressed the volume-outcome relationship with allotransplantation.56 Survival for 1,313 patients between 1983 and 1988 of HLA-identical sibling bone marrow transplantations for acute leukemia in first remission or chronic myelogenous leukemia in first chronic phase was assessed by center volume. Twenty-four percent of centers performed five or fewer transplantations per year, and five (6%) performed more than 40 per year. After adjustment for patient and disease characteristics, treatment-related mortality (RR, 1.53; P ⬍ .01) and treatment failure (RR, 1.38; P ⬍ .04) were higher at centers that performed five or fewer transplantations per year. High-volume centers had an absolute 10% benefit in 2-year survival compared with all other centers (65% v 55%). No differences were observed in centers that performed more than five but fewer or equal to 40 transplantations per year. This registry has not reported any volume-outcome evaluations for other conditions. DISCUSSION Patients and their families are increasingly seeking information to guide their therapy for cancer. Sites related to medical information are one of the largest categories of Internet use. Although information is increasingly available, it is often not readily understandable, of widely variable accuracy, and of questionable relevance. In addition to specific treatments, socioeconomic and organizational factors are known to affect processes and outcome for many noncancer conditions. For cancer patients, does where they live, insurance status, physician’s specialty, or type of medical center and volume of cases of a specific cancer matter? With the exception of factors associated with BCS and local radiation for early-stage breast cancer, the answers are unknown and, for most conditions, unexamined. This may not be surprising because the organization of cancer care in the United States is so diffuse and diverse that providers have not had to be accountable for specific processes or outcomes. Where organizational factors have been assessed, the predominant relationship is between higher volumes and better outcomes, particularly for complex surgical procedures. Besides case volume, a variety of hospital or organizational factors, such as the breadth of services and technology, nurse staff levels, multidisciplinary teams, internal quality programs, American Cancer Society or NCI designation, have been suggested to be associated with or to be indicators of superior cancer care. We found only an occasional study that considered these factors, likely because these factors are too detailed to abstract. For example, studies of hospital characteristics include at most three variables: size, residency status, and type (usually categorized as university, large community, or small community). However, when available, these characteristics describe an entire hospital, not just its cancer program. Additional, unexplored factors that may affect oncology include the stage of managed care in the local marketplace and other indicators of competition. This does not mean, however, that these factors do not have face validity or are not important to insurers in their selection of physicians or medical centers. One process area that may account for better outcomes is the reorganizing of care from diversified locations into a single-site multidisciplinary clinic. Although many hospitals advertise their integrated approach for common cancers, this benefit must be considered only to be intuitively better because no pre- versus posttreatment comparisons from single centers or between centers were found. The motivations behind and limitations of the articles that cited an association of higher volume with better outcome could affect the strength of their methods and conclusions. These include the importance and relevance of when data was gathered, the data source itself, the completeness of efforts to control and adjust for case mix, the motives of the single supercenters who write about their superiority, and the high probability of publication bias. All reports were retrospective and predominantly used data collected in the 1980s. The question of the usefulness of such old data highlights the need to create tools that allow collection that is more rapid and timely for reporting. In this review, only studies that stratified or adjusted for clinical stage were included. In addition, each was assessed for whether it identified and controlled for case mix by adjusting for differences in demographics and comorbidity. However, the ability to adequately control for case mix is weaker when VOLUME/SPECIALIZATION AND CANCER CARE OUTCOMES discharge summary diagnoses from administrative data are used, which was the case in almost all studies, and not from clinical databases.57 One interesting issue is how to assess single-institutions, compared among themselves (all of which have complete detailed data on their patients), with an external data set. Examples of this are the comparisons of the surgical reports from Johns Hopkins with the Maryland state hospital discharge summaries, of Memorial Sloan-Kettering Cancer Center with SEER, and of comprehensive cancer centers with SEER. These reports each suggest that bigger is better but are also consistent with studies published only for their self-interest. Should these findings be viewed as analogous to comparing phase II data with historical controls? The absolute long-term survival differences between the highvolume and specialty centers in the care of breast cancer, Hodgkin’s disease, and testicular and ovarian cancers were all markedly greater than the overall temporal trend of improvements in survival over the last 20 years. Were there subtle differences in the populations that attended SEER sites and non–Johns Hopkins hospitals, or should major quality improvement efforts begin to include the direction of patients to selected centers? Ultimately, the question is who should judge and on what data should this judgement be based. Although a relationship between higher volume and better outcome is intuitively attractive, it is often difficult to determine the direction of the causal relationship: whether volume affects quality or whether better units and clinicians attract more patients.10,58 If the relationship is true, why are higher volume centers associated with better outcomes? For 30-day mortality, the associated processes are predominantly the technical expertise of the primary physician, usually a surgeon, and his or her team. The advocate of the high-volume center will speculate that the surgeon does a more complete primary procedure, that the care of the intensive care unit is more effective, and that the increased availability of consultants and the relationship between high-volume surgeons and high-volume radiation therapists or medical oncologists improve the hand off of care into the adjuvant setting. What have not yet been dissected are the individual processes, such as the use of specific procedures or drugs that could be included in a practice guideline. The skeptic will point out that most noncancer studies that make the best adjustments for case mix show less benefit from increased volume and a decreasing effect over time. A research agenda that addresses this issue should be initiated now, with or without efforts to concentrate care today. The relationship between volume and outcome deserves careful study to determine the clinical differences that produce the better outcome. As Hannan58 noted in a recent editorial related to hospital volume and outcomes for acute 2337 myocardial infarction, a dialog between providers, insurers, and the general public needs to begin regarding how these studies should be incorporated into policies aimed at improving the quality of care. Results presented here should prompt patients and their families to seek out high-volume services. However, there will be varying levels of resistance to patients moving large distances for their care. Of all patients with breast or lung cancer, only approximately 4% are treated at NCI-designated centers and another 17% at teaching hospitals. Alternatively, if the clinical mechanisms that explain these differences were clearer, local initiatives could be put into place that address shortcomings that would improve results. Acting on the results presented above may change outcomes for large populations of patients. However, which action to take to define models of excellence, such as moving patients, providing better training, or requiring local attention to specific clinical procedures, is difficult to sort out based on current information.59 Assuming that the volume-outcome relationship holds up to careful scrutiny, it will be important to ask how specialized the specialist has to be to achieve the best outcome and who will set the thresholds. How few is enough is a highly charged issue, particularly among surgeons. For instance, should the initial treatment of sarcoma be performed by a general surgeon, a surgical oncologist, a specialized sarcoma surgical oncologist, or a specialized sarcoma surgical oncologist only if he or she operates in a high-volume hospital with a designated sarcoma service? Is it proper for a community medical oncologist to provide adjuvant therapy for breast cancer, or should all women who require adjuvant therapy be treated by a breast cancer medical oncologist at a special site that may be 100 miles away? These are the central questions in response to these findings. There is no evidence to support the claim that care in the United States for the less common cancers is currently being directed to high-volume centers based on data from National Cancer Database reports (Table 11). For testicular and pancreatic cancer, both relatively rare and with strong evidence of a volume-outcome effect, the distribution of treatment location was no different from that of the most common cancers. The national median hospital volume for new cases of ovarian cancer was only 11 cases per year in 1993.64 The image of insurers and regulators as those who construct barriers to care is evolving. For years, many insurers have had centers of excellence programs for organ transplantation. At least one national insurer (UnitedHealthcare, Minneapolis, MN) intends to soon open a similar program for cancer surgery (Richard Watt, personal communication, December 1999). An important concern of patients is whether their insurers impede prompt access to cancer-specific evaluation and specialty care. Variation in 2338 HILLNER, SMITH, AND DESCH Table 11. Cancer Source Uncommon Pancreas Testes Common Lung Colon Breast Stratification of Relative Percent of Individual Cancers Initially Treated by the Total Annual Hospital Cancer Volume Annual Hospital Cancer Volume for New Cases of All Types (%) ⬎ 1000 500-599 150-499 ⬍ 150 Unknown 32.0 36.6 37.7 35.0 18.3 19.2 0.7 8.0 11.2 1.2 29.0 30.0 35.2 40.7 42.5 41.5 20.4 23.5 19.8 0.9 2.4 1.6 8.9 1.6 1.9 NOTE. Data abstracted from National Cancer Database reports on cancer of the pancreas,13 testes,60 lung,61 Colon,62 and breast.63 indicators of the process of care, such as delays in getting to see a physician or specialist, and clinical process indicators in the perioperative, adjuvant, or follow-up care are major concerns of patients, advocacy groups, and clinicians. Barriers on a case-by-case basis certainly exist. Most patients are familiar with techniques of health care rationing through inconvenience, such as prolonged waiting on hold while on the telephone, preauthorization of services being referred for review, and limited access to emergency care. However, a detailed dissection of the taxonomy by cancer type, insurer, location, and type of treatment will be needed to determine this effect on processes and outcomes. The appropriateness of physician self-referral is an ongoing ethical and economic challenge in oncology. It is uncertain whether it is a problem of quality for the most common cancer, but it is an obvious barrier to concentration of care. The number of surgeons who performed colectomies for colorectal cancer in Maryland was approximately three-fold that in Ireland in 1989. Mitchell and Sunshine65 found that the frequency and costs of radiation therapy at free-standing centers in Florida were 40% to 60% higher than in the rest of the country. Medical oncologists are the only specialty physicians to sell a high-priced, high-volume commodity from their practice. Kurowski66 reports that 40% to 60% of a medical oncologist’s income is derived from revenue related to office-based drug administration. Whether these issues relate to differences in quality and patient outcomes in unknown. Future studies could audit processes of care for appropriateness and use the financial organization of the site of care as the unit of analysis. Lastly, should either the public or insurers give cancer merit special attention, compared with all other medical conditions, in explicitly defining quality? We believe the answer is yes, but it will require substantial changes in how information is collected and shared. The focus needs to shift from quantifying the cancer burden to how to maximize the quality of its care. Cancer is the number-one health condition that the public fears, and there is only one chance for cure, if there is one at all. From a conceptual framework, cancer also has compelling data characteristics that can be readily combined to define prospectively quality processes (Table 12).67 First, it is necessary to know when disease is first identified. Cancer is the only chronic disease, other than human immunodeficiency virus, for which the incidences are registered. Second, disease severity must be known when the disease is first identified. The tumor-node-metastasis system for cancer is the most widely agreed on taxonomy for severity of any medical condition. These two essential elements are collected by national registries. However, because these data are hospital-based, they are not readily available to insurers, providers, patients, or researchers. Third, the relevant processes of care must be defined and tracked. Obtaining this information will be the primary barrier. Processes of care that describe evaluation and treatment are principally documented in administrative claims that may not be available at the particular hospital that is the site of the cancer registry. New creative arrangements and alliances need to be explored that allow different sources to exchange data in a much more real-time, anonymous manner. Fourth, substantial variation in processes and outcomes of cancer care exist as noted in this review. Lastly, a relationship between the process of care and outcomes must be established. This relationship may seem obvious but has only been shown for selected high-risk surgery. The process factors associated with long-term recurrence-free or overall survival, such as coordination between specialists and the use of adjuvant therapy, have only been superficially studied. In 1996, the National Coalition for Cancer Survivorship prepared a report on imperatives and principles for quality Table 12. ● ● ● ● Data Elements Needed for Identifying Quality Care When is condition first identified? How severe is the disease (stage)? Processes of care units must be defined. Meaningful variation in processes and outcomes of care must be identified. ● Relationship between processes of care and outcomes must be established. 2339 VOLUME/SPECIALIZATION AND CANCER CARE OUTCOMES of cancer care, which was followed in 1998 by an American Federation of Clinical Oncologic Societies statement related to access to quality cancer care.68,69 Neither of these seems to have initiated change on the national level to define and measure a core set of quality indicators for cancer. In April 1999, the National Cancer Policy Board made 10 detailed recommendations for ensuring quality cancer care. This report provides strong background for the Policy Board’s first recommendation: “Ensure that patients undergoing procedures that are technically difficult to perform and have been associated with higher mortality in lower-volume settings receive care at facilities with extensive experience.“ This should be done concurrently with the development, measurement, and monitoring of a core set of quality measures for cancer for which hospitals, provider groups, and managed care systems should be accountable.1 REFERENCES 1. Ensuring Quality Cancer Care. Washington, DC, National Academy Press, 1999 2. Luft HS, Bunker JP, Enthoven AC: Should operations be regionalized? The empirical relation between surgical volume and mortality. N Engl J Med 301:1364-1369, 1979 3. Medicare: A strategy for quality assurance. Washington, DC, National Academy Press, 1990 4. Blumenthal D: Part 1: Quality of care—What is it? [see comments] N Engl J Med 335:891-894, 1996 (editorial) 5. Brook RH, McGlynn EA, Cleary PD: Quality of health care: Part 2—Measuring quality of care [see comments]. N Engl J Med 335:966970, 1996 (editorial) 6. Cella DF, Orav EJ, Kornblith AB, et al: Socioeconomic status and cancer survival. J Clin Oncol 9:1500-1509, 1991 7. Lu-Yao GL, McLerran D, Wasson J, et al: An assessment of radical prostatectomy: Time trends, geographic variation, and outcomes. JAMA 269:2633-2636, 1993 8. Nattinger AB, Gottlieb MS, Veum J, et al: Geographic variation in the use of breast-conserving treatment for breast cancer [see comments]. N Engl J Med 326:1102-1107, 1992 9. Grilli R, Minozzi S, Tinazzi A, et al: Do specialists do it better? The impact of specialization on the processes and outcomes of care for cancer patients. Ann Oncol 9:365-374, 1998 10. Sowden AJ, Deeks JJ, Sheldon TA: Volume and outcome in coronary artery bypass graft surgery: True association or artefact? [see comments]. BMJ 311:151-155, 1995 11. Glasgow RE, Mulvihill SJ: Hospital volume influences outcome in patients undergoing pancreatic resection for cancer. West J Med 165:294-300, 1996 12. Lieberman MD, Kilburn H, Lindsey M, et al: Relation of perioperative deaths to hospital volume among patients undergoing pancreatic resection for malignancy. Ann Surg 222:638-645, 1995 13. Janes RH Jr, Niederhuber JE, Chmiel JS, et al: National patterns of care for pancreatic cancer: Results of a survey by the Commission on Cancer. Ann Surg 223:261-272, 1996 14. Gordon TA, Burleyson GP, Tielsch JM, et al: The effects of regionalization on cost and outcome for one general high-risk surgical procedure [see comments]. Ann Surg 221:43-49, 1995 15. Gordon TA, Bowman HM, Tielsch JM, et al: Statewide regionalization of pancreaticoduodenectomy and its effect on in-hospital mortality. Ann Surg 228:71-78, 1998 16. Sosa JA, Bowman HM, Gordon TA, et al: Importance of hospital volume in the overall management of pancreatic cancer. Ann Surg 228:429-438, 1998 17. Birkmeyer JD, Warshaw AL, Finlayson SR, et al: Relationship between hospital volume and late survival after pancreaticoduodenectomy. Surgery 126:178-183, 1999 18. Begg CB, Cramer LD, Hoskins WJ, et al: Impact of hospital volume on operative mortality for major cancer surgery [see comments]. JAMA 280:1747-1751, 1998 19. Patti MG, Corvera CU, Glasgow RE, et al: A hospital’s annual rate of esophagectomy influences the operative mortality rate. J Gastrointest Surg 2:186-192, 1998 20. Choti MA, Bowman HM, Pitt HA, et al: Should hepatic resections be performed at high-volume referral centers? J Gastrointest Surg 2:11-20, 1998 21. Ginsberg RJ, Vokes EE: Non-small cell lung cancer, in Devita VT, Hellman S, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology. Philadelphia, PA, Lippincott-Raven, 1997, pp 858-910 22. Whittle J, Steinberg EP, Anderson GF, et al: Use of Medicare claims data to evaluate outcomes in elderly patients undergoing lung resection for lung cancer [see comments]. Chest 100:729-734, 1991 23. Romano PS, Mark DH: Patient and hospital characteristics related to in-hospital mortality after lung cancer resection. Chest 101:1332-1337, 1992 24. Silvestri GA, Handy J, Lackland D, et al: Specialists achieve better outcomes than generalists for lung cancer surgery [see comments]. Chest 114:675-680, 1998 25. McArdle CS, Hole D: Impact of variability among surgeons on postoperative morbidity and mortality and ultimate survival [see comments]. BMJ 302:1501-1505, 1991 26. Kingston RD, Walsh S, Jeacock J: Curative resection: The major determinant of survival in patients with large bowel cancer. J R Coll Surg Edinb 36:298-302, 1991 27. Mella J, Biffin A, Radcliffe AG, et al: Population-based audit of colorectal cancer management in two UK health regions: Colorectal Cancer Working Group, Royal College of Surgeons of England Clinical Epidemiology and Audit Unit. Br J Surg 84:1731-1736, 1997 28. Kee F, Wilson RH, Harper C, et al: Influence of hospital and clinician workload on survival from colorectal cancer: Cohort study [see comments]. BMJ 318:1381-1385, 1999 29. Harmon JW, Tang DG, Gordon TA, et al: Hospital volume can serve as a surrogate for surgeon volume for achieving excellent outcomes in colorectal resection. Ann Surg 230:404-411, 1999 30. Khuri SF, Daley J, Henderson, et al: Relation of surgical volume to outcome in eight common operations: Results from the VA National Surgical Quality Improvement Program. Ann Surg 230:414-429, 1999 31. Rosen L, Stasik JJ Jr, Reed JF III, et al: Variations in colon and rectal surgical mortality: Comparison of specialties with a statelegislated database. Dis Colon Rectum 39:129-135, 1996 32. Porter GA, Soskolne CL, Yakimets WW, et al: Surgeon-related factors and outcome in rectal cancer [see comments]. Ann Surg 227:157-167, 1998 2340 32a. Holm T, Johansson H, Cedermark B, et al: Influence of hospital and surgeon-related factors on outcome of rectal cancer with or without preoperative radiotherapy. Br J Surg 84:657-663, 1997 33. Sainsbury R, Haward B, Rider L, et al: Influence of clinician workload and patterns of treatment on survival from breast cancer. Lancet 345:1265-1270, 1995 34. Gillis CR, Hole DJ: Survival outcome of care by specialist surgeons in breast cancer: A study of 3786 patients in the west of Scotland [see comments]. BMJ 312:145-148, 1996 35. Bonett A, Roder D, Esterman A: Case-survival rates for infiltrating ductal carcinomas by category of hospital at diagnosis in South Australia. Med J Aust 154:695-697, 1991 36. Roohan PJ, Bickell NA, Baptiste MS, et al: Hospital volume differences and five-year survival from breast cancer. Am J Public Health 88:454-457, 1998 37. Lee-Feldstein A, Anton-Culver H, Feldstein PJ: Treatment differences and other prognostic factors related to breast cancer survival: Delivery systems and medical outcomes [see comments]. JAMA 271:1163-1168, 1994 38. Guadagnoli E, Weeks JC, Shapiro CL, et al: Use of breastconserving surgery for treatment of stage I and stage II breast cancer. J Clin Oncol 16:101-106, 1998 39. Guadagnoli E, Shapiro CL, Weeks JC, et al: The quality of care for treatment of early stage breast carcinoma: Is it consistent with national guidelines? Cancer 83:302-309, 1998 40. Johnson TP, Ford L, Warnecke RB, et al: Effect of a National Cancer Institute Clinical Alert on breast cancer practice patterns. J Clin Oncol 12:1783-1788, 1994 41. Solin LJ, Fowble BL, Martz KL, et al: Results of the 1983 patterns of care process survey for definitive breast irradiation. Int J Radiat Oncol Biol Phys 20:105-111, 1991 42. Kutcher GJ, Smith AR, Fowble BL, et al: Treatment planning for primary breast cancer: A patterns of care study. Int J Radiat Oncol Biol Phys 36:731-737, 1996 43. 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 44. Nguyen HN, Averette HE, Hoskins W, et al: National survey of ovarian carcinoma: Part V—The impact of physician’s specialty on patients’ survival. Cancer 72:3663-3670, 1993 45. Karakiewicz PI, Bazinet M, Aprikian AG, et al: Thirty-day mortality rates and cumulative survival after radical retropubic prostatectomy. Urology 52:1041-1046, 1998 46. Kehoe S, Powell J, Wilson S, et al: The influence of the operating surgeon’s specialisation on patient survival in ovarian carcinoma. Br J Cancer 70:1014-1017, 1994 47. Woodman C, Baghdady A, Collins S, et al: What changes in the organisation of cancer services will improve the outcome for women with ovarian cancer? Br J Obstet Gynaecol 104:135-139, 1997 48. Junor EJ, Hole DJ, Gillis CR: Management of ovarian cancer: Referral to a multidisciplinary team matters. Br J Cancer 70:363-370, 1994 49. Munoz KA, Harlan LC, Trimble EL: Patterns of care for women with ovarian cancer in the United States. J Clin Oncol 15:3408-3415, 1997 50. Davis S, Dahlberg S, Myers MH, et al: Hodgkin’s disease in the United States: A comparison of patient characteristics and survival in the Centralized Cancer Patient Data System and the Surveillance, Epidemiology, and End Results Program. J Natl Cancer Inst 78:471478, 1987 HILLNER, SMITH, AND DESCH 51. Feuer EJ, Frey CM, Brawley OW, et al: After a treatment breakthrough: A comparison of trial and population-based data for advanced testicular cancer. J Clin Oncol 12:368-377, 1994 52. Harding MJ, Paul J, Gillis CR, et al: Management of malignant teratoma: Does referral to a specialist unit matter? [see comments] Lancet 341:999-1002, 1993 53. Collette L, Sylvester RJ, Stenning SP, et al: Impact of the treating institution on survival of patients with “poor-prognosis” metastatic nonseminoma: European Organization for Research and Treatment of Cancer Genito-Urinary Tract Cancer Collaborative Group and the Medical Research Council Testicular Cancer Working Party [see comments]. J Natl Cancer Inst 91:839-846, 1999 54. Aass N, Klepp O, Cavallin-Stahl E, et al: Prognostic factors in unselected patients with nonseminomatous metastatic testicular cancer: A multicenter experience. J Clin Oncol 9:818-826, 1991 55. Stiller CA, Benjamin S, Cartwright RA, et al: Patterns of care and survival for adolescents and young adults with acute leukaemia: A population-based study. Br J Cancer 79:658-665, 1999 56. Horowitz MM, Przepiorka D, Champlin RE, et al: Should HLA-identical sibling bone marrow transplants for leukemia be restricted to large centers? [see comments] Blood 79:2771-2774, 1992 57. Jollis JG, Ancukiewicz M, DeLong ER, et al: Discordance of databases designed for claims payment versus clinical information systems. Ann Intern Med 119:844-850, 1993 58. Hannan EL: The relation between volume and outcome in health care. N Engl J Med 340:1677-1679, 1999 (editorial) 59. Smith TJ, Hillner BE, Desch CE: The Quality of Cancer Care: Models of Excellence. Background paper prepared from the National Cancer Policy Board, 1999. http://www4.nas.edu/IOM/IOMHome.nsf/ Pages/National%2bCancer%2bPolicy%2bBoard1999. Accessed July 8, 1999 60. Steele GS, Richie JP, Stewart AK, et al: The national cancer data base report on patterns of care for testicular carcinoma, 1985-. Cancer 86:2171-2183, 1999 61. Fry WA, Menck HR, Winchester DP: The National Cancer Data Base report on lung cancer. Cancer 77:1947-1955, 1996 62. Jessup JM, McGinnis LS, Steele GD Jr, et al: The National Cancer Data Base: Report on colon cancer. Cancer 78:918-926, 1996 63. Jessup JM, Menck HR, Winchester DP, et al: The National Cancer Data Base report on patterns of hospital reporting. Cancer 78:1829-1837, 1996 64. Partridge EE, Phillips JL, Menck HR: The National Cancer Data Base report on ovarian cancer treatment in United States hospitals. Cancer 78:2236-2246, 1996 65. Mitchell JM, Sunshine JH: Consequences of physicians’ ownership of health care facilities: Joint ventures in radiation therapy [see comments]. N Engl J Med 327:1497-1501, 1992 66. Kurowski B: Cancer carve outs, specialty networks, and disease management: A review of their evolution, effectiveness, and prognosis. Am J Manag Care 4:SP71-SP89, 1998 (suppl) 67. Hillner BE, Smith TJ: Hospital volume and patient outcomes in major cancer surgery: A catalyst for quality assessment and concentration of cancer services. JAMA 280:1783-1784, 1998 (editorial) 68. Imperatives for Quality Cancer Care: Access, Advocacy, Action, and Accountability, 1996. [Position paper presented at the Congress Leadership Forum and posted on CancerNet, a Web site of the National Cancer Institute.] http://cancernet.nci.nih.gov/imperatives/ quality.htm. Accessed July 8, 1999 69. Access to quality cancer care: Consensus statement—American Federation of Clinical Oncologic Societies [published erratum appears in J Clin Oncol 16:2001, 1998]. J Clin Oncol 16:1628-1630, 1998