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Ann Thorac Surg 2003;76:1155-1162
© 2003 The Society of Thoracic Surgeons
a Department of Anesthesiology, University of Rochester Medical Center, School of Medicine and Dentistry, Rochester, New York, USA
b Department of Community and Preventive Medicine, University of Rochester Medical Center, School of Medicine and Dentistry, Rochester, New York, USA
c Department of Health Policies, University of Rochester Medical Center, School of Medicine and Dentistry, Rochester, New York, , USA
d Department of Surgery, The University of Vermont College of Medicine, Burlington, Vermont, USA
Accepted for publication May 9, 2003.
* Address reprint requests to Dr Glance, Department of Anesthesiology, University of Rochester Medical Center, 601 Elmwood Ave, Box 604, Rochester, NY 14642, USA
e-mail: laurent_glance{at}urmc.rochester.edu
| Abstract |
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METHODS: This retrospective cohort analysis was conducted using data from the Cardiac Surgery Reporting System database on all patients (20,078) undergoing CABG surgery in New York State who were discharged in 1996. The main outcome measure was in-hospital mortality as a function of procedure volume after adjusting for severity of disease. Logistic regression modeling was used to explore the interaction between patient risk and procedure volume.
RESULTS: There is a significant interaction between procedure volume and patient risk (p = 0.01). The final model exhibits excellent discrimination (C statistic = 0.818) and goodness-of-fit (Hosmer-Lemeshow statistic = 6.02; p = 0.645). Very low (<0.5%) and low-risk (0.5%2.0%) patients exhibit a greater reduction in CABG mortality than high (5.0%10.0%) and very high risk (>10%) patients at high-volume centers relative to low-volume centers. Among the highest risk patients (>25% risk of mortality), higher risk patients have better outcomes at higher volume centers.
CONCLUSIONS: For the vast majority of patients, low-risk patients benefit significantly more than high-risk patients from undergoing CABG surgery at high-volume centers instead of at low-volume centers. Low-risk patients benefit significantly more than high-risk patients from undergoing CABG surgery at high-volume centers instead of at low-volume centers. However, before generalizing these findings to other states, this study should be repeated using other regional population-based clinical databases.
| Introduction |
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Many studies have investigated the volume-outcome relationship for coronary artery bypass surgery [1, 2, 816]. Most of these studies have demonstrated that better outcomes are associated with higher hospital volumes [1, 2, 813, 1618]. However, the exact nature of the volume-outcome relationship for coronary artery bypass graft (CABG) surgery is less clear in some of the more recent studies. Birkmeyer and colleagues [1] published their findings from a study of more than 900,000 Medicare patients in an administrative database and found that higher procedure volumes resulted in lower mortality. The primary limitation of this study is that the risk adjustment methodology used is based on administrative data. ICD-9-CM codes do not represent all important clinical information, may not always be coded accurately by nonclinical personnel, and do not distinguish between preexisting conditions and complications [19]. Two other studies, both using prospectively collected clinical data on all patients undergoing CABG surgery in New York State (NYS) have also identified a clear volume-outcome association [12, 13]. However, another study also based on NYS showed no significant volume-outcome relationship [14]. This latter study was performed using administrative data, and thus may not adjust adequately for severity-of-disease. Two other large studies, both using clinical databases did not support the existence of a significant volume-outcome association: the first, based on The Society of Thoracic Surgery Cardiac database [20], the second, on the Department of Veterans Affairs database [15]. One of the limitations of the Veterans Affairs (VA) study, identified by the study authors, is that the CABG volumes at VA hospitals may not take into account the procedures performed at non-VA hospitals by VA surgeons.
One aspect of the volume-outcome relationship that has received very little attention is the question of whether the outcome benefit attributable to higher procedure volumes, if present, is modified by severity-of-disease. In other words, do patients who are more ill have a greater benefit from being treated at higher-volume centers than healthier patients? One of the early CABG studies demonstrated a stronger inverse relationship between volume and mortality in patients who underwent nonscheduled CABG surgery versus patients undergoing elective CABG surgery [11]. The only other study [16] to investigate the interaction between patient risk and the volume-outcome relationship was performed using a commercial outcomes benchmarking data set. After adjusting for severity-of-disease using All Patient Refined-Diagnosis Related Groups, patients with a moderate (2% to 5%) and high (5% to 20%) predicted risk of death were found to benefit more than patients at minimal (< 0.5%) and low (0.5 to 2%) risk of death from having CABG surgery performed at high-volume versus low-volume hospitals. No other volume-outcome studies for CABG surgery has evaluated whether the outcome benefit attributable to higher procedure volumes is modified by severity-of-disease. The finding that only specific subgroups of patients benefit from being treated at high-volume centers could lead to policies that promote targeted regionalization of care (ie, only transferring those patients who would benefit most from being treated at high-volume centers) [16].
This study extends previous work in this area by evaluating whether severity-of-disease modifies the volume-outcome relationship in CABG surgery using a clinical database. By using a clinical data set, our study is less likely to be biased by inadequate risk adjustment. Our study specifically models the interaction between patient risk and hospital volume in order to determine whether low-risk, intermediate-risk, and high-risk patients benefit equally from having CABG surgery at high-volume centers. The finding that low-risk, intermediate-risk, and high-risk patients do not benefit equally from receiving care at high-volume centers may have significant implications for the application of policies that advocate selective referral of CABG surgical patients.
| Material and methods |
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Exploratory data analysis
The median number of CABG procedures performed at hospitals in this database was 535. For the purpose of exploratory data analysis, hospitals with a CABG surgery volume greater than 500 cases per year were designated as high-volume hospitals. The demographics and risk factors of patients undergoing CABG surgery at low-volume and high-volume hospitals were compared using standard statistical techniques. We then used the 1996 CSRS CABG prediction model [22] (Model 1) to divide the patients in the data set into four risk groups for in-hospital mortality: very low (< 0.5%), low (0.5% to 2%), moderate (2.0% to 5.0%), high (5.0% to 10%), and very high (> 10%). This model has been previously validated [22] and shown to have excellent discrimination (C statistic equal to 0.813) and excellent calibration (Hosmer-Lemeshow statistic equal to 5.94) [23].
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The odds ratio for in-hospital mortality for patients at high-volume versus low-volume hospitals were then calculated for each of the four risk groups.
New models
A new logistic regression model was developed (Model 2) to explore the influence of hospital volume in patients undergoing CABG surgery. The set of covariates in this model includes all 18 risk factors in the 1996 CSRS CABG model [22] and hospital volume; hospital volume was included in this model as a main effect only. The volume measure was defined as the annual number of patients undergoing CABG surgery for a particular hospital in the database. A robust variance estimator [24] was used to accommodate the hierarchical structure of the data because individual patients are nested within hospitals, and therefore patient outcomes within the same hospital may be correlated.
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A third model was constructed (Model 3), which included hospital volume (V) as a main effect and an interaction term. This model was specified so that V would interact with the baseline probability of death. The "main effect" volume term in this model is specified by the term ßV*V'. The interaction terms are specified by ßV intV'(pbase).1 and ßV int'V'(pbase).3, where V' is the hospital volume minus the volume of the lowest-volume center, and pbase is the predicted probability of death for a patient if that patient were treated at the lowest-volume center. The model specification is shown below:
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| Results |
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| Comment |
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It is unclear why among patients with a mortality risk < 9% (95% of the patient sample) low-risk patients appear to benefit more than higher-risk patients from undergoing CABG surgery at high-volume centers. The conventional wisdom is that routine patients can be treated in community hospitals, whereas high-risk patients should be referred to tertiary care centers with greater expertise and higher patient volumes. One could speculate that perioperative care is more standardized and protocol-driven at high-volume centers resulting in less variation in care and improved outcomes. Perhaps low-risk patients are more likely to benefit from clinical pathways simply because their care is more routine than that of higher-risk patients whose clinical course is more likely to fall outside of clinical pathways.
The results of the study by Nallamothu and colleagues [16] suggest the opposite findings, namely that moderate-risk and high-risk patients benefit more than low-risk patients from having CABG surgery at high-volume centers. In these authors study, they compared the mortality rates of low-volume and high-volume hospitals for minimal, low, moderate, high, and severe-risk patients. However, because the CABG prediction model used to assign patients to different risk groups was based on administrative data, some of the patients may not have been assigned to the correct risk group. One of the most important limitations of administrative data sets for risk adjustment is that they do not distinguish between comorbidities, medical problems that existed before hospitalization and complications that occurred during the hospitalization. For example, a complication of care that is incorrectly identified as comorbidity may spuriously increase a patients predicted mortality. Therefore, in this study, it is not possible to know if the patients at low-volume hospitals had the same level of risk as the patients at high-volume hospitals within each risk strata.
Despite the extensive body of research on the subject of the relationship between volume and mortality, the question of whether higher volumes result in lower mortality (practice makes perfect hypothesis) or lower mortality leads to higher patient volumes through increased referrals (selective referral hypothesis) remains unanswered [2]. A similar question may be raised with respect to the interaction between volume and mortality. Is it possible that low risk patients are being triaged to lower quality hospitals and higher risk patients are selectively referred to higher quality hospitals, because referring physicians believe that the patients who are more ill need to be treated at better hospitals? Addressing this question is beyond the scope of this study. However, the answer to this question is important for translating these results into policy.
The nature of the structures and processes resulting in superior outcomes at high-volume centers [5] is also left undefined by this and other studies investigating volume-outcome relationships. Some groups have advocated evidenced-based hospital referrals based simply on hospital volume as a means of improving outcomes [6, 7]. However, such a policy could have important indirect effects. This could create incentives for some hospitals near the volume threshold to operate on patients who may have otherwise been managed nonoperatively so as to qualify as a high-volume center [7]. Regionalization of services could reduce competition and lower quality of care [6]. Regionalization could also result in loss of specialists and limit patient access to specialty care [6]. Finally, a policy of regionalizing CABG surgery based on volume criteria alone could result in the closing of some high-quality centers that have low patient volumes. Volume, by itself, does not necessarily lead to better outcomes. More likely, "It is a proxy measure for other factors that affect care" [5]. The existence of a wide variation in processes of care in the clinical setting is well recognized [28]. For CABG surgery, the differences in structure and processes of care between low-volume and high-volume centers could be studied in order to identify the best practices, which could then be adapted to individual institutions. This approach avoids some of the problems inherent in evidence-based referrals using volume as a quality proxy. Because there may be a much greater outcome differential between low-volume and high-volume hospitals for low-risk patients versus high-risk patients, it may be very useful to uncover the best practices responsible for producing superior outcomes in low-risk patients at high-volume hospitals.
There are several potential limitations to this study. (1) In-hospital mortality was used because 30-day mortality data were not available in the CSRS database. In-hospital mortality is potentially biased by variation in length of stays across institutions [2]. However, the 30-day mortality rate also may be biased, because it includes deaths unrelated to CABG surgery and will not include patient deaths whose hospital length of stay is longer than 30 days [12]. (2) Although this study assessed the impact of hospital volume on mortality, mortality is only one of several indirect measures of quality of care. Quality of care, as defined by The Institute of Medicine, is the "degree to which health services for individuals and populations increases the likelihood of desired health outcomes..." [29]. Although complications of care can result in significant patient morbidity, these were not included in our analysis. Unlike mortality, complications are not always recorded accurately [30], and the accuracy of complication data are difficult to verify through database audits. Moreover, quality of care also encompasses the issue of whether the care rendered is appropriate [31]. Future outcome studies should also consider evaluating appropriateness of the care delivered. Finally, the hospitals in NYS may not be representative of the hospitals performing CABG surgery nationwide. With the release of CABG surgery "report cards" in NYS to the public beginning in 1991, there has been an "exodus of low-volume surgeons with highrisk-adjusted mortality" [13]. However, the elimination of some of the lowest-volume providers would be expected to bias the results in this analysis to show less of a volume-outcome relationship. Therefore, perhaps we would expect to see a more substantial volume-outcome effect in other regions that do not have similar outcome reporting programs in place.
This study has several strengths. By using the CSRS database, which contains prospectively collected clinical data, our findings are not subject to the limitations inherent to analyses based on administrative data. Risk adjustment using administrative data are complicated by the fact that most administrative databases do not distinguish complications of care from comorbidities present before hospital admission [19] and may not include all patient diagnoses. For CABG surgery in NYS, Hannan and colleagues [32] have shown that a prediction model based on the CSRS database exhibited better discrimination than a model based on an administrative database (ie, the Statewide Planning and Research Cooperative System database.
This study also presents an innovative approach to modeling the interaction between patient risk and hospital volume. Although the conceptualization of the statistical model is relatively straightforward, implementation of the model involved programming the likelihood function, because conventional statistical programs are not able to provide maximum likelihood estimates of the variables for this model.
We believe that our study is the first to evaluate the interaction between hospital volume and patient risk in a clinical database. There is no reason to believe, a priori, that all patients undergoing CABG surgery would benefit equally from being treated at high-volume centers. We constructed a statistical model that allowed us to assess the interaction between hospital volume and aggregate patient risk in patients who had CABG surgery. This approach could also be extended to assess the impact of patient risk on the volume-mortality relationship for other surgical procedures, as well as other nonoperative therapies.
In conclusion, this study suggests that low-risk patients benefit more than high-risk patients from having their surgery at high-volume centers instead of low-volume centers. Before generalizing this finding to areas outside of NYS, this study should be repeated using other regional and national population-based clinical databases. If this finding is validated in other settings, it may have important policy implications. The practice of referring low-risk patients to community hospitals with low operative volumes, and selectively referring only high-risk patients to high-volume centers may need to be reevaluated. However, volume is an imperfect proxy for quality of care and should not be used as the sole basis for regionalizing care. Instead, the information generated from this analysis and others like it should be used to help guide quality improvement efforts. Because low-risk patients stand to benefit the most by having CABG surgery in high-volume centers, future studies should focus on identifying the specific processes of care at high-volume centers that lead to improved outcomes in this subset of patients. Then these processes could be adapted to low-volume and intermediate-volume centers performing CABG surgery. We also believe that the efforts of the Leapfrog group to impose volume standards based on the evidence of a volume-outcome relationship in studies such as this one should serve as a call to arms to the medical community to lead this country toward the development of a national, population-based system to measure health care outcomes, instead of relying on imperfect volume cutoffs to identify high-quality care.
| Acknowledgments |
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| References |
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This article has been cited by other articles:
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L. G. Glance, T. M. Osler, D. B. Mukamel, and A. W. Dick Estimating the potential impact of regionalizing health care delivery based on volume standards versus risk-adjusted mortality rate Int. J. Qual. Health Care, August 1, 2007; 19(4): 195 - 202. [Abstract] [Full Text] [PDF] |
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E. Losina, E. A. Wright, C. L. Kessler, J. A. Barrett, A. H. Fossel, A. H. Creel, N. N. Mahomed, J. A. Baron, and J. N. Katz Neighborhoods Matter: Use of Hospitals With Worse Outcomes Following Total Knee Replacement by Patients From Vulnerable Populations Arch Intern Med, January 22, 2007; 167(2): 182 - 186. [Abstract] [Full Text] [PDF] |
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J. H. Liu, D. S. Zingmond, M. L. McGory, N. F. SooHoo, S. L. Ettner, R. H. Brook, and C. Y. Ko Disparities in the utilization of high-volume hospitals for complex surgery. JAMA, October 25, 2006; 296(16): 1973 - 1980. [Abstract] [Full Text] [PDF] |
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K. F. Welke, M. J. Barnett, M. S. Vaughan Sarrazin, and G. E. Rosenthal Limitations of Hospital Volume as a Measure of Quality of Care for Coronary Artery Bypass Graft Surgery Ann. Thorac. Surg., December 1, 2005; 80(6): 2114 - 2119. [Abstract] [Full Text] [PDF] |
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B. K. Nallamothu, K. A. Eagle, V. A. Ferraris, and R. M. Sade Should Coronary Artery Bypass Grafting Be Regionalized? Ann. Thorac. Surg., November 1, 2005; 80(5): 1572 - 1581. [Full Text] [PDF] |
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R. H. Jones The year in cardiovascular surgery J. Am. Coll. Cardiol., May 5, 2004; 43(9): 1706 - 1714. [Full Text] [PDF] |
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