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J Thorac Cardiovasc Surg 2009;137:23-29
© 2009 The American Association for Thoracic Surgery
General Thoracic Surgery |
a Division of Thoracic Surgery, Johns Hopkins School of Medicine, Baltimore, Md
b Department of Surgery, Johns Hopkins School of Medicine, Baltimore, Md
Received for publication May 5, 2007; revisions received June 20, 2008; accepted for publication September 16, 2008. * Address for reprints: Robert A. Meguid, MD, MPH, Division of Thoracic Surgery, Department of Surgery, 600 N. Wolfe St, Blalock 240, The Johns Hopkins Hospital, Baltimore, MD 21287. (Email: rmeguid1{at}jhmi.edu).
| Abstract |
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Methods: Retrospective analysis was performed on patients undergoing esophageal resection for cancer in the 1998 to 2005 Nationwide Inpatient Sample. A series of multivariable analyses were performed, changing the resection volume cutoff to account for the range of annual hospital resections. The goodness of fit of each model was compared by pseudo r2, the amount of data variance explained by each model.
Results: A total of 4080 patients underwent esophageal resection. The median annual hospital resection volume was 4 (range: 1–34). The mortality rate of "high-volume" centers ranged from 9.94% (
2 resection/year) to 1.56% (
30 resections/year). The best model was with an annual hospital resection volume greater than or equal to 15 (3.87% of data variance explained). The difference in goodness of fit between the best model and other models with different volume cutoffs was 0.64%, suggesting that volume explains less than 1% of variance in perioperative death.
Conclusion: Our data do not support the use of volume cutoffs for defining centers of excellence for esophageal cancer resections. Although volume has an incremental impact on mortality, volume alone is insufficient for defining centers of excellence. Volume seems to function as an imperfect surrogate for other variables, which may better define centers of excellence. Additional work is needed to identify these variables.
| Introduction |
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| See related article on page 10.
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Resection of the esophagus, either total or partial, is a complex surgical procedure that carries a relatively high risk of operative mortality. Because of this, a significant body of work has focused on the relationship between volume and outcome for esophageal resections. The beneficial effect of increased volume of esophagectomy on outcome has been clearly demonstrated in multiple studies.1-4
On the basis of the results of these and similar studies, esophageal resection has been identified as a potential procedure for volume-based regionalization, and as such resection volume has been proposed as a measurement for defining centers of excellence. An example of this is the Leapfrog Group, which defined criteria for "evidence-based hospital referral" for esophageal resection as hospitals performing a minimum of 13 resections per year.5
In addition to the volume cutoff for esophageal resections set by the Leapfrog Group, various other thresholds for defining high-volume centers have been used in the literature. These annual hospital volume thresholds range from 6 to 20 esophageal resections per year.2,6,7
However, these cutoff points have often been imprecisely or arbitrarily defined, and there are little data to support the use of specific volume cutoffs.
The aim of this study was to determine if an objective, evidence-based threshold of operative volume associated with improved hospital-level outcomes for esophageal resection for cancer could be defined. Should this threshold be identified, it could potentially be considered a candidate in the criteria for defining high-volume hospitals for esophageal resection.
| Materials and Methods |
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Patient Population
Initial inclusion criteria for this study were patients from the NIS database older than 17 years of age admitted with the diagnosis of esophageal cancer as identified by the International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes (150.X).10
Inclusion criteria was further limited to patients who underwent esophageal resection as identified by ICD-9 Clinical Modification procedure codes of 42.4 and 42.40 (esophagectomy NOS), 42.41 (partial esophagectomy), 42.42 (total esophagectomy), and 43.99 (esophagogastrectomy).2
Statistical Analysis
Multivariable analysis was performed with in-hospital death as the outcome of record from the discharge summaries. Independent variables included annual hospital resection volume, teaching status of the hospital where the procedure was performed, the year the procedure was performed, patient age, gender, race, and comorbidities as measured by the Charlson Index. The NIS dataset defines teaching hospital status as hospitals that have any American Medical Association-approved residency program, belong to the Council of Teaching Hospitals, or have a ratio of no more than 4:1 beds to full-time equivalent interns and residents.11
Patient comorbidities were standardized via calculation of the Deyo modification of the Charlson Index12,13
per the methods of Romano and colleagues.14
A standardized calculation of patient health, the Charlson Index is determined by weighted scoring of comorbidities, including cardiac, vascular, pulmonary, neurologic, endocrine, renal, hepatic, gastrointestinal, and immune diseases, as well as any documented history of cancer.
Individual annual hospital procedure volume was determined by calculating the number of esophageal resections performed using NIS-assigned unique hospital identification numbers. The annual hospital mortality rate for esophageal resections was calculated using the NIS annual hospital resection volume for esophageal resections.
Esophageal resection volume was included as a dichotomous variable to identify the volume cutoff that best models outcome. A series of sequential multiple logistic regression models with a dependent variable of in-hospital death; a set of common independent variables including patient age, gender, race, and Charlson Index of comorbidities, procedure year, and hospital teaching status; and a sequentially changing independent variable of dichotomized annual hospital resection volume were tested. This sequentially changing variable of annual hospital resection volume was dichotomized at 2 continuously up to 34, accounting for all of the esophageal resections in the NIS database in the time period studied. The resection volumes within this range are nearly continuous.
Each volume threshold dichotomizes the data and creates 2 categories for comparison: hospitals with an annual resection volume less than that cutoff and hospitals with an annual resection volume greater than or equal to that cutoff. Each volume threshold is then taken forward in the multivariable regression analysis as the independent variable.
Statistical analysis was performed using the software package STATA 10.0 (StataCorp LP, College Station, Tex). Bivariate analysis of categoric data was performed using the chi-square test. Analysis of continuous data was performed using the Student t test. Multivariable analysis was performed using linear and logistic regression models. The goodness of fit, a measurement of the amount of variability in the data explained by the model, was tested for each model by calculation of McFadden's pseudo r2 and the area under the curve (AUC). McFadden's pseudo r2 is one such measure of goodness of fit and has been re-scaled from 0% to 100% for ease of interpretation and comparison. It represents the percent of variance in a data pattern that is explained by the set of variables in a particular model. For instance, a model explaining 7% of the variation in the data would have a pseudo r2 of 0.07. Results are primarily reported as pseudo r2.15-17
AUC is also reported and improves as the value approaches 1.
| Results |
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| Conclusions |
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Given the well-established inverse relationship between esophageal resection volume and in-hospital mortality, we sought to use statistical modeling to define a single value cutoff at which there is significantly reduced mortality. This would allow us to better determine hospital operative volumes required for improved outcomes for esophageal resection for cancer.
On analysis of dichotomous volume cutoff modeling, we found a statistically significant difference between mortality rates at hospitals with esophagectomy volumes above the volume threshold in comparison with mortality rates of hospitals with esophagectomy volumes below the volume threshold, irrespective of annual hospital resection volume cutoff (Figure 2). For example, defining high volume at 13 or more, as suggested by the Leapfrog Group,5
the resulting high-volume hospitals have a mortality rate of 5.39% in comparison with 10.26% at low-volume hospitals (P < .001). However, even defining the high-volume threshold at a volume of 2 resections per year produces significant differences in mortality rates between hospitals with esophagectomy volumes above and below that threshold. Our study confirms previous findings by Christian and colleagues,18
who also showed that the Leapfrog standards may not have been optimal for other surgical procedures; for example, they empirically found different thresholds for coronary artery bypass graft, abdominal aortic aneurysm, and esophagectomies compared with the Leapfrog standards; moreover, in contrast with Leapfrog, they found no good empiric threshold for carotid endarterectomies.
This finding reveals the true conundrum of volume modeling: No matter what the volume cutoff is set at, the mortality rates above and below it are almost always significantly different. Therefore, to determine the best model for high-volume centers, we examined goodness of fit of the model to the data instead of differences in mortality.
When multiple logistic regression of in-hospital death after esophageal resection includes the variables of patient age, gender, race, and Charlson Index of comorbidities and calendar year, but not resection volume, the resulting model explains 3.23% of the variance in the data. Adding hospital volume as a dichotomous variable, ranging from 2 to 34 resections per year, improves the explanatory power of the model, with pseudo r2 ranging between 3.35% and 3.87%. By using these criteria, the best model is one that defines a "high-volume" cutoff as 15 or more esophageal resections per hospital per year, because this has the highest McFadden's pseudo r2 value and accounts for the most variability in the data. It is interesting to note that the inclusion of volume into the multivariable model only accounts for a maximum of 0.64% of the variability in the data. Therefore, varying the volume threshold did not substantially change the explanatory power of the different dichotomous volume models for defining high-volume centers for esophageal resection. This is noteworthy given the attention that resection volume for esophageal surgery, among other procedures, has been afforded in the literature.
Although there is an overall trend of increased operative volume associated with decreased postoperative mortality, a curious finding is present in Table 2: The mortality rate at centers with annual resection volumes equal to or greater than the volume threshold tested do not necessarily have continuously diminishing values. The mortality rates given in Table 2 are calculated by averaging the mortality rates of every hospital that performs esophagectomies above or below the volume threshold. As can be seen, increased volume does not strictly correlate with decreased postoperative, in-hospital mortality. Therefore, factors other than annual hospital volume must certainly contribute to mortality rate.
The NIS database was chosen over other available databases because of the extensive nature of its records and the ability to provide a large sample size with which to compare outcomes across the United States. As in analyses of all administrative databases, the current analysis has several limitations. They include the retrospective database design and the associated constraints at the level of the data used for analysis, the inability to account for surgeon experience, the difficulty in examining other postoperative outcomes such as cause of death, and the inability to measure 30-day mortality, as opposed to in-hospital death. In examining the NIS database, we are unable to check the accuracy of the diagnostic and procedure coding. Although the validity of the coding may be verified, the appropriateness of the coding used for diagnosis and procedures may not. However, we assume that this type of error would be equally distributed across all groups of interest. The overall in-hospital mortality rate of 9.49% is consistent with reported mortality rates of other large series using 30-day mortality,19
adding validity to the data reported in the NIS database, and our use of in-hospital mortality as an outcome. In addition, it has been argued that for complex operations, in-hospital mortality may be a better measure of postoperative mortality than 30-day mortality because of improved capabilities of intensive care management to rescue critically ill patients.11
Other outcomes, such as complications associated with surgery or perioperative care and postdischarge outcomes, including deaths occurring outside of the surgical hospitalization, are not ascertainable from this database. Complications occurring after surgery cannot be differentiated from comorbidities existing preoperatively. This prevents us from examining and comparing postoperative complications. In addition, because these patients have undergone esophagectomy for cancer, it would be meaningful to measure disease-free and overall survival. When calculating the Charlson Index we assume that preexisting conditions and those same conditions arising after surgery have the same impact on patient outcomes. Proxies of non-death hospital outcome, including the need for postoperative procedural intervention and length of hospital stay, have been used by others studying different databases.20,21
There has been much recent postulation as to factors that influence postoperative outcomes at the hospital level. These focus on processes of care, which may be associated with improved outcome after surgery. Billingsley and colleagues21
have correlated improved outcomes after surgery for colon cancer with the presence of solid organ transplantation teams, as a proxy for patient care indices associated with improved postoperative outcomes. Other processes of care studied and correlated to improved outcomes include dedicated surgical intensive care units managed by dedicated intensive care specialists,3,22
patient safety initiatives,23
and the use of multidisciplinary teams and standardized clinical care pathways at high-volume centers, for example.24
We believe it is likely that these hospital-level processes of care are more readily available at high-volume centers, and as such, high-volume status may serve as a proxy for them in large administrative databases such as the NIS.
We show that, although there is a trend toward an inverse relationship between volume and mortality, volume is not sufficient for defining centers of excellence. Volume seems to function as an imperfect surrogate for other variables, which may better define centers of excellence, such as quality of dedicated intensive care, postoperative monitoring, clinical care pathways, and other processes of care.20,21,25,26
Additional work is needed to identify those variables associated with improved outcome after esophageal resection.
In addition, using a comparison of mortality rates and goodness of fit of different volume thresholds, we were unable to identify a clear, optimal volume threshold for improved outcomes after esophagectomy for esophageal cancer. We conclude that the use of volume thresholds alone for determining centers of excellence does not appropriately represent the variance in the data or necessarily guide appropriate decision making and should be avoided.
| Acknowledgments |
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| Footnotes |
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Read at the Eighty-seventh Annual Meeting of The American Association for Thoracic Surgery, Washington, DC, May 5-9, 2007.
| References |
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