Search

Clinical data registries are valuable tools that support evidence development, performance assessment, comparative effectiveness studies, and the adoption of new treatments into routine clinical practice. Although these registries do not have important information on long-term therapies or clinical events, administrative claims databases offer a potentially valuable complement. This article focuses on the regulatory and ethical considerations that arise from the use of registry data for research, including linkage of clinical and administrative data sets. (1) Are such activities primarily designed for quality assessment and improvement, research, or both, as this determines the appropriate ethical and regulatory standards? (2) Does the submission of data to a central registry, which may subsequently be linked to other data sources, require review by the institutional review board (IRB) of each participating organization? (3) What levels and mechanisms of IRB oversight are appropriate for the existence of a linked central data repository and the specific studies that may subsequently be developed using it? (4) Under what circumstances are waivers of informed consent and Health Insurance Portability and Accountability Act authorization required? (5) What are the requirements for a limited data set that would qualify a research activity as not involving human subjects and thus not subject to further IRB review? The approaches outlined in this article represent a local interpretation of the regulations in the context of several clinical data registry projects and focuses on a specific case study of the Society of Thoracic Surgeons National Database.

Objective: This study investigates the relationship between the cost of coronary artery bypass graft surgery and both hospital size and case volume., Methods: Retrospective administrative and cost data were obtained for all 12,774 patients who underwent isolated coronary bypass surgery at 12 Massachusetts hospitals during 1995 and 1996. Hospitals were stratified by number of operating beds into 3 groups (group I, <250 beds; group II, 250-450 beds; group III, >450 beds). Total (diagnosis-related groups 106 + 107) annual coronary bypass cases per hospital varied from 271 to 913 (mean 532). Univariate and multivariable analyses were used to study the relationship between the direct and total cost and a number of patient (age, sex, acuity class, payer) and hospital (bed capacity, annual case volume per diagnosis-related group, cardiothoracic residency) predictor variables. For each hospital, we also studied the relationship between changes in coronary bypass case volume and the corresponding changes in average cost from 1995 to 1996., Results: Scatterplots revealed a broad range of mean direct cost of coronary bypass surgery among hospitals with comparable case volumes. When annual cases were analyzed as continuous variables, there was no linear relationship of case volume with direct or total cost of coronary bypass (r = -0.05 to +0.08) for any diagnosis-related group or year. When hospital bed capacity and case volume were grouped into strata and studied by analysis of variance, there was no evidence of an inverse relationship between these variables and cost. In multivariable analysis, patient acuity class and diagnosis-related group were the most important predictors of cost. Beds and case volume met inclusion criteria for most models but added little to the "explanation" of variability R(2), often less than 1%. Finally, substantial interhospital differences were noted in the magnitude and direction (direct vs inverse) of their 1995 to 1996 change in volume versus change in cost., Conclusions: Within the range of hospital size and case volume represented in this study, there is no evidence that either variable is related to the cost of performing coronary bypass surgery. Massachusetts hospitals appear to function on different segments of different average cost curves. It is not possible to predict the relative cost of coronary bypass grafting at a given hospital based primarily on volume.

Objective: Many health planners promote the use of competition to contain cost and improve quality of care. Using a standard econometric model, we examined the evidence for "value-based" cardiac surgery provider selection in eastern Massachusetts, where there is significant competition and managed care penetration., Methods: McFadden's conditional logit model was used to study cardiac surgery provider selection among 6952 patients and eight metropolitan Boston hospitals in 1997. Hospital predictor variables included beds, cardiac surgery case volume, objective clinical and financial performance, reputation (percent out-of-state referrals, cardiac residency program), distance from patient's home to hospital, and historical referral patterns. Subgroup analyses were performed for each major payer category., Results: Distance from patient's home to hospital (odds ratio 0.90; P =.000) and the historical referral pattern from each patient's hometown (z = 45.305; P =.000) were important predictors in all models. A cardiac surgery residency enhanced the probability of selection (odds ratio 5.25; P =.000), as did percent out-of-state referrals (odds ratio 1.10; P =.001). Higher mortality rates were associated with decreased probability of selection (odds ratio 0.51; P =.027), but higher length of stay was paradoxically associated with greater probability (odds ratio 1.72; P =.000). Total hospital costs were irrelevant (odds ratio 1.00; P =.179). When analyzed by payer subgroup, Medicare patients appeared to select hospitals with both low mortality (odds ratio 0.43; P =.176) and short length of stay (odds ratio 0.76; P =.213), although the results did not achieve statistical significance. The commercial managed care subgroup exhibited the least "value-based" behavior. The odds ratio for length of stay was the highest of any group (odds ratio = 2.589; P =.000) and there was a subset of hospitals for which higher mortality was actually associated with greater likelihood of selection., Conclusions: The observable determinants of cardiac surgery provider selection are related to hospital reputation, historical referral patterns, and patient proximity, not objective clinical or cost performance. The paradoxic behavior of commercial managed care probably results from unobserved choice factors that are not primarily based on objective provider performance.

Objectives: This study was undertaken (1) to determine the prevalence of hospital readmission within 1 month of discharge after cardiac operations, (2) to categorize diagnoses responsible for readmission, and (3) to examine predischarge patient factors that influenced readmission., Methods: Data at 1 month after discharge were obtained for 1665 (98.4%) of 1692 patients who underwent cardiac operations between January 1996 and July 1998., Results: Two hundred twenty-five patients (13.5%) were readmitted to a hospital within a 1-month period after discharge. Forty-eight percent of readmissions were to other hospitals. The most common readmission problems were congestive heart failure (15.6%), atrial fibrillation (12.9%), chest pain (12.0%), wound problems (10.2%), and gastrointestinal problems (8.0%). Hospital discharge on or before the fifth postoperative day was associated with a lower prevalence of subsequent readmission. The independent predictors of a readmission for congestive heart failure were postoperative stay longer than 5 days, diabetes, New York Heart Association functional class IV, preoperative congestive heart failure, total blood product use, the need for postoperative inotropes, body mass index greater than 28 kg/m(2), and reoperation for bleeding., Conclusions: The prevalence of rehospitalization during the first month after discharge is not trivial. Other than postoperative atrial fibrillation, readmission is probably the single most likely adverse event to befall a patient in the early postoperative period. Patients who are discharged early do not appear to be at increased risk. Patterns in readmission diagnoses suggest opportunities for preventive strategies.

The impact of adjuvant coronary revascularization was studied in a group of 138 recipients of an implantable cardioverter-defibrillator, all of whom had ischemic heart disease as the cause of their arrhythmias. Patients chosen for revascularization had more severe anatomic, symptomatic, or physiologic evidence of active ischemia. There were no operative deaths among 23 patients who actually underwent coronary artery bypass combined with cardioverter-defibrillator implantation; however, operative mortality by the intention-to-treat principle was 8% (2/25). Total cardiac survival was better for patients who underwent revascularization than for those patients who had "high-risk" characteristics and did not undergo revascularization. Stratified subgroup analysis demonstrated significant survival advantages favoring revascularization in patients with three-vessel or left main coronary artery disease, class III or IV angina, and an ejection fraction greater than 25%. Multivariate analysis revealed that low ejection fraction and left main coronary artery disease were independent predictors of decreased survival.

The hypothesis that transvenous implantation of a cardioverter-defibrillator is associated with less morbidity than use of a transthoracic approach was investigated in a retrospective series of 146 patients. None of these patients had concomitant heart procedures, and the preoperative characteristics of the two groups were similar. When analyzed by actual technique used (transvenous, 57 patients; transthoracic, 89 patients) and by the intention-to-treat method (transvenous, 65 patients, 8 of whom actually underwent thoracotomy; thoracotomy, 81 patients), transvenous implantation was associated with a lower incidence of postoperative respiratory complications and atrial fibrillation. Total cardiac mortality and freedom from sudden cardiac death in the transvenous and transthoracic groups were comparable at 2 years.

A case report of a patient with an abscess of the lung caused by a pancreaticobronchial fistula is presented. The patient was treated by pulmonary resection and distal pancreatectomy-splenectomy.

Abnormal radiographic densities in the midportion of the chest are most commonly caused by neoplasms, cysts, or inflammatory disease. However, vascular lesions may present an identical x-ray appearance, with no distinguishing clinical history or physical findings. The cardiothoracic surgeon must be aware of this similarity in order to ensure the most appropriate diagnostic and therapeutic approach. In our experience, the most frequent problem in differential diagnosis is a lesion of the thoracic aorta or its arch branches simulating neoplasm. Nine such cases are presented, with pertinent conventional radiographs angiograms, and computed tomographic (CT) scans. These are considered in anatomic sequence: (1) ruptured sinus of Valsalva aneurysm; (2) ascending aortic aneurysm; (3) tortuosity or aneurysm of the innominate and subclavian arteries; (4) transverse arch aneurysm; (5) pseudocoarctation; and (6) descending aortic aneurysm. Such vascular lesions must be considered early in the evaluation of any juxta-aortic chest density, particularly if the patient is hypertensive and has other manifestations of atherosclerosis. Angiography and computed tomography establish the diagnosis in most instances, although both are less reliable when thrombus fills all or part of an aneurysm. If these methods fail to establish a vascular origin, the possibility of neoplasm is pursued. When neither a vascular nor neoplastic origin can be proved, surgical exploration is indicated in the otherwise good-risk patient.

An anastomotic leak into the right pleural space developed following esophagogastrectomy for cancer in a 56-year-old patient. Subsequently, a similar fistula occurred into the pericardium. This was managed successfully by a modification of Abbott's T-tube technique, together with a pericardial window, multiple drainage tubes, systemic antibiotics, and hyperalimentation. The anastomotic disruption healed completely, with only minimal narrowing on repeat roentgenograms of the upper gastrointestinal tract. Only four survivors of this rare and highly lethal problem have been previously reported.