Search

Background: In recent years, several studies in the medical and health service research literature have advocated the use of hierarchical statistical models (multilevel models or random-effects models) to analyze data that are nested (eg, patients nested within hospitals). However, these models are computer-intensive and complicated to perform. There is virtually nothing in the literature that compares the results of standard logistic regression to those of hierarchical logistic models in predicting future provider performance.Objective: We sought to compare the ability of standard logistic regression relative to hierarchical modeling in predicting risk-adjusted hospital mortality rates for coronary artery bypass graft (CABG) surgery in New York State.Design, Setting and Patients: New York State CABG Registry data from 1994 to 1999 were used to relate statistical predictions from a given year to hospital performance 2 years hence.Main Outcome Measures: Predicted and observed hospital mortality rates 2 years hence were compared using root mean square errors, the mean absolute difference, and the number of hospitals whose predicted mortality rate data was within a 95% confidence interval around the observed mortality rate.Results: In these data, standard logistic regression performed similarly to hierarchical models, both with and without a second level covariate. Differences in the criteria used for comparison were minimal, and when the differences could be statistically tested no significant differences were identified.Conclusions: It is instructive to compare the predictive abilities of alternative statistical models in the process of assessing their relative performance on a specific database and application. [ABSTRACT FROM AUTHOR]

Background: Composite scores that combine several performance measures into a single ranking are becoming the accepted metric for assessing hospital performance. In particular, the Centers for Medicare & Medicaid Services Hospital Quality Incentive Demonstration (HQID) project bases financial rewards and penalties on these scores. Although the HQID composite calculation is straightforward and easily understood, its method of combining process and outcome measures has not been validated., Methods and Results: Using data on 530 hospitals from the Society of Thoracic Surgeons National Cardiac Database, we replicated the HQID methodology with 6 nationally endorsed performance measures (5 process measures plus survival) for coronary artery bypass surgery. Composite scores were essentially determined by process measure performance alone; the survival component explained only 4% of the composite score's total variance. This result persisted even when the survival component was allowed a 5-fold greater weighting in the composite summary. The popular "all-or-none" measurement approach was also dominated by the process component. Substantial disagreement was found among hospital rankings when several alternative methods were used; up to 60% of hospitals eligible for the top financial reward under HQID would change designation depending on the composite methodology used. The application of a simple statistical adjustment (standardization) to each method would provide more consistent results and a more balanced assessment of performance based on both process and outcomes., Conclusions: Existing methods used to create composite performance measures have remarkably different weighting of process versus outcomes metrics and lead to highly divergent provider rankings. Simple alternative methods can create more balanced process-outcome performance assessments.

Objective: To define the most sensitive biochemical test to establish the diagnosis of pheochromocytoma and also to assess the potential role of iodine 131-labeled metaiodobenzylguanidine scintigraphy (I-MIBG) in the diagnosis of this tumor., Summary Background Data: Pheochromocytoma is a rare, catecholamine-producing tumor with preferential localization in the adrenal gland. Despite its importance, the most sensitive test to establish the diagnosis remains to be defined., Methods: Prospective data collection was done on patients with pheochromocytoma treated at the Duke University Medical Center and the Durham Veterans Affairs Medical Center, Durham, NC. All urinary, plasma, and platelet analyses were highly standardized and supervised by one investigator (J.M.F.). I-MIBG scans were independently reviewed by 2 nuclear medicine physicians., Results: A total of 152 patients (55.3% female) were enrolled in the present analysis. Patients were predominantly white (73.7%). Spells (defined as profuse sweating, tachycardia, and headache) and hypertension at diagnosis were present in 51.4% and 66.6%, respectively. Bilateral disease was found in 12.5%, malignant pheochromocytoma in 29.6%, and hereditary forms in 23.0%. The most sensitive tests were total urinary normetanephrine (96.9%), platelet norepinephrine (93.8%), and I-MIBG scintigraphy (83.7%). In combination with I-MIBG scintigraphy, platelet norepinephrine had a sensitivity of 100%, plasma norepinephrine/MIBG of 97.1%, total urine normetanephrine/MIBG of 96.6%, and urine norepinephrine/MIBG of 95.3%., Conclusions: The tests of choice to establish the diagnosis of pheochromocytoma are urinary normetanephrine and platelet norepinephrine. A combination of I-MIBG scintigraphy and diagnostic tests in urine, blood, or platelets does further improve the sensitivity. We thus advocate performing an MIBG scan if the diagnosis of pheochromocytoma is clinically suspected and catecholamine measurements are within the normal range.

Background: Although black cardiac patients receive fewer revascularization procedures than whites, it is unclear whether this has a detrimental impact on outcomes. The objective of our study was to compare 6-month functional status and angina outcomes among blacks and whites with documented coronary disease and to assess whether differential use of revascularization procedures affects these outcomes., Methods and Results: We identified a prospective cohort of 1534 white and 337 black patients undergoing cardiac catheterization between August 1998 and April 2001. Health status was assessed at baseline and 6 months with the Short-Form 36 (SF-36) Health Survey and the Seattle Angina Questionnaire (SAQ) Angina Frequency Scale. Compared with whites, blacks received fewer coronary revascularization procedures (52.5% versus 66.0%; P<0.01). By 6 months, blacks had similar mortality (odds ratio, 1.03; 95% CI, 0.57 to 1.9) but worse scores in 5 SF-36 domains (physical, social, role physical, role emotional, and mental health function). Blacks also reported higher rates of angina at 6 months than whites (34.2% versus 24.6%; P<0.01). After adjustment for baseline functional status and clinical and demographic variables, blacks had significantly worse summary physical component scores, summary mental component scores, and SAQ Angina Frequency Scale scores. However, differences in physical component summary scores and SAQ scores between blacks and whites were no longer significant after adjustment for revascularization status., Conclusions: Our study is among the first to document greater symptoms and functional impairment among black cardiac patients relative to whites. Differential use of coronary revascularization may contribute to the poorer functional outcomes observed among black patients with documented coronary disease.

Background: The purpose of this study was to evaluate whether women undergoing cardiac surgery are more likely to suffer neurological complications than men and whether these complications could explain, at least in part, their higher perioperative mortality., Methods and Results: The Society of Thoracic Surgery National Cardiac Surgery Database was examined for the years 1996 and 1997 to determine the frequency of new neurological events (stroke, transient ischemic attack, or coma) occurring after cardiac surgery. We reviewed clinical information on 416 347 patients (32% women) for whom complete neurological outcome data were available. New neurological events after surgery were higher for women than for men (3.8% versus 2.4%, P=0.001). For the whole group, the 30-day mortality was higher for women than for men (5.7% versus 3.5%, P=0.001), and among those patients who suffered a perioperative neurological event, mortality was also significantly higher for women than men (32% versus 28%, P=0.001). After adjustment for other risk factors (eg, age, history of hypertension and/or diabetes, duration of cardiopulmonary bypass, and other comorbid conditions) by multivariable logistic regression, female sex was independently associated with significantly higher risk of suffering new neurological events after cardiac surgery (OR 1.21, 95% CI 1.14 to 1.28, P=0.001)., Conclusions: Women undergoing cardiac surgery are more likely than men to suffer new perioperative neurological events, and they have higher 30-day mortality when these complications occur. The higher incidence of perioperative neurological complications in women cannot be explained by currently known risk factors.

Unlabelled: The onset time and duration of action of ropivacaine during an interscalene block are not known. The potentially improved safety profile of ropivacaine may allow the use of higher concentrations to try and speed onset time. We compared bupivacaine and ropivacaine to determine the optimal long-acting local anesthetic and concentration for interscalene brachial plexus block. Seventy-five adult patients scheduled for outpatient shoulder surgery under interscalene block were entered into this double-blind, randomized study. Patients were assigned (n = 25 per group) to receive an interscalene block using 30 mL of 0.5% bupivacaine, 0.5% ropivacaine, or 0.75% ropivacaine. All solutions contained fresh epinephrine in a 1:400,000 concentration. At 1-min intervals after local anesthetic injection, patients were assessed to determine loss of shoulder abduction and loss of pinprick in the C5-6 dermatomes. Before discharge, patients were asked to document the time of first oral narcotic use, when incisional discomfort began, and when full sensation returned to the shoulder. The mean onset time of both motor and sensory blockade was <6 min in all groups. Duration of sensory blockade was similar in all groups as defined by the three recovery measures. We conclude that there is no clinically important difference in times to onset and recovery of interscalene block for bupivacaine 0.5%, ropivacaine 0.5%, and ropivacaine 0.75% when injected in equal volumes., Implications: In this study, we demonstrated a similar efficacy between equal concentrations of ropivacaine and bupivacaine. In addition, increasing the concentration of ropivacaine from 0.5% to 0.75% fails to improve the onset or duration of interscalene brachial plexus block.

Background: Exercise testing is useful in the assessment of symptomatic patients for diagnosis of significant or extensive coronary disease and to predict their future risk of cardiac events. The Duke treadmill score (DTS) is a composite index that was designed to provide survival estimates based on results from the exercise test, including ST-segment depression, chest pain, and exercise duration. However, its usefulness for providing diagnostic estimates has yet to be determined., Methods and Results: A logistic regression model was used to predict significant (>/=75% stenosis) and severe (3-vessel or left main) coronary artery disease, and a Cox regression analysis was used to predict cardiac survival. After adjustment for baseline clinical risk, the DTS was effectively diagnostic for significant (P<0.0001) and severe (P<0.0001) coronary artery disease. For low-risk patients (score >/=+5), 60% had no coronary stenosis >/=75% and 16% had single-vessel >/=75% stenosis. By comparison, 74% of high-risk patients (score <-11) had 3-vessel or left main coronary disease. Five-year mortality was 3%, 10%, and 35% for low-, moderate-, and high-risk DTS groups (P<0.0001)., Conclusions: The composite DTS provides accurate diagnostic and prognostic information for the evaluation of symptomatic patients evaluated for clinically suspected ischemic heart disease.

Background: In the ESSENCE trial, subcutaneous low-molecular-weight heparin (enoxaparin) reduced the 30-day incidence of death, myocardial infarction, and recurrent angina relative to intravenous unfractionated heparin in 3171 patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction). No increase in major bleeding was seen., Methods and Results: Of the 936 ESSENCE patients randomized in the United States, 655 had hospital billing data collected. For the remainder, hospital costs were imputed with a multivariable linear regression model (R2=.86). Physician fees were estimated from the Medicare Fee Schedule. During the initial hospitalization, major resource use was reduced for enoxaparin patients, with the largest effect seen with coronary angioplasty (15% versus 20% for heparin, P=.04). At 30 days, these effects persisted, with the largest reductions seen in diagnostic catheterization (57% versus 63% for heparin, P=.04) and coronary angioplasty (18% versus 22%, P=.08). All resource use trends seen in the US cohort were also evident in the overall ESSENCE study population. In the United States, the mean cost of a course of enoxaparin therapy was $155, whereas that for heparin was $80. The total medical costs (hospital, physician, drug) for the initial hospitalization were $11 857 for enoxaparin and $12620 for heparin, a cost advantage for the enoxaparin arm of $763 (P=.18). At the end of 30 days, the cumulative cost savings associated with enoxaparin was $1172 (P=.04). In 200 bootstrap samples of the 30-day data, 94% of the samples showed a cost advantage for enoxaparin., Conclusions: In patients with acute coronary syndrome, low-molecular-weight heparin (enoxaparin) both improves important clinical outcomes and saves money relative to therapy with standard unfractionated heparin.

Background: Recent subgroup analyses of randomized trials have suggested that percutaneous intervention in diabetic patients with multivessel disease results in higher mortality than coronary artery bypass graft surgery (CABG). We studied the relationship between diabetes and survival after revascularization in a large prospective cohort of patients with multivessel coronary artery disease., Methods and Results: By analyzing data for 3220 patients (24% diabetic) with symptomatic two- or three-vessel coronary disease who were undergoing percutaneous transluminal coronary angioplasty (PTCA) or CABG at Duke University Medical Center between 1984 and 1990, we found that at 5 years, unadjusted survival in the group of patients undergoing CABG was 74% in diabetics and 86% in nondiabetics. Similarly, 5-year survival among PTCA patients was 76% in diabetics and 88% in patients without diabetes. After adjustment for baseline characteristics, diabetic patients receiving either PTCA or CABG had significantly poorer survival than nondiabetics (chi2=43.56, P<.0001). Unlike previous studies, however, there was no significant differential effect of diabetes on outcome between patients treated with PTCA and those treated with CABG (chi2=0.01, P=.91)., Conclusions: Although diabetes was associated with a worse long-term outcome after both PTCA and CABG in patients with multivessel coronary artery disease, the effect of diabetes on prognosis was similar in both treatment groups. Thus, our findings support the concept that the choice of initial revascularization strategy should not be based exclusively on a history of diabetes but rather should rely on other factors, such as angiographic suitability and clinical status.

Background: With the expectation that physicians who perform larger numbers of coronary angioplasty procedures will have better outcomes, the American College of Cardiology/ American Heart Association guidelines recommend minimum physician volumes of 75 procedures per year. However, there is little empirical data to support this recommendation., Methods and Results: We examined in-hospital bypass surgery and death after angioplasty according to 1992 physician and hospital Medicare procedure volume. In 1992, 6115 physicians performed angioplasty on 97,478 Medicare patients at 984 hospitals. The median numbers of procedures performed per physician and per hospital were 13 (interquartile range, 5 to 25) and 98 (interquartile range, 40 to 181), respectively. With the assumption that Medicare patients composed one half to one third of all patients undergoing angioplasty, these median values are consistent with an overall physician volume of 26 to 39 cases per year and an overall hospital volume of 196 to 294 cases per year. After adjusting for age, sex, race, acute myocardial infarction, and comorbidity, low-volume physicians were associated with higher rates of bypass surgery (P < .001) and low-volume hospitals were associated with higher rates of bypass surgery and death (P < .001). Improving outcomes were seen up to threshold values of 75 Medicare cases per physician and 200 Medicare cases per hospital., Conclusions: More than 50% of physicians and 25% of hospitals performing coronary angioplasty in 1992 were unlikely to have met the minimum volume guidelines first published in 1988, and these patients had worse outcomes. While more recent data are required to determine whether the same relationships persist after the introduction of newer technologies, this study suggests that adherence to minimum volume standards by physicians and hospitals will lead to better outcomes for elderly patients undergoing coronary angioplasty.

Objectives: The purpose of this study was to examine the national variability in patient-level cost and length of stay for coronary artery bypass grafting (CABG) in Medicare patients., Methods: Retrospective multivariate regression analysis was done using Medicare administrative files and American Hospital Association files. Patients in the study had an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure code for CABG, with accompanying 1990 procedure data, in the Medicare Provider Analysis and Review File (n = 92,449)., Results: Outcome measures used were inpatient cost (exclusive of professional fees) and inpatient length of stay associated with bypass admission. The national average cost of bypass surgery was $22,847 (median $18,783), with an accompanying average length of stay of 16 days (median 13 days). Multivariate regression analysis revealed that patient-level cost and length of stay were related to clinical, demographic, hospital, and regional characteristics (R2 = 25% and 16%, respectively). After accounting for these characteristics at the patient level, considerable variation among states persisted in both cost and length of stay. In addition, states with similar adjusted lengths of stay varied widely with respect to adjusted cost. No relation was found at the state level between level of resource use and either procedural mortality or 60-day mortality/readmission rates., Conclusions: Considerable variability exists among states in patient-level cost and length of stay for CABG surgery, after adjusting to the extent possible for clinical, demographic, hospital, and regional characteristics. The lack of association at the state level between resource use and rates of mortality and hospital readmission suggests that costs could be reduced in many areas of the United States without compromising quality of care.

Background: Coronary artery bypass graft surgery is increasingly common in patients of age > or = 80 years. Single-institution reviews have cited a wide range of mortality results after bypass surgery in this age group, in part because of limited sample sizes. Using claims data, we examined recent national trends in the use and outcomes of bypass surgery in the very elderly., Methods and Results: From an examination of Medicare data from 1987 through 1990, we identified 24,461 patients of age > or = 80 years who underwent bypass surgery. We compared surgical outcomes in these patients with those in Medicare patients of age 65 to 70 years. We found that the national use of bypass surgery in patients of age > or = 80 years increased 67% between 1987 and 1990. Compared with patients of age 65 to 70 years, the very elderly had significantly longer postoperative hospital stays (mean, 14.3 versus 10.4 days), higher charges (mean, $48,200 versus $38,000), and greater costs (mean, $27,200 versus $21,700). In-hospital (11.5% versus 4.4%), 1-year (19.3% versus 7.9%), and 3-year mortality rates (28.8% versus 13.1%) after bypass surgery were also significantly higher in patients of age > or = 80 years compared with younger patients. Although their initial surgical risk was high, octogenarians who underwent bypass surgery had a long-term survival rate similar to that of the general US octogenarian population., Conclusions: The use of bypass surgery in patients of age > or = 80 years in increasing. These very elderly patients face high surgical risks and accumulate significant hospital expenses. Further research is indicated to determine whether the long-term benefits from bypass surgery in the very elderly outweigh the increased procedural risks.

The clinical and laboratory effects of low-dose heparin prophylaxis was prospectively studied in a controlled trial of 182 patients undergoing major surgery for gynecologic malignancy. Low-dose heparin was given in 5000 U subcutaneously two hours preoperatively and every 12 hours for seven days postoperatively. Low-dose heparin-treated patients had a significantly increased daily retroperitoneal hemovac drainage. Although not statistically significant, low-dose heparin was associated with increased estimated intraoperative blood loss, transfusion requirements, and wound hematomas. Fifteen percent of patients receiving low-dose heparin were found to have an activated partial thromboplastin time greater than 1.5 times the control value. In these patients, all clinical bleeding parameters were significantly increased. Low-dose heparin-treated patients also had significantly prolonged activated partial thromboplastin time and lower final platelet counts as compared with the control patients. When using low-dose heparin for thromboembolism prophylaxis, patients should be closely observed for clinical hemorrhagic complications. Activated partial thromboplastin times and platelet counts should be monitored throughout therapy.

We compared secular trends in ischemic heart disease (IHD) mortality in four southeastern states (North Carolina, Georgia, South Carolina, and Virginia) with those in three selected other states (California, New York, and Utah). Mortality data were obtained from U.S. vital statistics and population information from the U.S. Census Bureau. Age-adjusted IHD mortality increased until 1968 in the southeastern states and then declined and declines were greatest in the nonwhite female population. In contrast, IHD mortality in all groups in California and in the female population in New York and Utah began to decline in the early 1950s, with accelerated declines since 1968. In all states the decline in rates in nonwhite populations have been greatest in the younger age groups. This has not been true in the white populations. Declining IHD mortality correlated moderately well with the decline in death from all cardiovascular disease and from all causes, but not with the declining cerebrovascular disease mortality. Respiratory cancer mortality increased in similar proportions in California and South Carolina, two states with dissimilar IHD trends. These findings suggest that improved control of hypertension and changing patterns of cigarette smoking may not be responsible for the recent decline in IHD mortality.

Deep venous thrombosis is a major complication following gynecologic surgery. Assessing a patient's risk of developing deep venous thrombosis is important for patient selection and in choosing appropriate prophylactic methods. Four hundred eleven patients undergoing major gynecologic surgery were evaluated prospectively. All known variables associated with deep venous thrombosis were recorded. Deep venous thrombosis was diagnosed by 125I fibrinogen leg counting of all patients. Univariate analysis of all variables identified the following to be significantly related (P less than .05) to postoperative deep venous thrombosis: a prior history of deep venous thrombosis, leg edema or venous stasis changes, venous varicosities, degree of preoperative ambulation, type of surgery, nonwhite race, recurrent malignancy, prior pelvic radiation therapy, age above 45 years, excessive body weight, intraoperative blood loss, and duration of anesthesia. A stepwise logistic regression analysis of these variables was performed. The following preoperative prognostic factors remained significant: type of surgery, age, leg edema, nonwhite patients, severity of venous varicosities, prior radiation therapy, and prior history of deep venous thrombosis. Duration of anesthesia was also important when intraoperative factors were considered in the analysis. Using these factors, a prognostic model was created and tested. The model resulted in a degree of concordance of 0.82 and allows one to evaluate the risks of postoperative deep venous thrombosis for an individual patient.