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Biomedical subjects

R D Cebul

Publications and source records attributed to R D Cebul.

At least 19 recordsLinked to original sources

A cost analysis of alternative treatments for duodenal ulcer.

OBJECTIVE: To compare the costs of alternative strategies for the treatment of duodenal ulcer. DESIGN: A cost comparison using decision analysis. METHODS: A decision model was used to compare the costs per cure of an endoscopically documented duodenal ulcer for three initial treatment strategies: 1) H2-receptor antagonist therapy for 8 weeks, 2) antibiotic therapy for Helicobacter pylori infection plus H2-receptor antagonist therapy, and 3) urease test-based treatment. For symptomatic recurrences, secondary treatment strategies included empiric retreatment with the same or other regimen, and treatment based on repeat endoscopy-guided urease test or biopsy, with an assumption of subsequent cure. The cohort modeled for this analysis consisted of patients at low risk for a malignant ulcer. Probability estimates were derived from published clinical trials, cohort studies, and expert opinion. Side effects from combination therapy with antibiotics and H2-receptor antagonists and resulting costs were included from the perspective of a group practice model health maintenance organization. RESULTS: For all secondary treatment strategies, initial therapy with antibiotics for H. pylori infection plus an H2-receptor antagonist resulted in the lowest average costs per symptomatic cure when the prevalence or likelihood of H. pylori infection exceeded 66% to 76%; the costs ranged from $284 for secondary (re)treatment with empiric antibiotic and H2-receptor antagonist therapy to $398 for endoscopy-guided secondary treatment. Initial treatment with an H2-receptor antagonist resulted in the highest costs, ranging from $372 for secondary treatment with empiric antibiotic and H2-receptor antagonist therapy to $679 for endoscopy-guided secondary treatment. The results were not sensitive to the rates of duodenal ulcer recurrence after either treatment, to the cost of either treatment, or to prevalence of H. pylori. CONCLUSIONS: This cost analysis indicates that, regardless of the secondary treatment used for ulcer recurrence, initial therapy with antibiotics for H. pylori infection plus an H2-receptor antagonist provides the lowest costs per symptomatic cure. These cost savings and the lower recurrence rates associated with this treatment favor eradication of H. pylori as part of the initial treatment of duodenal ulcer.

Anti-Bacterial Agents

Improving compliance with breast cancer screening in older women. Results of a randomized controlled trial.

BACKGROUND: To compare three approaches for improving compliance with breast cancer screening in older women. METHODS: Randomized controlled trial using three parallel group practices at a public hospital. Subjects included women aged 65 years and older (n = 803) who were seen by residents (n = 66) attending the ambulatory clinic from October 1, 1989, through March 31, 1990. All provider groups received intensive education in breast cancer screening. The control group received no further intervention. Staff in the second group offered education to patients at their visit. In addition, flowsheets were used in the "Prevention Team" group and staff had their tasks redefined to facilitate compliance. RESULTS: Medical records were reviewed to determine documented offering/receipt of clinical breast examination and mammography. A subgroup of women without previous clinical breast examination (n = 540) and without previous mammography (n = 471) were analyzed to determine the effect of the intervention. During the intervention period, women without a previous clinical breast examination were offered an examination significantly more often in the Prevention Team group than in the control group, adjusting for age, race, and comorbidity and for physicians' gender and training level. The patients in the Prevention Team group were offered clinical breast examination (31.5%) more frequently than those in the patient education or control groups, but this was not significant after adjusting for the above covariates. Likewise, mammography was offered more frequently to patients in the Prevention Team and in the patient education group than to patients in the control group, after adjusting for the factors above using logistic regression. CONCLUSIONS: The results provide support for patient education and organizational changes that involve nonphysician personnel to enhance breast cancer screening among older women, particularly those without previous screening.

Aged

Controlled trial using computerized feedback to improve physicians' diagnostic judgments.

The goal of this study was to test an innovative method to improve physicians' diagnostic judgments by integrating the use of a computer program (employing cognitive feedback to teach a clinical rule that predicts the probability of streptococcal pharyngitis), a traditional lecture, and periodic disease-prevalence reports. In a controlled trial using pre- and postintervention measures involving 885 patients, the authors compared the effects of the integrated method on the diagnostic judgments of seven experienced physicians at a university health service (from 1982 to 1985) with the effects of the lecture alone on the judgments of seven experienced physicians at a different university health service (1986 to 1987). The integrated method significantly improved the quality of the physicians' judgments as measured by calibration curves and Brier scores, and increased the level of agreement between the physicians' judgments and those made by the clinical prediction rule. The lecture alone produced less improvement in the quality of the physicians' judgments, and decreased the level of agreement with the rule. The authors conclude that this method, based on cognitive psychology, is a promising educational tool.

Computer-Assisted Instruction

Efforts to improve compliance with the National Cholesterol Education Program guidelines. Results of a randomized controlled trial.

STUDY OBJECTIVE: We compared three approaches for improving compliance with the practice guidelines of the National Cholesterol Education Program (NCEP). DESIGN: A randomized controlled trial. SETTING: Academic group practices of a major urban teaching hospital. PARTICIPANTS: Study physicians were three equivalent groups of PG-2 and PG-3 residents (N = 33) seeing patients in equivalent outpatient clinics. Continuity patients of these residents were included (N = 240) if they were younger than 66 years, saw their primary physician during the intervention period, were not pregnant, and had no serious life-shortening noncardiac illnesses. INTERVENTIONS: Three interventions were implemented over a 5-week period. Control group physicians (group 1) were offered only a standard lecture provided through the Physician Cholesterol Education Program (PCEP). Group 2 physicians were offered the PCEP lecture and also received generic chart reminders of the NCEP guidelines on each eligible patient's chart. Group 3 physicians were offered the PCEP lecture and also received timely patient-specific feedback, including acknowledgement of recent lipid values and management, and explicit recommendations for further action. Knowledge of lipid disorders was tested before and after the PCEP lecture, and physicians' attitudes were surveyed following the intervention period. MEASUREMENTS AND MAIN RESULTS: The three groups were similar in baseline (preintervention) compliance with NCEP recommendations (average, 39%) and physicians' knowledge. Patients were similar across groups in number of coronary artery disease risk factors and cholesterol values. Significant within-group improvements in compliance were noted for groups 2 and 3 (7.6% and 10.6%, respectively), but not for group 1 (4.5%). Importantly, there were no differences observed in improvements across groups. In exploratory analyses, however, there was a significant correlation between improved compliance and the number of patients seen by each provider in group 3 that was not observed in groups 1 or 2. Notably, changes in compliance were unrelated to PCEP lecture attendance (8.6% vs 8.1% for attenders vs nonattenders, respectively), level of postgraduate training, baseline or later tests of knowledge, or patient factors. The postintervention survey revealed marked overestimation by physicians of their personal compliance with NCEP guidelines, although there was strong support for clinic efforts that would screen patients for lipid disorders independent of physician initiative. CONCLUSIONS: This study raises questions about the effectiveness of education alone for improving compliance with NCEP guidelines. The effectiveness and efficiency of timely, individualized feedback should be explored in studies over a longer period. Innovative alternative approaches are suggested by the responses to our survey and other research in preventive practices.

Ambulatory Care

Randomized, controlled trials using the Metro Firm System.

The Firm System at MetroHealth Medical Center was begun almost two decades ago to foster improved continuity of patient care and teaching of medical students and residents in Internal Medicine. For the past 8 years, these parallel teams of providers and patients also have been used to conduct clinical, educational, and health care delivery research. Randomized, controlled trials are made possible by ongoing random assignment of patients and providers to the three teams, or small group practices. Each group practice has equivalent inpatient and outpatient areas supported by nonrotating nursing, paramedical, and clerical staff. The system's current relationships were established after a controlled trial established both decreased costs and increased effectiveness of the "group practice model" as compared to more traditional approaches to patient care by residents in an academic medical center. Other trials, both on the inpatient and outpatient settings, have been used to guide ongoing institutional change. The unique advantages of the randomized controlled trial are high-lighted by contrasting the results of within-group changes during an intervention with results that incorporate control group changes. A variety of methodologic and logistical issues must be addressed when conducting controlled trials that use ongoing randomization within a single institution. These include determination that the groups are equivalent for all important parameters preintervention, choosing an analytic approach that accounts for potential differences among providers and patients, and, in trials designed to affect behavior, assurance that a "steady state" exists prior to initiating another trial designed to affect similar behavior. Consideration also must be given to the possibilities of cross-team contamination, the Hawthorne effect, the "dominant attending effect," and ethical issues related to informed consent. Clinical trials in a single institution may be performed for common problems and those with well defined stages of severity. Since the costs of maintaining the ongoing randomization are relatively small, the incremental costs of conducting randomized controlled trials are low by comparison to traditional approaches. The establishment of analogous systems at other institutions will permit multisite trials for less common clinical problems, enhance the generalizability of findings, and permit new types of health services research, including the rigorous evaluation of practice guidelines.

Health Services Research

Carotid endarterectomy.

STUDY OBJECTIVE: To evaluate the usefulness of doing carotid endarterectomy in patients with symptomatic or asymptomatic carotid artery disease. DESIGN: Synthesis and summarization of data on the untreated course of cerebrovascular disease, and review of selected evidence and expert opinion on the risks and benefits of endarterectomy and medical therapy. MAIN RESULTS: There is a large body of data related to the untreated course of cerebrovascular disease, the efficacy of aspirin in patients with transient ischemic attacks, and the comparative responsiveness to surgery of symptomatic patients with different presentations. Randomized trials in progress will increase the knowledge about the effects of aspirin in asymptomatic patients, the comparative efficacy of aspirin and endarterectomy in asymptomatic and symptomatic patients, and the factors that influence surgical risk. Clinicians and investigators wish to define a more limited and precise set of indications for carotid endarterectomy. In setting standards, attention has properly focussed on "maximum acceptable complication rates," native stroke risk, and surgical efficacy for patients with different clinical presentations. Illustrative, acceptable surgical mortality rates are less than 1%, and stroke-related morbidity is less than 3% for patients who have had a transient ischemic attack; surgical mortality and stroke-related morbidity are less than 2% for patients with asymptomatic carotid stenosis. Medical comorbidity and angiographic findings are important factors affecting specific recommendations. CONCLUSIONS: Data from ongoing clinical trials will provide a more scientific foundation for recommendations about when to do carotid endarterectomy. Current evidence suggests that fewer endarterectomies should be done, and those on the basis of a more precise set of indications. Clinicians should consider the clinical presentation, the patient's comorbidity and native stroke risk, angiographic findings, and the experience of the surgical team.

Anticoagulants

Guiding individual decisions: a randomized, controlled trial of decision analysis.

In early 1983, all 1,280 faculty and resident physicians at one hospital who were eligible to be vaccinated against hepatitis B were divided randomly into three groups: Group 1 physicians received general information about the risks and benefits of alternative vaccine decisions; Group 2 physicians were additionally invited to provide personal information for an individualized decision analysis (12.6 percent responded); and Group 3 physicians, who served as controls, were not contacted. In one year's follow-up, 20 percent of physicians were screened for hepatitis B antibody or vaccinated. More Group 2 physicians whose decision analyses recommended screening or vaccination took these actions (39 percent) than any other group. Group assignment remained significantly associated with vaccine decisions after analyzing results by the "intention to treat" principle, and after adjusting for training status, exposure to blood and blood products, and pre-study intentions about the vaccine. Despite the low overall vaccine acceptance rate, it is concluded that individualized decision analysis can influence the clinical decisions taken by knowledgeable and interested patients.

Clinical Trials as Topic

Biochemical profiles. Applications in ambulatory screening and preadmission testing of adults.

Evidence bearing on the utility of biochemical profiles for ambulatory care screening and preadmission testing was reviewed, and recommendations were formulated. Certain biostatistical principles relevant to this analysis include the concepts of regression to the mean, the meaning of biochemical "normality" (particularly as it relates to multiple testing), and the effects of disease prevalence on the post-test probability of disease for individual test results. Applying these principles to a typical 12-test battery in asymptomatic adults, one would expect a low yield of unanticipated diagnoses and a high proportion of false-positive results. For the typical test battery, the empirical evidence supports these expectations in ambulatory care screening. In addition, routine preadmission use of biochemical profiles is not supported by studies examining their impact on patient care, hospital costs, or lengths of stay. Whereas components of these profiles can be endorsed for screening or preadmission testing, we recommend that the routine use of the entire profile be abandoned in these settings.

Adult

The comparative cost-effectiveness of statistical decision rules and experienced physicians in pharyngitis management.

We examined whether probability-based decisions for streptococcal pharyngitis, using probabilities derived from predictive models along with Tompkins' decision rules, could be more cost-effective than the actual decisions of ten physicians. We retrospectively calculated the probability of a positive throat culture ("disease") for each of 310 patients using four different models based on discriminant analysis (1), a branching algorithm (2), and logistic regression (3 and 4). "Projected decisions" were based on these probabilities and Tompkins' rules. We calculated direct medical and indirect costs per correct action taken (diseased patient-treated or nondiseased patient-not-treated). Two models' projected decisions were more cost-effective than the physicians'. Model 1 primarily would have reduced treatment costs (leaving no diseased patient untreated); model 4 primarily would have reduced throat culture costs (with 15% projected undertreatment). While using statistical decision rules may be cost-effective in this setting, their adoption should be consistent with physician and patient priorities.

Algorithms

The importance of disease prevalence in transporting clinical prediction rules. The case of streptococcal pharyngitis.

Because clinical prediction rules often are applied in new settings to calculate the probability of a disease, we evaluated the accuracy of three rules for predicting streptococcal pharyngitis in 310 patients. Use of the rules led to overestimations of disease probability in 47%, 82%, and 93% of the patients. When we used receiver-operating characteristic curve analysis, no rule lost power to discriminate streptococcal from nonstreptococcal causes of pharyngitis. The overestimations in disease probability likely were caused by differences in disease prevalence between our setting (5%) and the settings in which they were developed (15% to 17%). All rules led to accurate predictions when they were adjusted for the disease prevalence found in our setting using a likelihood ratio formulation of Bayes' theorem. The value of prediction rules, like that of other diagnostic tests, is affected by differences in disease prevalence in different settings. Failure to recognize and adjust for these differences may cause poor decision making or the premature dismissal of valid rules.

Humans

Utility of rheumatoid factor in the diagnosis of juvenile rheumatoid arthritis.

Rheumatoid factor is commonly used by clinicians to assess children with possible juvenile rheumatoid arthritis. To assess its usefulness, we reviewed the case histories of patients in whom latex agglutinating rheumatoid factor was determined during 1981 to 1982 at our institution. A total of 437 charts were available for review. There were 11 patients with positive tests for rheumatoid factor, of whom five had juvenile rheumatoid arthritis, all polyarticular. A total of 426 children had negative results, of whom 100 had juvenile rheumatoid arthritis. This yields a sensitivity of 4.8% and a specificity of 98%. We then estimated the prevalence of juvenile rheumatoid arthritis in three clinical settings: a primary practitioner's office, a tertiary children's hospital walk-in clinic, and a pediatric rheumatology center. The predictive values and marginal benefits for rheumatoid factor were then calculated in those settings using Bayes' theorem. In the two general outpatient settings, the primary practitioner's office and tertiary walk-in clinic, the positive predictive values were 0.7% and 0.5%, respectively; marginal benefits were 0.4% and 0.3%, respectively. Rheumatoid factor testing appeared to be of some benefit in the pediatric rheumatology center with a positive predictive value of 72.5% and marginal benefit of 22.5%. In no case was rheumatoid factor testing helpful in establishing a diagnosis of juvenile rheumatoid arthritis or in ruling it out. Testing for rheumatoid factor is a poor screening procedure for juvenile rheumatoid arthritis in the general situations in which it is more likely to be requested and of supportive diagnostic value only in the highly restricted population of older children with polyarticular arthritis.

Arthritis, Juvenile