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Biomedical subjects

E Oddone

Publications and source records attributed to E Oddone.

12 recordsLinked to original sources

Quality Enhancement Research Initiative in stroke: prevention, treatment, and rehabilitation.

Stroke is the third leading cause of death and a leading cause of adult disability in the United States. Both within and outside of the Veterans Health Administration (VHA), the lack of a systematic approach to stroke prevention and treatment may have contributed to reduced rates of compliance with recommended practices and increased rates of stroke. Gaps in the knowledge base inhibit a systematic approach to high-quality care within the veteran population. Initial recommendations for closing those gaps are proposed. In some cases (eg, systematic anticoagulation management), the VHA is perceived as a leader in applied research; therefore, a systematic national policy for implementing these clinics may significantly reduce stroke rates. In other areas (eg, carotid endarterectomy), databases exist that would help advance quality and outcomes, but short-term studies are necessary to establish their utility. To promote strategic improvement in prevention, treatment, and rehabilitation for veterans who may be at risk or have had a stroke, specific objectives are proposed to (1) identify best practices for the effective delivery of long-term anticoagulation and enhance veterans' access to these services, (2) develop risk-adjusted models for the surgical preventive procedure carotid endarterectomy to understand facility variation in outcomes so practices can be improved, (3) define a systematic acute stroke management system so that high-quality stroke-related care can be generalizable to a variety of VHA settings, and (4) assess the impact of poststroke rehabilitation on risk adjustment and the location of outcomes so as to facilitate the implementation of best rehabilitation practices.

Adult↗

Measuring costs in multisite randomized controlled trials: lessons from the VA Cooperative Studies Program.

OBJECTIVES: The interest in the economic impact of new health care interventions has increased dramatically over recent years; however, the results can be highly variable depending upon the economic assumptions made and the approaches taken in collecting the data and in conducting the analyses. This paper describes experiences from the VA Cooperative Studies Program in measuring health care utilization and costs for studies that evaluate clinical interventions. METHODS: Experiences from two multisite randomized clinical trials (RCTs) are highlighted to illustrate strategies used to measure costs by directly measuring health care utilization and economic data within the context of the trials. CONCLUSIONS: Despite the substantial resources required to gather evidence about the cost of care for health care innovations, future VA multisite studies should include accepted health economic approaches to make important contributions to health planning and health policy within and outside the VA health care system.

Costs and Cost Analysis↗

Cooperative studies in health services research in the Department of Veterans Affairs.

The Department of Veterans Affairs, through its Cooperative Studies Program, has a long history of conducting large-scale, multihospital biomedical clinical trials. The agency's Health Services Research and Development Service, although newer, has a distinguished record of mainly single-site research into the organization, delivery, and financing of health services. In 1990, a joint program was initiated to conduct multicenter studies in health services research. This article describes the studies developed in the new program and the research design issues encountered in planning them. Identification of the patient population, specification and measurement of the intervention, and description of the control group, as well as attention to the unit of randomization and analysis, outcome variables and choice of effect size, data quality, and ethical considerations are among the important issues related to the design of these studies and future studies in health services.

Delivery of Health Care↗

Measuring activities in clinical trials using random work sampling: implications for cost-effectiveness analysis and measurement of the intervention.

Determining research-related costs from intervention-related costs is important for both clinical and health services research. Often this task involves estimating what proportion of the workday personnel spend on a variety of activities. We used a portable random reminder beeper to measure the daily work activities and contacts of study nurses within the context of a multi-site randomized trial designed to assess the effectiveness of primary care. Nurses recorded 4920 work activities over 140 consecutive workdays. Research-related activities consumed the largest proportion of the workday, 42.5% (95% CI, 38.1-46.7) followed by patient care, 28.8% (24.1-33.2), personal time 16.4% (12.0-20.7), and time spent in transit 12.5% (9.1-15.9). Because this research-related time is spent performing tasks specific to the enrollment of patients and measurement of outcome variables, we will use an adjusted annual salary for these nurses (from $56,392-$32,425) when attributing costs of the intervention in cost-effectiveness analyses and for future management projections. Work sampling is a flexible, inexpensive method that was well accepted by the nurses in this study. Our results provide important insights into the costs analysis of complex interventions involving health professionals and may allow us to explore why the intervention worked or did not work at individual sites.

Clinical Trials as Topic↗

Time analysis of a general medicine service: results from a random work sampling study.

OBJECTIVE: To describe a novel method of time analysis for health care settings by quantifying internal medicine housestaff's work activities and contacts. DESIGN: Observational work sampling study based on random sampling technique. SETTING: General medicine service in a university hospital. PARTICIPANTS: All housestaff (18 interns, 18 residents) rotating through the general medicine service during a 12-week period. MAIN OUTCOME MEASURES: Proportion of time spent doing 22 work activities and proportion of time spent with 13 work contacts, reported separately for interns and residents and for on-call days and off-call days. RESULTS: The authors sampled 6,599 unique time observations (3,533 from on-call days, 3,066 from off-call days) during 193 housestaff workdays. The housestaff spent a majority of their time engaged in direct patient care activities (81% of the interns' workdays, and 64.5% of the residents' workdays), primarily in patient evaluation and follow-up (48% of the interns' and 39% of the residents' workdays). Compared with the interns, the residents spent relatively more time in direct educational activities (conferences, reading, teaching): 27% of the residents' workdays versus 10% of the interns' workdays. Analysis of work contacts showed that the housestaff spent a large portion of the workday alone: 27% of the residents' and 34% of the interns' workdays. The housestaff also spent a large portion of the workday with attending physicians: 23% of the residents' and 11% of the interns' workdays. This translates into 21 hours/week of attending supervision for the residents and 10 hours/week for the interns. CONCLUSIONS: Using random work sampling, the authors found that the vast majority of the houseofficer's workday was spent in direct patient care. This method of time analysis may be used to describe housestaff training and supervision, as well as to evaluate administrative interventions designed to change housestaff work experience.

Hospitals, University↗

Lack of association between patients' measured burden of disease and risk for hospital readmission.

Identifying patients at increased risk for hospital readmission is important for clinicians, health policy-makers, hospital administrators, and researchers. We used a retrospective case-control design to compare the clinimetric properties of five validated indices that measure a patient's disease burden. The study was conducted on a random sample of patients discharged from the general medicine service at the Durham Department of Veterans Affairs Medical Center. Trained observers (two research assistants, one nurse, and two physicians) blinded to readmission status abstracted the required data elements from the medical record for three indices (Charlson, Kaplan-Feinstein, Index of Coexistent Disease). The hospital's computer provided data elements for two indices (Smith, adapted Charlson). Indices varied in the time required to complete, the ability to capture individual heterogeneity, and inter-observer variability. However, none of the indices discriminated among patients who did and those who did not have 6-month hospital readmissions. Factors other than summary scores derived from these indices should be used to identify patients at high risk for readmission.

Aged↗

Comparison of housestaff's estimates of their workday activities with results of a random work-sampling study.

BACKGROUND: Accurately quantifying housestaff's workday activities is acquiring increasing importance as resources become constrained and programs become more accountable for medical education. The authors compared a traditional method of time analysis based on housestaff's estimates of how they spent their workdays with the results of a formal time-analysis study based on random work sampling. METHOD: All housestaff (18 interns and 18 residents) rotating on a general medicine service at Duke University Medical Center between December 1991 and March 1992 participated in the study. Twenty-six of the housestaff first provided estimates of how they spent their workdays, and then all 36 wore random reminder beepers and recorded what they were doing (activity) and with whom (contact) at each beep. RESULTS: The housestaff overestimated the amounts of time spent in patient evaluation (e.g., the mean estimated proportion of time spent performing histories and physical examinations was 29%, whereas the mean actual proportion was 17%) and in educational activities (e.g., the mean estimated proportion of reading time was 8.4%, whereas the mean actual proportion was 2.7%). The housestaff underestimated the amount of supervision by attending physicians: the mean estimated proportion was 7.7%, whereas the mean actual proportion was 16.9%. CONCLUSION: The Housestaff's estimates of workday times differed from the observed times measured by random work sampling. These inaccuracies were manifest in several important areas, such as patient evaluation, educational activities, and attending physicians' supervision. These results suggest that program directors who seek to describe housestaff's work activities or wish to determine the effects of administrative interventions should use random work sampling as the measure.

Humans↗

Cost-effectiveness models of clinical trials of new pharmaceuticals for AIDS-related Pneumocystis carinii pneumonia: are they helpful to policy makers?

BACKGROUND: Pneumocystis carinii pneumonia (PCP) has been the most common and most costly complication of acquired immunodeficiency syndrome (AIDS). Because of concern over the high costs of care for persons with AIDS, policy makers have instituted a number of new measures to encourage cost-effectiveness. Although the clinical efficacy of new pharmaceutical agents is evaluated extensively before approval, comparative trials of a new agent with its major competitor are sometimes not carried out, and estimates of cost-effectiveness are therefore difficult to obtain. METHODS: We describe methodologic issues associated with the development of economic models of new pharmaceutical agents and illustrate these issues with an analysis of second-line therapeutic options for PCP. RESULTS: A new drug, trimetrexate, and the standard second-line therapy, pentamidine, are both inferior to the standard first-line therapy, trimethoprim/sulfamethoxazole, as initial therapy for moderate to severe PCP. However, as many as half of the patients with PCP are either intolerant or refractory to trimethoprim/sulfamethoxazole therapy for PCP. Economic models suggest that, if the two drugs have identical survival rates, then trimetrexate, despite a higher acquisition cost, is both less expensive and more effective in achieving toxicity-free survival than pentamidine in patients who require second-line therapy for PCP. Sensitivity analyses indicate that trimetrexate is less expensive than pentamidine over a wide range of estimates of costs and effectiveness. CONCLUSIONS: To make well-informed therapeutic decisions, policy makers and physicians require head-to-head studies of a new pharmaceutical agent with its major competitor. However, economic models can be used to derive estimates of cost-effectiveness of new pharmaceutical agents when such data are lacking. The interpretation of these models raises general issues related to the perspective of the investigators, study design, estimation of costs of care, rates of response, toxicity, and survival, and generalizability of the results to other settings as well as methodologic issues that are unique to human immunodeficiency virus (HIV) disease. If a comparative trial found better survival rates, then cost-effectiveness models would be of limited usefulness; almost all physicians would use the drug with the higher survival rate.

AIDS-Related Opportunistic Infections↗

Hospital credentialing for laparoscopic cholecystectomy: is stricter better?

OBJECTIVE: Hospital credentialing standards for laparoscopic cholecystectomy were established to improve surgical outcomes, but standards vary by hospital. We hypothesized that more stringent credentialing would result in better outcomes. DESIGN: Univariate and multivariate logistic analyses were performed using a 1996 survey on hospital credentialing practices. Surgical-outcome data were obtained from statewide hospital discharge abstracts and hospital chart reviews. Multivariate logistic analysis was used to calculate the effects of hospital credentialing stringency and nine credentialing practices on operative and postoperative outcomes (including death), controlling for patient and hospital characteristics. SETTING: Short-stay community hospitals performing laparoscopic cholecystectomy. PATIENTS: Statewide hospital discharge data included 1995 inpatient discharges for laparoscopic cholecystectomy. Medical-records review included 843 laparoscopic cholecystectomy patients selected from 14 North Carolina hospitals with widely different credentialing practices. RESULTS: Surgical complications from laparoscopic cholecystectomies appeared unrelated to stringency of the hospital credentialing environment. Important factors predicting complications included hospital volume and other hospital characteristics such as the number of registered nurses per patient day. CONCLUSIONS: Given current levels of training, performance, and credentialing standards, tightening of credentialing practices may not improve patient outcomes for laparoscopic cholecystectomy.

Cholecystectomy, Laparoscopic↗