Using medical registries and data sets for technology assessment. An overview of seven case studies.
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Databases, Factual↗
Biomedical subjects
E Burdick
Publications and source records attributed to E Burdick.
Using medical registries and data sets for technology assessment.
Explore the source record for details and available documents.
Databases, Factual↗
An empirical study of the possible relation of treatment differences to quality scores in controlled randomized clinical trials.
Meta-analytic investigations sometimes use assessments of research quality according to a formal protocol as a tool for improving research synthesis. We asked whether a particular quality scoring system could have a direct use in adjusting the summary estimates of a treatment difference. In an empirical study of the relation of quality scores to treatment differences in published meta-analyses of 7 groups of controlled randomized clinical trials comprising 107 primary studies, we found no relation between treatment difference and overall quality score. We also found no relation between quality score and variation in treatment difference. The level of quality scores has increased at a rate of 9% per decade for three decades, averaging 0.51 on a scale of 0 to 1 for the 1980s, and leaving much room for improvement. Nevertheless, attention to quality of studies by editors, reviewers, and authors may be raising both the level of research done and quality of the reports.
Meta-Analysis as Topic↗
Current issues in health care technology assessment.
This article presents an overview of technology assessment in the United States. The authors argue that while there are numerous institutions carrying out assessments, the United States requires an overall plan that would provide a national system for technology assessment. If technology assessment were more organized and systematized, the authors argue, it would be more efficient and would reach the public and the medical world effectively.
Government Agencies↗
Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report.
BACKGROUND: Adverse drug events (ADEs) are both common and costly. Most hospitals identify ADEs using spontaneous reporting, but this approach lacks sensitivity; chart review identifies more events but is expensive. Computer-based approaches to ADE identification appear promising, but they have not been directly compared with chart review and they are not widely used. OBJECTIVES: To develop a computer-based ADE monitor, and to compare the rate and type of ADEs found with the monitor with those discovered by chart review and by stimulated voluntary report. DESIGN: Prospective cohort study in one tertiary-care hospital. PARTICIPANTS: All patients admitted to nine medical and surgical units in a tertiary-care hospital over an eight-month period. MAIN OUTCOME MEASURE: Adverse drug events identified by the computer-based monitor, by chart review, and by stimulated voluntary report. METHODS: A computer-based monitoring program identified alerts, which were situations suggesting that an ADE might be present (e.g., an order for an antidote such as naloxone). A trained reviewer then examined patients' hospital records to determine whether an ADE had occurred. The results of the computer-based monitoring strategy were compared with two other ADE detection strategies: intensive chart review and stimulated voluntary report by nurses and pharmacists. The monitor and the chart review strategies were independent, and the reviewers were blinded. RESULTS: The computer monitoring strategy identified 2,620 alerts, of which 275 were determined to be ADEs. The chart review found 398 ADEs, whereas voluntary report detected 23. Of the 617 ADEs detected by at least one method, 76 ADEs were detected by both computer monitor and chart review. The computer monitor identified 45 percent; chart review, 65 percent; and voluntary report, 4 percent. The ADEs identified by computer monitor were more likely to be classified as "severe" than were those identified by chart review (51 versus 42 percent, p = .04). The positive predictive value of computer-generated alerts was 16 percent during the first eight weeks of the study; rule modifications increased this to 23 percent in the final eight weeks. The computer strategy required 11 person-hours per week to execute, whereas chart review required 55 person-hours per week and voluntary report strategy required 5. CONCLUSIONS: The computer-based monitor identified fewer ADEs than did chart review but many more ADEs than did stimulated voluntary report. The overlap among the ADEs identified using different methods was small, suggesting that the incidence of ADEs may be higher than previously reported and that different detection methods capture different events. The computer-based monitoring system represents an efficient approach for measuring ADE frequency and gauging the effectiveness of ADE prevention programs.
Adverse Drug Reaction Reporting Systems↗
The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group.
OBJECTIVE: To assess the additional resource utilization associated with an adverse drug event (ADE). DESIGN: Nested case-control study within a prospective cohort study. PARTICIPANTS: The cohort included 4108 admissions to a stratified random sample of 11 medical and surgical units in 2 tertiary-care hospitals over a 6-month period. Cases were patients with an ADE, and the control for each case was the patient on the same unit as the case with the most similar pre-event length of stay. MAIN OUTCOME MEASURES: Postevent length of stay and total costs. METHODS: Incidents were detected by self-report stimulated by nurses and pharmacists and by daily chart review, and were classified as to whether they represented ADEs. Information on length of stay and charges was obtained from billing data, and costs were estimated by multiplying components of charges times hospital-specific ratios of costs to charges. RESULTS: During the study period, there were 247 ADEs among 207 admissions. After outliers and multiple episodes were excluded, there were 190 ADEs, of which 60 were preventable. In paired regression analyses adjusting for multiple factors, including severity, comorbidity, and case mix, the additional length of stay associated with an ADE was 2.2 days (P=.04), and the increase in cost associated with an ADE was $3244 (P=.04). For preventable ADEs, the increases were 4.6 days in length of stay (P=.03) and $5857 in total cost (P=.07). After adjusting for our sampling strategy, the estimated postevent costs attributable to an ADE were $2595 for all ADEs and $4685 for preventable ADEs. Based on these costs and data about the incidence of ADEs, we estimate that the annual costs attributable to all ADEs and preventable ADEs for a 700-bed teaching hospital are $5.6 million and $2.8 million, respectively. CONCLUSIONS: The substantial costs of ADEs to hospitals justify investment in efforts to prevent these events. Moreover, these estimates are conservative because they do not include the costs of injuries to patients or malpractice costs.
Boston↗