The gold standard for making therapeutic judgments is the randomized controlled trial. However, a single trial by itself is rarely definitive even if it is properly designed and has adequate sample size. The practitioner is therefore faced with the need to amalgamate the results of a number of similar trials and to make an informed judgment concerning the value of a therapeutic approach. The usual approach is via meta-analysis in which results from a number of trials are pooled. A major limitation in this approach has to do with dependence on the published literature, where selective factors may influence publication strategies and decisions. Thus use of meta-analysis may lead to biased judgement, if the """"""""file drawer"""""""" problem (unpublished results) is large or the results in the file drawers are different from those published. In order to address this problem we plan: 1. An assessment of published reports of perinatal clinical trials to gauge their robustness against bias in data collection and reporting processes, 2. A survey of departments of perinatal medicine to assess the magnitude of the file drawer problem, 3. A comparison of results of published and unpublished trials as a means of assessing the nature of the bias represented by the file drawer problem. In addition, an ongoing inventory of clinical trials in the perinatal field will be established to provide a continuing database for evaluation of operating features of trials in the field.
The aim will be to use it as a resource for the design and conduct of future trials and for gauging the magnitude of the """"""""file drawer"""""""" problem in the future.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
1R01HS005523-01
Application #
3371454
Study Section
Epidemiology and Disease Control Subcommittee 3 (EDC)
Project Start
1986-04-01
Project End
1989-03-31
Budget Start
1986-04-01
Budget End
1987-03-31
Support Year
1
Fiscal Year
1986
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Type
Schools of Public Health
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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Chalmers, T C (1991) Problems induced by meta-analyses. Stat Med 10:971-9;discussion 979-80
Andrews, T C; Reimold, S C; Berlin, J A et al. (1991) Prevention of supraventricular arrhythmias after coronary artery bypass surgery. A meta-analysis of randomized control trials. Circulation 84:III236-44
Coplen, S E; Antman, E M; Berlin, J A et al. (1990) Efficacy and safety of quinidine therapy for maintenance of sinus rhythm after cardioversion. A meta-analysis of randomized control trials. Circulation 82:1106-16
Chalmers, T C; Frank, C S; Reitman, D (1990) Minimizing the three stages of publication bias. JAMA 263:1392-5
Chalmers, T C (1990) The need for early randomization in the development of new drugs for AIDS. J Acquir Immune Defic Syndr 3 Suppl 2:S10-5
Chalmers, T C; Hewett, P; Reitman, D et al. (1989) Selection and evaluation of empirical research in technology assessment. Int J Technol Assess Health Care 5:521-36
Hine, L K; Laird, N M; Hewitt, P et al. (1989) Meta-analysis of empirical long-term antiarrhythmic therapy after myocardial infarction. JAMA 262:3037-40
Longnecker, M P; Berlin, J A; Orza, M J et al. (1988) A meta-analysis of alcohol consumption in relation to risk of breast cancer. JAMA 260:652-6
Chalmers, T C (1988) Meta-analysis in clinical medicine. Trans Am Clin Climatol Assoc 99:144-50

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