Publication bias in clinical research.
In a retrospective survey, 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987, were studied for evidence of publication bias. As of May, 1990, 285 of the studies had been analysed by the investigators, and 52% of these had been published. Studies with statistically significant results were more likely to be published than those finding no difference between the study groups (adjusted odds ratio [OR] 2.32; 95% confidence interval [Cl] 1.25-4.28). Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor. An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results, and with increasing sample size. The tendency towards publication bias was greater with observational and laboratory-based experimental studies (OR = 3.79; 95% Cl = 1.47-9.76) than with randomised clinical trials (OR = 0.84; 95% Cl = 0.34-2.09). We have confirmed the presence of publication bias in a cohort of clinical research studies. These findings suggest that conclusions based only on a review of published data should be interpreted cautiously, especially for observational studies. Improved strategies are needed to identify the results of unpublished as well as published studies.
Easterbrook
P J
PJ
Division of Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205.
Berlin
J A
JA
Gopalan
R
R
Matthews
D R
DR
D015982:Bias; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D016001:Confidence Intervals; D003625:Data Collection; D035081:Editorial Policies; D026724:Ethical Review; D028744:Ethics Committees, Research; D033181:Information Dissemination; D016017:Odds Ratio; D010506:Periodicals as Topic / Q000706:statistics & numerical data; D011643:Publishing / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic; D012106:Research / Q000706:statistics & numerical data*; D012107:Research Design; D012189:Retrospective Studies