Quality of reporting of randomized trials as a measure of methodologic quality.

摘要

CONTEXT: The evaluation of the methodologic quality of randomized controlled trials (RCTs) is central to evidence-based health care. Important methodologic detail may, however, be omitted from published reports, and the quality of reporting is therefore often used as a proxy measure for methodologic quality. We examined the relationship between reporting quality and methodologic quality of published RCTs. METHODS: Study of 60 reports of placebo-controlled trials published in English-language journals from 1985 to 1997. Reporting quality was measured using a 25-item scale based on the 1996 issue of the Consolidated Standards of Reporting Trials (CONSORT). Concealment of allocation, appropriate blinding, and analysis according to the intention-to-treat principle were indicators of methodologic quality. Methodologic quality was compared between groups of trials defined by reporting quality scores of low, intermediate, and high. Reporting quality scores were compared between groups defined by high and low methodologic quality. RESULTS: Among 23 trials of low reporting quality (median score, 9 [range, 3.5-10.5]), allocation concealment was unclear for all but 1 trial, but there were 16 trials (70%) with adequate blinding and 9 trials (39%) that had been analyzed according to the intention-to-treat principle. Among 18 trials of high reporting quality (median score, 18 [range 16.5-22.0]), there were 8 trials (44%) with adequate allocation concealment, 16 trials (89%) with adequate blinding, and 13 trials (72%) analyzed according to the intention-to-treat principle. The median reporting score was 15.0 for the 33 trials that were analyzed according to intention-to-treat principle and 14.5 for the 14 trials with on-treatment analyses (P =.67). CONCLUSIONS: Similar quality of reporting may hide important differences in methodologic quality, and well-conducted trials may be reported badly. A clear distinction should be made between these 2 dimensions of the quality of RCTs.