Reporting Discrepancies Between the Results Database and Peer-Reviewed Publications

Oregon Health and Science University, Portland, Oregon, United States
Annals of internal medicine (Impact Factor: 17.81). 04/2014; 160(7):477-83. DOI: 10.7326/M13-0480
Source: PubMed

ABSTRACT requires reporting of result summaries for many drug and device trials.
To evaluate the consistency of reporting of trials that are registered in the results database and published in the literature. results database and matched publications identified through and a manual search of 2 electronic databases.
10% random sample of phase 3 or 4 trials with results in the results database, completed before 1 January 2009, with 2 or more groups.
One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified.
Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 33 (87%) reported more SAEs in Among the 84 trials that reported SAEs in, 11 publications did not mention SAEs, 5 reported them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in, 28% differed from the matched publication.
Small sample that included earliest results posted to the database.
Reporting discrepancies between the results database and matching publications are common. Which source contains the more accurate account of results is unclear, although may provide a more comprehensive description of adverse events than the publication.
Agency for Healthcare Research and Quality.

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