Presentation of continuous outcomes in randomised trials: an observational study.

Abstract:

OBJECTIVE:To characterise the percentage of available outcome data being presented in reports of randomised clinical trials with continuous outcome measures, thereby determining the potential for incomplete reporting bias. DESIGN:Descriptive cross sectional study. DATA SOURCES:A random sample of 200 randomised trials from issues of 20 medical journals in a variety of specialties during 2007-09. MAIN OUTCOME MEASURES:For each paper's best reported primary outcome, we calculated the fraction of data reported using explicit scoring rules. For example, a two arm trial with 100 patients per limb that reported 2 sample sizes, 2 means, and 2 standard deviations reported 6/200 data elements (1.5%), but if that paper included a scatterplot with 200 points it would score 200/200 (100%). We also assessed compliance with 2001 CONSORT items about the reporting of results. RESULTS:The median percentage of data reported for the best reported continuous outcome was 9% (interquartile range 3-26%) but only 3.5% (3-7%) when we adjusted studies to 100 patients per arm to control for varying study size; 17% of articles showed 100% of the data. Tables were the predominant means of presenting the most data (59% of articles), but papers that used figures reported a higher proportion of data. There was substantial heterogeneity among journals with respect to our primary outcome and CONSORT compliance. LIMITATIONS:We studied continuous outcomes of randomised trials in higher impact journals. Results may not apply to categorical outcomes, other study designs, or other journals. CONCLUSIONS:Trialists present only a small fraction of available data. This paucity of data may increase the potential for incomplete reporting bias, a failure to present all relevant information about a study's findings.

journal_name

BMJ

authors

Schriger DL,Savage DF,Altman DG

doi

10.1136/bmj.e8486

subject

Has Abstract

pub_date

2012-12-18 00:00:00

pages

e8486

eissn

0959-8138

issn

1756-1833

journal_volume

345

pub_type

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