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Inadequate reporting of trials compromises the applicability of systematic reviews

Published online by Cambridge University Press:  21 July 2009

Gerald Gartlehner ,
Patricia Thieda ,
Richard A. Hansen ,
Laura C. Morgan ,
Janelle A. Shumate  and
Daniel B. Nissman
Gerald Gartlehner
Affiliation:
Danube University, Krems
Patricia Thieda
Affiliation:
University of North Carolina at Chapel Hill
Richard A. Hansen
Affiliation:
University of North Carolina at Chapel Hill
Laura C. Morgan
Affiliation:
University of North Carolina at Chapel Hill
Janelle A. Shumate
Affiliation:
University of North Carolina Hospitals
Daniel B. Nissman
Affiliation:
Medical University of South Carolina
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Abstract

Background: Uncertainty about the applicability of controlled trial findings is an increasing concern for clinicians and policy decision makers. This study aimed to determine whether information reported in studies included in systematic reviews was adequate enough to assess their applicability.

Methods: We used the databases of four recently conducted systematic reviews on the comparative efficacy and safety of second-generation antidepressants, inhaled corticosteroids, Alzheimer's drugs, and targeted immune modulators. We developed and pilot-tested a questionnaire to assess the adequacy of reporting with respect to seven previously validated criteria of study design that distinguish explanatory from pragmatic studies. For each of the 137 included studies, two reviewers independently assessed the adequacy of reporting.

Results: Overall, only 12 percent of the included studies provided sufficient information to reliably distinguish explanatory from pragmatic studies. The areas with the greatest lack of reporting were the setting of the study, methods of adverse event assessment, and sample size considerations to determine a minimally important difference from a patient perspective.

Conclusions: Substantial shortcomings in reporting exist in aspects of study design important to determine whether a study is applicable to specific populations of interest.

Keywords

EffectivenessEfficacyPragmatic studiesExplanatory studiesSystematic reviewsMethods study
Type
General Essays
Information
International Journal of Technology Assessment in Health Care , Volume 25 , Issue 3 , July 2009 , pp. 323 - 330
Copyright
Copyright © Cambridge University Press 2009

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