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Open Access Research article

Recommendations by Cochrane Review Groups for assessment of the risk of bias in studies

Andreas Lundh and Peter C Gøtzsche*

  • * Corresponding author: Peter C Gøtzsche pcg@cochrane.dk

  • † Equal contributors

Author Affiliations

Nordic Cochrane Centre, Rigshospitalet Dept. 3343, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark

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BMC Medical Research Methodology 2008, 8:22  doi:10.1186/1471-2288-8-22

Published: 21 April 2008

Abstract

Background

Assessing the risk of bias in individual studies in a systematic review can be done using individual components or by summarizing the study quality in an overall score.

Methods

We examined the instructions to authors of the 50 Cochrane Review Groups that focus on clinical interventions for recommendations on methodological quality assessment of studies.

Results

Forty-one of the review groups (82%) recommended quality assessment using components and nine using a scale. All groups recommending components recommended to assess concealment of allocation, compared to only two of the groups recommending scales (P < 0.0001). Thirty-five groups (70%) recommended assessment of sequence generation and 21 groups (42%) recommended assessment of intention-to-treat analysis. Only 28 groups (56%) had specific recommendations for using the quality assessment of studies analytically in reviews, with sensitivity analysis, quality as an inclusion threshold and subgroup analysis being the most commonly recommended methods. The scales recommended had problems in the individual items and some of the groups recommending components recommended items not related to bias in their quality assessment.

Conclusion

We found that recommendations by some groups were not based on empirical evidence and many groups had no recommendations on how to use the quality assessment in reviews. We suggest that all Cochrane Review Groups refer to the Cochrane Handbook for Systematic Reviews of Interventions, which is evidence-based, in their instructions to authors and that their own guidelines are kept to a minimum and describe only how methodological topics that are specific to their fields should be handled.