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Open Access Highly Accessed Research article

Room for improvement? A survey of the methods used in systematic reviews of adverse effects

Su Golder1*, Yoon Loke2 and Heather M McIntosh13

Author affiliations

1 Centre for Reviews and Dissemination (CRD), University of York, York, YO10 5DD, UK

2 University of East Anglia Norwich NR4 7TJ, UK

3 NHS Quality Improvement Scotland, Delta House, 50 West Nile St, Glasgow, G1 2NP, UK

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Citation and License

BMC Medical Research Methodology 2006, 6:3  doi:10.1186/1471-2288-6-3

Published: 27 January 2006

Abstract

Background

Although the methods for conducting systematic reviews of efficacy are well established, there is much less guidance on how systematic reviews of adverse effects should be performed.

Methods

In order to determine where methodological research is most needed to improve systematic reviews of adverse effects of health care interventions, we conducted a descriptive analysis of systematic reviews published between 1994 and 2005. We searched the Database of Abstracts of Reviews of Effects (DARE) and The Cochrane Database of Systematic Reviews (CDSR) to identify systematic reviews in which the primary outcome was an adverse effect or effects. We then extracted data on many of the elements of the systematic review process including: types of interventions studied, adverse effects of interest, resources searched, search strategies, data sources included in reviews, quality assessment of primary data, nature of the data analysis, and source of funding.

Results

256 reviews were included in our analysis, of which the majority evaluated drug interventions and pre-specified the adverse effect or effects of interest. A median of 3 resources were searched for each review and very few reviews (13/256) provided sufficient information to reproduce their search strategies. Although more than three quarters (185/243) of the reviews sought to include data from sources other than randomised controlled trials, fewer than half (106/256) assessed the quality of the studies that were included. Data were pooled quantitatively in most of the reviews (165/256) but heterogeneity was not always considered. Less than half (123/256) of the reviews reported on the source of funding.

Conclusion

There is an obvious need to improve the methodology and reporting of systematic reviews of adverse effects. The methodology around identification and quality assessment of primary data is the main concern.