Document Detail

Unpublished data can be of value in systematic reviews of adverse effects: methodological overview.
MedLine Citation:
PMID:  20457510     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To assess the impact of including unpublished data on adverse effects in systematic reviews.
STUDY DESIGN AND SETTING: We carried out a systematic review of methodological evaluations that compared the quantitative reporting of adverse effects data between published and unpublished sources, in particular, the frequency, rate, or risk of reported adverse effects. Included studies were sought from 10 databases as well as by checking references, handsearching, searching citations, and contacting experts.
RESULTS: We identified 6,218 potential articles yielding 10 relevant methodological evaluations. One evaluation found that adverse effects were reported more often in unpublished trials. For anecdotal case reports, two evaluations found a higher frequency of unpublished cases, whereas one study identified a greater number of published cases. Another evaluation indicated that differences in frequency of published and unpublished case reports were topic dependent. A comparison of relative risk estimates from five studies suggested no major systematic variation in risk estimates from published and unpublished studies.
CONCLUSION: Inclusion of unpublished studies can provide additional adverse effects information and more precise risk estimates. However, there is insufficient evidence to indicate whether inclusion of unpublished studies has a major influence on the pooled risk estimates in meta-analyses of adverse effects.
Su Golder; Yoon K Loke; Martin Bland
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review     Date:  2010-05-10
Journal Detail:
Title:  Journal of clinical epidemiology     Volume:  63     ISSN:  1878-5921     ISO Abbreviation:  J Clin Epidemiol     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-08-23     Completed Date:  2010-11-16     Revised Date:  2014-02-19    
Medline Journal Info:
Nlm Unique ID:  8801383     Medline TA:  J Clin Epidemiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1071-81     Citation Subset:  IM    
Copyright Information:
Copyright (c) 2010 Elsevier Inc. All rights reserved.
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MeSH Terms
Clinical Trials as Topic
Drug Industry / statistics & numerical data*
Drug-Related Side Effects and Adverse Reactions / epidemiology*
Meta-Analysis as Topic
Publication Bias / statistics & numerical data*
Risk Assessment
Grant Support
G0601692//Medical Research Council

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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