Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review |
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| Authors: | Su Golder Yoon K Loke Kath Wright Gill Norman |
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| Institution: | 1Department of Health Sciences, University of York, York, United Kingdom;2Norwich Medical School, University of East Anglia, Norwich, United Kingdom;3Centre for Reviews and Dissemination (CRD), University of York, York, United Kingdom;4School of Nursing, Midwifery & Social Work, University of Manchester, Manchester, United Kingdom;Stanford University School of Medicine, UNITED STATES |
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| Abstract: | BackgroundWe performed a systematic review to assess whether we can quantify the underreporting of adverse events (AEs) in the published medical literature documenting the results of clinical trials as compared with other nonpublished sources, and whether we can measure the impact this underreporting has on systematic reviews of adverse events.ConclusionsThere is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study. The inclusion of unpublished data can also reduce the imprecision of pooled effect estimates during meta-analysis of adverse events. |
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