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Drug-Related Adverse Events
A Readers' Guide to Assessing Literature Reviews and Meta-analyses
Susan D. Ross, MD, FRCPC
Arch Intern Med. 2001;161:1041-1046.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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IN THE SETTING of increasing concern about drug safety and a burgeoning
literature on the subject, the objective of this article is to provide readers
with a practical guide to critically appraising reviews and meta-analyses
of source studies of drug-related adverse events. A critique of a recent highly
publicized meta-analysis of adverse drug reactions is used as a case study
here to highlight several contentious issues. The published literature on
drug-related adverse events is fraught with problems, starting with the original
reports and extending to systematic reviews and meta-analyses thereof. A fundamental
and universal taxonomy does not exist. For original reports, prospective protocols
are missing; event ascertainment is poorly described and executed; and analytic
methods are questionable and lead to problems of imprecise estimates, multiple
correlations, and generalizability of results. It is recommended that for
reviews and syntheses of original reports, explicit search methods and . . . [Full Text of this Article]OBJECTIVE
TAXONOMY
PROSPECTIVE PROTOCOL
LITERATURE SEARCH
STUDY SELECTION Study Characteristics Event Ascertainment ANALYTIC METHODS Heterogeneity and Bias
Precision Multiple Correlations INTERPRETATION AND GENERALIZABILITY OF RESULTS
CONCLUSIONS
MetaWorks, Inc 10 President's Landing Medford, MA 02155 (e-mail: SDR@Metawork.com)
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