Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials.

TitleIncomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials.
Publication TypeJournal Article
Year of Publication2001
AuthorsDerry S, Loke YK, Aronson JK
JournalBMC medical research methodology
Volume1
Pagination7
Date Published2001
ISSN1471-2288
KeywordsAbstracting and Indexing as Topic; Adverse Drug Reaction Reporting Systems; Databases, Factual; Guidelines as Topic; Humans; MEDLINE; Randomized Controlled Trials as Topic; Research Design
AbstractBACKGROUND: We would expect information on adverse drug reactions in randomised clinical trials to be easily retrievable from specific searches of electronic databases. However, complete retrieval of such information may not be straightforward, for two reasons. First, not all clinical drug trials provide data on the frequency of adverse effects. Secondly, not all electronic records of trials include terms in the abstract or indexing fields that enable us to select those with adverse effects data. We have determined how often automated search methods, using indexing terms and/or textwords in the title or abstract, would fail to retrieve trials with adverse effects data. METHODS: We used a sample set of 107 trials known to report frequencies of adverse drug effects, and measured the proportion that (i) were not assigned the appropriate adverse effects indexing terms in the electronic databases, and (ii) did not contain identifiable adverse effects textwords in the title or abstract. RESULTS: Of the 81 trials with records on both MEDLINE and EMBASE, 25 were not indexed for adverse effects in either database. Twenty-six trials were indexed in one database but not the other. Only 66 of the 107 trials reporting adverse effects data mentioned this in the abstract or title of the paper. Simultaneous use of textword and indexing terms retrieved only 82/107 (77%) papers. CONCLUSIONS: Specific search strategies based on adverse effects textwords and indexing terms will fail to identify nearly a quarter of trials that report on the rate of drug adverse effects.
Alternate JournalBMC Med Res Methodol