Challenges in meta-analysis of randomized clinical trials for rare harmful cardiovascular events: the case of rosiglitazone

dc.contributor.authorHernandez, A. V.en
dc.contributor.authorWalker, E.en
dc.contributor.authorIoannidis, J. P.en
dc.contributor.authorKattan, M. W.en
dc.date.accessioned2015-11-24T19:31:06Z
dc.date.available2015-11-24T19:31:06Z
dc.identifier.issn1097-6744-
dc.identifier.urihttps://olympias.lib.uoi.gr/jspui/handle/123456789/23208
dc.rightsDefault Licence-
dc.subjectAdverse Drug Reaction Reporting Systemsen
dc.subjectCardiovascular Diseases/*chemically induced/epidemiologyen
dc.subjectDose-Response Relationship, Drugen
dc.subjectDrug Administration Scheduleen
dc.subjectFemaleen
dc.subjectHumansen
dc.subjectHypoglycemic Agents/*adverse effects/therapeutic useen
dc.subjectIncidenceen
dc.subjectMaleen
dc.subject*Meta-Analysis as Topicen
dc.subjectRandomized Controlled Trials as Topicen
dc.subjectRare Diseasesen
dc.subjectReproducibility of Resultsen
dc.subjectRisk Assessmenten
dc.subjectSensitivity and Specificityen
dc.subjectThiazolidinediones/*adverse effects/therapeutic useen
dc.titleChallenges in meta-analysis of randomized clinical trials for rare harmful cardiovascular events: the case of rosiglitazoneen
heal.abstractRare cardiovascular events of commonly used drugs are important to document and investigate, but single trials are notoriously underpowered to provide conclusive evidence. Recently, meta-analyses have been used to improve on the power. A recent rosiglitazone meta-analysis heightened the debate about the usefulness and limitations of meta-analysis in this setting. In this review, we examined the methods used in previous published meta-analyses for harmful cardiovascular events, with special attention to the rosiglitazone meta-analyses, and give suggestions for the improvement of methods and interpretation of such meta-analyses. The conduct of meta-analysis in this context is particularly difficult and requires timely investigation, availability of high-quality data on harms, and statistical expertise. There are important decisions that need to be made about selecting the appropriate analytical methods and performing sensitivity analyses to evaluate whether the results are robust to different analytical choices.en
heal.accesscampus-
heal.fullTextAvailabilityTRUE-
heal.identifier.primary10.1016/j.ahj.2008.03.002-
heal.identifier.secondaryhttp://www.ncbi.nlm.nih.gov/pubmed/18585493-
heal.identifier.secondaryhttp://ac.els-cdn.com/S0002870308001622/1-s2.0-S0002870308001622-main.pdf?_tid=829091dfa1746f53354092b0eb394698&acdnat=1333363794_ba88eeb65d374de8425588c77419be0c-
heal.journalNameAm Heart Jen
heal.journalTypepeer-reviewed-
heal.languageen-
heal.publicationDate2008-
heal.recordProviderΠανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικήςel
heal.typejournalArticle-
heal.type.elΆρθρο Περιοδικούel
heal.type.enJournal articleen

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