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dc.contributor.authorHodkinson, Alex
dc.contributor.authorDietz, Kristina Charlotte
dc.contributor.authorLefebvre, Carol
dc.contributor.authorGolder, Su
dc.contributor.authorJones, Mark A., B.Sc., Ph.D.
dc.contributor.authorDoshi, Peter
dc.contributor.authorHeneghan, Carl
dc.contributor.authorJefferson, Tom
dc.contributor.authorBoutron, Isabelle
dc.contributor.authorStewart, Lesley
dc.date.accessioned2018-08-13T11:58:29Z
dc.date.available2018-08-13T11:58:29Z
dc.date.issued2018-08-08
dc.identifier.citationHodkinson A, Dietz KC, Lefebvre C, Golder S, Jones M, Doshi, P, Heneghan C, Jefferson T, Boutron I, Stewart L. (2018). The use of clinical study reports to enhance the quality of systematic reviews: a survey of systematic review authors. Systematic Reviews, 7:117. DOI: https://doi.org/10.1186/s13643-018-0766-xen_US
dc.identifier.urihttp://hdl.handle.net/10713/8126
dc.description.abstractBackground: Clinical study reports (CSRs) are produced for marketing authorisation applications. They often contain considerably more information about, and data from, clinical trials than corresponding journal publications. Use of data from CSRs might help circumvent reporting bias, but many researchers appear to be unaware of their existence or potential value. Our survey aimed to gain insight into the level of familiarity, understanding and use of CSRs, and to raise awareness of their potential within the systematic review community. We also aimed to explore the potential barriers faced when obtaining and using CSRs in systematic reviews. Methods: Online survey of systematic reviewers who (i) had requested or used CSRs, (ii) had considered but not used CSRs and (iii) had not considered using CSRs was conducted. Cochrane reviewers were contacted twice via the Cochrane monthly digest. Non-Cochrane reviewers were reached via journal and other website postings. Results: One hundred sixty respondents answered an open invitation and completed the questionnaire; 20/160 (13%) had previously requested or used CSRs and other regulatory documents, 7/160 (4%) had considered but not used CSRs and 133/160 (83%) had never considered this data source. Survey respondents mainly sought data from the European Medicines Agency (EMA) and/or the Food and Drug Administration (FDA). Motivation for using CSRs stemmed mainly from concerns about reporting bias 11/20 (55%), specifically outcome reporting bias 11/20 (55%) and publication bias 5/20 (25%). The barriers to using CSRs noted by all types of respondents included current limited access to these documents (43 respondents), the time and resources needed to obtain and include these data in evidence syntheses (n = 25) and lack of guidance about how to use these sources in systematic reviews (n = 26). Conclusions: Most respondents (irrespective of whether they had previously used them) agreed that access to CSRs is important, and suggest that further guidance on how to use and include these data would help to promote their use in future systematic reviews. Most respondents who received CSRs considered them to be valuable in their systematic review and/or meta-analysis.en_US
dc.description.urihttps://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-018-0766-xen_US
dc.language.isoen_USen_US
dc.publisherLondon: BioMed Centralen_US
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectclinical study reportsen_US
dc.subject.meshMeta-Analysis as Topicen_US
dc.subject.meshSystematic Reviews as Topicen_US
dc.titleThe use of clinical study reports to enhance the quality of systematic reviews: a survey of systematic review authorsen_US
dc.typeArticleen_US
dc.description.versionYesen_US
dc.description.urinameClick here for the free full-text article on publisher's websiteen_US
refterms.dateFOA2019-02-19T18:34:49Z


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