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Syst Rev. 2018 Aug 8;7(1):117. doi: 10.1186/s13643-018-0766-x.

The use of clinical study reports to enhance the quality of systematic reviews: a survey of systematic review authors.

Author information

1
LCentre for Primary Care, Division of Population Health, Health Services Research & Primary Care, Williamson Building, Oxford Road, Manchester, M13 9PL, UK. alexander.hodkinson@manchester.ac.uk.
2
Centre for Reviews and Dissemination, A/B Block, Alcuin College, University of York, York, YO10 5DD, UK.
3
Lefebvre Associates Ltd, Oxford, UK.
4
Department of Health Sciences, University of York, York, UK.
5
School of Public Health, University of Queensland, Brisbane, Australia.
6
Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD, USA.
7
Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, Primary Sciences Division, University of Oxford, Oxford, UK.
8
METHODs Team, Centre of Research in Epidemiology and Statistics Sorbonne Paris Cité, INSERM UMR, University Paris Descartes, Paris, France.

Abstract

BACKGROUND:

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.

PMID:
30089508
PMCID:
PMC6083614
DOI:
10.1186/s13643-018-0766-x
[Indexed for MEDLINE]
Free PMC Article

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