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

Alex Hodkinson, Kristina Charlotte Dietz, Carol Lefebvre, Su Golder, Mark Jones, Peter Doshi, Carl Heneghan, Tom Jefferson, Isabelle Boutron, Lesley Stewart

Research output: Contribution to journalArticleResearchpeer-review

4 Citations (Scopus)
6 Downloads (Pure)

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.

Original languageEnglish
Article number117
JournalSystematic Reviews
Volume7
Issue number1
DOIs
Publication statusPublished - 8 Aug 2018
Externally publishedYes

Fingerprint

Surveys and Questionnaires
Clinical Studies
Publication Bias
Information Storage and Retrieval
United States Food and Drug Administration
Marketing
Publications
Meta-Analysis
Motivation
Research Personnel
Clinical Trials
Recognition (Psychology)

Cite this

Hodkinson, Alex ; Dietz, Kristina Charlotte ; Lefebvre, Carol ; Golder, Su ; Jones, Mark ; Doshi, Peter ; Heneghan, Carl ; Jefferson, Tom ; Boutron, Isabelle ; Stewart, Lesley. / The use of clinical study reports to enhance the quality of systematic reviews : A survey of systematic review authors. In: Systematic Reviews. 2018 ; Vol. 7, No. 1.
@article{5073d8b96c3d466cb270958cebfacefd,
title = "The use of clinical study reports to enhance the quality of systematic reviews: A survey of systematic review authors",
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.",
author = "Alex Hodkinson and Dietz, {Kristina Charlotte} and Carol Lefebvre and Su Golder and Mark Jones and Peter Doshi and Carl Heneghan and Tom Jefferson and Isabelle Boutron and Lesley Stewart",
year = "2018",
month = "8",
day = "8",
doi = "10.1186/s13643-018-0766-x",
language = "English",
volume = "7",
journal = "Systematic Reviews",
issn = "2046-4053",
publisher = "BMC",
number = "1",

}

Hodkinson, 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, vol. 7, no. 1, 117. https://doi.org/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. / Hodkinson, Alex; Dietz, Kristina Charlotte; Lefebvre, Carol; Golder, Su; Jones, Mark; Doshi, Peter; Heneghan, Carl; Jefferson, Tom; Boutron, Isabelle; Stewart, Lesley.

In: Systematic Reviews, Vol. 7, No. 1, 117, 08.08.2018.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - The use of clinical study reports to enhance the quality of systematic reviews

T2 - A survey of systematic review authors

AU - Hodkinson, Alex

AU - Dietz, Kristina Charlotte

AU - Lefebvre, Carol

AU - Golder, Su

AU - Jones, Mark

AU - Doshi, Peter

AU - Heneghan, Carl

AU - Jefferson, Tom

AU - Boutron, Isabelle

AU - Stewart, Lesley

PY - 2018/8/8

Y1 - 2018/8/8

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85051289878&partnerID=8YFLogxK

U2 - 10.1186/s13643-018-0766-x

DO - 10.1186/s13643-018-0766-x

M3 - Article

VL - 7

JO - Systematic Reviews

JF - Systematic Reviews

SN - 2046-4053

IS - 1

M1 - 117

ER -