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Research Note

A review of data sharing statements in observational studies published in the BMJ: A cross-sectional study

[version 1; peer review: 1 approved, 1 approved with reservations]
PUBLISHED 19 Sep 2017
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This article is included in the Research on Research, Policy & Culture gateway.

Abstract

In order to understand the current state of data sharing in observational research studies, we reviewed data sharing statements of observational studies published in a general medical journal, the British Medical Journal. We found that the majority (63%) of observational studies published between 2015 and 2017 included a statement that implied that data used in the study could not be shared. If the findings of our exploratory study are confirmed, room for improvement in the sharing of real-world or observational research data exists.

Keywords

Data-sharing, real-world data, observational

Introduction

Over the recent years, a number of articles and movements have called for the sharing of clinical trial data13. However the access to and sharing of real-world/observational data receives little and arguably insufficient attention. In this study we sought to assess the current state of data sharing in published observational studies in a general medical journal, namely the British Medical Journal (BMJ). The BMJ was chosen as the journal does not enforce a commitment of data sharing for observational studies4, but all research articles are required to contain a data sharing statement5.

Methods

All observational research articles published in the BMJ between 1st January 2015 and 31st August 2017 were investigated. These dates were chosen as it provides a reasonable sample size for analysis and recent data post-dating some of the articles regarding clinical trial data sharing2. Observational research articles were defined as cohort, case-control and cross-sectional studies, as well as case series. Meta-analyses, systematic reviews, randomised controlled trials and genetic/Mendelian randomisation studies were excluded. The data sharing statements of these studies were reviewed. If the statement written was “no additional data available”5 or that data was not publicly available, the study data was classed as not shared. Statements alluding to data being available from the corresponding author, or a referral to access policies of the data source the study data was classed as shared. Where statements alluded to code or technical appendix being available, but no reference to data specifically being available, the study data was classed as not shared.

Results

Two hundred and thirty seven observational studies were included. A review of the data sharing statements of these studies revealed that 149 (63%) studies had a statement implying that the data underlying the study could not be shared.

Dataset 1.Raw data showing the studies identified from the BMJ and whether the data sharing statements indicated data was not/were available.

Conclusions

In our review of the data sharing statements of observational studies published in the BMJ, we identified that the majority of studies did not share data. Whilst there are likely many reasons for this, including patient confidentiality concerns and the access possibilities of the data source, the lack of data sharing in observational research is a potential cause for concern. The key limitation of our study was the scope of the data. We only reviewed the data sharing statements of one medical journal and therefore the generalisability of our results is unclear. Our analysis should be seen as exploratory rather than definitive. Further studies are needed, in greater depth, to confirm or refute our findings. If consistent findings are seen, the lack of sharing of observational research data is an area that warrants further attention.

Data availability

Dataset 1: Raw data showing the studies identified from the BMJ and whether the data sharing statements indicated data was not/were available. doi, 10.5256/f1000research.12673.d1778716

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Version 2
VERSION 2 PUBLISHED 19 Sep 2017
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how to cite this article
McDonald L, Schultze A, Simpson A et al. A review of data sharing statements in observational studies published in the BMJ: A cross-sectional study [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2017, 6:1708 (https://doi.org/10.12688/f1000research.12673.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 19 Sep 2017
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22
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Reviewer Report 02 Nov 2017
 Robin E. Champieux, OHSU Library, Ontology Development Group, Oregon Health & Science University, Portland, OR, USA 
Approved with Reservations
VIEWS 22
This exploratory analysis contributes to the literature on biomedical data sharing practices, and demonstrates the importance of the further understanding of data sharing policies, practices, and barriers for domain and type specific data sets, such as those associated with observational ... Continue reading
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HOW TO CITE THIS REPORT
Champieux  E. Reviewer Report For: A review of data sharing statements in observational studies published in the BMJ: A cross-sectional study [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2017, 6:1708 (https://doi.org/10.5256/f1000research.13724.r26439)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 06 Nov 2017
    Sreeram Ramagopalan, Centre for Observational Research and Data Sciences, Bristol-Myers Squibb, Uxbridge, UB8 1DH, UK
    06 Nov 2017
    Author Response
    We thank the reviewer for their comments. We focussed on the BMJ because of the journal being a key backer of the all trials initiative but we agree with the ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 06 Nov 2017
    Sreeram Ramagopalan, Centre for Observational Research and Data Sciences, Bristol-Myers Squibb, Uxbridge, UB8 1DH, UK
    06 Nov 2017
    Author Response
    We thank the reviewer for their comments. We focussed on the BMJ because of the journal being a key backer of the all trials initiative but we agree with the ... Continue reading
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19
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Reviewer Report 26 Sep 2017
Laurie A. Tomlinson, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK 
Approved
VIEWS 19
This is an interesting study that draws attention to an important area - open access to the data underpinning research papers allowing assessment of reproducibility. It is of course limited by it's focus on one journal as data-sharing policies vary ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Tomlinson LA. Reviewer Report For: A review of data sharing statements in observational studies published in the BMJ: A cross-sectional study [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2017, 6:1708 (https://doi.org/10.5256/f1000research.13724.r26085)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 2
VERSION 2 PUBLISHED 19 Sep 2017
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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