Evidence map›Paper›PMID 32398016›Full record

ArticleBMC medical research methodology2020

Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide.

Matthew Ventresca, Holger J Schünemann, Fergus Macbeth, Mike Clarke, Lehana Thabane, Gareth Griffiths, Simon Noble, David Garcia, Maura Marcucci, Alfonso Iorio and 7 more

Abstract readScoping Review
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical research methodology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 10 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  6. Addressing Systematic Missing Data in the Context of Causally Interpretable Meta-analysis.Prevention science : the official journal of the Society for Prevention Research · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Matthew VentrescaDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Holger J SchünemannDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada. schuneh@mcmaster.ca.
Fergus MacbethCentre for Trials Research, School of Medicine, Cardiff University, Cardiff, Wales, UK.
Mike ClarkeNorthern Ireland Hub for Trials Methodology Research and Cochrane Individual Participant Data Meta-analysis Methods Group, Queen's University Belfast, Belfast, UK.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Gareth GriffithsWales Cancer Trials Unit, School of Medicine, Cardiff University, Wales, UK; Faculty of Medicine, University of Southampton, Southampton General Hospital, Southampton, UK.
Simon NobleMarie Curie Palliative Care Research Centre, Cardiff University, Cardiff, Wales, UK.
David GarciaDepartment of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
Maura MarcucciDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Alfonso IorioDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Qi ZhouDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Mark CrowtherDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Elie A AklDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Gary H LymanDepartment of Medicine, University of Washington School of Medicine, Seattle, Washington, USA.
Viktoria GloyBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
Marcello DiNisioDepartment of Medicine and Ageing Sciences, University G. D'Annunzio, Chieti-Pescara, Italy.
Matthias BrielDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Funding

Cancer Research UK 15954Cancer Research UK 25350Cancer Research UK 25352Marie Curie MCCC-FCO-11-CMedical Research Council G0901530
6 · The paper itself

Abstract

backgroundShifts in data sharing policy have increased researchers' access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the challenges of retrieving IPD for an IPDMA and provide practical guidance on obtaining and managing datasets based on a review of the literature and practical examples and observations.

methodsWe systematically searched MEDLINE, Embase, and the Cochrane Library, until January 2019, to identify publications focused on strategies to obtain IPD. In addition, we searched pharmaceutical websites and contacted industry organizations for supplemental information pertaining to recent advances in industry policy and practice. Finally, we documented setbacks and solutions encountered while completing a comprehensive IPDMA and drew on previous experiences related to seeking and using IPD.

resultsOur scoping review identified 16 articles directly relevant for the conduct of IPDMAs. We present short descriptions of these articles alongside overviews of IPD sharing policies and procedures of pharmaceutical companies which display certification of Principles for Responsible Clinical Trial Data Sharing via Pharmaceutical Research and Manufacturers of America or European Federation of Pharmaceutical Industries and Associations websites. Advances in data sharing policy and practice affected the way in which data is requested, obtained, stored and analyzed. For our IPDMA it took 6.5 years to collect and analyze relevant IPD and navigate additional administrative barriers. Delays in obtaining data were largely due to challenges in communication with study sponsors, frequent changes in data sharing policies of study sponsors, and the requirement for a diverse skillset related to research, administrative, statistical and legal issues.

conclusionsKnowledge of current data sharing practices and platforms as well as anticipation of necessary tasks and potential obstacles may reduce time and resources required for obtaining and managing data for an IPDMA. Sufficient project funding and timeline flexibility are pre-requisites for successful collection and analysis of IPD. IPDMA researchers must acknowledge the additional and unexpected responsibility they are placing on corresponding study authors or data sharing administrators and should offer assistance in readying data for sharing.

Indexed as

Information DisseminationMotivationCommunicationHumansInformation Storage and RetrievalResearch PersonnelData collectionData sharingIndividual participant data meta-analysisPractical guideSystematic review

Identifiers

PMID32398016
PMCPMC7218569

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.