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Reporting Transparency and Completeness in Trials: Paper 2 - Reporting of randomised trials using registries was often inadequate and hindered the interpretation of results
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada.
Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.
National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Center for Research on Population and Health, Faculty of Health Sciences, American University of Beirut, Ras Beirut, Lebanon.
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2022 (English)In: Journal of Clinical Epidemiology, ISSN 0895-4356, E-ISSN 1878-5921, Vol. 141, p. 175-186Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: Registries are important data sources for randomised controlled trials (RCTs), but reporting of how they are used may be inadequate. The objective was to describe the current adequacy of reporting of RCTs using registries.

STUDY DESIGN AND SETTING: We used a database of trials using registries from a scoping review supporting the development of the 2021 CONSORT extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting completeness of 13 CONSORT-ROUTINE items was assessed.

RESULTS: We assessed reports of 47 RCTs that used a registry, published between 2011 and 2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of reports (2 in at least 80%). The 7 other items were related to routinely collected data source eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data used for outcome assessment (8% adequate), validation and completeness of data used for participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6% adequate) and interpretation of results in consideration of registry use (25% adequate).

CONCLUSION: Reporting of trials using registries was often poor, particularly details on data linkage and quality. Better reporting is needed for appropriate interpretation of the results of these trials.

Place, publisher, year, edition, pages
Pergamon Press, 2022. Vol. 141, p. 175-186
Keywords [en]
CONSORT, CONSORT-ROUTINE, randomised controlled trials, registries, reporting guideline, routinely collected data
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
URN: urn:nbn:se:oru:diva-94433DOI: 10.1016/j.jclinepi.2021.09.012ISI: 000821354900008PubMedID: 34525408Scopus ID: 2-s2.0-85118728305OAI: oai:DiVA.org:oru-94433DiVA, id: diva2:1595076
Note

Funding agencies:

Canadian Institutes of Health Research (CIHR) PJT-156172 PCS-161863  

United Kingdom National Institute of Health Research (NIHR) Clinical Trials Unit Support Funding

Wellcome Senior Clinical Fellowship in Science 205039/Z/16/Z 

University Research Chair

United Kingdom Medical Research Council through a Clinician Scientist Fellowship

Canada Research Chairs

Available from: 2021-09-17 Created: 2021-09-17 Last updated: 2024-01-16Bibliographically approved

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