Reporting Transparency and Completeness in Trials: Paper 2 - Reporting of randomised trials using registries was often inadequate and hindered the interpretation of resultsBehavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands.
Library Services, Children's Hospital of Eastern Ontario, Ottawa, Canada.
Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, UK.
Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Nottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, United Kingdom.
Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Departments of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada.; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada.
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland; Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA .
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland; Meta-Research Innovation Center Berlin (METRIC-B), Berlin Institute of Health, Berlin, Germany; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA.
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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
2021-09-172021-09-172024-01-16Bibliographically approved