Reporting Transparency and Completeness in Trials: Paper 4 - Reporting of randomised controlled trials conducted using routinely collected electronic records - room for improvementBehavioural 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, United Kingdom.
Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Canada.
Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, United Kingdom.
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department 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; Department of Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada.
Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.
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, Building 42, University Park, Nottingham, United Kingdom.
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2022 (English)In: Journal of Clinical Epidemiology, ISSN 0895-4356, E-ISSN 1878-5921, Vol. 141, p. 198-209Article in journal (Refereed) Published
Abstract [en]
OBJECTIVE: To describe characteristics of randomised controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.
STUDY DESIGN: MEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011-2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form.
RESULTS: 183 RCT publications were identified; 122 (67%) used EHRs to identify eligible participants, 139 (76%) used the EHR as part of the intervention and 137 (75%) to ascertain outcomes. When 60 publications were evaluated against the CONSORT 2010 item and the corresponding extension for the 8 modified items, four items were 'adequately reported' for the majority of trials. Five new reporting items were identified for the CONSORT-ROUTINE extension; when evaluated, one was 'adequately reported', three were reported 'inadequately or not at all', the other 'partially'. There were, however, some encouraging signs with adequate and partial reporting of many important items, including descriptions of trial design, the consent process, outcome ascertainment and interpretation.
CONCLUSION: Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.
Place, publisher, year, edition, pages
Pergamon Press, 2022. Vol. 141, p. 198-209
Keywords [en]
CONSORT-ROUTINE extension routinely collected data
National Category
Health Care Service and Management, Health Policy and Services and Health Economy
Identifiers
URN: urn:nbn:se:oru:diva-94438DOI: 10.1016/j.jclinepi.2021.09.011ISI: 000821354900010PubMedID: 34525409Scopus ID: 2-s2.0-85117769886OAI: oai:DiVA.org:oru-94438DiVA, id: diva2:1595111
Note
Funding agency:
National Institute for Health Research (NIHR)
2021-09-172021-09-172024-01-16Bibliographically approved