Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records - room for improvement.

Electronic Health Records Electronics Humans Randomized Controlled Trials as Topic Research Design
CONSORT-ROUTINE Collected Data Extension Health Routinely

Journal

Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383

Informations de publication

Date de publication:
01 2022
Historique:
received: 14 12 2020
revised: 27 07 2021
accepted: 07 09 2021
pubmed: 16 9 2021
medline: 9 4 2022
entrez: 15 9 2021
Statut: ppublish

Résumé

To describe characteristics of randomized 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. 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. Of the 183 RCT publications 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 most 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. Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.

Identifiants

DOI: 10.1016/j.jclinepi.2021.09.011 PMID: 34525409 PMC: PMC8982641
pubmed: 34525409
pii: S0895-4356(21)00291-2
doi: 10.1016/j.jclinepi.2021.09.011
pmc: PMC8982641
pii:
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

198-209

Subventions

Organisme : Wellcome Trust
ID : 205039/Z/16/Z
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/N008405/1
Pays : United Kingdom
Organisme : CIHR
ID : PJT-156172
Pays : Canada
Organisme : CIHR
ID : PCS-161863
Pays : Canada
Organisme : Department of Health
Pays : United Kingdom

Informations de copyright

Copyright © 2021. Published by Elsevier Inc.

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Auteurs

Stephen J McCall (SJ)

Nuffield Department of Population Health, National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford, United Kingdom; Center for Research on Population and Health, American University of Beirut, Ras Beirut, Lebanon.

Mahrukh Imran (M)

Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.

Lars G Hemkens (LG)

Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.

Kimberly Mc Cord (K)

Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.

Linda Kwakkenbos (L)

Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands.

Margaret Sampson (M)

Library Services, Children's Hospital of Eastern Ontario, Ottawa, Canada.

Sena Jawad (S)

Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.

Merrick Zwarenstein (M)

Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Canada.

Clare Relton (C)

Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, United Kingdom.

Sinéad M Langan (SM)

Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.

David Moher (D)

Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Ole Fröbert (O)

Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.

Brett D Thombs (BD)

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.

Chris Gale (C)

Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.

Edmund Juszczak (E)

Nuffield Department of Population Health, National Perinatal Epidemiology Unit Clinical Trials Unit, University of Oxford, Oxford, United Kingdom; Nottingham Clinical Trials Unit, Applied Health Research Building, University of Nottingham, Nottingham, United Kingdom. Electronic address: ed.juszczak@nottingham.ac.uk.

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