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

Stephen J McCall; Mahrukh Imran; Lars G Hemkens; Kimberly Mc Cord; Linda Kwakkenbos; Margaret Sampson; Sena Jawad; Merrick Zwarenstein; Clare Relton; Sinéad M Langan; David Moher; Ole Fröbert; Brett D Thombs; Chris Gale; Edmund Juszczak; CONSORT Extension for Trials Conducted Using Cohorts and RoutinelyCollected Data Group

doi:10.1016/j.jclinepi.2021.09.011

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

J Clin Epidemiol. 2022 Jan:141:198-209. doi: 10.1016/j.jclinepi.2021.09.011. Epub 2021 Sep 12.

Authors

Stephen J McCall¹, Mahrukh Imran², Lars G Hemkens³, Kimberly Mc Cord³, Linda Kwakkenbos⁴, Margaret Sampson⁵, Sena Jawad⁶, Merrick Zwarenstein⁷, Clare Relton⁸, Sinéad M Langan⁹, David Moher¹⁰, Ole Fröbert¹¹, Brett D Thombs¹², Chris Gale⁶, Edmund Juszczak¹³; CONSORT Extension for Trials Conducted Using Cohorts and RoutinelyCollected Data Group

Affiliations

¹ 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.
² Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.
³ Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
⁴ Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands.
⁵ Library Services, Children's Hospital of Eastern Ontario, Ottawa, Canada.
⁶ Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.
⁷ Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Canada.
⁸ Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, United Kingdom.
⁹ Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
¹⁰ Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹¹ Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.
¹² 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.
¹³ 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.

Abstract

Objective: 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.

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: 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.

Conclusion: Aspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.

Keywords: CONSORT-ROUTINE; Collected; Data; Extension; Health; Routinely.

Publication types

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

MeSH terms

Electronic Health Records
Electronics
Humans
Randomized Controlled Trials as Topic*
Research Design*

Abstract

Publication types

MeSH terms

Grants and funding