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Reporting Transparency and Completeness in Trials: Paper 4 - Reporting of randomised controlled trials conducted using routinely collected electronic records - room for improvement
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.
Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
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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)

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

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Fröbert, Ole

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