Reporting transparency and completeness in trials: Paper 4 - reporting of randomised controlled trials conducted using routinely collected electronic records – room for improvement
File(s)
Author(s)
Type
Journal Article
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.
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.
Date Issued
2022-01-01
Date Acceptance
2021-09-07
Citation
Journal of Clinical Epidemiology, 2022, 141, pp.198-209
ISSN
0895-4356
Publisher
Elsevier
Start Page
198
End Page
209
Journal / Book Title
Journal of Clinical Epidemiology
Volume
141
Copyright Statement
© 2021 Elsevier Ltd. All rights reserved. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International Licence http://creativecommons.org/licenses/by-nc-nd/4.0/
Sponsor
Canadian Institutes of Health Research
Grant Number
389515
Subjects
CONSORT-ROUTINE
Collected
Data
Extension
Health
Routinely
Electronic Health Records
Electronics
Humans
Randomized Controlled Trials as Topic
Research Design
CONSORT Extension for Trials Conducted Using Cohorts and RoutinelyCollected Data Group
Humans
Electronics
Research Design
Randomized Controlled Trials as Topic
Electronic Health Records
01 Mathematical Sciences
11 Medical and Health Sciences
Epidemiology
Publication Status
Published
Date Publish Online
2021-09-12