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* (Corresponding Author), CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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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.

Original languageEnglish
Pages (from-to)198-209
Number of pages12
JournalJournal of Clinical Epidemiology
Early online date25 Mar 2022
Publication statusPublished - 2022

Bibliographical note

This part of the project was funded by the National Institute for Health Research (NIHR) CTU Support Funding scheme - Supporting efficient/innovative delivery of NIHR research (PI Juszczak, Co-PI Gale, supported salary of SM). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The development of CONSORT-ROUTINE and the present study were funded by grants from the Canadian Institutes of Health Research (PI Thombs, #PJT-156172; PIs Thombs and Kwakkenbos, #PCS-161863) and from the United Kingdom National Institute of Health Research (NIHR) Clinical Trials Unit Support Funding. Dr. Langan was supported by a Wellcome Senior Clinical Fellowship in Science (205039/Z/16/Z). Dr. Gale was supported by the United Kingdom Medical Research Council through a Clinician Scientist Fellowship. Dr. Thombs was supported by a Fonds de recherche du Québec - Santé researcher salary award and a Tier 1 Canada Research Chair. Dr. Moher was supported by a University Research Chair (uOttawa).

Data Availability Statement

Additional data beyond that reported in the main and supplementary materials can be requested from the corresponding author.


  • Extension
  • Routinely
  • Collected
  • Health
  • Data


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