Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results
File(s)
Accepted version
Author(s)
Type
Journal Article
Abstract
Objective: Registries are important data sources for randomised controlled trials (RCTs), but
reporting of how they are used may be inadequate. The objective was to describe the current
adequacy of reporting of RCTs using registries.
Study Design and Setting: We used a database of trials using registries from a scoping
review supporting the development of the 2021 CONSORT extension for Trials Conducted
Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting
completeness of 13 CONSORT-ROUTINE items was assessed.
Results: We assessed reports of 47 RCTs that used a registry, published between 2011 and
2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of
reports (2 in at least 80%). The 7 other items were related to routinely collected data source
eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data
used for outcome assessment (8% adequate), validation and completeness of data used for
participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6%
adequate) and interpretation of results in consideration of registry use (25% adequate).
Conclusion: Reporting of trials using registries was often poor, particularly details on data
linkage and quality. Better reporting is needed for appropriate interpretation of the results of
these trials.
Keywords: registries, CONSORT, CONSORT-ROUTINE, randomised controlled trials,
reporting guideline, routinely collected data
Running Title: Completeness and Transparency of Reporting of RCTs using Registries
reporting of how they are used may be inadequate. The objective was to describe the current
adequacy of reporting of RCTs using registries.
Study Design and Setting: We used a database of trials using registries from a scoping
review supporting the development of the 2021 CONSORT extension for Trials Conducted
Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reporting
completeness of 13 CONSORT-ROUTINE items was assessed.
Results: We assessed reports of 47 RCTs that used a registry, published between 2011 and
2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half of
reports (2 in at least 80%). The 7 other items were related to routinely collected data source
eligibility (32% adequate), data linkage (8% adequate), validation and completeness of data
used for outcome assessment (8% adequate), validation and completeness of data used for
participant recruitment (0% adequate), participant flow (9% adequate), registry funding (6%
adequate) and interpretation of results in consideration of registry use (25% adequate).
Conclusion: Reporting of trials using registries was often poor, particularly details on data
linkage and quality. Better reporting is needed for appropriate interpretation of the results of
these trials.
Keywords: registries, CONSORT, CONSORT-ROUTINE, randomised controlled trials,
reporting guideline, routinely collected data
Running Title: Completeness and Transparency of Reporting of RCTs using Registries
Date Issued
2022-01-01
Date Acceptance
2021-09-07
Citation
Journal of Clinical Epidemiology, 2022, 141, pp.175-186
ISSN
0895-4356
Publisher
Elsevier
Start Page
175
End Page
186
Journal / Book Title
Journal of Clinical Epidemiology
Volume
141
Copyright Statement
© 2021 The Authors. Published by Elsevier Inc. 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
CONSORT-ROUTINE
Randomised controlled trials
Registries
Reporting guideline
Routinely collected data
Humans
Outcome Assessment, Health Care
Publications
Registries
Research Report
CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group
Humans
Registries
Publications
Research Report
Outcome Assessment, Health Care
01 Mathematical Sciences
11 Medical and Health Sciences
Epidemiology
Publication Status
Published
Date Publish Online
2021-09-12