TY - JOUR
T1 - Reporting transparency and completeness in Trials
T2 - Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results
AU - Mc Cord, Kimberly A
AU - Imran, Mahrukh
AU - Rice, Danielle B
AU - McCall, Stephen J
AU - Kwakkenbos, Linda
AU - Sampson, Margaret
AU - Fröbert, Ole
AU - Gale, Chris
AU - Langan, Sinéad M
AU - Moher, David
AU - Relton, Clare
AU - Zwarenstein, Merrick
AU - Juszczak, Edmund
AU - Thombs, Brett D
AU - Hemkens, Lars G
AU - CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group
N1 - Funding: The development of CONSORT-ROUTINE and the present review 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. (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. Dr. Langan was supported by a Wellcome Senior Clinical Fellowship in Science (205039/Z/16/Z). Dr. Moher is supported by a University Research Chair (uOttawa). Dr. Gale was supported by the United Kingdom Medical Research Council through a Clinician Scientist Fellowship. Dr. Thombs was supported by a Tier 1 Canada Research Chair
PY - 2021/9/12
Y1 - 2021/9/12
N2 - OBJECTIVE: Registries are important data sources for randomized 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.
AB - OBJECTIVE: Registries are important data sources for randomized 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.
KW - Registries
KW - CONSORT
KW - CONSORT-ROUTINE
KW - Randomised controlled trials
KW - Reporting guidelines
KW - routinely collected data
U2 - 10.1016/j.jclinepi.2021.09.012
DO - 10.1016/j.jclinepi.2021.09.012
M3 - Article
C2 - 34525408
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
SN - 0895-4356
ER -