@article{Mc:2022:10.1016/j.jclinepi.2021.09.012,
author = {Mc, Cord K and Imran, M and Rice, DB and McCall, SJ and Kwakkenbos, L and Sampson, M and Frobert, O and Gale, C and Landgan, SM and Moher, D and Relton, C and Zwarenstein, M and Juszczak, E and Thombs, BD and Hemkens, LG and on, behalf of theCONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group},
doi = {10.1016/j.jclinepi.2021.09.012},
journal = {Journal of Clinical Epidemiology},
pages = {175--186},
title = {Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results},
url = {http://dx.doi.org/10.1016/j.jclinepi.2021.09.012},
volume = {141},
year = {2022}
}

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TY  - JOUR
AB  - Objective: Registries are important data sources for randomised controlled trials (RCTs), butreporting of how they are used may be inadequate. The objective was to describe the currentadequacy of reporting of RCTs using registries.Study Design and Setting: We used a database of trials using registries from a scopingreview supporting the development of the 2021 CONSORT extension for Trials ConductedUsing Cohorts and Routinely Collected Data (CONSORT-ROUTINE). Reportingcompleteness of 13 CONSORT-ROUTINE items was assessed.Results: We assessed reports of 47 RCTs that used a registry, published between 2011 and2018. Of the 13 CONSORT-ROUTINE items, 6 were adequately reported in at least half ofreports (2 in at least 80%). The 7 other items were related to routinely collected data sourceeligibility (32% adequate), data linkage (8% adequate), validation and completeness of dataused for outcome assessment (8% adequate), validation and completeness of data used forparticipant 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 datalinkage and quality. Better reporting is needed for appropriate interpretation of the results ofthese trials.Keywords: registries, CONSORT, CONSORT-ROUTINE, randomised controlled trials,reporting guideline, routinely collected dataRunning Title: Completeness and Transparency of Reporting of RCTs using Registries
AU  - Mc,Cord K
AU  - Imran,M
AU  - Rice,DB
AU  - McCall,SJ
AU  - Kwakkenbos,L
AU  - Sampson,M
AU  - Frobert,O
AU  - Gale,C
AU  - Landgan,SM
AU  - Moher,D
AU  - Relton,C
AU  - Zwarenstein,M
AU  - Juszczak,E
AU  - Thombs,BD
AU  - Hemkens,LG
AU  - on,behalf of theCONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group
DO  - 10.1016/j.jclinepi.2021.09.012
EP  - 186
PY  - 2022///
SN  - 0895-4356
SP  - 175
TI  - Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results
T2  - Journal of Clinical Epidemiology
UR  - http://dx.doi.org/10.1016/j.jclinepi.2021.09.012
UR  - http://hdl.handle.net/10044/1/91754
VL  - 141
ER  - 

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