@article{Imran:2022:10.1016/j.jclinepi.2021.09.010,
author = {Imran, M and McCord, K and McCall, SJ and Kwakkenbos, L and Sampson, M and Frobert, O and Gale, C and Hemkens, LG and Langan, SM and Moher, D and Relton, C and Zwarenstein, M and Juszczak, E and Thombs, BD},
doi = {10.1016/j.jclinepi.2021.09.010},
journal = {Journal of Clinical Epidemiology},
pages = {187--197},
title = {Reporting transparency and completeness in trials: Paper 3 - trials conducted using administrative databases do not adequately report elements related to use of databases},
url = {http://dx.doi.org/10.1016/j.jclinepi.2021.09.010},
volume = {141},
year = {2022}
}

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TY  - JOUR
AB  - Objective: We evaluated reporting completeness and transparency in randomised controlled trials (RCTs) conducted using administrative data based on 2021 CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.Study Design and Setting: MEDLINE and the Cochrane Methodology Register were searched (2011 and 2018). Eligible RCTs used administrative databases for identifying eligible participants or collecting outcomes. We evaluated reporting based on CONSORT-ROUTINE, which modified eight items from CONSORT 2010 and added five new items.Results: Of 33 included trials (76% used administrative databases for outcomes, 3% for identifying participants, 21% both), most were conducted in the United States (55%), Canada (18%), or the United Kingdom (12%). Of eight items modified in the extension; six were adequately reported in a majority (>50%) of trials. For the CONSORT-ROUTINE modification portion of those items, three items were reported adequately in >50% of trials, two in <50%, two only applied to some trials, and one only had wording modifications and was not evaluated. For five new items, four that address use of routine data in trials were reported inadequately in most trials. Conclusion: How administrative data are used in trials is often sub-optimally reported. CONSORT-ROUTINE uptake may improve reporting.
AU  - Imran,M
AU  - McCord,K
AU  - McCall,SJ
AU  - Kwakkenbos,L
AU  - Sampson,M
AU  - Frobert,O
AU  - Gale,C
AU  - Hemkens,LG
AU  - Langan,SM
AU  - Moher,D
AU  - Relton,C
AU  - Zwarenstein,M
AU  - Juszczak,E
AU  - Thombs,BD
DO  - 10.1016/j.jclinepi.2021.09.010
EP  - 197
PY  - 2022///
SN  - 0895-4356
SP  - 187
TI  - Reporting transparency and completeness in trials: Paper 3 - trials conducted using administrative databases do not adequately report elements related to use of databases
T2  - Journal of Clinical Epidemiology
UR  - http://dx.doi.org/10.1016/j.jclinepi.2021.09.010
UR  - http://hdl.handle.net/10044/1/91626
VL  - 141
ER  - 

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