TY - JOUR
T1 - Reporting transparency and completeness in trials
T2 - Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases
AU - Imran, Mahrukh
AU - Mc Cord, Kimberly
AU - McCall, Stephen J.
AU - Kwakkenbos, Linda
AU - Sampson, Margaret
AU - Fröbert, Ole
AU - Gale, Chris
AU - Hemkens, Lars G.
AU - Langan, Sinéad M.
AU - Moher, David
AU - Relton, Clare
AU - Zwarenstein, Merrick
AU - Juszczak, Edmund
AU - Thombs, Brett D.
AU - on behalf of CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group
N1 - Publisher Copyright:
© 2021
PY - 2022/1
Y1 - 2022/1
N2 - Objective: We evaluated reporting completeness and transparency in randomized 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.
AB - Objective: We evaluated reporting completeness and transparency in randomized 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.
KW - Administrative data
KW - CONSORT
KW - CONSORT-ROUTINE
KW - Randomized controlled trials
KW - Reporting guideline
KW - Routinely collected data
UR - http://www.scopus.com/inward/record.url?scp=85117407651&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2021.09.010
DO - 10.1016/j.jclinepi.2021.09.010
M3 - Journal article
C2 - 34520851
AN - SCOPUS:85117407651
SN - 0895-4356
VL - 141
SP - 187
EP - 197
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -