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 - Publisher Copyright:
© 2021 The Authors
PY - 2022/1
Y1 - 2022/1
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 - CONSORT
KW - CONSORT-ROUTINE
KW - Randomised controlled trials
KW - Registries
KW - Reporting guideline
KW - Routinely collected data
UR - http://www.scopus.com/inward/record.url?scp=85118728305&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2021.09.012
DO - 10.1016/j.jclinepi.2021.09.012
M3 - Journal article
C2 - 34525408
AN - SCOPUS:85118728305
SN - 0895-4356
VL - 141
SP - 175
EP - 186
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -