Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases

Mahrukh Imran; Kimberly Mc Cord; Stephen J. McCall; Linda Kwakkenbos; Margaret Sampson; Ole Fröbert; Chris Gale; Lars G. Hemkens; Sinéad M Langan; David Moher; Clare Relton; Merrick Zwarenstein; Edmund Juszczak; Brett D. Thombs; CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group

doi:10.1016/j.jclinepi.2021.09.010

Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases

Mahrukh Imran, Kimberly Mc Cord, Stephen J. McCall, Linda Kwakkenbos, Margaret Sampson, Ole Fröbert, Chris Gale, Lars G. Hemkens, Sinéad M Langan, David Moher, Clare Relton, Merrick Zwarenstein, Edmund Juszczak, Brett D. Thombs^* (Corresponding Author), CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group

^*Corresponding author for this work

Applied Health Sciences

Research output: Contribution to journal › Article › peer-review

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Abstract

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

Original language	English
Pages (from-to)	187-197
Number of pages	25
Journal	Journal of Clinical Epidemiology
Volume	141
Early online date	11 Sept 2021
DOIs	https://doi.org/10.1016/j.jclinepi.2021.09.010
Publication status	Published - 1 Jan 2022

Bibliographical note

Acknowledgments
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.

Keywords

Administrative data
CONSORT
CONSORT-ROUTINE
Randomized controlled trials
Reporting guideline
Routinely collected data

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10.1016/j.jclinepi.2021.09.010Licence: CC BY

Imran_etal_JCE_Reporting_Transparency_And_VoR
© 2021 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
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Imran, M., Mc Cord, K., McCall, S. J., Kwakkenbos, L., Sampson, M., Fröbert, O., Gale, C., Hemkens, L. G., Langan, S. M., Moher, D., Relton, C., Zwarenstein, M., Juszczak, E., Thombs, B. D., & CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group (2022). Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases. Journal of Clinical Epidemiology, 141, 187-197. https://doi.org/10.1016/j.jclinepi.2021.09.010

Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases. / Imran, Mahrukh; Mc Cord, Kimberly; McCall, Stephen J. et al.
In: Journal of Clinical Epidemiology, Vol. 141, 01.01.2022, p. 187-197.

Research output: Contribution to journal › Article › peer-review

Imran, M, Mc Cord, K, McCall, SJ, Kwakkenbos, L, Sampson, M, Fröbert, O, Gale, C, Hemkens, LG, Langan, SM, Moher, D, Relton, C, Zwarenstein, M, Juszczak, E, Thombs, BD & CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group 2022, 'Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases', Journal of Clinical Epidemiology, vol. 141, pp. 187-197. https://doi.org/10.1016/j.jclinepi.2021.09.010

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abstract = "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 ",

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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 - CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group

N1 - Acknowledgments 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.

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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

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Reporting transparency and completeness in trials: Paper 3 – trials conducted using administrative databases do not adequately report elements related to use of databases

Abstract

Bibliographical note

Keywords

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