Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results

Mc Cord, Kimberly A.; Imran, Mahrukh; Rice, Danielle B.; McCall, Stephen J.; Kwakkenbos, Linda; Sampson, Margaret; Fröbert, Ole; Gale, Chris; Langan, Sinéad M.; Moher, David; Relton, Clare; Zwarenstein, Merrick; Juszczak, Edmund; Thombs, Brett D.; Hemkens, Lars G.

Abstract

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.

Citation

Mc Cord, K. A., Imran, M., Rice, D. B., McCall, S. J., Kwakkenbos, L., Sampson, M., Fröbert, O., Gale, C., Langan, S. M., Moher, D., Relton, C., Zwarenstein, M., Juszczak, E., Thombs, B. D., & Hemkens, L. G. (2022). Reporting transparency and completeness in Trials: Paper 2 - reporting of randomised trials using registries was often inadequate and hindered the interpretation of results. Journal of Clinical Epidemiology, 141, 175-186. https://doi.org/10.1016/j.jclinepi.2021.09.012

• Journal Article Type: Article
• Acceptance Date: Sep 7, 2021
• Online Publication Date: Sep 12, 2021
• Publication Date: Jan 1, 2022
• Deposit Date: Nov 16, 2021
• Publicly Available Date: Nov 16, 2021
• Journal: Journal of Clinical Epidemiology
• Print ISSN: 0895-4356
• Electronic ISSN: 1878-5921
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 141
• Pages: 175-186
• DOI: https://doi.org/10.1016/j.jclinepi.2021.09.012
• Public URL: https://nottingham-repository.worktribe.com/output/6726614
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S0895435621002924?via%3Dihub