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

J Clin Epidemiol. 2022 Jan:141:187-197. doi: 10.1016/j.jclinepi.2021.09.010. Epub 2021 Sep 11.

Authors

Mahrukh Imran¹, Kimberly Mc Cord², Stephen J McCall³, Linda Kwakkenbos⁴, Margaret Sampson⁵, Ole Fröbert⁶, Chris Gale⁷, Lars G Hemkens², Sinéad M Langan⁸, David Moher⁹, Clare Relton¹⁰, Merrick Zwarenstein¹¹, Edmund Juszczak¹², Brett D Thombs¹³; CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group¹⁴

Affiliations

¹ Lady Davis Institute for Medical Research, Jewish General Hospital, 4333 Cote Ste. Catherine Road, Montréal, Quebec, Canada.
² Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
³ National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Center for Research on Population and Health, Faculty of Health Sciences, American University of Beirut, Ras Beirut, Lebanon.
⁴ Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, the Netherlands.
⁵ Library Services, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
⁶ Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.
⁷ Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.
⁸ Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
⁹ Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹⁰ Centre for Clinical Trials and Methodology, Barts Institute of Population Health Science, Queen Mary University, London, United Kingdom.
¹¹ Department of Family Medicine, Western University, London, Ontario, Canada; Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
¹² National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom; Nottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, United Kingdom.
¹³ Lady Davis Institute for Medical Research, Jewish General Hospital, 4333 Cote Ste. Catherine Road, Montréal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.
¹⁴ Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada.

PMID: 34520851
DOI: 10.1016/j.jclinepi.2021.09.010

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 <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.

Keywords: Administrative data; CONSORT; CONSORT-ROUTINE; Randomized controlled trials; Reporting guideline; Routinely collected data.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Canada
Databases, Factual
Humans
Randomized Controlled Trials as Topic
Research Report*
United Kingdom

Abstract

Publication types

MeSH terms

Grants and funding