1. Reporting transparency and completeness in trials: Paper 3 - Trials conducted using administrative databases do not adequately report elements related to use of databases
- Author
-
David Moher, Ole Fröbert, Lars G. Hemkens, Merrick Zwarenstein, Mahrukh Imran, Stephen J. McCall, Chris Gale, Brett D. Thombs, Margaret Sampson, Clare Relton, Kimberly A. Mc Cord, Linda Kwakkenbos, Edmund Juszczak, Sinead Langan, and Canadian Institutes of Health Research
- Subjects
Research Report ,Canada ,CONSORT ,Databases, Factual ,Epidemiology ,MEDLINE ,Administrative data ,computer.software_genre ,law.invention ,Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18] ,Experimental Psychopathology and Treatment ,Randomized controlled trial ,law ,Medicine ,Humans ,01 Mathematical Sciences ,11 Medical and Health Sciences ,Randomized Controlled Trials as Topic ,Not evaluated ,Database ,business.industry ,Reporting guideline ,CONSORT Extension for Trials Conducted Using Cohorts and Routinely Collected Data Group ,United Kingdom ,humanities ,Transparency (graphic) ,CONSORT-ROUTINE ,Randomized controlled trials ,business ,computer ,Routinely collected data - Abstract
Contains fulltext : 237435.pdf (Publisher’s version ) (Open Access) Objective: We evaluated reporting completeness and transparency in randomised 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
- Published
- 2022