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

Research output: Contribution to journalArticlepeer-review

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 languageEnglish
Number of pages25
JournalJournal of Clinical Epidemiology
Early online date11 Sep 2021
DOIs
Publication statusE-pub ahead of print - 11 Sep 2021

Keywords

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

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