Consolidated Standards of Reporting Trials (CONSORT) extensions covered most types of randomized controlled trials, but the potential workload for authors was high

Abstract

ObjectivesOur aim was to determine the coverage of randomized controlled trials (RCTs) by the Consolidated Standards of Reporting Trial (CONSORT) Statement and its extensions and to evaluate the potential workload for authors to adhere to the guidelines. Study Design and SettingWe identified CONSORT extensions from the CONSORT Web site. We randomly selected a sample of 1,000 RCTs indexed in PubMed in 2016 and recorded whether they were covered by CONSORT extensions for specific study designs or interventions. We evaluated the potential workload for authors by counting the number of documents and pages they have to consult to have a full understanding of the guidelines. ResultsWe identified 14 extensions. Only one extension was updated concurrently with the main CONSORT in 2010, three were updated after 2–7 years, and three are still based on CONSORT 2001. Overall, 81% of RCTs are covered by relevant CONSORT guidelines; missing extensions for specific study designs were under development at the time of the search (Nov 2018). However, 6 of 10 extensions covered <2% of the trials. A median [Q1–Q3] of 4 [4–5] documents and 67 [57–78] pages should be consulted. ConclusionMost RCTs indexed in PubMed are covered by the CONSORT Statement and extensions, but the potential workload for authors could be high.