Shaun Treweek1, Kirsty Loudon. 1. Quality, Safety & Informatics Research Group, University of Dundee, Kirsty Semple Way, Dundee DD2 4BF, UK. streweek@mac.com
Abstract
OBJECTIVES: To review the reporting of key items of recruitment information in trial reports and estimate the number needed to screen to recruit one additional participant. STUDY DESIGN AND SETTING: Review of breast cancer trials published in the years 2003-2005, 2007, and 2008. RESULTS: The search identified 1,570 potentially eligible studies. After a random selection of 20% from each year and checking against inclusion criteria, a total of 207 studies were included in the review. Some items of information were well reported, such as the number included in the analysis. Sample size calculations were often not presented, but reporting is slowly improving. Who recruits participants and how many individuals were screened are often not reported. The median number needed to screen to recruit one additional participant was two (range, 1-593). CONCLUSIONS: Without reporting the when, where, by whom, and how many of recruitment, trialists deny readers part of the contextual description they need to judge whether a trial's results are applicable to their own situation. Trialists and journal editors need to be more diligent in following the reporting recommendations of the Consolidated Standards of Reporting Trials statement.
OBJECTIVES: To review the reporting of key items of recruitment information in trial reports and estimate the number needed to screen to recruit one additional participant. STUDY DESIGN AND SETTING: Review of breast cancer trials published in the years 2003-2005, 2007, and 2008. RESULTS: The search identified 1,570 potentially eligible studies. After a random selection of 20% from each year and checking against inclusion criteria, a total of 207 studies were included in the review. Some items of information were well reported, such as the number included in the analysis. Sample size calculations were often not presented, but reporting is slowly improving. Who recruits participants and how many individuals were screened are often not reported. The median number needed to screen to recruit one additional participant was two (range, 1-593). CONCLUSIONS: Without reporting the when, where, by whom, and how many of recruitment, trialists deny readers part of the contextual description they need to judge whether a trial's results are applicable to their own situation. Trialists and journal editors need to be more diligent in following the reporting recommendations of the Consolidated Standards of Reporting Trials statement.
Authors: Rafael Dal-Ré; David Moher; Christian Gluud; Shaun Treweek; Jacques Demotes-Mainard; Xavier Carné Journal: PLoS Med Date: 2011-12-27 Impact factor: 11.069
Authors: Shaun Treweek; Erna Wilkie; Angela M Craigie; Stephen Caswell; Joyce Thompson; Robert J C Steele; Martine Stead; Annie S Anderson Journal: Trials Date: 2013-12-18 Impact factor: 2.279
Authors: Mary Pegington; Judith E Adams; Nigel J Bundred; Anna M Campbell; Anthony Howell; Sacha J Howell; Shaun Speed; Jane Wolstenholme; Michelle N Harvie Journal: Integr Cancer Ther Date: 2017-01-23 Impact factor: 3.279