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Understanding the applicability of results from primary care trials: lessons learned from applying PRECIS-2

Citation
Forbes G, Loudon K, Treweek S, Taylor S & Eldridge S (2017) Understanding the applicability of results from primary care trials: lessons learned from applying PRECIS-2, Journal of Clinical Epidemiology, 90, pp. 119-126.

Abstract
Objective 

To compare two approaches for trial teams to apply PRECIS-2 to pragmatic trials: independent scoring and scoring following a group discussion. 
Study Design and Setting 
We recruited multidisciplinary teams who were conducting or had conducted trials in primary care in collaboration with the Pragmatic Clinical Trials Unit, Queen Mary University of London. Each team carried out two rounds of scoring on the 9 PRECIS-2 domains: first independently using an online version of PRECIS-2 and secondly following a discussion. 
Results 
Seven teams took part in the study. Prior to the discussion within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved following the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, though some domains were more pragmatic than others. 
Conclusion 
PRECIS-2 can facilitate information exchange within trial teams. To apply PRECIS-2 successfully we recommend a discussion between those with detailed understanding of: what usual care is for the intervention, the trial’s design including operational and technical aspects, and the PRECIS-2 domains. For some cluster randomised trials greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and one at the cluster level.

Keywords
Randomized controlled trials; Clinical trial methodology; Pragmatic trial; primary care; Trial design

StatusPublished
AuthorsForbes Gordon, Loudon Kirsty, Treweek Shaun, Taylor Stephanie, Eldridge Sandra
Publication date10/2017
Publication date online17/06/2017
Date accepted by journal12/06/2017
PublisherElsevier
ISSN 0895-4356
LanguageEnglish

Journal
Journal of Clinical Epidemiology: Volume 90

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