Gordon Forbes1, Kirsty Loudon2, Shaun Treweek3, Stephanie J C Taylor4, Sandra Eldridge4. 1. Centre for Primary Care and Public Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London E1 2AB, UK. Electronic address: g.forbes@qmul.ac.uk. 2. Nursing, Midwifery and Allied Health Professions Research Unit, University of Stirling, Stirling FK9 4LA, UK. 3. Health Services Research Unit University of Aberdeen Health Sciences Building, Foresterhill, Aberdeen AB25 2ZD, UK. 4. Centre for Primary Care and Public Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London E1 2AB, UK.
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 nine PRECIS-2 domains: first independently using an online version of PRECIS-2 and second following a discussion. RESULTS: Seven teams took part in the study. Before the discussion, within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved after the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, although 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-randomized trials, greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and another at the cluster level.
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 nine PRECIS-2 domains: first independently using an online version of PRECIS-2 and second following a discussion. RESULTS: Seven teams took part in the study. Before the discussion, within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved after the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, although 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-randomized trials, greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and another at the cluster level.
Authors: Jennifer A Palmer; Vincent Mor; Angelo E Volandes; Ellen McCreedy; Lacey Loomer; Phoebe Carter; Faye Dvorchak; Susan L Mitchell Journal: Trials Date: 2018-08-22 Impact factor: 2.279
Authors: Charles A Brunette; Stephen J Miller; Nilla Majahalme; Cynthia Hau; Lauren MacMullen; Sanjay Advani; Sophie A Ludin; Andrew J Zimolzak; Jason L Vassy Journal: Clin Transl Sci Date: 2019-12-18 Impact factor: 4.689