PT  - JOURNAL ARTICLE
AU  - Katie Mellor
AU  - Saskia Eddy
AU  - Nicholas Peckham
AU  - Christine M Bond
AU  - Michael J Campbell
AU  - Gillian A Lancaster
AU  - Lehana Thabane
AU  - Sandra M Eldridge
AU  - Susan J Dutton
AU  - Sally Hopewell
TI  - Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting
AID  - 10.1136/bmjopen-2020-048178
DP  - 2021 Jun 01
TA  - BMJ Open
PG  - e048178
VI  - 11
IP  - 6
4099  - http://bmjopen.bmj.com/content/11/6/e048178.short
4100  - http://bmjopen.bmj.com/content/11/6/e048178.full
SO  - BMJ Open2021 Jun 01; 11
AB  - Objectives Prespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports.Study design Methodological review.Methods We searched four journals through PubMed: British Medical Journal Open, Pilot and Feasibility Studies, Trials and Public Library of Science One. Eligible publications reported external randomised pilot trial protocols or results, were published between January 2018 and December 2019 and reported progression criteria. We double data extracted 25% of the included publications. Here we report the progression criteria characteristics.Results We included 160 publications (123 protocols and 37 completed trials). Recruitment and retention were the most frequent indicators contributing to progression criteria. Progression criteria were mostly reported as distinct thresholds (eg, achieving a specific target; 133/160, 83%). Less than a third of the planned and completed pilot trials that included qualitative research reported how these findings would contribute towards progression criteria (34/108, 31%). The publications seldom stated who established the progression criteria (12/160, 7.5%) or provided rationale or justification for progression criteria (44/160, 28%). Most completed pilot trials reported the intention to proceed to a definitive trial (30/37, 81%), but less than half strictly met all of their progression criteria (17/37, 46%). Prepublication peer reviewer reports were available for 153/160 publications (96%). Peer reviewer reports for 86/153 (56%) publications mentioned progression criteria, with peer reviewers of 35 publications commenting that progression criteria appeared not to be specified.Conclusions Many external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial.Data are available upon reasonable request. Data from this review will be included in a DPhil thesis published open access through the Oxford University Archive upon KM’s DPhil completion.