Proposed changes to the future definitive trial
RECRUITMENT
Survey branching logic was used to invite participants who indicated that a future definitive trial would be feasible with changes to design (38/98, 39% of respondents across all four surveys) to specify what changes they would make. This information was offered by 37 of the 38 respondents, who often described the intention to make more than one change.The most frequent change related to the intervention (17/37, 46%) with nine respondents describing how their intervention needed further development or refinement, eight suggesting that they would change their mode of intervention delivery, and two describing how more training would be provided to those delivering the intervention. Twelve respondents suggested that they would make changes to their recruitment strategy (12/37, 32%) including recruiting more sites, recruiting sites simultaneously rather than sequentially and altering the recruitment timeframe. Changes were also often described in relation to trial outcome measures (5/37, 14%), methods of data collection or follow-up (5/37, 14%), the patient population or eligibility criteria (4/37, 11%) and the overall trial design (4/37, 11%; e.g. adding or dropping arms, and moving to a cluster randomised design).