Intentions reported in completed external randomised pilot trial results publications
| Data | Completed (n=37) n (%) |
| Progression criteria met | |
| All | 17 (46) |
| None | 4 (11) |
| Some | 13 (35) |
| Unclear | 3 (8) |
| Progression decision | |
| Proceed/future RCT is feasible | 30 (81) |
| With intended design | 0 (0) |
| With amendments | 28 (93) |
| Not reported whether changes will be made to definitive RCT design | 2 (7) |
| Funding intentions | |
| Funding for definitive RCT identified | 4 (13) |
| Non-industry | 3 (75) |
| Unclear | 1 (25) |
| Expected funding for definitive RCT not reported | 26 (87) |
| Timing intentions | |
| Time frame of expected progression reported | 1 (3) |
| Time frame of expected progression not reported | 29 (97) |
| Conduct further pilot/feasibility work | 4 (11) |
| Not proceed/future RCT is not feasible | 3 (8) |
| Justification reported for the progression decision reported | |
| Yes | 36 (97) |
| No | 1 (3) |
| Comment on data quality (eg, proportion of missing/incomplete data from questionnaires or results) | |
| Yes | 27 (73) |
| No | 10 (27) |
| Comment on refinement of hypotheses | |
| Yes | 1 (3) |
| No | 36 (97) |
| Published protocol available | |
| Yes | 16 (43) |
| No | 1 (3) |
| Alternative available (eg, trial registration or REC submission) | 20 (54) |
| Progression criteria in earlier trial record (protocol or registration) | |
| No change | 10 (28) |
| Yes change | 26 (72) |
| Reasons for change reported | 1 (4) |
| No reason for change reported | 3 (12) |
| Progression criteria were not reported in the earlier trial record | 22 (85) |
Percentages may not sum up to 100 due to rounding.
RCT, randomised controlled trial; REC, Research Ethics Committee.