Table 3.
Progression criteria | Assessment of whether criteria have been met | Outcome and decision |
---|---|---|
1. Feasibility to recruit and retain sufficient participants to meet targets within timeframe |
Recruitment: percentage of eligible patients recruited; if > 30% recruited = proceed, if < 10% = unlikely to be feasible; if 10–30% = CI to consider feasibility of proceeding based on screening rate and possible steps to increase recruitment. Retention: percentage of participants retained; if > 80% = proceed, if < 60% = unlikely to be feasible, if 60–80% = CI to consider feasibility of proceeding based on available data and possible steps to increase retention. |
Recruitment: 45 were eligible (96 were screened); 16% of eligible patients (7% of those screened) were recruited. CI decision was ‘unlikely to be feasible’ based on lower than anticipated screening rate. Retention: 71% of participants starting the intervention were retained. CI decision was ‘unlikely to be feasible’ based on lower than anticipated screening and recruitment rates. |
2. Intervention adherence | Based on a hypothesised minimum dose; if > 80% = proceed, if < 70% = unlikely to be feasible, if 70–80% = CI to consider feasibility of proceeding based on available data. | Adherence was 72% (76 out of a possible 105 sessions completed) for all participants. Based on the 5 participants that did not drop-out, adherence was 97% (73 out of 75 sessions completed). CI decision was ‘proceed’ based on available data from participants that completed the study. |
3. Intervention is acceptable to participants | Intervention acceptability was considered by measuring FS, RPE, and EES responses. Aggregate values for proceed were as follows: FS = > 0, RPE < 15; EES = > 3. Values below these thresholds = CI to consider feasibility of proceeding based on magnitude of values. | Acceptability of the intervention was good (see Table 2). Decision was ‘proceed’. |
4. Randomisation processes acceptable to recruited participants | > 50% of recruited participants report agree about the acceptability of randomisation processes; the CI will apply discretion in judging whether this criterion has been met via discussion with participants. | Although planned, randomisation was not applied due to low recruitment. Control arm of the trial was abandoned. |
5. Outcome measures acceptable to participants | Percentages of participants reporting acceptability of outcome measures on self-report questions. If > 80% = proceed, if < 50% = unlikely to be feasible, if 50–80% = CI to consider feasibility of proceeding based on available data and possible steps to increase acceptability. | Five out of 5 participants (100%) who completed the intervention recorded all measures and self-reported them to be acceptable. Decision was ‘proceed’. |
Progression criteria based on Hawkins et al. [47]. Abbreviations: CI chief investigator, EES exercise enjoyment scale, FS feeling scale, RPE rating of perceived exertion