Table 4.
Summary of criteria for progression to a definitive trial
| Criterion | Assessment | Conclusion |
|---|---|---|
| A minimum of 75% of patients had their surgeries within 10 days of the 4–8-week intervention window between visit 1 (usual care) or visit 3 (intervention), and pre-surgery (visit 4 or T2) | 36.67% (n = 11) patients had the pre-surgery visit (T2) between 18 and 66 days after their preceding study visit. However, of these, only n = 8 had surgeries that were scheduled in the week after this visit. This constitutes only 26.67% of those retained until T2 | This aspect was not feasible |
| Rate of uptake meets or exceeds 10% | The rate of uptake was 14.2% | This aspect was feasible |
| Participant retention rate exceeds 75% between baseline and pre-surgery visits | The retention rate at pre-surgery (T2) was 85.7% | This aspect was feasible |
| Study satisfaction must be ≥ 4/5, and risk of harm should be < 2/5, as assessed by the feasibility questionnaire given to participants | All these criteria were met at both T2 and T3. Overall mean satisfaction for both groups was 4.75. Risk of harm was assessed no higher than 1 by any participant | This aspect was feasible |
| The frequency of adverse events does not call into question the safety of the trial as determined by the medical expert on the study (ETD) | One adverse event occurred. This was classified as a serious adverse event, but it was not related to the study | This aspect was feasible |