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. 2020 Jan 23;32(12):2565–2585. doi: 10.1007/s40520-020-01475-6

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