Research progression criteria summary
| Research progression criteria | Total‡ | Feasibility rounds‡ | Evaluation | Considerations and comments | ||
| 1.0 | 2.0 | 3.0 | ||||
| Recruitment rate (mean number recruited (referred) per month; n per group) | 5.7 (17.5) 5 (4–6) | 6.7 (28.0) 5 (4–5) | 4.3 (13.3) 5 (5) | 6.7 (27.3) 5 (5*–6) | Amber/solve | Recruitment n≥3 per month did not guarantee a minimum of 5 in all groups, despite mean 5 per group. With the current recruitment intensity, the recruitment must begin at least ≥2 months before baseline assessment. |
| Participant retention† (n (total), %) | 31 (40) 77.5% | 9 (9) 100% | 10 (11) 90.9% | 12 (20) 60.0% | Green/continue | The lockdown affected the participant retention negatively, solutions allowing the intervention to continue during force majeure situations shall be considered; follow-up assessment completion needs to be secured. |
| Programme adherence greater than 75% of sessions, % mean (range) | 77.5% (38.5–100) | 77.8% (57.1–92.9) | 81.8% (44.4–100) | 75.0% (38.5–100) | Green/continue | Adherence ≤50% of the sessions can occur in few participants and needs attention; self-assessments demand more effective procedure. |
| Patients’ self-perceived relevance, timing and mode of delivery (% mean) | 97.0% (91.9–100) | 94.5% (87.3–100) | 96.3% (89.6–100) | 98.4% (92.5–100) | Green/continue | Continuous monitoring is useful; personal preferences may appear; sufficient time for peer discussions shall be provided; afternoon groups may be relevant for some participants. |
| Assessment procedure acceptance (n, %) | 38 (40) 95.0% | 9 (9) 100% | 9 (11) 81.8% | 20 (20) 100% | Green/continue | The assessment procedure may need the assessment load reduction; further evaluation of the outcomes may support the improvements; assessment performance needs closer monitoring for timely completion. |
| Adverse events (% caused discontinuation) | 0% | 0% | 0% | 0% | Green/continue | Several participants experienced discomfort from cuff algometry, though none was at health risk or discontinued. |
| Fidelity of delivery (n, % evaluations collected; % contents delivered as planned) | 80.1% 194 (233) 83.3% | 60.7% 28 (37) 75.0% | 100% 14 (23) 60.9% | 100% 152 (173) 87.9% | Amber/solve | Peer support component may be a barrier in the fidelity of delivery, exceeding the protocolised time of delivery; the intervention providers need flexibility, for example, extra calendar space for new appointments/other problem solving. |
*One participant stopped after baseline assessment.
†Exclusive 17 participants who discontinued involuntarily due to the COVID-19 lockdown.
‡Colors correspond with the red ('Stop')-amber ('Solve')-green ('Continue') method.