Research progression criteria for feasibility outcomes
| Feasibility outcomes | Evaluation source | Decision/action to be taken† | ||
| Continue | Solve | Stop | ||
| Recruitment rate | Number recruited per month (n per group) | n≥3 (5) | n=2 (2) | n=1 (1) |
| Participant retention | Completion rates | ≥80% | 75%–79.9% | <75% |
| Programme adherence greater than 75% of sessions | Adherence rates | ≥75% | 50%–74.9% | <50% |
| Patients’ self-perceived relevance, timing and mode of delivery | Patient evaluations (positive) | ≥75% | 50%–74.9% | <50% |
| Assessment procedure* acceptance | Patient evaluations | ≥75% | 50%–74.9% | <50% |
| Adverse events, % discontinued | Patient journals and PainData | 0% | 0.1%–9.9% | ≥10% |
| Fidelity of delivery | Process evaluations | ≥90% | 50%–89.9% | <50% |
*Assessment procedure planned for the randomised controlled trial (RCT) included: (a) completion of PainData standard questionnaire with an attachment (developed for the project purposes) assessing sociodemographics, quality of life, pain self-efficacy, pain intensity, pain catastrophising, pain localisation and sleep quality; (b) interview-based assessment of occupational performance and participation; (c) measuring blood pressure, waist circumference and bioimpedance; (d) cuff algometry; and (e) actigraphy for physical wake time activity (see online supplemental appendix 4 for the assessment tools used).
†Colors correspond with the red ('Stop')-amber ('Solve')-green ('Continue') method.