Table 1 Research progression criteria for continuing to the definitive randomized controlled trial
Outcome | Green | Amber | Red |
|---|---|---|---|
Participant recruitment | Inclusion rate of at least 1.25 participant per week (approximately n = 5 per month) | (n < 4 after first month). If recruitment rate falls behind, reasons for exclusion will be explored after the first month to adjust eligibility criteria | No recruitment after 2 months |
Completion of the outcome measures | Mean < 60 min to complete all objective outcome measures and that participants found duration acceptable | Mean < 90 min to complete all objective outcome measures | > 90 min to complete all objective outcome measures |
Participant retention | Ten or more participants attend at 12-week follow-up | Only 6–9 participants attend to 12-week follow-up | Below 6 participants attend to 12-weeks follow-up |
Adherence to intervention | Minimum 75% of participants adhering to at least 75% of the intervention sessions | Only 50–75% of participants adhering to 2–3 of intervention sessions | < 50% of participants adhering to intervention sessions |
Adverse events | No or minor adverse events and no participants discontinuing the study | Minor or serious adverse events leading to 2 or less participants discontinuing the study | Serious adverse events leading to > 2 participants discontinuing the study |