Progression criteria | Monitored how | Actions | ||
---|---|---|---|---|
Green | Amber | Red | ||
Recruitment | Continuously throughout the project period, simple count of inclusions every 2 weeks | 3–4 patients per MDT: continue | 2–3 patients per MDT: look into motivational efforts and reminder information to raise referral rates | < 2 patients per MDT: use MDT time slot to make adjustments (e.g. can nurses also refer? Allow patient self-referral?) |
Adherence to protocol | Every 3 months, assess if there are uncertainties too great to continue (e.g. impossible to keep time schedule in MDT, technical issues like video conference not working) | All or close to all process indicatorsa are being followed: continue | 2–10 process indicators are not being followed: consider revising protocol. If time schedule in MDT is not kept, downscaling to 3 patients per MDT might be necessary | > 10 process indicators are not being followed: consider pausing the project in order to evaluate and redesign intervention |
Data completeness | Every 6 months, evaluate if the data collection is complete enough. Missing answers in surveys? Unable to retrieve certain register data? | > 80% data completeness: continue | 70–80% data completeness: make efforts to collect missing data (e.g. contacting participants) | < 70% data completeness: consider revising protocol. Can data be obtained otherwise? Can data be excluded from study? |
Participant retention | Every 6 months, register how many participants lost to follow-up. Simple count and register reason if known (e.g. death, unwilling to participate) | Loss to follow-up caused by death, change of mind, or unable to participate will of course be accepted | If not returning questionnaire at 6-month follow-up, then contact by phone to remind and encourage | If < 75% complete follow-up, then look into protocol amendments |