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Table 1 Progression criteria for RCT

From: A comparison of standard occupational therapy versus early enhanced occupation-based therapy in a medical/surgical intensive care unit: study protocol for a single site feasibility trial (EFFORT-ICU)

Domain Proceed with RCT Proceed with changes to protocol Do not proceed unless problem resolution
Recruitment Recruitment of 30 eligible patients within 6 months Recruitment of eligible patients within 6–12 months Unable to recruit 30 patients in 12 months
Retention Minimum of 75% retention to follow-up Minimum of 50 % retention to follow-up Less than 50% retention to follow-up
Completion of intervention At least 50% complete intervention for 40–60 min per day At least 50% complete intervention for 20–40 min per day Less than 50% complete intervention for 20 min per day
Outcome measures acceptability Able to administer 80% of the outcome measures at each time point Able to administer 80% of the outcome measures at each time point Able to administer 80% of the outcome measures at each time point
Adverse events No serious therapy-related adverse events during trial Less than 5 serious therapy-related adverse events during trial Five or more serious therapy-related adverse events during trial