Statistical Analysis and Stop-Go Criteria
The study is not powered to detect efficacy. D-SSI feasibility is defined as at least an 85% completion rate. The full RCT proceeds if at least three of five predefined criteria are met. The minimum total sample size is 216 participants, b…
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The study is not powered to detect efficacy. D-SSI feasibility is defined as at least an 85% completion rate. The full RCT proceeds if at least three of five predefined criteria are met. The minimum total sample size is 216 participants, based on 54 participants per arm after allowing for 25% attrition. Post-intervention skill-use protocol feasibility is defined as 60% adherence. Failure to meet the stop-go threshold means the study will not proceed to a full trial.