Outcome | Outcome measure | Key feasibility criteria |
---|---|---|
Process | ||
Recruitment rate | Number of participants recruited per week. | Recruit 40 participants in 52 weeks. |
Retention rate | Number of participants completing the intervention. | Complete the intervention in 80% of all recruited participants. |
Supplement adherence rate | Symptom diary. | Â |
Change in RBC total LCn-3PUFA content. | ≥2% change in total RBC LCn-3PUFA. | |
Capsule count at study completion. | ≥80% of capsules consumed. | |
Refusal rate | Number of identified volunteers who decline to participate/randomize. | Â |
Time lost to exacerbation | Symptom diary. | Â |
Scientific | ||
Supplement safety | Reported symptoms from supplement. | Â |
Estimate effect size | Listed scientific outcomes. | A positive moderate effect size (≥0.2) in at least CRP, dyspnea and FEF25-75. |
Estimate variance | Standard deviations of listed outcomes. | Â |