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Table 2 Feasibility outcomes and key feasibility criteria

From: Feasibility of omega-3 fatty acid supplementation as an adjunct therapy for people with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

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.

 

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.

 

Time lost to exacerbation

Symptom diary.

 

Scientific

Supplement safety

Reported symptoms from supplement.

 

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.

 
  1. CRP, C-reactive protein; FEF25-75, forced expiratory flow between 25 and 75% of forced vital capacity; LCn-3PUFA, long chain omega-3 polyunsaturated fatty acid; RBC, red blood cell.