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Table 1 Summary of feasibility and clinical outcome measures and key criteria

From: Fish oil supplementation in chronic obstructive pulmonary disease: feasibility of conducting a randomised controlled trial

Outcome

Outcome measure

Key criteria

Feasibility

 Recruitment rate

n participants enrolled in 52 weeks

40 participants enrolled after 52 weeks.

 Retention rate

n participants completing intervention

80% of all enrolled participants to complete

 Supplement adherence rate

Change in RBC LCn-3PUFA content (expressed as percentage of total fatty acids)

Capsule count at study completion

≥ 2% increase in percent of LCn-3PUFA in RBC

≥ 80% of capsules consumed

 Refusal rate

n identified volunteers who decline to participate/be randomised

 

 Time lost to exacerbation

n days, self-reported exacerbation

 

Clinical (proposed in original protocol)

 Safety

Reported symptoms from supplement

 

 Effect size

Inflammatory biomarkers, spirometry, impulse oscillometry (IOS), gas transfer and plethysmography, dyspnoea (Dyspnoea-12 questionnaire and visual analogue scale), functional exercise capacity (six-minute walk test), and well-being (hospital anxiety and depression scale (HADS) and chronic respiratory questionnaire (CRQ))

A positive moderate effect size (≥ 0.5) for at least CRP, dyspnoea and FEF25–75.

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