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Table 4 Plan for analysis of secondary outcomes

From: Update of statistical analysis plan for: Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)

Outcome

Hypothesis

Outcome measure

Method of analysis

Number of cigarettes smoked

Reduction in number of cigarettes

Self-reported daily number of cigarettes smoked

t-test and regression methods with secondary outcomes as dependent variable adjusted for variables defined in Table 2

Carbon monoxide in exhaled air

Reduced CO levels

Carbon monoxide in ppm in exhaled air

C-reactive protein

Reduced levels

CRP in mg/L

Leucocyte count

Levels within reference limit

Leucocyte count in 109/L

Psychological well-being

Increased score

Hopkins Symptom Checklist (SCL-10)

Physical fitness

Increased score

4-min step test, number of steps

Quality of life

Increased score

EuroQoL EQ-5D-5L-questionaire

Fatigue

Less Fatigue

Fatigue Symptom Scale (FSS-3)

Dyspnoea

Less after intervention

Modified Medical Research Council (mMRC)-scale

Physical activity

Increased

Physical Activity Questionnaire (IPAQ)