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Table 2 Compliance

From: OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain—a statistical analysis plan

 

Opioid (n = xxx)

Placebo (n = xxx)

GP prescription daily dose of study medication — either opioid or placebo (mg/day)

Mean (95% CI), n

Mean (95% CI), n

 Week 1

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Week 2

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Week 3

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Week 4

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Week 5

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Week 6

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Cumulative dose (over entire treatment period)

xxx mgs

xxx mgs

Self-reported daily dose (mg/day)

Mean (95% CI), n

Mean (95% CI), n

 Week 1

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Week 2

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Week 3

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Week 4

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Week 5

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Week 6

xx.x (xx.x to xx.x), n

xx.x (xx.x to xx.x), n

 Cumulative dose

xxx mgs

xxx mgs

 Participants returning study medicines

n/N (%)

n/N (%)

Participants consuming ≥80% of prescribed dose

 Per participant medicine dairy

n/N (%)

n/N (%)

 Per returned medicines

n/N (%)

n/N (%)

Participants discontinuing study medication

 

n/N (%)

n/N (%)

Reasons for discontinuation

 Pain resolved

n/N (%)

n/N (%)

 Felt medicine was ineffective

n/N (%)

n/N (%)

 Others

n/N (%)

n/N (%)

Assessment of participant blinding (participant estimation)

 Opioid

n/N (%)

n/N (%)

 Placebo

n/N (%)

n/N (%)

 Do not know

n/N (%)

n/N (%)

  1. mg/day milligrammes per day