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. 2014 Sep 17;2014(9):CD003115. doi: 10.1002/14651858.CD003115.pub4

Friedmann 2011.

Methods Randomised controlled trial
 2‐arm parallel group design
 Trial duration: 14 weeks
 Multicentre trial with 61 centres
 Power calculation reported
Participants Participants with moderate‐to‐severe osteoarthritis pain using NSAIDs or opioids were eligible
 412 participants were randomised
 412 participants with knee or hip osteoarthritis were reported at baseline
 Affected joints: 323 knees and 89 hips
 Number of females: 288 of 412 (70%)
 Mean age: 58 years
Interventions Experimental intervention 
 Oral extended‐release oxycodone (Remoxy), 5‐20 mg twice daily
Control intervention 
 Placebo, twice daily
Treatment duration: 12 weeks
 Unclear whether analgesics other than study drugs allowed
Outcomes Extracted pain outcome: global pain after 14 weeks
 No function outcome reported
 Primary outcome: change in pain intensity score
Notes Sponsor: Pain Therapeutics, King, Pfizer
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method used to generate random sequence of allocation was not reported, so the risk of selection bias was unclear
Allocation concealment (selection bias) Unclear risk Method used to conceal the random sequence of allocation was not reported, so the risk of selection bias was unclear
Described as double‐blind? Low risk Quote: "...a double‐blind, multicenter, placebo‐controlled trial..."
Blinding of patients? Unclear risk It was unclear if method used to blind participants was appropriate
Blinding of physicians? Unclear risk Physicians were not explicitly described as blinded, so the risk of performance bias was unclear
Blinding of outcome assessors? Unclear risk Because outcomes were self reported, and because it was unclear whether participants were properly blinded, it was unclear whether outcome assessors were blinded
Interventions reported as indistinguishable? High risk Interventions were not reported as indistinguishable
Double‐dummy technique used? Unclear risk Description of intervention is not detailed enough to assess whether double‐dummy technique was used
Intention‐to‐treat analysis performed? 
 Pain High risk 2 of 205 participants excluded in experimental group, 0 of 207 participants excluded in control group
Intention‐to‐treat analysis performed? 
 Function Unclear risk Not applicable, no function outcome reported