Roth 2000.
Methods | RCT followed by open‐label case series Duration: 14 day RCT plus 12 month case series; total 12.5 months | |
Participants | N = 133 enrolled in RCT, 106 remained for long‐term follow up
Primary condition: Osteoarthritis Baseline pain score: Mean 2.5 (SD 1.2)/3 Likert scale (0 being no pain, 3 being severe pain) Time since onset: Mean 9 years Mean age: 62 years (Range 32 to 90) Female: 73.3% Previous opioid analgesics: Not reported |
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Interventions | Oral controlled‐release oxycodone Dose: 20 or 40 mg/day, divided Supplemental analgesics: NSAIDS were allowed to continue if dose was stable for 1 month prior to enrolment and not changed during the study. No other analgesics, including opioids or rescue analgesics, were allowed. |
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Outcomes | Discontinuation due to adverse events Discontinuation due to insufficient pain relief Pain, continuous/categorical | |
Notes | Both RCT and open‐label continuation are reported on in this citation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Comparability of patients at baseline and follow‐up (continuous data) All outcomes | Unclear risk | Due to attrition |
Selection method random or consecutive | Unclear risk | Not reported |
Prospective | Low risk | Prospective |
Free from confounding treatment(s) | High risk | Use of analgesics other than NSAIDS prohibited |
Patient compliance monitored and reported at at least 85%? | Unclear risk | Not reported |
Attrition and right censoring less than 15% (continuous data) All outcomes | High risk | Greater attrition |
Funding from a source without financial conflict of interest? | High risk | Funding by Perdue Pharma LP |