Brewer 1982.
Methods |
Allocation: randomised Blinding: double‐blind Controlled: active comparator Centre: multicentre Arm: 2 arms, parallel groups |
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Participants |
Inclusion criteria: children with juvenile rheumatoid arthritis Exclusion criteria: unstated Baseline characteristics N = 99 Age: range unstated; mean age 8.5 years Gender: male (23); female (76) Number randomised: fenoprofen (49); aspirin (50) Number completed: fenoprofen (47); aspirin (40) Setting and location: multicentre, location unstated |
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Interventions |
Intervention group (N = 49): aspirin 1500 mg/m2/day increased to 3000 mg/m2/day, maximum 5450 mg/day Control group (N = 50): fenoprofen 900 mg/m2/day increased to 1800 mg/m2/day, maximum 3200 mg/day Study duration: 12 weeks |
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Outcomes |
Primary outcomes
Secondary outcomes
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Notes | Sources of funding: unstated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "99 patients were randomized into the study" Comment: No information regarding method of randomisation |
Allocation concealment (selection bias) | Unclear risk | Quote: Insufficient information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "capsules containing either fenoprofen or ASA were white opaque size #2 for the 0.5 to 0.75m2 groups, and white opaque size #1 for the 0.76m2 and over groups. Therefore it was impossible to determine which drug the subjects were receiving by observing capsule size, colour, or administration regimen" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Insufficient information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: All participants were accounted for. Lost to follow‐up and withdrawals explained. However, authors do not report whether there were significant differences between completers and non‐completers. |
Selective reporting (reporting bias) | Unclear risk |
Quote: "all investigators used an identical protocol and case report forms" Comment: No outcomes were not set out in the methods. Unable to locate protocol. |
Size | High risk | Comment: Total participants = 99 (< 50 per treatment arm) |
Other bias | Low risk | Comment: No other potential sources of bias found. |