Hanks 1995.
Methods | Design: randomised, double blind (double dummy), two phase cross‐over study. Assessments x 4 on last day of each treatment phase Duration: 2 x 3 days Setting: |
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Participants | Advanced malignant disease with pain requiring at least 400 mg morphine/day N = 25 (19 completed) M 11, F 14 Mean age 56 years (range 35 ‐ 69) |
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Interventions |
Exact dose made up with standard CR morphine tablets (30 ‐ 100 mg), but dose remained constant throughout study Rescue medication: morphine elixir ≤ 1/6 total daily dose |
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Outcomes | PI: VAS Symptom score: categorical 4‐point. Scores taken x 4 on days 3 and 6 Use of rescue medication Morphine plasma concentrations in 4 participants |
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Notes | Oxford Quality Score: R = 1, DB = 2, W = 1. Total = 4/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "patients were randomised". Method used to generate sequence not clearly stated |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "double blind double dummy crossover ...." "identical tablets" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "double blind double dummy crossover ...." "identical tablets" |
Incomplete adverse event outcome data‐ patient level | Low risk | > 90% of participants included |
Selective reporting bias for adverse events | High risk | Selective reporting of AEs |
Size | High risk | < 50 participants per treatment arm |