Ahmedzai 1997.
Methods | Design: multicentre, randomised, open label, two‐period cross‐over study. Initial opioid dose calculated using manufacturers recommendations, with dose titration at start of each period to achieve pain control. Assessed at baseline and 8, 16, 23, 31 days, and by daily patient diary Duration: 2 x 15 days, no washout between periods + titration Setting: Palliative care centres, UK |
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Participants | Adult cancer patients requiring strong opioid analgesia and receiving stable dose of morphine for at least 48 hours Life expectancy > 1 month N = 202 M 112, F 90 Mean age 62 years (range 18 to 89) |
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Interventions |
MIR was used freely to titrate pain at the start of study and at cross‐over Where possible other medication remained unchanged, but other analgesics allowed: e.g. NSAIDs, permitted radiotherapy, nerve blocks |
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Outcomes | Sleep, rescue medication, drowsiness: VAS, daily diary Pain and mood: Memorial Pain Assessment Card, twice daily QoL (self‐rated): EORTC (European Organisation for Research and Treatment of Cancer) QLQ‐C30 Performance status (clinician rated): WHO scale Treatment preference Adverse events |
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Notes | Oxford Quality Score: R = 1, DB = 0, W = 1. Total = 2/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | 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 | High risk | Open study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open study |
Incomplete adverse event outcome data‐ patient level | Unclear risk | Presented as numbers of AEs but not clear whether this is events or participants. Denominator unclear. |
Selective reporting bias for adverse events | High risk | Only commonest events reported |
Size | Low risk | > 200 participants per treatment arm |