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. 2014 May 29;2014(5):CD011056. doi: 10.1002/14651858.CD011056.pub2

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
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)
Interventions
  1. Transdermal fentanyl patch, new patch every 72 hours

  2. Sustained release oral morphine, given 12‐hourly


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
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
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