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

van Seventer 2003.

Methods Design: multicentre, randomised, open label, parallel group study. Assessements by investigator and participant at baseline, 7 and 28 days. Participants also kept a daily diary
Duration: 4 weeks
Setting: Community
Participants Moderate‐severe cancer‐related pain requiring opioid treatment, with life expectancy ≥ 3 months. Participants could be opioid naïve or using opioids for mild‐to‐moderate pain before entry. Participants using opioids for moderate‐to‐severe pain in 30 days preceding study entry were excluded
N = 131
M 85, F 46
Mean age 65 (±12) years
Interventions
  1. Transdermal fentanyl, initially 25 μg/h every 72 hours, (dose increments of 25 μg/h to achieve adequate pain control) n = 67

  2. Sustained release oral morphine, initially 30 mg every 12 hours (dose increments of 30% ‐ 50% 12 hours after previous administration to achieve adequate pain control), n = 64


Rescue medication: 10 mg severedol every 2 ‐ 4 hours, as required
Concomitant medication recorded
Outcomes Pain control: Shortened Wisconsin brief pain inventory: 11‐point scale (0 = no, 10 = extreme), daily
Global assessment of pain relief, sleep, interruption of daily activities and caregiver's activities, troublesome side effects: 4‐point scale (1 = not at all, 4 = very much) at start and 28 days
Overall assessment: 11‐point scale (0 = very poor, 10 = very good)
Constipation: questionnaire (bowel function normal, constipated, diarrhoeal) at start, 7 and 28 days
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 not adequately described but states "centrally randomised"
Allocation concealment (selection bias) Unclear risk Method not adequately described but states "centrally randomised"
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 Low risk <90% participants included
Selective reporting bias for adverse events High risk Selective reporting of most serious or most frequent
Size Unclear risk 50 ‐ 200 participants per treatment arm