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 |
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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 |
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Interventions |
Rescue medication: 10 mg severedol every 2 ‐ 4 hours, as required Concomitant medication recorded |
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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 |
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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 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 |