Vecht 1989.
Study characteristics | ||
Methods | Randomised, multi‐centre controlled trial Study duration: 1 week |
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Participants | 37 participants (22 high‐dose, 15 low‐dose) with metastatic spinal cord compression (SCC) | |
Interventions | High‐dose: 100 mg dexamethasone dissolved in glycerol and water Low‐dose: 10 mg dexamethasone dissolved in glycerol and water, both delivered immediately following diagnosis of SCC by myelography |
|
Outcomes | NRS for pain (0 to 10) Ambulatory status (grade 1, walking independently – grade 5, no power in legs) Bladder function |
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Notes | High‐dose versus low‐dose dexamethasone plus radiotherapy for SCC No difference seen in pain, ambulation or bladder function |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised Not specified how the random sequence was generated 22 patients received high‐dose and 15 low‐dose (no explanation given) |
Allocation concealment (selection bias) | Low risk | Coded ampoules blindly administered |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Code broken by statistician at final analysis |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Code broken by statistician at final analysis |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 40 patients randomised, 3 had insufficient data for analysis |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | High risk | Sample size: 37 participants; < 50 participants per treatment arm |