Graham 2006.
Study characteristics | ||
Methods | Pilot randomised controlled trial 8 recruiting centres Study duration: 14 days |
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Participants | 20 participants with malignant spinal cord compression (MSCC) Inclusion criteria:
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Interventions | High‐dose: 96 mg dexamethasone intravenously day 0, continued to day 2 then weaned to 0 by day 15 or Low‐dose: 16 mg dexamethasone intravenously day 0, continued to day 2 then weaned to 0 by day 15 Radiotherapy in both arms |
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Outcomes | Visual analogue pain score (0 to 10) Toxicity (method not specified) Survival Ambulation and functional outcome (method not specified) |
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Notes | High‐dose versus low‐dose dexamethasone study terminated because of inadequate recruitment No significant difference in pain in the first week Analgesic use tended to be lower in high dose arm Pilot study, not powered for outcome, descriptive analysis Pain one of several endpoints |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients randomised via the Superdex website |
Allocation concealment (selection bias) | Low risk | Website protected with password unique to each investigator |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Physicians were provided with patient's assigned treatment |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Physicians were provided with patient's assigned treatment |
Incomplete outcome data (attrition bias) All outcomes | High risk | 4 out of 20 patients not evaluable |
Selective reporting (reporting bias) | Low risk | None detected |
Other bias | High risk | Sample size: 20 participants (pilot study); < 50 participants per treatment arm |