Brilstra 2000.
Methods | Method of randomisation: sealed envelopes Blinding of outcome assessment: no Analysis: intention to treat Excluded participants: 9 prior to randomisation Cross‐over cases: no Losses to follow‐up: at 1‐year follow‐up: 2 participants in the endovascular coiling group and 2 participants in the neurosurgical clipping group Definition of outcomes: stated |
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Participants | Location: University Medical Centre Utrecht and St Elisabeth Hospital Tilburg, The Netherlands Coiling: 10 (men: 3 (30%)) Clipping: 10 (men: 3 (30%)) Age range: 35–75 years Entry criteria: documented aneurysmal SAH by either CT or DSA within the preceding 4 days, clinical state justifying treatment, aneurysm suitable for both treatment modalities Comparability of treatment groups: good for major prognostic factors Clinical grade on admission:
Aneurysm location:
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Interventions | Endovascular coiling Neurosurgical clipping |
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Outcomes | Clinical outcomes: dependency and death at 1‐year follow‐up (Rankin score 3–6), rebleeding, epilepsy, quality of life at 1 year and neuropsychological outcomes Additional measures: cost‐effectiveness |
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Notes | Exclusion criteria: the logistic conditions for early operation could not be fulfilled Follow‐up duration: 3 months and 1 year |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used a computer‐generated list |
Allocation concealment (selection bias) | Low risk | Allocation concealment performed by sealed envelopes that were not within reach of the treating physician. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants of personnel was not possible due to the characteristics of the interventions. However, review authors judged that the risk of performance bias was low. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Participants or their carers interviewed by telephone to assess functional outcome 3 months after SAH and 12‐month functional outcome assessed at outpatients clinic by a neurologist or by a neurosurgeon who had not operated on the participant. Unclear whether blinding was performed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Data complete for all outcomes |
Selective reporting (reporting bias) | Low risk | Study protocol not available but it was clear that the obtained data include all expected outcomes, including those that were prespecified. |
Other bias | Low risk | Other sources of bias not identified |