Shimony 2016.
Methods | Study design: randomized controlled trial (2 arms) Study duration: not reported Study setting: hospital, single centre, Israel |
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Participants | Adults undergoing elective craniotomy for tumour resection (n = 100) Inclusion criteria
Exclusion criteria
Mean age, range (years)
Numbers allocated to each arm
Male gender
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Interventions |
Technique and timing
Dosage 150 mg per dose |
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Outcomes |
Primary
Secondary
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Notes |
Funding None |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization list |
Allocation concealment (selection bias) | High risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | It was clear how participants were blinded. Quote: ''patients in the placebo group were given identical capsules containing 500 mg of starch at the same time points''. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The trial was reported as 'double‐blinded' but it was not clear how investigations were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 12 participants were lost to follow‐up, 5 in the intervention group and 7 in the control group. The reasons were not clearly explained in the report with the CONSORT flowchart mentioning these as having (quote): ''dropped out''. However, the authors did perform an intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Low risk | Outcomes reported as specified |
Other bias | Unclear risk | Massive number of comparisons were made with no statistical adjustment for multiple testing. |