| Methods |
Method of randomisation: odd/even hospital number (patient randomised)
Not blind
Cross‐overs: shunt: 3 patients not shunted (analysed in original group)
Exclusions during trial: none
Loss to follow‐up: none |
| Participants |
USA
Shunt: 53 participants (63 operations)
No shunt: 65 participants (75 operations)
Age: range 40 to 79 years
Sex: unknown
Comparability: age, vascular risk factors, indication for operation, degree of stenosis in operated artery similar between treatment and control
More severe contralateral artery disease in shunt group: stenosis > 90% to 32% versus 19% |
| Interventions |
Treatment: Javid shunt
Control: no shunt
All operations done under general anaesthetic; no monitoring; primary closure |
| Outcomes |
Death plus stroke‐related death, any stroke (during operation, within 24 hours and 30 days of operation), ipsilateral stroke, haemorrhage from operation site, infection at operation site, nerve palsy |
| Notes |
Exclusions: none
Follow‐up: 30 days |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
Not reported |
| Allocation concealment (selection bias) |
High risk |
Not reported |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not reported |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not reported |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No missing data |
| Selective reporting (reporting bias) |
High risk |
Study authors did not report prespecified outcome |
| Other bias |
High risk |
Quote: "All CEs were performed by either the attending neurosurgeon or by a senior neurosurgical resident under direct supervision". No data showed the percentage of operations done by residents in each arm. Obviously residents had less experience than the attending physician, even though such operations were done under direct supervision. This might be a risk of bias, if there was a significant proportion of residents as operators in 1 group |
