AbuRahma 2010.
| Study characteristics | ||
| Methods | Method of randomisation: unknown Concealment: sealed envelopes that were opened just before surgery Blinding: not reported Cross‐overs: none (ITT analysis) Exclusions during trial: none Loss to follow‐up: none | |
| Participants | USA 200 participants, 200 operations Routine shunting: 98 operations Selective shunting: 102 operations Age: 45 to 89 years, mean 68 years Gender: 48% male, 52% female Comparability: age, gender, vascular risk factors similar between 2 groups More asymptomatic ipsilateral arteries in routine shunting group: 58% versus 53% Contralateral artery stenosis (mean %) routine shunting group: 38%; selective shunting group: 40% | |
| Interventions | Treatment: selective shunting group; shunt selected if systolic stump pressure < 40 mmHg Control: routine shunting group All operations under general anaesthetic; unknown patching rate | |
| Outcomes | TIA, stroke, combined stroke/TIA, death, bleeding, myocardial infarction, congestive heart failure, asymptomatic carotid thrombosis, recurrent laryngeal injury, all complications, number of shunted arteries | |
| Notes | Exclusion: none Follow‐up: 30 days | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "200 CEA patients were randomised into" However, the randomised method was unknown. |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomization was done using sealed envelopes that were open just before surgery". |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up in either group |
| Selective reporting (reporting bias) | Unclear risk | Study authors did not report prespecified outcome. |
| Other bias | Low risk | No other potential biases |