Devine 2004.
| Methods | Site: Femoral to AK and BK popliteal Study design: RCT Method of randomisation: concealed randomisation using computer generated randomisation envelopes Blinding: unblinded, intention to treat Exclusions post randomisation: none Losses to follow up: none |
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| Participants | Country: UK Setting: hospital No. of participants: 209 (AK: 88 PTFE, 91 HBD; BK: 15 PTFE, 15 HBD) Age (mean): 63 yrs Sex: 142 males, 67 females Inclusion criteria: severe claudication, SFA occlusion with one to three runoff vessels Exclusion criteria: emergency surgery for trauma, acute thrombosis, embolism, or popliteal artery thrombosis Symptoms not sufficiently severe to disrupt lifestyle or ABI > 0.8 at rest (unless aneurysm), the diagnosis or treatment for malignancy within 12 months including all cases with residual malignancy being followed up or observed, hospital inpatient treatment for cardiac failure in the previous 6 months, where adequate follow‐up would be impossible to arrange because the patient lived or was moving to an area where independent follow up could not be arranged |
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| Interventions | HBD or PTFE (diameter at discretion of operating surgeon) Anticoagulation not stated |
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| Outcomes | Primary patency | |
| Notes | Anticoagulation not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization, stratified for AK or BK and by surgeon, was performed for eligible patients, using a dedicated computer program." |
| Allocation concealment (selection bias) | Low risk | Quote: "Sealed randomization envelopes (1 for AK, 1 for BK) were delivered to the vascular surgeon before surgery." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Operative blinding impossible in this type of trial |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors and patients not obviously blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No losses, but numbers at risk not given for below knee outcomes so attrition not clear for this outcome |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | Unclear risk | Anticoagulation protocol not stated |