Tofigh 2007.
Methods | Site: AK Study design: RCT Method of randomisation: unclear Blinding: unblinded, intention to treat Exclusions post randomisation: none Losses to follow up: 6 (6%) |
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Participants | Country: France Setting: hospital No. of participants: 85 (103 limbs; 51 reversed vein, 52 polyester) Age (median): 69 yrs Sex: 49 males, 36 females Inclusion criteria: severe claudication, rest pain, tissue loss Exclusion criteria: patients with earlier bypass or un‐useable LSV |
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Interventions | 6 mm collagen‐impregnated woven polyester prosthesis and reversed vein graft Oral warfarin from one day pre‐op continued for 6 months. 38 mg aspirin afterwards |
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Outcomes | Primary and secondary patency 5‐year follow‐up |
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Notes | No medication compliance checks. Unclear randomisation | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description of randomisation technique |
Allocation concealment (selection bias) | Unclear risk | No clear description |
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 | Low risk | No losses, clear data |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Low risk | No obvious other source of bias |