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. 2018 Feb 11;2018(2):CD001487. doi: 10.1002/14651858.CD001487.pub3

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%)
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
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
Outcomes Primary and secondary patency
5‐year follow‐up
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