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

Abbot 1997.

Methods Site: Femoral to AK popliteal
Study design: Multicentre RCT
Method of randomisation: central randomisation, but exact method unclear
Blinding: unblinded, intention to treat
Exclusions post randomisation: not discussed
Losses to follow up: high rate of losses to follow‐up (37 within first 12 months of follow‐up)
Participants Country: USA
Setting: multicentre
No. of participants: 231 patients (240 limbs; 122 PTFE, 118 Dacron)
Age: mean 67.1 yrs
Sex: 145 male, 95 female
Inclusion criteria: angiographically demonstrated superficial femoral artery occlusion with reconstitution of a popliteal segment above the knee
Exclusion criteria: earlier infrainguinal vascular procedures
Unclear whether patients had IC or critical ischaemia
Interventions PTFE versus Dacron (diameter at discretion of operating surgeon)
Outcomes Primary patency, secondary patency, peri‐operative complications
Notes 13 patients randomised but not described. Unclear how many patients had post‐op aspirin
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients were randomised centrally after eligibility was determined by the operating surgeon and informed consent obtained."
Allocation concealment (selection bias) Unclear risk Not specifically stated. Probably not done
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 High risk 37 patients randomised lost by 12 months
Selective reporting (reporting bias) Low risk All stated outcomes reported
Other bias Unclear risk Anticoagulation protocol not stated