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

Aalders 1992.

Methods Site: Femoral to AK popliteal
Study design: Single‐centre RCT
Method of randomisation: sealed envelopes
Blinding: unblinded, intention to treat
Exclusions post randomisation: none
Losses to follow up: none
Participants Country: Holland
No. of participants: 85 patients(93 limbs; 46 PTFE, 47 HUV)
Age: 64 yrs
Sex: 67 male, 18 female
DM 16, critical 17
 Inclusion criteria: AK femoro‐popliteal graft for IC (or limb salvage if vein unavailable)
Exclusion criteria: those with previous femoro‐popliteal graft
Interventions 6 mm PTFE versus 6 mm HUV
Outcomes Primary patency, secondary patency, complications
Notes All had post‐op anticoagulants
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Random permuted blocks"
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 Unclear risk Some patients lost to follow‐up early on, but clear life table data
Selective reporting (reporting bias) Low risk All stated outcomes reported
Other bias Low risk No other obvious bias