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

Klinkert 2003.

Methods Site: Femoral to AK 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: 11 (7%)
Participants Country: the Netherlands
Setting: hospital
No. of participants: 136 (151 limbs; 75 Saphenous vein, 76 PTFE)
Age (median): 69 yrs
Gender: 88 males, 48 females
Inclusion criteria: severe claudication, rest pain, tissue loss
Exclusion criteria: patients with earlier bypass or previously removed long saphenous vein
Interventions 6 mm PTFE 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 compliance checks
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Unclear. No specific description
Allocation concealment (selection bias) Low risk Quote: "randomization took place with closed envelope allocation."
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 13 patients lost to long term follow up, clearly described
Selective reporting (reporting bias) Low risk All stated outcomes reported
Other bias Low risk Oral warfarin from one day pre‐op continued for 6 months. 38mg aspirin afterwards