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

Scharn 2008.

Methods Site: AK
Study design: RCT
Method of randomisation: controlled by the BOA‐trial agency using a dedicated computer program
Blinding: unblinded, intention to treat
Exclusions post randomisation: 8 (6%)
Losses to follow up: 13 (9%)
Participants Country: the Netherlands
Setting: hospital
No. of participants: 137 (137 limbs with 8 excluded; 59 HBD, 70 HUV)
Age (median): 65 yrs
Sex: 87 males, 50 females
Inclusion criteria: severe claudication, rest pain, tissue loss
Exclusion criteria: patients younger than 30 or older than 90 yrs of age; patients with an ABI higher than 0.8 at rest, emergency surgery for trauma, acute thrombosis or embolism of the popliteal artery, the diagnosis or treatment for malignancy within 12 months, hospital in‐patient treatment for cardiac failure in the previous 6 months, the absence of the possibility for adequate follow up or contraindications for anticoagulant drug therapy
Interventions Heparin bonded Dacron and HUV (diameter at discretion of operating surgeon)
Aspirin 80 mg daily or coumarin derivates (Sintrom)
Outcomes Primary patency. 5‐year follow‐up
Notes No consistent anticoagulation protocol. No compliance checks
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was controlled by the BOA‐trial agency using a dedicated computer program."
Allocation concealment (selection bias) Low risk Not specifically stated but assumed done as BOA‐trial agency involved
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 life table data
Selective reporting (reporting bias) Low risk All stated outcomes reported
Other bias Unclear risk No consistent anticoagulation protocol