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

Jensen 2007.

Methods Site: Femoral to AK popliteal (POPUP study)
Study design: RCT
Method of randomisation: randomisation envelopes
Blinding: unblinded, intention to treat
Exclusions post randomisation: 13 (8 Dacron, 5 PTFE)
Losses to follow up: 51 (12%)
Participants Country: Scandinavia
Setting: hospital (13 departments)
No. of participants: 426 (413 for analysis due to exclusions; 205 PTFE, 208 Dacron)
Age (mean): 66 yrs
Sex: 152 males, 261 females
Inclusion criteria: "chronic lower limb ischaemia"
Exclusion criteria: less than 18, pregnant, could not obtain informed consent
Interventions 6 mm PTFE and 6 mm Dacron graft
Anticoagulation as per individual centre protocol
Outcomes Primary patency, secondary patency and limb survival
Notes No common anticoagulation pathway. Multiple, different surgeons
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Grafts were contained in envelopes, however the randomisation procedure is unclear. Probably done as other papers from this unit clearly use random sequences (Eiberg 2006; Vogt 2007)
Allocation concealment (selection bias) Low risk Quote: "Immediately before surgery, the graft material was selected by a pre‐processed sealed envelope. Randomisation was stratified for each centre."
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 Anticoagulation as per individual centre protocol and therefore inconsistent