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%) |
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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 |
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Interventions | 6 mm PTFE and 6 mm Dacron graft Anticoagulation as per individual centre protocol |
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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 |