Gaspard 1972.
Methods | Study design: randomised, not blinded
Method of randomisation: states random, method unknown Losses to follow up: no losses to follow up |
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Participants | Country: USA Number of participants: 43 (29 participants with IC and 14 with rest pain) Sex: male and female Age: mean age 56.5 years Inclusion criteria: individuals requiring aorto‐ilio‐femoral reconstruction Exclusion criteria: individuals with disease confined to the aorto‐iliac segment | |
Interventions | Treatment: bypass graft using a Dacron bifurcated prosthesis, either woven or knitted Control: thromboendarterectomy Duration: postoperative period only | |
Outcomes | Mortality Treatment failure Complications of surgery/intervention | |
Notes | No source of funding/sponsorship was reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “randomly assigned”. Comment: Insufficient information about the random generation process. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information about allocation concealment. |
Blinding (performance bias and detection bias) All outcomes | Low risk | See below. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Probably no blinding because of the nature of the operative procedure, but the review authors judged that the outcome and the outcome measurement were not likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information available. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent loss of data. |
Selective reporting (reporting bias) | High risk | Outcome measures not clearly defined and the study failed to include key outcomes. |
Other bias | Low risk | No other source of bias was identified. |