| Methods |
Study design: intention to treat
Method of randomisation: equal probability of assignment to each of the two study groups using automated telephone/computer
Concealment of allocation: unblinded |
| Participants |
Country: United States
Number: 1136
Age: 50 to 79 years
Sex: men (n = 1126) and women (n = 10)
Inclusion criteria: small (4.0 cm to 5.5 cm) non‐tender asymptomatic AAAs considered fit for immediate surgery. Patients who were considered unfit for immediate surgery, had symptoms associated the aneurysm, were unable to attend the follow‐up visit, or were unable to give informed consent were excluded. Patients who received a revascularization procedure within 3 months of enrolment, who had a myocardial infarction within 6 months of enrolment, or who were expected to survive less than 5 years because of invasive cancer or other life‐threatening disease were also excluded. |
| Interventions |
Treatment: surgery, n = 569 of whom 527 had immediate aneurysm repair; 42 had no elective operation due to death, refusal, etc.
Surveillance, n = 567 of whom 349 had aneurysm repair when they met the criteria listed below (in 9%, the procedures were performed despite an AAA that did not meet the repair criteria listed below).
Participants assigned to the immediate‐surgery group received standard open repair within 6 weeks after randomisation, while participants assigned to selective surveillance were followed without repair at similar regular intervals (at minimum once every 6 months), and surgery was performed within 6 weeks if: a) the aneurysm reached 5.5 cm; or b) the aneurysm enlarged by a minimum of 0.7 cm in 6 months or 1.0 cm in 1 year; or c) the aneurysm became symptomatic. |
| Outcomes |
Primary: survival during mean follow‐up (range 3.5 to 8.0 years, mean 4.9 years)
(30‐day surgical mortality)
Secondary: healthcare costs |
| Notes |
Supported by the Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development, Washington, DC, USA |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
The method of randomisation was of equal probability of assignment to each of the two study groups using automated telephone/computer. |
| Allocation concealment (selection bias) |
Unclear risk |
Concealment of allocation: unblinded |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Cannot blind participants |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Unlikely given the study outcome (mortality) and low lost‐to‐follow‐up rate. Vital status was assessed using the same methodology for both participants in the immediate‐repair group and participants in the routine ultrasound surveillance group‐‐in case misclassification occurred this would have been non‐differential and its impact on the study results would be limited. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Unlikely given the study outcome (mortality) and low lost‐to‐follow‐up rate |
| Selective reporting (reporting bias) |
Low risk |
Authors published findings on all the study outcomes including the study outcome of this review. |
| Other bias |
Low risk |
We did not identify other possible risk of bias. |