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Background A number of published economic evaluations of elective endovascular aneurysm repair ( EVAR) versus open repair for abdominal aortic aneurysm ( AAA) have come to differing conclusions about whether EVAR is cost-effective. This paper reviews the current evidence base and presents up-to-date cost-effectiveness analyses in the light of results of four randomized clinical trials: EVAR-1, DREAM, OVER and ACE. Methods Markov models were used to estimate lifetime costs from a UK perspective and quality-adjusted life-years ( QALYs) based on the results of each of the four trials. The outcomes included in the model were: procedure costs, surveillance costs, reintervention costs, health-related quality of life, aneurysm-related mortality and other-cause mortality. Alternative scenarios about complications, reinterventions and deaths beyond the trial were explored. Results Models based on the results of the EVAR-1, DREAM or ACE trials did not find EVAR to be cost-effective at thresholds used in the UK (up to £30 000 per QALY). EVAR seemed cost-effective according to models based on the OVER trial. These results seemed robust to alternative model scenarios about events beyond the trial intervals. Conclusion These analyses did not find that EVAR is cost-effective compared with open repair in the long term in trials conducted in European centres. EVAR did appear to be cost-effective based on the OVER trial, conducted in the USA. Caution must be exercised when transferring the results of economic evaluations from one country to another. [ABSTRACT FROM AUTHOR]

Background: Trials in surgery pose some special problems. This paper examines these with reference to 10 years of methodological research sponsored by the UK National Health Service Research and Development programme. Methods: Solutions to common problems encountered in surgical studies were considered, such as issues of blinding, dependence of results on technical skill and continued evolution of technology. Results: Numerous methodological developments are described, including the tracker trial concept in which trial design can be adapted to take account of technical developments and interim results. The governance of trials, solutions to ethical conundra and the rising importance of databases are also discussed. Conclusion: Like surgery itself, the methodological toolkit for evaluation of surgical procedures continues to evolve. The rules of statistical and scientific probity provide plenty of scope for imaginative design solutions for surgical trials. [ABSTRACT FROM AUTHOR]