From accuracy to patient outcome and cost-effectiveness evaluations of diagnostic tests and biomarkers: an exemplary modelling study.
BACKGROUND
Proper evaluation of new diagnostic tests is required to reduce overutilization and to limit potential negative health effects and costs related to testing. A decision analytic modelling approach may be worthwhile when a diagnostic randomized controlled trial is not feasible. We demonstrate this by assessing the cost-effectiveness of modified transesophageal echocardiography (TEE) compared with manual palpation for the detection of atherosclerosis in the ascending aorta.


METHODS
Based on a previous diagnostic accuracy study, actual Dutch reimbursement data, and evidence from literature we developed a Markov decision analytic model. Cost-effectiveness of modified TEE was assessed for a life time horizon and a health care perspective. Prevalence rates of atherosclerosis were age-dependent and low as well as high rates were applied. Probabilistic sensitivity analysis was applied.


RESULTS
The model synthesized all available evidence on the risk of stroke in cardiac surgery patients. The modified TEE strategy consistently resulted in more adapted surgical procedures and, hence, a lower risk of stroke and a slightly higher number of life-years. With 10% prevalence of atherosclerosis the incremental cost-effectiveness ratio was € 4,651 and € 481 per quality-adjusted life year in 55-year-old men and women, respectively. In all patients aged 65 years or older the modified TEE strategy was cost saving and resulted in additional health benefits.


CONCLUSIONS
Decision analytic modelling to assess the cost-effectiveness of a new diagnostic test based on characteristics, costs and effects of the test itself and of the subsequent treatment options is both feasible and valuable. Our case study on modified TEE suggests that it may reduce the risk of stroke in cardiac surgery patients older than 55 years at acceptable cost-effectiveness levels.
Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Mailstop STR 6.131, P.O. Box 85500, 3508, Utrecht, GA, The Netherlands. h.koffijberg@umcutrecht.nl
Hendrik
H
Koffijberg
Bas
B
van Zaane
Karel G M
KG
Moons
D000368:Aged; D003324:Coronary Artery Disease / Q000175:diagnosis* / Q000453:epidemiology / Q000401:mortality; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D017548:Echocardiography, Transesophageal / Q000191:economics; D005260:Female; D006801:Humans; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D010173:Palpation / Q000191:economics*; D012306:Risk; D012680:Sensitivity and Specificity; D020521:Stroke / Q000517:prevention & control; D013903:Thoracic Surgery / Q000191:economics; D016896:Treatment Outcome