Delaney, B.C.; Moayyedi, P.; Logan, R.F.A.; Qume, M.; Roalfe, A.; Wilson, S.; Barton, P.
April 2003
Gut;Apr2003 Supplement 1, Vol. 52, pA80
Academic Journal
Background: Only a small number of trials have directly addressed the management of patients with "uninvestigated" dyspepsia. The design of trials to determine cost effectiveness is more complex than efficacy trials, and can be enhanced by pre-trial modelling. Methods: A simulation model of 72 alternative management strategies for a dyspeptic patient was constructed. The model simulated the flow of individual patients with potential upper Gl disorders through potential investigations and therapies, including endoscopy, non-invasive testing for H pylori, acid suppression therapy, and H pylori eradication. Epidemiological data and meta-analyses were used to specify parameters within the model. The model was used to establish the important comparisons for future research and to establish likely effect sizes in terms of cost and efficacy. Sensitivity analysis explored potential effect modifiers and the MRC-CUBE study was designed and powered on the basis of the model. Results: Recent trials have supported some of the model's findings, in that only empiric acid suppression with either an antacid or a PPI, or H pylori "test and treat", followed by acid suppression were cost effective. Test and treat was more effective, but more costly than empiric acid suppression alone. Based on the model, the minimum effect size would be 7%, assuming a maximum willingness to pay For a patient free of dyspepsia for a year of 100, and a control event rate of 70%. 1940 patients would be required for an α of 0.05 and β 0.1. Conclusions: The MRC-CUBE trial is about to start recruitment in 60 practices, a large, multi-centre trial being justified on the basis of the model. As well as informing the selection of appropriate comparisons, pre-trial modelling enables cost effectiveness trials to be powered for cost as well as effectiveness outcomes.


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