During the event "Puls 2014" the Dutch Heart Foundation awarded two grants of €50.000 for innovative research. One grant went to Radboudumc researchers for the proposal "Improving therapy adherence by n-of-1 trials with Bayesian analysis".
The proposal is a combined initiative of the departments of Internal Medicine (Jaap Deinum), HTA (Willem Woertman, Gert Jan van der Wilt) and Pharmacy (Bas van Vlijmen). It addresses a frequent problem in patient care: non-adherence to essential drug therapy by patients with high cardiovascular risk. Very often patients perceive side effects that made them stop taking the drugs. There are good reasons to believe that these side effects have other origins than a biological effect. The proposal aims to investigate whether n-of-1 trials can help the physician and the patient to decide whether it is safe and worthwile to resume the medication that appeared not to be tolerated. N-of-1 trials are multiple cross-over trials in single subjects, in which two drugs or a drug and placebo are compared in randomized blocks in a double-blinded way. They are used in assessing reversible treatment effects in chronic conditions in individual patients. Because they do this assessment in an objective way they provide the best evidence for treatment success in individuals. In this case patients will score the side effects during treatment blocks with either a statin (a frequently prescribed highly effective risk-lowering drug in cardiovascular medicine) or a placebo. Scores will be analysed by Bayesian techniques, taking into account the prior beliefs and attributions of the patient. Application of n-of-1 trials to side effects is novel, but the most innovative part of the study is this Bayesian analysis. If it turns out that scores do not differ between placebo and statin, which is expected in the majority of patients, the patient might be persuaded to resume treatment. Outcome measure then is reduction in cardiovascular risk. If this method indeed increased drug adherence its use may be extended to other drugs with presumed side effects as well.
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