Aernoud Fiolet
387 General summary predictor of intolerance, while obesity and high-dose statin use are directionally inversely related to the odds of intolerance; these findings are thought to reflect a combination of both biological and non-biological mechanisms. PART IV: IMPROVING PRAGMATIC TRIAL CONDUCT In Chapter 13 , we use the data from the LoDoCo2 trial to evaluate whether it is possible to use routinely collected health care data for the purpose of clinical research. We show that with the use of a text-mining algorithm, it is possible to efficientlyandaccuratelyidentifyeligiblepatients fortrial participation. Inaddition, we show that the same algorithm can collect baseline data from participants, with varying levels of accuracy. We conclude that this method could help to reduce the operational costs of clinical research, albeit in the context of a predefined level of accuracy. In Chapter 14 , we evaluate the use of routinely collected health care data for trial outcome assessment, comparing it with investigator-reported and adjudicated end point data from the LoDoCo2 trial. We report a high sensitivity and very high specificity of this method in detecting the occurrence of major cardiovascular outcomes, but low negative predictive value. Sensitivity is limited when less strictly defined clinical outcomes are used as outcome data. We conclude that this can complement data collection in various scenarios of clinical research. PART IV: GENERAL DISCUSSION AND SUMMARY In Chapter 15, we put the aforementioned findings into clinical, mechanistic, and methodological perspective. We address currently unanswered questions and formulate recommendations for future research of drug repurposing. Considering the output from more than six years of clinical research summarized in this thesis, we conclude to have—hopefully—not only added data that will improve the clinical outcomes of patients with coronary disease in particular, but also added data that will improve clinical research in general.With this,we provide a translational model summarised with the aphorism of “using the available to enable the sustainable”.
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