Efficacy of clinical decision support systems: methods and estimates

Clinical decision support (CDS) systems are the medical technologies that go through their life cycle. Evaluation of effectiveness and safety should be carried out at its various stages – at the development, in clinical trials, licensing, clinical and economic analysis, health technologies assessment. To date, the effectiveness and safety of CDS systems vary and are ambiguous – there are both successes and failures. Hundreds of clinical trials are carried out, and more than a hundred of systematic reviews are published. When evaluating the efficacy and safety of CDS systems, two types of outcomes are usually estimated: indicators of medical care (volume, time, costs, etc.), and patient outcomes (clinical and surrogate). A slight increase in physicians’ adherence to clinical guidelines has been observed, but it had very small influence on surrogate outcomes, and there is no effect on clinical patient outcomes. A slight increase in risk with respect to patient outcomes was found in only a few studies. However, the methodological quality of the evidence is very low. In this regard, a few products based on artificial intelligence have so far approached the licensing phase. The field of CDS systems is developing, but not yet sufficiently studied, and there is a long way to real successes ahead. Meanwhile, there is a wide gap between the postulated and empirically demonstrated benefits of CDS systems.