Evaluation Methods Applied to Digital Health Interventions: What Is Being Used beyond Randomised Controlled Trials?-A Scoping Review.

Despite the potential of digital health interventions (DHIs), evaluations of their effectiveness face challenges. DHIs are complex interventions and currently established evaluation methods, e.g., the randomised controlled trial (RCT), are limited in their application. This study aimed at identifying alternatives to RCTs as potentially more appropriate evaluation approaches. A scoping review was conducted to provide an overview of existing evaluation methods of DHIs beyond the RCT. Cochrane Central Register of Controlled Trials, MEDLINE, Web of Science, and EMBASE were screened in May 2021 to identify relevant publications, while using defined inclusion and exclusion criteria. Eight studies were extracted for a synthesis comprising four alternative evaluation designs. Factorial designs were mostly used to evaluate DHIs followed by stepped-wedge designs, sequential multiple assignment randomised trials (SMARTs), and micro randomised trials (MRTs). Some of these methods allow for the adaptation of interventions (e.g., SMART or MRT) and the evaluation of specific components of interventions (e.g., factorial designs). Thus, they are appropriate for addressing some specific needs in the evaluation of DHIs. However, it remains unsolved how to establish these alternative evaluation designs in research practice and how to deal with the limitations of the designs.