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.

Engagement in Health Risk Behaviours before and during the COVID-19 Pandemic in German University Students: Results of a Cross-Sectional Study.

Tobacco and cannabis use, alcohol consumption and inactivity are health risk behaviors (HRB) of crucial importance for health and wellbeing. The impact of the COVID-19 pandemic on university students' engagement in HRB has yet received limited attention. We investigated whether HRB changed during the COVID-19 pandemic, assessed factors associated with change and profiles of HRB changes in university students. A web-based survey was conducted in May 2020, including 5021 students of four German universities (69% female, the mean age of 24.4 years (SD = 5.1)). Sixty-one percent of students reported consuming alcohol, 45.8% binge drinking, 44% inactivity, 19.4% smoking and 10.8% cannabis use. While smoking and cannabis use remained unchanged during the COVID-19 pandemic, 24.4% reported a decrease in binge drinking while 5.4% reported an increase. Changes to physical activity were most frequently reported, with 30.6% reporting an increase and 19.3% reporting a decrease in vigorous physical activity. Being female, younger age, being bored, not having a trusted person and depressive symptoms were factors associated with a change in HRB. Five substance use behavior profiles were identified, which also remained fairly unchanged. Efforts to promote student health and wellbeing continue to be required, also in times of the COVID-19 pandemic.