Methods for evaluating the efficacy and effectiveness of direct-to-consumer mobile health apps: a scoping review.

Background: There is an evaluation crisis in mobile health (mHealth). The majority of mHealth apps are released with little evidence base. While many agree on the need for comprehensive evaluations to assess the efficacy and effectiveness of mHealth apps, the field is some way from achieving that. This scoping review describes the current state of direct-to-consumer mHealth app evaluations so as to inform how the situation can be improved. Results: Findings showed a predominance of wellness management apps, focusing on fitness, diet, mental health, or other lifestyle factors. Evaluations were conducted by companies at varied financing stages, with a mix of start-ups, scale-ups, and public companies. Most studies employed full-scale or pilot randomised controlled trial designs. Conclusions: Participant demographics indicate a need for more inclusive recruitment strategies around ethnicity and gender so as to avoid worsening health inequalities. Measurement tools varied widely, highlighting the lack of standardisation in assessing mHealth apps. Promoting evidence-based practices in digital health should be a priority for organisations in this space. [ABSTRACT FROM AUTHOR]