What is the strength of evidence to support decision-making on the use of digital mental health technologies? A cross-sectional analysis of studies supporting NICE evaluations (Preprint)

BACKGROUND Digital mental health technologies (DMHTs) are playing an increasing role in mental health services. The quality of evidence for DMHTs is variable and there are concerns that evidence is not sufficient to support decision-making. OBJECTIVE This study used a cross-sectional analysis of evidence supporting DMHTs included in NICE evaluations to examine the strength of evidence available for decision-making. METHODS We identified all NICE evaluations relating to DMHTs by reviewing details of published NICE evaluations on the NICE website. From each of these evaluations, we identified included DMHTs and reviewed committee documentation to identify studies which provided supporting evidence for each of these technologies. We extracted information on a series of items relating to study quality and summarised the characteristics of evidence both at the level of individual studies and across the package of evidence from multiple studies supporting DMHTs. We also identified key evidence gaps in available evidence. RESULTS We included 78 studies supporting 30 DMHTs in nine NICE evaluations. We identified common evidence gaps relating to effectiveness compared to relevant comparators, use of appropriate outcomes including on health-related quality of life, cost of delivery and impact on resource use, and reporting of adverse events. CONCLUSIONS Our study highlights that some DMHTs have been supported by high-quality studies and that evidence to support DMHTs is likely to be developed across a series of studies. However, there are often key evidence gaps that need to be addressed to provide a stronger case for adoption. Developers should ensure that they consider these gaps while planning evidence generation and where possible address them earlier in the product lifecycle. CLINICALTRIAL Not applicable