Adherence to Usability and Accessibility Principles in Digital Health Applications for Patients With Diabetes: Systematic Review (Preprint)

<sec> <title>BACKGROUND</title> Health apps have the potential to enable people with diabetes to access care more easily, monitor their condition, and reduce the number of times they need to attend health care appointments. However, the development pipeline for apps may differ widely before the apps are released for use, due to limited funding, difficulty in obtaining iterative feedback from patients/users, and varying levels of developer expertise. In response to concerns about the quality and consistency of apps being released, two guidelines were created: the Digital Technology Assessment Criteria (DTAC) and the National Institute for Health and Care Excellence (NICE) Evidence Standards Framework. These two frameworks aim to standardize the development and evaluation of digital health technologies (DHTs). They outline core requirements, such as accessibility, clinical safety, data protection, interoperability, usability, and safeguarding, which help ensure that digital health apps are accessible, safe, effective, and suitable for real-world use. </sec> <sec> <title>OBJECTIVE</title> This systematic review evaluated the performance of diabetes digital health apps, as presented in published studies, in terms of adherence to DTAC 2021 and NICE 2022 guidelines during development. </sec> <sec> <title>METHODS</title> We systematically searched Embase and MEDLINE and identified 43 studies that met the inclusion criteria. Each study was assessed against 13 binary scoring criteria derived from the two frameworks. </sec> <sec> <title>RESULTS</title> Our findings highlighted that 93% (n=40) of the studies met fewer than 40% of the recommended criteria. Specifically, 88.4% (n=38) studies did not report accurate and reliable measurements, 86% (n=37) omitted app accuracy validation, and 83.7% (n=36) failed to address inequalities considerations. Only 3 (7%) studies achieved scores between 7 and 9 out of a possible 13, and none fully adhered to the guideline criteria. </sec> <sec> <title>CONCLUSIONS</title> These results suggest a significant gap between digital health guidelines and real-world app development practices. We recommend the adoption of DTAC and NICE guidelines more widely and consistently during design and development. Additionally, we suggest that journals request that authors submit an adherence checklist alongside their manuscript to improve standardization and transparency across digital health publications. </sec> <sec> <title>CLINICALTRIAL</title> PROSPERO CRD42022322040; https://www.crd.york.ac.uk/PROSPERO/view/CRD42022322040 </sec>