Which Usability Assessment for Digital Therapeutics and Patient Support Programs?

Abstract

Computer systems can significantly affect the health of their users in both positive and negative ways. In past decades, this finding led the scientific community to create medical devices, primarily based on the effects of the hardware of computer systems. More recently, clinical trials have allowed the validation of new digital therapies, in which the active ingredient is not from biochemistry: it is an algorithm, implemented as a software. Digital Therapeutics (DTx) and Digital Patient Support Programs (DSx) are the names of the two class of digital applications used for this type of interventions. As for other critical software impacting the security and safety of human beings, the quality of DTx and DSx is of paramount relevance. Because of this reason and the unique requirements and constraints associated with the clinical trials adopted to validate each new therapy, specific evaluation techniques are needed to help clinicians and researchers develop new DTxs and support their continuous improvement. To this end, we discuss a flexible method for evaluating DTxs and DSxs. The proposed method incorporates the International Measurement System (IMS) scale and the Mobile Application Rating Scale (MARS) in a framework derived from a simplified version of phase III clinical trials. The method was co-designed by IT experts, health professionals and patients to ensure due rigor while including, from the outset, aspects of privacy, confidentiality, ease of use and sustainability. An example of the application of the proposed approach to a real DSx is discussed in the second part of the paper.