Evaluating Digital Health Solutions in Diabetes and the Role of Patient-Reported Outcomes: Targeted Literature Review.

Background: Digital health solutions (DHS) are technologies with the potential to improve patient outcomes as well as change the way care is delivered. The value of DHS for people with diabetes is not well understood, nor is it clear how to quantify this value.

Objective: We aimed to summarize current literature on the use of patient-reported outcome measures (PROMs) in diabetes as well as in selected guidelines for Health Technology Assessment (HTA) of DHS to highlight gaps, needs, and opportunities for the use of PROMs to evaluate DHS.

Methods: We searched PubMed and ClinicalTrials.gov to establish which PROMs were most used in diabetes clinical trials and research between 1995 and May 2024. HTA guidelines on DHS evaluation from France, Germany, and the United Kingdom were also assessed to identify PROMs for DHS evaluation in general.

Results: A total of 46 diabetes-specific PROMs and 16 nondiabetes-specific PROMs were identified. The most used diabetes-specific PROMs were (1) Diabetes Distress Scale, (2) Problem Areas in Diabetes, (3) Diabetes Empowerment Scale, (4) Diabetes Quality of Life, and (5) Diabetes Treatment Satisfaction Questionnaire. The most used nondiabetes-specific PROMs were Beck Depression Inventory, Sickness Impact Profile, EuroQol 5-Dimension, and Short Form 36-Item Health Survey. In HTA guidelines, the most prominent domain was health-related quality of life, for whose assessment there are well-established measures (Short Form 36-Item Health Survey and EuroQol 5-Dimension).

Conclusions: Of the many PROMs used in diabetes care, few are currently used to evaluate DHS, and certain domains of value in diabetes are not mentioned in HTA guidelines. A common, comprehensive DHS-specific HTA framework could facilitate and accelerate the evaluation of DHS.