JMIR Publications

ABSTRACT

Background:

Digital health solutions (DHS) are technologies with the potential to improve 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 Outcomes 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 October 2020. HTA guidelines on DHS evaluation from France, Germany, and the UK were also assessed to identify PROMs for DHS evaluation in general.

Results:

Forty-six diabetes-specific PROMs and 16 non-diabetes–specific PROMs were identified. The most used diabetes-specific PROMs were: Diabetes Distress Scale; Problem Areas in Diabetes; Diabetes Empowerment Scale; Diabetes Quality of Life; and Diabetes Treatment Satisfaction Questionnaire. The most used non-diabetes–specific PROMs were: Beck Depression Inventory; Sickness Impact Profile; EQ-5D; and SF-36. In HTA guidelines, the most prominent domain was health-related quality of life, for whose assessment there are well-established measures (SF-36 and EQ-5D).

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.