Integration of Patient-Reported Outcome Measures in the Evaluation of Digital Health Solutions: Research in Diabetes
Author(s)
Cerletti P1, Van Haelst P1, Gyldmark M1, Varriale P2, Wilczynski O2
1Roche Diabetes Care, Basel, BS, Switzerland, 2Carenity, Paris, France
OBJECTIVES: Although the field of Digital Health Solutions (DHS) for improving outcomes in diabetes has evolved rapidly over the last 20 years, there are still significant challenges in generating relevant evidence and demonstrating the value such solutions bring to patients and the overall health-care value chain. Research was conducted to review guidelines from national health authorities regarding patient outcomes to consider in the evaluation of DHS and to determine if existing Patient-Reported Outcome Measures (PROMs) are adequate tools for assessing the value of DHS. METHODS: Guidelines for evaluating DHS from national health authorities in France (HAS), Germany (BfArM), the UK (NICE), and the US (FDA) were reviewed. Recommended patient outcomes were retrieved, as well as the role of PROMs in assessing them. In addition, a list of PROMs used in diabetes care was identified from the ProQolid database, Clinicaltrials.gov and PubMed. Each instrument was evaluated on multiple attributes, including previous use in assessing DHS, and classified by patient value domain. RESULTS: Five guidelines were reviewed identifying 12 domains of patient outcomes. Most guidelines focused on a particular type of DHS and there was no consensus across guidelines on patient outcomes. Nevertheless, all health authorities recognize PROMs as important tools to demonstrate the value of DHS. Overall, 62 PROMs were identified (46 diabetes-specific and 16 non-diabetes-specific) in the literature. There was a clear alignment between some of the outcomes covered in both the guidelines and PROMs, such as satisfaction, empowerment, health literacy, adherence and quality of life. However, some patient outcomes in the guidelines were poorly covered by (existing) PROMs, such as engagement, autonomy in daily life, coping strategies and reduction of efforts. CONCLUSIONS: It is urgent to develop frameworks aiming at integrating relevant domains of patient value in the evaluation of DHS to ensure alignment across national jurisdictions in reimbursement processes.
Conference/Value in Health Info
2021-05, ISPOR 2021, Montreal, Canada
Value in Health, Volume 24, Issue 5, S1 (May 2021)
Code
PDB32
Topic
Medical Technologies, Methodological & Statistical Research
Topic Subcategory
Digital Health, PRO & Related Methods
Disease
Diabetes/Endocrine/Metabolic Disorders