COMBINED USE OF CLINICAL OUTCOME ASSESSMENTS AND DIGITAL HEALTH TECHNOLOGY MEASURES: A SCOPING REVIEW
Author(s)
Valentina Vodopivec, MSc1, Karlijn Homminga, MSc1, Nguyet Tran, MBA, MPH2, Catharina Groothuis-Oudshoorn, PhD1, Janine van Til, MSc, PhD1.
1University of Twente, Enschede, Netherlands, 2Erasmus School of Health Policy & Management, Rotterdam, Netherlands.
1University of Twente, Enschede, Netherlands, 2Erasmus School of Health Policy & Management, Rotterdam, Netherlands.
OBJECTIVES: The UNIFIED project aims to advance decision-ready guidance for integrating patient-centred data across the medical product lifecycle. This scoping review supports that aim by characterising how Clinical Outcome Assessments (COAs) and Digital Health Technology Measures (DHTMs) are used in combination in the literature to inform evidence generation and healthcare decision-making.
METHODS: A comprehensive search of PubMed, Scopus, Web of Science, and PsycINFO identified peer-reviewed articles published during 2016-2026. Abstracts were independently screened by two reviewers, supported by a relevance prediction AI tool (ASReview). Included abstracts were analysed qualitatively using inductive coding, with themes refined iteratively through expert consultation and grouped into categories representing distinct areas of combined COA and DHTM use.
RESULTS: Of 3,225 unique publications identified, 520 met the inclusion criteria. Studies clustered into three themes of use: psychometric (evaluation of the measuring instrument), real-world, and research applications. Psychometric focus was most common, with 28% of the studies assessing whether DHTMs accurately and reliably measure outcomes, typically using COAs as reference standards or anchors. Other psychometric studies compared the responsiveness and sensitivity of DHTMs and COAs in detecting clinical changes or patient-group differences (8%). Real-world applications included remote monitoring studies (21%) and use of combined measures to inform clinical decision-making (24%). Research applications combined DHTM and COA data for predictive modelling of disease progression and treatment responses (14%) or for developing composite measures (5%).
CONCLUSIONS: While the measurement credibility of DHTMs appears to be a major focus within the field, the reviewed abstracts also reflect a diversity of opportunities for combined use of DHTMs and COAs, and efforts toward innovative analytical approaches. In the future, more detailed analysis of the identified evidence will inform the design of UNIFIED use cases and address the remaining knowledge gaps for combining different patient-centred measures into robust evidence to better support regulatory, HTA, and healthcare decision-making.
METHODS: A comprehensive search of PubMed, Scopus, Web of Science, and PsycINFO identified peer-reviewed articles published during 2016-2026. Abstracts were independently screened by two reviewers, supported by a relevance prediction AI tool (ASReview). Included abstracts were analysed qualitatively using inductive coding, with themes refined iteratively through expert consultation and grouped into categories representing distinct areas of combined COA and DHTM use.
RESULTS: Of 3,225 unique publications identified, 520 met the inclusion criteria. Studies clustered into three themes of use: psychometric (evaluation of the measuring instrument), real-world, and research applications. Psychometric focus was most common, with 28% of the studies assessing whether DHTMs accurately and reliably measure outcomes, typically using COAs as reference standards or anchors. Other psychometric studies compared the responsiveness and sensitivity of DHTMs and COAs in detecting clinical changes or patient-group differences (8%). Real-world applications included remote monitoring studies (21%) and use of combined measures to inform clinical decision-making (24%). Research applications combined DHTM and COA data for predictive modelling of disease progression and treatment responses (14%) or for developing composite measures (5%).
CONCLUSIONS: While the measurement credibility of DHTMs appears to be a major focus within the field, the reviewed abstracts also reflect a diversity of opportunities for combined use of DHTMs and COAs, and efforts toward innovative analytical approaches. In the future, more detailed analysis of the identified evidence will inform the design of UNIFIED use cases and address the remaining knowledge gaps for combining different patient-centred measures into robust evidence to better support regulatory, HTA, and healthcare decision-making.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR269
Topic
Clinical Outcomes, Medical Technologies, Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation
Disease
No Additional Disease & Conditions/Specialized Treatment Areas