ADVANCING STANDARDIZATION IN DIGITAL HEALTH: INTEGRATING PICOTS-COMTEC AND CHEERS-DHI TO IMPROVE EVALUATION, REPORTING, AND ECONOMIC ASSESSMENT
Author(s)
Carl V. Asche, BA, MBA, MSc, PhD1, Rossella Di Bidino, Sr., MSc, PhD2, Donald Husereau, BSc, MSc3, Anita D. Burrell, BA, MA, MBA4, Zsombor János Zrubka, MBA, PhD, MD5, Annette Champion, BSc, MBA6, Brian Seal, MBA, RPh, PhD7, Artem Tarasovic Boltyenkov, MBA, PhD8, Steven McPhail, PhD9, Rachel C. Yang, MSc, PharmD10.
1Executive Director, Pharmacotherapy Outcomes Research Center, University of Utah, Salt Lake City, UT, USA, 2Gemelli Teaching Hospital, Roma, Italy, 3University of Ottawa, Ottawa, ON, Canada, 4Anita Burrell Consulting LLC, Flemington, NJ, USA, 5Obuda University, Budapest, Hungary, 6Healthcare Research Insights, Inc, Lake Forest, IL, USA, 7Organon Pharmaceuticals, Germantown, MD, USA, 8Siemens Healthcare Diagnostics Inc., Lexington, SC, USA, 9Queensland University of Technology, Yeronga, Australia, 10University of Utah, Salt lake city, UT, USA.
1Executive Director, Pharmacotherapy Outcomes Research Center, University of Utah, Salt Lake City, UT, USA, 2Gemelli Teaching Hospital, Roma, Italy, 3University of Ottawa, Ottawa, ON, Canada, 4Anita Burrell Consulting LLC, Flemington, NJ, USA, 5Obuda University, Budapest, Hungary, 6Healthcare Research Insights, Inc, Lake Forest, IL, USA, 7Organon Pharmaceuticals, Germantown, MD, USA, 8Siemens Healthcare Diagnostics Inc., Lexington, SC, USA, 9Queensland University of Technology, Yeronga, Australia, 10University of Utah, Salt lake city, UT, USA.
OBJECTIVES: Digital health interventions (DHIs), including digital therapeutics, mobile health applications, remote monitoring systems, and wearable devices, are increasingly incorporated into healthcare delivery. However, inconsistent characterization and reporting of these interventions hinder evidence synthesis, HTA, and economic evaluation. This study explores the complementary roles of the PICOTS-ComTeC framework and the proposed CHEERS-DHI extension in improving the evaluation and reporting of DHIs.
METHODS: A multi-phase international research initiative was undertaken by members of the ISPOR Digital Health SIG. PICOTS-ComTeC was developed through a scoping review and a Delphi process by adapting the traditional PICOTS framework and adding the Communication, Technology, and Context domains. Subsequently, 20 international experts in digital health economics, HTA, and journal editing participated in semi-structured interviews to examine the adequacy of CHEERS 2022 for DHI evaluations and to identify reporting gaps. Interview transcripts, recordings, and investigator notes were independently reviewed by two researchers using a structured extraction matrix, followed by consensus-based thematic analysis.
RESULTS: Experts consistently highlighted limitations of existing reporting frameworks when applied to dynamic digital technologies. Key themes included the importance of context, implementation setting, patient and system preferences, access and equity considerations, technology evolution, behavioral engagement, and additional cost components such as development, training, maintenance, and monitoring. Participants emphasized the value of PICOTS-ComTeC in improving intervention specification and comparator selection. Findings supported the development of CHEERS-DHI, an extension of CHEERS 2022 that incorporates DHI-specific reporting considerations while maintaining alignment with established health economic evaluation standards.
CONCLUSIONS: Standardized evaluation and reporting frameworks are essential to ensure transparency, reproducibility, and comparability of DHI evidence. PICOTS-ComTeC provides a structured approach to defining digital health interventions and their implementation contexts, while CHEERS-DHI addresses key reporting challenges in economic evaluations of digital technologies. Together, these frameworks have the potential to strengthen HTA, HEOR, reimbursement decision-making, and evidence generation for digital health innovations.
METHODS: A multi-phase international research initiative was undertaken by members of the ISPOR Digital Health SIG. PICOTS-ComTeC was developed through a scoping review and a Delphi process by adapting the traditional PICOTS framework and adding the Communication, Technology, and Context domains. Subsequently, 20 international experts in digital health economics, HTA, and journal editing participated in semi-structured interviews to examine the adequacy of CHEERS 2022 for DHI evaluations and to identify reporting gaps. Interview transcripts, recordings, and investigator notes were independently reviewed by two researchers using a structured extraction matrix, followed by consensus-based thematic analysis.
RESULTS: Experts consistently highlighted limitations of existing reporting frameworks when applied to dynamic digital technologies. Key themes included the importance of context, implementation setting, patient and system preferences, access and equity considerations, technology evolution, behavioral engagement, and additional cost components such as development, training, maintenance, and monitoring. Participants emphasized the value of PICOTS-ComTeC in improving intervention specification and comparator selection. Findings supported the development of CHEERS-DHI, an extension of CHEERS 2022 that incorporates DHI-specific reporting considerations while maintaining alignment with established health economic evaluation standards.
CONCLUSIONS: Standardized evaluation and reporting frameworks are essential to ensure transparency, reproducibility, and comparability of DHI evidence. PICOTS-ComTeC provides a structured approach to defining digital health interventions and their implementation contexts, while CHEERS-DHI addresses key reporting challenges in economic evaluations of digital technologies. Together, these frameworks have the potential to strengthen HTA, HEOR, reimbursement decision-making, and evidence generation for digital health innovations.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE452
Topic
Economic Evaluation, Health Technology Assessment, Methodological & Statistical Research
Topic Subcategory
Value of Information
Disease
No Additional Disease & Conditions/Specialized Treatment Areas