How Well Does the PICOTS-ComTeC Framework Fit With Established Digital Health Intervention Frameworks and Guidelines?
Author(s)
Champion A1, Zrubka Z2, Holtorf AP3, Di Bidino R4, Earla JR5, Boltyenkov A6, Tabata-Kelly M7, Asche C8, Seal B9, Fotovvat H10, Kilburg A11, Weiss L12, Burrell A13
1Healthcare Research Insights, Inc, Lake Forest, IL, USA, 2Óbuda University, Budapest, PE, Hungary, 3Health Outcomes Strategies GmbH, Basel, Switzerland, 4Graduate School of Health Economics and Management (ALTEMS), Roma, RM, Italy, 5Merck, Rahway, NJ, USA, 6Siemens Healthcare Diagnostics Inc., Newark, DE, USA, 7Brandeis University, Waltham, MA, USA, 8University of Utah, Salt Lake City, UT, USA, 9Organon, Jersey City, NJ, USA, 10Evidera, Bethesda, MD, USA, 11Boehringer Ingelheim, Ingelheim am Rheim, Germany, 12St. Francis College, New York, NY, USA, 13Anita Burrell Consulting LLC, Flemington, NJ, USA
OBJECTIVES: PICOTS-ComTeC, a flexible framework for defining digital health interventions (DHIs) for HEOR purposes, resulted from a scoping review of DHI definitions and a Delphi consensus study. We compared PICOTS-ComTeC (Population, Intervention, Comparator, Outcomes, Timing, Setting, Communication, Technology, Context) to established DHI assessment frameworks, to determine the degree of overlap, what PICOTS-ComTeC added, and how the frameworks could be used together.
METHODS: Sixteen frameworks/guidelines (DHI international (9), DHI national (6), and HEOR reporting (1)) were mapped to 9 domains and 32 subcategories of PICOTS-ComTeC. Pairs of reviewers extracted information (e.g. framework title, objective, DHI definition) and if PICOTS-ComTeC domains and subcategories were present (by copying text). The pairs agreed on a consensus spreadsheet, which was examined by a third reviewer.
RESULTS: Sixteen frameworks matched 81% of possible PICOTS-ComTeC domains (average 7.3 domains, range 4 - 9). Eight of the frameworks (50%) matched 9 (WHO CDISAH, Belgium RIZIV, Germany DiGA, UK NICE, CONSORT EHEALTH) or 8 (Finland Digi-HTA, iCHECK-DH, WHO mERA) domains. Subcategory matching was less complete (48% of possible matches). WHO CDISAH was the most complete framework, with all 9 domains and 26/32 subcategories. The Population domain was present for all 16 frameworks, followed by Communication (15), Technology (15), Intervention (14) and Outcomes (14) domains.
CONCLUSIONS: The degree to which PICOTS-ComTeC is congruous with a number of diverse DHI frameworks suggests that PICOTS-ComTeC may represent a common ground for defining and reporting DHIs. PICOTS-ComTeC can supplement some frameworks by suggesting additional domains/subcategories for defining DHIs, while other frameworks, e.g. WHO CDISAH, can provide more granularity to PICOTS-ComTeC DHI definitions.
Conference/Value in Health Info
Value in Health, Volume 27, Issue 12, S2 (December 2024)
Code
HTA244
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas