Mapping Definitions of Patient-Facing Digital Health Intervention in Published Frameworks Against the PICOTS-ComTeC Minimum Information Framework

Speaker(s)

Zrubka Z1, Champion A2, Holtorf AP3, Di Bidino R4, Earla JR5, Boltyenkov A6, Tabata-Kelly M7, Asche C8, Seal B9, Fotovvat H10, Kilburg A11, Weiss L12, Burrell A13
1Óbuda University, Budapest, Hungary, 2Healthcare Research Insights, Inc, Lake Forest, IL, USA, 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., Hellertown, PA, USA, 7Brandeis University, Waltham, MA, USA, 8University of Utah, Salt Lake City, UT, USA, 9Organon, Jersey City, NJ, USA, 10Evidera, Bethesda, MD, USA, 11KilburgDialogue, Basel, BS, Switzerland, 12St. Francis College, New York, NY, USA, 13Anita Burrell Consulting LLC, Flemington, NJ, USA

Presentation Documents

OBJECTIVES: Despite several published guidelines and frameworks for standardizing the reporting, evidence generation and assessment of digital health interventions (DHIs), concerns persist about the quality of definitions used in DHI studies. We aim to compare and map the definition domains of DHI assessment frameworks against those of the consensus-based PICOTS-ComTeC minimum information framework for defining patient-facing DHIs for health economics and outcomes research purposes.

METHODS: The domains of PICOTS-ComTeC include population, intervention, comparator, outcome, timing, setting, communication, technology and context, involving subcategories to specify optional details. The following frameworks were matched to PICOTS-ComTeC: Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth (CONSORT-EHEALTH), Guidelines and Checklist for the Reporting on Digital Health Implementations (iCHECK-DH), the Mobile Application Rating Scale (MARS), the Mobile Health Evidence Reporting and Assessment Checklist (mERA), the Target user, Evaluation focus, Connectedness and Health domain (TECH) systematic app review framework, Evidence in Digital health for EFfectiveness of INterventions with Evaluative Depth (Evidence DEFINED), DHI assessment and reimbursement frameworks from Australia, Belgium, France, Finland, Germany, and the United Kingdom, the World Health Organisation’s Classification of Digital Interventions, Services and Applications in Health (CDISAH), the Value Framework to Assess Patient-Facing Digital Health Technologies That Aim to Improve Chronic Disease Management (VF-DHT), the CEN-ISO/TS 82304-2 standard on labelling the quality and reliability of health and wellness apps, and the Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022).

RESULTS: The included 16 frameworks were mapped against the 9 domains and 32 subcategories of PICOTS-ComTeC. While there is consistency between the domains of DHI definitions or descriptions of the included frameworks, differences and gaps exist which reflect the purpose of the instruments.

CONCLUSIONS: PICOTS-ComTeC is a comprehensive, yet flexible and versatile framework that allows the identification of comparable DHIs and the selection of comparators that deliver similar effects to patients.

Code

MT22

Topic

Medical Technologies, Study Approaches

Topic Subcategory

Literature Review & Synthesis

Disease

No Additional Disease & Conditions/Specialized Treatment Areas