The PICOTS-ComTeC Framework for Defining Digital Health Interventions: An ISPOR Special Interest Group Report

Area of Science:

• Digital Health
• Health Informatics
• Outcomes Research

Background:

• Digital health interventions (DHIs) lack standardized definitions, hindering clarity in outcomes research.
• Existing definitions of digital health terms (DHTs) are numerous but imprecise.
• A systematic review and expert consensus were needed to establish a clear framework.

Purpose of the Study:

• To develop a minimum information framework for defining patient-facing digital health interventions (DHIs).
• To enhance precision and clarity in the reporting of DHIs for outcomes research.
• To create a standardized tool for identifying appropriate DHIs and comparators.

Main Methods:

• Systematic review of DHT definitions followed by content analysis.
• Application of frameworks including PICOTS, Shannon-Weaver, AHRQ Measures, and WHO Classification.
• Online Delphi study with experts to establish a minimum information framework, pilot-tested with hypothetical cases.

Main Results:

• Identified 101 unique definitions for 67 DHTs, revealing 95 different concept patterns.
• Most frequent concepts included WHO system (84.5%), message (75.7%), intervention (58.3%), and technology (52.4%).
• The Delphi study resulted in the PICOTS-ComTeC framework, comprising 9 domains and 32 subcategories.

Conclusions:

• PICOTS-ComTeC provides a standardized method for specifying patient-facing DHIs.
• This framework facilitates the selection of appropriate interventions and comparators in decision-making.
• PICOTS-ComTeC is a versatile tool for researchers and clinicians to improve study design and reporting.