Table 4.

Eligibility criteria based on the PCC framework (Population, Concept, Context)

Criteria	Inclusion	Exclusion
Population	Studies with a focus on mHealth applications designed for independent use by patients in real-world settings Study participants 18 years or older	Studies focusing on mHealth applications intended to be used by HCPs or caregivers Studies focusing on mHealth applications designed to collect data for HCPs without an interface for patients or without an active role for the patient in data collection and usage Study participants under 18 years
Concept	Studies evaluating the effectiveness of mHealth applications in achieving their intended health outcomes using RWD Preliminary efficacy studies were included, provided they were conducted with diagnosed patients	Studies evaluating user experience, usability, or acceptance of mHealth applications Studies on economic value/cost savings Preliminary efficacy, validation or feasibility studies with fewer than 30 participants
Context	Studies conducted in real-world care settings (e.g., at home, in the community or clinical practice) Studies acquiring data within routine use of the application using standard in-app functionalities (e.g., sensor tracking, app usage logs, in-app symptom tracking, in-app surveys), without modification of the core application functionality for research purposes. Study-specific recruitment was permitted Studies using routinely collected healthcare system data generated in the context of real-world application use (e.g., claims data, electronic health records, pharmacy dispensing data, or hospital utilization)	Study settings not reflecting real-world use of the device (e.g., simulated or laboratory-based settings) Studies using applications modified specifically for research Studies in which outcome data were collected primarily through external, study-specific instruments or platforms explicitly described as separate from the routine app environment, including separate survey tools, email questionnaires, or non–app-based assessments. Studies where data is generated primarily through professional-grade equipment in structured clinical environments (e.g., hospital at home), even if supplemented by consumer wearables
Application Characteristics/Scope	mHealth applications, defined as smartphone or web-based health applications on mobile devices (e.g., smartphones and tablets) mHealth applications may operate standalone or in combination with (external) sensors mHealth applications must be intended to improve health outcomes, support behavior change, or assist with chronic disease self-management	mHealth applications designed solely for passive information delivery (e.g., educational apps without tracking, personalization, or intervention components) mHealth applications limited to patient–provider communication (e.g., secure messaging platforms, SMS-based triage, or remote consultation tools) that do not generate patient-entered or device-captured data during routine use and do not provide a patient-facing data interface
Other Criteria	Peer-reviewed empirical studies using quantitative, qualitative, or mixed methods Studies published between January 2007 and November 2024 Language of publication: English	Reviews, books or non-empirical research (e.g., systematic reviews, letters, opinion pieces, theoretical papers) Study protocols and non-peer-reviewed articles (e.g., preprints, unpublished trial data, conference proceedings) Studies published before 2007 Studies published in languages other than English