Suitable Evaluation Frameworks for Disease-Agnostic Platforms for Remote Patient Monitoring: Scoping Review.

BACKGROUND

Disease-agnostic platforms (DAPs) are a digital health intervention (DHI) category that can support patients across multiple clinical conditions. While their versatility and configurability can address the fragmentation caused by condition-specific DHIs, DAPs present challenges for evaluation and certification, as they must be assessed across multiple therapeutic areas and diverse applications. A core challenge is identifying suitable evaluation frameworks that can accommodate the highly adaptable nature of this technology.

OBJECTIVE

This review explored whether there are suitable evaluation frameworks for the appraisal and subsequent certification of DAPs, whether any were applied in previous evaluations of DHIs and were available through open access (OA) publications.

METHODS

Twelve databases (PubMed, Embase, PsycINFO, MEDLINE, Scopus, Web of Science, ACMDL, IEEE Xplore, CINAHL, Cochrane Library, Compendex, and Business Source Complete) were searched on January 28, 2024. Titles, abstracts, and full texts were screened by 1 reviewer, with a minimum 10% sample dual-screened. Inclusion criteria included describing an evaluation framework applied to a DHI. Studies were excluded if there was no novel evaluation framework available to researchers, applicable to digital health evaluation domains, and applicable to a broad patient population. Evaluation frameworks identified were combined with those identified from 5 previous reviews, alongside handsearching and gray literature results. Each framework was assessed against essential and desirable criteria. Essential criteria were applicability across different therapeutic areas and populations, applicability to all domains of digital health, ability to support both formative and summative evaluation, and availability to researchers. Frameworks that met all essential criteria were assessed against desirable criteria, which included presence of operational guidance, evidence of considerations specific to digital health, and incorporation of an evidence assessment method.

RESULTS

A total of 40,907 search results contained 72 new frameworks. These were combined with 181 frameworks identified from previous reviews and 1 framework from handsearching and gray literature. Of the 254 frameworks assessed, 15 met all essential criteria, indicating potential suitability for DAP evaluation. One framework, the WHO (World Health Organization) guideline on monitoring and evaluating DHIs, met all desirable criteria. All suitable frameworks had been applied to DHIs and were available in at least 1 OA publication.

CONCLUSIONS

We found that at least 15 existing frameworks appear suitable for DAP evaluation and can be used to benchmark DAPs against other DHIs. Limitations include potential bias from screening methods and underpinning reviews. Prior use of these frameworks in DHI evaluations and their availability in OA publications enables standardized, high-quality evaluation. Identification of suitable frameworks indicates that research efforts can focus on other outstanding questions related to DAP evaluation, including the acceptable performance benchmark for DAPs, the range of therapeutic areas DAPs need to be favorably evaluated in, and how to synthesize findings across multiple therapeutic areas.

TRIAL REGISTRATION

OSF Registries 10.17605/OSF.IO/X578S; https://osf.io/x578s.