Current Practices and a Novel Operational Framework for Planning Research on Digital Health Promotion Interventions...

The UK Medical Research Council's Guidance on Developing and Evaluating Complex Interventions (MRC GDECI) outlines a 4-phase framework for structuring research programs on interventions: development, feasibility, evaluation, and implementation. However, it provides limited practical direction on how researchers should select which phases to conduct or determine when and whether to progress between phases. This gap is particularly challenging in the context of digital health interventions (DHIs), given their fast-paced and rapidly evolving nature.

This scoping review examined the research phases conducted, how researchers progressed through them, and the intervention characteristics associated with overall program structure and duration in DHI research, to inform the design of future research programs.

We searched PubMed, Embase, CINAHL, PsycINFO, and ClinicalTrials.gov to identify complex DHIs promoting health among adolescents and young adults, implemented between 2017 and 2026, for which at least 2 phases of the MRC GDECI were reported, including the evaluation phase. For each eligible intervention, all related protocols, preprints, and published articles were retrieved to reconstruct the full research program. For each program, we analyzed the presence of each research phase, its organization (ie, phase arrangements), and the mechanisms guiding progression between phases (ie, progression mechanisms). Phase-specific and overall program durations were recorded.

A total of 31 research programs, covering 31 interventions and reported in 130 articles, were included. Development, feasibility, evaluation, and implementation phases were reported in 26, 23, 31, and 7 research programs, respectively. Three types of phase arrangements were identified: sequential, iterative, and overlapping. Progression mechanisms between phases included automatic progression, conditional progression based on researchers' appraisal of findings without prespecified criteria, and progression based on predefined quantitative criteria. Six main research program structures were observed, combining phase arrangements and progression mechanisms. Iterative arrangements were most common, observed in 22 research programs, followed by overlapping (n=10) and strictly sequential structures (n=7). Most progressions relied on researchers' appraisal of findings without prespecified criteria. Justifications for phase iteration, omission, or progression decisions were rarely reported. The median program duration was 5.8 (IQR 3.8-6.6) years (n=13). Based on these findings, a novel 4-step operational framework and visualization tools were developed to guide the design and planning of DHIs, highlighting key considerations for each step, as well as the strengths, limitations, and risks associated with each phase arrangement and progression mechanism.

This scoping review is the first to systematically examine phase arrangements and progression mechanisms in DHI research programs. Beyond descriptive reporting, it provides a conceptualization of research program structures and offers a flexible operational framework to support the concrete implementation of the MRC GDECI. Greater explicitness in decisions about program structure may enhance methodological rigor, reduce research waste, and improve the integrity and reproducibility of interventions.

PROSPERO CRD42023401979; https://tinyurl.com/mvc265y3.