ArticleBMJ open2026
Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an eDelphi study.
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPrescription digital therapeutics (PDTx) represent an emerging frontier in healthcare, leveraging software-based solutions to treat or manage specific medical conditions. However, despite rising interest and encouraging evidence of clinical benefits, the policy landscape remains fragmented. Jurisdictions vary widely in their regulatory approaches, reimbursement pathways and processes for clinical integration, thus creating uncertainties for developers, payers and healthcare providers. This protocol outlines an eDelphi study to develop and validate a comprehensive policy maturity framework guiding systematic assessment of national or regional readiness for PDTx adoption. METHODS AND ANALYSIS: We will conduct an e-Delphi study with up to three rounds to refine and validate a PDTx policy maturity framework. Experts will be recruited purposively from six stakeholder groups (regulators, healthcare providers, payers/health economists, developers, researchers and patient advocates), prioritising Europe while seeking variation across health system types and levels of economic development; a small number of non-European experts may be invited to broaden perspectives. An optional pilot round will gather initial feedback on the prototype framework, followed by iterative rounds to assess and revise domains, scoring criteria and maturity thresholds. A 5-point Likert scale (from 'strongly disagree' to 'strongly agree') will collect quantitative data, while open-text prompts will capture qualitative insights. Consensus will be defined as ≥70% agreement and/or an IQR ≤1 for critical items. Quantitative summaries and thematic analysis will guide iterative revisions of the model. This Delphi protocol aims to produce a consensus-driven framework that captures the essential elements of PDTx policy development and implementation. If validated, the framework can serve as a reference for policymakers, industry leaders, healthcare providers and researchers seeking to benchmark or advance the adoption of PDTx within health systems. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the Ethics Committee of the Faculty of Medicine of the University of Porto (reference: 320/CEFMUP/2025). Panellists will provide electronic informed consent, and data will be kept confidential. The finalised framework will be disseminated via peer-reviewed publications, conference presentations and policy briefs targeting stakeholders involved in digital health governance.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.