DELphi Procedure for Developing Recommendations for the Implementation of Wearable Devices and Polygenic Risk Scores (DEL-DIP)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: CVD - Cardiovascular Disease; Primary Prevention; Polygenic Risk Score; Wearable Electronic Devices

Study type: Observational

Funder types: Other

Identifiers

NCT07358481

8217

Details and patient eligibility

About

DEL-DIP is a prospective observational study employing a Delphi methodology (at least two online rounds) to elicit and consolidate the views of an expert panel within the INNOPREV project. The study aims to develop operational recommendations to support the coordinated implementation of Polygenic Risk Scores (PRS) and wearable devices in cardiovascular prevention. Specifically, it addresses the following research question: which recommendations and requirements-genomic, digital, and clinical/organizational-are necessary to integrate PRS and wearable technologies into routine practice and healthcare services, and for which of these elements do experts achieve consensus (defined as a Content Validity Index, CVI, > 79%)

Full description

The DEL-DIP project aims to develop operational recommendations to support the coordinated implementation of Polygenic Risk Scores (PRS) and wearable devices within cardiovascular prevention pathways, where the integration of genomics and digital health may enhance risk stratification and enable continuous monitoring.

The study adopts a Delphi methodology comprising anonymous, web-based rounds in which an expert panel rates its level of agreement with a series of proposed recommendations. Following each round, responses are aggregated and summarized, and the items are re-circulated to allow participants to reconsider and refine their judgments in light of group feedback, thereby facilitating iterative convergence toward consensus.

Data are collected via Microsoft Forms and centralized for analysis. Safeguards are implemented to ensure data security, anonymity, and privacy, and electronic informed consent is obtained prior to questionnaire access.

For each item, the Content Validity Index (CVI) is calculated as the proportion of experts assigning a rating of 4 or 5. A CVI > 79% indicates consensus and supports item inclusion; CVI values between 70% and 79% indicate partial agreement and the need for item revision and/or additional Delphi rounds; values < 70% suggest item exclusion.

The final output will consist of a set of recommendations organized by domain (genomic, digital, and clinical/organizational), together with an assessment of response stability across successive rounds (i.e., changes in CVI), to inform implementation within healthcare services.

Enrollment: 10 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Experts in cardiology
• Experts in personalized medicine
• Experts in digital health.

Exclusion criteria

- Failure to provide informed consent (i.e., non-acceptance of the informed consent form)

Trial design

10 participants in 1 patient group

INNOPREV expert panel

Description:

Professionals involved in the INNOPREV project with expertise in cardiology, personalized medicine, and/or digital health will be invited to participate. Enrollment will occur by invitation only, contingent upon provision of electronic informed consent. A panel of at least 10 experts is planned