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

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

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%)

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Prevention; Wearable Electronic Devices; CVD - Cardiovascular Disease; Polygenic Risk Score

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: STEFANIA BOCCIA, PHD; Phone Number: +390630154396; Email: stefania.boccia@unicatt.it
• Study Contact Backup: Name: LUIGI RUSSO, MD; Email: luigi.russo12@icatt.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00168
      • Policlinico Universitario Fondazione Agostino Gemelli IRCCS
      • Contact: STEFANIA BOCCIA, PHD; Phone Number: +390630154396; Email: stefania.boccia@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A panel of at least 10 experts will be recruited from professionals involved in the INNOPREV project (internal and/or external members) with expertise in cardiology, personalized medicine, and/or digital health. Participation will be by email invitation and will require acceptance of the informed consent form (exclusion criterion: failure to provide informed consent)

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
INNOPREV expert panel; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of expert-panel consensus on recommendations for the implementation of PRS and wearable devices, as assessed by the Content Validity Index (CVI)	Achievement of consensus among the expert panel on the proposed recommendations. Consensus will be defined, for each item, as a Content Validity Index (CVI) > 79%, where the CVI represents the proportion of experts assigning a rating of 4 or 5	At the end of the Delphi process (up to 4 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of recommendations with partial agreement (CVI 70-79%)	Identification of items/recommendations with a Content Validity Index (CVI) between 70% and 79%, indicating the need for item revision and/or additional Delphi rounds	After each Delphi round, through completion of the process (up to 4 months)
Development of the final set of recommendations, structured by domain (genomic, digital, and clinical/organizational)	Production of the final set of recommendations, organized by domain (genomic, digital, and clinical/organizational)	At completion of the Delphi process (up to 4 months)
Stability of responses across successive rounds (assessment of changes in CVI)	Assessment of response stability by comparing, for each item, changes in the CVI across successive Delphi rounds	Between successive Delphi rounds, until completion of the process (up to 4 months)

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: STEFANIA BOCCIA, PHD, Policlinico Universitario Fondazione Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cardiovascular prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Genetic Predisposition to Disease; Pathological Conditions, Signs and Symptoms; Genetic Risk Score; Cardiovascular Diseases
• Other Study ID Numbers: 8217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No