CVD - Cardiovascular Disease, Polygenic Risk Score, Primary Prevention, Wearable Electronic Devices
Conditions
Keywords
cardiovascular prevention
Brief summary
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%)
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.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of expert-panel consensus on recommendations for the implementation of PRS and wearable devices, as assessed by the Content Validity Index (CVI) | At the end of the Delphi process (up to 4 months) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of recommendations with partial agreement (CVI 70-79%) | After each Delphi round, through completion of the process (up to 4 months) | 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 |
| Development of the final set of recommendations, structured by domain (genomic, digital, and clinical/organizational) | At completion of the Delphi process (up to 4 months) | Production of the final set of recommendations, organized by domain (genomic, digital, and clinical/organizational) |
| Stability of responses across successive rounds (assessment of changes in CVI) | Between successive Delphi rounds, until completion of the process (up to 4 months) | Assessment of response stability by comparing, for each item, changes in the CVI across successive Delphi rounds |
Countries
Italy
Contacts
CONTACTSTEFANIA BOCCIA, PHD
CONTACTLUIGI RUSSO, MD
PRINCIPAL_INVESTIGATORSTEFANIA BOCCIA, PHD
Policlinico Universitario Fondazione Agostino Gemelli IRCCS
Outcome results
None listed