DEL-DIP: DELphi Procedure for Developing Recommendations for the Implementation of Wearable Devices and Polygenic Risk Scores
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Achievement of expert-panel consensus on recommendations for the implementation of PRS and wearable devices, as assessed by the Content Validity Index (CVI)
研究概览
简要总结
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%)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Experts in cardiology
- •Experts in personalized medicine
- •Experts in digital health.
排除标准
- •- Failure to provide informed consent (i.e., non-acceptance of the informed consent form)
研究组 & 干预措施
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
结局指标
主要结局
Achievement of expert-panel consensus on recommendations for the implementation of PRS and wearable devices, as assessed by the Content Validity Index (CVI)
时间窗: 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
次要结局
- Identification of recommendations with partial agreement (CVI 70-79%)(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)(At completion of the Delphi process (up to 4 months))
- Stability of responses across successive rounds (assessment of changes in CVI)(Between successive Delphi rounds, until completion of the process (up to 4 months))