DELphi Procedure for Developing Recommendations for the Implementation of Wearable Devices and Polygenic Risk Scores
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Wearable Electronic Devices, Polygenic Risk Score, CVD - Cardiovascular Disease, Primary Prevention. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
DEL-DIP: DELphi Procedure for Developing Recommendations for the Implementation of Wearable Devices and Polygenic Risk Scores
Обзор
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%)
Подробное описание
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.
Первичные конечные точки
- Achievement of expert-panel consensus on recommendations for the implementation of PRS and wearable devices, as assessed by the Content Validity Index (CVI) [Срок оценки: At the end of the Delphi process (up to 4 months)]
Вторичные конечные точки (3)
- Identification of recommendations with partial agreement (CVI 70-79%) [Срок оценки: 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) [Срок оценки: At completion of the Delphi process (up to 4 months)]
- Stability of responses across successive rounds (assessment of changes in CVI) [Срок оценки: Between successive Delphi rounds, until completion of the process (up to 4 months)]
Критерии участия
Критерии включения
- Experts in cardiology
- Experts in personalized medicine
- Experts in digital health.
Критерии исключения
\- Failure to provide informed consent (i.e., non-acceptance of the informed consent form)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Италия · 1 центр
- Policlinico Universitario Fondazione Agostino Gemelli IRCCS — Roma
Идентификаторы
NCT: NCT07358481 · 8217