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临床试验/NCT07428005
NCT07428005招募中不适用

Development of an Italian Questionnaire to Assess Awareness and Knowledge of Infectious Risk Prevention Strategies in Splenectomized Patients Using a Delphi Consensus Method

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Development of a consensus-based questionnaire

研究概览

简要总结

This study aims to develop an Italian-language questionnaire assessing awareness, knowledge of infectious risk prevention strategies, and vaccination attitudes among splenectomized individuals. The questionnaire will be developed through a structured Delphi consensus process involving a multidisciplinary panel of healthcare professionals experienced in infection prevention and vaccination strategies. Two Delphi rounds will be conducted online to evaluate item relevance and clarity. Items reaching predefined consensus thresholds will be included in the final questionnaire. The resulting tool will support future studies assessing preventive care awareness and vaccination uptake among splenectomized patients.

详细描述

Individuals without a functioning spleen face a lifelong increased risk of severe infections, particularly from encapsulated bacteria. Preventive strategies include vaccination, antibiotic prophylaxis, and patient education. However, adherence to preventive measures remains suboptimal, partly due to limited awareness and knowledge among patients.

This study aims to develop a validated Italian-language questionnaire to assess awareness, knowledge of preventive strategies, and attitudes toward vaccination among splenectomized individuals.

A modified Delphi consensus methodology will be used. A multidisciplinary panel of healthcare professionals involved in managing asplenic patients will be recruited. Following a preliminary literature scoping review, draft questionnaire items will be generated and submitted to two Delphi rounds conducted online.

Participants will rate each item for relevance and clarity using structured Likert scales. Items reaching predefined consensus thresholds will be retained and refined between rounds. The final questionnaire will consist only of items achieving expert consensus.

The study does not involve patients directly and poses minimal risk, as participation is voluntary and responses are anonymized.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthcare professionals working at Fondazione Policlinico Universitario A. Gemelli IRCCS
  • Professional experience in vaccination or infection prevention
  • Clinical involvement in care of patients with asplenia or related conditions
  • Italian native language proficiency
  • Provision of informed consent

排除标准

  • Participation in the expert panel is restricted to individuals who meet all predefined inclusion criteria. Failure to satisfy any inclusion criterion automatically results in exclusion from the study population

结局指标

主要结局

Development of a consensus-based questionnaire

时间窗: At study completion (4 months)

Availability of a finalized Italian questionnaire developed through Delphi consensus to assess awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurenti Patrizia

Professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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