NCT07428005

Development of an Italian Questionnaire for Splenectomized Patients Using a Delphi Consensus Method

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Splenectomy; Status
• Asplenia
• Splenectomized Patients

Interventions

Type	Name	Description
OTHER	Delphi Consensus Process	A structured Delphi consensus process involving a multidisciplinary panel of healthcare professionals aimed at developing and validating questionnaire items assessing awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals. Participants evaluate questionnaire items across two online Delphi rounds, rating relevance and clarity. Items reaching predefined consensus thresholds are retained to produce the final questionnaire.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-02-23
• Last updated: 2026-04-08

Locations

1 site across 1 country: Italy