Development of an Italian Questionnaire for Splenectomized Patients Using a Delphi Consensus Method
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Delphi Consensus Process.
- Who it may be relevant to
- Registry conditions: Splenectomy; Status, Asplenia, Splenectomized Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of an Italian Questionnaire to Assess Awareness and Knowledge of Infectious Risk Prevention Strategies in Splenectomized Patients Using a Delphi Consensus Method
Overview
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.
Interventions
- 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.
Primary outcome measures
- Development of a consensus-based questionnaire for assessing awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals. [Time frame: At study completion (4 months)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome
Identifiers
NCT: NCT07428005 · 8121