Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168, Italy
Location status: Recruiting
Location contact
Patrizia Laurenti
PRINCIPAL_INVESTIGATOR
Patrizia Laurenti, Professor
CONTACT
NCT Number: NCT07428005
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rome, Lazio, 00168, Italy
Location status: Recruiting
Patrizia Laurenti
PRINCIPAL_INVESTIGATOR
Patrizia Laurenti, Professor
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At study completion (4 months)
The outcome consists of the development of a finalized Italian questionnaire through a Delphi consensus process. As this outcome refers to the creation of a new instrument within the study, no scoring system, scale range, or interpretation of scores is applicable at this stage.
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Development of an Italian Questionnaire to Assess Awareness and Knowledge of Infectious Risk Prevention Strategies in Splenectomized Patients Using a Delphi Consensus Method
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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