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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07428005
Enrollment
20
Registered
2026-02-23
Start date
2026-01-01
Completion date
2026-04-01
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asplenia, Splenectomized Patients, Splenectomy; Status

Keywords

splenectomy, asplenia, vaccination, infection prevention, delphi study, questionnaire development

Brief 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.

Interventions

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.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Development of a consensus-based questionnaire for assessing awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals.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.

Countries

Italy

Contacts

CONTACTLAURENTI PATRIZIA, PROFESSOR
patrizia.laurenti@policlinicogemelli.it0630159333
PRINCIPAL_INVESTIGATORLAURENTI PATRIZIA, PROFESSOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026