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

NCT07428005 | Recruiting

• 1 other identifier: 8121
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Splenectomy; Status; Asplenia; Splenectomized Patients

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  At study completion (4 months)

Interventions

Delphi Consensus Process OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of a multidisciplinary panel of healthcare professionals, including physicians, nurses, and healthcare assistants working at Fondazione Policlinico Universitario A. Gemelli IRCCS, with clinical or academic experience in vaccination and infection prevention, particularly in the management of patients with asplenia. Participants are selected to ensure representation from different specialties involved in the care of asplenic patients and will participate in a Delphi consensus process aimed at developing a questionnaire on infectious risk prevention awareness and vaccination attitudes.

You may qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

Study Officials

• LAURENTI PATRIZIA, PROFESSOR

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LAURENTI PATRIZIA, PROFESSOR

CONTACT

0630159333; patrizia.laurenti@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

IT (1)