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NCT Number: NCT07428005

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location status: Recruiting

Location contact

Patrizia Laurenti

PRINCIPAL_INVESTIGATOR

Patrizia Laurenti, Professor

CONTACT

[email protected]

+390630155701

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

LAURENTI PATRIZIA, PROFESSOR

CONTACT

[email protected]

0630159333

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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