Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear

Completed

• Conditions: Chronic Otitis Media
• Interventions: Other: Administration of questionnaire

• Registration Number: NCT02226718
• Lead Sponsor: University of Zurich

Brief Summary

For measuring quality of life in patients with chronic inflammation of the middle ear, only two questionnaires currently exist. However, these questionnaires are designed only to measure either disease-specific health or hearing-related quality of life. The aim of this project is the validation of a pre-existing comprehensive questionnaire, which is routinely administered in the investigators clinic but has never been validated. Following a retrospective item reduction based on existing data, this questionnaire will be prospectively validated. Applying the resulting questionnaire in future studies on chronic middle ear inflammation, not only objective outcome parameters (e.g. audiograms) but also quality of life will be assessed. Therefore, the investigators questionnaire will add substantial information to these outcome studies by providing a subjective outcome parameter.

Detailed Description

See Summary that contains all the details

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-27
• Study Start: 2014-10
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• clinical diagnosis of chronic otitis media

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Exclusion Criteria

none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
questionnaire	Administration of questionnaire	Otitis patients and controls

Primary Outcome Measures

Name	Time	Method
Validity	day 1 (day of consultation)	Several aspects of Validity will be determined by different methods: * content validity is made certain by construction procedure of the questionnaire (e.g. involving of specialists and patients); * construct validity by factor analysis; * criterion validity by correlating a global question with the overall questionnaire score

Trial Locations

Locations (1)

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland