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

Chronic Otitis Media Clinical Trial

Official title:

Validation of a Questionnaire for Measuring Health-related Quality of Life in Patients With Chronic Otitis Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226718
• Other study ID #: HRQOL-COM1
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

See Summary that contains all the details

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of chronic otitis media Exclusion Criteria: none

Related Conditions & MeSH terms

• Chronic Otitis Media
• Otitis
• Otitis Media

Intervention

Other:
• Administration of questionnaire

Locations

Country	Name	City	State
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity	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	day 1 (day of consultation)