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

NCT02226718 | Completed

• 1 other identifier: HRQOL-COM1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Otitis Media

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

questionnaire

Otitis patients and controls

Other: Administration of questionnaire

Interventions

Administration of questionnaire OTHER

questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients suffering from chronic otitis media, visiting a tertiary referral centre

You may qualify if:

• clinical diagnosis of chronic otitis media

You may not qualify if:

• none

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Study Officials

• Alexander Huber, M.D.

  Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 27, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

CH (1)