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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02226718
Enrollment
60
Registered
2014-08-27
Start date
2014-10-31
Completion date
2018-12-31
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Otitis Media

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

Interventions

OTHERAdministration of questionnaire

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* clinical diagnosis of chronic otitis media

Exclusion criteria

none

Design outcomes

Primary

MeasureTime frameDescription
Validityday 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026