Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery

Completed

• Conditions: Chronic Otitis Media

• Registration Number: NCT04864912
• Lead Sponsor: Cochlear

Brief Summary

The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing loss. The study has a retrospective part (extraction of medical chart data) and a prospective part with a survey and three questionnaires collecting data on the use of health care services, on health related quality of life and hearing performance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-29
• Study Start: 2022-02-01
• Primary Completion: 2023-10-09
• Study Completion: 2023-10-09
• Results First Submitted: 2024-10-08
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Results First Posted: 2025-03-07
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Adult subjects, 18 years or older.
• Subjects with conductive or mixed hearing loss.
• Subjects with historically documented diagnosis of Chronic Otitis Media (COM) with or without cholesteatoma in the operated ear.
• Subjects who have undergone primary tympanoplasty type I-V to improve hearing between 2010-2016.
• Subjects with a Pure Tone Average (PTA)4 air-bone gap ≥30 decibels (dB) OR PTA4 air-bone gap between 25-30 dB with an air conduction threshold PTA4 ≥40 dB HL within 12 months after primary tympanoplasty in the operated ear.
• Subjects who have been recommended by their health care professional to try a hearing aid to improve hearing in the operated ear.
• Pre-op audiogram, maximum 1 year prior to the primary tympanoplasty, and post-op audiogram for the primary tympanoplasty are available.
• Aided audiogram, unaided if no hearing device is used, available between 2018 and the point of enrolment.
• Subjects are fluent in the language used for study questionnaires: German, French, Spanish.
• Subjects are willing and able to provide written informed consent. For France: subjects do not oppose to participate in the study.
• Medical Record data is available throughout the defined data search period, from primary tympanoplasty to point of enrolment.

Exclusion Criteria

• Subjects are unable or unwilling to comply with the requirements of the study as determined by the investigator.
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this study.

For France only:

• Subjects who are not affiliated to social security.
• Subjects who are under legal protection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number and Type of Contacts With Health Care Providers	From primary tympanoplasty to time of enrolment, up to 13 years	Contacts are obtained from medical records, counted and categorized.
Number and Type of Interventions and/or Procedures	From primary tympanoplasty to time of enrolment, up to 13 years	Medical examinations, surgical procedures and hearing rehabilitation are obtained from medical records, counted and categorized.
Number and Type of Medications and Therapies	From primary tympanoplasty to time of enrolment, up to 13 years	Medications are obtained from medical records, counted and categorized. Therapies from medical records are listed.

Secondary Outcome Measures

Name	Time	Method
Hearing Performance Assessed Via an Audiogram	Up to 6 years prior to study enrollment	PTA4 (0.5, 1, 2 and 4 kHz) for both air and bone conduction, under unaided and when applicable aided conditions. Data obtained from participant medical records.
Health Care Costs	From primary tympanoplasty to time of enrolment.	Direct medical costs were calculated by applying the reported Diagnosis Related Group (DRG) codes for Chronic Otitis Media related health care utilization were obtained to the unit cost in each participating country for each participant.; Note: No outcome measures are reported as there was insufficient data collection
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey	At enrolment	Demographic data, medical history, hearing rehabilitation, health care utilisation related to ear infection and hearing difficulties and employment information data are collected.
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.	At enrolment	HUI provides descriptive evidence on multiple dimensions of health status, a score for each dimension of health and an overall Health Related Quality of life score. The HUI3 classification system is comprised of 8 attributes: Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain - each with 5 or 6 levels of ability/disability The scoring systems provide utility (preference) scores on a generic scale where 0.00 indicates death and 1.00 indicates perfect health.
Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire.	At enrolment	COMOT-15 measures Health Related Quality of life of participants with COM. It consists of three subscales: ear symptoms, hearing function, and mental health forming the overall score. In addition, two questions related to COM are asked: one on the general evaluation of quality of life and one on the frequency of doctor visits in the last six months. The total score and the sub-scores are transformed to a 0-100 scale by dividing the sum of the raw scores of the items by the sum of spans of the items, then multiplying by 100. A higher score indicates a worse health-related quality of life.
Self-reported Auditory Disability Via the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) Questionnaire	At enrolment	SSQ-12 measures speech, spatial and hearing experiences. The total(overall) score summarizes these parameters. A scale from 0 to 10 is used. A mark 0 means "be quite unable to do or experience what is described" and a mark 10 means "be perfectly able to do or experience what is described in the question".
Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish	At enrollment	Mean score of Chronic Otitis Media Outcome Test -15 (COMOT-15) in German, French and Spanish (0-100 scale). This questionnaire consists of 15 questions that query 3 subscales: ear symptoms, hearing function, and mental health. Additionally, it includes a question about quality of life and specialist doctor visit frequency.; The total score is summed, transformed and presented on a 0 - 100 scale where 0 is a good outcome and 100 is the worst possible outcome.

Trial Locations

Locations (6)

Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP; 🇫🇷 Le Kremlin-Bicêtre, France

Universitätsklinik für Hals-, Nasen und Ohrenheilkunde; 🇩🇪 Freiburg, Germany

ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan; 🇫🇷 Toulouse, France

Hospital Universitario Donostia; 🇪🇸 Donostia, Spain

Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain