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

A Retrospective Mapping of Health Care Utilisation and Current Quality of Life Status in Adult Subjects With a History of Chronic Otitis Media With or Without Cholesteatoma Who Have Undergone a Primary Tympanoplasty

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.

Study Overview

• Status: Completed
• Conditions: Chronic Otitis Media
• Intervention / Treatment: Other: Questionnaires and survey

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

• Study Contact: Name: Karin Ekström; Phone Number: +46317924400; Email: kekstrom@cochlear.com
• Study Contact Backup: Name: Johan Blechert; Email: jblechert@cochlear.com

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94275
    • Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP
  • Toulouse, France, 31059
    • ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan
• Germany
  • Freiburg, Germany, 79106
    • Universitätsklinik für Hals-, Nasen und Ohrenheilkunde
  • Heidelberg, Germany, 69120
    • Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg
• Spain
  • Donostia, Spain, 20080
    • Hospital Universitario Donostia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with a history of chronic otitis media who have undergone a primary tympanoplasty to improve hearing between 2010-2016 but still have conductive or mixed hearing loss.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and type of contacts with health care providers	Contacts are obtained from medical records, counted and categorized.	From primary tympanoplasty to time of enrolment, up to 13 years
Number and type of interventions and/or procedures	Medical examinations, surgical procedures and hearing rehabilitation are obtained from medical records, counted and categorized.	From primary tympanoplasty to time of enrolment, up to 13 years
Number and type of medications and therapies	Medications are obtained from medical records, counted and categorized. Therapies from medical records are listed.	From primary tympanoplasty to time of enrolment, up to 13 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing performance assessed via an audiogram	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.	Pre-primary tympanoplasty
Hearing performance assessed via an audiogram	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.	Post- primary tympanoplasty during follow-up appointment (clinic dependent)
Hearing performance assessed via an audiogram	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.	Between 2018 and the time of enrolment
Health care costs	Direct medical costs associated to Chronic Otitis Media (COM)-related health care utilisation are obtained from medical records and calculated for each participant using unit cost in each participating country	From primary tympanoplasty to time of enrolment.
Socio-economic status and health care data via the Client Service Receipt Inventory (CSRI) survey	Demographic data, medical history, hearing rehabilitation, health care utilisation related to ear infection and hearing difficulties and employment information data are collected.	At enrolment
Self-reported health status and health related quality of life via the Health Utilities Index Mark III (HUI3) questionnaire.	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.	At enrolment
Self-reported health related quality of life of participants with COM via the Chronic Otitis Media Outcome Test-15 (COMOT-15) questionnaire.	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.	At enrolment
Self-reported auditory disability via the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) questionnaire	SSQ-12 measures speech, spatial and hearing experiences. The total 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".	At enrolment
Validation of the COMOT-15 questionnaire in French and Spanish	Questionnaire to be completed by a minimum of 30 participants per language with an accompanying audiogram done within 12 months of questionnaire completion. The Cronbach's alpha value of 0.7 is used as a cut-off to measure consistency between the data.	Within one year of questionnaire completion

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: QbD Clinical; Suministros Hospitalarios Medical Group
• Investigators: Study Director: Christiane D'hondt, Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): October 9, 2023
• Study Completion (Actual): October 9, 2023

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Primary tympanoplasty
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: CBAS5780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No