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

Overview

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.

Full Title of Study: “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”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Other
• Study Primary Completion Date: March 2023

Interventions

• Other: Questionnaires and survey
  • Questionnaires: Health Utilities Index Mark III, Chronic Otitis Media Outcome Test-15 and Speech, Spatial, and Qualities of Hearing Scale-12 Survey: Client Service Receipt Inventory (adapted version)

Clinical Trial Outcome Measures

Primary Measures

• Number and type of contacts with health care providers
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: 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 Measures

• Hearing performance assessed via an audiogram
  • Time Frame: Pre-primary tympanoplasty
  • 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.
• Hearing performance assessed via an audiogram
  • Time Frame: Post- primary tympanoplasty during follow-up appointment (clinic dependent)
  • 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.
• Hearing performance assessed via an audiogram
  • Time Frame: Between 2018 and the time of enrolment
  • 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
  • Time Frame: From primary tympanoplasty to time of enrolment.
  • 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
• Socio-economic status and health care data via the Client Service Receipt Inventory (CSRI) survey
  • Time Frame: 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.
  • Time Frame: 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.
  • Time Frame: 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
  • Time Frame: At enrolment
  • 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”.
• Validation of the COMOT-15 questionnaire in French and Spanish
  • Time Frame: Within one year of questionnaire completion
  • Questionnaire to be completed by a minimum of 30 participants per language with an accompanying audiogram done within 12 months of questionnaire completion and with completed SSQ-12 and HUI3 questionnaires. The Cronbach’s alpha value of 0.7 is used as a cut-off to measure consistency between the data.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Cochlear
• Collaborator
  • QbD Clinical
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Johan Blechert, Study Director, Cochlear
• Overall Contact(s)
  • Karin Ekström, +46317924400, kekstrom@cochlear.com