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 Type
OBSERVATIONAL
Enrollment
69
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)
Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP
Le Kremlin-Bicêtre, France
ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan
Toulouse, France
Universitätsklinik für Hals-, Nasen und Ohrenheilkunde
Freiburg im Breisgau, Germany
Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg
Heidelberg, Germany
Number and Type of Contacts With Health Care Providers
Contacts are obtained from medical records, counted and categorized.
Time frame: 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.
Time frame: 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.
Time frame: From primary tympanoplasty to time of enrolment, up to 13 years
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.
Time frame: Up to 12 months prior to 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.
Time frame: Within 12 months after 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.
Time frame: Up to 6 years prior to study enrollment
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Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Health Care Costs
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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(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".
Time frame: At enrolment
Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish
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.
Time frame: At enrollment