Trial Outcomes & Findings for Retrospective Health Care Utilisation and Current Quality of Life in Adults With Chronic Otitis Media Who Had a Middle Ear Surgery (NCT NCT04864912)
NCT ID: NCT04864912
Last Updated: 2025-03-07
Results Overview
Contacts are obtained from medical records, counted and categorized.
Recruitment status
COMPLETED
Target enrollment
69 participants
Primary outcome timeframe
From primary tympanoplasty to time of enrolment, up to 13 years
Results posted on
2025-03-07
Participant Flow
Participant milestones
| Measure |
Observational Cohort
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.
|
|---|---|
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Overall Study
STARTED
|
69
|
|
Overall Study
COMPLETED
|
69
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Observational Cohort
n=69 Participants
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.
|
|---|---|
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Age, Continuous
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50.8 years
STANDARD_DEVIATION 18.08 • n=69 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=69 Participants
|
|
Diabetes
No
|
65 participants
n=69 Participants
|
|
Diabetes
Yes
|
4 participants
n=69 Participants
|
|
Turner Syndrome
No
|
69 participants
n=69 Participants
|
|
Turner Syndrome
Yes
|
0 participants
n=69 Participants
|
|
Cleft Palate
No
|
69 participants
n=69 Participants
|
|
Cleft Palate
Yes
|
0 participants
n=69 Participants
|
|
Down Syndrome
No
|
69 participants
n=69 Participants
|
|
Down Syndrome
Yes
|
0 participants
n=69 Participants
|
|
Cholesteatoma
No
|
33 participants
n=69 Participants
|
|
Cholesteatoma
Yes
|
36 participants
n=69 Participants
|
PRIMARY outcome
Timeframe: From primary tympanoplasty to time of enrolment, up to 13 yearsContacts are obtained from medical records, counted and categorized.
Outcome measures
| Measure |
Observational Cohort
n=69 Participants
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.
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|---|---|
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Number and Type of Contacts With Health Care Providers
Contact for 1 surgical procedure
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45 Participants
|
|
Number and Type of Contacts With Health Care Providers
Contact for 2 surgical procedures
|
14 Participants
|
|
Number and Type of Contacts With Health Care Providers
Contact for 3 surgical procedures
|
5 Participants
|
|
Number and Type of Contacts With Health Care Providers
Contact for 4 surgical procedures
|
3 Participants
|
|
Number and Type of Contacts With Health Care Providers
Contact for more than four surgical procedures
|
2 Participants
|
|
Number and Type of Contacts With Health Care Providers
Contact for 2 audiograms
|
45 Participants
|
|
Number and Type of Contacts With Health Care Providers
Contact for 3 audiograms
|
5 Participants
|
|
Number and Type of Contacts With Health Care Providers
Contact for 4 audiograms
|
3 Participants
|
|
Number and Type of Contacts With Health Care Providers
Contact for more than four audiograms
|
16 Participants
|
|
Number and Type of Contacts With Health Care Providers
1 other healthcare contacts
|
5 Participants
|
|
Number and Type of Contacts With Health Care Providers
2 other healthcare contacts
|
1 Participants
|
|
Number and Type of Contacts With Health Care Providers
3 other healthcare contacts
|
4 Participants
|
|
Number and Type of Contacts With Health Care Providers
4 other healthcare contacts
|
7 Participants
|
|
Number and Type of Contacts With Health Care Providers
More than 4 other healthcare contacts
|
36 Participants
|
PRIMARY outcome
Timeframe: From primary tympanoplasty to time of enrolment, up to 13 yearsMedical examinations, surgical procedures and hearing rehabilitation are obtained from medical records, counted and categorized.
Outcome measures
| Measure |
Observational Cohort
n=69 Participants
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.
|
|---|---|
|
Number and Type of Interventions and/or Procedures
CT scan of the temporal bone and/or sinuses
|
12 Participants
|
|
Number and Type of Interventions and/or Procedures
MRI of the temporal bone or the brain
|
23 Participants
|
|
Number and Type of Interventions and/or Procedures
another medical examination
|
14 Participants
|
|
Number and Type of Interventions and/or Procedures
primary tympanoplasty
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65 Participants
|
|
Number and Type of Interventions and/or Procedures
revision surgeries
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25 Participants
|
|
Number and Type of Interventions and/or Procedures
planned staged or second look surgeries
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18 Participants
|
PRIMARY outcome
Timeframe: From primary tympanoplasty to time of enrolment, up to 13 yearsMedications are obtained from medical records, counted and categorized. Therapies from medical records are listed.
Outcome measures
| Measure |
Observational Cohort
n=69 Participants
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.
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|---|---|
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Number and Type of Medications and Therapies
Antiinfective
|
20 Participants
|
|
Number and Type of Medications and Therapies
Analgesics and anesthetics
|
1 Participants
|
|
Number and Type of Medications and Therapies
Anilides
|
14 Participants
|
|
Number and Type of Medications and Therapies
Antivertigo preparations
|
3 Participants
|
|
Number and Type of Medications and Therapies
Benzodiazepine derivatives
|
1 Participants
|
|
Number and Type of Medications and Therapies
Combinations of penicillins, incl. beta-lactamase inhibitors
|
4 Participants
|
|
Number and Type of Medications and Therapies
Corticosteroids
|
5 Participants
|
|
Number and Type of Medications and Therapies
Corticosteroids and antiinfectives in combination
|
12 Participants
|
|
Number and Type of Medications and Therapies
Fluoroquinolones
|
3 Participants
|
|
Number and Type of Medications and Therapies
Glucocorticoids
|
5 Participants
|
|
Number and Type of Medications and Therapies
Macrolides
|
1 Participants
|
|
Number and Type of Medications and Therapies
Other otologicals
|
2 Participants
|
|
Number and Type of Medications and Therapies
Other cicatrizants
|
1 Participants
|
|
Number and Type of Medications and Therapies
Other opioids
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6 Participants
|
|
Number and Type of Medications and Therapies
Penicillins with extended spectrum
|
2 Participants
|
|
Number and Type of Medications and Therapies
Pyrazolones
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months prior to primary tympanoplastyPopulation: Bone conduction studies were not carried out for all participants
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.
Outcome measures
| Measure |
Observational Cohort
n=69 Participants
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.
|
|---|---|
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Hearing Performance Assessed Via an Audiogram
Air Conduction
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53.2 db HL (decibel hearing loss)
Standard Deviation 19.64
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|
Hearing Performance Assessed Via an Audiogram
Bone Conduction
|
23.8 db HL (decibel hearing loss)
Standard Deviation 14.76
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SECONDARY outcome
Timeframe: Within 12 months after primary tympanoplastyPopulation: Bone conduction studies were not carried out for all participants
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.
Outcome measures
| Measure |
Observational Cohort
n=69 Participants
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.
|
|---|---|
|
Hearing Performance Assessed Via an Audiogram
Air Conduction
|
58.7 db HL (decibel hearing loss)
Standard Deviation 14.9
|
|
Hearing Performance Assessed Via an Audiogram
Bone conduction
|
25.3 db HL (decibel hearing loss)
Standard Deviation 14.85
|
SECONDARY outcome
Timeframe: Up to 6 years prior to study enrollmentPopulation: Bone conduction studies were not carried out for all participants
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.
Outcome measures
| Measure |
Observational Cohort
n=69 Participants
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.
|
|---|---|
|
Hearing Performance Assessed Via an Audiogram
Air conduction
|
56.7 db HL (decibel hearing loss)
Standard Deviation 21.16
|
|
Hearing Performance Assessed Via an Audiogram
Bone conduction
|
25.2 db HL (decibel hearing loss)
Standard Deviation 13.89
|
SECONDARY outcome
Timeframe: From primary tympanoplasty to time of enrolment.Population: A small number of DRG codes from only a single clinic were reported in this study. A cost could not be directly linked to these codes as the hospitals negotiate the tariffs with the health insurers and these tariffs are not made public. Hence, despite having collected a small number of codes, the health care costs could not be calculated, and results are not available for this outcome measure.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At enrolmentDemographic data, medical history, hearing rehabilitation, health care utilisation related to ear infection and hearing difficulties and employment information data are collected.
Outcome measures
| Measure |
Observational Cohort
n=69 Participants
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.
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|---|---|
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Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
part-time employment
|
5 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
married/living as married
|
41 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
single
|
14 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
widowed
|
7 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
divorced/separated
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6 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
living with spouse/partner and children
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24 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
living with spouse/partner without children
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19 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
living alone
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13 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
living with their parents
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6 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
lived in other conditions
|
6 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
place of residence was an owner occupied flat/house
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44 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
place of residence was a privately rented flat/house
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15 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
place of residence was a flat/house rented from a local authority or housing association
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4 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
other places of residence
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5 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
highest level of education was university or higher
|
20 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
highest level of education was high school
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19 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
highest level of education was vocational training
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17 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
highest level of education was primary school
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12 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
high blood pressure
|
12 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
autoimmune disease
|
4 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
cancer
|
1 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
heart disease
|
5 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
diabetes
|
4 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
chronic lung disease
|
4 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
chronic kidney disease
|
2 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
mood disorders
|
8 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
substance dependency
|
1 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
other chronic disease
|
13 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
never smoked
|
39 Participants
|
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Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
current smokers
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16 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
previous smokers
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13 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
full-time employment
|
31 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
retired
|
20 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
retired (because of ill health), unemployed, student or housewife/husband
|
2 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
self-employed
|
1 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
currently use a hearing aid or hearing device
|
31 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
bone conduction implant
|
7 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
visited a general practitioner
|
21 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
attended a day hospital or accident and emergency
|
2 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
visited an ENT
|
31 Participants
|
|
Socio-economic Status and Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Visited audiologist
|
14 Participants
|
SECONDARY outcome
Timeframe: At enrolmentHUI 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.
Outcome measures
| Measure |
Observational Cohort
n=67 Participants
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.
|
|---|---|
|
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
Overall
|
0.7 score on a scale
Standard Deviation 0.28
|
|
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
Vision
|
0.9 score on a scale
Standard Deviation 0.17
|
|
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
Hearing
|
0.8 score on a scale
Standard Deviation 0.29
|
|
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
Speech
|
0.9 score on a scale
Standard Deviation 0.15
|
|
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
Dexterity
|
1 score on a scale
Standard Deviation 0.11
|
|
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
Emotion
|
0.9 score on a scale
Standard Deviation 0.16
|
|
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
Cognition
|
0.9 score on a scale
Standard Deviation 0.14
|
|
Self-reported Health Status and Health Related Quality of Life Via the Health Utilities Index Mark III (HUI3) Questionnaire.
Pain
|
0.9 score on a scale
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: At enrolmentCOMOT-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.
Outcome measures
| Measure |
Observational Cohort
n=68 Participants
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.
|
|---|---|
|
Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire.
Overall
|
43 units on a scale
Standard Deviation 18.25
|
|
Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire.
Ear symptoms
|
29.4 units on a scale
Standard Deviation 20.28
|
|
Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire.
Hearing function
|
65 units on a scale
Standard Deviation 22.84
|
|
Self-reported Health Related Quality of Life of Participants With COM Via the Chronic Otitis Media Outcome Test-15 (COMOT-15) Questionnaire.
Mental Health
|
46.5 units on a scale
Standard Deviation 27.31
|
SECONDARY outcome
Timeframe: At enrolmentSSQ-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".
Outcome measures
| Measure |
Observational Cohort
n=65 Participants
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.
|
|---|---|
|
Self-reported Auditory Disability Via the Speech, Spatial and Qualities of Hearing Scale (SSQ-12) Questionnaire
|
5.5 score on a scale
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: At enrollmentPopulation: Participants only completed the questionnaire in one language and one participant in the study did not complete the questionnaire.
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.
Outcome measures
| Measure |
Observational Cohort
n=68 Participants
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.
|
|---|---|
|
Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish
German
|
36.8 score on a scale (0-100)
Standard Deviation 14.76
|
|
Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish
French
|
46.3 score on a scale (0-100)
Standard Deviation 22.73
|
|
Chronic Otitis Media Outcome Test -15 (COMOT-15) Questionnaire in German, French and Spanish
Spanish
|
45 score on a scale (0-100)
Standard Deviation 17.12
|
Adverse Events
Observational Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first publication would be a joint publication covering data from all centers, and subsequent publications will refer to that first publication. Investigators can publish or present after agreement between the Coordinating and Principal Investigators, and the Sponsor after the main publication is submitted and approved. Conference presentations or publications must be sent for review at least to the Sponsor 30 - 60 days (site-specific) prior to submission or presentation.
- Publication restrictions are in place
Restriction type: OTHER