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| Name | Class |
|---|---|
| QbD Clinical | INDUSTRY |
| Suministros Hospitalarios Medical Group | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires and survey | Other | 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) |
| 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 |
| 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. | Up to 12 months prior to primary tympanoplasty |
| Hearing Performance Assessed Via an Audiogram |
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Inclusion Criteria:
Exclusion Criteria:
For France only:
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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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| Name | Affiliation | Role |
|---|---|---|
| Christiane D'hondt | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP | Le Kremlin-Bicêtre | 94275 | France | |||
| ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Type of Contacts With Health Care Providers | Contacts are obtained from medical records, counted and categorized. | Posted | Count of Participants | Participants | From primary tympanoplasty to time of enrolment, up to 13 years |
|
|
Not applicable. Survey administered at a single timepoint and retrospective chart review design.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed due to cross-sectional and retrospective chart review study design.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist | Cochlear | +61 2 9428 6555 | cltd-prs-admin@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2022 | Oct 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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. |
| 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. | Up to 6 years prior to study enrollment |
| 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 | 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(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". | 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. | At enrollment |
| Toulouse |
| 31059 |
| France |
| Universitätsklinik für Hals-, Nasen und Ohrenheilkunde | Freiburg im Breisgau | 79106 | Germany |
| Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Hospital Universitario Donostia | Donostia / San Sebastian | 20080 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Diabetes | Number | participants |
|
| Turner Syndrome | Number | participants |
|
| Cleft Palate | Number | participants |
|
| Down Syndrome | Number | participants |
|
| Cholesteatoma | Number | participants |
|
|
| Primary | Number and Type of Interventions and/or Procedures | Medical examinations, surgical procedures and hearing rehabilitation are obtained from medical records, counted and categorized. | Posted | Count of Participants | Participants | From primary tympanoplasty to time of enrolment, up to 13 years |
|
|
|
| Primary | Number and Type of Medications and Therapies | Medications are obtained from medical records, counted and categorized. Therapies from medical records are listed. | Posted | Count of Participants | Participants | From primary tympanoplasty to time of enrolment, up to 13 years |
|
|
|
| Secondary | 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. | Bone conduction studies were not carried out for all participants | Posted | Mean | Standard Deviation | db HL (decibel hearing loss) | Up to 12 months prior to primary tympanoplasty |
|
|
|
| Secondary | 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. | Bone conduction studies were not carried out for all participants | Posted | Mean | Standard Deviation | db HL (decibel hearing loss) | Within 12 months after primary tympanoplasty |
|
|
|
| Secondary | 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. | Bone conduction studies were not carried out for all participants | Posted | Mean | Standard Deviation | db HL (decibel hearing loss) | Up to 6 years prior to study enrollment |
|
|
|
| Secondary | 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 | 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. | Posted | From primary tympanoplasty to time of enrolment. |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At enrolment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At enrolment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | At enrolment |
|
|
|
| Secondary | 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". | Posted | Mean | Standard Deviation | score on a scale | At enrolment |
|
|
|
| Secondary | 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. | Participants only completed the questionnaire in one language and one participant in the study did not complete the questionnaire. | Posted | Mean | Standard Deviation | score on a scale (0-100) | At enrollment |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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.
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Title | Measurements |
|---|---|
|
| primary tympanoplasty |
|
| revision surgeries |
|
| planned staged or second look surgeries |
|
| Title | Measurements |
|---|
|
| Antivertigo preparations |
|
| Benzodiazepine derivatives |
|
| Combinations of penicillins, incl. beta-lactamase inhibitors |
|
| Corticosteroids |
|
| Corticosteroids and antiinfectives in combination |
|
| Fluoroquinolones |
|
| Glucocorticoids |
|
| Macrolides |
|
| Other otologicals |
|
| Other cicatrizants |
|
| Other opioids |
|
| Penicillins with extended spectrum |
|
| Pyrazolones |
|
|
|
|
| Title | Measurements |
|---|---|
|
| divorced/separated |
|
| living with spouse/partner and children |
|
| living with spouse/partner without children |
|
| living alone |
|
| living with their parents |
|
| lived in other conditions |
|
| place of residence was an owner occupied flat/house |
|
| place of residence was a privately rented flat/house |
|
| place of residence was a flat/house rented from a local authority or housing association |
|
| other places of residence |
|
| highest level of education was university or higher |
|
| highest level of education was high school |
|
| highest level of education was vocational training |
|
| highest level of education was primary school |
|
| high blood pressure |
|
| autoimmune disease |
|
| cancer |
|
| heart disease |
|
| diabetes |
|
| chronic lung disease |
|
| chronic kidney disease |
|
| mood disorders |
|
| substance dependency |
|
| other chronic disease |
|
| never smoked |
|
| current smokers |
|
| previous smokers |
|
| full-time employment |
|
| retired |
|
| part-time employment |
|
| retired (because of ill health), unemployed, student or housewife/husband |
|
| self-employed |
|
| currently use a hearing aid or hearing device |
|
| bone conduction implant |
|
| visited a general practitioner |
|
| attended a day hospital or accident and emergency |
|
| visited an ENT |
|
| Visited audiologist |
|
| Title | Measurements |
|---|---|
|
| Speech |
|
| Dexterity |
|
| Emotion |
|
| Cognition |
|
| Pain |
|
| Title | Measurements |
|---|---|
|
| Mental Health |
|
|
| Spanish |
|
|