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The aim of this study is to provide baseline acute otitis media data in East European countries.
Each subject's involvement in this study will include a retrospective and prospective part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Subjects aged < 6 years who are registered in primary care clinics of any of the participating countries (Estonia, Lithuania, Poland, Romania and Slovenia). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection (Retrospective) | Other | For the retrospective part of the study, the parent(s)/ legally acceptable representative(s) of the subjects will be interviewed to collect information on factors potentially related to risk for middle ear diseases. The medical records of the subjects will also be reviewed and all acute otitis media related problems that occurred during the last year prior to enrolment (for subjects aged 1 to < 6 years) or since birth (for subjects aged < 1 year) will be recorded in the electronic case report form. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by a family physician and documented in medical records - retrospective part of the study | Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year | |
| Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by the physician or specialist - prospective part of the study | Prospective data for 12 months after study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of otitis media with effusion among acute otitis media cases aged < 6 years in the four consecutive seasons of the year | Prospective data for 12 months after study entry | |
| Occurrence of suspected acute otitis media as reported by the parent(s)/ legally acceptable representative(s) (and not diagnosed by any physician) during the bi-monthly follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects aged < 6 years who are registered in primary care clinics of any of the participating countries (Estonia, Lithuania, Poland, Romania and Slovenia) will be enrolled in this study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tallinn | 10621 | Estonia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27457584 | Derived | Usonis V, Jackowska T, Petraitiene S, Sapala A, Neculau A, Stryjewska I, Devadiga R, Tafalla M, Holl K. Incidence of acute otitis media in children below 6 years of age seen in medical practices in five East European countries. BMC Pediatr. 2016 Jul 26;16:108. doi: 10.1186/s12887-016-0638-2. |
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|
| Data collection (Prospective) | Other | For the prospective part of the study, the enrolled subjects will be followed up for a period of 1 year starting from the consent date, during which the parent(s)/ legally acceptable representative(s) will be asked to bring the subject for a visit each time they notice symptoms of acute otitis media or respiratory tract infection in the subject. In case AOM is diagnosed by the investigator, detailed information on the signs, symptoms, severity, course and treatment will be recorded. The parent(s)/ legally acceptable representative(s) of the subjects will also be required to fill up a parental quality of life questionnaire and an Otitis Media-6 children's quality of life questionnaire. |
|
| Prospective data for 12 months after study entry |
| Occurrence of recurrent acute otitis media | Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year and prospective data for 12 months after study entry |
| Occurrence of acute otitis media treatment failures | Prospective data for 12 months after study entry |
| Assessment of the impact of acute otitis media on the quality of life of the subject and family by the parental quality of life questionnaire and the Otitis Media-6 children's quality of life questionnaire | Prospective data for 12 months after study entry |
| Direct medical, direct non-medical costs and indirect medical costs of one incident of acute otitis media | Prospective data for 12 months after study entry |
| Occurrence of acute otitis media as diagnosed by the study physician or any other doctor | Prospective data for 12 months after study entry |
| Use of antimicrobial therapy and other forms of treatment for acute otitis media, diagnostic procedures | Prospective data for 12 months after study entry |
| Vilnius |
| LT-03147 |
| Lithuania |
| GSK Investigational Site | Vilnius | LT-04318 | Lithuania |
| GSK Investigational Site | Vilnius | LT-07156 | Lithuania |
| GSK Investigational Site | Bydgoszcz | 85-796 | Poland |
| GSK Investigational Site | Dębica | 39-200 | Poland |
| GSK Investigational Site | Katowice | 40-018 | Poland |
| GSK Investigational Site | Kielce | 25-711 | Poland |
| GSK Investigational Site | Siemianowice Śląskie | 41-103 | Poland |
| GSK Investigational Site | Tarnów | 33-100 | Poland |
| GSK Investigational Site | Warsaw | 01-809 | Poland |
| GSK Investigational Site | Wejherowo | 84-200 | Poland |
| GSK Investigational Site | Wola | 43-225 | Poland |
| GSK Investigational Site | Łęczna | 21-010 | Poland |
| GSK Investigational Site | Bacau | 600316 | Romania |
| GSK Investigational Site | Brasov | 500260 | Romania |
| GSK Investigational Site | Bucharest | 051821 | Romania |
| GSK Investigational Site | Craiova | 200128 | Romania |
| GSK Investigational Site | Galati | 800394 | Romania |
| GSK Investigational Site | Ljubljana | 1000 | Slovenia |
| GSK Investigational Site | Ljubljana | 1210 | Slovenia |
| GSK Investigational Site | Maribor | 2000 | Slovenia |
| GSK Investigational Site | Maribor | Slovenia |
| GSK Investigational Site | Ptuj | 2250 | Slovenia |
| GSK Investigational Site | Ruše | 2342 | Slovenia |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| D012189 | Retrospective Studies |
| D008137 | Longitudinal Studies |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D016022 | Case-Control Studies |
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D015331 | Cohort Studies |
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