ID

32294

Descripción

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT00466947 Clinicaltrials.gov Identifier: NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains the form of acute otitis media (AOM). It has to be filled in if an AOM case is confirmed during study. It's only for workbook 2.

Link

https://clinicaltrials.gov/ct2/show/NCT00466947

Palabras clave

Versiones (2)
  1. 25/10/18 25/10/18 -
  2. 26/10/18 26/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de octubre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    Vaccination against pneumonia and otitis media, NCT00466947

    Inglés

    AOM

    1 formularios  
    1. StudyEvent: ODM
      1. AOM
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Descripción

    Subject number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of AOM suspicion case
    Descripción

    Date by when AOM was suspected or by when the general physician diagnosed

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0205178
    UMLS CUI [1,2]
    C0029882
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0242114
    Case number
    Descripción

    Case number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1698493
    UMLS CUI [1,2]
    C0600091
    HEALTH CARE FACILITIES
    Descripción

    HEALTH CARE FACILITIES

    Alias
    UMLS CUI-1
    C0018704
    In which health care facilities Acute Otitis Media (AOM) was detected? Ambulatory / Outpatient
    Descripción

    Health care facility: Ambulatory / Outpatient

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1511790
    UMLS CUI [1,2]
    C0205178
    UMLS CUI [1,3]
    C0029882
    UMLS CUI [1,4]
    C0018704
    UMLS CUI [2]
    C0439841
    UMLS CUI [3]
    C0029921
    In which health care facilities Acute Otitis Media (AOM) was detected? Emergency room
    Descripción

    Health care facility: Emergency room

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1511790
    UMLS CUI [1,2]
    C0205178
    UMLS CUI [1,3]
    C0029882
    UMLS CUI [1,4]
    C0018704
    UMLS CUI [2]
    C0583237
    In which health care facilities Acute Otitis Media (AOM) was detected? Hospital
    Descripción

    Health care facility: Hospital

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1511790
    UMLS CUI [1,2]
    C0205178
    UMLS CUI [1,3]
    C0029882
    UMLS CUI [1,4]
    C0018704
    UMLS CUI [2]
    C0019994
    In which health care facilities Acute Otitis Media (AOM) was detected? Other
    Descripción

    Health care facility: Other

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1511790
    UMLS CUI [1,2]
    C0205178
    UMLS CUI [1,3]
    C0029882
    UMLS CUI [1,4]
    C0018704
    UMLS CUI [2]
    C0205394
    If there is an other health care facility please specify
    Descripción

    Other health care facility

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0018704
    UMLS CUI [1,2]
    C0205394
    Has the patient been hospitalized due to this AOM case?
    Descripción

    Hospitalization of patient during AOM case

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0205178
    UMLS CUI [1,4]
    C0029882
    If the patient was hospitalized please note number of days
    Descripción

    Not necessarily consecutive days

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0019993
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C0439228
    PRIMARY HEALTH CARE PHYSICIAN CLINICAL ASSESSMENT
    Descripción

    PRIMARY HEALTH CARE PHYSICIAN CLINICAL ASSESSMENT

    Alias
    UMLS CUI-1
    C0033131
    UMLS CUI-2
    C3845884
    Has a primary health care physician done an assessment?
    Descripción

    If yes please complete below

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0033131
    UMLS CUI [1,2]
    C3845884
    Clinical signs and symptoms noted at the primary health care physician assessment
    Descripción

    Clinical signs and symptoms

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0033131
    UMLS CUI [1,3]
    C1516048
    The visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)
    Descripción

    visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0041445
    UMLS CUI [1,3]
    C0700364
    UMLS CUI [2]
    C0332575
    UMLS CUI [3]
    C0857010
    UMLS CUI [4]
    C0576887
    The presence of middle ear fluid effusion (as demonstrated by simple or pneumatic otoscopy or by microscopy)
    Descripción

    middle ear fluid effusion (simple or pneumatic otoscopy or by microscopy)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0037088
    UMLS CUI [2]
    C0456498
    UMLS CUI [3]
    C1112284
    UMLS CUI [4]
    C0444678
    UMLS CUI [5]
    C0026018
    Fever
    Descripción

    At least two of the signs and symptoms listed below presented during the 5 days previous of the first consultation. Fever is defined as: Axillary > 37.5°C Oral > 37.5°C Rectal > 38° C Tympanic (oral conversion) > 37.5°C Tympanic (rectal conversion) > 38° C

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0015967
    If Fever, measurement
    Descripción

    Fever measurement

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C0242485
    °C
    measurement location/route
    Descripción

    Measurement location

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0449687
    UMLS CUI [1,2]
    C0005903
    Ear pain
    Descripción

    At least two of the signs and symptoms listed below presented during the 5 days previous of the first consultation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0013456
    Ear discharge
    Descripción

    At least two of the signs and symptoms listed below presented during the 5 days previous of the first consultation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0155540
    Hearing loss
    Descripción

    At least two of the signs and symptoms listed below presented during the 5 days previous of the first consultation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C3887873
    Lethargy
    Descripción

    At least two of the signs and symptoms listed below presented during the 5 days previous of the first consultation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0023380
    Irritability
    Descripción

    At least two of the signs and symptoms listed below presented during the 5 days previous of the first consultation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0022107
    Anorexia
    Descripción

    At least two of the signs and symptoms listed below presented during the 5 days previous of the first consultation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0003123
    Vomiting
    Descripción

    At least two of the signs and symptoms listed below presented during the 5 days previous of the first consultation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0042963
    Diarrhoea
    Descripción

    At least two of the signs and symptoms listed below presented during the 5 days previous of the first consultation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0011991
    PRIMARY HEALTH CARE PHYSICIAN ASSESSMENT OF AOM SEVERITY
    Descripción

    PRIMARY HEALTH CARE PHYSICIAN ASSESSMENT OF AOM SEVERITY

    Alias
    UMLS CUI-1
    C0033131
    UMLS CUI-2
    C1516048
    UMLS CUI-3
    C0439793
    UMLS CUI-4
    C0205178
    UMLS CUI-5
    C0029882
    Temperature
    Descripción

    (at the time of consultation)

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    measurement location/route
    Descripción

    Measurement location

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0449687
    UMLS CUI [1,2]
    C0005903
    Irritability severity
    Descripción

    Irritability

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0022107
    UMLS CUI [1,2]
    C0439793
    If occasional/frequent, specify severity
    Descripción

    Severity of occasional/frequent

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0439793
    Ear Ache
    Descripción

    Ear Ache

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0013456
    Tugging
    Descripción

    Pulling at ears

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0847233
    Feeding
    Descripción

    Feeding

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0015745
    Sleeping
    Descripción

    Sleeping

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0474396
    CLINICAL SIGNS NOTED DURING OTOSCOPY AT THE ENT SPECIALIST ASSESSMENT
    Descripción

    CLINICAL SIGNS NOTED DURING OTOSCOPY AT THE ENT SPECIALIST ASSESSMENT

    Alias
    UMLS CUI-1
    C0037088
    UMLS CUI-2
    C1112284
    UMLS CUI-3
    C0150934
    UMLS CUI-4
    C2348234
    UMLS CUI-5
    C3845884
    Was the child seen by ENT?
    Descripción

    If yes please complete below

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0150934
    The visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)
    Descripción

    visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0041445
    UMLS CUI [1,3]
    C0700364
    UMLS CUI [2]
    C0332575
    UMLS CUI [3]
    C0857010
    UMLS CUI [4]
    C0576887
    The presence of middle ear fluid effusion (as demonstrated by simple or pneumatic otoscopy or by microscopy)
    Descripción

    middle ear fluid effusion (simple or pneumatic otoscopy or by microscopy)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0037088
    UMLS CUI [2]
    C0456498
    UMLS CUI [3]
    C1112284
    UMLS CUI [4]
    C0444678
    UMLS CUI [5]
    C0026018
    OTOSCOPY
    Descripción

    OTOSCOPY

    Alias
    UMLS CUI-1
    C1112284
    Side of otoscopy
    Descripción

    Side of otoscopy

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0441987
    UMLS CUI [1,2]
    C1112284
    Does the ENT specialist clinically confirm AOM?
    Descripción

    Please tick for both sides (right and left)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0205178
    UMLS CUI [1,2]
    C0029882
    UMLS CUI [1,3]
    C0750484
    ENT ASSESSMENT
    Descripción

    ENT ASSESSMENT

    Alias
    UMLS CUI-1
    C0150934
    UMLS CUI-2
    C1516048
    Side of ENT assessment
    Descripción

    Only applicable if ENT specialist clinically confirms AOM

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0441987
    UMLS CUI [1,2]
    C0150934
    UMLS CUI [1,3]
    C1516048
    Appearance of ENT assessment
    Descripción

    Please tick for each side (right and left)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1148438
    UMLS CUI [1,2]
    C0150934
    UMLS CUI [1,3]
    C1516048
    Severity of apperance
    Descripción

    Please tick for each side (right and left)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0439793
    UMLS CUI [1,2]
    C1148438
    Spontaneous perforation
    Descripción

    Spontaneous perforation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0205359
    UMLS CUI [1,2]
    C0549099
    GRADE
    Descripción

    GRADE

    Alias
    UMLS CUI-1
    C0441800
    Side of grade
    Descripción

    Side of grade

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0441987
    UMLS CUI [1,2]
    C0441800
    OS-8 Scale (Friedman/McCormick scale)
    Descripción

    Tick only one. Reminder: A tympanocentesis must be proposed above grade 4.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0681889
    UMLS CUI [1,2]
    C0041445
    UMLS CUI [1,3]
    C0441469
    EAR, NOSE AND THROAT (ENT) CLINICAL SPECIALIST ASSESSMENT
    Descripción

    EAR, NOSE AND THROAT (ENT) CLINICAL SPECIALIST ASSESSMENT

    Alias
    UMLS CUI-1
    C0150934
    UMLS CUI-2
    C2348234
    UMLS CUI-3
    C3845884
    Middle ear fluid (MEF) - side
    Descripción

    Only applicable if ENT specialist clinically confirms AOM. Please tick all that apply in the following for each side.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0456498
    UMLS CUI [1,2]
    C0441987
    Has a MEF sample been collected?
    Descripción

    MEF sample collection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0456498
    UMLS CUI [1,2]
    C0200345
    If MEF sample has been collected, date of Informed Consent
    Descripción

    MEF sample collection, Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0456498
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0021430
    UMLS CUI [1,4]
    C0011008
    How has MEF sample been collected?
    Descripción

    Way of MEF sample collection

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0456498
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0184661
    If spontaneous drainage, date by when it started
    Descripción

    Start of spontaneous drainage

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0205359
    UMLS CUI [1,3]
    C0012621
    How was the macroscopic aspect of the fluid? Serous
    Descripción

    Tick all applicable

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0456498
    UMLS CUI [1,2]
    C0440743
    How was the macroscopic aspect of the fluid? Bloody
    Descripción

    Macroscopic aspect of fluid: Bloody

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0456498
    UMLS CUI [1,2]
    C0333275
    How was the macroscopic aspect of the fluid? Purulent
    Descripción

    Macroscopic aspect of fluid: Purulent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0456498
    UMLS CUI [1,2]
    C0439665
    How was the macroscopic aspect of the fluid? Other
    Descripción

    Macroscopic aspect of fluid: Other

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0456498
    UMLS CUI [1,2]
    C0205394
    If other macroscopic aspect of fluid
    Descripción

    Please specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0456498
    UMLS CUI [1,2]
    C0205394
    Results
    Descripción

    Results

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1254595
    If positive please tick that apply
    Descripción

    Positive results

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1254595
    Streptococcus pneumoniae, sample code
    Descripción

    Several codes are possible. Reminder: Please send the identified bacteria sample to the Reference lab for confirmation.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0038410
    UMLS CUI [1,2]
    C0805701
    Haemophilus influenzae, sample code
    Descripción

    Several codes are possible. Reminder: Please send the identified bacteria sample to the Reference lab for confirmation.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0018483
    UMLS CUI [1,2]
    C0805701
    Other results
    Descripción

    Please specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C1254595
    Did the subject take antibiotic before the sample was obtained?
    Descripción

    Applicable only if a MEF sample has been collected.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0338237
    MEDICATION
    Descripción

    MEDICATION

    Alias
    UMLS CUI-1
    C0013227
    Has any medication been administered due to this AOM case?
    Descripción

    If yes please complete the following items.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0205178
    UMLS CUI [1,2]
    C0029882
    UMLS CUI [1,3]
    C0013227
    Trade/Generic name of medication
    Descripción

    Trade/Generic name of medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065
    Reason for medication
    Descripción

    Reason for medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Route of medication
    Descripción

    Route of medication

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013153
    Total daily dose
    Descripción

    Total daily dose

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348070
    Start date of medication
    Descripción

    Start date of medication

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    End date of medication
    Descripción

    tick following box if continuing

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Medication continuing
    Descripción

    Medication continuing

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
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    Similar models

    AOM

    1 formularios
    1. StudyEvent: ODM
      1. AOM
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Date of AOM suspicion case
    Item
    Date of AOM suspicion case
    date
    C0205178 (UMLS CUI [1,1])
    C0029882 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0242114 (UMLS CUI [1,4])
    Case number
    Item
    Case number
    integer
    C1698493 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    HEALTH CARE FACILITIES
    C0018704 (UMLS CUI-1)
    Health care facility: Ambulatory / Outpatient
    Item
    In which health care facilities Acute Otitis Media (AOM) was detected? Ambulatory / Outpatient
    boolean
    C1511790 (UMLS CUI [1,1])
    C0205178 (UMLS CUI [1,2])
    C0029882 (UMLS CUI [1,3])
    C0018704 (UMLS CUI [1,4])
    C0439841 (UMLS CUI [2])
    C0029921 (UMLS CUI [3])
    Health care facility: Emergency room
    Item
    In which health care facilities Acute Otitis Media (AOM) was detected? Emergency room
    boolean
    C1511790 (UMLS CUI [1,1])
    C0205178 (UMLS CUI [1,2])
    C0029882 (UMLS CUI [1,3])
    C0018704 (UMLS CUI [1,4])
    C0583237 (UMLS CUI [2])
    Health care facility: Hospital
    Item
    In which health care facilities Acute Otitis Media (AOM) was detected? Hospital
    boolean
    C1511790 (UMLS CUI [1,1])
    C0205178 (UMLS CUI [1,2])
    C0029882 (UMLS CUI [1,3])
    C0018704 (UMLS CUI [1,4])
    C0019994 (UMLS CUI [2])
    Health care facility: Other
    Item
    In which health care facilities Acute Otitis Media (AOM) was detected? Other
    boolean
    C1511790 (UMLS CUI [1,1])
    C0205178 (UMLS CUI [1,2])
    C0029882 (UMLS CUI [1,3])
    C0018704 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [2])
    Other health care facility
    Item
    If there is an other health care facility please specify
    text
    C0018704 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Hospitalization of patient during AOM case
    Item
    Has the patient been hospitalized due to this AOM case?
    boolean
    C0019993 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0205178 (UMLS CUI [1,3])
    C0029882 (UMLS CUI [1,4])
    Number of days in hospital
    Item
    If the patient was hospitalized please note number of days
    integer
    C0019993 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0439228 (UMLS CUI [1,3])
    Item Group
    PRIMARY HEALTH CARE PHYSICIAN CLINICAL ASSESSMENT
    C0033131 (UMLS CUI-1)
    C3845884 (UMLS CUI-2)
    Has a primary health care physician done an assessment?
    Item
    Has a primary health care physician done an assessment?
    boolean
    C0033131 (UMLS CUI [1,1])
    C3845884 (UMLS CUI [1,2])
    Clinical signs and symptoms
    Item
    Clinical signs and symptoms noted at the primary health care physician assessment
    boolean
    C0037088 (UMLS CUI [1,1])
    C0033131 (UMLS CUI [1,2])
    C1516048 (UMLS CUI [1,3])
    visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)
    Item
    The visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)
    boolean
    C0037088 (UMLS CUI [1,1])
    C0041445 (UMLS CUI [1,2])
    C0700364 (UMLS CUI [1,3])
    C0332575 (UMLS CUI [2])
    C0857010 (UMLS CUI [3])
    C0576887 (UMLS CUI [4])
    middle ear fluid effusion (simple or pneumatic otoscopy or by microscopy)
    Item
    The presence of middle ear fluid effusion (as demonstrated by simple or pneumatic otoscopy or by microscopy)
    boolean
    C0037088 (UMLS CUI [1])
    C0456498 (UMLS CUI [2])
    C1112284 (UMLS CUI [3])
    C0444678 (UMLS CUI [4])
    C0026018 (UMLS CUI [5])
    Symptoms: Fever
    Item
    Fever
    boolean
    C1457887 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Fever measurement
    Item
    If Fever, measurement
    float
    C0015967 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Item
    measurement location/route
    text
    C0449687 (UMLS CUI [1,1])
    C0005903 (UMLS CUI [1,2])
    Measurement location
    Code List
    measurement location/route
    CL Item
    Axillary (A)
    CL Item
    Oral (O)
    CL Item
    Rectal (R)
    Symptoms: Ear pain
    Item
    Ear pain
    boolean
    C1457887 (UMLS CUI [1,1])
    C0013456 (UMLS CUI [1,2])
    Symptoms: Ear discharge
    Item
    Ear discharge
    boolean
    C1457887 (UMLS CUI [1,1])
    C0155540 (UMLS CUI [1,2])
    Symptoms: Hearing loss
    Item
    Hearing loss
    boolean
    C1457887 (UMLS CUI [1,1])
    C3887873 (UMLS CUI [1,2])
    Symptoms: Lethargy
    Item
    Lethargy
    boolean
    C1457887 (UMLS CUI [1,1])
    C0023380 (UMLS CUI [1,2])
    Symptoms: Irritability
    Item
    Irritability
    boolean
    C1457887 (UMLS CUI [1,1])
    C0022107 (UMLS CUI [1,2])
    Symptoms: Anorexia
    Item
    Anorexia
    boolean
    C1457887 (UMLS CUI [1,1])
    C0003123 (UMLS CUI [1,2])
    Symptoms: Vomiting
    Item
    Vomiting
    boolean
    C1457887 (UMLS CUI [1,1])
    C0042963 (UMLS CUI [1,2])
    Symptoms: Diarrhoea
    Item
    Diarrhoea
    boolean
    C1457887 (UMLS CUI [1,1])
    C0011991 (UMLS CUI [1,2])
    Item Group
    PRIMARY HEALTH CARE PHYSICIAN ASSESSMENT OF AOM SEVERITY
    C0033131 (UMLS CUI-1)
    C1516048 (UMLS CUI-2)
    C0439793 (UMLS CUI-3)
    C0205178 (UMLS CUI-4)
    C0029882 (UMLS CUI-5)
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    measurement location/route
    text
    C0449687 (UMLS CUI [1,1])
    C0005903 (UMLS CUI [1,2])
    Measurement location
    Code List
    measurement location/route
    CL Item
    Axillary (A)
    CL Item
    Oral (O)
    CL Item
    Rectal (R)
    Item
    Irritability severity
    integer
    C0022107 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    Irritability
    Code List
    Irritability severity
    CL Item
    Absent (1)
    CL Item
    Occasional (2)
    CL Item
    Frequent (3)
    Item
    If occasional/frequent, specify severity
    integer
    C0439793 (UMLS CUI [1])
    Severity of occasional/frequent
    Code List
    If occasional/frequent, specify severity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Ear Ache
    integer
    C0013456 (UMLS CUI [1])
    undefined item
    Code List
    Ear Ache
    CL Item
    Absent (1)
    CL Item
    Occasional (2)
    CL Item
    Frequent (3)
    Item
    Tugging
    integer
    C0847233 (UMLS CUI [1])
    Tugging
    Code List
    Tugging
    CL Item
    Absent (1)
    CL Item
    Mild (2)
    CL Item
    Moderate (3)
    CL Item
    Severe (4)
    Item
    Feeding
    integer
    C0015745 (UMLS CUI [1])
    Feeding
    Code List
    Feeding
    CL Item
    Feeds well (1)
    CL Item
    Mild (2)
    CL Item
    Very poor appetite (3)
    Item
    Sleeping
    integer
    C0474396 (UMLS CUI [1])
    Sleeping
    Code List
    Sleeping
    CL Item
    Normal (1)
    CL Item
    Some restless (2)
    CL Item
    Very poor sleep (3)
    Item Group
    CLINICAL SIGNS NOTED DURING OTOSCOPY AT THE ENT SPECIALIST ASSESSMENT
    C0037088 (UMLS CUI-1)
    C1112284 (UMLS CUI-2)
    C0150934 (UMLS CUI-3)
    C2348234 (UMLS CUI-4)
    C3845884 (UMLS CUI-5)
    ENT
    Item
    Was the child seen by ENT?
    boolean
    C0150934 (UMLS CUI [1])
    visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)
    Item
    The visual appearance of the tympanic membrane (i.e. redness, bulging, loss of light reflex)
    boolean
    C0037088 (UMLS CUI [1,1])
    C0041445 (UMLS CUI [1,2])
    C0700364 (UMLS CUI [1,3])
    C0332575 (UMLS CUI [2])
    C0857010 (UMLS CUI [3])
    C0576887 (UMLS CUI [4])
    middle ear fluid effusion (simple or pneumatic otoscopy or by microscopy)
    Item
    The presence of middle ear fluid effusion (as demonstrated by simple or pneumatic otoscopy or by microscopy)
    boolean
    C0037088 (UMLS CUI [1])
    C0456498 (UMLS CUI [2])
    C1112284 (UMLS CUI [3])
    C0444678 (UMLS CUI [4])
    C0026018 (UMLS CUI [5])
    Item Group
    OTOSCOPY
    C1112284 (UMLS CUI-1)
    Item
    Side of otoscopy
    text
    C0441987 (UMLS CUI [1,1])
    C1112284 (UMLS CUI [1,2])
    Side of otoscopy
    Code List
    Side of otoscopy
    CL Item
    Right side (R)
    CL Item
    Left side (L)
    AOM confirm
    Item
    Does the ENT specialist clinically confirm AOM?
    boolean
    C0205178 (UMLS CUI [1,1])
    C0029882 (UMLS CUI [1,2])
    C0750484 (UMLS CUI [1,3])
    Item Group
    ENT ASSESSMENT
    C0150934 (UMLS CUI-1)
    C1516048 (UMLS CUI-2)
    Item
    Side of ENT assessment
    text
    C0441987 (UMLS CUI [1,1])
    C0150934 (UMLS CUI [1,2])
    C1516048 (UMLS CUI [1,3])
    Side of ENT assessment
    Code List
    Side of ENT assessment
    CL Item
    right (R)
    CL Item
    left (L)
    Item
    Appearance of ENT assessment
    text
    C1148438 (UMLS CUI [1,1])
    C0150934 (UMLS CUI [1,2])
    C1516048 (UMLS CUI [1,3])
    Appearance of ENT assessment
    Code List
    Appearance of ENT assessment
    CL Item
    Redness (1)
    CL Item
    Bulging (2)
    Item
    Severity of apperance
    text
    C0439793 (UMLS CUI [1,1])
    C1148438 (UMLS CUI [1,2])
    Severity of apperance
    Code List
    Severity of apperance
    CL Item
    Absent (1)
    CL Item
    Mild (2)
    CL Item
    Moderate (3)
    CL Item
    Severe (4)
    Spontaneous perforation
    Item
    Spontaneous perforation
    boolean
    C0205359 (UMLS CUI [1,1])
    C0549099 (UMLS CUI [1,2])
    Item Group
    GRADE
    C0441800 (UMLS CUI-1)
    Item
    Side of grade
    text
    C0441987 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    Side of grade
    Code List
    Side of grade
    CL Item
    right (R)
    CL Item
    left (L)
    Item
    OS-8 Scale (Friedman/McCormick scale)
    integer
    C0681889 (UMLS CUI [1,1])
    C0041445 (UMLS CUI [1,2])
    C0441469 (UMLS CUI [1,3])
    OS-8 Scale
    Code List
    OS-8 Scale (Friedman/McCormick scale)
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    Item Group
    EAR, NOSE AND THROAT (ENT) CLINICAL SPECIALIST ASSESSMENT
    C0150934 (UMLS CUI-1)
    C2348234 (UMLS CUI-2)
    C3845884 (UMLS CUI-3)
    Item
    Middle ear fluid (MEF) - side
    text
    C0456498 (UMLS CUI [1,1])
    C0441987 (UMLS CUI [1,2])
    Middle ear fluid (MEF) - side
    Code List
    Middle ear fluid (MEF) - side
    CL Item
    right (R)
    CL Item
    left (L)
    MEF sample collection
    Item
    Has a MEF sample been collected?
    boolean
    C0456498 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    MEF sample collection, Date
    Item
    If MEF sample has been collected, date of Informed Consent
    date
    C0456498 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Item
    How has MEF sample been collected?
    text
    C0456498 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0184661 (UMLS CUI [1,3])
    Way of MEF sample collection
    Code List
    How has MEF sample been collected?
    CL Item
    Tympanocentesis (1)
    CL Item
    Spontaneous drainage (2)
    Start of spontaneous drainage
    Item
    If spontaneous drainage, date by when it started
    date
    C0808070 (UMLS CUI [1,1])
    C0205359 (UMLS CUI [1,2])
    C0012621 (UMLS CUI [1,3])
    Macroscopic aspect of fluid: Serous
    Item
    How was the macroscopic aspect of the fluid? Serous
    boolean
    C0456498 (UMLS CUI [1,1])
    C0440743 (UMLS CUI [1,2])
    Macroscopic aspect of fluid: Bloody
    Item
    How was the macroscopic aspect of the fluid? Bloody
    boolean
    C0456498 (UMLS CUI [1,1])
    C0333275 (UMLS CUI [1,2])
    Macroscopic aspect of fluid: Purulent
    Item
    How was the macroscopic aspect of the fluid? Purulent
    boolean
    C0456498 (UMLS CUI [1,1])
    C0439665 (UMLS CUI [1,2])
    Macroscopic aspect of fluid: Other
    Item
    How was the macroscopic aspect of the fluid? Other
    boolean
    C0456498 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other macroscopic aspect of fluid
    Item
    If other macroscopic aspect of fluid
    text
    C0456498 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item
    Results
    integer
    C1254595 (UMLS CUI [1])
    Results
    Code List
    Results
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    Item
    If positive please tick that apply
    integer
    C1254595 (UMLS CUI [1])
    Positive results
    Code List
    If positive please tick that apply
    CL Item
    Streptococcus pneumoniae (1)
    CL Item
    Haemophilus influenzae (2)
    CL Item
    Staphylococcus aureus (3)
    CL Item
    Streptococcus pyogenes (group A) (4)
    CL Item
    Moraxella Catarrhalis (5)
    CL Item
    Other (6)
    Streptococcus pneumoniae, sample code
    Item
    Streptococcus pneumoniae, sample code
    text
    C0038410 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Haemophilus influenzae, sample code
    Item
    Haemophilus influenzae, sample code
    text
    C0018483 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Other results
    Item
    Other results
    text
    C0205394 (UMLS CUI [1,1])
    C1254595 (UMLS CUI [1,2])
    Item
    Did the subject take antibiotic before the sample was obtained?
    integer
    C0338237 (UMLS CUI [1])
    Antibiotic therapy
    Code List
    Did the subject take antibiotic before the sample was obtained?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Item Group
    MEDICATION
    C0013227 (UMLS CUI-1)
    Medication AOM
    Item
    Has any medication been administered due to this AOM case?
    boolean
    C0205178 (UMLS CUI [1,1])
    C0029882 (UMLS CUI [1,2])
    C0013227 (UMLS CUI [1,3])
    Trade/Generic name of medication
    Item
    Trade/Generic name of medication
    text
    C2360065 (UMLS CUI [1])
    Reason for medication
    Item
    Reason for medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Route of medication
    Item
    Route of medication
    text
    C0013153 (UMLS CUI [1])
    Total daily dose
    Item
    Total daily dose
    text
    C2348070 (UMLS CUI [1])
    Start date of medication
    Item
    Start date of medication
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End date of medication
    Item
    End date of medication
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Medication continuing
    Item
    Medication continuing
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
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