ID

32294

Beskrivning

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.

Länk

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

Nyckelord

Versioner (2)
  1. 2018-10-25 2018-10-25 -
  2. 2018-10-26 2018-10-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 oktober 2018

DOI

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Licens

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

Engelsk

AOM

1 Formulär  
  1. StudyEvent: ODM
    1. AOM
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

text

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

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

Datatyp

date

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

Case number

Datatyp

integer

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

HEALTH CARE FACILITIES

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

Health care facility: Ambulatory / Outpatient

Datatyp

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
Beskrivning

Health care facility: Emergency room

Datatyp

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
Beskrivning

Health care facility: Hospital

Datatyp

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
Beskrivning

Health care facility: Other

Datatyp

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
Beskrivning

Other health care facility

Datatyp

text

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

Hospitalization of patient during AOM case

Datatyp

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
Beskrivning

Not necessarily consecutive days

Datatyp

integer

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

PRIMARY HEALTH CARE PHYSICIAN CLINICAL ASSESSMENT

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

If yes please complete below

Datatyp

boolean

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

Clinical signs and symptoms

Datatyp

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)
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

boolean

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

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

Datatyp

boolean

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

Fever measurement

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0242485
°C
measurement location/route
Beskrivning

Measurement location

Datatyp

text

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

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
Beskrivning

(at the time of consultation)

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
measurement location/route
Beskrivning

Measurement location

Datatyp

text

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

Irritability

Datatyp

integer

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

Severity of occasional/frequent

Datatyp

integer

Alias
UMLS CUI [1]
C0439793
Ear Ache
Beskrivning

Ear Ache

Datatyp

integer

Alias
UMLS CUI [1]
C0013456
Tugging
Beskrivning

Pulling at ears

Datatyp

integer

Alias
UMLS CUI [1]
C0847233
Feeding
Beskrivning

Feeding

Datatyp

integer

Alias
UMLS CUI [1]
C0015745
Sleeping
Beskrivning

Sleeping

Datatyp

integer

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

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?
Beskrivning

If yes please complete below

Datatyp

boolean

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

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

Datatyp

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)
Beskrivning

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

Datatyp

boolean

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

OTOSCOPY

Alias
UMLS CUI-1
C1112284
Side of otoscopy
Beskrivning

Side of otoscopy

Datatyp

text

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

Please tick for both sides (right and left)

Datatyp

boolean

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

ENT ASSESSMENT

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

Only applicable if ENT specialist clinically confirms AOM

Datatyp

text

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

Please tick for each side (right and left)

Datatyp

text

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

Please tick for each side (right and left)

Datatyp

text

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

Spontaneous perforation

Datatyp

boolean

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

GRADE

Alias
UMLS CUI-1
C0441800
Side of grade
Beskrivning

Side of grade

Datatyp

text

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

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

Datatyp

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
Beskrivning

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
Beskrivning

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

Datatyp

text

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

MEF sample collection

Datatyp

boolean

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

MEF sample collection, Date

Datatyp

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?
Beskrivning

Way of MEF sample collection

Datatyp

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
Beskrivning

Start of spontaneous drainage

Datatyp

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
Beskrivning

Tick all applicable

Datatyp

boolean

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

Macroscopic aspect of fluid: Bloody

Datatyp

boolean

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

Macroscopic aspect of fluid: Purulent

Datatyp

boolean

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

Macroscopic aspect of fluid: Other

Datatyp

boolean

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

Please specify

Datatyp

text

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

Results

Datatyp

integer

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

Positive results

Datatyp

integer

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

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

Datatyp

text

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

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

Datatyp

text

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

Please specify

Datatyp

text

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

Applicable only if a MEF sample has been collected.

Datatyp

integer

Alias
UMLS CUI [1]
C0338237
MEDICATION
Beskrivning

MEDICATION

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

If yes please complete the following items.

Datatyp

boolean

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

Trade/Generic name of medication

Datatyp

text

Alias
UMLS CUI [1]
C2360065
Reason for medication
Beskrivning

Reason for medication

Datatyp

text

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

Route of medication

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Total daily dose
Beskrivning

Total daily dose

Datatyp

text

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

Start date of medication

Datatyp

date

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

tick following box if continuing

Datatyp

date

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

Medication continuing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Tillbaka till toppen

Similar models

AOM

1 Formulär
  1. StudyEvent: ODM
    1. AOM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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