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Childhood Adenotonsillectomy Trial

Name Label Folder
clusterid
Recoded Site ID for longitudinal models
Recoded Site ID for longitudinal models

The original Site ID was removed from the dataset because it was considered identifiable. This variable has obfuscated the original Site IDs.

Administrative
new_pid
Original Participant ID
Original Participant ID

This is the participant identifier that is present on Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) datasets. Use nsrrid when linking these data to other data on the National Sleep Research Resource (NSRR).

Administrative
nsrrid
NSRR Subject Identifier
NSRR Subject Identifier

The National Sleep Research Resource (NSRR) subject identifer links the subject's data and files. Use new_pid to link with Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) and cohort-specific data.

Administrative
completer_per_protocol
Participant completed the study as per protocol
Participant completed the study as per protocol Administrative/CONSORT Diagram Components
arm
Treatment Arm
Treatment Arm

The randomization code assigned by the Data Management System (DMS).

Administrative/Randomization
vnum
Visit Number
Visit Number Administrative
change_in_symptoms
Change in symptoms
Change in symptoms Administrative/CONSORT Diagram Components
crossovers
Did this child crossover?
Did this child crossover? Administrative/CONSORT Diagram Components
followup_status
Patient received followup
Patient received followup Administrative/CONSORT Diagram Components
had_surgery
Child had surgery?
Child had surgery? Administrative/CONSORT Diagram Components
itt
Completed study (intention to treat)
Completed study (intention to treat) Administrative/CONSORT Diagram Components
surgery_status
Patient surgery status
Patient surgery status Administrative/CONSORT Diagram Components
treated
Has child been treated
Has child been treated Administrative/CONSORT Diagram Components
treatment_failure
The Medical Monitor confirmed treatment failure?
The Medical Monitor confirmed treatment failure? Administrative/CONSORT Diagram Components
mat1
Were educational materials provided to the child?
Were educational materials provided to the child? Administrative/Materials Provided
mat2
Was saline spray provided to the child?
Was saline spray provided to the child? Administrative/Materials Provided
mat2b
Were directions and application uses reviewed with the parent or guardian?
Were directions and application uses reviewed with the parent or guardian? Administrative/Materials Provided
ran1
Has the participant met all eligibility criteria and signed the consent form; and has the principle investigator reviewed and certified the individual as being eligible?
Has the participant met all eligibility criteria and signed the consent form; and has the principle investigator reviewed and certified the individual as being eligible? Administrative/Randomization
ran2
Has the participant had an ear, nose, and throat (ENT) evaluation within 90 days of baseline, and is considered a candidate for surgery?
Has the participant had an ear, nose, and throat (ENT) evaluation within 90 days of baseline, and is considered a candidate for surgery? Administrative/Randomization
ran3
Has the participant had an overnight Polysomnography (PSG) evaluation, and is within the protocol defined limits?
Has the participant had an overnight Polysomnography (PSG) evaluation, and is within the protocol defined limits? Administrative/Randomization
ran4
Was the child able to perform the neurocognitive testing?
Was the child able to perform the neurocognitive testing? Administrative/Randomization
ran5
Date the parent signed the consent form
Date the parent signed the consent form Administrative/Randomization
ran6
Date of randomization
Date of randomization

The original date has been removed as part of deidentification.

Administrative/Randomization
ran7
Randomization Code assigned by Data Management System (DMS)
Randomization Code assigned by Data Management System (DMS) Administrative/Randomization
sst1
Did the participant complete the study, as per protocol?
Did the participant complete the study, as per protocol? Administrative/Study Stop
sst2
Date the participant stopped
Date the participant stopped Administrative/Study Stop
sst3
What was the primary reason that the participant stopped?
What was the primary reason that the participant stopped? Administrative/Study Stop
tst1
Date the participant's treatment stopped
Date the participant's treatment stopped Administrative/Treatment Stop
tst2
What was the primary reason that the participant's treatment was stopped?
What was the primary reason that the participant's treatment was stopped? Administrative/Treatment Stop
tst2a
Other medical or neuropsychological necessitated reason, specify
Other medical or neuropsychological necessitated reason, specify Administrative/Treatment Stop
tst3
Has the Medical Monitor confirmed this to be a treatment failure?
Has the Medical Monitor confirmed this to be a treatment failure? Administrative/Treatment Stop
tst4
Did this participant crossover?
Did this participant crossover? Administrative/Treatment Stop
tst4a
If yes, please indicate the primary reason
If yes, please indicate the primary reason Administrative/Treatment Stop
tst5
Will the participant be continuing with follow-up visits?
Will the participant be continuing with follow-up visits? Administrative/Treatment Stop
ubl1
Date participant was unblinded
Date participant was unblinded Administrative/Unblinding of Participant
ubl2
What was the participant's randomization arm?
What was the participant's randomization arm? Administrative/Unblinding of Participant
ubl3
Why was the participant unblinded?
Why was the participant unblinded? Administrative/Unblinding of Participant
ubl_pidate
Date
Date Administrative/Unblinding of Participant