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 |
Administrative | |
nsrrid
NSRR Subject Identifier
|
NSRR Subject Identifier
The National Sleep Research Resource (NSRR) subject identifer links the subject's data and files. Use |
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 | |
ref1
Recruitment source
|
Recruitment source | Administrative | |
ref3
What is the screening Polysomnography (PSG) date?
|
What is the screening Polysomnography (PSG) date? | Administrative | |
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 | |
pos2
After their adenotonsillectomy, did the child require evaluation in the emergency room (ER)
|
After their adenotonsillectomy, did the child require evaluation in the emergency room (ER) | Administrative/Post-Op Phone Call | |
pos2a
If child required evaluation in the emergency room (ER), what was the reason?
|
If child required evaluation in the emergency room (ER), what was the reason? | Administrative/Post-Op Phone Call | |
pos3
Did the child have post operative pain requiring pain medication for greater than 3 weeks after surgery?
|
Did the child have post operative pain requiring pain medication for greater than 3 weeks after surgery? | Administrative/Post-Op Phone Call | |
pos3a
Has this concern required evaluation or care by a medical professional?
|
Has this concern required evaluation or care by a medical professional? | Administrative/Post-Op Phone Call | |
pos4
Are there any current eating or drinking concerns?
|
Are there any current eating or drinking concerns? | Administrative/Post-Op Phone Call | |
pos4a
Has this concern required evaluation or care by a medical professional?
|
Has this concern required evaluation or care by a medical professional? | Administrative/Post-Op Phone Call | |
pos5
Are there any current concerns about the child's voice?
|
Are there any current concerns about the child's voice? | Administrative/Post-Op Phone Call | |
pos5a
Has this concern required evaluation or care by a medical professional?
|
Has this concern required evaluation or care by a medical professional? | Administrative/Post-Op Phone Call | |
pos6
Has the breathing or snoring worsened since surgery?
|
Has the breathing or snoring worsened since surgery? | Administrative/Post-Op Phone Call | |
pos7
Are there any other major health concerns?
|
Are there any other major health concerns? | Administrative/Post-Op Phone Call | |
pos8
Has the child begun any new medications?
|
Has the child begun any new medications? | Administrative/Post-Op Phone Call | |
preop1
How was this information obtained?
|
How was this information obtained? | Administrative/Pre-Operative Questionnaire | |
preop2
What was the pre-operation Tonsil size?
|
What was the pre-operation Tonsil size? | Administrative/Pre-Operative Questionnaire | |
preop3
Is the child a candidate for Adenotonsillectomy?
|
Is the child a candidate for Adenotonsillectomy? | Administrative/Pre-Operative Questionnaire | |
preop4
Are there any known contraindications for surgery?
|
Are there any known contraindications for surgery? | Administrative/Pre-Operative Questionnaire | |
tonsize
Tonsilar Size
|
Tonsilar Size | Administrative/Pre-Operative Questionnaire | |
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 |