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Study Information

dbGaP Study Accession: phs002945

NIH Institute/Center: NICHD

RADx Data Program: RADx-rad

DOI: 10.60773/277p-e595

Release Date: 11/07/2022

Study Description: The primary objective of this study was to design and validate a predictive decision support system for the identification, treatment and management of SARS-CoV-2 associated with multisystem inflammatory syndrome in children (MIS-C). To develop this system, the study adapted and retrained machine learning algorithms which have previously trained in patients with Kawasaki Disease, a pediatric inflammatory vasculopathy with clinical overlap with MIS-C but different etiology. This study, performed in collaboration with the International Kawasaki Disease Registry (IKDR) consortium. This dataset contains the development and international validation data for all algorithms developed as part of this study.

Updated Date: 12/09/2022

Principal Investigator: Manlhiot, Cedric

Has Data Files: Yes

Study Domain: Artificial Intelligence or Machine Learning; Multisystem Inflammatory Syndrome (MIS); Multisystem Inflammatory Syndrome in Children (MIS-C)

Data Collection Method: Disease Registry

Keywords: Kawasaki; Pediatrics

Study Design: Cross-Sectional

Multi-Center Study: Yes

Study Sites: See attached list

Data Types: Clinical; Electronic Medical Records; Environmental; Family History; Individual Phenotype; Questionnaire or Survey

Study Start Date: 01/01/2021

Study End Date: 04/30/2022

Species: Human

Estimated Cohort Size: 900

Study Population Focus: Children

Publication URL: https://pubmed.ncbi.nlm.nih.gov/35624313/; https://pubmed.ncbi.nlm.nih.gov/36455760/; https://pubmed.ncbi.nlm.nih.gov/36947454/; https://pubmed.ncbi.nlm.nih.gov/37290536/

Acknowledgement Statement: This study was supported through funding, 4R61HD105591-02, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-rad program. Data for this study was acquired through the International Kawasaki Disease Registry (IKDR). Approved users should acknowledge the provision of data access by dbGaP for accession phs002945.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: RFA-OD-20-023

NIH Grant or Contract Number(s): 4R61HD105591-02

Consent/Data Use Limitations: General Research Use; IRB required

Variable Information
Total Variables: 109
Study Variables Information Table
Variable Name
Label
nih_record_idUser ID
nih_raceWhat is your race?
nih_ethnicityAre you of Hispanic or Latino origin? May include Spanish origin.
nih_ageWhat is your age?
nih_sexWhat is your biological sex assigned at birth?
nih_education_yrsHow many years of education have you completed?
nih_zipWhat is your zip code?
nih_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_deafAre you deaf or do you have serious difficulty hearing?
nih_blindAre you blind or do you have serious difficulty seeing, even when wearing glasses?
nih_vaping_ynVaping use (Yes or No)
nih_nicotine_ynNicotine use (Yes or No)
nih_alcohol_ynAlcohol use (Yes or No)
nih_asthmaAsthma
nih_cancerCancer
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_kidney_diseaseChronic kidney disease
nih_chronic_lung_diseaseChronic lung disease
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_immunosuppressive_conditionImmunosuppressive condition
nih_serious_mental_illnessSerious mental illness
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
nih_coughCough
nih_fever_chillsFever or Chills
nih_diff_breathShortness of breath or difficulty breathing
nih_headacheHeadache
nih_muscle_acheMuscle ache
nih_olfactoryNew loss of taste or smell
nih_fatigueExcessive fatigue
nih_nausea_vomiting_diarrheaNausea, vomiting, or diarrhea
nih_abdom_painAbdominal pain
nih_skin_rashSkin rash
nih_conjunctivitisConjunctivitis
nih_heightWhat is your height in inches?
nih_weightWhat is your weight in pounds?
abdominal_painAbdominal pain
ageWhat is your age? (Age in years. For babies less than 1 year old, write 0 as the age)
alcohol_useAlcohol Use
asthmaAsthma
blindAre you blind or do you have serious difficulty seeing, even when wearing glasses?
cancerCancer
cardiovascular_diseaseCardiovascular disease
chillsChills
chronic_kidney_diseaseChronic kidney disease
chronic_lung_diseaseChronic lung disease
conjunctivitisConjunctivitis
coughCough
deafAre you deaf or do you have serious difficulty hearing?
diabetesDiabetes
diarrheaDiarrhea
educationHow many years of education have you completed? (Years of education from 0 - 20+)
employmentAre you employed?
ethnicityAre you of Hispanic or Latino origin?
excessive_fatigueExcessive fatigue
feverFever
headacheHeadache
height_feetHeight Feet
height_inchesHeight Inches
hypertensionHypertension
immunosuppressive_conditioImmunosuppressive condition
insuranceWhat kind of health insurance do you have?
muscle_acheMuscle ache
nausea_vomitingNausea/vomiting
new_loss_of_taste_or_smellNew loss of taste or smell
nicotineNicotine Use
pregnancy_statusPregnancy status
raceWhat is your race? Mark one or more boxes.
serious_mental_illnessSerious mental illness
sexWhat is your biological sex assigned at birth?
shortness_of_breath_or_difShortness of breath or difficulty breathing
sickle_cell_diseaseSickle cell disease
skin_rashSkin rash
vapingVaping Use
weight_lbsWhat is your weight? (Weight in pounds)
zipZip or Postal Code: (De-Identified zip code)
anorexia-
cpl_kd-
criteria-
dress_bathe_dis_pediatric-
DS_HOSPINF-
dx_covid-
dx_kd-
dx_misc-
education_parent_A-
education_parent_B-
employment_parent_A-
employment_parent_B-
errand_dis_1-
errand_dis_2-
inc_kd-
irritability-
memory_dis_1-
memory_dis_2-
r_allergies-
rds_highesttemp-
r_familyimm-
r_familykd-
r_gestwk-
r_inf_contact6wk-
r_inf_stat-
r_prevkd-
r_week-
study_id-
walking_climbing_dis_1-
walking_climbing_dis_2-
year-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002945_Addendum_01MAR2021.pdf311.06 KB
Study Documentationphs002945_Protocol_01MAR2021.pdf358.51 KB
Data Files
Total Files: 6
Data Files: 2
Metadata Files: 2
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
rad_023_591-01_Clinical_DATA_transformcopy.csvTabular Data - Harmonizedcsv944
rad_023_591-01_Clinical_DATA_origcopy.csvTabular Data - Non-harmonizedcsv944