Details - CureSickleCell

Study ID	1005
Name	Sickle Cell Disease Implementation Consortium Registry (SCDIC-I)
Contact Email	byk@rti.org
Acronym	SCDIC-I Registry
Period	2017-2022
Design	Longitudinal cohort study
Study PI	Barbara Kroner
Institution	RTI International
URL	https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs004203.v1.p1
CTGovID	NA
Funding Agency	NHLBI
Grant Number	1U24HL133948-01

Overview	The SCDIC-I Registry is a longitudinal observational cohort study. At enrollment, data collection included a medical record abstraction of clinical history, the most recent lab results, and a participant survey which included several patient reported outcomes from PROMIS, ASCQ-Me and NeuroQoL. Similar surveys were administered at annual follow-up. Four to five years after enrollment, a second record abstraction was completed with all clinical events that occurred since enrollment and another set of recent labs. There were many research questions proposed to be answered with the study data thus there was no primary outcome.
Focus Areas	1. Pregnancy/Fertility 2. Acute/Chronic Pain 3. Organ Function 4. Hydroxyurea vs. Non-Hydroxyurea Patients and SCD Diagnosis Comparisons 5. Adherence/Access to Care
Outcomes	1. SCD Complications/Co-morbidities 2. SCD Treatment 3. SCD Access to Care 4. SCD Quality of life and Patient Reported Outcomes

Data Location	BioLINCC, BioData Catalyst
Biospecimen Available	N/A
Data Consent	Consent form includes statement that de-identified data will be shared
Biospecimen Consent	N/A
Contact Consent	Yes, with permission on consent
Genomic Data	No

Age Range	15-45 at the time of enrollment
No. Participants	2436
Inclusion Criteria	1. Age 15 years up to and including 45 years 2. English speaking 3. Confirmed SCD diagnosis. Confirmed is defined as supported by documentation in the medical record of a positive test for one of the following: Hb SS, Hb SC, Hb Sß-thalassemia, Hb SO, Hb SD, Hb SG, Hb SE, Hb SF. If no medical record is available, the enrolling Center may conduct its own laboratory test as confirmation. 4. Willing and cognitively able to give informed consent and complete the Patient Enrollment Survey
Exclusion Criteria	1. Unwilling or unable to give consent/assent or complete the Patient Enrollment Survey 2. Sickle cell trait (i.e., Hb AS) 3. Received a curative therapy for SCD

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Clinical status (230)

Behavior (0)

Blood (6)

Concept	Variables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease	p1f1q03 p1f1q03a p1f5q4 p1f6q00_c SCD_DIAG SCD_TYPE

Cancer (5)

Concept	Variables
Cancer	p1f1q62 p1f1q62a1_1 p1f1q62a1_2 p1f1q62a1_3 p1f1q62a1_4

Cardiovascular (10)

Concept	Variables
Aneurysm
Cardiac Failure	p1f5q28f
Cardiovascular Problem	p1f1q46 p1f1q46_1 p1f1q46b p1f1q46b_1 p1f5q28g
Heart Problem	p1f1q40b p1f1q40b_1 p1f1q41 p1f1q41_1

Digestive (2)

Concept	Variables
Gastrointestinal Problem	p1f1q44 p1f1q44_1
Hepatitis
Liver Problem

Endocrine (3)

Concept	Variables
Diabetes Mellitus	p1f1q56 p1f1q56_1 p1f5q28j
Endocrine Problem

Family MedHx (0)

General Health (0)

Genitourinary (38)

Concept	Variables
Genitourinary Problem	p1f8label2 p1f8q02_a p1f8q02_a2 p1f8q02_b p1f8q02_b2 p1f8q02_c p1f8q02_d p1f8q02_e p1f8q02_e2
Kidney Problem	p1f1q35 p1f1q35_1 p1f1q36 p1f1q36_1 p1f1q36a p1f1q36a_1 p1f5q28b p1f8label1 p1f8q01_a p1f8q01_a2 p1f8q01_b p1f8q01_b2 p1f8q01_c p1f8q01_d p1f8q01_e p1f8q01_e2 p1f8q04a p1f8q04b p1f8q04e p1f8q04e_a p1f8q04e_b p1f8q04f p1f8q04f_a p1f8q04f_c
Priapism	p1f1q37 p1f1q37_1 p1f4q10
Renal Dialysis History	p1f8q04c p1f8q04d

Immune (5)

Concept	Variables
Fever
HIV Infection
Immune Problem	p1f1q47 p1f1q47_1
Infection	p1f1q50 p1f1q50_1 p1f1q51
Vaccination

Lymphatic (9)

Concept	Variables
Sarcoidosis
Spleen Problem	p1f1q45 p1f1q45_1 p1f1q45a p1f1q45a_1 p1f1q45b p1f1q45b_1 p1f1q45c p1f1q45c_1 p1f5q30

Medical Event (15)

Concept	Variables
Adverse event
Death	p1f7q03 p1f7q04 p1f7q05 p1f7q05a p1f7q05b p1f7q06 p1f7q06a1 p1f7q06a1_13 p1f7q06a1_14 p1f7q06a1_15 p1f7q06a2 p1f7q06a2_13 p1f7q06a2_14 p1f7q06a2_15 p1f7q07
Disability Status
Hospitalization
Medical Event
Serious Adverse Event

Medical History (14)

Concept	Variables
Medical History	p1f1q52 p1f1q52_1 p1f1q52a p1f1q52a_1 p1f1q52b p1f1q52b_1 p1f1q52c p1f1q52c_1 p1f1q52d p1f1q52d_1 p1f1q52e p1f1q52e_1 p1f1q52f p1f1q52f_1

Mental Health (18)

Concept	Variables
Anxiety	p1f1q59 p1f1q59_1
Depression	p1f1q60 p1f1q60_1 p1f5q38 p1f5q39 p1f5q39a p1f5q39b
Emotional Health	p1f5q37a p1f5q37b p1f5q37c p1f5q37d p1f5q37e p1f5q37f p1f5q37g
Mental status
Psychiatric Disorder	p1f1q61 p1f1q61_1 p1f1q61_2

Musculoskeletal (15)

Concept	Variables
Musculoskeletal Problem	p1f5q28d
Osteomyelitis	p1f1q34 p1f1q34_1
Osteonecrosis	p1f1q32 p1f1q32_1 p1f1q32a p1f1q32a_1 p1f1q32b p1f1q32b_1 p1f1q32c p1f1q32c_1
Rheumatic Diseases	p1f1q48 p1f1q48_1 p1f1q49 p1f1q49_1

Neurodevelopmental (8)

Concept	Variables
Behavior
Cognition	p1f5q35a p1f5q35b p1f5q35c p1f5q35d p1f5q36a p1f5q36b p1f5q36c p1f5q36d
Developmental
Motor
Sensation

Neurologic (13)

Concept	Variables
Meningitis
Neurologic Event	p1f1q38a p1f1q38a_1 p1f1q38b p1f1q38b_1 p1f1q39 p1f1q39_1
Seizure
Stroke	p1f1q38 p1f1q38_1 p1f1q38d p1f1q38d_1 p1f5q28h
Transient Ischemic Attack	p1f1q38c p1f1q38c_1

Nutritional and Metabolic (2)

Concept	Variables
Nutritional and Metabolic	p1f1q57 p1f1q57_1

Ocular (3)

Concept	Variables
Ocular Problem
Sickle Retinopathy	p1f1q55 p1f1q55_1 p1f5q28c

Oral (0)

Pain (6)

Concept	Variables
Abdominal Pain
Headache
Management	p1f1q15_2 p1f1q15_3 p1f1q16_2 p1f1q16_3 p1f1q17_3 p1f1q17_4

Reproductive (35)

Concept	Variables
Birth Outcome
Gestational Age
Menstruation
Pregnancy	p1f3q01 p1f3q02 p1f3q03_1 p1f3q04_1 p1f3q08_1 p1f3q09_1 p1f3q09a_1r p1f3q10_1 p1f3q11_1 p1f3q11a_1 p1f3q12_1 p1f3q12a_1 p1f3q13 p1f3q14 p1f3q15 p1f3q16 p1f3q17 p1f4q03_1 p1f4q04_1 p1f4q07a_1r p1f4q08_1 p1f4q09_1 p1f4q09a_1
Reproductive Behavior	p1f3q05_1 p1f3q06_1 p1f3q07_1 p1f4q01 p1f4q02 p1f4q05_1 p1f4q06_1 p1f4q07_1 p1f4q11 p1f4q12 p1f4q13 p1f4q14

Respiratory (16)

Concept	Variables
Acute Chest Syndrome	p1f1q42 p1f1q42_1 p1f1q42_2
Asthma	p1f1q43 p1f1q43_1 p1f5q28i
Lung Disease	p1f1q40 p1f1q40_1 p1f1q40a p1f1q40a_1 p1f1q46a p1f1q46a_1 p1f5q28a p1f5q28e
Other Respiratory Problem	p1f1q53 p1f1q53_1

Skin (3)

Concept	Variables
Skin Problem	p1f1q54 p1f1q54_1 p1f5q29

Sleep (2)

Concept	Variables
Sleep Problem	p1f5q34a p1f5q34b

Surgery History (2)

Concept	Variables
Cardiovascular
Digestive
Genitourinary
Lymphatic	p1f1q45d p1f1q45d_1
Musculoskeletal
Ocular
Respiratory
Surgery History

COVID-19 (52)

Diagnosis (15)

Concept	Variables
COVID-19	cov19_q1 cov19_q5 cov19_q6
Long COVID
Symptoms	cov19_q13 cov19_q13a cov19_q13b cov19_q14 cov19_q15 cov19_q15a cov19_q7 cov19_q8 cov19_q8a
Test	cov19_q2 cov19_q3 cov19_q4

Impact (31)

Concept	Variables
Behaviors and Risks	cov19_q20a cov19_q20b cov19_q20c cov19_q20d cov19_q20e cov19_q20f
Healthcare	cov19_q16 cov19_q17 cov19_q18a cov19_q18b cov19_q18c cov19_q18d cov19_q18e cov19_q18f cov19_q18g cov19_q19a cov19_q19b cov19_q19c cov19_q19d cov19_q19e cov19_q19f cov19_q19g
Psychosocial and Mental Health	cov19_q21a cov19_q21b cov19_q21c cov19_q21d cov19_q21e cov19_q21f cov19_q21g cov19_q21h cov19_q21i

Treatment (6)

Concept	Variables
Hospitalization	cov19_q10 cov19_q11 cov19_q12 cov19_q12a cov19_q12b cov19_q9

Vaccination (0)

Demographics (22)

Demographics (9)

Concept	Variables
Address
Age	p1f1q33_1 p1f5q3
Ethnic Group	p1f5q41 p1f6q03
Gender	p1f5q40 p1f6q04
Language	p1f5q43
National Origin
Nuclear Family
Race	p1f5q42 p1f6q02

Social Determinants of Health (SDoH) (4)

Concept	Variables
Community
Individual	p2f2q01 p2f2q01a p2f2q02 p2f2q02a

Socioeconomic Status (9)

Concept	Variables
Annual Income	p1f5q46
Education	p1f5q47
Employment Status	p1f5q48 p1f5q48a
Household	p1f5q45a p1f5q45b
Insurance	p1f1q63 p1f1q63a
Marital Status	p1f5q44

Environmental Exposure (0)

Exposure (0)

Health Care (22)

Acute Care Utilization (18)

Concept	Variables
Facility Type	p1f1q15 p1f1q16 p1f1q17
Provider Type	p1f1q18 p1f1q19 p1f1q20 p1f1q21 p1f1q22 p1f1q23 p1f1q24 p1f1q25 p1f1q26 p1f1q27 p1f5q5 p1f5q5r
Quality of Care
Visit	p1f1q04a_1 p1f1q04a_2 p1f4q04a_1a

Health Services (0)

Healthcare utilization (3)

Concept	Variables
Country of Care
Facility Type
Quality of Care	p1f5q32 p1f5q33 p1f5q33a

Hospitalization (1)

Concept	Variables
Final Diagnosis
Hospitalization	p1f1q17_2
ICU

SCD Management (0)

Imaging (57)

Angiogram (0)

Catheterization (0)

CT Scan (0)

Echocardiogram (44)

Concept	Variables
Echocardiogram	p1f9label1 p1f9label2 p1f9label3c p1f9label8_2 p1f9label8_3 p1f9label8_4 p1f9label8_5 p1f9label9_2 p1f9label9_2b p1f9label9_3 p1f9q00b p1f9q01 p1f9q02 p1f9q03 p1f9q03_a p1f9q03_b p1f9q04 p1f9q04_a p1f9q05 p1f9q05_a p1f9q06 p1f9q06_a p1f9q06_a_na p1f9q06_b p1f9q06_b_na p1f9q07 p1f9q07_a p1f9q07_b p1f9q08 p1f9q08_a p1f9q08_b1 p1f9q08_b1b p1f9q08_b2 p1f9q08_b3 p1f9q08_b3b p1f9q08_b4 p1f9q08_b4b p1f9q09 p1f9q09_a p1f9q09_b1 p1f9q09_b2 p1f9q09_b3 p1f9q10 p1f9q10_a

Electrocardiogram (ECG) (13)

Concept	Variables
Electrocardiogram (ECG)	p1f9q11 p1f9q11_a p1f9q11_b p1f9q12_a p1f9q12_b p1f9q13_a p1f9q13_b p1f9q14_a p1f9q14_b p1f9q15_a p1f9q15_b p1f9q16_a p1f9q16_b

Electrodiagnosis (0)

General Imaging (0)

MRI/MRA (0)

Nuclear Medicine Imaging (0)

PET scan (0)

Transcranial Doppler (TCD) (0)

Ultrasound (0)

X-Ray (0)

Parent/Caretaker (0)

Demographics (0)

Psychosocial (0)

Quality of Life (0)

Quality of Life (14)

Functional Status (0)

General Health (0)

Pain (14)

Concept	Variables
General Pain	p1f1q58 p1f1q58_1 p1f5q12a p1f5q12b p1f5q13a p1f5q13b p1f5q14a p1f5q14b
Pain Attack	p1f5q10 p1f5q11 p1f5q7 p1f5q8 p1f5q9
Skeletal and Joint Pain	p1f1q33

Tests (29)

Biopsy (0)

Blood (5)

Concept	Variables
Blood Differential Test
Blood Gases	p1f1q11
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count
Comprehensive Metabolic Panel (CMP)	p1f8label5 p1f8q03a p1f8q03b
Enzyme
General
Hemoglobin Typing	p1f1q05
Iron

Cardiovascular (15)

Concept	Variables
Cardiovascular Test	p1f9q17_1 p1f9q17_a p1f9q17_b p1f9q18_a p1f9q18_b p1f9q19_a p1f9q19_b p1f9q20_a p1f9q20_b p1f9q21_a p1f9q21_b p1f9q22_a p1f9q22_b p1f9q23_a p1f9q23_b

Genitourinary (0)

Immune (0)

Microbiology Culture (0)

Musculoskeletal (0)

Neurologic (0)

Ocular (0)

Other (0)

Physical Exam (9)

Concept	Variables
Abdomen
Anthropometrics	p1f1q06 p1f1q07
Cardiovascular
Extremities
General
Liver
Reproductive
Respiratory
Spleen
Vital signs	p1f1q08 p1f1q09 p1f1q10 p1f1q12 p1f1q12_1 p1f1q12_2 p1f1q12_3

Reproductive (0)

Respiratory (0)

Therapeutics (52)

Medication (21)

Concept	Variables
Antibiotics
Asthma
Blood Medication History
Cardiovascular
Compliance
Current Medication
Depression Medication History
Hydroxyurea	p1f1q13 p1f1q13a p1f1q13b p1f1q13c p1f1q13c1 p1f1q13d p1f1q13d_2 p1f5q15 p1f5q16 p1f5q16a p1f5q17 p1f5q18 p1f5q19 p1f5q19a p1f5q20 p1f5q21 p1f5q22 p1f5q22a
Medication	p1f1q14 p1f5q31_1
Neurologic Medication History
Pain	p1f5q6
SCD Medication
Sildenafil
Supplements

Surgery (0)

Transfusion (31)

Concept	Variables
Blood Transfusion	p1f1q28 p1f1q28_1 p1f1q28_2 p1f1q28_3 p1f1q28_4 p1f1q28_5 p1f1q30 p1f1q30_1 p1f1q30_2 p1f1q30_3 p1f1q30_4 p1f1q30_5 p1f5q23 p1f5q24 p1f5q25 p1f5q26 p1f5q27
Chronic Transfusion	p1f1q29 p1f1q29_1 p1f1q29_2 p1f1q29_3 p1f1q29_4 p1f1q29_5 p1f1q29_6 p1f1q31 p1f1q31_1 p1f1q31_2 p1f1q31_3 p1f1q31_4 p1f1q31_5 p1f1q31_6
Transfusion Complications

Transplantation (0)

Treatment (0)

Study Publications

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Mental Health (10)

Concept	Variables
ASCQ-Me Emotional Impact	p1f5q37e p1f5q37f
ASCQ-Me Social Functioning	p1f5q39 p1f5q39a p1f5q39b
Brief Resiliency Scale
NeuroQOL Fatigue	p1f5q37g
NIH Toolbox Loneliness
Pearlin Enhanced Self-Efficacy Scale
Profile of Mood States (POMS)
PROMIS Anger
PROMIS Anxiety
PROMIS Depression	p1f5q37a p1f5q37b p1f5q37c p1f5q37d
PROMIS Emotional Support
PROMIS Fatigue
PROMIS Global Mental Health
PROMIS Satisfaction with Participation in Discretionary Social Activities

Neurodevelopment (8)

Concept	Variables
Achenbach Child Behavior Checklist (CBCL)
Bayley Scale of Infant and Toddler Development
Behavior Rating Inventory of Executive Function (BRIEF)
California Verbal Learning Test
Children's Memory Scale
Connor's Continuous Performance Test II
Delis-Kaplan Executive Function System (D-KEFS)
NeuroQOL Cognitive Function	p1f5q35a p1f5q35b p1f5q35c p1f5q35d p1f5q36a p1f5q36b p1f5q36c p1f5q36d
Peabody Picture Vocabulary Test (PPVT)

Neuropsychological (4)

Concept	Variables
Adaptive Behavior Assessment System-II
Adverse Childhood Experience Questionnaire (ACE-Q)	p2f2q01 p2f2q01a p2f2q02 p2f2q02a
Beery Developmental Test of Visual-Motor Integration
Benton Tactile Form Perception Test
Mini Mental Status Examination (MMSE)
Oral Verbal Fluency Test
PROMIS Cognitive Function
Purdue Pegboard (SPA version)
Test of Everyday Attention (TEA)
Vineland Adaptive Behavior Summary
Wechsler Intelligence Scales
Wechsler Memory Scale
Wisconsin Card Sorting Test
Woodcock-Johnson Revised, Tests of Achievement
Woodcock-Johnson, Revised, Tests of Cognitive Ability

Pain (11)

Concept	Variables
ASCQ-Me Pain Episode	p1f5q10 p1f5q11 p1f5q7 p1f5q8 p1f5q9
ASCQ-Me Pain Impact	p1f5q12a p1f5q12b p1f5q13a p1f5q13b
ASCQ-Me Stiffness Impact
Brief Pain Inventory (BPI)
Chronic Pain
PROMIS Neuropathic Pain Quality	p1f5q14a
PROMIS Nociceptive Pain Quality	p1f5q14b
PROMIS Pain Behavior
PROMIS Pain Interference

Physical Function (0)

Psychosocial (0)

Quality of Care (0)

Quality of Life (0)

Sleep (2)

Concept	Variables
ASCQ-Me Sleep Impact	p1f5q34a p1f5q34b
PROMIS Sleep Distrubance

Technology Support (0)

Study Documentation Select All	Sickle_Cell_Disease_Patient_Registry_Protocol
Forms Select All	1. Medical_Record_Abstraction 2. Laboratory_Reporting 3. Pregnancy_Conception–Female 4. Pregnancy_Conception–Males 5. Patient_Enrollment_Survey 6. Patient_Registration 7. Registry_Off_Study_Form 8. Renal_Form 9. Pulmonary_hypertension_LV_dysfunction 10. Patient Follow-up 1&2 Survey 11. Patient Follow-up 3&4 Survey 12. COVID Impact Survey 13. Adverse Childhood Experience Questionnaire (ACE-Q)

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