Details - CureSickleCell

Study ID	1005
Name	Sickle Cell Disease Implementation Consortium Registry
Contact Email	byk@rti.org
Acronym	SCDIC Registry
Period	ongoing
Design	Registry Study
Study PI	Barbara Kroner
Institution	RTI International
URL	https://scdic.rti.org/
CTGovID	NA
Funding Agency	NHLBI

Overview	The Sickle Cell Disease Implementation Consortium (SCDIC) is the first research program to use implementation science to identify and address barriers to quality care in SCD. Patients enrolled in the implementation research studies may be selected from the SCD Registry. The Registry is designed during Year 1 and begins recruitment in Year 2. The goal is to enroll at least 2,400 patients (300 per Center) between the ages of 15 and 45 years by the end of January 2019 or the time that recruitment for the implementation research studies begins. To achieve these goals, the Registry will:a. Develop standard data collection tools and methods which will be used to characterize the SCD population leading to the development and implementation of research studies;b. Identify gaps in research;c. Conduct data queries and analyze data collected;d. Provide access to these resources to Registry investigators who are interested in advancing the understanding of the SCD population; ande. Publish and disseminate results.
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	RTI International
Biospecimen Available	N/A
Data Consent	Consent form includes statement that de-identified data will be shared
Biospecimen Consent	No sample
Contact Consent	Yes, with permission on consent
Genomic Data	No

Age Range	0-17
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. Successful bone marrow transplant

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Clinical status (288)

Behavior (0)

Blood (6)

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

Cancer (5)

Data Element	Variables
Cancer	p1f1q62 p1f1q62a1_1 p1f1q62a1_2 p1f1q62a1_3 p1f1q62a1_4

Cardiovascular (12)

Data Element	Variables
Aneurysm
Cardiac Failure	p1f5q28f
Cardiovascular Problem	p1f1q46 p1f1q46_1 p1f1q46b p1f1q46b_1 p1f5q28g p2f1q16f p2f1q16g
Heart Problem	p1f1q40b p1f1q40b_1 p1f1q41 p1f1q41_1

Digestive (3)

Data Element	Variables
Gastrointestinal Problem	p1f1q44 p1f1q44_1
Hepatitis
Liver Problem	p2f1q16k

Endocrine (4)

Data Element	Variables
Diabetes Mellitus	p1f1q56 p1f1q56_1 p1f5q28j p2f1q16j
Endocrine Problem

Family MedHx (0)

General Health (0)

Genitourinary (39)

Data Element	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 p2f1q16b
Priapism	p1f1q37 p1f1q37_1 p1f4q10
Renal Dialysis History	p1f8q04c p1f8q04d

Immune (5)

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

Lymphatic (10)

Data Element	Variables
Sarcoidosis
Spleen Problem	p1f1q45 p1f1q45_1 p1f1q45a p1f1q45a_1 p1f1q45b p1f1q45b_1 p1f1q45c p1f1q45c_1 p1f5q30 p2f1q15

Medical Event (15)

Data Element	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)

Data Element	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 (27)

Data Element	Variables
Anxiety	p1f1q59 p1f1q59_1
Depression	p1f1q60 p1f1q60_1 p1f5q38 p1f5q39 p1f5q39a p1f5q39b p2f1q33a p2f1q33b p2f1q33c p2f1q33d p2f1q33e p2f1q33f p2f1q33g p2f1q36a p2f1q36b
Emotional Health	p1f5q37a p1f5q37b p1f5q37c p1f5q37d p1f5q37e p1f5q37f p1f5q37g
Mental status
Psychiatric Disorder	p1f1q61 p1f1q61_1 p1f1q61_2

Musculoskeletal (16)

Data Element	Variables
Musculoskeletal Problem	p1f5q28d p2f1q16d
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 (12)

Data Element	Variables
Behavior
Cognition	p1f5q35a p1f5q35b p1f5q35c p1f5q35d p1f5q36a p1f5q36b p1f5q36c p1f5q36d p2f1q35a p2f1q35b p2f1q35c p2f1q35d
Developmental
Motor
Sensation

Neurologic (14)

Data Element	Variables
Meningitis
Neurologic Event	p1f1q38a p1f1q38a_1 p1f1q38b p1f1q38b_1 p1f1q39 p1f1q39_1
Seizure
Stroke	p1f1q38 p1f1q38_1 p1f1q38d p1f1q38d_1 p1f5q28h p2f1q16h
Transient Ischemic Attack	p1f1q38c p1f1q38c_1

Nutritional and Metabolic (2)

Data Element	Variables
Nutritional and Metabolic	p1f1q57 p1f1q57_1

Ocular (4)

Data Element	Variables
Ocular Problem
Sickle Retinopathy	p1f1q55 p1f1q55_1 p1f5q28c p2f1q16c

Oral (0)

Pain (36)

Data Element	Variables
Abdominal Pain
General Pain	p1f1q58 p1f1q58_1 p1f5q12a p1f5q12b p1f5q13a p1f5q13b p1f5q14a p1f5q14b p2f1q_duke1 p2f1q_duke3 p2f1q_duke4 p2f1q08a p2f1q08b p2f1q09a p2f1q09b p2f1q10a p2f1q10b p2f1q11
Headache
Management	p1f1q15_2 p1f1q15_3 p1f1q16_2 p1f1q16_3 p1f1q17_3 p1f1q17_4
Pain Attack	fp1f5q06 p1f5q10 p1f5q11 p1f5q7 p1f5q8 p1f5q9 p2f1q03 p2f1q04 p2f1q05 p2f1q07
Skeletal and Joint Pain	p1f1q33 p1f1q33_1

Reproductive (35)

Data Element	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 (19)

Data Element	Variables
Acute Chest Syndrome	p1f1q42 p1f1q42_1 p1f1q42_2 p2f1q16a
Asthma	p1f1q43 p1f1q43_1 p1f5q28i p2f1q16i
Lung Disease	p1f1q40 p1f1q40_1 p1f1q40a p1f1q40a_1 p1f1q46a p1f1q46a_1 p1f5q28a p1f5q28e p2f1q16e
Other Respiratory Problem	p1f1q53 p1f1q53_1

Skin (4)

Data Element	Variables
Skin Problem	p1f1q54 p1f1q54_1 p1f5q29 p2f1q16l

Sleep (4)

Data Element	Variables
Sleep Problem	p1f5q34a p1f5q34b p2f1q32a p2f1q32b

Surgery History (2)

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

Demographics (21)

Demographics (8)

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

Social Determinants of Health (SDoH) (4)

Data Element	Variables
Community
Individual	p2f2q01 p2f2q01a p2f2q02 p2f2q02a

Socioeconomic Status (9)

Data Element	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 (25)

Acute Care Utilization (18)

Data Element	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

Healthcare utilization (6)

Data Element	Variables
Country of Care
Facility Type
Quality of Care	p1f5q32 p1f5q33 p1f5q33a p2f1q39 p2f1q40 p2f1q40a

Health Services (0)

Hospitalization (1)

Data Element	Variables
Final Diagnosis
Hospitalization	p1f1q17_2
ICU

SCD Management (0)

Imaging (57)

Angiogram (0)

CT Scan (0)

Echocardiogram (44)

Data Element	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)

Data Element	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 (9)

General Health (0)

Pain (0)

Patient Functioning (4)

Data Element	Variables
Cognitive Functioning	p2f1q34a p2f1q34b p2f1q34c p2f1q34d
Emotional Functioning
Physical Functioning
School Functioning
Social Functioning

SCD (5)

Data Element	Variables
SCD Impact
SCD Management	p2f1q37 p2f1q38a p2f1q38b p2f1q38c p2f1q38d

Tests (126)

Biopsy (0)

Blood (83)

Data Element	Variables
Blood Differential Test	p1f2q10 p1f2q11 p1f2q12 p1f2q13
Blood Gases	p1f1q11
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count	p1f2q1 p1f2q2 p1f2q4 p1f2q5 p1f2q6 p1f2q7 p1f2q8 p1f2q9
Comprehensive Metabolic Panel (CMP)	p1f2q1_1b p1f2q14 p1f2q15 p1f2q16 p1f2q17 p1f2q18 p1f2q19 p1f2q20 p1f2q21 p1f2q22 p1f2q23 p1f2q24 p1f2q25 p1f2q26 p1f2q26_1a p1f2q27 p1f2q28 p1f2q29 p1f2q3 p1f2q30 p1f2q31 p1f2q32 p1f2q33 p1f2q35 p1f2q36 p1f2q41 p1f2q42 p1f8label5 p1f8q03a p1f8q03b
Enzyme	p1f2q34
General
Hemoglobin Electrophoresis	p1f1q05 p1f2q50 p1f2q50_1 p1f2q50_10 p1f2q50_2 p1f2q50_3 p1f2q50_4 p1f2q50_5 p1f2q50_6 p1f2q50_7 p1f2q50_8 p1f2q50_9 p1f2q51 p1f2q51_1 p1f2q51_10 p1f2q51_2 p1f2q51_3 p1f2q51_4 p1f2q51_5 p1f2q51_6 p1f2q51_7 p1f2q51_8 p1f2q51_9 p1f2q52 p1f2q52_1 p1f2q52_10 p1f2q52_2 p1f2q52_3 p1f2q52_4 p1f2q52_5 p1f2q52_6 p1f2q52_7 p1f2q52_8 p1f2q52_9
Iron	p1f2q37 p1f2q38 p1f2q39 p1f2q39_1a p1f2q40

Cardiovascular (15)

Data Element	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 (19)

Data Element	Variables
Genitourinary Test
Urine Test	p1f2q43 p1f2q43_1 p1f2q43_1a p1f2q44 p1f2q44_1 p1f2q45 p1f2q45_1 p1f2q46 p1f2q46_1 p1f2q47 p1f2q47_1 p1f2q48 p1f2q48_1r p1f2q48_1r_2 p1f2q48_unit p1f2q49 p1f2q49_1r p1f2q49_1r_2 p1f2q49_unit

Immune (0)

Microbiology Culture (0)

Musculoskeletal (0)

Neurologic (0)

Ocular (0)

Other (0)

Physical Exam (9)

Data Element	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 (80)

Medication (47)

Data Element	Variables
Antibiotics
Asthma
Blood Medication History
Cardiovascular	p2f1q29 p2f1q29a
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 p2f1q17 p2f1q18 p2f1q19 p2f1q19a p2f1q20 p2f1q21 p2f1q22 p2f1q22a
Medication	p1f1q14 p1f5q31_1 p2f1q28 p2f1q30 p2f1q30a
Neurologic Medication History
Pain	p1f5q6 p2f1q01 p2f1q02 p2f1q02a p2f1q02b
SCD Medication	p2f1q14 p2f1q23 p2f1q24 p2f1q25 p2f1q25a p2f1q26 p2f1q27 p2f1q27a p2f1q31
Sildenafil
Supplements

Surgery (0)

Transfusion (33)

Data Element	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 p2f1q12 p2f1q13
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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Functional Exercise Capacity (0)

Mental Health (19)

Data Element	Variables
ASCQ-Me Emotional Impact	p1f5q37e p1f5q37f p2f1q33e p2f1q33f
ASCQ-Me Social Functioning	p1f5q39 p1f5q39a p1f5q39b p2f1q36a p2f1q36b
NeuroQOL Fatigue	p1f5q37g p2f1q33g
Pearlin Enhanced Self-Efficacy Scale
Profile of Mood States (POMS)
PROMIS Emotional Distress- Depression	p1f5q37a p1f5q37b p1f5q37c p1f5q37d p2f1q33a p2f1q33b p2f1q33c p2f1q33d

Neurodevelopment (16)

Data Element	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
NeuroQOL Cognitive Function	p1f5q35a p1f5q35b p1f5q35c p1f5q35d p1f5q36a p1f5q36b p1f5q36c p1f5q36d p2f1q34a p2f1q34b p2f1q34c p2f1q34d p2f1q35a p2f1q35b p2f1q35c p2f1q35d
Peabody Picture Vocabulary Test (PPVT)

Neuropsychological (4)

Data Element	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
Oral Verbal Fluency Test
Purdue Pegboard (SPA version)
Vineland Adaptive Behavior Summary
Wechsler Intelligence Scales
Woodcock-Johnson Revised, Tests of Achievement
Woodcock-Johnson, Revised, Tests of Cognitive Ability

Pain (22)

Data Element	Variables
ASCQ-Me Pain Episode	fp1f5q06 p1f5q10 p1f5q11 p1f5q7 p1f5q8 p1f5q9 p2f1q03 p2f1q04 p2f1q05 p2f1q07
ASCQ-Me Pain Impact	p1f5q12a p1f5q12b p1f5q13a p1f5q13b p2f1q08a p2f1q08b p2f1q09a p2f1q09b
Brief Pain Inventory (BPI)
PROMIS Neuropathic Pain Quality	p1f5q14a p2f1q10a
PROMIS Nociceptive Pain Quality	p1f5q14b p2f1q10b
PROMIS Pain Interference

Physical Exam (0)

Psychosocial (0)

Quality of Care (0)

Quality of Life (4)

Data Element	Variables
Child Health Questionnaire (CHQ)
Ladder of Life
Pediatric Quality of Life Inventory Child Report (ages 13-18)
Pediatric Quality of Life Inventory Child Report (ages 8-12)
Pediatric Quality of Life Inventory Parent Report for Child (ages 13-18)
Pediatric Quality of Life Inventory Parent Report for Child (ages 8-12)
PROMIS Self-Efficacy for Managing Medications and Treatment	p2f1q38a p2f1q38b p2f1q38c p2f1q38d
SF-36 Health Survey

Sleep (4)

Data Element	Variables
ASCQ-Me Sleep Impact	p1f5q34a p1f5q34b p2f1q32a p2f1q32b

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 Survey 11. Adverse Childhood Experience Questionnaire (ACE-Q)

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