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BLOOD TRANSFUSION RESEARCH
USING ELECTRONIC DATABASES:
THE NHLBI REDS-III PROGRAM
Beth St. Lezin, MD
Ed Murphy, MD, MPH
Na...
REDS: History and Acronyms
1989 2005 2011 2018
REDS REDS-II REDS-III
2006 – International Programs
REDS and REDS-II=
Retro...
Domestic Program
 Address scientific research priorities in blood banking
and transfusion medicine in the US
 Continue r...
REDS-III Institutional Infrastructure
Yale/New
England
ARC
ITxM
BCW
UCSF/BCP
BSRI/Brazil Hub
(4 Blood centers)
JHU/China
(...
Domestic Program – Phase 2
Planned Phase 2 studies:
1. RBC Transfusion in the Elderly Transfusion
Outcomes (RETRO)
• 6 min...
6
REDS-III Database Approach
• Monthly downloads of type & cross and issued unit
data from hospital transfusion services
• M...
UCSFMC
Apex EMR
VAMC
Vista EMR
THREDS
& CTSI ARS
VAMC
programmer
Clarity Tables
to IT
consultant
BCP
Blood Donor &
Blood P...
Blood Components Data
Combined Data
VA
Donor & Donation Data
UCSF
VA
SF GH
Snap-shot of SFGH Pilot data
Recipient Gender Age Race Diagnosis Service Discharge
ID Diagnosis
2 Male 54 White
Anemia Chr...
Snap-shot of SFGH Pilot data
Patient Database Components Database Donor/Donation DatabaseRecipient Gender Age Race Diagnos...
IRB, HIPAA and Honest Broker
• UCSF CHR approval obtained with waiver of consent
• Data use agreement with VAMC; MOU with ...
Possible Recipient database analyses
• Epidemiology of blood component transfusion:
• RBC, Platelets and Plasma – incidenc...
Status Report
• First quarter 2013 data uploaded from UCSF-MC; VAMC and
SFGH uploads imminent pending admin approvals
• Ba...
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UCSF Informatics Day 2014 - Elizabeth St. Lezin, "Blood Transfusion Research using Electronic Databases: The NHLBI REDS-III Program"

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UCSF Informatics Day 2014 - Elizabeth St. Lezin, "Blood Transfusion Research using Electronic Databases: The NHLBI REDS-III Program"

  1. 1. BLOOD TRANSFUSION RESEARCH USING ELECTRONIC DATABASES: THE NHLBI REDS-III PROGRAM Beth St. Lezin, MD Ed Murphy, MD, MPH Nareg Roubinian, MD Brian Custer, MPH, PhD Roberta Bruhn, MS, PhD Anne Guiltinan, MA, LMFT Ebi Fiebig, MD Ashok Nambiar, MD
  2. 2. REDS: History and Acronyms 1989 2005 2011 2018 REDS REDS-II REDS-III 2006 – International Programs REDS and REDS-II= Retrovirus Epidemiology Donor Study REDS –III = Recipient Epidemiology and Donor evaluation Study
  3. 3. Domestic Program  Address scientific research priorities in blood banking and transfusion medicine in the US  Continue research aimed at donor/donations and blood banking issues  Start to address transfusion practice and recipient risk issues:  Evaluating blood product utilization practices in various clinical settings and in specific patient populations and their associated outcomes and costs  Evaluating the risks of allogeneic blood transfusion and their determinants on clinical outcomes  Evaluating the potential clinical benefit(s) of introducing a modified product or treatment strategy  Characterization of the risks, benefits, and clinical outcomes of prophylactic versus therapeutic transfusion strategies, and alternatives to allogeneic transfusions  Education and training component 3
  4. 4. REDS-III Institutional Infrastructure Yale/New England ARC ITxM BCW UCSF/BCP BSRI/Brazil Hub (4 Blood centers) JHU/China (5 Blood Centers) UCSF/South Africa (SANBS) CL (BSRI) H H H H H H H H Hospitals U.S. Hubs NHLBI US-Foreign Partnerships DCC (RTI) H H H H
  5. 5. Domestic Program – Phase 2 Planned Phase 2 studies: 1. RBC Transfusion in the Elderly Transfusion Outcomes (RETRO) • 6 minute walk test and quality of life surveys 1. Severe Transfusion Reactions including Pulmonary Edema (STRIPE) • Active surveillance of tx reactions and a case- control study of TACO 1. Genetic basis of differential RBC storage capacity and iron balance and clinical syndromes in high Intensity blood donors (RBC-Omics) • GWAS of 14,000 donors characterized by hemolysis of their stored RBCs and by their donation intensity 5
  6. 6. 6
  7. 7. REDS-III Database Approach • Monthly downloads of type & cross and issued unit data from hospital transfusion services • Matching to clinical data from hospital medical information system • Identity coding by honest broker function and uploading data to secure MyResearch website • Download data to CCC and matching to donor/donation database • Formulation of three deliverable databases
  8. 8. UCSFMC Apex EMR VAMC Vista EMR THREDS & CTSI ARS VAMC programmer Clarity Tables to IT consultant BCP Blood Donor & Blood Product Data UCSF/BSRI REDS-III Hub CTSI MyResearch Honest Broker SFGH EMR Donation Components Recipient Databases sent to REDS-III Data Coordinating Center REDS-III Data Flow
  9. 9. Blood Components Data Combined Data VA Donor & Donation Data UCSF VA SF GH
  10. 10. Snap-shot of SFGH Pilot data Recipient Gender Age Race Diagnosis Service Discharge ID Diagnosis 2 Male 54 White Anemia Chr Disease Nec Medicine Longterm Care End Stage Renal Disease Mental Health Rehab. Dead, Other Death, Autopsy Performed Atrial Fibrillation Cachexia Blood Unit ID Blood Transfusion Donation Donation Component Date Number Date W117009128332LRA RBC 11/12/2009 W117009128332005 10/31/2009 W117009133548LRA RBC 11/13/2009 W11700913354800 L 11/5/2009 Donor ID Sex Age Race Education Donor Procedure Donation Type Type Type 65006037199 3 Male 17 Hispanic High School or less First Whole Blood Homologous 65006030417 7 Male 52 White Master's or Professional Degree Repeat Whole Blood Homologous Patient Database Components Database Donor/ Donation Database
  11. 11. Snap-shot of SFGH Pilot data Patient Database Components Database Donor/Donation DatabaseRecipient Gender Age Race Diagnosis Service Discharge Blood Unit ID Blood Transfusion Donation Donation Donor ID Gender Age Race Education Donor Procedure ID Status Component Date Number Date Type Type SFGH001 Female 47 Black Acc Pois-Anticonvulsant FamilyMedicine Routine W117009130462LRA RBC 11/12/2009 W117009130462007 11/3/2009 650060305992 Female 38 White Some College/Tech.School First Whole Blood End Stage Renal Disease Discharge Home SFGH002 Male 54 White Anemia Chr Disease Nec Medicine Longterm Care W117009128332LRA RBC 11/12/2009 W117009128332005 10/31/2009 650060371993 Male 17 Hispanic High School or less First Whole Blood End Stage Renal Disease Mental Health Rehab. Dead, Other Death, W117009133548LRA RBC 11/13/2009 W11700913354800L 11/5/2009 650060304177 Male 52 White Master's or Prof. Degree Repeat Whole Blood Cachexia Autopsy Performed SFGH003 Male 61 Black Luekocytopenia, Unspecified Lhh Acute Medical Longterm Care W117009135232LRA2 RBC 11/16/2009 W11700913523200T 11/2/2009 650060372232 Male 31 White Master's or Prof. Degree Repeat 2RBC Open Wound Buttock-Comp Lhh Bed Hold Other Facility R/O Hiv Disease Medicine Acute Care Facility SFGH007 Male 61 Asian Ac Osteomyelitis-Ankle Trauma Active W117009224115LRA1 RBC 11/1/2009 W11700922411500N 10/10/2009 650060191503 Male 24 White High School or less Repeat 2RBC Acute Renal Failure Nos Lhh SnfRehab Active Chronic Kidney Disease, Stage V SFGH008 Female 63 Asian Disorder Bone &Cart Nos Orthopedics Rehab Facility W117009339905LRA RBC 11/11/2009 W117009339905009 10/29/2009 650060263725 Female 19 White High School or less Repeat Whole Blood Female Breast Ca Nos Lhh SnfRehab Routine Knee Replacement Status Discharge Home SFGH009 Male 50 Hispanic Ac RespiratoryFailure FamilyMedicine Rehab Facility W117009125577LRA RBC 11/8/2009 W11700912557700B 10/10/2009 650026346189 Male 35 Hispanic Bachelor's Degree Repeat Whole Blood R/O Hiv Disease Lhh SnfRehab W117009224107LRA RBC 11/9/2009 W11700922410700N 10/10/2009 650060341853 Male 27 White High School or less Repeat Whole Blood Sepsis Buttock Cellulitis SFGH010 Male 49 Asian Abn Rxn-Surgical Px Nec Urology Rehab Facility W117009124571LRA1 RBC 11/1/2009 W117009124571002 10/7/2009 650060255650 Male 29 Hispanic High School or less Repeat 2RBC Abnormal Glucose Nec Longterm Care W117009337849LRA2 RBC 11/1/2009 W11700933784900P 10/7/2009 650060369524 Male 30 White Some College/Tech.School First 2RBC Atrial Fibrillation W117009131270LRA RBC 11/2/2009 W117009131270007 10/28/2009 650060303614 Male 25 N/A High School or less Repeat Whole Blood Acute Renal Failure Nos W117009130360LRA RBC 11/3/2009 W11700913036000J 11/1/2009 650060372043 Male 43 White Bachelor's Degree First Whole Blood Cerebral Embol W Infarct W117009134580LRA RBC 11/3/2009 W117009134580005 11/1/2009 650060305952 Male 41 Asian Master's or Prof. Degree Repeat Whole Blood W117009222936LRA2 RBC 11/4/2009 W11700922293600I 10/10/2009 650060267910 Male 37 White Some College/Tech.School Repeat 2RBC W117009127098LRA1 RBC 11/5/2009 W117009127098009 10/13/2009 657000010800 Male 58 White Master's or Prof. Degree Repeat Apheresis SFGH012 Male 66 Black Bronchus/Lung Ca Nec Neurology Acute Care Facility W117009133992LRA RBC 11/9/2009 W11700913399200I 11/7/2009 650060372892 Female 16 White High School or less First Whole Blood Chr Blood Loss Anemia W117009135339LRA RBC 11/9/2009 W117009135339007 11/7/2009 650060372884 Female 28 White Bachelor's Degree First Whole Blood SFGH014 Male 64 Hispanic Alc Dep Nec & Nos-Cont Medicine Routine W117009126916LRA RBC 11/7/2009 W11700912691600Q 10/8/2009 650060282969 Male 57 Asian Master's or Prof. Degree Repeat Whole Blood Alcohol Liver Cirrhosis Discharge Home W117009128984LRA RBC 11/7/2009 W117009128984007 10/10/2009 650060071034 Female 53 White Master's or Prof. Degree Repeat Whole Blood SFGH00022Female 67 Black Abn Rxn-Artificial Impl Orthopedics Routine W117009222880LRA1 RBC 11/3/2009 W11700922288000I 10/6/2009 650060369345 Male 16 White High School or less First 2RBC Mechan.Compl.Of Int.Orth. Dev Discharge Home W117009338294LRA RBC 11/3/2009 W11700933829400A 10/6/2009 650060096234 Male 28 White Some College/Tech.School Repeat Whole Blood
  12. 12. IRB, HIPAA and Honest Broker • UCSF CHR approval obtained with waiver of consent • Data use agreement with VAMC; MOU with SFGH pending • Use of UCSF CTSI MyResearch secure portal by the CCC to maintain REDS-III data directories securely UCSF CTSI offers “honest broker” service through its MyResearch secure portal: • Holds identified data and translation keys in secure escrow. • Provides de-identified data to researchers. • Provides de-identification and re-identification services for researchers.
  13. 13. Possible Recipient database analyses • Epidemiology of blood component transfusion: • RBC, Platelets and Plasma – incidence, secular trends and outcomes • Transfusion Reactions • Compare active surveillance (clinical study) and passive reporting; estimate degree of underreporting using changes in vital signs or post transfusion interventions eg medications, chest xrays etc. • Trauma • Epidemiology of transfusions, outcomes, risk factors for poor outcomes. • Neurosurgery and neurologic injury • Identifying Predictors of Transfusion • Extending Kaiser models to REDS-III recipient database for predicting transfusion of red cells, platelets or plasma
  14. 14. Status Report • First quarter 2013 data uploaded from UCSF-MC; VAMC and SFGH uploads imminent pending admin approvals • Backfill additional quarters of data into 2014 Conclusions • REDS-III leverages the EMR to address important clinical questions regarding the utilization and outcomes of blood transfusion • The work involved is not trivial, and demands close interaction between programmers and content (medical) experts

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