radiation injury treatment network® data collection ... case jr... · cullen case jr., cem 2017...

-Fortuna Favet Paratis-

est. 2006

Radiation Injury Treatment Network®

Data Collection Through FormsNet

Cullen Case Jr., CEM2017 Data Managers Conference-Orlando

February 2017 Data Managers Conference www.RITN.net

What is RITN?

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RITN is a collaborative effort led by the NMDP and ASBMT of hospitals preparing for the medical surge resulting from a distant radiological incident with mass casualties

Established in 2006

Not 1st RespondersNo trauma care

February 2017 Data Managers Conference www.RITN.net3

Wikipedia, June 2011

The Scenario


Why Cancer Centers

• Through cancer treatment process patients are irradiated or given chemotherapy to destroy their immune system

• High doses (>2 Gy**) of ionizing radiation can cause Acute Radiation Syndrome (ARS)

• ARS mimics what hematology/oncology staff see daily from the treatment of blood cancers

Image Source: NCI https://www.cancer.gov/about-cancer/treatment/types/radiation-therapy/radiation-fact-sheet accessed 11/29/16

**Chest CT = 7 mSv : ~0.007 Gy == 2 Gy ~286 chest CTsPET/CT = 25 mSv : ~0.025 Gy == 2 Gy ~ 80 PET/CTs

https://www.cancer.gov/about-cancer/treatment/types/radiation-therapy/radiation-fact-sheet


RITN Connection to ONR and Be The Match registry

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1979 1987 2006 Today

68,0

00+

National Organ Transplant Act of 1984 creates National Bone Marrow Registry

NMDP est. 1987

13 Hospitals form as RITN in 2006

Funding from the Office of Naval Research to improve outcomes from transplant includes contingency planning as a desired outcome

2010 BeTheMatchbecomes public brand

NMDP Facilitated Transplants


RITN centers plan to:– Accept patient transfers– Provide supportive care– Provide treatment expertise– Provide consultation– Collect data on victims treated

at their centers– Facilitate marrow transplant

76 cancer centers /hospitals/ blood donor

centers/cord blood banks

Updated Map and complete list of centers is on RITN website at

www.ritn.net/about/


Timeline

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Months later for data entry


Updated Map and complete list of centers is on RITN website at www.ritn.net/about/


RITN Preparedness Efforts…. Exercises, Training and More….

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13,500+ medical staff trained***Free web-based courses available on RITN.net

16,900+ doses of G-CSF in operational inventory ***Fluctuates throughout year, is sum of inventory at each RITN hospital

Since 2006

580 exercises***All exercise materials available on RITN.net


Background on NMDP and CIBMTR Data Collection

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We were thinking about data collection from the beginning

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Data Collection• Since 2006 have

maintained Marrow Toxic injury consent protocols and forms for patients treated at RITN hospital

• These are approved locally by each hospitals Institution Review Board

• Released web based data collection forms in 2015

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Form Development Process

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Who was involved

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• CIBMTR• Dana-Farber Cancer

Institute/Harvard Medical School• DHHS - Assistant Secretary for

Preparedness and Response• DHHS - Biomedical Advanced

Research and Development Authority

• Health Resources and Service Administration

• NMDP• Office of Naval Research• Radiation Emergency Assistance

Center and Training Site• RITN Centers-Data Mgrs• RITN Exec Cmte• Trissential• UCLA• University of Minnesota• Westwood Cancer Center-

University of Kansas Hospital• CDC• Emory University


Data Collection

• Forms are accessed through CIBMTR FormsNet3 system

• Data managers at hospitals enter data into FormsNet

• Keep in mind these are research forms

• Not real-time

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Baseline Form Sections

• Demographics• Co-Morbid Conditions• Radiation Exposure

Information• Patient Trauma and Illness• Organ Function• Complete Blood Count

(CBC)• Lymphocyte Analysis• Therapy and Infection

Prophylaxis18

Baseline Form263 questions (11 pages)


Baseline Form

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Form Manuals

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When Data is Collected

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Data Collection Exercise (June 2016)

• Exercising collection and reporting on data– 12 hospitals entered data for three

patients– Transplant patient with Marrow Toxic

Injuries from radiological incident– Patient cared for that recovered

without transplant– Patient given other cellular therapy

(TCells, etc..)

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Data Collection Exercise

• Each center enters data daily on all cellular therapy collected nationwide

• Test is of our forms and reports

• Will use real data for 90% of what is entered

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Data Collection Exercise• Since 2006 have maintained consent protocols

for patients treated at RITN hospital• These are approved locally by each hospitals

IRB• Released web based data collection forms in

2015• Exercising collection and reporting June 2016

– 13 hospitals entering data for three patients– Transplant patient with Marrow Toxic Injuries from

radiological incident– Patient cared for that recovered without transplant– Patient given other cellular therapy (TCells, etc..)

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Data Collection Exercise

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Data Collection Exercise Results

• It worked• Handful of issues that were fixed “inflight”• Changes to instructions done during exercise• No significant issues

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Partners Are Critical to Our Success

Partners


“the specter of nuclear terrorism still threaten us all.”-President Barack Obama

June 2, 2016 address to the US Air Force Academy

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