Deceased Donor Potential Study

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National Deceased Donor Potential Study:
Updates and Next Steps
Karl J. McCleary, Ph.D., M.P.H., Scientific Director, CTSE
Principal Investigator, DDPS
Affiliate Faculty, School of Medicine,
Virginia Commonwealth University
Acknowledgement: The Deceased Donor Potential Study is a commissioned study funded by the Organ
Procurement and Transplantation Network (OPTN) under Task 6 of the existing contract. The OPTN is supported
by Health Resources and Services Administration (HRSA), Healthcare Systems Bureau, Division of Transplantation’s
contract #234-2005-370011C. The content described here is the responsibility of the author alone and does not
necessarily reflect the views or policies of the Department of Health and Human Services, the OPTN, or UNOS; nor
does mention of trade names, commercial products, or organizations imply endorsement by the US Government.
The “Question”
What
is the “true” potential for
deceased organ donation in the United
States?
Purpose of Study
 The
DDPS aims to generate more current scientific
evidence that is based on rigorous epidemiologic,
population, demographic, and geographic analyses
of the deceased donor system for the purposes of
determining the potential number of organ donors,
and to determine the potential trend in that number
over time.
Specific Aims: Objectives
To compile
descriptive
information
about
characterizing
deceased
donor
potential in
the United
States.
To identify the
number of possible
deceased donors
and the types of
donation for which
they are suitable;
parsing and allow
for modifications in
deceased donor
organ categorization
as scientifically
and/or clinically
appropriate.
To estimate
trends in
deceased
donor
potential
over the
next five to
ten years.
To test and
propose
options that
best govern
potential
changes in
the
deceased
donor
transplant
system that
will
increase
organ
donation.
Research Strategy
 Build
a unifying framework for understanding
deceased donor potential, linking existing bodies
of knowledge and specific research traditions that
are relevant to transplantation WITH the power of
transdisciplinary science approach.
 Examine
deceased donor potential from a complex
system view.
Important Qualifiers or
Clarifying Points about the Study
 What
the study is not:
Does not include OPTN policy formation and analysis.
 Does not include any focus on organ allocation or
distribution.
 Does not include any recommendations on differing
geographic units of measure or operational approaches.
 Study is not focused on current understandings or
classifications typically used for compliance reasons (ECD,
SCD, etc.).

Deceased Donor Potential Study:
3 Threads
Donor
Potential
Number
Donor Gap
Analyses
Donor
Policy
Projections
DDPS : Expert Group that Informs this Work
The Committee
DDPS Stakeholder Committee is
comprised of transplant and nontransplant professionals (50
members)
•Critical Care, Neuro, Trauma, Emergency
Medicine
•OPO Professionals (Executives, Directors of
Procurement, Clinical Operations,
Communications, Quality Improvement)
•Transplant Surgeons and Physicians,
Transplant Nurses
•Other Subject Matter Experts—Geography,
Epidemiology, Economics, Health Services
Research, Statistics, System Dynamics, and
Human Subjects Protection
•Transplant Recipient and Citizen
Participant
•HRSA
•CMS
•AHA
The Subcommittees
OPO Subcommittee
Data Subcommittee
Caregiver Informant Group
Subcommittee
System Dynamics Work Group
Evidence-Based Review
Subcommittee
Open Innovation
Subcommittee
Deceased Donor Potential Study
Subcommittee Contributions
Caregiver
Informant
Group
Donor
Potential
Number
OPO
Subcommittee
Data
Subcom
System Dynamics
Donor Team
Donor GapEvidencePolicy
based
Analyses Review
Projections
Open Innovation
Inside the Mortality Funnel:
Path from All Deaths to Deceased Donors
3. Donors
2. All Medically Suitable Deaths
Source: Adapted from T.
Beigay, M. Reibel, & J.
Rosendale, 2011.
*Note: Graphic is not drawn to scale.
1. All Deaths
Data source triangulation for
Donor Potential Number
NCHS
Vital
Statistics
OPTN
HCUP
CA
Inpatient
and ED
Death
Data
• The CIG, OPO, and Data
Subcommittees will
collaborate to provide
three different estimates
of donor potential using
different databases and
similar filters
• This range of estimates
will also be used in the
System Dynamics
Deceased Donor Potential
model
Data Source Options
Data Source
Strengths
Limitations
DDPS Project Utility
National Mortality
Data NVSS
Includes all deaths
Not coded for all
Use for Deceased
medical exclusionary Donor Potential
criteria
Estimate #1
National Hospital
HCUP
Includes all
medically relevant
exclusionary criteria
Includes only deaths Use for Deceased
occurring in
Donor Potential
hospitals; No COD
Estimate #2
data
OPO Medical Record Includes medically
Reviews
relevant criteria
Disparate, nonstandard formats
Time required not
available
OPO Call Center
Records
Rich source of
qualitative data
Will not provide
deceased donor
potential per se
Time required not
available
California Mortality
Data
Includes complete,
Includes only
identified mortality California deaths
data allowing linking
to UNOS database;
10-yr series
Use for Deceased
Donor Potential
Estimate #3 and Gap
Analyses
Donor Potential Estimate #1
4. OPTN
Donors
3. OPTN
Database 2. All
Medically 1. All
Suitable
Deaths
Deaths
Custom
Criteria
for Filter
OPTN/UNOS
Exclusionary
criteria
(7.1.7)
• CIG Review and
Modify for
Clinical Accuracy
per Organ
• Use as filter for
HCUP data
Healthcare
Cost and
Utilization
Project Data
NIS & NEDS
• Filter deaths
with revised
clinical
exclusionary
criteria
• Analysis
includes
sensitivity ranges
Deceased
Donor
Potential
Range
Estimate #1
• Purely clinical
criteria
• Hospital and ED
patients only
Donor Potential Estimates #2 & #3
Custom
Criteria
for Filter
NCHS
National
Mortality
Data
• Filter deaths
with
synthesized
exclusionary
criteria
Deceased
Donor
Potential
Estimate #2
• CIG Review
and Modify
• OPO review
and modify
• Synthesize
above for
filter
OPTN/UNOS
Exclusionary
Criteria
(7.1.7)
California
Mortality
Data
4. OPTN
Donors
3. OPTN
Database 2. All
Medically 1. All
Suitable Deaths
Deaths
•Filter deaths with
synthesized
exclusionary
criteria
Deceased
Donor
Potential
Estimate #3
• Includes all
deaths
• May not
capture
medical
exclusions not
diagnosed time
of death
•May not capture
medical
exclusions not
diagnosed time of
death
•Includes only
California deaths
•Link to OPTN data
Proposed Procedure for Developing and Applying
Custom Criteria for Medical Suitability for Deceased
Donation
Goal: Apply Custom Filters
to Datasets
Criteria from
Clinicians and
Caregivers
(CIG Subcommittee)
Synthesize and
Operationalize
Criteria Within the
Constraints of
Available Data
(Data Subcommittee)
Criteria from OPO
Leaders and
Procurement
Professionals
(OPO Subcommittee)
Donor Potential Gap Analysis:
Actual v. Potential
4. OPTN
Donors
Gap 1
Gap 2
3. OPTN
Database 2. All
Medically
Suitable
Deaths 1. All
Deaths
Gap 3
• Build comprehensive dataset
(includes NCHS and
California’s Death Statistical
Master files match-merged
with OPTN Deceased
Donor data + Census data)
• Conduct comparative donor
gap analyses
• Use logistic regression models
to determine probability of
1.
2.
3.
Donation if eligible
OPTN Database - if
medically suitable
OPTN Donor- if medically
suitable
Donor Policy Projections
• What policies are most
effective to increase
donation and increase
realization of deceased
donor potential?
Data trends
Causal
Relationships
Effect Size
Parameters
Deceased Donor Simulator
Deaths
Outcomes
Graft Failure
End Stage
Chronic
disease
Transplant
Recipients
Waiting List
Risk
Tolerance
Organs per
Donor
Transplant
Rate
Donor Organs
Available
Donors
Transplant
Program Capacity
What
if …
Validation/
calibration
Successful Transplants per year
Updates
Key Milestones
Creating Custom Filters
OPO
Subcommittee
Data Warehousing
Mortality Data
CIG
National
Subcommittee
State
Health Services
Data
Subcommittee
Administrative
Data
Inpatient and ED
Analytic Decisions and Tasks
Incorporating population,
demographic, epidemiologic,
and geographic factors into
the study models
Exploring the feasibility of
using comorbidity or disease
severity of illness measures
that describe or characterize
donor potential status
Next Steps and Actions
Final Models
July
Compression
of Analytic
Tasks
Report of
Findings
July/August
September 2012
Acknowledgements
The Stakeholder Committee
Alexandra K. Glazier, Esq.
Betty C. Crandall, MS, RN
Danielle L. Cornell, RN, BSN, CPTC
David G. Jacobs, M.D.
David W. Bosch, MS
David H. Howard, Ph.D.
Dorothy L. Faulkner, M.P.H., Ph.D.
George F. Bergstrom, MA, FACHE
Gerard Rushton, Ph.D.
Glen Franklin, M.D.
Harry E. Wilkins, III, M.D., MHCM, FACS
Hazhir Rahmandad, Ph.D.
Howard M. Nathan, BS, CPTC
J. Elizabeth Tuttle-Newhall, M.D.
James J. Wynn, M.D.
Janice Whaley, MPH, CPTC
Jeffrey P. Orlowski, MS, CPTC
Jennie P. Perryman, RN, Ph.D.
Jesse Schold, Ph.D., M.Stat., M.Ed.
John Belcher, BS, CCEMT-P, CPTC
Julie A. Mayglothing, M.D.
Karen Garcia, M.S.Ed.
Kevin J. O'Connor, MS,PA
Laurie J. Lyckholm, M.D.
Linda Ohler, MSN, RN, CCTC, FAAN
Lori E. Markham, RN, MSN, CCRN, CPTC
M. Anjali Sastry, Ph.D.
Marcella Farinelli Fierro, M.D.
Maria DeLauro, RN, MSN,MPA
Mary Kelleher-Crabtree, MS, PMP, CIP, CCRP
Maryl R. Johnson, M.D.
Meg M. Rogers, BSN, CPTC
Nikolaos T. Pyrsopoulos, M.D., Ph.D.
P.J. Geraghty, EMT-P, BS, CPTC
Paul K. Halverson, Dr.P.H., M.S.H.A, FACHE
Renee Bennett, RN, BSN, CNOR, CCTN, CCTC
Richard D. Hasz, Jr., MFS
Robert S.D. Higgins, M.D., MSHA
Stuart J. Youngner, M.D.
Suzanne Lane Conrad, RN, MS
Thomas Mone, MS
Thomas A. Nakagawa, M.D.
Thomas P. Bleck, M.D., FCCM
Timothy L. Pruett, M.D.
Richard Durbin, MBA
Christopher J. McLaughlin
Teresa M. Beigay, Dr.P.H.
Brian Shepard
The Research Team
Name and Organizational Affiliation
Role on Team
Darren E. Stewart, M.S. (UNOS Research)
Data Analyst, CIG Support
David A. Wagstaff, Ph.D. (Penn State)
Data Analyst, CIG Support
Gary King, Ph.D., M.A. (Harvard)
Co-Investigator
John D. Rosendale, M.S. (UNOS Research)
Co-Investigator
Joyce D. K. Essien, M.D., M.P.H. (Emory, CDC-Retired)
Facilitator
Kevin A. Myer, M.S.H.A. (UNOS CTSE)
Co-Investigator
Khalid Saeed, Ph.D., M. Eng. (WPI)
Co-Investigator
Kristina Wile, S.M. (Systems Thinking Collaborative)
Facilitator, Project Management
Laura A. Siminoff, Ph.D., M.A. (VCU)
Co-Investigator
Leah B. Edwards, Ph.D. (UNOS Research)
Co-Investigator
L. Ebony Boulware, M.D., M.P.H. (Hopkins)
Co-Investigator
Michael Reibel, Ph.D. (Cal Poly)
Co-Investigator
Samuel Soret, Ph.D., M.P.H. (Loma Linda U)
Co-Investigator
Gary B. Hirsch, S.M. (Creator of Learning Environments and MIT)
Co-Principal Investigator
Karl J. McCleary, Ph.D., M.P.H. (UNOS CTSE and VCU)
Principal Investigator
Center for Transplant
System Excellence
Improving the care continuum
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