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Consideration of Net Benefit as applied to Organ Transplantation. Workgroup 3 – UNOS Strategic Planning Retreat, Boston 10/05. Worgroup 3 – Net Benefit. Dale Distant – Introduction to Net Benefit Bob Wolfe – Net Benefit Calculation and application Mark Stegall – Net Benefit and KARS

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Consideration of net benefit as applied to organ transplantation

Consideration of Net Benefit as applied to Organ Transplantation

Workgroup 3 – UNOS Strategic Planning Retreat, Boston 10/05


Worgroup 3 net benefit
Worgroup 3 – Net Benefit Transplantation

  • Dale Distant – Introduction to Net Benefit

  • Bob Wolfe – Net Benefit Calculation and application

  • Mark Stegall – Net Benefit and KARS

  • Bill Harmon – Workgroup 3 recommendations


Workgroup 3 members

Dale Distant Transplantation

Don Hillebrand

Maggie Allee

Dan Hayes

Bill Harmon

Abraham Shaked

Jill McMaster

Dolph Chianchiano

Geoffrey Land

Mark Stegall

Jorge Reyes

Clyde Barker

Rich Fine

Barry Kahan

Doug Heiney

Workgroup 3 - Members


Program assessment and rating tool
Program Assessment and Rating Tool Transplantation

  • In July 2004, the HRSA Division of Transplantation (DoT) participated in the Office of Management and Budget (OMB) Program Assessment Rating Tool (PART).

  • PART is a systematic method of assessing the performance of program activities across the Federal government.

  • The PART is a diagnostic tool; the main objective of which is to improve program performance.


Program assessment and rating tool1
Program Assessment and Rating Tool Transplantation

  • PART strengthens and reinforces performance measurement by encouraging careful development of performance measures according to outcome oriented standards and by requiring that agency goals be appropriately ambitious.

  • Because the ability to meet these targets is directly dependent on the efficient and effective operations of the OPTN, these goals will become the performance goals of the OPTN contract.

  • Because achieving these goals is among DoT’s most important priorities, the OPTN contractor must be a strategic partner in this effort.


Hhs transplantation goals
HHS Transplantation Goals Transplantation


Hhs transplantation goals1
HHS Transplantation Goals Transplantation

  • Long-Term Goal By 2013, increase the total expected life-years gained for kidney transplant recipients in the first 5 years after the transplant to 8,543 compared to what would be expected for these recipients had they remained on the waiting list.

  • Short-Term Goal Increase the average number of life-years gained in the first 5 years after transplantation for deceased kidney/kidney-pancreas transplants by 0.003 life-years until the goal of 0.436 life-years gained per transplant is achieved in 2013.


Hhs transplantation goals2
HHS Transplantation Goals Transplantation

  • Short-Term Goal Increase the total number of expected life-years gained in the first 5 years after the transplant for all deceased kidney and kidney-pancreas transplant recipients compared to what would be expected for these patients had they remained on the waiting list


Role of the optn
Role of the OPTN Transplantation

Stakeholders

Advancing the Science of Transplantation

Transplant

Clinicians

Government

Agencies

OPTN/SRTR

DSA’s

Academic

Centers

Corporate

Enterprise

Funding

Agencies

Immunology/

Immunosuppression

Donor

Management/

Donation/

Preservation

Policy/

Allocation

Collaboration

Recipient

Management

Research

Research

History of Continously Improving Results


Optn strategic plan
OPTN Strategic Plan Transplantation

  • Benefit – Net Benefit

  • Equity

  • Allocation Policy – Directives to committees

  • Data Collection

  • Continual Improvement


Net benefit
Net Benefit Transplantation

  • New terminology for transplant community but not a new concept

  • Net benefit describes utility

  • Utility considerations are already integral to organ allocation

    • HLA in kidney transplantation

    • MELD in liver transplantation

    • Lung Allocation Score – net benefit and waitlist mortality


Net benefit1
Net Benefit Transplantation

  • A more complete description of transplant utility

    • Can synthesize multiple metrics describing the benefits and harms of transplantation into a single concept

    • Readily quantifiable

    • May describe individual or group benefit

    • Allows comparison between individuals


Net benefit2
Net Benefit Transplantation

  • Not a single concept but a consistent methodology for answering questions of utility (maximizing benefit/reducing burdens)

    • Patient and Graft Survival

      • Best data – serial data for some organs not others

      • Waitlist mortality – MELD

    • Quality of Life – Limited data

      • Data collection beginning

    • Burden of disease – data in other databases


Net benefit3
Net Benefit Transplantation

  • Useful for all organs

    • Utility goals need to be determined for each organ

    • Components of net benefit calculation are organ specific

    • Projected estimates of net benefit are time dependent

    • Lung is the most advanced

  • Aids determination of futility or harm as a result of transplant


Lung allocation definitions

USA New Lung Allocation Policy: Pulmonary Medicine Conference 2005

Lung Allocation - Definitions

  • Waitlist Urgency Measure = Expected number of days lived without a transplant during an additional year on the waitlist

  • Post-transplant Survival Measure = Expected number of days lived during the first year post-transplant

  • Transplant Benefit Measure = Post-transplant Survival Measure minus Waitlist Urgency Measure i.e. expected extra days of life over the next year if that candidate receives a transplant rather than remaining on the waitlist

Lung Allocation Subcommittee, Thoracic Organ Committee, UNOS


Factors predicting survival after ltx

Forced vital capacity (FVC) Conference 2005

PA systolic (Group A, C, D)

O2 required at rest

(Group A, C, D)

Age

Body mass index (BMI)

IDDM

Functional status (NYHA)

6-minute walk distance

Ventilator use

Diagnosis

Forced Vital Capacity (FVC) (Group B, D)

PCW pressure  20 (Group D)

Ventilator use

Age

Creatinine

Functional Status (NYHA)

Diagnosis

USA New Lung Allocation Policy: Pulmonary Medicine Conference 2005

Factors predicting survival after ltx

Factors predicting waitlist survival

Lung Allocation Subcommittee, Thoracic Organ Committee, UNOS


Expected waitlist survival vs transplant benefit

allocation by urgency Conference 2005

allocation by benefit

USA New Lung Allocation Policy: Pulmonary Medicine Conference 2005

Expected Waitlist Survival vs. Transplant Benefit

based on number of transplant organs available for current blood type within 1 year

1

2

2

3

3

1

transplant benefit threshold

Lung Allocation Subcommittee, Thoracic Organ Committee, UNOS


Expected waitlist survival vs transplant benefit1

USA New Lung Allocation Policy: Pulmonary Medicine Conference 2005

Expected Waitlist Survival vs. Transplant Benefit

allocation balancing

urgency & benefit

2

1

patients don’t stay in one place!

3

Lung Allocation Subcommittee, Thoracic Organ Committee, UNOS


Net benefit caution
Net Benefit - Caution Conference 2005

  • New organ specific data elements or data collection intervals may be required

  • The language, assumptions, and methods are utilitarian

    • ethical dilemmas regarding distributive justice

  • Equity is a necessary separate discussion


Net benefit caution1
Net Benefit - Caution Conference 2005

  • … One fundamental difficulty is that the foundations of the economic analysis are ethically biased towards utilitarianism. In the choice between different health care allocations both economic and ethical aspects must be considered. If this ethical bias inherent in economic theories is not recognised, the choice could be dubious from an ethical point of view.

Malmgren K, Hedström A, Granqvist R, Malmgren H & Ben-Menachem E,

Cost analysis of epilepsy surgery and of vigabatrin treatment in patients with

refractory partial epilepsy.Epilepsy Research 25 (1996), 199-207.


Here is a story based on Foot (1978): Five people are in a hospital, dying. One can be saved only by a kidney transplant, another by a heart transplant, another by a brain transplant, etc. They are all young and will lead full lives if they are saved. But no donors are available.

Then, one day, Harry wanders into the emergency room to ask directions...

So the question for a utilitarian is, why not?

Heuristics and biases in equity judgments: a utilitarian approach

Jonathan BaronDepartment of PsychologyUniversity of Pennsylvania


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