achieving consensus on increased risk donors to improve access to organ transplantation
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Achieving Consensus on Increased Risk Donors to Improve Access to Organ Transplantation. Michael G. Ison, MD MS Associate Professor Divisions of Infectious Diseases & Organ Transplantation Update on Consensus Conference for the Advisory Committee on Organ Transplantation - PowerPoint PPT PresentationTRANSCRIPT
Michael G. Ison, MD MSAssociate Professor
Divisions of Infectious Diseases & Organ TransplantationUpdate on Consensus Conference for the
Advisory Committee on Organ TransplantationAugust 28, 2012 – Rockville, Maryland
Achieving Consensus on Increased Risk Donors to Improve Access to
Organ Transplantation
Funded by AHRQGrant: 1R13HS021060-01
Overview
• Background and Grant Development
• Meeting Process and Work Groups
• Goals of Meeting
• Findings of Workgroups & Recommendations
• Outputs of Meeting
Funded by AHRQGrant: 1R13HS021060-01
Reason for the Meeting
Background and Grant Development
• Winter 2010/Spring 2011o PHS guidelines undergoing revisiono Concern within the transplant community about increased risk
donors and donor screening Live donor screening recommendations Live donor increased risk consensus conference
o General sense within the transplant community that the donor screening issue was addressed by NAT consensus conference
• Ison/Pruett applied to AHRQ for Small Grant Program for Conference Support (R13; PA-09-231)o Reviewed by Special Emphasis Panel June 9, 2012o Award Notice: September 15, 2011o Organizational calls for meeting initiated in October 2011o Sought and obtained co-sponsorship by ASTS and AST
Funded by AHRQGrant: 1R13HS021060-01
Background and Grant Development
• Aggressive meeting planning after PHS Guideline public comment period completedo Selection of meeting date to minimize conflictso Selection of 2 chairs for work groups (one each from ASTS & AST)o Invitation to work group members
• Stated goals of meeting per grant application1. Disseminate research findings and evidence-based information about optimal
evaluation, classification of donors at increased risk of disease transmission in addition to optimal informed consent and post-transplant evaluation of recipients of organs from such donors with the goal of improving the outcomes, quality, access to, and utilization of such organs
2. Define issues and problems in the practice and delivery of solid organ transplant related to donors at increased risk of disease transmission and to develop a rational research agenda or strategy for studying these problems
Funded by AHRQGrant: 1R13HS021060-01
Meeting Specific Aims• Aim 1: To develop a consensus definition of donors at
increased risk of transmission of HIV, HBV, and HCV o Review current research findings and evidence-based information to inform a
standard definition of donors at increased risk of transmission of HIV, HBV, and HCV and disseminate these findings to the transplant community.
o To identify gaps in defining a standard definition of donors at increase risk of transmission of HIV, HBV, and HCV and develop a rational research agenda or
strategy to address these gaps.
• Aim 2: To define the optimal evaluation of living donors to mitigate against infectious disease transmission, with a focus on HIV, HBV, and HCV o Review current research findings and evidence-based information to inform the
optimal evaluation of living donors to mitigate against infectious disease transmission, with a focus on HIV, HBV, and HCV and disseminate these findings to the transplant community.
o To identify gaps in the evaluation of living donors to mitigate against infectious disease transmission, with a focus on HIV, HBV, and HCV and develop a rational research agenda or strategy to address these gaps.
Funded by AHRQGrant: 1R13HS021060-01
Meeting Specific Aims
• Aim 3: To define the optimal timing, content, and method of informed consent of candidates considering accepting an organ from an increased risk donoro Review current research findings and evidence-based information to define the optimal
timing, content, and method of informed consent of candidates considering accepting an organ from a donor at increased risk of HIV, HBV, and HCV transmission and disseminate these findings to the transplant community.
o To identify gaps in standardizing the timing, content, and method of informed consent of candidates considering accepting an organ from a donor at increased risk of HIV, HBV, and HCV transmission and develop a rational research agenda or strategy to address these gaps.
• Aim 4: To develop consensus on the optimal evaluation of recipients of organs from an increased risk donorso Review current research findings and evidence-based information to inform the optimal
evaluation of recipients of organs from donors at increased risk of HIV, HBV, and HCV transmission and disseminate these findings to the transplant community.
o To identify gaps in standardizing the optimal evaluation of recipients of organs from donors at increased risk of HIV, HBV, and HCV transmission and develop a rational research agenda or strategy to address these gaps.
Funded by AHRQGrant: 1R13HS021060-01
Work Group 1: Increased Risk Definitions
Member Expertise Program
Michael Green TID/Peds U Pittsburgh
Dorry Segev Transplant Surgery Johns Hopkins
Michael Abecassis Transplant Surgery Northwestern
David Cohen Transplant Nephrology Columbia
William Hasskamp Coordinator LifeShare of Carolinas
Dan Lebovitz OPO/Pulmonology Cleveland Clinic/LifeBanc
Jeff Orlowski OPO Ctr for Donation & Tx
Peter Reese* Transplant Nephrology U Pennsylvania
David Reich Transplant Surgery Drexell
John Roberts* Transplant Surgery U California-San Fran
Michael Volk Transplant Hepatology U Michigan
Charles Wright OPO LifeLink of Florida
*Unable to attend in-person meeting.
Funded by AHRQGrant: 1R13HS021060-01
Work Group 2: Live Donor Evaluation
Member Expertise Program
Connie Davis Transplant Nephrology U Washington
Chris Freise Transplant Surgery U California – San Fran
Talia Baker Transplant Surgery Northwestern
Sandi Cohen Social Worker U Chicago
Carrie Comellas Coordinator SUNY – Stony Brook
Stuart Flechner Transplant Surgery Cleveland Clinic
Jami Hanneman Social Worker Northwestern
Kevin Korenblat Transplant Hepatology Washington U
Dianne LaPointe-Rudow Coordinator Mt. Sinai
David Mulligan Transplant Surgery Mayo Clinic – Arizona
Doug Penrod Transplant Donor/TC Northwestern
Dorn Sanders Transplant Donor Patient
Funded by AHRQGrant: 1R13HS021060-01
Work Group 3: Informed ConsentMember Expertise Program
Emily Blumberg TID U Pennsylvania
Rich Freeman Transplant Surgery Dartmouth
Mark Barr Transplant Surgery U Southern California
Mary Amanda Dew Psych U Pittsburgh
Nicole Beauvais* Coordinator Northwestern
James Eason Transplant Surgery U Tennessee
Robert Gaston Transplant Nephrology U Alabama
Elisa Gordon Ethics Northwestern
Doug Hanto Transplant Surgery Harvard – BID
Mitch Henry Transplant Surgery Ohio State U
Bev Kosmach-Park Coordinator/Peds U Pittsburgh
Gwen McNatt* Administrator Northwestern
Michelle Vogel* Alliance for Pt Advocacy*Unable to attend in-person meeting.
Funded by AHRQGrant: 1R13HS021060-01
Work Group 4: IR Recipient Evaluation
Member Expertise Program
Jay Fishman TID Harvard/MGH
Tim Pruett Transplant Surgery U Minnesota
Peter Abt Transplant Surgery U Pennsylvania
Amy Bobrowski Transplant Neph/Peds Northwestern
Peter Chin-Hong TID U California – San Fran
Tracy Evans-Walker Coordinator Cleveland Clinic
Bob Higgins* Transplant Surgery Ohio State U
Dan Kaul TID U Michigan
Alan Langnas Transplant Surgery U Nebraska
Martha Pavlakis Transplant Nephrology Harvard – BID
Stephen Rayhill Transplant Surgery U Washington
*Unable to attend in-person meeting.
Funded by AHRQGrant: 1R13HS021060-01
Outcomes of This Meeting
• Summary of Meetingo Slides and work group documents available for attendeeso Key findings and Work Group slides available to the public
http://www.feinberg.northwestern.edu/transplant/Increased%20Risk%20Consensus%20Conference/index.html
o Preliminary findings of the meeting and attendee survey submitted to AHRQ and available on the public website
• Publication of Meetingo An executive summary of the meeting with all approved
recommendations and gaps will be submitted to the American Journal of Transplantation
o Groups may prepare individual publications based on their own groups work
Funded by AHRQGrant: 1R13HS021060-01
Risk Factor in last 12 months* Abilty to Identify Risk Factor?
Strength of Risk for Infection?
What is estimated Risk?
Proportion of Donors Affected?
≥ 2 Partners Very Weak Weak Cannot Tell > 10%
Sex with known of suspected infected partner Very Weak Weak Cannot Tell 1-5%
Men who had sex with MSM Weak Strong 1:1000 -1:10000 1-5%
Women who had sex with MSM Very Weak Very Weak Cannot Tell < 1%
Sex in exchage for $$ or drugs Very Weak Weak >1:1000 1-5%
Sex with someone who had sex in exchange for $ or drug
Very Weak Weak > 1:1000 5-10%
Sex with someone who injected drugs for non-medical reasons
Very Weak Strong Cannot Tell 1-5%
Infants ≤ 2 years born to infected mother* Very Strong Strong > 1:1000 < 1%
Person who injected drugs for non-medical reasons
Very Strong Strong > 1:1000 1-5%
Intranasal use of illicit drug Very Weak Weak 1:10,000 – 1:100,000
1-5%
Inmate for ≥ 3 Days* Strong vs Weak?
Strong Vs Weak
1:1000-1:10,000 < 1%
Person treated for syphilis, gonorrhea or genital ulcers
Very Weak Weak Cannot Tell > 10%
Person on hemodialysis Very Strong Strong > 1:1000 1-5%
Immigration to US from country with higher HBV prevalence
Very Strong/Strong
Weak/Very Weak Cannot Tell < 1%
Work Group 2: Live Donor
• Perform testing consistently for all donorso Screen all live donors for risk behavior for HIV, HBV, and HCV
as defined by this conferenceo Screening pre-transplant (any time point): HIV, HBV, and HCV
serologyo Testing within 30 days, but preferably within 14 days, prior to
surgery: HIV NAT, HCV NAT, HBsAg Vote for recommending for testing 29 For, 10 Against (reasons to
vote against: not worth it, risk/benefit – loss of donors/pairs; heightened fear)
Votes on XX days (First round with 3 options in ())o (30 Days: For 7)o 14 Days: For 18 (Without 30 days option = 18)o Within 30 days but preferably within 14 days For 13 (Without 30 days
option = 21)
Funded by AHRQGrant: 1R13HS021060-01
Work Group 2: Live Donor
• Psychosocial Issueso Provide all donors education on how to avoid
contracting HIV, HBV, and HCV at any pointo Place in context of total risk
Funded by AHRQGrant: 1R13HS021060-01
Work Group 3: Consent
• Live donors should consent for disclosure of their relevant medical and social information to recipients o 5 individuals voted no against this recommendation
• Risk is a continuum – donor issues should be placed within the full context of risk
• Recipient consent process should be the same for deceased and live donors
• Consent should be obtained by knowledgeable, trained personnel
• Consent should be comprehensible to recipient, utilizing format and language appropriate to recipient
• Encourage involvement of recipient social support (family, significant other, etc) in the consent process
Funded by AHRQGrant: 1R13HS021060-01
Work Group 3: Consent
• At least 2 discrete times for educationo Prior to listing and at time of offero Reinforcement of education throughout the waiting period
• Risk described in comprehensible terms (same as before)
• Explain post transplant testing• Protect patient (donor and recipient) confidentiality• Documentation of process• There is a need for an educational tool for training
professionals delivering consent discussions with talking points
Funded by AHRQGrant: 1R13HS021060-01
Work Group 4: Recipient Testing
• Diagnostic tests should be used• Nucleic acid tests (NAT) are preferred for HIV and
HCV (HBsAg adequate for HBV)• Recommended testing paradigm would include
testing of recipients of organs from “donors at increased risk for transmission of infection” o Pre-transplantation (baseline) and o 1 and 3 months after transplantationo HBV testing at a later time point (between 6 and 12
months)• All data on these tests should be collected centrally
Funded by AHRQGrant: 1R13HS021060-01
Identified Gaps• Limited data on the optimal screening of live and deceased donors for HIV, HBV and
HCV. A prospective study could be designed to determine how many donors were positive by antibody and NAT at different timing to assess the relative yield of screening
• There is currently no data on post-transplant screening results of recipients of standard and increased risk donor organs to assess the incidence of donor-derived disease transmission. A prospective study which tested recipients at fixed intervals post-transplant could inform optimal recipient screening and yields.
• Assessment of the cost of implementation of testing by serology and/or NAT in live and deceased organ donors
• Potential factors related to false positive serologic and nucleic acid testing results for live and deceased organ donor screening.
• The number and impact of false positive tests on the number of transplants performed, recipient transmissions, wait list time and potential donor psychological, medical and financial outcomes.
• Assessment of yield and false positive and negative results if FDA-approved, licensed or cleared diagnostic or monitoring NAT assays were utilized for live and deceased donor screening.
• There is limited data of the impact of the informed consent process on transplantation, especially with regard to use of increased risk donors.
Funded by AHRQGrant: 1R13HS021060-01
Identified Gaps• There are currently no standardized tools to assess comprehension of the informed
consent in transplantation, particularly with regard to the use of organs from an increased risk donor.
• There is currently limited data on how best to tailor the content and level of detail of consent from the patients point of view (patient-centered consent) with regard to the use of organs from an increased risk donor.
• There is a need for a decision analysis which quantitatively weighs the magnitude of harm associated with window period infections against the magnitude of unused organs. Such analysis would have to take into account that variations in utilization of organs by identified risk, accepting center, and type of organ being transplanted.
• There are currently limited data to address the strength of risk for unsuspected window period infection for many of the potential risks which limits the ability to assess the net value of including the risk factor.
• Can we identify more precisely the “times” associated with proposed risks to enhance their specificity to identify window period infections?
• Incidence studies of people in various putative risk groups, particularly those where high- ‐quality incidence studies do not currently exist.
• Expanded national data collection on the specific risk factors underlying "CDC high risk" designation.
Funded by AHRQGrant: 1R13HS021060-01
Identified Gaps
• Studies of patient attitudes, concerns, and priorities regarding infectious risk and the specific categories used to define higher infectious risk.
• Improvements in efficiency, accuracy, and availability of nucleic acid testing. • Better quantification of false- ‐positive rates of nucleic acid tests. • National consensus and homogeneity among OPO's regarding nucleic acid testing
methods. • Comparative Risk analysis: between risk of infection and risks of turning down an
organ or donor withdrawing (i.e. no transplant)
Funded by AHRQGrant: 1R13HS021060-01
Opinions of Attendees of Meeting
• Opinion of attendees about the quality and outcome of the meeting was assessed via SurveyMonkey
• 32 (65% of invited attendees) individuals responded• Attendees felt that the meeting was well managed and
achieved the stated goals o 93.8% of respondents felt that the meeting was productiveo 90.6% felt that the meeting accurately reflects the transplant
community's opinion on issues related to the increased infectious diseases risk donor
• Nearly all attendees felt that the 4 work groups reviewed the existing data
• All respondents felt that the identified gaps in knowledge accurately reflect the gaps in existing knowledge
Funded by AHRQGrant: 1R13HS021060-01
Special Thanks
• Sue Benning• Mike Abecassis, MD MBA• Tim Pruett, MD• American Society of Transplant Surgeons &
American Society of Transplantationo For co-sponsoring the meeting
• The Work Groups and their chairso For putting in the work and attending this meeting!
• Everyone who is attending the meeting• AHRQ for funding the meeting (1R13HS021060-01)
Funded by AHRQGrant: 1R13HS021060-01
Questions? Michael G. Ison, MD [email protected]
I am a registered organ donor!Are you?