Living Donors Online Message Board
Living Donation Discussion and News => Living Donation Forum => Topic started by: Clark on September 20, 2011, 09:34:19 AM
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All comment solicited:
http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/proposals.asp
This proposal:
http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSub_295.pdf
Exhibit:
http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSurveyExhibit_38.pdf
Precis:
Living Donor Committee: Proposal To Establish Requirements for the Medical Evaluation of Living Kidney Donors
This proposal would establish policy requirements for the medical evaluation of living kidney donors. This proposal is in response to a directive from the Health Resources and Services Administration (HRSA), and based on recommendations from a Joint Societies Steering Committee composed of representatives of the American Society of Transplantation (AST); the American Society of Transplant Surgeons (ASTS) and the North American Transplant Coordinators Organization (NATCO) to the Living Donor Committee.
Please read the two pdf files and discuss them in this thread. If you are moved to formally submit your comments at http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/submitYourComment.asp?PropID=319 , please consider providing a copy here. Thanks!
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http://communication.unos.org/2011/08/fall-2011-regional-business-meetings-schedule/
Fall 2011 Regional Business Meetings Schedule
Here’s the schedule of upcoming fall 2011 regional business meetings, where transplant professionals can participate in discussions and learn about regional business, committee activity, and policy and bylaw proposals that are out for public comment. All UNOS members are welcome. There is no registration fee and no need to pre-register.
• Region 6 Business Meeting: September 23, 2011 in Honolulu, HI
• Region 1 Business Meeting: September 26, 2011 in Worcester, MA
• Region 10 Business Meeting: September 30, 2011 in Dayton, OH
• Region 9 Business Meeting: October 12, 2011 in Albany, NY
• Region 7 Business Meeting: October 14, 2011 in Chicago, IL
• Region 3 Business Meeting: October 14, 2011 in Atlanta, GA
• Region 11 Business Meeting: October 14, 2011 in Atlanta, GA
• Region 2 Business Meeting: October 28, 2011 in Philadelphia, PA
• Region 4 Business Meeting: December 2, 2011 in Houston, TX
• Region 8 Business Meeting: December 2, 2011 in Kansas City, MO
• Region 5 Business Meeting: December 15, 2011 in Las Vegas, NV
Visit the UNOS Calendar on www.unos.org for more information or contact the UNOS administrator responsible for your region.
• Regions 1,4,9: Shannon Edwards – Shannon.Edwards@unos.org
• Regions 2, 6, 8: Betsy L. Gans – Betsy.Gans@unos.org
• Regions 5, 7, 10: Chrystal Graybill – Chrystal.Graybill@unos.org
• Regions 3, 11: Clifton McClenney – Clifton.McClenney@unos.org
FYI, here's a link to the regional map for those who don't know which one they're in. Do try to attend, and identify yourself to the Regional Counselor, who will chair the meeting. http://optn.transplant.hrsa.gov/latestData/stateData.asp?type=region
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FYI, I plan to attend Monday's Region 1 meeting. See you there?
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What a difference from the first run around the block with this! Passed without dissent, discussion, or comment in Region 1 today.
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I've received some informal feedback about the public comment received to date and it can be summarized in two words: sparse and negative. Don't let this be all that the committee and the board sees! Get your comments in, attend the regional meetings, be a visible witness! There's time to get your comments in, but the regional meetings are upon us.
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The Albany meeting is tomorrow, and more regional meetings are coming up thick and fast. Anybody attending? This proposal is rewritten and coming around for the second time in formal development as HHS made clear that a "voluntary guideline" was not adequate to meet the standard set in the 2006 Federal Register announcement that the OPTN would henceforth develop living donations policy with the same rigor and process as had been standard for deceased donation. This will be policy, if adopted by the board, and OPTN members not in compliance may be censured, potentially losing CMS funding. Is it complete? Correct? Enough? Too much? Do you want it? Our presence at these regional meetings is noted, often formally by the chair if you introduce yourself before the meeting. It is harder for them to vote against these proposals with us in the room. Do attend. Do tell us about your experience. Thanks.
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Clark,
Thanks very much for your careful & well-expressed observations. I assume you and other LDOers will send comments to UNOS as public comments. I & other members of the Living Donor Committee who are faithful readers [and sometimes posters] of LDO will bring all comments posted on LDO to our meeting as well.
Anyone else with comments?
Bill
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So, anybody been to a meeting? Submitted comments?
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Just about a month left to concentrate your thoughts and get your public comments in!
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Due Friday!
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Comments from Donna Luebke: https://livingdonorsonline.org/UNOSProposals/DLuebke-MedicalEvaluationofLKDsDec2011.pdf
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Comments submitted:
I support this proposal as an acceptable first step. I recommend immediate adoption and rapid implementation, with full compliance required, and regular audits to confirm compliance. Note that as a first step toward compliance with HHS requirements regarding living donation it is welcome, long overdue, and will need to be revisited and updated regularly and often. I am aware that medical, psychiatric, social services, and insurance professionals who are also living donors have offered recommended improvements to the details of this proposal. I urge close attention to these recommendations and incorporation of them immediately or in near term updates.
(Identity slug.)
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http://sirencristy.blogspot.com/2011/12/optn-public-comment-medical-evaluation.html
My submitted comment
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Part of my submitted comments [long] Bill
SUMMARY: I strongly support adopting / approving the Proposal. However, I propose a few minor modifications, as given below.
A. "EXCLUSION CRITERIA" NOTE: Could the clinical precision or nuance of three listed items be improved?
1] "Diabetes." Proposed modification:
Type 1, type 2, gestational, or active forms of other types of diabetes, using the diagnostic criteria in the latest American Diabetes Association standards of medical care in diabetes published every January.
[NOTE: the 2012 ADA "Standards of Medical Care in Diabetes--2012" are found at: http://care.diabetesjournals.org/content/35/Supplement_1.toc . The Diagnostic Criteria for the diagnosis of diabetes are found in: http://care.diabetesjournals.org/content/35/Supplement_1/S64.full .]
2] "Evidence of donor coercion." Proposed modification:
1] Active external coercion on the donor that adversely affects the potential donor's decision-making capacity and ability to give truly-informed, true, consent and to refuse to donate, or 2] coercion with evidence of a potential donor's serious reservation to be a donor.
[Evidence of coercion by others applied to the potential donor by itself is not sufficient to exclude that potential donor; many families in possible intra-family donation exert that "coercion" even if inadvertently. Rather, the concern should be whether the potential donor's free decision is being changed against her/his true desires.]
3] "Untreated psychiatric conditions, including suicide risk." Proposed modification:
Unresolved or presently active psychiatric conditions that potentially adversely affects either: 1] the potential donor's informed consent decision-making capacity; or 2] the potential donor's likely emotional response to donation.
[The issue is not whether the psychiatric condition is untreated (some conditions do not need treatment) or treated (some conditions in some people remain problematic for donation even while under treatment). The issue is whether the current situation has a likely adverse impact on the donation.]
B. "RELATIVE CONTRAINDICATIONS." NOTE: Could the clinical precision or nuance of several listed items be improved?
1] "History of cancer, including metastatic." Proposed modification:
History of cancer, either metastatic or without standard oncologic-acceptable evidence of cure.
[For instance, non-metastatic prostate cancer treated for cure with undetectable PSAs, and cervical cancer including CIN I to CIN III treated to cure and no evidence of recurrence for 5 years, should not be Relative Contraindications.]
2] "Creatinine clearance or isotopic GFR greater than 1 standard deviations below the mean for age and gender." Proposed modification.
Creatinine clearance or isotopic GFR greater than 1 standard deviation below the mean for age and gender (that is, less than the 34th percentile), in ['a potential kidney donor' vs. 'the general'] population, given in [cited reference].
[The item as written does not specify the population of reference, or the citation where the age-gender-specific GFR values are found. One study gave age-specific mean GFR +/- 1 standard deviation; it was in a population of potential living organ donors. I believe that is the appropriate reference population. The item should also give the actual publish reference. I recommend the article, Berg Ulla B. Differences in decline in GFR with age between males and females: Reference data on clearances of inulin and PAH in potential kidney donors. Nephrol Dial Transplant (2006) 21: 2577-82.]
3] "Impaired fasting glucose with other features of the metabolic syndrome in a donor younger than age 50." Proposed modification.
Potential donor in Categories of Increased Risk for Diabetes, with the laboratory criteria in the latest American Diabetes Association standards of medical care in diabetes published every January, and either: 1] with other features of the metabolic syndrome in a donor younger than age 50 [specify reference]; or 2] the potential donor's increased risk has not been controlled/resolved to achieve normoglycemia.
["Categories of Increased Risk for Diabetes" include more than impaired fasting glucose. The reference citations are the same as above.]
4] "Hypertension in a Caucasian younger than age 50." Proposed modification:
Hypertension in a Caucasian younger than age 50, or prior history of hypertension not now normotensive without drug treatment by 24+ hour home/ambulatory blood pressure monitor.
[Some people adopt a low salt, high exercise, life-style and the hypertension resolves. The measurement to determine resolution should be by 24+ hour ambulatory blood pressure.]
5] "Hypertension in a Caucasian greater than age 50 on more than one anti-hypertensive medication." Proposed modification.
Hypertension in a Caucasian greater than age 49 on more than one anti-hypertensive medication AND not now normotensive by 24+ hour home/ambulatory blood pressure monitor.
[Note that in the original wording, this and the prior Relative Contraindication together did not refer to a 50 year old potential donor.]
6] "Hypertension in a racial or ethnic groups at elevated risk at any age." Proposed modification.
Hypertension in a racial or ethnic groups at elevated risk at any age.
[NOTE: If the relative contraindications for hypertension in Caucasians are adopted, should a related change albeit stricter be added to this one about non-Caucasians?]
C. "RELATIVE CONTRAINDICATIONS"
The proposal stated that "recommended relative contraindications [not be] included as background information," because they could not be included as policy. I agree. But it is possible to include in the policy something like the following:
Living kidney donation with a donor with any Relative Contraindication requires a full, written, justification for the Center, potential donor, and potential recipient to proceed to donation. That justification must include an assessment of the medical risk and medical benefit of the donation and transplantation, and done by the transplant center(s) conducting the donor's nephrectomy and recipient's transplantation. That justification must also include documentation of fully informed consent by both the potential donor and potential recipient that includes their understanding of that medical risk-benefit assessment in lay language.
D. GENERAL ADDITIONS.
1] I recommend that these standards be given to all potential donors who continue to be considered after the first basic initial screening steps. These standards should be expressed in lay language. The document should have simple tables giving the values when relevant. (For instance, the ADA laboratory criteria for diagnosis of diabetes could be given in a table, as could the age-sex-specific mean GFR and 34th percentile (one standard deviation below the mean). I recommend that every Center be required to give every potential donor and recipient this lay language version.
2] The current process of proposed standards and policies being developed by the Joint Society Policy Steering Group is excellent. One concern, however, is that for standards and policies related to Living Donors, a group representing living donors themselves are not in either that Steering Group or in the later process of development and issuing the standards and policies.
I recognize that the Living Donor Committee (LDC) has living donors and is involved in the process thereafter; I am a living donor member of the LDC. I also recognize that individual living donors can comment on the proposed standards and policies during the public comment period. And, I recognize there is not yet a group composed of living donors in which those living donors themselves choose their representatives to be involved in this process.
If living donors form such a group, I strongly recommend that UNOS then formally incorporate that group into the process of development, as the "stakeholder" with the special expertise of having been a living donor. The representatives of that group would supplement quite well the expertises of living donor members of the LDC -- just as the Joint Society Policy Steering Group supplements the expertises of the ATS, ASTS, NATCO, OPTN/UNOS, and HRSA members of the LDC.
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There were two living donors who participated in the joint societies work group. Myself as a rep from NATCO and one other donor.
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Bill,
I support a living donor group would be incorporated into any process involving living donation. I do not see UNOS as providing the leadership since have already had over 8 years with no results. The ACOT Living Donor Subcommittee (past group) was much appreciated and I found had leadership which I did not see during my UNOS years. Not sure who will continue their work moving forward.
Living donors who work in transplant are few. No U.S. surgeon has joined our ranks even though they want more of the public to step up and donate. A collective voice of living donors not involved in transplantation as their work would be more powerful. Those who work in transplant can join this group.
thanks Bill--keep us posted as move forward. Have to start somewhere. For sure we support these proposals in spirit but not its results. Many of us have provided a laundry list of suggestions.
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Comments from Jane Zill:
Regarding: Proposal to Establish Requirements for the Medical Evaluation of Living Kidney Donors
Donors with family histories of genetic renal disease are not included in Exhibit A which lists Considerations for Relative Contraindications to Living Donation. This is a serious omission by the Committee and does not reflect to the characteristics of a group of donors who progress to ESRD or do not sustain an acceptable GFR, and are therefore subject to co-morbidities associated with decreased renal function.
Family genetic diseases such as polycystic kidney disease, Alport syndrome, sickle cell trait, and thin basement membrane disease should be considered as a relative contraindication of donation. Additionally, donors with these family histories are require more scrupulous evaluation, follow-up, and informed consent.
Regarding Alport sydrome, for example, there is a body of literature warning against the use of donors with this particular medical history, yet this it totally unacknowledged in these proposed guidelines for medical evaluation or the attached exhibit.
“Living Kidney Donor Transplantation from Relatives with Mild Urinary Abnormalities in Alport syndrome: Long-term, risk, benefit, and outcome,” Nephrology Dialysis Transplantation 2009 24(5):1626-1630; doi:10.1093/ndt/gfn635
http://ndt.oxfordjournals.org/content/22/6/1499.full
http://www.alportsyndrome.org/IPNA/Rheault/
The clinical importance of nephron mass has been increasingly recognized as significant for recipients and donors. Those with more nephron mass sustain greater kidney function. It is estimated that individual endowment of nephrons can have great variability, “among 37 normal Danish adults, the average Nglom was 617,000 per kidney (range 331,000 to 1,424,000).37 Kidney weight was also proportional to Nglom.37” Low birth weight is considered a surrogate marker for nephron mass. (V. A. Luyckx., B.M. Brenner (2010), “The Clinical Importance of Nephron Mass.” J Am Soc of Nephrology 21: 898 -910, 2010) Yet, this simple and objective measure of the donor is not included in the medical evaluation. Given the national interest in KPD and emerging trends in transplant tourism, donors from impoverished areas in which malnutrition and low birth weight may be common, may be a particularly vulnerable group, yet they are individuals most likely to be pressured by poverty to consider selling an organ.
Assessment of depression and other psychiatric disorders should be objectively assessed in the psychosocial evaluation. In the DONOR meta-analysis, which combined the results of 51 studies, symptoms of depression and anxiety were present in 23% of donors. Among studies that used the Beck inventory, 31% of donors were classified as depressed and 19% as excessively tearful. The number of donors with serious psychiatric symptoms varied from 6-33% (Clemens, K. K., H. Thiessen-Philbrook, et al (2006) “Psychosocial Health of Living Kidney Donors; a systematic review.” Am J Transplant 6 (12): 2965-77) Among donors whose recipients had adverse outcomes, 50% felt negative about donating and transplantation in general, 5% felt guilty or developed markedly increased hostility, 11% had periods of suicidal ideation, and 5% sought and went to counseling. (Clemens, K. K., N. Boudville, et all. (2011) “The long-term quality of life of living kidney donors: a systematic review.” Am J Transplant 11 (3): 463-9
The DSM-IV states,“ the number of prior episodes predicts the likelihood of developing a subsequent Major Depressive Episode….. …About 5% to 10% of individuals with Major Depressive Disorder, Single Episode, subsequently develop a Manic Episode (pages 341-342).
“In addition, depression is increasingly recognized as a risk factor for a variety of illnesses - whether as a consequence, an exacerbation, or a cause. In medical settings, those with Major Depressive Disorder have more pain, physical illness, and decreased physical, social, and role functioning" (DSM –IV, p. 340.)
The presence of psychiatric conditions, treated or untreated, needs careful, objective assessment before donation and should be considered a relative contraindication to donation.
For all donors, data collection and medical evaluation should be melded into one coherent program because data collection of living donors should begin at time zero. Electronic medical evaluation forms should be linked to donor follow-up forms. However, this would require designation of specific tests, assessments, and check lists, whether they be laboratory or objective psychological assessments. Specificity in tests and protocols are resisted by the transplant community due to concern that they would increase litigation and limit autonomy in medical judgment. However, without this level of specificity, it is unlikely that a standardized assessment for potential kidney donors will ever be developed.
Submitted by Jane Zill, L.I.C.S.W.
Living Kidney Donor, 1991
Living Donor Committee, OPTN 2007-2009
Living Donor Data Task Force, OPTN 2008
Jane Zill, L.I.C.S.W.