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.
Topic: OPTN Comment due 12/23/11: #10: Living Donor Medical Evaluation (Read 12899 times)