OPTN Comment due 12/23/11: #8: Living Donor Informed Consent

[Clark]

My comments, already submitted.  Note that as someone who's read hundreds of these, I know the value of clarity and brevity, as well as disclosure of potential bias.

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.

I became an unrelated directed living kidney donor more than eight years ago.  Both I and my recipient continue to be very well.  I am a former public representative to the OPTN/UNOS Board of Directors, Executive Committee, Kidney Transplantation Committee, and Ad Hoc Committee on the Public Solicitation of Organ Donors.  I participate in follow up efforts by the LODN and my transplant center, Brigham and Women’s Hospital.  I am a volunteer discussion moderator for the International Association of Living Organ Donors, Inc., on its web site, https://livingdonorsonline.org. I am a scientist, and not in any way a medical professional, employed by a medical institution, or benefiting monetarily from any outcome of this proposed policy.

[WilliamLFreeman]

My comments on this proposal.  [Clark, I did not have time to get REALLY concise!    ]


SUMMARY:  I strongly support adopting / approving the Proposal.  However, I do recommend certain modifications to specific components of the "Living Donor Consent" section of the proposal.

A.  SUGGESTIONS SPECIFIC FOR THIS PROPOSAL.

Michael Murphy has already submitted almost everything -- and much more! --of what I would propose.  I strongly recommend adopting his recommendations.  Donna Luebke also submitted recommendations for additions, and I recommend adopting many of hers as well.

I will not repeat them here, but instead will add two modifications to the list.

First, Michael Murphy's next-to-last paragraph includes the following:  "Prospective donors should also be informed of the average duration of hospital stays and average recovery times, including the number of weeks before traveling, returning to work, and returning to exercise."  I recommend modify that sentence to something like:
     Prospective donors should also be informed of both the average duration of hospital stays and average recovery times, as well as the typical range of possible stays (e.g., one day to one week for laparoscopic nephrectomy) and possible recovery times (e.g., one week to two months or more), including the number of weeks before traveling, returning to work, and returning to moderate exercise.

Second, I recommend adding the contact information for a national, respected, resource staffed and composed primarily by living donors, for information and personal contact with living donors.  (Many programs include Living Donors Online, for instance, in their information.)

I do not want these suggestions to postpone implementation of this Proposal.

B.  GENERAL SUGGESTION.

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, ACTS, NATO, OPEN/UNOS, and HRSA members of the LDC.

[Donna Luebke]

Thanks Bill.  Thanks to Michael, Clark, and Cristy, too for sharing their public comment.  Consent is not an easy issue.  Must include what a particular donor (his/her unique story) needs to hear; not what a surgeon wants to tell.  I do not like standardized forms for this reason.  Consent must be individualized. Anything that increases a particular donor's risk must have a detailed explanation.  I have long been troubled by the transplant literature's use of the word 'safe' or saying is 'minimal risk.'  No major surgery is safe or minimal risk.  Live organ donation is an exception to the basic premise of medicine/surgery.  Benefits must outweigh the risks--and above all else 'do no harm.'  Surgeons cannot claim donor autonomy when the donor does not act alone AND no surgeon is justified in adding to the risks citing donor autonomy.  Many public discussions are long overdue.  Those who claim live organ donation is 'safe' should join our team.  

Donors should get copies of any forms they sign.  Make a 'donor folder', take notes and names. Collect business cards for each person you meet.  Know who is your contact person if you have any questions or concerns.  Be sure you are comfortable with your donor team, your surgeon, your Anesthesiologist.  If not, do not sign the consent form for surgery.  Bring a friend or family member who you trust to be present throughout all encounters.  You are a patient first and foremost.  

[Michael]

Comments from Jane Zill:

I oppose the “Proposal to Establish Requirements for the Informed Consent of Living Organ Donors.”

It is unlikely that the Joint Societies Work Group (JSWG) will ever support efforts to standardize informed consent, which would require much greater specificity than is provided in this proposal, due to their fear of litigation, resentment over limiting “medical judgment,” and awareness that more specific information may discourage living organ donation. The JSWG is primarily comprised of individuals and organizations with professional and commercial interest in promoting living donor transplantation.  Their conflict of interest regarding living donors could not be more apparent.

Specific mention of death, hernia, pulmonary embolism, adrenal dysfunction, nerve impingement, testicular injury, to name only a few known surgical complications, are not specified in this proposal.  Long-term, poorly understood consequences of nephrectomy such as hyper filtration, insulin resistance, Vit A malabsorption, elevated homocysteine levels, protein in urine, microalbuminaria, or the many complications associated with CKD, such as anemia, fractures, increased risk of injury from dye contrast, hyperparathyroidism, CVD, dementia, and depression are neglected altogether.

Likewise, regional disparities that are foreseeable now that will impact former donors in need of a transplant are not described, such as the trends in deceased donor allocation that will disadvantage older transplant candidates.   There is not disclosure about the absence of a national plan for former donors who progress to ESRD, nor are the disparities in access to high quality dialysis disclosed.  Daily home dialysis confers the same survival advantage as deceased donor transplantation, but this treatment modality may not be available to former donors who progress to ESRD.  And certainly, progression to CKD or ESRD will create serious psychosocial problems occurring long after the post-surgical period, but this document does not specifically disclose these risks. 

This proposal would require substantial modifications to be meaningful.   It will not lead to standardization of a comprehensive informed consent document for living organ donors.

Also, the use of the word “recovery” of living donor organs reveals a fundamental lack of empathy and appreciation for living organ donors.  Organs from the living are not “recovered,” they are donated.  Living organ donors return to their home communities as medically vulnerable individuals.  The surgical transplant community is not necessarily expert in internal medicine, nephrology, endocrinology, cardiology, oncology, pharmacy, or psychosocial evaluation and treatment.  Not only is this professional group unprepared with data and expertise, they are emotionally and psychologically ill equipped to make recommendations regarding the care of living organ donors.  As a living kidney donor, I am not comfortable with this community of professionals addressing informed consent for living donors beyond the donor surgery. 

Regarding the provisions made for monitoring compliance, I object to blind, internal review of programs by peers and colleagues.   Additionally, centers routinely ask for and receive variances to excuse them from UNOS/OPTN policy compliance.

Regarding the provisions made for independent donor advocacy (IDA), the OPTN and CMS, have separated the medical and psychosocial evaluation of living organ donors from the role of independent donor advocates.  How will they gain their information about a donor?

IDAs come from a range of disciplines, including clergy, medicine, nursing, psychology, social work, and education. Their professional skills, knowledge, and perspectives are not uniform.  This means that many IDAs are subject to the same vulnerabilities as living organ donors regarding lack of knowledge about living organ donation.

Within this proposal, IDAs are to be employed or contracted by centers with powerful institutional motivation to perform living donor transplants.  Due to the hierarchical nature of most medical institutions, with surgeons enjoying the most prestige, those who come from other disciplines or professions lack institutional prestige and authority compared to their surgical colleagues.

Whether from lack of skill, knowledge, position, or a limited role, IDAs may lack an in-depth understanding of the donor and of living donor kidney transplantation, and cannot, therefore, be expected to be effective advocates for informed consent

Although it is true that the Secretary gave the OPTN authority regarding matters of living donation in 2006, “What the Secretary giveth, the Secretary can taketh away.”  Taxpayers should stop spending money on UNOS/OPTN activities that serve the interests of this industry at the expense public safety.
 

Jane Zill, L.I.C.S.W.
Living Donor Committee, OPTN 2007-2009
Living Donor Data Task Force, OPTN 2008
Living Kidney Donor, 1991