Changes to informed consent requirements for potential living donors: Public Com

[Clark]

https://optn.transplant.hrsa.gov/governance/public-comment/changes-to-informed-consent-requirements-for-potential-living-donors/


OPTN/UNOS Public Comment due by October 15th, 2016: Changes to informed consent requirements for potential living donors


Full proposal: https://optn.transplant.hrsa.gov/media/1920/ld_informed_consent_living_donors_20160815.pdf

[Fr Pat]

     As I mentioned in my response to this at the FaceBook page of Living Donors on Line, when I tried to read through the whole document it appeared to me that while the "informed consent" included the mention of possible pain it was expressed in terms of pain such as might result from any surgery. It has been noted that a good percentage of male kidney donors suffer from testicle pain on the side of the donation, sometimes quite severy and long-lasting. The medical literature seems to be sayinf that this is particular to kidney donation, yet many male donors report not having been warned or informed about this.  So I think that it should be mentioned much more clearly as a possible complication.

[Michael]

I salute OPTN/UNOS's willingness to revisit the requirements for informed consent given revelations from medical research, specifically the increase in the risk of kidney failure after donation and the higher risks of gestational hypertension (preeclampsia).

I believe there are additional opportunities to improve the effectiveness of informed consent for potential living donors with these additions, which are open for your input, discussion, and constructive criticism:

• On page 7, the comment from AST/ASTS/NATCO is "...donors don't want to pursue follow up." Huh? I have to admit I don't have hard peer-reviewed evidence, but I have yet to run across anyone who was a living donor who didn't expect to participate in follow up. In fact, it's more likely for me to hear that the hospital didn't make an effort to follow up. So perhaps the correct statement should be "transplant centers don't want to pursue follow up." It takes time, effort, and money to follow up, so why not ignore it, especially if there are no consequences? What if the consequences were denial of Medicare reimbursement or closure of the transplant program? Maybe we would get better compliance.
• Along the same line, page 10 said members will be evaluated for compliance by a "site surveyor [who] will continue to review a sample of living donor medical records...." Again, no consequences are mentioned for noncompliance.
• Item 7 (page 6 of the Policy Language): I'm hoping there's a way of simplifying this message. I think the message is "Your transplant recipient may have adverse outcomes including rejection of the donated organ or even death." Item 7 sounds like it was written by Dilbert, and the fundamental message to the donor--that bad things could happen despite your heroic effort--is obfuscated. Let's get something understandable in a statement of informed consent.
• Item 13 (page 6 of the Policy Language): The hospital should also state WHY the donor was refused. Sending the potential donor off to another transplant center, in the hope of finding a center that's less judicious in evaluating donors, is frightful, especially without at least informing the donor why they were denied donation in the first place.
• Table 14-2. a. Wow. This an important admission--one that deserves our praise and recognition.
• Talbe 14-2.b. Quickly followed by a confusing statement about... um.. what? The message is based on medical research that shows (1) living donors have better longer term health than the general population and (2) does NOT have better longer term health than other equally healthy (at the time of donation) people. In fact, the risk of ESRD is HIGHER compared to other equally healthy non-donors. The implication is that donors are usually more healthy than the "general population." I think that distinction gets lost in the verbiage. This needs to be more clear to potential donors. In my view, the only measure that really matters is the second: compared to other people who are equally healthy but not donors, your likelihood of getting kidney disease is higher.
• Table 14-2: Surgical risks. That's all that has to be disclosed? Medical research shows many additional risks and complications: http://www.livingdonor101.com/risks.shtml
• I don't see how you can have informed consent without giving a potential donor educational information that is (1) in their native language and (2) at an educational level they can understand. Inability to provide translated information or access to translation services is a FAIL. Inability to provide information that is understandable to the donor at their educational level is a FAIL. And these "FAILs" should be viewed by a transplant center as (unfortunately) a potential lawsuit, de-listing from UNOS, and denial of Medicare reimbursement.
• Ultimately, what is the basis of enforcement? There needs to be significant consequences for a failure to meet these basic requirements of informed consent. Is the transplant center dropped from the UNOS system? Do they fail the Medicare Final Rule and lose Medicare reimbursement for transplants? Right now there are no "teeth" in enforcement of the "requirements."

I'm also thinking LDO might give more publicity and transparency to the living donor follow-up rates, especially for high volume living donor transplant centers. At the least, we'll make LDO visitors more aware of the level of effort, interest, and success in following up with living donors (as required by Medicare). Should there be a "Greatest Fail" award (in the worst possible sense) for transplant centers that have both high volume and low donor follow up? Sometimes shame is a (sadly necessary) motivator.

I look forward to others' comments--most importantly shared with UNOS/OPTN.

[Clark]

Thanks for your thoughts! I hope you'll include them in your own public comment responses on the site I linked to originally. Thanks!-John

[donor99]

On page 7, the comment from AST/ASTS/NATCO is "...donors don't want to pursue follow up." Huh? I have to admit I don't have hard peer-reviewed evidence, but I have yet to run across anyone who was a living donor who didn't expect to participate in follow up. In fact, it's more likely for me to hear that the hospital didn't make an effort to follow up. So perhaps the correct statement should be "transplant centers don't want to pursue follow up."

Sometimes Michael even with dedicated effort, some donors do not come for follow up. Especially at the 2 year mark where they are feeling fine. Try to convince a 28 year old who is working and going to school to take time off for a follow up visit. They are busy people who feel well. We call, email and send registered letters to the donors, starting 2 months before the due date and 2 months after. People do have the right to decline follow up, and sadly many of them do.

[Clark]

Region 1 just voted to support the Living Donor Informed Consent Guidance update as written! Progress!

[Michael]

Looks like the regions are voting on the proposal without modifications even though the comment period isn't closed. Is that correct?

[Clark]

Correct, the regions get the same text as everyone else during the comment period, and submit comments as well as voting up or down overall.