OPTN Comment due 12/23/11: #9: Living Donor Follow Up

[Donna Luebke]

Bill

One piece missing in any of these proposals is a section on the Electronic Medical Record (EMR).  EMRs are going to be mandatory by 2014 or Medicare will not reimburse a hospital for services.  I am familiar with EPIC.  EPIC has a  "My Chart" access for patients to get into their own records, schedules, etc.  Also includes ways to contact providers, etc. 

EPIC has flagged me during visits with my physicians since have a diagnosis of 'donor nephrectomy.'  I was flagged to get the Pneumovax as someone with a chronic medical condition.  My PCP gets an eGFR each visit since our lab standard calculates this information using my age, gender and last creatinine.  The EMR is invaluable for donors. 

I very much support a model where donors can access what is submitted to UNOS on their behalf.  We should verify our data for accuracy, completeness and that is our record. I would not consider it complete until a donor verifies it.   The Living Donor Data Task Force conclusions included that some of the SS#s submitted were the recipient's so whatever data they had was not the donor's; cases where data was submitted at 6 mos when the donor was not seen at that time which is falsification of records; and donors who never moved/changed phone numbers yet were marked lost to followup.

Someone at each center should be designated as the person responsible for followup. There should be sanctions for noncompliance.  A history of 'no consequences' perpetuates the disrespect for a mandatory policy.   Since we are 'donors of organs' we have always been part of this policy. 

Thanks for all who shared their public comment. 

Clark--can you tell us more about the Region 1 vote.  Were these propoals voted down since not enough or still too prescriptive? 

Donor99--maybe you can share more about the JSWG.

[Michael]

Comments from Jane Zill:

Regarding: Proposal to Establish Minimum Requirements for Living Kidney Donor Follow-up

The OPTN has been contractually required by DHS to collect data on donors since 1999.  Yet, centers are still balking at collecting data for two years, the OPTN has very narrowly defined the data to be collected, donor self reports about their short-term experience will not be collected, and the data to be  collected will never speak to the long-term health of living organ donors.  Although much of this is clearly acknowledged in the proposal, acknowledging the reality does not change it.

The time frame for this proposal, along with the plan to monitor compliance by peers and colleagues assigned to UNOS/OPTN Committees, will mean that in another 12 years, in 2023, another Living Donor Data Task Force (LDDTF) will likely conclude that OPTN data is “woefully inadequate.”

We need a prospective registry of living donors now, conceptualized and managed independently from those with professional and commercial interest in transplantation.  Current data collection efforts should be about the legacy we leave our children and grandchildren.  The lesson learned from UNOS/OPTN data collection to date is this:  We should not allow UNOS/ OPTN to continue involvement in donor data collection.

Although this proposed program for data collection may enable UNOS/OPTN to  meet contractual obligations with DHS to collect donor data, it will not enhance the safety and the environment pertaining to living donation  The proposed data collection will mean wasted health care dollars.  For future generations of living organ donors it will mean inadequate informed consent.

The title of the proposal should be changed to delete references to follow-up. The proposal does not provide for medical follow-up.

Any research effort is only as good as the data obtained – garbage in, garbage out.  The proposal allows for information to be provided by mail, the recipient, the donor, or a health care facility.  The donor may never return to the center; the source and veracity of the data submitted from remote locations will not be verifiable.

Data collected on creatinine is obsolete without data on gender, age, and weight.  The standard measurement for renal function now, even though imperfect, is GFR.  We want to know about detriments in GFR in donors.  Efforts to cross reference information at a later date or collect other needed information to determine changes in GFR would be laborious and expense. 

There is literature on living organ donors that suggests that decline in GFR accompanies changes in other biomedical markers that are associated with cardiovascular risk.  There is evidence of insulin resistance after donation.   This is the type of short-term information we need to understand the risks of kidney donation.

We obviously want to know about donors who need dialysis within two years of the donation, but this would be rare since time from the donation is the greatest risk factor for ESRD.  Collecting this data appears to be about framing the risks about donation to the public in a positive way – it is about marketing donation, not about promoting public safety.

However, there is evidence that a significant percentage of donors experience major depression after donation surgery, which is not directly related to the outcome of the recipient.  Data about this specific, devastating, short-term complication is not addressed:  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, Sinlge 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.)
 
Capturing other new diagnoses after donation is important, but, again, the “who” and “where” of this will be problematic, especially since a significant amount of donors do not have health insurance and there are not provisions for medical follow-up. 

The issues at stake here regarding the expenditures of public dollars on health care are pressing. In this era of wild promotion of living organ donation as the solution to the national epidemic of ESRD, the challenges to public safety are menacing.  We cannot continue along this path of useless OPTN efforts to collect data on living donors.

Contact Jane Zill for information sources.

Jane Zill,  Kidney Donor 1991
Living Donor Committee, OPTN 2007-2009
Data Subcommittee, Evaluation Subcommittee
Living Donor Data Task Force, OPTN 2008