Introductions and Welcome
Nancy Ascher, M.D., Ph.D.
University of California, San Francisco
Chair of ACOT
Nancy Ascher, M.D., Ph.D., welcomed participants to the fourth meeting of the Department of Health and Human Services (HHS) Advisory Committee on Organ Transplantation (ACOT). She urged the committee to continue to address difficult issues regarding donor/recipient needs.

Dr. Ascher read a letter from Secretary Tommy Thompson, in which the Secretary expressed his regrets for being unable to attend the meeting. The Secretary commended committee members for their dedication to promoting organ donation and helping to create a safer and more effective system of organ donation that is saving lives. Secretary Thompson noted that the committee’s recent recommendations had been well received by the Department, and he looked forward to continuing to work with the committee.

HHS Actions in Response to ACOT Recommendations
Jack Kress, J.D., Executive Director, ACOT
Jack Kress, J.D., reported that on April 25, Secretary Thompson spoke at a groundbreaking ceremony for the United Network of Organ Sharing (UNOS) donor memorial in Richmond, Virginia. During his talk, the Secretary specifically announced support for several “excellent” ACOT recommendations.

Participants viewed a video of the speech, in which Secretary Thompson announced that significant progress has been made on five elements of his donation initiative. Specifically, approximately one million copies of the uniform donor card have been distributed, a registry clearinghouse is being established to help motor vehicle registration offices, and an education curriculum on organ donation will be issued in partnership with the Department of Education. The Secretary is also working with congressional leaders to start a gift of life congressional medal. The goal of establishing 5,000 workplace partnerships has been exceeded, as more than 7,000 workplaces with more than 50 million employees have agreed to increase workplace donation. A new, sixth element of the Secretary’s donation initiative will share best practices for increasing organ donation with the largest hospitals in the Nation.

The Secretary announced his endorsement of four new initiatives based on ACOT’s recommendations:

Mr. Kress reported that a taskforce has been established by HHS to ensure that all ACOT recommendations receive thorough review and, for those recommendations supported by Secretary Thompson, the promptest possible implementation. Mr. Kress reviewed the actions taken by HHS in response to each of the 18 ACOT recommendations from its December 2002 meeting:

Following Mr. Kress’s report, ACOT’s four subcommittees met separately, before reconvening to present their reports.

Report and Recommendations of Subcommittee A: Organ Supply Concerns
Gail B. Agrawal, J.D., M.P.H.
Ms. Agrawal announced that Subcommittee A has been discussing three issues:

Donor Designation
The Uniform Anatomical Gift Act (UAGA) makes clear that a donor’s anatomical gift does not require the consent of anyone else. Thus, an anatomical gift is irrevocable at death. In spite of this, a majority of OPOs today would refuse an anatomical gift if the donor’s family objects. Possible reasons for this practice include:

In studying this issue, Subcommittee A would like to determine the extent to which the family’s wishes override those of the donor. It is not clear how many donors, if any, are lost as a result of this practice. The subcommittee therefore recommended a pilot program to determine if a problem exists and, if so, its scope. The subcommittee has identified several questions that could capture this information.

But even if the data show that few donors are lost due to the practice of honoring family members’ wishes, even when they conflict with those of the potential donor, the subcommittee endorsed the principle that the donor’s wishes are primary. Currently, a mixed message is being disseminated, because members of the public are encouraged to sign a donor card but are told that if they have not shared their wishes with their families, their wishes may not be honored. The subcommittee believes that ACOT should join the Association of Organ Procurement Organizations (AOPO) and the UNOS consensus conference in endorsing the notion that the donor’s wishes should be honored as the primary goal of the procurement system.

Valuable Consideration
The National Organ Transplantation Act (NOTA) prohibits the exchange of human organs for valuable consideration, which raises the question of what should be considered valuable consideration. The lay view is that valuable consideration refers to monetary compensation with commercial value. But lawyers regard valuable consideration as anything with value that motivates an act, regardless of whether that value is commercial. The transplant community believes that this prohibition is not intended to preclude paired exchanges, which are beneficial practices in many transplant centers. UNOS lawyers have argued that this prohibition is not intended to restrict paired exchanges but, as private lawyers, they have no authority to bind the government.

The subcommittee therefore recommended that ACOT endorse the principle reflected in Senator First’s bill to change NOTA to exempt certain kinds of benefits from the prohibition on valuable consideration. The purpose of this amendment is to allow a practice that is working well in some centers, while maintaining the prohibition on the buying and selling of organs.

The subcommittee also discussed whether it might be appropriate or necessary to suggest other legal changes to allow the Secretary to initiate demonstration projects that would offer what might be considered to be valuable consideration in order to increase donation. Alternatively, ACOT could recommend an amendment to NOTA giving the Secretary regulatory authority to define what is meant by valuable consideration. However, the subcommittee decided not to make a recommendation in this area at this time.

Presumed Consent
The current donation system is an “opt-in” system for anatomical gifts, in contrast to presumed consent, which is an “opt-out” system. Presumed consent would not do away with donor designation and the subcommittee supports compliance with donor intent. Presumed consent is another method of obtaining donor authorization. The subcommittee will continue to discuss this issue, and will consider whether an opt-in, opt-out, or combination system is most appropriate.

Presumed Consent
Phil Berry, M.D.
Southwest Transplant Alliance
David Courtney
Vice President, Presumed Consent Foundation
Dr. Phil Berry, M.D., a member of ACOT, reported that no two words evoke deeper feeling in those working within the transplantation field than “presumed consent.” Transplant personnel either believe that more education is needed to implement presumed consent, or that presumed consent will never be implemented because it will infringe on people’s freedoms. The latter group argues that presumed consent might antagonize potential donors and reduce donations. But the first group believes that anything might be better than the current system, and presumed consent is worth trying.

Many European countries have presumed consent in some form and have documented successes, although presumed consent may not be the hoped-for panacea. In 2000, donation rates in the United States were 22.3 per million population, compared to 24 per million in Austria, 25.6 per million in Belgium, and 33.9 per million in Spain. Some transplant physicians deny that presumed consent is the primary reason for Spain’s high donation rates, but it was not until implementation of presumed consent that other efforts to increase donation materialized in Spain.

Dr. Berry believes that the publicity alone from suggesting presumed consent will increase discussion of organ donation. Although many will argue against presumed consent, raising this possibility will force the issue into the light. Some states might be willing to try the concept, and could generate useful data about whether presumed consent will improve donation rates.
David Courtney reported that the only public survey on presumed consent was conducted in west Texas. Of those surveyed, 57 percent were in favor of presumed consent. The survey also found that only 69 percent had heard, read, or seen anything about organ donation or transplantation in the last year. This shows that awareness efforts are not effective. Of those who supported organ donation, 62 percent supported presumed consent and 95 percent of all respondents believed that presumed consent would increase the number of organs available for transplantation.

Mr. Courtney reported that, when he gives presentations, his audiences do not argue against presumed consent but instead ask why it has not been done before. The Presumed Consent Foundation has more than 700 members in all 50 states who believe that presumed consent would work. Over 20 physicians and four major patient organizations have said publicly that they believe that presumed consent would increase the supply of organs. A recent poll by the International Society for Heart and Lung Transplantation found that 75 percent of 739 respondents supported presumed consent. Legislation for presumed consent has been filed in the Texas House of Representatives this year and a California legislator has similarly proposed legislation for presumed consent.

Presumed consent may not be the panacea, but it will be the fastest and easiest way to reduce the current organ shortage. Presumed consent is an opt-out program. In those European nations with presumed consent, fewer than 2 percent of people actually opt out. In nearly 20 countries with some form of presumed consent, it works.

For presumed consent to be implemented in the United States, four integral areas of capability would be required:

Discussion
Edgar Milford, M.D., argued against using the phrase “presumed consent,” which implies that the decision has been taken away from the individual. What is meant by presumed consent in the ACOT discussions does not involve taking decisions away from individuals, but forcing people to make explicit their decisions and to register their choices.

Roger Evans, Ph.D., supports presumed consent. He does not believe that it would have a dramatic impact, but it could remove one more barrier. However, transplantation focuses too much on the dead at the expense of the living. Dr. Evans would like to see the discussion focus more on the living and issues of death and dying.

Barry Kahan, M.D., Ph.D., reported that presumed consent has received strong support in Texas, where it might be an appropriate subject for a demonstration project. However, he wondered if the poll mentioned by Mr. Courtney involved a representative sample. Dr. Kahan also noted that a very objective analysis of impact would be needed. When Poland enacted presumed consent, donation rates declined, and several other events (such as the use of non-heart beating and aged donors) occurred in Spain at the same time as presumed consent that might have led to the increase in donation rates.

Mr. Courtney replied that most of the respondents to the Texas poll were Caucasian, although the area polled was predominantly Hispanic. Mr. Courtney also noted that presumed consent alone is not the solution. But other countries have found that implementing presumed consent resulted in other mechanisms to increase donation rates.

J. Harold Helderman, M.D., supports the use of opt-out consent for addressing the wait list problem, at least in small measure. Success will come from some of the details, such as the format used to obtain opt-out consent and the ability to change one’s opt-out decision. But where the information will be obtained, how it will be maintained, and how the opportunity to change a decision will be provided must be determined to make presumed consent more acceptable.

Michael Williams, M.D., agreed that the potential impact of presumed consent in the United States is not known, as it has not been examined. Mistrust of the health system is a major barrier to success. People fear that organs would be obtained from individuals who did not want to donate or whose families argued that the individual did not want to donate. When patients’ wishes are known, the consent rate is very high, so presumed consent is geared to those without expressed wishes. Some research efforts are currently addressing an approach model in which the presumption is that the person wanted to consent, to see if this reduces the opt-out rate. It needs to be clear that coercion is not the goal of presumed consent, and that people’s individual choices will still be respected.
Arlene Locicero pointed out that, on June 30, 1993, UNOS issued a report on presumed consent. Ms. Locicero recommended that committee members read this report, which is available on the UNOS website.

Amadeo Marcos, M.D., expressed concern about the enforcement of presumed consent. If OPOs do not enforce consent from donors when the family disagrees, they are unlikely to enforce presumed consent when the family does not agree.
Deborah Surlas, R.N., believes that if first person consent (donor designation) is upheld by OPOs as a cultural change, presumed consent might be more easily accepted. If only 69 percent of the public has heard anything about organ donation, as suggested by the west Texas poll, then a great deal of education will be required to ensure that 100 percent of the population knows how to opt out of presumed consent.

James Shanteau, Ph.D., noted that the west Texas survey showed that, except for committed donors, most individuals have not really considered the subject of organ donation. The presumed consent proposal would force people to at least think about donation.

Dr. Kahan described a Texas law that says that if the family has not come forward within 24 hours after a patient is declared brain dead, the organs may be recovered, and this is a first step toward presumed consent. The presumption is that if no one argues against the donation, then the patient would be in favor of donating. These circumstances have not arisen often, so the impact is limited. But on two occasions when the family did come forward after the organs were procured, they were grateful that the procurement took place.

William Harmon, M.D., suggested that the west Texas poll results show that while many people believe that it is acceptable to take their organs, it is not acceptable for someone else to make that decision. The potential for losing control is a concern in the United States. The organ shortage must be solved by marketers, not physicians, because perceptions must be changed. A revolution in concept is needed more than new tools.

Dr. Berry pointed out that the west Texas poll results are 10 years old, and opinions may have changed since then. A larger sample is needed to obtain an accurate view of the public’s reactions to presumed consent. HHS or ACOT should recommend such a poll. If support for presumed consent is high, ACOT could propose meshing an opt-out system with the existing system.

Mr. Kress interjected that the HHS (HRSA) Division of Transplantation is indeed presently preparing a large scale public opinion survey that will include questions on the presumed consent issue.

Dr. Berry suggested that the term “presumed consent” should be changed so that it does not imply that someone else presumes to know what a patient thinks.

Howard Nathan noted that, unlike other countries with presumed consent, the United States has a great deal of media interest in organ donation and a great deal of litigation. In 1993, when Pennsylvania Act 102 was initially presented, it supported presumed consent. But this version of the bill produced a firestorm of media until the act was changed. Although ACOT can support the concept of presumed consent, it can only be implemented by the states.

Dr. Evans suggested coupling presumed consent with presumed benefit. When transplantation is marketed, people are rarely encouraged to think of the day when they themselves might become beneficiaries. The possibilities of donating and receiving should be presented together. If we presume that people can benefit from transplantation if they need it, we should also presume that they will consent to donate. First person consent (donor designation) must also be addressed and combined with presumed consent and presumed benefit.

Dr. Kahan pointed out that many families who are approached about having their relatives become donors could not benefit from organ transplantation because they lack health insurance. The presumption of potential benefit might be different in countries with universal healthcare coverage. Dr. Evans suggested that if someone does not stand to benefit, they should be informed of this before deciding whether to donate.

Michael Seely suggested that donor designation be the initial focus to pave the way for presumed consent. If presumed consent were imposed immediately, it would not be successful. Now that people are interested in signing up for registries, the concept of registries should be linked to presumed consent.

Lawrence Hunsicker, M.D., Ph.D., pointed out that the entire community moved from not wearing seatbelts to wearing them. This started with the presumption that most people would rather be safe when they drive. Laws were then passed and, eventually, enforced. Currently, organ donation consent is highest among younger age groups, probably because the young have received the most education about donation. As the community ages, the willingness to donate will increase. More data are needed on the community’s current status before developing pilot programs.

Dr. Williams noted that marketing is important, but talking with the family of someone declared dead about organ donation is a human endeavor. Dr. Williams’s work is attempting to determine how to do that better, and it underlies the failure or success of many of these models. The successes in Spain and elsewhere may be due more to having coordinators in hospitals work with families and physicians than to presumed consent. There is a need to understand the population’s views on presumed consent, which might identify areas where pilot projects can be attempted. Presumed consent is the next step after donor designation.

Mr. Courtney believes that presumed consent is primarily a public relations challenge. In the west Texas poll, 91 percent supported donation of organs for transplant, but barely 70 percent were likely to want their organs donated after their death. Moreover, 82 percent of respondents believed that most people who need a transplant do not receive one. Every adult in the United States that is employed pays taxes, and 90 percent of adults have a driver’s license or state-issued identification card, so several avenues exist to provide information on presumed consent. But action needs to be taken quickly because the battle is being lost. If presumed consent is implemented and the attempt shows that changes are needed, this would be better than the status quo.

Mr. Kress noted that one of the best arguments for presumed consent is that it relieves the family, in their most anxious moment of grief, of having even to decide whether to donate their relative’s organs.

Diana Lugo-Zenner, R.N., M.B.A., suggested that people applying for a driver’s license be asked whether they do not want to donate, instead of whether they do want to donate. Unless the driver indicates that they do not want to donate, the presumption would be that they would like to donate. But Mr. Seely suggested that this could have a negative effect. A staff person in a department of motor vehicles (DMV) office argued against donation, and this resulted in a large number of people declining to donate on their driver’s licenses.

Dr. Williams noted that it has been reported that if the patient’s preference is known and the family is informed of the patient’s decision instead of being asked if they want to donate their relative’s organs, this changes the dynamics of the conversation with the family. If everyone expressed a choice, a first person approach would be sufficient.

James Young, M.D., pointed to some impassioned beliefs that presumed consent is “against the American way.” He wondered if those against presumed consent could be identified, so that this group could be targeted for an education campaign.

Mr. Seely characterized the concern as trust in the system. If presumed consent is not implemented carefully, it will raise fears of losing control over a loved one’s body.

Ms. Locicero noted that one of the greatest fears of families is that their loved one will undergo pain during the procurement. Agreeing to submit a loved one to surgery requires courage on the part of family members.

Dr. Evans suggested that collecting data on presumed consent would be challenging, as it is difficult to collect data on misconceptions. When people refuse to donate, they should think about potential beneficiaries, because they are potentially handing several others a death sentence. But conversations about donation should not happen in hospitals. The difficulty most people have in thinking about their own death, let alone that of a loved one, makes transplantation very difficult to discuss.

Carlton Young, M.D., suggested that ACOT investigate the efficacy of presumed consent. But this raises educational issues, especially in minority communities that have so much distrust of the system. Until educational issues can be addressed, especially in minority communities, it will be very difficult to persuade the public to accept presumed consent.

First Person Consent/Donor Designation
Giving the Donor a Voice: Donation by Donor Authorization
Helen W. Leslie, R.N., C.P.T.C.
President-Elect, AOPO
Executive Director, Lifenet OPO
Virginia Beach, Virginia
Ms. Leslie explained that the public does not understand the term, “first person consent.” She therefore prefers the term “donor authorization,” or perhaps “donor designation.”

When Ms. Leslie became a procurement coordinator, she learned that according to the UAGA, the donor card is a legal and valid way of indicating a desire to donate. But the donor card or designation on a driver’s license is typically only used if the family agrees. The transplant field has long been repeating a myth concerning a patient with a donor card and no next of kin. According to this account, when the family showed up, just as the patient’s organs were about to be procured, they stated that the donor had changed his mind. The mythical account continued: the OPO decided to procure the organs anyway and, after the story went public, donations plummeted. This story is simply not true and the UAGA clearly allows individuals to declare themselves as donors. The UAGA’s opt-in language allows, in the absence of indication by the donor, the next of kin to make a gift. The UAGA has been underused for many years.

The Virginia Hospital Association distributed a memo informing its members that the code of Virginia states, “an anatomical gift…that is not revoked by the donor before death is irrevocable and does not require the consent or concurrence of any person after the donor’s death.” As executive director of an OPO, Ms. Leslie had to change her OPO’s practice. When she announced this change, staff expressed deep concern that donor families would object that they wanted to honor the wishes of their loved ones. The media expressed very little interest in this policy change.

Building staff competency was the biggest hurdle to implementing donor designation. Very consistent approaches with staff needed to be developed with the assistance of donor families. Discussions with families continued to be sensitive, compassionate, and open ended, but staff were to begin by establishing whether the patient had indicated a desire to donate. If so, staff approached the family by saying that the loved one had made a decision about donation and they were there to honor that decision. Everything done by the OPO staff was predicated on honoring the donor’s wishes and offering service to the family.

In the 18 months since the OPO has changed its practices, responses from families of donors have been highly positive. Families find it much easier when they know what their loved one wanted to do, and thank the OPO staff for helping carry out their relative’s wishes. But more data are needed before any major conclusions can be drawn.

Accurate donor registries are critical for implementing the donor designation principle. Half the five million entries in Virginia’s registry were “yeses” but several million “nos” were incorrectly entered, because the DMV’s computer used a default and automatically entered non-responses as nos.

OPO staff initially found it difficult to change their paradigm of care. But today, coordinators express disappointment when they cannot carry out a donor’s intent. All OPOs have registries, but only about half recognize the donor’s intent to donate, while the remainder views the donor’s intent as guidance that need not be followed.

The 1987 amendments to the UAGA are only accepted by approximately 23 states. The amendments include routine referral and medical examiner provisions, which may be why they are not uniformly accepted. An opportunity to revisit the UAGA will occur in the fall, when suggestions can be offered to which all states can agree.

The UNOS Consensus Conference Report: Research to Practice
Jeffrey M. Prottas, Ph.D.
Professor, Heller Graduate School of Social Welfare, Brandeis University
Dr. Prottas reported the results of the April 2003 UNOS consensus conference, which focused on improving consent rates to increase the supply of organs. The sense of participants was that the system does have failures but that it is not overall a failed system. Almost 20,000 people a year in the United States receive an organ transplant as a result of this system.

Meeting participants were primarily OPO representatives. After hearing reports from recent research, participants divided into subgroups that developed a series of recommendations. Each subgroup then reported on their discussions to the entire group.

Consensus was reached on several operational recommendations regarding how OPOs can increase conversion rates, as well as on policy recommendations.

Operational recommendations (best practices)

Several reports presented at the meeting indicate that, taken together, these changes can result in substantial increases in available organs. OPOs that do many of these things have much higher procurement rates than other OPOs. However, the impact of these changes will not be seen immediately. A straightforward, simple, easily executed solution to this complex and long-term problem is not likely to be found.

Policy recommendations

Discussion of the Report and Recommendations of Subcommittee A: Organ Supply Concerns
Ms. Agrawal presented several recommendations of Subcommittee A to ACOT for discussion and approval.

Public Comment
Dolph Chianchiano of the National Kidney Foundation offered to share information with ACOT on two public opinion surveys on presumed consent. The first is a 1991 survey by UNOS in which 52 percent of respondents objected to presumed consent, while 39 percent were in favor. A year later, UNOS and the National Kidney Foundation surveyed 1,203 respondents, and found that 55 percent objected to presumed consent, while 38 percent were in favor.

Myles Kaye spent his working life running a pharmacy, first in a hospital, and then privately. Organ donation was never raised in any conversation he had with a broad range of health professionals, until the summer of 2000 when Mr. Kaye’s wife needed a liver transplant and neither Mr. nor Mrs. Kaye had signed a donor card. Mr. Kaye now wears an organ donation pin, and has answered many questions prompted by the pin about organ donation. Mr. Kaye believes that his experiences are shared by many members of his generation, as well as many health professionals.

Report and Recommendations of Subcommittee B: Recipient Concerns
Kathy Turrisi, R.N., M.S.N.
Kathy Turrisi, R.N., M.S.N., presented several recommendations suggested by Subcommittee B for consideration by the full Committee.
The first recommendation addresses the need for a standardized request for information (RFI) to reduce the number of forms that must be completed by transplant centers. UNOS has developed a standardized form, but many insurance companies continue to request additional information. Completing these forms is time consuming and costly, and insurance companies often ask for data that transplant centers have already submitted.

Discussion

Report and Recommendations of Subcommittee A: Organ Supply Concerns (Revisited)
Gail Agrawal, J.D., M.P.H.
Ms. Agrawal presented the committee with additional recommendations from Subcommittee A:

Report and Recommendations of Subcommittee C: Public Concerns
Roger Evans, Ph.D.
Dr. Evans explained that Subcommittee C defined a set of goals and objectives for its deliberations, and identified five areas of interest:

Dr. Evans described the procedure used by the subcommittee to identify tasks within each area of interest and rank those tasks in the order of their importance.

The subcommittee agreed that public perception frequently shapes the public’s response to advanced biomedical technology, and transplantation is no exception. Many people express concern or distrust about transplantation, so Subcommittee C adopted public perception as a primary operational concept.

The subcommittee is attempting to review its 35 tasks and condense some of them into conclusions and, eventually, recommendations by area. Its preliminary conclusions are:

Measuring Quality of Life
Nancy G. Kutner, Ph.D.
Emory University School of Medicine
Dr. Kutner identified three general types of quality of life measures: health profiles, satisfaction ratings, and health preferences. Each type of measure elicits different views and aspects of health-related quality of life.

The health profiles measures includes those that are most widely thought of as assessing perceived health status, especially physical and mental health, and usually in multiple domains. These generic measures can be used across diseases and compared with norms for the general population. The Medical Outcomes Study Short Form 36 (SF-36) is widely used. Disease-specific health-related quality of life instruments often include generic tools like the SF-36 but add items that capture symptoms or other factors specific to a particular condition.

Quality of life/satisfaction ratings provide cognitive judgments of satisfaction with one’s life or “overall quality of life.” One life satisfaction index is used with transplant recipients.

Health preferences (or utilities) are considered the most objective measures in this field. These instruments rate health status on a scale from 0 (death) to 1 (perfect health). With the most common health preference scales, patients are asked to assess various aspects of their lives in various domains but the weights assigned to those answers are derived from experts or members of the general public. The utilities obtained with one method might differ from those obtained with another method.

The concept of health-adjusted life years includes quality-adjusted life years (QALYs) and disability-adjusted life years (DALYs). DALYs are usually used to rate the effect of different diseases and disabilities in a population and how they interfere with achieving ideal health.

If key factors predict post-transplantation quality of life, they should be considered in clinical decisions. A study of live transplantation recipients in the United Kingdom used the SF-36 and Euroqol scales. The investigators found that the shorter the patient’s duration of illness, the better their quality of life post-transplantation; however, the more severely ill the person, the worse their quality of life after transplantation. The possibility for change, however, is much greater in more severely disabled individuals.

A large study of 1,100 patients followed for up to 10 years post-transplantation with annual SF-36 scores showed that diabetics had lower physical functioning and general health scores but similar mental health scores to non-diabetics. Different domains of quality of life do not necessarily parallel one another. For long-term outcomes, most patients rated their health as about the same or better than it had been the previous year. But some rated their health as much or somewhat worse than in the previous year. Most researchers focus on the benefits of transplantation, so little information is available on those who do not perceive their health as improved.

Pre-transplant quality of life is related to post-transplantation outcomes. An old study used the Nottingham health profile for heart transplant recipients. A survival analysis that controlled for a number of demographic and clinical variables found that the only variables that predicted post-transplantation survival were age of the recipient and the pre-transplant Nottingham health profile score. Patients with fewer quality of life restrictions pre-transplant had a higher likelihood of survival. A small study of patients receiving kidney transplants found that higher pre-transplant physical functioning was significantly correlated with fewer post-transplant emergency department visits and lower post-transplant hospitalization charges.

Wave 2 of the United States Renal Data System Dialysis Morbidity and Mortality Study provides the only national dataset of dialysis patients with questionnaire results. Dr. Kutner and her colleagues examined their status at one year and found that average baseline physical functioning score was associated with one-year status. Those who had undergone transplant had an average baseline score of 63.3, those on dialysis had a score of 37.2 to 46.6, and those who were deceased had an average score of 25.1. These results are explained, in part, by the fact that people with the highest physical functioning status were the most likely to be transplanted.

For patients with relatively high pre-transplant functioning, the post-transplantation goal is to maintain that functioning, so people with better functioning status might be more likely to be transplanted. But those at lower levels of functioning might also be transplanted with the goal of improving their functioning.

A great deal of work is now being done with repeated quality of life measures over time to factor in changes, often in clinical trials. While graft or patient survivals are discrete outcomes, quality of life is never a yes or no issue, unless methodological tools are used to reduce it to such a metric.

Discussion
Ms. Solarz asked about research on transplant candidates and how to anticipate what their post-transplant life would be compared to the actual outcome. She also noted that when a patient is ill for a long time, their family dynamics change. This makes it more difficult for some patients to adopt a healthier lifestyle post-transplant. Dr. Kutner agreed that expectations regarding outcome influence many things. In addition, the tradeoffs involved in moving from the sick role to a more independent role will influence individual differences in quality of life.

Dr. Hunsicker asked how to measure total benefit of transplantation or burden of disease. Objective measures tend to be stable, although it is not clear how to weight them, but subjective measures may not be stable. Dr. Kutner replied that more studies are needed, as little information is available on what happens over time. Even deterioration on dialysis is not well studied. One study found that over three years, a group of elderly adults on dialysis and a group of controls became more functionally impaired and more depressed; however, the community controls also had lower life satisfaction while the dialysis patients maintained their life satisfaction levels. Individuals have a great capacity to adapt to chronic illness.

In response to a question from Dr. Shanteau, Dr. Kutner explained that the Living Donor Network is collecting SF-36 scores on donors before and after transplant at repeated intervals. Mr. Kress added that New York State is collecting similar data, and that the Adult to Adult Living Donor Liver Transplantation Cohort Study, presently underway at NIH, will also be collecting such data.

Dr. Kutner noted that with health preferences, the person doing the rating is a very important variable. This needs to be better understood.

Report and Recommendations of Subcommittee D: Allocation Concerns
Hans Sollinger, M.D., Ph.D.
Dr. Sollinger explained that Subcommittee D focused on three areas

The subcommittee believes that it is only a matter of time before the transplant community, the public, and legislators look into rationing/triage. While the shortage of organs becomes more acute, success rates are increasing and the number of people wanting a transplant is growing. The gap between those who receive an organ and those who do not will only grow. Dr. Sollinger sees patients everyday who are not suitable candidates for transplant. Some are self-referred and expect to become candidates, especially for kidney/pancreas.

Dr. Sollinger pointed out that the subcommittee’s conclusions on rationing/triage are not recommendations. Subcommittee members agreed that allocation issues are likely to grow and arise repeatedly. The discussion will take place primarily outside the transplant community, which will offer technical assistance.

Subcommittee D recommended initiating discussions with the ethics boards of the American Society of Transplant Surgeons, the American Society of Transplant Physicians, UNOS, and others. Once their feedback is obtained, these issues should be brought back to ACOT for discussion.

With respect to wait list mortality and liver allocation, a dataset is available from SRTR that the OPTN liver committee reviewed at its May 15 meeting. The data show that patients with low MELD scores (mid-teens to 1) have a much better chance of staying alive if they are not transplanted. This is an important finding and the transplant community will need to pay a great deal of attention to these data.

Preliminary MELD data suggest that regional sharing in the entire United States would save 49 lives every six months, or 0.4 percent of the wait list. An open question remains on whether regional sharing would have a strong effect on primary liver non-function related to cold ischemic time. This is because cold ischemic time greater than 10-12 hours is associated with a significantly higher risk of non-function.

Subcommittee D’s recommendations on waiting list mortality and liver allocation were:

The subcommittee’s preliminary conclusions with respect to non-directed donors are:

Discussion
Support UNOS in establishing a MELD score of 10 as the lower limit.
Robert Gibbons, Ph.D., was struck by the SRTR finding that wait list mortality is lower than post-transplant mortality for as many as one-third of the patients transplanted in this country. Many patients with low MELD scores are transplanted in small OPOs that have few sick patients. Dr. Gibbons supported the notion of identifying a MELD score below which transplants should not be done. This would also lead to broader sharing.

Dr. Gibbons also suggested not expressing the 49 lives that could be saved through regional allocation as a percentage. This figure should be compared to the number of transplants being done if it is compared at all. Dr. Gibbons suggested the following recommendations:

Dr. Sollinger is particularly concerned about exposing the patients who would be transplanted under regional sharing to the dangers of increased cold ischemic time.

Dr. Port pointed out that the length of follow-up for MELD is limited, so the conclusions about patients who receive no benefit from transplant are based on only six months of follow-up. In the longer term, these patients may experience some benefit, but the data are not yet available. But even if patients with lower MELD scores experience some benefit over time, the benefits to patients with higher MELD scores are much greater. The OPTN liver committee recently recommended that patients with MELD scores of less than 10 not be considered candidates for transplantation.

Dr. James Young noted that one difficulty with hearts and lungs is the belief, supported by some data, that outpatients do not benefit from transplantation. The OPTN thoracic organ committee tried to encourage development of MELD-like criteria but has been stymied. Although near-dead and dying patients benefit from heart transplant, over half of transplants are done in stable outpatients. A huge impact could be made on this disparity by shifting allocation to the most ill patients. A formula for risk definition is needed for lungs and hearts.

Dr. Marcos pointed out that when an extended organ is available, most centers try to transplant it into someone who is very sick and has a high MELD score. But this is not effective, as organs must be matched to recipients. Dr. Gibbons explained that 58 percent of all organs are accepted on first offer and are often transplanted in small OPOs. Only 11 percent of organs are transplanted in OPOs with large populations.

Dr. Hunsicker commented on some suggestions presented by Dr. Sollinger:

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