ESTIMATED DISTRIBUTION OF DONOR
POTENTIAL BY SIZE
We devote this issue of Progress Notes to a major conference that took place in early June in Dallas, cohosted by The Partnership for Organ Donation and the Harvard School of Public Health. The objective of Joining Forces: A Meeting of Transplant Leaders to Increase Organ Donation was to motivate leaders in the transplant community to work collaboratively to resolve the organ shortage, and identify a research-based strategy for doing so. Much of the focus was on the role of hospitals in bringing about better donation practices.
Since The Partnership's founding, we have co-sponsored three conferences, all built around specific themes, all with the goal of illuminating key strategic issues in the effort to increase organ donation. In each conference we have brought together state-of-the-art thinking on key problems, provided participants with insights they can put to practical use, and looked to the participants to help shape and guide our own work.
The first conference, in 1990, co-sponsored by the Annenberg Washington Program, was devoted to understanding the informational and emotional needs of families experiencing the sudden loss of a loved one. A wide range of medical professionals, donor family members, ethicists, and bereavement experts participated, laying the foundation for the in-hospital donation process we support today.
In 1993, we worked with the Harvard School of Public Health and 17 organ procurement organizations to conduct the largest-ever Gallup poll on organ donation. The conference, "Helping Families Decide: Educational Priorities for Solving the Donor Shortage," brought together a multi-disciplinary group, including not only transplant and organ procurement professionals, but also media, public relations, and health communications experts. This time we focused on identifying educational goals that could have the greatest impact on donation. One striking finding was the potential for family communication about donation wishes to bring about donation increases, an idea that has permeated most recent public education campaign strategies.
Joining Forces, also co-sponsored with the Harvard School of Public Health, was similar in some ways to past conferences, but also had important differences. As in the past, we focused on a single key issue, shared recent research, and invited participants to shape appropriate action steps. Nearly 70 participants from leading transplant centers and pharmaceutical companies -- including CEOs, senior executives, administrators, transplant surgeons and representatives from organ procurement and other national organizations -- worked together to identify the causes of the donor shortage and to agree upon priorities and a course of action to address them.
Unlike past conferences, this one focused not only on the theory of how to increase organ donation, but also on successful case studies, and practical implications for institutionalizing donation improvements.
There is little debate in the procurement and hospital communities about the needs of families in donation, or about the importance of a consistent and high quality donation process. The impact of hospital process on families' decisions was vividly illustrated at the conference in data presented on donor and non-donor families' experiences.
Yet, the results of several years of effort involving ourselves and members of the OPO community, have forced us to reevaluate our strategy for improving the donation process. Our data from prior work with several OPOs show that fewer than one in five potential donor families received a process that had the basic elements of quality -- decoupling, privacy for the request, and a team request including both hospital and OPO staff.
This is not surprising given that the OPO cannot be involved until the process is fairly far along. Too often we have heard stories of skilled OPO staff responding to a potential donor call only to find the process is already broken beyond repair. Therefore, we believe that it is time to formalize the hospital protocol to safeguard the quality of the process from the moment the family arrives until they eventually leave. Only hospital staff can provide this safety net.
The conference presented models for hospital involvement with donation, based on a team of designated donation experts within hospitals to manage family communication and provide a reliable link to the OPO. Much work remains to fully test this model, but early results are encouraging, and the overall destination is clear.
At the conference, we shared a vision for the donation system that we believe is attainable and will greatly improve both the treatment of donor families, and the availability of transplants to those in need.
Referring to organ donation as "largely a free-style event," Michael Evanisko, President of The Partnership for Organ Donation, opened the conference calling for a more strategic approach to resolving the donor shortage.
"The Partnership was founded in 1990 to bring a problem-solving, systems approach to resolving the organ shortage," Evanisko said. He described four key components of The Partnership's analysis of the donation situation: 1) the shortage was worsening, despite significant untapped potential; 2) public and professional attitudes toward donation were largely favorable; 3) no standard of practice for the request process existed; and 4) many donation and transplant professionals believed that enacting required request legislation would solve the problem.
"We started with several fundamental hypotheses about organ donation. We believed that the number of potential donors was measurable, the reasons for non-donation could be uncovered and that potential donors would likely be concentrated in a small fraction of hospitals which are trauma centers and large community hospitals."
"In addition, we expected that the way the request for donation was handled would have an enormous effect on whether or not the family consented to donation," Evanisko continued. "If the family was given a clear explanation of brain death and time to have their questions answered before they were asked to consider donating organs, we believed they would be more likely to consent. We aimed to convert the donation process from a free-style event to a more consistent, systematic process."
"By collecting data from hospital medical records and OPOs, we were able to confirm that there is significant unrealized donor potential concentrated in the larger hospitals. We also analyzed the reasons why potential donors were not realized. Based on chart reviews at 69 hospitals in four OPO regions, we found that 27 percent were never asked about donation. Forty- nine percent of those who were asked denied consent. Also, the practice of decoupling -- the separation of the explanation of brain death from the request for donation -- was associated with higher rates of consent across the country and with all demographic groups."
In addition to confirming the initial hypotheses, The Partnership observed that the percent of potential donors realized by individual hospitals varied widely, from a low of zero percent in this sample to a high of 68 percent, with an average of 33 percent. Somewhat surprisingly, the research also showed that transplant centers did not achieve higher donation rates than hospitals that do not perform transplants.
Evanisko highlighted the importance of standards of practice and training for hospital staff involved in donation. "We have surveyed thousands of health care professionals who are involved in the care of severely brain-injured patients and who make the request for organ donation. Overwhelmingly they support organ donation, but underestimate the size of the waitlist and are not up-to-date on transplant success rates. They report a lack of training in how to make the request for donation as well as a lack of consensus on the appropriate time to mention donation."
Evanisko concluded by suggesting that a better methodology for donation exists, which if applied with the right focus and intensity on the part of all the participants, will lead to enormous gains in donation, helping the patients who desperately need donated organs to restore their health.
"Today we have a situation where nine people die daily due to the organ shortage and there are no standards of practice for the donation request. Our goal is to move to a situation tomorrow where few, if any, patients die waiting and there is a systematic and sensitive donation process practiced universally."
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All donors are cared for in hospitals, putting hospitals at the center of many aspects of donation. Yet, in today's turbulent health care environment, what role can and should hospitals play in improving organ donation?
Sylvester Sterioff, MD, Director of Transplantation at the Mayo Clinic and Raymond Schultze, MD, Director of the UCLA Medical Center addressed the question of the institutional role, speaking about the importance of transplantation to institutions and highlighting the roles that hospital professionals can play in increasing donation.
Dr. Sterioff shared the transplant surgeon's perspective on the shortage, describing the frustration experienced by surgeons as their patients suffer from the lack of available organs. "The lack of available organs is distressing because what this discrepancy means is that patients die while waiting and waiting times become longer."
Yet the shortage does not need to exist, said Sterioff. Noting that performance -- measured by donors per million -- of organ procurement organizations varies widely, Sterioff observed that there could be a "two- or three- times improvement in the number of cadaver organ donors" if all OPOs performed up to a higher level. Sterioff spoke of his experience on the board of LifeSource Upper Midwest OPO which has shown steady improvement in donation since 1989.
The transplant surgeon can play a role in improving the donation situation in several ways, Sterioff observed. He or she can be a resource for education, set an example in the community as a person who is seeking this not for self-serving reasons but for the benefit of patients, and as a facilitator and director of the organ procurement organization.
Dr. Schultze, sharing the perspective of a hospital director, spoke about the benefits accruing to hospitals with transplant programs. Quoting from a survey of hospital administrators conducted before the conference (see related article, "Survey Confirms Transplantation as an Institutional Priority"), he observed that everybody believed "their institution's reputation was soundly enhanced by the presence of a transplant program," and that having a program allows institutions to be more competitive and contributes to their financial health.
Schultze described the respondents' plans for growth, noting that 85 percent plan to increase their programs by 20-50 percent. The prevailing strategies were growing the waitlist (95 percent), becoming a center of excellence (95 percent) and reducing the cost per transplant procedure (94 percent).
The problem with these strategies, noted Schultze, is that unless the supply of organs is increased, transplant programs will only grow by taking organs away from other hospitals. "While 95 percent of centers expect to grow by becoming a center of excellence, the problem is that all of these centers are excellent, and are likely to be equally successful in applying these measures."
"Under this scenario," he continued, "there would be no growth. In order to grow then, we need a supply side rather than a demand side strategy: More organs will produce growth."
In order to increase the organ supply, Schultze emphasized the need for hospitals to "allocate time and resources to the task of acquiring organs. We have been relatively passive in the past....We should ask Ôcan we do this better? Are there ways in which we can stimulate better performance?'" He suggested a conceptual "hospital without walls," one in which hospitals and OPOs collaborate, developing an environment in which knowledge is shared and learning is applied.
Schultze concluded by saying that it is "up to hospital people to help organize and sustain the effort to identify the obstacles and overcome them so we can achieve what we have long dreamed of: having those [transplant waiting] lists shrink rather than increase."
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By understanding the size and characteristics of the potential donor pool, the concentration and location of potential donors, and factors influencing low rates of donation, it is possible to identify opportunities to improve the organ donation system, according to Steven Gortmaker, PhD, of the Harvard School of Public Health.
Sharing the results of research supported by a grant from the Division of Organ Transplantation in the Department of Health and Human Services, Gortmaker shed some light on the following questions:
Concluding that the family's experience in the hospital plays a major role in their decision about organ donation and that it is impossible to anticipate what any one family's decision will be, William DeJong, PhD, of the Harvard School of Public Health advised health care providers to "approach every family as if there is a genuine chance of a donation resulting."
DeJong shared the results of a major study of donor and non-donor families, undertaken by The Partnership and the Harvard School of Public Health in collaboration with the Delaware Valley Transplant Program, New Jersey Organ and Tissue Sharing Network, and New York Regional Transplant Program. The study consisted of in-depth interviews with 102 donor families and 62 non-donor families in three regions of the US and addressed two key research questions: What leads a family to donate or not to donate a loved one's organs? Are there steps that health care personnel could take to better meet the needs of families and make donation more likely?
The interview covered four basic areas: Family background; general beliefs about organ donation and transplantation; respondents' perceptions of the quality of care provided to their relative; and their perceptions of the donation process itself.
Several important differences between donor and non-donor family background were observed: non-donor families more often reported an income of less than $35,000; there was a higher proportion of minorities among the non-donor families; and the non-donor respondents were more likely to have been born outside the US.
Examining general beliefs, the study uncovered significant differences between donor and non-donor families. Non-donor families were more likely than donor families to cite religious objections to donation, and over two-thirds of non-donor families felt it was important for a person's body to be buried intact, while fewer than one-fifth of donor families felt this way. "In all the years I've been doing research I don't think I've ever come across a result quite that striking," observed DeJong.
The two groups also differed in their perceptions of the fairness of the system, with higher proportions of non-donor families expressing concern about economic equity and belief in a black market for organs. DeJong said, "It was clear that the non-donor families were much more likely to have real doubts about whether the donation system is fair."
Regarding the hospital experience, significantly more non-donor than donor families felt that their relative did not receive the best possible care before he or she died. Significant differences between the groups were seen in their perception of the following aspects of the donation process, with non-donor families consistently more likely to disagree with the following statements:
Prior to the Joining Forces conference, The Partnership conducted a national survey of administrators and health care professionals in large transplant centers across the country. The goals were to develop a broad perspective on the priority of transplantation in the changing health care environment; understand the future vision for transplantation within large transplant institutions; and learn how senior executives and leading transplant surgeons see their strategic options for increasing organ donation.
Out of 177 hospital professionals receiving the survey, 82 individuals responded including 12 CEOs, 21 transplant surgeons, 19 medical directors, 26 business administrators, and four others.
(Each respondent selected three)
Joining Forces provided a forum for conference participants to raise issues related to donation and transplantation requiring attention from the community. The group recognized that no single organization can pursue all of these ideas and approaches, and agreed that organizations will need to work together in a coordinated and complementary fashion, with each organization carrying out the activities that play to its strengths.
Some of the issues raised by participants include:
Spain has risen from one of the lowest donation rates in the world to one of the highest, going from 14 to 25 donors per million population. This increase followed nation-wide implementation of a standard donation process, focusing responsibility for handling the donation process with hospital-based donation teams. Hospitals are held responsible for their performance in donation. Spain continues to achieve donation improvements when the rest of Europe shows flat or declining rates of donation.
Spain's story of donation and transplantation began in 1965, when the first transplants were done in Madrid and Barcelona. In 1979 legislation was passed that enabled donation and transplantation to expand. Modest growth continued until the mid-eighties, when progress in donation stalled.
In 1989, The Organizacion Nacional de Trasplantes (ONT) was formed to address the problem of declining donation rates. The organization believed that the problem was not lack of suitable donors, but rather a problem of identifying potential donors and obtaining consent.
Blanca Miranda, MD, Assistant Director of ONT in Spain, spoke about her country's program at Joining Forces. The following are excerpts from an interview with Dr. Miranda after the conference.
What is the main reason Spain's donation rate is so high?
We have implemented a standardized donation process in each and every hospital in the country. Our system focuses the responsibility for handling the donation process into the hands of specially trained individuals called "donation teams." These donation teams are then held responsible for the performance of donation in their hospital.
Why does the in-hospital team work so well?
It is very important that the teams consist of the right individuals who can manage the process and provide accountability. The individuals chosen for the team are physicians and nurses from the ICUs who are very well respected in their institution and willing to take on this part-time position in addition to their current responsibilities.
Additionally, in transplant hospitals the teams must be completely independent of the transplant teams and report to the director of the hospital. This ensures accountability for performance.
What is the role of the in-hospital team?
They manage the whole process. They identify all potential donors, handle the evaluation and management of the donor, ensure the family understands that death has occurred, and makes the request for organ donation. They are also involved in education, management of resources, media relations, and other administrative tasks.
When is the most appropriate time to approach a potential donor family?
We tell all of our coordinators that they cannot speak about organ donation before the family has understood that brain death has occurred. Before making the request for donation, it is important that the coordinator has established a relationship with the family. To facilitate this, the coordinator gets involved very early. In fact, the coordinators are notified of every patient admitted with a severe head injury.
The exact timing of the request for donation differs from family to family. When the coordinator first meets with the family, the purpose is to begin to assess the family's understanding of the situation. At each step in the process you must examine the current situation and analyze all the information the family has been given by the physician. At the end, you must make sure that the physician has explained that death has occurred and the family understands this information.
You must also determine how many family members are at the hospital and which person is the decision-maker. You must remember that in Spain the family is very close so you can have as many as ten people at the hospital. As the coordinator you have to make sure you are talking to the decision-maker of the family.
What can the US learn from the Spanish system?
Probably, the entire Spanish system is not transplantable to the US - you can't export it like bananas - but all of us can learn from other systems and make changes. The biggest problem I see in the US is that there is not just one person in the hospital who is responsible for organ donation. There are many people involved in the process and no one has to report results.
Hospitals need to invest time in developing teams. Organ donation is a medical activity just like anything else that goes on in the hospital. You have cardiac teams, neurology teams, so it only makes sense to also have a donation team.
What are your next areas for improvement?
We estimate that Spain has potential of nearly 50 donors per million population and we are currently at 25 donors per million. To decrease this gap there are three things we need to improve.
The first is donor identification. We estimate that we lose about 10 donors per million population because the patient is never identified as a potential donor. The second area of improvement is the clinical management of donors. We currently lose 10 to 14% of our donors to cardiac arrest, severe hemodynamic instability or intractable sepsis. Finally, we need to decrease the family refusal rates. Our refusal rate is 24%, but with more training we believe this could be even lower.
In addition to improving cadaveric donation, we will also probably focus more on living related donation. Currently this accounts for only one percent of all kidney activity. We've also begun to do some work with non-heart beating donors and are preparing a consenus conference on the subject. We need to analyze the results of the programs in place and decide if they should be more widespread.
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Much of the improved success of transplantation over the last 10 to 15 years is due to the availability of effective drugs to manage the immune system. At the recent Joining Forces conference, pharmaceutical leaders from two of the industry giants shared their perspectives on future opportunities and challenges for the field. The executives described the commitments their companies have made towards increasing donation and issued strong calls for hospital stakeholders to assume a more active role in supporting donation initiatives.
Drawing upon his own experience in pharmaceuticals, Mark Pulido, Chief Operating Officer of Sandoz Pharmaceuticals, identified similarities between bringing efficacious new drugs to market and developing programs to resolve the organ donor shortage.
"When we design clinical trials, we start with a well developed project and establish clear methodologies, outcome measures and evaluation plans," said Pulido. "Similar to testing new drugs, a plan for improving donation has to have sufficient scale to achieve statistical significance, and must be tested across a wide range of institutions and practitioners." Pulido emphasized the importance of involving many partners and donation sites.
Highlighting the fact that programs such as these often take time to produce results, he cautioned the community not to abandon them too quickly. And when they have shown their efficacy, the community must provide for the active dissemination of the findings.
Joseph Mahady, President of Wyeth-Ayerst Pharmaceuticals, spoke about successful pharmaceutical industry collaboration with health care providers. Acknowledging that such collaborations are frequently "fraught with controversy," Mahady said nonetheless, there are great opportunities if the community agrees upon, and shows commitment to, a course of action.
"If we are to succeed," he said, "we need to select those activities where we think we have a high probability of success and move forward." Referring to information presented by Harvard researchers, UTMB, and Spain, Mahady pointed to improving donation within hospitals as a solution with great promise. "It makes sense to focus on efforts that have demonstrated some success and move from the concept stage into the action stage." Focusing on a specific course of action does not preclude other types of solutions or improvements, he added.
Mahady stressed the importance of continuing to take a research-based approach, observing that "research is the obligation of any organization" pursuing a solution to the organ shortage.
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