Report 4 of the Council on Scientific Affairs (I-02)
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Increasing Organ Donation

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This Council on Scientific Affairs report, written in response to Resolution 512 (A-02), briefly summarizes published reviews and data on the organ donor shortage in the United States, examines past and current AMA activity in this area, and presents several recommendations.

Methods

A systematic review of the literature was conducted using the MEDLINE database for the years 1985 to 2002. English-language articles were selected based on their ability to: (1) inform as to the availability of and need for donated organs; (2) articulate racial and ethnic disparities in the need for and availability of organs; and (3) examine the role of physicians and physician organizations in improving organ and tissue donation rates. Further relevant articles and books were selected from the reference listings of the primary journal articles. Other sources of information included the United Network for Organ Sharing (UNOS) annual reports and online databases.

Background: The "Donation Gap"

The success of solid-organ transplantation has greatly increased the need for expanded numbers of organ donors.^1-3 Since 1990, the number of patients awaiting an organ transplant has grown from just over 20,000 to more than 80,000. Despite the fact that most Americans indicate a willingness to donate their own organs,^4-5 supply has not kept up with demand.^1,6 Over the last decade, the compounded rate (1990-2000) of increase in the number of patients on waiting lists has averaged 14.1% a year, while the rate of increase of donors has averaged only 2.9% a year.⁷ This "donation gap" has led to a crisis in organ transplantation. In 2000, nearly 6,000 patients died while waiting for a life-saving transplantation.⁸ Between 1991 and 2000 the death rate (per 1,000 patient-years-at-risk) of individuals on the transplant waiting list has also not declined significantly.⁸ Of the patients awaiting transplantation who died in 2000, 48% were waiting for a kidney, 29% a liver, 10% a heart, and 8% a lung.

Unrealized donor potential accounts for much of the donation gap, with studies suggesting that the number of potential donors far exceeds current procurement rates.^6,9-11 For example, estimates using national mortality data suggest that the number of potential cadaveric donors nationwide ranges between 6,900 and 10,700 annually.¹² Other estimates put the figure as high as 23,000.¹³ Yet in 1999 only 5,549 cadaveric transplant donors were actually recovered.⁸ Two problems appear to account for most of the unrealized donor potential. First, it is estimated that 25% of the families of eligible donors are not even given the option of donation. Either the donors are not identified or the health care team fails to approach families of eligible donors for donation. Inadequate education in identifying the suitability of donors or notifying appropriate services, attitudes of health care professionals toward donation, and a lack of communication between the medical and nursing staffs are often cited as reasons why potential donors are missed.^14-16 Second, more than half of the families decline donation when it is offered. Family refusal to give permission for organ recovery or to participate in organ donation remains relatively high despite ongoing public education efforts.¹⁷

Racial and Ethnic Disparities in the Donation Gap

Racial and ethnic minorities are disproportionately affected by the donation gap, especially African Americans.^18-21 For example, while African-American patients represent more than 30% of those waiting for organs, studies indicate that blacks may have even less interest in donating organs than whites.²⁰ Because African-American patients have a decreased likelihood of successful transplantation due to poor tissue match if the donor is not also African-American,¹⁹ this failure to support donation results in a disproportionately large number of African Americans waiting for organ transplantation and a paucity of potential organs available for transplantation.^{20, 22-23} Although less acute, similar disparities exist for Hispanics and other racial/ethnic groups.^24-26 The failure to identify potential donors is an important factor in racial and ethnic disparities in the donation gap. Even after controlling for cause of death, the risk that African-American donors will not be identified is more than twice that for whites.²⁷ There is also evidence suggesting that hospital staff are less likely even to approach families of racial and ethnic minorities for donation.²⁸ Other factors influencing the reluctance of racial and ethnic minorities to donate organs include:

• lack of awareness of or familiarity with transplantation^19-20;
• religious beliefs and misperceptions (superstitions) ¹⁹;
• poor access to medical care¹⁹; and
• distrust of the medical community.^{19, 24, 29}

Efforts to Reduce the Donation Gap

A number of efforts have been made to increase the supply of transplantable organs and reduce the donation gap. For example, the Department of Health and Human Services and others have launched several media and/or educational campaigns aimed at increasing donation. Also important is expansion of the criteria for donation,^{2-3, 6, 30} which has dramatically increased the number of organs (mostly kidneys) procured from living donors, primarily from genetic relatives.^{6, 31-33} Currently, more than 35% of transplanted kidneys nationwide come from living, related donors.⁸ Procedures also exist for obtaining nonrenal transplants from living, related donors, including lung segmentectomy or lobectomy, hemipancreatectomy, and liver segmentectomy.^{6, 34-36}

Donor criteria have also been expanded to include the use of asystolic donors (those declared dead on the basis of traditional cardiopulmonary criteria).^{6, 37-43} Asystolic donors are usually divided into 3 categories: those pronounced dead on arrival from the hospital, those in whom in-hospital resuscitation has been unsuccessful, and those who previously requested that resuscitation and life support be withheld. The latter is the most common asystolic donor; this is typically referred to as controlled donation.⁶ Organs recovered from asystolic donors include the kidney, liver, pancreas, and lung.^{41, 44-46} Finally, experts have begun to re-examine the consent processes for donation.^{9, 47-48} For example, an Organ Procurement Organization (OPO) in Pittsburgh approaches family members with a statement rather than a question. Other OPOs have employed specialists who empathize with the next of kin, reassuring them that their critically ill relatives are being well cared for. The latter approach has been validated by a study at the University of Pittsburgh and Case Western Reserve University⁴⁹ and by the LifePoint Organ Procurement Organization in South Carolina.⁵⁰ In both these instances, families who spent more time discussing care issues and donation with OPO staff were more likely to consent, as were families who were asked to make a decision only after such discussions.

However, living donation (kidney and occasional segmental liver or lung) and the use of "expanded donor" criteria have bridged the donor gap only slightly. Public service and educational campaigns also have not dramatically affected the donation gap. As early as 1993, a Gallup poll found overwhelming support for donation, but when offered the chance to donate organs of a relative, only about half of those asked consent to doing so.⁹ In truth, despite ongoing public initiatives to increase cadaveric organ donation and living donation, and expand the potential number of donors by broadening criteria for cadaveric organ donation, the donation gap remains intractable.^{6, 9, 14}

Reducing the Donation Gap: The Physician’s Role

Efforts to improve donation have highlighted the importance of physicians in the organ donation process, which has been described as a specialized form of end-of-life (EOL) care.^51-52 This care can take place in both acute and nonacute situations, but there are significant barriers to effective physician response in either setting.^52-53 For example, while many patients prefer to receive information from physicians who provide routine care to them and their family, a majority of primary care physicians report never discussing organ donation with patients during routine office visits and only 5% had information on donation available.^53-54

Family practice residents also report little knowledge about organ donation and transplantation.⁵⁵ EOL decision-making involving organ donation in the ICU is also complicated, with the process, sequence, timing, and coordination of the donation process all vital to obtaining consent for donation.^{28, 56-58} For example, evidence exists that the consent rate for organ donation is higher when the request is decoupled from the discussion of brain death.⁵⁹ However, evidence also suggests that many physicians and nurses are unskilled or poorly trained in the skills of communication and problem resolution that are required to broach organ donation-related EOL decisions with patients and their families.^{51-52, 60-62} Poor decision-making and poor communication skills combine to produce family dissatisfaction and anxiety on the part of health care providers that can escalate into dilemmas and conflicts, with potentially detrimental consequences for organ retrieval.

The federal Conditions of Participation (COP) from the Centers for Medicare and Medicaid Services (CMS) and many state laws now require that all families be presented with the option of organ and tissue donation when death is imminent.⁶³ The CMS COP also require that persons initiating a discussion about organ donation with a family should be trained and skilled in doing so. This requirement is problematic for many physicians who are not adequately trained or prepared to discuss severe brain injury, brain death, and organ donation with families.^{51-52, 60} Such limitations in training are often used to justify a greater reliance on OPO coordinators and/or requestors.⁵¹ However, physicians still play a vital role in the consent process and must be encouraged to become proficient in this area and to work with the OPO coordinators and requestors to improve donation rates.⁵¹ Often it is the attending physician, working with the requestor, who is in the best position to devise a plan that notifies the family of its options to donate and to assist the family in dealing with the stress associated with the impending death of a loved one.

The Role of the American Medical Association

Given the importance of organ donation as a public health issue and the critical role of physicians in the request process, the AMA has long been concerned about the donation gap. There is extensive AMA policy on organ and tissue donation, ranging from support for organ donation education for physicians and their patients (H-370.984; H-370.996, AMA Policy Database) to the exploration of new methods to increase donation, such as "presumed consent" and financial incentives (E-2.155; E-2.15; H-370.979). In 1998 the AMA launched the "Live and Then Give" program to increase physician awareness of the need for organ donation. This program was modeled after the successful program originating with the Texas Medical Association, the Texas Medical Alliance, and the Texas Transplant Society. Live and Then Give encourages physicians to lead by example; eg, by teaching physicians more about organ donation and by encouraging physicians to become organ donors. Finally, in 2002, the AMA completed a joint study with the Health Resources and Services Administration (HRSA) examining the physician’s role in the recruitment of organ donors. This study focused on the opportunities and barriers within medicine to physician participation in the consent process and on physicians’ collaboration with OPO coordinators and requestors in efforts to improve donation rates.⁵²

The Council on Scientific Affairs believes that future efforts by the AMA should build on the strengths of the Association and on the strengths/failures of past initiatives. For example, it is imperative that our policies stay current with the ethical and/or professional debates that accompany emerging initiatives to improve donation rates. Recent examples include the debate over the use of financial incentives for organ donation and the use of and long-term health implications for the living donation donor. The AMA’s experiences with Live and Then Give can also inform new directions. Outside of a few – targeted – efforts,^{19, 63} national educational interventions have not been shown to definitively impact donation rates.^64-65 This is not to say that education is not an important component of an overall national strategy to improve donation rates.⁶⁶ Rather, it suggests that more appropriate educational interventions take place at the state or community level, where they can be tailored to state laws governing organ donations. Alternatively, these interventions may be better implemented at the hospital level, where they can be matched with the procurement/transplantation programs at individual institutions. Finally, the AMA may build on the HRSA collaboration, working with key stakeholders to identify best practices for physician involvement in organ donation as a specialized form of EOL care. Best practices for organ procurement exist for OPOs and nurses,^67-68 but do not exist for primary practitioners. UNOS is developing a set of recommendations for physicians,⁶⁹ but it is not clear that these will address organ donation as a specialized form of EOL care. This last step would also build on one of the major strengths of the AMA - our ability to convene.

Existing AMA Policy on Organ Donation  [Editor's Note:  See Recommendations, below, for AMA policy and directives adopted at the December 2002 AMA Interim Meeting.]

H-140.897 Cadaveric Organ Donation: Encouraging the Study of Motivation
H-270.963 Organ Donation
H-370.975 Ethical Issues in the Procurement of Organs Following Cardiac Death
H-370.977 The Inclusion of Advance Directives Concerning Organ Donation in Living Wills
H-370.979 Financial Incentives for Organ Procurement
H-370.980 Strategies for Cadaveric Organ Procurement
H-370.981 Organ Procurement Legislation
H-370.983 Tissue and Organ Donation
H-370.984 Organ Donation Education
H-370.986 Donor Tissues and Organs for Transplantation
H-370.987 Transplant Centers
H-370.990 Transplantable Organs as a National Resource
H-370.995 Organ Donor Recruitment
H-370.996 Organ Donor Recruitment
H-370.998 Organ Donation and Honoring Organ Donor Wishes
E-2.06 Capital Punishment
E-2.10 Fetal Research Guidelines
E-2.145 Pre-Embryo Splitting
E-2.15 Financial Incentives for Organ Donation
E-2.155 Mandated Choice and Presumed Consent for Cadaveric Organ Donation
E-2.157 Organ Procurement Following Cardiac Death
E-2.16 Organ Transplantation Guidelines
E-2.167 The Use of Minors as Organ and Tissue Donors
E-10.02 Patient Responsibilities

CONCLUSION

The widening donation gap has led to a crisis in organ transplantation that persists despite ongoing efforts to improve donation. This crisis is most pronounced among racial and ethnic minority populations. Physicians play an important role in the donation process, which has been described as a specialized form of EOL care. The federal COP also encourage increased involvement of physicians in the donation process. However, while they are often in the position to provide best care for patients and families in these trying circumstances, physician facilitation of organ donation is frequently limited by lack of training and/or education on the special issues involved. The AMA can play an important role in preparing physicians for participation in the consent process and in improving donation rates.

RECOMMENDATIONS

The following statements, recommended by the Council on Scientific Affairs, were adopted by the AMA House of Delegates as AMA policy and directives at the December 2002 AMA Interim Meeting:

1. The AMA (a) recognizes the importance of physician participation in the organ donation process; and (b) acknowledges organ donation as a specialized form of end-of-life care. (Policy)
2. AMA policies H-270.963, H-370.975, H-370.977, H-370.979, H-370.980, H-370.981, H-370.983, H-370.984, H-370.986, H-370.990, H-370.995, H-370.996, and H-370.998 (AMA Policy Database) are reaffirmed. (Reaffirm Policy)
3. The AMA will continue to promote organ donation awareness. (Directive)
4. The AMA will seek extramural funding to update the Live and Then Give program to increase physician awareness of the need for organ donation and make a Web-based version of this program available for state and specialty societies for adaptation. (Directive)
5. The AMA will seek extramural funding to convene a workshop with members of the Federation, the transplant community, and the Health Resources and Services Administration, Division of Transplantation, to develop best practices for physician participation in the organ donation process and for the medical management of potential organ donors. (Directive)
6. The AMA reaffirms existing AMA policy regarding organ donation and will reissue AMA donor cards to all AMA members and their patients to the extent permitted by and consistent with applicable laws. In addition, donor cards should be readily available on the AMA Web site for downloading. (Directive)
   
   
   

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Resolution 512 (A-02), introduced by the Texas Delegation at the 2002 American Medical Association (AMA) Annual Meeting and referred to the Board of Trustees, asks: