Assessing Organ Donation from the Dead Should Not Be Done by Reporting a Census of the Living

Abstract

In this issue of the American Journal of Transplantation, Miranda, Villardell and Grinyo (1) report their experience with cadaver organ donation in Spain, which is widely acclaimed for its success (2, 3). Indeed, the ‘Spanish Model’ is a paradigm of performance that is unmatched by other countries throughout the world. The authors note that the number of donors per million population (DPMP) achieved in Spain is double that of the other European countries. This accomplishment in Spain certainly exceeds what is reported in America according to an accompanying article on organ donation performance from Chang and colleagues (4). We commend the Spanish for their success; however, we would also suggest that the comparative measure of donation performance used by Miranda and Chang in each of their reports, the DPMP, is scientifically flawed. Missing in these reports is a fundamental determination of the potential of organ donation from the dead. The assessment of organ donation from the deceased should not be referenced to a census of the living population because it is does not provide an analysis of the essential data elements: a comparison of the number of actual organ donors to the number of deceased potentially suitable donors (Figure 1). Numerous studies have identified the shortcomings of the DPMP method as the comparative standard of performance (5-7). Although it is easily calculated, DPMP is a crude measure based upon an irrelevant census of the living. No meaningful comparison can be made unless a precise denominator (the number of deceased patients who are medically suitable to be an organ donor) is determined or at least estimated (7). In this donor potential framework, the reference base is appropriately the dead. Conversion rate of potential to actual donors. Donor conversion rate = Actual organ donors/Medically suitable potential donors. Assessing the number of potential donors is best done by conducting death record reviews (DRR). DRR involve the following tasks: reviewing a list of all deaths; eliminating those deaths that are beyond a certain age (e.g. >80 years of age); reviewing the ICD discharge diagnosis codes to selectively eliminate those deaths that fall into certain ICDM 9 codes that are absolute rule-outs for organ donation (e.g. AIDS or current cancer); and reviewing the actual medical records of all remaining deaths, looking for those patients who were declared brain dead or had clinical symptoms consistent with brain death. The determination of organ donor potential, by either the number of brain dead or the number of cardiac dead who are suitable for organ recovery, has revealed a wide variation from one region to another (8). Many Organ Procurement Organizations (OPOs) determine this vital statistic through concurrent and retrospective reviews of deaths in their affiliated hospitals. The percentage of these potential donors converted into actual donors (conversion rate) becomes a more accurate and consistent measure of organ donation effectiveness (Figure 1). Otherwise, evaluating OPO performance (or a nation's organ donation performance as given by Chang and colleagues) (4) based on DPMP misrepresents some Donation Service Areas (DSAs) as underachievers, when in fact they simply have fewer potential donors (Figure 2). Ojo and colleagues of the Scientific Registry of Transplant Recipients (SRTR) have proposed a revised standard for reporting organ donation performance (7). The Ojo method assesses deaths categorized by their cause (for example, trauma vs. stroke) to extrapolate a reference base of potential suitable donors (Figure 2). Assessment of performance comparing the UNOS region donors per million population (pmp) versus donors from evaluable deaths. A high rank of donors per million does not correlate with donors per 1000 evaluable deaths. The death rate from stroke and cardiovascular disease vs. trauma varies among countries (9). Chang and colleagues report substantial differences in cerebrovascular deaths between Spain and the United States (4). SRTR data shown in Figure 2 record evaluable deaths among DSAs that bring a compelling conclusion: suitable potential organ donors are not uniformly distributed geographically. Thus, it is possible to find regions of the United States where the DPMP is similar to that of Spain. However, it is wrong to assume that the same donation rate will prevail across a nation with a population seven times that of Spain, with a much greater level of ethnic diversity and multiple care systems. Finally, death data must be recorded and analyzed prospectively, because in this day of advanced directives and a common intensive care unit experience of the withdrawal of futile treatment from the terminally ill, we may be in the midst of a declining donor potential. For that purpose, the Secretary of Health and Human Services, Tommy Thompson, has just issued a directive that the 200 hospitals with the largest number of medically suitable potential donors in the United States (which account for a majority of the annual number of organ donors) must monitor their conversion rates of potential to actual donors in a ‘Hospital Best Practice’ initiative, so that a target conversion rate of 75% is achieved. There are important lessons to be learned from the report of Miranda and colleagues. Spain has a presumed consent law that promotes social responsibility within its culture. Although families are still approached about donation, the nature of the conversation is to determine if the deceased had ever ‘opted out’ as an organ donor, not to obtain consent. This is the reverse of the American system where the deceased prior to death, or the deceased's family must actively opt in. With this presumed consent approach in Spain, Miranda reports national consent rates of up to 80%. In contrast, there is a consent rate in North America approximating 50%. The pool of potential brain-dead deceased donors in the United States is estimated to be 10 500–13 800. If the Spanish consent rate could be achieved in United States, performance could resemble what has been achieved in Spain. Perhaps, the first-person consent approach that documents the designation of a person's donation intent prior to death will be helpful. In those instances in which the family is aware of the intent of donation, the consent rate is virtually 100%. Nevertheless, the objective of this approach is to determine the previously established consent of the decedent (either through a registry or a donor card) and not to permit a ruling from the family to override the donor's wishes. Spanish hospitals ‘own’ the donation process by having a compensated staff physician who assumes primary responsibility for donation. Many North American hospitals lack such an internal ‘champion’. Not mentioned in the Miranda or Chang reports, however, is the role of this Spanish health care professional in the triage of traumatized victims with irreversible brain injury to an organ donation possibility. These head trauma patients affect donor potential and these kinds of data are central to determining comparative organ donation performance. In a medical care system such as Spain, where all providers are funded by the government, financial incentives for organ donation are more readily accomplished than in other countries. In addition to indirect financial incentives to hospitals, Spain also provides a modest contribution toward funeral expenses for some donors (10). Thus, American legislators should note a system that has balanced the ideal of altruism with the reality of providing an incentive that is not perceived to be a payment or bribe. This approach has been proposed by the American Society of Transplant Surgeons, but it has been misconstrued by the media to represent an objectionable payment for organs (11). Chang and colleagues (4) also call attention to the use of older aged deceased donors as a significant component of the Spanish success and the most readily adoptable aspect of the Spanish system. Our Spanish colleagues have recognized the life-saving benefit of transplanting older age kidneys into matched older recipients. New wait-list strategies proposed by Chang to identify appropriate recipients for expanded criteria donor (ECD) kidneys have been devised (12), and a study is underway in New England to examine the impact of the new expedited system of organ allocation upon the use of ECD kidneys (13). No single method is going to solve the crisis, but we can derive encouragement and direction from the Spanish. As we modify organ donation policy to adopt innovative approaches, we urge the reporting of precise data that compare the dead… to the dead, in assessing organ donor potential.