The shortage will probably worsen as transplantation becomes more successful and is offered to sicker and older patients ([3], [4]). The number of organ donors is unlikely to keep pace with this increased demand. Although the largest source of potential organ donors are persons who have been declared dead according to neurologic criteria ("brain dead"), estimates of this potential pool of donors have been revised downward from a high of 32 000 to between 6000 and 10 000 potential donors annually. This downward revision is due to overly optimistic initial estimates and improved public health measures such as the use of seat belts and motorcycle helmets ([5], [6]).

Given the limited number of potential donors, there is a constant effort to increase the efficiency of the procurement system. The current system is based on the voluntary decisions of patients or their families to donate organs to help others. This emphasis on voluntariness is consistent with the value of respecting individual autonomy and the dignity of the body after death. Supporters of the current system of organ donation argue that altruism must be the overriding factor in the decision to donate ([7], [8]).

Education campaigns are designed to make the public aware of the good that can come from transplantation. Public opinion surveys show that these campaigns have been effective—more than 95% of Americans are aware of transplantation and as many as 75% say that they would be willing to donate an organ after death (9; The Gallup Organization, The American public's attitude toward organ donation and transplantation. Survey conducted for the Partnership for Organ Donation; 1993).

This overwhelming public support for donation, coupled with the low number of procured organs, led U.S. public policy analysts to conclude that the low procurement rate was due to the failure of health providers to request donation from families of donor-eligible patients ([10]). Various findings seem to support this diagnosis. These include wide variations in procurement rates among hospitals; results of attitudinal surveys of health care professionals that reflected misunderstandings about eligibility criteria; legal concerns; and ambivalence regarding talking with families about procurement ([11], [12]).

These data, juxtaposed with the widespread public support of organ transplantation, persuaded legislators that if health care professionals would only identify and talk to families, families would be willing to consent to donation. Twenty-six states and the District of Columbia passed some variant of a law (called Required Request) requiring that hospitals ensure that health care professionals approach the families of eligible donors to give them the opportunity to donate. Subsequently, the Health Care Financing Administration required hospitals to develop Required Request policies as a prerequisite for Medicare reimbursement, and the Joint Commission on Accreditation of Health Care Organizations made it a requirement for hospital accreditation ([13]).

Required Request legislation has not, however, resulted in the expected increase in the number of procured organs, tissues, or corneas. Studies in several states have shown that although there was a small immediate increase in procurement after the passage of Required Request laws, these increases were modest and leveled off after the first 2 years ([11], [14]).

Without clear data on how the organ procurement system in the United States works, one cannot be confident about how to improve the process. Unfortunately, the development of public policy on organ procurement has relied more on theory than on empiric data. Procurement of tissues and corneas has suffered from benign neglect and has merely been folded into policies designed to procure organs with no regard to their applicability. The few studies that have examined the organ procurement process have reached different conclusions about how the system should be modified to increase procurement. Some blame the failure of Required Request legislation on the continued failure of health care professionals to approach families about donation and call for legislation strengthening the role of organ procurement organizations ([15]). Others claim that the fear of legal liability impedes health care professionals from approaching families about donation and call for intensive education ([16], [17]).

One factor that has not received enough attention is the willingness of families to consent to donation when asked. Available data raise questions about the long-held belief that most families will consent to donation (18; Seamons TC. Unpublished data; 1989). Little is known about the request process itself and what affects families' willingness to donate ([19]). Two small studies of families that consented to donation reported that provision of information and the need for time to accept the death of the patient were important factors ([20], [21]). Although educating health care professionals to perform this function is probably crucial, current recommendations on how to make the request (for example, communicate the concept of brain death clearly and discuss donor options after declaration of death) are our best guess as to what works ([22]). No good empiric data definitely show which techniques are best. Therefore, recent proposals challenging the fundamental underpinnings of the current system are of concern because we do not really understand how to motivate people to donate. Financial incentives, for example, assume that self-interest, rather than the desire to help others, is the overriding factor in the decision to donate ([25], [26]). Whether such a strategy would be effective is unknown.

Our study was designed to provide the first comprehensive, empiric analysis of how organ, tissue, and cornea procurement works in actual clinical practice. Our objectives were to determine the ability of health care professionals to identify donor-eligible patients, the frequency with which health care professionals approach families about donation, rates of consent to donation by families, and the factors associated with successful procurement.

Methods

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Study Sample

We obtained a representative sample of hospitals in the Pittsburgh, Pennsylvania, and Minneapolis-St. Paul, Minnesota, greater metropolitan areas, each of which comprises a diverse rural-urban mix of about 2 000 000 people. It is expected that awareness and knowledge of transplantation would be high in these areas because major, world-renowned transplantation centers are located within them. Thus, the data obtained in both areas are likely to reveal practices and values that are at least as well informed about transplantation as those anywhere else in the United States. Nevertheless, organ procurement rates from these two metropolitan areas mirror the national average.

A stratified random sample of 23 hospitals was chosen from the 62 acute-care hospitals in the two regions. The strata represent 3 large trauma hospitals, 2 of which have active transplantation services; 2 children's hospitals; 6 medium-to-large non-trauma hospitals; and 12 small (<200 beds) nontrauma hospitals.

Determination of Donor Eligibility

Each week during the study, the medical charts of all patients who had died at all 23 hospitals were reviewed to determine the patient's eligibility for organ, tissue, and cornea donation. The chart review form developed for this purpose was initially conceived during a pilot study done in Pittsburgh ([27]). The chart review form was developed using the existing literature on eligibility and after extensive discussions with personnel from local organ, tissue, and eye procurement organizations ([28], [29]). Eligibility criteria were finalized through structured informational interviews with all procurement organizations in the study's catchment areas. The interviewers asked questions about the effect on eligibility of more than 100 diseases, the use of various drugs, and the use of medical technologies such as ventilators and dialysis machines. A pilot of the chart review form was used to review sample charts. These charts were then reviewed with procurement organizations to validate our eligibility criteria ([27]).

The final chart review form used a decision-tree model to establish donor eligibility. Age was the starting cut-off point; patients were then excluded on the basis of major diseases, infections, medications, and the use of certain medical technologies. This strategy allowed us to distinguish among organ, tissue, and cornea donors because an individual person might be eligible to donate, for example, organs but not tissues or corneas. Patients younger than 37 weeks' gestation or older than 70 years, those with metastatic cancer or active tuberculosis, and those who were seropositive for the human immunodeficiency virus were ineligible to donate organs. (Since the completion of our study, the criteria have changed. In the Pittsburgh area, patients as old as 90 years are evaluated for donation. Criteria also vary with locality.) In contrast, cornea donors as old as 75 years are eligible to donate; they may also have cancer and may have died of cardiopulmonary disorders. The chart review form also accounted for local variations in eligibility. Data on patient demographic characteristics and on other variables (for example, type of health insurance and length of stay) were also collected.

Research staff at both study sites were rigorously trained to follow standardized procedures to ensure high levels of consistency and reliability. Ten percent of all charts were reabstracted for quality control, and all eligible charts were reviewed by two investigators. Reliability was calculated at 98%.

Classification of Patients' Donor Status and Sampling Method

Although many patients were eligible to donate some combination of organs, tissues, and corneas, cases were classified hierarchically to account for the fact that organ donation takes precedence, even if the donor is eligible for all other types of donation, because of the limited number of potential organ donors and the life-sustaining character of organ transplants. Procurement activities are aimed at maintaining the potential organ and obtaining consent for organs rather than for tissues or corneas. Thus, patients who were organ eligible were classified as such regardless of tissue and cornea eligibility. Patients classified as tissue eligible could donate tissues or tissues and corneas; those classified as cornea eligible could donate only corneas. This strategy enabled us to examine the ways in which the procurement process differs for each type of eligibility without confusing procurement activities for organs with those for tissues and corneas. All organ-eligible cases were included in the interview sample. Approximately 30% of eligible cornea donors and 80% of eligible tissue donors were sampled using a randomized block method. ([30])

Determination of Health Care Professional Interviews

Interviews were conducted with health care providers, including physicians, nurses, organ procurement organization staff, and others (generally medical social workers and clergy) who either spoke with the family after the patient's death or discussed donation with the family.

Likely study-eligible health care professionals were contacted within 2 weeks of the patient's death. To ensure that all eligible health care professionals were contacted, a snowball approach was used. Health care professionals involved in patient care were initially identified through chart review. This initial pool of participants was asked to identify other health care professionals who had either spoken with the family after the patients' deaths or were known to be directly involved with the donation process. All health care professionals were screened before administering the interview to determine whether they met the study's entry criteria. Informed consent had been obtained. The study was approved by the institutional review boards of all the participating hospitals and the Universities of Pittsburgh and Minnesota.

The interview instrument was based on results of a previous study, input by the local organ procurement organizations, and piloting done for a month at both study sites in January 1990 ([27]). The instrument consists of two parts. The first part focuses on the ability of health care professionals to identify specific donor-eligible patients and their discussions with families about donation. The second part elicits their general knowledge and attitudes about various aspects of donation and collects sociodemographic data about the health care professionals. Health care professionals who were identified in more than one eligible patient case completed the first half of the interview for each case; however, to eliminate possible study effect, they completed the second part of the interview schedule only once. An independent rater coded all completed interviews.

Measurement of Rates of Donor Identification, Approach and Donation

Organ procurement requires the completion of three steps before surgical retrieval: 1) donor identification: At least one member of the health care team must identify the donor-eligible patient; 2) asking the family to donate: Once a potential donor is identified, at least one member of the health care team must approach the family; and 3) reaching a decision about donation: The family must decide to either donate or refuse to donate and must convey this decision to an appropriate health care professional.

Measuring Donor Identification Rates

All health care professionals were asked about patients' eligibility to donate organs, tissues, and corneas. On the basis of information available to health care professionals at the time of the patient's death, we determined whether the health care professional's assessment was correct. Patients who were excluded for donation after postmortem examination (for example, microscopic assessment of the cornea) were treated as "eligible" when health care professionals' ability to identify donors was determined. Health care professionals who correctly identified a patient as a donor, even when incorrectly maintaining that a particular organ or tissue was not eligible, were coded as having correctly identified the patient as a donor.

Although knowledge of individual members of a health care team is important, only one member needs to correctly identify the patient as a donor to set the procurement process into motion. We therefore calculated donor identification rates by dividing the number of cases in which one health care professional correctly identified the patient as eligible by the total number of eligible patients.

Measuring Approach Rates

A similar method was used to measure the frequency with which families were approached about donation. Two measures were calculated: 1) the frequency with which the donor family was approached about donating; and 2) the approach rates of individual health care professionals. We calculated donor family approach rates by dividing the total number of cases in which at least one member of the health care team approached the family to request donation by the number of eligible patients. In some cases, patients were asked to donate even though no member of the health care team formally identified the patient as a donor. None of the study's 23 hospitals used designated requesters, and 972 individual health care providers made at least one request during the study period.

Measuring Willingness To Donate

Each health care professional was asked whether the family agreed to donate and what the family consented to donate. We verified these decisions with the pertinent regional organ procurement organizations. Family decisions were classified in three ways: 1) decision to donate all that was requested 2) decision to donate with conditions (for example, to donate only certain organs or no corneas); and 3) refusal to donate anything.

Statistical Analysis

We used descriptive statistics to describe the general patterns of behaviors of health care professionals and families regarding donation. We used the Student t-test to test levels of association for interval-level variables and examined contingency tables using the chi-square statistic. Contingency tables were subdivided into analyses for organs, tissues, and corneas for most of the analyses because patterns of approach and consent to donation for these three types vary significantly.

Results

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We reviewed 10 681 patient deaths that occurred in 23 hospitals between February 1991 and September 1992. Of the patients who died, 1760 (16.5%) were eligible to donate some combination of organs, tissues and corneas. In-depth interviews were triggered by 841 eligible cases. Interviews were obtained for 827 (98.3%) of these cases (201 organ-eligible, 354 tissue-eligible, and 272 cornea-eligible cases). Table 1 provides the sociodemographic characteristics of the sample selected for interview and of the ineligible cases. Interestingly, 18.6% of organ-eligible cases were patients older than 59 years of age, and 97.7% died in the intensive care unit.

A total of 1809 interviews about the three steps of the organ procurement were completed with 661 physicians, 893 nurses, and 255 medical social workers and clergy. Health care providers were interviewed about a case even if they did not correctly identify the patient as a potential donor. This was done because, in 46 cases, the family was asked to donate even though no health care provider was sure that the patient was a potential organ donor. The overall response rate was 92.3% (physicians, 84.0%; nurses, 97.4%; social workers and clergy, 98.4%). Almost two thirds (64.3%) of the health care professionals interviewed were female, 93.2% were white, and 69.4% were younger than age 40 years.

Donor Identification

To ascertain the ability of individual health care professionals to identify donor-eligible patients, we asked about the eligibility of each of their study patients to donate organs, tissues, or corneas. These assessments were retrospective and do not indicate whether the health care professional made a correct judgment about eligibility at the time of the patient's death. Most health care providers could identify donor-eligible patients when specifically asked: Eighty-one percent, 87.0%, and 82.1% correctly identified potential organ, tissue, and cornea donors as eligible. We found no significant differences in ability to identify donor eligible patients among types of health care providers.

In most cases, at least one member of the health care team could identify eligibility for each patient case when asked: Ninety-two percent, 96.6%, and 88.6% correctly identified organ-, tissue-, and cornea-eligible patients as donors (Table 2). Few of the patients' sociodemographic characteristics correlated with the health care professionals' ability to identify a patient's donor status, although younger patients were most likely to be identified as organ eligible. Factors that were not associated with health care professionals' ability to identify donor-eligible patients were patients' race or ethnicity, marital status, health insurance status, and time of death.

Asking Families about Donation

Families of organ-eligible patients were most likely to be approached. Almost 87% of families were approached about donation by at least one member of the health care team compared with 69.5% and 67.3% of tissue- and cornea-eligible patients, respectively (Table 2). The families of organ-eligible patients were less likely to be approached if the patient was female, was on a general medical or surgical floor, or was being cared for on a medical service. The families of younger tissue-eligible patients were less likely to be approached, as were those of nonwhite patients and patients who were cared for on surgical services. The families of cornea-eligible patients who died on general medical or surgical floors were also less likely to be asked to donate than others (Table 3).

None of the study hospitals specified health care professionals whose specific task was to ask about donation. More health care professionals were involved in speaking to families of organ-eligible patients (mean, 2.99; range, 1 to 11) than to those of either tissue-eligible (mean, 2.22; range, 1 to 5) or cornea-eligible patients (mean, 1.87; range, 1 to 5). Physicians were most apt to approach patients' families about organ donation (91.7%) but less likely to do so when the patient could only donate tissues (68.8%) or corneas (67.3%). Nurses were most likely to approach families about tissue donation (76.6%), whereas nonmedical health care professionals most frequently asked families of cornea-eligible patients about donation (87.9%). A procurement organization staff person spoke with families in 8.5% of all cases. Involvement of such staff was limited almost exclusively to requests for organ donation.

Reaching A Decision about Donation

The final donation decisions of 587 (97.3%) of the 603 donor-eligible families that were asked to donate organs, tissues, or corneas were ascertained. Slightly more than 34% of eligible donor families agreed to donate something. The frequencies with which families consented to organ, tissue, and cornea donation differed significantly. Of the 170 organ-eligible cases for which donation was requested and a decision known, only 46.5% donated. Even fewer tissue and cornea donation requests were answered affirmatively; 34.5% and 23.5%, respectively (Table 2). Willingness to donate organs was associated with the patient's age; families of younger patients were more likely to donate than those of older patients. Interestingly, we found no significant differences between the rates with which white and nonwhite families donated. However, only 24 nonwhite potential donors were identified. Other factors, such as patient sex, insurance status, type of service, and location of death, were not associated with the family's willingness to donate organs. No particular patient characteristic was associated with consent to cornea and tissue donation (Table 4).

The data indicate that the type of health care provider involved in discussing donation with the family may make a difference. When a clinician (physician or nurse) was involved in requesting organ donation, consent was 51.1%. However, when a medical social worker or clergy member was involved, the rate of consent increased to 66.0% (P = 0.05). This difference might mean that these health care professionals do something different with families (for example, spend more time with them) or that there may be some selection bias concerning the cases to which these types of health care professionals are referred. We also found that health care professionals who had received formal training about donation were more likely to ask families to donate (P < 0.001) but were no more successful in obtaining consent than those who had no formal training (P = 0.95).

Variation among hospitals was not statistically significant. Rates of consent to organ donation ranged from 37.8% for medium hospitals to 56.3% for children's hospitals (P = 0.59) (Table 5). Although certain small hospitals had considerably lower rates of consent than larger hospitals, these hospitals see only a fraction of the number of potential donors seen by larger institutions. The 12 small hospitals in our study averaged only 1.7 organ-eligible cases per year compared with 6.8 per year for medium hospitals, 17.5 per year for children's hospitals, and 53.0 per year for trauma hospitals. Children's hospitals had the highest average rate of consent (56.3%), a finding consistent with results of another recent study ([31]).

Discussion

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Our results show the low efficiency of the procurement system—only 40.3% of all potential eligible organ donors, 23.9% of potential tissue donors, and 15.8% of potential cornea donors actually became donors. The failure of health care professionals to approach families, although less common, particularly in the organ-eligible population, accounted for 13.4% of lost donors. Nevertheless, the major impediment to procurement was the low rate of family consent: More than 50% of families refused to donate, and 22.2% of families who did donate placed conditions on the donation. These surprising data confirm the findings of other smaller studies and anecdotal reports that have received little attention from policymakers ([32]).

Our findings call into question the two central assumptions of U.S. public policy on organ donation: 1) that health care professionals fail to ask families to donate and 2) that, if asked, families will donate. Why do these assumptions still dominate public policy discussion? To date, public policy on organ donation has been grounded in retrospective chart reviews, reports of organ procurement organizations, surveys of the attitudes of health care professionals, and public opinion polls. These techniques present a distorted and inadequate picture of the procurement process. Patient records are notoriously incomplete. Previous studies have shown, and our study confirms, that health care professionals poorly document their behavior in medical records. Thus, record reviews tend to underestimate the number of families asked to donate. Reports from organ procurement organizations overestimate the percentage of families consenting to donation because these organizations see mostly those who express an initial willingness to donate.

Public opinion polls, which report that the public is favorable, if not enthusiastic, about organ donation are also flawed. There may be a high social desirability factor that is biasing survey results. Although the public may not be comfortable with the idea of donation itself, they are enthusiastic about the idea of saving lives through transplantation. Moreover, these surveys ask respondents to speculate on behavior for which they have no experiential basis. Thus, respondents' answers to such questions are less likely to predict future behavior than, for example, a poll asking respondents how they will vote in an upcoming election. It is not surprising that our findings indicate that health care providers approach families frequently about donation and that families refuse more frequently than has been previously reported.

Our findings suggest that any attempt to increase the rate of donation must address families' reluctance to donate. Required Request legislation has largely accomplished its overt agenda: that hospital staff ask families about donation. Because organ donation commands so much public attention, with only cursory attention given to tissue and cornea donation, the policy has been most successful in encouraging organ donation. Given the already high compliance with the goals of Required Request, further improvement of the abilities of health care providers to identify or approach families is likely to be time-consuming and cost-intensive. Improving family consent rates, the missing link from Required Request policies, is more likely to increase procurement rates.

Recent recommendations for increasing procurement suggest either expanding the definition of who is eligible to become an organ donor (for example, non-heartbeating donation or those that have organs preserved using cold perfusion) or rejecting the basis of the current system (voluntariness and altruism) in favor of a system based on financial incentives or one in which voluntariness is proscribed (presumed consent). In addition to the philosophic arguments on the propriety of abandoning altruism, there are practical questions about whether alternative policies would actually increase procurement ([11], [38]). It is also unclear how the public would respond to financial incentives, such as money to pay for funeral expenses, as an inducement to donations ([39], [40]). In one public opinion poll. 52% of Americans thought financial or nonfinancial compensation should be offered to increase donation, whereas results of another survey showed that 78% of those surveyed rejected the idea that families be paid in order to increase the rate of donation (41; The Gallup Organization. The American public's attitude toward organ donation and transplantation. Survey conducted for the Partnership for Organ Donation; 1993). More disturbingly, a survey of families that consented to donation found that 85% of the families opposed financial incentives ([25]).

Others have argued that the United States should adopt policies similar to those of Belgium, Austria, and France, according to which it is assumed that all adults wish to donate their organs unless they have specifically stated otherwise ([42]). How acceptable this policy would be in the United States is questionable, given differences in cultural beliefs regarding death and individual autonomy. Public opinion polls have reported that only 39% of respondents favor this policy ([41]). Furthermore, presumed consent has not been universally successful. In France, for example, presumed consent has not resulted in higher donor rates ([3], [43]).

If the current system is to be retained, voluntary altruism needs to be generated or captured in new ways. One option that is gaining increasing support is mandated choice. The American Medical Association, for example, has recently urged that persons be "required to state their preferences regarding organ donation when they renew their drivers' licenses, file income tax returns or perform some other task mandated by the states" ([44]). Although such a policy has the ethical advantage of promoting, at least superficially, individual autonomy in decisions about organ donation, there are arguments against such a policy. Mandated choice artificially forces persons to choose what they would want done at some point in the future rather than allowing t hem to delegate the decision to a surrogate they trust. Given the common fear, particularly among minorities, that persons who are willing to donate may be declared dead too soon, mandated choice may result in lower, not higher, consent rates ([45, 46]; Lieberman Research. How people feel about organ donation; 1991). This problem is likely to be compounded by having persons make this decision without the benefit of an informed discussion. Indeed, the recent experience of mandated choice in the State of Texas, which has implemented such a law, is not encouraging. To date, mandated choice has resulted in a refusal rate of 80% (Texas Department of Public Safety statistics; 1994).

Improving the current system requires a better understanding of the reason why families refuse to donate. Although public policy emphasizes that the individual should be the decision maker for donating, the familial, group nature of the real decision-making process has been all but ignored. In almost all cases in this study, the actual decision makers were not the patients but the patients' families. Little is known about how families, particularly families who refuse to consent to donation, experience a donation request nor about how the process influences the decisions of potential donor families in a time of great stress ([26], [47]). Some families report that donating provides comfort; for others, the act of donation itself may serve as a painful affirmation of the death of a loved one ([19]).

Problems with the ways in which families are asked about donation, rather than the failure of voluntariness and altruism, may account for the high refusal rate. There is controversy about who should approach the family about donation. Should it be the health care provider with whom families have the greatest rapport or the organ procurement organization personnel, who have greater interest and the best training ([51]; Perkins, KA, Unpublished data)? The best time to raise these issues is also unclear. In one study, consent to donation was more likely if the request was separated from the declaration of death, presumably to give the family time to process the patient's death ([52]). One factor that does seem clear is that the family's knowledge of the patients previous wishes is central to decision making ([48], [49]). This suggests that educational efforts should stress the importance of telling one's family what one's wishes are concerning donation rather than anonymously checking off an option on a driver's license at a motor vehicle bureau.

Most information about families' experience of the donation request comes from families that agreed to donate. Even among these families, complaints about the lack of information on brain death, the cost of donation, the effect of donation on funeral arrangements, and health care providers' insensitivity were relatively common ([27], [48], [49]). This suggests that better training in the methods of discussing organ donation with grieving families may increase consent to donation. More research is needed on which health care professionals are best placed to discuss donation with the family or whether this should be left wholly in the hands of specially trained professionals.

We have shown that health care providers do identify eligible donors, particularly organ donors, and request donation from families as mandated by Required Request legislation. However, even when approached, most families refuse the opportunity to donate. Well-planned empirically based education campaigns directed at health care professionals and the general public are needed to maximize donation within the existing framework for procurement. We must, however, realize that despite out best efforts, there will always be people who choose not to donate. Public policy must be oriented to ensure that all families who might donate are offered the option in a sensitive manner and in a climate that fosters decisions that reflect the prospective donors' legitimate wishes.