* Abbreviation: STICU, surgical and trauma intensive care unit.
Procurement of transplantable organs has been identified as a major public health problem in many countries. The scarcity of organs available for transplantation has been attributed in turn to legal constraints, medical issues, and cultural and religious attitudes. Legal constraints are considered a leading cause of nonprocurement in the United States(1-4). The reform of the current system, introducing presumed consent, whereby a brain-dead individual is presumed to agree to donation, unless having stated otherwise, was proposed. Presumed consent, which is the law in several European countries, including France (the first law on presumed consent was voted on December 22, 1976, abrogated, and replaced by the “loi Bioéthique” on July 29, 1994)(5), failed to solve the crisis of organ procurement. The current situation with regard to consent to organ procurement in French hospitals has been called “weak” presumed consent(6): the attending physician asks the family whether their brain-dead patient has opposed organ donation during his/her lifetime, and accepts the family's word. No written statement from the brain-dead parent is requested.
Cultural and religious causes of family refusals have been mentioned in several medical publications (7, 8) and in the sociological literature (9-11). Causes of failure of organ procurement other than family refusal include medical ineligibility (12), inappropriate resuscitation(7, 13, 14), and opposition from the coroner because of the circumstances of death. Medical contraindications to organ donation have been found dependent on local practice patterns-their part in overall nonprocurement was estimated between 9% and 27%(12).
From 1991 to 1994, the rate of organ procurement in French hospitals dropped from an average 70% of potential donors during the previous years to less than 60%. In France, during the year 1994, of a total of 1536 brain-dead potential donors, 868 (57%) underwent organ procurement. Causes of nonprocurement were divided into broad categories: age and medical conditions(19%), failure to resuscitate, including failure due to medical and organizational conditions (15%), opposition from the family (61%), and other causes (5%) (15).
Although national and regional actions in support of procurement are required to deal with, respectively, legal issues and the organization of a network among hospitals to increase identification and transfer potential donors (16), we hypothesized that local actions could be efficient in reducing losses from failure to resuscitate and denial of consent. Denial of consent is the largest single cause of nonprocurement for transferred potential donors, and the cause that exhibits the widest variations from one country to another (1, 4, 17).
Our objective was to investigate in a prospective study the overall efficacy of organ procurement at our institution, and more specifically of causes of nonprocurement that could be acted upon, i.e., (1) identify the different steps involved in the organ procurement process, with the possible delays, (2) explore the possible organizational causes of failure to provide efficient physiological support, and (3) provide explicit and documented information on the causes of family denial of consent.
MATERIALS AND METHODS
Setting. Hôpital Henri Mondor is a 1100-bed acute care university hospital, with a special interest in transplantation (kidney, heart, and liver) and neurosurgery. Although our institution is not exclusively dedicated to the care of multiple trauma patients, 280-300 of such patients are admitted every year in the trauma intensive care unit. In addition, the neurosurgical department is in charge, 1 day a week, of managing all head injuries and other emergency cases (e.g., brain hemorrhage) for Paris and the surrounding suburbs.
All potential donors were hospitalized in the surgical and trauma intensive care unit (STICU*). The total number of beds in the STICU was 10. There were 6 senior medical staff and 39 nonmedical personnel. One bed was dedicated to providing extended physiological support to potential donors. Every senior intensivist took shifts for the responsibility of organ procurement and interviews with the families of potential donors. The person in charge of obtaining consent for organ donation was always a senior physician assisted by a head nurse. If the family of a potential donor could be reached only by telephone, the policy (although not the law) was to not request donation. Organ donations investigated were kidney, liver, heart, lungs, and pancreas, and tissue donation included skin, cornea, bones, and blood vessels.
The average yearly number of potential donors between 1989 and 1993 was 60±10. We defined potential donors as brain-dead patients according to the bylaw of April 24, 1986. The French definition of brain death is no response to brainstem reflex stimulation, no spontaneous breathing after 10 min of an apnea test, and a completely flat electroencephalogram for 20 min, at rest and during stimulation. These patients underwent intensive care support and the usual clinical and biological workup (9). The average yearly number of actual donors was 30±4.
Medical factors related to nonprocurement. Medical causes of failure to retrieve organs were investigated in a prospective study of patients hospitalized in 1994 and 1995. All patients hospitalized in the STICU with potential brain death were eligible. A data collection chart was designed(Table 1) and data on each patient were collected by a research assistant. Medical causes of noneligibility were age over 65, serological status positive for human immunodeficiency virus, human T-cell lymphoma virus and hepatitis C virus, documented malignancy, and chronic cardiac or renal failure (8, 13, 18, 19).
Organizational factors related to nonprocurement. Also investigated were the organizational factors occurring prior to admission, i.e., cause and place of death and the number of referrals before the patient was admitted in the STICU.
Sociological and cultural attitudes of families toward organ procurement. Both consent and denial of consent were investigated(20, 21). A preliminary study on 12 families had highlighted the fact that the determining factors for the decision depended on the representation and images associated with the body and its integrity(22).
All families who had been asked for their consent to organ procurement during the year 1994 were eligible. Families who had been reached by telephone only and had not seen the STICU team were excluded. The list was obtained through the STICU records log. A letter requesting an interview was mailed to all families. The letter was addressed to the person in the family who accepted or refused donation at the time of his or her relative's brain death, most commonly the patient's closest relative. Mailing was scheduled to ensure that an identical 1-year period between the request for donation and the interview would be respected for all families. The study was carried out in the form of semidirective interviews with the families of the deceased in their own homes. Three sets of questions were systematically asked covering(1) the circumstances surrounding the request for the organ donation, (2) the way that the request was formulated, and (3) the role of those involved. The interview was conducted and decoded by a trained sociologist (R.W.).
A qualitative approach was considered the most appropriate to analyze the behavior of the families and to retrace the route taken by the request formulated by the physicians and the coordinator(23-25). Content analysis listed the main topics (categories) and their occurrences along with the behavior of the interviewees with regard to these topics. Whenever an occurrence was coded in a category, it was compared with occurrences in the same category for the same person and for other persons (e.g., when a person mentioned the willingness of the deceased person to help others, it was coded in the category“altruism”). Concepts that came from the individuals involved(parents, spouse, etc.) described processes and behaviors, whereas concepts elaborated by the sociologist explained them. The core ideas used in the analyses of all interviews dealt with: (1) the religious dimension likely to define behavior with regard to refusal or acceptance, (2) the beliefs in rumors concerning the possible trade in organs, (3) the understanding of the medical aspects of brain death and organ donation, and (4) the wish to control the end use of the donated organs.
Patient numbers. Patient number was computed so as to detect differences in the distribution of nonprocurement causes (in broad categories) nationwide and at our hospital. Given the nationwide distribution described above, patient number was chosen to enable us to determine (with 5% α and β risks) differences of 10% or more between regional and national percentages. Agreement that a 10% difference was meaningful was reached after historical data and regional variations in organ procurement were reviewed by STICU physicians. Computations of patient number were made in each broad causal category and yield the highest figure of 103 patients.
Categorical data were assessed using chi-square analysis and significance was attributed at P<0.05.
The study design and the letter requesting the family interview were approved by the Ethics Advisory Board of Paris Hospitals (AP-HP).
Medical and organizational aspects. During the 24 months of the study, a total of 105 patients (56 patients in 1994 and 49 patients in 1995) were admitted to the STICU and diagnosed brain-dead and eligible for donation. Patients had been found in their homes in 55 cases (54%) and in a public place in 50 cases. The cause of death was traumatic (suicide or accident) in 62 cases (60%) and nontraumatic in 43 cases (37%). Demographic characteristics of the patients are presented in Table 2. Two patients were already hospitalized in another department of the study hospital and did not have to be transferred. Patients were brought to the STICU directly form the initial location in 51 cases, admitted to one institution before referral in 41 cases, and admitted to two or more different institutions in 10 cases (mean number of transfers, 2). Survival times in the STICU for donors and nondonors are presented in Figure 1. Of the 105 patients, 9 were not eligible for donation because of medical reasons (drug abuse proven or suspected, serological status, sepsis, age over 65 years). In six cases, cardiac arrest occurred before organ procurement. Failure of physiologic support measures could be associated with organ failure appearing during hospitalization, diabetes insipidus, pulmonary edema, and coagulopathy. Denial of consent from the coroner occurred in 7 cases, and consent was requested in 82 cases. As the word “family” has been left undefined by the text of the “loi Bioethique,” persons interviewed included parents, children, spouse or companion, siblings, other relatives, and friends. In 34 cases, only one representative of the “family” was contacted, and in 48 cases, two to five family members were asked for consent. In a majority of cases, the relationship of the deceased to the persons interviewed to request donation did not fall into the classical categories used to define members of the family: interviewees were stepparents, children of divorced spouses, and friends. Consent was obtained in 53 cases and denied in 29 cases.
Detailed results for donors and nondonors and comparisons with national data are presented in Tables 3 to 5. Our results did not differ from national results.
Final outcomes of the procurement process were as follows: kidney, n=56; heart, n=35; heart and lungs, n=2; lungs, n=6; tissues, blood vessels, cornea, and bones, n=28. Elective opposition of the family to tissue procurement was registered and acknowledged in 27 cases.
Family interviews. Investigation of family attitudes toward organ donation was attempted in 42 cases (29 families who had accepted and 13 families who had denied donation) of the 60 for the year 1994. Families who had been very antagonistic at the time donation was requested, families who had no address, and families who could not speak French were excluded. Eight families (six who had accepted and two who had denied donation) refused to be interviewed. Reasons for approval and refusal are presented inTable 6.
Families who had given consent reported the importance of having a physician in the intensive care unit make the request rather than an administrative representative or someone from outside. The physician of the STICU was personally present and informed the family that the patient was brain dead. The request followed at once, with detailed information on organ donation and medical benefits of transplantation. Openness concerning the removal of organs was stressed, i.e., how many organs would be taken and which ones.
The reasons for donation stemmed less from religious convictions and more from representation of the dead body that could be used to help others and from altruism. The ability to “transmit” the life of the deceased was mentioned by the families as a reason to authorize a donation. Families wanted to follow the deceased persons will, whether or not it had been explicitly stated. When it had not been stated, they tried to infer it from analogies, for example between organ donation and blood donation. When the deceased person donated blood, the family assumed that he or she would have agreed to organ donation. Another factor in favor of donation was the community effect, i.e., either knowing the problems faced by persons waiting for a transplant or knowing someone who had benefited from one.
The importance of preserving the dignity of the corpse in terms of its appearance was mentioned. The generation effect was also cited, whereby elderly members of the family could not be told about donation. Answers to the question of the end use of the donation showed the acceptance of anonymity, but a desire to foresee an end-use congruent with the family's values.
Families who refused donation were found to have misunderstood the information given to them. They had felt that information was given to them gradually, because they had a delayed personal contact with the STICU team, or they felt that removing organs would result in the death of a person who was still alive, because they did not understand the meaning of brain death. Thus, there was an impression of opacity surrounding the process of organ procurement.
Conceptual arguments for refusing the donation stemmed from the family's inability to get over the pain of their loss and to move from the private realm to the public. These arguments against donation centered on the appropriation of the body by the medical profession and on the inability to understand that the person was actually dead. Families refused to take responsibility for the decision in the absence of precise instructions from the deceased person. Concern about illegal trading of organs was not mentioned.
We studied the processes involved in organ procurement in a tertiary care institution. Our focus was the understanding of those causes of failure to retrieve organs that could be acted upon locally. Our findings on medical and organizational causes of nonprocurement do not differ from those reported by other authors, in France and abroad. Half the number of potential donors reached our center after of two transfers or more. This number could be reduced by greater information of referring hospitals, or use of image transfer of brain magnetic resonance imaging or CT scanner results(19).
Family refusals represent overall 50% of failure to retrieve organs at our institution, and this figure compares favorably with the 67% figure nationwide(15). Our study of families' motivations to accept or deny donation represented a first attempt to collect information from the actual individuals involved. Motivations could be monetary or nonmonetary: the use of financial incentives for organ donation has been advocated(26-28), but, in addition to being questionable from the economic and ethical standpoints(29, 30), such incentives are illegal in France. As far as nonmonetary incentives are concerned, other authors have reported findings on the attitude of the general population and of the professionals, or on particular ethnic groups whose behavior was different from that of the Caucasian population in the United States (7, 25, 31). We interviewed all the families who agreed to participate in order to identify as many representations as possible leading to either acceptance of refusal of donation. A first finding was that the traditional notion of“family” was irrelevant in more than half the cases. French law does not state a precise definition of who the “family” is, which is consistent with current societal evolution but may result in difficulties when the medical team has to identify the person in charge.
The focus of the sociological study was to identify social representations of the families, under the assumption that representations govern persons' relationships with the world and other people, behavior, and social communication and are a vector of action, for individuals as described by the sociologist Max Weber (32). The gift of life via an organ from a living or deceased person to another living person constitutes a social relationship based on reciprocity and solidarity. Persons who authorize the donation are faced with a situation that they may need to have recourse to for themselves someday. Do the characteristics of the social link established in such circumstances therefore correspond to the cycle “give, receive, give back” observed in archaic societies? The meaning of this act taking place in an area of private relationships, the criteria (social, cultural) influencing those confronted by a request for organ donations, and the conditions under which families respond to the request formulated by the professionals were investigated (33). There is a generally shared revulsion to the idea of a destruction of the body and the exchange of organs, represented in different ways in the social unconscious. The viewpoint of lay people and society may differ from that of medical professionals. For the deceased person's kin, the corps mori belongs to the private sphere, whereas for medical professionals, the body of the deceased no longer belongs to the family, as stated by the law. The urgency involved in the removal of organs is such that the dead body is considered to belong to the public health domain because of the number of lives it can save: this notion can be understood by some families who have acquired through individual experience and their own values an understanding of the medical world.
Favorable responses to organ donation came from individuals who accepted the idea that the meaning of organ donation was to ensure transmission of life from the brain-dead patient. In this way, the donation is understood as a way to give life to the unknown people who receive the donation, and as a completely free “gift,” with no strings attached, even if the possibility of finding oneself or a member of one's family on the receiving end at some time in the future is considered. It was clear, however, that families did not consider organ donation to be a step that could be taken naturally. It was an idea that had to be almost forced upon them by the deceased person's will or attitude toward the medical profession and society.
Respecting the opinions of the deceased about donation was a general concern. In cases where no clear statement had been made during the patient's lifetime, families of brain-dead patients tried to guess what that statement would have been, using memories of their relative's behavior toward the medical profession and “the others” in general. This scenario is grounds for increasing public awareness and encouraging people to state their attitudes toward organ donation.
The interviews also highlighted the public's poor understanding of the notion of brain death and of the medical aspects of organ donation. Families who knew at least a little about medical aspects of donation or transplantation, via relatives or neighbors tended to accept donation. Our interpretation was that their knowledge enabled them to shift from the traditional social paradigm of respecting the integrity of the deceased body to the medical paradigm of seeing the deceased's body as a possible treatment for other patients (34). These findings should encourage public health decision makers to initiate information campaigns targeting the general public (35).
Several local changes were proposed based on the results of this study. The environment where families are asked for consent was changed, and the sequential course of the request included detailed explanation of the significance of brain death and of the composition of the STICU team requesting donation. In countries where presumed consent is not the rule, one could consider using the analogy made by some families between blood donation and organ donation to approach blood donors and suggest acquiring a donor's card.
General changes should involve the possibility for each person to state clearly their attitude toward donation and information for the general public on the meaning of brain death and on the medical aspects of organ transplantation. In view of the determinants of donation found in this study, local interventions will have limited effects if they are not supported by national promotion of changes in people's attitudes.
1. Randall T. Too few human organs for transplantation, too many in need... and the gap widens. JAMA 1991; 265: 1223.
2. Spital A. The shortage of organs for transplantation: where do we go from here? N Engl J Med 1991; 325: 1243.
3. Veatch R. Routine inquiry about organ donation: an alternative to presumed consent. N Engl J Med 1991; 325: 1246.
4. Kittur DS, Hogan MM, Thukral VK, McGaw LJ, Alexander JW. Incentives for organ donation? Lancet 1991; 338: 1441.
5. Du respect du corps humain (Chap. 2). In: Journal officiel loi no. 94-653. Paris: Direction des Journaux Officiels, 1994: 11056.
6. Spital A. The shortage of organs for transplantation[Letter]. N Engl J Med 1992; 326: 1026.
7. Randall T. Key to organ donation may be cultural awareness. JAMA 1991; 265: 176.
8. Mackersie R, Bronsther O, Shackford S. Organ procurement in patients with fatal head injuries: the fate of the potential donor. Ann Surg 1991; 213: 143.
9. Fox RC, Swazey JP. Spare parts. New York: Oxford University Press, 1992.
10. Prottas J. The most useful gift: altruism and the public policy of organ transplants. San Francisco: Jossey-Bass Publishers, 1994.
11. Simmons RG, Klein D, Simmons RL. The gift of life. New York: John Wiley & Sons, 1977.
12. Gore S, Armitage J, Briggs D, et al. Consensus on general medical contraindications to organ donation? BMJ 1992; 305: 406.
13. Huber F. The shortage of organs for transplantation[Letter]. N Engl J Med 1992; 326: 1025.
14. Perkins H, Tolle S. The shortage of organs for transplantation [Letter]. N Engl J Med 1992; 326: 1025.
15. Conseil médical et scientifique de l'Etablissement Francais des Greffes. Le prélèvement et la greffe en France en 1994 [Report]. Paris: Etablissement Francais des Greffes, 1995.
16. Gnamt MFX, Wamser P, Goetzinger P, Sauter T, Steininger R, Muelbacher F. The impact of the presumed consent law and a decentralized organ procurement system on organ donation: quadruplication in the number of organ donors. Transplant Proc 1991; 23: 2685.
17. Siminoff L, Arnold R, Caplan A, Virnig B, Seltzer D. Public policy governing organ and tissue procurement in the United States: results form the national organ and tissue procurement study. Ann Intern Med 1995; 123: 10.
18. Novello AC, Sundwall DN. Organ transplantation in the United States: recommendations of the task force. Transplant Proc 1987; 19: 1505.
19. River EP, Buse S, Bivins B, Horst M. Organ and tissue procurement in the acute care setting: principles and practice. Ann Emerg Med 1990; 19: 193.
20. Fox RC, Swazey J. The courage to fail: a social view of organ transplants and dialysis. Chicago: University of Chicago Press, 1978.
21. Simmons RG, Klein SD, Simmons RL. The social and psychological impact of transplantation. New York: John Wiley & Sons, 1977.
22. Waissman R. Mort, prélèvement d'organe et société. In: Club de la Transplantation, 7ème séminaire. Paris: Club de la Transplantation, 1995.
23. Glaser BG, Strauss A. The discovery of grounded theory: strategies for a qualitative research. New York: Aldine Publishing Co., 1967.
24. Strauss A, Corbin J. Basics of qualitative research, grounded theory, procedures and techniques, 1st ed. London: Sage Publications, 1990.
25. Randall T, Marwick C. Physicians' attitudes and approaches are pivotal in procuring organs for transplantation. JAMA 1991; 265: 1227.
26. Pellegrino ED. Families' self interest and the cadaver's organs: what price consent? JAMA 1991; 265: 1305.
27. Peters TG. Life or death: the issue of payment in cadaveric organ donation. JAMA 1991; 265: 1302.
28. Evan RW. Organ procurement expenditures and the role of financial incentives. JAMA 1993; 269: 3113.
29. Prottas J. Buying human organs: evidence that money doesn't change everything. Transplantation 1992; 53: 1371.
30. Kiberd B. Organ procurement [Letter]. Transplantation 1993; 55: 235.
31. Creecy R, Wright R, Berg W. Discriminators of willingness to consider cadaveric kidney donation among black Americans. Soc Work Health Care 1992; 18: 105.
32. Weber M. Les catégories de la sociologie. Paris: Pocket Agora, 1995: 42.
33. Shibutani T. Reference groups as perspectives. Am J Soc 1955; 60: 565.
34. Traeger J, Colpart J-J. Causes and socio-psychological dimensions in donation refusal. In: Touraine JL, Traeger J, Bétuel H, Dubernard JM, Revillard JP, Dupuy C, eds. Organ shortage: the solutions. Dordrecht, The Netherlands: Kluwer Academic Publishers, 1995: 41.
35. Schütt G, Duncker G. Disappointing rate of altruism in the population. In: Touraine JL, Traeger J, Bétuel H, Dubernard JM, Revillard JP, Dupuy C, eds. Organ shortage: the solutions. Dordrecht, The Netherlands: Kluwer Academic Publishers, 1995: 49.