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Guidelines for the psychosomatic evaluation of living liver donors
Guidelines for the Psychosomatic Evaluation of Living Liver Donors: Analysis of Donor Exclusion Y. Erim, M. Malago´, C. Valentin-Gamazo, W. Senf, and C.E. Broelsch
T
HE BENEFITS OF LDLT have to be weighed against the risks to the healthy donor. To achieve maximal safety, standardized guidelines for selection have to be established for the psychosomatic evaluation of the donors. There are some publications about results of donor evaluation and donor outcome, but guidelines and results of the psychosomatic or psychiatric evaluation have not been published in detail yet.1– 4 The psychosomatic evaluation consists of two relevant aspects: (1) psychological stability of the potential donor and (2) verification of the informed consent. PSYCHOLOGICAL STABILITY OF THE POTENTIAL DONOR
To ensure psychological stability of the potential donor, we examine whether a history of psychiatric disorders exists. Further, we test coping skills, social and family support, cognitive skills, and competence to consent. Recipient and donor are first evaluated by two different physicians. Main aspects of the evaluation are the dynamics of the relationship between donor and recipient and the psychological stability of the donor. In the last session, evaluating physicians, donor, and recipient meet. INFORMED CONSENT
The demands for informed consent were adopted by the German transplantation law in 1997. A premise in the German transplantation law is information for the living donor (TPG § 8 (1) 1b), voluntariness (TPG § 8 (3)), and competence to consent (TPG § 8 (19), 1b). We deem it important to discuss and inform on the prospect of success of the transplantation and the presumed survival time of the organ recipient after the transplantation. We know from experience that some patients change their mind after being informed if they realize that there is no promising rate of success for the recipient. In these cases, it is important to allow the donors a medical excuse to change their decision since it is understandable that the potential donor does not want to affront the recipient. The principle of assisting the potential donor in developing an appropriate medical disclaimer is suggested in the guidelines of the German Medical Association. Special issues of informed consent are enclosure of information, compe© 2003 by Elsevier Science Inc. 360 Park Avenue South, New York, NY 10010-1710 Transplantation Proceedings, 35, 909 –910 (2003)
tence to consent, voluntariness, and verification of the informed consent. EXCLOSURE OF INFORMATION
The psychosomatic clinician assesses whether the donor has been extensively informed and recommends that the donor obtain further information from surgical or internal medicine side if too little information had been previously provided to the donor. It must be clear to the donor that segmental liver donation in adults is an innovative therapy and that personal safety for the probands may at present be found somewhere halfway between scientific research and established routine. We inform the potential donors that the results for living liver donation to children are not fully applicable to living liver donation to adults. COMPETENCE TO CONSENT
According to Appelbaum and Grisso5 competence to consent consists of four related skills: communicating a choice, understanding relevant information, appreciating the situation and its consequences, and the ability to manipulate information rationally. Taking these points into consideration, we have not encountered any donation candidates whose competence to consent has been restricted in any way. VOLUNTARINESS
Socially it is desirable and acceptable to help those family members whose health is endangered. Great pressure may therefore arise within the familial system, especially if the recipient is in poor health and the situation is urgent.6 Pressure can be high in LDLT cases since livesaving alternative therapies, as in the case of renal insufficiency and dialysis, do not exist. In our own practical work, we now differentiate between two important restrictions of volunFrom the Departments of Psychotherapy and Psychosomatics (Y.E., W.S.) and the Department of General Surgery and Transplantation (M.M., C.V.-G., C.E.B.), University Hospital Essen, Essen, Germany. Address reprint requests to Yesim Erim, MD, Klinik fu¨r Psychotherapie und Psychosomatik, Universita¨tsklinikum Essen, Virchowstr. 174, 45147 Essen, Germany. 0041-1345/03/$–see front matter doi:10.1016/S0041-1345(03)00159-3 909
910
ERIM, MALAGÓ, VALENTIN-GAMAZO ET AL Table 1. Donor Selection and Exclusion Analysis
Total donors evaluated Total rejected Total living donors Rejection in the initial screening Rejection in steps 1 ⫹ 2
Psychosomatic evaluation Further evaluation
n⫽385 n⫽305 n⫽ 80 n⫽ 50 n ⫽ 140 (blood group, hepatitis, medical risk, volumetry, graft history) n⫽ 21 n ⫽ 7 (steps 3 ⫹ 4)
tariness: first, expectations toward the potential donor from the family may be so extreme that it may present a great external pressure or coercion; the second restriction being that unconscious neurotic conflicts as an internal pressure may make a voluntary decision impossible. These patients remain ambivalent, though they have had several talks with the psychosomatic and the surgeon team.
Table 2. Donors Rejected for Psychosomatic Reasons (n ⴝ 21) Missing psychosocial stability (n ⫽ 4) 1. Ongoing cannabis addiction (ICD 10: F12.2) and severe social problems 2. Mixed drug abuse (ICD 10: F19.1) 3. Prolonged mourning reaction (ICD 10: F43.2) 4. Ongoing alcohol addiction (ICD 10: F10.1) Generalized anxiety disorder (ICD 10: F41.1) Prior depressive episode and suicide attempt Ambivalence concerning donation without being able to make a clear decision (n ⫽ 7) Refusal of donation after additional information about potential surgical complications for the donor or the expected outcome for the recipient (n ⫽ 5) Excluded because the “special personal closeness” after the German transplantation law could not be verified (n ⫽ 3) Family member not willing to donate; wants to have a medical excuse (n ⫽ 1) Suspected financial dependency of the donor from the recipients family (n ⫽ 1)
CONDITIONS OF THE EVALUATION PROCEDURE Consensus Conference
In our model, the final decision for accepting a candidate as a donor is made in a so-called consensus conference. All evaluating departments such as transplant surgery, hepatology, anesthesiology, and psychosomatics take part at this conference. Moratorium
The donors are given sufficient time after the first disclosure of information and after the psychosomatic evaluation. That way they can reconsider their decision to donate.
department. After exclusion of 305 donors within several steps of medical evaluation as listed in Table 1, only 80 donor candidates were finally accepted for transplant (Table 1). Of the potential donors, 171 were referred to the psychosomatic unit for further evaluation. Twenty one potential liver donors were rejected for psychosomatic reasons as listed in Table 2. Contemplation about the given information had a great impact on the decision of the potential donors: 12 candidates either refused to be a donor after additional information or could not overcome their ambivalence.
Translators
If the donor is not fluent in the German language, an independent, court-examined translator is provided. Family members are not allowed to be translators; thereby it is assured that the potential donor can express hesitations, health problems, or other family issues that he may not wish to discuss with other family members, in a confidential environment. Possibility of Therapeutic Support for the Donor
We deem it an ethical commitment of the transplant team that therapeutic support is possible if needed after the transplantation of the donors, for instance in cases when the recipient has died or when conflicts in the family are triggered by the donor evaluation process. PRELIMINARY RESULTS AND ANALYSIS OF DONOR EXCLUSION
Between August 1998 and November 2001, 385 potential living liver donors have been evaluated in the surgical
CONCLUSIONS
Psychosomatic assessment is important for those donors who are under great pressure; it should serve to clarify the donor’s own motivation as well as to provide support if the donor considers withdrawing from his original decision. Follow-up care and evaluation of the liver donor is necessary to elucidate the psychosocial outcome and the prognostic value of psychosomatic predictions.
REFERENCES 1. Goldman LS: Psychosomatics 34:234, 1993 2. Sterneck M, Fischer L, Nischwitz U, et al: Transplantation 60:667, 1995 3. Trotter JF, Talamantes M, Mc Clure M, et al: Liver Transpl 7:485, 2001 4. Beavers KL, Sandler RS, Fair JH, et al: Liver Transpl 7:943, 2001 5. Appelbaum PS, Grisso T: NEJM 319:1635, 1988 6. Fellner H, Marshall JR: Am J Psychiatry 126:79, 1970
T
HE BENEFITS OF LDLT have to be weighed against the risks to the healthy donor. To achieve maximal safety, standardized guidelines for selection have to be established for the psychosomatic evaluation of the donors. There are some publications about results of donor evaluation and donor outcome, but guidelines and results of the psychosomatic or psychiatric evaluation have not been published in detail yet.1– 4 The psychosomatic evaluation consists of two relevant aspects: (1) psychological stability of the potential donor and (2) verification of the informed consent. PSYCHOLOGICAL STABILITY OF THE POTENTIAL DONOR
To ensure psychological stability of the potential donor, we examine whether a history of psychiatric disorders exists. Further, we test coping skills, social and family support, cognitive skills, and competence to consent. Recipient and donor are first evaluated by two different physicians. Main aspects of the evaluation are the dynamics of the relationship between donor and recipient and the psychological stability of the donor. In the last session, evaluating physicians, donor, and recipient meet. INFORMED CONSENT
The demands for informed consent were adopted by the German transplantation law in 1997. A premise in the German transplantation law is information for the living donor (TPG § 8 (1) 1b), voluntariness (TPG § 8 (3)), and competence to consent (TPG § 8 (19), 1b). We deem it important to discuss and inform on the prospect of success of the transplantation and the presumed survival time of the organ recipient after the transplantation. We know from experience that some patients change their mind after being informed if they realize that there is no promising rate of success for the recipient. In these cases, it is important to allow the donors a medical excuse to change their decision since it is understandable that the potential donor does not want to affront the recipient. The principle of assisting the potential donor in developing an appropriate medical disclaimer is suggested in the guidelines of the German Medical Association. Special issues of informed consent are enclosure of information, compe© 2003 by Elsevier Science Inc. 360 Park Avenue South, New York, NY 10010-1710 Transplantation Proceedings, 35, 909 –910 (2003)
tence to consent, voluntariness, and verification of the informed consent. EXCLOSURE OF INFORMATION
The psychosomatic clinician assesses whether the donor has been extensively informed and recommends that the donor obtain further information from surgical or internal medicine side if too little information had been previously provided to the donor. It must be clear to the donor that segmental liver donation in adults is an innovative therapy and that personal safety for the probands may at present be found somewhere halfway between scientific research and established routine. We inform the potential donors that the results for living liver donation to children are not fully applicable to living liver donation to adults. COMPETENCE TO CONSENT
According to Appelbaum and Grisso5 competence to consent consists of four related skills: communicating a choice, understanding relevant information, appreciating the situation and its consequences, and the ability to manipulate information rationally. Taking these points into consideration, we have not encountered any donation candidates whose competence to consent has been restricted in any way. VOLUNTARINESS
Socially it is desirable and acceptable to help those family members whose health is endangered. Great pressure may therefore arise within the familial system, especially if the recipient is in poor health and the situation is urgent.6 Pressure can be high in LDLT cases since livesaving alternative therapies, as in the case of renal insufficiency and dialysis, do not exist. In our own practical work, we now differentiate between two important restrictions of volunFrom the Departments of Psychotherapy and Psychosomatics (Y.E., W.S.) and the Department of General Surgery and Transplantation (M.M., C.V.-G., C.E.B.), University Hospital Essen, Essen, Germany. Address reprint requests to Yesim Erim, MD, Klinik fu¨r Psychotherapie und Psychosomatik, Universita¨tsklinikum Essen, Virchowstr. 174, 45147 Essen, Germany. 0041-1345/03/$–see front matter doi:10.1016/S0041-1345(03)00159-3 909
910
ERIM, MALAGÓ, VALENTIN-GAMAZO ET AL Table 1. Donor Selection and Exclusion Analysis
Total donors evaluated Total rejected Total living donors Rejection in the initial screening Rejection in steps 1 ⫹ 2
Psychosomatic evaluation Further evaluation
n⫽385 n⫽305 n⫽ 80 n⫽ 50 n ⫽ 140 (blood group, hepatitis, medical risk, volumetry, graft history) n⫽ 21 n ⫽ 7 (steps 3 ⫹ 4)
tariness: first, expectations toward the potential donor from the family may be so extreme that it may present a great external pressure or coercion; the second restriction being that unconscious neurotic conflicts as an internal pressure may make a voluntary decision impossible. These patients remain ambivalent, though they have had several talks with the psychosomatic and the surgeon team.
Table 2. Donors Rejected for Psychosomatic Reasons (n ⴝ 21) Missing psychosocial stability (n ⫽ 4) 1. Ongoing cannabis addiction (ICD 10: F12.2) and severe social problems 2. Mixed drug abuse (ICD 10: F19.1) 3. Prolonged mourning reaction (ICD 10: F43.2) 4. Ongoing alcohol addiction (ICD 10: F10.1) Generalized anxiety disorder (ICD 10: F41.1) Prior depressive episode and suicide attempt Ambivalence concerning donation without being able to make a clear decision (n ⫽ 7) Refusal of donation after additional information about potential surgical complications for the donor or the expected outcome for the recipient (n ⫽ 5) Excluded because the “special personal closeness” after the German transplantation law could not be verified (n ⫽ 3) Family member not willing to donate; wants to have a medical excuse (n ⫽ 1) Suspected financial dependency of the donor from the recipients family (n ⫽ 1)
CONDITIONS OF THE EVALUATION PROCEDURE Consensus Conference
In our model, the final decision for accepting a candidate as a donor is made in a so-called consensus conference. All evaluating departments such as transplant surgery, hepatology, anesthesiology, and psychosomatics take part at this conference. Moratorium
The donors are given sufficient time after the first disclosure of information and after the psychosomatic evaluation. That way they can reconsider their decision to donate.
department. After exclusion of 305 donors within several steps of medical evaluation as listed in Table 1, only 80 donor candidates were finally accepted for transplant (Table 1). Of the potential donors, 171 were referred to the psychosomatic unit for further evaluation. Twenty one potential liver donors were rejected for psychosomatic reasons as listed in Table 2. Contemplation about the given information had a great impact on the decision of the potential donors: 12 candidates either refused to be a donor after additional information or could not overcome their ambivalence.
Translators
If the donor is not fluent in the German language, an independent, court-examined translator is provided. Family members are not allowed to be translators; thereby it is assured that the potential donor can express hesitations, health problems, or other family issues that he may not wish to discuss with other family members, in a confidential environment. Possibility of Therapeutic Support for the Donor
We deem it an ethical commitment of the transplant team that therapeutic support is possible if needed after the transplantation of the donors, for instance in cases when the recipient has died or when conflicts in the family are triggered by the donor evaluation process. PRELIMINARY RESULTS AND ANALYSIS OF DONOR EXCLUSION
Between August 1998 and November 2001, 385 potential living liver donors have been evaluated in the surgical
CONCLUSIONS
Psychosomatic assessment is important for those donors who are under great pressure; it should serve to clarify the donor’s own motivation as well as to provide support if the donor considers withdrawing from his original decision. Follow-up care and evaluation of the liver donor is necessary to elucidate the psychosocial outcome and the prognostic value of psychosomatic predictions.
REFERENCES 1. Goldman LS: Psychosomatics 34:234, 1993 2. Sterneck M, Fischer L, Nischwitz U, et al: Transplantation 60:667, 1995 3. Trotter JF, Talamantes M, Mc Clure M, et al: Liver Transpl 7:485, 2001 4. Beavers KL, Sandler RS, Fair JH, et al: Liver Transpl 7:943, 2001 5. Appelbaum PS, Grisso T: NEJM 319:1635, 1988 6. Fellner H, Marshall JR: Am J Psychiatry 126:79, 1970