Kidneys from marginal donors: views of patients on informed consent

Marie Omnell Persson1,, Nils H. Persson1, Ragnar Källén1, Henrik Ekberg1 and Göran Hermerén2

1 Department of Nephrology and Transplantation, Malmö University Hospital, Lund University, SE-205 02 Malmö and 2 Department of Medical Ethics, St Gra°brödersgatan 16, Lund University, SE-222 22 Lund, Sweden



   Abstract
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusions
 References
 
Background. Considering the fact that donor age is a major risk factor for graft survival, and taking into account the importance attached to the principle of autonomy in the Swedish Health Care Law, we decided that allocation of kidneys from marginal donors should be restricted to patients who have given their informed consent. Written information was given to the patients on the waiting list for kidney transplantation in the southern part of Sweden. Patients were asked to state whether they would accept either a single kidney or dual transplantation kidneys from marginal donors. The aim of this study was to investigate the views of patients on the information they received about kidneys from marginal donors and their reaction to being asked to make a decision on this issue.

Methods. A questionnaire was posted to 61 patients who had already replied to the question of whether or not they would accept kidneys from a marginal donor for themselves. The median age of the patients was 52 years (range 22–74 years). Answers were given anonymously.

Results. Among the 53 respondents, 48 considered the information to be comprehensible. The extent of the information was considered sufficient by 43 patients. No patient thought that the information was too extensive. According to 41 patients, it is totally right to be asked to make a decision on this type of issue. Two patients thought it was totally wrong. Finally, 33 patients thought it was easy to make a decision on this issue.

Conclusions. This study indicates that patients on the waiting list for kidney transplantation accept information on donor-related risk factors and most patients want to be involved in the decision concerning transplantation with a kidney from a marginal donor.

Keywords: decision-making; informed consent; kidney transplantation; marginal donor



   Introduction
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusions
 References
 
Due to the shortage of organs available for transplantation, efforts to increase the donor pool are being made in different ways, for example by accepting so-called ‘marginal donors’. The concept of marginal donors includes older organ donors, donors with complicating diseases, non-heartbeating donors and sometimes infants. There is no standard definition. At the transplant unit in Malmö the definition of a marginal donor is one who is >=70 years of age, one who is <60 years of age with several risk factors, or a donor who is 60–69 years of age with at least one of the following risk factors: severe hypertension, diabetes mellitus or significant cardiovascular disease. We perform dual transplantation with both kidneys to one patient if the donor is over the age of 80 years. Dual transplantation is also performed using donors with a significant reduction in kidney function that is not regarded as temporary in connection with the emergency situation.

The transplant unit in Malmö has many years of experience with elderly donors. As early as 10 years ago, we abandoned our upper age limit of 70 years for a kidney donor. During the last decade, the median age for cadaver kidney donors has been well above 50 years, and in 1998 it was as high as 62 years. Early graft survival with kidneys from donors over the age of 70 years can be regarded as acceptable, but there is an increased risk of losing transplant function within 5 years (Figure 1Go). Donor age is also a major risk factor for graft survival in large series [1].



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Fig. 1.  Graft survival by donor age, cadaver donor renal transplantation 1988–2001.

 
The Swedish Health Care Law
The Swedish Health Care Law expresses that, amongst other considerations, care should be built on respect for the autonomy and integrity of the patient, and furthermore that as far as possible, care and treatment should be devised and carried out in consultation with the patient. The patient should also be given individually adjusted information about his/her state of health and about the methods of investigation, care and treatment available [2].

The principle of autonomy is based on the idea of having respect for the individual and has been expressed as follows: ‘Anyone who is affected directly or indirectly by a decision or its consequences ought to have a possibility of influencing that decision; and if a particular person is the only one who is affected by that decision, that person alone should be entitled to make the decision’ [3].

Considering patient autonomy and the results of previous transplants using marginal donors, we decided that patients should receive information and have the possibility of taking part in the decision-making process of whether or not to be transplanted with a kidney from a marginal donor. The allocation of kidneys from marginal donors should be restricted to patients who have given their informed consent.

Patient information on ‘marginal donors’
Written information was compiled by the transplant surgeons, commented on by the transplant coordinators at the transplant unit in Malmö, and presented at a regional meeting with the nephrologists in Southern Sweden in the autumn of 1998. The idea of and procedure for information were discussed and firmly established. The written information was sent to the local nephrologists in Southern Sweden and then handed over, step by step, to their patients on the waiting list for renal transplantation.

The two and a half page folder presented information on the shortage of organs for transplantation, describing reasons such as improved traffic security with less accidents as well as better results in neurosurgery and intensive care. These conditions lead to a decrease in the number of patients, especially young patients, who die under circumstances that make organ donation possible. With the increasing number of patients wanting to be transplanted, this shortage of organs has resulted in a longer waiting time (average 2 years), with a risk of it increasing yet further. Facts were also given about the improvements in transplant surgery allowing extended donor criteria, e.g. a previous upper age limit of 70 years has been abolished and a few donors over 80 years of age have been accepted. Information was given on statistics from larger populations of transplanted patients, showing that high donor age or donor diseases such as diabetes or high blood pressure have a negative impact on results post-transplantation.

Furthermore, among the patients transplanted in Malmö, the proportion of patients with a functioning graft at 1 year is the same regardless of whether a kidney was received from a younger or an older donor. On the other hand, among patients who received a kidney from an older donor there is a tendency towards worse transplant function (a higher level of serum creatinine) and more patients have returned to dialysis after 3–4 years.

Patients were told that acceptance of a kidney from a marginal donor would mean an increased possibility of being offered a transplant and thereby a shorter waiting time. The term ‘fully acceptable donor’ was also used and related to the risk of having to wait longer. Accepting a kidney from only such a donor might, for an older patient, create a risk of not being offered a transplant before the general condition of the patient deteriorated, and other diseases would also lead to a situation where the patient could not remain on the waiting list. It was clearly stated that patients accepting kidneys from marginal donors remained on the ordinary waiting list, with the same chances as any other patient of being offered a kidney from a fully acceptable donor. They were also included on a separate waiting list, to be used only when kidneys from marginal donors were available. It was emphasized that the transplant surgeon would only accept a marginal donor if he/she believed there was a good chance of a successful transplantation. Dual transplantation was mentioned as a possibility for achieving adequate kidney function.

The patients were encouraged to discuss the matter with their nephrologists and were invited to contact transplant surgeons or transplant coordinators at the transplant unit in Malmö. Finally, the patients were asked to state whether they would accept kidneys from marginal donors, either as a single or a dual transplantation, by indicating this on the form provided at the end of the information folder (Figure 2Go). Another way of providing an answer to the question was to tell the nephrologist, who would inform the transplant surgeon of the patient's choice.



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Fig. 2.  Last page of patient information folder, where patients are asked to indicate whether they would accept kidneys from marginal donors, either as a single kidney or as a dual transplantation.

 

Criticism of the information and consent procedure
The information and consent procedure on marginal donors was criticized by the Swedish National Board of Health and Welfare. The authority expressed the view that it would be too difficult for the patients to handle the information and to be involved in the decision-making process. They decided to arrange a hearing in May 1999 on patient information and informed consent with respect to marginal donors for kidney transplantation. A fear was expressed by the patient organization that young people who desperately wanted a kidney transplantation would sign up for a kidney from a marginal donor. These discussions prompted a debate in the media concerning marginal donors and the information and consent procedure.

It was not our impression that our concept of marginal donors and the information outlined above was too difficult for the patients to understand. Neither was it our belief that it was too difficult for the patients to make an autonomous choice on the basis of this information. We therefore decided to study the views of the patients on the information on marginal donors. An additional letter was also sent to the nephrologists in our region, explaining that younger patients with longer life expectancy should not be considered as recipients for kidneys from marginal donors.

The aim of this study was to investigate the views of patients on the waiting list for kidney transplantation on the information they received about kidneys from marginal donors, and the patients’ reaction to being asked to make a decision on this issue.



   Subjects and methods
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusions
 References
 
Questionnaires were distributed to the patients who had replied to the question of whether or not they would accept a marginal donor for themselves. A questionnaire was given out as soon as the answer from each patient had been received by the transplant unit in February, March and April 1999. The timing was chosen to make sure that the results of the study had been analysed before the hearing on patient information and consent on marginal donors had taken place. This resulted in questionnaires being posted to 61 patients out of 98 who were on the waiting list for renal transplantation in Southern Sweden at that time. Some of the remaining 37 patients might have received information on marginal donors but not sent in their answers within the study period. However, an important reason for not being able to send the questionnaires to all patients was that there was a delay in the distribution of the information folder by some local nephrologists. The median age of the possible respondents was 52 years (range 22–74 years) and 21 patients were >=60 years of age. The median age of the patients on the total waiting list at that time was 53 years (range 19–74 years) and 32 patients were >=60 years of age.

The questionnaire consisted of six questions, four of which concerned the possibility of understanding the information on marginal donors, the extent of the information and the patient's opinion on and experience of being involved in the decision-making process. The questionnaire was drawn up and discussed among the transplant surgeons and the transplant coordinators at the transplant unit in Malmö, and was judged by those involved to measure the views of the patients on this matter. The answers were given anonymously.

The overall response rate was 53 out of 61 (87%), and among patients over 60 years of age it was 100%.

The regional ethics committee considered this project to be a quality assurance study and therefore did not consider that approval from their committee was required. Hence, the study was not evaluated by them from a research ethics point of view.



   Results
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusions
 References
 
Among the 53 respondents, 48 considered the information to be comprehensible (Table 1Go). The extent of the information was considered to be sufficient by 43 patients, and eight wanted yet more information. No patient regarded the information as incomprehensible (Table 1Go) or too extensive (Table 2Go). According to 41 patients, it is totally right to be asked to make a decision on this type of issue; but six found it doubtful and two found it totally wrong (Table 3Go). Thirty-three patients thought it was easy to make a decision on this issue and eight thought it was difficult (Table 4Go). Attitudes were similar in patients above or below 60 years of age. Among the patients, 43 discussed their decision with their nephrologist and 10 did not.


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Table 1.  Question number 2: ‘In this question we want to know how you experienced the information’

 

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Table 2.  Question number 3: ‘How did you experience the quantity of information?’

 

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Table 3.  Question number 5: ‘Do you think it is right or wrong that you as a patient are asked to make a decision on this type of issue?’

 

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Table 4.  Question number 6: ‘How did you experience making a decision on this issue?’

 



   Discussion
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusions
 References
 
The study was small but the result is unambiguous. Most patients thought that it was easy or very easy to make the decision, that it was correct to be asked, and that the information given was comprehensible and sufficient. Non-respondents numbered eight (13%) and belonged to the group <60 years of age. Since the questionnaire was answered anonymously, these non-respondents were not identified. We preferred anonymity to confidentiality since some patients might be afraid of revealing their identity and thereby refrain from answering the questionnaire or give answers to please the profession. One assumption was that those who did have an opinion in this matter, negative or positive, would answer the questionnaire. If this is the case, the proportion of the alternative ‘don't know's would have been higher if all patients had responded to the questionnaire. According to feedback from the nephrologists, there were no complaints about the information.

The three inclusion criteria for the patients in this study were that: (i) they should be on the waiting list for kidney transplantation, (ii) they should have had information on marginal donors, and (iii) they should have sent in their answers whether they accepted a kidney from a marginal donor for themselves or not. The time-frame for distribution of the questionnaire was limited by the time of the hearing in May. By that time, not all the patients on the waiting list had received information on marginal donors since the information was not distributed by all nephrologists at the same time. There was a particular delay by a few nephrologists and therefore their patients could not be included in the study. We have no reason to believe that the patients of those nephrologists differed from the other patients. The median age and range were similar among the patients included in the study and the total number of the patients on the waiting list.

There was a discrepancy between the result of this study and the opinion of the Swedish National Board of Health and Welfare. The criticism of the information and consent procedure from the National Board of Health and Welfare focused on the consideration that it would be too difficult for the patients to be involved in the decision-making process. The majority of patients, however, were satisfied with the information given and about being involved in the decision-making procedure. We do not know how many of these patients have also given consent to receiving a kidney from a marginal donor. For patients of >60 years of age, the choice of accepting a kidney from a marginal donor is a reality. Patients of <60 years of age are not the principal target group. During this initial phase, however, they also gave an answer as to whether they would accept a kidney from a marginal donor for themselves. One possibility could be that this latter group of patients accepts information more readily than the older patients because the younger patients know that they are not in fact the target group. However, with respect to making a decision on this matter, the only question with a wider range of responses, the distribution of answers from patients below and over 60 years of age was similar.

Although most of the patients in this study were content with the information and the decision making, there were a few who thought it was doubtful or even wrong to be asked to make this kind of decision. It is surprising that only eight patients thought it was difficult to make the decision. Our patients were not left to make the decision alone, however. This is based on discussions between the patient and the nephrologist and/or the transplant surgeon, and sometimes also the transplant coordinator, with the individual patient's situation in mind. The aim is not to relieve the physician of his or her responsibility. The positive result obtained can therefore be interpreted as the patients having received sufficient support from the professionals.

A comparison can be made between the decision-making process of the recipient with that of the living donor. The potential living donor is expected to decide whether he or she would be willing to donate one kidney to a close relative with end-stage renal disease. The decision is based on information from the nephrologist, the transplant surgeon and transplant coordinator, and sometimes other people become involved. This decision is not regarded as too difficult to make, although in this case it is being made for the sake of helping someone else by a healthy person who does not need to undergo any examination or surgery.

Patient and graft survival after renal transplantation have improved since the procedure was established in the 1960s. During the 1970s, with only limited results available, some patients still hesitated in accepting renal transplantation and preferred to continue on dialysis. As the results improved during the 1980s many of them changed their minds and were transplanted successfully. As above, patients were able to make difficult decisions on the basis of information on previous results.

It is worth noting that giving informed consent to receive a kidney from a marginal donor does not necessarily mean that transplantation with such a kidney will take place [4]. The patient remains on the waiting list for a fully acceptable kidney as well, and patients still have the option of declining a kidney from a marginal donor. Thus, they are not in a less favourable situation than patients who do not want a kidney from a marginal donor.

The transplant unit in Malmö is the only transplant unit within Scandiatransplant where this formal information and consent procedure regarding marginal donors is practised.

Matas et al. analysed 937 first and second cadaver transplants with the aim of determining whether the information available at the time of an offer could be used to predict long-term graft survival. The background for their study was the questions voiced by potential recipients as to whether they should accept a particular kidney or not. They summarized their findings as follows: ‘This information should help potential recipients and their physicians determine whether or not to accept a particular kidney’ [5]. The authors seemed to think that such a discussion is well accepted, although they are referring to the acute situation which is different to that in our study. Even Sells [6] seems to be considering the acute situation when he writes: ‘Donor risk factors may be known that call for excruciatingly difficult, quick decisions by the patient’. Panico et al., on the other hand, argue that ‘written informed consent for criteria used by the specific transplant centre in accepting kidney donors should be obtained prior to listing with the specific program’ [7].

Within the European organ exchange organization Eurotransplant, there is a concept termed the ‘Eurotransplant senior program’ [8]. Since January 1999, kidneys from donors aged 65 years and above have been allocated to a select group of patients in the same age group [9].

During the spring of 2001, a consensus meeting took place in the United States to discuss ways of improving the utilization of cadaveric donors for transplantation. The participants were the American Society of Transplantation and the American Society of Transplant Surgeons, and, among others, representatives from the National Kidney Foundation and the United Network for Organ Sharing. There was a proposal to ‘allocate older donor kidneys >=60 years of age to a pre-informed group of patients based upon waiting time only’. The discussion concerned, amongst other issues an alternative list ‘which included patients who had agreed beforehand of their willingness to accept an older donor kidney’; but the patients would remain on the larger main list ‘for receipt of an ideal donor if one becomes available’. They also stated that ‘Potential recipients might include older aged patients willing to assume more risk for potentially shorter waiting times, or a patient whose vascular and peritoneal access for dialysis is exhausted’ [10]. The reasoning at this meeting is in line with our thoughts and policy.



   Conclusions
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusions
 References
 
Most patients answering the questionnaire found the information to be fully comprehensible and sufficient. Most patients also thought it was totally right and easy to make a decision on this issue. Thus, we conclude that this study indicates that patients on the waiting list for kidney transplantation accept information on donor-related risk factors and most patients want to be involved in the decision concerning transplantation with a kidney from a marginal donor.

Clinical application
We now use this information procedure routinely for all patients, but it is mainly patients with a shorter life expectancy, i.e. those who are >=60 years of age, who are asked to consider transplantation with a kidney from a marginal donor. We find this procedure to be of great help when we allocate kidneys from marginal donors. However, patient opinion on this matter is not the only argument for continuing to inform patients and asking them to make a decision on marginal donors; another reason is the importance attached to the principle of autonomy within the Swedish Health Care Law.



   Acknowledgments
 
This paper was supported by Landstings-finansierad Regional Forskning.



   Notes
 
Correspondence and offprint requests to: Marie Omnell Persson, Department of Nephrology and Transplantation, Malmö University Hospital, Lund University, SE-205 02 Malmö, Sweden. Email: marie.omnell\|[hyphen]\|persson{at}kir.mas.lu.se Back



   References
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusions
 References
 

  1. Cecka JM. The UNOS Scientific Renal Transplant Registry. In: Cecka JM, Terasaki PI, eds. Clinical Transplants 1998. UCLA Tissue typing Laboratory, Los Angeles, 1999; 1–16
  2. Hälso-och sjukva°rdslag. In: Sahlin J, ed. Hälso-och sjukva°rdslagen med kommentarer. Norstedts Juridik AB, Stockholm, 2000; 281–282
  3. Hermerén G. Materialinsamling. In: Hermerén G, ed. Kunskapens pris, forskningsetiska problem och principer i humaniora och samhällsvetenskap. Swedish Science Press, Stockholm, 1996; 129–166
  4. Persson NH, Omnell Persson M, Ekberg H, Källén R, Waldner A. Renal transplantation from marginal donors—results and allocation strategies. Transplant Proc2001; 33: 3759–3761[ISI][Medline]
  5. Matas AJ, Gillingham K, Payne WD et al. Should I accept this kidney? Clin Transplant2000; 14: 90–95[ISI][Medline]
  6. Sells RA. Informed consent from recipients of marginal donor organs. Transplant Proc1999; 31: 1324–1325[ISI][Medline]
  7. Panico M, Solomon M, Burrows L. Issues of informed consent and access to extended donor pool kidneys. Transplant Proc1997; 29: 3667–3668[ISI][Medline]
  8. Cohen B, Smits J. Future trends in organ allocation. In: Cohen B, ed. Balancing Supply and Demand in Organ Transplantation. Groen BV, Leiden, University of Maastricht, 2001; 101–107
  9. Smits JMA, Persijn GG, van Houwelingen HC et al. Evaluation of the senior program (ESP). The result of the first year. Abstract in the Third International Transplant Coordinator Society (ITCS) Congress in Nagoya, Japan, July2001
  10. Alfrey E. Presented at the American Society of Transplantation (AST) ‘Transplant 2000’, Chicago, 11–16 May2001
Received for publication: 6.11.01
Accepted in revised form: 5. 4.02