Decisions concerning potentially life-sustaining treatments in paediatric nephrology: a multicentre study in French-speaking countries

Isabelle Fauriel1, Grégoire Moutel1, Marie-Laure Moutard2, Luc Montuclard1, Nathalie Duchange1, Ingrid Callies1, Irène François1, Pierre Cochat3 and Christian Hervé1

1Laboratoire d’Ethique médicale, de Droit de la santé et de Santé publique, Faculté de médecine Necker, Paris, 2Hôpital Saint Vincent de Paul, Paris and 3Hôpital Edouard Herriot, Lyon, France

Correspondence and offprint requests to: Professor Christian Hervé, MD, PhD, Laboratoire d’Ethique Médicale, de Droit de la santé et de Santé publique, 156 rue de Vaugirard, 75015 Paris, France. Email: herve{at}necker.fr



   Abstract
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusion
 References
 
Background. Few studies have looked at how decisions are made to withhold or to withdraw potentially life-sustaining treatments (LST) in paediatric nephrology. The aim of this work was to evaluate such practices in all nephrology centres in French-speaking European countries, so that guidelines could be discussed and drawn up by professionals.

Methods. We used semi-directed interviews to question health care professionals prospectively. We also retrospectively analysed the medical files of all children (n = 50) for whom a decision to withhold or to withdraw LST had been made in the last 5 years. The doctors (n = 31) who had been involved in the decision-making process were interviewed.

Results. All 31 of the French-speaking paediatric nephrology centres in Europe were included in this study. Of these, 18 had made decisions in the previous 5 years about withholding or withdrawing LST. Resultant quality of life, based on long-term living conditions, was the principal criterion used to make the decisions. Relational aspects of life and the child's prognosis were also considered. The decision-making processes were not always collective, even though interactions between doctors and the rest of the medical team seemed to be key elements to them. The parents’ involvement in the decision-making process differed between centres.

Conclusions. The criteria used to decide whether to withhold or to withdraw LST are not standardized, and no specific guidelines exist.

Keywords: dialysis; ethics; life-sustaining treatments; nephrology; paediatric; treatment withholding or withdrawal



   Introduction
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusion
 References
 
Decisions to withdraw or to withhold treatment have to be made for 82–87% of patients in neonatology units [1,2] and for 30–58% of patients in paediatric intensive care units [3]. The decision to stop dialysis is the most common cause of death for adult nephrology patients in the United States and Canada after cardiovascular diseases, affecting ~17% of patients with end-stage kidney failure [4,5]. However, no studies concerning the frequency of such decisions in paediatric nephrology have been published. The aims of this study were to identify the decisions made in different clinical situations and to review the decision-making processes used by health care professionals in various situations with the intent to improve them. Improved decision-making guidelines are sought by the French speakers’ Paediatric Nephrology Society (SFNP), which supported this study.



   Subjects and methods
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusion
 References
 
This study was designed jointly by experts from the SFNP and from the Medical Ethics Laboratory at the Faculty of Medicine of the Necker Hospital des Enfants-Malades.

Organization of the study
University hospitals are the only centres in France to have paediatric nephrology departments. We contacted the heads of all these departments. We also contacted all those francophone university hospitals in Europe whose medical practices and organization of the hospital environment is similar to France.

All 31 French-speaking paediatric nephrology centres were included—25 in France, two in Switzerland, three in Belgium and one in Luxembourg.

One investigating doctor carried out the two-step study during 2001 as follows:

(1) Study of the medical files of children suffering from kidney diseases for whom a decision to withhold or to withdraw life-sustaining treatment (LST) had been made between January 1995 and December 2001, inclusive.

In the initial analysis, a tabulation grid was used to collect data concerning 11 items possibly associated with the decision-making process [3,68]: prediction by the doctor of a poor post-intervention quality of life, presence of a severe neurological handicap, association with a severe extra-renal disease, impact of the child's disease on the family, opinion of the family, renal insufficiency since birth, social context, suffering of a child resistant to major analgesics, likelihood of survival, treatment failure and cost.

We also collected data concerning the practical aspects of the withdrawal or withholding of treatment: the administration of sedatives or analgesics to suppress pain (even if there was a risk of respiratory depression and death), the written record of the medical end-of-life decision in the medical file (observation or hospitalization summary), the existence of a written order not to resuscitate the patient, cases in which, despite the doctors’ decision to withdraw or withhold it, the treatment was continued, the interval between the decision and the patient's death, when the decision was taken, and any review by an ethics committee before the decision.

Finally, we collected data concerning the characteristics of the child in question: the age at the time the end-of-life decision was made, the nature of the disease and whether or not the child had undergone renal transplantation.

(2) Semi-directed, face-to-face interviews were carried out with the doctors involved in LST decisions. These interviews were recorded with the doctor's consent and in accordance with the conditions of the medical secrecy act. The questions asked are listed in Table 1. We collected the following data concerning the doctors: age, sex and number of years in practice of paediatric nephrology. The data collected from the medical files and from interviews were maintained anonymously.


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Table 1. Questions asked during the semi-directed interviews

 
Analysis of the results
The information in the medical files was tabulated using a standardized grid. We classified children into two groups on the basis of age—under 1 year (Group 1) and over 1 year (Group 2)—as both the renal diseases encountered and the medical care required are different between these two groups [9,10].

The interviews were analysed in a double-blind manner, by two evaluators, using a tabulation grid. The two evaluators met to discuss their results with the aim of reaching a consensus in cases of disagreement. The data from the interviews and from the medical files were analysed using Excel and Statistica software. The results are expressed as absolute values and as percentages. The chi-square test (P<0.05) was used for comparisons.



   Results
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusion
 References
 
Of the 31 centres, 18 had files concerning the withdrawal or withholding of LST during the 5 years of study. These 18 centres saw a total of 440 children with end-stage renal disease, and a decision was made to stop treatment in 50 of these cases (11.5%). Of the 34 paediatric nephrologists involved in making these decisions, 31 were interviewed—three refused to participate. One centre refused to take such decisions in principle and 12 centres did not have to treat such situations in the last 5 years.

The children
Of the children, 27 (54%) were < 1 year old when the decision to stop treatment was made (Group 1). That decision was made when the child was < 2 months old in 80% of these cases—when the child was < 1 month old in 62%. The mean age at the time of decision was 45 days (range: 0 days to 8 months). Of the children, 23 (46%) were over 1 year old when the decision was made (Group 2), with a mean age of 9.7 years (range: 1.3–18 years).

Group 1 included children with chronic and acute diseases, whereas all the children in Group 2 had chronic diseases (Table 2). Two children in Group 2 had undergone kidney transplants.


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Table 2. Aetiologies of renal diseases in the 50 children affected by decisions to withdraw or to withhold LST

 
Characteristics of the doctors
Of the 31 doctors interviewed, 17 (55%) were men. The mean age of the doctors was 48.5 years (range: 33–61 years). The mean number of years of practice as a paediatric nephrologist was 18.2 years (range: 3–34 years).

End-of-life decision
In the medical files. The reasons for the decisions to withhold or to withdraw LST are given in Table 3 (several reasons could be indicated in a single file). The frequency of the reasons concerning subsequent quality of life and damage to the central nervous system differed significantly between Groups 1 and 2 (chi-square test, P<0.05). No significant differences were observed between the groups for the other criteria. In Group 1, in most cases the decision to stop treatment was made during the hospitalization following birth (88%), with the child never being taken home. In contrast, in 53% of cases in Group 2 the decision was made during a nephrological monitoring visit. The difference is statistically significant (P = 0.01).


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Table 3. Analysis of the decision-making criteria recorded in the 50 patients’ files: several reasons are possible for each child

 
The types of treatment withdrawn or withheld are shown in Table 4. Sedatives, including morphine and related products, were prescribed when treatment was withdrawn or withheld in 15 cases in Group 1 and seven cases in Group 2 (P = 0.05).


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Table 4. Types of treatment withdrawn or withheld

 
The end-of-life decision was noted in the patient's file in 27 cases. The reasons for the decision were given for 25 patients. An order not to resuscitate the patient was explicitly written in the medical files of 18 patients.

The mean time between making the decision and the patient's death was 6.3 days in Group 1 and 206.88 days (6.8 months) in Group 2 (P = 0.04).

Interviews
The question, ‘What are the most important criteria when making decisions?’, was used to identify the reasons for making the end-of-life decision. The replies given by the doctors were analysed using a grid (Table 5).


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Table 5. Analysis of the decision-making criteria cited by the 31 doctors interviewed

 
Decision-making process
The opinions of the medical and paramedical teams. In most cases, the doctor alone or the doctor and the paramedical team initiated the discussion (Table 6).


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Table 6. Who initiated the discussions (n = 31 centres)?

 
In 10 centres, decisions were made during formal meetings involving the doctors and the paramedical team, at which everyone was allowed to speak. In five centres, the doctors decided collectively after individual, informal discussions with members of the paramedical team. In two centres, decisions were made during meetings that included members of the team selected on the basis of their length of time in practice and their likelihood to favour non-treatment. In one centre, the head of the department made the decision after consulting his co-workers and the paramedical team. In no case did the referring doctor decide alone and in no case was the medical decision imposed on the team without prior discussion.

The opinions of the parents. The doctors stated that they had provided parents with information concerning the prognosis and the future of their child (n = 17) and the failure of treatment (n = 11). Two doctors were unable to answer this question, as the head of their department was the only health professional to contact the parents. One doctor said that the parents were not informed of the decision to withhold treatment.

For 21 doctors, informing the parents consisted largely of gradually helping the parents to accept the medical decision. In other instances, the opinion of the parents was taken into account in two ways. In five cases, all of the medical information available was given to the parents as objectively as possible, to enable the parents to decide for themselves. In five other cases, the information was given to the parents with the aim of determining their preferences, and the doctors then made the final decision, taking into account the parents’ opinion.

In two cases, the doctors chose to stop dialysis, but this was not done because the parents disagreed.

The opinion of the child. During the interviews, the participation of the child in the decision-making process was explored with the question, ‘If the child has a sufficiently high intellectual capacity and is old enough, to what extent do you allow him/her to participate in your discussions?’ The patients of 26 doctors were considered not to have the intellectual capacity required (presence of severe damage of the central nervous system) or were not old enough (neonates); four doctors said that they took into account the child's desire to live.

Ethics committees. An ethics committee was consulted at 22.2% of the centres, thus opening the debate to non-doctors. Seven of the medical files (14%) had been submitted to ethics committees. All the medical files submitted concerned questions relating to the initiation or non-initiation of dialysis. This procedure was followed systematically at the two centres in Switzerland. The other instances involving ethics committees were at two centres in France because there was disagreement between the medical team's decision and the wishes of the family. In six cases, the ethics committees supported the medical decisions not to dialyse. In one case, the ethics committee felt unable to be the final judge, but helped the medical team to reflect further.



   Discussion
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusion
 References
 
This study shows that paediatric nephrology centres confronted with the decision to withdraw or to withhold LST feel the need for collective decision-making. This situation arises frequently: for one-tenth of the children with end-stage renal disease treated in 18 centres in the last 5 years. We observed differences in the ways such decisions are made, and our results confirm those of Devictor et al. [3]: the parents are not routinely involved in the decision, discussions do not follow standardized procedures and may not even take place, and no clear-cut medical criteria are available for making these decisions.

This highlights the need to consider guidelines. We clarified several steps of the procedures based on the answers given by professionals, the analysis of files and the analysis of existing guidelines [1113]. In order to identify useful criteria, our study was based mainly on the 34 cases (68%) in which the decision made seemed satisfactory. Guidelines might structure the decision-making process, but it is important that they not be too rigid, so that each patient can be considered individually.

Need to prepare decisions: role of meetings involving all of the medical and paramedical staff
Ethics theory suggests that the absence of any guidelines whatsoever has a negative effect on the organization of the discussion that occurs before a final medical decision is made [14]. Furthermore, the need for group thinking has already been shown in case reports [14,15]. Individual reflection on this subject needs to be replaced by a policy of collective discussion, so that a consensus can be reached within the department based on standardized decision-making procedures and criteria [16].

Recommendations for organizing the discussion and structuring the decision-making process
Except in rare cases, the decision to stop or to withhold LST should be made in several stages rather than all at once.

Assessment of the prognosis. This concerns mainly the medical team. Our study shows that both negative (those favouring the withdrawal of treatment) and positive (those favouring the continuation of care) criteria should be taken into account. Negative criteria: neonatal renal insufficiency, incurable extrarenal disease. Positive criterion: isolated renal insufficiency other than during the neonatal period.

Assessment of the quality of life. These criteria are often considered to be the most important. However, they are extremely complex and health care professionals generally lack reliable tools for predicting quality of life [1721]. Based on our results, we can suggest some criteria. Negative criteria include: severe neurological handicap affecting interpersonal relationships, impossibility of providing social help or finding a suitable care centre (after extensive research by a social worker with expertise in the field). Positive criterion: a child well integrated in the family or a suitable social structure.

Note that pain and the technical difficulties associated with caring for patients with end-stage kidney disease are not criteria—given the progress that has been made in dialysis [22,23]. It is also important to note that the quality of life can only be estimated by a team after collecting data concerning the child in his or her hospital (from nurses, psychologists, auxiliaries, doctors) and external (from GPs, paediatricians, teachers, parents) environments, and the social level of the family (from social workers).

Sharing information with members of the paramedical team and their role in the decision-making process. The complexity of the criteria bearing on the decision is such that information concerning medical care must be exchanged between doctors and paramedical personnel, similarly, information concerning the roles played by family members in caring and the daily life of the patient. Consensuses should be drawn up by professionals during group meetings and recorded in the medical file. Finally, a report that can be consulted by members of the team should be written (according to the terms of the shared medical secrecy act [24]).

Information given to the child and parents, and their roles in the decision-making process. In our study, nearly all of the children concerned were unable to take part in the discussions of care issues, either because they were handicapped or because they were newborns. In some cases the parents were involved and in others they were not.

The need to inform the parents both of the diagnoses and the therapeutic possibilities is highlighted both in national [2426] and international [27,28] publications. The doctor must obtain consent from minors, if possible, but the ultimate decision falls on those with parental rights [26].

During repeated interviews with the medical team, information should be given to the parents, with or without the child's presence, concerning the consequences of the various choices available: no renal replacement therapy vs treatment options without that therapy, outcomes of stopping or continuing dialysis, outcomes of not transplanting the patient [20]. Clear and informative language should be used during these discussions. A trusted individual, as described in the (French) Law of the 4th March 2002 on patients’ rights, may help the family [24]. This may be a member of the family, a friend or a doctor from another medical team who advises the family. Whatever the decision reached, the family should be offered counselling, both to help them cope and also to help them assess the consequences of the decision on the family. No reports have described the effects of such a decision, be it to allow the child to die or to continue to receive long-term treatment.

What to do in cases of disagreement. If members of the medical team disagree with the parents or each other, a specially convened committee may be requested to render an opinion. This opinion, which would be only advisory, may shed new light, but the final decision is up to the doctor managing the patient. This doctor should try to obtain approval from the parents after obtaining such a committee's opinion. Such committees should consist of representatives of all caregivers, of various schools of thought and of patients’ associations, as well as social workers and experts in the fields of paediatric nephrology and ethics. These committees would be able to analyse the difficult cases and provide a foundation for the health care teams to base their considerations.



   Conclusion
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusion
 References
 
This study highlights the sensitivity of the topic of withholding or withdrawing LST in paediatric nephrology centres. Our analysis of the practices at these centres leads us to suggest guidelines for the decision-making process. These guidelines should be further discussed by health care professionals and their respective societies so that they can be adapted to the real situations encountered.



   Acknowledgments
 
This study was supported by grants from the Association Des Juniors en Pédiatrie, Société Gallia and the Institut International de Recherche en Bioéthique (IIREB).

Conflict of interest statement. None declared.



   References
 Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 Conclusion
 References
 

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Received for publication: 28. 3.03
Accepted in revised form: 26.11.03