ABSTRACT
A group composed of parents, nurses, and physicians involved in pediatric cancerology has reflected on medical errors within the Espace Éthique de l'Assistance publique-Hôpitaux de Paris. Based on narratives and qualitative analysis of histories and testimonies, this discussion aimed at exploring the causes, circumstances, and impacts of medical errors on the relations between these individuals. The study demonstrated that some circumstances actually promote medical errors, such as hard working conditions, mistrust, unreliable control procedures, not listening to parents, and caring for children in extreme situations of pain and suffering. Errors almost always result from the accumulation of several shortcomings. The tensions raised by a medical error can be overcome, provided that parents and caregivers trust each other from the onset of disease and that the medical errors are disclosed in a sincere way, whatever the medical consequences. The feelings raised by the painful experience of a medical error do not solely depend on the severity of the consequences, since seemingly benign errors may lead to long-term trauma, whereas severe errors, even those leading to death, do not necessarily breach trust. The keyword here is permanent vigilance. The capacity of caregivers to question their practice, from both a technical and ethical point of view, will determine their ability to learn from an error for the future. The depth and quality of this questioning, in the best of times encouraged by the institution, may also help children affected by a medical error and their family to move forward in their personal history, beyond such painful experiences.
Subject(s)
Delivery of Health Care/standards , Medical Errors , Nurses , Parents , Physicians/ethics , Truth Disclosure/ethics , Child , Delivery of Health Care/ethics , France , Humans , Medical Errors/ethics , Risk Factors , Trust , WorkloadABSTRACT
OBJECTIVE: To evaluate the extent to which parents are satisfied with and understand the information they are given when their consent is sought for their child to participate in a phase III randomised clinical trial and the reasons for their decision. PATIENTS AND METHOD: The authors carried out a prospective study. The authors included all parents whose consent was sought for their child to participate in the FRALLE 2000A protocol (acute lymphoblastic leukaemia) at two centres. The parents were questioned twice by a qualified psychologist using a semidirected interview, 1 and 6 months after consent was sought. RESULTS: 43 first interviews were carried out. All the parents declared they were satisfied with the explanations provided by the physician. 35 (81%) parents felt that the information provided with the request for consent was appropriate. Eight (19%) parents did not realise that their child had been included in a research protocol. 16 (39%) parents did not understand the concept of randomisation. Half the parents could explain neither the aim of the clinical trial nor the potential benefit of inclusion to their child. Only one third of the parents were aware that they had an alternative. The principal factor underlying their decision, as stated by 29 parents (67%), was confidence in the medical team. CONCLUSIONS: The parents signed consent forms without having fully understood all the elements specific to the experimental protocol. Rather, the parents based their decision on their confidence in the medical team, even when their child's life was at risk.
Subject(s)
Health Knowledge, Attitudes, Practice , Informed Consent/psychology , Parents/psychology , Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy , Randomized Controlled Trials as Topic , Child , Child, Preschool , Clinical Trials, Phase III as Topic , Comprehension , Consumer Behavior/statistics & numerical data , Decision Making , Female , Humans , Infant , Male , Patient Selection , Prospective StudiesABSTRACT
Although announcement of the risks related to treatment has become a general rule in the healthcare relationship, doctors, nurses and parents of severely ill children tend to feel uncomfortable in relation to this mandatory information. The work conducted by the AP-HP Espace éthique working party in collaboration with parents, healthcare personnel and a philosopher demonstrates the need to announce these risks, even beyond the legal framework, while bearing in mind the difficulties and hazards inherent to changes in legislation and by observing the philosophical values that subtend this legislation. Faced with the broad range of diverse and complex risks, the working party proposes a classification of risks and hierarchisation of the difficulties encountered by the doctor during this announcement, which is difficult to make, and difficult to hear, as intimately related to the child's quality of life. The very concept of the probability of a risk raises concepts that are difficult to accept: chance, randomness, and uncertainty. Informing the patient involves hearing as much as talking, listening as much as explaining and requires availability, time, space and an ability to listen to the patient. This article proposes several good practice guidelines designed to consolidate the therapeutic alliance by sharing the uncertainty of the risk and allowing the various partners to remain actors. Nonconfiscation of knowledge by doctors does not lead to a loss or transfer of their responsibility, but allows decisions to be taken in the context of the alliance, while taking the risks into account.
Subject(s)
Neoplasms/diagnosis , Child , Diagnosis, Differential , France , Humans , Legislation, Medical , Neoplasms/psychology , Physician-Patient Relations , Psychology, Child , Quality of Life , Reproducibility of Results , Risk FactorsABSTRACT
The objective of a phase I trials in paediatrics is to determine the recommended dose of a new treatment in children while evaluating its toxicity. These trials are proposed when no effective curative treatment is available. The probability of a benefit in terms of disease control is certainly very low, but greater than zero. On the basis of the work conducted by an Assistance publique-Hôpitaux de Paris Espace éthique group in collaboration with parents, healthcare personnels and a philosopher, phase I therapeutic trials can be considered to be an ethically acceptable proposal provided the criteria and risks of inclusion in such a trial are clearly defined. This article discusses the main elements of this process and is designed to provide guidelines for healthcare personnel and parents. The need for an information provided gently but honestly, the importance of a sufficient time to think about the proposed trial, a two-sided dialogue and partnership between the various actors, and the priority given to the child's best interest, as should always be the case, constitute the decisive elements to guide the proposed inclusion in a phase I trial. These conditions help to ensure that a decision is reached which appears to be morally founded for all parties, while allowing the child to remain alive up until the end, i.e. a human being capable of relating. This decision allows parents and healthcare personnel to retain a good self-image; if the child dies, it is by keeping their self-esteem that parents can live with their bereavement and healthcare personnel can reinvest in other patients.
