"...because I am something special" or "I think I will be something like a guinea pig": information and assent of legal minors in clinical trials – assessment of understanding, appreciation and reasoning

<p>Abstract</p> <p>Background</p> <p>The aim of this study is to assess and evaluate the capacities for understanding, appreciation and reasoning of legal minors with psychiatric disorders and their parents and their competence to consent or assent to participation in clinical trials. The beliefs, fears, motivation and influencing factors for decision-making of legal minors and parents were also examined.</p> <p>Methods</p> <p>Using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), an instrument developed for adults whose capacities to consent are unclear, we provided information about clinical trials and assessed understanding, appreciation and reasoning. We adapted this tool for legal minors and examined 19 children and adolescents between the ages of 7 and 15 with attention deficit/hyperactivity disorder (ADHD) or ADHD combined with oppositional defiant disorder (DSM-IV 314.00/314.01/312.8) enrolled in clinical trials. Parents were also examined using the MacCAT-CR.</p> <p>Results</p> <p>Facts such as the procedures involved in trials or their duration were well understood by legal minors, but more abstract issues like the primary purpose of the trial were not understood by children and adolescents or by many parents. Legal minors also had difficulties understanding the nature of placebo and the probability of receiving placebo. Children's and adolescents' decisions were influenced by fears about their disorder worsening and by problems in their relationship with their parents. Parents wanted the best therapy for their children in order to minimize problems in school.</p> <p>Conclusion</p> <p>Legal minors and parents need to be informed more precisely about specific issues like placebo and the primary purpose of trials. In general, the reasoning of children and adolescents was influenced by their experience with their disorder and decision making was based on reasonable arguments. Their fears were based on everyday experiences such as school performance or family relationships.</p

Factors Associated With Parental Activation in Pediatric Hematopoietic Stem Cell Transplant

Patient activation, the extension of self-efficacy into self-management, is an essential component of effective chronic care. In pediatric populations, caregiver activation is also needed for proper disease management. This study investigates the relationships between parental activation and other characteristics of parent–child dyads (N = 198) presenting for pediatric hematopoietic stem cell transplant. Parental activation concerning their child’s health was assessed using the Parent Patient Activation Measure (Parent-PAM), a modified version of the well-validated Patient Activation Measure (PAM). Using hierarchical linear regression and following the Belsky process model for determining parenting behaviors, a multivariate model was created for parental activation on behalf of their child that showed that the parent’s age, rating of their own general health, self-activation, and duration of the child’s illness were significantly related to Parent-PAM score. Our findings characterize a potentially distinct form of activation in a parent–child cohort preparing for a demanding clinical course

Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences

Contains fulltext : 97879.pdf (publisher's version ) (Open Access)BACKGROUND: Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. METHODOLOGY: An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. RESULTS: Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic misconception between them and parents. CONCLUSION: Due to the integration of research and care, their different ethical perspectives become intertwined in the daily practice of pediatric oncology. Increasing awareness of what this means for the communication between parents and physicians is essential. Future research should focus on efforts that overcome the problems that the synchronicity of research and care evokes

How do parents experience being asked to enter a child in a randomised controlled trial?

<p>Abstract</p> <p>Background</p> <p>As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words.</p> <p>Discussion</p> <p>Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make.</p> <p>Summary</p> <p>Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties.</p

Instructions, feedback, and reinforcement in reducing activity levels in the classroom.

The biomotometer, an electronic device which simultaneously measures motor activity and provides auditory feedback, was used in combination with material reinforcers in an experiment to reduce children's activity level in a classroom setting. Subjects were nine boys and two girls, aged 9--13, from a day hospital program for emotionally disturbed children. After five baseline trials, each child had five contingent reinforcement trials in which he/she received feedback "beeps" from the biomotometer and was given toy or candy rewards after each trial in which activity fell at least 20% below mean baseline level. Then five noncontingent reinforcement trials were run in which children received rewards for wearing the apparatus without the feedback attachment. Results indicated that the intervention "package," including instructions, feedback, and contingent reinforcement, was successful in all five trials for 8 of 11 children. Activity levels increased during the final noncontingent phase

Modification of activity level through biofeedback and operant conditioning.

The biomotometer, an electronic device that simultaneously measures activity and provides auditory feedback to the subject, was used in combination with material reinforcers in two experiments attempting to modify activity level in children. In the first study the activity level of an 11-year-old highly active boy was decreased below mean baseline during conditioning in a classroom setting. His level of activity returned to baseline when feedback was withdrawn. In the second study, activity level of a 10-year-old hypoactive boy was increased over mean baseline level during conditioning in a free-play setting, and returned to slightly below baseline during five extinction trials. Results of these studies indicate that the biomotometer is a useful instrument for modification of activity level