Medical Research Involving Children - Giving Weight to Children's Views

The quality of health care for children depends much on the availability of relevant results from medical research with children as subjects. Yet, because of their vulnerability and assumed incompetence to take part in decision-making, children have often been excluded from taking part in medical research, so as to prevent them from harm. Empirical data on children's competence to consent to such research used to be rare, but recent developments in this field have created more insights in the myths and realities concerning minor patients' capacities to decide on medical research participation. Against the background of relevant international, European and domestic legal frameworks concerning the rights of children as participants in medical research, this article goes into instruments such as MacCAT-CR, a semi-structured interview format useable as a competence assessment tool for clinical research involving children. On the basis of this, several recommendations are defined to enhance such research, as these may do sufficient justice to the health interests and the capacities of children, while at the same time supporting researchers and child research participants when facing decisions about pediatric research options

End-of-Life Decisions in Dutch Neonatal Intensive Care Units

Objective: To clarify the practice of end-of-life decision making in severely ill newborns. Design: Retrospective descriptive study with face-to-face interviews. Setting: The 10 neonatal intensive care units in the Netherlands from October 2005 to September 2006. Patients: All 367 newborn infants who died in the first 2 months of life in Dutch neonatal intensive care units. Adequate documentation was available in 359 deaths. Outcome Measures: Presence of end-of-life decisions, classification of deaths in 3 groups, and physicians' considerations leading to end-of-life decisions. Results: An end-of-life decision preceded death in 95% of cases, and in 5% treatment was continued until death. Of all of the deaths, 58% were classified as having no chance of survival and 42% were stabilized newborns with poor prognoses. Withdrawal of life-sustaining therapy was the main mode of death in both groups. One case of deliberate ending of life was found. In 92% of newborns with poor prognoses, end-of-life decisions were based on patients' future quality of life and mainly concerned future suffering. Considerations regarding the infant's present state were made in 44% of infants. Conclusions: Virtually all deaths in Dutch neonatal intensive care units are preceded by the decision to withdraw life-sustaining treatment and many decisions are based on future quality of life. The decision to deliberately end the life of a newborn may occur less frequently than was previously assumed

Conflicts About End-of-Life Decisions in NICUs in the Netherlands

OBJECTIVE: To determine the frequency and background of conflicts about neonatal end-of-life (EoL) decisions. METHODS: We reviewed the medical files of 359 newborns who had died during 1 year in the 10 Dutch NICUs and identified 150 deaths that were preceded by an EoL decision on the basis of the child's poor prognosis. The attending neonatologists of 147 of the 150 newborns were interviewed to obtain details about the decision-making process. RESULTS: EoL decisions about infants with a poor prognosis were initiated mainly by the physician, who subsequently involved the parents. Conflicts between parents and the medical team occurred in 18 of 147 cases and were mostly about the child's poor neurologic prognosis. Conflicts within the team occurred in 6 of 147 cases and concerned the uncertainty of the prognosis. In the event of conflict, the EoL decision was postponed. Consensus was reached by calling additional meetings, performing additional diagnostic tests, or obtaining a second opinion. The chief causes of conflict encountered by the physicians were religious convictions that forbade withdrawal of life-sustaining treatment and poor communication between the parents and the team. CONCLUSIONS: The parents were involved in all EoL decision-making processes, and consensus was ultimately reached in all cases. Conflicts within the team occurred in 4% of the cases and between the team and the parents in 12% of the cases. The conflicts were resolved by postponing the EoL decision until consensus was achieved. Pediatrics 2009; 124: e112-e11