Parental Enrollment Decision-Making for a Neonatal Clinical Trial.

OBJECTIVE: To describe the parental experience of recruitment and assess differences between parents who participated and those who declined to enroll in a neonatal clinical trial. STUDY DESIGN: This was a survey conducted at 12 US neonatal intensive care units of parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and encephaLopathy (HEAL) trial or who were eligible but declined enrollment. Questions assessed 6 factors of the parental experience of recruitment: (1) interactions with research staff; (2) the consent experience; (3) perceptions of the study; (4) decisional conflict; (5) reasons for/against participation; and (6) timing of making the enrollment decision. RESULTS: In total, 269 of 387 eligible parents, including 183 of 242 (75.6%) of those who enrolled their children in HEAL and 86 of 145 (59.3%) parents who declined to enroll their children in HEAL, were included in analysis. Parents who declined to enroll more preferred to be approached by clinical team members rather than by research team members (72.9% vs 49.2%, P = .005). Enrolled parents more frequently reported positive initial impressions (54.9% vs 10.5%, P < .001). Many parents in both groups made their decision early in the recruitment process. Considerations of reasons for/against participation differed by enrollment status. CONCLUSIONS: Understanding how parents experience recruitment, and how this differs by enrollment status, may help researchers improve recruitment processes for families and increase enrollment. The parental experience of recruitment varied by enrollment status. These findings can guide future work aiming to inform optimal recruitment strategies for neonatal clinical trials.

Declaração de consenso da seção de psiquiatria geriátrica da Associação Mundial de Psiquiatria sobre ética e capacidade em pessoas idosas com doença mental / World Psychiatric Association section of old age psychiatry consensus statement on ethics and capacity in older people with mental disorders

CONTEXTO: A Seção de Psiquiatria Geriátrica da Associação Mundial de Psiquiatria (AMP), desde 1997, vem desenvolvendo Declarações de Consenso relevantespara a prática da Psiquiatria Geriátrica. Desde 2006, a Seção vem trabalhando para desenvolver uma Declaração de Consenso sobre Ética e Capacidade em pessoas idosas com transtornos mentais. MÉTODO: Uma Conferência de Consenso foi realizada em Praga em setembro de 2008. Organizada pela Seção de Psiquiatria da Pessoa Idosa da AMP, ela contou com a participação do International Council of Nurses, Alzheimer Europe e Alzheimer Disease International. Os participantes foram reconhecidos pela sua perícia nesse domínio e vieram de 11 países. Incluíam psiquiatras, uma neurologista, um enfermeiro e representantes de cuidadores familiares. RESULTADOS: Após dois dias de reuniões e debate, redigiu-se um rascunho da declaração que foi submetida para análise nas diversas organizações/associações que participaram da reunião. Após as sugestões finais recolhidas, um texto definitivo foi preparado em inglês e publicado. A presente versão em português é da responsabilidade de dois participantes lusófonos da reunião, que são também coautores da declaração de consenso final. CONCLUSÕES: Essa Declaração de Consenso oferece aos clínicos em saúde mental que cuidam de pessoas idosas com transtornos mentais, cuidadores, outros profissionais da saúde e o público em geral as definições e o debate sobre os princípios éticos que podem frequentemente ser complexos e desafiadores, apoiados em orientações práticas para satisfazer tais necessidades e padrões éticos e encorajar a boa prática clínica.

BACKGROUND: The World Psychiatric Association (WPA) Section of Old Age Psychiatry, since 1997, has developed Consensus Statements relevant to the practice of Old Age Psychiatry. Since 2006 the Section has worked to develop a Consensus Statement on Ethics and Capacity in older people with mental disorders. METHOD: A Consensus Conference was realized in Prague, September 2008. The meeting was organized by the WPA Section of Old Age Psychiatry, with the participation of International Council of Nurses, Alzheimer Europe and Alzheimer Disease International. Participants who are recognised for their expertise in this area came from 11 countries and include psychiatrists, a neurologist, a nurse and family caregiving representatives. RESULTS: After two days of debate a draft was prepared and submitted to the organizations/associations represented at the meeting. When their respective comments were collected, a final text was prepared and published originally in English. This Portuguese version was prepared by two members of the meeting who came from Portuguese spoken countries. DISCUSSION: This Consensus Statement offers to mental health clinicians caring for older people with mental disorders, caregivers, other health professionals and the general public the setting out of and discourse in ethical principles which can often be complex and challenging, supported by practical guidance in meeting such ethical needs and standards, and to encouraged good clinical practice.