Clinical ethics support services in paediatric practice: protocol for a mixed studies systematic review on structures, interventions and outcomes.

INTRODUCTION: Clinical ethics support services (CESS) have been developing worldwide with growing interest in evaluating their quality. Paediatric-specific CESSs (p-CESS) have received little attention, and evidence from adult services might not be generalisable. Evidence on service models and practices is crucial to inform further research and debate on quality evaluation and minimum standards for p-CESSs. We aim to systematically identify, appraise and synthesise evidence for p-CESS structures, processes and outcomes. METHODS AND ANALYSIS: We will conduct a mixed-studies systematic review including peer-reviewed empirical studies published in English or Spanish language providing data on the evaluation and/or impact on any aspect of p-CESS. We will search seven electronic databases: MEDLINE, Philosopher's Index, EMBASE, PsycINFO, LILACS, Web of Science and CINHAL, without filters applied. Search terms will be related to "clinical ethics support" AND "paediatrics" AND "structure/process/outcome". Reference and citation list of included studies will be handsearched. A 10% random sample of retrieved titles/abstracts and all full texts will be independently dual-screened. We will conduct narrative and thematic synthesis for quantitative and qualitative data, respectively, following sequential explanatory synthesis guided by Donabedian's framework of structure, process and outcomes. Quality will be assessed using the Mixed-Methods Appraisal Tool (2018). The review will be reported using the adapted Preferred Reporting Items for Systematic Reviews and Meta-Analyses for reporting systematic reviews of qualitative and quantitative evidence template. Stakeholders will be involved twice in the review process; prior to data extraction and synthesis and after preliminary results. ETHICS AND DISSEMINATION: As a systematic review of published data, no ethical approval is necessary. Results will be published in a relevant academic peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021280978.

Incidence, risk factors, prognosis, and health-related quality of life after stroke in a low-resource community in Chile (ÑANDU): a prospective population-based study.

BACKGROUND: Stroke is a leading cause of disability and death worldwide. The best estimates of local, national, and global burden of stroke are derived from prospective population-based studies. We aimed to investigate the incidence, risk factors, long-term prognosis, care, and quality of life after stroke in the Ñuble region of Chile. METHODS: We did a prospective community-based study with use of multiple overlapping sources of hospitalised, ambulatory, and deceased cases. Standardised diagnostic criteria were used to identify and follow up all cases occurring in the resident population of the Ñuble region, Chile (in a low-income rural-urban population including predominantly people of Indigenous-European heritage), for 1 year. Participants were included if they had a clinical diagnosis of stroke confirmed according to the study criteria. All cases were adjudicated by vascular neurologists. Incidence rates of first-ever stroke were calculated from the population of Ñuble according to the 2017 national census. FINDINGS: From April 1, 2015, to March 31, 2016, we ascertained 1103 stroke cases, of which 890 (80·7%) were first-ever incident cases. The mean age of patients with first-ever stroke was 70·3 years (SD 14·1) and 443 (49·8%) were women. A CT scan was obtained in 801 (90%) of 890 patients (mean time from symptom onset to scan of 13·4 h (SD 29·8). The incidence of first-ever stroke age-adjusted to the world population was 121·7 (95% CI 113·7-130·1) per 100 000. The age-adjusted incidence rates, per 100 000 inhabitants, by main pathological subtypes were as follows: ischaemic stroke (101·5 [95% CI 90·9-113·0]); intracerebral haemorrhage (17·9 [13·5-23·4]), and subarachnoid haemorrhage (4·2 [2·1-7·3]). The 30-day case-fatality rate was 24·6% (21·9-27·6). At 6 months after the stroke, 55·9% (432 of 773) of cases had died or were disabled, which increased to 61·0% (456 of 747) at 12 months. Health-related quality of life in survivors was low at 6 months, improving slightly at 12 months after the stroke. INTERPRETATION: The incidence of stroke in this low-resource population was higher than our previous finding in northern Chile and within the mid-range of most population-based stroke studies. This result was due mainly to a higher incidence of ischaemic stroke, probably associated with increasing age and a high prevalence of cardiometabolic risk factors in the population studied. Our findings suggest that more should be done for the prevention and care of stroke in communities like the Ñuble population. FUNDING: The National Agency for Research and Development and the Technology-Health Research Fund, Clínica Alemana de Santiago, Boehringer Ingelheim, Bristol Meyers Squibb, The Herminda Martin Clinical Hospital of Chillán, Universidad Mayor, and Universidad de Concepción.

Ética, derecho y regulación de la investigación biomédica en Chile / Ethics, law and the regulation of biomedical research in Chile / Ética, direito e regulamentação da pesquisa biomédica no Chile

Resumen El presente trabajo analiza la relación entre ética y derecho en la regulación de la investigación biomédica en Chile. Para ello, se lleva a cabo un estudio comparativo entre el marco legal chileno y las principales normativas éticas internacionales ( Declaración de Helsinki y Pautas del Consejo de Organizaciones Internacionales de las Ciencias Médicas), teniendo como referente los requisitos para evaluar una investigación biomédica propuestos por Emanuel, Wendler y Grady. Se examinan y comentan tensiones e inconsistencias entre estos ámbitos regulatorios, en particular aquellas donde la legislación chilena tiene vacíos, falencias o es más exigente que el estándar ético internacional. Se concluye con sugerencias para mejorar la regulación jurídica chilena, entre las que se incluyen fortalecer el rol deliberativo de los comités ético-científicos y sistematizar el marco relacionado con investigación con el fin de lograr un cuerpo legal más orgánico y completo.

Abstract This article analyzes the relationship between ethics and law in the regulation of biomedical research in Chile. To this end, a comparative study was carried out on the main international ethical regulations ( Declaration of Helsinki and Guidelines of the Council for International Organizations of Medical Sciences), having as a reference the ethical requirements for assessing biomedical research proposed by Emanuel, Wendler and Grady. The tensions and inconsistencies found between the two regulatory areas are evaluated and commented, especially those in which the Chilean legislation presents legal gaps, deficiencies or is more demanding than the international ethical standard. We make some suggestions for improving the Chilean legal regulation of biomedical research, including strengthening the deliberative role of ethics committees and systematizing the legal framework related to research to achieve a more structured and complete legal body.

Resumo Este trabalho analisa a relação entre ética e direito na regulamentação da pesquisa biomédica no Chile. Para isso, realizou-se estudo comparativo entre o marco legal chileno e as principais regulamentações éticas internacionais ( Declaração de Helsinki e Diretrizes do Conselho de Organizações Internacionais de Ciências Médicas), tendo como referência os requisitos éticos propostos por Emanuel, Wendler e Grady para avaliar pesquisas biomédicas. São analisadas e comentadas tensões e inconsistências entre essas áreas regulatórias, particularmente aquelas em que a legislação chilena apresenta lacunas, deficiências ou é mais exigente do que o padrão ético internacional. Concluímos com sugestões para aprimorar a regulamentação legal chilena, incluindo o fortalecimento do papel deliberativo dos comitês de ética em pesquisa e a sistematização do arcabouço normativo relacionado à pesquisa, a fim de alcançar legislação mais estruturada e completa.