Physical Restraint Use in Intensive Care Units: Exploring the Decision-Making Process and New Proposals. A Multimethod Study.

AIM: The general aim of this study was to explore the decision-making process followed by Intensive Care Unit (ICU) health professionals with respect to physical restraint (PR) administration and management, along with the factors that influence it. METHOD: A qual-quant multimethod design was sequenced in two stages: an initial stage following a qualitative methodology; and second, quantitative with a predominant descriptive approach. The multicenter study was undertaken at 17 ICUs belonging to 11 public hospitals in the Madrid region (Spain) across the period 2015 through 2019. The qualitative stage was performed from an interpretative phenomenological perspective. A total of eight discussion groups (DG) were held, with the participation of 23 nurses, 12 patient care nursing assistants, and seven physicians. Intentional purposive sampling was carried out. DG were tape-recorded and transcribed. A thematic analysis of the latent content was performed. In the quantitative stage, we maintained a 96-h observation period at each ICU. Variables pertaining to general descriptive elements of each ICU, institutional pain-agitation/sedation-delirium (PAD) monitoring policies and elements linked to quality of PR use were recorded. A descriptive analysis was performed, and the relationship between the variables was analyzed. The level of significance was set at p ≤ 0.05. FINDINGS: A total of 1070 patients were observed, amounting to a median prevalence of PR use of 19.11% (min: 0%-max: 44.44%). The differences observed between ICUs could be explained by a difference in restraint conceptualization. The various actors involved jointly build up a health care culture and a conceptualization of the terms "safety-risk", which determine decision-making about the use of restraints at each ICU. These shared meanings are the germ of beliefs, values, and rituals which, in this case, determine the greater or lesser use of restraints. There were different profiles of PR use among the units studied: preventive restraints versus "Zero" restraints. The differences corresponded to aspects such as: systematic use of tools for assessment of PAD; interpretation of patient behavior; the decision-making process, the significance attributed to patient safety and restraints; and the feelings generated by PR use. The restraint-free model requires an approach to safety from a holistic perspective, with the involvement of all team members and the family.

Respuesta: Regulación de la obtención de muestras procedentes de cadáveres / Reply: Regulation of specimen from corpses

No disponible

Biobancos y utilización de muestras de origen humano en investigación quirúrgica. Marco normativo actual / Biobanks and use of samples of human origin for surgical research. Current regulatory framework

En los últimos años se ha despertado un interés creciente por el desarrollo de colecciones de muestras biológicas y biobancos que faciliten a los investigadores el acceso a muestras de calidad y a sus datos clínico-epidemiológicos asociados. Así, los biobancos se han convertido en plataformas tecnológicas indispensables para el desarrollo de la investigación tanto básica como clínica. Las propiedades de la muestra biológica como soporte de información personal y familiar requieren que sean tratadas de acuerdo a nuevos estándares éticos. Por ello, la Ley de Investigación Biomédica dota de un novedoso marco normativo al proceso de obtención de las muestras y a su almacenamiento con fines de investigación, donde el consentimiento del sujeto fuente, la protección de datos, el informe favorable de un comité de ética de la investigación, la contratación de un seguro previo ante posibles efectos adversos, y los requisitos de calidad y seguridad en el tratamiento y gestión de estos materiales son elementos clave (AU)

In recent years, there has been a growing interest in the development of biological samples and biobanks that make it easier for investigators to have access to quality samples and their associated clinical and epidemiological data. Thus, biobanks have become indispensible technological platforms for the development of both basic and clinical research. The properties of the biological sample as a support medium of personal and family information require that they are treated in accordance with new ethical standards. For this reason, the Law on Biomedical Research, provides a new regulatory framework in the process of obtaining samples and their storage for research purposes, where the consent of the source subject, data protection, the favourable opinion of a Research Ethics Committee, the prior taking out of an insurance policy against possible adverse effects, and the quality and safety requirements in the handling and management of these materials are key elements (AU)

[Biobanks and use of samples of human origin for surgical research. Current regulatory framework]. / Biobancos y utilización de muestras de origen humano en investigación quirúrgica. Marco normativo actual.

In recent years, there has been a growing interest in the development of biological samples and biobanks that make it easier for investigators to have access to quality samples and their associated clinical and epidemiological data. Thus, biobanks have become indispensible technological platforms for the development of both basic and clinical research. The properties of the biological sample as a support medium of personal and family information require that they are treated in accordance with new ethical standards. For this reason, the Law on Biomedical Research, provides a new regulatory framework in the process of obtaining samples and their storage for research purposes, where the consent of the source subject, data protection, the favourable opinion of a Research Ethics Committee, the prior taking out of an insurance policy against possible adverse effects, and the quality and safety requirements in the handling and management of these materials are key elements.

Estimating the burden of disease for autism spectrum disorders in Spain in 2003.

Autism Spectrum Disorders (ASD) are lifelong neurodevelopmental disabilities. Burden of Disease is an indicator that provides important information on health status and outcomes such as premature mortality and disability. In order to estimate the burden of disease of ASD in the Spanish population during 2003, we followed the procedures used in the WHO Global Burden of Disease Study. ASD generated 43,928 Disability Adjusted Life Years (DALY) in Spain in 2003, from which 33,797 were attributable to Autistic Disorder and 10,131 were caused by Asperger's Disorder and Pervasive Developmental Disorder-Not Otherwise Specified. DALY could be a useful tool for health policy makers for setting health service priorities, allocating available resources effectively and providing a comparable measure of output for early intervention.

Estimating the burden of scleroderma disease in Spain.

OBJECTIVE: Scleroderma (systemic sclerosis) is a rare disease that results in great suffering. We estimated the burden of disease posed by scleroderma and its relative importance in the health of the Spanish population. METHODS: We estimated scleroderma-based burden of disease following procedures developed for the Global Burden of Disease study to ensure comparability. RESULTS: Despite its low prevalence, scleroderma generated 1732 disability-adjusted life-years (DALY) in Spain in 2001, comprising 562 (32%) years of life lost and 1170 (68%) years lived with disability. Most scleroderma-related DALY (73%) occurred in the population aged 15-54 years. Estimated DALY accounted for 0.59% of other musculoskeletal disorder-related DALY in the European A subregion (countries with low mortality rate in both adults and children in the World Health Organization classification), a significant value in the overall burden of disease. CONCLUSION: The burden of scleroderma in Spain was high, with disability being the major contributing factor. Burden of disease is an important measure in rare diseases, and may be an important indicator to be considered as a health unit in developed countries.

Characteristics of disability and handicap among Toxic Oil Syndrome (TOS) cohort patients: a cross-sectional study, 17 years after the original food intoxication.

PURPOSE: In 1981, a progressive multi-systemic disease called Toxic Oil Syndrome (TOS) appeared in Spain as an epidemic that affected 20,000 people. The International Classification of Impairments, Disabilities and Handicaps (ICIDH) was chosen to characterize the health status of patients more severely affected by TOS. METHODS: A random sample of 292 with permanent disability was selected. Disability was assessed with a questionnaire based on ICIDH and the Stanford Health Assessment Questionnaire. Handicap was measured using London Handicap Scale. Distributions of the proportions and 95% confidence intervals for disabilities, handicaps were calculated and stratified by dimensions, age and sex. The chi2 test was used for inter-group comparisons. RESULTS: Two hundred and fourteen patients were interviewed. Mobility-related and behaviour disabilities were most prevalent. Disability rose with age and was higher among women, except for behaviour disabilities which were more frequent in young men. Mean handicap score was 78.0 +/- 12.7. Handicap dimensions most affected were physical independence and economic self-sufficiency. CONCLUSIONS: The health profile of the population hardest hit by TOS is characterized by the presence of important functional and psychosocial disabilities that limit performance of daily living activities and social role, and are in accord with the handicap that such persons suffer.