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.

La información clínica almacenada en registros de diverso tipo constituye una herramienta fundamental para la investigación biomédica. Hasta hace pocos años la creación y uso de registros epidemiológicos, o la utilización de información procedente de registros pre-existentes con fines de investigación, apenas tenía limitaciones. Esta situación ha cambiado de modo sustancial debido básicamente a la creciente importancia que las leyes actuales conceden a la protección de la intimidad, la privacidad y la confidencialidad de los datos de carácter personal. Aunque el marco legal es ya muy explícito, hay un cierto espacio para la deliberación ética y el consejo prudente, al objeto de realizar con dicha información una investigación válida y útil y que, al mismo tiempo, respete los derechos de los sujetos y la legalidad vigente. En las presentes directrices se abordan aquellos aspectos que se han considerado relevantes desde un punto de vista ético en el manejo de registros con fines de investigación, incluyendo no sólo el uso sino la creación misma del registro. Se proporcionan 24 recomendaciones agrupadas en 10 apartados: justificación de la creación de un registro, organización y definición de responsabilidades, validez científica del proyecto de investigación, requisitos éticos de las colecciones de datos anónimos y de los registros anonimizados, requisitos éticos de los registros que contienen datos de carácter personal, usos de la historia clínica con fines de investigación, uso de registros históricos y de personas fallecidas, contacto con los sujetos de investigación, comunicación de resultados y revisión por un Comité de Ética de la Investigación.