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"documento" => "simple-article" "crossmark" => 1 "subdocumento" => "crp" "cita" => "Med Clin. 2022;159:536-40" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Brief report</span>" "titulo" => "Adaptation and initial validation of the Spanish version of the chronic otitis media questionnaire-12 (COMQ-12) and chronic otitis media benefit inventory (COMBI)" "tienePdf" => "en" "tieneTextoCompleto" => "en" "tieneResumen" => array:2 [ 0 => "en" 1 => "es" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "536" "paginaFinal" => "540" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Adaptación y validación inicial de la versión en lengua española del Cuestionario de otitis media crónica-12 (COMQ-12) y del Inventario de beneficios en otitis media crónica (COMBI)" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 3411 "Ancho" => 2508 "Tamanyo" => 753351 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Spanish version of the COMQ-12 (COMQ-12-Spa).</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Nesly Gonzalez-Sanchez, Maria J. Dura, Marta Perez-Grau, Laura Samara, John Phillips, Francisco Larrosa" "autores" => array:6 [ 0 => array:2 [ "nombre" => "Nesly" "apellidos" => "Gonzalez-Sanchez" ] 1 => array:2 [ "nombre" => "Maria J." "apellidos" => "Dura" ] 2 => array:2 [ "nombre" => "Marta" "apellidos" => "Perez-Grau" ] 3 => array:2 [ "nombre" => "Laura" "apellidos" => "Samara" ] 4 => array:2 [ "nombre" => "John" "apellidos" => "Phillips" ] 5 => array:2 [ "nombre" => "Francisco" "apellidos" => "Larrosa" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S238702062200537X?idApp=UINPBA00004N" "url" => "/23870206/0000015900000011/v2_202301310812/S238702062200537X/v2_202301310812/en/main.assets" ] "en" => array:12 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Editorial note</span>" "titulo" => "Restraint measures in the agitated patient, safety or danger?" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "541" "paginaFinal" => "542" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "María del Mar García Andreu, Jesús Díez-Manglano" "autores" => array:2 [ 0 => array:2 [ "nombre" => "María del Mar" "apellidos" => "García Andreu" ] 1 => array:4 [ "nombre" => "Jesús" "apellidos" => "Díez-Manglano" "email" => array:1 [ 0 => "jdiez@aragon.es" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Medicina Interna, Hospital Royo Villanova, Zaragoza, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Medidas de sujeción en el paciente agitado, ¿seguridad o peligro?" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Nowadays, many healthcare professionals are forced to use mechanical restraints in their daily practice to ensure the safety of patients. However, despite its common use, there is no specific regulation at national level and no evidence-based scientific-technical positioning to help clinicians apply this measure safely and proportionally. Physical restraint, which started to be used for psychiatric patients at risk of self-harm or heteroaggressiveness, is nowadays widely used not only in intensive care units and conventional hospital wards, but also outside the health care setting in residential care homes for the elderly. Despite this, there are few studies analysing actual hospital prevalence with highly variable figures. Some studies have reported use in 11.8% of hospitalised patients, 32.9% of patients admitted to intensive care units and 68% of agitated patients visiting non-psychiatric emergency departments<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1–3</span></a>. The use of physical restraints in nursing homes in Spain is much higher. 84.5% of residents have bed rails and 26.9% have seat belts<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>. Although the main objective of any health care provider applying this measure is to protect the patient from harm, its use is an ethically controversial issue as it is not a harmless intervention, as it involves some physical and psychological trauma to the patient<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a>.</p><p id="par0010" class="elsevierStylePara elsevierViewall">According to the WHO, mechanical or physical restraint is the use of devices to immobilise someone or restrict the ability to move part of their body freely<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a>. The Spanish Bioethics Committee defines a broader concept to include any physical or pharmacological restraint that is intended to deprive a person of his or her freedom of movement<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a>. The purpose of physical restraint is to protect the patient and should therefore only be used in situations of real risk when there is a threat to physical integrity in situations of risk of falls or blows, to prevent postural defects or injuries, in situations of threat to the physical integrity of other persons and to ensure the therapeutic environment in terms of preventing manipulation or removal of venous lines, probes or catheters as well as when rest is a necessary therapeutic objective. Restraint may be partial if only trunk or limb mobility is limited, or total when the methods used limit most of the patient's movements<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a>. There are a number of different devices that can be used, including bed side rails, vests, abdominal belts and limb restraints. In addition to mechanical restraint, there is also chemical or pharmacological restraint with antipsychotic drugs or benzodiazepines, which in most cases are used together.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The State Attorney General’s Office has recently issued an instruction to provide guidance on the use of means of restraint in psychiatric units and in residential care homes for elderly or disabled persons<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a>. It includes the basic principles necessary to guarantee that its use respects the dignity, privacy and autonomy of the person, and these are: care, exceptionality, individualisation, necessity assessed by medical prescription, proportionality, appropriateness, gradation, minimum possible intensity, provisional nature and prohibition of excess. It also includes the obligation for the centres to have a specific restraint protocol and an adequate transparency-based registration system.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Mechanical restraints deprive of freedom and violate the dignity of the person. To apply restraint correctly, it must be properly indicated for the benefit of the patient when there is no other way to achieve the therapeutic objectives, it must be as short and as non-restrictive as possible, and it must be monitored appropriately once it is prescribed. Medical prescription is required in all cases and there must always be informed consent from the patient, relative or legal guardian except in life-threatening emergencies. Effective and safe materials as well as quality training of the professionals involved in their application are also necessary to minimise the risk of adverse events<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a>. In addition, it is essential that all these aspects are recorded in the patient's medical record. Applying mechanical restraint without following these principles may have legal implications as it deprives patients of their freedom, one of the fundamental rights recognised by our Constitution.</p><p id="par0025" class="elsevierStylePara elsevierViewall">Patients with a previous diagnosis of dementia or cognitive impairment are increasingly present on hospital wards and are at greater risk of experiencing disorientation episodes during hospitalisation. Episodes of <span class="elsevierStyleItalic">delirium</span> are also common in patients with organ impairment. In these patients and in cases where it is well indicated and justified, restraint can be effective, safe and warranted as it facilitates the diagnosis and treatment and protects the patient from suffering injuries or from causing them to health personnel<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a>.</p><p id="par0030" class="elsevierStylePara elsevierViewall">During daily clinical practice there are emergency situations posing a danger to the patient such as intense psychomotor agitation where there is a clear risk of harm and where the need for both pharmacological and mechanical restraint is evident. However, outside of these dangerous situations, mechanical restraint has failed to demonstrate benefit for the patient and there is insufficient quality scientific evidence on this topic, probably because of the difficulty in conducting experimental design studies due to obvious ethical limitations.</p><p id="par0035" class="elsevierStylePara elsevierViewall">Given the current level of concern about this issue, there are observational studies describing physical complications arising from its use, which in some cases can be serious, although they are very uncommon, given the high prevalence of its use<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a>. Therefore, the main drawback and limitation of the use of mechanical restraint is the violation of the individual's freedom and autonomy<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a>. This is why applying it when it is not well indicated or maintaining it beyond what is strictly necessary can be a serious mistake with significant physical and psychological implications for the patient as well as legal consequences for the health personnel.</p><p id="par0040" class="elsevierStylePara elsevierViewall">Studies in nursing homes have shown that their long-term use does not reduce the number of falls but may increase the occurrence of dystonia and pressure ulcers, worsen bone loss and decrease muscle tone<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">12,14,15</span></a>. There are other observational studies describing serious complications such as becoming trapped, suffocation or sudden death which fortunately are very rare and have been reported more often in geriatric centres than in hospitals<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a>. Restraint should never be prescribed to reduce the burden on healthcare staff, in fact, the patient who is restrained needs more attention during the acute episode, and close monitoring is the best measure to prevent accidents and related complications.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Given the awareness of this problem in recent years, studies have also been conducted with programmes that attempt to avoid or reduce the use of mechanical restraint, obtaining modest results, achieving improvements in mobility and basic activities of daily living during hospitalisation, with no increase in the number of falls but having no impact on mortality, although in some cases reducing hospital stay, especially in patients with cognitive impairment<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a>.</p><p id="par0050" class="elsevierStylePara elsevierViewall">In summary, the use of mechanical restraint can pose serious problems for the patient if used indiscriminately and on a long-term basis, especially outside the hospital where it is of no benefit to patients and may even increase the risk of complications due to immobilisation, as well as compromising their freedom, dignity and autonomy. In the context of an acute hospital admission, physical restraint can be a beneficial safety measure for the patient if it is applied in accordance with the principles of its use, at times of real risk, when there are no other alternatives and when it is frequently re-evaluated to ensure that it is not unnecessarily prolonged in time, and that it is carried out in a safe manner. To achieve this goal, it is necessary to develop protocols based on the best available evidence and to conduct studies to better understand their use and find areas for improvement<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">17,18</span></a>.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interests</span><p id="par0055" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflict of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflict of interests" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:18 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Use of physical restraints in acute hospitals in Germany: a multi-centre cross-sectional study" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "C. 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