Análisis modal de fallos y efectos en las transferencias de pacientes de urgencias a hospitalización / Patient transfers from emergency departments to other in-hospital areas: a failure mode and effects analysis

Objetivo: Este estudio analiza en profundidad el proceso de transferencia de pacientes de urgencias a hospitalización y posibles fallos para evitar problemas de seguridad mediante la identificación de líneas de mejora. Método: Se conformó un grupo de trabajo multidisciplinar compuesto por profesionales asistenciales de urgencias y hospitalización de adultos que, mediante la metodología de análisis modal de fallos y efectos (AMFE), analizó pormenorizadamente el proceso de transferencia de pacientes de urgencias a hospitalización. Para los puntos críticos identificados se estableció el índice de prioridad del riesgo (IPR) en base a su gravedad, probabilidad de aparición y de detección. Resultados: Se identificaron 8 subprocesos y 14 puntos críticos que podrían generar fallos en el proceso de transferencia. Los aspectos relacionados con la administración de medicamentos y el proceso de identificación fueron los que obtuvieron mayores puntuaciones de IPR. Para todos ellos se establecieron acciones de mejora. Se elaboró un procedimiento específico de transferencia de pacientes entre estas áreas y un listado de verificación de ingresos en hospitalización. Conclusiones: Con la metodología AMFE se ha conseguido desgranar un proceso de especial vulnerabilidad como es la transferencia de pacientes de urgencias a hospitalización y definir acciones de mejora en aras de incrementar la seguridad de los pacientes. (AU)

Objectives: To perform an in-depth analysis of the process of transferring patients from an emergency department (ED) to other areas inside a hospital and identify possible points of failure and risk so that strategies for improvement can be developed. Methods: We formed a multidisciplinary group of ED and other personnel working with hospitalized adults. The group applied failure mode and effects analysis (FMEA) to understand the in-hospital transfer processes. A risk priority scoring system was then established to assess the seriousness of each risk and the likelihood it would appear and be detected. Results: We identified 8 transfer subprocesses and 14 critical points at which failures could occur. Processes related to administering medications and identifying patients were the components that received the highest risk priority scores. Improvement strategies were established for all risks. The group created a specific protocol for in-hospital transfers and a checklist to use during handovers. Conclusion: The FMEA method helped the group to identify points when there is risk of failure during patient transfers and to define ways to improve patient safety. (AU)

Patient transfers from emergency departments to other in-hospital areas: a failure mode and effects analysis. / Análisis modal de fallos y efectos en las transferencias de pacientes de urgencias a hospitalización.

OBJECTIVES: To perform an in-depth analysis of the process of transferring patients from an emergency department (ED) to other areas inside a hospital and identify possible points of failure and risk so that strategies for improvement can be developed. MATERIAL AND METHODS: We formed a multidisciplinary group of ED and other personnel working with hospitalized adults. The group applied failure mode and effects analysis (FMEA) to understand the in-hospital transfer processes. A risk priority scoring system was then established to assess the seriousness of each risk and the likelihood it would appear and be detected. RESULTS: We identified 8 transfer subprocesses and 14 critical points at which failures could occur. Processes related to administering medications and identifying patients were the components that received the highest risk priority scores. Improvement strategies were established for all risks. The group created a specific protocol for in-hospital transfers and a checklist to use during handovers. CONCLUSION: The FMEA method helped the group to identify points when there is risk of failure during patient transfers and to define ways to improve patient safety.

OBJETIVO: Este estudio analiza en profundidad el proceso de transferencia de pacientes de urgencias a hospitalización y posibles fallos para evitar problemas de seguridad mediante la identificación de líneas de mejora. METODO: Se conformó un grupo de trabajo multidisciplinar compuesto por profesionales asistenciales de urgencias y hospitalización de adultos que, mediante la metodología de análisis modal de fallos y efectos (AMFE), analizó pormenorizadamente el proceso de transferencia de pacientes de urgencias a hospitalización. Para los puntos críticos identificados se estableció el índice de prioridad del riesgo (IPR) en base a su gravedad, probabilidad de aparición y de detección. RESULTADOS: Se identificaron 8 subprocesos y 14 puntos críticos que podrían generar fallos en el proceso de transferencia. Los aspectos relacionados con la administración de medicamentos y el proceso de identificación fueron los que obtuvieron mayores puntuaciones de IPR. Para todos ellos se establecieron acciones de mejora. Se elaboró un procedimiento específico de transferencia de pacientes entre estas áreas y un listado de verificación de ingresos en hospitalización. CONCLUSIONES: Con la metodología AMFE se ha conseguido desgranar un proceso de especial vulnerabilidad como es la transferencia de pacientes de urgencias a hospitalización y definir acciones de mejora en aras de incrementar la seguridad de los pacientes.

Clinical and functional assessment in patients admitted with pluripathological dysphagia according to the mode of feeding: Through a gastrostomy tube or oral.

INTRODUCTION: Multipathological patients are a vulnerable population with high comorbidity, functional impairment, and nutritional risk. Almost 50% of these hospitalized patients have dysphagia. There is no consensus on whether placement of a percutaneous endoscopic gastrostomy (PEG) tube provides greater clinical benefit. The purpose of this study was to know and compare 2 groups of multipathological patients with dysphagia according to the mode of feeding: PEG vs. oral. METHOD: Retrospective descriptive study with hospitalized patients (2016-19), pluripathological, with dysphagia, nutritional risk, over 50 years with diagnoses of: dementia, cerebrovascular accident (CVA), neurological disease, or oropharyngeal neoplasia. Terminally ill patients with jejunostomy tube or parenteral nutrition were excluded. Sociodemographic variables, clinical situation, and comorbidities were evaluated. Bivariate analysis was performed to compare both groups according to their diet, establishing a significance level of p < .05. RESULTS: 1928 multipathological patients. The PEG group consisted of 84 patients (n122). A total of 84 were randomly selected to form the non-PEG group (n434). This group had less history of bronchoaspiration/pneumonia (p = .008), its main diagnosis was stroke versus dementia in the PEG group (p < .001). Both groups had more than a 45% risk of comorbidity (p = .77). CONCLUSIONS: multipathological patients with dysphagia with PEG usually have dementia as their main diagnosis, however, stroke is the most relevant pathology in those fed orally. Both groups have associated risk factors, high comorbidity, and dependence. This causes their vital prognosis to be limited regardless of the mode of feeding.

A protocol for a randomized trial measuring flowmetry in risk areas for pressure ulcer: Hyperoxygenated fatty acids vs olive oil.

BACKGROUND: Pressure ulcers are a common adverse event in healthcare. To date, no flowmetry studies have been conducted to compare hyperoxygenated fatty acids (HFA) vs. extra-virgin olive oil (EVOO) in alleviating this condition. AIMS: To determine and evaluate the effect of the application of HFA vs. EVOO on tissue oxygenation and perfusion in heels under pressure, in healthy persons and in hospitalised patients. DESIGN: Two-phase experimental study. METHODS: Phase 1 will be conducted with healthy subjects, using a randomised, open study design, evaluating an intrasubject control group. Phase 2 will focus on hospitalised subjects, with a randomised, open study group vs. a control group. DISCUSSION: This Project is undertaken to identify the mechanisms that intervene in the genesis of pressure ulcers and to determine whether there are differences in outcomes between the application of HFA vs. EVOO as a preventive measure The results of this study are of economic importance (due to the price difference between the products used) and will also impact on usual clinical practice for patients with impaired mobility and liable to suffer from pressure ulcers, by considering an alternative to established preventive measures.

Multimodal intervention for preventing peripheral intravenous catheter failure in adults (PREBACP): a multicentre, cluster-randomised, controlled trial.

BACKGROUND: 2 billion peripheral intravenous catheters (PIVC) are inserted into inpatients worldwide each year. Almost one in two PIVCs fail before completion of intravenous therapy. We aimed to determine the efficacy and costs of a multimodal intervention to reduce PIVC failure among hospitalised patients. METHODS: PREBACP was a cluster-randomised, controlled trial done at seven public hospitals in Spain. Clusters (hospital wards) had at least 70% permanent staff and data were collected from patients aged 18 years and older with one or more PIVCs at the start of intravenous therapy. Clusters were randomly assigned (1:1) to the multimodal intervention or control group using a centralised, web-based randomisation software, and stratified by type of setting. We concealed randomisation to allocation, without masking patients or professionals to the intervention. An intervention using a multimodal model and dissemination of protocols, education for health-care professionals and patients, and feedback on performance was implemented for 12 months in the intervention group. The control group received usual care. The primary outcome was all-cause PIVC failure at 12 months (phlebitis, extravasation, obstruction, or infections). Subsequently, through an amendment to the protocol approved on July 25, 2021, we included dislodgement as part of PIVC failure. Analysis was by modified intention to treat, which included all randomly assigned hospital wards for whom data on the primary endpoint were available. This trial is registered with the ISRCTN Registry, ISRCTN10438530. FINDINGS: Between Jan 1, 2019, and March 1, 2020, we randomly assigned 22 eligible clusters to receive the multimodal intervention (n=11 clusters; 2196 patients, 2235 PIVCs, and 131 nurses) or usual practice in the control group (n=11 clusters; 2282 patients, 2330 PIVCs, and 138 nurses). At 12 months, the proportion of PIVC failures was lower in the intervention group than in the control group (37·10% [SD 1·32], HR 0·81 [95% CI 0·72 to 0·92] vs 46·49% [2·59], HR 1·23 [1·04 to 1·39]; mean difference -9·39% [95% CI -11·22 to -7·57]; p<0·0001). Per-protocol-prespecified analysis of the primary outcome excluding dislodgement also showed the intervention significantly reduced PIVC failure compared with the control group at 12 months (33·47% [SD 2·98], HR 0·85 [95% CI 0·75 to 0·96] vs 41·06% [4·62], HR 1·18 [1·04 to 1·33]; mean difference -7·59% [95% CI -11·05 to -4·13]; p<0·0001). INTERPRETATION: A multimodal intervention reduced PIVC failure, thereby reducing potentially serious complications for hospitalised patients. The findings of PREBACP enabled a deeper understanding of decision making, knowledge mobilisation, and sense making in routine clinical practice. FUNDING: The College of Nurses of the Balearic Islands. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Perfil del paciente que sufre caídas en el entorno hospitalario: estudio multicéntrico / Profile of the patient who suffers falls in the hospital environment: Multicenter study

OBJETIVOS: Analizar el perfil de los pacientes que sufren caídas en el entorno hospitalario. MÉTODO: Estudio longitudinal, de seguimiento prospectivo de una cohorte de pacientes reclutada de mayo de 2014 a marzo de 2016. Participaron 5 hospitales de agudos de la Comunidad de Andalucía de unidades médicas, quirúrgicas y cuidados intensivos. Se incluyeron pacientes mayores de 16 años. Las variables de caracterización fueron: edad, sexo, unidad, estancia, medidas preventivas; y las de resultado: nivel de conciencia, déficits sensoriales, movilidad, número de caídas, circunstancias y consecuencias, medicamentos, caídas previas. RESULTADOS: Se reclutaron 1.247 pacientes, de los que 977 completaron el estudio. La incidencia de caídas fue del 2,35%. La edad media de las personas que sufrieron caídas fue de 73,6 años (p = 0,015). El evento aconteció sobre todo en las mujeres (56,5%) y en las unidades médicas (79%). Las caídas ocasionaron daños menores. La reordenación del mobiliario demostró ser la única medida protectora (OR=3,95; IC95% 1,46-10,68; p = 0,015). Los factores predictivos del suceso fueron: haber ingresado en el hospital tras una caída (HR=5,88; IC95% 3,23-10,67; p < 0,001), seguido de problemas visuales, ir al baño con frecuencia y haber sufrido caídas previas. CONCLUSIONES: El perfil del paciente que sufre caídas en el hospital se presenta como mayor de 70 años, mujer, ingresada en una unidad médica, durante el turno de noche, estando en cama y solo, sin deterioro del nivel de conciencia y con antecedentes de caídas

AIMS: To analyse the profile of patients suffering from falls in the hospital environment. METHOD: Longitudinal study, prospective follow-up of a cohort of patients recruited from May 2014 to March 2016. Medical, surgical and intensive care units of 5 acute hospitals of the Community of Andalusia participated. Patients older than 16 years were included. The variables of characterization were: age, sex, unit, stay, preventive measures, and those of result: level of consciousness, sensory deficits, mobility, number of falls, circumstances and consequences, medications, previous falls. RESULTS: 1,247 patients were recruited, of whom 977 completed the study. The incidence of falls was 2.35%. The average age of the faller was 73.6 years (P=.015). The event occurred mostly in women (56.5%) and in medical units (79%). The falls caused minor damage. Rearrangement of the furniture proved to be the only protective measure (OR= 3.95, 95% CI 1.46-10.68, P=.015). The predictors of the event were: having been admitted to the hospital after a fall (HR= 5.88, 95% CI 3.23-10.67, P<.001), followed by visual problems, frequent visits to the bathroom and having suffered previous falls. CONCLUSIONS: The profile of the patient suffering falls in the hospital is presented as aged over 70 years old, female, admitted to a medical unit, during the night shift, being in bed and alone, without impaired level of consciousness and with a history of falls

Risk Factors for Difficult Peripheral Intravenous Cannulation. The PIVV2 Multicentre Case-Control Study.

BACKGROUND: Difficult peripheral intravenous cannulation (DPIVC) is associated with serious complications related to vascular access. These complications might be avoided if the risk factors were identified previously, enabling the detection of potentially difficult situations at an early stage. The aim of this study is to consider these risk factors, to determine the influence of the hospital setting, to examine the association between DPIVC and the different techniques of catheter insertion and to analyse the importance of the clinician's experience in this context. METHODS: Case-control study following a previously published protocol, conducted in 48 units of eight public hospitals in Spain. Adult patients requiring a peripheral intravenous cannula were prospectively included in the study population during their hospital stay. Over a period of 11 months, for consecutive eligible patients, nurses in each participating unit recorded data on their assessment of the vascular access performed and the technique used. Variables related to these medical personnel were also recorded. One of the researchers reviewed the patients' clinical history to compile the relevant health variables and to characterise the healthcare process. The statistical analysis included association tests among the main study variables. The risk factors were analysed using bivariate logistic regression. The variables found to be statistically significant were included in a multivariate logistic regression model incorporating each of the healthcare environments identified. RESULTS: The study population was composed of 2662 patients, of whom 221 (8.3%) presented with DPIVC. A previous history of difficulty, the presence of non-palpable veins, acute upper limb alterations and punctures in the ante-cubital fossa were found to be independent risk factors for DPIVC. Differences were found in the frequency of occurrence of DPIVC and in some risk factors, according to the healthcare context. The variables related to the characteristics of the hospital personnel did not influence the study event. CONCLUSION: The present study identifies four independent risk factors for DPIVC that can be incorporated into algorithms aimed at preventing its occurrence and facilitating the referral of patients to vascular access specialist teams.

Profile of the patient who suffers falls in the hospital environment: Multicenter study. / Perfil del paciente que sufre caídas en el entorno hospitalario: estudio multicéntrico.

AIMS: To analyse the profile of patients suffering from falls in the hospital environment. METHOD: Longitudinal study, prospective follow-up of a cohort of patients recruited from May 2014 to March 2016. Medical, surgical and intensive care units of 5 acute hospitals of the Community of Andalusia participated. Patients older than 16 years were included. The variables of characterization were: age, sex, unit, stay, preventive measures, and those of result: level of consciousness, sensory deficits, mobility, number of falls, circumstances and consequences, medications, previous falls. RESULTS: 1,247 patients were recruited, of whom 977 completed the study. The incidence of falls was 2.35%. The average age of the faller was 73.6 years (P=.015). The event occurred mostly in women (56.5%) and in medical units (79%). The falls caused minor damage. Rearrangement of the furniture proved to be the only protective measure (OR= 3.95, 95% CI 1.46-10.68, P=.015). The predictors of the event were: having been admitted to the hospital after a fall (HR= 5.88, 95% CI 3.23-10.67, P<.001), followed by visual problems, frequent visits to the bathroom and having suffered previous falls. CONCLUSIONS: The profile of the patient suffering falls in the hospital is presented as aged over 70 years old, female, admitted to a medical unit, during the night shift, being in bed and alone, without impaired level of consciousness and with a history of falls.

Perfusion, tissue oxygenation and peripheral temperature in the skin of heels of healthy participants exposed to pressure: a quasi-experimental study.

AIM: To evaluate the relationship between the pressure exerted on the heel of one foot resting directly on a mattress, versus that exerted on the other heel, protected by a pillow beneath the Achilles tendon area and the changes thus produced in perfusion, oxygenation and temperature in the skin of heels of healthy volunteers lying in a supine position. DESIGN: Experimental study in a pre-clinical phase, with healthy volunteer participants and intrapeople control. METHODS: The study was carried out from November 2017 - May 2018. A pressure measurement surface was placed between the participant and the constant low-pressure support surface. Doppler laser devices were used to measure local temperature and perfusion. The degree of oxygenation was determined using an infrared beam close to the pressure zone in each heel. Both feet rested immobile on the bed, in a natural position, for 2 hr. To ensure intrapeople control, in every case the left heel was raised slightly, compared with the right. RESULTS: Eighteen participants took part in this study. Analysis of the results obtained showed that capillary blood flow was significantly reduced in the heel subjected to pressure, compared with the other heel, while no significant effects on oxygen saturation or temperature were observed. The variables associated with greater oxygen saturation were capillary blood flow, local temperature and pressure exerted. Fat-free mass, fat mass and duration of exposure to pressure were all significantly associated with reduced oxygen saturation. CONCLUSIONS: In healthy participants, when the heel is subjected to constant pressure against a constant low-pressure support surface, there is a significant reduction in blood flow, compared with the heel where pressure is relieved. However, there are no significant differences in temperature or tissue oxygenation. IMPACT: Significant reductions in vascular flow were observed; however, the oxygenation and temperature of the heel tissues remained unchanged. These findings, corroborated in real patients, would advance our understanding and facilitate decision-making on measures to prevent pressure ulcers, such as repositioning or tissue protection. TRIAL REGISTRATION: The protocol is registered in ClinicalTrials.gov (NCT02736838).

Implementation of a knowledge mobilization model to prevent peripheral venous catheter-related adverse events: PREBACP study-a multicenter cluster-randomized trial protocol.

BACKGROUND: Peripheral venous catheters are the most commonly used invasive devices in hospitals worldwide. Patients can experience multiple adverse events during the insertion, maintenance, and management of these devices. Health professionals aim to resolve the challenges of care variability in the use of peripheral venous catheter through adherence to clinical practice guidelines. The aim of this cluster-randomized controlled trial is to determine the efficacy of a multimodal intervention on incidence of adverse events associated with the use of peripheral venous catheters in adult hospital patients. Additional aims are to analyze the fidelity of nurses and the relationship between contextual factors on the use of best available and the outcomes of the intervention. METHODS: Five public hospitals in the Spanish National Health System, with diverse profiles, including one university hospital and four second-level hospitals, will be included. In total, 20 hospitalization wards will be randomized for this study by ward to one of two groups. Those in the first group receive an intervention that lasts 12 months implementing evidence-based practice in healthcare related to peripheral catheters through a multimodal strategy, which will contain updated and poster protocols insertion, maintenance and removal of peripheral venous catheters, technologies applied to e-learning, feedback on the results, user and family information related to peripheral catheter, and facilitation of the best evidence by face-to-face training session. PRIMARY OUTCOME MEASURES: Incidence of adverse events associated with the use of peripheral venous catheters is measured by assessing hospital records. SECONDARY OUTCOME MEASURES: Nurses' adherence to clinical practice guidelines, clinical outcomes, and the cost of implementing the multimodal intervention. DISCUSSION: Clinical implementation is a complex, multifaceted phenomenon which requires a deep understanding of decision-making, knowledge mobilization, and sense making in routine clinical practice. Likewise, the inclusion of strategies that promote fidelity to recommendations through multicomponent and multimodal intervention must be encouraged. The use of a transfer model could counterbalance one of the greatest challenges for organizations, the evaluation of the impact of the implementation of evidence in the professional context through quality indicators associated with prevention and control of infections. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10438530 . Registered 20 March 2018.

Calidad de la sedación con propofol administrada por personal no anestesiólogo en una unidad de endoscopia digestiva, resultados tras un año de implantación / Quality of sedation with propofol administered by non-anesthetists in a digestive endoscopy unit: the results of a one year experience

Introducción: existe evidencia de que un equipo formado por endoscopista y enfermera puede hacerse cargo de la sedación de un paciente con propofol de forma eficaz, segura y eficiente. Para ello, es fundamental una adecuada formación y entrenamiento específico que les otorgue las competencias necesarias. El objetivo principal de este estudio fue realizar, tras un año de implantación, una evaluación de la calidad del procedimiento de sedación administrada por personal no anestesiólogo en una unidad de endoscopia digestiva. Métodos: se realizó un estudio de cohortes prospectivo sobre los pacientes que recibieron sedación con propofol por personal no anestesiólogo. Posteriormente, se seleccionó una muestra aleatoria de registros clínicos para evaluar la adherencia de los profesionales a diferentes criterios de calidad, así como la aparición de eventos adversos relacionados con la sedación. Resultados: en el periodo de estudio se realizaron un total de 595 procedimientos bajo sedación con propofol. La tasa de eventos adversos fue del 2,4% (n = 507), principalmente episodios de hipotensión e hipoxemia. Los porcentajes de adherencia al procedimiento de sedación se situaron por encima del 80% en la mayoría de los criterios, aunque fue menor en la cumplimentación de la valoración del riesgo ASA. Conclusión: los resultados del estudio sugieren que el propofol puede ser administrado con seguridad y eficacia por un equipo cualificado de endoscopista y enfermera, en pacientes con un riesgo ASA I-II. Las auditorías sobre la adherencia de los profesionales al procedimiento permiten identificar necesidades de mejora para poder seguir trabajando sobre aspectos aún no consolidados

Introduction: research has shown that an endoscopist-nurse clinical team can perform sedation with propofol effectively, safely and efficiently. To do so, it is essential to provide specific and appropriate training in the necessary skills. The main aim of the present study was to evaluate the quality of the sedation procedure administered by non-anesthetists in a digestive endoscopy unit, one year after its introduction. Methods: a prospective cohort study was performed in patients given propofol sedation by non-anesthetists. Subsequently, a random sample of clinical records was selected in order to evaluate the adherence of professionals to the quality criteria and to assess the rate of adverse events related to sedation. Results: a total of 595 procedures were performed under propofol sedation during the study period. The rate of adverse events was 2.4% (n = 507), mainly involving hypotension and hypoxemia. Adherence to the sedation procedure was above 80% for most of the applicable criteria, although it was lower for the completion of ASA risk evaluation. Conclusions: the results of the study suggest that propofol can be administered safely and effectively by a qualified endoscopist-nurse team, in patients with an ASA I-II risk. Audits of adherence by medical staff to the recommended procedure facilitate the identification of areas for improvement; further work is needed on the aspects that have not yet been consolidated

Quality of sedation with propofol administered by non-anesthetists in a digestive endoscopy unit: the results of a one year experience.

INTRODUCTION: research has shown that an endoscopist-nurse clinical team can perform sedation with propofol effectively, safely and efficiently. To do so, it is essential to provide specific and appropriate training in the necessary skills. The main aim of the present study was to evaluate the quality of the sedation procedure administered by non-anesthetists in a digestive endoscopy unit, one year after its introduction. METHODS: a prospective cohort study was performed in patients given propofol sedation by non-anesthetists. Subsequently, a random sample of clinical records was selected in order to evaluate the adherence of professionals to the quality criteria and to assess the rate of adverse events related to sedation. RESULTS: a total of 595 procedures were performed under propofol sedation during the study period. The rate of adverse events was 2.4% (n = 507), mainly involving hypotension and hypoxemia. Adherence to the sedation procedure was above 80% for most of the applicable criteria, although it was lower for the completion of ASA risk evaluation. CONCLUSIONS: the results of the study suggest that propofol can be administered safely and effectively by a qualified endoscopist-nurse team, in patients with an ASA I-II risk. Audits of adherence by medical staff to the recommended procedure facilitate the identification of areas for improvement; further work is needed on the aspects that have not yet been consolidated.

Peripheral perfusion and oxygenation in areas of risk of skin integrity impairment exposed to pressure patterns. A phase I trial (POTER Study).

AIM: The aim of this study was to analyse the change in peripheral oxygenation and microvascular flow in tissues subjected to different pressure regimes in healthy subjects and in hospitalized patients. BACKGROUND: The presence of pressure ulcers in hospitalized patients is a common complication that has a negative impact on health and often prolongs hospital stay and increases healthcare costs. DESIGN: Experimental non-controlled, non-randomized study in two phases: pre-clinical and clinical. METHODS: The pre-clinical phase will be conducted in healthy volunteers and the clinical phase, in patients at risk of impaired skin integrity. Vascular flow, tissue oxygenation and local temperature in areas at risk of pressure ulcers will be evaluated by Doppler laser in subjects lying on a capacitive surface to measure pressure at 10,249 points. Different levels of pressure will be generated by changes in body position and changes in tissue perfusion and oxygenation will be monitored for up to 4 hours, to determine the implications for repositioning interventions in patients at risk. This study was funded in July 2015. The protocol is registered in ClinicalTrials.gov (NCT02736838). DISCUSSION: Pressure ulcer is a significant and complex health problem in long-term bedridden patients and there is currently no effective treatment or efficient prevention method. The information provided by our study will provide an accurate assessment of different thresholds for the onset of damage to the skin, associated with different body positions and pressure levels. TRIAL REGISTRATION: The protocol is registered in ClinicalTrials.gov (NCT02736838).

Development and psychometric validation of a questionnaire to evaluate nurses' adherence to recommendations for preventing pressure ulcers (QARPPU).

AIM OF THE STUDY: The main objective of this work is the development and psychometric validation of an instrument to evaluate nurses' adherence to the main recommendations issued for preventing pressure ulcers. MATERIAL AND METHODS: An instrument was designed based on the main recommendations for the prevention of pressure ulcers published in various clinical practice guides. Subsequently, it was proceeded to evaluate the face and content validity of the instrument by an expert group. It has been applied to 249 Spanish nurses took part in a cross-sectional study to obtain a psychometric evaluation (reliability and construct validity) of the instrument. The study data were compiled from June 2015 to July 2016. RESULTS: From the results of the psychometric analysis, a final 18-item, 4-factor questionnaire was derived, which explained 60.5% of the variance and presented the following optimal indices of fit (CMIN/DF: 1.40 p < 0.001; GFI: 0.93; NFI: 0.92; CFI: 0.98; TLI: 0.97; RMSEA: 0.04 (90% CI 0.025-0.054). CONCLUSIONS: The results obtained show that the instrument presents suitable psychometric properties for evaluating nurses' adherence to recommendations for the prevention of pressure ulcers.

Adaptación transcultural del instrumento «STRATIFY» para la valoración del riesgo de caídas / Cross-cultural adaptation of the STRATIFY tool in detecting and predicting risk of falling

OBJETIVOS: Adaptar al castellano la escala STRATIFY para su uso clínico en el contexto español. MÉTODO: Se realizó un estudio transversal, multicéntrico, en 2 ámbitos asistenciales: hospitales de agudos y residencias geriátricas, de adaptación transcultural realizado en la Comunidad Autónoma de Andalucía durante el año 2014. El proceso de adaptación se estructuró en 4 etapas: traducción, retrotraducción, equivalencia entre las 2 retrotraducciones y pilotaje, obteniendo la versión definitiva en español. Se tuvieron en cuenta la validez de aspecto, la validez de contenido y el tiempo necesario en cumplimentar la escala. La validez de contenido se obtuvo a través del cálculo del índice global de validez de contenido. Para su análisis se calculó la mediana, la tendencia central y dispersión de las puntuaciones. RESULTADOS: El índice global de validez de contenido obtuvo un resultado positivo de 1. Para la validez de aspecto se tuvieron en cuenta la claridad y comprensión de las preguntas. De las 5 preguntas del instrumento, 2 presentaron una pequeña discordancia solventada con la introducción de una frase aclaratoria para conseguir una equivalencia conceptual. Las medianas de ambas preguntas fueron iguales o superiores a 5. El tiempo medio de cumplimentación de la escala fue inferior a los 3min. CONCLUSIONES: El proceso de adaptación al castellano de STRATIFY ha permitido obtener una versión semántica y culturalmente equivalente a la original de fácil cumplimentación y comprensión para su uso en el contexto español

AIMS: To adapt to Spanish language the STRATIFY tool for clinical use in the Spanish-speaking World. METHOD: A multicenter, 2 care settings cross-sectional study cultural adaptation study in acute care hospitals and nursing homes was performed in Andalusia during 2014. The adaptation process was divided into 4 stages: translation, back-translation, equivalence between the 2 back-translations and piloting of the Spanish version, thus obtaining the final version. The validity of appearance, content validity and the time required to complete the scale were taken into account. For analysis, the median, central tendency and dispersion of scores, the interquartile range, and the interquartile deviation for the possible variability in responses it was calculated. RESULTS: Content validity measured by content validity index reached a profit of 1. For the validity aspect the clarity and comprehensibility of the questions were taken into account. Of the 5 questions of the instrument, 2 had a small disagreement solved with the introduction of an explanatory phrase to achieve conceptual equivalence. Median both questions were equal or superior to 5. The average time for completion of the scale was less than 3 minutes. CONCLUSIONS: The process of adaptation to Spanish of STRATIFY has led to a semantic version and culturally equivalent to the original for easy filling and understanding for use in the Spanish-speaking world

Cross-cultural adaptation of the STRATIFY tool in detecting and predicting risk of falling. / Adaptación transcultural del instrumento «STRATIFY¼ para la valoración del riesgo de caídas.

AIMS: To adapt to Spanish language the STRATIFY tool for clinical use in the Spanish-speaking World. METHOD: A multicenter, 2 care settings cross-sectional study cultural adaptation study in acute care hospitals and nursing homes was performed in Andalusia during 2014. The adaptation process was divided into 4 stages: translation, back-translation, equivalence between the 2 back-translations and piloting of the Spanish version, thus obtaining the final version. The validity of appearance, content validity and the time required to complete the scale were taken into account. For analysis, the median, central tendency and dispersion of scores, the interquartile range, and the interquartile deviation for the possible variability in responses it was calculated. RESULTS: Content validity measured by content validity index reached a profit of 1. For the validity aspect the clarity and comprehensibility of the questions were taken into account. Of the 5 questions of the instrument, 2 had a small disagreement solved with the introduction of an explanatory phrase to achieve conceptual equivalence. Median both questions were equal or superior to 5. The average time for completion of the scale was less than 3 minutes. CONCLUSION: The process of adaptation to Spanish of STRATIFY has led to a semantic version and culturally equivalent to the original for easy filling and understanding for use in the Spanish-speaking world.

Validation of the STRATIFY falls risk-assessment tool for acute-care hospital patients and nursing home residents: study protocol.

AIM: To evaluate the accuracy of the STRATIFY tool in detecting and predicting fall risk in acute-care hospitals and nursing homes for the older people. BACKGROUND: Falls are the predominant cause of injury in people aged over 65 years. Testing the falls risk-assessment tools in settings other than those for which they were originally developed obtained conflicting results and has highlighted difficulties in their adoption for widespread use. Current guidelines for practice call into question the appropriateness of using these instruments. DESIGN: Two-stage study: a cross-cultural adaptation and psychometric validation; and a longitudinal, prospective follow-up of the cohort of patients recruited. METHODS: A cross-cultural adaptation of STRATIFY, followed by its empirical validation will be performed, on a total sample of 2097 patients. The diagnostic validity will be assessed by calculating the sensitivity, specificity, positive and negative predictive values and the ratios of positive and negative probability. Data for statistical reliability and the internal consistency of the instrument will be calculated; construct validity will be assessed by factor analysis and criterion validity determined according to the Downton index. The incidence and the hazard ratio of falls will be analysed for the study factors included. Funding of the review was confirmed in December 2013. DISCUSSION: The rigorous assessment of STRATIFY using large samples, in populations with different levels of risk and implementing a longitudinal follow-up to determine the effect of revaluation on the incidence of falls, will give stronger evidence for the establishment of future recommendations in Clinical Practice Guidelines.

Instruments for assessing the risk of falls in acute hospitalized patients: a systematic review protocol.

AIM: The purpose of this article is to present the research protocol of a systematic review about fall risk assessment tools in acute hospitalized patients. BACKGROUND: Various risk assessment tools for falls have been developed, but with uncertainties derived from validation in heterogeneous environments and variations in their sensitivity, specificity and predictive validity. DESIGN: Systematic review and meta-analysis. METHODS: Two independent reviewers will extract data in a blinded process. Quality of studies will be assessed using various standardized instruments. A meta-analysis will be performed if applicable. For all studies, sensitivity, specificity, positive and negative predictive values, together with the positive and negative likelihood ratios and Youden index will be calculated. The diagnostic odds ratio of the studies and the hierarchical summary Relative Operating Characteristic curve and bivariate model will be applied. Calculations will be made from random effects models. Forest-plot diagrams for sensitivity and specificity and likelihood ratios, in addition to Cochrane's Q test and the I(2) statistic, will be calculated. Funding of the review was confirmed in December 2010. DISCUSSION: The results of this review will help to clarify some uncertainties provoked by earlier research findings and enable informed choice of a validated, reproducible instrument for assessing the risk of falls by hospital patients, so that preventive action may be taken to minimize this risk.