Prioritising deteriorating patients using time-to-event analysis: prediction model development and internal-external validation.

BACKGROUND: Binary classification models are frequently used to predict clinical deterioration, however they ignore information on the timing of events. An alternative is to apply time-to-event models, augmenting clinical workflows by ranking patients by predicted risks. This study examines how and why time-to-event modelling of vital signs data can help prioritise deterioration assessments using lift curves, and develops a prediction model to stratify acute care inpatients by risk of clinical deterioration. METHODS: We developed and validated a Cox regression for time to in-hospital mortality. The model used time-varying covariates to estimate the risk of clinical deterioration. Adult inpatient medical records from 5 Australian hospitals between 1 January 2019 and 31 December 2020 were used for model development and validation. Model discrimination and calibration were assessed using internal-external cross validation. A discrete-time logistic regression model predicting death within 24 h with the same covariates was used as a comparator to the Cox regression model to estimate differences in predictive performance between the binary and time-to-event outcome modelling approaches. RESULTS: Our data contained 150,342 admissions and 1016 deaths. Model discrimination was higher for Cox regression than for discrete-time logistic regression, with cross-validated AUCs of 0.96 and 0.93, respectively, for mortality predictions within 24 h, declining to 0.93 and 0.88, respectively, for mortality predictions within 1 week. Calibration plots showed that calibration varied by hospital, but this can be mitigated by ranking patients by predicted risks. CONCLUSION: Time-varying covariate Cox models can be powerful tools for triaging patients, which may lead to more efficient and effective care in time-poor environments when the times between observations are highly variable.

Construction of a Risk Prediction Model for the Occurrence of Acute Skin Failure in Critically Ill Patients: A Prospective Study.

BACKGROUND: The risk factors for acute skin failure (ASF), a serious complication of the skin, are not fully understood. PURPOSE: This study was designed to explore the risk factors for ASF in critically ill patients and construct a clinical prediction model. METHODS: Intensive care unit patients were prospectively observed and assigned into two groups: with and without ASF. A logistic regression model was constructed, and its predictive power and clinical utility were evaluated. RESULTS: Of the 204 eligible patients enrolled as participants, 58 (28.43%) developed ASF. Sepsis, vasoactive drugs, and age were shown to be risk factors for ASF, whereas peripheral perfusion index ratio and albumin level were shown to be protective factors. The area under the receiver operating characteristic curve was 0.83. The maximum Youden index of the model was 0.39 (specificity: 0.87, sensitivity: 0.77). The Hosmer-Lemeshow test (p = .20) and calibration curve showed good fitness and predictive utility with respect to the model. CONCLUSIONS: The developed model effectively predicts ASF risk, allowing for the early identification of high-risk patients. Identifying risk factors such as sepsis, vasoactive drugs, and age and considering protective factors such as peripheral perfusion index and albumin levels may help optimize care plans. Clinical staff should pay special attention to these factors and their impact on skin health in critically ill patients.

Development of a quantitative index system for evaluating the quality of electronic medical records in disease risk intelligent prediction.

OBJECTIVE: This study aimed to develop and validate a quantitative index system for evaluating the data quality of Electronic Medical Records (EMR) in disease risk prediction using Machine Learning (ML). MATERIALS AND METHODS: The index system was developed in four steps: (1) a preliminary index system was outlined based on literature review; (2) we utilized the Delphi method to structure the indicators at all levels; (3) the weights of these indicators were determined using the Analytic Hierarchy Process (AHP) method; and (4) the developed index system was empirically validated using real-world EMR data in a ML-based disease risk prediction task. RESULTS: The synthesis of review findings and the expert consultations led to the formulation of a three-level index system with four first-level, 11 second-level, and 33 third-level indicators. The weights of these indicators were obtained through the AHP method. Results from the empirical analysis illustrated a positive relationship between the scores assigned by the proposed index system and the predictive performances of the datasets. DISCUSSION: The proposed index system for evaluating EMR data quality is grounded in extensive literature analysis and expert consultation. Moreover, the system's high reliability and suitability has been affirmed through empirical validation. CONCLUSION: The novel index system offers a robust framework for assessing the quality and suitability of EMR data in ML-based disease risk predictions. It can serve as a guide in building EMR databases, improving EMR data quality control, and generating reliable real-world evidence.

Development and psychometric evaluation of the death risk perception scale for advanced cancer patients.

BACKGROUND: An accurate perception of death risk is a prerequisite for advanced cancer patients to make informed end-of-life care decisions. However, there is to date no suitable scale to measure death risk perception. This study was to develop and psychometrically test the death risk perception scale (DRPS) for advanced cancer patients. METHODS: Process of instrument development and psychometric evaluation were used. First, qualitative research, a literature review, brainstorming, a Delphi study, and cognitive interviews were conducted to construct a pretest scale of death risk perception. Second, a scale-based survey was administered to 479 advanced cancer patients. Item, exploratory factor, and confirmatory factor analyses were employed to optimize the scale. The Cronbach's alpha was calculated as a reliability analysis. The validity analysis included construct, convergent, discriminant, and content validity values. RESULTS: A three-dimension, 12-item scale was developed, including deliberative, affective, and experiential risk perception. The confirmatory factor analysis supported the three-factor model with satisfactory convergent and discriminant validity levels. The Cronbach's alpha coefficient for internal consistency was 0.807 and scale-level content validity index was 0.98. CONCLUSIONS: The 12-item DRPS is a reliable and valid instrument for assessing the level of death risk perception in advanced cancer patients. More studies are needed to examine its structure and robustness prior to use.

Development and validation of a risk prediction model for community-acquired pressure injury in a cancer population: A case-control study.

BACKGROUND: Patients with cancer are susceptible to pressure injuries, which accelerate deterioration and death. In patients with post-acute cancer, the risk of pressure injury is ignored in home or community settings. OBJECTIVE: To develop and validate a community-acquired pressure injury risk prediction model for cancer patients. METHODS: All research data were extracted from the hospital's electronic medical record system. The identification of optimal predictors is based on least absolute shrinkage and selection operator regression analysis combined with clinical judgment. The performance of the model was evaluated by drawing a receiver operating characteristic curve and calculating the area under the curve (AUC), calibration analysis and decision curve analysis. The model was used for internal and external validation, and was presented as a nomogram. RESULTS: In total, 6257 participants were recruited for this study. Age, malnutrition, chronic respiratory failure, body mass index, and activities of daily living scores were identified as the final predictors. The AUC of the model in the training and validation set was 0.87 (95 % confidence interval [CI], 0.85-0.89), 0.88 (95 % CI, 0.85-0.91), respectively. The model demonstrated acceptable calibration and clinical benefits. CONCLUSIONS: Comorbidities in patients with cancer are closely related to the etiology of pressure injury, and can be used to predict the risk of pressure injury. IMPLICATIONS FOR PRACTICE: This study provides a tool to predict the risk of pressure injury for cancer patients. This suggests that improving the respiratory function and nutritional status of cancer patients may reduce the risk of community-acquired pressure injury.

Assessing the safety of physical rehabilitation in critically ill patients: a Delphi study.

BACKGROUND: Physical rehabilitation of critically ill patients is implemented to improve physical outcomes from an intensive care stay. However, before rehabilitation is implemented, a risk assessment is essential, based on robust safety data. To develop this information, a uniform definition of relevant adverse events is required. The assessment of cardiovascular stability is particularly relevant before physical activity as there is uncertainty over when it is safe to start rehabilitation with patients receiving vasoactive drugs. METHODS: A three-stage Delphi study was carried out to (a) define adverse events for a general ICU cohort, and (b) to define which risks should be assessed before physical rehabilitation of patients receiving vasoactive drugs. An international group of intensive care clinicians and clinician researchers took part. Former ICU patients and their family members/carers were involved in generating consensus for the definition of adverse events. Round one was an open round where participants gave their suggestions of what to include. In round two, participants rated their agreements with these suggestions using a five-point Likert scale; a 70% consensus agreement threshold was used. Round three was used to re-rate suggestions that had not reached consensus, whilst viewing anonymous feedback of participant ratings from round two. RESULTS: Twenty-four multi-professional ICU clinicians and clinician researchers from 10 countries across five continents were recruited. Average duration of ICU experience was 18 years (standard deviation 8) and 61% had publications related to ICU rehabilitation. For the adverse event definition, five former ICU patients and one patient relative were recruited. The Delphi process had a 97% response rate. Firstly, 54 adverse events reached consensus; an adverse event tool was created and informed by these events. Secondly, 50 risk factors requiring assessment before physical rehabilitation of patients receiving vasoactive drugs reached consensus. A second tool was created, informed by these suggestions. CONCLUSIONS: The adverse event tool can be used in studies of physical rehabilitation to ensure uniform measurement of safety. The risk assessment tool can be used to inform clinical practise when risk assessing when to start rehabilitation with patients receiving vasoactive drugs. Trial registration This study protocol was retrospectively registered on https://www.researchregistry.com/ (researchregistry2991).

The frequency of pressure injury in level 3 intensive care units and determination of risk factors: A cross-sectional study.

AIM: This study was carried out to determine the prevalence of pressure injury and risk factors in patients hospitalized in a university hospital's level 3 intensive care unit. DESIGN: It is a descriptive, prospective, observational type study. METHOD: The sample of the study consisted of 176 patients aged 18 and over who were admitted to the intensive care units of a University Hospital for at least 24 h. Patient Information Form and Braden Risk Assessment Scale, Glasgow Coma Scale were used to collect data. IBM SPSS Statistics 20 program was used to analyze the data. RESULTS: Presence of chronic disease in the development of pressure injury (22.7%), high-risk patients according to the Glasgow Coma Scale (21%), high-risk patients according to the Braden Risk Assessment Scale (84.2%), low hemoglobin (31%), low albumin levels (32.4%) and duration of stay in the intensive care unit until the day of evaluation were found to be independent risk factors (p < 0.05). The prevalence of pressure injury was determined to be 32.4%, and the rate of pressure injury due to medical devices was 7.4%. CONCLUSION: Pressure injuries are still common in adult intensive care patients. In terms of patient safety, it is important to give more space to care standards and awareness-raising research and training to prevent pressure injuries.

Complementing Braden scale for pressure ulcer risk with clinical and demographic-related factors in a large cohort of hospitalized Italian patients.

AIMS: To determine the prevalence, risk, and determinants of pressure ulcer risk in a large cohort of hospitalized patients. DESIGN: A prospective cross-sectional study with data collection in January 2023. METHODS: Registered nurses collected data from 798 patients admitted to 27 health care units of an Italian hospital. The pressure ulcer risk was assessed using the Braden scale. The presence of comorbidities was collected from clinical reports. Obesity was assessed according to international indicators (Body Mass Index). The receiver operating characteristic (ROC) curve was used to estimate the sensitivity and specificity of different Braden scores for identifying participants with pressure ulcers. RESULTS: The prevalence of pressure ulcers was 9.5%, and 57.4% of the sample were at risk of developing pressure ulcers. The area under the ROC curve was 0.88. The best sensitivity and specificity were found for a Braden cutoff score of 15.5 (sensibility = 0.76; specificity = 0.85). The determinants of lower Braden scores were older age (p < 0.001), comorbidities (p < 0.001), wounds of other nature (p = 0.001), urinary incontinence (p < 0.001), fecal incontinence (p < 0.001), and urinary catheterization (p < 0.001). CONCLUSION: Several demographic factors and specific clinical indicators have been identified as determinants of the risk of developing pressure ulcers, which are easily ascertainable by healthcare providers; thus, they may routinely complement the Braden Scale in the assessment of pressure ulcer risk in order to reinforce and accelerate clinical judgment.

Psychometric properties of the Braden scale to assess pressure injury risk in intensive care: A systematic review.

OBJECTIVE: To analyse the psychometric properties of the Braden scale to assess pressure injury risk in adults in intensive care. DESIGN: A systematic review was conducted, with literature searches undertaken in five electronic databases. No date limits were applied. Selection, data extraction and risk of bias assessment were completed by two reviewers independently. A customised data extraction template was used, with risk of bias conducted using the COSMIN Risk of Bias checklist. Data were analysed using narrative synthesis. RESULTS: Thirty-four studies met inclusion criteria. Two studies reported internal consistency with Cronbach's alpha ranging from poor (0.43) to good (0.85). For interrater reliability, only four studies reported intraclass correlation, ranging from 0.66 to 0.96 for Braden sum score. Three studies reported convergent validity, with strong associations found between the COMHON Index (r = 0.70), Cubbin-Jackson scale (r = 0.80), and Norton scale (r = 0.77), but contrasting associations with the Waterlow score (r = 0.22 to 0.72). A large majority of studies reported predictive validity (n = 29), with wide variability. Several studies investigated optimal cut-off scores, with the majority indicating this was in the range of 12-14. CONCLUSIONS: This review demonstrates inconsistency in the psychometric properties of the Braden scale in ICU settings. Further research is needed to determine suitability of the Braden scale for ICU before it can be recommended as standard for clinical practice, including comparison with other ICU-specific risk assessment tools. IMPLICATIONS FOR CLINICAL PRACTICE: When used in ICU, the reliability, validity and reported cut-off scores of the Braden scale are variable. As a predictive tool, the scale should be used cautiously. In ICU, the value of the Braden scale resides in its ability to identify patients that are most at risk of developing a pressure injury and to implement preventative measures to mitigate identified risk factors.

Pressure ulcer risk assessment in the ICU. Is it time for a more objective measure?

BACKGROUND: The Braden scale, one of the most widely used risk assessment tools is often criticized when used in the Intensive Care Unit. Most patients in the Intensive Care Unit are at risk of pressure ulcer development meaning that the Braden score will usually indicate high risk for these patients. This study set out to determine the correlation between Sub-Epidermal Moisture measurements and Braden scores among Intensive Care Unit patients. METHODS: This study employed an observational research design. Braden score was assessed on all study days (1-5), in addition to visual skin assessment and Sub-Epidermal Moisture measurements at the sacrum and heels. Sub-Epidermal Moisture measurements were categorised as low (<0.5), borderline abnormal (≥0.5), and high (≥0.8). Correlation was assessed between Sub-Epidermal Moisture levels and Braden scores. RESULTS: A total of 53 participants were recruited. The median (interquartile range) baseline Braden score was 9 (9-10) and 81 % (n = 43) of participants were at very high/high risk of pressure ulcer development. Braden scores remained relatively constant over time with little fluctuation in scores. 19 % (n = 10) of patients had normal (<0.5) Sub-Epidermal Moisture delta measurements on enrolment, and all developed abnormal measurements by day 2. There were no significant correlations between Braden scores and Sub-Epidermal Moisture measurements. CONCLUSION: Although this was not its original intention, a missing link with the Braden scale is that it does not provide information on how patients are responding to the adverse effects of pressure and shear forces. Furthermore, in patients who are critically unwell, most patients are classified as being "at risk" of pressure ulcer development. Therefore, an objective measure of how patients are responding to pressure and shear forces at different anatomical areas is needed. IMPLICATIONS TO CLINICAL PRACTICE: Sub-Epidermal Moisture measurements can offer more information, not only on identifying those who are at risk, but also how those patients are tolerating this risk at different anatomical sites.

Assessment of pressure injury risk in intensive care using the COMHON index: An interrater reliability study.

OBJECTIVES: To assess the interrater reliability of the COMHON (level of COnciousness, Mobility, Haemodynamics, Oxygenation, Nutrition) Index pressure injury risk assessment tool. DESIGN: Interrater reliability was tested. Twenty-five intensive care patients were each assessed by five different nurse-raters from a pool of intensive care nurses who were available on the days of assessment. In total, 25 nurses participated. SETTING: Two general and one cardiovascular surgery intensive care units in Istanbul, Turkey. MAIN OUTCOME MEASURES: Interrater reliability was analysed using intraclass correlations, and standard errors of measurement (SEM) were calculated for sum scores, risk level and item scores. Minimally detectable change (MDC) was also calculated for sum score. Consistency between paired raters was analysed using Pearson's Product Moment Correlation (r) for sum score and Spearman's rho (rs) for ordinal variables. RESULTS: All assessments were completed in ≤5 min. Interrater reliability was very high [ICC (1,1) = 0.998 (95 % CI 0.996 - 0.999)] with a SEM of 0.14 and MDC of 0.39. Consistency between paired raters was strong for sum and item scores and risk levels (coefficients >0.6). All scale items showed correlations of >.3 with the sum score. CONCLUSION: The results demonstrate near-perfect interrater reliability. Further research into the psychometric properties of the COMHON Index and its impact on preventative intervention use is warranted. IMPLICATIONS FOR CLINICAL PRACTICE: Pressure injury risk assessment within intensive care should be setting-specific due to the unique risk factors inherent to the patient population, which are not considered by general pressure injury risk assessment tools. An intensive care-specific pressure injury risk assessment tool was tested and demonstrated high reliability between intensive care nurses. Further research is needed to understand how its use in practice affects preventative intervention implementation and, in turn, how it impacts pressure injury outcomes.

Guía para la gestión de riesgos de los dispositivos médicos para el diagnóstico / Risk management guidance for diagnostic medical devices

Introducción: Los fabricantes de los dispositivos médicos no siempre disponen de experiencia para realizar un proceso de gestión de riesgos que cumpla con la norma ISO 14971:2019 e incluya los requisitos metrológicos necesarios; por tanto, para un mejor uso de estos equipos, especialmente los de diagnóstico, se debe implementar y mantener un proceso de gestión de riesgos basado en las normativas establecidas. Objetivo: Proponer una guía para la gestión de los riesgos indirectos en pacientes con diagnósticos incorrectos o retrasados. Métodos: Se revisaron las normas internacionales aplicables y se analizaron expedientes de gestión del riesgo de dispositivos médicos, entre ellos reactivos para el diagnóstico in vitro. Resultados: La guía ofrece elementos orientadores para cada etapa del proceso de gestión de riesgos en los dispositivos médicos para el diagnóstico: plan de gestión del riesgo, análisis, valoración y control del riesgo, evaluación del riesgo residual global, revisión de la gestión de riesgo y retroalimentación a partir de la información de producción o posproducción. Conclusiones: Esta guía es una herramienta útil para diseñadores, fabricantes, evaluadores de dispositivos médicos para el diagnóstico, asesores en temas de gestión de riesgos y la calidad de los dispositivos y personal médico(AU)

Introduction: Manufacturers of medical devices do not always have the expertise to perform a risk management process that complies with ISO 14971:2019 and includes the necessary metrological requirements; therefore, for better use of these devices, especially diagnostic devices, a risk management process based on established regulations should be implemented and maintained. Objective: To provide guidance for the management of indirect risks in patients with incorrect or delayed diagnoses. Methods: Applicable international standards were reviewed and risk management dossiers for medical devices, including in-vitro diagnostic reagents, were analyzed. Results: The guidance provides guiding elements for each step of the risk management process for diagnostic medical devices: risk management plan, risk analysis, risk assessment, risk evaluation and control, overall residual risk assessment, risk management review, and feedback from production or post-production information. Conclusions: This guide is a useful tool for designers, manufacturers, evaluators of diagnostic medical devices, risk management and device quality assessors, and medical personnel(AU)

Prognostic Prediction of Cardiopulmonary Exercise Test Parameters in Heart Failure Patients with Atrial Fibrillation / Previsão Prognóstica dos Parâmetros do Teste de Esforço Cardiopulmonar em Pacientes com Insuficiência Cardíaca e Fibrilação Atrial

Abstract Background: Atrial fibrillation (AF) is associated with increased mortality in heart failure (HF) patients. Objective: To evaluate whether the risk of AF patients can be precisely stratified by relation with cardiopulmonary exercise test (CPET) cut-offs for heart transplantation (HT) selection. Methods: Prospective evaluation of 274 consecutive HF patients with left ventricular ejection fraction ≤ 40%. The primary endpoint was a composite of cardiac death or urgent HT in 1-year follow-up. The primary endpoint was analysed by several CPET parameters for the highest area under the curve and for positive (PPV) and negative predictive value (NPV) in AF and sinus rhythm (SR) patients to detect if the current cut-offs for HT selection can precisely stratify the AF group. Statistical differences with a p-value <0.05 were considered significant. Results: There were 51 patients in the AF group and 223 in the SR group. The primary outcome was higher in the AF group (17.6% vs 8.1%, p = 0.038). The cut-off value of pVO2 for HT selection showed a PPV of 100% and an NPV of 95.5% for the primary outcome in the AF group, with a PPV of 38.5% and an NPV of 94.3% in the SR group. The cut-off value of VE/VCO2 slope showed lower values of PPV (33.3%) and similar NPV (92.3%) to pVO2 results in the AF group. Conclusion: Despite the fact that AF carries a worse prognosis for HF patients, the current cut-off of pVO2 for HT selection can precisely stratify this high-risk group.

Resumo Fundamento: A fibrilação atrial (FA) está associada ao aumento da mortalidade em pacientes com insuficiência cardíaca (IC). Objetivo: Avaliar se o risco de pacientes com FA pode ser estratificado com precisão em relação aos pontos de corte do teste de esforço cardiopulmonar (TECP) para seleção do transplante cardíaco (TC). Métodos: Avaliação prospectiva de 274 pacientes consecutivos com IC com fração de ejeção do ventrículo esquerdo ≤ 40%. O endpoint primário foi um composto de morte cardíaca ou TC urgente no seguimento de 1 ano. O endpoint primário foi analisado através de vários parâmetros do TECP para a maior área sob a curva e para o valor preditivo positivo (VPP) e negativo (VPN) em pacientes com FA e ritmo sinusal (RS) para detectar se os atuais pontos de corte para a seleção de TC podem estratificar com precisão o grupo com FA. Diferenças estatísticas com valor de p < 0,05 foram consideradas significativas. Resultados: Havia 51 pacientes no grupo de FA e 223 no grupo RS. O endpoint primário foi maior no grupo FA (17,6% vs. 8,1%, p = 0,038). O valor de corte de pVO2 para a seleção do TC mostrou um VPP de 100% e um VPN de 95,5% para o endpoint primário no grupo FA, com um VPP de 38,5% e um VPN de 94,3% no grupo RS. O valor de corte da inclinação VE/VCO2 apresentou valores mais baixos de VPP (33,3%) e valor semelhante de VPN (92,3%) aos resultados de pVO2 no grupo FA. Conclusões: Apesar do fato de a FA apresentar um pior prognóstico para os pacientes com IC, o atual ponto de corte de pVO2 para a seleção de TC pode estratificar com precisão esse grupo de alto risco.

Evaluation of user embracement software with pediatric risk classification / Evaluación del software para el acogimiento con clasificación de riesgo en pediatria / Avaliação de software para acolhimento com classificação de risco em pediatria

ABSTRACT Objective: to evaluate functional performance and technical quality of user embracement software with pediatric risk classification. Method: descriptive exploratory study developed based on the quality requirements set forth in ISO/IEC 25010. The evaluated characteristics were: functional adequacy, reliability, usability, performance efficiency, compatibility, safety, maintainability and portability. Eight specialists from the area of informatics and 13 from nursing participated in the evaluation. The characteristics were considered adequate when they reached more than 70% of indication as very and/or completely appropriate in the evaluations of each group of specialists. Results: The results obtained from the evaluation of informatics and nursing specialists were: functional adequacy (100.0%, 96.2%), reliability (82.6%, 88.5%), usability (84.9%; 98.7%), performance efficiency (93.4%; 96.2%), compatibility (85.0%, 98.1%), safety (91.7%, 100.0%), and, yet, maintainability (95.0%) and portability (87.5%) evaluated by the first ones. Conclusion: the software was considered adequate regarding technical quality and functional performance.

RESUMEN Objetivo: evaluar el desempeño funcional y la calidad técnica del software para el acogimiento con clasificación de riesgo en pediatría. Método: estudio exploratorio descriptivo, fundamentado en los requisitos de calidad dispuestos en la norma ISO/IEC 25.010. Las siguientes características fueron evaluadas: adecuación funcional, confiabilidad, facilidad de uso, eficiencia del desempeño, compatibilidad, seguridad, manutención y portabilidad. En la evaluación participaron 8 expertos en el área de informática y 13 en enfermería. Se consideradon adecuadas las características cuando habían alcanzado más del 70,0% de indicación como "muy y/o completamente apropiadas" en las evaluaciones de cada grupo de expertos. Resultados: Los resultados obtenidos a partir de la evaluación de los expertos en informática y en enfermería fueron respectivamente: adecuación funcional (100,0%; 96,2%); confiabilidad (82,6%; 88,5%); facilidad de uso (84,9%; 98,7%); eficiencia del desempeño (93,4%; 96,2%); compatibilidad (85,0%; 98,1%); seguridad (91,7%; 100,0%); y también manutención (95,0%) y portabilidad (87,5%) evaluados por los primeros. Conclusión: se observó que el software es adecuado en relación con la calidad técnica y el rendimiento funcional.

RESUMO Objetivo: avaliar desempenho funcional e qualidade técnica de software para acolhimento com classificação de risco em pediatria. Método: estudo exploratório descritivo desenvolvido com base nos quesitos de qualidade dispostos na norma ISO/IEC 25010. As características avaliadas foram: adequação funcional, confiabilidade, usabilidade, eficiência de desempenho, compatibilidade, segurança, manutenibilidade e portabilidade. Participaram da avaliação oito especialistas da área de informática e 13 de enfermagem. As características foram consideradas adequadas quando atingiram mais de 70,0% de indicação como muito e/ou completamente apropriadas nas avaliações de cada grupo de especialistas. Resultados: Os resultados obtidos a partir da avaliação dos especialistas de informática e de enfermagem foram respectivamente: adequação funcional (100,0%; 96,2%), confiabilidade (82,6%; 88,5%), usabilidade (84,9%; 98,7%), eficiência de desempenho (93,4%; 96,2%), compatibilidade (85,0%; 98,1%), segurança (91,7%; 100,0%), e, ainda, manutenibilidade (95,0%) e portabilidade (87,5%) avaliados pelos primeiros. Conclusão: o software foi considerado adequado em relação à qualidade técnica e ao desempenho funcional.

Translation and cultural adaptation into Brazilian Portuguese of the Finnish Diabetes Risk Score (FINDRISC) and reliability assessment / Tradução e adaptação transcultural para o português brasileiro do Escore Finlandês de Risco de Diabetes (FINDRISC) e avaliação da confiabilidade

ABSTRACT: Introduction: The Finnish Diabetes Risk Score (FINDRISC) is a tool that was initially developed to predict the risk of developing type 2 diabetes mellitus in adults. This tool is simple, quick to apply, non-invasive, and low-cost. The aims of this study were to perform a translation and cultural adaptation of the original version of FINDRISC into Brazilian Portuguese and to assess test-retest reliability. Methodology: This work was done following the ISPOR Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes Measures. Once the final Brazilian Portuguese version (FINDRISC-Br) was developed, the reliability assessment was performed using a non-random sample of 83 individuals attending a primary care health center. Each participant was interviewed by trained registered dieticians on two occasions with a mean interval of 14 days. The reliability assessment was performed by analyzing the level of agreement between the test-retest responses of FINDRISC-Br using Cohen's kappa coefficient and the intraclass correlation coefficient (ICC). Results: The steps of ISPOR guidelines were consecutively followed without major problems. Regarding the reliability assessment, the questionnaire as a whole presented adequate reliability (Cohen's kappa = 0.82, 95%CI 0.72 - 0.92 and ICC = 0.94, 95%CI 0.91 - 0.96). Conclusion: FINDRISC was translated into Brazilian Portuguese and culturally adapted following standard procedures. FINDRISC-Br has thus become available for use and has potential as a screening tool in different Brazilian settings and applications.

RESUMO: Introdução: O Escore Finlandês de Risco de Diabetes (FINDRISC) é um instrumento que inicialmente foi desenvolvido para predizer o risco de desenvolver diabetes mellitus tipo 2 em adultos. Esse instrumento é simples, rápido de aplicar, não invasivo e de baixo custo. Os objetivos deste estudo foram descrever o processo de tradução e adaptação transcultural do FINDRISC para o português do Brasil e avaliar a sua confiabilidade teste-reteste. Metodologia: O projeto foi conduzido de acordo com as recomendações dos Princípios de Boas Práticas para o Processo de Tradução e Adaptação Transcultural de Medidas de Resultados Relatados pelo Paciente desenvolvidas pela ISPOR. Uma vez desenvolvida a versão final em português brasileiro (FINDRISC-Br), realizou-se a avaliação da confiabilidade usando uma amostra não aleatória de 83 indivíduos atendidos em uma unidade de atenção básica. Cada participante foi entrevistado por nutricionistas registradas treinadas em duas ocasiões com intervalo médio de 14 dias. A avaliação da confiabilidade foi realizada por meio da análise do nível de concordância entre as respostas do teste-reteste, utilizando-se o coeficiente kappa de Cohen e o coeficiente de correlação intraclasse (CCI). Resultados: As etapas das diretrizes da ISPOR foram seguidas consecutivamente sem maiores problemas. Em relação à avaliação da confiabilidade do teste-reteste, o questionário como um todo apresentou confiabilidade adequada (kappa de Cohen = 0,82; IC95% 0,72 - 0,92 e CCI = 0,94; IC95% 0,91 - 0,96). Conclusão: O FINDRISC foi traduzido e adaptado transculturalmente para o português do Brasil seguindo procedimentos padronizados. O FINDRISC-Br já está disponível para uso e tem potencial para ser usado como ferramenta de rastreamento em diferentes cenários brasileiros.

Evaluación del riesgo biológico en el área quirúrgica de una instalación de salud / Assessment of Biological Risk in the Surgical Area of a Health Facility

RESUMEN Introducción: El personal que labora en el área quirúrgica de un hospital, está expuesto a riesgos biológicos que requieren más que un tratamiento médico. Para la prevención, además, de ocuparse de la integridad del paciente, se le ha agregado la de proteger la salud del equipo quirúrgico, susceptibles a contaminarse con objetos infectados. Estos aspectos no son de estricto cumplimiento por el personal que labora en los salones o salas quirúrgicas de hospitales y centros de salud. Objetivo: Realizar un análisis de riesgo biológico en el área quirúrgica de una instalación de salud. Métodos: Se realizó el análisis de riesgo, que consistió en tres procesos generales: evaluación del riesgo, gestión del riesgo y comunicación del riesgo. Resultados: Se identificaron y caracterizaron los peligros de contaminación a los que pueden estar sometidos los trabajadores. Se identificaron las vulnerabilidades presentes, empleándose para ello, una lista de chequeo diseñada, teniéndose en cuenta los principios de la bioseguridad y, se evaluaron los riesgos biológicos empleándose una matriz de estimación del riesgo (posibilidad por consecuencia). Conclusiones: Se discuten medidas aplicables para la gestión de la bioseguridad en áreas quirúrgicas de instituciones de salud cubanas(AU)

ABSTRACT Introduction: The personnel working in the surgical area of a hospital are exposed to biological risks requiring more than medical treatment. In view of prevention, apart from taking care of the integrity of the patient, they have been assigned protecting the health of the surgical team, which are susceptible to becoming contaminated with infected objects. These aspects are not strictly complied with by the personnel working in the operating or surgical rooms of hospitals and health centers. Objective: To assess the biological risk in the surgical area of a health facility. Methods: The risk analysis was carried out, which consisted of three general processes: risk assessment, risk management, and risk communication. Results: The contamination hazards to which workers may be subjected were identified and characterized. The existing vulnerabilities were identified using a checklist designed taking into account the biosecurity principles. The biological risks were evaluated, using a risk estimation matrix (possibility by consequence). Conclusions: Measures are discussed that can be applied for the management of biosecurity in surgical areas of Cuban health institutions(AU)

Validation by experts of Risk of suicide Nursing Diagnosis in the elderly / Validación por especialistas del Diagnóstico de Enfermería Riesgo de suicidio en ancianos / Validação por especialistas do Diagnóstico de Enfermagem Risco de suicídio em idosos

ABSTRACT Objective: to validate the conceptual and operational definitions content of factors for Risk of suicide Nursing Diagnosis in the elderly. Method: this is validation of the conceptual and operational definitions content of factors for Risk of suicide in the elderly, performed by 15 experts, from November 2015 to March 2016. Risk factors were classified into three hierarchical chuncks. The data were analyzed by descriptive statistics and binomial test. Results: of the 54 validated risk factors, only eight presented problems regarding clarity, simplicity and accuracy: chronic pain, vision problems, retirement, frustration, medication neglect and depression. Only rigidity was not validated as relevant for the study diagnosis. Conclusion: content validation of the risk factors for Nursing Diagnosis can guide the clinical practice of the nurse in the early detection of risk of suicide in the elderly.

RESUMEN Objetivo: validar el contenido de las definiciones conceptuales y operacionales de los factores del Diagnóstico de Enfermería Riesgo de suicidio en ancianos. Método: estudio de validación de contenido de las definiciones conceptuales y operativas de los factores del diagnóstico de enfermería Riesgo de suicidio en ancianos, por 15 especialistas, en noviembre de 2015 a marzo de 2016. Los factores de riesgo se clasificaron en tres bloques jerárquicos. Los datos fueron analizados por medio de estadística descriptiva y prueba binomial. Resultados: de los 54 factores de riesgo validados, ocho presentaron problemas en la claridad, simplicidad y precisión: dolor crónico, problemas visuales, jubilación, frustración, descuido con la medicación y depresión. Sólo la rigidez no fue validada como relevante para el diagnóstico. Conclusión: la validación de contenido de los factores de riesgo del diagnóstico de enfermería puede orientar la práctica clínica del enfermero en la detección precoz del riesgo de suicidio en ancianos.

RESUMO Objetivo: validar o conteúdo das definições conceituais e operacionais dos fatores do Diagnóstico de Enfermagem Risco de suicídio em idosos. Método: trata-se de validação de conteúdo das definições conceituais e operacionais dos fatores do Diagnóstico de Enfermagem Risco de suicídio em idosos, realizada por 15 especialistas, no período de novembro de 2015 a março de 2016. Os fatores de risco foram classificados em três blocos hierarquizados. Os dados foram analisados por meio de estatística descritiva e teste binomial. Resultados: dos 54 fatores de risco validados, apenas oito apresentaram problemas quanto à clareza, simplicidade e precisão: dor crônica, problemas visuais, aposentadoria, frustração, descuido com a medicação e depressão. Apenas rigidez não foi validada como relevante para o diagnóstico em estudo. Conclusão: a validação de conteúdo dos fatores de risco do Diagnóstico de Enfermagem pode nortear a prática clínica do enfermeiro na detecção precoce do risco de suicídio em idosos.

Validade e confiabilidade da versão brasileira da Johns Hopkins Fall Risk Assessment Tool para avaliação do risco de quedas / Validity and reliability of the Brazilian version of the Johns Hopkins Fall Risk Assessment Tool to assess the risk of falls

RESUMO: Objetivo: Avaliar a validade e a confiabilidade da escala Johns Hopkins Fall Risk Assessment Tool (JH-FRAT) para avaliação do risco de quedas em pacientes hospitalizados. Método: Estudo retroativo com 297 pacientes de um hospital privado de São Paulo usando dados de 2014. A validade foi avaliada por meio da acurácia (sensibilidade, especificidade, valores preditivos positivo - VPP e negativo - VPN), da validade de critério, verificando-se as associações entre a classificação do risco pelas escalas JH-FRAT e Morse, e da análise discriminante (comparação dos pacientes com e sem quedas em relação aos itens da escala e verificação de situações prévias de risco em relação ao dano ocorrido). Foram utilizados os testes de associação χ2. A confiabilidade foi avaliada por meio da reprodutibilidade teste-reteste interobservadores, usando as estatísticas Kappa ponderado quadrático e prevalence-adjusted and bias-adjusted Kappa (PABAK). Resultados: A sensibilidade foi de 97,0%, a especificidade, 14,6%, o VPP, 36,2%, e o VPN, 90,6%. A análise de critério mostrou associação (p < 0,0001) entre as avaliações pelas duas escalas. Cinco dos oito itens da escala e a classificação geral mostraram capacidade de discriminação do risco (p < 0,050). A reprodutibilidade interobservadores variou entre itens (PABAK de 0,25 a 1,00) e foi substancial na classificação do risco global (PABAK = 0,71). Conclusão: A JH-FRAT apresentou validade e confiabilidade esperadas para um instrumento de triagem do risco de quedas, podendo contribuir na aplicação de estratégias para a gestão de quedas em hospitais.

ABSTRACT: Objective: To evaluate the validity and reliability of the Johns Hopkins Fall Risk Assessment Tool (JH-FRAT), which assesses the risk of falls in hospitalized inpatients. Method: Study with 297 patients at a hospital in São Paulo, using retrospective data form 2014. Validity was assessed by accuracy (sensitivity, specificity, positive predictive value - PPV and negative predictive value - NPV) and discriminant analysis (comparison of patients with and without falls in relation to the scale items and comparison of previous risk situations in relation to the injury). The χ2 test and Fisher's exact test were used. Reliability was assessed by reproducibility between methods and interobserver test-retest comparison in a subsample of 60 patients. We used the Kappa, quadratic weighted Kappa and PABAK statistics. Results: Sensitivity was 97.0%, specificity was 6%, PPV was 36.2% and NPV was 90.6%. Five of the eight items of the scale and the overall classification showed risk discrimination capability (p < 0.050). The risk of previous situations did not discriminate the injury resulting from the falls (p = 0.557). Reproducibility between methods was substantial (PABAK = 0.71). The interobserver reproducibility ranged between items (PABAK 0.25 to 1.00) and was substantial to the overall risk classification (PABAK = 0.71). Conclusion: JH-FRAT showed validity and reliability expected of a screening tool for risk of falls, and it can contribute to the implementation of fall management strategies in hospitals.