A systematic review of sham acupuncture validation studies.

BACKGROUND: Acupuncture is widely used worldwide; however, studies on its effectiveness have been impeded by limitations regarding the design of appropriate control groups. In clinical research, noninvasive sham acupuncture techniques can only be applied through validation studies. Therefore, this systematic review aimed to evaluate the scope of existing literature on this topic to identify trends. METHODS: We queried Pubmed, EMBASE, and the Cochrane Central Register of Controlled Trials databases from inception to July 2022 for relevant articles. Author names were used to identify additional relevant articles. Two independent reviewers assessed the identified articles based on the inclusion and exclusion criteria. The following data were extracted: study design, information regarding acupuncturists and participants, general and treatment-related characteristics of the intervention and control groups, participants' experience of acupuncture, and research findings. RESULTS: The database query yielded 673 articles, of which 29 articles were included in the final review. Among these, 18 involved the use of one of three devices: Streitberger (n = 5), Park (n = 7), and Takakura (n = 6) devices. The remaining 11 studies used other devices, including self-developed needles. All the included studies were randomized controlled trials. The methodological details of the included studies were heterogeneous with respect to outcomes assessed, blinding, and results. CONCLUSIONS: Sham acupuncture validation studies have been conducted using healthy volunteers, with a focus on blind review and technological developments in sham acupuncture devices. However, theren may be language bias in our findings since we could not query Chinese and Japanese databases due to language barriers. There is a need for more efforts toward establishing control groups suitable for various acupuncture therapy interventions. Moreover, there is a need for more rigorous sham acupuncture validation studies, which could lead to higher-quality clinical studies.

Content Validity and Psychometric Properties of the German Version of the Holm and Cordoba Urinary Tract Infection Score for Uncomplicated Urinary Tract Infections in Women: Protocol for a Validation Study.

BACKGROUND: Uncomplicated urinary tract infections (UTIs) in women are among the most common bacterial infections in primary care. Given the health threats related to the overuse of antibiotics, alternative options are of increasing importance. Patient-reported outcome measures are valuable tools for including the patients' perspective when evaluating the efficacy of these strategies. Aiming to identify a suitable instrument to measure the severity and bothersomeness of UTI symptoms in women, we performed a systematic review of the literature and identified the Holm and Cordoba Urinary Tract Infection Score (HCUTI), which measures the severity, bothersomeness, and impact of uncomplicated UTIs on daily activities. This instrument showed sufficient content validity but needs translation and further validation before it can be used in German research. OBJECTIVE: For use in the German setting, we aim (1) to perform translation and linguistic validation of the HCUTI and (2) to evaluate content validity and psychometric properties of the German version of the HCUTI in a population of women with uncomplicated UTIs. METHODS: The HCUTI will be translated and linguistically validated using the dual-panel method. This process involves a bilingual translation panel and a lay panel to check the comprehensibility of the translation. Content validity of the translated questionnaire will be assessed using cognitive interviews according to the criteria for good content validity as recommended by the COSMIN (Consensus-based Standards for the selection of health Measurement Instruments) group involving women with uncomplicated UTIs and health care professionals. Subsequent psychometric validation of the German version of the HCUTI in a population of women with uncomplicated UTIs will include the assessment of structural validity, internal consistency, test-retest reliability, construct validity, responsiveness, and interpretability. RESULTS: Results of the translation and linguistic validation process and the results of the content validity study were obtained in September 2023 and will be published separately. Data on the psychometric properties of the German version of the HCUTI are anticipated in mid-2024. CONCLUSIONS: We expect that data from the content validity study will provide important suggestions for potential modifications of the HCUTI for use in the German setting. The final version of the questionnaire will be used for the assessment of its psychometric properties in a large population of women with uncomplicated UTIs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/49903.

Validation of the Scandinavian guidelines for minor and moderate head trauma in children: protocol for a pragmatic, prospective, observational, multicentre cohort study.

INTRODUCTION: Mild traumatic brain injury is common in children and it can be challenging to accurately identify those in need of urgent medical intervention. The Scandinavian guidelines for management of minor and moderate head trauma in children, the Scandinavian Neurotrauma Committee guideline 2016 (SNC16), were developed to aid in risk stratification and decision-making in Scandinavian emergency departments (EDs). This guideline has been validated externally with encouraging results, but internal validation in the intended healthcare system is warranted prior to broad clinical implementation. OBJECTIVE: We aim to validate the diagnostic accuracy of the SNC16 to predict clinically important intracranial injuries (CIII) in paediatric patients suffering from blunt head trauma, assessed in EDs in Sweden and Norway. METHODS AND ANALYSIS: This is a prospective, pragmatic, observational cohort study. Children (aged 0-17 years) with blunt head trauma, presenting with a Glasgow Coma Scale of 9-15 within 24 hours postinjury at an ED in 1 of the 16 participating hospitals, are eligible for inclusion. Included patients are assessed and managed according to the clinical management routines of each hospital. Data elements for risk stratification are collected in an electronic case report form by the examining doctor. The primary outcome is defined as CIII within 1 week of injury. Secondary outcomes of importance include traumatic CT findings, neurosurgery and 3-month outcome. Diagnostic accuracy of the SNC16 to predict endpoints will be assessed by point estimate and 95% CIs for sensitivity, specificity, likelihood ratio, negative predictive value and positive predictive value. ETHICS AND DISSEMINATION: The study is approved by the ethical board in both Sweden and Norway. Results from this validation will be published in scientific journals, and a tailored development and implementation process will follow if the SNC16 is found safe and effective. TRIAL REGISTRATION NUMBER: NCT05964764.

Avoiding a reproducibility crisis in regulatory toxicology-on the fundamental role of ring trials.

The ongoing transition from chemical hazard and risk assessment based on animal studies to assessment relying mostly on non-animal data, requires a multitude of novel experimental methods, and this means that guidance on the validation and standardisation of test methods intended for international applicability and acceptance, needs to be updated. These so-called new approach methodologies (NAMs) must be applicable to the chemical regulatory domain and provide reliable data which are relevant to hazard and risk assessment. Confidence in and use of NAMs will depend on their reliability and relevance, and both are thoroughly assessed by validation. Validation is, however, a time- and resource-demanding process. As updates on validation guidance are conducted, the valuable components must be kept: Reliable data are and will remain fundamental. In 2016, the scientific community was made aware of the general crisis in scientific reproducibility-validated methods must not fall into this. In this commentary, we emphasize the central importance of ring trials in the validation of experimental methods. Ring trials are sometimes considered to be a major hold-up with little value added to the validation. Here, we clarify that ring trials are indispensable to demonstrate the robustness and reproducibility of a new method. Further, that methods do fail in method transfer and ring trials due to different stumbling blocks, but these provide learnings to ensure the robustness of new methods. At the same time, we identify what it would take to perform ring trials more efficiently, and how ring trials fit into the much-needed update to the guidance on the validation of NAMs.

GRADE concept paper 8: judging the certainty of discrimination performance estimates of prognostic models in a body of validation studies.

BACKGROUND: Prognostic models incorporate multiple prognostic factors to estimate the likelihood of future events for individual patients based on their prognostic factor values. Evaluating these models crucially involves conducting studies to assess their predictive performance, like discrimination. Systematic reviews and meta-analyses of these validation studies play an essential role in selecting models for clinical practice. METHODS: In this paper, we outline 3 thresholds to determine the target for certainty rating in the discrimination of prognostic models, as observed across a body of validation studies. RESULTS AND CONCLUSION: We propose 3 thresholds when rating the certainty of evidence about a prognostic model's discrimination. The first threshold amounts to rating certainty in the model's ability to classify better than random chance. The other 2 approaches involve setting thresholds informed by other mechanisms for classification: clinician intuition or an alternative prognostic model developed for the same disease area and outcome. The choice of threshold will vary based on the context. Instead of relying on arbitrary discrimination cut-offs, our approach positions the observed discrimination within an informed spectrum, potentially aiding decisions about a prognostic model's practical utility.

A Predictive Noninvasive Single-Nucleotide Variation-Based Biomarker Signature for Resectable Pancreatic Cancer: Protocol for a Prospective Validation Study.

BACKGROUND: Single-nucleotide variations (SNVs; formerly SNPs) are inherited genetic variants that can be easily determined in routine clinical practice using a simple blood or saliva test. SNVs have potential to serve as noninvasive biomarkers for predicting cancer-specific patient outcomes after resection of pancreatic ductal adenocarcinoma (PDAC). Two recent analyses led to the identification and validation of three SNVs in the CD44 and CHI3L2 genes (rs187115, rs353630, and rs684559), which can be used as predictive biomarkers to help select patients most likely to benefit from pancreatic resection. These variants were associated with an over 2-fold increased risk for tumor-related death in three independent PDAC study cohorts from Europe and the United States, including The Cancer Genome Atlas cohorts (reaching a P value of 1×10-8). However, these analyses were limited by the inherent biases of a retrospective study design, such as selection and publication biases, thereby limiting the clinical use of these promising biomarkers in guiding PDAC therapy. OBJECTIVE: To overcome the limitations of previous retrospectively designed studies and translate the findings into clinical practice, we aim to validate the association of the identified SNVs with survival in a controlled setting using a prospective cohort of patients with PDAC following pancreatic resection. METHODS: All patients with PDAC who will undergo pancreatic resection at three participating hospitals in Switzerland and fulfill the inclusion criteria will be included in the study consecutively. The SNV genotypes will be determined using standard genotyping techniques from patient blood samples. For each genotyped locus, log-rank and Cox multivariate regression tests will be performed, accounting for the relevant covariates American Joint Committee on Cancer stage and resection status. Clinical follow-up data will be collected for at least 3 years. Sample size calculation resulted in a required sample of 150 patients to sufficiently power the analysis. RESULTS: The follow-up data collection started in August 2019 and the estimated end of data collection will be in May 2027. The study is still recruiting participants and 142 patients have been recruited as of November 2023. The DNA extraction and genotyping of the SNVs will be performed after inclusion of the last patient. Since no SNV genotypes have been determined, no data analysis has been performed to date. The results are expected to be published in 2027. CONCLUSIONS: This is the first prospective study of the CD44 and CHI3L2 SNV-based biomarker signature in PDAC. A prospective validation of this signature would enable its clinical use as a noninvasive predictive biomarker of survival after pancreatic resection that is readily available at the time of diagnosis and can assist in guiding PDAC therapy. The results of this study may help to individualize treatment decisions and potentially improve patient outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54042.

Validez y fiabilidad del cuestionario ARMS-e en pacientes con Diabetes mellitus tipo 2 / Validity and reliability of the ARMS-e questionnaire in patients with type 2 Diabetes mellitus

Introducción: El cuestionario “Adherence to Refills and Medications Scale” (ARMS) se diseñó para medir adherencia al tratamiento. Fue traducido y adaptado al español, pero no se han evaluado sus propiedades psicométricas. El objetivo fue evaluar dichas propiedades en una población con diabetes mellitus tipo 2. Método: El estudio se llevó a cabo en farmacias comunitarias de Granada (España) mediante entrevista. Se realizó un análisis factorial de componentes principales (AFCP) con rotación Varimax (validez de constructo), un análisis de concordancia (validez de criterio concurrente y fiabilidad por estabilidad temporal) y alfa de Cronbach y correlación ítem-total (fiabilidad por homogeneidad). Resultados: 107 pacientes entraron en el estudio. El 54,2 % (58) fueron hombres y la edad media fue 70,5 años (D.E.: 9,7). El AFCP extrajo 4 factores que explicaron el 57,49 % de la varianza total. El alfa de Cronbach= 0,428 y el test-retest κ= 0,627 (p > 0,001). Conclusiones: El ARMS-e no puede ser considerado una herramienta útil para medir la adherencia al tratamiento antidiabético oral en esta muestra. (AU)

Introduction: The Adherence to Refills and Medications Scale questionnaire (ARMS) was designed to measure ad-herence to treatment. It was translated and adapted into Spanish, but its psychometric properties have not been evaluated. The aim was to evaluate these properties in a population with type 2 diabetes mellitus. Method: The study was carried out in community pharmacies in Granada (Spain) by interview. A principal compo-nent factor analysis (PCA) with Varimax rotation (construct validity), a concordance analysis (concurrent criterion validity and reliability by temporal stability) and Cronbach’s alpha and item-total correlation (reliability by homo-geneity) were performed. Results: 107 patients entered the study. 54.2 % (58) were male and the mean age was 70.5 (SD: 9.7). The PCA extract-ed 4 factors that explained 57.49 % of the total variance. Cronbach’s alpha= 0.428, and in the test-retest κ= 0.627 (p > 0.001). Conclusions: The ARMS-e cannot be considered a useful tool to measure adherence to oral antidiabetic treatment in this sample. (AU)

Validación de la escala Short FES-I en población española mayor de 70 años / Validation of the short FES-I scale in Spanish population over 70 years

Introducción Las caídas deterioran la calidad de vida de los ancianos y el miedo a estas ha demostrado ser un factor de riesgo independiente para fragilidad, por lo que es prioritario disponer de herramientas para su evaluación. La escala ShortFalls Efficacy Scale-International (FES)-I, versión corta (siete ítems) de la escala FES-I (16 ítems), evalúa el miedo a caer (MC). El objetivo de este estudio es validar la escala Short FES-I en población española mayor de 70 años y analizar la relación entre el miedo a las caídas, el riesgo de las mismas y la fragilidad. Material y métodos Se trata de un estudio observacional transversal. La muestra consistió en 227 sujetos (50,7% varones; edad media 75,8 años). La ubicación fue en el norte de España. Las variables empleadas fueron sociodemográficas, clínicas, pruebas de ejecución Short Physical Performance Battery (SPPB) y Timed Up and Go Test (TUG), FES-I y Short FES-I. Se analizaron las propiedades psicométricas: validez y fiabilidad. Resultados La escala Short FES-I muestra excelentes consistencia interna (alfa de Cronbach = 0,90, coeficiente correlación intraclase = 0,89) y reproducibilidad test-retest (Rho Spearman = 0,76). Tiene una elevada validez de criterio concomitante analizada por su correlación con FES-I (Rho Spearman = 0,90). La validez de constructo discriminante ha sido confirmada tanto para SPPB como TUG. Short FES-I presenta buena capacidad de clasificación de fragilidad (definida por SPPB) con área bajo la curva [AUC] = 0,715; como punto de corte se propone un valor Short FES-I>8 para miedo moderado/alto de caídas. Conclusiones La escala Short FES-I es un buen instrumento para estudiar el miedo a las caídas en población española mayor de 70 años y es válida para su uso clínico y en investigación. (AU)

Introduction Falls deteriorate the quality of life of the elderly and the fear of falling has been shown to be an independent risk factor for frailty, so having tools for its evaluation is a priority. The short FES-I scale, short version (7 items) of the FES-I scale (16 items), assesses fear of falling. The objective of this study is to validate the short FES-I scale in the Spanish population over 70 years and to analyze the relationship between fear of falling, risk of falls and frailty. Material and methods Cross-sectional observational study. Sample: 227 subjects (50.7% male; mean age 75.8 years). Setting: northern Spain. Variables: sociodemographic, clinical, short physical performance battery (SPPB) and timed up and go test (TUG) execution tests, FES-I and short FES-I. Analysis of psychometric properties: validity and reliability. Results The short FES-I scale shows excellent internal consistency (Cronbach's alpha = 0.90, intraclass correlation coefficient = 0.89) and test–retest reliability (rho Spearman = 0.76). It has a high concomitant criterion validity analyzed by its correlation with FES-I (rho Spearman = 0.90). The discriminant construct validity has been confirmed for both SPPB and TUG. Short FES-I presents good capacity for frailty classification (defined by SPPB) with AUC = 0.715. As a cut-off point, a short FES-I value > 8 is proposed for moderate/high fear of falling. Conclusions The short FES-I scale is a good instrument to study fear of falling in the Spanish population over 70 years and is valid for clinical and research use. (AU)

Validación de la escala Short FES-I en población española mayor de 70 años / Validation of the short FES-I scale in Spanish population over 70 years

Introducción Las caídas deterioran la calidad de vida de los ancianos y el miedo a estas ha demostrado ser un factor de riesgo independiente para fragilidad, por lo que es prioritario disponer de herramientas para su evaluación. La escala ShortFalls Efficacy Scale-International (FES)-I, versión corta (siete ítems) de la escala FES-I (16 ítems), evalúa el miedo a caer (MC). El objetivo de este estudio es validar la escala Short FES-I en población española mayor de 70 años y analizar la relación entre el miedo a las caídas, el riesgo de las mismas y la fragilidad. Material y métodos Se trata de un estudio observacional transversal. La muestra consistió en 227 sujetos (50,7% varones; edad media 75,8 años). La ubicación fue en el norte de España. Las variables empleadas fueron sociodemográficas, clínicas, pruebas de ejecución Short Physical Performance Battery (SPPB) y Timed Up and Go Test (TUG), FES-I y Short FES-I. Se analizaron las propiedades psicométricas: validez y fiabilidad. Resultados La escala Short FES-I muestra excelentes consistencia interna (alfa de Cronbach = 0,90, coeficiente correlación intraclase = 0,89) y reproducibilidad test-retest (Rho Spearman = 0,76). Tiene una elevada validez de criterio concomitante analizada por su correlación con FES-I (Rho Spearman = 0,90). La validez de constructo discriminante ha sido confirmada tanto para SPPB como TUG. Short FES-I presenta buena capacidad de clasificación de fragilidad (definida por SPPB) con área bajo la curva [AUC] = 0,715; como punto de corte se propone un valor Short FES-I>8 para miedo moderado/alto de caídas. Conclusiones La escala Short FES-I es un buen instrumento para estudiar el miedo a las caídas en población española mayor de 70 años y es válida para su uso clínico y en investigación. (AU)

Introduction Falls deteriorate the quality of life of the elderly and the fear of falling has been shown to be an independent risk factor for frailty, so having tools for its evaluation is a priority. The short FES-I scale, short version (7 items) of the FES-I scale (16 items), assesses fear of falling. The objective of this study is to validate the short FES-I scale in the Spanish population over 70 years and to analyze the relationship between fear of falling, risk of falls and frailty. Material and methods Cross-sectional observational study. Sample: 227 subjects (50.7% male; mean age 75.8 years). Setting: northern Spain. Variables: sociodemographic, clinical, short physical performance battery (SPPB) and timed up and go test (TUG) execution tests, FES-I and short FES-I. Analysis of psychometric properties: validity and reliability. Results The short FES-I scale shows excellent internal consistency (Cronbach's alpha = 0.90, intraclass correlation coefficient = 0.89) and test–retest reliability (rho Spearman = 0.76). It has a high concomitant criterion validity analyzed by its correlation with FES-I (rho Spearman = 0.90). The discriminant construct validity has been confirmed for both SPPB and TUG. Short FES-I presents good capacity for frailty classification (defined by SPPB) with AUC = 0.715. As a cut-off point, a short FES-I value > 8 is proposed for moderate/high fear of falling. Conclusions The short FES-I scale is a good instrument to study fear of falling in the Spanish population over 70 years and is valid for clinical and research use. (AU)

Translating the potential of the urine steroid metabolome to stage NAFLD (TrUSt-NAFLD): study protocol for a multicentre, prospective validation study.

INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) affects approximately one in four individuals and its prevalence continues to rise. The advanced stages of NAFLD with significant liver fibrosis are associated with adverse morbidity and mortality outcomes. Currently, liver biopsy remains the 'gold-standard' approach to stage NAFLD severity. Although generally well tolerated, liver biopsies are associated with significant complications, are resource intensive, costly, and sample only a very small area of the liver as well as requiring day case admission to a secondary care setting. As a result, there is a significant unmet need to develop non-invasive biomarkers that can accurately stage NAFLD and limit the need for liver biopsy. The aim of this study is to validate the use of the urine steroid metabolome as a strategy to stage NAFLD severity and to compare its performance against other non-invasive NAFLD biomarkers. METHODS AND ANALYSIS: The TrUSt-NAFLD study is a multicentre prospective test validation study aiming to recruit 310 patients with biopsy-proven and staged NAFLD across eight centres within the UK. 150 appropriately matched control patients without liver disease will be recruited through the Oxford Biobank. Blood and urine samples, alongside clinical data, will be collected from all participants. Urine samples will be analysed by liquid chromatography-tandem mass spectroscopy to quantify a panel of predefined steroid metabolites. A machine learning-based classifier, for example, Generalized Matrix Relevance Learning Vector Quantization that was trained on retrospective samples, will be applied to the prospective steroid metabolite data to determine its ability to identify those patients with advanced, as opposed to mild-moderate, liver fibrosis as a consequence of NAFLD. ETHICS AND DISSEMINATION: Research ethical approval was granted by West Midlands, Black Country Research Ethics Committee (REC reference: 21/WM/0177). A substantial amendment (TrUSt-NAFLD-SA1) was approved on 26 November 2021. TRIAL REGISTRATION NUMBER: ISRCTN19370855.

COVID-19 nas prisões: validação de um inquérito de conhecimento, atitude e prática / COVID-19 en las cárceles: validación de un estudio de conocimiento, actitud y práctica / COVID-19 in prisons: validity of a knowledge, attitude and practice survey

Resumo Objetivo Validar um inquérito de conhecimento, atitude e prática sobre medidas preventivas da COVID-19 para os funcionários do sistema penitenciário, fundamentado na teoria ambientalista. Métodos Estudo metodológico desenvolvido em quatro etapas: estabelecimento da estrutura conceitual, elaboração do instrumento, validação do conteúdo por juízes e avaliação da aparência pelo público-alvo. O conteúdo de cada item foi validado quanto a objetividade, clareza e relevância. A aparência do inquérito foi avaliada quanto ao objetivo, a organização, ao estilo da escrita e a motivação. Utilizou-se o coeficiente de validação de conteúdo para avaliar a concordância entre os juízes e entre o público-alvo. Os dados foram analisados por meio de distribuições brutas, percentuais, medidas de posição e de dispersão. O índice alfa de Cronbach foi utilizado para analisar a consistência das avaliações dos juízes e do público-alvo. Resultados Quanto ao conteúdo e a aparência, os requisitos avaliados obtiveram concordância superior a 0,9. Na avaliação da consistência, obteve-se índice alfa de Cronbach > 0,9 e > 0,7, quanto ao conteúdo e à aparência, respectivamente, indicando que juízes e público-alvo tenderam a fazer avaliações similares. Conclusão O inquérito apresentou validade de conteúdo e aparência para a coleta de dados referentes a conhecimento, atitude e prática sobre prevenção da COVID-19, para os funcionários do sistema penitenciário, indicando que poderá contribuir para o planejamento e a avaliação de ações de educação em saúde.

Resumen Objetivo Validar un estudio de conocimiento, actitud y práctica sobre medidas preventivas de COVID-19 para los empleados del sistema penitenciario, fundamentado en la teoría ambientalista. Métodos Estudio metodológico llevado a cabo en cuatro etapas: establecimiento de la estructura conceptual, elaboración del instrumento, validación del contenido por jueces y evaluación de la apariencia por el público destinatario. Se validó el contenido de cada ítem respecto a la objetividad, claridad y relevancia. Se evaluó la apariencia del estudio respecto al objetivo, la organización, el estilo de escritura y la motivación. Se utilizó el coeficiente de validez de contenido para evaluar la concordancia entre los jueces y entre el público destinatario. Los datos se analizaron mediante distribuciones brutas, porcentajes, medidas de posición y de dispersión. Se utilizó el índice alfa de Cronbach para analizar la consistencia de las evaluaciones de los jueces y del público destinatario. Resultados Respecto al contenido y a la apariencia, los requisitos evaluados obtuvieron concordancia superior a 0,9. En la evaluación de la consistencia, se obtuvo un índice alfa de Cronbach > 0,9 respecto al contenido y > 0,7 respecto a la apariencia, lo que indica la tendencia de los jueces y del público destinatario a realizar evaluaciones similares. Conclusión El estudio presentó validez de contenido y apariencia para la recopilación de datos referentes a conocimiento, actitud y práctica sobre prevención de COVID-19 para empleados del sistema penitenciario, lo que indica que podrá contribuir a la planificación y evaluación de acciones de educación para la salud.

Abstract Objective To validate a knowledge, attitude and practice survey on preventive measures against COVID-19 for penitentiary system staff based on environmental theory. Methods This is a methodological study developed in four stages: conceptual structure establishment; instrument elaboration; content validity by judges; and appearance assessment by the target audience. The content of each item was validated for objectivity, clarity and relevance. Survey appearance was assessed regarding objective, organization, writing style and motivation. Content validity coefficient was used to assess agreement among judges and the target audience. Data were analyzed using gross distributions, percentages, position and dispersion measures. Cronbach's alpha index was used to analyze the consistency of judges' and target audience's assessments. Results Regarding content and appearance, the assessed requirements achieved agreement greater than 0.9. In consistency assessment, a Cronbach's alpha index > 0.9 and > 0.7 was obtained for content and appearance, respectively, indicating that judges and target audiences tended to make similar assessments. Conclusion The survey presented content and appearance validity for collecting data regarding knowledge, attitude and practice regarding COVID-19 prevention for penitentiary system staff, indicating that it could contribute to health education action planning and assessment.

Elaboração de instrumento e validação de uma matriz de competências para enfermeiros da estratégia saúde da família / Development of an instrument and validation of a competence matrix for nurses in the family health strategy / Desarrollo de un instrumento y validación de una matriz de competencias para enfermeros en la estrategia de salud de la familia

Objetivo: Descrever o processo de validação de uma matriz de competências para o Enfermeiro da Estratégia Saúde da Família. Método: Relato de experiência desenvolvido a partir da validação de uma matriz de competências utilizando o referencial de Philippe Zarifian. Resultados: É descrito o processo de validação da matriz, com nove competência e suas definições, o envio e recebimento dos questionários, o passo a passo da técnica de Delphi até o processo de validação da consistência, confiabilidade e índice de avaliação de conteúdo. Conclusão: A proposta de descrição das etapas desenvolvidas no estudo de validação de matriz de competências mostra-se adequado e pode auxiliar na elaboração destes em outras áreas da Enfermagem.

Objective: To describe the validation process of a competency matrix for the Family Health Strategy Nurse. Method: Experience report developed from the validation of a competency matrix using Philippe Zarifian's framework. Results: The validation process of the matrix is described, with nine competences and their definitions, the sending and receiving of questionnaires, the step-by-step process of the Delphi technique until the process of validation of consistency, reliability and content evaluation index. Conclusion: The proposed description of the stages developed in the study of validation of the matrix of competences is adequate and can help in the elaboration of these in other areas of Nursing.

Objetivo: Describir el proceso de validación de una matriz de competencias para el Enfermero de la Estrategia de Salud de la Familia. Método: Informe de experiencia desarrollado a partir de la validación de una matriz de competencias utilizando el frame- work de Philippe Zarifian. Resultados: Se describe el proceso de validación de la matriz, con nueve competencias y sus definiciones, el envío y recepción de cuestionarios, el pro- ceso paso a paso de la técnica Delphi hasta el proceso de validación de consistencia, con- fiabilidad y evaluación de contenido. índice. Conclusión: La descripción propuesta de las etapas desarrolladas en el estudio de validación de la matriz de competencias es adecuada y puede auxiliar en la elaboración de estas en otras áreas de Enfermería.

Construção e validação de cartilha educativa sobre suporte básico de vida para estudantes do ensino médio / Construction and validation of an educational booklet on basic life support for high school students / Construcción y validación de carpeta educativa sobre soporte vital básico para estudiantes de secundaria

O objetivo deste estudo é construir e validar uma cartilha educativa para estudantes do ensino médio sobre Suporte Básico de Vida nas escolas. Trata-se de uma pesquisa metodológica, realizada em três etapas. Na primeira etapa foi realizada revisão bibliográfica, na segunda etapa procedeu-se a elaboração da cartilha educativa e por fim, a validação do material por especialistas. Entre os resultados destaca-se que a cartilha aborda as principais recomendações acerca da segurança do socorrista e suporte básico de vida no adulto e possui 14 páginas. Conclui-se que todos os itens da cartilha educativa obtiveram índice de validade de conteúdo maior que 0,82 conseguindo a validação.

The objective of this study is to build and validate an educational booklet for high school students about Basic Life Support in schools. This is a methodological research, carried out in three stages. In the first stage, a bibliographic review was carried out, in the second stage, the educational booklet was elaborated and, finally, the material was validated by specialists in the subject. Among the results, it is highlighted that the booklet addresses the main recommendations regarding rescuer safety and basic adult life support and has 14 pages. It was concluded that all items in the educational booklet had a content validity index greater than 0.82, achieving validation.

El objetivo de este estudio es construir y validar una cartilla educativa para estudiantes de secundaria sobre Soporte Vital Básico en las escuelas. Se trata de una investigación metodológica, realizada en tres etapas. En la primera etapa se realizó una revisión bibliográfica, en la segunda etapa se elaboró la cartilla educativa y, finalmente, el material fue validado por especialistas en el tema. Entre los resultados, se destaca que la cartilla aborda las principales recomendaciones sobre seguridad del reanimador y soporte vital básico del adulto y tiene 14 páginas. Se concluyó que todos los ítems de la cartilla educativa tuvieron un índice de validez de contenido superior a 0,82, lográndose la validación.

Interpersonal forgiveness: validation of the Enright Forgiveness Inventory (EFI-30) in aSpanish sample / Perdón interpersonal: validación del Enright Forgiveness Inventory (EFI-30) en una muestra española

Antecedentes: Diversos estudios demuestran la relevancia del per-dón interpersonal tras una ofensa para mejorar la salud y el bienestar. A pe-sar de su importancia, es evidente la falta de instrumentos de evaluación del perdón adaptados al contexto español. El Enright Forgiveness Inventory (EFI-30) es el instrumento que operacionaliza uno de los modelos teóricos más asentados y reconocidos en el área del perdón a nivel mundial. El obje-tivo del presente estudio es adaptar el EFI-30 a la población española y re-visar suspropiedades psicométricas. Método: 426 estudiantes de grado y más-ter (98 hombres y 328 mujeres) con edades entre 18 y 30 años (M= 21.24; DE= 2.91), completaron el EFI-30 tras su adaptación, así como Trans-gression Related Interpersonal Motivations Inventory (TRIM-18), Reme-dial Strategies Scale (RSS) y Depression Anxiety and Stress Scale (DASS-21). Resultados: El Análisis Factorial Confirmatorio indicó buen ajuste a la estructura original de seis factores (CFI=.91, TLI=.90, IFI=.91, RMSEA= .067). La fiabilidad de las subescalas y del instrumento general fue buena, similar a la versión original. Los resultados mostraron adecuada validez convergente y de criterio. Conclusiones:EFI-30 muestra adecuadas propiedades psicométricas en un contexto español, siendo una medida apropiada para evaluar el perdón interpersonal de una ofensa especifica en al ámbito de la investigación e intervención clínica.(AU)

Background: Numerous studies have demonstrated the im-portance of interpersonal forgiveness after a specific offense for improving the health and well-being of individuals. Despite its importance, there is an evident lack of forgiveness evaluation instruments adapted to the Spanish context. The Enright Forgiveness Inventory (EFI-30) is the questionnaire that implements one of themost establishedand recognized theoretical models in thearea offorgiveness. The aim of the present study is to adapt the EFI-30 for the Spanish population and evaluate its psychometric prop-erties. Method: A sample of 426 undergraduate and graduate students (98 men, 328 women) aged from 18 to 30 years (M= 21.24; SD=2.91), com-pleted the EFI-30 after its adaptation to the Spanishcontext, as well as the Transgression Related Interpersonal Motivations Inventory (TRIM-18), the Remedial Strategies Scale (RSS) and the Depression Anxiety and Stress Scale (DASS-21). Results: The Confirmatory Factor Analysis showed a good fit tothe original six-factor structure (CFI=.91, TLI=.90, IFI=.91, RMSEA= .067). The reliability of these subscales and the instrument was similar to the original version. The results showed adequate criteria and convergent validity. Conclusions:The EFI-30 shows adequatepsycho-metric properties within the Spanish context and is an appropriate instru-ment for evaluating interpersonal forgiveness of a specific offense in re-search and clinical intervention.(AU)

Validation of the DYOP visual acuity test

Purpose: The dynamic optotype (DYOP) visual acuity (VA) test is based on motion detection rather than element resolution and has been proposed for routine clinical assessment. This investigation examined the validity, inter- and intra-session repeatability and subjective preference for the DYOP versus a static letter chart and examined its utility in detecting astigmatic defocus. Methods: VA of 103 participants was measured three times with the letter and DYOP charts and repeated within two weeks in 75 participants who also rated their subjective experience. The VA of 29 participants was measured using DYOP, letter, Landolt C, and Tumbling E charts, with habitual correction and astigmatism induced with +1.00, +2.00 or +3.00 cylinders at 45, 60, 90 and 180°. Results: The charts differed by a mean of 0.02 logMAR, with 81% of the measurements within one line of acuity. Inter-session, intraclass correlation coefficients, within-subject SD and repeatability were 0.03 logMAR, 0.95, 0.11 and 0.30 versus 0.01 logMAR, 0.92, 0.15 and 0.42 for the DYOP and letter charts, respectively. The DYOP was significantly more frustrating (1.79 vs.1.36), with 59% preferring the letter chart. The DYOP was least affected by induced astigmatism. Conclusions: The DYOP and letter charts differed significantly in their mean values with wide limits of agreement. DYOP had better within-subject SD and narrower limits of agreement between sessions, though clinically insignificant, and performed significantly worse for the detection of uncorrected astigmatism. Thus, it is difficult to recommend this test for the clinical determination of refractive error. (AU)

Validation of the culturally adapted Edinburgh postpartum depression scale among east Asian, southeast Asian and south Asian populations: A scoping review.

The Edinburgh Postnatal Depression Scale (EPDS) is a widely used self-report instrument to screen for postpartum depression (PPD). Assessing the relevance of the EPDS as a screening tool for minority ethnic populations is pertinent for ensuring culturally appropriate care. This scoping review aimed to explore what is known about the cultural adaptations of the EPDS in antepartum and postpartum mothers and fathers in East Asian, Southeast Asian and South Asian populations, and to what extent these adaptations are able to accurately screen for postpartum depression symptoms among these cultural groups. The scoping review was guided by the PRISMA-ScR checklist. The search strategy included databases of MEDLINE, PsycINFO, EMBASE, CINAHL and Grey literature. Included studies were primary articles published in English language peer-reviewed journals that investigated the validation or cultural adaptation of the EPDS in mothers who were pregnant and/or had recently given birth, or fathers who were new parents, and were limited to the following cultural groups, whether living locally or abroad in a foreign country: East Asian, Southeast Asian or South Asian populations. Thirty-six of 2469 studies met criteria for inclusion. Twenty-one of 36 studies utilizing a culturally validated EPDS demonstrated a cut-off score lower than the original recommended cut-off. Important themes identified included the Role of Culture, Somatization of PPD, Method of Interview, and contrasting performance compared to other scales used to assess depression and/or anxiety. Accessibility to translated and validated EPDS and mindfulness of ethnically relevant EPDS cut-off scores are critical when using this tool among minority ethnic populations.

Inteligencia artificial en enfermedades infecciosas / Artificial intelligence in infectious diseases

Estamos asistiendo a una verdadera revolución tecnológi-ca en el campo de la salud. Los procesos basados en la aplicación de la inteligencia artificial (IA) y el aprendizaje automático (AA) están llegando progresivamente a todas las áreas disciplinares, y su aplicación en el campo de las enfermedades infecciosas es ya vertiginoso, acelerado por la pandemia de COVID-19.Hoy disponemos de herramientas que no solamente pue-den asistir o llevar adelante el proceso de toma de deci-siones basadas en guías o algoritmos, sino que también pueden modificar su desempeño a partir de los procesos previamente realizados. Desde la optimización en la identificación de microorganis-mos resistentes, la selección de candidatos a participar en ensayos clínicos, la búsqueda de nuevos agentes terapéu-ticos antimicrobianos, el desarrollo de nuevas vacunas, la predicción de futuras epidemias y pandemias, y el segui-miento clínico de pacientes con enfermedades infecciosas hasta la asignación de recursos en el curso de manejo de un brote son actividades que hoy ya pueden valerse de la inteligencia artificial para obtener un mejor resultado. El desarrollo de la IA tiene un potencial de aplicación expo-nencial y sin dudas será uno de los determinantes principa-les que moldearán la actividad médica del futuro cercano.Sin embargo, la maduración de esta tecnología, necesaria para su inserción definitiva en las actividades cotidianas del cuidado de la salud, requiere la definición de paráme-tros de referencia, sistemas de validación y lineamientos regulatorios que todavía no existen o son aún solo inci-pientes

We are in the midst of a true technological revolution in healthcare. Processes based upon artificial intelligence and machine learning are progressively touching all disciplinary areas, and its implementation in the field of infectious diseases is astonishing, accelerated by the COVID-19 pandemic. Today we have tools that can not only assist or carry on decision-making processes based upon guidelines or algorithms, but also modify its performance from the previously completed tasks. From optimization of the identification of resistant pathogens, selection of candidates for participating in clinical trials, the search of new antimicrobial therapeutic agents, the development of new vaccines, the prediction of future epidemics and pandemics, the clinical follow up of patients suffering infectious diseases up to the resource allocation in the management of an outbreak, are all current activities that can apply artificial intelligence in order to improve their final outcomes.This development has an exponential possibility of application, and is undoubtedly one of the main determinants that will shape medical activity in the future.Notwithstanding the maturation of this technology that is required for its definitive insertion in day-to-day healthcare activities, should be accompanied by definition of reference parameters, validation systems and regulatory guidelines that do not exist yet or are still in its initial stages

Measurement of person-centred consultation skills among healthcare practitioners: a systematic review of reviews of validation studies.

BACKGROUND: Person-centred care is integral to high-quality health service provision, though concepts vary and the literature is complex. Validated instruments that measure person-centred practitioner skills, and behaviours within consultations, are needed for many reasons, including in training programmes. We aimed to provide a high-level synthesis of what was expected to be a large and diverse literature through a systematic review of existing reviews of validation studies a of instruments that measure person-centred practitioner skills and behaviours in consultations. The objectives were to undertake a critical appraisal of these reviews, and to summarise the available validated instruments and the evidence underpinning them. METHODS: A systematic search of Medline, EMBASE, PsycINFO and CINAHL was conducted in September 2020. Systematic reviews of validation studies of instruments measuring individual practitioner person-centred consultation skills or behaviours which report measurement properties were included. Review quality was assessed with the Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses. Details of the reviews, the included validation studies, and the instruments themselves are tabulated, including psychometric data, and a narrative overview of the reviews is provided. RESULTS: Four reviews were eligible for inclusion. These used different conceptualisations of person-centredness and targeted distinct, sometimes mutually exclusive, practitioners and settings. The four reviews included 68 unique validation studies examining 42 instruments, but with very few overlaps. The critical appraisal shows there is a need for improvements in the design of reviews in this area. The instruments included within these reviews have not been subject to extensive validation study. DISCUSSION: There are many instruments available which measure person-centred skills in healthcare practitioners and this study offers a guide to what is available to researchers and research users. The most relevant and promising instruments that have already been developed, or items within them, should be further studied rigorously. Validation study of existing material is needed, not the development of new measures.

Observations on strategies used by people with dementia to manage being assessed using validated measures: A pilot qualitative video analysis.

BACKGROUND: Analysis of video data was conducted of validated assessments with people with dementia as part of a feasibility control study comparing a lifelong learning service with other dementia services. OBJECTIVE: The aim was to provide a new perspective on what occurs during the assessment process when using validated measures in research and explore which strategies people with dementia use to manage their participation. DESIGN: Video recordings were made of pre- and postintervention assessments of people with dementia. An initial pilot analysis of 10 videos of the pre-assessments was conducted. SETTING: Lifelong learning services and other dementia services situated in six municipalities in Northern Denmark took part in this study, with 55 people with dementia participating. RESULTS: The themes identified were: 'State of mind' and 'Mental resources', showing how these aspects influenced the participants' reactions and the strategies they used. DISCUSSION: The results are discussed in relation to how individual personality traits influence the assessment process and the way a person with dementia will manage the situation. CONCLUSION: The assessment situation is complex and can be influenced by the strategies adopted by individuals with dementia as they try to manage the assessment process. PATIENT OR PUBLIC CONTRIBUTION: People with dementia supported the decision-making for the choice of validated measure used within this study.