Identifying people living with cystic fibrosis in the Danish National Patient Registry: A validation study.

BACKGROUND: The Danish National Patient Registry (DNPR) serves as a valuable resource for scientific research. However, to ensure accurate results in cystic fibrosis (CF) studies that rely on DNPR data, a robust case-identification algorithm is essential. This study aimed to develop and validate algorithms for the reliable identification of CF patients in the DNPR. METHODS: Using the Danish Cystic Fibrosis Registry (DCFR) as a reference, accuracy measures including sensitivity and positive predictive value (PPV) for case-finding algorithms deployed in the DNPR were calculated. Algorithms were based on minimum number of hospital contacts with CF as the main diagnosis and minimum number of days between first and last contact. RESULTS: An algorithm requiring a minimum of one hospital contact with CF as the main diagnosis yielded a sensitivity of 96.1 % (95 % CI: 94.2 %; 97.4 %) and a PPV of 84.9 % (82.0 %; 87.4 %). The highest-performing algorithm required minimum 2 hospital visits and a minimum of 182 days between the first and the last contact and yielded a sensitivity of 95.9 % (95 % CI: 94.1 %; 97.2 %), PPV of 91.0 % (95 % CI: 88.6 %; 93.0 %) and a cohort entry delay of 3.2 months at the 75th percentile (95th percentile: 38.7 months). CONCLUSIONS: The DNPR captures individuals with CF with high sensitivity and is a valuable resource for CF-research. PPV was improved at a minimal cost of sensitivity by increasing requirements of minimum number of hospital contacts and days between first and last contact. Cohort entry delay increased with number of required hospital contacts.

Validation and clinical discovery demonstration of breast cancer data from a real-world data extraction platform.

Objective: To validate and demonstrate the clinical discovery utility of a novel patient-mediated, medical record collection and data extraction platform developed to improve access and utilization of real-world clinical data. Materials and Methods: Clinical variables were extracted from the medical records of 1011 consented patients with breast cancer. To validate the extracted data, case report forms completed using the structured data output of the platform were compared to manual chart review for 50 randomly-selected patients with metastatic breast cancer. To demonstrate the platform's clinical discovery utility, we identified 194 patients with early-stage clinical data who went on to develop distant metastases and utilized the platform-extracted data to assess associations between time to distant metastasis (TDM) and early-stage tumor histology, molecular type, and germline BRCA status. Results: The platform-extracted data for the validation cohort had 97.6% precision (91.98%-100% by variable type) and 81.48% recall (58.15%-95.00% by variable type) compared to manual chart review. In our discovery cohort, the shortest TDM was significantly associated with metaplastic (739.0 days) and inflammatory histologies (1005.8 days), HR-/HER2- molecular types (1187.4 days), and positive BRCA status (1042.5 days) as compared to other histologies, molecular types, and negative BRCA status, respectively. Multivariable analyses did not produce statistically significant results. Discussion: The precision and recall of platform-extracted clinical data are reported, although specificity could not be assessed. The data can generate clinically-relevant insights. Conclusion: The structured real-world data produced by a novel patient-mediated, medical record-extraction platform are reliable and can power clinical discovery.

Evaluación de la consistencia interna y dimensionalidad de la Escala de Capital Social Cognitivo en adultos colombianos

Introducción: durante las últimas dos décadas, el concepto de capital social se ha utilizado con creciente frecuencia en las ciencias de la salud debido a las relaciones directas e indirectas entre el capital social y la salud física y mental de las poblaciones. Por tanto, es necesario construir un instrumento para cuantificar este concepto con seguridad y confiabilidad. Objetivo: analizar la consistencia interna y dimensionalidad de una escala de siete ítems para medir el capital social en adultos de la población general de Colombia. Metodología: se realizó un estudio de validación en línea, que incluyó una muestra de 700 adultos de entre 18 y 76 años, el 68 % eran mujeres. Los participantes completaron una escala de siete ítems llamada Escala de Capital Social Cognitivo (ECSC). El alfa de Cronbach y el omega de McDonald se calcularon para probar la consistencia interna. Se realizaron análisis factoriales exploratorios y confirmatorios para explorar la dimensionalidad de la ECSC. Resultados: la ECSC presentó una consistencia interna baja (alfa de Cronbach de 0,56 y omega de McDonald de 0,59) y pobre dimensionalidad. Seguidamente, se probó una versión de cinco ítems (ECSC-5). La ECSC-5 mostró una alta consistencia interna (alfa de Cronbach de 0,79 y omega de McDonald de 0,80) y una estructura unidimensional con indicadores de bondad de ajuste aceptables. Discusión: la ECSC-5 presenta alta consistencia interna y una estructura unidimensional para medir el capital cognitivo social en adultos colombianos. Se recomienda la ECSC-5 para la medición del capital social en la población general colombiana. Futuras investigaciones deben corroborar estos hallazgos en aplicaciones de lápiz y papel y explorar otros indicadores de confiabilidad y validez.

Introduction: During the last two decades, the concept of social capital has been used increasingly frequently in health sciences due to the direct and indirect relationships between social capital and populations' physical and mental health. Therefore, it is necessary to build an instrument to quantify this concept confidently and reliably. Objective: The study aimed to internal consistency and dimensionality of a seven-item scale to measure social capital in Colombia's general population of adults. Methods: An online validation study included a sample of 700 adults aged between 18 and 76 years; 68% were females. Participants completed a seven-item scale called the Cognitive Social Capital Scale (CSCS). Cronbach's alpha and McDonald's omega were computed to test internal consistency. The authors explore the internal consistency and dimensionality of the CSCS. Results: The CSCS presented a low internal consistency (Cronbach's alpha of 0.56 and McDonald's omega of 0.59) and poor dimensionality. Then, the researchers tested a five-item version (CSCS-5). The CSCS-5 showed high internal consistency (Cronbach's alpha of 0.79 and McDonald's omega of 0.80) and a one-dimension structure with acceptable goodness-of-fit indicators. Discussion: The CSCS-5 presents high internal consistency and a one-dimensional structure to measure cognitive capital social in the Colombian sample. Authors can recommend measuring social capital in the general Colombian population. Further research should corroborate this pencil and paper application findings and explore other reliability and validity indicators.

Patient-reported outcomes in Hodgkin lymphoma trials: a systematic review.

Background: Lymphoma treatment can lead to long-term consequences such as fatigue, infertility and organ damage. In clinical trials, survival outcomes, clinical response and toxicity are extensively reported while the assessment of treatment on quality of life (QoL) and symptoms is often lacking. Objective: We evaluated the use and frequency of patient-reported outcome (PRO) instruments used in randomized controlled trials (RCTs) for Hodgkin lymphoma (HL) and their consistency of reporting. Methods: MEDLINE, CENTRAL and trial registries for RCTs investigating HL were systematically searched from 01/01/2016 to 31/05/2022. Following trial selection, trial, patient characteristics and outcome data on the use of PRO measures (PROMs) and reporting of PROs using a pre-defined extraction form were extracted. To assess reporting consistency, trial registries, protocols and publications were compared. Results: We identified 4,222 records. Following screening, a total of 317 reports were eligible for full-text evaluation. One hundred sixty-six reports of 51 ongoing/completed trials were included, of which 41% of trials were completed and 49% were ongoing based on registry entries. Full-text or abstract were available for 33 trials. Seventy percent of trials were conducted in the newly diagnosed disease setting, the majority with advanced HL. In 32 trials with published follow-up data, the median follow-up was 5.2 years. Eighteen (35%) completed/ongoing trials had mentioned PRO assessment in registry entries, protocol or publications. Twelve trials (67%) had published results and only 6 trials (50%) reported on PROs in part with the exception of 1 trial where PROs were evaluated as secondary/exploratory outcome. The most referenced global PROM was the EORTC-QLQ-C30 (12 studies), the EQ-5D (3 studies) and the FACT-Neurotoxicity (3 studies). FACT-Lymphoma, a disease-specific PROM for non-HL was mentioned in one ongoing trial. None of the trials referenced the EORTC QLQ-HL27, another disease-specific PROM developed specifically for HL patient's QoL assessment. Discussions: Only one-third of RCTs in HL report PROs as an outcome and only half present the outcome in subsequent publications, showcasing the underreporting of PROs in trials. Disease-specific PROMs are underutilized in the assessment of QoL in HL patients. Guidance on the assessment of PROs is needed to inform on comprehensive outcomes important to patients. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=391552, identifier CRD42023391552.

Measurement Properties of Patient-Reported Outcome Measures for Adolescent and Young Adult Survivors of a Central Nervous System Tumor: A Systematic Review.

Purpose: To identify and evaluate patient-reported outcome measures (PROMs) for assessing survivorship-related concepts for adolescent and young adult (AYA) survivors of central nervous system (CNS) tumors. Methods: We searched five electronic databases. Two researchers independently screened all titles for inclusion and used consensus-based standards for the selection of health measurement instruments (COSMIN) guidance to grade the quality of evidence for each measurement property. Results: Four studies met eligibility criteria: single-item pain thermometer; single-item fatigue thermometer; 37-item pediatric functional assessment of cancer therapy-brain tumor survivors, measuring quality of life; and 12-item Perceived Barriers Scale to assess barriers to employment. The Perceived Barrier Scale showed high-quality evidence for internal consistency and moderate quality evidence for construct and structural validity. Evidence for the measurement properties of the other PROMs was low-to-moderate quality. Conclusion: We found one PROM with sufficient evidence for good measurement properties to support its use. This warrants development and evaluation of further PROMs to inform ongoing supportive care for this population. Implications for Cancer Survivors: The Perceived Barriers Scale is sufficiently validated and could be considered to guide support for AYA survivors of CNS tumors to achieve their employment goals.

Cognitive Interview Validation of a Novel Household Hazard Vulnerability Assessment Instrument.

BACKGROUND: Weather and climate disasters are responsible for over 13 000 US deaths, worsened morbidity, and $1.7 trillion in additional costs over the last 40 years with profound racial disparities. OBJECTIVES: This project empirically generated items for a novel survey instrument of household hazard vulnerability with initial construct validation while addressing racial bias in the data collection process. METHODS: Cognitive interviews facilitated understanding regarding the performance of drafted survey questions with transdisciplinary expert panelists from diverse US regions on unique hazard/disaster/event items. To prevent representation bias in data collection, those with Black and/or African American racial, biracial, or multiracial identities were over-sampled. Interview video recordings were qualitatively analyzed using thematic and pattern coding. RESULTS: A cognitive process mapped to themes of disaster characteristics, resources, individual life facets, and felt effects was revealed. We identified 379 unique instances of linked terms as synonyms, co-occurring, compounding, or cascading events. Potential for racial bias in data collection was elucidated. Analysis of radiation exposure, trauma, and criminal acts of intent items revealed participants may not interpret survey items with these terms as intended. CONCLUSION: Potential for racial bias exists relative to water dam failure, evacuation, external flood, suspicious packages/substances, and transportation failure. Hazard terms that were not interpreted as intended require further revision in the validation process of individual or household disaster vulnerability assessments. Several commonalities in the cognitive process and mapping of disaster terms may be utilized in disaster and climate change research aimed at the individual and household unit of analysis.

Protocolo gráfico de validação para avaliação da assistência de enfermagem segura em hemodiálise / Protocolo gráfico de validación para evaluación de asistencia de enfermería segura en hemodiálisis / Validation graphic protocol for assessing safe nursing care in hemodialysis

Resumo Objetivo Validar o conteúdo e a aparência de um protocolo gráfico para avaliação do cuidado seguro de enfermagem a pacientes em hemodiálise. Método Estudo metodológico com abordagem quantitativa, organizado em três procedimentos: teóricos, a partir de uma scoping review; empíricos, na qual ocorreu processo de construção do protocolo gráfico e checklist para avaliação do cuidado seguro; por fim, os analíticos, para a validação propriamente dita com uso da técnica Delphi e participação de nove juízes especialistas em duas rodadas para o alcance da concordância. Resultados Elaboraram-se o checklist e o protocolo gráfico. Quanto à validade de conteúdo, em Delphi I, três critérios obtiveram Coeficiente de Validade de Conteúdo =0,77 no checklist. No que corresponde ao Delphi II, foram alcançados 80% em todos os itens referentes ao Coeficiente de Validade de Conteúdo, e todos os índices ficaram acima de 0,80. A validação de aparência ocorreu utilizando critérios de Suitability Assessment of Materials no Delphi I. Foi possível atingir um Coeficiente de Validade de Conteúdo total maior que 0,80 em todos, enquanto que, no Delphi II, os protocolos alcançaram concordância maior que 80% e Coeficiente de Validade de Conteúdo maior que 0,88, já que o checklist apresentou maior Coeficiente de Validade de Conteúdo com 0,91. Conclusão Apresentam-se o protocolo gráfico e o checklist para avaliação do cuidado seguro aos pacientes em hemodiálise válidos em seu conteúdo e aparência.

Resumen Objetivo Validar el contenido y la apariencia de un protocolo gráfico para la evaluación del cuidado seguro de enfermería a pacientes en hemodiálisis. Métodos Estudio metodológico con enfoque cuantitativo, organizado en tres procedimientos: teórico, a partir de una scoping review; empírico, donde se realizó el proceso de elaboración del protocolo gráfico y checklist para la evaluación del cuidado seguro; y por último, analítico, para la validación propiamente dicha mediante el uso del método Delphi y la participación de nueve jueces especialistas en dos rondas para alcanzar la concordancia. Resultados Se elaboró la checklist y el protocolo gráfico. Respecto a la validez del contenido, en Delphi I tres criterios obtuvieron Coeficiente de Validez de Contenido = 0,77 en la checklist. En lo referente al Delphi II, se alcanzó el 80 % en todos los ítems relacionados con el Coeficiente de Validez de Contenido, y todos los índices fueron superiores a 0,80. La validación de la apariencia se realizó con los criterios de la Suitability Assessment of Materials en Delphi I. Se logró alcanzar un Coeficiente de Validez de Contenido total mayor a 0,80 en todos, mientras que en Delphi II, los protocolos lograron una concordancia mayor a 80 % y Coeficiente de Validez de Contenido mayor a 0,88, ya que la checklist presentó mayor Coeficiente de Validez de Contenido con 0,91. Conclusión El protocolo gráfico y la checklist para la evaluación del cuidado seguro a pacientes en hemodiálisis demostraron ser válidos en su contenido y apariencia.

Abstract Objective To validate the content and appearance of a graphic protocol for evaluating safe nursing care for hemodialysis patients. Methods Methodological study with a quantitative approach, organized into three procedures: theoretical from a Scoping Review; empirical in which the process of constructing the graphic protocol and checklist for the evaluation of safe care took place; finally, the analytics for the validation itself using the Delphi technique and the participation of nine expert judges in two rounds to reach agreement. Results The checklist and the graphic protocol were elaborated. As for content validity in Delphi I, three criteria obtained Content Validity Coefficient =0.77 in the checklist. In what corresponds to Delphi II, 80% was achieved in all items regarding the Content Validity Coefficient, all indices were above 0.80. Appearance validation took place using criteria of the Suitability Assessment of Materials in Delphi I, it was possible to achieve a total Content Validity Coefficient greater than 0.80 in all, while in Delphi II the protocols reached agreement greater than 80% and Content Validity Coefficient greater than 0.88, since the checklist showed a higher Content Validity Coefficient with 0.91. Conclusion The graphic protocol and checklist for evaluating safe care for hemodialysis patients are presented, valid in their content and appearance.

Vulnerabilidade em saúde: evidências de validade de um banco de itens / Vulnerabilidad en salud: evidencias de validez de un banco de ítems / Health vulnerability: evidence of validity of an item bank

Resumo Objetivo Analisar as evidências de validade de conteúdo e processo de resposta de um banco de itens sobre vulnerabilidade em saúde. Métodos Estudo psicométrico, subsidiado pelo polo teórico de Pasquali. Foram selecionados 62 especialistas com características sociodemográficas e acadêmicas distintas. Desses, 15 responderam ao questionário de validade de conteúdo. Após os ajustes, o banco passou para fase de validade de processo de resposta e foi avaliado por 12 usuários dos serviços de saúde. Utilizou-se coeficiente de validade de conteúdo para avaliação dos itens e do banco, cuja confiabilidade foi verificada pelo teste binomial, considerando percentual de 80% e p-valor >0,05. Resultados O banco apresentou boa evidência de validade de conteúdo pelos especialistas, cujos coeficientes foram 0,87 para o elemento sujeito, 0,86 para o elemento social e 0,865 para o geral. O público-alvo realizou sugestões na fase de validade de processo de resposta para melhor compreensão dos itens (coeficiente total: 0,89), sendo considerado, claro, preciso e compreensível. Conclusão A versão final do banco de itens possui 535 itens, sendo 238 para o sujeito e 297 para o social. Apresenta indícios de evidência de validade de conteúdo e processo de resposta e está apto para testagem de validade de estrutura interna.

Resumen Objetivo Analizar las evidencias de validez de contenido y proceso de respuesta de un banco de ítems sobre vulnerabilidad en salud. Métodos Estudio psicométrico, fundamentado por el polo teórico de Pasquali. Se seleccionaron 62 especialistas con características sociodemográficas y académicas diferentes. Entre ellos, 15 respondieron al cuestionario de validez de contenido. Después de las adaptaciones, el banco pasó a la fase de validez del proceso de respuesta y fue evaluado por 12 usuarios de los servicios de salud. Se utilizó el coeficiente de validez de contenido para evaluar los ítems y el banco, cuya fiabilidad ser verificó mediante la prueba binominal, que consideró un porcentaje de 80 y p-valor >0,05. Resultados El banco presentó buena evidencia de validez de contenido por los especialistas, cuyos coeficientes fueron 0,87 en el elemento sujeto, 0,86 en el elemento social y 0,865 en el general. El público destinatario realizó sugerencias en la fase de validez del proceso de respuesta para una mejor comprensión de los ítems (coeficiente total: 0,89) y fue considerado claro, preciso y comprensible. Conclusión La versión final del banco de ítems contiene 535 ítems, de los cuales 238 son para el sujeto y 297 para el social. Presenta indicios de evidencia de validez de contenido y proceso de respuesta y está apto para una prueba de validez de estructura interna.

Abstract Objective To analyze the evidence of content validity and response process of a health vulnerability item bank. Methods Psychometric study with support of Pasquali's theoretical pole in which 62 specialists with different sociodemographic and academic characteristics were selected and 15 of them responded to the content validity questionnaire. After adjustments, the bank moved to the response process validity phase and was evaluated by 12 health service users. A content validity coefficient was used to evaluate the items and the bank, which had the reliability assessed by the binomial test, considering a percentage of 80% and p-value >0.05. Results The bank presented good evidence of content validity by experts. The coefficients were 0.87 for the subject element, 0.86 for the social element and 0.865 for the general element. The target audience made suggestions in the response process validity phase to better understand the items (total coefficient: 0.89), which were considered clear, accurate and understandable. Conclusion The final version of the item bank has 535 items, 238 for the subject and 297 for the social element. It presents evidence of validity of content and response process and is suitable for testing the validity of internal structure.

Performance of externally validated machine learning models based on histopathology images for the diagnosis, classification, prognosis, or treatment outcome prediction in female breast cancer: A systematic review.

Numerous machine learning (ML) models have been developed for breast cancer using various types of data. Successful external validation (EV) of ML models is important evidence of their generalizability. The aim of this systematic review was to assess the performance of externally validated ML models based on histopathology images for diagnosis, classification, prognosis, or treatment outcome prediction in female breast cancer. A systematic search of MEDLINE, EMBASE, CINAHL, IEEE, MICCAI, and SPIE conferences was performed for studies published between January 2010 and February 2022. The Prediction Model Risk of Bias Assessment Tool (PROBAST) was employed, and the results were narratively described. Of the 2011 non-duplicated citations, 8 journal articles and 2 conference proceedings met inclusion criteria. Three studies externally validated ML models for diagnosis, 4 for classification, 2 for prognosis, and 1 for both classification and prognosis. Most studies used Convolutional Neural Networks and one used logistic regression algorithms. For diagnostic/classification models, the most common performance metrics reported in the EV were accuracy and area under the curve, which were greater than 87% and 90%, respectively, using pathologists' annotations/diagnoses as ground truth. The hazard ratios in the EV of prognostic ML models were between 1.7 (95% CI, 1.2-2.6) and 1.8 (95% CI, 1.3-2.7) to predict distant disease-free survival; 1.91 (95% CI, 1.11-3.29) for recurrence, and between 0.09 (95% CI, 0.01-0.70) and 0.65 (95% CI, 0.43-0.98) for overall survival, using clinical data as ground truth. Despite EV being an important step before the clinical application of a ML model, it hasn't been performed routinely. The large variability in the training/validation datasets, methods, performance metrics, and reported information limited the comparison of the models and the analysis of their results. Increasing the availability of validation datasets and implementing standardized methods and reporting protocols may facilitate future analyses.

Psychometric properties and reliability of the Brazilian version of Parent Attitudes about Childhood Vaccine (PACV-BR) / Propriedades psicométricas e confiabilidade da versão brasileira do Parent Attitudes about Childhood Vaccine (PACV-BR)

ABSTRACT Objective: To evaluate the psychometric properties and reliability of the Brazilian version of the tool Parent Attitudes about Childhood Vaccine (PACV-BR). Methods: The sample included 110 parents of children up to two years old served by Family Health Basic Units. The tool's internal consistency and factor validity were respectively assessed by Cronbach's alpha and exploratory factor analysis (EFA). The test-retest reliability was assessed by the intraclass correlation coefficient (ICC). Results: The EFA results indicated a proper structural adequacy of the PACV-BR (15 items and two factors). The reliability generated Cronbach's alpha values between 0.715 and 0.854 for the items, of 0.918 for the tool as a whole, of 0.877 for factor 1 and of 0.825 for factor 2, in addition to an ICC of 0.984. Conclusions: The PACV-BR showed evidence of construct validity and reliability.

RESUMO Objetivo: Avaliar as propriedades psicométricas e a confiabilidade da versão brasileira do instrumento Parent Attitudes about Childhood Vaccine (PACV-BR). Métodos: A amostra incluiu 110 pais de crianças de até dois anos atendidas em Unidades Básicas de Saúde da Família. A consistência interna e a validade fatorial do instrumento foram avaliadas, respectivamente, pelo alfa de Cronbach e pela análise fatorial exploratória (EFA). A confiabilidade teste-reteste foi avaliada pelo coeficiente de correlação intraclasse (ICC). Resultados: Os resultados da AFE indicaram adequação estrutural do PACV-BR (15 itens e dois fatores). A confiabilidade indicou valores de alfa de Cronbach entre 0,715 e 0,854 para os itens, de 0,918 para o instrumento como um todo, de 0,877 para o fator 1 e de 0,825 para o fator 2, além de ICC de 0,984. Conclusões: O PACV-BR apresentou evidências de validade de construto e confiabilidade.

Validation and calibration of the Food Consumption Frequency Questionnaire for pregnant women

ABSTRACT BACKGROUND: Few food frequency questionnaires (FFQ) have been validated for pregnant women, particularly those in small- and medium-sized cities in different regions of Brazil. OBJECTIVES: To validate and calibrate a semiquantitative FFQ for pregnant women. DESIGN AND SETTING: The study was validated with a sample of 50 pregnant women (≥ 18 years) enrolled in Brazilian prenatal services. METHODS: An FFQ and a 24-hour recall were used to evaluate dietary intake. Dietary variables were tested for normality and log-converted when asymmetrical. Pearson's Correlation Coefficient was used to validate the questionnaire. Linear regression was applied to extract calibration factors. All variables underlying the consumption analysis were adjusted for energy. RESULTS: The mean age of the pregnant women was 26 years ± 6.2 years; 58% were in their first trimester, and 30% were identified as overweight/obese. The Pearson correlation analysis results indicated that the FFQ overestimated energy and nutrient intake, whose coefficients ranged from −0.15 (monounsaturated fat) to 0.50 (carbohydrate). Adjusting for energy reduced the mean values of intake coefficients, which now ranged from −0.33 (sodium) to 0.96 (folate). The calibration analysis results indicated variation in the coefficients from −0.23 (sodium) to 1.00 (folate). Calibration produced satisfactory coefficients for the FFQ compared with the reference standard for energy, macronutrients, monounsaturated fat, cholesterol, vitamins B12/C, folate, sodium, iron, and calcium. CONCLUSIONS: After validating and calibrating tests, we observed that the FFQ was adequately accurate for assessing the food consumption of the pregnant women in this study.

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.

Validation of Mobile Messages for an mHealth Intervention for Smokeless Tobacco Cessation in India.

BACKGROUND: With the growth in use of mobile messages for behaviour change, the need to incorporate personal needs and cultural characteristics of target users has been promoted. The study aimed to describe the findings of content validation of mobile messages designed to promote smokeless tobacco cessation in primary care. METHODS: This study used a concurrent mixed-method approach with 13 patients who were tobacco users at urban primary care clinics. The clarity and appeal of 32 messages were rated on a Likert scale from 1 to 10. A mean clarity and appeal score per message was generated. A 5-item discussion guide was used for in-depth interviews and data was analysed using framework analysis. RESULTS: Participants found the content of the messages useful, and preferred shorter and audio formatted messages. The clarity scores for the messages ranged from 7.9 to 9.4 with an average score of 8.7 (SD 0.5). The appeal scores ranged from 7.3 to 9.2, with an average score of 8.5 (SD 0.6). CONCLUSIONS: Twenty-six from a total of 32 messages were found appropriate and finalised for use. This methodology can be used when developing contextually relevant mobile message interventions in other low resource settings.

Normatização dos escores da escala eHealth Literacy Scale para avaliação do letramento digital em saúde / Standardization of eHealth Literacy Scale scores for assessing digital health literacy / Estandarización de las puntuaciones de la escala eHealth Literacy Scale para evaluar la alfabetización digital en salud

Objetivo: analisar os dados de normatização dos escores da versão brasileira do instrumento eHealth Literacy Scale (eHeals) para avaliação do letramento digital em saúde. Método: estudo transversal com 502 adultos brasileiros, realizado em 2019. Dados coletados pelo instrumento eHeals e questionário sociodemográfico. Foram aplicadas árvores de decisão e análise discriminante. Estudo aprovado pelo Comite de Ética em Pesquisa. Resultados: a análise discriminante determinou as faixas de classificação do eHeals a partir da distribuição dos escores. A árvore de decisão indicou que a escolaridade afetou de forma relevante os resultados da escala. Os indivíduos com escolaridade até o ensino fundamental II incompleto: baixo (até 10), médio (11 a 25), alto (27 a 40), e escolaridade acima: baixo (até 25), médio (25 a 32) e alto LDS (33 a 40). Conclusão: a classificação dos níveis de letramento digital em saúde de adultos pelo eHeals deve ser controlada pelos níveis de escolaridade dos participantes.

Objective: to analyze the normative data of the scores of the Brazilian version of the eHealth Literacy Scale (eHeals) instrument for assessing digital health literacy. Method: cross-sectional study with 502 Brazilian adults in 2019. Data collected using the eHeals instrument and sociodemographic questionnaire. Decision trees and discriminant analysis were applied. Study approved by the Research Ethics Committee. Results: Discriminant analysis determined the eHeals classification ranges based on the distribution of scores. The decision tree indicated that education significantly affected the scale results. Thus, individuals with incomplete elementary school education up to II: low (up to 10), medium (11 to 25), high (27 to 40), and higher education: low (up to 25), medium (25 to 32) and high LDS (33 to 40). Conclusion: the classification of digital health literacy levels using eHeals in adults should be controlled by the participants' education levels.

Objetivo: analizar los datos de estandarización de las puntuaciones de la versión brasileña del instrumento eHealth Literacy Scale (eHeals) para evaluar la alfabetización digital en salud. Método: estudio transversal con 502 adultos brasileños que tuvo lugar en 2019. La recolección de datos se hizo mediante el instrumento eHeals y un cuestionario sociodemográfico. Se aplicaron árboles de decisión y análisis discriminante. El Comité de Ética en Investigación aprobó el estudio. Resultados: El análisis discriminante determinó los rangos de clasificación de eHeals con base en la distribución de puntuaciones. El árbol de decisión indicó que la educación afectó significativamente los resultados de la escala. Individuos con educación primaria incompleta: baja (hasta 10), media (11 a 25), alta (27 a 40), y educación superior a esa mencionada: baja (hasta 25), media (25 a 32) y alto LDS (33 a 40). Conclusión: la clasificación de los niveles de alfabetización en salud digital en adultos con eHeals debe ser controlada por los niveles de educación de los participantes.

Adaptation and validation of the Brazilian version of the Measure of Moral Distress for Healthcare Professionals (MMD-HP BR) in the context of palliative care.

BACKGROUND: The Measure of Moral Distress for Health Care Professionals (MMD-HP) scale corresponds to the update of the globally recognized Moral Distress Scale-Revised (MDS-R). Its purpose is to measure moral distress, which is a type of suffering caused in a professional prevented from acting according to one's moral convictions due to external or internal barriers. Thus, this study has the objective to translate, culturally adapt, and validate the Brazilian version of the MMD-HP BR in the context of Palliative Care (PC). METHODS: The study had the following steps: translation, cross-cultural adaptation and validation. The MMD-HP BR is composed of 27 Likert-rated items for frequency and intensity of moral distress. In total, 332 health professionals who work in PC participated in the study, 10 in the pre-test stage, and 322 in the validation stage. RESULTS: It was possible to identify six factors, which together explain 64.75% of the model variation. The reliability of Cronbach's alpha was 0.942. In addition, the score was higher in those who are considering or have already left their positions due to moral distress, compared to those who do not or have never had such an intention. CONCLUSIONS: MMD-HP BR is a reliable and valid instrument to assess moral distress in the PC context. It is suggested that the scale be standardized in other healthcare contexts, such as clinical settings. In addition, further research on moral distress is encouraged to identify and reduce the phenomenon and its consequences.

Translation, cross-cultural adaptation and validation of the sickle cell self-efficacy scale (SCSES)

ABSTRACT Objective: To translate, cross-culturally adapt and validate the Sickle Cell Self-Efficacy Scale for application in the Brazilian cultural context. Methods: This is a methodological study performed in 6 steps: 1- Forward translation; 2- Translation synthesis; 3- Back-translation; 4- Assessment by expert committee, with computation of the Content Validity Index (CVI); 5- Cultural adequacy (pre-test); 6- Reproducibility. A pre-test was performed with the participation of 10 adolescents/young adults with sickle cell disease through a telephone call and their responses were recorded on a form in a web platform. The instrument validation step was carried out with 55 adolescents/young adults with sickle cell disease, 43 of them having participated in the retest. The analysis of internal consistency and reproducibility was calculated using the Cronbach's alpha coefficient and the Intraclass Correlation Coefficient (ICC), in the R statistical programming environment. Results: The translated instrument had good acceptance among the experts, reaching an average CVI of 1.0. In assessing reliability, the scale showed acceptable internal consistency, with a Cronbach's alpha of 0.84. In the agreement analysis, the ICC was 0.923 (95% CI: 0.857 to 0.958), which indicates good temporal reproducibility. Conclusions: Following the process of translation, cross-cultural adaptation and validation, we obtained the Brazilian version of the Sickle Cell Self-Efficacy Scale, considered valid and reliable to be applied to adolescents and young adults with sickle cell disease in Brazil.

Studies of Health Insurance Claims Data in Japan: A Scoping Review.

Background: Health insurance claims data are used in various research fields; however, an overview on how they are used in healthcare research is scarce in Japan. Therefore, we conducted a scoping review to systematically map the relevant studies using Japanese claims data. Methods: MEDLINE, EMBASE, and Ichushi-Web were searched up to April 2021 for studies using Japanese healthcare claims data. We abstracted the data on study characteristics and summarized target diseases and research themes by the types of claims database. Moreover, we described the results of studies that aimed to compare health insurance claims data with other data sources narratively. Results: A total of 1,493 studies were included. Overall, the most common disease classifications were "Diseases of the circulatory system" (18.8%, n = 281), "Endocrine, nutritional, and metabolic diseases" (11.5%, n = 171; mostly diabetes), and "Neoplasms" (10.9%, n = 162), and the most common research themes were "medical treatment status" (30.0%, n = 448), "intervention effect" (29.9%, n = 447), and "clinical epidemiology, course of diseases" (27.9%, n = 417). Frequent diseases and themes varied by type of claims databases. A total of 19 studies aimed to assess the validity of the claims-based definition, and 21 aimed to compare the results of claims data with other data sources. Most studies that assessed the validity of claims data compared to medical records were hospital-based, with a small number of institutions. Conclusions: Claims data are used in various research areas and will increasingly provide important evidence for healthcare policy in Japan. It is important to use previous claims database studies and share information on methodology among researchers, including validation studies, while informing policymakers about the applicability of claims data for healthcare planning and management.

Validation of the regret coping scale for healthcare professionals (RCS-HCP) in portuguese for Brazil

Introduction: assessing the ability to cope with regret can contribute to support strategies for health professionals. However, in Brazil only few instruments evaluate this ability in general. Objective: this study aimed was to adapt and validate the Regret Coping Scale for Healthcare Professionals (RCS-HCP) to Brazilian Portuguese . Methods: the instruments were translated, and the psychometric properties evaluated for validity and reliability. Three hundred and forty-one professionals participated, with an average age of 38.6 ± 9.2, and 87 participated in a retest survey 30 days later. Results: exploratory factor analysis showed adequacy of the structure (KMO = 0.786) composed of three factors. In the confirmation, the performance was close to acceptable. Reliability was good for the maladaptive strategies (α = 0.834) and adequate for the problem-focused initiatives (α = 0.717), but slightly too low for adaptive strategies (α = 0.595). Test- retest showed lower than expected values, with a Spearman- Brown coefficient of 0.703. Conclusion: the RCS-HCP scale showed satisfactory performance in relation to the properties evaluated.

Introdução: a avaliação da capacidade de lidar com o arrependimento pode contribuir para estratégias de apoio aos profissionais de saúde. No entanto, no Brasil existem poucos instrumentos que avaliam essa habilidade no contexto geral. Objetivo: o objetivo do estudo foi adaptar e validar a Regret Coping Scale for Healthcare Professionals (RCS-HCP) para profissionais de saúde brasileiros. Método: na validação, os instrumentos foram traduzidos e as propriedades psicométricas avaliadas quanto à validade e confiabilidade. Participaram 341 profissionais, com média de idade de 38,6 ± 9,2, e 87 participaram de uma pesquisa de reteste 30 dias depois. Resultados: a análise fatorial exploratória mostrou adequação da estrutura (KMO = 0,786) composta por três fatores. Na confirmação, o desempenho ficou próximo do aceitável. A confiabilidade foi boa para as estratégias mal adaptativas (α = 0,834) e adequada para as estratégias focadas no problema (α = 0,717), mas um pouco baixa demais para as estratégias adaptativas (α = 0,595). Teste-reteste apresentou valores abaixo do esperado, com coeficiente de Spearman-Brown de 0,703. Conclusão: a escala RCS-HCP apresentou desempenho satisfatório em relação às propriedades avaliadas.

Description of the scientific method for the preparation and validation of educational technologies in digital format: a methodological study

Introduction: the use of digital technologies constitutes a process that allows the dynamization of the care process, based on aspects related to criticality and creativity. It is emphasized that the development of technologies must, therefore, be inserted in a context for changes and innovation in response to the population's health demand, and must follow a precise methodological path that goes from the construction to the validation of the appearance, content and effect . Objective: to describe the scientific method of elaboration and validation of educational technologies in digital format. Methods: methodological study, conducted according to the following steps: development of the research project and submission to the Research Ethics Committee; data collection; elaboration of the content, script, illustrations and layout of the booklet; and validation of educational technology. Results: the process of developing a technology requires methodological rigor, enabling coherence between theory and the purpose of the desired product, guaranteeing the internal quality of the developed technology. The use of educational technologies in health reinforces information, serving as a guide for guidelines regarding care and assisting in decision-making. Technological innovations in health, consists of a socio-technical process , permeated by professional and user reflections and experiences. Final considerations: educational technologies represent a potential resource for the development of health education practices, encouraging greater interaction between professionals and users, and an active attitude regarding self-care actions related to their health condition.

Introdução: o uso de tecnologias digitais constitui como um processo que permite a dinamização no processo de cuidar, pautada nos aspectos relacionados a criticidade e criatividade. Enfatiza-se, que o desenvolvimento de tecnologias deve, portanto, insere-se em um contexto por mudanças e inovação em resposta a demanda de saúde da população devendo seguir um percurso metodológico preciso que vai desde a construção à validação da aparência, conteúdo e efeito. Objetivo: descrever o método científico de elaboração e validação de tecnologias educativas no formato digital. Método: estudo metodológico, conduzido de acordo com as seguintes etapas: elaboração do projeto de pesquisa e submissão ao Comitê de Ética em Pesquisa; levantamento dos dados; elaboração do conteúdo, roteiro, ilustrações e diagramação da cartilha; e validação da tecnologia educacional. Resultados: o processo de elaboração de uma tecnologia requer rigor metodológico, possibilitando coerência entre teoria e finalidade do produto desejado, garantindo qualidade interna da tecnologia elaborada. O uso de tecnologias educativas em saúde reforça informações, servindo como guia para orientações quanto ao cuidado e auxiliando nas tomadas de decisões. Inovações tecnológicas em saúde, consiste em um processo sócio-técnico, permeado por reflexões e experiências profissionais e usuários. Considerações finais: tecnologias educacionais representam um recurso potencializador para o desenvolvimento de práticas de educação em saúde, estimulando maior interação entre profissionais e usuários, e uma postura ativa quanto a ações de autocuidado relacionado a sua condição de saúde.

Diseño y Validación de una Aplicación Móvil, para el Diagnóstico de Anemia en Pre-Escolares. Estudio de Precisión Diagnóstica / Design and Validation of a Mobile Application for the Diagnosis of Anemia in Preschoolers. Diagnostic Accuracy Study

La anemia afecta a miles de niños. Para el diagnóstico se cuantifica la hemoglobina (Hb); técnica que no se encuentra al alcance de toda la población. Contar con un instrumento validado de fácil aplicación, puede ayudar al diagnóstico. El objetivo de este estudio fue validar una aplicación móvil (APP) para diagnosticar anemia en niños de 2 a 5 años, aplicable por padres o tutores. Estudio de validación de escalas. Mediante búsqueda bibliografía se recopilaron ítems y dominios relacionados con anemia en niños. Una vez reducidos, se construyó un cuestionario para pilotaje, con tres hematólogos pediatras. El resultado de este fue posteriormente validado por 22 expertos mediante aplicación de escalas tipo Likert. Los ítems validados, se contrastaron con la Hb de niños de 267 niños de 2 a 5 años de los andes ecuatorianos (2.560 msnm). Se determinó asociación de los ítems con Hb y con los resultados obtenidos y se construyó la APP. 14 ítems fueron analizados. Todos ellos puntuaron sobre la mediana de la distribución (35,5 puntos) y fueron valorados por, al menos el 50 % de los expertos. Se seleccionaron palidez palmar, astenia y sueño en horas no habituales. Todos mostraron asociación significativa con anemia (p<0,05), y fueron aplicados como preguntas a padres o tutores y contrastados con el valor de Hb. Sensibilidad y especificidad para palidez fue: 85,1 % y 85,0 %; astenia: 72,3 % y 87,7 %; sueño en horas no habituales: 68,1 % y 87,7 %; palidez más astenia o sueño: 95,7 % y 74,6 %; y debilidad más sueño: 92,5 % y 76,8 %. Se desarrolló y validó una APP para diagnóstico de anemia en niños de 2 a 5 años aplicable por padres o tutores.

SUMMARY: Anemia affects thousands of children, and to reach a diagnosis, hemoglobin (Hb) is quantified. This technique however, is not always accessible to the general population. Therefore, the availability of a validated instrument can be useful in the diagnosis. The aim of this study was to validate a mobile application (APP), to diagnose anemia in children from 2 to 5 years old, applicable by parents or guardians. Scale validation study. Through a bibliographic search, items and domains related to anemia in children were collected. Once reduced, a pilot questionnaire was constructed with three pediatric hematologists. The result was later validated by 22 experts through the application of the Likert-type scales. The validated items were contrasted with the Hb of children of 267 children from 2 to 5 years of age from the Ecuadorian Andes (2,560 meters above sea level). The association of the items with Hb and with the results obtained was determined, and the APP was constructed. 14 items were analyzed. All of them scored above the median of the distribution (35.5 points) and were valued by at least 50 % of the experts. Palmar pallor, asthenia, and sleep at unusual hours were selected. All showed a significant association with anemia (p<0.05) and were applied as questions to parents or guardians and contrasted with the Hb value. Sensitivity and specificity for pallor was: 85.1 % and 85.0 %; asthenia: 72.3 % and 87.7 %; sleep at unusual hours: 68.1 % and 87.7 %; paleness plus fatigue or sleepiness: 95.7 % and 74.6 %; and weakness plus sleep: 92.5 % and 76.8 %. An APP for the diagnosis of anemia in children from 2 to 5 years old applicable by parents or guardians was developed and validated.