Hospitalizaciones evitables por problemas de salud sensibles a cuidados ambulatorios: construcción y validación de la lista Uruguaya de patologías

Introducción: Las hospitalizaciones por Ambulatory Care Sensitive Conditions es un indicador que mide la utilización de los servicios hospitalarios por problemas de salud que podrían haber sido prevenidos en el primer nivel de atención. El concepto se refiere a los procesos en que la atención ambulatoria efectiva puede ayudar a disminuir los riesgos de hospitalización, en un segundo nivel de atención. El objetivo del estudio fue construir y validar una lista uruguaya de problemas de salud sensibles a cuidados ambulatorios (PSSCA) según CIE-10. Metodología: Para la construcción de la lista inicial de códigos de PSSCA se realizó una revisión de los listados existentes y se propuso un listado inicial que fue validado a través del Método Delphi. Se propone un listado de 99 códigos diagnósticos de PSSCA adaptado a nuestro entono sanitario. Los mismos permiten identificar y cuantificar problemas de salud que pueden producir hospitalizaciones potenciamente evitables mediante cuidados ambulatorios accesibes y oportunos en el primer nivel de atención. Resultados: Se conformó un panel de 12 expertos. A partir de los datos obtenidos, considerando los 99 diagnósticos clasificados por CIE-10, éstos se pueden subclasificar en función de si la patología es infecciosa o no, obteniendo un resultado general de 62 patologías en un total de 99 que pueden ser clasificadas como infecciosas, lo que se corresponde a un 62 %. Discusión: De la comparación de la lista uruguaya de PSSCA a la que hemos arribado y las listas validadas utilizadas para la construcción inicial del listado de patologías propuesto, podemos decir que la primera presenta un mayor porcentaje de coincidencia con la lista de patologías de Bello Horizonte. Podemos mencionar que la mayoría de los problemas de salud identificados con base en el listado de PSSCA, son sensibles de ser resueltos con la atención primaria oportuna y de calidad que podría evitar o disminuir de una manera significativa su hospitalización. Conclusiones: Este trabajo describe el proceso de construcción y validación de una lista de códigos de PSSCA adaptados al contexto uruguayo a través del método Delphi. Hemos arribado a un listado que comprende un total de 99 diagnósticos, agrupadas en un total de diecinueve categorías que considera la especificidad del contexto uruguayo del indicador.

Introduction: Hospitalizations for Ambulatory Care Sensitive Conditions is an indicator that measures the use of hospital services for health problems that could have been prevented at the first level of care. The concept refers to the processes in which effective outpatient care can help reduce the risks of hospitalization, at a second level of care. The objective of the study was to build and validate a Uruguayan list of health problems sensitive to outpatient care (PSS-CA) according to ICD-10. Methodology: To construct the initial list of PSSCA codes, a review of the existing lists was carried out and an initial list was proposed that was validated through the Delphi Method. A list of 99 PSSCA diagnostic codes adapted to our healthcare environment is proposed. They make it possible to identify and quantify health problems that can lead to potentially avoidable hospitalizations through accessible and timely outpatient care at the first level of care. Results: A panel of 12 experts was formed. From the data obtained, considering the 99 diagnoses classified by ICD-10, these can be subclassified depending on whether the pathology is infectious or not, obtaining a general result of 62 pathologies in a total of 99 that can be classified as infectious, which corresponds to 62%. Discussion: From the comparison of the Uruguayan list of PSSCA that we have arrived at and the validated lists used for the initial construction of the proposed list of pathologies, we can say that the first presents a higher percentage of coincidence with the list of pathologies of Bello Horizonte . We can mention that most of the health problems identified based on the PSSCA list are sensitive to being resolved with timely and quality primary care that could prevent or significantly reduce hospitalization. Conclusions: This work describes the process of construction and validation of a list of PSSCA codes adapted to the Uruguayan context through the Delphi method. We have arrived at a list that includes a total of 99 diagnoses, grouped into a total of nineteen categories that consider the specificity of the Uruguayan context of the indicator.

Introdução: As Internações por Condições Sensíveis à Atenção Ambulatorial são um indicador que mede a utilização de serviços hospitalares para problemas de saúde que poderiam ter sido evitados no primeiro nível de atenção. O conceito refere-se aos processos em que um atendimento ambulatorial eficaz pode auxiliar na redução dos riscos de internação, em um segundo nível de atenção. O objetivo do estudo foi construir e validar uma lista uruguaia de problemas de saúde sensíveis à atenção ambulatorial (PSS-CA) segundo a CID-10. Metodologia: Para construir a lista inicial de códigos PSSCA foi realizada uma revisão das listas existentes e foi proposta uma lista inicial que foi validada através do Método Delphi. É proposta uma lista de 99 códigos de diagnóstico PSSCA adaptados ao nosso ambiente de saúde. Permitem identificar e quantificar problemas de saúde que podem levar a hospitalizações potencialmente evitáveis ​​através de cuidados ambulatórios acessíveis e oportunos no primeiro nível de cuidados. Resultados: Foi formado um painel de 12 especialistas. A partir dos dados obtidos, considerando os 99 diagnósticos classificados pela CID-10, estes podem ser subclassificados consoante a patologia seja infecciosa ou não, obtendo-se um resultado geral de 62 patologias num total de 99 que podem ser classificadas como infecciosas, o que corresponde para 62%. Discussão: A partir da comparação da lista uruguaia de PSSCA a que chegamos e das listas validadas utilizadas para a construção inicial da lista de patologias proposta, podemos dizer que a primeira apresenta um maior percentual de coincidência com a lista de patologias de Belo Horizonte. Podemos mencionar que a maioria dos problemas de saúde identificados com base na lista PSSCA são sensíveis para serem resolvidos com cuidados primários oportunos e de qualidade que possam prevenir ou reduzir significativamente a hospitalização. Conclusões: Este trabalho descreve o processo de construção e validação de uma lista de códigos PSSCA adaptados ao contexto uruguaio através do método Delphi. Chegamos a uma lista que inclui um total de 99 diagnósticos, agrupados em um total de dezenove categorias que consideram a especificidade do contexto uruguaio do indicador.

Loyola Generativity Scale e Generative Behavior Checklist: Um estudo psicométrico com idosos espanhóis LGBT+ / Loyola Generativity Scale and Generative Behavior Checklist: A Psychometric Study with Spanish LGBT+ Older Adults / Loyola Generativity Scale y Generative Behavior Checklist: Un estudio psicométrico con personas mayores españolas LGBT+

Resumo Enquadramento: A generatividade tem sido associada à resiliência e à satisfação com a vida na velhice, incluindo entre a população lésbica, gay, bissexual e transgénero (LGBT+) mais velha. Objetivo: Analisar as propriedades psicométricas da Loyola Generativity Scale (LGS) e da Generative Behavior Checklist (GBC) para idosos espanhóis LGBT + (com mais de 50 anos). Metodologia: Foi realizado um estudo psicométrico com 141 idosos espanhóis LGBT+ com o objetivo de examinar a validade de construto (análise fatorial exploratória), a validade convergente e a fiabilidade (consistência interna) da LGS e da GBC. Resultados: Os métodos de análise paralela e a análise fatorial exploratória sugeriram um modelo de dois fatores para ambos os instrumentos com boa adequação da amostra. A LGS explicou 45,1% da variância e apresentou uma consistência interna de 0,78. O GBC explicou 41,76% da variância e apresentou uma consistência interna de 0,879. Foi encontrada uma correlação positiva e estatisticamente significativa entre a satisfação com a vida e as escalas generativas. Foi também observada uma correlação positiva e significativa (rs = 0,310) entre os dois instrumentos. Conclusão: Ambos os instrumentos demonstraram ser válidos e fiáveis para medir a generatividade em idosos espanhóis LGBT+.

Abstract Background: Generativity has been associated with resilience and life satisfaction in older age, including among lesbian, gay, bisexual, and transgender (LGBT+) older adults. Objective: To examine the psychometric properties of the Loyola Generativity Scale (LGS) and Generative Behavior Checklist (GBC) for Spanish LGBT+ older adults (over the age of 50). Methodology: A psychometric study was conducted with 141 Spanish LGBT+ older adults to examine the construct validity (exploratory factor analysis), convergent validity, and reliability (internal consistency) of the LGS and the GBC. Results: Parallel and exploratory factor analyses suggested a two-factor model with good sample adequacy for both scales. The LGS explained 45.1% of the variance and had an internal consistency of 0.78. The GBC explained 41.76 % of the variance and had an internal consistency of 0.879. A positive and statistically significant correlation was found between life satisfaction and the generative scales. A positive and significant correlation (rs = 0.310) was also observed between both instruments. Conclusion: Both instruments proved valid and reliable for measuring generativity in Spanish LGBT+ older adults.

Resumen Marco contextual: La generatividad se asocia con la resiliencia y la satisfacción con la vida en la vejez, incluidas las de las personas adultas lesbianas, gays, bisexuales y transexuales (LGBT+). Objetivo: Examinar las propiedades psicométricas de la Loyola Generativity Scale (LGS) y la Generative Behavior Checklist (GBC) en adultos mayores LGBT+ españoles (mayores de 50 años). Metodología: Estudio psicométrico con 141 adultos mayores LGBT+. Se analizó la validez de constructo (análisis factorial exploratorio), la validez convergente y la consistencia interna de cada escala. Resultado: Los análisis factoriales paralelos y exploratorios sugieren un modelo bifactorial para ambas escalas con una buena adecuación a la muestra. La LGS explica el 45,1% de la varianza y tiene una consistencia interna de 0,78. La GBC explica el 41,76% de la varianza y tiene una consistencia interna de 0,879. Se encontró una correlación positiva estadísticamente significativa entre la satisfacción con la vida y las escalas de generatividad. Las dos escalas mostraron una correlación positiva y significativa (rs = 0,310). Conclusión: Ambas escalas han demostrado ser válidas y fiables para medir la generatividad en adultos mayores LGBT+ españoles.

RAMA-WeRA Risk Score in Predicting the Ruptured Appendicitis in Emergency Department; a Multicenter Study for External Validation.

Introduction: Distinguishing between ruptured and non-ruptured acute appendicitis presents a significant challenge. This study aimed to validate the accuracy of RAMA-WeRA Risk Score in predicting ruptured appendicitis (RA) in emergency department. Methods: This study was a multicenter diagnostic accuracy study conducted across six hospitals in Thailand from February 1, 2022, to January 20, 2023. The eligibility criteria included individuals aged >15 years suspected of acute appendicitis, presenting to the ED, and having an available pathology report following appendectomy or intraoperative diagnosis by the surgeon. We assessed the screening performance characteristics of RAMA-WeRA Risk Score, in detecting the ruptured appendicitis (RA) cases. Results: 860 patients met the study criteria. 168 (19.38%) had RA and 692 (80.62%) patients had non-RA. The area under the receiver operating characteristic curve (AuROC) of RAMA-WeRA Risk Score was 75.11% (95% CI: 71.10, 79.11). The RAMA-WeRA Risk Score > 6 points (high-risk group) demonstrated a positive likelihood ratio (LR) of 3.22 in detecting the ruptured cases. The sensitivity and specificity of score in > 6 cutoff point was 43.8% (95%CI: 36.2, 51.6) and 86.4% (95%CI: 83.6, 88.9), respectively. Conclusions: The RAMA-WeRA Risk Score can predict rupture in patients presenting with suspected acute appendicitis in the emergency department with total accuracy of 75% for high-risk cases.

Persian Translation of the Sport Concussion Assessment Tool 6 (SCAT6); a Cross-Cultural Adaptation and Validation Study.

Introduction: Sport Concussion Assessment Tool (SCAT) aids the physicians in early management of concussion among suspected athletes and its 6th version was published in 2023 in English. This study aimed to describe the translation and validation process of SCAT6 from English to Persian. Methods: The Persian translation of SCAT6 and its evaluation has been done in seven stages: initial translation, appraisal of the initial translation, back translation, appraisal of the back-translation, validation (face and content validities), final reconciliation and testing by simulation. Results: Initial translation, was done by two bilingual translators followed by an initial appraisal, which was made by both translators and one general physician. Back translation was done by two naïve translators who were unfamiliar with SCAT6, followed by its appraisal by initial translators. Face and content validity of the translation were surveyed by medical professionals and athletes and the results of the validation process were provided to the reconciliation committee and this committee made the modifications needed. Finally, the use of Persian SCAT6 was simulated and the mean time needed to complete the Persian SCAT6 was roughly a little more than 10 minutes. Conclusions: The present study provides the readers with the translation and cross-cultural adaptation process of SCAT6 from English to Persian. This translated version will be distributed among the Iranian sports community for assessing concussions among athletes.

Psychometric Properties of the Portuguese Version of the Quality of Life in Autism Questionnaire (QoLA).

The aim of this study was to cross-culturally adapt and validate of the Brazilian Portuguese version of the Quality of Life in Autism Questionnaire (QoLA) among parents of children ASD. The translated version was administered to 91 parents (Male: 4, Female: 85, other: 2) of individuals diagnosed with ASD. Among these, 22 completed the questionnaire twice, providing data for the assessment of test-retest reliability (ICC). The B-QoLA score ranged from 41 to 122, with a mean (SD) of 74.3 ± 18.5 in Part A and ranged from 22 to 94, with a mean (SD) of 61.6 ± 16.4, in Part B. Cronbach's alpha coefficient was 0.94 for Part A, 0.92 for Part B and 0.94 for total B-QoLA, indicating excellent internal consistency. Test-retest reliability was assessed using the intraclass correlation coefficient, which was 0.96 for the total scale, 0.94 for Part A, and 0.95 for Part B. Part A-X2 (df) = 297, (167), X2/2 = 1.7, CFI = 0.85, TLI = 0.84, GFI = 0.78, AGFI = 0.75, and RMSEA (95%CI) = 0.09 (0.07-0.11); Part B-X2 (df) = 297, (167), X2/2 = 1.7, CFI = 0.85, TLI = 0.84, GFI = 0.78, AGFI = 0.75, and RMSEA (95%CI) = 0.09 (0.07-0.11), thus indicating moderate fit of the model. The Brazilian version of the QoLA shows encouraging psychometric properties on each of the two subscales, showing strong internal consistency and good construct validity.

Psychometric properties of the modified Drug Abuse Screening Test Sinhala version (DAST-SL): evaluation of reliability and validity in Sri Lanka.

BACKGROUND: Psychoactive drug use is an important public health issue in Sri Lanka as it causes substantial health, social and economic burden to the country. Screening for substance use disorders in people who use drugs is vital in preventive health care, as it can help to identify problematic use early. Screening can aid in referring those in need, for the most appropriate treatment and care. Thus, preventing them from developing severe substance use disorders with complications. The Drug Abuse Screening Test (DAST-10) is an evidence-based tool widely used to assess the severity of psychoactive drug use. This study aimed to culturally adapt and evaluate the validity and reliability of the Drug Abuse Screening Test (DAST-10) in Sri Lanka. METHODS: The DAST-10 was culturally adapted, and the nine-item Sinhala version (DAST-SL) was validated using exploratory and confirmatory factor analysis. The validation study was conducted in the Kandy district among people who use drugs, recruited using respondent-driven sampling. Criterion validity of the questionnaire was assessed by taking the diagnosis by a psychiatrist as the gold standard. Cut-off values for the modified questionnaire were developed by constructing Receiver Operating Characteristic (ROC) curves. The reliability of the DAST-SL was assessed by measuring its internal consistency and test re-test reliability. RESULTS: The validated DAST-SL demonstrated a one-factor model. A cut-off value of ≥ 2 demonstrated the presence of substance use disorder and had a sensitivity of 98.7%, specificity of 91.7%, a positive predictive value of 98.8% and a negative predictive value of 91.3%. The area under the curve of the ROC curve was 0.98. A cut-off score of ≤ 1 was considered a low level of problems associated with drug use. The DAST-SL score of 2-3 demonstrated a moderate level of problem severity, a score of 4-6 demonstrated a substantial level of problems, and a score of ≥ 7 demonstrated a severe level of drug-related problems. The questionnaire demonstrated high reliability with an internal consistency of 0.80 determined by Kuder-Richardson Formula-20 and an inter-class correlation coefficient of 0.97 for test re-test reliability. CONCLUSION: The DAST-SL questionnaire is a valid and reliable tool to screen for drug use problem severity in people who use drugs in Sri Lanka.

Italian validation of the body odor disgust scale.

Introduction: Disgust sensitivity to body odors plays a role in a set of psychological mechanisms supposedly evolved to avoid pathogens. To assess individual differences in body odor disgust, we previously developed the body odor disgust scale (BODS) and validated it in English. The BODS presents six scenarios where disgust could be evoked by smells coming from an internal source and an external source. The present study aimed to validate the BODS in the Italian population and to find further evidence for its structural, construct, and criterion validity. Methods: We used two large samples (N = 1,050, F = 527; and N = 402, F = 203, respectively) that were representative of the Italian population for sex and age. Results: Across these two studies, we confirmed the hypothesized bifactor structure, with all the items loading onto a general body odor disgust sensitivity factor, and on two specific factors related to the internal structure. In terms of construct validity, we found that the BODS converged with pathogen disgust sensitivity of the three-domain disgust scale (TDDS) but was distinct from a general propensity to experience negative emotions. The BODS showed criterion validity in predicting the behavioral intentions toward COVID-19 avoidance behavior, although it did not seem to be incrementally valid when compared to the TDDS pathogen subscale. We also established scalar measurement invariance of the BODS regarding gender and found that women display higher levels of BODS. Discussion: Results from the Italian version of the BODS indicate its structural, construct, nomological and criterion validity. Furthermore, our result on sex differences in disgust sensitivity are consistent with previous literature, and we discuss them in the broader context of cross-cultural and primate findings that points toward a possible evolutionary explanation of this difference.

Validation of the Difficulties in Emotion Regulation Scale-Short Form in a sample of Italian adolescents.

OBJECTIVE: The primary objective of the present study is to validate the Difficulty in Emotion Regulation Scale-Short Form (DERS-SF) in a sample of Italian adolescents. Additionally, we aim to evaluate its factorial structure by examining the contribution of each subscale (i.e., Nonacceptance, Clarity, Awareness, Goals, Impulse, Strategy) on the general factor using bi-factor models by replicating a past study. METHOD: The sample comprises N = 704 adolescents aged 11-17 years (M = 13.38, SD = 1.37; 53.12% females). To establish external validity, correlation and path analyses were conducted between the DERS-SF sub-scales, the total score, and measures of internalizing and externalizing symptoms, as well as Problematic Smartphone Use (PSU). Measurement invariance was tested comparing males versus females and pre-adolescents and adolescents. RESULTS: Overall, results supported the multidimensional nature of the DERS-SF, confirming its original six-factor structure. However, bi-factor models analysis revealed that the Awareness subscale should be excluded when calculating the total score. Furthermore, findings indicated that the Strategy subscale variance is largely accounted for by the general factor rather than the specific subscale. In terms of external validity, significant positive associations between the DERS-SF sub-scales, the total score, and PSU, internalizing and externalizing symptoms were observed. Measurement invariance was supported. CONCLUSIONS: Altogether, findings support the validity of the DERS-SF among Italian Adolescents and provide insights relevant to the understanding of the multifaceted facets of emotion regulation, emphasizing its relevance as a transdiagnostic process.

Reliability, validity and minimal detectable change of the Chinese Version of the Assessment of Physical Activity in Frail Older People (APAFOP-C).

BACKGROUND: Physical activity (PA) is essential in mitigating frailty syndrome, and it is necessary to measure PA in older adults with frailty. Assessment of Physical Activity in Frail Older People (APAFOP) is a suitable patient-reported outcome measure (PROM) for assessing PA among older adults with frailty. This study aimed to determine the reliability, validity and minimal detectable change of the Chinese version of the APAFOP (APAFOP-C). METHODS: This cross-sectional validation study was designed to measure the reliability and criterion validity of the APAFOP-C with 124 frail community-residing older adults. APAFOP-C was completed twice within an interval of 7-17 days to determine test-retest reliability. The investigator triangulation method was used to investigate inter-rater reliability, and a pedometer was used as the reference measurement to assess the criterion validity. Reliability and criterion validity were assessed using the intraclass correlation coefficient (ICC2,1), Pearson correlation coefficient for normally distributed variables, Spearman correlation coefficient, Wilcoxon signed-rank test for skewed variables, and the minimal detectable change at 95% level of confidence (MDC95). Agreement assessment was conducted using Bland-Altman plots for inter-rater reliability and criterion validity. Kendall's W test assessed absolute agreement among three raters in inter-rater reliability. The Mann-Whitney U test was used to evaluate whether any particular day was more representative of certain daily activities. RESULTS: Total PA on any arbitrarily chosen day illustrates daily activity (Z= -0.84, p = 0.40). The APAFOP-C exhibited strong-to-very strong test-retest reliability (ICC2,1=0.73-0.97; Spearman ρ = 0.67-0.89), and the total PA score demonstrated MDC95 < 10%. Inter-rater reliability was also strong-to-very strong (ICC2,1=0.96-0.98; Spearman ρ = 0.88-1.00), and moderate criterion validity when compared with total PA score on pedometer readings (Spearman ρ = 0.61). Limits of agreement among different raters regarding the APAFOP-C and the pedometer were narrow. CONCLUSION: The APAFOP-C was found to have limited but acceptable psychometric properties for measuring PA among community-dwelling older adults with frailty in China. It was a feasible comparative PROM for assessing PA worldwide. Practitioners can develop individualized exercise programs for frail older adults and efficiently track changes in PA utilizing the APAFOP-C.

External validation of an artificial intelligence-based method for the detection and classification of molar incisor hypomineralisation in dental photographs.

OBJECTIVES: This ex vivo diagnostic study aimed to externally validate an open-access artificial intelligence (AI)-based model for the detection, classification, localisation and segmentation of enamel/molar incisor hypomineralisation (EH/MIH). METHODS: An independent sample of web images showing teeth with (n=277) and without (n=178) EH/MIH was evaluated by a workgroup of dentists whose consensus served as the reference standard. Then, an AI-based model was used for the detection of EH/MIH, followed by automated classification and segmentation of the findings (test method). The accuracy (ACC), sensitivity (SE), specificity (SP) and area under the curve (AUC) were determined. Furthermore, the correctness of EH/MIH lesion localisation and segmentation was evaluated. RESULTS: An overall ACC of 94.3% was achieved for image-based detection of EH/MIH. Cross-classification of the AI-based class prediction and the reference standard resulted in an agreement of 89.2% for all diagnostic decisions (n=594), with an ACC between 91.4% and 97.8%. The corresponding SE and SP values ranged from 81.7% to 92.8% and 91.9% to 98.7%, respectively. The AUC varied between 0.894 and 0.945. Image size had only a limited impact on diagnostic performance. The AI-based model correctly predicted EH/MIH localisation in 97.3% of cases. For the detected lesions, segmentation was fully correct in 63.4% of all cases and partially correct in 33.9%. CONCLUSIONS: This study documented the promising diagnostic performance of an open-access AI tool in the detection and classification of EH/MIH in external images. CLINICAL SIGNIFICANCE: Externally validated AI-based diagnostic methods could facilitate the detection of EH/MIH lesions in dental photographs.

Psychometric Properties of the FRAIL Scale for Frailty Screening: A Scoping Review.

OBJECTIVES: The aim of this study was to identify and map the available psychometric evidence of the FRAIL scale to screen frailty among older adults. DESIGN: Scoping review of published articles on 9 databases (PubMed, Scopus, Web of Science, CINAHL, Cochrane, Embase, PsycINFO, VHL Regional Portal, and Epistemonikos) and 8 gray literature sources. SETTING AND PARTICIPANTS: Studies in adults or older adults, in both inpatient and outpatient settings (without context restrictions). METHODS: Cross-cultural adaptations, validity and reliability evidence studies, whose main objective was to develop and/or validate and/or culturally adapt the FRAIL Scale to assess frailty in adults or older adults, published since 2007 were included in this scoping review. The databases were searched between February and March 2023.The JBI methodology for scoping reviews was used to guide the process. The protocol of this study was registered on the Open Science Framework platform. RESULTS: Of the 1031 records found during the search, 40 articles that met the established criteria for analysis were included. Nearly 1 in 10 countries worldwide (11.9%) have psychometric evidence regarding this scale. Ten studies were identified with the goal of cross-cultural adaptation and/or validation in a different cultural context for the first time. Twenty-one of 40 studies used Morley 2012 operationalization of FRAIL Scale criteria. Thirty-nine studies provided evidence of associations with other variables. The rest of the evidence for content, internal structure, response processes, and reliability was only evaluated in cross-cultural adaptation studies, with limitations. CONCLUSIONS AND IMPLICATIONS: In conclusion, there is some evidence of validity for FRAIL Scale; nevertheless, studies are needed to adapt the scale to new cultures, using rigorous Cross-Cultural Adaptation processes, and to provide new evidence of validity and reliability, to strengthen and consolidate the body of knowledge for its application to various patient groups and context.

Filling the "GAP" in Real-World Assessment of Psoriatic Arthritis Disease Activity: Performance Characteristics of a Global/Pain Composite Endpoint.

INTRODUCTION: Some retrospective data sources, such as electronic health records in the USA, report composite outcome measures not fully validated in psoriatic arthritis (PsA). However, they often contain global assessments, such as a Physician Global Assessment (PhGA) and Patient Global Assessment (PatGA), along with patient-reported pain scores, which individually are considered validated in PsA. This research described the performance characteristics of a 3-item global assessment and pain (GAP) composite endpoint using data from the ixekizumab phase 3 PsA clinical trial program. METHODS: Discrimination of GAP was assessed by comparing placebo to active treatment arms. The magnitude of treatment effect and responsiveness were compared to Disease Activity Index for PsA (DAPSA), clinical DAPSA, DAPSA28, and Psoriatic Arthritis Disease Activity Score (PASDAS) using effect size (ES) and standardized response mean (SRM), respectively. Construct validity was evaluated through correlation among the composite endpoints, and with other physician- and patient-reported outcomes. Change in GAP was compared in patients who reached low disease activity (LDA) levels based on DAPSA, cDAPSA, and PASDAS vs those who did not. RESULTS: GAP discriminated between active treatment and placebo with statistically significant separation as early as week 1. The largest ES/SRM was seen with GAP (2.29/1.74) and PASDAS (2.47/1.68). GAP had the strongest correlation with PASDAS (0.81-0.92) and showed moderate correlations with patient-assessed physical function, low correlations with physician-assessed skin and nail psoriasis, and low to moderate correlation with physician-assessed enthesitis. A significantly greater improvement in GAP was seen in the groups achieving LDA states compared to those not (p < 0.001). CONCLUSION: The GAP composite, an abbreviated endpoint comprising measures common in electronic health records, has promising performance characteristics and could be used to address important clinical questions regarding outcomes and impact of PsA in existing datasets. CLINTRIALS. GOV IDENTIFIER: NCT01695239; NCT02349295.

When doctors are assessing patients with psoriatic arthritis in clinical trials, they use tools, which include questions that patients answer and questions that doctors answer, in addition to a physical exam, to help evaluate how patients are doing. In a routine clinical practice setting, all of these same tools may not be used because they take a longer time to document information during a patient office visit. The goals of this research were to (1) create a new tool, which uses questions that patients and doctors answer, to help doctors evaluate how patients with psoriatic arthritis are doing in routine clinical practice, and (2) to assess if this new tool works as well as older tools. The new tool has fewer questions for the doctor and patient to answer and may take less time to document information but may result in some symptoms that patients experience not being regularly assessed. Data from clinical trials were used to compare the new tool to older tools to evaluate if doctors are able to assess psoriatic arthritis the same way. The results of the study showed that doctors are able to assess patients with psoriatic arthritis similarly with the new tool compared to older tools. This information will increase awareness of the new tool and could make it easier for doctors to evaluate patients with psoriatic arthritis in routine clinical practice.

Ten-year prognostic outcomes of molar survival using the Miller-Mcentire Periodontal Prognostic Index - A longitudinal prospective study.

Background: A 10-year survival analysis was performed to assess the predictive validity of the periodontal risk score (formerly known as Miller-McEntire Periodontal Prognostic Index [MMPPI]) to predict long-term survival of periodontally diseased molars in a longitudinally assessed cohort. Materials and Methods: The MMPPI scores were computed at baseline by summarizing scores allocated for individual factors. The cohort was treated, followed up, and placed under regular periodontal maintenance. Molar survival data collected up to 10 years of follow-up were analyzed. Cox proportional regression was performed, and hazards ratio (HR) were computed for each prognostic factor and the MMPPI score. To estimate the predictive value of MMPPI, a receiver operating curve (ROC) curve analysis was performed. Results: From 1032 molars, 155 molars were extracted over the 10-year follow-up duration. Cox proportional hazard analysis showed significant hazard ratios for tooth loss for the component variables significant HR was noted for age: 4.92 (3.34:7.27), smoking: 1.74 (1.38-2.22), diabetes: 1.66 (1.49-1.86), molar type: 1.39 (1.15-1.67), probing depth: 2.00 (1.63-2.46), furcation: 2.64 (2.30-3.03), mobility: 3.45 (2.98-4.01), and total MMPPI score: 1.98 (1.85-2.12). ROC curve analysis showed an area under the curve value of 0.94 for the MMPPI index as a predictor of molar loss at 8 years, and the Youden index was maximized at the optimal cutoff point score of 7. Conclusions: All component scores of MMPPI showed significant hazard ratios at 10 years. These findings support the previous results from the 5-year analysis of this university-based cohort and warrant validation in independent cohorts.

Materiais educativos digitais sobre habilidades culinárias como estratégia de promoção de saúde na Atenção Primária / Digital educational materials on culinary skills as a health promotion strategy in Primary Health Care

Resumo Este estudo visa reportar desenvolvimento e validação de materiais educativos digitais baseados nas dimensões de habilidades culinárias domésticas (HCD) avaliadas por escala destinada aos profissionais da APS, nas recomendações do Guia Alimentar Para a População Brasileira e no Marco de Educação Alimentar e Nutricional (EAN) para Políticas Públicas. Foram desenvolvidos 5 vídeos e materiais gráficos com propostas de atividades para desenvolvimento de HCD e estímulo à sua implementação em ações e orientações junto à comunidade e em atendimentos profissionais. O conteúdo dos materiais foi avaliado por especialistas utilizando técnica Delphi de 2 rounds e análises estatísticas para evidência de consenso. Especialistas proferiram comentários para aprimoramento dos produtos e sua aplicabilidade. Os materiais apresentaram linguagem decodificada, ilustrações lúdicas, com personagens representativos da população-alvo. Apresentaram evidência de validade de conteúdo satisfatória e podem ser utilizados em ações de educação permanente, visando a qualificação da força de trabalho, e em ações de EAN junto aos sujeitos de direito. Os materiais gráficos possibilitam associar o conteúdo dos vídeos à prática, em contextos condizentes com a realidade dos sujeitos.

Abstract This study aims to report on the development and validation of digital educational materials based on the dimensions of home cooking skills (HCS) assessed on a scale destined for PHC professionals, following the recommendations of The Dietary Guidelines for the Brazilian Population and on The Food and Nutrition Education Framework (FNE) for Public Policies. Five videos and graphic materials were developed with proposals for activities to develop HCS and encourage its implementation in actions and guidelines in the community and in professional care. The content of the materials was evaluated by experts using the Two-Round Delphi-based technique and statistical analyses for evidence of consensus. Specialists presented comments to improve the products and their applicability. The materials presented decoded language and playful illustrations with characters representative of the target population. Evidence of satisfactory content validity was presented and can be used in permanent education actions, seeking the qualification of the workforce and in FNE actions within the scope of the law. The graphic materials make it possible to associate the content of the videos with practice in contexts consistent with the reality of the individuals.

Nursing consultation tools for peoplewith elimination stomas in Brazil: a scoping review / Instrumentos para consulta de enfermagem no Brasil às pessoas com estomias eliminatórias: revisão de escopo

Objetivo: Mapear as proposições e validações de instrumentos no Brasil para nortear a consulta de enfermagem junto às pessoas adultas em pré e pós-operatório de estomias de eliminação. Método: Revisão de Escopo preconizada pelo JBI. A busca ocorreu sem limitação temporal e de idioma nas bases de dados MEDLINE, IBECS, LILACS, CINAHL, Academic Search Premier e Scopus, utilizando descritores indexados no Medical Subject Headings: Nursing, Ostomy, Colostomy, Ileostomy, Patients, Practice guidelines, Preoperative Care, Postoperative Care, Validation studies e o termo livre Urostomy, incluindo literatura cinzenta. Resultados: Dos 828 estudos encontrados, somente cinco atenderam os critérios estabelecidos e tiveram como objetivos: construir e validar instrumento (3); realizar a adaptação transcultural e validar o conteúdo (1); e analisar a validade teórica (1). Todos produtos de teses e/ou dissertações de cursos de pós-graduação Stricto sensu e publicados entre 2013 e 2021. As teorias de Dorothea Orem e Callista Roy nortearam quatro instrumentos. A fase pós-operatória foi a única abordada em todos os instrumentos. Conclusão: O mapeamento demonstrou o interesse dos pesquisadores brasileiros em instrumentalizar a consulta de enfermagem à pessoa com estomia, a começar pela validação de conteúdo dos instrumentos. Os resultados apontam para a necessidade de realizar estudos objetivando a validação clínica. (AU)

Objective: To map the proposals and validity of instruments in Brazil to guide nursing consultations with adults in the pre- and post-operative stages of elimination stomas. Method: A scoping review recommended by JBI. The search took place without time or language limitations in the MEDLINE, IBECS, LILACS, CINAHL, Academic Search Premier and Scopus databases, using descriptors indexed in the Medical Subject Headings, such asNursing, Ostomy, Colostomy, Ileostomy, Patients, Practice guidelines, Preoperative Care, Postoperative Care, Validation studies, and the free term Urostomy, including gray literature. Results:of the 828 studies found, five were selected which aimed to: construct and validate an instrument (03); carry out cross-cultural adaptation and validate content (1); and analyze theoretical validity (1). All were the product of theses and dissertations published between 2013 and 2021. Dorothea Orem's and Callista Roy's theories guided four instruments. The postoperative phase was the only one addressed in all the instruments. Conclusion:the mapping showed Brazilian researchers' interest in instrumentalizing nursing consultation for stoma patient, starting with instrument content validity. The results point to the need for studies aimed at clinical validity. (AU)

Objetivo: Mapear las propuestas y validaciones de instrumentos en Brasil para orientar las consultas de enfermería con adultos en el pre y postoperatorio de estomas de eliminación. Método: Revisión de alcance recomendada por el JBI. La búsqueda se realizó sin limitaciones de tiempo o idioma en las siguientes bases de datos: MEDLINE, IBECS, LILACS, CINAHL, Academic Search Premier y Scopus, utilizando descriptores indexados en los Medical Subject Headings: Nursing, Ostomy, Colostomy, Ileostomy, Patients, Practice guidelines, Preoperative Care, Postoperative Care, Validation studies y el término libre: Urostomy, incluyendo literatura gris. Resultados: De los 828 estudios encontrados, se seleccionaron 05 cuyo objetivo era: construir y validar un instrumento (03); realizar una adaptación transcultural y validar el contenido (1); y analizar la validez teórica (1). Todos fueron producto de tesis y/o disertaciones de cursos de posgrado Stricto sensu y publicados entre 2013 y 2021. Las teorías de Dorothea Orem y Callista Roy guiaron cuatro instrumentos. La fase postoperatoria fue la única abordada en todos los instrumentos. Conclusión: El mapeo mostró el interés de los investigadores brasileños en instrumentalizar la consulta de enfermería con el paciente estomático, a partir de la validación de contenido de los instrumentos. Los resultados apuntan a la necesidad de realizar estudios dirigidos a la validación clínica. (AU)

Adaptación y validación del Voice Handicap Index y su versión abreviada al español rioplatense de Argentina

Objetivo: Este estudio tuvo como objetivo principal validar el Voice Handicap Index (VHI) y su versión abreviada (VHI-10) adaptados al español rioplatense de Argentina, con objetivos específicos centrados en evaluar su fiabilidad y validez. Metodología: La adaptación cultural incluyó técnicas de traducción directa, síntesis y retrotraducción, evaluación de la equivalencia semántica y aplicación a un grupo piloto. Para la validación se evaluó la fiabilidad de ambos índices adaptados mediante la consistencia interna (coeficiente alfa de Cronbach) y la estabilidad test-retest (prueba de Bland-Altman, CCI y r de Spearman). Además, se examinó la validez de criterio y de constructo. 213 sujetos participaron en la validación del índice adaptado de 30 ítems (123 disfónicos; 90 de control); 113, en la del índice abreviado (63 disfónicos; 50 de control). Resultados: Se constituyó el Índice de Desventaja Vocal (IDV) como la versión adaptada del VHI al español rioplatense de Argentina. Ambos índices demostraron excelente consistencia interna (IDV-30 α = 0,96; IDV-10 α = 0,92) y estabilidad y concordancia (IDV-30 CCI = 0,95; IDV-10 CCI = 0,96). Se halló alta correlación entre los puntajes de ambos índices y la autoevaluación de la severidad de la disfonía de los participantes (r = 0,85). Ambos índices demostraron capacidad de diferenciar entre individuos con disfonía y sujetos sanos (p< 0,001). El análisis factorial reveló tres factores para el IDV-30 y un factor para el IDV-10. Conclusiones: El IDV-30 e IDV-10 presentan grados adecuados de fiabilidad y validez. Ambos pueden ser incluidos en protocolos de valoración de la función vocal por profesionales de Argentina.

Aim: This study aimed to validate the Voice Handicap Index (VHI) and its abbreviated version (VHI-10) adapted into Rioplatense Spanish from Argentina, with specific goals centered on assessing their reliability and validity. Methods: Cultural adaptation involved direct translation, synthesis and back-translation techniques, followed by an assessment of semantic equivalence and application to a pilot group. For the validation process, the reliability of both adapted indices was assessed through measures of internal consistency (Cronbach's alpha coefficient) and test-retest stability (Bland-Altman test, ICC and Spearman's correlation coefficient). Additionally, we conducted analyses to asses criterion and construct validity. 213 subjects participated in the validation of the adapted 30-items index, (123 with dysphonia; 90 from control group); 113, in the abbreviated version (63 with dysphonia; 50 from control group). Results: The "Índice de Desventaja Vocal" (IDV) was established as the adapted version of the VHI into Rioplatense Spanish from Argentina. Both indeces exhibited excellent internal consistency (IDV-30 α = 0,96; IDV-10 α = 0,92) and satisfactory stability and agreement (IDV-30 CCI = 0,95; IDV-10 CCI = 0,96). Regarding validity, a strong correlation was observed between the scores of both indeces and the participant's self-assessment of dysphonia degree (r = 0,85). Both indices effectively differentiated between individuals with dysphonia and healthy subjects (p< 0,001). Factor analysis revealed three factors for the IDV-30 and one factor for the IDV-10. Conclusion: The IDV-30 and IDV-10 demonstrate satisfactory levels of reliability and validity. Both indices can be incorporated into the assessment protocols for evaluating the vocal function by professionals in Argentina.

Medication Literacy Test for Older Adults: psychometric analysis and standardization of the new instrument.

BACKGROUND: Low medication literacy is prevalent among older adults and is associated with adverse drug events. The Medication Literacy Test for Older Adults (TELUMI) was developed and content validated in a previously published study. AIM: To evaluate the psychometric properties and provide norms for TELUMI scores. METHOD: This was a cross-sectional methodological study with older adults selected from the community and from two outpatient services. Descriptive item-analysis, exploratory factor analysis (EFA), item response theory (IRT), reliability, and validity analysis with schooling and health literacy were performed to test the psychometric properties of the TELUMI. The classification of the TELUMI scores was performed using percentile norms. RESULTS: A total of 344 participants, with a mean age of 68.7 years (standard deviation = 6.7), were included; most were female (66.6%), black/brown (61.8%), had low schooling level (60.2%) and low income (55.2%). The EFA pointed to the one-dimensional structure of TELUMI. A three-parameter logistic model was adopted for IRT. All items had an adequate difficulty index. One item had discrimination < 0.65, and three items had an unacceptable guessing index (< 0.35) and were excluded. The 29-item version of TELUMI had excellent internal consistency (KR20 = 0.89). There was a positive and strong association between TELUMI scores and health literacy and education level. The scores were classified as inadequate medication literacy (≤ 10.0 points), medium medication literacy (11-20 points), and adequate medication literacy (≥ 21 points). CONCLUSION: The results suggest that the 29-item version of TELUMI is psychometrically adequate for measuring medication literacy in older adults.

[Characterization and risk prediction of cardiovascular surgeries with cardiopulmonary bypass: a cross-sectional study] / Caracterización y predicción del riesgo de cirugías cardiovasculares con uso de bomba de circulación extracorpórea.

Introduction: Cardiovascular surgery risk prediction models are widely applied in medical practice. However, they have been criticized for their low methodological quality and scarce external validation. An additional limitation added in Latin America is that most of these models have been developed in the United States or Europe, which present marked geographical differences. The objective of this study is to characterize the postoperative clinical events of cardiovascular surgeries with the use of cardiopulmonary bypass pump in a local setting and to evaluate the prediction of postoperative mortality using the EuroSCORE II predictive model. Methods: Cross-sectional study in an urban university hospital in Buenos Aires. Patients ≥21 years of age were included, with a clinical indication for on-pump cardiovascular surgery. Patients with incomplete clinical data regarding EuroSCORE II variables or in-hospital survival, ≥95 years of age, or undergoing heart transplantation were excluded. Results: 195 patients were enrolled. Postoperative mortality estimated by EuroSCORE II presented a clear underestimation of risk (3.0% vs 7.7%). Discrimination (AUC = 0.82; 95% CI 0.74-0.92) and goodness of fit of the model were adequate (χ2 = 7.91; p = 0.4418). The most frequent postoperative complications were postoperative heart failure (35.9%), vasoplegic shock (13.3%), and cardiogenic shock (10.26%). Conclusion: The EuroSCORE II is an appropriate tool to discriminate between different risk categories in patients undergoing on-pump cardiovascular surgery, although it underestimates the risk.

Introducción: Los modelos de predicción de riesgo de cirugías cardiovasculares se aplican ampliamente a la práctica médica. Sin embargo, han sido criticados por su baja calidad metodológica y escasa validación externa. En América Latina se agrega la limitación de que la mayoría de estos modelos fueron desarrollados en Estados Unidos o Europa, existiendo diferencias geográficas marcadas. Objetivo: El objetivo de este estudio es caracterizar los eventos clínicos postoperatorios de cirugías cardiovasculares con uso de bomba de circulación extracorpórea en un escenario local y evaluar la predicción de mortalidad postoperatoria del modelo predictivo EuroSCORE II. Métodos: Corte transversal en un hospital universitario urbano de Buenos Aires. Se incluyeron a pacientes ≥21 años de edad, con indicación de cirugía cardiovascular con uso de bomba. Se excluyeron a pacientes con datos clínicos incompletos respecto a las variables del EuroSCORE II o respecto a la sobrevida intrahospitalaria, con ≥95 años de edad o sometidos a trasplante cardíaco. Resultados: Se enrolaron 195 pacientes. La mortalidad postoperatoria estimada por el EuroSCORE II presentó una clara subestimación del riesgo (3,0% vs 7,7%). La discriminación (AUC = 0,82; IC95% 0,74-0,92) y la bondad del ajuste del modelo fueron adecuadas (χ2 = 7,91; p = 0,4418). Las complicaciones postoperatorias más frecuentes fueron insuficiencia cardíaca postoperatoria (35,9%), shock vasopléjico (13,3%) y shock cardiogénico (10,26%). Conclusión: El EuroSCORE II es una herramienta apropiada para discriminar entre diferentes categorías de riesgo en pacientes sometidos a cirugías cardiovasculares con uso de bomba, si bien subestima el riesgo.

[Spanish translation, cross-cultural adaptation and validation of the ADTC scale (Atopic Dermatitis Control Tool)] / Traducción al español, adaptación transcultural y validación de la escala ADTC (Atopic Dermatitis Control Tool).

OBJETIVES: Obtain a version to validate it in a population of adults with AD. MATERIALS AND METHODS: 1) Translation into Spanish and cross-cultural adaptation of the questionnaire from the original version in English, through a seven-step process. 2) Evaluation of the unidimensionality of the resulting scale by means of an exploratory factor analysis (EFA), of its reliability by means of Cronbach's alpha coefficient, and of its validity by evaluating the correlation of its score with those of the POEM and DLQI questionnaires. (external reference criteria). RESULTS: The version resulting from the translation and cross-cultural adaptation process was well understood by the target population. The AFE of the 66 questionnaires documented the unidimensionality of the scale based on compliance with all the criteria used for its verification. Its reliability was excellent (Cronbach's Alpha: 0.917) and its score had a very high correlation with the external reference criteria (POEM: Spearman's Rho 0.85; p < 0.0001; DLQI Spearman's Rho = 0.81; p < 0 .0001). CONCLUSIONS: The version translated into Spanish and adapted for transculturation of the ADCT questionnaire has appropriate psychometric characteristics, which will contribute to optimizing the care processes of Spanish-speaking patients.

INTRODUCCIÓN: El cuestionario ADCT (Atopic Dermatitis Control Tool) permite objetivar en forma breve y autoadministrada la repercusión de la dermatitis atópica (DA) sobre la vida cotidiana de quien la padece. OBJETIVO: Obtener una versión validarla en una población de adultos con DA. MATERIALES Y METODOS: 1) Traducción al español y adaptación transcultural del cuestionario a partir de la versión original en inglés, a través de un proceso de siete pasos. 2) Evaluación de la unidimensionalidad de la escala resultante mediante un análisis factorial exploratorio (AFE), de su confiabilidad mediante el coeficiente alfa de Cronbach, y de su validez mediante la evaluación de la correlación de su puntaje con los de los cuestionarios POEM y DLQI (criterios externos de referencia). RESULTADOS: La versión resultante del proceso de traducción y adaptación transcultural fue bien comprendida por la población blanco. El AFE de los 66 cuestionarios documentó la unidimensionalidad de la escala a partir del cumplimiento de todos los criterios utilizados para su verificación. Su confiabilidad fue excelente (Alfa de Cronbach: 0,917) y su puntaje tuvo muy alta correlación con los criterios de referencia externos (POEM: Spearman's Rho 0,85; p < 0,0001; DLQI Spearman's Rho = 0,81; p < 0,0001). CONCLUSION: La versión traducida al español y adaptada transculturación del cuestionario ADCT tiene características psicométricas apropiadas, lo que contribuirá a optimizar los procesos de cuidado de pacientes de habla hispana.

Assessing Functional Capacity in Directly and Remotely Monitored Home-Based Settings in Individuals With Chronic Respiratory Diseases: Protocol for a Multinational Validation Study.

BACKGROUND: Pulmonary rehabilitation is widely recommended to improve functional status and as secondary and tertiary prevention in individuals with chronic pulmonary diseases. Unfortunately, access to timely and appropriate rehabilitation remains limited. To help close this inaccessibility gap, telerehabilitation has been proposed. However, exercise testing is necessary for effective and safe exercise prescription. Current gold-standard tests, such as maximal cardiopulmonary exercise testing (CPET) and the 6-minute walk test (6MWT), are poorly adapted to home-based or telerehabilitation settings. This was an obstacle to the continuity of services during the COVID-19 pandemic. It is essential to validate tests adapted to these new realities, such as the 6-minute stepper test (6MST). This test, strongly inspired by 6MWT, consists of taking as many steps as possible on a "stepper" for 6 minutes. OBJECTIVE: This study aims to evaluate the metrological qualities of 6MST by (1) establishing concurrent validity and agreement between the 6MST and CPET, as well as with the 6MWT; (2) determining test-retest reliability in a home-based setting with direct and remote (videoconferencing) monitoring; and (3) documenting adverse events and participant perspectives when performing the 6MST in home-based settings. METHODS: Three centers (Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec in Québec, Groupement des Hôpitaux de l'Institut Catholique de Lille in France, and FormAction Santé in France) will be involved in this multinational project, which is divided into 2 studies. For study 1 (objective 1), 30 participants (Québec, n=15; France, n=15) will be recruited. Two laboratory visits will be performed to assess anthropometric data, pulmonary function, and the 3 exercise tolerance tests (CPET, 6MWT, and 6MST). Concurrent validity (paired sample t tests and Pearson correlations) and agreement (Bland-Altman plots with 95% agreement limits) will be evaluated. For study 2 (objectives 2 and 3), 52 participants (Québec, n=26; France, n=26) will be recruited. Following a familiarization trial (trial 1), the 6MST will be conducted on 2 separate occasions (trials 2 and 3), once under direct supervision and once under remote supervision, in a randomized order. Paired sample t test, Bland-Altman plots, and intraclass correlations will be used to compare trials 2 and 3. A semistructured interview will be conducted after the third trial to collect participants' perspectives. RESULTS: Ethical approval was received for this project (October 12, 2023, in Québec and September 25, 2023, in France) and the first participant was recruited in February 2024. CONCLUSIONS: This study innovates by validating a new clinical test necessary for the development and implementation of new models of rehabilitation adapted to home and telerehabilitation contexts. This study also aligns with the United Nations Sustainable Development Goals by contributing to augmenting health care service delivery (goal 3) and reducing health care access inequalities (goal 11). TRIAL REGISTRATION: ClinicalTrials.gov NCT06447831; https://clinicaltrials.gov/study/NCT06447831. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57404.