Performance of risk scores in predicting major bleeding in left ventricular assist device recipients: a comparative external validation.

Background: Implantation of a left ventricular assist device (LVAD) is a crucial therapeutic option for selected end-stage heart failure patients. However, major bleeding (MB) complications postimplantation are a significant concern. Objectives: We evaluated current risk scores' predictive accuracy for MB in LVAD recipients. Methods: We conducted an observational, single-center study of LVAD recipients (HeartWare or HeartMate-3, November 2010-December 2022) in the Netherlands. The primary outcome was the first post-LVAD MB (according to the International Society on Thrombosis and Haemostasis [ISTH] and Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS], and INTERMACS combined with intracranial bleeding [INTERMACS+] criteria). Mortality prior to MB was considered a competing event. Discrimination (C-statistic) and calibration were evaluated for the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly score, Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke score, Anticoagulation and Risk Factors in Atrial Fibrillation score, Outpatient Bleeding Risk Index, venous thromboembolism score, atrial fibrillation score, and Utah Bleeding Risk Score (UBRS). Results: One hundred four patients were included (median age, 64 years; female, 20.2%; HeartWare, 90.4%; HeartMate-3, 9.6%). The cumulative MB incidence was 75.7% (95% CI 65.5%-85.9%) by ISTH and INTERMACS+ criteria and 67.0% (95% CI 56.0%-78.0%) per INTERMACS criteria over a median event-free follow-up time of 1916 days (range, 59-4521). All scores had poor discriminative ability on their intended prediction timeframe. Cumulative area under the receiving operator characteristic curve ranged from 0.49 (95% CI 0.35-0.63, venous thromboembolism-BLEED) to 0.56 (95% CI 0.47-0.65, UBRS) according to ISTH and INTERMACS+ criteria and from 0.48 (95% CI 0.40-0.56, Anticoagulation and Risk Factors in Atrial Fibrillation) to 0.56 (95% CI 0.47-0.65, UBRS) per INTERMACS criteria. All models showed poor calibration, largely underestimating MB risk. Conclusion: Current bleeding risk scores exhibit inadequate predictive accuracy for LVAD recipients. There is a need for an accurate risk score to identify LVAD patients at high risk of MB who may benefit from patient-tailored antithrombotic therapy.

Design and validation of a GMP stem cell manufacturing protocol for MPSII hematopoietic stem cell gene therapy.

Hematopoietic stem cell gene therapy (HSCGT) is a promising therapeutic strategy for the treatment of neurodegenerative, metabolic disorders. The approach involves the ex vivo introduction of a missing gene into patients' own stem cells via lentiviral-mediated transduction (TD). Once transplanted back into a fully conditioned patient, these genetically modified HSCs can repopulate the blood system and produce the functional protein, previously absent or non-functional in the patient, which can then cross-correct other affected cells in somatic organs and the central nervous system. We previously developed an HSCGT approach for the treatment of Mucopolysaccharidosis type II (MPSII) (Hunter syndrome), a debilitating pediatric lysosomal disorder caused by mutations in the iduronate-2-sulphatase (IDS) gene, leading to the accumulation of heparan and dermatan sulfate, which causes severe neurodegeneration, skeletal abnormalities, and cardiorespiratory disease. In HSCGT proof-of-concept studies using lentiviral IDS fused to a brain-targeting peptide ApoEII (IDS.ApoEII), we were able to normalize brain pathology and behavior of MPSII mice. Here we present an optimized and validated good manufacturing practice hematopoietic stem cell TD protocol for MPSII in preparation for first-in-man studies. Inclusion of TEs LentiBOOST and protamine sulfate significantly improved TD efficiency by at least 3-fold without causing adverse toxicity, thereby reducing vector quantity required.

Evidence of content validity of the nursing outcome "sexual functioning" from the nursing outcome classification.

PURPOSE: To evaluate the content validity evidence of the nursing outcome "sexual functioning" from the Nursing Outcomes Classification (NOC). METHODS: A multi-method study, including a methodological study analyzing the content validity evidence of the NOC outcome and sexual functioning, and a quantitative, descriptive, cross-sectional study. In the first phase, a literature review was conducted to map and identify clinical indicators associated with sexual functioning to construct the conceptual (CD) and operational definitions (ODs) of each outcome indicator. In the second phase, experts assessed the CD and OD for clarity, theoretical relevance, and theoretical pertinence. The critical validity ratio (CVR) was calculated for each indicator. In the third phase, a pilot test of sexual functioning measurement was conducted with 33 patients hospitalized for coronary artery disease. Internal consistency was calculated through Cronbach's alpha. RESULTS: The CD and OD were constructed based on 120 articles and analyzed by 13 experts; four rounds were required to achieve the critical CVR in each phase. In the pilot test, the nursing outcome achieved a Cronbach's alpha of 0.95, and the mean assessment time was 26 min. Indicators with the highest mean scores were related to knowledge of personal needs and capabilities and comfort with one's own body. CONCLUSION: The CD and OD developed for the NOC outcome, sexual functioning, had adequate evidence of content validity. The outcome content has high internal consistency. Further studies on the validity of the nursing outcome should be conducted to increase its validity. IMPLICATIONS FOR PRACTICE: The nursing outcome, sexual functioning, can be a tool used by nurses to evaluate the effect of nursing education and interventions on sexual functioning in the adult population.

PURPOSE: Desenvolver e avaliar as evidências de validade de conteúdo das definições conceituais e operacionais dos indicadores do resultado de Enfermagem "Funcionamento Sexual" da Classificação dos Resultados de Enfermagem (NOC). METHODS: Estudo metodológico dividido em três fases. Na primeira fase foi realizada uma revisão de literatura para mapear e identificar os indicadores clínicos associados ao funcionamento sexual para a construção das definições conceituais (DC) e operacionais (DO) de cada indicador do resultado de enfermagem em estudo. Na segunda fase foi realizada a análise das evidências de validade de conteúdo das DC e DO dos indicadores por meio da avaliação pelos especialistas. Na terceira fase foi realizada um pré­teste do resultado de enfermagem em 33 pacientes hospitalizados por doença arterial coronariana. RESULTS: Foram selecionados 120 artigos que serviram de base para a construção das definições conceituais e operacionais analisadas por 13 especialistas, necessário quatro rodadas para alcançar o coeficiente de validade de conteúdo crítico estabelecido para o número de juízes respondentes. pré­testeo resultado de enfermagem estudado um alfa de Cronbach de 0,95 e o tempo médio de aplicação foi de 26 minutos. Os indicadores com maiores médias estavam relacionados ao conhecimento das necessidades e capacidade pessoais e conforto com o próprio corpo. CONCLUSION: As DC e DO dos indicadores do resultado "Funcionamento Sexual" da NOC desenvolvidas apresentaram adequadas evidências de validade de conteúdo. O pré­teste o apresentou elevado nível de consistência interna. Outros estudos de evidências de validade do resultado estudado devem ser realizados visando o aumento no nível de validade do resultado. IMPLICATION FOR PRACTICE: O resultado estudado pode ser uma ferramenta utilizada pelo enfermeiro para avaliação do funcionamento sexual na população adulta visando a individualização das orientações e intervenções de enfermagem.

Cultural Adaptation and Validation of the Punjabi Version of EPIC.

BACKGROUND: With earlier prostate cancer (PCa) diagnosis and increased survivorship, post-treatment quality of life (QoL) has become increasingly important. The Expanded Prostate Cancer Index Composite (EPIC) is a widely adopted QoL instrument for PCa. We aimed to create a Punjabi version of EPIC to further research in the Punjabi-speaking population. METHODS: A prototype of the Punjabi version of EPIC was created by forward-backward translations and revision. After concluding the cultural adaptation phase by interviewing 15 participants, a pilot version was created. Validation of the pilot version was performed by having 72 participants complete the Punjabi EPIC and another commonly used QoL instrument, the EORTC QLQ-c30, twice within a 4-week period. Test retest reliability (Pearson's correlations and difference distribution) and internal consistency (Cronbach's alpha) were measured using SAS version 9.4. RESULTS: Modifications were needed for the prototype Punjabi version after forward-backward translations. Cultural adaptation has highlighted a few issues including syntax and terminology.  Test-retest reliability of the Urinary, Bowel, Sexual and Hormone domains were 0.88, 0.91, 0.91, and 0.95, respectively, and subscale correlations ranged from 0.75 to 0.93. Internal consistency for domains and subscales was good except for Sexual Domain. Performance of EPIC is comparable, and in some cases, slightly better than validated Punjabi version of EORTC QLQ-C30. CONCLUSIONS: The EPIC questionnaire was successfully translated into Punjabi and was culturally adapted.  The resultant Punjabi version has high reliability and validity and will be an important tool for QoL research in the Punjabi population. EPIC was successfully translated, culturally adapted, and validated with high reliability and validity into Punjabi. It will be a valuable QoL tool for physicians in clinical and research settings, and for patients in decision-making.

Clinical validation of the nursing outcome "Swallowing status: pharyngeal phase" in patients with laryngeal cancer.

AIMS AND OBJECTIVES: This study aimed to clinically validate the nursing outcome "Swallowing status: pharyngeal phase" (1013). METHODS: A two-stage study was designed: (1) Chinese translation and cultural adaptation and (2) clinical validation. Internal consistency and interrater reliability tests were performed on 285 patients with laryngeal cancer, and an additional 130 patients were randomly selected from the 285 patients as an independent sample. Criterion-related validity tests were performed using the standardized swallowing assessment (SSA). Nursing outcome sensitivity was detected by scoring two time points. RESULTS: The Cronbach's alpha coefficients were 0.951 for the nursing outcome and 0.942-0.965 for each indicator. The interclass correlation coefficient (ICC) values for each indicator ranged from 0.73 to 0.929. The scores of the nursing outcome were negatively correlated with the SSA scores (r = -0.555, p < 0.01). With the exception of two indicators, there was a significant difference (p < 0.05) between the total scores of the scale and its 11 indicator scores for the two time points. The results indicated that the nursing outcome "Swallowing status: pharyngeal phase" (1013) exhibited satisfactory psychometric properties and high sensitivity to change. CONCLUSIONS: The nursing outcome "Swallowing status: pharyngeal phase" (1013) demonstrated good reliability, validity, and sensitivity in patients with laryngeal cancer. IMPLICATIONS FOR NURSING PRACTICE: The nursing outcome "Swallowing status: pharyngeal phase" (1013) can be used to assess swallowing function in patients with laryngeal cancer and provide guidance for the development of rehabilitation intervention plans and nursing care.

Translation, Cross-Cultural Adaptation, and Validation of Measurement Instruments: A Practical Guideline for Novice Researchers.

Cross-cultural validation of self-reported measurement instruments for research is a long and complex process, which involves specific risks of bias that could affect the research process and results. Furthermore, it requires researchers to have a wide range of technical knowledge about the translation, adaptation and pre-test aspects, their purposes and options, about the different psychometric properties, and the required evidence for their assessment and knowledge about the quantitative data processing and analysis using statistical software. This article aimed: 1) identify all guidelines and recommendations for translation, cross-cultural adaptation, and validation within the healthcare sciences; 2) describe the methodological approaches established in these guidelines for conducting translation, adaptation, and cross-cultural validation; and 3) provide a practical guideline featuring various methodological options for novice researchers involved in translating, adapting, and validating measurement instruments. Forty-two guidelines on translation, adaptation, or cross-cultural validation of measurement instruments were obtained from "CINAHL with Full Text" (via EBSCO) and "MEDLINE with Full Text". A content analysis was conducted to identify the similarities and differences in the methodological approaches recommended. Bases on these similarities and differences, we proposed an eight-step guideline that includes: a) forward translation; 2) synthesis of translations; 3) back translation; 4) harmonization; 5) pre-testing; 6) field testing; 7) psychometric validation, and 8) analysis of psychometric properties. It is a practical guideline because it provides extensive and comprehensive information on the methodological approaches available to researchers. This is the first methodological literature review carried out in the healthcare sciences regarding the methodological approaches recommended by existing guidelines.

[Translated article] Validated questionnaires on medication adherence and associated factors in chronic patients: A systematic review.

OBJECTIVE: To identify validated questionnaires to assess medication adherence, and its associated factors, in adult patients with chronic pathologies. METHOD: A systematic review of scientific publications that describe validated medication adherence questionnaires in PubMed and Scopus was carried out during May 2022. The search strategy combined the MeSH heading "Medication adherence" with the keywords: "Questionnaire" and "Validation"; adding "Spanish" to rescue questionnaires in our language. Systematic reviews, meta-analyses, or scientific articles with full text available in Spanish or English were selected; published from January 2000 to April 2022; that present the application and validation of a medication adherence questionnaire in adults with chronic pathologies; and publications of the initial validation of a questionnaire, recovered through bibliographic citations of the previously identified publications, even if they are prior to the year 2000. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed to represent the search process, inclusion and exclusion of the retrieved publications. RESULTS: (97) records in PubMed and 3 adding "Spanish" were retrieved; in Scopus, 334 records were retrieved and 13 with "Spanish". 118 records were retrieved through bibliographic citations identification. From the analysis of the previous publications, 14 validated questionnaires were identified that assess medication adherence and are applied in English and/or Spanish in adult patients with chronic pathologies. For each questionnaire, the following characteristics were described: name, authors, year of publication, dimensions (barriers and facilitators factors), number and wording of the items, response scale, form of administration, language, and pathologies of the initial validation. Of the subsequent validations, only those carried out in English and/or Spanish were presented. So far, 6 questionnaires were validated in Spanish and only for certain chronic pathologies. CONCLUSIONS: (14) validated questionnaires were identified, 6 of them were validated in Spanish. They are designed to evaluate medication adherence in a comprehensive manner, being useful to be applied in hospital and community pharmaceutical services. This review provides health professionals with tools to develop and validate their own questionnaire, adapting the wording to the local language and context of the health system.

Translation, Cross-Cultural Adaptation, and Psychometric Properties of the Revised Fibromyalgia Impact Questionnaire (FIQR) for Use in Arabic-Speaking Patients in Saudi Arabia.

Background/Aim: Fibromyalgia (FM) is a complex and debilitating condition that significantly impacts patients' daily lives. The continuous assessment of the impact and severity of FM is essential to manage the condition effectively. Assessment tools in Arabic are lacking for use in Saudi Arabia, which might lead to ineffective management. This study aimed to translate and cross-culturally adapt and validate the Arabic version of the Revised Fibromyalgia Impact Questionnaire (FIQR). Methods: Following translation guidelines, 2 Arabic translators and 2 English-certified translators performed forward and backward translations of the FIQR. In a cross-sectional study design, the questionnaire was piloted with 5 participants and then subjected to cognitive interviews and psychometric analysis. Participants were FM patients recruited from a University Hospital in Riyadh and FM support groups in Saudi Arabia. The internal consistency, and reliability using the Cronbach α and interclass correlation coefficient (ICC) of 2-week test-retest, and criterion validity were evaluated. Results: The results included a total of 42 participants with FM. Six minor modifications were made during the stepwise translation of the questionnaire. The Arabic version of the FIQR had good internal consistency and test-retest reliability, with a Cronbach α of 0.855 for the physical functioning domain, 0.663 for overall well-being, 0.803 for symptoms, and 0.895 for the total FIQR, and the Pearson correlation coefficient of the ICC for physical functioning was 0.769 (95% confidence interval (CI), 0.541-0.884) for the overall well-being domain, 0.555 (95% CI, 0.129-0.772) for the symptoms domain, and 0.720 (95% CI, 0.370-0.868) and 0.794 (95% CI, 0.579-0.899) for the total FIQR score (p < 0.001), respectively. Conclusion: The Arabic version of the FIQR is a valid, reliable, and practical tool for assessing the impact of FM on Arabic-speaking patients and potentially contributing to the improvement of FM outcomes.

Validation of the Saga Fall Injury Risk Model.

Background: Predicting fall injuries can mitigate the sequelae of falls and potentially utilize medical resources effectively. This study aimed to externally validate the accuracy of the Saga Fall Injury Risk Model (SFIRM), consisting of six factors including age, sex, emergency transport, medical referral letter, Bedriddenness Rank, and history of falls, assessed upon admission. Methods: This was a two-center, prospective, observational study. We included inpatients aged 20 years or older in two hospitals, an acute and a chronic care hospital, from October 2018 to September 2019. The predictive performance of the model was evaluated by calculating the area under the curve (AUC), 95% confidence interval (CI), and shrinkage coefficient of the entire study population. The minimum sample size of this study was 2,235 cases. Results: A total of 3,549 patients, with a median age of 78 years, were included in the analysis, and men accounted for 47.9% of all the patients. Among these, 35 (0.99%) had fall injuries. The performance of the SFIRM, as measured by the AUC, was 0.721 (95% CI: 0.662-0.781). The observed fall incidence closely aligned with the predicted incidence calculated using the SFIRM, with a shrinkage coefficient of 0.867. Conclusions: The external validation of the SFIRM in this two-center, prospective study showed good discrimination and calibration. This model can be easily applied upon admission and is valuable for fall injury prediction.

Characterization of the 263K-derived microsomal fraction: a source of prions for nanofiltration validation studies.

BACKGROUND: The manufacturing processes of plasma products include steps that can remove prions. The efficacy of these steps is measured in validation studies using animal brain-derived prion materials called spikes. Because the nature of the prion agent in blood is not known, the relevance of these spikes, particularly with steps that are based on retention mechanisms such as nanofiltration, is important to investigate. STUDY DESIGN AND METHODS: The aggregation and sizes of PrPres assemblies of microsomal fractions (MFs) extracted from 263K-infected hamster brains were analyzed using velocity gradients. The separated gradient fractions were either inoculated to Tg7 mice expressing hamster-PrPc to measure infectivity or used in Protein Misfolding Cyclic Amplification for measuring seeding activity. The collected data allowed for reanalyzing results from previous nanofiltration validation studies. RESULTS: A significant portion of MFs was found to be composed of small PrPres assemblies, estimated to have a size ≤24 mers (~22-528 kDa), and to contain a minimum of 20% of total prion infectivity. With this data we could calculate reductions of 4.10 log (15 N), 2.53 log (35 N), and 1.77 log (35 N) from validation studies specifically for these small PrPres objects. CONCLUSION: Our gradient data provided evidence that nanofilters can remove the majority of the smallest PrPres entities within microsomes spikes, estimated to be in a size below 24 mers, giving insight about the fact that, in our conditions, size exclusion may not be the only mechanism for retention nanofiltration.

[Convergent and discriminative validity of the Frail-VIG index with the Pfeiffer test in people cared for in home care]. / Validez convergente y discriminativa del índice Frágil-VIG con el test de Pfeiffer en personas atendidas en atención domiciliaria.

INTRODUCTION: The Frail-VIG index-and the Pfeiffer test are measurements used in Primary Care for assessment frailty and the cognitive impairment screening. The Frail-VIG index is a multidimensional instrument that allows a rapid assessment of the degree of frailty in the context of clinical practice. OBJECTIVE: Our aim was to investigate the convergent and discriminative validity of the Frail-VIG index with regard to Pfeiffer test value. DESIGN: A cross-sectional study. SITE: Two urban Primary Health Care centres of the Catalan Institute of Health, Barcelona (Spain). PARTICIPANTS: All people included under a home care programme during the year 2018. No exclusion criteria were applied. MAIN MEASUREMENTS: We used the Frail-VIG index to measure frailty and the Pfeiffer test to cognitive impairment screening. Trained nurses administered both instruments during face-to-face assessments in a participant's home during usual care. The relationships between both instruments were examined using Pearson's correlation coefficient. RESULTS: A total of 412 participants were included. Frail-VIG score and Pfeiffer test value were moderately correlated (r=0.564; P<0.001). Non-frail people had a lower risk of developing cognitive impairment than moderate to severe frail people. The value of the Pfeiffer test increased significantly as the Frail-VIG index score also increased. CONCLUSIONS: Frail-VIG index demonstrated a convergent validity with the Pfeiffer test. Its discriminative validity was optimal, as their scores showed an excellent capacity to differentiate between people with a higher and lower risk of developing cognitive impairment. These findings provide additional pieces of evidence for construct validity of the Frail-VIG index.

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.

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 of the Spanish version of the Pediatric Asthma Severity Score (PASS) in a population of Hispanic children.

BACKGROUND: The Pediatric Asthma Severity Score (PASS) is one of the most-used clinical scoring systems for assessing the severity of asthma exacerbations in children. The aim of the present study was to validate a Spanish version of the PASS in a population of Hispanic children with asthma exacerbations living in urban Bogota, Colombia. METHODS: In a prospective cohort and a validation study, parents/caregivers of children between 2 and 18 years old attended in the emergency department (ED) with asthma exacerbations who were admitted to the inpatient unit were invited to participate in the study. During the hospitalization period, we gathered the necessary data for assessing the criterion validity (comparing its score with the Pediatric Respiratory Assessment Measure [PRAM]), construct validity, interrater reliability, responsiveness, and internal consistency of the Col-PASS, the Colombian version of the PASS. RESULTS: At baseline, the scores of the Col-PASS correlated positively with the scores of the PRAM score (ρ = 0.588, p < .001). The baseline Col-PASS scores in patients who required admission to a more complex service were significantly higher than those in patients who presented clinical improvement (1.0 (0.0-2.0) vs. 0.0 (0.0-0.0), p < .001). The interrater reliability was found to be κ = 0.897, 95% CI 0.699-1.000, p < .001. Cronbach's α was .701 for the questionnaire as a whole. CONCLUSION: The Col-PASS has excellent construct validity, adequate criterion validity, interrater reliability, responsiveness; and acceptable internal consistency when used in children between 2 and 18 years old with asthma exacerbations.

External validation of two clinical prediction models for mortality in COVID-19 patients (4C and NEWS2), in three centers in Medellín, Colombia: Assessing the impact of vaccination over time.

OBJECTIVES: External validation of the 4C and NEWS2 scores for the prediction of in-hospital mortality in COVID-19 patients, and evaluation of its operational performance in two time periods: before and after the start of the vaccination program in Colombia. METHODS: Retrospective cohort in three high complexity hospitals in the city of Medellín, Colombia, between June 2020 and April 2022. RESULTS: The areas under the ROC curve (AUC) for the 4C mortality risk score and the NEWS2 were 0.75 (95% CI 0.73-0.78) and 0.68 (95% CI 0.66-0.71), respectively. For the 4C score, the AUC for the first and second periods was 0.77 (95% CI 0.74-0.80) and 0.75 (95% CI 0.71-0.78); whilst for the NEWS2 score, it was 0.68 (95% CI 0.65-0.71) and 0.69 (95% CI 0.64-0.73). The calibration for both scores was adequate, albeit with reduced performance during the second period. CONCLUSIONS: The 4C mortality risk score proved to be the more adequate predictor of in-hospital mortality in COVID-19 patients in this Latin American population. The operational performance during both time periods remained similar, which shows its utility notwithstanding major changes, including vaccination, as the pandemic evolved.

Development and psychometric properties of the Turkish version of the Orofacial Esthetic Scale.

OBJECTIVE: This study aimed to develop the Turkish version of the Orofacial Esthetic Scale (OES-Tr) and to evaluate its psychometric properties. MATERIALS AND METHODS: The OES-Tr questionnaire was obtained from the English version of OES by translation and back-translation. The current version's psychometric properties were evaluated in a cohort of 221 participants (81 dental students, 70 dentists with 1-10 years of clinical experience, and 70 dentists with 11-20 years of clinical experience). To assess the test-retest reliability, the OES was administered twice to all participants, with a time interval of 2-4 weeks. The reliability and validity of the questionnaire were assessed. Also, in validity studies, OES total scores were correlated with Oral Health Impact Profile-Turkish Version (OHIP-Tr) total scores. RESULTS: The Cronbach's alpha value obtained from seven items was 0.866 in the examination performed on all individuals. Reliability results show that all questionnaire items are consistent within the test. Bartlett's test of sphericity was statistically significant (p < 0.05) and Kaiser-Meyer-Olkin test was 0.794. The results of the exploratory factor analysis indicated the creation of a single-factor structure. The examinations conducted on all participants revealed a statistically significant weak negative correlation between OES and OHIP scores (r = -0.144). CONCLUSIONS: OES-Tr can be utilized as a reliable tool to evaluate an individual's perception of their orofacial appearance. With its excellent psychometric properties, it serves as a valuable instrument for assessing self-perceived orofacial esthetics. CLINICAL SIGNIFICANCE: OES-Tr is a valuable instrument for assessing the appearance of the orofacial region, with good psychometric properties.

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.

Propiedades psicométricas del Eating Attitudes Test-26 en escolares españoles / Psychometric properties of the Eating Attitudes Test-26 in Spanish schoolchildren

Introducción: Las Actitudes y los Comportamientos Alimentarios Desordenados (DEAB, por sus siglas en inglés) pueden afectar tanto a la salud mental como física en los niños/as. Su detección temprana es crucial para prevenir complicaciones y mejorar las posibilidades de recuperación. El Eating Attitudes Test-26 (EAT-26) es una herramienta ampliamente utilizada para evaluar las DEAB debido a su costo/efectividad.ObjetivoEvaluar las propiedades psicométricas del EAT-26, analizando la estructura factorial, la consistencia interna, la validez convergente e invarianza de medida entre ambos sexos en escolares españoles.MétodoEstudio instrumental con una muestra de 718 escolares. La muestra se dividió aleatoriamente en 2 grupos, cada uno con 359 participantes, realizando un análisis factorial exploratorio (AFE) y un análisis factorial confirmatorio (AFC). Posteriormente, se estimó la consistencia interna con el alfa ordinal, la validez convergente con el cuestionario SCOFF y la invarianza de medida entre ambos sexos.ResultadosLos hallazgos del AFE y AFC respaldaron una estructura multidimensional del EAT, compuesta por 6 factores y 21 ítems. Estos factores subyacen en un modelo de segundo orden de las DEAB. La consistencia interna fue suficiente para la mayoría de los factores. Se mostró una validez convergente moderada con el cuestionario SCOFF para la mayoría de los factores. Se alcanzó una invarianza estricta entre ambos sexos. (AU)

Introduction: Disordered Eating Attitudes and Behaviours (DEABs) can impact both the mental and physical health of children. Early detection is crucial to prevent complications and improve outcomes. The Eating Attitudes Test-26 (EAT-26) is a widely used, cost-effective tool for assessing DEABs.ObjectiveTo evaluate the psychometric properties of the EAT-26 by analysing its factor structure, internal consistency, convergent validity, and measurement invariance across sexes in Spanish schoolchildren.MethodValidation study in a sample of 718 schoolchildren. The sample was randomly divided into two groups, each with 359 participants, and we carried out an exploratory factor analysis (EFA) and a confirmatory factor analysis (CFA) of the instrument. Subsequently, for the total sample, we assessed the internal consistency by means of the ordinal alpha, the convergent validity with the SCOFF questionnaire and the measurement invariance between the sexes.ResultsThe results of the EFA and CFA supported a multidimensional structure of the EAT comprising six factors and 21 items. These factors underlie a second-order model of DEABs. The internal consistency was adequate for most factors. The SCOFF questionnaire showed a moderate convergent validity for most factors. We found strict invariance across the sexes. (AU)

Protocol for preliminary, multicenteric validation of "PoCOsteo device": A point of care tool for proteomic and genomic study of osteoporosis.

One of the goals of the HORIZON 2020 project PoCOsteo was to develop a medical device, which would measure and/or quantify proteomic as well as genomic factors as present in whole blood samples collected through finger prick. After validating the tool in the clinical setting, the next step would be its clinical validation based on the existing guidelines. This article presents the protocol of a validation study to be carried out independently at two different centers (Division of Endocrinology and Diabetology at the Medical University of Graz as a clinic-based cohort, and the Endocrinology and Metabolism Research Institute at the Tehran University of Medical Sciences as a population-based cohort). It aims to assess the tool according to the Clinical & Laboratory Standards Institute guidelines, confirming if the proteomics and genomics measurements provided by the tool are accurate and reproducible compared with the existing state-of-the-art tests. This is the first time that such a detailed protocol for lab validation of a medical tool for proteomics and genomic measurement is designed based on the existing guidelines and thus could be used as a template for clinical validation of future point-of-care tools. Moreover, the multicentric cohort design will allow the study of a large number of diverse individuals, which will improve the validity and generalizability of the results for different settings.

Psychometric properties of the Arabic version of the everyday memory questionnaire - revised (EMQ-R) among the Lebanese population.

Objective: This study aimed to evaluate the psychometric properties of the Arabic version of the Everyday Memory Questionnaire- Revised (EMQ-R-A) in a sample of Lebanese adults. Methods: A cross-sectional study was conducted in August 2023. A diverse sample of 483 Lebanese adults aged 18 to 60 years from all Lebanese governorates was recruited. Participants completed an Arabic-language questionnaire comprising three sections: socio-demographic characteristics, health-related inquiries, the EMQ-R-A and the Arabic version of the Prospective and Retrospective Memory Questionnaire (PRMQ). Results: The study's findings indicated that the EMQ-R-A displayed strong internal consistency (Cronbach's alpha = 0.925). Convergent validity was supported by a significant correlation with PRMQ. Test-retest results demonstrated strong reliability with a Cronbach's alpha of 0.925. Confirmatory factor analysis revealed a three-factor model including retrieval related factors, attentional tracking related factors, and other factors. The factors labeled "Retrieval" and "Attentional Tracking" elucidate aspects of memory retrieval system efficacy and attention-related challenges. Higher EMQ-R-A scores were found to be associated with the female gender, lower attention, physical inactivity, lower educational levels, and higher number of comorbid disorders. Conclusion: The EMQ-R-A exhibits good validity and reliability. The identified factors associated with memory decline underscore the importance of addressing lifestyle factors, such as promoting physical activity, better educational attainment, and addressing comorbid health conditions, to potentially mitigate memory challenges.