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.

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

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

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

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

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.

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.

[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.

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.

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 Disability of Arm Shoulder and Hand (DASH) in subjects with frozen shoulder: a reliability and validity study.

BACKGROUND: Frozen Shoulder (FS) is a painful condition characterized by severe pain and progressive restriction of shoulder movement, leading to functional impairment and reduced quality of life. While different Patient Reported Outcome Measurements (PROMs) tools exist for assessing shoulder diseases, few specific PROMs are validated for FS patients. PURPOSE: This study aims to assess the psychometric properties of the Disability of Arm, Shoulder, and Hand (DASH) questionnaire in FS patients. METHODS: One hundred and twenty-four subjects (mean ± SD age = 55.4 ± 7.9 years; 55.6% female) diagnosed with FS were included and completed the DASH questionnaire, the Numerical Pain Rating Scale (NPRS), the Shoulder Pain and Disability Index (SPADI), and the Short-Form Health Survey 36 (SF-36). Floor or ceiling effects were investigated. Structural validity was analysed through a unidimensional Confirmatory Factor Analysis (CFA), internal consistency through Cronbach's alpha, test-retest reliability through the Intraclass Correlation coefficient (ICC), measurement error through the Standard Error of Measurement (SEM), and the Minimum Detectable Change (MDC), and construct validity through the hypothesis testing with the correlation with the other outcome measures used. RESULTS: No floor or ceiling effects were observed. CFA confirmed a one-factor structure after addressing local item dependency (Root Mean Square Error of Approximation = 0.055; Standardized Root Mean Square Residual = 0.077; Comparative Fit Index = 0.970; Tucker-Lewis Index = 0.968). Cronbach's alpha was high (= 0.951), and test-retest reliability was excellent (ICC = 0.999; 95% CI: 0.998-1.000). SEM was equal to 0.5 points, and MDC to 1.5 points. Construct validity was considered satisfactory as 80% of the a-priori hypotheses were met. CONCLUSION: The DASH questionnaire demonstrated good psychometric properties in FS patients, supporting its use as a valuable tool for assessing the impact of FS in clinical and research settings.

Assessment of management reasoning: Design considerations drawn from analysis of simulated outpatient encounters.

PURPOSE: Management reasoning is a distinct subset of clinical reasoning. We sought to explore features to be considered when designing assessments of management reasoning. METHODS: This is a hybrid empirical research study, narrative review, and expert perspective. In 2021, we reviewed and discussed 10 videos of simulated (staged) physician-patient encounters, actively seeking actions that offered insights into assessment of management reasoning. We analyzed our own observations in conjunction with literature on clinical reasoning assessment, using a constant comparative qualitative approach. RESULTS: Distinguishing features of management reasoning that will influence its assessment include management scripts, shared decision-making, process knowledge, illness-specific knowledge, and tailoring of the encounter and management plan. Performance domains that merit special consideration include communication, integration of patient preferences, adherence to the management script, and prognostication. Additional facets of encounter variation include the clinical problem, clinical and nonclinical patient characteristics (including preferences, values, and resources), team/system characteristics, and encounter features. We cataloged several relevant assessment approaches including written/computer-based, simulation-based, and workplace-based modalities, and a variety of novel response formats. CONCLUSIONS: Assessment of management reasoning could be improved with attention to the performance domains, facets of variation, and variety of approaches herein identified.

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.

The Simplified Medication Adherence Questionnaire: validation of a Brazilian-Portuguese version in hypertensive adults.

Background: Self-reported adherence scales are widely used in research and practice because they are low in cost and easy to apply. A free version in Brazilian-Portuguese of the Simplified Medication Adherence Questionnaire (SMAQ) can be a useful alternative for determining the adherent behavior of hypertensive patients. Purpose: To translate and evaluate the psychometric properties of the Brazilian-Portuguese version of the SMAQ therapeutic adherence scale for patients with arterial hypertension. Patients and methods: A multicenter, cross-sectional study was conducted in five outpatient units in Maceió-AL and Aracaju-SE between January and July 2019. A total of 117 patients aged over 18 years using antihypertensive drugs were recruited. The cross-cultural adaptation followed international methodological recommendations. Internal consistency (Cronbach's alpha) was tested as a reliability parameter. Criterion and construct validity were verified by concurrent validation, exploratory factor analysis (EFA), and validation by known groups. Results: The participants had a mean age of 56.6 years (SD = 10.7 years); most were female (72.6%). The mean number of antihypertensives prescribed per patient was 1.87 (SD = 0.87). There were 79.5% (n = 86) of patients considered non-adherent. Internal consistency was satisfactory (Cronbach's alpha = 0.63). A satisfactory correlation coefficient was verified with the Morisky-Green-Levine test as an external criterion (r = 0.56, p < 0.001). The scale's sensitivity measured through known group validity was 75.3%, specificity 29.5%, positive predictive value 63.9%, and negative predictive value 41.9%. We identified two factors of the instrument's construct from EFA: specific medication-taking behaviors and barriers to adherence. The initial KMO measure of sampling adequacy was 0.691, and Bartlett's test of sphericity was significant (χ2 = 118.342, p < 0.001). Conclusion: The Brazilian-Portuguese version of the SMAQ scale proved valid and reliable for determining adherence to the pharmacotherapy in hypertensive patients. It showed more ability to detect non-adherent patients but with low specificity, possibly influenced by high social desirability.

Psychometric properties of the Eating Attitudes Test-26 in Spanish schoolchildren.

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. OBJECTIVE: To 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. METHOD: Validation study in a sample of 718 schoolchildren. The sample was randomly divided into 2 groups, each with 359 participants, and we carried out an exploratory factor analysis (EFA) and a confirmatory factor analysis (CFA) of the instrument. Subsequently, we assessed the internal consistency by means of the ordinal alpha, the convergent validity with the SCOFF questionnaire and the measurement invariance across the sexes. RESULTS: The results of the EFA and CFA supported a multidimensional structure of the EAT comprising 6 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 of the EAT-21 factors. We found measurement invariance across the sexes. CONCLUSIONS: The abbreviated EAT-21 scale exhibited modest and promising psychometric properties, making it a suitable instrument for assessing DEABs in both sexes in educational settings.

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)

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

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

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

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

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

Cultural adaptation, validation and evaluation of the psychometric properties of Childbirth Experience Questionnaire version 2.0 in the Spanish context.

BACKGROUND: Several instruments have been designed to assess the childbirth experience. The Childbirth Experience Questionnaire (CEQ) is one of the most widely used tools. There is an improved version of this instrument, the Childbirth Experience Questionnaire (CEQ 2.0), which has not been adapted or validated for use in Spain. The aim of present study is to adapt the CEQ 2.0 to the Spanish context and evaluate its psychometric properties. METHODS: This research was carried out in 2 stages. In the first stage, a methodological study was carried out in which the instrument was translated and back-translated, content validity was assessed by 10 experts (by calculating Aiken's V coefficient) and face validity was assessed in a sample of 30 postpartum women. In the second stage, a cross-sectional study was carried out to evaluate construct validity by using confirmatory factor analysis, reliability evaluation (internal consistency and temporal stability) and validation by known groups. RESULTS: In Stage 1, a Spanish version of the CEQ 2.0 (CEQ-E 2.0) was obtained with adequate face and content validity, with Aiken V scores greater than 0.70 for all items. A final sample of 500 women participated in Stage 2 of the study. The fit values for the obtained four-domain model were RMSEA = 0.038 [95% CI: 0.038-0.042], CFI = 0.989 [95% CI: 0.984-0.991], and GFI = 0.990 [95% CI: 0.982-0.991]. The overall Omega and Cronbach's Alpha coefficients were 0.872 [95% CI: 0.850-0.891] and 0.870 [95% CI: 0.849-0.890] respectively. A coefficient of intraclass correlation of 0.824 [95% CI: 0.314-0.936] (p ≤ 0.001) and a concordance coefficient of 0.694 [95% CI: 0.523-0.811] were obtained. CONCLUSIONS: The Spanish version of CEQ 2.0 (CEQ-E 2.0), has adequate psychometric properties and is a valid, useful, and reliable instrument for assessing the childbirth experience in Spanish women.

Turkish Translation and Cross-Cultural Validity of Whoqol-HIV Bref Tool.

BACKGROUND: The assessment of health-related quality of life among people living with HIV (PLWH) has gained increasing importance as it assesses their overall well-being, guides treatment decisions, and addresses psychosocial challenges, improving their quality of life. This study focuses on adapting and validating the Turkish version of the WHOQOL-HIV Bref, a tool developed by the World Health Organization (WHO) to measure health-related quality of life in PLWH. This adaptation is based on the generic WHOQOL-Bref Turkish and WHOQOL-HIV Bref inventory. METHODS: In line with WHO guidelines, the tool was translated and tested on 189 PLWH from Istanbul Sisli Hamidiye Etfal Training and Research Hospital's HIV outpatient clinic. A variety of statistical methods were employed to assess content, construct, concurrent, and known-group validity, as well as internal consistency and reliability. RESULTS: Participants' median age was 35 years (IQR: 14), with 178(94%) being male. The Turkish WHOQOL-HIV Bref showed overall satisfactory psychometric properties. Despite limitations in the spirituality domain, it demonstrated good internal consistency (alpha coefficient: 0.93) and strong validity across several metrics, including test-retest reliability (ICC: 0.79). CONCLUSION: The WHOQOL-HIV BREF in Turkish is a reliable and valid instrument for assessing the quality of life in Turkish PLWH.

Cross-Cultural Adaptation of the Scale of the Nursing Work Index With Nurses From Seven Countries.

Background and Purpose: The aims of this study are as follows: to adapt and validate the psychometric properties of the Spanish version of the Practice Environment Scale of the Nursing Work Index (PES-NWI) adapted to the nursing home environment across seven Spanish-speaking countries and to cross-culturally adapt the Scale of the Nursing Work Index with nurses from seven countries. Methods: Adaptation process and psychometric validation of the instrument included translation and back-translation, content validity, test-retest reliability, internal consistency, and construct validity. Results: A total of 134 nursing homes belonging to the same religious order were randomly selected from seven Spanish-speaking countries with a sample of 378 nurses. The exploratory factor analysis explained a five-factor structure (56% of the explained variance) with adequate goodness-of-fit indices in the final factor solution. Conclusions: The validation process indicates that the Spanish language version of the PES-NWI with five factors and 31 items, for long-term care facilities for the elderly, is valid and reliable in its current version and can be used to measure the environment of nurses working in clinical practice in Spanish-speaking nursing homes.