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.

Validation of Database Autopsy for Review of Pregnancy-Associated Deaths in Canada.

The database autopsy method was developed to determine probable causes of maternal deaths in the Canadian Institute for Health Information's hospital discharge abstract database, but the method has yet to be validated. Using immediate cause of death information from Quebec's hospitalization database as the gold standard, this study assessed the validity and reliability of the database autopsy method for pregnancy-associated deaths. The method had high sensitivity and specificity for identifying the most common causes of these deaths, as well as high interobserver agreement. We conclude that the database autopsy method is valid and reliable overall.

Validity and Reliability Assessment of the Complete Persian Version of the Temperament Evaluation of Memphis, Pisa, Paris, and San Diego Auto-Questionnaire in an Iranian Population.

Objective: The Temperament Evaluation of Memphis, Pisa, Paris, and San Diego - Auto-questionnaire (TEMPS-A) assesses five affective temperaments and has been translated into 32 languages. A 35-item short version is available in Persian, but the complete version is not yet translated. This study aimed to assess the validity and reliability of the complete Persian version of the TEMPS-A in an Iranian population. Method : This descriptive study translated the TEMPS-A questionnaire from English to Persian using a standard forward-backward method. The translation was evaluated for face and content validity by 10 psychiatry specialists, with quantitative content validity assessed through content validity ratio (CVR) and content validity index (CVI) calculations. The Persian TEMPS-A was completed twice, with a two-week interval, by 30 individuals out of the 319 medical staff of Imam Hossein Hospital in Tehran, Iran, who participated in the study, and its reliability was evaluated using Cronbach's alpha. The questionnaire was then distributed to the entire sample (n = 319) for the analysis of temperament frequencies and statistical indices by a statistician. Results: The Persian version of the TEMPS-A, consisting of 110 items across five factors (depressive, cyclothymic, hyperthymic, irritable, and anxious), demonstrated excellent reliability with Cronbach's alpha values of 0.910, 0.909, 0.911, 0.910, and 0.909, respectively. The questions related to cyclothymic and hyperthymic temperaments exhibited the highest and lowest correlation coefficients with the general scale, respectively. Most subscales in the Persian TEMPS-A version showed correlation coefficients ranging from 0.28 to 0.68. An ANOVA with Cochrane's test revealed a significant difference in the mean scores of the questionnaire items (P < 0.001), with a grand mean score of 1.73 across all questions. Conclusion: The Persian version of the TEMPS-A, consisting of 110 items, showed good internal consistency and a strong correlation with the original version. This suggests that it is suitable for use in temperament studies among the Iranian population.

Construct validity and reliability of the BARRIERS scale in the Spanish context.

OBJECTIVE: To establish the construct validity of the Spanish version of the BARRIERS scale. METHOD: Methodological study of validation of a measurement instrument based on data from previously published studies. The study population consisted of nurses from the Basque Health Service and the Canary Health Service. The following variables were extracted and unified: Years of professional experience, possession of a specialist nursing degree, possession of a doctorate, type of activity performed by the professional and field of work. For construct validation, a confirmatory factor analysis (CFA) was performed based on the initial model proposed for the scale and RASCH analysis. A polychoric correlation matrix, factor extraction by unweighted least squares and PROMIN oblique rotation were used. For the RASCH analysis, the Joint Maximun Likelihood estimation (JMLE) method was used; the fit of the items and persons were estimated by means of outfit - Unweighted Mean Square fit statistic (UMS) and infit -Weighted Mean Square Fit Statistic (WMS), as well as the reliability and separation of items and persons. RESULTS: A total of 1200 nurses and midwives made up the final validation sample (n = 1200), with a mean professional experience of 21.22 ± 9.26 years. The CFA presented a good fit to the data (KMO = 0.935 [95% CI: 0.921-0.945]), changing the factorial assignment in 6 items, while 5 items received factorial scores in more than one factor. The fit values for the 4-factor solution were RMSEA = 0.026 [95% CI: 0.026-0.027] and GFI = 0.991 [95% CI: 0.986-0.991]. In the RASCH analysis most items presented infit-WMS and outfit-UMS values with a good fit. CONCLUSIONS: The Spanish version of the BARRIERS scale has adequate construct validity although there are changes in the assignment of items to the dimensions compared to the original model. The RASCH analysis indicates adequate fit for both persons and items.

Development and validation of meta-measurement instruments: A methodological approach.

A valid and reliable nursing assessment is essential for identifying required care and ensuring patient safety. The convenience of conducting a comprehensive assessment of the patient has led to a significant increase in assessment tools that may slow down the process. Nevertheless, the possibility of consolidating various instruments that measure common or similar constructs into a meta-instrument is considered an alternative that could enhance assessment efficiency. A meta-instrument can be defined as a measurement tool that consolidates other instruments based on measuring related constructs and sharing dimensions or items, aiming to achieve a more parsimonious measurement. Literature on such assessment tools is scarce, and there are numerous options for their construction and initial validation. Additionally, it is advisable to confirm their psychometric properties and ensure that they maintain, at the very least, the same diagnostic capacity as the original instruments. This article presents a proposal for the phases to follow in constructing meta-instruments, along with various methodological alternatives that can be employed based on the characteristics of the original instruments and the purpose of creating the meta-instrument. Furthermore, special attention is given to the checklists that should be used to study the psychometric properties and diagnostic capacity of the meta-instruments. Finally, future lines of research and challenges in the development of nursing assessment meta-instruments are discussed.

Instrument to evaluate the perception of abuse and/or disrespectful treatment during childbirth: A validation study.

AIM: To design and validate a tool to assess a woman's perception of whether she has experienced a situation of abuse or disrespect during childbirth attendance: "Childbirth Abuse and Respect Evaluation-Maternal Questionnaire" (CARE-MQ). METHODS: Multidisciplinary panel of experts (gynecologists, midwives, mothers) participated in creating CARE-MQ. A cross-sectional study was carried out on 901 Spanish women who had given birth between 1 and 3 months before to determine psychometric characteristics. Finally, an exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and a convergent validity study were carried out with the Quality Questionnaire from the Patient's Perspective-Intrapartum (QPP-I), and a reliability study using internal consistency (Cronbach's α) and coefficient of intraclass correlation (CCI). FINDINGS: The KMO test gave a value of 0.935, and Bartlett's sphericity test was <0.001. The EFA identified four components ("Emotional Abuse", "Inadequate Professionalism", "Physical Abuse" y "Lost contact") that explained 55.16 % of variance. In the CFA, a good fit was observed for most of the evaluated indicators. CARE-MQ correlated negatively with QPP-I (Spearman's rho = -0.641, 95 % CI: -0.679, -0.600; p < 0.001) and was statistically associated with variables related to childbirth experience (p < 0.005) such as the use of a birth plan, use of regional analgesia, type of birth, episiotomy, presence of severe tears, skin-to-skin contact, length of hospital stay and postpartum surgical intervention. Cronbach's α value was 0.903. The ICC of absolute agreement after administering the questionnaire one week after was 0.927 (95 % CI: 0.85-0.97). CONCLUSIONS: CARE-MQ is a valid and reliable instrument to evaluate the perception of a woman regarding the situation of abuse and/or disrespect that she may have experienced during birth in a population of Spanish postpartum women.

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.

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.

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.

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.

[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.

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.

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.

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.

[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.