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.

A practical guide to estimating treatment effects in patients with rheumatic diseases using real-world data.

OBJECTIVE: Randomized controlled trials are considered the gold standard in study methodology. However, due to their study design and inclusion criteria, these studies may not capture the heterogeneity of real-world patient populations. In contrast, the lack of randomization and the presence of both measured and unmeasured confounding factors could bias the estimated treatment effect when using observational data. While causal inference methods allow for the estimation of treatment effects, their mathematical complexity may hinder their application in clinical research. METHODS: We present a practical, nontechnical guide using a common statistical package (Stata) and a motivational simulated dataset that mirrors real-world observational data from patients with rheumatic diseases. We demonstrate regression analysis, regression adjustment, inverse-probability weighting, propensity score (PS) matching and two robust estimation methods. RESULTS: Although the methods applied to control for confounding factors produced similar results, the commonly used one-to-one PS matching method could yield biased results if not thoroughly assessed. CONCLUSION: The guide we propose aims to facilitate the use of readily available methods in a common statistical package. It may contribute to robust and transparent epidemiological and statistical methods, thereby enhancing effectiveness research using observational data in rheumatology.

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.

Investigación cualitativa en el contexto de la Salud Pública: actualización de conceptos

Los enfoques cualitativos en la investigación han sido fundamentales en las ciencias sociales y son cruciales para el estudio de la salud y los servicios sanitarios. Con el progreso en medicina, mayor especialización, expectativas crecientes de los pacientes y la complejidad de los servicios de salud, los profesionales se enfrentan a un entorno laboral cada vez más complicado. Los métodos cualitativos, aunque distintos de las técnicas experimentales y cuantitativas de la investigación clínica y biomédica, son indispensables para la investigación en servicios de salud. Esto se debe a que permiten explorar aspectos no medibles cuantitativamente, como las creencias sobre la salud, y porque proporcionan una base -descriptiva necesaria para la investigación cuantitativa, especialmente en campos con escasa investigación previa.

Qualitative approaches in research have been fundamental in the social sciences and are crucial to the study of health and health services. With progress in medicine, greater specialization, increasing patient expectations and the complexity of health services, professionals face an increasingly complicated work environment. Qualitative methods, although different from the experimental and quantitative techniques of clinical and biomedical research, are essential for health services research. This is because they allow us to explore aspects that are not quantitatively measurable, such as beliefs about health, and because they provide a necessary descriptive basis for quantitative research, especially in fields with little previous research.

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.

'Spin' in urology non-randomised studies comparing therapeutic interventions: a temporal analysis.

OBJECTIVE: To determine the prevalence of 'spin' (i.e., reporting practices that distort the interpretation of results by positively reflecting negative findings or downplaying potential harms) strategies and level of spin in urological observational studies and whether the use of spin has changed over time. MATERIALS AND METHODS: MEDLINE and Embase were searched to identify observational studies comparing therapeutic interventions in the top five urology journals and major urological subspecialty journals, published between 2000 and 2001, 2010 and 2011, and 2020 and 2021. RESULTS: A total of 235 studies were included. Spin was identified in 81% of studies, with a median of two strategies per study. The most commonly used strategies were inadequate implication for clinical practice (30%), causal language or causal claim (29%), and use of linguistic spin (29%). Moderate to high levels of spin were found in 55% of conclusions. From 2000 to 2020, the average number of strategies used has significantly decreased each decade (H = 27.459, P < 0.001), and the median level of spin in conclusions was significantly lower in studies published in the 2020s and 2010s than in the 2000s (H = 11.649, P = 0.003). CONCLUSIONS: Our results suggest that 81% of urological observational studies comparing therapeutic interventions contained spin. Over the past two decades, the use of spin has significantly declined, but this remains an area for improvement, with 70% of included studies published in the 2020s employing spin. Medical writing should scrupulously avoid words or phrases that are not supported by data in the manuscript.

Development of Emerging Infectious Diseases Preventive Health Behavior (EID-PHB) Scale and Validation of the Complex Models.

Introduction: Emerging Infectious Diseases are one of the world's leading causes of death, and preventive measures must be implemented to minimize human casualties. Research on preventive behavior relies on the preventive behavior scale and it has an impact on the findings. Purpose: This study aimed to develop an Emerging Infectious Diseases Preventive Health Behavior (EID-PHB) Scale and verify the validity and reliability of the complex models. Methods: Initial items were generated through a literature review and interviews, based on the proposed conceptual framework of transmission-based precautions. 14 experts reviewed the preliminary items for content validity and 20 adults for face validity. Data were collected online by a research company from April 28 to May 3, 2023. A total of 533 participants completed the survey, and subjects were assigned through simple random sampling. The first sample (n = 330) was used for item analysis and Exploratory Factor Analysis (EFA), and the second sample (n = 203) was used for Confirmatory Factor Analysis (CFA), convergent validity, discriminant validity, criterion validity, and reliability. The test-retest reliability was assessed in 34 adults. Results: The final instrument derived six components (droplet, contact, airborne, bloodborne, environmental prevention, and psychological coping), nine indicators, and 34 items. The CFA indicated that all the complex models had a good fit and the integrated factors were confirmed through validity tests. The Cronbach's alpha for the 34 items was 0.92, and the criterion validity was verified (r = 0.85, p < 0.001). Conclusion: The EID-PHB is a valid and reliable tool that can be used to determine preventive behaviors against emerging infectious diseases. This tool is expected to provide a conceptual framework for future research, contribute to the clinical practice and education, and establish strategies and policies for improving individual and public health.

Triptorelin therapy for lower urinary tract symptoms (LUTS) in prostate cancer patients: A systematic meta-analysis.

Objective: This systematic meta-analysis aimed to assess the effectiveness of triptorelin therapy in reducing lower urinary tract symptoms (LUTS) in men with prostate cancer (PCa). Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. PubMed, Web of Science and EMBASE databases were searched for studies conducted between 2013 and 2023. Eligible studies included PCa patients undergoing androgen deprivation therapy (ADT) with triptorelin, with reported baseline and follow-up International Prostate Symptom Scores (IPSS) and quality of life (QoL) data. The Newcastle-Ottawa Scale (NOS) was used to assess the risk of bias, and a random-effects model was applied for the meta-analysis. Results: A total of 29 articles were identified, and three studies met the inclusion criteria. Triptorelin therapy showed a clinically significant reduction in IPSS over 48 weeks in PCa patients with moderate to severe LUTS. The meta-analysis revealed a pooled effect size of 1.05 (95% CI: 0.65; 1.45), indicating a statistically significant improvement in LUTS. QoL also improved in patients receiving triptorelin therapy, although heterogeneity among the studies and a moderate to high risk of bias were noted. Conclusion: Triptorelin therapy demonstrated a positive impact on LUTS in PCa patients. The meta-analysis showed significant reductions in IPSS scores and improved QoL after 48 weeks of triptorelin treatment. However, the results should be interpreted cautiously due to study heterogeneity and potential biases. Further well-designed studies are needed to confirm these findings and determine the optimal use of triptorelin for managing LUTS in men with PCa. Implications for Practice: Triptorelin therapy may offer an effective treatment option for men with PCa experiencing moderate to severe LUTS. Its positive impact on QoL can lead to improved patient well-being and treatment adherence. Clinicians should consider triptorelin as a potential treatment choice, especially in patients who may be reluctant to undergo surgical interventions for their LUTS. However, careful patient selection and close monitoring are essential due to the observed study heterogeneity and risk of bias. Future research should focus on evaluating triptorelin's cost-effectiveness and comparing its efficacy with other LH-RH agonists in managing LUTS in PCa patients.Video Abstract: URL (Reviewers/Editors to select from) Link 1: https://brighton.cloud.panopto.eu/Panopto/Pages/Viewer.aspx?id=071419c8-1ad5-4502-a222-b04300c2ca5e Link 2: https://brighton.cloud.panopto.eu/Panopto/Pages/Viewer.aspx?id=b6305a8a-b977-4fcd-a69e-b04300bed728.

Safety of herbal decoctions: A scoping review of clinical studies in South Korea focusing on liver and kidney functions.

ETHNOPHARMACOLOGICAL RELEVANCE: Approximately 27% of individuals seeking Korean medicine (KM) services in South Korea are prescribed herbal decoctions. The South Korean government has considered the validity of providing National Health Insurance coverage for herbal decoctions. Therefore, it is important to investigate their safety. AIM OF THE STUDY: To investigate the safety of herbal decoctions commonly prescribed by KM doctors and to assess their effects on liver and kidney function by comprehensively analyzing Korean clinical studies in a scoping review. MATERIALS AND METHODS: The Arksey and O'Malley framework and modified methods were applied in this scoping review. A comprehensive search of seven electronic health databases was conducted, and relevant clinical studies published between 2000 and 2022 were identified. Subsequently, only clinical studies reporting the results of liver and/or renal function tests in patient prescribed herbal decoctions by KM doctors were included. The characteristics of the included clinical studies and the reported proportion of each liver and/or renal function indicator were analyzed. Meta-analyses of the effects of herbal decoction on liver and/or renal function reported in prospective cohort studies were also performed. RESULTS: Fifty-nine clinical studies were included in this review. The proportion of prospective cohort studies markedly decreased in the 2010s compared to the 2000s, while there was no noticeable change in the number of relevant clinical studies. Herbal decoctions were prescribed for less than one month in most included studies. Abnormal changes in liver or renal function indicators were identified in a small number of studies (3.70% and 7.69%, respectively). In a meta-analysis of 15 prospective cohort studies, no statistically significant changes in four liver function indices and two renal function indices were observed before and after the prescription of herbal decoctions. CONCLUSIONS: Qualitative and quantitative analyses demonstrated favorable safety profiles for herbal decoctions. This scoping review includes the gaps noted between clinical application and research regarding the safety profiles of herbal decoctions. These findings could be used as evidence to support the inclusion of herbal decoction prescriptions in the National Health Insurance coverage in South Korea.

Unmet need for and impact of adopting immunobiological drugs for moderate to severe plaque psoriasis in a pediatric population

ABSTRACT Objective Therefore, this study aimed to evaluate the impact of secukinumab and ustekinumab against moderate-to-severe plaque psoriasis in a Brazilian pediatric population with access to public healthcare. Methods A survey of immunobiological treatments registered for use against pediatric psoriasis at the National Health Surveillance Agency was conducted. These treatments were compared to the list available in the same treatment category in the public health system through the Clinical Protocol and Therapeutic Guidelines for psoriasis. A quantitative analysis of the data of patients treated with immunobiological drugs the previous year in accordance with the Clinical Protocol and Therapeutic Guidelines was performed using data available in the DATASUS portal. Results The public budget impact scenarios analyzed were comparable to the investment already planned for acquiring the only available drug option. Conclusion The incorporation of two therapeutic options in the Clinical Protocol and Therapeutic Guidelines list for moderate-to-severe pediatric psoriasis was feasible in a horizon of 5 years compared to the investment into the single option available to pediatric patients. These findings can facilitate the local analysis of budgetary impact and discussions on the feasibility of this therapeutic incorporation at the state level.

Sociodemographic and undergraduate-related variables as predictors of dental students' empathy: an e-survey in a south brazilian dental school / Variáveis sociodemográficas e relacionadas à graduação como preditoras da empatia de estudantes de odontologia: um e-survey em uma faculdade de odontologia do Sul do Brasil

Aim: To assess the associations between sociodemographic and undergraduate-related characteristics and empathy scores among dental students in a school in Southern Brazil. Materials and methods: Cross-sectional study developed from self-administered online questionnaires to undergraduate dental students at the Federal University of Pelotas. Outcomes were the total score of empathy obtained through the Interpersonal Reactivity Index (IRI) and the scores obtained in four domains: perspective-taking (PT), fantasy (FA), empathic concern (EC), and personal distress (PD). In RStudio version 4.1.3 simple and adjusted linear regression models with robust residual standard errors were performed. Results: Eighty-seven students were included (response rate 24.4%). Considering the total IRI score, there was a mean score of 3.62 (SD=0.64) by item, and dental students had a mean score of 94.07 (SD=16.62). In adjusted analysis, being a woman increased the IRI (0.505;95%CI 0.187;0.823), EC (0.494;95%CI 0.168;0.819), and PT (0.822; 95%CI 0.329;1.315) scores compared to men. Adjusted associations were found between the EC domain and skin color and between the PT domain and family income. FA scores increased with age and family income and, decreased with dissatisfaction with undergraduate studies, only in the bivariate analysis. Discussion: Dental professionals' empathy is essential in daily practice, improving the patient-professional relationship in a patient-centered care approach. Thus, it is relevant to recognize predictors of empathy among dental students to promote strategies to increase empathy in dental practice. Conclusion: Gender, skin color, family income, age, and satisfaction with undergraduate studies were associated with empathy scores among dental students.

Objetivo: Avaliar associações entre as características sociodemográficas e relacionadas à graduação e os escores de empatia entre estudantes de odontologia de uma escola do Sul do Brasil. Materiais e métodos: Estudo transversal desenvolvido com questionários on-line autoadministrados para estudantes de graduação em odontologia da Universidade Federal de Pelotas. Foram considerados desfechos o escore total de empatia medido pelo Índice de Reatividade Interpessoal (IRI) e os escores obtidos em quatro domínios: tomada de perspectiva (TP), fantasia (FA), consideração empática (CE) e angústia pessoal (AP). No RStudio versão 4.1.3 foram realizadas regressões lineares simples e múltiplas com erros residuais robustos. Resultados: Foram incluídos 87 alunos (taxa de resposta=24,4%). Considerando a pontuação total do IRI, houve média de 3,62 (DP=0,64) por item, e de 94,07 (DP=16,62) por estudante. Na análise multivariável, mulheres tiveram maiores pontuações no IRI (0,505; IC95%0,187;0,823), CE (0,494; IC95%0,168;0,819) e AP (0,822; IC95%0,329;1,315) em comparação aos homens. Foram encontradas associações ajustadas entre o domínio CE e cor da pele e entre o domínio PT e renda familiar. Os escores do domínio FA aumentaram com idade e renda familiar e diminuíram com insatisfação com a graduação, somente em análise bivariada. Discussão: A empatia do profissional de odontologia é essencial na prática diária, melhorando a relação paciente-profissional. Assim, é relevante reconhecer os preditores da empatia entre os estudantes de odontologia, visando estratégias para aumentar a empatia na prática odontológica. Conclusão: Gênero, cor da pele, renda familiar, idade e satisfação com a graduação foram associados aos escores de empatia entre estudantes de odontologia.

Changes in oral microflora following 0.3% cetylpyridinium chloride-containing mouth spray intervention in adult volunteers after professional oral care: Randomized clinical study.

OBJECTIVES: This study explored the changes in bacterial flora composition and total bacterial count in the saliva and tongue coating, along with the change in the tongue coating index (TCI) following an intervention with 0.3% cetylpyridinium chloride (CPC) mouth spray after professional oral care. MATERIALS AND METHODS: Fifty-two adult volunteers aged 30-60 years were equally divided into CPC spray (n = 26) and control (n = 26) groups. All subjects underwent scaling and polishing. The CPC spray group was administered four puffs of CPC spray to the tongue dorsum four times a day for 3 weeks. The control group performed only routine daily oral care (brushing) and did not use any other spray. Bacteriological evaluation of saliva and tongue coating was performed using 16S ribosomal RNA gene sequencing and quantitative polymerase chain reaction. The tongue coating was evaluated to calculate the TCI. A per-protocol analysis was conducted for 44 subjects (CPC spray group, n = 23; control group, n = 21). RESULTS: At 1 and 3 weeks after CPC spray use, the flora of the saliva and tongue coating changed; the genus Haemophilus was dominant in the CPC spray group, whereas the genus Saccharibacteria was dominant in the control group. The sampling time differed among individual participants, which may have affected the bacterial counts. There was no significant intragroup change in TCI in either group. CONCLUSIONS: CPC spray affected the bacterial flora in the saliva and tongue coating, particularly with respect to an increase in the abundance of Haemophilus. However, CPC spray did not change the TCI. These results suggest that it may be optimal to combine CPC spray with a physical cleaning method such as using a tongue brush or scraper. Clinical Trial Registration: University Hospital Medical Information Network UMIN000041140.

Validez de apariencia y racionalidad de una metodología para estudiar la causalidad en salud / Appearance and rational validity of a methodology to study causality in health

Introducción: Es objetivo fundamental de la medicina, determinar las causas que producen las enfermedades; para llevar a cabo este estudio, a finales del siglo XX se emplearon técnicas estadísticas multivariadas confiables en el análisis simultáneo de diferentes variables independientes sobre un desenlace. Objetivo: Determinar la aplicación de la validez racional y de apariencia en la metodología empleada para el estudio de la causalidad en salud. Métodos: Para evaluar si la metodología se correspondía con los requerimientos de la investigación, se aplicó la validez de apariencia para valorar los resultados obtenidos en su aplicación, específicamente, si las reglas reflejan verazmente, lo que ocurre en la práctica médica, mediante el empleo de la validez racional. Resultados: Los usuarios potenciales de la metodología la consideraron aceptable en los aspectos medidos sobre la regresión logística binaria. El mayor porcentaje de las reglas analizadas está en correspondencia con lo planteado en la literatura, pocas plantean aspectos que no se dan necesariamente en la práctica médica, pero tampoco se contradicen con la literatura. Los resultados de la validez de apariencia no fueron favorables, pues la metodología no había sido empleada antes en el contexto. En cuanto a la validez racional, se verificó un alto porcentaje de correspondencia entre lo planteado por las reglas y la literatura. Es importante tener en cuenta, que el hallazgo de algo conocido reafirma la validez de esa regla. Conclusiones: Las reglas obtenidas de la aplicación de la metodología reflejan, en general, lo que ocurre en la práctica médica.

Introduction: the fundamental objective of medicine is to determine the causes that produce diseases. At the end of the 20th century, multivariate statistical techniques were used as reliable in the simultaneous analysis of different independent variables on an outcome. Objective: to determine the application of appearance and rational validity of a methodology to study causality in health. Methods: to evaluate whether the methodology corresponded to the research requirements, appearance validity was applied to assess the results obtained in its application, specifically, if the rules accurately reflect what happens in medical practice, through the use of rational validity. Results: the potential users of the methodology considered it acceptable in the measured aspects of the binary logistic regression. The highest percentage of the rules analyzed is in correspondence with what is stated in the literature; few raise aspects that do not necessarily occur in medical practice, but they do not contradict the literature either. The results of face validity were not favourable, since the methodology had not been used before in the context. A high percentage of correspondence regarding rational validity was verified between what was stated by the rules and the literature. It is important to note that finding something known reaffirms the validity of that rule. Conclusions: the rules obtained from the application of the methodology reflect, in general, what happens in medical practice.

Engaging interested parties to optimize wildfire smoke communication in Canada: challenges with initiating change.

Background: In February 2022, an online Wildfire Smoke Communication Workshop series identified priorities and strategies to improve wildfire smoke communication in Canada. We evaluated the engagement methods, the workshop series and workshop summary report, to determine if participants/organizations initiated changes identified in the workshop to optimize wildfire smoke communication plans. Methods: Three evaluation surveys were developed using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework dimensions and PRISM (Practical, Robust, Implementation, and Sustainability Model) contextual domains to measure the engagement impact. Surveys 1, 2, and 3 were disseminated to workshop participants between February 2022 (post-workshop series), May 2022 (pre-wildfire season), and September 2022 (post-wildfire season). Likert survey responses were analyzed descriptively using means and standard deviations. Open-ended written responses were analyzed using deductive reasoning and response proportions. Results: Of 69 workshop participants, 28, 19, and 13 responded to surveys 1, 2, and 3, respectively. Workshop participation helped survey 1 respondents consider optimizing wildfire smoke communication (M = 3.93, SD = 0.88). Workshop participation and the summary report helped survey 2 respondents consider new actions to optimize wildfire smoke communication (M = 3.84, SD = 0.74). The most intended action in survey 2 (68%, n = 13) and the most common action taken in survey 3 (62%, n = 8) was to simplify message content. The primary limitation to optimization was capacity. Conclusion: The engagement methods, particularly the summary report, were beneficial for organizations to take action to optimize wildfire smoke communication in Canada. Future engagement methods should examine persisting system-level issues and capacity limitations as they undermine the ability to optimize wildfire smoke communication in Canada.

Cultural Adaptation, Validation and Evaluation of the Psychometric Properties of an Obstetric Violence Scale in the Spanish Context.

Obstetric violence refers to dehumanized or derogative treatment of women in their pregnancy, childbirth or postpartum periods and may be manifested in different ways. Currently, there is no tool validated in Spain to measure women's perception of obstetric violence. The objective of this study was to carry out the cultural adaptation and validation of an existing 14-item obstetric violence scale in the Spanish context and to evaluate its psychometric properties. The research was conducted in two phases: first, a methodological study designed to evaluate content validity, through assessments by eight experts (calculating the Aiken V coefficient) and face validity in a sample of 20 women; second, a cross-sectional study to evaluate construct validity (through confirmatory factor analysis and Rasch analysis), divergent validity against a scale of birth satisfaction, known-groups validity and, finally, reliability. In Phase 1, Aiken V values higher than 0.71 were obtained for all items. Phase 2 was conducted on a sample of 256 women and the fit values for the unidimensional model were RMSEA: 0.070 (95% CI: 0.059-0.105) and GFI: 0.982 (95% CI: 0.823-0.990). The Rasch analysis indicated poor performance of item 2, which was removed. The Omega and Cronbach's Alpha coefficients were 0.863 and 0.860, respectively. A final 13-item version of the Obstetric Violence Scale was produced, with a total score ranging from 0 (no obstetric violence perception) to 52 (maximum obstetric violence perception). The Obstetric Violence Scale is a reliable and useful tool to measure women's perception of obstetric violence. This study was not registered.

Orofacial Myofunctional Aspects of Nursing Infants and Preschoolers.

Introduction Clinical assessment in orofacial motricity is required for the speech therapist to diagnose and treat disorders involving the stomatognathic system. Validated tools can help establish a prognosis and outline intervention methods connected to human development. Objective The goal of the present study was to examine the domains of the oromyofunctional assessment of nursing infants and preschoolers according to sex and age group, as well as the application of the MMBGR Protocol - Nursing Infants and Preschool Children. Methods A quantitative technique was used to conduct an analytical and cross-sectional investigation. The present study included a total of 214 healthy breastfeeding infants and preschoolers of both sexes. The Mann-Whitney test was used to compare the medians. The Spearman correlation of each test domain was determined. R Core Team 2021 (R Foundation, Vienna, Austria) was used, and the significance threshold was set at 5%. Results In intraoral and extraoral examinations, there was a difference between sexes for tongue scores in nursing infants (d = - 0.428; p = 0.045), worse in males. When the orofacial functions were considered in nursing infants, there were differences between the sexes for the liquid/solid/semisolid deglutition scores (d = 0.479; p = 0.031), with females performing worse. There were sex differences in solid/semisolid deglutition (d = - 0.335; p = 0.043), and speech in preschoolers (d = - 0.478; p = 0.034), including the production of phones/phonemes (d = - 0.599; p = 0.007), which were always worse in males. Conclusion The research revealed sex disparities and related the domains of oromyofunctional assessment, according to scores, of the domains of myofunctional assessment, as recorded in a standardized oromyofunctional assessment protocol by age group.

The Effect of Sepsis and Septic Shock on the Viscoelastic Properties of Clot Quality and Mass Using Thromboelastometry: A Prospective Observational Study.

Background: Sepsis is associated with wide variable coagulation abnormalities. Thromboelastography (TEG) effectively measures the viscoelastic properties of the clots. This study aims to illustrate the viscoelastic properties of clot quality and mass in sepsis and septic shock patients using TEG, as an effective tool over standard coagulation tests. Materials and methods: A single-center, prospective observational study was conducted. 50 patients each meeting the criteria for sepsis and septic shock, and a healthy group of 30 patients was included in the study. Blood samples were obtained and analyzed for standard coagulation tests, platelet count, fibrinogen, and TEG study. Results: A total of 130 patients were included. Septic shock patients had a higher sequential (sepsis-related) organ failure score. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) were increased significantly as compared to the sepsis and control groups. TEG markers such as alpha angle, and maximum amplitude (MA) were significantly prolonged while reaction time (R time), was significantly shortened in the sepsis group as compared to the healthy group, suggestive of a hypercoagulable state in sepsis patients. While in septic shock patients, MA and Lysis Index 30 (LY 30) were significantly prolonged and, R time was significantly shortened compared to all other groups. Even though LY30 in sepsis patients was found to be within the normal range (p < 0.001), 18% of patients had prolonged LY30 indicating a hypercoagulable state with impaired fibrinolysis. Conclusion: Thromboelastography, as a point-of-care test combined with conventional coagulation tests can provide additional, clinically relevant information on coagulopathy, and outcome, and thus help guide treatment modality in sepsis and septic shock-induced coagulopathy. How to cite this article: Mohapatra P, Kumar A, Singh RK, Gupta R, Hussain M, Singh S, et al. The Effect of Sepsis and Septic Shock on the Viscoelastic Properties of Clot Quality and Mass Using Thromboelastometry: A Prospective Observational Study. Indian J Crit Care Med 2023;27(9):625-634.

Method validation for the quantification of fluconazole and its organic impurities in raw material using high-performance liquid chromatography / Validación de la metodología para cuantificar el fluconazol y sus impurezas orgánicas en materia prima por cromatografía líquida de alta resolución

Introduction. The real laboratory conditions of each country, including climate, can affect the method's efficiency in analyzing a pharmacological substance. Thus, it is necessary to validate the process according to the corresponding guidelines and optimize it to ensure success and confidence in the results. Objective. The objective was to validate a methodology for fluconazole and its organic impurities quantification in raw material using high-performance liquid chromatography, with a diode array detector, under tropical climate conditions, and complying with all regulatory requirements. Materials and methods. We performed pre-validation tests of the method consisting of system adequacy, filters study, quantification limit, absence of systematic error, forced degradation studies, and solutions stability. In addition, we validated the specificity, linearity, accuracy, precision, and robustness of the system. Results. Separation of the degradation products from the analyte peaks allowed the achievement of the method's spectral purity. The solution's stability was not affected during the evaluated time (24 hours) at room temperature and under refrigeration. Linearity resulted in correlation coefficients greater than or equal to 0.999 for the evaluation and greater than or equal to 0.997 for impurities. We obtained a fluconazole recovery varying from 98 to 102% with an accuracy between 80 to 120% for impurities detection. The repeatability and reproducibility factor did not exceed a relative standard deviation of 2.0% for the evaluation and of 5.0% for the impurities, demonstrating the adequate robustness of the method. In addition, a short analysis execution time allowed the quick determination of the raw material quality. Conclusion. We demonstrated that the fluconazole quantification method validated by high-performance liquid chromatography is sufficiently selective, precise, exact, linear, and robust to generate accurate analytical results under real conditions, including the tropical climate of Colombia.

Introducción. La eficiencia de una metodología para analizar una sustancia farmacológica puede verse afectada por las condiciones reales del laboratorio de cada país, incluyendo el clima. Por esta razón, se requiere validar el método con las pautas recomendadas para ello y optimizar el proceso, para asegurar el éxito y la confianza en los resultados. Objetivo. Validar una metodología para la cuantificación simultánea del fluconazol (materia prima) y sus impurezas orgánicas mediante cromatografía líquida de alta resolución con detector de arreglo de diodos en condiciones de clima tropical y con todos los requisitos normativos. Materiales y métodos. Se hicieron pruebas previas a la validación del método: idoneidad del sistema, estudio de filtros, límite de cuantificación, ausencia del error sistemático, estudios de degradación forzada y estabilidad de las soluciones. Además, se validaron: la especificidad, la linealidad, la exactitud, la precisión y la robustez. Resultados. La pureza espectral del método se logró al obtener la separación de los productos de degradación de los picos de los analitos. La estabilidad de las soluciones no se vio afectada, en la frecuencia evaluada de 24 horas, a temperatura ambiente y de refrigeración. Se obtuvo una linealidad con coeficientes de correlación mayores o iguales a 0,999 para la valoración y mayores o iguales a 0,997 para las impurezas. La recuperación estuvo en el rango de 98 a 102,0 % de fluconazol, con una exactitud entre el 80 y el 120 % para las impurezas. El factor de repetibilidad y reproducibilidad no superó la desviación estándar relativa del 2,0 % para la valoración y, la del 5,0 %, para las impurezas, lo cual mostró una solidez adecuada del método. Además, se obtuvo un tiempo corto de ejecución del análisis, lo que permitió la rápida determinación de la calidad de la materia prima. Conclusión. Se demostró que el método de cuantificación de fluconazol, validado por cromatografía líquida de alta resolución con detector de arreglo de diodos, es lo suficientemente selectivo, preciso, exacto, lineal y robusto; además, es capaz de generar resultados analíticos veraces en condiciones de uso reales, incluyendo el clima tropical de Colombia.