Economic evaluation of second measles containing vaccine (MCV) dose: a systematic review of available evidence.

INTRODUCTION: The global measles incidence has decreased from 145 to 49 cases per 1 million population from 2000 to 2018, but evaluating the economic benefits of a second measles-containing vaccine (MCV2) is crucial. This study reviewed the evidence and quality of economic evaluation studies to guide MCV2 introduction. METHODS: The systematic review of model-based economic evaluation studies was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search yielded 2231 articles, with 876 duplicates removed and 1355 articles screened, with nine studies included for final analysis. RESULTS: Six studies reported a positive benefit-cost ratio with one resulting in net savings of $11.6 billion, and two studies estimated a 2-dose MMR vaccination program would save $119.24 to prevent one measles case, and a second dose could prevent 9,200 cases at 18 months, saving $548.19 per case. The most sensitive variables were the discount rate and vaccination administration cost. CONCLUSIONS: Two MCV doses or a second opportunity with an additional dose of MCV were highly cost-beneficial and resulted in substantial cost savings compared to a single routine vaccine. But further research using high-quality model-based health economic evaluation studies of MCV2 should be made available to decision-makers. PROSPERO REGISTRATION: CRD42020200669.

A Mixed-Methods Comparison of Interventions to Increase Advance Care Planning.

PURPOSE: Although interventions can increase advance care planning (ACP) engagement, it remains unclear which interventions to choose in primary care settings. This study compares a passive intervention (mailed materials) to an interactive intervention (group visits) on participant ACP engagement and experiences. METHODS: We used mixed methods to examine ACP engagement at baseline and six months following two ACP interventions. Eligible patients were randomized to receive mailed materials or participate in two ACP group visits. We administered the 4-item ACP Engagement survey (n = 110) and conducted interviews (n = 23). We compared mean scores and percent change in ACP engagement, analyzed interviews with directed content analysis to understand participants' ACP experiences, and integrated the findings based on mailed materials or group visits intervention. RESULTS: All participants demonstrated increased ACP engagement scores. At six months, group visit participants reported higher percent change in mean overall score compared with mailed materials participants (+8% vs +3%, P < .0001). Group visits participants reported that being prompted to think about end-of-life preferences, gaining knowledge about ACP, and understanding the value of completing ACP documentation influenced their ACP readiness. While both interventions encouraged patients to start considering and refining their end-of-life preferences, group visits made patients feel more knowledgeable about ACP, highlighted the importance of completing ACP documentation early, and sparked further ACP discussions with others. CONCLUSIONS: While primary care patients may benefit from mailed ACP materials, patients reported increased readiness after ACP group visits. Group visits emphasized the value of upstream preparation, ongoing conversations, and increased knowledge about ACP.

Matching study design to prescribing intention: The prevalent new-user design for studying abuse-deterrent formulations of opioids.

PURPOSE: In drug studies, research designs requiring no prior exposure to certain drug classes may restrict important populations. Since abuse-deterrent formulations (ADF) of opioids are routinely prescribed after other opioids, choice of study design, identification of appropriate comparators, and addressing confounding by "indication" are important considerations in ADF post-marketing studies. METHODS: In a retrospective cohort study using claims data (2006-2018) from a North Carolina private insurer [NC claims] and Merative MarketScan [MarketScan], we identified patients (18-64 years old) initiating ADF or non-ADF extended-release/long-acting (ER/LA) opioids. We compared patient characteristics and described opioid treatment history between treatment groups, classifying patients as traditional (no opioid claims during prior six-month washout period) or prevalent new users. RESULTS: We identified 8415 (NC claims) and 147 978 (MarketScan) ADF, and 10 114 (NC claims) and 232 028 (MarketScan) non-ADF ER/LA opioid initiators. Most had prior opioid exposure (ranging 64%-74%), and key clinical differences included higher prevalence of recent acute or chronic pain and surgery among patients initiating ADFs compared to non-ADF ER/LA initiators. Concurrent immediate-release opioid prescriptions at initiation were more common in prevalent new users than traditional new users. CONCLUSIONS: Careful consideration of the study design, comparator choice, and confounding by "indication" is crucial when examining ADF opioid use-related outcomes.

Comparison of the Efficacies of Vicryl Rapide and Prolene Sutures in Transcolumellar Incision.

<b><br>Introduction:</b> Septorhinoplasty aims to enhance nasal function and appearance. This common but complex procedure has demonstrated advancements with both open and endonasal approaches. The selection of sutures can impact patient comfort and scar outcomes, presenting both advantages and disadvantages.</br> <b><br>Aim:</b> This study was conducted to compare the cosmetic outcomes of the use of absorbable polyglactin 910 (PG) (Vicryl Rapide 5/0; Ethicon Inc.) and nonabsorbable polypropylene (PP) (Prolene 5/0; Ethicon Inc.) in open septorhinoplasty in terms of surgical scarring.</br> <b><br>Methods:</b> The sample of this prospective, randomized, single-blind study consisted of 42 patients who underwent open septorhinoplasty. The patients were randomized into the vicryl rapide (n = 16) and prolene (n = 26) suture groups. The groups were comparatively evaluated by two surgeons in terms of surgical scarring, pigmentation, level difference, indentation, and general appearance based on patient photographs taken in the 2nd week, 6th weeks and 12th week post-op.</br> <b><br>Results:</b> The mean age of the vicryl rapide and prolene groups was 26.9 5.7 years and 24.6 3.9 years, respectively. There was no significant difference between the groups in any of the parameters investigated within the scope of the study in postoperative week 2, 6, and 12 (P > 0.05). On the other hand, intragroup analyses revealed that suture scar significantly decreased in the vicryl rapide group in the 6th and 12th weeks compared to the 2nd week (P < 0.05), while no significant difference was observed in the prolene group in the suture scars in week 6 and 12 compared to week 2 (P > 0.05).</br> <b><br>Conclusions:</b> Inverted V trans-columellar incisions sutured with rapidly absorbable suture material resulted in significantly less suture discomfort and did not significantly increase the risk of postoperative infection compared to nonabsorbable suture material. However, there was no significant difference between the two suture materials in terms of scar appearance.</br>.

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.

Avaliação do processo de aprendizagem no ambiente virtual do Programa Saúde com Agente / Evaluation of the learning process in the virtual environment of the Health Program with Agent / Evaluación del proceso de aprendizaje en el entorno virtual del Programa Salud con Agente

RESUMO: O estudo aqui apresentado teve por objetivo avaliar a percepção da qualidade do processo de aprendizagem no ambiente virtual dos estudantes do Programa Saúde com Agente. Tratou-se de um estudo transversal, realizado em 2022, com 9.145 estudantes dos cursos de Técnico em Agente Comunitário de Saúde e Técnico em Vigilância em Saúde com Ênfase no Combate às Endemias. Informações sobre a qualidade do processo de aprendizagem foram obtidas por meio do questionário Constructivist On-Line Learning Environment Survey, que consiste em 24 questões agrupadas em seis dimensões: relevância, reflexão crítica, interação, apoio dos tutores, apoio dos colegas e compreensão. Avaliaram-se o perfil sociodemográfico dos participantes e as principais formas de acesso ao curso e acompanhamento. Realizou-se análise descritiva; para análise de associação, utilizou-se o teste qui-quadrado ou exato de Fisher. A maioria dos participantes é do sexo feminino, faixa etária de 40 a 49 anos, da região Nordeste; realiza as atividades em casa e usa o celular/smartphone. Ao se considerarem as seis dimensões avaliadas, relevância, interação e apoio dos colegas obtiveram diferenças estatisticamente significativas entre os estudantes dos cursos de Técnico em Agente Comunitário de Saúde e Técnico em Vigilância em Saúde com Ênfase no Combate às Endemias.

ABSTRACT: The study presented here aimed to evaluate the perception of the quality of the learning process in the virtual environment of the students of the Health Program with Agent. It was a cross-sectional study conducted in 2022 with 9,145 students from the Community Health Agent Technician and Health Surveillance Technician courses with an Emphasis on Combating Endemic Diseases. Information on the quality of the learning process was obtained through the Constructivist On-Line Learning Environment Survey, which consists of 24 questions grouped into six dimensions: relevance, critical reflection, interaction, tutor support, peer support, and understanding. The sociodemographic profile of the participants and the primary forms of access to the course and monitoring were evaluated. Descriptive analysis was performed; for association analysis, the chi-square or Fisher's exact test was used. Most participants are females aged 40 to 49 from the Northeast region; they perform activities at home and use their cell phones/smartphones. When considering the six dimensions evaluated, relevance, interaction, and support of colleagues obtained statistically significant differences between the students of the courses of Community Health Agent Technician and Health Surveillance Technician with Emphasis on Combating Endemic Diseases.

RESUMEN: El objetivo del estudio presentado fue evaluar la percepción de la calidad del proceso de aprendizaje en el entorno virtual de los alumnos del Programa Salud con Agentes. Se trató de un estudio transversal realizado en 2022 con 9.145 alumnos de los cursos de Técnico en Agente Comunitario de Salud y Técnico en Vigilancia Sanitaria con énfasis en la lucha contra las enfermedades endémicas. La información sobre la calidad del proceso de aprendizaje se obtuvo a través de la Encuesta Constructivist On-Line Learning Environment Survey, que consta de 24 preguntas agrupadas en seis dimensiones: relevancia, reflexión crítica, interacción, apoyo de los tutores, apoyo de los alumnos y comprensión. Se evaluó el perfil sociodemográfico de los participantes y las principales vías de acceso al curso y seguimiento. Se realizó un análisis descriptivo y se utilizó la prueba de chi-cuadrado o la prueba exacta de Fisher para analizar las asociaciones. Los participantes eran en su mayoría mujeres, en la franja de edad 40 a 49 años, de la región Nordeste; realizaban las actividades en casa y utilizaban teléfonos móviles/smartphones. Al considerar las seis dimensiones evaluadas, la relevancia, la interacción y el apoyo de los compañeros mostraron diferencias estadísticamente significativas entre los alumnos de los cursos de Técnico en Agente Comunitario de Salud y Técnico en Vigilancia Sanitaria con Énfasis en la Lucha contra las Enfermedades Endémicas.

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.

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.

Cross-Cultural Adaptation and Reliability of the Toddler Sensory Profile 2 for Brazilian Children Aged 7 to 35 Months.

Aim: To organize a cross-cultural adaptation study and analyze the reproducibility and test-retest reliability of a Brazilian version of the Toddler Sensory Profile 2 (TSP2Br) for children aged 7-35 months. Methods: The English language version of the profile was translated and culturally adapted into Brazilian Portuguese, administered to 168 caregivers of toddlers aged 7-35 months, and then re-administered to a portion of the sample (39 caregivers; 23%) for 7-14 days for test-retest reliability. The internal consistency and test-retest reliability was analyzed using the Cronbach's alpha and kappa coefficient, respectively. As it is a norm-referenced standardized assessment, the cut-off scores used were 1.0 and 2.0 standard deviations above and below the mean for each group of items established as the preliminary cut-off scores for the Brazilian children. Results: The TSP2Br showed good internal consistency (>0.70) when measured on the total scale; however, when it was analyzed for sensory areas, five to seven areas presented alpha values <.70. By quadrants, alpha was <.70, for all items. The test-retest values fell into the category of near-perfect agreement (.89-.97). The preliminary cut-off points of the Brazilian scores were distinct from those of the Americans. Conclusions: The TSP2Br showed preliminary reliability and validity in the identification of sensory processing problems in Brazilian children aged 7-35 months; however, it would be necessary to increase the sample size to generalize our findings to the general Brazilian population.

Social Prescribing Schemes in Primary Care in Spain (EvalRA Project): a mixed-method study protocol to build an evaluation model.

BACKGROUND: Social Prescribing is a Primary Health Care service that provides people with non-clinical care alternatives that may have an impact on their health. Social Prescribing can be more or less formal and structured. Social Prescribing Schemes are formal Social Prescribing of health assets by Primary Health Care teams in coordination and follow-up of patients with providers. The emerging evidence suggests that this service can improve people's health and well-being, create value and provide sustainability for the healthcare system. However, some evaluations note that the current evidence regarding social prescribing is insufficient and needs further investigation. The EvaLRA project aims to elaborate an evaluation model of Social Prescribing Schemes in Primary Health Care based on a set of structure, process, and outcomes indicators. METHODS: In the region of Aragon, the Community Health Care Strategy aims to promote the development of social prescription schemes in Primary Health Care teams. This study is divided into two stages. Stage 1: identification of primary health care teams that implement social prescribing schemes and establish a first set of indicators to evaluate social prescribing using qualitative consensus techniques with experts. Stage 2 evaluation of the relevance, feasibility and sensitivity of selected indicators after 6 and 12 months in primary health care teams. The results will provide a set of indicators considering structure, process and outcomes for social prescribing schemes. DISCUSSION: Current evaluations of the application of social prescribing schemes use different criteria and indicators. A set of agreed indicators and its piloting in primary health care teams will provide a tool to evaluate the implementation of social prescription schemes. In addition, the scorecard created could be of interest to other health systems in order to assess the service and improve its information system, deployment and safety.

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.

Methodology for evaluating bibliographic references for works published under the Ecimed publishing label / Metodología de evaluación de referencias bibliográficas para las obras editadas bajo el sello editorial Ecimed

Introduction: what is meritorious and necessary about quality bibliographic citations and references is that they support the contents, provide reliability and allow verification and expansion of knowledge with transparency. The Ciencias Médicas Publishing House is immersed in the implementation of the quality management system, which covers all editorial processes to facilitate the publication of high-quality works. Objective: establish the methodology for evaluating the quality of citations and bibliographic references of the works to be edited. Methods: to design the methodology, a qualitative documentary research study was carried out, aimed at obtaining information through the collection, organization and analysis of documents of any kind such as bibliographic, newspaper or archival sources, both physical and digital. The methodology designed by the Mexican authors Martín and Lafuente was taken as a basis, who in 2017 published nine evaluation indicators of bibliographic references, which were analyzed, tempered and the dimensions that gave rise to the methodology were designed. For each dimension, with its criteria, indicators, norms and/or evaluation standards were built, harmonized according to the identified guidelines, thus designing the first version of the methodology. Results: after the evaluative analysis of each dimension, the final evaluation of the references of the work was carried out and for this the evaluation criteria proposed in the methodology to be implemented were output. Conclusions: the methodology for evaluating the quality of bibliographies citations that we propose for works published under the Ecimed publishing label requires an implementation and validation process. Generating quality citations for researchers that are useful in their own research contributes to Open Science.

Introducción: lo meritorio y necesario de las citas y referencias bibliográficas con calidad, es que sirven de sostén a los contenidos, proporcionan fiabilidad y permiten su verificación y ampliación de conocimientos con transparencia. La Editorial Ciencias Médicas está inmersa en la implementación del sistema de gestión de la calidad, que abarca todos los procesos editoriales para facilitar la publicación de obras de elevada calidad. Objetivo: establecer la metodología de evaluación de la calidad de las citas y referencias bibliográficas de las obras a editar. Métodos: para el diseño de la metodología se realizó un estudio cualitativo, de investigación documental, dirigida a la obtención de información mediante la recopilación, organización y análisis de documentos de cualquier especie como fuentes bibliográficas, hemerográficas o archivísticas, tanto físicas como digitales. Se tomó como base la metodología diseñada por las autoras mexicanas Martín y Lafuente, quienes en 2017 publicaron nueve indicadores de evaluación de las referencias bibliográficas, los que se analizaron, atemperaron y se diseñaron las dimensiones que dieron salida a la metodología. A cada dimensión, con sus criterios, se le construyeron indicadores, normas y/o estándares de evaluación, armonizados según las pautas identificadas, quedando diseñada la primera versión de la metodología. Resultados: posterior al análisis evaluativo de cada dimensión se realizó la evaluación final de las referencias de la obra y para ello se dieron salida a los criterios de evaluación que se proponen en la metodología a implementar. Conclusiones: la metodología de evaluación de la calidad de las citas bibliografías que proponemos para las obras editadas bajo el sello editorial Ecimed, requiere de un proceso de implementación y validación. Generar citas de calidad para los investigadores y que les sean útiles en su propia investigación, tributa a la Ciencia Abierta.

A guide to evaluating systematic reviews for the busy clinicians or reluctant readers.

Systematic reviews (SRs) provide a solution to handle information overload for busy clinicians by summarising and synthesizing studies on a specific issue. However, because SRs are complicated and often boring to read, the busy or reluctant reader may make do with the abstract. When, as it has been shown, many authors overstate efficacy or understate harm in their abstracts, not consulting the underlying article could be misleading. This means that the prudent reader must have the ability to identify the 'tender points' of SRs to avoid falling for 'spin'. To this end we briefly review the method of SRs and ways to relatively quickly determine trustworthiness.

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.

Sustaining a New Model of Acute Stroke Care: A Mixed-Method Process Evaluation of the Melbourne Mobile Stroke Unit.

BACKGROUND: Internationally, Mobile Stroke Unit (MSU) ambulances have changed pre-hospital acute stroke care delivery. MSU clinical and cost-effectiveness studies are emerging, but little is known about important factors for achieving sustainability of this innovative model of care. METHODS: Mixed-methods study from the Melbourne MSU (operational since November 2017) process evaluation. Participant purposive sampling included clinical, operational and executive/management representatives from Ambulance Victoria (AV) (emergency medical service provider), the MSU clinical team, and receiving hospitals. Sustainability was defined as ongoing MSU operations, including MSU workforce and future model considerations. Theoretically-based on-line survey with Unified Theory of Acceptance and Use of Technology (UTAUT), Self Determination Theory (SDT, Intrinsic Motivation), and open-text questions targeting barriers and benefits was administered (June-September 2019). Individual/group interviews were conducted, eliciting improvement suggestions and requirements for ongoing use. Descriptive and regression analyses (quantitative data) and directed content and thematic analysis (open text and interview data) were conducted. RESULTS: There were 135 surveys completed. Identifying that the MSU was beneficial to daily work (ß=0.61), not experiencing pressure/tension about working on the MSU (ß=0.17) and thinking they did well working within the team model (ß=0.17) were significantly associated with wanting to continue working within the MSU model [R2=0.76; F(15, 60)=12.76, P<.001]. Experiences varied between those on the MSU team and those working with the MSU. Advantages were identified for patients (better, faster care) and clinicians (interdisciplinary learning). Disadvantages included challenges integrating into established systems, and establishing working relationships. Themes identified from 35 interviews were MSU team composition, MSU vehicle design and layout, personnel recruitment and rostering, communication improvements between organisations, telemedicine options, MSU operations and dispatch specificity. CONCLUSION: Important factors affecting the sustainability of the MSU model of stroke care emerged. A cohesive team approach, with identifiable benefits and good communication between participating organisations is important for clinical and operational sustainability.

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

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.

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.

Mandatory immunizations for health students in Lyon (France), overview and evaluation / Obligations d'immunisation des étudiants en santé de Lyon, état des lieux et évaluation

OBJECTIVES: To establish an overview of vaccination amongst health students in Lyon 1 University and to evaluate the implementation of a new verification system of immunization obligations with an electronic vaccination card (EVC) from the “MesVaccins.net” website. METHODS: A questionnaire was sent by the Lyon 1 University Student Health Service (SHS) to the first-year health studies students over the age of 18 in Lyon in 2020-2021 who shared their EVC; exploitation of these EVCs’ data. RESULTS: Amongst all students, 67.4% transmitted their information to the SHS. They reported organizational difficulties in updating (33.3%) and certifying their EVC with a healthcare professional (55.9%). Global satisfaction of the students was 78.0%. This study highlighted many differences between Lyon Est and Lyon Sud campuses, especially about general knowledge of the SHS, visibility of the promotion campaign, rate of students who transmitted their information to the SHS and rate of up-to-date students. Regarding mandatory immunization, 83.4% of the students were up-to-date with diphtheria-tetanus-poliomyelitis, 56.8% with hepatitis B, and 64.7% had done a tuberculin intradermal test; 43.4% of the students were simultaneously up-to-date with these three immunizations. CONCLUSION: The rate of up-to-date students is insufficient. This study stresses the necessity of an early campaign of immunizations promotion, with better access to healthcare professionals able to certify EVCs.

Objectifs: Établir un état des lieux de la vaccination des étudiants en santé de l'université Lyon 1 et évaluer la mise en place d'un nouveau dispositif de vérification des obligations d'immunisation à l'aide du carnet de vaccination électronique (CVE) MesVaccins.net. Méthodes: Questionnaire envoyé par le Service de santé universitaire (SSU) de Lyon 1 aux étudiants majeurs en première année de santé en 2020-2021 ayant partagé leur CVE ; exploitation des données de ces CVE. Résultats: Les étudiants étaient 67,4 % à avoir transmis leurs informations au SSU. Ils ont rapporté des difficultés organisationnelles pour se mettre à jour (33,3 %) et pour faire valider leur CVE par un professionnel de santé (55,9 %). La satisfaction globale des étudiants vis-à-vis de ce dispositif était de 78,0 %. Cette étude a mis en avant plusieurs différences entre les campus de Lyon Est et Lyon Sud, notamment sur la connaissance du SSU, la visibilité de la campagne, le pourcentage d'étudiants qui ont transmis leurs informations et le pourcentage d'étudiants à jour. Concernant les immunisations obligatoires, 83,4 % des étudiants étaient à jour du vaccin diphtérie-tétanos-poliomyélite, 56,8 % de l'hépatite B et 64,7 % avaient pratiqué une intradermoréaction ; 43,4 % des étudiants étaient à jour simultanément de ces trois immunisations. Conclusion: Le pourcentage d'étudiants à jour est insuffisant. Cette étude souligne la nécessité d'une campagne précoce de promotion des immunisations avec un meilleur accès des étudiants à des professionnels de santé validant les CVE.