Risk of false conformity decisions due to measurement uncertainty of Active Pharmaceutical Ingredient: A multiparametric evaluation

Abstract Medicines must be subject to physical, chemical, and biological analysis to guarantee their quality, safety, and effectiveness. Despite the efforts to ensure the reliability of analytical results, some uncertainty will always be associated with the measured value, which can lead to false decisions regarding conformity/non-conformity assessment. This work aims to calculate the specific risk of false decisions regarding conformity/non-conformity of acetaminophen oral solution dosage form. The acetaminophen samples from five different manufacturers (A, B, C, D, and E) were subject to an active pharmaceutical ingredient assay, density test, and dose per drop test according to the official compendia. Based on measured values and their respective uncertainties, the risk values were calculated using the Monte Carlo method implemented in an MS Excel spreadsheet. The results for two acetaminophen oral solution samples (C and D) provided an increased total risk value of false acceptance (33.1% and 9.6% for C and D, respectively). On the other hand, the results for the other three acetaminophen samples (A, B, and E) provided a negligible risk of false acceptance (0.004%, 0.025%, and 0.045% for A, B, and E, respectively). This indicates that measurement uncertainty is very relevant when a conformity assessment is carried out, and information on the risks of false decisions is essential to ensure proper decisions.

Multivariate guard-bands and total risk assessment on multiparameter evaluations with correlated and uncorrelated measured values

Abstract The quality, efficacy, and safety of medicines are usually verified by analytical results. Measurement uncertainty is a critical aspect for the reliability of these analytical results. The pharmacopeial compendia usually adopt a simple acceptance rule that does not consider information from measurement uncertainty. In this work, we compared decision-making using simple acceptance and decision rules with the use of guard-band for multiparameter evaluation of ofloxacin ophthalmic solution and acyclovir topical cream. Ciprofloxacin ophthalmic solution and acyclovir topical cream samples were subject to pharmacopeial tests and assays. Multivariate guard-band widths were calculated by multiplying the standard uncertainty (u) by an appropriate multivariate coverage factor (k'). The multivariate coverage factor (k') was obtained by the Monte Carlo method. According to the simple acceptance rule, all the results obtained for ciprofloxacin ophthalmic solution and acyclovir topical cream are within the specification limits. However, the risk of false conformity decisions increases for ciprofloxacin tests. Decisions made using the simple acceptance rule and decision rules with the use of guard-band may differ. The simple acceptance rule may increase the risk of false conformity decisions when the measured value is close to the regulatory specification limits and/or when the measurement uncertainty value is inappropriately high. Nevertheless, the guard-band decision rule will always reduce the risk of false conformity decisions. Therefore, using information on measurement uncertainty in conformity assessment is highly recommended to ensure the proper efficacy, safety, and quality of medicines.

Evaluación cuantitativa de un modelo SEIR para predecir casos de COVID-19 / Quantitative evaluation of a SEIR model for forecasting COVID-19 cases

Resumen Introducción : Los modelos epidemiológicos han sido ampliamente utilizados durante la pandemia de COVID-19, aunque la evaluación de su desempeño ha sido limitada. El objetivo del presente trabajo fue evaluar de forma retrospectiva un modelo SEIR para la predicción de casos a corto plazo (1 a 3 semanas), cuantificando su desempeño real y potencial, me diante la optimización de los parámetros del modelo. Métodos : Se realizaron proyecciones para cada día de la primera ola de casos (31 de julio de 2020 al 11 de marzo de 2021) en el municipio de General Pueyrredón (Argentina), cuantificando el desempeño del modelo en términos de incertidumbre, inexactitud e imprecisión. La evaluación se realizó con los parámetros originales del modelo (utilizados en proyecciones que fueron oportunamente publicadas), y luego variando distintos parámetros a fin de identificar valores óptimos. Resultados : El análisis del desempeño del modelo mostró que valores alternativos de algunos parámetros, y la corrección de los valores de entrada utilizando un filtro de "media móvil" para eliminar las variaciones semanales en los reportes de casos, habrían otorgado mejores resultados. El modelo con los parámetros opti mizados logró disminuir desde casi 40% a menos de 15% la incertidumbre, con valores similares de inexactitud, y con una imprecisión levemente mayor. Discusión : Modelos epidemiológicos sencillos, sin grandes requerimientos para su implementación, pue den ser de utilidad para la toma de decisiones rápi das en localidades pequeñas o con recursos limitados, siempre y cuando se tenga en cuenta la importancia de su evaluación y la consideración de sus alcances y limitaciones.

Abstract Introduction : Epidemiological models have been widely used during the COVID-19 pandemic, although performance evaluation has been limited. The objec tive of this work was to thoroughly evaluate a SEIR model used for the short-term (1 to 3 weeks) predic tion of cases, quantifying its actual past performance, and its potential performance by optimizing the model parameters. Methods : Daily case forecasts were obtained for the first wave of cases (July 31, 2020 to March 11, 2021) in the district of General Pueyrredón (Argentina), quantifying the model performance in terms of uncertainty, inac curacy and imprecision. The evaluation was carried out with the original parameters of the model (used in the forecasts that were published), and also varying different parameters in order to identify optimal values. Results : The analysis of the model performance showed that alternative values of some parameters, and the correction of the input values using a "mov ing average" filter to eliminate the weekly variations in the case reports, would have yielded better results. The model with the optimized parameters was able to reduce the uncertainty from almost 40% to less than 15%, with similar values of inaccuracy, and with slightly greater imprecision. Discussion : Simple epidemiological models, without large requirements for their implementation, can be very useful for making quick decisions in small cities or cities with limited resources, as long as the importance of their evaluation is taken into account and their scope and limitations are considered.

Afrontando la incertidumbre en pandemia: construyendo paz desde la prosocialidad / Facing uncertainty in pandemic times: peacebuilding from a prosociality stance / Enfrentando a incerteza na pandemica: construindo paz a partir de uma posição com base na prosocialidade

El estudio de la construcción de paz desde una postura con base en los comportamientos prosociales es un área nueva en la investigación psicosocial en Bolivia, mucho más si se tiene la intención de rescatar y resaltar la presencia de salud psicológica comunitaria aun en una época caracterizada por una poderosa incertidumbre producto de la combinación de dos factores: la inestabilidad y violencia política sumada a la presencia de la pandemia Covid-19 y la emergencia sanitaria derivada de ella. En esta investigación han participado 400 adultos jóvenes de entre 20 y 30 años de edad (162 varones y 268 mujeres de las ciudades de La Paz - 255 participantes - y El Alto - 155 participantes) con el objetivo de describir la relación entre tipos específicos de respuesta a la incertidumbre (político-económica y sanitaria) y conductas prosociales asociadas a ella durante la pandemia Covid-19. Se ha encontrado una correlación positiva significativa entre la presencia de Prosocialidad y la Respuesta a la Incertidumbre, implicándose la posibilidad de comportamientos de construcción de paz como mecanismos de adaptación a la misma. También se ha establecido que existe igualdad en un grado amplio con respecto a la magnitud de comportamientos prosociales entre La Paz y El Alto y que en las zonas donde se han registrado más casos positivos también se ha encontrado una mayor presencia de prosocialidad en especial en la ciudad de La Paz, existiendo, finalmente, ciertas diferencias específicas entre varones y mujeres en cuanto a la ejecución y orientación de comportamientos prosociales in-pandemia.

Peacebuilding studies from a prosociality stance is a new area in psychosocial research in Bolivia, even more if there is an academic marked intention to rescue and highlight the presence of psychological communal health, in a time characterized by a powerful uncertainty derived from the combination of two unfortunate factors: political violence and instability coupled with the presence of the Covid-19 pandemic and the subsequent sanitary emergency and social stress. In this research, 400 young adults have participated, all of them among 20 to 30 years old (162 men and 268 women) from La Paz and El Alto cities, with the objective of describing the relationship between specific mechanisms to face uncertainty and the possible presence of associated prosocial behaviors in 2020 and 2021. A positive, significant correlation was found between prosociality and effective uncertainty-facing mechanisms, implying the possibility to execute peacebuilding conducts as a way to adapt to the pandemic. It has also been established that there is a great degree of similitude in regards to effective prosocial behaviors in La Paz and in El Alto cities, that in the zones where a greater number of positive cases was found, there was also a larger presence of prosociality, especially in La Paz, and that there are detailed executional differences between men and women in terms of prosocial in-pandemic behavior.

O estudo da construção da paz a partir de uma posição baseada em comportamentos pró-sociais é uma nova área na pesquisa psicossocial na Bolívia, muito mais se a intenção é resgatar e destacar a presença de saúde psicológica comunitária mesmo em uma época caracterizada por um poderoso produto da incerteza do combinação de dois fatores: instabilidade e violência política somadas à presença da pandemia Covid-19 e a emergência de saúde derivada dela. 400 jovens adultos entre 20 e 30 anos (162 homens e 268 mulheres das cidades de La Paz - 255 participantes - e El Alto - 155 participantes) participaram desta pesquisa com o objetivo de descrever a relação entre tipos específicos de resposta à incerteza (político-econômica e de saúde) e aos comportamentos pró-sociais associados a ela durante a pandemia de Covid-19. Encontrou-se uma correlação positiva significativa entre a presença da Prosocialidade e a Resposta à Incerteza, implicando na possibilidade de comportamentos de construção da paz como mecanismos de adaptação a ela. Também foi estabelecido que existe uma grande igualdade com respeito à magnitude do comportamento pró-social entre La Paz e El Alto e que nas áreas onde mais casos positivos foram registrados, uma maior presença de pró-socialidade também foi encontrada. especialmente na cidade de La Paz, havendo, finalmente, certas diferenças específicas entre homens e mulheres quanto à execução e orientação de comportamentos pró-sociais em situação de pandemia.

Intolerância à incerteza em estudantes durante a pandemia de Covid-19: scoping review / Intolerance of uncertainty in students during the Covid-19 pandemic: scoping review / Intolerancia a la incertidumbre en los estudiantes durante la pandemia de Covid-19: scoping review

Compreende-se que o fator intolerância à incerteza é um construto que implica na dificuldade do indivíduo em lidar com contextos imprevistos. A literatura indica que a intolerância à incerteza pode apresentar impacto negativo ao bem-estar, principalmente, quando se está vivenciando um contexto inesperado, como a pandemia de COVID-19. Nessa perspectiva, o objetivo deste estudo foi realizar uma sinopse sobre o que foi estudado sobre a intolerância à incerteza em estudantes do ensino superior durante o contexto de pandemia de COVID-19 por meio de uma scoping review. A coleta foi realizada nas bases de dados EMBASE, MEDLINE/PubMed, Web of Science, PsychInfo e CINAHL com descritores em inglês. A partir da aplicação dos critérios de elegibilidade, realizada por dois juízes, selecionou-se um total de nove estudos. Os três tópicos principais de pesquisa dos estudos analisados foram a relação da intolerância à incerteza com (1) características envolvendo saúde mental, (2) medo, e (3) com atividades acadêmicas e aspectos de carreira. A maioria dos estudos evidenciou a falta de tolerância à incerteza como preditor para fatores prejudiciais. Além disso, verificou-se que não foram efetuadas intervenções direcionadas ao constructo nos estudos. A presente revisão destaca a habilidade de tolerar a incerteza como um componente relevante de ser avaliado em estudantes e a importância na realização de intervenções psicológicas direcionadas à intolerância à incerteza em contextos precários.

It is understood that the factor intolerance of uncertainty is a construct that implies the individual's difficulty in dealing with unforeseen contexts. The literature indicates that intolerance of uncertainty can have a negative impact on well-being, especially when experiencing an unexpected context, such as the COVID-19 pandemic. In this perspective, the objective of this study was to perform a synopsis on what has been studied about intolerance of uncertainty in higher education students during the context of the COVID-19 pandemic through a scoping review. Data collection was performed in the EMBASE, MEDLINE/PubMed, Web of Science, PsychInfo and CINAHL databases with descriptors in English. From the application of eligibility criteria, performed by two judges, a total of nine studies were selected. The three main research topics of the studies analyzed were the relationship of intolerance of uncertainty with (1) characteristics involving mental health, (2) fear, and (3) with academic activities and career aspects. Most studies showed a lack of tolerance of uncertainty as a predictor for harmful factors. In addition, it was found that no interventions aimed at the construct were carried out in the studies. The present review highlights the ability to tolerate uncertainty as a relevant component of being evaluated in students and the importance of carrying out psychological interventions aimed at intolerance of uncertainty in precarious contexts.

Se entiende que el factor intolerancia a la incertidumbre es un constructo que implica la dificultad del individuo para enfrentarse a contextos imprevistos. La literatura indica que la intolerancia a la incertidumbre puede tener un impacto negativo en el bienestar, especialmente cuando se vive un contexto inesperado, como la pandemia de COVID-19. En esta perspectiva, el objetivo de este estudio fue realizar una sinopsis de lo estudiado sobre la intolerancia a la incertidumbre en estudiantes de educación superior durante el contexto de la pandemia del COVID-19 a través de una scoping review. La recolección de datos se realizó en las bases de datos EMBASE, MEDLINE/PubMed, Web of Science, PsychInfo y CINAHL con descriptores en inglés. De la aplicación de los criterios de elegibilidad, realizada por dos jueces, fueron seleccionados un total de nueve estudios. Los tres principales temas de investigación de los estudios analizados fueron la relación de la intolerancia a la incertidumbre con (1) características relacionadas con la salud mental, (2) el miedo y (3) con actividades académicas y aspectos profesionales. La mayoría de los estudios mostraron una falta de tolerancia a la incertidumbre como predictor de factores dañinos. Además, se constató que en los estudios no se realizaron intervenciones dirigidas al constructo. La presente revisión destaca la capacidad de tolerar la incertidumbre como componente relevante de ser evaluado en los estudiantes y la importancia de realizar intervenciones psicológicas dirigidas a la intolerancia a la incertidumbre en contextos precarios.

Effects of self-help mindfulness-based stress reduction training on illness uncertainty and sleep quality in atrial fibrillation patients after radiofrequency ablation / 中国实用护理杂志

Objective:To investigate the effects of self-help mindfulness-based stress reduction (MBSR) training on illness uncertainty andsleep quality in patients with atrial fibrillation (AF) after radiofrequency ablation. To provide the basis for improving the quality of life of these patients.Methods:This was a randam controlled Test. A convenient sampling method was used to select 90 patients with atrial fibrillation who underwent radiofrequency ablation in the First Peoples Hospital of Changzhou from January 2021 to December 2021. According to the random number table method. They were divided into the experimental group and the control group, with 45 cases in each group. The control group received routine nursing, and the observation group received home-based self-help MBSR training based on the routine nursing. Five Facet Mindfulness Questionnaire (FFMQ), Mishel Uncertainty in Illness Scale and the Pittsburgh Sleep Quality Index Scale (PSQI) were used to evaluate the scores of each scale before intervention, 8 weeks and 3 months after intervention.Results:A total of 42 cases were completed in the experimental group and 41 cases in the control group. Repeated measurement analysis of variance showed that there were interaction effect ( F interaction = 90.98, 46.27, 39.61, all P<0.01), time effect ( F time = 298.67, 179.06, 76.32, all P<0.01) and inter-group effect ( F intergroup = 19.88, 4.07, 18.70, all P<0.05) on mindfulness score, disease uncertainty score, total score of sleep quality and scores of all dimensionsin between the two groups. Simple effect analysis showed that scores of all scales in experimental groups were significantly better than those in control group after the intervention ( F values were 11.75 to 66.49, all P<0.01). Conclusion:Self-help MBSR training can improve the level of mindfulness, reduce the feeling of uncertainty and improve the quality of sleep in patients with atrial fibrillation after radiofrequency ablation.

Mediating effects of disease perception on disease uncertainty and health behaviors among thrombolysis therapy in patients with acute ischemic stroke / 中国实用护理杂志

Objective:To explore the mediating effects of disease perception on disease uncertainty and health behaviors among thrombolysis therapy in patients with acute ischemic stroke, to provide a theoretical basis for improving patient health behavior.Methods:By cross-sectional survey methods, from June 2021 to June 2022, a total of 123 thrombolysis therapy in patients with acute ischemic stroke were investigated by general information, Mishel Uncertainty in Illness Scale, Health Behavior Scale for Stroke Patients and Revised Illness Perception Questionnaire by convenience sampling method. The mediating effect of disease perception between disease uncertainty and health behavior was verified by structural equation model.Results:The scores of disease uncertainty, health behaviors and disease perception were (52.21 ± 7.67), (63.77 ± 9.40), (127.70 ± 26.19) points in patients with acute ischemic stroke. Health behaviors and each dimension including exercise, medication, instruction, nutrition, responsibility, tobacco and alcohol were negatively correlation between disease uncertainty ( r values were -0.762 to -0.411, all P<0.01), and positively correlation between disease perception ( r values were 0.689 to 0.912, all P<0.01). Disease uncertainty was a significantly negative predictor for health behaviors ( β= -0.71, P<0.01); disease perception was also a significantly negative predictor for disease perception ( β = -0.85, P<0.01). Disease uncertainty had a significantly indirect effect on the health behaviors for thrombolysis therapy in patients with acute ischemic stroke through disease perception, which showed the mediating effect of health behaviors accounts for 15.2% of total effect. Conclusions:Disease perception play a mediating role in the relationship between disease uncertainty and health behaviors among thrombolysis therapy in patients with acute ischemic stroke.

Path analysis of the influence of shared decision-making between doctors and patients on psychological stress among patients with coronary heart disease / 中国实用护理杂志

Objective:To explore the influencing factors of psychological stress in patients with coronary heart disease, and the effect path of joint decision-making between doctors and patients on psychological stress and to provide reference for the formulation of management plan for physical and mental health of patients with coronary heart disease.Methods:From July 2017 to April 2022, 715 retired patients with coronary heart disease hospitalized in General Hospital of the People′s Liberation Army and Air Force Hospital in Western Military Theater of the People′s Liberation Army were investigated adopted cross-sectional survey method by simple random sampling using general information questionnaire, Stress Response Questionnaire, Shared Decision-making Questionnaire between Doctors and Patients, Uncertainty in Illness Scale and Simple Coping Style Questionnaire. By using structural equation modeling, the direct and indirect influence paths of shared decision-making between doctors and patients on psychological stress were analyzed.Results:The scores of psychological stress, shared decision-making, uncertainty in illness, positive coping style and negative coping style were 49.81 ± 11.06, 79.24 ± 8.68, 76.40 ± 12.56, 21.67 ± 5.51 and 8.90 ± 3.12. Correlation analysis showed that the scores of psychological stress were positively correlated with the scores of uncertainty in illness and negative coping style ( r=0.661, 0.591, both P<0.01), and negatively correlated with the scores of shared decision-making between doctors and patients and positive coping style ( r=-0.623, -0.451, both P<0.01). Path analysis showed that shared decision-making between doctors and patients had a direct effect on psychological stress, accounting for 23.81% of the total effect; the uncertainty in illness, positive coping style and negative coping style played a part of intermediary role between the joint decision-making between doctors and patients and psychological stress, accounting for 32.35%, 8.40% and 17.93% of the total effect respectively; the uncertainty in illness and negative coping style had a chain mediating effect between them, accounting for 17.51% of the total effect. Conclusions:It suggests that the shared decision-making between doctors and patients with coronary heart disease is not only directly related to psychological stress, but also indirectly related to psychological stress through uncertainty in illness and coping style, among which coping style may play a role of "pivot" to a certain extent.

The level of mindfulness and fear of recurrence in patients after radical gastrectomy for gastric cancer: the chain mediating effect of illness uncertainty and negative coping styles / 中国实用护理杂志

Objective:To explore the relationship between the level of mindfulness, illness uncertainty, negative coping style and fear of recurrence in patients after radical resection of gastric cancer, and to understand the internal mechanism of how mindfulness affects the fear of recurrence.Methods:This was a cross sectional survey. From January 2019 to March 2021, the convenience sampling method was used to select 227 patients undergoing radical gastric cancer surgery in the Affiliated Hospital of Naval Medial University of Chinese PLA as the research objects. The general information questionnaire, Mindfulness Attention and Awareness Scale, Fear of Disease Progression Simplified Scale, Mishel′s Illness Uncertainty Scale and Simplified Coping Style Questionnaire were used for questionnaire surveys. The relationship between the level of mindfulness, illness uncertainty, negative coping style and fear of recurrence was explored and the model was tested.Results:The returned questionnaires were 207 with a recovery rate of 91.19%(207/227). Pearson correlation analysis showed that the level of mindfulness was negatively correlated with illness uncertainty, negative coping style, and fear of recurrence ( r=-0.176, -0.269, -0.480, all P<0.01). Illness uncertainty, negative coping styles were positively correlated with fear of recurrence ( r=0.433, 0.420, both P<0.01). The mediation model test showed that mindfulness had a significant direct effect on fear of relapse (effect value was -0.220), illness uncertainty and negative coping styles had significant partial mediating effect between mindfulness level and fear of recurrence (effect value were -0.036, -0.030). And the chain mediating effect of illness uncertainty and negative coping style was also significant (effect value was -0.006). Conclusions:The level of mindfulness can not only have a direct impact on the fear of recurrence in patients after radical gastrectomy, but also indirectly affect the fear of recurrence through the chain mediating effect of illness uncertainty, negative coping style, and disease uncertainty→negative coping style.

Influence and mechanism of intolerance of uncertainty on anxiety / 四川精神卫生

The purpose of this paper is to review the research on the influence and mechanism of intolerance of uncertainty （IU） on anxiety both at home and abroad in recent years. IU refers to the individual's disgust response due to the intolerance of perceived lack of prominent， critical or sufficient information， and it has individual tendency. IU plays an important role in the occurrence and development of anxiety， but the specific process and mechanism remain unclear. This paper reviews the influence of IU on anxiety， and clarifies its mechanism of action on the generation and development of anxiety from the perspectives of cognition， emotion and behavior， so as to provide references for preventing the development of general anxiety into anxiety disorders and developing new psychological intervention and treatment strategies.

Determination of purity of a new anti-fatty liver drug IMH by differential scanning calorimetry method and uncertainty evaluation / 药学学报

The purity of 4,4′-dimethoxy-5,6,5′,6′-bis (methylenedioxy)-2′-morpholine methylenebiphenyl-2-methyl formate methanesulfonate (IMH), a new drug for fatty liver treatment, was determined through differential scanning calorimetry (DSC). Analysis of two-factor non repeatability method was performed in the investigation the effects of two factors (heating rate and sample weight) on purity determination. The DSC experimental parameters were optimized as follows: heating rate was 10 ℃·min-1, temperature range was 150-300 ℃, sample weight was 2.0-4.1 mg, and N2 flow rate was 80 mL·min-1. The linear correlation coefficient (r) of this DSC method was 0.999 8. The RSD value (n = 6) of precision was 0.03%. The standard value and uncertainty of the purity results of the multiple batches of IMH drugs were (99.74 ± 0.29)%, (99.91 ± 0.28)%, (99.90 ± 0.28)%, and (99.81 ± 0.28)% with inclusion factor (K) of 2 and confidence probability (P) of 0.95. The results were basically consistent with the results of the mass balance method. The DSC mehod is a simple, rapid and accurate method, and provides a new reference method for determining the purity of IMH drugs, improves the accuracy and reliability of purity determination.

Spirituality in the uncertainty of illness: the perspective of oncology patients / Espiritualidad en la incertidumbre frente a la enfermedad: la perspectiva de pacientes oncológicos / Espiritualidade na incerteza da doença: a perspectiva de pacientes oncológicos

ABSTRACT Objective: To analyze spirituality in the process of illness uncertainty in cancer patients. Methods: This is a qualitative study, in which Merle Mishel's Theory of Uncertainty of Disease was used as a theoretical framework; and as a methodological reference, the stages of Bardin's Content Analysis. As a technique for obtaining information, a semi-structured interview was used. Results: Spirituality in the uncertainty of the disease varies from patient to patient and acts in a unique way. They presented readaptation attitudes in their reports. The presence of spirituality in their lives acted as the main force mechanism to deal with the uncertainty of the disease, and this moment was called by Mishel "probabilistic thinking". Conclusion: Patients demonstrated readaptation attitudes in their reports, and spirituality acted as the main mechanism of strength to deal with uncertainty in the disease

RESUMEN Objetivo: Analizar espiritualidad en el proceso de la incertidumbre de la enfermedad en el paciente oncológico. Métodos: Investigación cualitativa, en la cual fue utilizada como referencial teórico la Teoría de la Incertidumbre Frente a la Enfermedad, de Merle Mishel; y como referencial metodológico, las etapas del Análisis de Contenido de Bardin. Como técnica de obtención de las informaciones, fue usada la entrevista semiestructurada. Resultados: La espiritualidad en la incertidumbre de la enfermedad varia de paciente para paciente y actúa de manera singular. Ellos presentaron actitudes de readaptación en sus relatos. La presencia de la espiritualidad en sus vidas actuó como el principal mecanismo de fuerza para lidiar con la incertidumbre de la enfermedad, siendo, eso momento, llamado por Mishel de "pensamiento probabilístico". Conclusión: Los pacientes demostraron actitudes de readaptación en sus relatos, y la espiritualidad actuó como el principal mecanismo de fuerza para lidiar con la incertidumbre en la enfermedad.

RESUMO Objetivo: Analisar a espiritualidade no processo da incerteza da doença no paciente oncológico. Métodos: Trata-se de uma pesquisa qualitativa, na qual foi utilizada como referencial teórico a Teoria da Incerteza da Doença, de Merle Mishel; e como referencial metodológico, as etapas da Análise de Conteúdo de Bardin. Como técnica de obtenção das informações, foi usada a entrevista semiestruturada. Resultados: A espiritualidade na incerteza da doença varia de paciente para paciente e atua de forma singular. Eles apresentaram atitudes de readaptação nos seus relatos. A presença da espiritualidade em suas vidas agiu como o principal mecanismo de força para lidar com a incerteza da doença, sendo, esse momento, chamado por Mishel de "pensamento probabilístico". Conclusão: Os pacientes demonstraram atitudes de readaptação nos seus relatos, e a espiritualidade atuou como o principal mecanismo de força para lidar com a incerteza na doença.

La aplicación de la neutrosofía en las ciencias médicas: una revisión bibliográfica narrativa / The Application of Neutrosophy in Medical Sciences: A Narrative Literature Review

El presente estudio tiene como objetivo principal examinar la aplicación de la neutrosofía en el campo de las ciencias médicas, a través de una revisión bibliográfica narrativa. Se ha determinado que la neutrosofía se relaciona con áreas como la imagenología, el análisis clínico y la toma de decisiones en el diagnóstico y la gestión de la salud. La implementación de la neutrosofía en la toma de decisiones puede disminuir la probabilidad de cometer errores, tanto en aspectos administrativos como en el diagnóstico y tratamiento de enfermedades. La presencia de herramientas neutrosóficas en la tecnología médica resulta fundamental para superar dificultades y mejorar la eficiencia en la atención médica. La integración de sistemas de diagnóstico asistido por ordenador, información clínica y administrativa puede potenciar los flujos de trabajo, optimizando así la prestación de servicios médicos. La neutrosofía, al reducir la incertidumbre en la práctica médica, ofrece la posibilidad de revolucionar la forma en que se brinda atención médica. Su aplicación conlleva el potencial de transformar los procesos y mejorar la calidad de la atención, lo que implica un avance significativo en el campo de la medicina(AU)

The main objective of this study is to examine the application of neutrosophy in the field of medical sciences through a narrative literature review. It has been determined that neutrosophy is related to areas such as imaging, clinical analysis, and decision-making in diagnosis and health management. Implementing neutrosophy in decision-making can reduce the likelihood of errors, both in administrative aspects and in diagnosing and treating diseases. The presence of neutrosophic tools in medical technology is essential to overcome challenges and improve efficiency in healthcare. Integrating computer-assisted diagnosis systems, clinical and administrative information can enhance workflow, thereby optimizing the provision of medical services. By reducing uncertainty in medical practice, Neutrosophy offers the possibility to revolutionize the way healthcare is delivered. Its application has the potential to transform processes and improve the quality of care, representing a significant advancement in medicine(AU)

Experiencias de pacientes COVID-19 en su transición por cuidados intensivos: un enfoque fenomenológico

Introducción: La enfermedad por coronavirus desencadena en algunas ocasiones la hospitalización de los pacientes en un área crítica, convirtiéndose en un acontecimiento incierto y desconocido. Objetivo: Explorar las experiencias de pacientes Covid-19 en su transición por cuidados intensivos en la ciudad de Santo Domingo de los Tsáchilas en Ecuador. Métodos: Estudio cualitativo con diseño fenomenológico, se realizó un muestreo por conveniencia en el que participaron ocho pacientes que estuvieron hospitalizados en el área mencionada, a los cuales se aplicó entrevistas semiestructuradas. Resultados: Se obtuvieron las categorías: Aceptación frente al ingreso a la unidad de cuidados intensivos, Sentimientos ante la muerte, Incertidumbre por su enfermedad durante la hospitalización, Valorar la vida posterior al egreso, Sentimientos positivos al egresar de la unidad de cuidado intensivo, Sentimientos negativos al ingresar a la unidad de cuidado intensivo, Permanecer aislado de la familia, Acercamiento a Dios y a la familia y Fortalecimiento de vínculo entre enfermero-paciente. Conclusiones: Ingresar a la unidad de cuidados intensivos generó sentimientos negativos en los pacientes, al ocasionar inseguridad sobre el futuro de los mismos. De modo similar, durante su hospitalización presentaron temor a la muerte e incertidumbre por la enfermedad, sin embargo, tuvieron mecanismos de afrontamiento como el aferrarse a Dios, a la familia y contar con el cuidado de enfermería. En cuanto al egreso de los pacientes, manifestaron alegría y felicidad, valorando una nueva oportunidad de vida.

Introduction: Coronavirus disease sometimes triggers hospitalization of patients in a critical area, becoming an uncertain and unknown event. Objective: To explore the experiences of Covid-19 patients in their transition through intensive care in the city of Santo Domingo de los Tsáchilas in Ecuador. Methods: Qualitative study with phenomenological design, a convenience sampling was carried out with the participation of 8 patients who were hospitalized in the aforementioned area, to whom semi-structured interviews were applied. Results : The following categories were obtained: Acceptance of admission to the intensive care unit, Feelings about death, Uncertainty about their illness during hospitalization, Valuing life after discharge, Positive feelings upon discharge from the intensive care unit, Negative feelings upon admission to the intensive care unit, Remaining isolated from the family, Closeness to God and the family and Strengthening of the nurse-patient bond. Conclusions: Entering the intensive care unit generated negative feelings in patients, causing insecurity about their future. Similarly, during their hospitalization they presented fear of death and uncertainty about the disease; however, they had coping mechanisms such as clinging to God, to the family and counting on nursing care. As for the patients' discharge, they expressed joy and happiness, valuing a new opportunity in life.

Effectiveness of personal dose monitoring intercomparison results in a laboratory in Shanghai / 环境与职业医学

Background Individual monitoring of occupational external exposure is an essential part of the occupational health management of radiation workers, and is an important basis for the evaluation of individual absorbed dose and the diagnosis of occupational radiation diseases. Continuous participation of monitoring service providers in intercomparison is a fundamental quality assurance for routine monitoring, which can identify problems and improve them in time. Objective Taking the Laboratory of Radiation Protection in Shanghai Institute of Preventive Medicine as an example, to evaluate the performance of an individual occupational external dose monitoring system in the laboratory, identify influencing factors of the monitoring results, and provide a basis for improving the quality of daily monitoring by analyzing the process and results of a national intercomparison of individual dose monitoring. Methods According to the Testing criteria of personnel dosimetry performance for external exposure (GBZ 207-2016), and the relevant requirements of Class II (photon) inspection, a total of 20 groups of blind sample dosimeters were measured for four consecutive years from 2018 to 2021. The radiation energy source of each group was identified, and related personal dose equivalent Hp(10), the uncertainty of measurement results, and the deviation between the reported value and the reference value were calculated. The national intercomparison process and results of individual dose monitoring were also analyzed. Results The energy sources of the blind samples in the tested laboratory for four years were N100 or Cs-137. The reported dose values of the blind samples were 0.57-4.61 mSv, the combined uncertainties were 0.043-0.365 mSv, the expanded uncertainties (k=2) were 0.09-0.73 mSv, and the relative expanded uncertainties (k=2) were 13.8%-16.4%. The single-group performance ∣Pi∣ of 20 sets of blind samples in the four years was ≤0.10, the yearly comprehensive performance of 5 sets of blind samples was ≤0.10, and the yearly Q score of the test report was >15 points. The laboratory achieved excellent results in the national intercomparison of individual dose monitoring in four consecutive years, except the Q value not reaching full score. Conclusion The laboratory exhibits standardized data processing of individual dose monitoring, generates accurate and reliable results, and meets the requirements of relevant national standards; but it should continue to participate in the national intercomparison of individual dose monitoring, strengthen the angular response research of energy identified dosimeter, improve the monitoring ability of low-dose X-rays, analyze the key points of reducing the uncertainty of measurement results, and continuously improve the monitoring ability.

Factors affecting the disease uncertainty among caregivers of colorectal cancer patients undergoing chemotherapy / 预防医学

Objective@#To investigate the status and influencing factors of disease uncertainty among caregivers of colorectal cancer patients receiving chemotherapy, so as to provide insights into psychological interventions among caregivers. @*Methods@#Caregivers of colorectal cancer patients hospitalized in Hunan Cancer Hospital, the Third Xiangya Hospital and the Second Xiangya Hospital for chemotherapy from March 2020 to December 2021 were recruited. Caregivers' demographics, health status, medical and nursing support and social support, as well as patients' demographics, frequency of chemotherapy and disease stage were collected using questionnaire surveys. Caregivers' disease uncertainty was evaluated using Chinese version of the Uncertainty in Illness Scale for Family Members, and factors affecting caregivers' disease uncertainty were identified using a multivariable linear regression model.@*Results@#A total of 318 caregivers were enrolled, including 115 men (36.16%) and 203 women (63.84%), with a mean age of (45.89±6.57) years, and there were 186 caregivers as patients' spouses (58.49%). The mean score of disease uncertainty was (86.65±10.82) points, and the scores of the unpredictability dimension, uncertainty dimension, complexity, and lack of information dimension were (3.21±0.35), (2.98±0.48), (2.84±0.49) and (2.36±0.59) points, respectively. There were 285 participants with a high level of disease uncertainty (89.62%), and multivariable linear regression analysis identified social support (β′=-0.199), medical and nursing support (β′=-0.118), patient's age (β′=-0.155) and stage Ⅲ and Ⅳ of colorectal cancer (β′=0.151) as factors affecting caregiver's disease uncertainty.@*Conclusion@#Caregivers of colorectal cancer patients with chemotherapy have a high level of disease uncertainty, which is affected by social support, medical and nursing support, patient's age and duration of disease.

Results and analysis of intercomparison in the 2019—2021 national personal dose monitoring / 中国辐射卫生

@#<b>Objective</b> To analyze the process of intercomparison of national personal dose monitoring, evaluate the ability of personal dose monitoring, and ensure the accuracy and reliability of monitoring results in our laboratory. <b>Methods</b> In accordance with the intercomparison protocol for 2019—2021, an energy-discriminant thermoluminescence dosimeter was used for measurement at different doses. The uncertainty of measurement was evaluated and compared with the reference value. <b>Results</b> <i>H</i>_p(10) was measured for intercomparison in 2019—2021. In 2019, the single group performance difference was −0.02 to 0.02 and the comprehensive performance was 0.02. These values were 0.02-0.10 and 0.05 in 2020, and −0.02 to 0.02 and 0.01 in 2021. The intercomparison results were rated as excellent in the three consecutive years. <b>Conclusion</b> The personal dose monitoring system in our laboratory was in good condition, and the monitoring results were accurate and reliable. Improving the knowledge of personnel and cultivating a serious working attitude are important for intercomparison and personal dose monitoring.

The impact of chronic comorbidity in elderly people on relatives’ physical and mental health during the nursing home confinement:A multiple mediator analysis / 西安交通大学学报(医学版)

【Objective】 To explore the relationship between chronic comorbidity and the physical and mental health of relatives of elderly people during the nursing home confinement, and to analyze the mediating effects of perceived stress and intolerance of uncertainty in this context. 【Methods】 A total of 568 family members of elderly people in nine elderly institutions in Shaanxi Province were selected. The survey included the short version of the Perceived Stress Scale, Intolerance of Uncertainty Scale, and The World Health Organization-5 Well-being Index. The data were analyzed with Stata for correlation and mediation effects. 【Results】 ① The comorbidities of chronic diseases was positively correlated with the perceived stress (r=0.16, P<0.001) and intolerance of uncertainty (r=0.11, P=0.006) of the family members, but negatively correlated with the physical and mental health of the family members (r=-0.13, P=0.002). ② The mediating effect of perceived stress between chronic disease co-morbidity and physical and mental health of family members in older adults was -0.023, accounting for 18.8% of the total effect; the mediating effect of intolerance of uncertainty between chronic disease co-morbidity and physical and mental health of family members in older adults was -0.041, accounting for 33.5% of the total effect. 【Conclusion】 During closed management in a nursing facility, the physical and mental health of family members of older adults with chronic co-morbidities is poorer than that of family members of non-chronic co-morbidities. And it can lead to a decline in physical and mental health of family members through increased perceived stress and intolerance of uncertainty.

Determination uncertainty of aluminum residues in human albumin using top-down evaluation / 中国输血杂志

【Objective】 To evaluate the determination uncertainty of aluminum residues in human albumin by inductively coupled plasma mass spectrometry (ICP-MS). 【Methods】 The aluminum residues in human albumin was determined by ICP-MS, and the top-down method was applied to assess the reasons of uncertainty and calculate the uncertainty. 【Results】 The relative standard uncertainty of the aluminum content in human albumin at the three quality control levels was 0.54 ng/mL, 1.68 ng/mL and 4.54 ng/mL, respectively, which met the requirements of the guidelines for bioanalytical methods in the Chinese Pharmacopoeia(2020). 【Conclusion】 The top-down method is simple and quick to assess the uncertainty of aluminum residues in human albumin, and is suitable for the uncertainty assessment of analytical methods in biological laboratories.

Evaluation of uncertainty in determination of cetrimonium bromide residue in polysaccharide vaccines by ultra performance liquid chromatography-mass spectrometry / 中国生物制品学杂志

@#Objective To determine the cetrimonium bromide(CTAB)residue in polysaccharide vaccines using ultra performance liquid chromatography-mass spectrometry(UPLC/MS-MS),and analyze and evaluate the uncertainty of the determination results.Methods By establishing a mathematical model,the sources and values of uncertainty introduced in the measurement process were analyzed,the uncertainty components of each influencing factor were calculated,and the standard uncertainty and expanded uncertainty were synthesized to form an uncertainty report.Results At 95% confidence interval,the expanded uncertainty was 0. 002 8 mg/kg. The determination result of CTAB residue in polysaccharide vaccine was reported as(1. 000 6 ± 0. 002 8)mg/kg(k = 2,confidence interval p = 95%).Conclusion The main factors affecting the accuracy of determination results are the preparation of standard solution and the introduction of recovery rate,which should be focused on and controlled in the experiment process to make the detection results more reliable.