Significancia clínica y significancia estadística. ¿Qué es más significativo? / Clinical significance and statistical significance. What is more significant?

Una de las dificultades más comunes que enfrentan los lectores de artículos del área de la biomedicina y epidemiología es la interpretación del término "significativo". El término "estadísticamente significativo" a menudo se malinterpreta como un resultado "clínicamente significativo". La confusión surge del hecho de que muchas personas equiparan "significativo" con su significado literal de "importante", sin embargo, la significación estadística cuantifica la probabilidad de que los resultados de un estudio se deban al azar, mientras que la significancia clínica refleja la importancia práctica o relevancia en el contexto de la atención médica o práctica clínica. Este artículo aborda la diferencia entre la significación estadística y la relevancia o importancia clínica en la interpretación de los resultados de una investigación biomédica.

One of the most common difficulties faced by readers of articles in the area of biomedicine and epidemiology is the interpretation of the term "significant". The term "statistically significant" is often misinterpreted as a "clinically significant" result. Confusion arises from the fact that many people equate "significant" with its literal meaning of "important," however, statistical significance quantifies the probability that the results of a study are due to chance, while clinical significance reflects the practical importance or relevance in the context of health care or clinical practice. This article addresses the difference between statistical significance and clinical relevance or importance in the interpretation of biomedical research results.

Aspectos de la vida y obra del Dr. Bernardo Alberto Houssay / Aspects of the life and work of Dr. Bernardo Alberto Houssay

Con motivo del Día Mundial de la Ciencia y la Tecnología, se realizó en la Casa Museo Bernardo Houssay un conversatorio en el que expertos biógrafos resaltaron algunos aspectos de la trayectoria profesional del Premio Nobel de Medicina de 1947, destacando su actividad como investigador en fisiología y sus cualidades humanas. Estos importantes estudiosos del tema compartieron sus conocimientos en un selecto auditorio. (AU)

On the occasion of World Science and Technology Day, a discussion was held at the Bernardo Houssay House Museum in which expert biographers highlighted some aspects of the professional career of the 1947 Nobel Prize in Medicine, highlighting his activity as a researcher in physiology and his human qualities. These important scholars of the subject shared their knowledge in a select audience. (AU)

Investigación relacionada con salud humana e inteligencia artificial: Un desafío para la revisión ética por parte de los Comités de Ética de la Investigación / Research related to human health and artificial intelligence: A challenge for ethical review by Research Ethics Committees

La inteligencia artificial (IA) tiene numerosas aplicaciones en diferentes campos, entre ellos la salud humana. Se pueden incluir entre ellas el diagnóstico médico, diagnóstico por imágenes, la medicina personalizada, el monitoreo y predicción de enfermedades, la asistencia en cirugía y la investigación médica para analizar grandes conjuntos de datos y acelerar el descubrimiento de nuevos medicamentos, identificar patrones y tendencias en la salud poblacional, y ayudar en la identificación de biomarcadores para enfermedades. En este trabajo se analizan las consideraciones éticas y metodológicas que plantea la evaluación ética de los protocolos de IA en salud por parte de los comités de ética de investigación (CEI). Sumado a las particularidades referidas a privacidad y confidencialidad, consentimiento informado, sesgo y equidad, interpretabilidad y transparencia, responsabilidad y rendición de cuentas e impacto social, se analizarán especialmente los desafíos para la conformación y funcionamiento de los CEI destinados a evaluar este tipo de investigaciones. (AU)

Percepciones sobre la importancia de las ciencias básicas en estudiantes de odontología y medicina / Perceptions of the importance of basic sciences in odontology and medical students

Introducción: El aprovechamiento de los cursos de ciencias básicas puede depender de las percepciones estudiantiles sobre la importancia de estos en su vida profesional, por lo que se hace necesario determinar el grado de importancia que los estudiantes le confieren a este tipo de cursos. Materiales y métodos: Se presentó un cuestionario con 9 declaraciones a 54 estudiantes de odontología y medicina. Las respuestas se pasaron a una escala numérica para su análisis. Se usó una prueba de U de Mann-Whitney con el fin de evaluar diferencias entre estudiantes de ambas facultades. Resultados: Los estudiantes en conjunto mostraron tener una buena opinión de la importancia de las ciencias básicas en la práctica clínica. Se observó también que es mayor la proporción de estudiantes de odontología que consideran que la investigación básica no es útil para su práctica clínica. Conclusión: Los estudiantes consideran las ciencias básicas necesarias para un buen desempeño profesional.

Introduction: The benefit of basic science courses may depend on students' perceptions of the importance of these courses in their professional life, therefore, it's necessary to determine the degree of importance that students give to this type of courses. Materials and methods: A questionnaire with 9 statements was presented to 54 dental and medical students. The responses were converted to a numerical scale for analysis. Using a Mann-Whitney U test, differences between students from both faculties were evaluated. Results: The students showed a good opinion of the importance of basic sciences in clinical practice. It was also observed that the proportion of dental students who consider that basic research is not useful for their clinical practice is higher. Conclusion: Students consider the basic sciences necessary for good professional performance.

Christofredo Jakob, los cimientos de la neurociencia argentina / Christofredo Jakob, the foundations of argentine neuroscience

El presente artículo es una reseña biográfica de la vida del Dr. Christofredo Jakob, desde su formación en Alemania, las personalidades que acompañaron su desarrollo y las publicaciones científicas en suelo germano. Luego llegarían los inicios de su trabajo en la Argentina y los principales alcances de sus investigaciones. A través de esta reseña recorremos los comienzos del estudio sistemático del sistema nervioso en el país y recordamos el Día del Neurocientífico argentino. (AU)

This article is a biographical review of the life of Dr. Christofredo Jakob, from his training in Germany, the personalities who accompanied his development and the scientific publications on German soil. Then came the beginnings of his work in Argentina and the main achievements of his research. Through this review, we retrace the beginnings of the systematic study of the nervous system in the country and we remember the Day of the Argentine Neuroscientist. (AU)

Desafíos a la ética en la investigación frente al envejecimiento poblacional / Ethical challenges in research regarding aging population

El mundo está experimentando un acelerado proceso de envejecimiento poblacional. Este cambio epidemiológico se asocia a la necesidad de incrementar la investigación orientada a mejorar la calidad de vida en las edades avanzadas. Esta investigación requiere de la participación de personas mayores, tanto en áreas del ámbito científico-tecnológico como en el sociocultural. Esta realidad lleva a plantear una serie de interrogantes relacionadas con la forma como se desarrolla esta actividad con las personas mayores, relacionadas con las brechas, desigualdades e inequidades, su vulnerabilidad, su acceso a los productos generados, su capacidad para consentir, entre otros. El objetivo del ensayo es reflexionar acerca de algunas de estas interrogantes, revisando algunos de los preceptos básicos de la ética de la investigación en seres humanos, y plantear algunas necesidades y desafíos para la actualización en las pautas y guías que la orientan. Se espera que las personas mayores que participan en investigación biomédica sean respetadas, se les asegure un adecuado balance riesgo/beneficio y se seleccionen en forma equitativa. Estos principios básicos, aunque reconocidos en términos generales por las guías y regulaciones éticas disponibles, no están completamente garantizados, como evidenció la pandemia de COVID-19. El tema plantea diversos desafíos y amerita su consideración en las pautas y guías éticas para la investigación biomédica con participación de personas mayores.

Aging population is a global reality that forces public policies based on transdisciplinary research focused on older adults. This raises a series of issues, such as feasability, inequalities, inequities, vulnerability, access to the products generated, and ability to consent, among others. This essay's objective is to reflect on some of the questions that arise from this reality, review basic precepts of research ethics in human beings, and expose the challenges for updating the current guidelines for ethical biomedical research. Aged adults participating in clinical research should be respected, assured of an adequate risk/benefit balance, and selected fairly. The available guidelines generally recognize these basic principles, but they are not entirely guaranteed, as evidenced during the COVID-19 pandemic. This issue poses various ethical challenges and deserves to be considered in the guidelines and regulations for biomedical research with the participation of older adults.

Una Revisión de los tipos de Fraude Científico más Frecuentes / A Review of the most frequent types of Scientific Fraud

La presión que existe hoy por publicar ha llevado a que muchos investigadores cometan malas conductas científicas, siendo el fraude la más grave de todas. Este ocurre en forma de fabricación, falsificación, plagio, problemas de autoría, manipulación de imágenes y publicaciones redundantes. El fraude científico se define como una tergiversación deliberada por parte de alguien que conoce la verdad. En la historia de la humanidad se han conocido importantes casos de fraude científico, dentro de ellos se pueden destacar: el hombre de Piltdown, caso Shinichi Fujimura, el escándalo de las vacunas, caso Pearce, el caso Yoshitaka Fujii, entre otros. Con el objetivo de neutralizar el fraude, se han desarrollado diferentes estrategias dirigidas a detectarlo, dentro de ellas encontramos: evaluación mediante pares evaluadores, programas de Conducta de Investigación Responsable (RCR), regulaciones que la misma comunidad científica realiza, donde encontramos la fundación PubPeer y el blog For Better Science. Del mismo modo, se han impuesto diferentes medidas para contrarrestar el fraude, tales como: transparencia de las presiones y oportunidades, disponibilidad pública de los datos que sustentan la hipótesis y denuncia pública de los fraudes científicos. El impacto de un fraude trae consecuencias importantes para la ciencia, estudiar a partir de información falsa o errónea conlleva a un gran retroceso en los avances científicos del mundo actual. Es responsabilidad de cada uno ser consciente de lo que se escribe y lo que se lee, ya que como se sabe, esa es la única manera de combatirlo. Como investigadores somos responsables de actuar éticamente en nuestras investigaciones y tener conocimiento de las medidas que existen hoy para detectar y combatir el fraude científico.

The pressure to publish today has led many researchers to commit scientific misconduct, fraud being the most serious of all. This occurs in the form of fabrication, falsification, plagiarism, authorship problems, image manipulation, and redundant posting. Scientific fraud is defined as deliberate misrepresentation by someone who knows the truth. In the history of humanity, important cases of scientific fraud have been known, among them the following can be highlighted: the Piltdown man, the Shinichi Fujimura case, the vaccine scandal, the Pearce case, the Yoshitaka Fujii case, among others. In order to neutralize fraud, different strategies have been developed to detect it, among them we find: evaluation by peer reviewers, Responsible Research Conduct (RCR) programs, regulations that the scientific community itself carries out, where we find the PubPeer Foundation and the For Better Science blog. Similarly, different measures have been imposed to counteract fraud, such as: transparency of pressures and opportunities, public availability of the data that support the hypothesis, and public denunciation of scientific fraud. The impact of a fraud has important consequences for science, studying from false or wrong information leads to a great setback in scientific advances in the world today. It is the responsibility of each one to be aware of what is written and what is read, since as is known, that is the only way to combat it. As researchers we are responsible for acting ethically in our research and being aware of the measures that exist today to detect and combat scientific fraud.

Experiencia en la introducción de resultados científicos desde la formación doctoral / Experience in the introduction of scientific results from the doctoral training i: en

Durante estos años, condicionados por los efectos de una pandemia y la situación económica global, la incorporación oportuna de los resultados científico-técnicos es necesidad y responsabilidad de la comunidad científica. En este trabajo se expone una experiencia en la introducción de resultados científicos desde la formación doctoral, dirigida al área de la atención inicial al paciente con traumatismo maxilofacial. La importancia de esta práctica radica en los aportes social, científico y profesional y en la formación de recursos humanos para lograr la transformación y el mejoramiento de la realidad.

During these years, conditioned by the effects of a pandemic and the global economic situation, the opportune incorporation of the scientific technical results is necessity and responsibility of scientific community. An experience in the introduction of scientific results from the doctoral training, directed to the area of initial care to the patient with maxillofacial traumatism, is presented in this work. The importance of this practice resides in the social, scientific, professional contributions and in the formation of human resources to achieve the transformation and improvement of reality.

Fundamentos metodológicos para investigación clínica en estomatología / Methodological basis for clinical research in stomatology

La investigación científica en Odontología es la herramienta clave para generar conocimiento y resolver problemas que conduzcan al desarrollo exponencial y progreso tecnológico de la profesión. A su vez, e indispensable el estudio epidemiológico y etiopatogénico de las enfermedades estomatológicas, factores de riesgo y manifestaciones orales relacionadas a la salud sistémica, para implementar estrategias sanitarias y establecer un adecuado manejo multidisciplinario. La odontología basada en evidencia (OBE) exige al profesional realizar una práctica informada, responsable, actualizada y soportada en una sólida base científica para la toma de decisiones y garantizar resultados altamente predecibles. La mayoría de los estudios clínicos en Odontología se realizan bajo el enfoque cuantitativo utilizando los diseños epidemiológicos; por lo que es necesario identificar la ruta ideal para resolver cada problema científico, la presente revisión comprende las bases metodológicas de investigación en Odontología, la clasificación de tipos de estudio y una perspectiva futura de investigación.

Scientific research in Dentistry is the key tool to generate knowledge and solve problems that lead to the exponential development and technological progress of the profession. At the same time, the epidemiological and etiopathogenic study of stomatological diseases, risk factors and oral manifestations related to systemic health is essential to implement health strategies and establish adequate multidisciplinary management. Evidence-based dentistry (OBE) requires the professional to carry out an informed, responsible, up-to-date practice supported by a solid scientific basis for decision-making and to guarantee highly predictable results. Most of the clinical studies in Dentistry are carried out under a quantitative approach using epidemiological designs; Therefore, it is necessary to identify the ideal route to solve each scientific problem. This review includes the methodological bases of research in Dentistry, the classification of study types and a future research perspective.

Researchers' Knowledge About the Ethical Norms of National Natural Science Foundation of China Funded Medical Research:Current Status and Suggestions / 中国医学科学院学报

Objective To understand the current status of Chinese medical researchers' knowledge regarding the ethical norms of the research involving humans or laboratory animals,and provide reference for further improving the ethics review norms. Methods The questionnaire method was employed to survey the applicants for the 2019 projects supported by the Department of Medical Sciences,National Natural Science Foundation of China (NSFC) about their knowledge of ethical requirements.Furthermore,the ethical supervision of the NSFC and affiliations at the project application and implementation stages was analyzed. Results The survey showed that 29.9% medical researchers were familiar with NSFC's ethical requirements for research involving human or laboratory animals.During the project application stage,59.0% affiliations adopted the simplified review method.Regarding the ethical supervison,95.5% medical researchers believed that the affiliations should fulfill the ethical supervision obligations and take relevant measures during the project implementation period.In addition,55.0% medical researchers fully agreed to discuss with the review experts about the ethical issues involved in the project. Conclusions The NSFC should establish rules and regulations to improve institutional management responsibilities and institutionalize the training about research ethics to comprehensively strengthening the training.Taking the management of research project ethics as a starting point,the NSFC should form a multi-party linkage between project funding and management and establish an accountability mechanism for ethics management.Furthermore,the NSFC should double the endeavors at the review of ethical issues during expert review and process management and attach importance to the research,judgment,and prevention of ethical risks.

Analysis of the characteristics of retracted scientific papers in the field of global liver diseases published by Chinese scholars / 中华肝脏病杂志

Objective: To analyze the characteristics of scientific papers in the field of global liver diseases published by Chinese scholars that were retracted for diverse reasons from the Retraction Watch database, so as to provide a reference to publishing-related papers. Methods: The Retraction Watch database was retrieved for retracted papers in the field of global liver disease published by Chinese scholars from March 1, 2008 to January 28, 2021. The regional distribution, source journals, reasons for retraction, publication and retraction times, and others were analyzed. Results: A total of 101 retracted papers that were distributed across 21 provinces/cities were retrieved. Zhejiang area (n = 17) had the most retracted papers, followed by Shanghai (n = 14), and Beijing (n = 11). The vast majority were research papers (n = 95). The journal PLoS One had the highest number of retracted papers. In terms of time distribution, 2019 (n = 36) had the most retracted papers. 23 papers, accounting for 8.3% of all retractions, were retracted owing to journal or publisher concerns. Liver cancer (34%), liver transplantation (16%), hepatitis (14%), and others were the main areas of retracted papers. Conclusion: Chinese scholars have a large number of retracted articles in the field of global liver diseases. A journal or publisher chooses to retract a manuscript after investigating and discovering more flawed problems, which, however, require further support, revision, and supervision from the editorial and academic circles.

Investigation and analysis of Chinese public 's cognition for clinical research / 中南大学学报(医学版)

OBJECTIVES@#Clinical research plays a vital role in disease research and population health. The public is the main source of clinical research volunteers. Understanding the public's cognition of clinical research plays a decisive role in the development of clinical research. This study aims to understand the Chinese public's cognition for clinical research and the influencing factors.@*METHODS@#The questionnaire based on Chinese-translated Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment (PARTAKE) was used to investigate the public's cognition for clinical research.@*RESULTS@#Of the 2 513 valid respondents, 91.84% had heard of "clinical research", 91.76% of the respondents believed that clinical research was beneficial to society, 65.90% were willing to participate in clinical research, 87.50% believed that confidentiality was a very important thing, 73.70% believed that their personal information had been protected when participating in clinical research, and, 46.40% did not know whether volunteers participating in clinical research could receive adequate compensation. Educational levels, employment status, and annual income impacted in public perceptions of willingness to participate in clinical research, especially in privacy protection, informed consent, whether clinical research is intended for society, compensation for clinical research, and safety of clinical research (all P<0.01).@*CONCLUSIONS@#The Chinese public's cognition level for clinical research is acceptable, but there is still a lot of room for improvement in privacy protection, informed consent, and compensation. By designing a reasonable knowledge training program for clinical research and using the multimedia, improving access to the relevant knowledge, more public will know about clinical research recruitment information, which is of great significance for the development of clinical research in China.

Application of bridging study design in preventive vaccine clinical trials / 中华预防医学杂志

Bridging study in vaccine clinical trials means a series of small-scale additional tests on the basis that the original safety and effectiveness of a vaccine have been confirmed in clinical trials, to prove that the characteristics of safety, immunogenicity and effectiveness of a vaccine are similar or consistent after component, population and immunization procedure change to other types which can extrapolate data from existing clinical trials. Compared with traditional vaccine clinical trials, bridging trials can promote the approval of vaccines to the market, accelerate the expansion of vaccine application, and promote the use of vaccines across regions and populations. In recent years, the application of bridge study design in vaccine clinical research has become more and more common. In order to better guide and promote the application of bridging trial design in the field of vaccine clinical research, we reviewed the design characteristics and application examples of bridging study design in vaccine clinical trials, and systematically elaborated the design ideas, key points and statistical evaluation methods of bridging study.

Application of bridging study design in preventive vaccine clinical trials / 中华预防医学杂志

Bridging study in vaccine clinical trials means a series of small-scale additional tests on the basis that the original safety and effectiveness of a vaccine have been confirmed in clinical trials, to prove that the characteristics of safety, immunogenicity and effectiveness of a vaccine are similar or consistent after component, population and immunization procedure change to other types which can extrapolate data from existing clinical trials. Compared with traditional vaccine clinical trials, bridging trials can promote the approval of vaccines to the market, accelerate the expansion of vaccine application, and promote the use of vaccines across regions and populations. In recent years, the application of bridge study design in vaccine clinical research has become more and more common. In order to better guide and promote the application of bridging trial design in the field of vaccine clinical research, we reviewed the design characteristics and application examples of bridging study design in vaccine clinical trials, and systematically elaborated the design ideas, key points and statistical evaluation methods of bridging study.

Visualization analysis of research hotspots in pathogenesis of diabetic nephropathy in China / 中华预防医学杂志

The aim of this study is to analyze the research hotspots and development trends in the field of pathogenesis of diabetic nephropathy in China from 2013 to 2022. Based on China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, China Science and Technology Journal Database, China Biology Medicine disc, Web of Science core collection and PubMed database, the related literatures in the field of pathogenesis of diabetic nephropathy in China from 2013 to 2022, were retrieved to establish the database, and the VOSviewer software was used for bibliometric analysis. A total of 1 664 Chinese and 2 149 English literatures are included in this study. The scientific research results from 2013 to 2022 have shown an overall increasing trend. The research hotspots in the field of pathogenesis of diabetic nephropathy in China are mainly concentrated in Podocytes, Oxidative stress, Inflammation, Renal fibrosis, Urine protein, etc. The frontier hotspots in this field include Biomarkers, Nrf2, Gut microbiota, NLRP3 inflammasome, Apoptosis, MicroRNA, etc. Through visual analysis, the research hotspots and frontier trends of the pathogenesis of diabetic nephropathy in China can be visually presented, and then provide new ideas and directions for the further in-depth research on the pathogenesis of diabetic nephropathy.

Progress in research of long-term protective efficacy of human papillomavirus vaccine / 中华流行病学杂志

The efficacy of HPV vaccine in preventing cervical cancer has been demonstrated in numerous clinical trials and clinical uses. The follow-up after clinical trials usually last for 5-6 years to evaluate the long-term efficacy, and a series of long-term follow-up studies have been conducted in some regions. The literature retrieval of HPV vaccine long term efficiency research both at home and abroad indicated that the protective efficacy of the vaccine against vaccine-type-related cervical intraepithelial neoplasia grade 2 and above is higher than 90%.

Circadian rhythm and health: dialogue between traditional Chinese medicine and modern medicine / 中国中药杂志

Circadian rhythm refers to the daily rhythmic variations in an organism. The irregular lifestyles of modern humans have led to a high incidence of chronic diseases, highlighting an inseparable relationship between disrupted circadian rhythm and disease development. TCM has long discussed rhythmic variations, with records dating back to the Yellow Emperor's Inner Canon(Huang Di Nei Jing), which laid a rich theoretical foundation for the research on circadian rhythm. Modern medical research has provided a more comprehensive explanation of its molecular mechanisms. This article integrated the current understanding of circadian rhythm in both Chinese and western medicine, emphasizing the crucial relationship between rhythm regulation and disease treatment. By highlighting the interdisciplinary nature of the two fields, it offers new directions for exploring the field of chronomedicine.