الملخص
El artículo informa acerca de la validación de un instrumento sobre la aplicación de los principios bioéticos de la corriente principialista en cada uno de los elementos de los protocolos de investigación clínica. Para ello, se realizó la valoración de un instrumento de 173 ítems por medio del método Delphi, con la colaboración de 12 expertos latinoamericanos en bioética de la investigación. El instrumento tuvo dos rondas de revisión. Al final solo se tuvieron 171 ítems, en el que se aplicaron los principios bioéticos en 208 ocasiones, de los cuales 87 (41,82%) pertenecían a Beneficencia, 63 (30,29%) a No Maleficencia, 36 (17,31%) a Justicia y 22 (10,58%) a Autonomía. En cuanto a la congruencia de los principios en general respecto de las variables de los elementos del protocolo de investigación clínica, se encontró en 189 (90,87% IC 95% 86.10 a 94.41) ocasiones, K=0.98 (0.01), p=<0.0001. Se concluye que ell instrumento validado nos brinda la opción de aplicar los principios bioéticos de la corriente principialista a cada uno de los elementos de los protocolos de investigación clínica.
The aim of this article is to report on the validation of an instrument on the application of principialist bioethical principles in each of the elements of clinical research protocols. To this end, a 173-item instrument was evaluated using the Delphi method, with the collaboration of 12 Latin American experts in research bioethics. The instrument underwent two rounds of revision. In the end there were only 171 items, in which the bioethical principles were applied 208 times, of which 87 (41.82%) belonged to Beneficence, 63 (30.29%) to Non-Maleficence, 36 (17.31%) to Justice and 22 (10.58%) to Autonomy. Regarding the congruence of the principles in general with respect to the variables of the elements of the clinical research protocol, it was found on 189 (90.87% CI 95% 86.10 to 94.41) occasions, K=0.98 (0.01), p=<0.0001. It is concluded that the validated instrument gives us the option of applying the bioethical principles of the principialist current to each of the elements of the clinical research protocols.
O objetivo deste artigo é informar acerca da validação de um instrumento sobre a aplicação dos princípios bioéticos da corrente principialista em cada um dos elementos dos protocolos de investigação clínica. Para isso, realizou-se a valoração de um instrumento de 173 itens por meio do método Delphi, com a colaboração de 12 especialistas latino-americanos em bioética da investigação. O instrumento teve duas rodadas de revisão. Ao final, analisou-se 171 itens, aos quais se aplicaram os princípios bioéticos em 208 ocasiões, dos quais 87 (41,82%) pertenciam a Beneficência, 63 (30,29%) a Não Maleficência, 36 (17,31%) a Justiça e 22 (10,58%) a Autonomia. Quanto à congruência dos princípios em geral, a respeito das variáveis dos elementos do protocolo de investigação clínica, encontrou-se em 189 (90,87% IC 95% 86.10 a 94.41) ocasiões, K=0.98 (0.01), p=<0.0001. Concluiu-se que o instrumento validado nos dá a opção de aplicar os princípios bioéticos da corrente principialista a cada um dos elementos dos protocolos de investigação clínica.
الملخص
En el cruce entre la revolución tecnológica y la educación en ciencias de la rehabilitación y del movimiento humano, la inteligencia artificial (IA) emerge como herramienta transformadora en los cursos de metodología de investigación. Este artículo destaca su potencial para optimizar la experiencia de aprendizaje y personalizar la instrucción, pero enfatiza la necesidad crucial de abordar desafíos éticos y pedagógicos. Propone orientaciones para equilibrar la innovación educativa y la responsabilidad académica, resaltando la importancia de la implementación consciente y planificada de la IA en los equipos de investigación en ciencias de la rehabilitación y del movimiento humano, garantizando así la integridad científica y ética en este campo en constante evolución.
In the intersection between technological advancements and education in rehabilitation science, artificial intelligence (AI) emerges as a transformative tool in research methodology. This article navigates the ethical and academic considerations tied to the incorporation of AI in rehabilitation and movement science courses. While acknowledging its potential to enhance learning experiences, it critically addresses the imperative to tackle ethical and pedagogical challenges. The paper offers guidance to strike a balance between educational innovation and academic responsibility. It emphasizes the need for a conscientious and planned implementation of AI, ensuring both scientific integrity and ethical adherence in this dynamically evolving field.
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Pancreatic cancer is a highly malignant digestive tract tumor with hidden symptoms,limited treatment options and rapid progression.With an increasing incidence rate year by year,pancreatic cancer has increasingly become a prominent issue endangering public health,causing a huge social burden.Although there was no significant improvement in survival rates for pancreatic cancer patients in the past two decades,recent progress in epidemiology,basic research and clinical research of pancreatic cancer has accelerated significantly compared to the past.Some findings have already enabled a small proportion of pancreatic cancer patients to achieve better survival.This article provided a review of the significant progress made in research,diagnosis and treatment of pancreatic cancer in 2023.
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Breast cancer is the most prevalent malignant tumor among women globally,posing a serious threat to women's health.With the establishment of staging and typing principles for breast cancer diagnosis and treatment,and the development and application of novel antitumor drugs,the survival and quality of life of breast cancer patients have been continuously improving.In China,the large base of breast cancer patients possesses unique incidence characteristics,necessitating ongoing exploration of more appropriate treatment strategies;the volume and level of clinical research are also continuously advancing.In 2023,significant clinical research results were reported for different subtypes of breast cancer.In surgical treatment,clinical trials on targeted axillary lymph node dissection and the establishment of a predictive model BRCA-CRisk for contralateral breast cancer risk provide more evidence for de-escalation in surgical treatment.In the area of human epidermal growth factor receptor 2(HER2)-positive breast cancer,pyrotinib has shown significant efficacy in advanced breast cancer treatment.In triple-negative breast cancer,precision subtype treatment and immunotherapy continue to improve patient survival.For hormone receptor-positive breast cancer,significant research results were obtained in exempting low-risk patients from chemotherapy and exploring alternative options after resistance to endocrine therapy.In the aspect of BRCA mutations,BGB-290-201 further confirmed the therapeutic efficacy and safety of poly(ADP-ribose)polymerase(PARP)inhibitors for the Chinese population.For advanced HER2-negative patients carrying germline BRCA(gBRCA)1/2 mutations,pamiparib will be an ideal treatment choice.This article reviews the important clinical research in the field of breast cancer in China in 2023,summarizes key results,and aims to provide reference ideas for future clinical research.
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The incidence of breast cancer is rising annually.Along with the broader implementation of tumor screening and increased health awareness,there has been a significant uptick in the diagnosis of early-stage breast cancer.Early-stage breast cancer is generalized to breast cancer without distant metastasis,which is compared to the concept of late-stage breast cancer.The aim of treatment for early-stage breast cancer is to achieve a cure.Treatment is guided by evidence-based medicine,following guidelines and consensus to administer personalized and precise therapies to patients.Clinical research,as the foundational evidence for these guidelines and consensus,brings more optimized treatment for breast cancer patients.According to the updates of domestic and international guidelines and consensus between 2022 and 2023,this review summarized and classified the important clinical studies that have changed the clinical practice for early-stage breast cancer.These studies were based on molecular sub-types and categorized into optimization of neoadjuvant and adjuvant treatment of early breast cancer,escalating and de-escalating of adjuvant treatment,and the optimization of local treatment.The studies related to the optimization of neoadjuvant and adjuvant treatment of human epidermal growth factor receptor 2(HER2)-positive breast cancer included the PHEDRA study which aimed at the application of pyrotinib,a small molecule tyrosine kinase inhibitor(TKI),to neoadjuvant treatment,the ExteNET study which investigated adjuvant treatment of neratinib,and FDChina study which confirmed the efficacy and safety of pertuzumab and trastuzumab fixed dose combination subcutaneous injection(PH FDC SC).The primary study addressing the optimization of neoadjuvant and adjuvant therapy in triple-negative breast cancer(TNBC)was the KEYNOTE-522 study.In terms of escalating in adjuvant therapy,the APHINITY study evaluated the efficacy of pertuzumab added to trastuzumab in high-risk HER2-positive breast cancer.MonarchE and NATALEE focused on the efficacy of abemaciclib and ribociclib in patients with hormone receptor-positive breast cancer.The SOFT TEXT study focused on ovarian function suppression(OFS)combining exemestane or tamoxifen in high-risk premenopausal breast cancer.Descending related studies in adjuvant therapy included the PLAN B study confirming 6 cycles of docetaxel in combination with cyclophosphamide in HER2 negative early intermediate to high-risk breast cancer.Among the studies related to the local treatment of breast cancer,the ACOSOG Z11102 study explored the feasibility of breast conservation in multicenter focal breast cancer.The SOUND study explored the exemption from axillary surgery in people with low-risk breast cancer.The PRIMEⅡ study explored the possibility of exemption from radiotherapy after breast conservation in elderly patients with low-risk breast cancer,and the IMPORT HIGH study compared different dose-escalated simultaneous integrated boost radiotherapy regimens after breast conservation surgery.The FAST-Forward study focused on hypofractionated breast radiotherapy.These studies provided robust evidence for the implementation of clinical practice and the formulation of diagnostic and treatment guidelines and consensus.In this review,we focused on the update of domestic and international breast cancer treatment guidelines,and the impact of these studies on the clinical practice for early-stage breast cancer.
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Tumor-associated macrophages(TAMs)are the predominant cell group in the tumor microenvironment(TME)and are the most important regulatory cells of immune system suppression and tumor cell proliferation in TIME.Src homology-2 domain-containing protein tyrosine phosphatase 2(SHP-2)is a non-receptor protein tyrosine phosphatase that plays an important role in the transmission of signals from the cell surface to the nucleus.SHP-2 is a key intracellular regulatory factor mediating cell proliferation and differentiation and is involved in a variety of growth factor and cytokine signaling pathways linking the cell surface to the nucleus.Recent studies have shown that SHP-2 is a key enzyme in determining the function of TAMs,but because of its variable function,it plays different or even opposite roles in different solid TMEs.This paper reviews the function of SHP-2 in TAMs and related solid tumors to provide a comprehensive reference for tumor immunity and targeted therapy research.
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Rubi fructus mainly contains contents of flavonoids,coumarins,phenolic acids,polysaccharides,alkaloids and trace elements.Meanwhile,it has activity effects of anti-tumor,anti-oxidation,anti-aging and anti-inflammation,and is widely used in medicine,food,health food and other fields.Research progress on chemical constituents,pharmacological action and clinical application of Rubi fructus were summarized in this paper,in order to provide the theoretical guidance for the rational use of Rubi fructus and the sustainable development of the resources.
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Informed consent is an important ethical symbol in clinical research,and researchers have the responsibility to fully inform participants of the research information before conducting clinical research.However,it is difficult to obtain complete informed consent form participants or their guardians within a narrow treatment time period in clinical research conducted in emergency situations.Currently,in addition to traditional general informed consent,there are also reality-accepted informed consent,including exemption of informed consent,broad informed consent,and deferred informed consent.By introducing the origin and development process of deferred informed consent in clinical research,this paper sorted out the current application status of deferred informed consent,proposed the prerequisites for applying deferred informed consent in emergency situations,and explored the issues that need to be noted during the application process of deferred informed consent.It is hoped to provide an ethical defense and ethical procedure for the application of deferred informed consent in clinical research in emergency situations.
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Therapeutic misconception refers to the misunderstanding of the essence,purpose,and potential benefits of clinical research among patients,who fail to recognize that participating in clinical research does not involve individualized treatment,but rather aims to obtain generalizable scientific knowledge.This paper explored the definition,causes,and impact of clinical research of"therapeutic misconception",and proposed strategies to address them.By gaining a deeper understanding of"therapeutic misconception",the quality of informed consent of research participants can be improved,their rights can be protected,and the quality of research can be enhanced.
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Objective:Currently,the medical Institutional Review Board(IRB)mainly rely on experience to analyse the risks and benefits of clinical research,lacking an assessment framework of risks and benefits.Methods:Using grounded theory,interviews were conducted on 29 ethical review workers in China.Through open coding,spindle coding,and selective coding,the framework of risks and benefits for clinical research in China was constructed.NVivo11 software was used for data storage,organization,encoding,and analysis.Results:A framework of risks and benefits for clinical research was proposed based on China's national conditions.Clinical research risks consisted of physiological risk,psychological risk,economic risk,and social risk.Research benefits consisted of subject benefits and society benefits.Conclusion:This paper systematically explained the connotation of the risks and benefits of clinical research,and constructed a framework of the risks and benefits of clinical research applicable to China.It has certain innovations in theoretical research,and also provides use for reference for researchers and ethics committees to evaluate risks and potential benefits in clinical research.
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Taking Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology as an example,it discusses the basic ideas and innovative practices of project organization from"passive order taking"to"active planning",platform construction from"free growth"to"directional cultivation",team construction from"wearing hats"to"focusing on actual combat",and achievement transformation from"resource guidance"to"comprehensive policy".It puts forward some suggestions that hospitals should play the leading role of"national team"in organizing scientific research and innovation practice,pay attention to the docking of national strategy,the linkage of university resources.
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The construction of clinical research management system in public hospitals is an important platform for China's clinical research workers to achieve new products conversion and application.At present,China have basically realized the informatization of clinical trial management process and scientific research project,improved the efficiency and quality of scientific research management,but there is still a large distance from the requirements of digital management platform.The core problem is that there is no unified standard for clinical data collection,disjointed management of the whole process,and backward communication and collaboration mode.The establishment of a standardized disease database has become an effective means to achieve standardized clinical data,and it is the basis for opening up the clogging point of the whole process management and realizing multi-department data sharing.
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Objective To analyze the registered clinical trials of headache treated by TCM;To discuss the current research status;To provide reference for the optimization of subsequent clinical trial research plans.Methods All clinical trials of headache treated by TCM were retrieved from the ChiCTR and the ClinicalTrials.The retrieval time was from the database establishment to May 22,2023.The general characteristics,study types,intervention measures and outcome indicators of the trials were analyzed respectively.Results A total of 104 registered studies were included,with the number of registered studies increasing since 2004 and reaching a peak in 2020,involving 25 provincial administrative regions or countries and 69 clinical trial institutions;the funding sources were mainly scientific research funds of universities,national finance and local finance.The research type was mainly intervention research;the designing scheme was mainly randomized parallel control study;the high frequency random method was simple random method;45 registered studies used blind methods.Exploratory studies/pre-trials were the most commonly used in the phases of clinical researches.Most of the registered studies were single-center clinical trials with a total sample size of 9 648 patients.The main interventions were acupuncture and oral Chinese medicines.The high frequency outcome indicators included life quality of score,headache attack frequency,headache attack days and headache severity,etc.There were some problems in outcome indicators,such as non-standard,lack of TCM characteristic advantages,and insufficient patient participation.Conclusion The number of registered studies of headache treated by TCM has increased by year,but there are some problems in design elements,such as random method,blind method,number of research centers,sample size and the setting of outcome indicator.
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Objective:To analyze the willingness of clinicians to carry out clinical research and its influencing factors, and to provide a reference basis for scientifically and effectively promoting clinical research and improving the enthusiasm of clinicians.Methods:A grade A tertiary hospital in Tianjin was selected as a questionnaire unit, and clinicians were selected by simple random sampling. SPSS26.0 was utilized for the Wilcoxon rank sum test, Kruskal-Wallis H test, and generalized linear model analysis.Results:The score of willingness to carry out clinical research among 273 clinicians was 5.00. The results of multivariate analysis showed that, in terms of working time, compare with ″≥31years″, ″≤10years″, ″11~20years″, and ″21~30years″ had statistical significance in association with the scores of willingness to carry out clinical researchs, all of which were positively correlated; compared with the ″clear″ awareness of hospital medical ethics review process, ″knowing some″ had a statistical significance in association with the willingness scores with a negative correlation; compared with ″having free time″, the association between ″busy clinical work and no time″ and the willingness scores was statistically significant, and showed a negative correlation; compared with ″time devoting can get results″, the association between ″a lot of time and efforts can not achieve results in a short time″ and the score of willingness was statistically significant, and was negatively correlated; compared with ″willing″ to participate in scientific research and training, ″it does not matter″ and ″unwilling″ showed statistical significance in association with the willingness scores, and negatively correlated.Conclusions:The willingness of clinicians to conduct clinical research was affected by multiple factors. Hospitals should emphasize the cultivation of young talents, carry out research training, and build research support teams to improve the enthusiasm for research.
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[Objective]To explore the clinical efficacy of Qingre Jiedu Decoction in the treatment of acute mastitis during lactation.[Methods]The clinical data of lactating mastitis patients who presented to the Galactophore Department of Beijing Hospital of Traditional Chinese Medicine,Capital Medical University from January 2019 to December 2020 were retrospectively analyzed.In the treatment group,80 patients received internal decoction;in control group,no decoction was taken.The severity index of mastitis,disease improvement rate,breast pain score,milk patency,nipple cracking condition and traditional Chinese medicine(TCM)systemic symptom score were observed.[Results]There were significant statistic differences in the severity index of mastitis,disease improvement rate,breast pain score,milk patency and TCM systemic symptoms scores(P＜0.05).The therapeutic effect of the treatment group was better than that of the control group.[Conclusion]Qingre Jiedu Decoction can effectively release pain,reduce the size of lumps,release swelling and milk stasis of lactation acute mastitis,and the curative effect is good.
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Empowered by the rapid development of artificial intelligence technology and information security technology, basic medicine, translational medicine, and clinical medicine have entered a new era. In this process, the relevant data such as text, genetics, images, and videos have increased at an astonishing rate. Traditional specialized disease databases cannot adapt to the multimodality of data and the multicentralization of data sources in the present/future. Therefore, establishing a next-generation multimodal and multicenter collaborative specialized disease database that is suitable for secure data sharing and ethical in clinical research is essential. This paper expounds the concept and basic framework of developing a next-generation clinical research disease database with universal use, emphasizing the establishment of a multimodal data integration mechanism, a multicenter collaborative system supported by privacy-preserving computing, highly intelligent software and hardware entities, and an integrated operational management mode. It also introduces the application of this concept in the construction of a breast cancer three-dimensional life database, a project of China Breast Cancer Innovation Alliance.
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Viral hepatitis is an important cause of liver cirrhosis and liver cancer， which has become a major public health problem in the world. Traditional Chinese medicine has unique advantages in treating viral hepatitis， which can inhibit virus replication and enhance immunity. It can effectively prevent liver fibrosis and canceration， improving liver function and symptoms significantly with definite clinical curative effects， a high level of safety， and seldom drug resistance. In addition， it reduces the side effects of western medicine， achieving the effect of synergy and attenuation while reducing the recurrence rate of patients after drug withdrawal. Attention has been paid to the research on the treatment of viral hepatitis with traditional Chinese medicine， and great progress has been made in experimental research and clinical practice. In this paper， the research progress of traditional Chinese medicine in the treatment of viral hepatitis at home and abroad in recent five years was systematically reviewed. Modern research has confirmed that traditional Chinese medicine can play a role in the treatment of viral hepatitis by directly or indirectly inhibiting the virus， anti-inflammatory， anti-fibrosis， anti-oxidation， regulating immunity， regulating autophagy， and other signal pathways. In clinics， traditional Chinese medicine compound or combined with western medicine is often adopted to ameliorate the clinical symptoms of patients such as fatigue and loss of appetite， improve the immune mechanism of the body， enhance the antiviral ability， shorten the treatment course of patients and improve their quality of life. The research provides a reference for pharmacological research， clinical research， and new drug development for viral hepatitis.
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ObjectiveThe aim is to construct an evaluation framework for clinical research benefits， and provide a reference for the formulate of evaluation standards for clinical research benefits. MethodsThe Delphi method was used to carry out expert consultation， and the mean， score of importance， coefficient of variation and coordination， etc. of evaluation indicators were summarized and calculated， to screen evaluation indicators for clinical research benefits. ResultsTwenty-three experts in this field were selected for correspondence， and their enthusiasm was 100% in both rounds， the authority coefficients were≥0.90， and Kendall’s coefficients of concordance were<0.25 （P<0.001）. By referring to the mean and coefficient of variation of the indicators， as well as combining them with expert suggestions， an evaluation framework for clinical research benefits was ultimately formed with 2 primary indicators， 5 secondary indicators， and 8 tertiary indicators. ConclusionThe evaluation framework for clinical research benefits constructed in this paper can comprehensively evaluate the research benefits， as well as provide a basis for reasonably determining the research risk-benefit ratio and developing quantitative evaluation tools for clinical research benefits.
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From the perspective of human development history， epidemic diseases have been accompanied by human life and reproduction， causing serious threats to human health and life safety. Epidemic diseases have a rapid onset and are highly infectious， once they occur， can quickly spread to the people around them， causing many people to be infected in a short time. Pulmonary system epidemic disease is the kind of disease with the highest incidence， prevalence， and infectivity among epidemic diseases， which will also have an impact on the economic and social development and even the historical process. Overview of ancient Chinese literature， the wisdom of ancient doctors has certain reference value for possible related work today or in the future. Starting from sorting out the classical theories recorded in the ancient books of traditional Chinese medicine， this paper dug deeply into them and re⁃understood them， with a view to providing a reference for clinical diagnosis and treatment， and public health services.
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Therapeutic misconception refers to the misunderstanding of the essence， purpose， and potential benefits of clinical research among patients， who fail to recognize that participating in clinical research does not involve individualized treatment， but rather aims to obtain generalizable scientific knowledge. This paper explored the definition， causes， and impact of clinical research of “therapeutic misconception”， and proposed strategies to address them. By gaining a deeper understanding of “therapeutic misconception”， the quality of informed consent of research participants can be improved， their rights can be protected， and the quality of research can be enhanced.