Enlightenment of Prevention Experience of Scientific Misconduct in Extraterritorial Medical Field to China / 中国医学伦理学

Scientific misconduct of researchers causes great waste of academic resources and academic life, which is not only related to the vigorous development of a country’s scientific undertaking, but also directly affects the reputation of the country in the field of scientific research. Based on the analysis of the causes of scientific misconduct of medical researchers in China, this paper comprehensively summarized a series of mature experiences of extraterritorial medical field in preventing scientific misconduct, and put forward corresponding and reasonable countermeasures and suggestions for China’s scientific research governance from three aspects: establishing an effective governance structure based on the normative framework, clarifying the definition standards of scientific research dishonesty in laws and regulations, and formulating good prevention procedures in a healthy academic environment, in order to promote the healthy development of scientific research in China’s medical field and further promote the innovation and progress of medical science and technology.

Case Study on Deductive Teaching of "Doctor-patient Communication" / 中国医学伦理学

By introducing the connotation of deductive teaching and analyzing the significance of early contact clinical course of "doctor-patient communication", the author reinterpreted the educational concept of deductive teaching combined with the characteristics of medical humanities, and reformed the early contact clinical course of "doctor-patient communication" by introducing deductive teaching method. Taking the early contact clinical course of "doctor-patient communication" of a medical university as an example, the teaching framework was designed to share experience from three aspects: teaching content, teaching process and teaching effect evaluation. At the same time, combined with the characteristics of the course and the needs of students, found out the problems encountered in the teaching process, and put forward constructive opinions and strategies, in order to provide theoretical and practical reference for the teaching of medical humanities course.

Study on the Protection of the Rights and Interests of Tumor Subjects in Clinical Trials in the Prevention and Control of the COVID -19 / 中国医学伦理学

The outbreak of the COVID -19 has had a big impact on the implementation of clinical trials of tumor drugs and the prevention and control measures such as traffic control and home isolation has caused clinical trials couldn’t proceed normally, so the protection of tumor subjects in clinical trials faces many new challenges. Based on Western and Chinese policies and guidelines on the management of clinical trials during the COVID -19, this paper expounded the impacts of the COVID -19 on tumor patients and tumor clinical trials, analyzed the challenges faced by the protection of tumor subjects in the prevention and control of the COVID -19, and then protected tumor subjects from aspects of optimizing the allocation of health resources, improving non-face-to-face informed consent procedures, strengthening subject visit management, and enhancing clinical trial safety evaluation. It is hoped that these optimization measures can face the future and continue to protect subjects after the end of the epidemic or in new public health emergencies.

Research on Satisfaction Degree of Doctor-patient Communication Quality based on Patient Perception / 中国医学伦理学

Objective sampling method was used to conduct a questionnaire survey on outpatients in two hospitals in Guangdong province in order to evaluate patients’ satisfaction with the quality of medical service. This paper explored the factors that affect patients’ evaluation of medical service quality, and found that patients’ age was negatively correlated with the evaluation of medical service quality. It is suggested that the establishment of friendly medical institutions should be carried out according to the national policy. At the same time, the management mechanism of hospital should be improved, the number of medical service centers for "efficient" should be increased, and the medical service personnel should be regularly trained; carry out medical knowledge education in community, improve the popularization of personal medical knowledge and close the cognitive gap between doctors and patients.

The Experience of Strengthening the Professional Motivation of Pediatricians Abroad and Its Enlightenment to China / 中国医学伦理学

At present, the contradiction between the lack of pediatricians and the increasing demand for pediatric medical services has become more and more prominent. Taking pediatricians as the research object, this paper explored the needs and motivation of professional development of pediatricians in China by referring to a series of excellent foreign research results, so as to improve the professional development of pediatricians, reconstruct the ecology of pediatricians and patients, then improve medical experience, and alleviate the "shortage of pediatricians" and "difficulty in seeing a doctor" in pediatrics. Enhancing the work enthusiasm and professional motivation of pediatricians can not only improve the satisfaction of patients, but also enhance the quality of medical services, so as to promote the growth of the hospital’s own economic and social benefits.

The Relevant Regulations of Vulnerability in Foreign Biomedical Research Ethics and Its Enlightenment to China / 中国医学伦理学

The advancement of medicine and biotechnology is based on biomedical research. The rights and safety protection of subjects in biomedical research is one of the core issues of research ethics,and the protection of vulnerable subjects should be the top priority importantly,research ethics should provide special protection for vulnerable subjects. Chinese laws and regulations have not yet given a clear definition of the concept of vulnerability,and the content and regulations related to vulnerability are relatively rough and not perfect. By drawing on the main international and foreign research ethics policies and guidelines,introducing the definition of vulnerability,clarifying the source of vulnerability,and applying vulnerability to the process of biomedical research in China. When applying vulnerabilities,one should avoid using the label approach to include people with common characteristics into vulnerable groups,but mainly analyze the types and sources of vulnerability,and includes as many vulnerable subjects of different types as possible to provide them with more comprehensive and adequate protection in biomedical research.

On the Time Value of Yu Weihan’s Spiritual Strength / 中国医学伦理学

Yu Weihan, academician of the Chinese Academy of Engineering, devoted his whole life to the prevention and control of endemic diseases and basically eradicated the epidemic of Keshan disease. Academician Yu Weihan’s struggle experience has left us with valuable spiritual wealth. His spiritual strength is manifested in many aspects, such as the spirit of bearing hardships first, the spirit of innovative daring to be the first, the spirit of craftsmen striving for perfection, the patriotic spirit of caring for the people, and the dedication of being indifferent to fame and wealth. His great medical feelings of bravely shouldering the mission, caring for the people and taking root in the grass-roots have forcefully answered the three important questions: what kind of doctor to be, who to be and how to be a good doctor in the learning and working career of doctors in the new era. He set an model for doctors in later generations and highlighted the value of this spiritual strength for the time.

Experience of Overseas Research on Electronic Health Literacy and Its Enlightenment to China in Public Health Emergencies / 中国医学伦理学

The Internet has become an important carrier of medical information.Good electronic health literacy can enhance the public’s ability to obtain correct medical and health information with the help of electronic resources,which is helpful for the public to use health information to prevent diseases,avoid drug abuse,reduce the waste of medical resources and strengthen the self-management of chronic diseases.The improvement of electronic health literacy is of great value to the healthy development of citizens’ health literacy and healthy behavior.In view of the late start and slow development in the field of electronic health literacy in China,by combing the theoretical and practical research experience of electronic health literacy outside the region and combining with the COVID-19,this paper put forward new thinking on electronic health literacy in China,in order to provide useful reference for improving electronic health literacy of Chinese citizens,realizing self-care,self-management and disease prevention.

Risk Factors and Countermeasures of Occupational Exposure of Medical Personnel under COVID-19 Epidemic / 中国医学伦理学

The COVID-19 is a severe respiratory pathogen infection, showing a distinct "hospital cluster" transmission characteristics. This paper illustrated the concept of occupational exposure and COVID-19. Combined with the actual situation of COVID-19, the infection status of medical personnel in this outbreak was analyzed from three aspects: the transmission risk and infection rate of medical personnel, the clinical characteristics and the undiscovered super-spreader. Through the analysis of the present situation, this paper summarized the possible occupational exposure risk factors of medical personnel in COVID-19 from five aspects: biological occupational risk factors, chemical occupational risk factors, physical occupational risk factors, violence factors and psychological factors. From isolating the source of infection and cutting off the transmission route, the "safety supervisor" mechanism is established to avoid the risks of biological, chemical and physical occupational exposure, from providing professional psychological counseling for medical personnel to reduce their psychological stress, and from improving the relevant legal level to reduce the risk of medical personnel’s violent occupational exposure.

Protection of the Right to Life and Health of Medical Staff in Public Health Emergency: Based on the Case of COVID-19 Epidemic / 中国医学伦理学

With the COVID-19 outbreak, many provinces and municipalities have announced the first-level response to public health emergencies. As the backbone of fighting the epidemic, medical staff are faced with many ethical dilemmas, such as the lack of medical protection materials, the high risk of virus infection, discrimination and so on, and their health and life rights and interests have been impacted. Starting with the concept of public health emergencies and the right to life and health, the theory and display basis of the right of life and health were discussed based on the practical guidelines of public health emergencies. Taking the COVID-19 epidemic as an example, this paper proposed measures for ensuring the right to life and health of medical staff in public health emergencies, so as to better cope with the epidemic of COVID-19 and protect the life and health of medical workers.

Effect of orthokeratology lens on the postoperative binocular vision rebuilding in patients with intermittent exotropia combined with myopia / 国际眼科杂志(Guoji Yanke Zazhi)

AIM: To investigate the effect of wearing an orthokeratology lens on postoperative binocular vision rebuilding in patients with intermittent exotropia combined with myopic refractive error.METHODS: Prospective control study. A total of 60 patients(120 eyes)with intermittent exotropia and myopia who underwent surgical treatment in our hospital from June 2019 to December 2020 were selected. Patients who wore orthokeratology lenses or monofocal frame glasses after surgery were divided into a treatment group(group A)and a control group(group B)according to the wishes of patients and their families, with 30 cases(60 eyes)in each group, and they were followed-up for 6mo. The third level visual function and Titmus near stereoscopic visual function of the two groups of patients were observed before and 6mo after surgery.RESULTS: There was no statistical significance in all observation indicators between group A and group B before surgery(P>0.05). After 6mo of surgery, patients with intermittent exotropia achieved significant improvement in binocular visual function and corrected eye position. Group A was superior to group B in terms of fusion range and near stereoscopic visual function(P<0.05). There was no statistical significance between the two groups in terms of simultaneous vision and stereoscopic visual function(P>0.05).CONCLUSION: The binocular visual function of patients with intermittent exotropia after surgery has significantly improved. Wearing orthokeratology lenses can effectively improve binocular visual function in patients with intermittent exotropia combined with myopia after surgery.

A real-world study on the efficacy and safety analysis of paclitaxel liposome in advanced breast cancer / 中华肿瘤杂志

Objective: To explore the application and efficacy of paclitaxel liposome in the treatment of advanced breast cancer among Chinese population in the real world. Methods: The clinical characteristics of patients with advanced breast cancer who received paclitaxel liposome as salvage treatment from January 1, 2016 to August 31, 2019 in 11 hospitals were collected and retrospectively analyzed. The primary outcome was progression free survival (PFS), and the secondary outcome included objective response rate (ORR) and safety. The survival curve was drawn by Kaplan-Meier analysis and the Cox regression model were used for the multivariate analysis. Results: Among 647 patients with advanced breast cancer who received paclitaxel liposome, the first-line treatment accounted for 43.3% (280/647), the second-line treatment accounted for 27.7% (179/647), and the third-line and above treatment accounted for 29.1% (188/647). The median dose of first-line and second-line treatment was 260 mg per cycle, and 240 mg in third line and above treatment. The median period of paclitaxel liposome alone and combined chemotherapy or targeted therapy is 4 cycles and 6 cycles, respectively. In the whole group, 167 patients (25.8%) were treated with paclitaxel liposome combined with capecitabine±trastuzumab (TX±H), 123 patients (19.0%) were treated with paclitaxel liposome alone (T), and 119 patients (18.4%) were treated with paclitaxel liposome combined with platinum ± trastuzumab (TP±H), 108 patients (16.7%) were treated with paclitaxel liposome combined with trastuzumab ± pertuzumab (TH±P). The median PFS of first-line and second-line patients (5.5 and 5.5 months, respectively) were longer than that of patients treated with third line and above (4.9 months, P<0.05); The ORR of the first line, second line, third line and above patients were 46.7%, 36.8% and 28.2%, respectively. Multivariate analysis showed that event-free survival (EFS) and the number of treatment lines were independent prognostic factors for PFS. The common adverse events were myelosuppression, gastrointestinal reactions, hand foot syndrome and abnormal liver function. Conclusion: Paclitaxel liposomes is widely used and has promising efficacy in multi-subtype advanced breast cancer.

Guidelines for Ideological and Political Teaching of the Doctor-patient Communication Courses / 中国医学伦理学

To promote the ideological and political construction of the doctor-patient communication course, the research group discussed the subject characteristics and proposed the goals, principles, elements, and paths of the ideological and political construction of the doctor-patient communication course combined with practical teaching and relevant policy documents. Besides, this paper put forward the top-level framework design for the implementation, curriculum assessment, and evaluation indicators of the ideological and political construction, and developed the Guidelines for Ideological and Political Teaching of the Doctor-patient Communication Course and related teaching evaluation indicators, with a view to providing reference evaluation standards for the ideological and political construction of the doctor-patient communication course in China.

Practical Strategies for Health Education during Pregnancy and Childbirth Period in Foreign Countries and Their Implications to China / 中国医学伦理学

Under the macro background of the comprehensive liberalization of the "three-child policy" and the strengthening attention to the health of women and children, China has increasingly attached importance to the topic of women’s health education and made various attempts in health education during pregnancy and childbirth period, including traditional education, situational teaching, health lecture, health salon and other forms. However, there are still some problems, such as serious stereotype and homogenization, and rigid education. The effectiveness of health education during pregnancy and childbirth period needs to be improved. By drawing on the practical experience of health education during pregnancy and childbirth period abroad, this paper aimed to comprehensively improve maternal health literacy in China, and provide a assistance for building a healthy China.

Enlightenment on the Construction of Medical Professionalism from the Perspective of Moral Injury / 中国医学伦理学

The purpose of medicine is to preserve and develop the treatment in the process of saving lives and helping injuries. Medical professionalism is a comprehensive expression of physician’s clinical abilities, relationships and values between different subjects. In practice, white robed doctors utilize high standards of professionalism to practice the medical purpose and goals of "always centering on the interests of the patient" in specific diagnosis and treatment behaviors. At the same time, fulfilling the promises and expectations of medicine to the public. For these reasons, selfless dedication, self-sacrifice, and one-way pure altruism are all internalized into the basic requirements of medical professionalism: doctors should not only have the skill to revive the dead, but also have the benevolence of evangelists; they not only need to achieve maximum efficiency in technology, but also achieve the highest truth, goodness, and beauty in virtue. When these qualities are exaggerated or unattainable due to uncontrollable reasons, there will be a rift between the entrenched value systems and practical needs. In recent years, the global epidemic has had a huge impact on the medical system and medical staff, and the moral beliefs, role expectations, and value systems of doctors have also been impacted unprecedentedly, resulting in moral injury. The international research on moral injury in medical field has also received attention. China is currently in the adjustment period of epidemic related policies, with medical personnel bearing the brunt. Therefore, referring to relevant international research on moral injury to re-examine the relationship between the medical professionalism, which emphasizes one-way pure altruism, dedication and weakening or even neglecting personal well-being, and current medical practices. And constructing a moral injury early warning-repair system that focuses on doctors, patients, medical teams, medical institutions, medical environments, health systems, and other stakeholders, and ensuring its healthy operation. Not only in extreme periods, but also in ordinary daily diagnosis and treatment, it can support doctors to actively, safely, and healthily fulfill their mission of saving lives and helping injuries.

Discussion on the Doctor-patient Relationship Model in Psychiatry Based on the Szasz & Hollender’s Model of Doctor-patient Relationship / 中国医学伦理学

Due to the particularity of mental diseases, doctor-patient relationship in psychiatric medicine is a subject that needs to be paid attention to. This paper focused on the discussion of the model of doctor-patient relationship in psychiatric medicine from the perspective of constructing a harmonious doctor-patient relationship. Based on the Szasz & Hollender’s Model of Doctor-patient Relationship and combined with the characteristics of psychiatric medicine, this paper discussed the applicable doctor-patient relationship models, namely, the shared participation model, the guidance-cooperation model, the active-passive model, and the protective-constraint model. The specific application of the shared participation model, the guidance-cooperation model, and the active-passive model in the psychiatric medicine context were introduced in detail, and the reasons and characteristics of the protective-constraint model added on the basis of Szasz & Hollender’s Model of Doctor-patient Relationship were elaborated. Meanwhile, the realization paths of the protective-constraint model in clinical practice were further explored, which included evaluating the behavioral capacity and consciousness state of patients with mental disorders, obtaining informed consent, and standardizing the use of intervention rights and withdrawal mechanisms. The discussion of this model will promote the improvement of doctor-patient relationship and the development of psychiatric medicine.

Treatment of palbociclib in hormone receptor positive breast cancer: a real-world study and efficacy prediction model / 中华肿瘤杂志

Objective: To summarize the clinical use of palbociclib and evaluate its efficacy and safety in hormone-receptor (HR)-positive advanced breast cancer patients. Methods: We retrospectively analyzed data from 66 HR-positive metastatic breast cancer patients treated with palbociclib and endocrine therapy at the Department of Oncology in the First Affiliated Hospital with Nanjing Medical University between 2018 and 2020. We evaluated the factors affecting the efficacy of palbociclib using Kaplan-Meier method and Log-rank test for survival analysis and Cox regressions for multivariate analysis. Nomogram model was built for predicting prognosis among HR-positive breast cancer patients who received palbociclib. Concordance index (C-index) and calibration curve were used for internal validation to assess the predictive ability and conformity of the model. Results: Of the 66 patients treated with palbociclib, 33.3%(22), 42.4%(28) and 24.2%(16) patients were treated without endocrine therapy, first-line endocrine therapy, second-line or above endocrine therapy after recurrence, respectively. 36.4%(24) patients had hepatic metastasis, 16.7% (11) patients were sensitive to previous endocrine therapy, 27.3%(18/66) patients had primary resistance to endocrine therapy, while 56.1% (37) patients had secondary resistance to endocrine therapy. The overall response rate was 14.3% (95% CI: 6.7%, 25.4%) and clinical benefit rate was 58.7% (95% CI: 45.6%, 71.0%). Better clinical outcomes were associated with non-hepatic metastasis (P=0.001), sensitive/secondary resistant to previous endocrine therapy (P=0.004), no or only one line of chemotherapy for metastatic breast cancer (P=0.004), recent pathological confirmation of immunohistochemical analysis (P=0.025). Hepatic metastasis (P=0.005) and primary resistance to endocrine therapy (P=0.016) were the independent risk factors of progression free survival. The C-index of predictive probability for the nomogram constructed from the patient clinical characteristics (whether liver metastasis, whether primary endocrine resistance, lines of chemotherapy after metastasis, lines of endocrine therapy, number of metastatic sites, and time to last immunohistochemistry) to predict the progression-free survival at 6 and 12 months for patients was 69.7% and 72.1%, respectively. The most common adverse events were hematologic toxicities. Conclusions: Our report indicates that palbociclib combined with endocrine therapy for HR-positive recurrent metastatic breast cancer is effective and safe; patients with hepatic metastases and primary resistance to endocrine therapy have worse prognoses and are independent risk factors for progression after palbociclib therapy. The constructed nomogram could help predict the survival and guide the use of palbociclib.

Ethical Enlightenment of Foreign Incentive Mechanism for Orphan Drugs Research and Development to China / 中国医学伦理学

There are a large number of patients with rare diseases in China, and most of them are faced with problems such as no medicine to cure, and have drugs outside of China but not inside. This paper combed the incentive policies of orphan drugs in the United States and the European Union, including orphan drugs legislation and setting up special management institutions, orphan drugs qualification certification, government funding, tax reduction and agreement assistance in the research and development process, providing accelerated listing channels in the examination and approval process, giving market monopoly period in the circulation stage, and giving priority to review. On this basis, it also explored the incentive measures of non-profit organizations in the research and development of orphan drugs, including providing financial support, clinical research and so on. From the perspective of guaranteeing the right to life and health of patients with rare diseases, the fairness and accessibility of medication, and the subjects’ right to know and privacy in clinical trials, this paper provides reference for perfecting the incentive mechanism of orphan drugs research and development in China.

Ethical Enlightenment of Foreign Rare Disease Treatment Guarantee System to China / 中国医学伦理学

By summarizing the policies and regulations of foreign countries on rare disease research and drug research and development, referring to the relevant policy support of treatment guarantee system in the development of rare diseases abroad, and combining with China’s national conditions, this paper analyzed the feasible points that China can learn from, and then put forward some suggestions on the ethical problems existing in the current rare disease research, so as to provide reference suggestions for the relevant policy formulation of rare disease treatment guarantee in China: adjusting regional differences based on the principle of fairness, and establishing a national rare disease information collection center; improving the ethical quality of scientific research in pharmaceutical companies, and strengthening ethical supervision; and the government and society fulfill their obligations to protect the rights and interests of patients with rare diseases.

Strategies for Improving Compliance of Cancer Patients in Foreign Countries and Their Enlightenment to China / 中国医学伦理学

Compliance is directly related to the patient’s understanding and implementation degree of treatment plans, and is closely related to treatment outcomes. But previous studies have shown that the compliance of cancer patients is generally low. Foreign countries have rich practical experience in improving the compliance of cancer patients. Therefore, this paper started with the concept of compliance, expounded the classification of compliance, analyzed the current situation and gaps of compliance of cancer patients at home and abroad, introduced experience of foreign cancer patients’ compliance improvement strategies from the three aspects of policy, doctors and patients, and put forward localized recommendations for improving the compliance of cancer patients in combination with the national conditions.