By dividing the evolution of the U.S. clinical trial registration system into three phases—emergence, inception, and maturity—this study systematically traces its half-century development and reveals the underlying tensions and institutional logic. The U.S. clinical trial registration system is not merely a technical instrument, but a comprehensive institutional platform reconciling the conflicts among scientific rationality, commercial interests, and the public’s right to know. The emergence phase (1971—1985) originated from the establishment and public disclosure of the International Cancer Database to meet cancer research needs and safeguard patients’ survival rights. The inception phase (1986—2004) unfolded against the backdrop of the FDA’s drug approval crisis, with the construction of major disease registration systems breaking the regulatory deadlock and achieving an "incremental revolution". The maturity phase (2004—2016) centered on controlling publication bias and advancing institutionalization and legalization. The 2004 paroxetine incident galvanized global consensus on trial registration, and the 2007 U.S. Congressional mandate marked the pivotal turning point toward a fully mature system. Today, China still faces low registration rates and insufficient legal constraints. Drawing on the U.S. experience, China should prioritize institutional publicness, legal enforceability, and the containment of publication bias to strategically upgrade its clinical trial registration system.
ObjectiveTo explore the implementation of standardized training of general practitioners system in China. MethodsA total of 25 bases of training general practitioners and its collaborative community service centers, which were located in the east and western region of China, met the inclusion criteria; qualitative interviews and questionnaires were done between November 2012 and November 2013, including 456 teachers, 281 students, and 166 teaching management staff. Survey content involved implementation of standardized training system, teaching method and so on. ResultsSatisfaction rate of training general practitioners training system with teachers, students, and administrators was 76.2%, 71.3%, and 86.3%, respectively (χ2=92.372, P<0.001). The average satisfaction rate of training model, teaching programme, teaching materials, teaching arrangements, the examination system, the quality of training, and supporting policies was 95.7%, 92.1%, 73.8%, 65.7%, 72.5%, 86.8%, and 48.9%, respectively (χ2=813.196, P<0.001). Satisfaction rate of teaching method with teachers, students, and administrators was 81.1%, 74.4%, and 67.7%, respectively (χ2=40.159, P<0.001). ConclusionSatisfaction rates of training general practitioners training system and teaching method with teachers, students, and administrators are low. The main impact factors are:the syllabus and textbooks are not practical, qualified teachers are short, teaching arrangements is unreasonable, teaching content is specialization, government support is inadequate and so on.
The operation mode of scientific research incentive mechanism in West China Hospital of Sichuan University is closely connecting individual needs with organizational objectives, and coordinating and adjusting again through communication and feedback. It can play an incentive role continuously and actively promotes the development of hospital scientific research. But the incentive mode, research funding management, research output rate, strengthening of effective communication and other aspects need to be constantly optimized and improved. Based on Porter Lawler’s comprehensive incentive theory, this paper explores and summarizes the operation mode of scientific research incentive mechanism in West China Hospital of Sichuan University. Finally, the paper puts forward suggestions, which aims to provide reference for the construction of scientific research incentive mechanism in large general hospitals.
Patient priority evaluation has been studied and applied abroad for a long time, which is a mature theory and widely used in practice now. This article uses the priority, patients, waiting list and criteria as keywords to search Wiley Inter Science, Web of Science, Scopus Pub Med, The Cochrane Library, Science Direct, Springer, and Jstor database (searching time is up to December 2017), to collect relevant indicators for patient admission priority evaluation. In addition, relevant citations and grey literature were searched, and experts from relevant fields in China were consulted to obtain more comprehensive research literature. On this basis, this article describes the concept of patient admission priority evaluation, and describes the meanings of the indicators and the countries of application from the three dimensions of clinical indicators, expected results, and social factors. It is considered that the research and implementation of the evaluation of the priority of patient admission has been relatively many. However, there are only a few related researches in the country and without unity. There is no systematic patient-related priority evaluation. It is necessary to use foreign mature theory research to establish a hospital admission priority evaluation system suitable for China’s national conditions.
Objective To compare the newest essential medicine lists (EMLs) of China and the World Health Organization (WHO) in 2009, so as to provide the evidence for the selection, adjustment and implementation of the newest national EML of China. Methods Differences in the procedures of selection, implementation and the categories as well as the number of medicines in 2009 EMLs of the WHO and China were compared by descriptive analysis. Result Principles and procedures of selecting and updating EML of China were based on those of the WHO EML. However, the transparency of procedures, methods of selection, and evidence of efficacy, safety, cost-effectiveness and suitability were not enough. Essential medicines of the WHO were categorized by the Anatomical-Therapeutic-Chemical (ATC) classification system, while those of China were classified by clinical pharmacology. Twenty-one identical categories of the first class were found in the two lists. There were 8 and 3 unique categories in the WHO EML and China EML, respectively. A total of 358 and 255 medicines (including medicines in its explanation) were included in the EMLs of the WHO and China, respectively, with 133 identical medicines as well as 206 and 108 unique medicines. There were 51 antiinfective medicines in China EML, accounting for half of the WHO EML. Forty medicines were the same in both lists, and 11 and 60 anti-infective medicines were unique in EMLs of China and the WHO, except for 40 identical medicines. Among them, 22 and 31 antibacterials were included in the lists of the WHO and China with 17 identical medicines. Antifungal, antituberculosis and antiviral medicines in China EML were fewer than those in the WHO EML. The numbers of the identical medicines acting on the respiratory, digestive, and nervous systems and hormones in the both lists were 1, 7, 9, and 17, respectively, while the unique ones in China EML were 6, 12, 7, and 14, respectively. However, most of them were selected without adequate evidence in efficacy and safety. The medicines acting on cardiovascular system were 19 and 29 in both lists with 14 identical medicines. Some antihypertensive and antiarrhythmic medicines were included in China EML with similar mechanism, whereas some of them were excluded by the EML. Conclusion The total numbers of both EMLs are close to each other with half of the identical medicines. The selection of China EML mostly meets the needs of disease burden in China. However, the transparency of selection and evidence are not enough. We suggest that health authorities should cooperate with other stakeholders to promote the transparency of selection, to enhance the capacity of producing high-quality evidence, to develop related technical documents and guidelines, and to disseminate and monitor the implementation of EML.
摘要:目的:探讨临床教学的全程制度化管理及其效果。方法:通过健全组织,完善制度,加强教学、临床及实习生管理、建立激励机制等措施,进行全程制度化的规范管理。结果:教学质量显著提高,不良事件鲜见,无恶性事件发生。近来医院已有6篇教学论文公开发表,4个先进集体和8名先进个人受到医院表彰,5名优秀带教教师和8名实习生受到各学院奖励。结论:临床教学全程制度化管理是提高教学质量的切实有效途径。Abstract: Objective: To investigate system management during the entire clinical teaching process and its effect. Methods: To robust organization, perfect rules, strengthen management of clinical teaching and intern student, and establish encouragement mechanism,and other measures, so as to conduct standard system management during the entire process. Results: Quality of teaching improved notably, bad event was scarce, no malignant event occurred. There were six teaching articles issued publicly, four advanced collectives and eight advanced individuals had been praised by hospital, and five excellent teachers,eight intern students had been rewarded by each college. Conclusion: System management during the entire clinical teaching process is an effective way to improve teaching quality.
Objective To analyze the proportions of interhospital and intrahospital consultation cases of chief residents in the Department of Endocrinology and Metabolism in West China Hospital of Sichuan University, and summarize the distribution characteristics of endocrine and metabolic diseases in other specialized departments, in order to promote the routine work optimization and the cultivation of specialists in endocrinology and metabolism. Methods A total of 1 299 cases were completed by the chief residents in the Department of Endocrinology and Metabolism between July 2012 and June 2013. Distribution of departments, composition and distribution of consultation cases were analyzed retrospectively. The characteristics of endocrine and metabolic diseases were summarized, and the difference of endocrine and metabolic consultation demand was compared among different departments . Results Among the 1 299 consultation patients, there were 612 males (47.11%) and 687 females (52.89%) aged between 14 and 96 years averaging at 56.3. There were 747 (57.51%) interhospital consultation cases and 552 (42.49%) intrahospital consultation cases. The most common reason for emergency consultation was stress hyperglycemia in diabetic patients after surgery or trauma, followed by thyroid diseases and electrolyte disturbances. Most consultation applications were from the Emergency Department, and the consultation purpose was mainly blood glucose control. The main consultation purpose of surgical and gynecologic departments was perioperative assessment and treatment adjustment in patients combined with endocrine diseases such as diabetes and thyroid diseases. Meanwhile,the purpose of obstetric consultation was mainly treatment for patients with hyperthyroidism complicated with pregnancy, gestational diabetes treatment and perioperative blood glucose control. Conclusions Clinical consultation work is challenging, which also provides an excellent chance for chief residents to study and review professional knowledge and accumulate clinical experiences. Chief residents should have the knowledge of the proportions and distribution of consultation cases in order to optimize daily work. They should also summarize consultation experiences so as to promote their knowledge of diagnosis and treatment.