Clinical trials are the most reliable means for scientifically rigorous evaluation of the efficacy and safety of drugs, and are the most crucial part receiving the most investment in development and innovation in the pharmaceutical industry. In recent years, the nation has formulated a set of policies and guiding principles to encourage pharmaceutical innovation, promote the independent innovation of China’s pharmaceutical industry and enhance clinical trial capacity. To further improve Chinese researchers’ ability to perform clinical trials, the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and the National Center for Cardiovascular Diseases invited a multi-disciplinary team of experts from various areas including clinical trial methodology and supervision to work on this consensus. In view of the common concern and puzzles regarding the issues in clinical trials, such as recruitment and retention of participants, outcome selection, quality control, information technology application, and ethics in data security, the expert consensus is based on domestic and international guidelines, the latest advancement of clinical research, and the advice and opinions from national experts. It aims to provide reference information and guidance for clinical trial researchers, and serves as a reference for relevant authorities to formulate clinical trial management policies.
Evidence-based evidence translated into health care services requires three conversion processes, preclinical research-clinical research-implementation research, which might take a very long time. In order to speed up the process of research results translated into daily medical practice and health policy, an effectiveness-implementation hybrid design combining the effectiveness research of clinical and implementation research was emerging. This paper introduced the concept, classification and application of effectiveness-implementation hybrid design, to provide references for researchers in this area.
This article systematically reviews the series of articles on randomized controlled trial (RCT) methodology guidance published in JAMA Surgery between 2022 and 2023. It focuses on providing an overview and guidance on critical aspects such as trial implementation and oversight, participant recruitment, statistical applications, and key points in manuscript publication. The aim is to offer valuable insights and references for surgeons to conduct efficient clinical trials and successfully publish their research findings.
The consolidated framework for implementation research (CFIR) is one of the most commonly used theoretical frameworks for implementation science. The updated CFIR was optimized based on the original version. The background, process and contents of the updated CFIR were introduced, and the domains and constructs of the updated CFIR were interpreted in this article. We analyzed the similarities and differences of the updated CFIR compared with the original CFIR, in order to provide methodological references for Chinese researchers to explore the determinants of implementation.
Effectiveness-implementation hybrid designs can test the effectiveness of interventions and the outcomes of implementation strategies concurrently and accelerate the transformation of research results into routine practice. This paper introduced three types of effectiveness-implementation hybrid designs and corresponding reporting guidelines, including standards for reporting implementation studies, cluster randomized design and CONSORT 2010, stepped-wedge cluster randomized design and extended version CONSORT 2018, qualitative research and COREQ reporting guideline, and provide references for domestic researchers to produce research reports on effectiveness-implementation hybrid design.
Objective We aimed to evaluate the current status of the construction and practice of the stroke center in West China Hospital of Sichuan University and develope a future strategy to promote the standardized developement of inpatients care and evidence practice. Methods The current status of the Stroke Center in West China Hospital of Sichuan University was assessed. The procedure of diagnosis and treatment was inspected in detail, including triage, thrombolytic therapy, antithrombotic medication and anticoagulant, primary and secondary prevention, filter of risk factors, rehabilitation and education for patients. After that, new plans were made on the basis of the assessment and experiences acquired from practices in the Stroke Center in West China Hospital. Results The primary Stroke Center had been constructed in West China Hospital. The practice in West China Hospital showed that the Stroke Center significantly reduced the mortality and shortened the length of hospital stay of the patients with stroke. Conclusion It is proved that construction and implementation of the Stroke Center in West China Hospital are feasible.
Guideline implementation with decision support checklist (GUIDES) aims to assist the self-reflection of evidence-based clinical decision support system (CDSS) related professionals to enhance the process monitor and continuous improvement of evidence-based CDSS. This paper interpreted the development process, target user, and assessment method of GUIDES, analyzed the practical value of GUIDES through a typical example, and then reflected on the GUIDES and current studies on evidence-based CDSS in China. It is expected to provide references for future studies.
Compared with traditional medical devices, artificial intelligence medical devices face greater challenges in the process of clinical trials due to their related characteristics of artificial intelligence technology. This paper focused on the challenges and risks in each stage of clinical trials on artificial intelligence medical devices for assisted diagnosis, and put forward corresponding coping strategies, with the aim to provide references for the performance of high-quality clinical trials on artificial intelligence medical devices and shorten the research period in China.
The vigorous development of day surgery is crucial to alleviating the contradiction between supply and demand of medical and health care and improving the efficiency of medical and health resources in China. The current path dependence, policy inertia, and lack of coordination in the development of day surgery have brought a more severe test to the healthy and orderly development of day surgery in China, and the vulnerability in the development of day surgery has also emerged gradually. By examining the positive and negative experiences and lessons learned in the current development of day surgery, from the perspective of “structure-resource-information- society” subsystems, and based on the identification of key competencies in the collaborative development system for day surgery, this article indicates that the day surgery resilience is a composite system composed of spatial resilience, digital resilience, resource oriented resilience, institutional resilience and management resilience, and analyzes the implementation path of day surgery collaborative development system, providing a theoretical basis for the healthy and orderly development of day surgery in China.
ObjectiveTo systematically review the effect of implementing the medicines zero mark-up policy in Chinese public hospitals.MethodsCNKI, WanFang Data, VIP, Sinomed, Web of Science, PubMed and EMbase databases were electronically searched to collect quantitative evaluations of the effect of implementing the medicines zero mark-up policy in Chinese public hospitals from inception to October 30th, 2020. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Descriptive analysis was then performed.ResultsThe existing evidence on the effect of implementing the medicines zero mark-up policy in Chinese public hospitals was from 3 studies based on national samples and 7 provincial level studies in Beijing, Shannxi and Fujian. After the implementation of the medicines zero mark-up policy, all included studies found that the medicines expenditure and the proportion of medicines expenditure to the total expenditure per outpatient visit or per hospitalization decreased. The expenditures of medical supplies, tests & examinations per outpatient visit or per hospitalization increased, and the medical expenditure per outpatient visit or per hospitalization increased in Beijing. The hospital annual revenue generated from medicines and its proportion to the total annual revenue both decreased across the country. Although the government allocated increased subsidy to compensate the revenue reduction of the public hospitals due to the implementation of the medicines zero-mark-up policy, the total annual revenue of traditional Chinese medicine hospitals at the county level across the country still decreased significantly.ConclusionsBased on the available evidence, we conclude that the policy objective of abolishing the mechanism of "compensating medical care with revenue generated from prescribing medicines" is achieved, while that of establishing a scientific compensation mechanism for public hospitals are partially achieved. Compared with other regions, Beijing has appropriately adjusted the prices of medical care while removing the mark-up of medicines, thus is a contributor to the establishment of a scientific compensation mechanism for public hospitals.