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 number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.
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.
This article provides a thorough interpretation of the recommendations for implementation research in healthcare-associated infection (HAI) prevention and control, jointly issued by the Society for Healthcare Epidemiology of America, the Infectious Diseases Society of America, and the Association of Professionals in Infection Control and Epidemiology. The recommendations elaborate on the concepts, strategies, determinants, and evaluation methods of implementation research, as well as the commonly used theories, models, and frameworks (TMF) in the field of HAI prevention and control. By expounding on these TMF, this article aims to guide readers in deeply considering the scientific issues related to the implementation of hospital infection prevention and control, and to provide guidance on selecting and applying appropriate resources in specific environments and situations. The release of these recommendations aims to promote the implementation of evidence-based guidelines in medical institutions and ultimately achieve the goal of reducing the incidence of hospital infections by promoting and guiding the conduct of implementation research in the field of HAI prevention and control.
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.
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.
The accuracy of the clinical prediction model determines its extrapolation and application value. When the prediction model is applied to a new setting, the differences between the new population and the initially modeled population in terms of study time, population characteristics, region, and other factors could lead to a reduction in its predictive performance. Calibrating or updating the prediction model with appropriate statistical methods is important to improve the accuracy of the prediction model in new populations. The model updating methods mainly include regression coefficients updating, meta-model updating and dynamic model updating. However, due to the limitations of meta-model updating and dynamic model updating in practical applications, the regression coefficient updating method is still the most common method in model updating. This paper introducd several types of model updating methods, the regression coefficients updating methods for two common clinical prediction models based on Logistic regression and Cox regression, and provide corresponding R codes for reference of researchers.
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.
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.
This paper introduces the background, significance, definition and types of clinical audit and describes five stages of clinical audit, including preparing for clinical audit, selecting criteria, measuring performance and sustaining improvement. This paper also introduces the international and national status quo of implementing clinical audit in nursing practice and describes the reporting guideline for articles of clinical audit. Finally, this article suggests that providing methodological training and creating a supportive environment are crucial strategies to promote the implementation of clinical audit and bridge the gaps between evidence and practice.