In 2019, the national government issued the document "Implementation Plan for Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Area", which allowed the use of innovative drugs and medical devices in medical institution of Boao Lecheng. These medical products had been designed to meet urgent clinical requirements and had been approved by regulatory authorities overseas. Through the use of these medical products, real-world data were generated in the routine clinical practice, based on which real-world evidence might be produced for regulatory decision-making by using scientific and rigorous methods. In March 2020, the first medical device product using domestic real-world data was approved, suggesting that the real-world data initiative in Boao Lecheng achieved initial success. This work also provided important experience for promoting the practice of medical device regulatory decision-making based on real-world evidence in China. Here, we shared the preliminary experiences from the study on the first approved medical device product and discussed the issues on developing a real-world data research framework in Boao Lecheng in attempt to offer insights for future studies.
Objective To investigate evidence retrieval, appraisal, and reevaluation during evidence-based clinical decision making in China. Also, to analyze the related factors, so as to find the problems in the course of evidence-based clinical decision making and put forward corresponding solutions. Methods We searched Chinese Biomedical Literature Disc (CBM) and China Journal Full-text Database (Medical sciences) of the China National Knowledge Infrastructure (CNKI) to collect clinical evidence-based case reports. Relevant information was extracted from these reports by a selfdesigned investigation form.Then statistical analyses were performed. Results The search tools used in the course of evidence-based clinical decision making varied. The most frequently used were MEDLINE/PubMed (82.08%) and The Cochrane Library (60.38%). 30.63% of evidence-based case reports described the search strategy in detail, and 9.01% described how they modified their search strategy. All doctors evaluated the association between evidence and disease, but few of them integrated patient factors and relevant external factors when evaluating evidence. The scientific nature and validity of the evidence was evaluated in 74 evidence-based case reports (66.67%), and such evaluation was mainly based on the criteria of evidence grading (50.00%). Reevaluation was mentioned in 85.59% of evidence-based case reports. Conclusion In China, the application of evidence-based decision making varied in different clinical departments. Problems existed in the course of evidence retrieval, appraisal, and reevaluation. This revealed the low information diathesis level of doctors and their lack of evidence-based medicine knowledge. It is suggested that information education and evidence-based medicine education should be strengthened to improve doctors’ ability to use evidence-based clinical decision making. It is also recommended that the search tools, relevant search strategy, the modification of search strategy, and reevaluation on practice results of each case should be mentioned in evidence-based case reports.
A well-conducted evidence-based guideline not only considers the efficiency and the cost of the recommended intervention, but also the acceptability and feasibility of the intervention during implementation. Systematic reviews of qualitative research aim to provide qualitative evidence such as the acceptability and feasibility of the intervention. In developing evidence-based guidelines, qualitative evidence helps to:(1) Define the scope of guideline; (2) Assess the acceptability of interventions; (3) Assess the feasibility of interventions; (4) Identify considerations when implementing guidelines. Systematic reviews provide the fundamental evidence required to develop robust and trustworthy guidelines. The CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach aims to grade the evidence from systematic reviews of qualitative research. After critically and scientifically appraising by CERQual, the acceptance and feasibility of an intervention are given different grading, which is the critical process of developing evidence-based guidelines. This paper will demonstrate the value of systematic reviews of qualitative research in developing evidence-based guidelines and how to implement recommendations from qualitative evidence.
The main task of Campbell Collaboration is to collaborate with Cochrane Collaboration so as to produce high quality evidence for the social welfare, education, justice and criminal, international development policy and other social sciences. This article systematically introduces Campbell Collaboration, its origins, achievements and development, with the purpose of allowing more scholars understand evidence-based ideas and methods of social science, providing evidence-based methodology basis for China's social policy.
Evidence-informed decision making is one of the most common, objective and important health policy research methods used by policy makers. Its purpose is to promote the application and dissemination of research knowledge on health policy and systems to change traditional and subjective models of health policy making in order to improve national and regional health systems. Three elements will influence the effectiveness of health policy making:research evidence, available health resources and the value of policy formulation. This paper introduces some pragmatic evidence-based approaches, especially systematic reviews, priority setting and a combined approach matrix (CAM). Systematic reviews have a b impact on the decision process for policy makers. We hope that the application and development of evidence-informed methods will increase in China’s health policy research.
Evidence-based dentistry has been established for more than a decade, and described as ‘the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients＇. However, Orthodontic clinicians in China still tend to base their treatment protocols on the ‘it works in my hands＇evidence provided by their peers, mainly due to their weak experience in searching and applying clinical evidences. In this article, authors are willing to share their experience with their Chinese peers, and to promote the dissemination and application of evidence-based orthodontics in clinical practice.
In the realm of data mining based on modern acupuncture clinical research, the impact of literature features such as literature quality, evidence level, sample size, and clinical efficacy on the quality of data mining outcomes remains uncertain. These issues are significant factors restricting the translational application of data mining research results. We suggest employing both entropy weight and linear weighting techniques to assess the specified indicators. This assessment results in a comprehensive weighted score for acupuncture prescriptions, serving as the foundation for our ensuing data mining endeavors. In this study, migraine research serves as an example to contrast the efficacy of weighted algorithms against that of classical algorithms. The findings demonstrate that the algorithm introduced in this research significantly contributes to studies focusing on the dispersed selection of acupuncture points. Its superiority lies in cluster analysis, where it adeptly discerns potential patterns in the amalgamation of acupoints. This algorithm amalgamates evidence-based acupuncture with data mining processes, providing innovative perspectives that augment the caliber of research in acupuncture data mining. Nonetheless, additional research is essential to corroborate these results.
At present, upper limb motor rehabilitation relies on specific rehabilitation aids, ignoring the initiative of upper limb motor of patients in the middle and late stages of rehabilitation. This paper proposes a fuzzy evaluation method for active participation based on trajectory error and surface electromyography (sEMG) for patients who gradually have the ability to generate active force. First, the level of motor participation was evaluated using trajectory error signals represented by computer vision. Then, the level of physiological participation was quantified based on muscle activation (MA) characterized by sEMG. Finally, the motor performance and physiological response parameters were input into the fuzzy inference system (FIS). This system was then used to construct the fuzzy decision tree (FDT), which ultimately outputs the active participation level. A controlled experiment of upper limb flexion and extension exercise in 16 healthy subjects demonstrated that the method presented in this paper was effective in quantifying difference in the active participation level of the upper limb in different force-generating states. The calculation results of this method and the active participation assessment method based on sEMG during the task cycle showed that the active participation evaluation values of both methods peaked in the initial cycle: (82.34 ± 9.3) % for this paper’s method and (78.44 ± 7.31) % for the sEMG method. In the subsequent cycles, the values of both showed a dynamic change trend of rising first and then falling. Trend consistency verifies the effectiveness of the active participation assessment strategy in this paper, providing a new idea for quantifying the participation level of patients in middle and late stages of upper limb rehabilitation without special equipment mediation.
Health Technology Assessment International (HTAi), in conjunction with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), initiated a joint Task Force and published guideline and a checklist for deliberative processes for health technology assessment (HTA). Currently, there is a lack of guidance for designing and implementing deliberative processes of HTA in China, so this paper performs a detailed interpretation of the guideline and checklist, with a view to providing a reference for China's HTA and deliberative process, in order to promote the dissemination and application of the HTA methodology, and advance the construction of domestic HTA deliberative processes capacity and institutional mechanism.
Doctor-patient shared decision making is an expansion and extension of the patient-centered concept, which emphasizes communication and collaboration between doctors and patients in making decisions, focuses on patients, needs, enhances communication and exchange between doctors and patients, and improves the status of patients in medical decision making. This paper reviews the concept, domestic and international research overview, advantages, and application of doctor-patient shared decision making in hip and knee arthroplasty, and discusses the future research directions, in order to provide a reference for the application of shared decision making between doctors and patients in hip and knee arthroplasty in China.
