The formation, evaluation and grade division of real-world evidence (RWE) are bottlenecks restricting the in-depth development and scientific application of real-world study methods. This paper briefly reviewed the design grade and evidence grade of clinical medical research, and proposed the key points of evidence grade of real-world clinical research, including emphasizing the comprehensive evaluation of internal authenticity and external authenticity, determining the "starting point" of real-world evidence, and using the real-world evidence quality evaluation method. Based on the internationally recognized "grading of recommendations assessment, development, and evaluation (GRADE)", combined with the classification and characteristics of real-world evidence, a preliminary grading scheme was formed. An example was given to illustrate the grading suggestion.
There are several main obstacles to structure clinical questions in the process of developing evidence-based clinical practice guidelines, such as clinicians have misconceptions about clinical question structure, and clinical questions do not fit clinical practice. These obstacles results in the incomplete structure and not standardized expression of the clinical questions, and reduce the quality and applicability of guidelines. To overcome these obstacles, this article introduced the application and specific details of clinical question framing and expression with practical examples, to assist clinicians in understanding clinical questions and to provide methodological references for clinical question formulation in the guidelines.
Objective To systematically review the requirements of patient participation in clinical practice guidelines (CPGs) in Chinese and foreign guideline development manuals. Methods Thirty-six authoritative society websites and guideline databases and 5 commonly used databases were searched online. Relevant information on patients’ participation in the guideline manuals was collected, summarized, and analyzed. Results A total of 37 manuals (33 foreign and 4 Chinese) were included. The requirements for the number of patients, the right to speak, status equality, and the right to vote in the guideline development manual accounted for 35.1%, 13.5%, 8.1%, and 5.4%, respectively. The requirements for participants’ mode of participation were not mentioned in the guideline development manuals from 2000 to 2010. There were 6 (16.2%) in 2011–2015 and 12 (32.4%) in 2016–2022. The comprehensive guidelines for multiple disease types accounted for 35.7%, 28.6%, and 57.1%, respectively, in terms of requirements for participants’ knowledge or experience, management of specialized personnel, and training support. The specific guidelines for a certain type of disease or drug accounted for 21.7%, 4.3%, and 17.4%, respectively; fifteen (40.5%) guideline development manuals mentioned the specific collection forms of patients’ values and preferences in guideline development. Conclusion Given changes to medical models and the emphasis on patients’ rights and interests, an increasing number of manuals have proposed requirements that consider the expression of patients’ values and preferences in manual development, and the dimensions of manual development are constantly enriched. However, manuals outlining the requirements of patient participation are still not comprehensive and can continue to improve.
In the formulation of the clinical question of traditional Chinese medicine clinical practice guidelines, even if the intervention elements (intervention or control) have an appropriate scope, guideline developers are still faced with a variety of interventions. By analyzing the difficulty and necessity of priority selection of intervention interventions, we propose the approach of extending expert evidence to the process of priority selection of intervention interventions, and further provide the methodology of expert evidence data collection table design, application, data presentation and expert decision-making method to provide references and guidance for guideline developers.
Clinical practice guidelines will be incorporated in different evidence sources and evidence types, the research and exploration of multiple sources of evidence at China and foreign, this paper advocates the construction of both characteristics of multi-source evidence of traditional Chinese medicine, by combing 70 guide manuals, analyze the necessity and advantages of multi-source evidence construction, and further from the multi-source evidence source and evidence logic theory interpretation and application, in order to provide methodological references for the formulation of evidence-based clinical practice guidelines of traditional Chinese medicine.
ObjectivesTo explore the characteristics of the international clinical studies using objective performance criteria (OPC) and provide a reference to design clinical trials and determine external controls.MethodsPubMed, The Cochrane Library and EMbase databases were searched for all clinical studies which used OPC. Two reviewers independently screened literature, extracted data and descriptive analysis was then performed.ResultsA total of 51 English language articles were included. Merely one was published in 2001, and others were published between 2010 and 2018. Twenty-seven articles (27/51, 52.9%) were published between 2017 and 2018, with accumulated impact factors of 411. In the article referring to the reasons for using the objective performance criteria, reasons for using OPC study was primarily the difficulties of randomization and comparison (8/11, 72.7%). Articles with cardiovascular disease and peripheral vascular disease accounted for 86%, and articles on the effectiveness or safety of medical devices accounted for 76.5%. Single-arm trial (40), randomized controlled trials (2), case-control studies (2), case series (5) and diagnostic tests (2) were included. OPCs were mostly derived from the data of clinical trials of other similar products, national standards, specialist association standard and meta-analysis of multiple clinical studies. A total of 27 articles (27/51, 52.9%) used hypothesis testing to compare research results with objective performance goal, and 24 articles (24/51, 47.1%) used the confidence interval method.ConclusionsOPC studies are primarily used for safety intervention and effect evaluation. OPC studies are developing very rapidly, especially in the field of cardiovascular studies. Methodological details are reported reasonably sufficient. Reasons for using OPC study are primarily the difficulties of randomization and comparison. Factors such as source of the OPC, sample size, and comparison method should be taken into account. The application of the OPC can not only solve the difficulties of the implementation of numerous clinical research, but also provide new insights for solving the practical difficulties of clinical research in the real-world.
In the process of formation of recommendations of clinical practice guidelines, experts have many difficult problems of lack of transparency and high subjectivity in making final decisions, such as incomplete comprehensive consideration of dimensions and great heterogeneity in the evaluation of importance between dimensions, etc. As a decision-making tool, multi-criterion decision analysis improves the decision-making level of recommendation by adding the combination of qualitative and quantitative methods. By analyzing the challenges facing the formation of recommendations, this paper introduces the decision assistance of multi-criterion decision, and analyzes and summarizes the advantages and methods of the application of multi-criterion decision, so as to provide reference and guidance for guide makers to solve the difficulties in the formation of recommendations.
In the process of formulation, traditional Chinese medicine clinical practice guidelines are often faced with the dilemma of lack of evidence. Guidelines development groups tend to make final decisions based on expert experience or expert opinion, but the limitations of cognitive bias reduce the credibility and transparency of the guidelines. By clarifying the difference between the expert experience and expert opinion and expert evidence, the expert evidence of traditional Chinese medicine discipline advantages and necessity, providing the recommendation form link using expert evidence methodology design and implementation details, retaining the empirical characteristics of traditional Chinese medicine and improving the lack of evidence, has certain practical application value.