This paper explores the methodological characteristics and key considerations of umbrella trials. By allocating different treatment strategies based on patients' molecular features, umbrella trials significantly enhance screening efficiency and can quickly identify ineffective therapies. Through the analysis of patient allocation strategies, statistical model selection, and error control methods, we can better utilize this design to accelerate drug development and achieve more efficient personalized treatment. However, despite significant progress in methodology and practice, umbrella trials still face multiple challenges during implementation, including trial design, sample size calculation, patient recruitment, informed consent, and resource allocation. Addressing these challenges in the future will help further optimize the application of umbrella trials. This study aims to provide thoughts and inspirations for researchers conducting umbrella trials and promote the steady development of this field.
Clinical practice guidelines need to be based on evidence, but traditional Chinese medicine, especially integration of traditional Chinese and Western medicine guidelines, inevitably need to combine clinical research evidence, ancient literature, and expert experience and consensus. In the process of formulating, there are deviations in understanding and application of the expert consensus method and expert experience, resulting in opaque of the recommendations, unclear of the details of the diagnosis and treatment strategy, less prominent of the advantages and value of traditional Chinese medicine, which affects the scientificity, transparency, applicability, promotion and application of the guidelines of traditional Chinese medicine or integration of traditional Chinese and Western medicine. This study discusses the guiding principle of "evidence as a core, consensus as a supplement, and experience as a reference" that was generally followed and puts forward detailed methodological suggestions to the formulation of guidelines for traditional Chinese medicine and integration of traditional Chinese and Western medicine.
Objective To evaluate the quality of Chinese literatures on the methodology of D-dimer diagnostic test. Method We searched CNKI (1994 to 2006) and CBM (1978 to 2006) for articles involving the diagnostic tests of D-dimer for coagulation disorders. Result A total of 63 relevant articles were retrieved and 7 were included in our review. Only one of these provided useful data on two two table for the evaluation of diagnostic accuracy. Conclusions Few studies on the diagnostic tests of D-dimer have been performed and publ ished in China, all of poor quality. Further studies should focus on clinical diagnostic sensitivity and specificity, so as to provide more valuable information for readers.
Based on the principles and methods of systematic review of randomized controlled clinical trials, systematic review of economic analyses can integrate information from multiple economic studies which focus on the same clinical questions. It can also provide important insights by systematically examining how differences among studies lead to different results. Generally, there are seven steps to conduct such a review: 1) formulating questions; 2) establishing eligibility criteria; 3) searching and selecting eligible economic analyses; 4) assessing the validity of economic analyses; 5) acquiring data; 6) analyzing and synthesizing data; and 7) presenting results. Owing to the specificity of economic analyses, many methodological challenges exist, including the varieties of economic models, analytic perspectives, time horizons, and uncertainty and sensitivity analysis among different economic analyses. This may cause difficulties for critical assessment of the economic analyses.
The formulation process of recommendations in evidence-based clinical practice guidelines was often complex and cumbersome. This paper described the evolution of levels of evidence and strength of recommendations in medical research and analyzed existing problems when making recommendations. We also summarized and introduced the method of formulating the final recommendation. At present, there isn’t a perfect and uniform method to guide the formulation of recommendations. But some organizations provided different content frameworks or auxiliary tools to guide formulation of recommendations. Developers of evidence-based clinical practice guidelines can learn from their experiences, combine with their own characteristics of guidelines such as specific target population and specific clinical situations, establish a rational method of recommendations formation.
The background and status of the quality assessment instruments of clinical trials, and several frequently used instruments both domesticly and abroad were introduced, and the problems in this field were discussed.
Background As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
Indirect comparison refers to a comparison of different healthcare interventions using data from separate studies, and is often used because of a lack of, or insufficient evidence from head-to-head comparative trials. We aimed to summarize the definition, fundamental theory, type, relevant statistical contents, and to clarify some question on how to use indirect comparison, in order to attract more researchers' attention and promote methodological development of indirect comparison.
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.