When prioritizing clinical questions in the development of the clinical practice guidelines, clinical questions with high recognition and low variability, or high score and less disagreement among experts were often prioritized, while questions with high recognition but high variability were excluded. By this approach, clinical questions with practical value but also showed high variability due to different causes were not accepted as priorities. There were some methodological and clinical limitations by doing so. By summarizing the causes and connotations of expert opinion variability in terms of clinical experience, expertise and values, this paper analyzed the advantages of the variability quantification application, and proposed corresponding methodological recommendations, so as to provide references for guideline developers in the priority selection of clinical questions.
Since the concept of core outcome set (COS) was introduced into clinical trials of traditional Chinese medicine (TCM), researchers have paid much more attention to develop COS for specific diseases. Although researchers believe that the characteristics of TCM, such as syndromes, should be considered in the COS of TCM, it was insufficiently addressed. In addition, the naming of TCM syndromes has not been standardized, and the classification and diagnostic criteria for specific diseases have been inconsistent. Thus, it is difficult to include TCM syndromes in the COS. Different diseases may show similar TCM syndromes which makes research difficult. Based on previous studies, this paper provided methods of developing core TCM syndromes set according to the model of combination of disease and syndrome and the model of syndrome dominating disease to provide references for future researches.
World Federation of Acupuncture-Moxibustion Societies (WFAS) standard Norms for Formulation and Evaluation of the Clinical Practice Guidelines of Acupuncture and Moxibustion (Hereinafter referred to as Norms) is the first methodological specification for the development of guidelines of acupuncture and moxibustion (Acup-Mox) issued by an international academic organization. The Norms stipulates the principles, procedures, review process and requirements of the development of WFAS guidelines of Acup-Mox. It also proposes the development method, evaluation method, and reporting standards of WFAS guidelines of Acup-Mox. This article introduces the development process of the Norms and provides an interpretation of the methodological supplementary requirements for key links such as "formulation of clinical questions", "evidence retrieval, evaluation and synthesis", and "consensus decision-making", as well as the "framework and contents of recommendation" to provide relevant references for users in learning and using the Guidelines.
This article introduces development methods and notices about evidence-based clinical practice guidelines of ventilator-associated pneumonia (VAP) and discuss the similarities and differences between GRADE system and the methodological studies of other clinical guidelines, focusing on the analysis of literature retrieval, quality of evidence, formation of recommendation strength, and detailed measures on how to ensure correct understanding and rationally using the GRADE system. Applying the GRADE system to develop evidence-based clinical practice guidelines of VAP could clearly present the quality of evidence and make recommendations.
AMSTAR (Assessment of Multiple Systematic Reviews) is currently developed as a measurement tool with extensive application to assess the methodological quality of systematic review/meta-analysis. It has good reliability, validity, and responsibility, and has been widely applied. This paper introduces AMSTAR to researchers and users in China, in view of development procedure, assessment items, and application status.
ObjectiveTo use the evidence map system to search and sort out the clinical research on the prevention and treatment of hyperlipidemia with proprietary Chinese medicine, and to understand the distribution of evidence in this field. MethodsThe literature on the treatment of hyperlipidemia with proprietary Chinese medicines was retrieved from CNKI, WanFang Data, VIP, SinoMed, PubMed, Cochrane Library, Embase and Web of Science databases from inception to December 2022. The distribution characteristics of evidence were analyzed and presented by means of text and graph. ResultsA total of 865 articles were included and 79 kinds of proprietary Chinese medicines were obtained. The Xuezhikang tablets or capsules were the most frequently used. In recent years, the number of published articles showed a downward trend, and the literature quality was generally low. Most of the research intervention programs only used Chinese patent medicine, and the sample size of a single study was mostly 60-100 patients, and the study course was 4-8 weeks. Clinical studies did not highlight the characteristics of traditional Chinese medicine, and only 12.7% of the studies limited the syndrome type of traditional Chinese medicine in the study population. In terms of the selection of outcome indicators, more attention was paid to blood lipid levels and safety indicators, while less attention was paid to indicators such as traditional Chinese medicine syndrome scores. ConclusionThe results show that Chinese patent medicine has certain advantages in the prevention and treatment of hyperlipidemia, but there are some deficiencies in the reports of methodology and clinical characteristics, and the overall quality of the research is low.
Objective To investigate the methodological characteristics of observational studies on the correlation between drug exposure during pregnancy and birth defects. Methods The PubMed database was searched from January 1, 2020 to December 31, 2020 to identify observational studies investigating the correlation between drug use during pregnancy and birth defects. Literature screening and data extraction were conducted by two researchers and statistical analysis was performed using R 3.6.1 software. Results A total of 40 relevant articles were identified, of which 8 (20.0%) were published in the four major medical journals and their sub-journals, 21 (42.5%) were conducted in Europe and the United States, and 4 were conducted (10.0%) in China. Cohort studies (30, 75.0%) and case-control studies (10, 25%) were the most commonly used study designs. Sixteen studies (40.0%) did not specify how the databases were linked. Sixteen studies (40.0%) did not report a clear definition of exposure, while 17 studies (42.5%) defined exposure as prescribing a drug that could not be guaranteed to have been taken by the pregnant women, possibly resulting in misclassification bias. Six studies (15.0%) did not report the diagnostic criteria for birth defects and 18 studies (45.0%) did not report the types of birth defects. In addition, 33 studies (82.5%) did not control for confounding factors in the study design, while only 19 studies (47.5%) considered live birth bias. Conclusion Improvements are imperative in reporting and conducting observational studies on the correlation between drug use during pregnancy and birth defects. This includes the methods for linking data sources, definition of exposure and outcomes, and control of confounding factors. Methodological criteria are needed to improve the quality of these studies to provide higher quality evidence for policymakers and researchers.
This study comprehensively reviews the theoretical foundations, historical development, practical applications, and potential challenges of network meta-analysis of diagnostic test accuracy (DTA-NMA). DTA-NMA, as a method for evaluating and comparing the accuracy of different diagnostic tests, demonstrates its unique value in improving diagnostic accuracy and optimizing treatment strategies by integrating direct and indirect evidence, providing crucial support for clinical decision-making. However, despite significant progress in methodology and practice, DTA-NMA still faces multiple challenges in implementation, including enhancing research transparency, integrating diverse evidence, accurately assessing bias risks, presenting and interpreting results, and evaluating evidence quality. In the future, further refinement of reporting standards and evidence grading specific to DTA-NMA research will be crucial for the development of this field, facilitating evidence-based efficient medical decision-making and ultimately improving patient outcomes. This study aims to provide scholars conducting DTA-NMA research with reflection and insights to promote the steady development of this field.
Scoping reviews are intended to help researchers in complex and extensive fields can better address exploratory research questions, comprehensive and systematic understanding of the current development of a field. However, the current scoping review needs to be unified in the implementation process, and the emergence of the JBI scoping review execution process can solve this problem well, which combines and improves the framework of the previous execution process, and regulates the whole process of scoping review production in depth and comprehensively from the aspects of the research purpose and questions, inclusion criteria, search, screening, data extraction, and analysis of the results, etc., and it has a strong authority and professionalism. Therefore, in order to help researchers better carry out and implement the scoping reviews, this paper focuses on the JBI scoping review execution process, and through detailed interpretation of the JBI scoping review execution process and demonstration of examples, it provides references for researchers to correctly apply the JBI scoping review execution process, in order to enhance the transparency and reliability of the research results, and to promote the scientific application of scoping reviews in China.
Evidence-based medicine advocates to support clinical decision-making with the best evidence, which is useful to objectively evaluate the clinical efficacy of traditional Chinese medicine and optimize clinical diagnosis and treatment. However, significant individualized characteristics identified from syndrome differentiation and treatment are incompatible with evidence-based clinical decision-making, which highlights population-level evidence, to some extent. In recent years, a number of new methods and technologies have been introduced into individualized clinical efficacy evaluation research of traditional Chinese medicine to assist managing and processing complex and multivariate information. These methods and technologies share similarities with evidence-based medicine, and are expected to link the clinical practice of traditional Chinese medicine with evidence-based clinical decision-making. They will guide the development of evidence-based clinical decision-making in traditional Chinese medicine.