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.
The use of core outcome sets reduces heterogeneity in the reporting of outcomes in clinical trials, increasing the value and significance of research. This paper first introduces and interprets “core outcome sets for myocardial infarction (COS-MI) in clinical trials of traditional Chinese medicine and Western medicine”, in order to help Chinese researchers better understand and use it. Second, this study surveyed the use of COS-MI in MI related clinical trials from January 1, 2023 to June 1, 2024, showing that 91% (10/11) of the 35 acute myocardial infarction clinical studies included reported core outcomes, and the median percentage of using core outcome sets was only 36% (4/11). As the publication time of the core outcome set is close to the literature search time, the understanding of domestic researchers about it is still unclear. Further research is needed to explore the application of core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine, providing a reference for its update and improvement.
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.
ObjectiveTo evaluate the methodological quality of cross-sectional surveys about Chinese medicine syndrome in a population at potential risk of cerebrovascular diseases. Methods The CNKI, WanFang Data, CBM and PubMed databases were electronically searched to collect cross-sectional surveys about Chinese medicine syndromes in a population at potential risk of cerebrovascular diseases from inception to December, 2022. The methodological quality was assessed using the JBI scale. Results A total of 105 studies were included. The average reporting rate of JBI was 52.06%, and the items with the highest scores included "sufficient coverage of the identified sample in data analysis" (100%), "description of study subjects and setting" (92.38%), and "using valid methods for the identification of the condition" (86.67%). Items with the lowest scores included "adequate sample size" (13.33%), "adequate response rate or low response rate managed appropriately" (14.29%), and "study participants recruited in an appropriate way" (20.95%). Subgroup analysis suggested that type of publication and number of implementation centers were potential factors influencing methodology quality (P<0.05). Conclusion The methods essential to a cross-sectional survey such as sampling, sample size calculation and handling with the response rate, and the syndrome diagnosis scales specific to Chinese medicine require further improvement.
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.
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.
目的 系统评价可作为将基础生命科学研究从实验室转化到人体研究和健康保健措施的工具。对动物研究的系统评价是否系统且不存在偏倚，目前尚不知。 方法 我们检索了MEDLINE、EMBASE、已知系统评价的参考文献（1996~2004）并联系相关专家，至少检索一个对公众开放的数据库全面收集基础科学文献的引文，均未设定语言限制。我们从中纳入那些在动物身上测量实验室参数或在活体动物身上给予治疗以评价疗效研究的系统评价，并将其与在实验室中研究人体或动物组织、细胞系统或器官标本以进一步了解疾病机理体外研究的系统评价进行比较。 结果 动物研究的系统评价通常缺少如定义供检验的假设（9/30，30％）；文献检索不设语言限制（8/30，26.6％）；评价发表偏倚（5/30，16.6％）、研究的真实性（15/30，50％）和异质性（10/30，33.3％）；及使用Meta分析用于定量合成（12/30，40％）等方法学特征。与体外研究的系统评价相比，动物研究的系统评价更多地限定了研究问题（96.6％ vs. 80％，P=0.04）、综合检索了多个数据库（60％ vs. 26.6％，P=0.01）、评价了研究质量（50％ vs. 20％，P=0.01）及探讨了研究异质性（33.3％ vs. 2.2％，P=0.001），因此更少出现偏倚。 结论 在各类系统评价中，方法学质量问题的出现频率似乎存在一定的梯度：虽然与人体临床试验的系统评价相比，整体动物研究的系统评价质量明显较差，但其仍优于体外研究的系统评价。在系统评价动物研究时，有必要更严格。
Objective To explore the methods used for developing evidence-based clinical practice guidelines for acupuncture. Methods Based on the characteristics of acupuncture in traditional Chinese medicine,and principles of evidence-based medicine, this article introduces and summarizes the processes and methods for developing an evidence-based clinical practice guideline for acupuncture. We analyzed similarities and differences between clinical practice guidelines for acupuncture and for other interventions. We used an evidence-based clinical practice guideline of acupuncture for depression as an example to illustrate the methods of literature search, grading of evidence and recommendations, evidence evaluation and consensus formation. Results Preliminary recommendations on the methods for developing evidence-based clinical practice guidelines for acupuncture were made. Conclusion Based on the optimized rational methodology for developing clinical guidelines, evidence-based high-quality clinical practice guidelines for acupuncture could be established.
Objective To systematically review the methodological quality of research on clinical prediction models of traditional Chinese medicine. Methods The PubMed, Embase, Web of Science, CNKI, WanFang Data, VIP and SinoMed databases were electronically searched to collect literature related to the research on clinical prediction models of traditional Chinese medicine from inception to March 31, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies based on prediction model risk of bias assessment tool (PROBAST). Results A total of 113 studies on clinical prediction models of traditional Chinese medicine (79 diagnostic model studies and 34 prognostic model studies) were included. Among them, 111 (98.2%) studies were rated at high risk of bias, while 1 (0.9%) study was rated at low risk of bias and risk of bias of 1 (0.9%) study was unclear. The analysis domain was rated with the highest proportion of high risk of bias, followed by the participants domain. Due to the widespread lack of reporting of specific study information, risk of bias of a large number of studies was unclear in both predictors and outcome domain. Conclusion Most existing researches on clinical prediction models of traditional Chinese medicine show poor methodological quality and are at high risk of bias. Factors contributing to risk of bias include non-prospective data source, outcome definitions that include predictors, inadequate modeling sample size, inappropriate feature selection, inaccurate performance evaluation, and incorrect internal validation methods. Comprehensive methodological improvements on design, conduct, evaluation, and validation of modeling, as well as reporting of all key information of the models are urgently needed for future modeling studies, aiming to facilitate their translational application in medical practice.
Objective To evaluate the methodological quality of clinical practice guidelines and consensuses of robot-assisted surgery. Methods The guidelines and consensuses were screened according to the inclusion and exclusion criteria by searching the domestic and overseas guidelines network and electronic database from 1 January, 2000 to 29 December, 2021. The Appraisal of Guidelines for Research and EvaluationⅡ (AGREEⅡ) instrument was used independently by two evaluators to evaluate the guidelines and consensuses. The consistency test of intraclass correlation coefficient (ICC) was carried out for two evaluators, and the score of guidelines and consensuses in the six domains of AGREEⅡ were calculated. Results A total of 34 guidelines and consensuses were included, including 10 guidelines and 24 consensuses. The ICC was all greater than 0.75, indicating that the consistency of the two evaluators was high. The average scores of the 34 guidelines and consensuses in the six domains of AGREEⅡ (scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability and editorial independence) were 81.0%, 43.5%, 28.2%, 81.5%, 12.7% and 51.7%, respectively. Conclusion These evaluated guidelines and consensuses of robot-assisted surgery still need to be improved in the domains of rigor of development, applicability and editorial independence. With the continuous development of robot-assisted surgery, more guidelines and consensuses based on higher level of evidence will be developed to promote the standardized use of robot-assisted surgery.