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.
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.
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 provide methodological guidance for the application of matching-adjusted indirect comparison (MAIC). Methods The methodology literature on MAIC was examined to clarify key steps and methodological points, and MAIC application literature in the non-small cell lung cancer field published after January 2016 was systematically reviewed to compare and analyze the current status and problems of MAIC. Results MAIC consisted of five key steps: data source and sample selection, matching variable screening, individual weight calculation, matching validity evaluation, and relative efficacy calculation. The systematic review revealed that studies primarily employed literature reviews to screen data sources, used statistical analysis and other scientific methods to screen matching variables, employed software for individual weight calculation, evaluated matching validity by reporting effective sample size (ESS), calculated relative efficacy using Cox, logistic, and other models, conducted sensitivity analyses to evaluate the uncertainty caused by different data sources and matching variable combinations, and the studies demonstrated good overall reporting standardization but significant differences in particular aspects. Concerning the connection between MAIC and pharmacoeconomic research, studies included mainly used target drugs as the reference group of survival data extrapolation, and proportional hazards (PH) assumptions were considered when utilizing hazard ratios (HR) in extrapolation. Conclusion There are some deficiencies in the method application and reporting standards of MAIC research, such as lack of explanation of data source selection criteria and matching variable screening criteria, insufficient reporting of weight distribution, and inadequate consideration of PH assumptions. It is recommended that future MAIC research systematically screen data sources and report covariate distribution evaluation, covariate status evaluation, weight distribution, uncertainty measurement, etc. Additionally, considering PH assumptions after calculating HR is suggested.
The necessity and methods of systematic review or Meta-analysis of observational studies were introduced. The difference between the systematic review or Meta-analysis of observational studies and randomized controlled trials was also described.
背景与目的 对卫生保健干预措施进行决策权衡需要有不良和有益的可靠证据,然而绝大多数系统评价针对的是研究方法非常成熟的随机对照试验及其有效性评价,系统地评价不良反应的方法尚未完善,对研究者而言,能作为相关指南的资源很少.为此,作者在文中报告了对不良反应进行系统评价的新近体会,同时提出进一步实践和研究的建议.方法 描述并比较3个包含不良反应评价的药物干预的系统评价的方法学,重点评价其研究问题、研究设计和质量评价.结果 1个研究关注于如何根据提供的特殊不良反应数据建立卫生经济学模式,而其它两个研究涉及更广泛的问题.尽管每个评价对纳入标准的定义不同,但它们均纳入了随机和观察性数据.对研究质量的评价采用了标准方法.由于研究设计不良、报告不充分和现有研究工具有限,在运用纳入标准和评估研究质量时,研究者遇到了各种问题.最终发现,3个评价都做了大量的工作,但对卫生保健决策者有用的资料不多.研究者确认,改善的关键在于如何提出系统评价的问题和发展不良反应研究的质量评价方法学.结论 若不良反应的系统评价只专注于一个中心问题,那么它会提供与临床决策更相关的资料,也有利于明确纳入系统评价研究的类型.系统评价中不良反应的质量评估的方法学需要进一步完善.
At present, there are many items/checklists used to assess the methodological quality of animal studies. Yet, no tool has been specifically designed for assessing internal validity of animal studies. This articles introduce and interprets SYRCLE's risk of bias tool for animal studies in detail for Chinese scholars to accurately assess the methodological quality of animal studies when they develop systematic reviews on animal studies, so as to provide references for scientific design and implementation of animal studies.
Objective To assess the methodological quality and reporting quality of meta-analysis published in Chinese Acupuncture & Moxibustion. Methods We searched CNKI database to collect meta-analysis published in Chinese Acupuncture & Moxibustion up to 2015. Methodological quality assessment was carried out using AMSTAR tool, and quality assessment was carried out by PRISMA checklist. Data analysis was performed by using SPSS 19.0 software. Results A total of 31 meta-analyses were enrolled. Among all the 31 meta-analyses, the first authors came from 19 institutions, and 21 meta-analysis were supported by fundings. All meta-analyses were about the evaluations of acupuncture intervention, involving 10 disease systems (ICD-10) and sub-health. The mean score of the methodological assessment was 7.42±1.13. In addition, the mean score of reporting quality was 18.79±2.04. Conclusion The meta-analyses published in Chinese Acupuncture & Moxibustion have high quality on methodology as well as reporting. Due to the limited quality and quantity of included studies, the above results are needed to be further assessed by more studies.
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.
ObjectiveTo evaluate the methodological quality of animal experiments published in high impact journals, in order to provide references for improving the quality of animal experiments.MethodsCSCD and Web of Science databases were electronically searched to collect intervening primordial animal experiments from 2014 to August, 2016. Four reviewers independently screened literatures, extracted data and assessed the methodological quality of included studies by using SYRCLE tool.ResultsA total of 1 999 animal experiments were included. The cited frequency of more than 90% studies were ≤5 times, and of which 52.53% studies were zero. The results of SYRCLE evaluation showed that 54.55% of sub items rated as "low risk" were less than 30%. And 84.62% of them were less than 10%.ConclusionThere are defeet in methodological quality of animal experiments either domestic or abroad. The problems of domestic researches in implementation bias, measurement bias and loss of access bias are particularly obvious. The coincidence rates of "low risk" are much lower than those of abroad studies. Therefore, we suggest that it is necessary to take specific measures to popularize SYRCLE tool to effectively guide the development of animal experiments and improve the design and implementation of animal experiments.