ObjectiveTo investigate the recommendations on imaging diagnosis in Chinese clinical practice guidelines (CPGs). MethodsWe electronically searched WanFang Data, VIP, CNKI and CBM databases from inception to December 31, 2014. Two reviewers independently screened literature and extracted data. The method of bibliometrics was used to analyze the data (including basic characteristics, strength of recommendation, quality of evidence, etc.). ResultsA total of 341 CPGs formulating the recommendations on diagnosis were included. 48.7% (166/341) guidelines developed the recommendations on imaging diagnosis (a total of 534). 25.7% (137/534) recommendations were with the symbols of quality of evidence and strength of recommendation, and 18.9% (101/534) with special words such as recommend, suggest. 22.3% (119/534) recommendations reported the strength of recommendation. Of which, 38.7% (46/119) were strong and 16.0% (19/119) were weak. However, 23.9% (11/46) strong recommendations were based on low quality of evidence. And 42.1% (8/19) weak recommendations were based on high quality of evidence. ConclusionAmong Chinese CPGs formulating the recommendations on diagnosis, the number of CPGs with recommendations on imaging is about 50%. And the quantity increases by years. The proportions of recommendations on imaging which report the strength of recommendation and/or quality of evidence are low. Meanwhile, the rating systems are uniform. Then the developers do not report the explanation for the strong recommendations based on low quality of evidence or the weak recommendations based on high quality of evidence in guideline.
直接证据来自直接比较我们关注的干预措施用于我们关注的患者人群，并测量患者重要结局的研究。间接证据可由以下4种方式之一产生。第一，患者可能与我们关注的患者不同（适用性一词常用于这类间接性）。第二，所检验的干预措施可能与我们关注的干预措施不同。有关患者和干预措施间接性的决策取决于对生物或社会因素差异是否大到可能使效应尺度出现预期的较大差异的考虑。第三，结果可能有别于最初设定的结局指标——如替代结果本身不重要，但测量之是基于替代结果的变化反映患者重要结局变化这一假设。第四类间接性在概念上与前三类不同，发生于临床医生必须在未经直接比较的两种干预措施间做出选择时。这种情况下比较治疗方案需要特定的统计方法，并根据患者人群、联合干预措施、结局测量指标及备选干预措施试验方法的差异程度，将证据级别降低1或2级。
It is a complex and time-consuming process to rate the certainty (quality) of evidence from network meta-analysis. This paper aims to introduce a web application for rating the certainty of network meta-analysis-the CINeMA. CINeMA is based on GRADE framework and contribution matrix of network meta-analysis, which considers 6 domains including within-study bias, across-studies bias, indirectness, imprecision, heterogeneity, and incoherence.
The methodology of conducting systematic review of prognostic studies has received a great deal of interest in recent years. Using GRADE for systematic review of prognostic studies, five aspects should be considered:risk of bias, indirectness, inconsistency, imprecision and publication bias. The methods of using GRADE system in systematic review of prognostic studies are similar to systematic review of interventional studies, meanwhile, there are differences. Not only the uniqueness of prognostic study but also the repeating downgrade should be taken into consideration in the GRADE process. Applying GRADE to systematic review of prognostic studies would be widely accepted along with the methodology development and quality improvement of systematic review of prognostic studies.
ObjectiveTo systematically review the research issues related to evidence quality grading methods for public health decision making. MethodsPubMed, Web of Science, CNKI, WanFang Data, CBM and VIP databases were electronically searched to collect studies related to the application of evidence quality grading methods for public health decision making from inception to December 2022. The questions were constructed according to the SPIDER model. The quality of the included literature was evaluated by using the CASP checklist, and a three-level interpretation analysis of the questions on the application of quality rating methods for public health decision making was conducted using the thematic synthesis method to establish a pool of question entries. ResultsA total of 14 papers were included, covering seven countries. GRADE was the commonly used method for grading the quality of evidence. CASP evaluation results showed eight high quality studies, four medium quality studies and two low quality studies. The thematic synthesis method summarized 13 question entries in 7 categories. ConclusionThe existing methodology for grading the quality of evidence for public health decision making suffers from the diversity of evidence sources and the underestimation of the level of evidence from complex intervention studies.
ObjectiveTo systematically review the researches on grading criteria for quality of evidence and strength of recommendations of traditional Chinese medicine (TCM). MethodsPubMed, EMbase, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect researches on grading criteria for quality of evidence and strength of recommendations of traditional Chinese medicine from inception to June 2021. Two reviewers independently screened literature, extracted data; and then, descriptive analysis was performed using qualitative methods. ResultsA total of 18 studies were included. Specifically, 8 studies presented both the level of evidence and the strength of recommendations, 9 presented the level of evidence, and 1 presented the strength of recommendations. Thirteen studies considered both TCM evidence and modern medical evidence sources, 3 included only evidence from ancient literature, 1 focused only on post-marketing safety evaluation of Chinese medicine, and 1 focused only on real-world studies of TCM. ConclusionCurrently, there are numerous criteria for TCM related quality of evidence and strength of recommendations, and some are developed only for TCM characteristic evidence. Most researchers of TCM guidelines expect to fully value the significance of ancient literature and expert experience or opinion in guideline development.
GRADE方法中，随机试验起评即为高质量证据，观察性研究起评即为低质量证据；但若证据本身存在高发表偏倚风险，则两者证据质量级别都应降低。即使最佳证据汇总表纳入的各项研究仅有低发表偏倚风险，发表偏倚仍会极大高估效应值。当可得证据来自小样本研究、且多数由厂商资助时，作者应怀疑存在发表偏倚。若干基于检验数据类型的方法可用于评价发表偏倚，其中最常用的为漏斗图，但这些方法都有较大局限。发表偏倚可能较常见，必须特别关注早期结果、对样本量与事件数都很小的早期试验结果尤需小心。
Evidence synthesis serves as a bridge between clinical practice and the best available evidence. Evidence synthesis based on high-quality randomized controlled trials is generally considered the highest level of evidence, but its external validity is limited. In some scenarios, the inclusion of non-randomized intervention studies (NRSI) in evidence synthesis may further supplement or even replace randomized controlled trial evidence, such as assessing intervention effectiveness and rare events in a broader population to provide more information for health care decision-making. With the rapid development of real-world data and the improvement of statistical analysis methods, real-world evidence, as an important source of evidence for NRSI, has accelerated the development of high-quality NRSI. However, there are numerous challenges in integrating evidence from randomized and non-randomized intervention studies due to selection and confounding biases caused by the lack of randomization. Based on previous studies, this paper systematically examines the current status of integrated randomized and non-randomized intervention studies, including integration premise, timing, methods, and result interpretation, in order to provide references for researchers and policy-makers to correctly use non-randomized research evidence and further promote optimal evidence generation and clinical practice translation.
The biggest advantages of network meta-analysis (NMA) are to compare the effectiveness of different interventions about one conditions using a quantitative way, pool the results of direct comparison and indirect comparison, and rank the effectiveness based on outcomes, so as to select the best decision for patients. In the paper we introduce the methods of applying GRADE system to NMAs based on the papers published by GRADE working group and other relative studies. The steps of using GRADE to NMAs are mainly based on four aspects: firstly, presenting direct and indirect effect estimates and 95% CI; secondly, rating of quality of direct and indirect estimates; thirdly, presenting the results of NMAs; and the last step is to rating the quality of NMA effect estimates. The methods of rating the quality of direct comparison are the same to use GRADE in traditional meta-analysis. The rating of the quality of the indirect estimates is based on the ratings of the two pairwise estimates that contributes to the indirect estimate of the comparison of interest. The lower confidence rating of the two direct comparisons constitutes the confidence rating of the indirect comparison. When both direct and indirect evidence are available, we suggest using the higher of the two quality ratings as the quality rating for NMA estimate. The four steps of rating the quality of NMA from GRADE working group have promoted the theoretical system of NMA. But the process requires the evaluators to be familiar with GRADE system, and conduct pilot test to make sure the evaluators had understood the items of GRADE system correctly. In addition, we also need to concern that the non-transitivity among different groups and the inconsistency between direct comparison and indirect comparison.
本文是GRADE（Grading of Recommendations Assessment，Development，and Evaluation）系列文章的导论。该系列文章为使用GRADE系统提供指导，介绍如何将该系统用于系统评价、卫生技术评估（HTAs）及临床实践指南中备选方案的证据质量评价和推荐强度评级。GRADE方法始于提出一个明晰的问题，包括对所有重要结果的详细说明。证据被收集和汇总后，GRADE提供了明确的标准来评价其质量，包括研究设计、偏倚风险、不精确性、不一致性、间接性及效应量大小。