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.
Objective To evaluate the quality of evidence of systematic reviews or meta-analyses regarding outcomes in nursing field in China using the Grade system, so as to get known of the status of the quality of evidence and promote the application of the evaluation of the quality of evidence of systematic reviews. Methods The quality of evidence regarding the included outcomes was input, extracted and qualitatively graded, using GRADEpro 3.6 software. Then, we carefully analyzed and elaborated the factors of downgrading and upgrading that affects the quality of evidence in the process of evaluation. Results 53 systematic reviews or meta-analyses involving 188 outcomes were identified and evaluated. The results showed that high, moderate, low and very low levels of quality of evidence were 2.7%, 27.1%, 51.1%, and 19.1%, respectively; and low-level quality of evidence accounted for the most. Conclusion The quality of evidence produced by systematic reviews or meta-analyses in nursing field in China is poor and urgently needs improvement. The reviewers should abide by the methodological standards in the process of making systematic reviews or meta-analyses. The quality of evidence in terms of each outcome should be evaluated and fully reported.
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.
High-quality randomized controlled trials are the best source of evidence to explain the relationship between health interventions and outcomes. However, in cases where they are insufficient, indirect, or inappropriate, researchers may need to include non-randomized studies of interventions to strengthen the evidence body and improve the certainty (quality) of evidence. The latest research from the GRADE working group provides a way for researchers to integrate randomized and non-randomized evidence. The present paper introduced the relevant methods to provide guidance for systematic reviewers, health technology assessors, and guideline developers.
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。
在GRADE方法中，若多数相关证据来自高偏倚风险的研究，则起初被定为高质量证据的随机试验和低质量证据的观察性研究均有可能被降低质量等级。随机试验已确定的局限性包括：未进行分配隐藏、未实施盲法、未报告失访情况及未恰当考虑意向性治疗原则。最近提出的局限性包括：因明显获益而早期终止试验和基于结果选择性报告结局。观察性研究的主要局限性包括使用不合适的对照及未能充分调整预后的不平衡。偏倚风险可因不同结果而异（如全死因死亡率的失访远少于生命质量的失访），许多系统评价都容易忽略这一点。在决定是否因偏倚风险而降低质量等级时，不管是随机试验还是观察性研究，作者不应采用对各个研究取平均值的方法。相反，对任何单个结果，当同时存在高、低偏倚风险的研究时，则应考虑只纳入较低偏倚风险的研究。
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.
Previous methods of grading evidence for systematic reviews of diagnostic test accuracy have generally focused on assessing the certainty (quality) of evidence at the level of diagnostic indicators. When the question is not limited to follow the diagnostic test accuracy results themselves, the grading results may be inaccurate due to the lack of consideration of the downstream effects of the test accuracy in specific settings. To address these challenges, the GRADE working group conducted a series of studies focused on updating methods to explore or simulate important downstream effects of diagnostic test accuracy outcomes within a contextual framework. This paper aimed to introduce advances in the contextual framework of the GRADE approach to rate the certainty of evidence from systematic reviews of single diagnostic test accuracy.
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。