This article discussed the development and current situation about both national and international diagnostic practice guidelines, as well as the role of evidence based medicine and systematic reviews in the development of such guidelines. Authors also analyzed the opportunities and challenges developers faced, and the methods and processes of development. Finally, authors proposed several strategic suggestions about how to improve the quality of diagnostic practice guideline in China.
Objective To explore the methodological characteristics of Chinese clinical practice guidelines/expert consensus based on usage of GRADE. MethodsCNKI, PubMed, WanFang Data databases, and Medlive.cn were electronically searched to collect Chinese clinical practice guidelines/expert consensus over the past 11 years from January 1st 2010 to December 31st 2020. Four reviewers independently extracted data according to the content of appraisal of guidelines quality evaluation tool AGREE Ⅱ. The clinical practice guidelines/expert consensus were divided into two groups based on whether GRADE was used or not. The changes and development of methodological quality in the past 11 years were explored between the two groups. ResultsIn recent years, the number of clinical practice guidelines/expert consensus which used the GRADE in China had increased annually. The practice guidelines/expert consensus which did not use GRADE had lower methodology quality (P<0.01). ConclusionsThe use of GRADE in clinical practice guidelines/expert consensus requires improvement, and mastering GRADE methodology can effectively improve the methodological quality of the clinical practice guidelines/expert consensus.
Grading the evidence of systematic reviews on animal studies will contribute to the improvement in the feasibility of transforming the results of animal studies into clinical trials or clinical practice. High quality evidence from animal studies is more likely to be successfully applied into clinical practice (i.e. more confident). Therefore, the present study will introduce the principles, methods and challenges of the application of GRADE in systematic reviews on animal studies.
Objective To evaluate the relevant systematic reviews/meta-analyses that focused on the prevention and treatment of complications after impacted tooth extraction. Methods The systematic reviews/meta-analyses on the prevention and treatment of complications after impacted tooth extraction were searched in PubMed, The Cochrane Library, CBM, CNKI and WanFang Data from inception to September 30th, 2012, and a total of 15 professional journals and the references of included studies were also retrieved manually. Two reviewers screened the literature according to the inclusion criteria and extracted the data. Then the AMSTAR was used to evaluate the quality of the included studies, and the GRADE system was used to evaluate the quality of evidence. Results A total of twelve relevant systematic reviews/meta-analyses were included, of which five focused on the prevention and treatment of dry socket, six on the prevention of swelling, seven on the prevention and treatment of pain, six on the prevention of limitation of mouth opening, two on the prevention of infection, three on the prevention of bleeding, and one on the treatment of nerve damage after tooth extraction. Based on AMSTAR, seven studies were minor limitations and five studies were moderate limitations. Based on GRADE system, two was high quality of evidence, twelve were moderate, nine were low, and seven were very low. Conclusion Currently, the systematic reviews/meta-analyses on the prevention and treatment of complications after impacted tooth extraction can provide some references for clinical practice, which should be combined with the real condition by clinical doctors when making an evidence-based decision. However, it also suggests performing more high quality and large sample studies to prove this conclusion.
ObjectiveTo systematically summarize and evaluate the existing evidence of Qishen Yiqi dropping pill (QSYQ) in the treatment of chronic heart failure (CHF), and to evaluate its quality. MethodsThe PubMed, Cochrane Library, EMbase, Web of Science, CNKI, CBM, WanFang Data databases were electronically searched to collect systematic reviews/meta-analyses(SRs/MAs) related to objectives from inception to December 31, 2022. Two researchers independently screened the literature and extracted data, and assessed the methodological quality, risk of bias, reporting quality, and quality of evidence of included SRs/MAs by using Assessment of Multiple Systematic Reviews 2 (AMSTAR-2), the Risk of Bias in Systematic(ROBIS) scale, the list of Preferred Reporting Items for Systematic Reviews and Meta-Analysis(PRISMA), and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. ResultsThis overview included 17 SRs/MAs. The methodological quality, reporting quality, risk of bias, and quality of evidence for outcome measures of SRs/MAs were all unsatisfactory. All SRs/MAs were of low quality according to the results of the AMSTAR-2 assessment. And only a small number of SRs/MAs were assessed as low risk of bias based on the results of the ROBIS assessment. The evaluation results of the PRISMA checklist showed that the report quality of the 24 studies included was relatively complete. According to the GRADE system evaluation results, 94% of the 84 outcome indicators were low-quality and very low-quality evidence. Limitations were the main factors leading to their degradation, followed by publication bias, inconsistency, imprecision and indirectness. ConclusionAt present, QSYQ has good clinical efficacy in the treatment of CHF, but the standardization and scientificity of clinical research and secondary research reports are insufficient, resulting in low quality of clinical recommendations evidence. In the future, it is necessary to further standardize and improve the quality of clinical and secondary research.
The focus of health equity is to enable the public to have fair access to health services and achieve satisfactory health outcomes. With research developments, guideline developers increasingly pay more attention to the fairness in the practice guidelines and have carried out exploration and practice in the relevant guidelines. The GRADE working group has begun to investigate how to use GRADE to assess health equity in practice guidelines since 2014. In 2017, the series of methodological guidelines of health equity in guideline development was officially published. It proposed 5 approaches to evaluate health equity and pointed out current methodological challenges of applying GRADE to assess health equity. This paper aims to introduce the GRADE equity guidelines, so as to provide a reference for Chinese researchers in their practice.
ObjectivesTo evaluate the methodological bias and the reliability of the conclusions of systematic reviews (SRs) of lanthanum carbonate in the treatment of chronic kidney disease with hyperphosphatemia. MethodsWe electronically searched databases including PubMed, EMbase, The Cochrane Library, PROSPERO, CNKI, CBM, WanFang Data and VIP to collect systematic reviews and meta-analysis about lanthanum carbonate in the treatment of chronic kidney disease with hyperphosphatemia from inception to August 31st, 2016. Two reviewers independently screened literature and extracted data, then AMSTAR tool was used to assess the methodological quality of included studies and the GRADE tool was used to grade the evidence quality of outcome measures included in the SRs. ResultsA total of eight relevant SRs were included and containing three main outcome measures. The assessment results of AMSTAR tool suggested that:four SRs were of high quality, and the other four were of medium quality. GRADE results showed:for serum phosphorus level, compared with placebo, the quality of the evidence of three SRs were medium, low and very low; compared with calcium carbonate or conventional phosphorus binder, four SRs were low, low, low and very low; compared with sevelamer, one SR was low. For serum calcium level, compared with placebo, the quality of the evidence of three SRs were high, medium and low, respectively; compared with calcium carbonate or conventional phosphorus binder, five SRs were low, low, low, very low and very low; compared with sevelamer, one SR was very low. For serum iPTH level, compared with placebo, the quality of the evidence of three SRs were medium, low and very low; compared with calcium carbonate or conventional phosphorus binder, five SRs were medium, low, low, very low and very low; compared with sevelamer, one SR was low. ConclusionAt present, methodological quality assessment for the treatment of hyperphosphatemia in chronic kidney disease with lanthanum carbonate is generally not high and the level of evidence for the conclusion is generally low. In drug safety, especially in the occurrence of adverse events of the digestive system is still controversial, and a large amount of high quality experimental is needed to demonstrate the safety of its long-term use. Clinicians need to be cautious in using these evidence to make clinical decisions.
GRADEpro GDT-Guideline Development Tool, is an online tool for the integration of important data and process of clinical practice guidelines and diagnostic guidelines. It is a new methodology progress of the GRADE system. This paper introduced how to use GRADEpro GDT to rate the quality of evidence in systematic reviews of intervention studies with an example.
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 investigate the status of research and development methods of Cochrane overviews. MethodsThe Cochrane Library and PubMed were searched up to March 2014 to identify Cochrane overviews. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data, and assessed and analyzed search strategy, quality assessment method, data analysis, and study results. ResultsA total of 18 Cochrane overviews were included. Among them, 4 (22.2%) overviews included formal statistical indirect comparison; 8 (44.4%) included only results from direct comparison; 6 (33.4%) only systematically analyzed current studies without data pooling; 12 (66.7%) only searched The Cochrane Library, while 6 (33.3%) expanded search to other databases; 14 (77.8%) applied the AMSTAR tool to assess methodological quality of included literature; 12 (66.7%) applied the GRADE system to assess the quality of evidence; and 9 (50%) yielded new outcomes. ConclusionCurrently, the development and reporting standards of Cochrane overviews are still immature. Investigators should choose proper methods based on research objectives when developing Cochrane overviews.