ObjectiveTo evaluate the methodological bias and the reliability of the conclusions of systematic reviews (SRs) about traditional Chinese medicine for essential hypertension. MethodsWe comprehensively searched PubMed, EMbase, The Cochrane library (Issue 4, 2014), CBM, CNKI and WanFang Data to collect SRs of traditional Chinese medicine for essential hypertension from the establishment time of databases to April 30th, 2014. The AMSTAR tool was applied for methodological quality assessment of included studies, and the GRADE system was applied for evidence quality assessment of included outcomes of SRs. ResultsA total of 12 SRs involving 31 outcomes were included, of which 11 SRs focused on the comparison of therapeutic effects between traditional Chinese medicine combined with western medicine and western medicine alone. Nine SRs adopted Jadad tool to assess methodological quality of included original studies. The results of assessment using AMSTAR showed that, among 11 items, there were the most problems concerning Item 1 "Was an 'a prior' design provided?" (none of the 12 SRs provided it); followed by Item 11 "Were potential conflict of interest included?" (nine SRs didn't described it), and Item 6 "Were the characteristics of included studies provided" (six SRs didn't provided it). The results of grading showed that, 29 outcomes were graded as "low" or "very low" quality. The main factors contributed to downgrading evidence quality were limitations (31 outcomes), followed by imprecision (12 outcomes), and inconsistency (13 outcomes). ConclusionCurrently, the methodological quality of SRs about traditional Chinese medicine for essential hypertension was poor on the whole, with low quality of evidence as well as lack of enough attention to the end outcomes of patients with essential hypertension. Thus, physicians should apply the evidence to make decision about traditional Chinese medicine for essential hypertension with caution in clinical practice.
In 2014, the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group published guidance in BMJ to evaluate the certainty of the evidence (confidence in evidence, quality of evidence) from network meta-analysis. GRADE working group suggested rating the certainty of direct evidence, indirect evidence, and network evidence, respectively. Recently, GRADE working group has published a series of papers to improve and supplement this approach. This paper introduces the frontiers and advancement of GRADE approach to rate the certainty of evidence from network meta-analysis.
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.
Adapting the existing guidelines in the context of specific regions can improve the efficiency of guidelines development, and reduce cost and time for developing guidelines. ADOLOPMENT is a methodological tool for guidelines adaptation, which was developed by the GRADE Working Group based on the standardized international guidelines making process. With ADOLOPMENT, developers can effectively use existing guidelines and evidence, avoid duplication of the evidence evaluation, and record the process from evidence to recommendations, which will ensure the transparency of adaptation, help users to understand the process, and improve the acceptability and credibility of guideline adaptation. This paper aims to introduce the ADOLOPMENT and its application.
We elaborated the reasons why systematic reviews need to use GRADE based on a couple of specific examples. Aiming to provide references to understand and use GRADE correctly, we also answered some frequently-asked questions and concerns about GRADE as follows: a) differentiating the uses of GRADE between its application in guidelines and in systematic reviews; b) how to determine the overall quality of evidence? c) can GRADE be used to access the quality of single study or not? d) different uses of GRADE between randomized controlled trials (RCTs) and observational studies; e) weight of GRADE items; and f) factors that might influence the results of GRADE and the balance between upgrading and downgrading.
Objective To evaluate the effectiveness and safety of Endostar combined with chemotherapy for non-small cell lung cancer (NSCLC). Methods Randomized controlled trials (RCTs) on Endostar combined with chemotherapy for NSCLC were searched in The Cochrane Library, MEDLINE, EMbase, VIP, CNKI, CBMdisc and other electronic databases. The quality of RCTs meeting inclusion criteria was evaluated and the data were extracted; meta-analyses were performed with RevMan 5.1 software, and then the GRADE System was used to rate the level of evidence and strength of recommendation. Results Among the 18 RCTs involving 1 825 cases included, 1 816 cases met the inclusion criteria. Meta-analyses showed that: compared with the single chemotherapy, Endostar combined with chemotherapy could increase the total effective rate (RR=1.85, 95%CI 1.56 to 2.11, Plt;0.000 01), and the clinical benefit response (RR=1.21, 95%CI 1.14 to 1.29, Plt;0.000 01), but decrease the incidence risk of leukopenia (RR=0.89, 95%CI 0.82 to 0.97, P=0.006). There were no signficant differences between the two groups in decreasing thrombocytopenia (RR=0.87, 95%CI 0.74 to 1.03, P=0.10), impaired renal function (RR=0.96, 95%CI 0.69 to 1.34, P=0.82), nausea and vomiting (RR=0.92, 95%CI 0.84 to 1.01, P=0.08) and other side effects. Based on GRADE, the level of evidence was Grade C, and the strength of recommendation was 2. Conclusion The present results of clinical trials show that Endostar combined with chemotherapy for NSCLC is a safe and effective therapy without increasing the toxic reaction and side effects; and based on GRADE, the level of evidence was Grade 2C, and the strength of recommendation was 2. However, in view of the limitations of this study, it is suggested that large-scale, high-quality researches on basic and clinical fields should be performed to further verify the above conclusion by critical outcome indicators.
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.
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.
ObjectivesTo evaluate the quality of methodology and evidence of the exiting systematic reviews (SRs) of acupuncture therapy for post-stroke spastic paralysis.MethodsCNKI, CBM, The Cochrane Library, PubMed and EMbase databases were electronically searched to collect SRs of acupuncture therapy for post-stroke spastic paralysis from inception to December 16th, 2018. Two reviewers independently screened literature, extracted data, and evaluated the quality of methodology and evidence by AMSTAR 2 scale and GRADE system.ResultsA total of 7 SRs were included. The results showed that acupuncture therapy had obvious advantages in treating post-stroke spastic paralysis without obvious adverse reactions. The results of AMSTAR 2 scale showed that the failure of key items 2 and 7 resulted in extremely low methodological quality. The results of GRADE system showed that 46.15% of which were low-level evidence quality, 42.31% were medium, 11.54% were extremely low, and no evidence quality were high.ConclusionsCurrent evidence shows that acupuncture and moxibustion therapy is effective in treating spastic paralysis after stroke, however, the quality of the SRs is low. The studies are required to be standardized and combined with the characteristics of TCM to obtain high quality evidence in the future.
ObjectiveTo analyze the current situation of adaptation guidelines. MethodsCBM, CNKI, VIP, WanFang Data, PubMed, EMbase, GIN, SIGN, NICE and AHRQ databases were electronically searched to collect studies related to adaptation guidelines from inception to August 31th, 2020. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Descriptive analysis was then conducted on the general situation of the adaptation guidelines. ResultsA total of 83 studies were included, involving 63 full-text studies, 16 methodological studies and 4 secondary studies. The quantity of published articles of the adapted guidelines had an overall upward trend, and 48.39% of the adapted guidelines were published in UK-hosted journals. 51.81% of the adapted guidelines reported receiving funding or project funding during the development process, and 67.46% reported information of conflict of interests. Among the 33 adaptation guidelines published in the past five years, 33.34% reported their methodology used ADAPTE, 6.1% reported their methodology used GRADE-Adolopment, and 60.56% did not report the adaptation method. ConclusionsAt present, the international research on the adapted guideline is extensive, however, it is still in its infancy in China. The adaptation guideline is also required to be based on a theoretical framework, standardize the development of methodology, and ensure the quality of the adaptation guideline.