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.
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.
Guideline Development Tool (GRADE pro GDT) is an online tool that addresses the integration of the important data and process of the clinical practice guidelines and diagnostic guidelines. GRADE pro GDT has been updated several times, including the whole style of the web page, details of the information recording, management of the conflict of interests, and the presentation and dissemination of the results. The new version of the tool is much more intellectualized and transparent, which makes the guideline development and rating quality of evidence more standardized and scientific. This paper introduces new aspects of this tool with examples.
Objectives To evaluate the methodological bias and the reliability of the conclusions of systematic reviews on acupuncture for polycystic ovary syndrome. Methods We comprehensively searched PubMed, EMbase, The Cochrane Library, CBM, CNKI and WanFang Data to collect systematic reviews on acupuncture for polycystic ovary syndrome from the establishment time of databases to January 5th, 2018. 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 systematic reviews. Results A total of 11 systematic reviews were included. The results of assessment using AMSTAR showed that, among the 11 items, most problems occurred in Item 5 " Were there any lists of research articles included and excluded”, followed by Item 1" Was an‘a prior’design provided?”and Item 11" Were potential conflict of interest included?”. GRADE grading results showed that quality of evidence for the outcome measure were" low”or" very low”. Conclusions Current acupuncture treatment of polycystic ovary syndrome has a certain effect, however, the quality of evidence is low. Thus, physicians should apply the evidence to make decision on acupuncture for polycystic ovary syndrome with caution in clinical practice and consider the actual situation, combined with the patient’s value preferences and economic factors.
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.
Depending on different designs of original studies, systematic reviews of diagnostic studies could be categorized into two kinds:one is based on diagnostic randomized controlled trials, of which the GRADE rating approach is similar to that of interventional systematic reviews; and the other is based on diagnostic accuracy tests, of which the GRADE rating approach is introduced in this article. This article explains the application of GRADE in systematic reviews of diagnostic accuracy tests mainly from the angle of theoretical analysis, including rationales, methods, and challenges.
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.
ObjectiveTo provide an overview of systematic reviews on the efficacy and safety of massage for the treatment of cervical spondylotic radiculopathy.MethodsCNKI, WanFang Data, VIP, CBM, PubMed, The Cochrane Library and EMbase databases were electronically searched to collect the systematic reviews on the efficacy and safety of massage for the treatment of cervical spondylotic radiculopathy from inception to December 30th, 2018. Two reviewers independently screened the literature and extracted the data, applied the AMSTAR2 scale to evaluate its methodological quality, and GRADE to evaluate the quality of the evidence.ResultsA total of 7 systematic reviews/meta-analysis were included. The AMSTAR2 scale evaluation showed that the quality of the included studies was extremely low. The GRADE evidence grading results showed that the quality of the VAS score outcome index of the two literatures was intermediate, and the quality of the OASCSR outcome index of one literature was intermediate. The quality of the remaining outcome indicators reported is low or very low.ConclusionThe available evidence shows that the efficacy and safety of manual treatment of cervical spondylotic radiculopathy is acceptable, but the overall methodological quality of the systematic review is extremely low, and the quality level of evidence is generally low. The future clinical trials and systematic reviews should be strictly followed. The scientific research design of the medical science provides high-quality evidence and provides reference for clinical practice.
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 formation, evaluation and grade division of real-world evidence (RWE) are bottlenecks restricting the in-depth development and scientific application of real-world study methods. This paper briefly reviewed the design grade and evidence grade of clinical medical research, and proposed the key points of evidence grade of real-world clinical research, including emphasizing the comprehensive evaluation of internal authenticity and external authenticity, determining the "starting point" of real-world evidence, and using the real-world evidence quality evaluation method. Based on the internationally recognized "grading of recommendations assessment, development, and evaluation (GRADE)", combined with the classification and characteristics of real-world evidence, a preliminary grading scheme was formed. An example was given to illustrate the grading suggestion.