Clinical practice guidelines (CPGs) serve as the cornerstone of medical decision-making, with evaluation tools such as AGREE and RIGHT designed to ensure that these guidelines are grounded in the best available evidence and contribute to enhancing healthcare quality. This article reviews the historical development and current status of CPG evaluation tools, examining their diversity, complexity, application challenges, and inconsistencies in evaluation outcomes. A thorough discussion is provided on the strengths and weaknesses of existing evaluation tools, along with proposed future developmental directions. It is recommended that future efforts prioritize the creation of more streamlined tool designs, foster enhanced international collaboration strategies, and incorporate artificial intelligence technologies. These initiatives aim to improve both the efficiency and accuracy of evaluative processes while facilitating advancements in healthcare practices towards elevated quality standards.
Objective To assess the methodological quality of clinical guidelines and consensus of lupus nephritis, to collect the recommendations of each guideline, and to provide references for clinical decision-making. Methods PubMed, CNKI, and CBM databases and related websites such as NGC, NICE, GIN, SIGN, and Medive were electronically searched from January 2012 to December 2020 to collect the clinical guidelines and expert consensus for lupus nephritis. After consistency evaluation by four evaluators, the methodological quality of the included guidelines or expert consensus was evaluated using AGREE Ⅱ. The relevant recommendations, evidence level, and recommended strength of each guideline in treating lupus nephritis were summarized. Results A total of eight guidelines and two consensus statements were included. Among them, eight guidelines or consensus statements were level B (generally recommended guidelines), and two were level C (non-recommended guidelines). Relevant recommendations mainly gave the corresponding treatment scheme according to the pathological type of lupus nephritis. Conclusion The methodological quality of lupus nephritis guideline formulation in China needs to be improved. The included guidelines and consensus can provide reference for clinical decision-makers. However, higher-quality clinical practice guidelines for the Chinese population are needed to be developed in the future.
ObjectiveTo systematically review the methodological quality of Chinese clinical practice guidelines (CPGs) for diagnosis and management of diabetic foot.MethodsCNKI, WanFang Data, VIP, CBM, Yimaitong databases, website of Diabetes Branch of Chinese Medical Association, website of Chinese Integrative Medicine Association and website of Peripheral Vascular Disease Professional Committee of Chinese Society of Microcirculation were electronically searched to collect relevant CPGs from inception to May, 2020. Four researchers independently evaluated the CPGs methodological quality by using AGREEⅡ tool.ResultsA total of 10 Chinese CPGs for diabetes foot were included. The standardized mean scores for various fields were 75.74% for scope and purpose, 36.58% for stakeholder involvement, 28.61% for rigor of development, 86.30% for clarity and presentation, 43.47% for applicability, and 9.44% for editorial independence. ConclusionsThere are merely a small quantity of diabetic foot guidelines in China, and the methodological quality is insufficient. Therefore, more attention should be focused on the establishment of guidelines in the future, so as to further improve the quality of Chinese diabetic foot guidelines.
Objective To survey and analyze the quality assessment of the included studies in the Overviews of reviews (Overviews), so as to provide methodology references for Overviews authors. Methods A computerized search was performed for collecting Overviews in The Cochrane Library (Issue 1, 2010), PubMed, EMBASE, and CBM, and the search time ended by December, 2009. Then the relevant data, such as assessment standard etc, were extracted, and the staple standards were analyzed. Results A total of 43 typical Overviews were included. Thirty-two (74.4%) of them assessed the methodology quality of the included systematic reviews with different standards, including OQAQ (34.9%/15), AMSTAR (9.1%/3), Checklist from DARE (4.6%/2), Assendelft scale (4.6%/2), Effective Public Health Practice Project standards (2.3%/1), self-formulated standards (14.0%/ 6), syntaxic standards (2.3%/1), and other standards (4.6%/2). Ten Overviews (23.6%) assessed the quality of evidence, including eight (18.6%) applied the GRADE system. Only 7 studies (16.3%) assessed the quality of evidence and applied the GRADE system as well. Conclusion The quality assessment in Overviews includes the assessment of both methodological quality and evidence quality. But most Overviews do not assess comprehensively. The methodological quality standards applied in current Overviews are numerous and no standard is acknowledged. Yet, the OQAQ and AMSTAR are applied widely and recommended because they are comprehensive and easy to be conducted. It suggests that Overviews authors should choose appropriate methodological quality assessment standards according to concrete conditions. The GRADE system is much more comprehensive and systematic than other systems, so it is recommended that Overviews authors should apply GRADE to assess the quality of evidence in their studies in order to make the study results more comprehensive and easier for clinical application.
ObjectiveTo investigate the methodological and reporting quality of clinical trials involving Xiaoyao San for chronic fatigue syndrome. MethodsWe searched PubMed, CBM, CNKI, VIP and WanFang Data to identify randomized controlled trials (RCTs) about Xiaoyao San for chronic fatigue syndrome. The methodological and reporting quality of included RCTs was respectively evaluated according to the assessment tool of risk of bias of the Cochrane Handbook 5.1.0 and the CONSORT 2010 statement, combined with complementary assessment by the characteristic indicators of traditional Chinese medicine (TCM). The methodological and reporting quality of included case series study was respectively assessed by the methods recommended by the Britain's National Institute for Clinical Excellence (NICE) and the STROBE statement. ResultsA total of 27 clinical trials were included, involving 11 RCTs and 16 case series studies. According to the assessment tool of risk of bias of the Cochrane Handbook, 54.5% of the RCTs performed proper random method, 9.1% conducted allocation concealment and blinding, 72.7% selected intention-to-treat (ITT) analysis without the report of loss to follow-up, and no RCT existed selective reports. Corresponding to the characteristic indicators of TCM, 54.5% of the RCTs did not conduct TCM syndrome diagnosis, the curative effect standard of TCM syndrome was discrepant, and no RCT was multi-center study. The CONSORT 2010 statement indicated that no RCT explained sample size estimation, implementation details of randomization, flow diagram of participant, use of ITT and clinical trial registration. According to the items recommended by Britain's NICE, 6.25% of the case series studies were multi-center, 81.25% did not report clear inclusion and exclusion criteria, and no case series study performed continuous patient recruitment and stratification analysis of outcome. The STROBE statement indicated that no case series study reported research design, sample size, flow chart, bias, limitations and generalizability. ConclusionThe quality of clinical trials about Xiaoyao San for chronic fatigue syndrome is still low in methodological and reporting aspects. It is suggested that the future clinical trials should be conducted with references of CONSORT statement and STROBE statement, to propel the modernization and internationalization of TCM.
Objectives To evaluate the quality of ophthalmic clinical practice guidelines in China by using the AGREE Ⅱ instrument. Methods CBM, CNKI, VIP, and WanFang Data databases were electronically searched to collect Chinese guidelines for ophthalmology from inception to December 2017. Three reviewers independently evaluated the included guidelines using the AGREE Ⅱ instrument. Results A total of 60 Chinese clinical guidelines for ophthalmology were included. The average scores of the six domains including scope and purpose, stakeholder involvement, rigorism of development, clarity of presentation, applicability and editorial independence were 66.4%, 24.6%, 13.5%, 67.4%, 14.5%, and 19.3%, respectively. The guidelines published from 2013 to 2017 scored higher than those published previously in all areas except for domain 4 clarity of presentation. Conclusions The quality of current ophthalmic clinical practice guidelines in China is low, and there is still a big gap between them and the international guidelines. Guidelines developers should place more emphasis on developing regulations to improve stakeholder involvement, rigorism of development, applicability and editorial independence.
ObjectivesTo assess the methodological quality of Chinese clinical practice guidelines (CPGs) for respiratory diseases published in 2017, so as to provide evidence for developing and updating CPGs of this field in the future.MethodsWanFang Data, CNKI, VIP, CBM databases, Medlive and other related websites were electronically searched to collect Chinese CPGs for respiratory diseases published from January 2017 to December 2017. Four reviewers independently evaluated the quality of eligible guidelines by using Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ) instrument.ResultsA total of 37 guidelines were included. The mean scores of the six AGREE Ⅱ domains (scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, editorial independence) were 59.3%, 25.1%, 10.8%, 59.1%, 25.8%, and 7.3%, respectively. Only 1 guideline (2.7%) was recommended for clinical use, and 2 guidelines (5.4%) were recommended with modification.ConclusionsThe CPGs for respiratory diseases published in China in 2017 have higher quality than CPGs published prior to 2017, however great discrepancies exist when comparing with international guidelines of average level. More attention should be paid on the rigorousness of methodology and the practicality of content in the future development of CPGs.
ObjectiveTo investigate the reporting and methodological quality of systematic reviews/ meta-analyses conducted by hospital pharmacists in China, so as to improve the quality of systematic reviews/ meta-analyses in this field. MethodsThe literatures were retrieved from CNKI, WanFang Data, VIP, CBM, CMCI, PubMed, EMbase, The Cochrane Library from the establishment date to March 17th, 2016. According to the inclusive and exclusive criteria, authors independently screened and extracted the published information. Reporting and methodological quality of included reviews were evaluated by PRIMSA statements and AMSTAR checklists. Data analysis was conducted by using Excel 2013 software and SPSS 20.0 software. ResultsOne thousand and eighteen systematic reviews/ meta-analyses were included, including 871 Chinese literatures and 147 English literatures. The average score of PRIMSA was 18.41±2.84, and the average score of AMSTAR was 7.38±1.28. The main problems of PRIMSA were structured summary, objectives, protocol and registration, additional analyses and funding. The main problems of AMSTAR were priori design, status of publication and list of studies (included and excluded). Univariate analysis showed that some factors could improve the quality of methodology and reporting, including studies in English (P<0.000 1), published after checklists' (P<0.000 1), hospital in higher-level (P<0.000 1), illuminating the funding or interest conflict (P<0.000 1). Pearson analysis indicated that linear correlation were detected between PRISMA scores and AMSTAR scores (P<0.000 1), as well as citations and AMSTAR scores (P=0.045). ConclusionEvidenced-based pharmacy in hospital has developed rapidly, the quality of methodology and reporting have increaseed year by year, but further improvement should be considered in different aspects. The methods to evaluate the clinical application of these systematic reviews/ meta-analyses should be developed in the future.
Objective To evaluate the methodological and reporting quality of randomized controlled trials involving traditional Chinese medicine in the treatment of cholelithiasis. Methods We searched CNKI (1994 to 2007), CMCC (1994 to 2007), VIP (1989 to 2007), MEDLINE (1966 to April 2007) and The Cochrane Library (Issue 4, 2006). Data from randomized controlled trials (RCTs) and quasi-RCTs were extracted by two reviewers independently. The methodological quality of included trials was assessed by using the quality assessment criteria recommended by The Cochrane Collaboration, and the reporting quality was assessed by using the CONSORT for TCM checklist. Results Seventeen studies including 16 RCTs and one quasi-RCT were included. The methodological and reporting qualities of included studies were generally low. All studies were graded C. The highest score evaluated by the CONSORT for TCM checklist was 18. Conclusion The quality of RCTs and quasi-RCTs involving traditional Chinese medicine for cholelithiasis is generally low, with a high risk of biases. The reporting of these trials is also incomplete, which would affect a reader’s understanding and evaluation of the validity, importance and applicability of the study results. Therefore, new randomized controlled trials of high quality are required to provide reliable evidence.
Objective To investigate the quality of randomized controlled trials (RCTs) involving Danhong Injection for angina of coronary heart disease, and to provide references for improving the quality of clinical research on Chinese medicine (CM) injection. Methods The RCTs published from 2002 to July 2010 about Danhong Injection for angina of coronary heart disease were searched. The methodological quality of the literatures was evaluated according to the methods recommended by the Cochrane Collaboration, and the reporting quality was assessed by means of the Jadad scale and the CONSORT checklist. Results A total of 104 RCTs were included. The assessment result of Jadad scale showed: nine RCTs (8.7%) scored two, 87 (83.6%) scored one, and the other 8 (7.7%) scored zero. According to the standard of CONSORT, only 1 RCT (0.96%) described the random method; no literatures explained how to execute randomization and use placebo control; 3 RCTs (2.9%) reported endpoint outcome; 1 (0.96%) RCT performed single blind; 2 (1.9%) RCTs performed double blind; 54 (51%) RCTs calculated statistic values; 5 (4.8%) RCTs reported follow-up; no RCT reported equivalent results or negative results; 74 (71.2%) RCTs reported adverse events; no RCTs conducted sample size estimation, intention-to-treat analyses and stratified analyses; no RCTs were multicenter trials; and no RCTs recorded the accreditation and the informed consent. Conclusion The quality of RCTs about Danhong Injection for angina of coronary heart disease is still low in methodological aspects such as randomization, estimation of sample size, statistic methods, reporting of follow-up and non-follow-up, and adverse reactions, which has influences on the real evaluation of the effect of Danhong Inection. It is suggested that the future RCTs on CM injection should be conducted with references of CONSORT statement, that a clinical mode of integration of disease and syndrome should be applied according to the treatment theory based on syndrome differentiation, and that more attention should be paid to the clinical observation on adverse reactions of CM injection, so as to be helpful for safe medication and patients’ right protection.