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.
ObjectivesTo assess the methodological quality of clinical practice guidelines of cervical cancer in China published from 2014 to 2018.MethodsCNKI, WanFang Data, CBM, VIP, Medlive.cn, the National Guideline Clearinghouse, PubMed, The Cochrane Library and EMbase were searched for cervical cancer clinical practice guidelines published in China from January 1st, 2014 to December 31st, 2018. Four reviewers searched and selected the literature independently according to the inclusion and exclusion criteria and assessed the methodological quality of the included guidelines by using AGREE Ⅱ.ResultsA total of 9 guidelines were included. The average score for each area was: scope and purpose 75.47%, stakeholders’ involvement 35.09%, the rigor of development 43.70%, clarity of presentation 87.74%, applicability 80.76%, and editorial independence 0%.ConclusionsThe quality of cervical cancer clinical practice guidelines in China requires further improvement.
ObjectivesTo evaluate the methodological and reporting quality of clinical guidelines and consensus for esophageal cancer.MethodsDatabases including PubMed, EMbase, Web of Science, CBM, WanFang Data and CNKI were electronically searched and major guideline websites such as GIN, NICE, NGC and Yimaitong were also searched to collect guidelines and consensus for esophageal cancer from inception to August 2018. Two reviewers independently screened the literatures and extracted data according to the inclusion and exclusion criteria and then evaluated the quality of the included guidelines using the AGREE II and RIGHT instruments.ResultsA total of 26 esophageal cancer guidelines and consensus were included. The mean scores for each domain of AGREE II was 49.63% for scope and purpose, 25.16% for stakeholder involvement, 23.42% for rigor of development, 49.25% for clarity of presentation, 16.91% for applicability, and 21.07% for editorial independence. The item with the highest reporting rate among the RIGHT evaluation items was 5 (84.62%), followed by 1a (80.77%), 1c (65.38%), 13a (65.38%), and 4 (61.54%), and the remaining items were all reported below 50%. Results of subgroup analysis showed that the guidelines and consensus developed based on the evidence-based medicine method had higher average scores in the six domains of AGREE II and the RIGHT score than the guidelines and consensus developed based on expert opinions or reviews. The foreign guidelines and consensus had higher average scores in the three domains of AGREE II (formulation rigor, clarity, editorial independence) and the RIGHT score than the domestic guidelines.ConclusionsThe methodological and reporting quality of the guidelines and consensus on esophageal cancer is low, with the guidelines and consensus in China even lower, requiring further improvement. It is suggested that the guideline developers should refer to the standards such as AGREE II and RIGHT to develop high-quality guidelines and promote their application, so as to better guide the standardized diagnosis and treatment of esophageal cancer.
Objective To systematically review indicators and methods of quality assessment for primary health care, to provide empirical evidence for quality improvement in this area. Methods We electronically searched databases including Proquest Dissertations and Theses, ISI Web of Knowledge, PubMed, EMbase, IDEAS, Jstor, SSRN, Popline and The Cochrane Library (Issue 4, 2014) and network resources on World Bank, World Health Organization and Google from inception to April 2014. Empirical studies about quality assessment of primary care system, organization and personnel were collected. Data was extracted using pre-designed form for qualitative analysis and description. Results A total of 59 studies were included. The quality assessment for primary health care in practice was mainly from four dimensions: (1) emphasize on the implementation of such basic characteristics of primary health care as first contact, coordination, comprehensiveness and continuous; (2) focus on the evaluation of primary care contents, such as basic medical care, preventive care, chronic diseases, etc.; (3) based on the structure, process and outcome quality proposed by Donabedian; (4) emphasize on patients’ perceived quality. Seven relevant tools were widely used in the process of quality assessment in practice. Conclusion The majority of included studies were from developed countries while such empirical studies lacked in developing countries. Included studies varied in the connotation and angel of the primary health care quality, among which, the GPAS (General Practice Assessment Survey) used for evaluating pati ent perceived quality and PCAT (Primary Care Assessment Tools) used for evaluating the basic characteristics of primary care were widely used.
ObjectivesTo evaluate the methodological quality of guidelines for pharmacological intervention of migraine in adults, to compare and analyze the differences in first-line drug recommendations in different regions and quality levels, so as to explore the evidence of drug recommendations, and provide a basis for clinical decision-making.MethodsPubMed, The Cochrane Library, EMbase, SinoMed, CNKI, VIP, and WanFang Data databases, Up To Date, as well as the related books, Yimaitong, Guideline Central, Guidelines International Network (GIN) and National Institute for Health and Clinical Excellence (NICE) were systematically searched to collect pharmacological intervention guidelines of migraine in adults from inception to January 12th, 2020. The methodological quality of the guidelines was evaluated by Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ).ResultsA total of 25 guidelines were included (including 22 evidence-based guidelines), covering 10 countries on 4 continents and World Health Organization (WHO) with a time span of 1997 to 2019. According to AGREE Ⅱ, 5 were A-level guidelines, 18 were B-level guidelines, and 2 were C-level guidelines. Scope and purpose, rigour of development, clarity of presentations and editorial independence obtained high average scores (more than 60%) among all 25 guidelines. The average scores of guidelines in different domains of AGREE Ⅱ varied with regions and countries. Triptans and NSAIDs were the most frequently recommended as first-line drugs for the acute management; beta-blockers and antiepileptic drugs were recommended for the first-line prevention drugs of migraine in adults. There were 2 guidelines that recommended complementary treatments, one recommended traditional Chinese medicine and another recommended herbal butterbur.ConclusionsThe methodological quality of the pharmacological intervention guidelines of migraine in adults is suboptimal among different regions or countries. The quality of evidence-based guidelines is superior to that established by consensus. The consistency of first-line drug recommendations is strong, but there are still regional differences. The therapeutic effect of traditional Chinese medicine requires further verification.
ObjectivesTo investigate the current situation of clinical practice guidelines (CPGs) of gastric cancer in China, and to assess the quality of these CPGs, so as to provide reference for developing the CPGs of gastric cancer normatively in the future.MethodsCNKI, WanFang Data, CBM and VIP databases were electronically searched to collect the CPGs of gastric cancer in China from inception to January 31st, 2018. Four reviewers independently screened literature, extracted data and assessed the quality of these CPGs using the Appraisal of Guidelines for Research and Evaluation Ⅱ(AGREE Ⅱ).ResultsA total of 12 guidelines published from 2007 to 2017 were included. Only 1 guideline was evidence-based guideline. The average scores of guidelines in six domains of AGREE Ⅱ were 83.3%, 42.2%, 16.3%, 80.2%, 37.3% and 0% respectively.ConclusionsThe overall quality of included CPGs is insufficient. There is a lack of evidence-based guidelines in China. More attention should be paid to rigor of development and applicability during the development of CPGs in the future, and a timely upgrade is also required.
Objective To assess the quality of reporting of randomized controlled trials (RCTs) related to traditional Chinese medicine (TCM) published in the Chinese Journal of Evidence-Based Medicine by CONSORT statement and Jadad scale. Methods We handsearched the Chinese Journal of Evidence-Based Medicine to identify TCM RCTs. The revised CONSORT statement and Jadad scale combined with self-established criteria were applied. Results A total of 57 RCTs were identified of which there were 17 TCM RCTs. Some items in CONSORT checklist were completely reported in all TCM RCTs, such as abstract, inclusion and exclusion criteria, intervention, randomization sequence generation, description of statistic method, description of baseline data, outcomes and estimation, and explain results. Compared with the previous findings, there were more trials in this study to report allocation concealment, randomization implementation, use of flow chart and appliance. Only 3 RCTs (17.6%) reported acknowledgements. One RCT did not describe syndrome type of TCM, and 4 RCTs (23.5%) carried out dummy. The mean Jadad score was 4.35±1.11 in all trials, of which 11 RCTs (64.7) ranked 5 points. Conclusion The comprehensive quality of reporting of TCM RCTs published in the Chinese Journal of Evidence-Based Medicine from 2001 to 2008 has been improved. After the publication of CONSORT statement and CONSORT for traditional Chinese medicine, the quality of reporting of TCM RCTs is improved. We are looking forward to improving the CONSORT for TCM.
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 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.
Objectives To assess the quality of clinical practice guidelines for primary hepatic carcinoma published in 2016 and 2017 in China. Methods CNKI, WanFang Data, CBM and VIP databases were searched for clinical practice guidelines for primary hepatic carcinoma in China. The search date was from Jan. 1st, 2016 to Jan. 1st, 2018. Four researchers independently selected literatures and extracted data according to the inclusion and exclusion criteria. The Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ) was utilized to assess the methodological quality of the guidelines. Results A total of 7 guidelines were included. The average scores of six domains for these guidelines were: 65.1% for scope and purpose, 39.4% for stakeholders’ involvement, 64.3% for rigor of development, 55.6% for clarity of presentation, 61.8% for applicability and 6.1% for editorial independence. Conclusions The quality of clinical practice guidelines for primary hepatic carcinoma in China is relative high, of which the recommendations are of great value in clinical practice, yet still required to be improved in some ways.