ObjectivesTo analyze the current methodological and reporting quality of both domestic and overseas clinical practice guidelines on acupuncture, and to provide reference for the development of high quality acupuncture clinical practice guidelines.MethodsGIN, NICE, AHRQ, PubMed, EMbase, AMED, CINAHL, WanFang Data, CNKI, VIP and CBM databases were electronically searched to collect domestic and overseas clinical practice guidelines on acupuncture from inception to September, 2018. Two reviewers independently screened literature, extracted data and evaluated the methodological and reporting quality by using AGREE Ⅱ and RIGHT tools.ResultsA total of 23 acupuncture clinical practice guidelines were included, in which three were developed by foreign institutions, and the remaining 20 guidelines were jointly developed by WHO Western Pacific Region and China Institute of Acupuncture and Moxibustion. Three foreign and two domestic guidelines were selected for evaluation. The AGREE Ⅱ evaluation showed that the domestic guidelines have higher scores in terms of " scope and purpose”, " stakeholder involvement”, " rigor of development”, " applicability” and " clarity of presentation”, while only " editorial independence” is lower. The overall recommendation is stronger than the foreign guidelines. The RIGHT evaluation showed that for three foreign guidelines, the " reported” items accounted for 52.38%, " unreported” items accounted for 38.09%, " partly reported” items accounted for 6.66%%; however, for domestic guidelines, the " reported” accounted for 45.71%, " unreported” items accounted for 40%, and " partly reported” items accounted for 14.28% respectively. Overall, the difference is not significant (SD<10%). Due to the specificity of acupuncture interventions, the use of AGREEⅡ and RIGHT to evaluate acupuncture clinical practice guidelines still had barriers to some extend on its applicability.ConclusionThe methodological and reporting quality of acupuncture clinical practice guidelines are relatively low. It is urgent to further improve the methodological level and reporting standards of the guidelines, and to develop evaluation tools for the acupuncture field guidelines.
Osteoarthritis research society international (OARSI) guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis in 2019 contained some recommendations in treating patients with osteoarthritis (OA) who are considering non-surgical treatment. Compared with domestic consensus on diagnosis and treatment for OA, this clinical practice guideline (CPG) prepared by OARSI had some advantages in terms of methodology selection and recommendation. Therefore, it is necessary to interpret this CPG to accelerate the understanding and dissemination of the CPG. The ultimate aims were: to strengthen the normative and understanding of non-surgical treatment of OA; to enhance the understanding of clinicians for this CPG in treating OA; to accelerate the development of guideline development methodologies in China; to provide methodological guidance for the development of CPG based on the current situation in China.
The background and status of the quality assessment instruments of clinical trials, and several frequently used instruments both domesticly and abroad were introduced, and the problems in this field were discussed.
Meta-analyses include meta-analysis of the published literature (MPL) and meta-analysis of individual patient data (MIPD). Recursive cumulative meta-analysis is a method used to reorganize the secondary analysis data based on original studies thus to ensure a timely update, in addition, it can also be used to analyze the data from longer followup of existing trials. By using this method, with the each newly included or updated study, the change of pooled effect size in each pooled step can be detected, therefore, the bias/heterogeneity and stability of pooled results can be evaluated. In this article, we briefly introduced the concept of recursive cumulative meta-analysis and an example was used to illustrate this method.
Objective To systematically review the requirements of patient participation in clinical practice guidelines (CPGs) in Chinese and foreign guideline development manuals. Methods Thirty-six authoritative society websites and guideline databases and 5 commonly used databases were searched online. Relevant information on patients’ participation in the guideline manuals was collected, summarized, and analyzed. Results A total of 37 manuals (33 foreign and 4 Chinese) were included. The requirements for the number of patients, the right to speak, status equality, and the right to vote in the guideline development manual accounted for 35.1%, 13.5%, 8.1%, and 5.4%, respectively. The requirements for participants’ mode of participation were not mentioned in the guideline development manuals from 2000 to 2010. There were 6 (16.2%) in 2011–2015 and 12 (32.4%) in 2016–2022. The comprehensive guidelines for multiple disease types accounted for 35.7%, 28.6%, and 57.1%, respectively, in terms of requirements for participants’ knowledge or experience, management of specialized personnel, and training support. The specific guidelines for a certain type of disease or drug accounted for 21.7%, 4.3%, and 17.4%, respectively; fifteen (40.5%) guideline development manuals mentioned the specific collection forms of patients’ values and preferences in guideline development. Conclusion Given changes to medical models and the emphasis on patients’ rights and interests, an increasing number of manuals have proposed requirements that consider the expression of patients’ values and preferences in manual development, and the dimensions of manual development are constantly enriched. However, manuals outlining the requirements of patient participation are still not comprehensive and can continue to improve.
ObjectiveTo systematically review the research issues related to evidence quality grading methods for public health decision making. MethodsPubMed, Web of Science, CNKI, WanFang Data, CBM and VIP databases were electronically searched to collect studies related to the application of evidence quality grading methods for public health decision making from inception to December 2022. The questions were constructed according to the SPIDER model. The quality of the included literature was evaluated by using the CASP checklist, and a three-level interpretation analysis of the questions on the application of quality rating methods for public health decision making was conducted using the thematic synthesis method to establish a pool of question entries. ResultsA total of 14 papers were included, covering seven countries. GRADE was the commonly used method for grading the quality of evidence. CASP evaluation results showed eight high quality studies, four medium quality studies and two low quality studies. The thematic synthesis method summarized 13 question entries in 7 categories. ConclusionThe existing methodology for grading the quality of evidence for public health decision making suffers from the diversity of evidence sources and the underestimation of the level of evidence from complex intervention studies.
Intensive discussions and debates concerning whether we should and how to apply evidence-based medicine (EBM) research in traditional Chinese medicine (TCM) have arisen worldwide. We always hold the opinion: TCM needs EBM; the evidence from EBM is not limited to randomized controlled trials and systematic reviews; innovative methodological studies are urged based on the characteristics of TCM theoretically and clinically. Based on the methodological training and studies in this area, the authors discussed how to promote the evidence based TCM from five aspects including completing clinical trial procedure, reporting clinical trials according to international standards, reviewing the current clinical studies on TCM systematically, promoting the methodological research and academic exchange and better evidence (knowledge) management.
ObjectiveThe application of the coefficient of variation (CV) in the development of clinical practice guidelines is limited to evaluating the consistency of the consensus panel in clinical questions rating, and the application of variability was limited. This study presents the application and results of variability evaluation in the development of guidelines. MethodsWe conducted a large-scale clinical survey through questionnaire survey, and conducted two rounds of questionnaire survey and face-to-face consensus meeting for the consensus group. Means and CV were calculated for clinical questions and outcome importance ratings. We performed the summary and analysis by SPSS and Microsoft Excel. ResultsA total of 356 clinical survey questionnaires and two rounds survey in consensus panel were collected. We found that in the clinical survey and the first-round of the consensus panel, the CV was greater than 25% for all clinical questions regardless of the overall importance score. In the consensus panel, the results of the second-round were greatly changed. On the one hand, compared with the first-round, the CV of almost all clinical questions was smaller in the second-round, and the CV of high-priority clinical questions was less than 25%, while the clinical questions with a CV greater than 25% were of low-priority. In view of the CV of outcome importance, the clinical survey was similar to the results of the first-round of consensus panel. The CV of very important outcomes was less than 30%. In the second-round of consensus panel, the variability of very important outcomes was less than 20%. The higher the importance level of the outcome was, the smaller the CV was. ConclusionThe study of variability evaluation has practical methodological value, which can assist clinical questions and outcomes priority selection, and help to fully consider the influence of different factors and values, and develop high-quality guidelines.
Objectives To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).Methods We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria. Results Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings. Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.
