Objective To assess the methodological quality of systematic reviews or meta-analyses of intervention published in the Chinese Journal of Evidence-Based Medicine, so as to provide evidence for improving the domestic methodological quality. Methods The systematic reviews or meta-analyses of intervention published from 2001 to 2011 were identified by searching the Chinese Journal of Evidence-Based Medicine. The methodological quality of included studies was assessed by AMSTAR scale. The Excel software was used to input data, and Mata-Analyst software was used to conduct statistical analysis. Results A total of 379 studies were included. The average score of AMSTAR was 6.15±1.35 (1.5-9.5 point). Just some items of AMSTAR scale were influenced by the following features of included studies: publication date, funded or not, number of author, author’s unit, and number of author’s unit. The total AMSTAR score of studies published after 2008 was higher than those published before 2008 (P=0.02), but the improvement of methodological quality was limited. While the total AMSTAR score of studies published by 3 or more than 3 authors were higher than those published by 2 or less than 2 authors (P=0.04). Conclusion The methodological quality of the included studies published in the Chinese Journal of Evidence-Based Pediatrics is uneven. Although the methodological quality improves somewhat after the publication of AMSTAR scale, there is no big progress, so it still needs to be further improved.
Trial Sequential Analysis (TSA), one kind of cumulative meta-analysis, is a method which introduces sequential analysis into traditional meta-analysis to avoid random errors (false positive or false negative outcomes) that occurred during repeated updates when traditional meta-analysis is performing. It is also applied to calculate required information size (RIS) of a firm conclusion. This study aims to summarize the proposal, fundamental theory, application software, and current limitation of TSA, and to clarify the advantages of TSA on the basis of detailed examples, in order to attract more attention of researchers and promote the methodological development of meta-analysis in China.
Objective To assess the evidence of Cochrane systematic reviews on the treatment of temporomandibular disorders (TMD) as well as the methodological quality of all randomized controlled trials (RCTs) of the included systematic reviews. Methods The Cochrane Library (Issue 3, 2008) was searched for systematic reviews on the treatment of temporomandibular disorders. The risk of bias was assessed independently by two authors. Results Three systematic reviews involving 25 RCTs were included. The methods of 23 studies were rated as of lower quality with high risk of various biases. Only 2 studies were of high quality. Conclusion There is insufficient or inconsistent evidence to support the use of hyaluronate, occlusal adjustment, and stabilization splint therapy for the treatment of TMD. The overall quality of RCTs about the treatment of TMD is generally low. Analysis of the included trials showed that some trials had no clear description of randomization methods, allocation concealment, sample size calculation, and intention-to-treat analysis. To improve the quality of the reporting of RCTs, clinical trial registration and the revised Consolidated Standards of Reporting Trials (CONSORT) statement should be introduced into the trial design and strictly followed.
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.
Objective To compare the efficiency of epidermis cell culture between big graft method and small strip method. Methods The big graft method was to cut the skin tissue reticularly from dermis layer while the epidermis were not cut off. After it was digested fully in trypsin, theepidermis was separated from skin and was used to culture epidermal cells. The small strip method was routine. The time to cut the skin and to separate the epidermis was recorded, and the number and quality of cells were compared between two methods. Results It took 8-10 minutes to cut an area of 5 cm2 skin into small strips and 1-2 minutes into big grafts. It took 10-15 minutes to separate the epidermis from the same area skin by small strip method and 2 minutes by big graft method. The cells showed better vigor and its number was more by big grafts than by small strips.The chance of fibroblast contamination was reduced obviously. Conclusion The big graft method is simpler than the small strip method and can culture more epidermis cells with less chance of fibroblast contamination.
AMSTAR (Assessment of Multiple Systematic Reviews) is currently developed as a measurement tool with extensive application to assess the methodological quality of systematic review/meta-analysis. It has good reliability, validity, and responsibility, and has been widely applied. This paper introduces AMSTAR to researchers and users in China, in view of development procedure, assessment items, and application status.
This is the second paper in the evidence-based medicine glossary series. It provides information on the principles for evidence-based medicine through definitions, criteria for inclusion and screening, regular flow-sheet, reporting format and the establishment of databases.
Objective To explore the methods used for developing evidence-based clinical practice guidelines for acupuncture. Methods Based on the characteristics of acupuncture in traditional Chinese medicine,and principles of evidence-based medicine, this article introduces and summarizes the processes and methods for developing an evidence-based clinical practice guideline for acupuncture. We analyzed similarities and differences between clinical practice guidelines for acupuncture and for other interventions. We used an evidence-based clinical practice guideline of acupuncture for depression as an example to illustrate the methods of literature search, grading of evidence and recommendations, evidence evaluation and consensus formation. Results Preliminary recommendations on the methods for developing evidence-based clinical practice guidelines for acupuncture were made. Conclusion Based on the optimized rational methodology for developing clinical guidelines, evidence-based high-quality clinical practice guidelines for acupuncture could be established.
Based on the principles and methods of systematic review of randomized controlled clinical trials, systematic review of economic analyses can integrate information from multiple economic studies which focus on the same clinical questions. It can also provide important insights by systematically examining how differences among studies lead to different results. Generally, there are seven steps to conduct such a review: 1) formulating questions; 2) establishing eligibility criteria; 3) searching and selecting eligible economic analyses; 4) assessing the validity of economic analyses; 5) acquiring data; 6) analyzing and synthesizing data; and 7) presenting results. Owing to the specificity of economic analyses, many methodological challenges exist, including the varieties of economic models, analytic perspectives, time horizons, and uncertainty and sensitivity analysis among different economic analyses. This may cause difficulties for critical assessment of the economic analyses.
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.