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.
The Campbell Collaboration is an international nonprofit academic organization which concerns about production, storage and transmission high quality systematic reviews of the effects of social interventions, and it is called the sister organization of Cochrane Collaboration. Now the thinking and methods of Evidence-based medicine has been widely used in the field of clinical medicine, but its application in non-clinical medicine fields such as education and social area is rarely understood and used. This paper introduced the writing procedures and techniques of Campbell Systematic Review (C2SR), and to make the researchers preliminary understand how to resolve the problems in non-clinical field using the systematic review, and to encourage researchers try to use and write C2SR.
ObjectiveTo systematically review the efficacy and safety of chemo-radiotherapy combined with hyperthermia (HCRT) for rectal cancer, and to provide evidence for clinical practice. MethodsWe searched the Cochrane Library (Issue 6, 2014), PubMed, EMbase, Web of Science, CBM, CNKI, VIP and WanFang Data databases from inception to July 2014. All relevant randomized controlled trials (RCTs) of HCRT for rectal cancer were collected. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software. ResultsA total of 9 RCTs involving 663 patients were included. The results of meta-analysis showed that:Compared with the chemo-radiotherapy (CRT) group, the HCRT group were significant superior in complete response (OR=3.74, 95%CI 2.14 to 6.53), total effective rate (OR=4.23, 95%CI 2.69 to 6.66), 3-year survival rate (OR=4.48, 95%CI 1.81 to 11.06) and recurrence rate (OR=0.19, 95%CI 0.09 to 0.42). ②Compared with the radiotherapy (RT) group, the HCRT group was associated with significant improvement in complete response rate (OR=3.01, 95%CI 1.24 to 7.29). ConclusionCurrent evidence shows, HCRT is superior to CRT or RT in the treatment of rectal cancer. However, due to the limited quantity and quality of the included studies, more high quality studies are needed to verify the above conclusion.
The Clearinghouse plays an important role in knowledge translation in western developed countries. It consistently provides the latest evidence to target customers according to its strict criteria in the specific fields. Clearinghouse is objectively and scientifically designed to assess the scientific nature and the practical applicability of evidence to provide the best current evidence to different service practitioners. It emphasizes much on the process from "knowledge production" to "knowledge utilization", which effectively fills the gap between scientific research and practice. It will play an increasing important role in the knowledge translation in the future. This article specifically introduces its history of development, characteristics and application and sets the construction of Chinese Clearinghouse for Evidence Translation in Child & Aging Health (CCET) as an example, fully elaborating the application status of Clearinghouse and providing assistance for evidence informed decision making.
Evidence-based medicine (EBM) emphasizes the combination of the physician's experience, the best research evidence and patient's values to ensure the best prevention and treatment effect. Evidence is the core of the EBM, and quantitative systematic review can synthesize interventional studies; however, it can't provide synthetic evidence for patients' demands, opinions and attitudes and so on. Qualitative systematic review can offset these limitations. With the development of methodology of qualitative research and systematic review of qualitative studies, the number of qualitative studies increased year by year and they provided more and more evidence for decision making in public health, social work, management and education. The international research institutions including the Cochrane Collaboration, the Campbell Collaboration and the 3ie have mature methods for qualitative systematic review; however, few studies introduced how to write it in China. Therefore, this paper briefly introduces how to write the qualitative systematic review.
The published methodological studies about network meta-analysis mostly focused on the binary variables, but study focused on the continuous variables was few. This study introduces how to use R, GeMTC and Stata softwares jointly to produce various graphics of continuous variable network meta-analysis. It also introduces how to perform the convergence diagnostics, trace and density plot, forest, rank probabilities and rankogram, internal relationship summary chart, network plot, contribution plot and publication bias test.
To meet the evidence users' requirement for qualitative systematic review, it is necessary to establish an evidence classification system for it. The Confidence of the Evidence from Reviews of Qualitative research (CERQual) approach was developed for evidence classification of qualitative systematic review. Four components contribute to the assessment in CERQual: (1) Methodological limitations: Refer to problems in the design or conduct of the primary studies which need to be evaluated by specific tools used for methodological assessment of qualitative research. (2) Relevance: Relevance is the extent to which the objective, population etc. of included studies are applicable to the review question. (3) Coherence: It is the extent to which the review finding is consistent with the results in primary studies or the patterns, differences across primary studies, were explained reasonably. (4) Adequacy of data: Refer to the degree of richness and quantity of data supporting a review finding. Finally, integrate each of the components and rate the confidence of individual review finding as high, moderate, low or very low confidence. CERQual provides a transparent method for assessing the confidence of evidence from reviews of qualitative research. It may facilitate the use of qualitative research in evidence-informed decision making and guideline development processes. This article will introduce CERQual approach in detail and give an example to explain how to use it.
A well-conducted evidence-based guideline not only considers the efficiency and the cost of the recommended intervention, but also the acceptability and feasibility of the intervention during implementation. Systematic reviews of qualitative research aim to provide qualitative evidence such as the acceptability and feasibility of the intervention. In developing evidence-based guidelines, qualitative evidence helps to:(1) Define the scope of guideline; (2) Assess the acceptability of interventions; (3) Assess the feasibility of interventions; (4) Identify considerations when implementing guidelines. Systematic reviews provide the fundamental evidence required to develop robust and trustworthy guidelines. The CERQual (Confidence in the Evidence from Reviews of Qualitative research) approach aims to grade the evidence from systematic reviews of qualitative research. After critically and scientifically appraising by CERQual, the acceptance and feasibility of an intervention are given different grading, which is the critical process of developing evidence-based guidelines. This paper will demonstrate the value of systematic reviews of qualitative research in developing evidence-based guidelines and how to implement recommendations from qualitative evidence.
MOOCs is a new education mode which by using the Internet to transmit the curriculums to the world to gratified the desire and the pursuit of people. In addition, it's not only an important way to accomplish convenience and mobility of study, but also a study way put emphasis on scenario and sharing. This paper will use the MOOCs and Flipped Classroom to design the teaching resources of evidence-based medicine. By combining the teaching content and characteristics of evidence-based medicine with the successful experience of the existing MOOCs, we make a teaching mode of the evidence-based medicine which is based on the students' autonomous learning and flipped classroom. And the practice of the MOOCs of evidence-based medicine will according to this mode in the future.