Testing Treatments is a book to help the public understand how to validate the efficacy of testing treatments and the possible bias and error in clinical trial, as well as to call for help to promote good study thus to improve the quality of health care. No matter for the first or the second edition, this book is very popular around the world, and its second edition has been translated into more than ten languages. To help the readers understand the content of the book, we established a website (www.testingtreatments.org) and other sibling sites in different languages. The website not only provided the full-texts to download, but also collected various popular science resources (videos, audios and cartoons) to help the readers assimilate more knowledge. The editors of all the different language websites have established an TTi Editorial Alliance to share experience and provide each other with mutual support, thus to promote health professionals, patients and public around the world to use reliable research to inform their health decisions.
ObjectiveTo acquaint the development process and item composition of the appraisal tools and reporting standards of clinical pathways worldwide, in order to improve the development and evaluation of clinical pathways. MethodsWe searched databases including PubMed, EMbase, Web of Science, CBM, CNKI and WanFang Data for articles about the appraisal tools and reporting standards of clinical pathways from inception to Jan, 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and compared the difference in development process and item composition among included appraisal tools and reporting standards of clinical pathways. ResultsA total of 7 appraisal tools and reporting standards were included. Among them, 3 were from UK, 1 from China, 1 from Australia, 1 from Belgium, and 1 from Saudi Arabia. All included appraisal tools contained 4 to 15 domains and 14 to 99 items. Based on the comparison of different domains and items of included appraisal tools, "Clinical Pathway Management Guidelines" published by the National Health and Family Planning Commission of the People's Republic of China and the research of Vannhaecht, we identified 17 key elements of clinical pathway as follows:organizational commitment, pathway project management, format of doc, content of pathway, multidisciplinary involvement, variance management, EBM/guidelines, maintenance of pathway, accountability, patient involvement, development of pathway, additional support systems & documents, operational arrangement, implementation, outcome management, safety and organization of the care process. ConclusionCurrently, the appraisal tools and reporting standards of clinical pathways are rudimentary, so we desperately needs to establish mature appraisal tool and reporting standard of clinical pathways to guide the development and implementation of clinical pathway, so as to improve their application effects in clinical practice and medical quality.
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.
Indirect comparison refers to a comparison of different healthcare interventions using data from separate studies, and is often used because of a lack of, or insufficient evidence from head-to-head comparative trials. We aimed to summarize the definition, fundamental theory, type, relevant statistical contents, and to clarify some question on how to use indirect comparison, in order to attract more researchers' attention and promote methodological development of indirect comparison.
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.
In response to the public health emergency and other urgent needs, World Health Organization (WHO) developed the concept and methodology of rapid advice guidelines (RAGs) in 2006. Compared with the standard guideline, striving to minimize the risk of bias, the RAG shortens the time to 1-3 months from more than 2 years. This study introduces the background, definition, application condition and performing methods of RAGs, and uses an example to clarify it, thus to provide a reference for the guideline development of public health emergency and other urgent need in China.
ObjectiveTo systematically review the diagnostic value of gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid (Gd-EOB-DTPA) for liver metastases. MethodsWe searched databases including CNKI, CBM, VIP, WanFang Data, PubMed, EMbase and The Cochrane Library from January 2011 to December 2014 to collect diagnostic tests about Gd-EOB-DTPA for liver metastases. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies by using the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2) tool. Then, meta-analysis was performed by using Stata 12.0 software. ResultsA total of 15 studies from seven countries were included, involving 2 040 nodules from 701 patients. The results of meta-analysis showed that, the pooled sensitivity (Sen), specificity (Spe), positive likelihood ratio (+LR), negative likelihood ratio (-LR) and diagnostic odds ratio (DOR) of Gd-EOB-DTPA for liver metastases were 0.92 (95%CI 0.89 to 0.95), 0.94 (95%CI 0.89 to 0.97), 14.51 (95%CI 8.01 to 26.28), 0.08 (95%CI 0.06 to 0.12), and 177.98 (95%CI 89.50 to 353.94), respectively. The area under curve (AUC) of SROC was 0.97 (95%CI 0.95 to 0.98). The results of subgroup analysis showed that Gd-EOB-DTPA had better Sen in nodules >10 mm than the nodules ≤10 mm in diameter (>10 mm: pooled Sen=0.97, 95%CI 0.94 to 0.99; ≤10 mm: pooled Sen=0.75, 95%CI 0.65 to 0.85; P<0.001); The 3.0T MR had better Sen in diagnosing liver metastases compared with 1.5T MR (3.0T: pooled Sen=0.95, 95%CI 0.92 to 0.97; 1.5T: pooled Sen=0.90, 95%CI 0.87 to 0.94; P<0.001). ConclusionGdEOB-DTPA is of value for the detection of liver metastases. In particular, it is of high sensitivity for the detection of nodules larger than 10 mm, and for the cases using 3.0T high-field MR system. Due to limited quantity and quality of the included studies, more high-quality studies are required to verify the above conclusion.
ObjectiveTo get known of the application of Preferred Items of Systematic Review and Meta Analysis (PRISMA). MethodsWe searched PubMed, EMbase, The Cochrane Library (Issue 10, 2013), CBM, WanFang Data and CNKI, to collect relevant literature about the application of PRISMA during 2009-2013. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and then bibliometric analysis was performed using Excel software. ResultsWe finally included 175 papers, including 26 conference abstracts and 149 full texts. The results of bibliometric analysis of full texts showed that, they were published in 118 journals, and PRISMA official website announced that 176 journals endorsed the application of PRISMA. According to study type, there were 111 systematic reviews and meta-analyses (SRs/MAs) for development and reporting, 20 overviews of SRs for reporting quality assessments, 7 versions of PRISMA interpretation, and 11 articles of other kinds. In 131 SRs/MAs as well as overviews, the studies about western medicine accounted for 77.8%, followed by public health (8.4%), and traditional Chinese medicine (4.6%). ConclusionThe application of PRISMA statement is still at the first phase and mainly confined to the field of western medicine, which needs more attention and understanding. Thus, it's necessary to interpret and disseminate the PRISMA statement.
Traditional Chinese Medicine (TCM) standardization is an important carrier for TCM inheriting and innovating. As an important content of TCM standardization system, TCM clinical practice guidelines' designation and revision play an important role for medical staff to regulate medical behavior, and improve the quality of health services. This paper expounds the significance and function of the TCM guidelines, analyzes the present situation, opportunities and challenges, and puts forward the strategies and suggestions to promote the development of evidence-based TCM guidelines.
This article discussed the development and current situation about both national and international diagnostic practice guidelines, as well as the role of evidence based medicine and systematic reviews in the development of such guidelines. Authors also analyzed the opportunities and challenges developers faced, and the methods and processes of development. Finally, authors proposed several strategic suggestions about how to improve the quality of diagnostic practice guideline in China.