Objective To assess the quality of the published randomized controlled trials published in Journal of Beijing University of Traditional Chinese Medicine (JBUTCM), Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai (AUTMSPS), Journal of Guangdong University of Traditional Chinese Medicine (JGUTCM), and Journal of Chengdu University of Traditional Chinese Medicine (JCUTCM) from 2000 to 2005. Method Guided by the Cochrane Center hand-searching guidelines, we searched 24 volumes (111 issues) of the four journals. The data were extracted according to the principles of clinical epidemiology and consolidated standards of reporting trials (CONSORT), as well as an evaluation scale for randomized controlled trials (RCTs). The data were managed by descriptive analysis and uniformity test. Results There were 365 RCTs. The diagnostic criteria were reported in 297 trials (81.37%). The inclusion and exclusion criteria were reported in 143 trials (39.18%) and 132 trials (36.16%), perspectively, None mentioned the estimation of sample size. The randomization and allocation concealment were reported in 70 trials (19.18%) and 9 trials, perspectively. The baseline data were described in 292 trials (80.00%). Blinding was mentioned in 35 trials (9.59%).Withdrawal occurred in 20 trials (5.48%). Informed consent was acquired in 2 trials. Adverse drug reactions were described in 97 trails (26.58%). Conclusion There are deficiencies in the reporting of these RCTs, Most of the trials do not describe the randomization, only a few trials use the allocation concealment and blinded method, no description of comparability of baseline data, most of the trials do not report the inclusion and exclusion criteria, and none estimate the sample size. These problems indicate that it is necessary to improve the quality of clinical research in Chinese medicine and pharmacology.
Objective To assess the quality of randomised controlled trials on traditional Chinese medicine (TCM) for coronary heart disease (CHD) angina published from 1977 to 2002. Method We did electronic search in Medline, Embase and hand searched 83 journals of traditional Chinese medicine (the earliest published in 1977 and the latest in June 2002). We assessed the quality of obstained studies. Results Four hundred and forty articles met the criteria,of which 33 (7.5%) described randomization. None of them mentioned allocation concealment; 94.77% (417 studies) mentioned diagnosis criteria; only one mentioned the calculation basement of sample size; 84.09% (370 studies) mentioned comparability of baseline. Fifty three studies (12.05%) noted double-blind; 28 studies used single blind. Twenty-five studies used double-blind. Drop-outs were described in 7 cases without intention-to-treat (ITT); 159 studies applied statistical methods properly, while 4 did not. Ten studies never mentioned statistical methods; 73.18％ (322 studies) used forms to express their results. Conclusions Till now, the quantity and quality of RCTs of traditional Chinese medicine for coronary heart disease angina were inadequate. Some well designed scientific methods were not adequately applied.
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.
ObjectiveTo systematically review methodological and reporting quality of systematic reviews/meta-analyses of interventions in the global research field on gliomas. MethodsDatabases including PubMed, EMbase, The Cochrane Library, CNKI and CBM were searched from inception to July 2013, for systematic reviews/meta-analyses of interventions in the research field on gliomas. Two reviewers independently screened literature. Then PRISMA and AMSTAR checklists were used to assess and analysis methodological and reporting quality of included studies. ResultsA total of 51 systematic reviews or meta-analyses were identified. The results showed that the weakness of methodological quality mainly contained lack of study design, incomprehensive of literature search, limited form of included publications, lack of assessing publication bias, lack of reporting of conflict of interest. The weakness of reporting quality included incomplete reporting of literature search, quality assessment, risk of bias and results (some studies lacked forest plots, estimated value of pooled results, 95%CI, and heterogeneity). ConclusionThere are problems at different levels regarding current methodological and reporting quality of systematic reviews/meta-analyses of interventions in the global research field on gliomas. The relevant researchers should improve the scientificity and standardization of systematic reviews/meta-analyses and report them according to the PRISMA statement.
ObjectiveTo investigate the reporting and methodological quality of systematic reviews/ meta-analyses conducted by hospital pharmacists in China, so as to improve the quality of systematic reviews/ meta-analyses in this field. MethodsThe literatures were retrieved from CNKI, WanFang Data, VIP, CBM, CMCI, PubMed, EMbase, The Cochrane Library from the establishment date to March 17th, 2016. According to the inclusive and exclusive criteria, authors independently screened and extracted the published information. Reporting and methodological quality of included reviews were evaluated by PRIMSA statements and AMSTAR checklists. Data analysis was conducted by using Excel 2013 software and SPSS 20.0 software. ResultsOne thousand and eighteen systematic reviews/ meta-analyses were included, including 871 Chinese literatures and 147 English literatures. The average score of PRIMSA was 18.41±2.84, and the average score of AMSTAR was 7.38±1.28. The main problems of PRIMSA were structured summary, objectives, protocol and registration, additional analyses and funding. The main problems of AMSTAR were priori design, status of publication and list of studies (included and excluded). Univariate analysis showed that some factors could improve the quality of methodology and reporting, including studies in English (P<0.000 1), published after checklists' (P<0.000 1), hospital in higher-level (P<0.000 1), illuminating the funding or interest conflict (P<0.000 1). Pearson analysis indicated that linear correlation were detected between PRISMA scores and AMSTAR scores (P<0.000 1), as well as citations and AMSTAR scores (P=0.045). ConclusionEvidenced-based pharmacy in hospital has developed rapidly, the quality of methodology and reporting have increaseed year by year, but further improvement should be considered in different aspects. The methods to evaluate the clinical application of these systematic reviews/ meta-analyses should be developed in the future.
ObjectiveTo evaluate the quality of traditional Chinese medicine (TCM) guidelines, so as to provide evidence for developing similar guidelines. MethodsWe systematically searched TCM guidelines published in domestic medical journals from WanFang Data, VIP, CNKI and CBM. We also searched Google, Amazon.cn and dangdang.com by hand in order to obtain TCM guidelines published in monographs. And we used AGREE II instrument to assess the methodological quality of included guidelines. ResultsA total of 115 guidelines (87 published in domestic medical journals and 28 published in monographs) were included. Scaled domain percentages from highest to lowest were:scope and purpose (41%), stakeholder involvement (28%), clarity of presentation (33%), rigour of development (20%), editorial independence (9%) and applicability (7%). ConclusionThere is still a large gap about methodological quality between TCM guidelines and international guidelines. So the guideline developers should systematically search, evaluate and synthesize the evidence based on structured problems. At the same time, they also need to consider the costs of recommendations, the implementation environment and the patients' preference and values. On this basis, the developer could further increase the transparency and independence during developing TCM guidelines.
The study appeared the comparison between CONSORT and CENT, and promoted the combination with GRADE and N-of-1 trial. Our objective is to further develop the method of N-of-1 trial and to widely use it in clinical researches of some diseases.
Objective To evaluate the methodological and reporting quality of randomized controlled trials involving traditional Chinese medicine in the treatment of cholelithiasis. Methods We searched CNKI (1994 to 2007), CMCC (1994 to 2007), VIP (1989 to 2007), MEDLINE (1966 to April 2007) and The Cochrane Library (Issue 4, 2006). Data from randomized controlled trials (RCTs) and quasi-RCTs were extracted by two reviewers independently. The methodological quality of included trials was assessed by using the quality assessment criteria recommended by The Cochrane Collaboration, and the reporting quality was assessed by using the CONSORT for TCM checklist. Results Seventeen studies including 16 RCTs and one quasi-RCT were included. The methodological and reporting qualities of included studies were generally low. All studies were graded C. The highest score evaluated by the CONSORT for TCM checklist was 18. Conclusion The quality of RCTs and quasi-RCTs involving traditional Chinese medicine for cholelithiasis is generally low, with a high risk of biases. The reporting of these trials is also incomplete, which would affect a reader’s understanding and evaluation of the validity, importance and applicability of the study results. Therefore, new randomized controlled trials of high quality are required to provide reliable evidence.
Objective Through assessing the quality of systematic reviews/meta-analyses conducted by hospital pharmacists in China, to learn relevant situations and to promote the development and application of evidence-based pharmacy in hospital. Methods The following databases such as CBM, CNKI, Wanfang Database, VIP, CMCI, The Cochrane Library, EMbase and PubMed were searched from the establishment date to April 15th, 2011, to collect all published systematic reviews/meta-analyses conducted by hospital pharmacists in China. Two reviewers independently extracted the published information according to the inclusive and exclusive criteria, and assessed the methodology and reporting quality of the included literatures with OQAQ and PRISMA. Disagreements were discussed or resolved by the third reviewer. Data analysis was conducted by using SPSS17.0 software. Results Two hundred and sixteen Chinese literatures (including 40 on traditional Chinese medicine), and 15 English literatures were identified. The number of literatures has increased rapidly since 2008. Beijing and Sichuan were the top 2 districts in the number of literatures. All of the included literatures were published in 62 magazines sponsored by 87 hospitals, such as China Pharmacy, and Chinese Journey of Evidence-Based Medicine. The total downloads of Chinese literatures were 14346, and the total citations of all literatures were 154. The methodology and reporting quality of the randomized controlled trials (RCTs) involved in 220 systematic reviews/meta-analyses literatures were assessed, which showed the highest and lowest scores of methodological quality were 6 and 3, respectively, and the average score was 4.27±0.55. The highest and lowest scores of reporting quality were 22.5 and 9, respectively, and the average score was 16.49±2.98. Conclusion Although the evidence-based pharmacy in hospital begins late in China, it develops rapidly, and offers lots of evidence to policy decision, guidelines and rational drug use. However, there is still room for improvement of the methodology and reporting quality in future reviews.
Objective To investigate the reporting quality of randomized controlled trials (RCT) on laparoscopic surgery for treating colorectal disease in three SCI indexed. Methods We electronically retrieved the Ovid MEDLINE(R) from 1950 to present with Daily Updates for RCTs on laparoscopic surgery published in Diseases of the Colon amp; Rectum, International Journal of Colorectal Disease, or Colorectal Disease. The revised CONSORT statement and additional surgical items were adopted to assess the reporting quality. One point was assigned for each full description of an item, 0 for no description, and 0.5 for a partial description. Results A total of 20 RCTs were included and 8 RCTs were excluded. Their reporting quality was low. The average scores for the following items were relatively lower, 0.150 for settings where data collected; 0.250 for sample size estimation; 0.500 for sequence generation of randomization; 0.325 for allocation concealment; 0.150 for implementation; 0.475 for measurement of outcome; 0.150 for participant flow chart; 0.450 for adverse events; 0.450 for external validity; 0.400 for financial conflicts of interest; 0.250 for perioperative pharmacological treatment; 0.075 for perioperative nonphamacological treatment; 0.000 for participation of a trial methodologist; 0.350 for surgeon’s experience (years or position). Items with the lower scores were mainly in the methods and results section and surgical items. Conclusions The reporting quality of laparoscopic RCTs in these journals is low. Colorectal surgeons should rigorously evaluate reports in these journals before they apply to them in clinical practice.