Objective To evaluate the quality of Chinese clinical practice guidelines published in domestic medical journals in 2011. Methods The following 4 Chinese databases including WanFang Data, VIP, CNKI and CBM were searched from January 2011 to December 2011. The quality of included guidelines was assessed by using AGREE II. Results A total of 75 guidelines published in 2011 were included. Among them, 10 guidelines (13%) stated the conflict of interest, 10 guidelines (13%) mentioned evidence-based developing, 5 guidelines (7%) performed evidence grading system, 8 guidelines (11%) performed recommendation strength grading system, and 4 guidelines (5%) performed both evidence and recommendation strength grading systems. The ratio of the 6 domains’ scores of AGREEⅡ were as follows: scope and purpose (18%), stakeholder involvement (11%), rigour of development (8%), clarity of presentation (34%), applicability (5%), and editorial independence (14%). Conclusion Compared with the guidelines published before, the guidelines of 2011 have a higher quality and some of them are progressively standardized in developing methodology.
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 assess the methodology and report quality of Chinese systematic reviews/ meta-analyses on prevention and control of six major diseases in public health. Methods Chinese literatures of systematic reviews/ meta-analyses on prevention and control of six major diseases, including cancer, cerebrovascular disease, cardiovascular disease, hepatitis B, tuberculosis, and AIDS were searched in CQVIP, WANFANG Database, CNKI, and the Chinese Biomedical Literature Database from the establishment date to June, 2010. Two researchers independently screened and evaluated the data, disagreements were resolved by discussion. Methodology quality and report quality of included reviews were evaluated by OQAQ scale and PRISMA scale. Result Of the 139 literatures included in the analysis, 32 were systematic reviews while 107 were meta-analyses. The highest and lowest scores of methodology quality were 6.5 and 1.5 respectively. The average score was 4.66±0.92 and no literature could meet all nine items. The main problems were insufficient in literatures resource, bias in data selection, lack of rigorous quality assessment for included original studies and so on. The average score of report quality were 15.28±2.91 and the main problems were incomplete report in abstract, data collection and analysis methods, bias control, conclusion and so on. Conclusion Both of the methodology quality and report quality of included literatures have problems in different levels, which require to be further improved.
Objective To assess the quality of diagnostic studies on detecting the tuberculosis antibody to diagnose tuberculosis.Methods CBM (1978 to 2006) and VIP (1994 to 2006) were searched; any author-claimed diagnostic studies which used the dot immunogold filtration assay (DIGFA) to detect the tuberculosis antibody and to diagnose tuberculosis were included. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS) was used to assess the quality of included diagnostic studies by two reviewers independently.Results Thirty-eight papers were included and assessed. We found that most of the quality items were not met with QUADAS. Most papers adopted the retrospective diagnostic case-control design. Thirty-one papers did not describe the selection criteria clearly, 18 did not describe whether all the included patients were verified by using a reference standard of diagnosis, 36 did not describe whether the index test results were interpreted without knowledge of the results of the reference standard, 37 did not report the uninterpretable/intermediate test results, and 34 did not report the withdrawals from the study.Conclusion There are few high quality studies on using DIGFA to detect tuberculosis antibody to diagnose tuberculosis.
Objective To evaluate the quality of diagnostic studies on detecting anti-cyclic citrullonated peptide antibody to diagnose rheumatoid arthritis. Methods We searched PubMed, EMbase, The Cochrane Library, and CBM to collect studies on using anti-cyclic citrullonated peptide antibody to diagnose rheumatoid arthritis. QUADAS items were used to evaluate the quality of included studies. Results A total of 195 studies were included. Sixty-nine were English studies and 126 were Chinese studies. All studies had good descriptions of the spectrum of patients and little potential for partial verification bias, differential verification bias, and incorporation bias. However, most studies were prone to disease progression bias, review bias, and clinical review bias. One study did not explain the intermediate test results, and another did not report part of the test results. The overall quality of English studies was better than that of Chinese studies. Conclusion The potential bias of the included studies mainly resulted from the absence of blinding when interpreting the test results. The reporting quality of the included studies was poor.
Objective To survey and analyze the quality assessment of the included studies in the Overviews of reviews (Overviews), so as to provide methodology references for Overviews authors. Methods A computerized search was performed for collecting Overviews in The Cochrane Library (Issue 1, 2010), PubMed, EMBASE, and CBM, and the search time ended by December, 2009. Then the relevant data, such as assessment standard etc, were extracted, and the staple standards were analyzed. Results A total of 43 typical Overviews were included. Thirty-two (74.4%) of them assessed the methodology quality of the included systematic reviews with different standards, including OQAQ (34.9%/15), AMSTAR (9.1%/3), Checklist from DARE (4.6%/2), Assendelft scale (4.6%/2), Effective Public Health Practice Project standards (2.3%/1), self-formulated standards (14.0%/ 6), syntaxic standards (2.3%/1), and other standards (4.6%/2). Ten Overviews (23.6%) assessed the quality of evidence, including eight (18.6%) applied the GRADE system. Only 7 studies (16.3%) assessed the quality of evidence and applied the GRADE system as well. Conclusion The quality assessment in Overviews includes the assessment of both methodological quality and evidence quality. But most Overviews do not assess comprehensively. The methodological quality standards applied in current Overviews are numerous and no standard is acknowledged. Yet, the OQAQ and AMSTAR are applied widely and recommended because they are comprehensive and easy to be conducted. It suggests that Overviews authors should choose appropriate methodological quality assessment standards according to concrete conditions. The GRADE system is much more comprehensive and systematic than other systems, so it is recommended that Overviews authors should apply GRADE to assess the quality of evidence in their studies in order to make the study results more comprehensive and easier for clinical application.
Objective To investigate the quality of randomized controlled trials (RCTs) involving Danhong Injection for angina of coronary heart disease, and to provide references for improving the quality of clinical research on Chinese medicine (CM) injection. Methods The RCTs published from 2002 to July 2010 about Danhong Injection for angina of coronary heart disease were searched. The methodological quality of the literatures was evaluated according to the methods recommended by the Cochrane Collaboration, and the reporting quality was assessed by means of the Jadad scale and the CONSORT checklist. Results A total of 104 RCTs were included. The assessment result of Jadad scale showed: nine RCTs (8.7%) scored two, 87 (83.6%) scored one, and the other 8 (7.7%) scored zero. According to the standard of CONSORT, only 1 RCT (0.96%) described the random method; no literatures explained how to execute randomization and use placebo control; 3 RCTs (2.9%) reported endpoint outcome; 1 (0.96%) RCT performed single blind; 2 (1.9%) RCTs performed double blind; 54 (51%) RCTs calculated statistic values; 5 (4.8%) RCTs reported follow-up; no RCT reported equivalent results or negative results; 74 (71.2%) RCTs reported adverse events; no RCTs conducted sample size estimation, intention-to-treat analyses and stratified analyses; no RCTs were multicenter trials; and no RCTs recorded the accreditation and the informed consent. Conclusion The quality of RCTs about Danhong Injection for angina of coronary heart disease is still low in methodological aspects such as randomization, estimation of sample size, statistic methods, reporting of follow-up and non-follow-up, and adverse reactions, which has influences on the real evaluation of the effect of Danhong Inection. It is suggested that the future RCTs on CM injection should be conducted with references of CONSORT statement, that a clinical mode of integration of disease and syndrome should be applied according to the treatment theory based on syndrome differentiation, and that more attention should be paid to the clinical observation on adverse reactions of CM injection, so as to be helpful for safe medication and patients’ right protection.
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.
Objective To assess the quality of reporting of randomized controlled trials (RCTs) related to traditional Chinese medicine (TCM) published in the Chinese Journal of Evidence-Based Medicine by CONSORT statement and Jadad scale. Methods We handsearched the Chinese Journal of Evidence-Based Medicine to identify TCM RCTs. The revised CONSORT statement and Jadad scale combined with self-established criteria were applied. Results A total of 57 RCTs were identified of which there were 17 TCM RCTs. Some items in CONSORT checklist were completely reported in all TCM RCTs, such as abstract, inclusion and exclusion criteria, intervention, randomization sequence generation, description of statistic method, description of baseline data, outcomes and estimation, and explain results. Compared with the previous findings, there were more trials in this study to report allocation concealment, randomization implementation, use of flow chart and appliance. Only 3 RCTs (17.6%) reported acknowledgements. One RCT did not describe syndrome type of TCM, and 4 RCTs (23.5%) carried out dummy. The mean Jadad score was 4.35±1.11 in all trials, of which 11 RCTs (64.7) ranked 5 points. Conclusion The comprehensive quality of reporting of TCM RCTs published in the Chinese Journal of Evidence-Based Medicine from 2001 to 2008 has been improved. After the publication of CONSORT statement and CONSORT for traditional Chinese medicine, the quality of reporting of TCM RCTs is improved. We are looking forward to improving the CONSORT for TCM.
It is the key for evidence-base decision to gain the high quality evidences. As a valuable method,systematic review has been widely used in medical areas with the improvement of the method, but it cannot be useddirectly in health policy field, because the characters of the health policy such as research topics, methods and objectives.The Center for Health Management and Policy of Shandong University has made some researches which focus on themethod under the support from the Alliance for Health Policy and Systems Research (WHO) from 2006. We haveexplored the two-stage systematic review method of health policy researches and applied it into reality. The purpose of thisarticle is to introduce the key technical of this method, which include quality assessment of the literatures, analysis andintegrated approaches. We also put forward the work which needs to be continued in the future.