Methodological quality and transferability will be important issues for the credibility and usefulness of both published studies and administrative methods for evaluating the socio-economic value of marketed medicines in China. This paper critically examines factors commonly contributing to, or inhibiting, the quality and transferability of socio-economic evidence of the value of medicines, with specific reference to the Chinese community. It discusses appropriate approaches to design, performance, and reporting of published economic evaluation studies, as well as guides on assessment of quality of economic evaluations and recommends two internationally established methods that may be suitable for training in this setting.
ObjectiveTo evaluate the methodological quality of cross-sectional surveys about Chinese medicine syndrome in a population at potential risk of cerebrovascular diseases. Methods The CNKI, WanFang Data, CBM and PubMed databases were electronically searched to collect cross-sectional surveys about Chinese medicine syndromes in a population at potential risk of cerebrovascular diseases from inception to December, 2022. The methodological quality was assessed using the JBI scale. Results A total of 105 studies were included. The average reporting rate of JBI was 52.06%, and the items with the highest scores included "sufficient coverage of the identified sample in data analysis" (100%), "description of study subjects and setting" (92.38%), and "using valid methods for the identification of the condition" (86.67%). Items with the lowest scores included "adequate sample size" (13.33%), "adequate response rate or low response rate managed appropriately" (14.29%), and "study participants recruited in an appropriate way" (20.95%). Subgroup analysis suggested that type of publication and number of implementation centers were potential factors influencing methodology quality (P<0.05). Conclusion The methods essential to a cross-sectional survey such as sampling, sample size calculation and handling with the response rate, and the syndrome diagnosis scales specific to Chinese medicine require further improvement.
ObjectiveTo evaluate the methodological quality of clinical practice guidelines and expert consensus of chronic heart failure domestically and abroad.MethodsPubMed, EMbase, SinoMed, CNKI, WanFang Data, and VIP databases, and related websites were searched to collect guidelines and expert consensus on chronic heart failure published from January 1st, 2011 to December 31st, 2020. Four reviewers evaluated the methodological quality of the guidelines and expert consensus with the AGREE Ⅱ tool after the consistency evaluation training.ResultsA total of 17 studies were included (consisting of 11 English and 6 Chinese studies). The recommended levels were B level (recommend after modification) for 10 studies and C level (not recommended) for 7 studies. The AGREE Ⅱ standardized mean scores for various fields were 69.61% (scope and purpose), 34.20% (stakeholder involvement), 33.13% (rigor of development), 84.53% (clarity and presentation), 42.40% (applicability), and 37.09% (editorial independence). The methodological quality of English guidelines was generally high (level B for 10 and level C for 1), while all scores of Chinese guidelines or consensus in the 6 fields were mostly lower than the average (level C for 6).ConclusionsThe guidelines for the diagnosis and treatment of chronic heart failure requires further improvement in terms of stakeholder involvement and rigor of development. It should develop standards and methods to improve the quality for Chinese guidelines and expert consensus to better serve clinical practice.
ObjectiveTo analyze the reporting and methodological quality of tranexamic acid meta-analyses published in Chinese journals. MethodsThe CNKI, WanFang Data, and CBM databases were electronically searched for meta-analyses of tranexamic acid from inception to August 12th, 2021. Two reviewers independently screened literature, extracted data, and used AMSTAR 2 and PRISMA 2009 to assess the methodological and reporting quality of publications. ResultsA total of 68 meta-analyses were included. The identified meta-analyses required improvement for items 2, 3, 4, 7, 8, 10, 12, 15, and 16 in the AMSTAR 2, and items 2, 5, 8, 12, 15, 17, 22, 24, and 27 in the PRISMA 2009 assessments, respectively. The methodological and reporting quality scores were positively correlated (rs=0.36, P=0.002). Linear regression analysis identified the mentioning of PRISMA and funding support as the independent factors potentially affecting the reporting quality score (P<0.05). ConclusionsBoth the methodological and reporting quality of the tranexamic acid meta-analyses published in Chinese journals require improvement.
ObjectiveTo evaluate the quality of randomized controlled trials (RCTs) of Chinese medicine (TCM) formulated granules published in core journals in China. MethodsComputerized searches were conducted in CNKI, VIP, WanFang Data and CBM databases. The publicly published RCTs of TCM formulated granules were collected, with sources from Peking University Core, CSSCI and EI. The following information was extracted: including title, the first author, the journals name, type of disease, year of publication, and source of drug. The included studies were evaluated using the CONSORT extension for CHM formulas (CONSORT-CHM formulas 2017), which included 25 items from title, abstract and keywords, introduction, research methods, steps, results, discussion, and other information. ResultsA total of 125 papers were included, which mainly included digestive system diseases (n=25), respiratory system diseases (n=17), and circulatory system diseases (n=17). The results showed that the overall reporting quality of RCTs of TCM formulated granules was poor. After the publication of the CONSORT-CHM formulas 2017, the reporting quality of RCTs of TCM formulated granules had no significant changes, while some items were still reported with poor quality. For example, 42.2% of RCTs did not adequately report how to generate allocation sequence, 93.3% of RCTs did not adequately report allocation concealment, and 62.2% of RCTs did not adequately report how to solve the missing data. ConclusionThe quality of RCTs reports on TCM formula granules published in Chinese journals still needs to be improved. It is recommended that researchers, journals and reviewers attach importance to the application of CONSORT-CHM formula throughout the whole process of paper writing. In the future, more scientific and detailed requirements should be put forward for trial design and reporting standards in line with the characteristics of clinical trials of TCM formula granules.
ObjectiveUsing SYRCLE tool (the SYstematic Review Centre for Laboratory animal Experimentation) to evaluate the risk of bias of animal studies in stroke field published in Chinese journals, identify problems of these studies in design, implementation and measurement, in order to provide references for improving the quality of animal studies in China. MethodsWe searched databases including CBM, VIP, CNKI and WanFang Data from inception to December 31st, 2014. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included animal studies using SYRCLE tool developed by the National Centre for the Replacement, Refinement and Reduction of Animals in Research. ResultsA total of 582 studies were included. The assessment results showed that the number of reported items with "Low Risk" in SYRCLE, which have 22 items, reported in >50% of the 4 items and in <30% the 16 items in articles of animals experiments. More than 99% of the studies fulfilled the 3 items and more than 17% of the articles to meet the 10 items while less than 1% of the documents met the 17 items. The quality of studies increased excepted the period of 2010 to 2014. The methodological quality of animal experiments presented a trend of increasing and no significant differences were found in CSCD indexed or not. ConclusionThe methodological quality of animal experiments of stroke is poor in China in terms of the selection bias, implementation bias, measurement bias, withdraw bias and reporting bias.
ObjectiveTo assess the methodological and reporting quality of systematic reviews/Meta-analyses (SRs/MAs) of transurethral procedure for benign prostatic hyperplasia (BPH). MethodWe electronically searched databases including PubMed, The Cochrane Library (Issue 12, 2014), Sciverse, CNKI, VIP and WanFang Data from inception to December 2014 to collect SRs/MAs of transurethral procedure about BPH. Two reviewers independently screened literature and assessed the methodological and reporting quality of included SRs/MAs by AMSTAR and PRISMA checklists. ResultsA total of 33 SRs/MAs were included. The results of qualitative analysis showed that:the main methodological weakness of included SRs/MAs included the lack of protocol, disappropriate conclusion formulation, the lack of publication bias assessment, and the lack of stating the conflict of interest. The average score of AMSTAR scale was 6.27±2.14. There were 11 items in PRISMA checklist with coincidence rate over 80%, 8 items between 50% to 80%, and 8 items less than 50%. ConclusionThe methodological and reporting quality of SR/MA of transurethral procedure for BHP is low, and that may decrease the reliability and value of results from SRs/MAs in the field. Future SRs/MAs should strictly follow the related reporting guidelines in order to improve the methodological and reporting quality, so as to provide more reliable evidence for clinical decision.
ObjectiveTo evaluate the methodological quality of systematic reviews and meta-analysis (SRs/MAs) in fields of integrated Chinese-western therapy for non-small cell lung cancer (NSCLC). MethodsSRs/MAs in fields of integrated Chinese-western therapy for NSCLC were searched inPubMed, EMbase, CBM, CNKI, VIP and WanFang Data from inception to July 10th, 2016. We also handsearched relevant journals such as Chin J Evid-based Med and reference of included studies, and tried to find the grey literature for additional studies. Two researchers independently screened literature and extracted data. Then methodological quality of included SRs/MAs were evaluated by AMSTAR scale. ResultsA total of 53 SRs/MAs were included, the highest and lowest scores of methodological quality were 9 and 1, respectively. The average score was 5.98±1.50. Results on the qualities of methodology or evaluation showed that 46 SRs/MAs (88.68%) was rated as moderate and 6 (11.32%) as low． The main problems were found in such areas as preliminary design scheme, literature searching, a list of included and excluded studies, etc.. ConclusionThe methodology of SRs/MAs in fields of integrated Chinese-western therapy for NSCLC have quality problems at different levels, further improvement should be expected.
ObjectivesTo evaluate the methodology quality and report quality of the published systematic reviews/meta-analyses (SRs/MAs) of pediatric tuina domestically and abroad.MethodsCBM, VIP, CNKI, WanFang Data, PubMed, EMbase, and The Cochrane Library were electronically searched to collect published pediatric tuina SRs/MAs from inception to December 10th, 2018. The SRs/MAs which includes scale evaluation used AMSTAR2 and the PRISMA report quality evaluation tool to systematically review methodology, adopts Excel to carry out data collation and statistical analysis. ResultsA total of 18 studies (14 in Chinese and 4 in English) on the SRs/MAs of pediatric tuina were finally included. In terms of methodological quality, 6 studies were of low quality and 12 studies were of very low quality. All studies did not explain the reasons for adopting a particular research design type, and few of them explained the pre-plan, exclusion list, reasons and funding. In terms of report quality, 7 studies were relatively complete, 10 studies had certain defects and one study had serious defects. The existing problems were program and registration, comprehensive retrieval, information sources, financial support and so on. ConclusionsSRs/MAs of pediatric tuina have different degrees of issues in terms of methodological quality and report quality which still require further improvement and continuous strengthening.
ObjectiveTo evaluate the methodological quality of animal experiments published in high impact journals, in order to provide references for improving the quality of animal experiments.MethodsCSCD and Web of Science databases were electronically searched to collect intervening primordial animal experiments from 2014 to August, 2016. Four reviewers independently screened literatures, extracted data and assessed the methodological quality of included studies by using SYRCLE tool.ResultsA total of 1 999 animal experiments were included. The cited frequency of more than 90% studies were ≤5 times, and of which 52.53% studies were zero. The results of SYRCLE evaluation showed that 54.55% of sub items rated as "low risk" were less than 30%. And 84.62% of them were less than 10%.ConclusionThere are defeet in methodological quality of animal experiments either domestic or abroad. The problems of domestic researches in implementation bias, measurement bias and loss of access bias are particularly obvious. The coincidence rates of "low risk" are much lower than those of abroad studies. Therefore, we suggest that it is necessary to take specific measures to popularize SYRCLE tool to effectively guide the development of animal experiments and improve the design and implementation of animal experiments.