背景与目的 对卫生保健干预措施进行决策权衡需要有不良和有益的可靠证据,然而绝大多数系统评价针对的是研究方法非常成熟的随机对照试验及其有效性评价,系统地评价不良反应的方法尚未完善,对研究者而言,能作为相关指南的资源很少.为此,作者在文中报告了对不良反应进行系统评价的新近体会,同时提出进一步实践和研究的建议.方法 描述并比较3个包含不良反应评价的药物干预的系统评价的方法学,重点评价其研究问题、研究设计和质量评价.结果 1个研究关注于如何根据提供的特殊不良反应数据建立卫生经济学模式,而其它两个研究涉及更广泛的问题.尽管每个评价对纳入标准的定义不同,但它们均纳入了随机和观察性数据.对研究质量的评价采用了标准方法.由于研究设计不良、报告不充分和现有研究工具有限,在运用纳入标准和评估研究质量时,研究者遇到了各种问题.最终发现,3个评价都做了大量的工作,但对卫生保健决策者有用的资料不多.研究者确认,改善的关键在于如何提出系统评价的问题和发展不良反应研究的质量评价方法学.结论 若不良反应的系统评价只专注于一个中心问题,那么它会提供与临床决策更相关的资料,也有利于明确纳入系统评价研究的类型.系统评价中不良反应的质量评估的方法学需要进一步完善.
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.
The necessity and methods of systematic review or Meta-analysis of observational studies were introduced. The difference between the systematic review or Meta-analysis of observational studies and randomized controlled trials was also described.
Objective To compare the efficiency of epidermis cell culture between big graft method and small strip method. Methods The big graft method was to cut the skin tissue reticularly from dermis layer while the epidermis were not cut off. After it was digested fully in trypsin, theepidermis was separated from skin and was used to culture epidermal cells. The small strip method was routine. The time to cut the skin and to separate the epidermis was recorded, and the number and quality of cells were compared between two methods. Results It took 8-10 minutes to cut an area of 5 cm2 skin into small strips and 1-2 minutes into big grafts. It took 10-15 minutes to separate the epidermis from the same area skin by small strip method and 2 minutes by big graft method. The cells showed better vigor and its number was more by big grafts than by small strips.The chance of fibroblast contamination was reduced obviously. Conclusion The big graft method is simpler than the small strip method and can culture more epidermis cells with less chance of fibroblast contamination.
ObjectivesTo provide an overview of whether the clinical decision support system (CDSS) was effective in reducing medication error and improving medication safety and to assess the quality of available scientific evidence.MethodsPubMed, EMbase, The Cochrane Library, CBM, WanFang Data, VIP and CNKI databases were electronically searched to collect systematic reviews (SRs) on application of clinical decision support system in the medication error and safety from January, 1996 to November, 2018. Two reviewers independently screened literature, extracted data and then evaluated methodological quality of included SRs by using AMSTAR tool.g AMSTAR tool.ResultsA total of 20 SRs including 256 980 healthcare practitioners and 1 683 675 patients were included. Specifically, 16 studies demonstrated moderate quality and 4 demonstrated high quality. 19 SRs evaluated multiple process of care outcome: 9 were sufficient evidence, 6 were limited evidence, and 7 were insufficient evidence which proved that CDSS had a positive effect on process outcome. 13 SRs evaluated reported patient outcomes: 1 with sufficient evidence, 3 with limited evidence, and 9 without sufficient evidence.ConclusionsCDSS reduces medication error by inconsistently improving process of care measures and seldom improving patient outcomes. Larger samples and longer-term studies are required to ensure a larger and more reliable evidence base on the effects of CDSS intervention on patient outcomes.
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.
ObjectiveTo evaluate the current status and trend of methodological quality of multi-center randomized controlled trials (RCTs) of stroke treatments in Chinese Mainland.MethodsMulti-center RCTs of stroke treatments conducted in Chinese Mainland published in Chinese or English language from January 2000 to December 2019 were retrieved from seven databases including PubMed, Cochrane Central Registry of Controlled Trials, Embase, China Biology Medicine, China National Knowledge Infrastructure, Chinese Science and Technique Journals Database, and Wanfang Database. The basic information was collected. Methodological items were referred to the Cochrane Collaboration’s tool for assessing risk of bias. The definitions of Wade were used to assess the outcome measure.ResultsA total of 90 multi-center RCTs were included, of which 39 were published from 2000 to 2009, and 51 were published from 2010 to 2019. The total number of trials published from 2010 to 2019 was 1.31 times of that published from 2000 to 2009. The research subjects were ischemic stroke patients in 58.9% (53/90) of the RCTs, intracerebral hemorrhage patients in 14.4% (13/90) of the RCTs, and ischemic stroke patients as well as hemorrhagic stroke patients in 26.7% (24/90) of the RCTs. There were 55.6% (50/90) drug trials, and 44.4% (40/90) non-drug trials. There were statistically significant differences in the loss of visit report (P=0.005), primary and secondary outcome indicators report (P=0.027), and adverse reaction report (P=0.007) between the two periods; there was no statistically significant difference in reported adequate randomized methods (P=0.341), allocation concealment (P=0.611), blindness (P=0.551), used intentionality analysis (P=0.573), or follow-up time (P=0.061) between the two periods.ConclusionIn the past 20 years in Chinese Mainland, the quality of stroke treatment RCTs improves slowly, and more attention should be paid to develop the RCTs of true randomization, blinding, and better patient outcome measures.
In recent years, the application of qualitative evidence synthesis results in health and social care policy has increased, and assessment of the limitations of qualitative research methodologies is critical in ensuring the credibility of qualitative evidence synthesis results. However, currently commonly used assessment tools are not designed specifically for Cochrane systematic reviews or qualitative evidence synthesis, and most lack evidence-based development background. To address this gap, the Cochrane qualitative methodological limitations tool (CAMELOT) was created to provide authors with a standardized tool specifically designed to assess the limitations of qualitative research methodologies. Based on the operation guide of evidence-based evaluation tool and Delphi consensus survey method, this paper introduces the development process of CAMELOT and expounds its field contents in detail.
Objective To investigate the methodological characteristics of observational studies on the correlation between drug exposure during pregnancy and birth defects. Methods The PubMed database was searched from January 1, 2020 to December 31, 2020 to identify observational studies investigating the correlation between drug use during pregnancy and birth defects. Literature screening and data extraction were conducted by two researchers and statistical analysis was performed using R 3.6.1 software. Results A total of 40 relevant articles were identified, of which 8 (20.0%) were published in the four major medical journals and their sub-journals, 21 (42.5%) were conducted in Europe and the United States, and 4 were conducted (10.0%) in China. Cohort studies (30, 75.0%) and case-control studies (10, 25%) were the most commonly used study designs. Sixteen studies (40.0%) did not specify how the databases were linked. Sixteen studies (40.0%) did not report a clear definition of exposure, while 17 studies (42.5%) defined exposure as prescribing a drug that could not be guaranteed to have been taken by the pregnant women, possibly resulting in misclassification bias. Six studies (15.0%) did not report the diagnostic criteria for birth defects and 18 studies (45.0%) did not report the types of birth defects. In addition, 33 studies (82.5%) did not control for confounding factors in the study design, while only 19 studies (47.5%) considered live birth bias. Conclusion Improvements are imperative in reporting and conducting observational studies on the correlation between drug use during pregnancy and birth defects. This includes the methods for linking data sources, definition of exposure and outcomes, and control of confounding factors. Methodological criteria are needed to improve the quality of these studies to provide higher quality evidence for policymakers and researchers.
Objective To systematically review the methodological quality of research on clinical prediction models of traditional Chinese medicine. Methods The PubMed, Embase, Web of Science, CNKI, WanFang Data, VIP and SinoMed databases were electronically searched to collect literature related to the research on clinical prediction models of traditional Chinese medicine from inception to March 31, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies based on prediction model risk of bias assessment tool (PROBAST). Results A total of 113 studies on clinical prediction models of traditional Chinese medicine (79 diagnostic model studies and 34 prognostic model studies) were included. Among them, 111 (98.2%) studies were rated at high risk of bias, while 1 (0.9%) study was rated at low risk of bias and risk of bias of 1 (0.9%) study was unclear. The analysis domain was rated with the highest proportion of high risk of bias, followed by the participants domain. Due to the widespread lack of reporting of specific study information, risk of bias of a large number of studies was unclear in both predictors and outcome domain. Conclusion Most existing researches on clinical prediction models of traditional Chinese medicine show poor methodological quality and are at high risk of bias. Factors contributing to risk of bias include non-prospective data source, outcome definitions that include predictors, inadequate modeling sample size, inappropriate feature selection, inaccurate performance evaluation, and incorrect internal validation methods. Comprehensive methodological improvements on design, conduct, evaluation, and validation of modeling, as well as reporting of all key information of the models are urgently needed for future modeling studies, aiming to facilitate their translational application in medical practice.