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评估系统评价偏倚风险的ROBISIS工具实例解读

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中国循证医学杂志 2016年第1期16卷 115-121页

作者：丁泓帆吴琼芳杨楠邓围王琪姚亮王小琴韦当陈耀龙杜亮兰州大学第二临床医学院兰州730000 北京大学第一医院麻醉科北京100034 兰州大学第一临床医学院兰州730000 兰州大学基础医学院循证医学中心兰州730000 甘肃省循证医学与临床转化重点实验室兰州730000 GRADE中国中心兰州730000 四川大学华西医院中国循证医学中心成都610041

目的通过对系统评价偏倚风险评估工具ROBIS的解读,促进其理解和正确使用。方法逐条解释ROBIS工具的评估条目,并用该工具示范性评估干预性系统评价《环磷酰胺治疗儿童肾病综合征随机对照试验的系统评价》的偏倚风险。结果示例系统评... 详细信息

目的通过对系统评价偏倚风险评估工具ROBIS的解读,促进其理解和正确使用。方法逐条解释ROBIS工具的评估条目,并用该工具示范性评估干预性系统评价《环磷酰胺治疗儿童肾病综合征随机对照试验的系统评价》的偏倚风险。结果示例系统评价的整体偏倚风险程度“高”,其风险主要存在于领域2~4,即研究的检索和筛选、数据提取和质量评价、数据合成和结果呈现等;领域1（研究的纳入标准）偏倚风险低;考虑到纳入研究与系统评价研究问题的相关性,且避免强调有统计学意义的结果。结论 ROBIS是目前值得推荐的系统评价偏倚风险评估工具。研究者制作系统评价时可参照该工具条目,以提高系统评价质量。

关键词： ROBIS 系统评价偏倚风险解读

坤泰胶囊治疗围绝经期综合征的系统评价再评价

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中国中药杂志 2021年第19期46卷 5103-5109页

作者：门晓亮赵丽萍杨杰李博北京市大兴区妇幼保健院妇女保健部北京102600 首都医科大学附属北京中医医院北京100010

该文对坤泰胶囊治疗围绝经期综合征的有效性和安全性的系统评价进行了再评价。检索中、英文数据库中有关坤泰胶囊治疗围绝经期综合征的系统评价,检索时间自建库至2020年8月31日,对最终纳入的系统评价使用AMSTER-2量表、GRADE量表及ROBI... 详细信息

该文对坤泰胶囊治疗围绝经期综合征的有效性和安全性的系统评价进行了再评价。检索中、英文数据库中有关坤泰胶囊治疗围绝经期综合征的系统评价,检索时间自建库至2020年8月31日,对最终纳入的系统评价使用AMSTER-2量表、GRADE量表及ROBIS工具分别进行方法学质量评价、证据质量等级及偏倚风险评价。共纳入6篇系统评价,28个结局指标。AMSTER-2方法学质量评估结果显示6篇系统评价中1篇为低质量,其余5篇均为极低质量。GRADE量表对28个临床结局指标进行质量评价,3个为中级证据,其余为低级或极低级证据,3个中级证据中1个采用Kupperman评分,2个采用总有效率。ROBIS偏倚风险评价纳入文献的系统评价均为高风险。结果表明坤泰胶囊治疗围绝经期综合征潮热出汗等症状临床是有效的,对雌二醇(E2)水平的改善不如激素替代组,不良反应较激素替代组低,但证据质量有待提高,方法学质量较低,偏倚风险较高,建议今后规范和合理的设计系统评价,重视研究方案的注册,并按照PRISMA声明书写研究报告。

关键词：坤泰胶囊围绝经期综合征系统评价再评价 AMSTER-2 GRADE ROBIS

Common traditional Chinese medicine therapies for diarrhea-predominant irritable bowel syndrome: An overview of systematic reviews

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Journal of Traditional Chinese Medical Sciences 2022年第3期9卷 330-339页

作者： Jun Zhao Xia Li Xiaowei Chen Hui Zheng Kun Ye Yunzhou Shi Xin Xie Jianfang Wang Min Chen Zhigang Li School of Acupuncture Moxibustion and TuinaBeijing University of Chinese MedicineBeijing102488China Department of Spleen StomachLiver and Gallbladder DiseasesDongfang Hospital Affiliated to Beijing University of Chinese MedicineBeijing100078China The Third Hospital/Acupuncture and Tuina School Chengdu University of Traditional Chinese MedicineChengdu610075China Anorectal Disease Department Hospital of Chengdu University of Traditional Chinese MedicineChengdu610072China

Objective: To critically evaluate and summarize the methodological quality of systematic reviews(SRs)and present objective and important outcomes on the effectiveness of traditional Chinese medicine(TCM) therapies, including Chinese herbal medicine(CHM), acupuncture, and moxibustion, for diarrheapredominant irritable bowel syndrome(IBS-D).Methods: We conducted a comprehensive literature search for SRs in 7 databases until April 16, 2022.Two reviewers independently extracted data and assessed the methodological quality of the reviews according to the Assessing the Methodological Quality of Systematic Reviews 2(AMSTAR-2), the Risk of Bias in Systematic reviews(ROBIS) tool, and the Preferred Reporting Item for Systematic Review and Meta-analysis(PRISMA) statement. The Grading of Recommendations, Assessment, Development, and Evaluation(GRADE) was used to rate the quality of evidence.Results: IBS-D patients included in 12 reviews were diagnosed in accordance with the Rome criteria, 9 reviews focused on CHM, 2 articles observed moxibustion and heat-sensitive moxibustion, 1 article studied acupuncture and CHM. The outcomes of the SRs were the effectiveness rate, the total effectiveness rate,global symptom improvement, and adverse effects. Based on AMSTAR-2, which measures the quality of methodology, all of the included studies were of low or critically low quality. According to the ROBIS tool, 10 SRs(83.33%) had a high risk of bias. With the PRISMA checklist, only 3 SRs reached over 90% compliance.Based on GRADE, most evidence was of low quality, and there was a moderate quality of evidence that the effectiveness rate of modified-Tongxie Yaofang was superior to Western medicine in the treatment of IBS-D.Conclusion: Given the suboptimal reporting and methodological quality of existing SRs, more studies are needed to clarify whether TCM therapies are more effective or safe than pharmacological medicine.Future studies should combine evidence-based medicine with TCM research according to the characteristics of TCM.

关键词： Diarrhea-predominant irritable bowel syndrome Overview Traditional Chinese medicine therapies AMSTAR-2 GRADE PRISMA ROBIS

针刺治疗原发性抑郁症系统评价的方法学质量及适用性评价

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中国循证医学杂志 2019年第11期19卷 1333-1340页

作者：徐桂兴李涓银子涵李雨谿付亚男周俊梁繁荣成都中医药大学针灸推拿学院

目的评价针刺治疗原发性抑郁症系统评价的方法学质量和研究结果的适用性。方法计算机检索Web of Science、EMbase、PubMed、The Cochrane Library、CNKI、CBM、WanFang Data和VIP数据库获取公开发表的针刺治疗原发性抑郁症的系统评价/M... 详细信息

目的评价针刺治疗原发性抑郁症系统评价的方法学质量和研究结果的适用性。方法计算机检索Web of Science、EMbase、PubMed、The Cochrane Library、CNKI、CBM、WanFang Data和VIP数据库获取公开发表的针刺治疗原发性抑郁症的系统评价/Meta分析,检索时限均从建库至2018年12月5日。由2名研究者独立筛选文献并提取资料,运用AMSTAR 2工具和ROBIS工具评价纳入研究质量,同时采用CASP-S.R中涉及结果适用性条目评价系统评价的适用性。结果最终纳入18篇系统评价/Meta分析,均以针刺干预为主,包含2个主要结局指标。根据AMSTAR 2评价结果,有4个高质量研究、12个中等质量研究和2个低质量研究。根据ROBIS工具,共有10个研究偏倚风险高,7个研究偏倚风险较低,1个研究偏倚风险不确定。根据CASP-S.R,仅有4篇研究设计结果可能适用于当地人群,没有研究设计获益与成本危害之间的关系。结论针刺治疗原发性抑郁症的系统评价方法学质量属中等水平,部分研究存在一定的偏倚,大部分研究可能不能直接适用于当地人群,所有研究均没有获益与成本危害之间的关系。期望今后的系统评价严格按照系统评价制作方法进行,以提高研究质量、减少偏倚,同时应当考虑到系统评价对不同人群的适用性以及获益与成本危害之间的关系。另外,尚需在针刺治疗原发性抑郁症的原始研究上投入更多的考虑,以提供更高质量、科学、精确的临床证据。

关键词：原发性抑郁症针刺系统评价再评价 AMSTAR ROBIS CASP-S.R

Acupuncture for post-stroke dysphagia: An overview of systematic reviews

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Journal of Hainan Medical University 2020年第11期26卷 28-35页

作者： Wei-Jing Fan Shi-Bing Liang Ren-Yan Huang Guo-Bin Liu Shanghai University of Traditional Chinese Medicine Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Evidence-based Medicine Center of Beijing University of Chinese Medicine

Objective: To overview the systematic reviews of acupuncture for Post-stroke Dysphagia. Methods: The Chinese and English databases were searched for the systematic reviews of dysphagia after acupuncture treatment. The retrieval time was until October 30, 2019. The final literature was evaluated for bias risk, methodology quality and evidence quality by using ROBIS tool, AMSTER-2 scale and GRADE method. Results: 9 systematic reviews and 36 outcomes were included. ROBIS bias risk assessment results show that all the studies are high bias risk;AMSTER-2 methodology quality assessment results show that all the systems are of very low quality;GRADE grading shows that there are only 7 intermediate evidences in 36 clinical evidences, the rest are low-level evidences or very low-level evidences, and there are multiple intermediate evidences in the clinical efficacy of acupuncture in the treatment of dysphagia after stroke. In addition, acupuncture can significantly improve the scores of all kinds of swallowing function related scales, such as Tengdao food intake swallowing function grade, swallowing disorder specific quality of life score, standard swallowing function evaluation scale, and the incidence of adverse reactions is low. Conclusion: Acupuncture is effective in the treatment of dysphagia after stroke. It can improve the scores of various swallowing function scales and has high safety. However, the risk of systematic evaluation bias is high, the quality of methodology is low, and the level of clinical evidence is low as a whole. In the future, the relevant research design should be more rigorous, and the research report should be written in strict accordance with the PRISMA statement.

关键词： Acupuncture Post-stroke Dysphagia Overview of Systematic Reviews ROBIS AMSTER-2 GRADE

维普期刊数据库评论

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针刺治疗脑卒中后吞咽障碍的系统评价再评价

海南医学院学报 2020年第11期26卷 829-837页

作者：樊炜静梁士兵黄仁燕柳国斌上海中医药大学上海200023 上海中医药大学附属曙光医院上海200023 北京中医药大学循证医学中心北京100029

目的:对针刺治疗脑卒中后吞咽障碍的系统评价/meta分析进行再评价。方法:计算机检索中英文数据库中有关针刺治疗脑卒中后吞咽障碍的系统评价,检索时间至2019年10月30日,对最终纳入文献使用ROBIS工具、AMSTER-2量表和GRADE方法分别进行... 详细信息

目的:对针刺治疗脑卒中后吞咽障碍的系统评价/meta分析进行再评价。方法:计算机检索中英文数据库中有关针刺治疗脑卒中后吞咽障碍的系统评价,检索时间至2019年10月30日,对最终纳入文献使用ROBIS工具、AMSTER-2量表和GRADE方法分别进行偏倚风险评价、方法学质量评价和证据质量等级评价。结果:共纳入9个系统评价,36个结局指标。ROBIS偏倚风险评价结果为所有研究为高偏倚风险;AMSTAR-2方法学质量评价结果为所有系统评价为极低质量;GRADE分级显示36个临床证据中仅有7个中级证据,其余均为低级证据或极低级证据,其中针刺治疗脑卒中后吞咽障碍临床疗效有多个中级证据。此外,针刺能明显改善藤岛摄食-吞咽功能等级评分、吞咽障碍特异性生活质量评分、标准吞咽功能评价量表等各类吞咽功能相关的量表评分,且不良反应发生率低。结论:针刺治疗脑卒中后吞咽障碍疗效确切,能改善各类吞咽功能量表的评分,且有较高安全性。但其系统评价偏倚风险较高,方法学质量低,且临床证据级别整体偏低。今后的相关研究设计应更加严谨,研究报告书写应严格按照PRISMA声明进行。

关键词：针刺脑卒中后吞咽障碍系统评价再评价 ROBIS AMSTER-2 GRADE

Chinese herbal medicine for hand-foot-and-mouth disease in children: An overview of systematic reviews

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Journal of Traditional Chinese Medical Sciences 2018年第2期5卷 83-93页

作者： Ruohan Wu Shigang Liu Jin Sun Lily Lai Jianping Liu Centre for Evidence-Based Chinese Medicine Beijing University of Chinese MedicineBeijing 100029China Department of Respiratory Diseases Guang'anmen HospitalChina Academy of Chinese Medical SciencesBeijing 100053China Complementary and Integrated Medicine Research Unit Primary Care and Population SciencesUniversity of SouthamptonSO16 5STUK

Objective:To summarize the use of Chinese herbal medicines (CHM) for the treatment of hand-foot-and-mouth disease (HFMD) in children and to provide high-level evidence for clinical decision-making.Methods:We conducted an overview of systematic reviews (SRs).Two English-language and four Chinese-language electronic databases were searched from inception to March 31,2018.Published SRs and meta-analyses evaluating CHM use in children with HFMD and reporting clinically-relevant outcomes such as time to fever resolution were eligible for inclusion in this overview.Reviews were accepted if the intervention featured CHM with or without other treatment.Two authors evaluated the methodological quality of the included SRs by using ASMTAR and ROBIS.Results:Thirty SRs comprising 90 244 children with HFMD were included in this overview of SRs.All SRs were published in Chinese between 2011 and 2017.All intervention arms received CHM with or without conventional treatment and were compared against control arms receiving no treatment,conventional treatment alone,or placebo.All 30 reviews reported the time to fever resolution and results demonstrated that CHM had a greater benefit in reducing fever compared with controls.Twenty-three reviews reported the time to rash resolution which presented similar results.Fourteen SRs reported the time to oral ulcer healing and CHM demonstrated a significantly reduced time to resolution compared to controls.The quality of the included SRs was low to moderate as assessed by the AMSTAR tool.Conclusion:Published reviews demonstrated potential benefits of CHM in children with HFMD.Overall,the methodological quality of reviews included in this overview of SRs was low and our findings should be interpreted with caution.We would strongly recommend that future SRs be designed and reported rigorously following PRISMA in order to provide more robust evidence on which to base clinical guidance.

关键词： Chinese herbal medicine Hand-foot-mouth disease Overview AMSTAR ROBIS

儿童针灸领域系统评价的方法学质量和偏倚风险评估

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中国循证心血管医学杂志 2020年第4期12卷 390-395页

作者：马圆柯立鑫毛雪艳贺春伟刘佳刘雅莉兰州大学第一临床医学院兰州730030 中山大学附属第一医院肝外科广州510080 兰州大学第二临床医学院兰州730030 中国中医科学院中医临床基础医学研究所兰州730030 国家儿童医学中心/首都医科大学附属北京儿童医院临床流行病学与循证医学中心北京100700

目的本文采用AMSTAR-2和ROBIS工具评价纳入儿童针灸领域系统评价/meta分析的方法学质量和偏倚风险,探讨两种评价工具的特点与不同,为合理选择AMSTAR-2和ROBIS工具提供参考依据。方法计算机检索PubMed、EMBASE、Cochrane Library、CBM、C... 详细信息

目的本文采用AMSTAR-2和ROBIS工具评价纳入儿童针灸领域系统评价/meta分析的方法学质量和偏倚风险,探讨两种评价工具的特点与不同,为合理选择AMSTAR-2和ROBIS工具提供参考依据。方法计算机检索PubMed、EMBASE、Cochrane Library、CBM、CNKI、维普和万方数据库,收集儿童针灸领域的系统评价/Meta分析,检索时限均为建库至2018年1月。两名评价员分别独立采用AMSTAR-2和ROBIS工具评价纳入研究的方法学质量和偏倚风险。结果共纳入66篇系统评价/Meta分析,CDSR 7篇、国际期刊34篇、中文期刊25篇。①AMSTAR-2评价结果显示,有7个条目报告率ROBIS评价结果显示,92.42%(61/66)的文献总体偏倚风险较高,其中四个领域(领域1研究的纳入排除标准、领域2研究的检索和筛选、领域3数据提取和质量评价和领域4数据合成和结果呈现)的偏倚风险高的文献分别占总数的78.79%(52/66)、81.82%(54/66)、40.91%(27/66)和66.67%(44/66)。③有15.15%(10/66)的文献AMSTAR-2显示方法学质量较高,ROBIS却显示其具有较高的偏倚风险。结论当前儿童针灸领域的系统评价质量仍有待提高。质量评价和偏倚风险评估结果大多数情况较为一致,但高方法学质量的文献也可能存在高风险偏倚。建议根据具体需求选择AMSTAR-2和ROBIS工具。

关键词： AMSTAR-2 ROBIS 儿童针灸