临床推荐意见分级标准的认可

临床实践指南分级面临挑战过去十年,临床实践指南质量的持续改善和提高得益于采纳了一些基本原则,如根据相关证据生产的系统评价对推荐意见和潜在证据的质量分级。但由此而产生的大量证据与推荐意见分级标准系统相互矛盾,让人困惑。由临床指南制定者、系统评价员和临床流行病学家组成的国际性小组已着手承担这项极具挑战的任务,以帮助解决不同证据和推荐意见分级     

GRADE：证据质量和推荐强度分级的共识

GRADET作组致中国读者： 推荐分级的评估、制定与评价（GRADE）工作组已取得长足进步。我们制定了系列指南文件,除发表文章外,该非正式组织已经发展成为一个评价证据、转化卫生保健领域知识用以指导决策者的智囊团。80余位国际专家研究和制定了该评价系统。正如其他科学一样,证据评价和指南制定科学不会停滞不前。     

医学研究中证据分级和推荐强度的演进

本文系统分析了1979-2007年间50个主要组织和机构的证据分级标准及推荐意见强度，遴选出最具代表性的5个国家和国际组织的11个标准，并从分级特点、影响范围、使用领域等角度将其分为三个发展阶段。目前医学领域的标准已趋于成熟，并逐步统一。未来的挑战是在管理、教育、基础研究、经济学、社会学、法学等非医非药领域引入证据分类分级理念，研究制定符合循证医学思想，满足各领域研究和实践需要的高质量证据分类分级标准和推荐意见强度，接受时间和实践的检验。     

JBI证据预分级及证据推荐级别系统（2014版）

证据具有等级性,证据的等级系统包括证据的质量等级（Quality level of evidence）和推荐级别（Grade of recommendation）。系统评价产生的证据,应标注其质量等级,而临床实践指南和证据总结等资源则应标注证据的推荐级别。因此,医疗卫生保健专业人员在将证据应用到临床实践中时,很重要的一步是对形成证据的研究进行方法学质量的严格评价,并进行分级,以明确该证据的推荐强度。多年来,全球各循证卫生保健组织构建了各自独特的证据质量分级和推荐强度系统,并不断更新。WHO于2004年推出证据的GRADE系统（Grades of Recommendations Assessment , Development and Evaluation ,GRADE）［1］,是目前最常用的证据分级系统,被较多国际循证卫生保健组织采纳和应用,包括世界卫生组织、美国卫生保健政策研究所（A HRQ ）、英国国家卫生与临床优化研究所（NICE）、英国医学杂志（BMJ）的临床证据数据库（Clinical Evidence）以及苏格兰院际指南网（SIGN ）等。澳大利亚 Joanna Briggs 循证卫生保健中心（Joanna Briggs Institute ,JBI）成立于1996年,是在全球拥有近50多个分中心的推广循证护理即循证卫生保健的学术机构,该中心在2003年前采用的证据分级系统是澳大利亚健康与医疗研究协会（A us‐tralian National Health & Medical Research Coun‐cil ,A N H M RC ）于1999年制订的临床实践指南的制订、应用与评估标准。2003年以后,JBI基于对证据多元性的认识,提出证据的FAM E结构（证据的可行性、适宜性、临床意义和有效性）,制订了“JBI证据等级系统”,并于2006年、2010年进行了更新。
　　随着GRADE系统的推广与普及,2014年JBI根据GRADE系统及JBI循证卫生保健模式制订了JBI证据预分级及证据推荐级别系统,该系统适用于护理学及其它卫生保健领域。本文主要介绍2014年版JBI证据预分级及证据推荐级别系统［2］。     

公共卫生决策证据质量分级方法问题的定性系统评价

目的 系统评价公共卫生决策证据质量分级方法相关研究问题。方法 计算机检索PubMed、Web of Science、CNKI、WanFang Data、CBM和VIP数据库,搜集公共卫生决策证据质量分级方法应用相关研究,检索时限均为建库至2022年12月。根据SPIDER模型构建问题,采用CASP清单对纳入文献进行质量评价,利用主题综合法对公共卫生决策证据质量分级方法的应用问题进行三级诠释分析,建立问题条目池。结果 共纳入14篇文献,涵盖7个国家。GRADE是常用的证据质量分级方法。CASP评价结果显示高质量研究8篇,中等质量研究4篇,低质量研究2篇。主题综合法归纳出7类13个问题条目。结论 现有的公共卫生决策证据质量分级方法存在证据来源多样、复杂干预研究的证据等级被低估等问题。     

中医护理环节质量评价体系的构建与应用

目的探讨中医护理环节质量评价体系的应用效果。方法 2010年12月依据《中医医院护理工作指南(试行)》构建中医护理环节质量评价体系;其中中医护理专科专病护理质量评价每月采取不定时检查,方式以提问、查看资料为主,按百分制进行评分;中医护理技术操作评价每月采取集中考核方式进行,占临床护理质量检查标准中0.1。采取便利抽样法分别于2011年6月及2012年11月对我院19个护理单元的364例住院患者进行问卷调查了解中医护理环节质量评价应用效果。结果患者对护士进行相关中医知识健康宣教的满意度由76.6%上升至93.1%(P0.05),总体满意度由84.6%上升至91.5%(P0.05),差异有统计学意义。结论中医护理环节质量评价体系保证了护理质量评价的公正,提升了临床健康宣教的质量,得到患者的认可,护理服务更加到位。     

诊断性试验和策略的证据质量和推荐强度的分级

GRADE系统能对诊断性试验或策略的证据质量和推荐强度进行分级。本文旨在阐释在此过程中如何考虑患者的重要结局,     

GRADE在系统评价中应用的必要性及注意事项

本文通过具体实例分析了为何需要在系统评价中应用GRADE分级的原因,以及在使用过程中可能存在的误区与注意事项,主要包括： 如何区分指南和系统评价中GRADE的不同应用,如何确定总的证据质量分级,是否应对单个研究进行分级,RCT和观察性研究分级的差异,分级条目权重的考虑,升降级级数的考虑和可能影响GRADE分级结果的因素,以期为正确理解和应用GRADE分级提供一定参考。     

中药熏蒸治疗肩手综合征的系统评价

目的：系统评价中药熏蒸治疗肩手综合征的临床疗效。方法：计算机搜索The Cochrane Library、EMbase、PubMed、CNKI、CBM、WanFang Data及VIP 数据库,寻找中药熏蒸治疗肩手综合征的随机对照试验（RCT）,搜索时间范围从数据库构建到2018年3月。由2位评估员根据纳入与排除标准独立进行文献筛选、资料提取及纳入研究的偏倚风险评估后,使用RevMan5.3软件进行Meta分析。结果：最终纳入13个研究,共880名患者。Meta分析结果显示：中药熏蒸组在治疗有效率［RR=1.23,95%CI（1.15,1.32）,P＜0.01］、FMA评分［MD= 8.1,95%CI（4.95,11.25）,P＜0.01］、VAS评分［MD= -1.74,95%CI（-2.23,-1.25）,P＜0.01］及肩关节活动度［MD =-0.64,95%CI（-0.89,-0.38）,P＜0.01］方面优于对照组,差异均有统计学意义;但两者在FMA评分的亚组干预2～3周中差异无统计学意义［MD= 7.02,95%CI（-1.00,15.05）,P=0.09］。结论：中药熏蒸可以改善肩手综合征患者的上肢运动功能,减轻疼痛,改善肩关节活动度。由于所包含研究的数量和质量的限制,需要更多的大样本高质量研究来验证上述结论。     

中医药系统评价/Meta分析证据库的构建

中医药系统评价/Meta分析证据库(SMD-TCM)是专注于二次研究证据转化与应用的数据库平台。目前已完成前后台网站搭建、文献证据录入及评价等,并将实现系统评价再评价自动化和证据信息可视化,为中医药二次研究的证据整合、分析、转化输出提供技术与平台支持。本研究从SMD-TCM的构建需求、设计原则、搭建情况、证据处理、证据质量保障、数据分析与利用等方面,对SMD-TCM进行介绍。     

The effect of Chinese herbal medicine on hemorrhagic shock: A systematic review and meta-analysis

BackgroundChinese herbal medicine (CHM) has been widely used in the treatment of hemorrhagic shock (HS) in China. Many controlled trials have been undertaken to investigate its efficacy.ObjectiveTo evaluate the effectiveness and safety of CHM for Hemorrhagic Shock patients.MethodsWe screening the Web of ScienceDirect database, PubMed, the Cochrane Library, EMBASE, China Biomedical Database web (CBM), China National Knowledge Infrastructure (CNKI) and WanFang database (WF), from inception to January 2015. All the randomized controlled trials (RCTs) that compared CHM plus conventional therapy with conventional therapy alone for HS patients were included. Meta-analysis on included studies was performed using fixed-effects model with RevMan 5.2. Risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) was used as effect measure. STATA 12.0 was used for publication bias.ResultsFifteen RCTs involving 1076 participants were included in the meta-analysis. CHM combined with conventional therapy was tested to be more effective in reduce mortality (RR = 0.24, 95%CI:0.13–0.46, P < 0.0001), reduce the incidence of MODS (RR = 0.47, 95%CI: 0.34–0.66,P < 0.00001), symptomatic improvement: increase blood pressure (BP) (MD = 8.83, 95%CI:6.82–10.84,P < 0.00001), regulate heart rate (MD = −7.6,95%CI:−9.17 to −6.02,P < 0.00001), increase urine volume (MD = 7.26, 95%CI:5.00–9.53, P < 0.00001), compared with conventional therapy alone. No serious adverse events were reported.ConclusionsCHM combined with conventional therapy seems to be more effective on HS patients. However, the analysis results should be interpreted with caution due to the low methodological quality of the included trials. Future, the rigorously designed, high methodological quality, multicenter and large-scale trials are needed to confirm these conclusions.     

Chinese medicine formulas for nonalcoholic fatty liver disease: Overview of systematic reviews

BACKGROUNDNonalcoholic fatty liver disease (NAFLD) affects more than one-quarter of the global population. Due to the lack of approved chemical agents, many patients seek treatment from traditional Chinese medicine (TCM) formulas. A variety of systematic reviews have been published regarding the effectiveness and safety of TCM formulas for NAFLD.AIMTo critically appraise available systematic reviews and sort out the high-quality evidence on TCM formulas for the management of NAFLD.METHODSSeven databases were systematically searched from their inception to 28 February 2020. The search terms included “non-alcoholic fatty liver disease,” “Chinese medicines,” “systematic review,” and their synonyms. Systematic reviews involving TCM formulas alone or in combination with conventional medications were included. The methodological quality and risk of bias of eligible systematic reviews were evaluated by using A Measure Tool to Assess Systematic Reviews 2 (AMSTAR 2) and Risk of Bias in Systematic Review (ROBIS). The quality of outcomes was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.RESULTSSeven systematic reviews were ultimately included. All systematic reviews were conducted based on randomized controlled trials and published in the last decade. According to the AMSTAR 2 tool, one systematic review was judged as having a moderate confidence level, whereas the other studies were rated as having a low or extremely low level of confidence. The ROBIS tool showed that the included systematic reviews all had a high risk of bias due to insufficient consideration of identified concerns. According to the GRADE system, only two outcomes were determined as high quality; namely, TCM formulas with the HuoXueHuaYu principle were better than conventional medications in ultrasound improvement, and TCM formulas were superior to antioxidants in alanine aminotransferase normalization. Other outcomes were downgraded to lower levels, mainly because of heterogeneity among studies, not meeting optimal information sample size, and inclusion of excessive numbers of small sample studies. Nevertheless, the evidence quality of extracted outcomes should be further downgraded when applying to clinical practice due to indirectness.CONCLUSIONThe quality of available systematic reviews was not satisfactory. Researchers should avoid repeatedly conducting systematic reviews in this area and focus on designing rigorous randomized controlled trials to support TCM formula applications.     

中医药治疗绝经后骨质疏松的疗效及安全性系统评价

目的分析中医药治疗绝经后骨质疏松症的效果和可能的不良反应.方法电子检索:MEDLINE(1966～2003)、EMBASE(1974～2003)、Cochrane Library 2003年第4期的Controlled Trials Register、Current Con-trolled Trials、The National Research Register、中国生物医学文献数据库(1978～2003)和中文科技期刊全文数据库(1977～2003)、中文学术期刊全文数据库(1994～2003),并手工检索相关领域杂志.检索截止至2003年11月.所有检索均不受语种限制.纳入以绝经后妇女为研究对象、比较中医药与其它疗法疗效的随机或半随机对照试验,评价纳入研究的质量,并用RevMan 4.2软件进行Meta分析.结果共纳入33个研究,包括2 337例患者和27种中药.部分中药或中西医结合治疗对提高患者骨密度、血清雌二醇、血清钙可能有一定疗效.例如补肾益骨膏和补肾强骨胶囊调节绝经后妇女雌激素的效果优于安慰剂,其WMD和95?分别为[0.76(0.65,0.87)]和[39.94(35.12,44.76)];其余中药因研究数较少或结论不一致尚未发现较明显的趋势.中药治疗未发现明显的副作用.结论中医药治疗绝经后骨质疏松症的疗效证据仍十分有限,尚需更多高质量研究以增加证据的强度.     

Chinese herbal medicine Kuntai capsule for treatment of menopausal syndrome: a systematic review of randomized clinical trials

ObjectivesKuntai capsule has been widely used for the treatment of menopausal syndrome in China for long time. We conducted this review to assess efficacy and safety of Kuntai capsule for the treatment of menopausal syndrome.MethodsWe searched studies in PubMed, ClinicalTrials, the Cochrane Library, China National Knowledge Infrastructure Database(CNKI), China Science and Technology Journal Database (VIP), Wan fang Database and Chinese Biomedical Literature Database(CBM) until November 20, 2014. Randomized trials on Kuntai capsule for menopausal syndrome, compared with placebo or hormone replacement therapy (HRT) were included. Two reviewers independently retrieved the randomized controlled trials (RCTs) and extracted the information. The Cochrane risk of bias method was used to assess the quality of the included studies, and a Meta-analysis was conducted with Review Manager 5.2 software.ResultsA total of 17 RCTs (1455 participants) were included. The studies were of low methodological quality. Meta-analysis indicated that there was no statistical difference in the Kupperman index (KI) [WMD = 0.51, 95% CI (−0.04, 1.06)], the effective rate of KI [OR = 1.21, 95% CI (0.72, 2.04)], E2 level [WMD = −15.18, 95% CI (−33.93, 3.56)], and FSH level [WMD = −3.46, 95% CI (−7.2, 0.28)] after treatment between Kuntai versus HRT group (P > 0.05). However, Compared with HRT, Kuntai capsule could significantly reduce the total incidence of adverse events [OR = 0.28, 95% CI (0.17, 0.45)].ConclusionsKuntai capsule may be effective for treating menopausal syndrome and lower risk of side effects. The studies we analyzed were of low methodological quality. Therefore, more strictly designed large-scale randomized clinical trials are needed to evaluate the efficacy of Kuntai capsule in menopausal syndrome.     

中医临床路径证据引用情况分析

目的分析我国发布的中医临床路径的证据引用情况,为中医临床路径的制订/修订提供参考。方法从国家中医药管理局网站和中华中医药学会网站获取已公开发布的中医临床路径,检索时限截至2019年6月。由2名研究者独立使用Excel标准化表格提取数据,并进行描述性分析。结果共发布中医临床路径405个,病种涉及内、外、妇、儿等科室,其中内科临床路径数量最多(133个)。405个路径均引用了证据,路径引用证据数量最大值为11个,最小值为1个,每个路径引用证据的中位数为3个。90%以上的路径在诊断和疗效评价部分均引用了证据,中、西医治疗部分引用证据的路径占比<75%,其它疗法及康复、护理部分引用证据的路径占比<2%。引用证据类型依次为标准指标(683次)、临床实践指南(488次)、教科书(236次)、共识意见、古籍和临床调研。89.25%的证据报告了发表时间,其中标准指标与路径发布时间间隔最久,在时间间隔大于15年的证据类型中标准指标占比最高(57.12%)。结论已发布的中医临床路径均基于证据制订,但不同部分内容证据引用率差异较大,部分中医临床路径未规范报告引用的证据,部分证据的时效性较差。