随机对照试验Meta分析的统一报告格式:QUOROM声明

随机对照试验作为循证医学研究中最有力的证据得到公认，基于随机对照试验的系统评价，为探求当前最佳的医疗证据提供了有效途径。而Meta分析是系统评价的基本方法，如何规范Meta分析报告，能为临床医疗实践提供切实可行的防治决策依据，是近年许多学致力研究的方向。QUOROM小组在回顾既往报告的基础上，改进不足，充分研讨，提出了一种统一的报告格式，即QUOROM声明。该声明包括一份核查单和一幅流程图，对规范报告格式、提高报告质量具有指导作用，目前已得到许多国际名医学期刊的认可，并作为Meta分析报告的作、审稿人和编撰写、评价和发表的重要指南。本对QLIOROM声明形成的背景、过程及其内容和要求进行介绍，展示了报告Meta分析结果的完整框架，期望对规范我国随机对照试验Meta分析报告工作有所裨益，以不断提高我国Meta分析论的质量。     

抗肿瘤坏死因子α单克隆抗体治疗溃疡性结肠炎的Meta分析/系统评价的方法学/报告质量再评价

目的:对已发表的抗肿瘤坏死因子α单克隆抗体治疗溃疡性结肠炎的Meta分析/系统评价进行方法学/报告质量再评价。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国生物医学文献数据库、万方数据和中国知网,检索时限均为自建库起至2018年11月,收集基于抗肿瘤坏死因子α单克隆抗体治疗溃疡性结肠炎的Meta分析/系统评价,对符合纳入标准的文献进行资料提取后,采用AMSTAR量表和PRISMA声明评价纳入研究的方法学质量和报告质量。结果:共纳入14篇Meta分析/系统评价。AMSTAR方法学质量(满分11分)平均得分为6.89分,方法学质量为中等。PRISMA清单得分(满分为27分)范围为15～26.5分。结论:抗肿瘤坏死因子α单克隆抗体治疗溃疡性结肠炎的Meta分析/系统评价的方法学质量和报告质量均不高。     

Meta分析论文的审稿要点

<正>Meta分析(Meta-analysis)是对具有相同目的且相互独立的多个研究结果进行系统的综合评价和定量分析的一种研究方法。系统评价(systematic review)常和Meta分析交叉使用,当系统评价采用了定量合成的方法对资料进行统计学处理时即称为Meta分析。但国内发表的Meta分析还存在一系列问题,如未报告文献检索流程、无敏感度分析、报告不规范等。本文结合Meta分析的报告规     

中药抗病毒注射剂治疗呼吸道感染随机对照试验Meta分析文献的质量评价

目的:为提高国内Meta分析研究水平提供参考。方法:以检索到的13篇国内中药抗病毒注射剂随机对照试验的Meta分析报告为研究样本,采用QUOROM声明、CONSORT声明、Jadad评分标准、Sacks等提出的Meta分析质量评价方法综合评价13篇Meta分析报告的质量。如果有争议采取讨论和仲裁方式解决。结果:13项研究的平均得分为(64±10.13)分,最高得分为84分,最低为52分。此次质量评价中考虑了5个方面的25个项目,13项研究都覆盖了这5个方面,对25个项目的覆盖率最低为60%,最高为88%。结论:Meta分析的应用在我国已取得长足进步,为使Meta分析结果更完善,更具可靠性,仍需对Meta分析方法的应用加以规范,只有规范严谨的分析方法才能得到可靠正确的结论。     

左氧氟沙星治疗耐多药肺结核疗效的系统评价/荟萃分析的质量评价

目的 评价国内发表的左氧氟沙星治疗耐多药肺结核疗效的系统评价/荟萃（Meta）分析的质量,促进左氧氟沙星的合理使用。方法 检索中国知网、中国生物医学文献数据库、维普、万方等数据库相关文献,收集近10年发表的左氧氟沙星治疗耐多药肺结核疗效的系统评价/Meta分析,由两名研究者独立进行文献的筛选、资料提取、质量评价等,再进行交叉核对。采用OQAQ量表、AMSTAR量表对纳入文献进行方法学质量评价,采用PRISMA量表进行报告质量评价,然后进行相关性分析。结果 共纳入14篇文献,4篇Meta分析,10篇系统评价。OQAQ方法学质量评分最高为7分,最低3.5分,平均6.21分;AMSTAR条目符合率最高的为条目1和9,条目2、4、8、10的符合率较好;PRISMA报告质量评分最高为21分,最低13.5分,平均19.29分。存在的问题主要有：检索策略和范围不全面、纳入与排除标准不具体、部分研究未报道选择偏倚和未进行质量评价。结论 国内关于左氧氟沙星治疗耐多药肺结核疗效的系统评价质量较好,但方法学质量和报告质量仍有待进一步提高。     

雷公藤多苷治疗糖尿病肾病的系统评价再评价

目的 针对雷公藤多苷（TG）治疗糖尿病肾病（DKD）的系统评价/Meta分析进行系统评价再评价（伞形综述）,以期为TG治疗DKD提供更高质量的循证依据。方法 检索中国知网、万方、维普、中国生物医学文献数据库和PubMed、Cochrane Library、Embase数据库中TG治疗DKD的系统评价/Meta分析,通过PRISMA 2020声明、AMSTAR 2量表、GRADE工具分别进行报告质量、方法学质量及证据质量评价,同时对纳入系统评价/Meta分析的定量结果进行综合分析。结果 共纳入18篇系统评价/Meta分析,PRISMA 2020声明评价结果显示,3篇文献报告较完整,13篇报告存在部分信息缺陷,2篇报告存在严重信息缺陷;AMSTAR 2量表评价结果显示,4篇文献方法学质量等级为低级,14篇文献方法学质量等级为极低级;GRADE工具评价结果显示,共106个结局指标,中级证据34个（占比为32.1%）、低级证据51个（占比为48.1%）,极低级证据21个（占比为19.8%）,无高级证据;各结局指标定量结果综合分析显示,TG对DKD总有效率、24 h尿蛋白定量、血清白蛋白均有确切...     

基于雷达图分析中药内服治疗腰椎间盘突出症系统评价/Meta分析的文献质量

目的:运用雷达图评估中药内服治疗腰椎间盘突出症的系统评价/Meta分析的文献质量,为其临床应用提供科学、有效的证据。方法:计算机检索自建库起至2018年10月1日中国知网、维普网、万方数据、中国生物医学数据库、PubMed、Cochrane图书馆、Embase收录的中药内服治疗腰椎间盘突出症系统评价/Meta分析的文献,对符合标准的文献进行资料提取后,从雷达图的6个方面(出版年份、设计类型、AMSTAR方法学质量评价、PRISMA报告学质量评价、同质性、发表偏倚风险)评价文献质量,并计算其秩数平均分。同时,采用Excel 2010、Adobe Illustrator CC等软件绘制并优化雷达图。结果:共纳入6篇合格文献,6个方面的秩数平均分分别为3.83、4.67、3.83、3.67、6.00、4.67分,所有项目的秩数平均分为4.56分。雷达图评价结果显示,质量较高的有2篇,质量偏低的有1篇,存在的主要问题在资料的选择偏倚、纳入与排除标准、发表情况、局限性、项目注册等方面。结论:中药内服治疗腰椎间盘突出症的系统评价/Meta分析文献质量仍有较大的提升空间,主要从加强方法学质量和报告学质量入手;雷达图为直观有效的图形化评价方法,值得推广应用。     

托伐普坦治疗低钠血症有效性与安全性的系统评价/Meta分析再评价

目的 对托伐普坦治疗低钠血症有效性和安全性的系统评价/Meta分析进行再评价。方法 计算机检索中国知网、万方数据、维普网、中国生物医学文献服务系统、PubMed、Embase、the Cochrane Library,收集托伐普坦治疗低钠血症的系统评价/Meta分析,检索时限为建库起至2022年6月15日。筛选文献、提取资料后,采用PRISMA声明评价纳入文献的报告质量,采用AMSTAR2量表评价纳入文献的方法学质量,采用GRADE工具评价纳入文献结局指标的证据质量。结果 共纳入6篇文献,其中1篇为系统评价,5篇为Meta分析,共56个结局指标。PRISMA评分为15.0～20.5分,报告质量均为中等。AMSTAR2量表评价结果显示,5篇文献的方法学质量等级为极低质量,1篇文献为低质量。GRADE证据质量评价结果显示,中级指标6个,低级指标13个,极低级指标35个,无法评价指标2个,造成降级的主要因素为局限性、不一致性、不精确性及发表偏倚。在有效性方面,托伐普坦可有效升高患者的血清钠浓度、增加尿量、降低体质量、缩小腹围、缓解水肿、降低丙氨酸转氨酶水平。在安全性方面,托伐普坦引起的总不良...     

中药注射剂治疗心脑血管疾病系统评价/Meta分析的现状研究

摘 要调查临床常用中药注射剂治疗心脑血管疾病系统评价/Meta分析的现状。 方法：检索中国知网(CNKI,1979~2015年)和PubMed(1990~2015年)文献数据库,筛选符合纳入标准的中药注射剂治疗心脑血管疾病的系统评价/Meta分析,提取有关信息,应用Microsoft Office 2010中Excel软件分析,并用AMSTAR和PRISMA量表对其方法学和发表质量进行评价。 结果：纳入中药注射剂治疗心脑血管疾病类系统评价/Meta分析224篇,其中中文215篇,英文9篇,发表数量整体呈增长的趋势。出版刊物涉及93种期刊,其中篇数最多的是《中国中医急症》24篇(11.2%)。涉及中药注射剂30余品种,被评价次数最多的为参麦注射液17次(7.6%);用于治疗心血管疾病和脑血管疾病的临床评价数量相当。方法学质量、发表质量均以中等水平居多。 结论：系统评价/Meta分析手段已得到较好的应用,为中药注射剂治疗心脑血管疾病临床循证决策提供了依据,但对中药注射剂的安全性问题鲜少涉及。因此,在今后的临床研究中,不仅需要进一步提高系统评价、临床试验水平,而且对中药注射剂治疗心脑血管疾病的有效性与安全性并重。     

中药注射剂治疗心律失常的系统评价再评价

目的：对中药注射剂治疗心律失常的Meta分析或系统评价进行再评价。方法：计算机检索PubMed、EMbase、the Cochrane Library、知网、万方、维普、CBMdisc等中英文数据库,检索中药注射剂治疗心律失常的系统评价,时间为建库至2019年6月。2位评价者独立进行文献筛选以及资料提取工作,应用AMSTAR2量表以及GRADE评估工具进行评价。结果：最终纳入7篇Meta分析或系统评价,包含25个结局指标,涉及4种中药注射剂。AMSTAR2量表评价结果中"是否提供前期设计方案"、"是否提供排除文献清单"、"纳入标准中是否考虑发表文献,如灰色文献"、"是否说明相关利益冲突"4项为导致方法学质量降低的主要因素。GRADE评估工具的评价结局中,纳入系统评价的局限性以及发表偏倚为引起结局指标证据质量降低的原因。对纳入文献再进行Meta分析显示,中药注射剂治疗心律失常,可提高治疗总有效率[Z=10.99,RR=1.45,95% CI （1.36,1.55）,P<0.01]、血管再通率[Z=2.29,OR=1.34,95% CI （1.04,1.72）,P=0.02],改善心率[Z=21.52,MD=4.80,95% CI （10.12,12.15）,P<0.01],降低心律失常发生率[Z=4.38,RR=0.53,95% CI （0.40,0.70）,P<0.01]、病死率[Z=5.94,RR=0.49,95% CI （0.39,0.62）,P<0.01]。结论：中药注射剂在治疗心律失常中发挥重要作用,但现今关于中药注射剂治疗心律失常的Meta分析或系统评价的评价方法尚不规范,证据质量偏低,对此次评价结论可靠性产生了影响。     

Reporting quality in systematic reviews of in vitro studies: a systematic review

Background: Systematic reviews (SRs) and/or meta-analyses of in vitro research have an important role in establishing the foundation for clinical studies. In this study, we aimed to evaluate the reporting quality of SRs of in vitro studies using the PRISMA checklist.

Method: Four databases were searched including PubMed, Virtual Health Library (VHL), Web of Science (ISI) and Scopus. The search was limited from 2006 to 2016 to include all SRs and/or meta-analyses (MAs) of pure in vitro studies. The evaluation of reporting quality was done using the PRISMA checklist.

Results: Out of 7702 search results, 65 SRs were included and evaluated with the PRISMA checklist. Overall, the mean overall quality score of reported items of the PRISMA checklist was 68%. We have noticed an increasing pattern in the numbers of published SRs of in vitro studies over the last 10 years. In contrast, the reporting quality was not significantly improved over the same period (p?=?.363). There was a positive but not significant correlation between the overall quality score and the journal impact factor of the included studies.

Conclusions: The adherence of SRs of in vitro studies to the PRISMA guidelines was poor. Therefore, we believe that using reporting guidelines and journals paying attention to this fact will improve the quality of SRs of in vitro studies.     

网状Meta分析优先报告规范简介和案例解读

网状Meta分析(Network Meta-Analysis, NMA)作为循证医学发展的二代方法学,越来越受到各国卫生技术评估组织的认可,然而目前NMA的报告存在严重的问题。最近针对NMA的优先报告规范——PRISMA扩展申明被发表在Annals of Internal Medicine上,本文将PRISMA扩展申明介绍给国内学者,为国内研究人员撰写和报告高质量的NMA提供借鉴和参考。     

Total glucosides of paeony for the treatment of rheumatoid arthritis: A methodological and reporting quality evaluation of systematic reviews and meta-analyses

ObjectiveTo assess the methodological, reporting and evidence quality of systematic reviews and meta-analyses of total glucosides of paeony (TGP) for rheumatoid arthritis (RA).MethodsWe comprehensively searched the literature in numerous databases from inception to July 29th, 2020. Two appraisers collected data and assessed the methodological and reporting quality of the included reviews by revised A MeaSurement Tool to Assess systematic Reviews (AMSTAR-2) tool and the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA), respectively. The level of evidence quality was evaluated by employing the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) scale.ResultsEleven relevant articles were collected. The results from AMSTAR-2 showed that the methodological quality of all included reviews was critically low; no authors met the standard of those critical domains (0%), particularly in item 2, item 4 and item 7. The PRISMA scores ranged from 16.5 to 25, and one meta-analysis almost conformed to the PRISMA structure. According to GRADE, the 11 studies included 59 outcomes: 27 had very low quality, 22 had low quality, 10 had moderate quality, and none had high quality evidence. The most prominent downgrading factors were risk of bias, followed by publication bias, inconsistency, imprecision, and indirectness.ConclusionsAlthough included studies summarized that TGP was effective and safe in the treatment of RA, the methodological and reporting quality and the quality of evidence was poor overall; decision-makers should be prudent when using TGP in treating RA patients. High-quality and multicenter studies investigating TGP for RA are urgently needed.     

Pitfalls in meta-analyses on adverse events reported from clinical trials

In recent years, comparative effectiveness research has been more aggressively pursued as a means to improve health care, including systematic reviews and meta-analyses to inform health policy decision making. Because most clinical trials have pre-specified approaches to collecting data on efficacy, the value of systematic reviews and meta-analyses in assessing efficacy outcomes is generally accepted. In contrast, collection of data on adverse events is seldom well structured. Hence, the methodological considerations for comparing adverse events from such non-aligned sources differ substantially from those for comparing efficacy endpoints. We address several important pitfalls in performing systematic reviews and meta-analyses on adverse events in clinical trials, and we offer recommendations for remedies. Some pitfalls arise from the fact that adverse events often are not the primary endpoints in clinical trials, hence incomplete reporting, inconsistent event definitions, various level of effort in reporting unexpected adverse events, and inappropriate use of statistical testing. Others are posed by certain important characteristics of adverse events data. The very concept of "adverse events" may skew the ascertainment, attribution, and reporting of the events. In addition, problems for meta-analysis methods arise in situations involving zero or rare events and withdrawal or loss to follow-up because of adverse events. We highlight recent initiatives that may improve the assessment and cross-study summary of adverse events. We anticipate that future guidance for conducting systematic reviews and meta-analyses will evolve to address the important methodological pitfalls we highlight here, and the practice of assessing the totality of evidence on drug safety will be improved.     

Does Outcome Reporting Bias “Cause” Cancer? Risks Associated with Hidden Data on Angiotensin Receptor Blockers

Conflicting reports have been published regarding the influence of angiotensin receptor blockers (ARBs) on the incidence of cancer. One meta-analysis reported a 1% absolute increase in the incidence of cancer associated with ARBs over 4 years. Contrasting findings were reported in an industry-sponsored meta-analysis and in another meta-analysis, both of which showed no difference in the incidence of cancer in ARB treatment groups relative to control groups. The US Food and Drug Administration has recently asserted that evidence does not support an association between ARBs and the development of cancer. The current review compares the 3 published meta-analyses assessing the association between ARBs and cancer and shows that outcome reporting bias contributed to the conflicting results. Given the prevalence of this form of bias in the scientific literature, the processes for systematic reviews and meta-analyses are under siege, and there is an important role for health care regulators to play. If all outcome data from clinical trials were to be reported in the public domain, independent analyses could be performed and the results of industry-sponsored trials verified. Furthermore, if regulators were to mandate the publication, in the public domain, of all clinical outcomes collected in clinical trials, outcome reporting bias could be eliminated.     

Methodological quality and risk of bias of meta-analyses of pharmacy services: A systematic review

BackgroundA suboptimal meta-analysis with misleading conclusions, frequently published in the healthcare journals, can compromise decision making in clinical practice.ObjectiveTo evaluate the reporting quality, methodological quality, and risk of bias of meta-analyses of pharmacy services.MethodsSystematic searches to identify all the meta-analyses reporting the effect of pharmacy services were performed in PubMed, Scopus, and Web of Science. The reporting quality, the methodological quality, and the risk of bias of the included meta-analyses were evaluated using PRISMA checklist, R-AMSTAR, and ROBIS, respectively.ResultsA total of 109 meta-analyses were eligible for the study. The heterogeneity, the quality of evidence, and the quality analyses were poorly reported on authors’ conclusions (14.3%, 14.7%, and 17.4%, respectively). The median scores of PRISMA and R-AMSTAR tolls were 24 (IQR 21.75–25), and 30 (IQR 27–32.5), respectively. Additionally, most of the studies were considered as high risk of bias (n = 83, 76.1%). No association between the date of publication and guideline compliance exists. PRISMA score was higher in studies published in high impact factor journals (rho = 0.313; p = 0.002), in articles that reported the quality of evidence obtained (p = 0.018), and in those that stated the need for future studies in their conclusions (p = 0.011). R-AMSTAR score was higher in studies published in high impact factor journals (rho = 0.338; p = 0.001), in those which reported the quality of evidence (p = 0.002), and in articles that described the quality analyses in their conclusions (p = 0.046). An association between the risk of bias and the recognition of the need for further studies in their conclusions (p = 0.041) was also found.ConclusionThe rapid increase of the meta-analyses of pharmacy services was not associated with higher quality. Mechanistic meta-analyses with poor conclusions are commonly published. Quality of the analyses, strength of evidence, heterogeneity, and absence of confrontation with current guidelines are rarely considered when synthetizing evidence and making recommendations.     

The need for trial identifiers

The medical literature is distorted by publication bias, duplicate publication and under-reporting of clinical trials. This can create problems in systematic numbering systems. The inclusion of trial identifiers reviews and meta-analysis which are increasingly used as the basis for evidence-based guidelines and therefore for treatment decisions. Various schemes for identifying trials and their associated publications are reviewed. These include trial registers and trial in all publications could greatly enhance the value of the medical literature and increase the robustness of systematic reviews and meta-analyses.     

The need for trial identifiers

SUMMARY

The medical literature is distorted by publication bias, duplicate publication and under-reporting of clinical trials. This can create problems in systematic reviews and meta-analysis which are increasingly used as the basis for evidence-based guidelines and therefore for treatment decisions. Various schemes for identifying trials and their associated publications are reviewed. These include trial registers and trial numbering systems. The inclusion of trial identifiers in all publications could greatly enhance the value of the medical literature and increase the robustness of systematic reviews and meta-analyses.     

Insomnia medication: Do published studies reflect the complete picture of efficacy and safety?

Selective publication can have a deleterious effect on evidence based medicine, health policy decision making and treatment guidelines. Using the European Public Assessment Reports (EPARs) as reference, this study examined selective publication and selective reporting of efficacy and safety of insomnia medication.EPARs of with three insomnia medications were used to identify all clinical trials that were performed between 1998 and 2007 for the purpose of registration in the EU. The matching publication for each trial was searched through a systematic literature search. Accuracy of information in the publications was examined by comparison to the information in the EPARs.Only 55% of the trials with insomnia medications identified in EPARs were published. Positive trials were approximately two times more likely to be published. The lag time from study completion to publication was shorter for the positive compared to the negative trials. Sample size did not correlate with publication of negative trials. The meta-analysis of the effect size of insomnia medication was 1.6 times larger in the published data compared to the complete data. While the primary end points of the trials were reported reliably in the publications, remarkable inconsistencies were detected in the reporting of the secondary end points, methods, results and, especially safety. In conclusion, selective publication and reporting lead to an overestimation of efficacy and underestimation of safety of insomnia products. Authors of treatment guidelines should be aware of this bias. EPARs/FDA reviews provide a more unbiased view of the benefit-risk balance of insomnia and other medications and hence these documents should be consulted by e.g. authors of meta-analyses and of treatment guidelines.     

Methodological standards for conducting and reporting meta-analyses: Ensuring the replicability of meta-analyses of pharmacist-led medication review

BackgroundMeta-analyses of clinical pharmacy services are frequently criticized for restricted data transparency and reproducibility.ObjectivesTo describe the methodological characteristics of meta-analyses of pharmacist-led medication reviews, to identify the elements that limit their replicability and robustness, and to propose recommendations for an appropriate conduction and reporting.MethodsA meta-research study was conducted. Systematic searches of the PubMed, Scopus, and Web of Science databases were performed to identify meta-analyses of pharmacist services. Meta-analyses assessing the effect of pharmacist-led medication reviews were selected for data extraction, analysis and replication. Two replication exercises were performed for the two most common outcomes: (i) considering the data provided by authors to construct the meta-analysis and (ii) considering the raw data available in the primary studies included. Prediction intervals (PI), fragility index (FI), and number needed to treat (NNT) were also calculated for each replicated meta-analysis.ResultsNine studies reporting meta-analyses about pharmacist-led medication review were found comprising 30 different outcomes. Eleven meta-analyses, including six for hospital admission and five for mortality, were replicated. In five meta-analyses, the pooled effect sizes of the replicated meta-analyses differed from the original ones. Only four meta-analyses mentioned the statistical method used. Other meta-analytic parameters (e.g., q-value, tau2) were omitted in all studies. In nine meta-analyses, the data from primary studies had been incorrectly extracted for at least one variable. The PI demonstrated that the uncertainty intervals of the effect sizes were always underestimated by the authors. NNTs showed wide intervals, ranging from benefit to harm, in almost all meta-analyses. Nine recommendations to facilitate the replication of a meta-analysis were proposed: providing all original data needed to build the analysis; informing about the imputed data or data obtained from different sources; performing sensitivity analyses for imputed or unpublished data; inform about all the statistical methods used; providing all statistical results; and reporting the PI, FI and NNT.ConclusionErrors in data extraction and poor reporting of meta-analytic parameters are common in the pharmacy literature. We proposed nine recommendations to enhance data reproducibility and interpretability. Journal editors and peer reviewers should ensure that authors strictly comply with minimum standards for conduction and reporting of meta-analyses.