GRADE指南:Ⅳ.证据质量分级——研究的局限性(偏倚风险)

在GRADE方法中,若多数相关证据来自高偏倚风险的研究,则起初被定为高质量证据的随机试验和低质量证据的观察性研究均有可能被降低质量等级。随机试验已确定的局限性包括:未进行分配隐藏、未实施盲法、未报告失访情况及未恰当考虑意向性治疗原则。最近提出的局限性包括:因明显获益而早期终止试验和基于结果选择性报告结局。观察性研究的主要局限性包括使用不合适的对照及未能充分调整预后的不平衡。偏倚风险可因不同结果而异(如全死因死亡率的失访远少于生命质量的失访),许多系统评价都容易忽略这一点。在决定是否因偏倚风险而降低质量等级时,不管是随机试验还是观察性研究,作者不应采用对各个研究取平均值的方法。相反,对任何单个结果,当同时存在高、低偏倚风险的研究时,则应考虑只纳入较低偏倚风险的研究。     

GRADE指南:Ⅴ.证据质量评价——发表偏倚

GRADE方法中,随机试验起评即为高质量证据,观察性研究起评即为低质量证据;但若证据本身存在高发表偏倚风险,则两者证据质量级别都应降低。即使最佳证据汇总表纳入的各项研究仅有低发表偏倚风险,发表偏倚仍会极大高估效应值。当可得证据来自小样本研究、且多数由厂商资助时,作者应怀疑存在发表偏倚。若干基于检验数据类型的方法可用于评价发表偏倚,其中最常用的为漏斗图,但这些方法都有较大局限。发表偏倚可能较常见,必须特别关注早期结果、对样本量与事件数都很小的早期试验结果尤需小心。     

偏倚风险评估工具在针刺Cochrane系统评价中的应用

目的客观评价偏倚风险评估工具在针刺Cochrane系统评价(CSR)的应用情况。方法全面检索Cochrane系统评价数据库(2011年第12期),查找有关针刺的CSR。由2位研究者根据纳入与排除标准独立筛选文献、提取资料,然后进行统计分析。结果共纳入41个CSR。其中有19个为更新的系统评价,33个发表于2009~2011年间;60.98%报告采用了Cochrane Handbook评估纳入研究偏倚风险/方法学质量;所有研究均评价了随机序列、分配隐藏及盲法信息,但未完整报告施盲对象;54.55%的研究分别报告了选择性报告偏倚和其他偏倚来源。结论大多数CSR选择使用Cochrane Handbook推荐的偏倚风险评估工具评估纳入研究的偏倚风险,但依然有评估条目报告不完整的问题存在。     

GRADE指南:Ⅲ.证据质量分级

本文介绍证据质量分级的GRADE方法。GRADE将证据质量分为高、中、低和极低四个级别。该分级应用于证据群,而非针对个别研究。系统评价中,质量反映了我们认为效应估计值正确的把握度。对推荐意见而言,质量反映了我们认为效应估计值足以支持某特定推荐的把握度。随机对照试验初定为高质量证据,观察性研究初定为低质量证据。GRADE中所使用的质量一词不只是意味着偏倚风险,还可能受研究结果的不精确性、不一致性和间接性,及发表偏倚的影响。此外,若干因素可增加我们对效应估计值的把握度。GRADE提供了一种系统方法来思考并报告各因素。GRADE将评估证据质量的过程与给出推荐建议的过程分开。推荐强度的判断不仅依赖于证据质量。     

GRADE指南:Ⅸ.证据质量升级

证据质量升级的最常见原因是效应量大。当方法学严谨的观察性研究表明风险至少降低或增加2倍时,GRADE建议考虑将证据质量升高1级;当风险至少降低或增加5倍时,考虑将证据质量升高2级。当存在剂量-反应关系,或所有合理的混杂、偏倚会降低明显的治疗效应,或混杂、偏倚使得结果无效为假效应时,系统评价作者和指南制定者也可考虑升高证据质量。其他考虑因素包括起效迅速、潜在的疾病(状态)趋势以及间接证据。     

发表性偏倚对系统评价的影响

系统评价可以为临床实践提供可靠的证据.但在对文献进行系统评价的过程中,由于杂志编辑、作者、研究资金及研究结果等各方面的原因,使系统评价难免受到发表性偏倚的影响.在将系统评价结果应用于临床之前,必须应用漏斗图、分析法等方法对其进行评估,才能为患者做出最好的诊治决策.     

我国干预性护理研究论文的质量评价

目的制订严格的质量评价标准,对我国内地干预性护理研究论文进行质量评价。方法检索我国内地干预性护理研究论文,阅读全文并按照质量评价标准进行评价。结果经过初筛,对4225篇期刊论文和179篇学位论文进行了严格的质量评价,纳入1257篇期刊论文和152篇学位论文,发现纳入论文中达标率较低的质量评价项目依次是盲法、样本流失的描述和随机分配。结论我国干预性护理研究论文的方法学质量和报告规范有待提高。     

正念减压法对结直肠癌患者干预效果的Meta分析

目的评估短期内正念减压疗法对结直肠癌患者心理、生理及生存质量的临床疗效。方法从建立数据库到2022年4月,共检索了10个数据库。只纳入了比较正念减压疗法干预组和对照组在结直肠癌患者症状减轻方面的干预性研究。使用随机效应模型计算合并MD、SMD和95%CI。使用了Cochrane偏倚风险工具评估纳入的研究。结果确定了17项高质量的干预性研究。7项研究集中在患者的焦虑、抑郁方面。有3项研究聚焦于睡眠质量。Meta分析显示,与对照组相比,干预组在治疗后的心理及生存质量均有改善,在生理方面的效果不明显。结论以正念为基础的减压干预对结直肠癌患者降低负性情绪、提高生活质量非常有效果。     

偏倚对系统评价质量的影响

系统评价被认为是当前提供治疗性干预的最佳证据，但是由于无法全面获得相关的研究资料，仍然不可避免的存在偏倚。偏倚的类型主要包括献发表性偏倚、献查寻偏倚和献筛选偏倚，其中最难克服的是献发表性偏倚。偏倚评估的方法常用漏斗图，控制方法包括预先注册临床试验、发布研究信息、系统评价时全面收集所有发表和未发表的临床试验。     

偏倚对系统评价质量的影响

系统评价被认为是当前提供治疗性干预的最佳证据,但是由于无法全面获得相关的研究资料,仍然不可避免的存在偏倚。偏倚的类型主要包括文献发表性偏倚、文献查寻偏倚和文献筛选偏倚,其中最难克服的是文献发表性偏倚。偏倚评估的方法常用漏斗图,控制方法包括预先注册临床试验、发布研究信息、系统评价时全面收集所有发表和未发表的临床试验。     

Effect of simulation-based teaching on nursing skill performance: a systematic review and meta-analysis

Objective: To summarize and produce aggregated evidence on the effect of simulation-based teaching on skill performance in the nursing profession. Simulation is an active learning strategy involving the use of various resources to assimilate the real situation. It enables learners to improve their skills and knowledge in a coordinated environment.Methods: Systematic literature search of original research articles was carried out through Google Scholar, Medline, and Cochrane Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases. Studies conducted on simulation-based teaching and skill performance among nursing students or clinical nursing staff from 2010 to 2019, and published in the English language, were included in this study. Methodological quality was assessed by Joanna Briggs Institute, and the risk of bias was also assessed by Cochrane risk of bias and the risk of bias assessment tool for non-randomized studies (ROBINS-I) checklists. Results: Initially, 638 titles were obtained from 3 sources, and 24 original studies with 2209 study participants were taken for the final analysis. Of the total studies, 14 (58.3％) used single group prep post design, 7 (29.1％) used high fidelity simulator (HFS), and 7 (29.1％) used a virtual simulator (VS). Twenty (83.3％) studies reported improved skill performance following simulation-based teaching. Simulation-based teaching improves skill performance among types of groups (single or double), study regions, high fidelity (HF), low fidelity (LF), and standard patient (SP) users. But the effect over vir tual and medium fidelity simulators was not statistically significant. Overall, simulation-based teaching improves the skill performance score among the experimental group (d = 1.01, 95％ confidence interval [CI] [0.69–1.33], Z = 6.18, P < 0.01, 93.9％). Significant heterogeneity and publication bias were observed during the pooled analysis. Conclusions: Simulation did improve skill performance among the intervention groups, but the conclusion is uncertain due to the significant heterogeneity. The large extent of difference among original research has necessitated the development of well-defined assessment methods for skills and standardized simulation set-up for proper assessment of their effects.     

Nursing workload and patient-focused outcomes in intensive care: A systematic review

The aim of this systematic review was to examine the association of nursing workload on patient outcomes in intensive care units. The primary outcome measure was patient mortality, with adverse events (AE), the secondary outcome measures. Electronic search of databases including MEDLINE, CINAHL, Cochrane, EMCARE, Scopus, and Web of Science were performed. Studies were excluded if they were in non-ICU settings, pediatric, neonatal populations, or if the abstract/full text was unavailable. Risk of bias was assessed by the ROBINS-I tool. After screening 4129 articles, 32 studies were identified as meeting inclusion criteria. The majority of included studies were assessed as having a moderate risk of bias. The nursing activities score (NAS) was the most frequently used tool to assess nursing workload. Our systematic review identified that higher nursing workload was associated with patient-focused outcomes, including increased mortality and AE in the intensive care setting. The varied approaches of measuring and reporting nursing workload make it difficult to translate the findings of the impact of nursing workload on patient outcomes in intensive care settings.     

近5年中国科学引文数据库护理干预性系统评价/Meta分析报告质量分析

目的 评价近5年中国科学引文数据库收录的护理期刊发表的干预性系统评价/Meta分析的报告质量,以期规范其研究过程和报告方法,提升系统评价/Meta分析质量。方法 计算机检索CNKI、VIP、CBM和Wanfang数据库,搜集中国科学引文数据库收录的护理期刊发表的干预性系统评价/Meta分析研究,检索时限为2015年1月—2020年6月。由2名研究者独立筛选文献、提取资料,采用系统评价和Meta分析优先报告的条目进行报告质量评价;采用Office Excel 2019、Stata 15.0软件对相关数据进行统计和分析。结果 共纳入干预性系统评价/Meta分析176篇,其PRISMA评分为14.5~24.5分（20.17±2.00）,其中有1篇研究评分≤15分,有严重信息缺失;122篇评分为15~21分,存在一定报告缺陷;53篇评分为21~27分,报告相对完全。报告质量不足主要表现为结构式摘要（0/176）,方案和注册（0/176）,检索策略（55/176）,研究间偏倚（26/176）和资金支持（0/176）报告不全面。亚组分析结果显示：有基金资助、作者单位性质为医院和单位数为1个可明显提高系统评价/Meta分析报告质量（P<0.05）;作者人数对系统评价/Meta分析的报告质量影响不显著（P>0.05）。结论 目前,我国护理领域干预性系统评价/Meta分析的报告质量差异较大。因此,有必要采取相应的措施,加大对PRISMA的宣传和普及,推动其在护理期刊稿约中的引用;研究人员应严格遵守PRISMA相关条目,规范、详细地进行报告;护理期刊的编辑和审稿人在同行评审阶段也要严格遵循PRISMA的指导方针,以期提高系统评价/Meta分析的质量。     

ICU转出患者心理障碍风险预测工具的范围综述

目的 对ICU转出患者心理障碍风险预测工具进行范围综述,为临床实践及相关研究提供参考.方法 检索PubMed、Embase、Web of Science核心合集、中国知网、万方数据库、中国生物医学文献数据库中有关ICU转出患者心理障碍风险预测工具的研究,检索时限为建库至2021年7月11日.由2名研究者独立筛选文献和提...     

Reviewing studies with diverse designs: the development and evaluation of a new tool

Rationale, aims & objective Tools for the assessment of the quality of research studies tend to be specific to a particular research design (e.g. randomized controlled trials, or qualitative interviews). This makes it difficult to assess the quality of a body of research that addresses the same or a similar research question but using different approaches. The aim of this paper is to describe the development and preliminary evaluation of a quality assessment tool that can be applied to a methodologically diverse set of research articles. Methods The 16‐item quality assessment tool (QATSDD) was assessed to determine its reliability and validity when used by health services researchers in the disciplines of psychology, sociology and nursing. Qualitative feedback was also gathered from mixed‐methods health researchers regarding the comprehension, content, perceived value and usability of the tool. Results Reference to existing widely used quality assessment tools and experts in systematic review confirmed that the components of the tool represented the construct of ‘good research technique’ being assessed. Face validity was subsequently established through feedback from a sample of nine health researchers. Inter‐rater reliability was established through substantial agreement between three reviewers when applying the tool to a set of three research papers (κ = 71.5%), and good to substantial agreement between their scores at time 1 and after a 6‐week interval at time 2 confirmed test–retest reliability. Conclusions The QATSDD shows good reliability and validity for use in the quality assessment of a diversity of studies, and may be an extremely useful tool for reviewers to standardize and increase the rigour of their assessments in reviews of the published papers which include qualitative and quantitative work.     

2006～2011年我国中医药护理临床试验的方法学质量评价

目的评价近6年来我国中医药护理临床试验的方法学质量。方法计算机检索CNKI、VIP、WanFang Data和CBM disc数据库中发表的中医药护理的临床试验文献,检索时限为2006年1月～2011年9月。同时手检2010年1月至2011年9月国内主要护理期刊,采用Cochrane偏倚风险评估表进行临床试验文献质量评估。结果共纳入临床对照试验854篇,其中随机对照试验706篇(82.7%),半随机对照试验108篇(12.6%),非随机对照试验40篇(4.7%)。方法学质量分析显示:91.8%的纳入研究(784篇)均描述了组间基线资料可比性,并有明确的诊断标准(498篇,58.3%)和排除标准(178篇,20.8%);97.3%的纳入研究(831篇)统计方法运用正确。但只有55篇(6.4%)报告了随机序列的产生方法;10篇(1.2%)阐述随机序列隐匿方法;22篇(2.6%)采用了盲法;98篇(11.5%)报告进行了随访,93篇(10.9%)报告了安全性,20篇(2.3%)报告了失访及退出情况,2篇进行了意向性分析;所有研究均未报告研究方案,无法判断是否存在选择性报告偏倚,但21篇(2.5%)试验结果中的结局指标明显少于方法中的结局指标数,可判断为存在偏倚。符合Cochrane低风险标准2条及以上的研究共81篇,其中2009年10篇(12.3%)、2010年26篇(32.1%)、2011年前9个月27篇(33.3%),呈上升趋势。结论按Cochrane偏倚风险评估标准,近6年来,中医药护理临床试验研究总体质量不高,均存在不同程度的缺陷,但研究质量有逐年增高的趋势。     

糖尿病足发病风险预测模型的系统评价

目的 系统地分析、评价糖尿病足发病风险预测模型,以期为护理实践提供参考依据。 方法 检索PubMed、Embase、Web of Science、Cochrane图书馆、中国生物医学文献数据库、中国知网和万方数据库中有关糖尿病足发病风险预测模型的研究,检索时限为建库至2020年3月1日。由2名研究者独立筛选文献和提取数据,并应用预测模型研究的偏倚风险评估工具分析纳入文献的偏倚风险和适用性。 结果 共纳入7项糖尿病足发病风险预测模型研究,包括6项开发研究和1项验证研究。7个模型的受试者工作特征曲线下面积为0.65~0.88。所有纳入模型中包含最多的预测因子是单丝试验不敏感。7项研究的适用性较好,但存在一定的偏倚,主要是因为未采取或未报告盲法、应变量事件数不足、忽略缺失数据、缺乏模型性能评估以及模型过度拟合。 结论 糖尿病足发病风险预测模型的研究还处于发展阶段,未来应开发性能优良、偏倚风险低的预测模型,并进行内部验证或外部验证。     

Update I. A systematic review on the efficacy and safety of chloroquine/hydroxychloroquine for COVID-19

PurposeTo assess efficacy and safety of chloroquine (CQ)/hydroxychloroquine (HCQ) for treatment or prophylaxis of COVID-19 in adult humans.Materials and methodsMEDLINE, PubMed, EMBASE and two pre-print repositories (bioRxiv, medRxiv) were searched from inception to 8th June 2020 for RCTs and nonrandomized studies (retrospective and prospective, including single-arm, studies) addressing the use of CQ/HCQ in any dose or combination for COVID-19.ResultsThirty-two studies were included (6 RCTs, 26 nonrandomized, 29,192 participants). Two RCTs had high risk, two ‘some concerns’ and two low risk of bias (Rob2). Among nonrandomized studies with comparators, nine had high risk and five moderate risk of bias (ROBINS-I). Data synthesis was not possible. Low and moderate risk of bias studies suggest that treatment of hospitalized COVID-19 with CQ/HCQ may not reduce risk of death, compared to standard care. High dose regimens or combination with macrolides may be associated with harm. Postexposure prophylaxis may not reduce the rate of infection but the quality of the evidence is low.ConclusionsPatients with COVID-19 should be treated with CQ/HCQ only if monitored and within the context of high quality RCTs. High quality data about efficacy/safety are urgently needed.     

Blended learning vs traditional teaching: The potential of a novel teaching strategy in nursing education - a systematic review and meta-analysis

AimThe primary goal of this analysis is to determine the effectiveness of blended learning versus traditional face-to-face teaching in nursing education from the three aspects of knowledge, skills and satisfaction.BackgroundWith the rapid development of health care, traditional teaching has been unable to meet the learning needs of nursing education. With the development of Internet technology, blended learning seems to be a new available choice to solve the current predicament. However, the effectiveness of blended learning is still controversial. In addition, most studies have primarily evaluated the teaching effect unilaterally.DesignSystematic review and meta-analysis.MethodsWe searched PubMed, Embase, Web of Science, CINAHL and the Cochrane Library for publications in English from inception to April 2021. Two researchers independently screened the eligibility of each publication and extracted the data. The Cochrane risk-of-bias tool and the MINORS (methodological items for non-randomized studies) were used to evaluate the quality of the studies. The statistical heterogeneity was analyzed by the meta-regression and subgroup analysis. Publication bias was assessed by Egger's test.ResultsThe search strategy identified a total of 3682 potentially relevant articles. We finally included 13 randomized controlled trials (RCTs) and 12 quasi-experimental studies (QRs), with a total of 2706 nursing students. The meta-analysis results showed that blended learning is more effective than traditional teaching in terms of knowledge, skill performance and learning satisfaction (SMD=0.64, z = 3.237, p = 0.001; SMD = 0.37, z = 2.58, p = 0.010; SMD = 0.32, z = 2.347, p = 0.019). Egger's test showed no significant publication bias. In addition, sensitivity analysis suggested that the results are relatively reliable. Through subgroup analysis and meta regression, we found that although the heterogeneity could not be significantly reduced or eliminated, the publication year, the study design and the duration of the intervention time and the number of items in the intervention may be the potential factors affecting heterogeneity of knowledge and learning satisfaction.ConclusionsThe research results showed that blended learning may be an effective teaching strategy and appears to have excellent long-term developmental potential. Although its initial construction may require specific investment to improve the teaching resources and standardize the design of blended learning, in the long term, this new teaching strategy can not only improve nursing students' professional ability and learning satisfaction but also save nursing education resources to promote the balanced development of nursing education. The results of this study can lay a foundation for establishing standardized blended teaching strategies and evaluation indicators in the future.     

介入手术护理配合路径图在肿瘤介入治疗中的应用

目的提高肿瘤介入手术护理配合质量。方法结合肿瘤介入手术患者住院时间短、科室手术多、接台时间短的实际情况，将肿瘤患者需求和规范的临床护理行为制作成肿瘤介入手术护理配合路径图。结果提高了肿瘤介入手术患者的满意度及手术换台速度；缩短了患者手术等候时间。结论手术护理配合路径图的应用，可以提高肿瘤介入手术护理配合质量。