偏倚风险评估系列:(四)整群设计随机对照试验

介绍整群设计随机对照试验Cochrane偏倚评估工具2.0版本（RoB2.0）的主要内容,阐述与平行设计RoB2.0的不同之处,并举例说明整群设计RoB2.0的使用方法和注意事项。RoB2.0针对整群设计的自身特点,设置了相应的信号问题,为将整群设计试验纳入系统综述进行证据整合提供偏倚风险信息。     

偏倚风险评估系列:(三)交叉设计随机对照试验

针对交叉设计随机对照试验Cochrane偏倚评估工具2.0版本（RoB2.0）的主要内容进行详细介绍,主要阐述了与平行设计RoB2.0的不同之处,并举例说明交叉设计RoB2.0的使用方法和注意事项。交叉设计RoB2.0针对交叉设计的自身特点,设置了相应的信号问题,为交叉设计试验纳入系统综述进行证据整合提供偏倚风险信息。     

偏倚风险评估系列:(六)诊断试验

本讲座详细介绍了诊断试验准确性研究的偏倚评估工具（QUADAS-2）的主要内容,同时阐述了QUADAS-2的开发过程及与第一版QUADAS工具的区别,并举例说明QUADAS-2的使用方法和注意事项。QUADAS-2相比第一版QUADAS工具有巨大改进,例如QUADAS-2删除了QUADAS中易混淆的条目内容,仅通过对重叠度最小的4个关键领域（Domain）的描述和对每个领域内信号问题的回答完成偏倚风险和适用性两个核心方面的评价,最后得出原始研究每个领域的偏倚风险和适用性为高（High）、低（Low）或不清楚（Unclear）的结论,而不再是给出原始研究质量评价的总分,这与Cochrane干预措施系统综述中偏倚风险的评估一致。同时,QUADAS-2还可以应用于金标准中包括随访但不涉及预后问题的原始研究的偏倚风险评价。虽然开展QUADAS-2评价需要花费更多时间,但这对于诊断准确性研究的偏倚风险评价非常重要。QUADAS-2研究组后续还将在比较多种待评价诊断试验的原始研究中应用QUADAS-2进行偏倚风险评估,使用者可持续关注其进展,同时也可在线反馈使用体验或提供改进建议。     

偏倚风险评估系列:(九)如何应用偏倚风险评估的结果

本文为偏倚风险评估系列讲座的最后一节,主要讨论偏倚风险评估结果的应用。偏倚风险评估是证据质量评估中关键的一环,能为循证决策提供重要的参考依据。偏倚风险评估结果可以用于单个研究的偏倚风险诊断,其结果可影响系统综述中对于原始研究的纳入排除和数据的分析。此外,本文重点讨论偏倚风险评估的结果如何应用到推荐分级的评价、制订与评估（GRADE）的整体证据质量评价,包括证据质量评价中的原则以及注意事项。     

偏倚风险评估系列:(五)非随机干预性研究

对非随机干预性研究（NRSI）偏倚评估工具ROBINS-I（Risk Of Bias In Non-randomised Studies-of Interventions）的主要内容进行详细介绍,并举例说明ROBINS-I的使用方法和注意事项。ROBINS-I针对NRSI的特点,设置了相应的评估领域和信号问题,为NRSI纳入系统综述进行证据整合提供偏倚风险信息。ROBINS-I为观察性研究和类实验领域新开发的评估工具,现已得到了一定程度的应用,但仍在进一步完善中,使用者可持续关注其后续更新与进展。     

暴露对结局影响的非随机对照研究偏倚分析工具ROBINS-E（2022）的介绍

本文介绍了2022年6月最新版非随机对照研究偏倚分析工具ROBINS-E（2022）的内容并举例说明其使用方法。ROBINS-E是一种评估暴露相关非随机对照研究偏倚风险的工具。与ROBINS-E（2019）相比，ROBINS-E（2022）补充了更多适用于观察性研究的偏倚，涵盖的偏倚更加全面，同时增加了针对研究外部真实性的评估。ROBINS-E（2022）增加了初步评估环节，便于提高评估的效率。此外ROBINS-E（2022）使用路径图的形式将信号问题的使用进行了可视化和工具化，使用更加便捷。ROBINS-E（2022）虽然对共暴露的问题有了更多的考虑，但仍然没有解决共暴露中的效应修饰问题，仍有扩展适用的研究范围的空间。     

美国卫生保健和质量机构干预性研究偏倚风险评价工具的解读

本文对美国卫生保健研究和质量机构（Agency for Healthcare Research and Quality,AHRQ）推荐的干预性研究偏倚风险评价工具的主要内容进行详细解读,并展示如何使用Revman软件制作偏倚风险评价图。AHRQ偏倚风险评价工具是一种综合评价工具,可用来评价常见的研究设计类型（随机对照试验研究、有对照的临床试验研究、队列研究、病例对照研究、病例系列研究、横断面研究）的偏倚风险。该工具从选择偏倚、实施偏倚、随访偏倚、测量偏倚、报告偏倚5个领域来评价研究的偏倚风险,每个领域含有不同的条目,每个条目适用于评价1种或几种研究设计类型。值得注意的是应根据不同的研究设计类型选择相应的条目进行评价而不是直接使用所有条目进行偏倚风险评价。当1个干预性研究的系统综述纳入了多种研究设计类型时,只需要用AHRQ工具就可以评价纳入研究存在的常见偏倚风险,省去了使用不同偏倚风险工具进行偏倚风险评价的繁琐过程。该工具条目相对简单易懂,评价流程不复杂。AHRQ推荐使用高、中、低的偏倚风险分类方法评价纳入研究总体偏倚风险的高低,但是,其对如何判定总体偏倚风险的高低没有给出推荐意见,如何具体判定干预性研究偏倚风险等级的界值,仍有待更多这方面的研究结果。     

偏倚风险评估系列：（八）系统综述

针对评价系统综述偏倚风险的ROBIS（Risk of Bias in Systematic Review）工具进行详细介绍,包括ROBIS的制定过程、应用ROBIS对系统综述进行评价的3个阶段、并举例说明ROBIS的使用方法和注意事项。ROBIS与AMSTAR（A Measurement Tool to Assess Systematic Reviews）工具不同,是第一个制定出用于全面评价系统综述偏倚风险的工具,为研究者制定临床实践指南或系统综述再评价提供依据。     

无应答偏倚

无应答偏倚是流行病学调查中一种常见的偏倚,它可以导致调查结果或估计值的真实性和可靠性下降。因此,国外学者较重视这方面的研究。本文就近年来的有关无应答偏倚的研究进展作一综述,旨在使医学科研工作者重视无应答偏倚的预防与控制,以提高调查研究的质量。     

无应答偏倚

无应答偏倚是流行病学调查中一种常见的偏倚,它可以导致调查结果或估计值的真实性和可靠性下降。因此,国外学者较重视这方面的研究。本文就近年来的有关无应答偏倚的研 究进展作一综述,旨在使医学科研工作者重视无应答偏倚的预防与控制,以提高调查研究的质量。     

Risk of bias in randomized controlled trials of psychological treatments for bulimia nervosa and binge eating

Purpose

In the context of Cochrane systematic reviews/meta-analyses of randomized clinical trials, risk of bias (RoB) is assessed using categorical indicators (low, unclear, or high RoB). This study sought to evaluate the indicators of the Cochrane RoB tool available for construct validity as applied to randomized clinical trials of psychological treatments for bulimia nervosa and binge eating.

偏倚风险评估系列:(七)预后因素研究

本讲座主要介绍采用QUIPS（Quality In Prognosis Studies）工具对预后因素研究中出现的偏倚进行评估,介绍相关评估要点,举例说明QUIPS工具的使用,并对该工具在使用中值得商榷的地方进行了讨论。该工具主要涉及研究对象、研究失访、预后因素测量、结局测量、研究混杂以及统计分析和报告6个方面,为预后因素研究中的偏倚评价提供了一个全新的方法。     

偏倚风险评估系列:(一)概述

本文回顾了偏倚风险的概念,将系统综述中的偏倚风险评价与证据质量、方法学质量、报告质量、精确性、外部真实性等方面的评价作了对比,然后讨论了偏倚风险评估工具的进展、工具本身存在的不足、以及工具使用的常见问题等,以帮助我国系统综述者更好地理解偏倚风险评估及其工具的使用。     

Sodium and Potassium Intake and Cardiovascular Disease in Older People: A Systematic Review

This review aims to examine the relationship of sodium and potassium intake and cardiovascular disease (CVD) among older people. Methods: We performed a literature search using PubMed and Web of Science (January 2015 to July 2020) without language restriction. Observational and experimental studies that reported the relationship between sodium, potassium, or sodium-to-potassium ratio with CVD among older adults aged higher than 60 years were included. The authors independently screened all identified studies, extracted information, and assessed the quality of included studies. Risk of bias was assessed using the Risk of Bias Assessment Tool for Nonrandomized Studies (RoBANS) for observational studies and the revised Cochrane risk-of-bias tool (RoB 2 tool) for randomized trials. Results: We included 12 studies (6 prospective cohort studies, 5 cross-sectional studies, and 1 experimental study). Five of the studies reported on sodium-to-potassium ratio (n = 5), and the others on potassium and/or sodium intake. Cardiovascular events (e.g., stroke and heart failure) were the most reported outcome (n = 9). Of the 12 studies included, five observational studies had low bias risk and the randomized controlled trial was judged as uncertain risk of bias. We found inconsistent results for the effect of the reduction of sodium intake in this population for lower risk of CVD. We found that both the increase of potassium intake and the decrease of sodium-to-potassium ratio were associated with lower risk of hypertension and CVD, particularly stroke. Conclusion: The present review suggests that both higher potassium and lower sodium-to-potassium ratio are associated with lower risk of CVD.     

Effect of Crocus sativus (Saffron) Intake on Top of Standard Treatment,on Disease Outcomes and Comorbidities in Patients with Rheumatic Diseases: Synthesis without Meta-Analysis (SWiM) and Level of Adherence to the CONSORT Statement for Randomized Controlled Trials Delivering Herbal Medicine Interventions

Rheumatic diseases (RDs) are often complicated by chronic symptoms and frequent side-effects associated with their treatment. Saffron, a spice derived from the Crocus sativus L. flower, is a popular complementary and alternative medicine among patients with RDs. The present systematic review aimed to summarize the available evidence regarding the efficacy of supplementation with saffron on disease outcomes and comorbidities in patients with RD diagnoses. PubMed, CENTRAL, clinicaltrials.gov and the grey literature were searched until October 2021, and relevant randomized controlled trials (RCTs) were screened for eligibility using Rayyan. Risk of bias was assessed using the Cochrane’s Risk of Bias-2.0 (RoB) tool. A synthesis without meta-analysis (SWiM) was performed by vote counting and an effect direction plot was created. Out of 125 reports, seven fulfilled the eligibility criteria belonging to five RCTs and were included in the SWiM. The RCTs involved patients with rheumatoid arthritis, osteoarthritis and fibromyalgia, and evaluated outcomes related to pain, disease activity, depression, immune response, inflammation, oxidative stress, health, fatigue and functional ability. The majority of trials demonstrated some concerns regarding overall bias. Moreover, the majority of trialists failed to adhere to the formula elaborations suggested by the CONSORT statement for RCTs incorporating herbal medicine interventions. Standardization of herbal medicine confirms its identity, purity and quality; however, the majority of trials failed to adhere to these guidelines. Due to the great heterogeneity and the lack of important information regarding the standardization and content of herbal interventions, it appears that the evidence is not enough to secure a direction of effect for any of the examined outcomes.