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Designing, refining and reflecting on 3 years of daily evidence surveillance for Australia's living national COVID-19 guidelines 为澳大利亚现行的国家 COVID-19 指南设计、改进和反思 3 年的日常证据监测工作
Pub Date : 2024-02-26 DOI: 10.1002/cesm.12045
Steve McDonald, Tari Turner

Australia's national living guidelines for COVID-19 were launched in April 2020 and include over 200 recommendations to guide the clinical care of patients with COVID-19. Until the guidelines were retired in August 2023, new evidence was continually monitored through daily surveillance. This paper describes the initial design for evidence surveillance (at a time when efforts to collate information on the novel coronavirus were in their infancy and often duplicative) and how it was refined throughout the pandemic. Among the wide range of sources monitored, the collections of COVID-19 research from leading medical journals, medRxiv preprints and PubMed auto alerts proved the most enduring in identifying time-critical and impactful evidence. The paper also explores how evidence was tracked and surveillance integrated into the overall evidence workflow by using messaging apps and communication platforms. Finally, we consider the implications for living guidelines and reflect on factors that contributed to the feasibility of daily surveillance: the clearly defined scope of the guidelines; focusing efforts on maximum impact; minimizing duplication by partnering with others; setting up simple but effective processes for managing evidence; and the value of continuous involvement of personnel from the outset. Australia's living COVID-19 guidelines were underpinned by a novel approach to evidence surveillance that was feasible and essential in maintaining COVID-19 living guidelines for over 3 years.

澳大利亚 COVID-19 国家生活指南于 2020 年 4 月推出,其中包括 200 多条建议,用于指导 COVID-19 患者的临床治疗。在该指南于 2023 年 8 月退役之前,通过日常监测对新证据进行持续监控。本文介绍了证据监测的最初设计(当时整理新型冠状病毒信息的工作尚处于起步阶段,而且经常出现重复)以及在整个大流行期间如何对其进行改进。在广泛的监测来源中,从主要医学期刊、medRxiv 预印本和 PubMed 自动提示中收集的 COVID-19 研究成果在识别时间关键和有影响的证据方面证明是最持久的。本文还探讨了如何利用信息应用程序和通信平台将证据跟踪和监控整合到整个证据工作流程中。最后,我们探讨了活指南的意义,并反思了促成日常监控可行性的因素:明确界定的指南范围;将工作重点放在最大影响上;通过与他人合作尽量减少重复;建立简单而有效的证据管理流程;以及人员从一开始就持续参与的价值。澳大利亚的 COVID-19 活指南以一种新颖的证据监测方法为基础,这种方法是可行的,而且对于将 COVID-19 活指南维持 3 年以上至关重要。
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引用次数: 0
Methods for conducting a living evidence profile on mpox: An evidence map of the literature 对麻风病进行活体证据分析的方法:文献证据图
Pub Date : 2024-02-22 DOI: 10.1002/cesm.12044
Kusala Pussegoda, Tricia Corrin, Austyn Baumeister, Dima Ayache, Lisa Waddell

Background

In May of 2022, several cases of mpox were identified in multiple nonendemic countries and on July 23, 2022 the World Health Organization declared mpox a Public Health Emergency of International Concern. During the first six months of the outbreak there was an urgent need to have up-to-date synthesized evidence on mpox to inform public health decision-making. At this point, evidence is changing too quickly for traditional evidence synthesis methods, as systematic reviews were out-of-date before publication. This paper describes the framework developed to manage and maintain a living evidence profile (LEP) to systematically identify, classify and synthesize evidence on a broad range of mpox topics at a rapid pace as the outbreak unfolded.

Methods

The LEP framework was based on principles of evidence synthesis, risk assessment, priority epidemiological parameters for infectious disease modeling and consultation with experts. The framework consisted of a systematic search conducted twice weekly; study selection; categorization into pre-determined foci and data extraction; integration and synthesis of evidence; internal peer-review and dissemination to stakeholders.

Results

Between April 14 and December 15, 2022, 2287 citations were identified, 687 were primary research studies or surveillance reports on the 2022 mpox outbreak and 496 were included in the final LEP. Each study was mapped to one of 32 foci and evidence was narratively synthesized. From June to December 2022, 23 LEPs were produced (approximately weekly) along with a searchable database of extracted data of the mpox literature. They were disseminated globally to public health researchers and decision-makers to inform public health response efforts.

Conclusions

The LEP framework is applicable to other public health emergencies when a rapid synthesis cycle is required because the evidence is evolving quickly. This efficient methodology for creating up-to-date summaries of the current evidence during the first few months of an outbreak or emergency supports public health decision-making and response activities.

背景 2022 年 5 月,在多个非疫区国家发现了几例天花疫情,2022 年 7 月 23 日,世界卫生组织宣布天花为国际关注的突发公共卫生事件。在疫情爆发的头六个月里,迫切需要有关天花的最新综合证据为公共卫生决策提供依据。此时,由于证据变化太快,传统的证据综合方法无法满足需要,因为系统综述在发表之前就已经过时。本文介绍了为管理和维护 "活证据档案"(LEP)而开发的框架,以便随着疫情的迅速发展,系统地识别、分类和综合有关水痘的各种证据。 方法 活证据档案框架以证据综合、风险评估、传染病建模的优先流行病学参数和专家咨询等原则为基础。该框架包括每周两次的系统搜索、研究选择、按预先确定的重点进行分类和数据提取、证据整合与综合、内部同行评审以及向利益相关者传播。 结果 在 2022 年 4 月 14 日至 12 月 15 日期间,共确定了 2287 篇引文,其中 687 篇是关于 2022 年麻风腮疫情的主要研究或监测报告,496 篇被纳入最终的 LEP。每项研究都被映射到 32 个病灶之一,并对证据进行了叙述性综合。从 2022 年 6 月到 12 月,共编制了 23 份 LEP(大约每周一次),同时还建立了一个可搜索的麻痘文献数据提取数据库。这些资料在全球范围内传播给公共卫生研究人员和决策者,为公共卫生应对工作提供信息。 结论 LEP 框架适用于其他公共卫生突发事件,因为这些事件中的证据变化很快,需要快速的综合周期。这种高效的方法可在疫情爆发或紧急情况发生的最初几个月内创建最新的当前证据摘要,为公共卫生决策和应对活动提供支持。
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引用次数: 0
The use of a large language model to create plain language summaries of evidence reviews in healthcare: A feasibility study 使用大型语言模型为医疗保健领域的证据综述创建通俗易懂的摘要:可行性研究
Pub Date : 2024-02-04 DOI: 10.1002/cesm.12041
Colleen Ovelman, Shannon Kugley, Gerald Gartlehner, Meera Viswanathan

Introduction

Plain language summaries (PLSs) make complex healthcare evidence accessible to patients and the public. Large language models (LLMs) may assist in generating accurate, readable PLSs. This study explored using the LLM Claude 2 to create PLSs of evidence reviews from the Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program.

Methods

We selected 10 evidence reviews published from 2021 to 2023, representing a range of methods and topics. We iteratively developed a prompt to guide Claude 2 in creating PLSs which included specifications for plain language, reading level, length, organizational structure, active voice, and inclusive language. PLSs were assessed for adherence to prompt specifications, comprehensiveness, accuracy, readability, and cultural sensitivity.

Results

All PLSs met the word count. We judged one PLS as fully comprehensive; seven mostly comprehensive. We judged two PLSs as fully capturing the PICO elements; five with minor PICO errors. We judged three PLSs as accurately reporting the results; and four with minor result errors. We judged three PLSs as having major result errors for incorrectly reporting total participants. Five PLSs met the target 6th to 8th grade reading level. Passive voice use averaged 16%. All PLSs used inclusive language.

Conclusions

LLMs show promise for assisting in PLS creation but likely require human input to ensure accuracy, comprehensiveness, and the appropriate nuances of interpretation. Iterative prompt refinement may improve results and address the needs of specific reviews and audiences. As text-only summaries, the AI-generated PLSs could not meet all consumer communication criteria, such as textual design and visual representations. Further testing should include consumer reviewers and explore how to best leverage LLM support in drafting PLS text for complex evidence reviews.

导言 普通语言摘要(PLS)使患者和公众能够获得复杂的医疗证据。大语言模型(LLM)可帮助生成准确、可读的 PLS。本研究探讨了如何使用 LLM Claude 2 创建来自美国医疗保健研究与质量局(AHRQ)有效医疗保健项目的证据综述的 PLS。 方法 我们选择了 10 篇发表于 2021 年至 2023 年的证据综述,它们代表了一系列方法和主题。我们反复编写了一份提示,用于指导 Claude 2 创建 PLS,其中包括对平实语言、阅读水平、篇幅、组织结构、主动语态和包容性语言的规范。我们对 PLS 进行了评估,以确定其是否符合提示规范、全面性、准确性、可读性和文化敏感性。 结果 所有 PLS 均符合字数要求。我们判定一份 PLS 完全全面;七份基本全面。我们判定两份 PLS 完全符合 PICO 要素;五份存在轻微的 PICO 错误。我们判定 3 份 PLS 准确地报告了结果;4 份有轻微的结果错误。我们判定 3 份 PLS 存在重大结果错误,因为它们错误地报告了参与者总数。五份 PLS 达到了六至八年级的目标阅读水平。被动语态使用率平均为 16%。所有 PLS 都使用了包容性语言。 结论 LLMs 有助于 PLS 的创建,但可能需要人工输入以确保准确性、全面性和适当的细微解释。迭代提示改进可能会改善结果,并满足特定评论和受众的需求。作为纯文本摘要,人工智能生成的 PLS 无法满足所有消费者沟通标准,如文本设计和视觉表现。进一步的测试应包括消费者审稿人,并探索如何在起草复杂证据综述的 PLS 文本时最好地利用 LLM 支持。
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引用次数: 0
Quality of randomized controlled trials and systematic reviews in pediatric surgery: A cross-sectional meta-research study 小儿外科随机对照试验和系统综述的质量:横断面荟萃研究
Pub Date : 2024-02-04 DOI: 10.1002/cesm.12042
Wilson Jiang, Bill Wang, Sandro Sperandei, Aidan Christopher Tan

Background

There are few randomized controlled trials (RCTs) in pediatric surgery, and their risk of bias is unknown. There is also little known about the methodological or reporting quality of systematic reviews (with or without meta-analyses) in pediatric surgery. Therefore, we conducted a cross-sectional meta-research study to determine the risk of bias and reporting quality of RCTs and systematic reviews and meta-analyses in pediatric surgery, and the associations between these outcomes and study characteristics.

Methods

We searched MEDLINE, Embase, Cochrane Library, JBI EBP Database, Centre for Reviews and Dissemination and Web of Science for all RCTs and systematic reviews in pediatric surgery published in 2021. We also searched the 2021 indexes of high-impact pediatric surgery journals. We assessed the risk of bias and reporting quality of RCTs using the RoB 2 and CONSORT tools respectively. We assessed the same parameters for systematic reviews and meta-analyses using the ROBIS and Preferred Reporting Items for Systematic Reviews and Meta-analyses tools.

Findings

We found 82 RCTs and 289 systematic reviews/meta-analyses published in 2021. More than half (n = 46, 56%) of RCTs and almost all (n = 278, 96%) systematic reviews and meta-analyses were at high risk of bias. Only one (1%) RCT and four (1%) systematic reviews and meta-analyses were adequately reported. Less than half (n = 40, 49%) of RCTs and just over a quarter (n = 77, 27%) of systematic reviews and meta-analyses had a registered protocol. Surprisingly, we found that more than half of systematic reviews and meta-analyse (n = 162, 56.1%), had no risk of bias assessment.

Conclusions

Recently published RCTs and systematic reviews in pediatric surgery are at high risk of bias and have poor reporting quality. Journals, universities, and research institutions should train authors to conduct and report higher quality studies and develop strategies to reduce risk of bias. However, research with high bias and low reporting does not necessarily lack value.

背景 儿科手术中的随机对照试验(RCT)很少,其偏倚风险也不明。关于小儿外科系统综述(含或不含荟萃分析)的方法或报告质量也知之甚少。因此,我们进行了一项横断面荟萃研究,以确定小儿外科 RCT、系统综述和荟萃分析的偏倚风险和报告质量,以及这些结果与研究特征之间的关联。 方法 我们检索了 MEDLINE、Embase、Cochrane 图书馆、JBI EBP 数据库、Centre for Reviews and Dissemination 和 Web of Science 中 2021 年发表的所有小儿外科 RCT 和系统综述。我们还检索了2021年高影响力小儿外科期刊的索引。我们分别使用 RoB 2 和 CONSORT 工具评估了 RCT 的偏倚风险和报告质量。我们使用 ROBIS 和系统综述和荟萃分析首选报告项目工具评估了系统综述和荟萃分析的相同参数。 研究结果 我们发现,2021 年共发表了 82 篇 RCT 和 289 篇系统综述/荟萃分析。半数以上(n = 46,56%)的研究性试验和几乎所有(n = 278,96%)的系统综述和荟萃分析存在高偏倚风险。只有一项(1%)研究性试验和四项(1%)系统综述和荟萃分析得到了充分报告。不到一半的研究性试验(n = 40,49%)和略高于四分之一的系统综述和荟萃分析(n = 77,27%)有注册协议。令人惊讶的是,我们发现一半以上的系统综述和荟萃分析(n = 162,56.1%)没有进行偏倚风险评估。 结论 近期发表的小儿外科 RCT 和系统综述存在较高的偏倚风险,报告质量较差。期刊、大学和研究机构应培训作者开展和报告更高质量的研究,并制定降低偏倚风险的策略。然而,高偏倚和低报告的研究并不一定没有价值。
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引用次数: 0
Menu labeling and portion size control to improve the out-of-home food environment: A scoping review 菜单标签和份量控制,改善户外食品环境:范围审查
Pub Date : 2024-01-23 DOI: 10.1002/cesm.12039
Kathiresan Jeyashree, Rizwan S. Abdulkader, Madhumitha Haridoss, Ranjithkumar Govindaraju, Amanda Brand, Marianne Visser, Sarah Gordon, Hemant Tiwari, T. S. Sumitha, Krupa Chandran, Denny Mabetha, Solange Durão

Background

Menu labeling and portion size control interventions may be effective strategies to mitigate the health risks posed by the out-of-home food environment. We conducted this scoping review to map the body of evidence (BoE) addressing the effects of menu labeling and portion size control interventions in the out-of-home food environment and to summarize the research gaps in this evidence base.

Methods

We searched PubMed, Embase, Epistemonikos, and PROSPERO in phase 1 for systematic reviews (SRs) and PubMed and Embase in phase 2 for primary studies in areas with insufficient SR evidence. We used a comprehensive search strategy without any restrictions on publication date, language, study population characteristics or outcomes. We screened all titles independently and in duplicate. We mapped the number of systematic reviews providing evidence per intervention-setting combination in a matrix. The gaps in the matrix informed the searches for primary studies in phase 2. For the included SR protocols and primary studies, we charted the population, intervention, comparator, outcome, period, and study design to facilitate their evaluation and inclusion in future evidence syntheses.

Results

We included 69 completed SRs; 37 on menu labeling, 9 on portion size control, and 23 on both. The types of menu labeling interventions studied were quantitative nutrient information (74%), interpretational guidance (48%), or contextual guidance (13%). Most reviews were from the United States, United Kingdom, and Canada. Most SRs included studies in establishments like cafeterias (51%) or restaurants (39%) and measured change in the quantity of food offered/ordered/consumed (96%). Phase 2 search yielded 24 primary studies; 16 experimental, 6 quasi-experimental, and 2 observational studies.

Conclusion

The BoE on the effectiveness of menu labeling and portion size control is predominantly from the developed world, on nutrient information labeling and reporting impact on consumer food choice. There is a need for studies in the online environment and reporting distal health outcomes.

背景 菜单标签和份量控制干预措施可能是减轻家庭外食品环境所带来的健康风险的有效策略。我们进行了此次范围界定综述,以绘制出针对家庭外食品环境中菜单标签和份量控制干预措施效果的证据库(BoE),并总结出该证据库中的研究空白。 方法 我们在第一阶段检索了 PubMed、Embase、Epistemonikos 和 PROSPERO 中的系统综述 (SR),在第二阶段检索了 PubMed 和 Embase 中 SR 证据不足领域的主要研究。我们采用了全面的检索策略,对发表日期、语言、研究人群特征或结果没有任何限制。我们对所有标题进行了独立、重复的筛选。我们将提供每种干预-设置组合证据的系统综述数量绘制成矩阵。矩阵中的空白为第二阶段主要研究的检索提供了依据。对于纳入的SR协议和主要研究,我们将人群、干预措施、比较者、结果、时间和研究设计绘制成图表,以便于对其进行评估并纳入未来的证据综合中。 结果 我们纳入了 69 项已完成的研究报告;其中 37 项关于菜单标示,9 项关于份量控制,23 项关于两者。所研究的菜单标签干预类型包括定量营养信息(74%)、解释性指导(48%)或情境指导(13%)。大多数综述来自美国、英国和加拿大。大多数研究报告纳入了在自助餐厅(51%)或餐馆(39%)等场所进行的研究,并测量了提供/订购/消费的食物数量的变化(96%)。第二阶段的搜索结果包括 24 项主要研究;16 项实验研究、6 项准实验研究和 2 项观察研究。 结论 关于菜单标签和份量控制效果的博易彩票主要来自发达国家,涉及营养信息标签和报告对消费者食品选择的影响。有必要对在线环境和报告远端健康结果进行研究。
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引用次数: 0
Mechanical ventilation core outcome set uptake in Cochrane systematic reviews: A cross-sectional study 机械通气核心结果集在 Cochrane 系统综述中的应用:横断面研究
Pub Date : 2024-01-10 DOI: 10.1002/cesm.12038
Luis Garegnani, Diego Ivaldi, Mariana Burgos, Gisela Oltra, Camila M. Escobar Liquitay

Introduction

The Cochrane Handbook acknowledges core outcome sets' (COS) relevance in defining review questions and planning systematic reviews. We aimed to assess the uptake of the mechanical ventilation (MV) COS in Cochrane systematic reviews of interventions.

Methods

A cross-sectional study. We included Cochrane systematic reviews and protocols of Cochrane systematic reviews of any intervention related to mechanically ventilated patients through a search in the Cochrane database of systematic reviews. We did not apply restrictions based on age or setting. One reviewer assessed the studies for eligibility and extracted data. Both processes were validated by a second author.

Results

We identified 233 reviews and protocols through our search strategy. We finally included 36 records. Thirty-four (94.44%) were Cochrane reviews and two (5.56%) were protocols. The included Cochrane reviews and protocols assessed a median of 13 (interquartile range [IQR]: 9–17) outcomes, with 35 (97.22%) reviews reporting at least one outcome from the MV COS. The median number of outcomes from the MV COS reported in the Cochrane reviews and protocols was 2.5 (IQR: 2–3). Only one (2.78%) study reported all the outcomes from the MV COS. None of the included Cochrane reviews and protocols cited the MV COS publication.

Conclusion

Completed Cochrane systematic reviews and protocols of Cochrane systematic reviews of interventions related to mechanically ventilated patients have an overall limited uptake of the MV COS so far. Mortality and duration of stay were the most reported outcomes, while extubation and reintubation were the least informed. These findings may serve as a starting point for the Cochrane Critical Care community to develop dissemination strategies for improving the MV COS uptake.

引言 Cochrane 手册承认核心结果集(COS)在确定综述问题和规划系统综述中的相关性。我们的目的是评估机械通气 (MV) COS 在 Cochrane 干预系统综述中的应用情况。 方法 横向研究。我们通过在 Cochrane 系统综述数据库中进行检索,纳入了与机械通气患者相关的任何干预措施的 Cochrane 系统综述和 Cochrane 系统综述协议。我们没有根据年龄或环境进行限制。一名审稿人负责评估研究的资格并提取数据。这两个过程均由第二位作者验证。 结果 我们通过搜索策略确定了 233 篇综述和方案。我们最终收录了 36 条记录。其中 34 篇(94.44%)为 Cochrane 综述,2 篇(5.56%)为规程。纳入的科克伦综述和方案评估的结果中位数为 13 项(四分位数间距 [IQR]:9-17),其中 35 项(97.22%)综述报告了至少一项来自 MV COS 的结果。科克伦综述和规程中报告的中压COS结果的中位数为2.5(IQR:2-3)。只有一项研究(2.78%)报告了中压COS的所有结果。所有纳入的 Cochrane 综述和协议均未引用 MV COS 出版物。 结论 已完成的Cochrane系统综述和Cochrane系统综述协议中与机械通气患者相关的干预措施中,迄今为止对MV COS的总体吸收有限。死亡率和住院时间是报道最多的结果,而拔管和再插管则是报道最少的结果。这些发现可作为 Cochrane 重症医学界制定传播策略以提高 MV COS 使用率的起点。
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引用次数: 0
Multiarm studies and how to handle them in a meta-analysis: A tutorial 多臂研究以及如何在荟萃分析中处理这些研究:教程
Pub Date : 2023-12-20 DOI: 10.1002/cesm.12033
Emma Axon, Kerry Dwan, Rachel Richardson

This tutorial focuses on multiarm studies. We will explain what multiarm studies are and how to include data from them in a meta-analysis.

本教程的重点是多臂研究。我们将解释什么是多臂研究,以及如何将多臂研究的数据纳入荟萃分析。
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引用次数: 0
Trustworthiness assessment as an inclusion criterion for systematic reviews—What is the impact on results? 作为系统综述纳入标准的可信度评估--对结果有何影响?
Pub Date : 2023-12-13 DOI: 10.1002/cesm.12037
Jo Weeks, Anna Cuthbert, Zarko Alfirevic

Background

There is increasing concern that a significant proportion of randomized controlled trials (RCTs) included in Cochrane reviews may not be trustworthy. Applying the Cochrane Pregnancy and Childbirth Trustworthiness Screening Tool (CPC-TST) has already had a clinically important effect on several reviews published by the Cochrane Pregnancy and Childbirth Group.

Objectives

We wanted to assess the impact of removing untrustworthy RCTs from already-published Cochrane reviews on a defined clinical area (antenatal and postnatal nutritional interventions).

Methods

We applied the tool to 18 Cochrane reviews (374 RCTs). The tool had four domains: (i) is the research governance trustworthy; (ii) are the baseline characteristics trustworthy; (iii) is the study feasible; (iv) are the results plausible? When additional information was needed, authors were contacted using a standard template. At least two attempts were made to contact the authors. At the end of the evaluation process each study was classified as: (i) included (YES to all questions); (ii) excluded (retracted study); or (iii) awaiting classification (any NO to the questions).

Results

Ninety-three out of 374 included studies (25%) were reclassified as “excluded” or “awaiting classification.” The number of included RCTs was reduced in 14 out of 18 reviews. Six reviews (33%) were judged to require updating because of important differences in the Summary of Findings tables (direction and size of effects and/or GRADE ratings), conclusions, implication for practice, and/or implication for research.

Conclusions

Formal assessment of trustworthiness, and inclusion only of studies that satisfy prespecified criteria for trustworthiness, affect conclusions in a relatively large number of Cochrane reviews, with potentially important clinical implications for practice and research.

越来越多的人担心Cochrane综述中纳入的相当大比例的随机对照试验(RCTs)可能不可信。应用Cochrane妊娠和分娩可信度筛查工具(CPC-TST)已经对Cochrane妊娠和分娩组发表的几篇综述产生了重要的临床影响。目的:我们想评估从Cochrane已发表的某一临床领域(产前和产后营养干预)综述中删除不可信的随机对照试验的影响。方法我们将该工具应用于18篇Cochrane综述(374项随机对照试验)。该工具有四个领域:(i)研究治理是否值得信赖;(ii)基线特征是否值得信赖;(iii)研究是否可行;(iv)结果是否可信?当需要额外的信息时,使用标准模板与作者联系。记者至少两次试图联系撰文人。在评估过程结束时,每个研究被分类为:(i)包括(对所有问题都是);(ii)被排除(撤回研究);或(iii)等待分类(对问题有任何否定)。结果374项纳入的研究中有93项(25%)被重新分类为“排除”或“等待分类”。18篇综述中有14篇减少了纳入的rct数量。6篇综述(33%)被判定需要更新,因为结论总结表(效果的方向和大小和/或GRADE评分)、结论、对实践的影响和/或对研究的影响存在重要差异。对可信度的正式评估,以及只纳入满足预先规定的可信度标准的研究,会影响相对大量Cochrane综述的结论,对实践和研究具有潜在的重要临床意义。
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引用次数: 0
Development of the InSynQ checklist: A tool for planning and reporting the synthesis questions in systematic reviews of interventions 开发 InSynQ 核对表:规划和报告干预措施系统综述问题的工具
Pub Date : 2023-12-12 DOI: 10.1002/cesm.12036
Miranda S. Cumpston, Joanne E. McKenzie, Rebecca Ryan, Ella Flemyng, James Thomas, Sue E. Brennan

Introduction

Methods guidance and appraisal tools for systematic reviews require specification of the question and eligibility criteria for the review (“PICO for the review”). Less emphasis has been given to specifying the question and criteria for each synthesis (“PICO for each synthesis”), yet decisions about which studies to include in each synthesis can critically influence the utility and findings of a review. This paper describes the rationale and methods for developing the InSynQ (Intervention Synthesis Questions) tool for planning and reporting synthesis questions in reviews of interventions. The aim is to provide transparency about the basis of the tool and contribute to evidence on methods for developing guidance for research conduct and reporting.

Methods

Informed by EQUATOR Network methods, we (1) established a project group; (2) examined reporting of the “PICO for each synthesis” in published reviews; (3) reviewed existing reporting guidance and the Cochrane Handbook for Systematic Reviews of Interventions; (4) drafted items with elaboration, explanation, and examples; (5) conducted consultation meetings, an evaluation survey and pilot test; (6) incorporated feedback.

Results

Existing reporting guidelines do not distinguish the review and synthesis PICO, with limited coverage of the elements needed to specify the PICO for each synthesis. Using the PRISMA 2020 format, the draft tool contained 10 items with essential and additional reporting elements, explanations, and examples. Revisions arising from consultation meetings (>30 people), included adding an eleventh item on consumer and stakeholder involvement, a figure explaining PICO for each synthesis, and integrating examples into elements/explanations. All respondents to the survey (12 people) said the tool would help them plan or appraise synthesis questions. InSynQ is available at https://InSynQ.info.

Conclusion

Transparent reporting of the development process contributes to the evidence base for methods to develop guidance. It may improve uptake of InSynQ, in turn enhancing the clarity of syntheses.

导言 系统综述的方法指南和评估工具要求明确综述的问题和资格标准("综述的 PICO")。然而,关于在每项综述中纳入哪些研究的决定会对综述的效用和结果产生至关重要的影响。本文介绍了开发 InSynQ(干预综述问题)工具的原理和方法,该工具用于规划和报告干预综述中的综述问题。目的是使该工具的基础透明化,并为制定研究行为和报告指南的方法提供证据。 方法 我们借鉴了 EQUATOR 网络的方法,(1) 成立了一个项目组;(2) 检查了已发表综述中 "每项综述的 PICO "的报告情况;(3) 回顾了现有的报告指南和《干预措施系统性综述 Cochrane 手册》;(4) 起草了附有详细说明、解释和示例的项目;(5) 召开了咨询会议,进行了评估调查和试点测试;(6) 纳入了反馈意见。 结果 现有的报告指南没有区分综述和综述的 PICO,对说明每项综述的 PICO 所需的要素覆盖有限。使用 PRISMA 2020 格式,工具草案包含 10 个项目,包括基本和附加报告要素、解释和示例。根据咨询会议(30 人)的意见进行了修订,包括增加第 11 个关于消费者和利益相关者参与的项目、每个综述的 PICO 解释图,以及将示例整合到要素/解释中。调查的所有受访者(12 人)都表示该工具有助于他们规划或评估综合问题。InSynQ 可在 https://InSynQ.info 网站上查阅。 结论 透明的开发过程报告有助于为指南开发方法提供证据基础。它可以提高 InSynQ 的使用率,进而提高综述的清晰度。
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引用次数: 0
Ten tips for successful assessment of risk of bias in randomized trials using the RoB 2 tool: Early lessons from Cochrane 使用RoB 2工具成功评估随机试验偏倚风险的十个提示:来自Cochrane的早期经验
Pub Date : 2023-12-03 DOI: 10.1002/cesm.12031
Theresa H. M. Moore, Julian P. T. Higgins, Kerry Dwan

Introduction

RoB 2 is a tool used by systematic reviewers to assess risk of bias in randomized trials. Over a period of 19 months working as editors for Cochrane, we saw many instances where users of RoB 2 frequently applied the tool in ways the developers had not intended, despite availability of detailed guidance, webinars and FAQs.

Methods

In this paper we highlight the ten main issues that we observed, with the aims of optimising the application of the RoB 2 tool, avoiding some of the frequent misapplications of the tool.

Results

Issues noted included failure to state an effect of interest, applying the tool to an entire study rather than to a specific numerical result, omitting key signaling questions and relying on outdated views of causes of bias.

Conclusion

Such omissions and misapplications can lead to overly harsh or lenient assessments of bias with potential to change the confidence we have in an evidence base of randomized trials. We recommend that teams planning to use RoB 2 include at least one member familiar with the RoB 2 detailed guidance and that they use the free resources, such as webinars and FAQs, from the developers of RoB 2 and Cochrane. Our ten tips should be useful to non-Cochrane systematic reviewers as well as to peer reviewers and editors in Cochrane and other journals.

RoB 2是系统审稿人用来评估随机试验偏倚风险的工具。在作为Cochrane编辑的19个月里,我们看到很多例子,RoB 2的用户经常以开发者意想不到的方式使用该工具,尽管有详细的指导、网络研讨会和常见问题解答。在本文中,我们强调了我们观察到的十个主要问题,目的是优化罗布2工具的应用,避免工具的一些频繁误用。注意到的问题包括未能说明感兴趣的影响,将工具应用于整个研究而不是特定的数字结果,忽略关键的信号问题以及依赖于过时的偏见原因观点。这样的遗漏和误用可能导致过于苛刻或宽松的偏倚评估,有可能改变我们对随机试验证据基础的信心。我们建议计划使用RoB 2的团队包括至少一名熟悉RoB 2详细指导的成员,并且他们使用RoB 2和Cochrane开发人员提供的免费资源,例如网络研讨会和faq。我们的十条建议应该对非Cochrane系统审稿人以及Cochrane和其他期刊的同行审稿人和编辑有用。
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引用次数: 0
期刊
Cochrane Evidence Synthesis and Methods
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