BMJ Evidence-Based Medicine最新文献

英文中文

Ambiguity in care delivery terminology: implications that affect pragmatic clinical trials using non-pharmacological interventions. 护理交付术语的歧义:影响使用非药物干预的实用临床试验的含义。

IF 9 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMJ Evidence-Based Medicine

Pub Date : 2024-09-20 DOI: 10.1136/bmjebm-2023-112547

Daniel I Rhon, Alison F Davis, Joseph Ali, Cynthia Brandt, Amy Burns, Whitley Lucio, Robert Vining, Stacey Young-McCaughan

引用次数: 0

Can a replication revolution resolve the duplication crisis in systematic reviews? 复制革命能否解决系统审查中的复制危机？

IF 9 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMJ Evidence-Based Medicine

Pub Date : 2024-09-20 DOI: 10.1136/bmjebm-2022-112125

Sathya Karunananthan, Jeremy M Grimshaw, Lara Maxwell, Phi-Yen Nguyen, Matthew J Page, Jordi Pardo Pardo, Jennifer Petkovic, Brigitte Vachon, Vivian Andrea Welch, Peter Tugwell

引用次数: 0

Shared decision-making and evidence-based medicine series: exploring contemporary challenges and future directions. 共同决策与循证医学系列：探讨当代挑战与未来方向。

IF 9 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMJ Evidence-Based Medicine

Pub Date : 2024-09-20 DOI: 10.1136/bmjebm-2024-113024

Paula Riganti, Tammy C Hoffmann

引用次数: 0

Clinical trial design and treatment effects: a meta-analysis of randomised controlled and single-arm trials supporting 437 FDA approvals of cancer drugs and indications. 临床试验设计与治疗效果：对支持 437 项 FDA 批准的癌症药物和适应症的随机对照试验和单臂试验进行的荟萃分析。

IF 9 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMJ Evidence-Based Medicine

Pub Date : 2024-09-20 DOI: 10.1136/bmjebm-2023-112544

Daniel Tobias Michaeli, Thomas Michaeli, Sebastian Albers, Julia Caroline Michaeli

Objectives: This study aims to analyse the association between clinical trial design and treatment effects for cancer drugs with US Food and Drug Administration (FDA) approval.

Design: Cross-sectional study and meta-analysis.

Setting: Data from Drugs@FDA, FDA labels, ClincialTrials.gov and the Global Burden of Disease study.

Participants: Pivotal trials for 170 drugs with FDA approval across 437 cancer indications between 2000 and 2022.

Main outcome measures: Treatment effects were measured in HRs for overall survival (OS) and progression-free survival (PFS), and in relative risk for tumour response. Random-effects meta-analyses and meta-regressions explored the association between treatment effect estimates and clinical trial design for randomised controlled trials (RCTs) and single-arm trials.

Results: Across RCTs, greater effect estimates were observed in smaller trials for OS (ß=0.06, p<0.001), PFS (ß=0.15, p<0.001) and tumour response (ß=-3.61, p<0.001). Effect estimates were larger in shorter trials for OS (ß=0.08, p<0.001) and PFS (ß=0.09, p=0.002). OS (ß=0.04, p=0.006), PFS (ß=0.10, p<0.001) and tumour response (ß=-2.91, p=0.004) outcomes were greater in trials with fewer centres. HRs for PFS (0.54 vs 0.62, p=0.011) were lower in trials testing the new drug to an inactive (placebo/no treatment) rather than an active comparator. The analysed efficacy population (intention-to-treat, per-protocol, or as-treated) was not consistently associated with treatment effects. Results were consistent for single-arm trials and in multivariable analyses.

Conclusions: Pivotal trial design is significantly associated with measured treatment effects. Particularly small, short, single-centre trials testing a new drug compared with an inactive rather than an active comparator could overstate treatment outcomes. Future studies should verify results in unsuccessful trials, adjust for further confounders and examine other therapeutic areas. The FDA, manufacturers and trialists must strive to conduct robust clinical trials with a low risk of bias.

研究目的本研究旨在分析获得美国食品药品管理局（FDA）批准的癌症药物的临床试验设计与治疗效果之间的关系：设计：横断面研究和荟萃分析：数据来源：Drugs@FDA、FDA 标签、ClincialTrials.gov 和全球疾病负担研究：2000年至2022年期间，FDA批准了170种药物的关键试验，涉及437种癌症适应症：治疗效果以总生存期（OS）和无进展生存期（PFS）的HRs以及肿瘤反应的相对风险来衡量。随机效应荟萃分析和荟萃回归探讨了随机对照试验（RCT）和单臂试验的治疗效果估计值与临床试验设计之间的关系：结果：在所有随机对照试验中，规模较小的试验的OS疗效估计值更大（ß=0.06，p结论：关键试验设计与OS疗效估计值显著相关：关键性试验的设计与测量的治疗效果密切相关。特别是小型、短期、单中心试验，将新药与非活性而非活性参照物进行比较，可能会夸大治疗效果。未来的研究应核实未成功试验的结果，调整更多的混杂因素，并考察其他治疗领域。美国食品及药物管理局、生产商和试验者必须努力开展稳健的临床试验，降低偏倚风险。

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引用次数: 0

Differences in shared decision-making: the East-West divide. 共同决策的差异：东西方的分歧。

IF 9 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMJ Evidence-Based Medicine

Pub Date : 2024-09-20 DOI: 10.1136/bmjebm-2023-112451

Weihua Chen, Huangruowen Zhang, Mingyue Xu, Rongchong Huang

引用次数: 0

Vibration of effects resulting from treatment selection in mixed-treatment comparisons: a multiverse analysis on network meta-analyses of antidepressants in major depressive disorder. 混合治疗比较中治疗选择导致的效应振动：重度抑郁症抗抑郁药网络荟萃分析的多元宇宙分析。

IF 9 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMJ Evidence-Based Medicine

Pub Date : 2024-09-20 DOI: 10.1136/bmjebm-2024-112848

Constant Vinatier, Clement Palpacuer, Alexandre Scanff, Florian Naudet

Objective: It is frequent to find overlapping network meta-analyses (NMAs) on the same topic with differences in terms of both treatments included and effect estimates. We aimed to evaluate the impact on effect estimates of selecting different treatment combinations (ie, network geometries) for inclusion in NMAs.

Design: Multiverse analysis, covering all possible NMAs on different combinations of treatments.

Setting: Data from a previously published NMA exploring the comparative effectiveness of 22 treatments (21 antidepressants and a placebo) for the treatment of acute major depressive disorder.

Participants: Cipriani et al explored a dataset of 116 477 patients included in 522 randomised controlled trials.

Main outcome measures: For each possible treatment selection, we performed an NMA to estimate comparative effectiveness on treatment response and treatment discontinuation for the treatments included (231 between-treatment comparisons). The distribution of effect estimates of between-treatment comparisons across NMAs was computed, and the direction, magnitude and statistical significance of the 1st and 99th percentiles were compared.

Results: 4 116 254 different NMAs concerned treatment response. Among possible network geometries, 172/231 (74%) pairwise comparisons exhibited opposite effects between the 1st and 99th percentiles, 57/231 (25%) comparisons exhibited statistically significant results in opposite directions, 118 of 231 (51%) comparisons derived results that were both significant and non-significant at 5% risk and 56/231 (24%) treatment pairs obtained consistent results with only significant differences (or only non-significant differences) at 5% risk. Comparisons based on indirect evidence only were associated with greater variability in effect estimates. Comparisons with small absolute values observed in the complete NMA more frequently obtained statistically significant results in opposite directions. Similar results were observed for treatment discontinuation.

Conclusion: In this multiverse analysis, we observed that the selection of treatments to be included in an NMA could have considerable consequences on treatment effect estimations.

Trial registration: https://osf.io/mb5dy.

目的：在同一主题的网络荟萃分析（NMA）中，经常会发现重叠的网络荟萃分析在纳入的治疗方法和效果估计方面存在差异。我们旨在评估选择不同的治疗组合（即网络几何结构）纳入 NMA 对效果估计值的影响：设计：多元分析，涵盖所有可能的关于不同治疗组合的 NMA：数据来自之前发表的一项NMA，该NMA探讨了22种治疗方法（21种抗抑郁药和1种安慰剂）治疗急性重度抑郁症的比较效果：Cipriani等人研究了包含在522项随机对照试验中的116 477名患者的数据集：对于每种可能的治疗选择，我们都进行了NMA，以估算所纳入治疗的治疗反应和治疗中止的比较效果（231次治疗间比较）。我们计算了各 NMA 治疗间比较效果估计值的分布情况，并比较了第 1 个百分位数和第 99 个百分位数的方向、幅度和统计学意义：4 116 254 个不同的 NMA 涉及治疗反应。在可能的网络几何图形中，172/231（74%）次成对比较显示出第 1 个百分位数和第 99 个百分位数之间的效应相反，57/231（25%）次比较显示出统计意义上的相反方向结果，231 次比较中的 118 次（51%）比较得出的结果在 5%风险下既显著又不显著，56/231（24%）次治疗对获得了一致的结果，在 5%风险下只有显著差异（或只有不显著差异）。仅基于间接证据的比较与效应估计值的较大变异有关。在完整的 NMA 中观察到的绝对值较小的比较更经常获得相反方向的具有统计学意义的结果。在中断治疗方面也观察到了类似的结果：在这一多重宇宙分析中，我们观察到，选择纳入NMA的治疗方法会对治疗效果估计产生相当大的影响。试验注册：https://osf.io/mb5dy。

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引用次数: 0

Four overlooked errors in ROC analysis: how to prevent and avoid. ROC 分析中被忽视的四个错误：如何预防和避免。

IF 9 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMJ Evidence-Based Medicine

Pub Date : 2024-09-19 DOI: 10.1136/bmjebm-2024-113078

Zhuoqiao He, Qingying Zhang, Manshu Song, Xuerui Tan, Wei Wang

引用次数: 0

Facilitating GRADE judgements about the inconsistency of effects using a novel visualisation approach. 利用新颖的可视化方法促进 GRADE 对效果不一致性的判断。

IF 9 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMJ Evidence-Based Medicine

Pub Date : 2024-09-19 DOI: 10.1136/bmjebm-2024-113038

Mohammad Hassan Murad, Zhen Wang, Yngve Falck-Ytter

引用次数: 0

Developing guideline recommendations about tests: educational examples of test-management pathways 制定有关测试的指导建议：测试管理途径的教育实例

IF 5.8 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMJ Evidence-Based Medicine

Pub Date : 2024-09-18 DOI: 10.1136/bmjebm-2024-112984

Mariska Tuut, Jochen Cals, Jesse Jansen, Jako S Burgers

Recommendations about healthcare related testing in guidelines are common. Tests can be used for several purposes: screening, surveillance, risk classification, diagnosis, staging, treatment triage, determination of prognosis and monitoring/follow-up.1 The development of testing recommendations in guidelines is challenging, especially because the benefit of a test not only depends on test characteristics, such as sensitivity and specificity, but also on population characteristics and test consequences, such as management.2–4 Furthermore, the role of a new test in comparison to the existing testing scenario should be defined, since this influences the interpretation of the new test’s value. The following roles of new tests have been identified in the literature: triage, replacement, add-on, and parallel/combined.5 As with treatment, testing can have negative consequences, including physical impairment, psychological distress, disease labelling, and costs.6 There is limited evidence on harms of testing, and healthcare professionals often overestimate its benefits while underestimating its harms.7 This is also true for patients' expectations of testing.8 Additionally, testing occasionally yields unexpected and coincidental findings, which may result in additional testing and treatment. There is a lack of transparency in processing the evidence and considerations that support testing recommendations in guidelines.9 To facilitate the development of test recommendations, we determined the minimum required knowledge for guideline panel members involved, supplementing the competency-based framework available for guideline development.10 11 The concept of the test-management pathway (figure 1) appeared key to understand. Figure 1 Test-management pathway concept. During our developmental study, the need for practical examples of test-management pathways became apparent.10 In our subsequent teach-the-teacher workshop at the 2023 Guideline International Network conference,12 participants requested additional elaboration of pathways for different test outcomes (such as false positives and false negatives) being helpful for explaining the test-management pathway concept to guideline …

在指南中提出与医疗保健相关的检验建议很常见。检验可用于多种目的：筛查、监测、风险分类、诊断、分期、治疗分流、确定预后和监测/随访。1 在指南中制定检验建议具有挑战性，特别是因为检验的益处不仅取决于检验的特点，如灵敏度和特异性，还取决于人群特点和检验的后果，如管理。5 与治疗一样，检验也会产生负面影响，包括身体损伤、心理困扰、疾病标签和费用。6 有关检验危害的证据有限，医护人员往往高估了检验的益处而低估了其危害。9 为促进检验建议的制定，我们确定了相关指南小组成员所需的最低知识要求，以补充指南制定中基于能力的框架。10 11 检验管理路径的概念（图 1）似乎是理解的关键。图 1 检验管理路径概念。在 2023 年指南国际网络会议12 上举办的 "教师授课 "研讨会上，与会者要求进一步阐述不同试验结果（如假阳性和假阴性）的路径，这有助于向指南专家解释试验管理路径概念。

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引用次数: 0

Do infographics ‘spin’ the findings of health and medical research? 信息图表会 "转述 "健康和医学研究结果吗？

IF 5.8 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMJ Evidence-Based Medicine

Pub Date : 2024-09-12 DOI: 10.1136/bmjebm-2024-113033

Ryan Muller, Giovanni Ferreira, Geronimo Bejarano, Andrew R Gamble, James Kirk, James Sindone, Joshua R Zadro

Objective To compare the prevalence of ‘spin’, and specific reporting strategies for spin, between infographics, abstracts and full texts of randomised controlled trials (RCTs) reporting non-significant findings in the field of health and medicine and to assess factors associated with the presence of spin. Design Cross-sectional observational study. Data source Publications in top quintile health and medical journals from August 2018 to October 2020 (Journal Citation Reports database). Eligibility criteria Infographics, abstracts and full texts of RCTs with non-significant results for a primary outcome. Main outcome(s) and measure(s) Presence of spin (any spin and spin in the results and conclusions of infographics, abstracts and full texts). Exposure(s) Conflicts of interest, industry sponsorship, trial registration, journal impact factor, spin in the abstract, spin in the full text. Results 119 studies from 40 journals were included. One-third (33%) of infographics contained spin. Infographics were not more likely to contain any spin than abstracts (33% vs 26%, OR 1.4; 95% CI 0.8 to 2.4) or full texts (33% vs 26%, OR 1.4; 95% CI 0.8 to 2.4). Higher journal impact factor was associated with slightly lower odds of spin in infographics and full texts, but not abstracts. Infographics, but not abstracts or full texts, were less likely to contain spin if the trial was prospectively registered. No other significant associations were found. Conclusions Nearly one-third of infographics spin the findings of RCTs with non-significant results for a primary outcome, but the prevalence of spin is not higher than in abstracts and full texts. Given the increasing popularity of infographics to disseminate research findings, there is an urgent need to improve the reporting of research in infographics. Data are available on reasonable request. Original data may be made available by the authors on reasonable request.

目的比较在健康和医学领域报告非显著性研究结果的随机对照试验（RCT）的信息图表、摘要和全文中 "自旋 "的普遍程度以及针对自旋的特定报告策略，并评估与自旋存在相关的因素。设计横断面观察研究。数据来源 2018年8月至2020年10月在前五分之一健康与医学期刊上发表的文章（期刊引文报告数据库）。资格标准主要结果不显著的 RCT 的信息图表、摘要和全文。主要结果和衡量标准是否存在自旋（信息图表、摘要和全文的结果和结论中的任何自旋和自旋）。利益冲突、行业赞助、试验注册、期刊影响因子、摘要中的自旋、全文中的自旋。结果共收录了来自 40 种期刊的 119 项研究。三分之一（33%）的信息图表中包含自旋内容。与摘要（33% vs 26%，OR 1.4；95% CI 0.8-2.4）或全文（33% vs 26%，OR 1.4；95% CI 0.8-2.4）相比，信息图表中含有自旋成分的可能性并不大。期刊影响因子越高，信息图表和全文中出现自旋的几率就越低，而摘要中出现自旋的几率则不高。如果试验是前瞻性注册的，信息图表（而非摘要或全文）中包含自旋的可能性较低。没有发现其他重要关联。结论近三分之一的信息图表对主要结果不显著的 RCT 结果进行了转述，但转述的普遍程度并不高于摘要和全文。鉴于信息图表在传播研究成果方面越来越受欢迎，因此迫切需要改进信息图表中的研究报告。如有合理要求，可提供数据。作者可根据合理要求提供原始数据。

{"title":"Do infographics ‘spin’ the findings of health and medical research?","authors":"Ryan Muller, Giovanni Ferreira, Geronimo Bejarano, Andrew R Gamble, James Kirk, James Sindone, Joshua R Zadro","doi":"10.1136/bmjebm-2024-113033","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113033","url":null,"abstract":"Objective To compare the prevalence of ‘spin’, and specific reporting strategies for spin, between infographics, abstracts and full texts of randomised controlled trials (RCTs) reporting non-significant findings in the field of health and medicine and to assess factors associated with the presence of spin. Design Cross-sectional observational study. Data source Publications in top quintile health and medical journals from August 2018 to October 2020 (Journal Citation Reports database). Eligibility criteria Infographics, abstracts and full texts of RCTs with non-significant results for a primary outcome. Main outcome(s) and measure(s) Presence of spin (any spin and spin in the results and conclusions of infographics, abstracts and full texts). Exposure(s) Conflicts of interest, industry sponsorship, trial registration, journal impact factor, spin in the abstract, spin in the full text. Results 119 studies from 40 journals were included. One-third (33%) of infographics contained spin. Infographics were not more likely to contain any spin than abstracts (33% vs 26%, OR 1.4; 95% CI 0.8 to 2.4) or full texts (33% vs 26%, OR 1.4; 95% CI 0.8 to 2.4). Higher journal impact factor was associated with slightly lower odds of spin in infographics and full texts, but not abstracts. Infographics, but not abstracts or full texts, were less likely to contain spin if the trial was prospectively registered. No other significant associations were found. Conclusions Nearly one-third of infographics spin the findings of RCTs with non-significant results for a primary outcome, but the prevalence of spin is not higher than in abstracts and full texts. Given the increasing popularity of infographics to disseminate research findings, there is an urgent need to improve the reporting of research in infographics. Data are available on reasonable request. Original data may be made available by the authors on reasonable request.","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":"11 1","pages":""},"PeriodicalIF":5.8,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142175805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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