BMJ Evidence-Based Medicine最新文献

{"title":"Incomplete reporting and spin in acupuncture randomised controlled trials: a cross-sectional meta-epidemiological study.","authors":"Yuting Duan, Pinge Zhao, Yuening Deng, Zhirui Xu, Siqi Wu, Lin Shi, Feng Jiang, Shujuan Liu, Xinyu Li, Binbin Tang, Jinjin Zhou, Lin Yu","doi":"10.1136/bmjebm-2024-113364","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113364","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the reporting, data sharing and spin (using reporting strategies to emphasise the benefit of non-significant results) in acupuncture randomised controlled trials (RCTs).</p><p><strong>Design: </strong>Cross-sectional meta-epidemiological study.</p><p><strong>Data sources: </strong>Eligible studies indexed in MEDLINE, Embase, CENTRAL, CBM, CNKI, Wanfang Data and VIP Database between 1 January 2014 and 1 May 2024.</p><p><strong>Eligibility criteria: </strong>Peer-reviewed acupuncture RCTs used traditional medicine (TM), published in English or Chinese, two parallel arms for humans.</p><p><strong>Main outcome measures: </strong>We assessed (1) the reporting of acupuncture RCTs by the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) checklist; (2) the data sharing level by the International Committee of Medical Journal Editors (ICMJE) data sharing statement; (3) spin frequency and level by the prespecified spin strategies.</p><p><strong>Results: </strong>This study evaluated 476 eligible studies, of which 166 (34.9%) explored the specific efficacy or safety of acupuncture in the nervous system, 68 (14.3%) in the motor system and 61 (12.8%) in the digestive system. 244 (57.7%) studies used conventional acupuncture, 296 (62.2%) used multicentre study design and 369 (77.5%) were supported by institutional funding. 312 (65.5%) eligible studies were poorly reported. The sufficiently reporting scores of the CONSORT 2010 statement and the STRICTA checklist differed from 0.63% to 97.5%, and 32 (59.3%) items were less than 50%. For the data sharing level of acupuncture RCTs, only 66 (17.2%) studies followed the ICMJE data sharing statement, but 49 (14.5%) need to require authors to obtain data, and only 5 (1.5%) provided data by open access. Spins were identified in 408 (85.7%) studies (average spin frequencies: 2.94). 59 (37.2%) studies with non-significant primary outcomes had spin levels.</p><p><strong>Conclusions: </strong>This study found that the reporting of acupuncture RCTs was low compliance with the CONSORT 2010 statement, the STRICTA checklist and the ICMJE data sharing statement, and spin appeared frequently. Journal policies on using reporting guidelines, data sharing and equitable consideration of non-significant results might enhance the reporting of acupuncture RCTs.</p><p><strong>Trial registration number: </strong>This study was registered at the Open Science Framework (OSF): (https://doi.org/10.17605/OSF.IO/2WTE6, and https://doi.org/10.17605/OSF.IO/9XDN4,).</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779072","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}

{"title":"Leading with options or issues to support purposeful shared decision-making in clinical practice.","authors":"Ricardo Loor-Torres, Yvonne Bui, Karina Dahl Steffensen, Anja Fog Heen, Thomas Agoritsas, Marleen Kunneman, Meg E Carley, Esteban Cabezas, Dawn Stacey, Ian Hargraves, Victor M Montori","doi":"10.1136/bmjebm-2024-113322","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113322","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762546","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}

{"title":"Advancing evidence-based medicine in China: an interview with Gordon Guyatt.","authors":"Huanyuan Luo, Qianling Shi, Dexing Zhang, Xuan Yu, Yue Yong, Guobao Li, Liang Li, Bohan Li, Yaolong Chen, Dong Roman Xu","doi":"10.1136/bmjebm-2024-113489","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113489","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762543","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}

{"title":"Efficacy of open-label placebos for premenstrual syndrome: a randomised controlled trial.","authors":"Antje Frey Nascimento, Jens Gaab, Bojana Degen, Mareike Rytz, Anja Holder, Dilan Sezer, Sarah Buergler, Andrea H Meyer, Irving Kirsch, Joe Kossowsky, Cosima Locher","doi":"10.1136/bmjebm-2024-112875","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-112875","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the efficacy and safety of open-label placebos (OLP) in premenstrual syndrome (PMS).</p><p><strong>Design: </strong>Randomised controlled trial.</p><p><strong>Setting: </strong>Switzerland, 2018-2020.</p><p><strong>Participants: </strong>150 women (18-45 years of age) with PMS or premenstrual dysphoric disorder.</p><p><strong>Intervention: </strong>Random assignment (1:1:1) to treatment as usual (TAU), OLP without treatment rationale (OLP-), or OLP with treatment rationale (OLP+). OLP consisted of two placebo pills per day for 6 weeks.</p><p><strong>Main outcome measures: </strong>Primary outcomes were PMS symptom intensity and interference between groups across three menstrual cycles (MC1-MC3); adverse events (ie, safety) were measured at weeks 3 and 6 after the start of the intervention. Secondary outcomes were psychological and somatic subscales of PMS symptom intensity, and adherence.</p><p><strong>Results: </strong>From 2 August 2018 to 3 December 2020, 150 women were randomly allocated to TAU (n=50), OLP- (n=50), and OLP+ (n=50), of whom 145 (96.7%) completed trial participation. Groups differed in symptom intensity (F(4)=4.419, p=0.002, r²=0.16) and interference (F(4)=3.159, p=0.014, r²=0.13) across three MCs. Mean symptom intensity at MC3 was lower for OLP+ compared to TAU (b=-9.97, SE=2.85, t(412)=3.50, p<0.001, d=0.90) and to OLP- (b=-6.10, SE=2.89, t(411)=2.11, p=0.036, d=0.55), but OLP- and TAU did not differ (b=-3.87, SE=2.87, t(411)=1.35, p=0.177, d=0.35). Mean interference at MC3 was lower for OLP+ compared to TAU (b=-1.23, SE=0.54, t(443)=2.30, p=0.022, d=0.55) and to OLP- (b=-1.10, SE=0.54, t(442)=2.02, p=0.044, d=0.48), but OLP- and TAU did not differ (b=-0.14, SE=0.54, t(442)=0.26, p=0.799, d=0.06). Four non-serious adverse events were reported in OLP- (n=1) and OLP+ (n=3). Improvement in psychological and somatic symptom intensity was comparable to primary outcomes. Adherence to the OLP intervention was high (93.18±18.95%), with no difference between groups.</p><p><strong>Conclusions: </strong>The results of our clinical trial indicate that OLP provided with a treatment rationale is an effective, safe, and acceptable treatment for PMS.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03547661 (submitted 2 May 2018).</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143708398","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}

{"title":"Simple tool implementing Bucher's method for indirect treatment comparisons in meta-analyses.","authors":"Samuel James Tingle, Georgios Kourounis, Felix Liu, Colin H Wilson, Rachel Richardson, Josie Sandercock","doi":"10.1136/bmjebm-2024-113103","DOIUrl":"10.1136/bmjebm-2024-113103","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"130-133"},"PeriodicalIF":9.0,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141854719","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}

{"title":"Safety implications of mask use: a systematic review and evidence map.","authors":"Wigdan Farah, Mohamed F Abusalih, Bashar Hasan, Elizabeth H Lees, Farah Fleti, Wiaam Y Elkhatib, Bruce D Johnson, Gary Toups, Michael Wolf, M Hassan Murad","doi":"10.1136/bmjebm-2024-113028","DOIUrl":"10.1136/bmjebm-2024-113028","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Widespread use of respiratory protection masks has become a critical component of public health response.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;This systematic review synthesises the evidence on the acute physiological, cognitive and psychological impacts associated with different types of masks and provides an evidence map of research gaps.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A comprehensive search from 2000 to 2023 was conducted across multiple databases (MEDLINE, EMBASE, Cochrane databases, Scopus and PubMed). An umbrella systematic overview was conducted for physiological outcomes using existing systematic reviews. We conducted de novo systematic reviews for cognitive and psychological outcomes. Pairs of independent reviewers determined eligibility, extracted data and assessed risk of bias. Certainty at an outcome level was appraised using the Grading of Recommendations Assessment, Development and Evaluation approach.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The search resulted in 13 370 potential citations, leading to the inclusion of nine systematic reviews for physiological outcomes (87 primary studies) and 10 primary studies for cognitive and psychological outcomes (3815 participants), with the majority of participants being healthy adults. Studies evaluating physiological outcomes demonstrated that various types of masks have little to no significant difference in heart rate (surgical mask (mean difference (MD): 0.96 (-1.01 to 2.93)), N95 mask (MD: 1.63 (-2.79 to 6.05)) and cloth mask (MD: -0.94 (-6.39 to 4.52))) or respiratory rate during rest or exercise (surgical mask (MD: -1.35 (-3.00 to 0.29)), N95 mask (MD: 0.10 (-3.10 to 3.29)) and cloth mask (MD: -2.57 (-6.44 to 1.29)) (low certainty for most outcomes)). Mask use may be associated with very small changes in minute ventilation (surgical mask (MD: -13.9 (-20.30 to -7.53)) and N95 mask (MD: -16.3 (-28.7 to -3.9))), tidal volume (surgical mask (MD: -0.14 (-0.23 to -0.05)) and N95 mask (MD: -0.10 (-0.33 to 0.13))), oxygen saturation (surgical mask (MD: -0.59% (-0.87 to -0.30)), N95 mask (MD: -0.35% (-0.75 to 0.05)) and cloth mask (MD: -0.50% (-1.23; 0.24))), carbon dioxide partial pressure (surgical mask (standardised MD (SMD): 1.17 (0.70 to 1.64)) and N95 mask (SMD: 0.43 (0.08 to 0.79))) and exercise performance (surgical mask (SMD: -0.12 (-0.39 to 0.15)), N95 mask (SMD: -0.42 (-0.76 to -0.08)) and cloth mask (SMD: -0.26 (-0.54 to 0.02)) (low certainty for most outcomes)). Studies evaluating cognitive outcomes showed mixed results. Some studies reported reduced mental workload, and others showed no significant effect or decreased performance. The impact on attention, errors and reaction time was variable. These studies were small and at moderate to high risk of bias. Evidence was insufficient to estimate the effect of mask use on psychological outcomes (claustrophobia, depression and anxiety) as these studies were small, non-longitudinal and at high risk of bias.&lt;/p&gt;&lt;","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"91-103"},"PeriodicalIF":9.0,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142341397","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}

{"title":"Peer reviewers' conflicts of interest in biomedical research: scoping review.","authors":"Christoffer Bruun Korfitsen, Camilla Hansen Nejstgaard, Asbjørn Hróbjartsson, Isabelle Boutron, Lisa Bero, Andreas Lundh","doi":"10.1136/bmjebm-2024-112967","DOIUrl":"10.1136/bmjebm-2024-112967","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Peer review may improve the quality of research manuscripts and aid in editorial decisions, but reviewers can have conflicts of interest that impact on their recommendations.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;The objective was to systematically map and describe the extent and nature of empirical research on peer reviewers' conflicts of interest in biomedical research.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;Scoping review METHODS: In this scoping review, we included studies investigating peer reviewers' conflicts of interest in journal manuscripts, theses and dissertations, conference abstracts, funding applications and clinical guidelines. We searched MEDLINE, Embase, The Cochrane Methodology Register, Google Scholar (up to January 2024) and other sources. Two authors independently included studies and extracted data on key study characteristics and results, and we organised data by study domain (eg, journal manuscripts) and study aims. We included studies directly investigating peer reviewers' conflicts of interest in our primary analysis, and studies investigating other questions (eg, reasons for retraction), but reporting relevant data on peer reviewers' conflicts of interest, were solely included in a supplementary analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;After screening 44 353 references, we included 71 studies, of which 41 were included in our primary analysis. The 41 studies were published between 2005 and 2023, and 34 (83%) were journal publications. 30 (73%) studies investigated journal manuscripts, 1 (2%) conference abstracts, 4 (10%) funding applications and 6 (15%) clinical guidelines. No studies investigated theses or dissertations. 37 (90%) studies used quantitative research methods, 2 (5%) qualitative and 2 (5%) mixed methods. 21 (51%) studies investigated both financial and non-financial interests, 6 (15%) solely financial interests, 5 (12%) solely non-financial interests and 9 (22%) did not report the type of interest. We organised included studies based on study aims, with some studies having multiple aims: impact on recommendations (one study), occurrence of peer reviewers' conflicts of interest (11 studies), stakeholders' experiences (13 studies) and policy and management (22 studies). One (2%) study investigated the impact of peer reviewers' personal connections with authors on reviewers' recommendations. Nine (22%) studies estimated prevalences of conflicts of interest among peer reviewers, ranging from 3%-91%. Two (5%) studies both reported that conflicts of interest were a reason for declining to review in 1% of cases. 13 (32%) studies investigated stakeholders' experiences with peer reviewers' conflicts of interest, primarily using questionnaires of reviewers, editors and researchers. 16 (39%) studies estimated prevalences of having conflict of interest policies for peer reviewers, ranging from 5%-96%, among journals, conferences and clinical guideline organisations. Finally, six (15%) studies es","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"104-117"},"PeriodicalIF":9.0,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142944311","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}

{"title":"Strengthening transparency in randomised trials related to multimorbidity: key points and recommendations to guide reporting.","authors":"Zijun Wang, Jako S Burgers, Ruitai Shao, Zhaoxiang Bian, Chen Wang, Yaolong Chen, Janne Estill","doi":"10.1136/bmjebm-2024-112907","DOIUrl":"10.1136/bmjebm-2024-112907","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"124-126"},"PeriodicalIF":9.0,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141260799","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}

{"title":"Stop searching and you will find it: Search-Resistant Concepts in systematic review searches.","authors":"Farhad Shokraneh","doi":"10.1136/bmjebm-2023-112798","DOIUrl":"10.1136/bmjebm-2023-112798","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"134-137"},"PeriodicalIF":9.0,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141896731","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}

{"title":"Hurdles of trying to avoid low-value care: two cheers for Choosing Wisely.","authors":"Dena S Davis","doi":"10.1136/bmjebm-2024-113283","DOIUrl":"10.1136/bmjebm-2024-113283","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"138-139"},"PeriodicalIF":9.0,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142963746","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}