{"title":"Ending nuclear weapons, before they end us.","authors":"Chris Zielinski","doi":"10.1136/bmjebm-2025-113922","DOIUrl":"https://doi.org/10.1136/bmjebm-2025-113922","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144075873","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}
Xufei Luo, Yih Chung Tham, Mauro Giuffrè, Robert Ranisch, Mohammad Daher, Kyle Lam, Alexander Viktor Eriksen, Che-Wei Hsu, Akihiko Ozaki, Fabio Ynoe de Moraes, Sahil Khanna, Kuan-Pin Su, Emir Begagić, Zhaoxiang Bian, Yaolong Chen, Janne Estill
{"title":"Reporting guideline for the use of Generative Artificial intelligence tools in MEdical Research: the GAMER Statement.","authors":"Xufei Luo, Yih Chung Tham, Mauro Giuffrè, Robert Ranisch, Mohammad Daher, Kyle Lam, Alexander Viktor Eriksen, Che-Wei Hsu, Akihiko Ozaki, Fabio Ynoe de Moraes, Sahil Khanna, Kuan-Pin Su, Emir Begagić, Zhaoxiang Bian, Yaolong Chen, Janne Estill","doi":"10.1136/bmjebm-2025-113825","DOIUrl":"https://doi.org/10.1136/bmjebm-2025-113825","url":null,"abstract":"<p><strong>Objectives: </strong>Generative artificial intelligence (GAI) tools can enhance the quality and efficiency of medical research, but their improper use may result in plagiarism, academic fraud and unreliable findings. Transparent reporting of GAI use is essential, yet existing guidelines from journals and institutions are inconsistent, with no standardised principles.</p><p><strong>Design and setting: </strong>International online Delphi study.</p><p><strong>Participants: </strong>International experts in medicine and artificial intelligence.</p><p><strong>Main outcome measures: </strong>The primary outcome measure is the consensus level of the Delphi expert panel on the items of inclusion criteria for GAMER (Rreporting guideline for the use of Generative Artificial intelligence tools in MEdical Research).</p><p><strong>Results: </strong>The development process included a scoping review, two Delphi rounds and virtual meetings. 51 experts from 26 countries participated in the process (44 in the Delphi survey). The final checklist comprises nine reporting items: general declaration, GAI tool specifications, prompting techniques, tool's role in the study, declaration of new GAI model(s) developed, artificial intelligence-assisted sections in the manuscript, content verification, data privacy and impact on conclusions.</p><p><strong>Conclusion: </strong>GAMER provides universal and standardised guideline for GAI use in medical research, ensuring transparency, integrity and quality.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972178","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}
Malkeet Singh, Abha Mehndiratta, Manuel Antonio Espinoza, Shankar Prinja, Ursula Giedion
{"title":"Prioritisation of candidates for HTA: insights from the Indian healthcare landscape.","authors":"Malkeet Singh, Abha Mehndiratta, Manuel Antonio Espinoza, Shankar Prinja, Ursula Giedion","doi":"10.1136/bmjebm-2023-112566","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112566","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969812","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}
Matthew G Wilson, Folkert W Asselbergs, Nausheen Saleem, Lelia Jeilani, David Brealey, Matthew R Sydes, Steve Harris
{"title":"Digital integration of research conduct into clinical care: results of the PROSPECTOR randomised feasibility study.","authors":"Matthew G Wilson, Folkert W Asselbergs, Nausheen Saleem, Lelia Jeilani, David Brealey, Matthew R Sydes, Steve Harris","doi":"10.1136/bmjebm-2024-113081","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113081","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the feasibility of conducting a clinically integrated randomised comparative effectiveness trial using digital clinical trial infrastructure within an electronic patient record (EPR).</p><p><strong>Design: </strong>A mixed-methods, unblinded, feasibility study of digital clinical trial system incorporating testing of two designs of electronic point-of-care randomisation prompt.</p><p><strong>Setting: </strong>The study was conducted at University College London Hospitals NHS Trust between March and November 2022. The study used a real clinical research question for context, comparing liberal vs restrictive strategies for magnesium supplementation to prevent new-onset atrial fibrillation in critical care.</p><p><strong>Participants: </strong>Adult patients undergoing elective, non-cardiac surgical procedures expecting postoperative admission to critical care were recruited.</p><p><strong>Interventions: </strong>A digital trial system screened participants continuously against eligibility criteria. Participants were automatically randomised (1:1) to (1) magnesium supplementation strategy and (2) one of two electronic randomisation prompt designs (nudge or preference).Electronic point-of-care randomisation prompts displayed to clinicians at regular intervals, inviting them to follow a randomised magnesium supplementation suggestion.</p><p><strong>Main outcome measures: </strong>The primary outcome measure was a composite determination of study design feasibility (including recruitment, technical performance and concordance between the randomised suggestion and the observed clinician action).</p><p><strong>Results: </strong>23 patients were recruited and 11 successfully randomised. The implemented digital systems for automated eligibility screening, randomisation, data collection and follow-up demonstrated technical feasibility. 47 electronic point-of-care randomisation prompts successfully deployed across 11 patients. Clinician actions were concordant with randomised suggestions in 32 prompts (68%).Technical and implementational barriers to delivering the electronic point-of-care randomisation prompts were identified. Patients were followed up to 30 days following discharge from hospital, with no serious adverse events attributable to participation identified.There was insufficient data to make a quantitative determination on the superiority of either prompt design. Clinician feedback suggested the simplified design (nudge) had greater utility.</p><p><strong>Conclusions: </strong>This study demonstrates that digitally embedding clinical trial infrastructure into a site-level EPR and integrating conduct into clinical care is safe and feasible. Future work will focus on improving and expanding the integrated digital trial design across multiple centres.</p><p><strong>Trial registration number: </strong>NCT05149820.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964069","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}
Julia Hirschwald, Paul Conroy, Gary Boyle, Tobias Warnecke, Margaret Walshe
{"title":"Developing a core outcome set for dysphagia interventions in Parkinson's disease: an international Delphi consensus study.","authors":"Julia Hirschwald, Paul Conroy, Gary Boyle, Tobias Warnecke, Margaret Walshe","doi":"10.1136/bmjebm-2024-113543","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113543","url":null,"abstract":"<p><strong>Objectives: </strong>To develop a core outcome set (COS) for oropharyngeal dysphagia (swallowing disorder) interventions in Parkinson's disease by agreeing core outcomes and definitions, outcome measurement instruments (OMIs) and time points of measurement for these core outcomes.</p><p><strong>Design: </strong>International online Delphi survey and consensus meetings.</p><p><strong>Participants: </strong>Individuals living with oropharyngeal dysphagia and Parkinson's disease, family members and caregivers, healthcare professionals and researchers in the field of oropharyngeal dysphagia and Parkinson's disease.</p><p><strong>Methods: </strong>A long list of outcomes was generated previously through scoping reviews, online surveys and focus groups with key stakeholders. Building on this, an international three-round online Delphi survey was conducted where participants rated the importance of outcomes. In subsequent online consensus meetings, core outcomes, their definitions, OMIs and time points of measurement were agreed on.</p><p><strong>Results: </strong>90 participants from 21 countries completed all three rounds of the Delphi survey. Of these, 35 participated in a consensus meeting. Six outcomes were agreed as the core outcomes: 'penetration/aspiration', 'aspiration pneumonia', 'choking', 'oropharyngeal dysphagia severity', 'swallowing related quality of life' and 'post swallow pharyngeal residue'.</p><p><strong>Conclusions: </strong>The use of a COS in future oropharyngeal dysphagia intervention studies in Parkinson's disease will facilitate comparative effectiveness research and ensure that outcomes are relevant to all key stakeholders. This should help improve the evidence base for oropharyngeal dysphagia interventions in Parkinson's disease.</p><p><strong>Registration: </strong>The study was registered prospectively with the Core Outcome Measures in Effectiveness Trials Database on 24 September 2021 (www.comet-initiative.org, registration number: 1942).</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143975690","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}
Yuting Duan, Pinge Zhao, Shujuan Liu, Siqi Wu, Yuening Deng, Zhirui Xu, Xinyu Li, Lin Shi, Yao Wu, Yuejuan Cai, Feng Jiang, Lin Yu
{"title":"Patient-reported outcomes and acupuncture-related adverse events are overlooked in acupuncture randomised controlled trials: a cross-sectional meta-epidemiological study.","authors":"Yuting Duan, Pinge Zhao, Shujuan Liu, Siqi Wu, Yuening Deng, Zhirui Xu, Xinyu Li, Lin Shi, Yao Wu, Yuejuan Cai, Feng Jiang, Lin Yu","doi":"10.1136/bmjebm-2024-113497","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113497","url":null,"abstract":"<p><strong>Objectives: </strong>To investigate the patient-reported outcomes (PROs) and acupuncture-related adverse events (A-AEs) in acupuncture randomised controlled trials (RCTs).</p><p><strong>Design: </strong>Cross-sectional meta-epidemiological study.</p><p><strong>Data sources: </strong>We comprehensively searched for eligible studies between 1 January 2014 and 1 May 2024, in MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang Data and VIP Database.</p><p><strong>Eligibility criteria: </strong>RCTs that used acupuncture as the intervention group to obtain the efficacy and/or safety of acupuncture therapy. Acupuncture therapy should be based on Traditional Medicine theory.</p><p><strong>Main outcome measures: </strong>We assessed (1) the general characteristics of acupuncture RCTs; (2) the general characteristics of PROs; (3) the reporting scores of PROs by the Extension of Consolidated Standards of Reporting Trials of Patient-Reported Outcomes (CONSORT PRO Extension); (4) the general characteristic of A-AEs; (5) the incidence of A-AEs.</p><p><strong>Results: </strong>We included 476 studies in this study. 296 (62.2%) used PROs as study outcomes, 272 (57.1%) reported safety outcomes. The Visual Analogue Scale (149, 23.7%) and the Pittsburgh Sleep Quality Index (42, 6.7%) were the most common PROs reported. The reporting of PROs was incomplete, with sufficiently reporting scores ranging from 2.7% to 97.6% across the CONSORT PRO Extension. 164 studies reported A-AEs, of which 141 reported specific details, and we found that the OR for the incidence of AEs in the acupuncture group compared to the control group was 1.434 (95% CI 1.148 to 1.793). We identified 1277 reports of A-AEs in eligible studies, predominantly tissue injury (eg, haematoma, bleeding), irritation (eg, pain, post-acupuncture discomfort), with no reports of serious A-AEs. The reporting of A-AEs lacked details on the acquisition methods (15.5%), occurrence time (5.5%), A-AEs' treatment (18.1%) and A-AEs' recovery (19.7%). Studies that reported funding, registry information, acupuncturist qualifications and non-significant primary outcomes were associated with the A-AEs' reporting, and the difference was statistically significant (p≤0.05).</p><p><strong>Conclusion: </strong>This study found that the reporting of PROs and A-AEs was insufficient in acupuncture RCTs. Future studies should clarify the clinical significance of using PROs as outcomes and report AEs comprehensively to provide patients with sufficient information on the benefits and harms of acupuncture treatments.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143973990","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":"Time deficiency: an affliction of healthcare systems and how to ameliorate it.","authors":"Stephen H Bradley, Victor M Montori","doi":"10.1136/bmjebm-2024-113455","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113455","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959396","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}
Sophie Juul, Pascal Faltermeier, Faiza Siddiqui, Johanne Juul Petersen, Caroline Barkholt Kamp, Rikke Hermann Jakobsen, Lehana Thabane, Joanna Moncrieff, Mark Horowitz, Zainab Samaan, Michael Pascal Hengartner, Lawrence Mbuagbaw, Markus Harboe Olsen, Christian Gluud, Janus Christian Jakobsen
{"title":"Challenges in the selection and measurement of outcomes in psychiatric trials.","authors":"Sophie Juul, Pascal Faltermeier, Faiza Siddiqui, Johanne Juul Petersen, Caroline Barkholt Kamp, Rikke Hermann Jakobsen, Lehana Thabane, Joanna Moncrieff, Mark Horowitz, Zainab Samaan, Michael Pascal Hengartner, Lawrence Mbuagbaw, Markus Harboe Olsen, Christian Gluud, Janus Christian Jakobsen","doi":"10.1136/bmjebm-2024-113171","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-113171","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967720","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}
Fiona Campbell, Anthea Sutton, Danielle Pollock, Chantelle Garritty, Andrea C Tricco, Lena Schmidt, Hanan Khalil
{"title":"Rapid reviews methods series: guidance on rapid scoping, mapping and evidence and gap map ('Big Picture Reviews').","authors":"Fiona Campbell, Anthea Sutton, Danielle Pollock, Chantelle Garritty, Andrea C Tricco, Lena Schmidt, Hanan Khalil","doi":"10.1136/bmjebm-2023-112389","DOIUrl":"10.1136/bmjebm-2023-112389","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143188195","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}