Dongmei Zhong, Nan Yang, Yaolong Chen, Dong Roman Xu
{"title":"Overcoming challenges in the implementation of clinical practice guidelines in China.","authors":"Dongmei Zhong, Nan Yang, Yaolong Chen, Dong Roman Xu","doi":"10.1136/bmjebm-2024-112896","DOIUrl":"https://doi.org/10.1136/bmjebm-2024-112896","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142457702","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}
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
{"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":"https://doi.org/10.1136/bmjebm-2024-113028","url":null,"abstract":"<p><strong>Background: </strong>Widespread use of respiratory protection masks has become a critical component of public health response.</p><p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":""},"PeriodicalIF":9.0,"publicationDate":"2024-09-26","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}
Glyn Elwyn, Padhraig Ryan, Daniel Blumkin, William B Weeks
{"title":"Meet generative AI… your new shared decision-making assistant.","authors":"Glyn Elwyn, Padhraig Ryan, Daniel Blumkin, William B Weeks","doi":"10.1136/bmjebm-2023-112651","DOIUrl":"10.1136/bmjebm-2023-112651","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"292-295"},"PeriodicalIF":9.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141309953","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}
Kristen Pickles, Romi Haas, Michelle Guppy, Denise A O'Connor, Thanya Pathirana, Alexandra Barratt, Rachelle Buchbinder
{"title":"Clinician and health service interventions to reduce the greenhouse gas emissions generated by healthcare: a systematic review.","authors":"Kristen Pickles, Romi Haas, Michelle Guppy, Denise A O'Connor, Thanya Pathirana, Alexandra Barratt, Rachelle Buchbinder","doi":"10.1136/bmjebm-2023-112707","DOIUrl":"10.1136/bmjebm-2023-112707","url":null,"abstract":"<p><strong>Objective: </strong>To synthesise the available evidence on the effects of interventions designed to improve the delivery of healthcare that reduces the greenhouse gas (GHG) emissions of healthcare.</p><p><strong>Design: </strong>Systematic review and structured synthesis.</p><p><strong>Search sources: </strong>Cochrane Central Register of Controlled Trials, PubMed, Web of Science and Embase from inception to 3 May 2023.</p><p><strong>Selection criteria: </strong>Randomised, quasi-randomised and non-randomised controlled trials, interrupted time series and controlled or uncontrolled before-after studies that assessed interventions primarily designed to improve the delivery of healthcare that reduces the GHG emissions of healthcare initiated by clinicians or healthcare services within any setting.</p><p><strong>Main outcome measures: </strong>Primary outcome was GHG emissions. Secondary outcomes were financial costs, effectiveness, harms, patient-relevant outcomes, engagement and acceptability.</p><p><strong>Data collection and analysis: </strong>Paired authors independently selected studies for inclusion, extracted data, and assessed risk of bias using a modified checklist for observational studies and the certainty of the evidence using Grades of Recommendation, Assessment, Development and Evaluation. Data could not be pooled because of clinical and methodological heterogeneity, so we synthesised results in a structured summary of intervention effects with vote counting based on direction of effect.</p><p><strong>Results: </strong>21 observational studies were included. Interventions targeted delivery of anaesthesia (12 of 21), waste/recycling (5 of 21), unnecessary test requests (3 of 21) and energy (1 of 21). The primary intervention type was clinician education. Most (20 of 21) studies were judged at unclear or high risk of bias for at least one criterion. Most studies reported effect estimates favouring the intervention (GHG emissions 17 of 18, costs 13 of 15, effectiveness 18 of 20, harms 1 of 1 and staff acceptability 1 of 1 studies), but the evidence is very uncertain for all outcomes (downgraded predominantly for observational study design and risk of bias). No studies reported patient-relevant outcomes other than death or engagement with the intervention.</p><p><strong>Conclusions: </strong>Interventions designed to improve the delivery of healthcare that reduces GHG emissions may reduce GHG emissions and costs, reduce anaesthesia use, waste and unnecessary testing, be acceptable to staff and have little to no effect on energy use or unintended harms, but the evidence is very uncertain. Rigorous studies that measure GHG emissions using gold-standard life cycle assessment are needed as well as studies in more diverse areas of healthcare. It is also important that future interventions to reduce GHG emissions evaluate the effect on beneficial and harmful patient outcomes.</p><p><strong>Prospero registration number: </strong>CRD4","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"300-312"},"PeriodicalIF":9.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11503105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141086863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniel I Rhon, Alison F Davis, Joseph Ali, Cynthia Brandt, Amy Burns, Whitley Lucio, Robert Vining, Stacey Young-McCaughan
{"title":"Ambiguity in care delivery terminology: implications that affect pragmatic clinical trials using non-pharmacological interventions.","authors":"Daniel I Rhon, Alison F Davis, Joseph Ali, Cynthia Brandt, Amy Burns, Whitley Lucio, Robert Vining, Stacey Young-McCaughan","doi":"10.1136/bmjebm-2023-112547","DOIUrl":"10.1136/bmjebm-2023-112547","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"296-299"},"PeriodicalIF":9.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138290245","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}
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
{"title":"Can a replication revolution resolve the duplication crisis in systematic reviews?","authors":"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","doi":"10.1136/bmjebm-2022-112125","DOIUrl":"10.1136/bmjebm-2022-112125","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"285-288"},"PeriodicalIF":9.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41190865","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":"Shared decision-making and evidence-based medicine series: exploring contemporary challenges and future directions.","authors":"Paula Riganti, Tammy C Hoffmann","doi":"10.1136/bmjebm-2024-113024","DOIUrl":"10.1136/bmjebm-2024-113024","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"283-284"},"PeriodicalIF":9.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141747433","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}
Daniel Tobias Michaeli, Thomas Michaeli, Sebastian Albers, Julia Caroline Michaeli
{"title":"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.","authors":"Daniel Tobias Michaeli, Thomas Michaeli, Sebastian Albers, Julia Caroline Michaeli","doi":"10.1136/bmjebm-2023-112544","DOIUrl":"10.1136/bmjebm-2023-112544","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Design: </strong>Cross-sectional study and meta-analysis.</p><p><strong>Setting: </strong>Data from Drugs@FDA, FDA labels, ClincialTrials.gov and the Global Burden of Disease study.</p><p><strong>Participants: </strong>Pivotal trials for 170 drugs with FDA approval across 437 cancer indications between 2000 and 2022.</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":" ","pages":"333-341"},"PeriodicalIF":9.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140955606","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}