BMJ Evidence-Based Medicine最新文献

{"title":"Major UK non-commercial sponsors’ efforts to reduce research waste: a mixed-methods study","authors":"Till Bruckner, Aminul Schuster, Belén Chavarría, Carolina Cruz, Fabiola Karely Lizárraga Illán, Ronak Borana, Tungamirai Ishe Bvute, Daniel Sánchez","doi":"10.1136/bmjebm-2023-112540","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112540","url":null,"abstract":"Worldwide, a significant proportion of clinical trials end up as costly research waste because their results are never made public.1–3 The resulting gaps in the medical evidence base harm patients and undermine public health.4 The Declaration of Helsinki and the WHO both call for all clinical trial results to be made public.5 6 In the wake of a 2018 UK parliamentary enquiry, non-commercial clinical trial sponsors in the UK substantially improved outcome reporting for drug trials (Clinical Trials of Investigative Medicinal Products, CTIMPs) by uploading the summary results of many CTIMPs onto the European Union Clinical Trials Register (EUCTR) which exclusively lists drug trials. However, these efforts typically did not extend to other types of trials, which are listed on other trial registries. This study assesses the current publication status of 145 clinical trials that are not CTIMPs that were sponsored by ten major UK non-commercial sponsors and were completed or terminated in 2017, allowing a 5-year follow-up period for publication. The lead researcher (TB) identified the 10 most prolific non-commercial sponsors of clinical trials in the UK by accessing the EU Trials Tracker on 27 October 2022, employing the …","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140612327","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":"Trivalent and quadrivalent seasonal influenza vaccine in adults aged 60 and older: a systematic review and network meta-analysis","authors":"Areti Angeliki Veroniki, Sai Surabi Thirugnanasampanthar, Menelaos Konstantinidis, Jasmeen Dourka, Marco Ghassemi, Dipika Neupane, Paul Khan, Vera Nincic, Margarita Corry, Reid Robson, Amanda Parker, Charlene Soobiah, Angela Sinilaite, Pamela Doyon-Plourde, Anabel Gil, Winnie Siu, Nasheed Moqueet, Adrienne Stevens, Kelly English, Ivan D Florez, Juan J Yepes-Nuñez, Brian Hutton, Matthew Muller, Lorenzo Moja, Sharon Straus, Andrea C Tricco","doi":"10.1136/bmjebm-2023-112767","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112767","url":null,"abstract":"Objectives To compare the efficacy of influenza vaccines of any valency for adults 60 years and older. Design and setting Systematic review with network meta-analysis (NMA) of randomised controlled trials (RCTs). MEDLINE, EMBASE, JBI Evidence-Based Practice (EBP) Database, PsycINFO, and Cochrane Evidence -Based Medicine database were searched from inception to 20 June 20, 2022. Two reviewers screened, abstracted, and appraised articles (Cochrane Risk of Bias (ROB) 2.0 tool) independently. We assessed certainty of findings using Confidence in Network Meta-Analysis and Grading of Recommendations, Assessment, Development and Evaluations approaches. We performed random-effects meta-analysis and network meta-analysis (NMA), and estimated odds ratios (ORs) for dichotomous outcomes and incidence rate ratios (IRRs) for count outcomes along with their corresponding 95% confidence intervals (CIs) and prediction intervals. Participants Older adults (≥60 years old) receiving an influenza vaccine licensed in Canada or the USA (vs placebo, no vaccine, or any other licensed vaccine), at any dose. Main outcome measures Laboratory-confirmed influenza (LCI) and influenza-like illness (ILI). Secondary outcomes were the number of vascular adverse events, hospitalisation for acute respiratory infection (ARI) and ILI, inpatient hospitalisation, emergency room (ER) visit for ILI, outpatient visit, and mortality, among others. Results We included 41 RCTs and 15 companion reports comprising 8 vaccine types and 206 032 participants. Vaccines may prevent LCI compared with placebo, with high-dose trivalent inactivated influenza vaccine (IIV3-HD) (NMA: 9 RCTs, 52 202 participants, OR 0.23, 95% confidence interval (CI) (0.11 to 0.51), low certainty of evidence) and recombinant influenza vaccine (RIV) (OR 0.25, 95%CI (0.08 to 0.73), low certainty of evidence) among the most efficacious vaccines. Standard dose trivalent IIV3 (IIV3-SD) may prevent ILI compared with placebo, but the result was imprecise (meta-analysis: 2 RCTs, 854 participants, OR 0.39, 95%CI (0.15 to 1.02), low certainty of evidence). Any HD was associated with prevention of ILI compared with placebo (NMA: 9 RCTs, 65 658 participants, OR 0.38, 95%CI (0.15 to 0.93)). Adjuvanted quadrivalent IIV (IIV4-Adj) may be associated with the least vascular adverse events, but the results were very uncertain (NMA: eight 8 RCTs, 57 677 participants, IRR 0.18, 95%CI (0.07 to 0.43), very low certainty of evidence). RIV on all-cause mortality may be comparable to placebo (NMA: 20 RCTs, 140 577 participants, OR 1.01, 95%CI (0.23 to 4.49), low certainty of evidence). Conclusions This systematic review demonstrated efficacy associated with IIV3-HD and RIV vaccines in protecting older persons against LCI. RIV vaccine may reduce all-cause mortality when compared with other vaccines, but the evidence is uncertain. Differences in efficacy between influenza vaccines remain uncertain with very low to moderate certainty of evidence. PROS","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140561447","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":"A call for community-shared decisions","authors":"Jason N Doctor, Daniella Meeker, Craig R Fox, Stephen D Persell, Zachary Wagner, Kathryn E Bouskill, Kyle A Zanocco, Robert J Romanelli, Chad M Brummett, Allison Kirkegaard, Katherine E Watkins","doi":"10.1136/bmjebm-2023-112641","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112641","url":null,"abstract":"Shared decision-making in medicine is widely viewed as a collaboration between the patient and the clinician. For example, Montori et al state, ‘The patient and clinician must collaborate to arrive at a useful formulation of the problem’.1 Patients are encouraged to evaluate care choices in light of the benefits and harms of each, state their preferences and identify the best course of action along with their doctor.2 Despite its broad reach, shared decision-making solely between a patient and doctor has clear limits. Over 30 years ago, Brock and Wartman cautioned that ‘[p]atients do not have an unqualified right to make even rational individual choices that risk serious harm to others’.3 Elywin et al noted that ‘limits on shared decision-making will occur when… wider interests overrule individual wishes’.4 These authors lay out problems with shared decisions for antibiotics, opioids and vaccine hesitancy. A crucial gap is how to address these problems in practice. Antibiotic-resistant bacterial infections, overdoses from diverted opioid pills and the resurgence of measles are all medical problems that affect an individual through actions others in the community have taken. Here cooperation has either failed or has not been attempted at all. Lack of cooperation occurs when individuals believe it is in their best interest to deviate from the action that they would like others to take.5 While various forms of cooperative behaviour exist in the wild (eg, a large number of individuals choose to recycle, vote, tip at restaurants and donate to charity),5 there are barriers to cooperation in medicine that require special attention. Two of the biggest barriers are a lack of awareness that cooperation is needed and the implementation of approaches to encourage cooperation. To address barriers, community members benefit from working towards a resolution on a common strategy that …","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140561446","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":"Teaching evidence-based medicine by using a systematic review framework: implementation in a Swedish university setting.","authors":"Maria Björklund, Martin Ringsten, Matteo Bruschettini, Martin Garwicz","doi":"10.1136/bmjebm-2023-112607","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112607","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140304827","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":"Can the HEARTS initiative reduce the burden of cardiovascular disease?","authors":"Martin O'Flaherty, Nikkil Sudharsanan, Chris Kypridemos","doi":"10.1136/bmjebm-2023-112590","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112590","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140189487","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":"Visualisation of evidence for shared decision making.","authors":"Marie-Anne Durand, Kevin Selby, Yasmina Okan","doi":"10.1136/bmjebm-2023-112565","DOIUrl":"10.1136/bmjebm-2023-112565","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134648383","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":"Does the format of result presentation and type of conclusion in Cochrane plain language summaries matter? A randomised controlled trial.","authors":"V Prakash, Kirti Gore, Gunjan Shukla, Priyanshi Tapiawala, Smit Thakkar","doi":"10.1136/bmjebm-2023-112433","DOIUrl":"10.1136/bmjebm-2023-112433","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to investigate whether the format and type of conclusion in Cochrane plain language summaries (PLSs) influence readers' perception of treatment benefit and decision-making.</p><p><strong>Design: </strong>An online parallel group, three-arm randomised controlled trial was conducted.</p><p><strong>Setting: </strong>The study was conducted online.</p><p><strong>Participants: </strong>The participants were physiotherapy students.</p><p><strong>Interventions: </strong>The participants read two Cochrane PLSs, one with a positive conclusion (strong evidence of benefit) and another with a negative conclusion (strong evidence of non-benefit). Each participant read the results of both reviews presented in one of three formats: (1) numerical, (2) textual or (3) numerical and textual.</p><p><strong>Main outcome measures: </strong>The primary outcome measure was the participants' perception of treatment benefit.</p><p><strong>Results: </strong>All three groups of participants perceived the treatment to have positive effects when the Cochrane PLS had a positive conclusion, regardless of the format of presentation (mean perception of treatment benefit score: textual 7.7 (SD 2.3), numerical 7.9 (SD 1.8), numerical and textual 7.7 (SD 1.7), p=0.362). However, when the Cochrane PLS had a negative conclusion, all three groups of participants failed to perceive a negative effect (mean perception of treatment benefit score: textual 5.5 (SD 3.3), numerical 5.6 (SD 2.7), numerical and textual 5.9 (SD 2.8), p=0.019).</p><p><strong>Conclusions: </strong>The format of Cochrane PLSs does not appear to significantly impact physiotherapy students' perception of treatment benefit, understanding of evidence, persuasiveness or confidence in their decision. However, participants' perception of treatment benefit does not align with the conclusion when the Cochrane PLS indicates strong evidence of non-benefit from the intervention.</p><p><strong>Trial registration number: </strong>CTRI/2022/10/046476.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50160610","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":"Talk to me, but rather: talk to each other.","authors":"Marloes Keeris","doi":"10.1136/bmjebm-2023-112653","DOIUrl":"10.1136/bmjebm-2023-112653","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72013432","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":"When does the placebo effect have an impact on network meta-analysis results?","authors":"Adriani Nikolakopoulou, Anna Chaimani, Toshi A Furukawa, Theodoros Papakonstantinou, Gerta Rücker, Guido Schwarzer","doi":"10.1136/bmjebm-2022-112197","DOIUrl":"10.1136/bmjebm-2022-112197","url":null,"abstract":"<p><p>The placebo effect is the 'effect of the simulation of treatment that occurs due to a participant's belief or expectation that a treatment is effective'. Although the effect might be of little importance for some conditions, it can have a great role in others, mostly when the evaluated symptoms are subjective. Several characteristics that include informed consent, number of arms in a study, the occurrence of adverse events and quality of blinding may influence response to placebo and possibly bias the results of randomised controlled trials. Such a bias is inherited in systematic reviews of evidence and their quantitative components, pairwise meta-analysis (when two treatments are compared) and network meta-analysis (when more than two treatments are compared). In this paper, we aim to provide red flags as to when a placebo effect is likely to bias pairwise and network meta-analysis treatment effects. The classic paradigm has been that placebo-controlled randomised trials are focused on estimating the treatment effect. However, the magnitude of placebo effect itself may also in some instances be of interest and has also lately received attention. We use component network meta-analysis to estimate placebo effects. We apply these methods to a published network meta-analysis, examining the relative effectiveness of four psychotherapies and four control treatments for depression in 123 studies.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10982636/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9698305","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}

{"title":"Dynamic intervention strategies await inclusion in clinical evidence synthesis.","authors":"Ting Pan, Peiming Zhang","doi":"10.1136/bmjebm-2023-112618","DOIUrl":"10.1136/bmjebm-2023-112618","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49674196","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}