BMJ Evidence-Based Medicine最新文献

{"title":"Decision architecture randomisation: extremely efficient clinical trials that preserve clinician and patient choice?","authors":"James Flory, Jessica S Ancker, Scott Yung Ho Kim, Gilad Kuperman, Andrew Vickers","doi":"10.1136/bmjebm-2023-112386","DOIUrl":"10.1136/bmjebm-2023-112386","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":"9841305","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":"Towards transparency: adoption of WHO best practices in clinical trial registration and reporting among top medical research funders in the USA.","authors":"Elise Gamertsfelder, Netzahualpilli Delgado Figueroa, Sarai Keestra, Alan Rossi Silva, Ronak Borana, Maximilian Siebert, Till Bruckner","doi":"10.1136/bmjebm-2023-112395","DOIUrl":"10.1136/bmjebm-2023-112395","url":null,"abstract":"<p><strong>Objective: </strong>To assess to what extent the clinical trial policies of the largest public and philanthropic funders of clinical research in the United States meet WHO best practices in trial registration and reporting.</p><p><strong>Methods: </strong>Public and philanthropic funders of clinical trials in the USA with >US$50 million annual spend were selected. The funders were assessed using an 11-item scoring tool based on WHO Joint Statement benchmarks. These 11 items fell into 4 categories, namely: trial registration, academic publication, monitoring and sanctions. An additional item captured whether and how funders referred to Consolidated Standards of Reporting Trials (CONSORT) within their trial policies. Each funder was independently assessed by two or three researchers. Funders were contacted to flag possible errors and omissions. Ambiguous or difficult-to-score items were settled by an independent adjudicator.</p><p><strong>Results: </strong>Fourteen funders were assessed. Our cross-sectional study found that, on average, funders have only implemented 4.1/11 (37%) of WHO best practices in clinical trial transparency. The most frequently adopted requirement was open access publishing (14/14 funders). The least frequently adopted were (1) requiring trial ID to appear in all publications (2/14 funders, 14%) and (2) making compliance reports public (2/14 funders, 14%). Public funders, on average, adopted more policy elements (5.2/11 items, 47%) than philanthropic funders (2.8/11 items, 25%). Only one funder's policy documents mentioned the CONSORT statement.</p><p><strong>Conclusions: </strong>There is a significant variation between the number of best practice policy items adopted by medical research funders in the USA. Many funders fell significantly short of WHO Joint Statement benchmarks. Each funder could benefit from policy revision and strengthening.</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":"71477843","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":"The Six Steps of SDM: linking theory to practice, measurement and implementation.","authors":"Marla L Clayman, Fülöp Scheibler, Jens Ulrich Rüffer, Kai Wehkamp, Friedemann Geiger","doi":"10.1136/bmjebm-2023-112289","DOIUrl":"10.1136/bmjebm-2023-112289","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":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10982624/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10226367","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":"Reducing the residue of retractions in evidence synthesis: ways to minimise inappropriate citation and use of retracted data.","authors":"Caitlin Bakker, Stephanie Boughton, Clovis Mariano Faggion, Daniele Fanelli, Kathryn Kaiser, Jodi Schneider","doi":"10.1136/bmjebm-2022-111921","DOIUrl":"10.1136/bmjebm-2022-111921","url":null,"abstract":"<p><p>The incorporation of publications that have been retracted is a risk in reliable evidence synthesis. Retraction is an important mechanism for correcting the literature and protecting its integrity. Within the medical literature, the continued citation of retracted publications occurs for a variety of reasons. Recent evidence suggests that systematic reviews and meta-analyses often unwittingly cite retracted publications which, at least in some cases, may significantly impact quantitative effect estimates in meta-analyses. There is strong evidence that authors of systematic reviews and meta-analyses may be unaware of the retracted status of publications and treat them as if they are not retracted. These problems are difficult to address for several reasons: identifying retracted publications is important but logistically challenging; publications may be retracted while a review is in preparation or in press and problems with a publication may also be discovered after the evidence synthesis is published. We propose a set of concrete actions that stakeholders (eg, scientists, peer-reviewers, journal editors) might take in the near-term, and that research funders, citation management systems, and databases and search engines might take in the longer term to limit the impact of retracted primary studies on evidence syntheses.</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/PMC10982619/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9860804","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":"Catalogue of bias: racial bias.","authors":"Ramona Naicker, David Nunan","doi":"10.1136/bmjebm-2023-112400","DOIUrl":"10.1136/bmjebm-2023-112400","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":"10123560","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":"Patient-reported effects of hospital-wide implementation of shared decision-making at a university medical centre in Germany: a pre-post trial.","authors":"Fülöp Scheibler, Friedemann Geiger, Kai Wehkamp, Marion Danner, Marie Debrouwere, Constanze Stolz-Klingenberg, Anja Schuldt-Joswig, Christina Gesine Sommer, Olga Kopeleva, Claudia Bünzen, Christine Wagner-Ullrich, Gerhard Koch, Marie Coors, Felix Wehking, Marla Clayman, Christian Weymayr, Leonie Sundmacher, Jens Ulrich Rüffer","doi":"10.1136/bmjebm-2023-112462","DOIUrl":"10.1136/bmjebm-2023-112462","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the feasibility and effectiveness of the SHARE TO CARE (S2C) programme, a complex intervention designed for hospital-wide implementation of shared decision-making (SDM).</p><p><strong>Design: </strong>Pre-post study.</p><p><strong>Setting: </strong>University Hospital Schleswig-Holstein (UKSH), Kiel Campus.</p><p><strong>Participants: </strong>Healthcare professionals as well as inpatients and outpatients from 22 departments of the Kiel Campus of UKSH.</p><p><strong>Interventions: </strong>The S2C programme is a comprehensive implementation strategy including four core modules: (1) physician training, (2) SDM support training for and support by nurses as decision coaches, (3) patient activation and (4) evidence-based patient decision aid development and integration into patient pathways. After full implementation, departments received the S2C certificate.</p><p><strong>Main outcome measures: </strong>In this paper, we report on the feasibility and effectiveness outcomes of the implementation. Feasibility was judged by the degree of implementation of the four modules of the programme. Outcome measures for effectiveness are patient-reported experience measures (PREMs). The primary outcome measure for effectiveness is the Patient Decision Making subscale of the Perceived Involvement in Care Scale (PICS_PDM). Pre-post comparisons were done using t-tests.</p><p><strong>Results: </strong>The implementation of the four components of the S2C programme was able to be completed in 18 of the 22 included departments within the time frame of the study. After completion of implementation, PICS_PDM showed a statistically significant difference (p<0.01) between the means compared with baseline. This difference corresponds to a small to medium yet clinically meaningful positive effect (Hedges' g=0.2). Consistent with this, the secondary PREMs (Preparation for Decision Making and collaboRATE) also showed statistically significant, clinically meaningful positive effects.</p><p><strong>Conclusions: </strong>The hospital-wide implementation of SDM with the S2C-programme proved to be feasible and effective within the time frame of the project. The German Federal Joint Committee has recommended to make the Kiel model of SDM a national standard of care.</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/PMC10982630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"61560716","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":"Rapid reviews methods series: assessing the appropriateness of conducting a rapid review.","authors":"Chantelle Garritty, Barbara Nussbaumer-Streit, Candyce Hamel, Declan Devane","doi":"10.1136/bmjebm-2023-112722","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112722","url":null,"abstract":"<p><p>This paper, part of the Cochrane Rapid Review Methods Group series, offers guidance on determining when to conduct a rapid review (RR) instead of a full systematic review (SR). While both review types aim to comprehensively synthesise evidence, RRs, conducted within a shorter time frame of typically 6 months or less, involve streamlined methods to expedite the process. The decision to opt for an RR depends on the urgency of the research question, resource availability and the impact on decision outcomes. The paper categorises scenarios where RRs are appropriate, including urgent decision-making, informing guidelines, assessing new technologies and identifying evidence gaps. It also outlines instances when RRs may be inappropriate, cautioning against conducting them solely for ease, quick publication or only cost-saving motives.When deciding on an RR, it is crucial to consider both conceptual and practical factors. These factors encompass the urgency of needing timely evidence, the consequences of waiting for a full SR, the potential risks associated with incomplete evidence, and the risk of not using synthesised evidence in decision-making, among other considerations. Key factors to weigh also include having a clearly defined need, a manageable scope and access to the necessary expertise. Overall, this paper aims to guide informed judgements about whether to choose an RR over an SR based on the specific research question and context. Researchers and decision-makers are encouraged to carefully weigh potential trade-offs when opting for RRs.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140130641","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":"Making an organisation for health technology assessment: lessons from India.","authors":"Victoria Y Fan, Abha Mehndiratta, Jubilee Ahazie","doi":"10.1136/bmjebm-2023-112484","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112484","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140130615","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":"Quantifying the time-varying association between objectively measured physical activity and mortality in US older adults over a 12-year follow-up period: the NHANES 2003-2006 study.","authors":"Neha Agarwala, Vadim Zipunnikov, Ciprian Crainiceanu, Andrew Leroux","doi":"10.1136/bmjebm-2023-112303","DOIUrl":"10.1136/bmjebm-2023-112303","url":null,"abstract":"<p><p>Objectively measuring physical activity (PA) has consistently shown an association with reduced all-cause mortality risk in cross-sectional studies. However, the strength of this association may change over time. We quantify the time-varying, covariate-adjusted association between the total volume of PA and all-cause mortality over a 12-year follow-up period using Cox regression with a time varying effect of population-referenced quantile total activity count adjusted for traditional risk factors. Analyses focus on participants 50-84 years old with adequate accelerometer wear time and without missing covariates. The findings suggest that (1) the use of baseline PA in Cox models with long follow-up periods may be inappropriate without time-varying effects and (2) the use of accelerometry derived volume of PA in risk score calculations may be most appropriate for short-term to medium-term risk scores.</p>","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":9.0,"publicationDate":"2024-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11390972/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140109060","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":"Measuring progress in institutionalising evidence-informed priority-setting in the Indian healthcare system: an application using the iProSE scale.","authors":"Adrian Gheorghe, Abha Mehndiratta, Peter Baker, Sophie Gulliver, Malkeet Singh, Kirti Tyagi, Javier Guzman","doi":"10.1136/bmjebm-2023-112485","DOIUrl":"https://doi.org/10.1136/bmjebm-2023-112485","url":null,"abstract":"","PeriodicalId":9059,"journal":{"name":"BMJ Evidence-Based Medicine","volume":null,"pages":null},"PeriodicalIF":5.8,"publicationDate":"2024-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140064786","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}