NEJM evidence最新文献

{"title":"Host-Directed Therapies for Posttuberculosis Lung Disease.","authors":"Akshay N Gupte, Edward A Nardell","doi":"10.1056/EVIDe2400181","DOIUrl":"https://doi.org/10.1056/EVIDe2400181","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 9","pages":"EVIDe2400181"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142074660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How Factorial Design Works.","authors":"Suellen Li, Juned Siddique, Emily Ling, Daniel Muller, C Corey Hardin, Chana A Sacks","doi":"10.1056/EVIDstat2400279","DOIUrl":"https://doi.org/10.1056/EVIDstat2400279","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 9","pages":"EVIDstat2400279"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142074661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Case for Access to Data Monitoring Committee Charters.","authors":"Deborah Zarin, Janet T Wittes, Thomas R Fleming, Frank Rockhold, Susan Ellenberg, David L DeMets","doi":"10.1056/EVIDctw2400058","DOIUrl":"10.1056/EVIDctw2400058","url":null,"abstract":"<p><p>AbstractClinical trials investigating novel or high-risk interventions often use data monitoring committees (DMCs) to ensure that the participants' best interests are safeguarded. The typical DMC charter describes procedures by which the DMC operates, including important details concerning organizational structure, membership, meeting frequency, statistical monitoring guidelines, and contents of DMC reports for interim review. These charters, however, are not routinely publicly available; in some cases, their access could be important to the interpretation of trial results. We recommend including DMC charters for such trials in ClinicalTrials.gov at the time of trial completion; trial protocols, informed consent documents, and statistical analysis plans are already available in this repository.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 9","pages":"EVIDctw2400058"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142074665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intensive Glucose Control in Critically Ill Patients - How Low Do We Go?","authors":"Shohinee Sarma","doi":"10.1056/EVIDe2400196","DOIUrl":"https://doi.org/10.1056/EVIDe2400196","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 8","pages":"EVIDe2400196"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141749882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A 53-Year-Old Woman with Axillary Lymphadenopathy.","authors":"Liem Pham, Javier Gomez Farias, Jennifer Bacci, Asina Wahab, Anish Nihalani","doi":"10.1056/EVIDmr2400040","DOIUrl":"https://doi.org/10.1056/EVIDmr2400040","url":null,"abstract":"<p><p>AbstractMorning Report is a time-honored tradition where physicians-in-training present cases to their colleagues and clinical experts to collaboratively examine an interesting patient presentation. The Morning Report section seeks to carry on this tradition by presenting a patient's chief concern and story, inviting the reader to develop a differential diagnosis and discover the diagnosis alongside the authors of the case. This report examines the story of a 53-year-old woman with a history of breast cancer who presented with abnormal axillary lymph nodes detected on surveillance imaging. Using history, physical examination, and diagnostic workup, an illness script for her presentation emerges. A differential diagnosis is developed and refined until a final diagnosis is confirmed.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 8","pages":"EVIDmr2400040"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141749876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Exchange about \"Population-Based Disease Odds for E-Cigarettes and Dual Use versus Cigarettes\".","authors":"","doi":"10.1056/EVIDe2400220","DOIUrl":"https://doi.org/10.1056/EVIDe2400220","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 8","pages":"EVIDe2400220"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141749878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Operative versus Nonoperative Treatment of Proximal Hamstring Avulsions.","authors":"Elsa Pihl, Sofia Laszlo, Anne-Mari Rosenlund, Målfrid Holen Kristoffersen, Jörg Schilcher, Carl Johan Hedbeck, Mikael Skorpil, Chiara Micoli, Martin Eklund, Olof Sköldenberg, Frede Frihagen, Kenneth B Jonsson","doi":"10.1056/EVIDoa2400056","DOIUrl":"10.1056/EVIDoa2400056","url":null,"abstract":"<p><strong>Background: </strong>Operative treatment is widely used for acute proximal hamstring avulsions, but its effectiveness compared with that of nonoperative treatment has not been shown in randomized trials.</p><p><strong>Methods: </strong>In this noninferiority trial at 10 centers in Sweden and Norway, we enrolled patients 30 to 70 years of age with a proximal hamstring avulsion in a randomized trial and a parallel observational cohort. Treatments were operative reinsertion of the tendons or nonoperative management. The primary end point was the Perth Hamstring Assessment Tool (PHAT) at 2 years of follow-up. Secondary outcomes included scores on the Lower Extremity Functional Scale (LEFS).</p><p><strong>Results: </strong>A total of 119 patients were enrolled in the randomized trial and 97 patients in the observational cohort. In the per-protocol analysis of the randomized trial, the mean (±standard deviation) PHAT scores were 79.9±19.5 and 78.5±19.4 in the operative and nonoperative groups, respectively (PHAT scores range from 0 to 100, with higher scores indicating higher function). The prespecified noninferiority limit of 10 points was not crossed (mean difference, -1.2; 95% confidence interval [CI], -8.6 to 6.2; P=0.009 for noninferiority). Analyses of secondary outcomes, including a mean difference in the LEFS score of -1.6 (95% CI, -5.2 to 2.0), aligned with the primary outcome. The observed numbers of adverse events in the randomized trial were nine in the operative group versus three in the nonoperative group (odds ratio, 0.3; 95% CI, 0.1 to 1.2). In the analysis of the observational cohort, the mean PHAT score difference between the nonoperative and operative treatment groups was -2.6 (95% CI, -9.9 to 4.6).</p><p><strong>Conclusions: </strong>In patients 30 to 70 years of age with proximal hamstring avulsions, nonoperative treatment was noninferior to operative treatment. (Funded by Afa Försäkring and others; ClinicalTrials.gov number, NCT03311997.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":" ","pages":"EVIDoa2400056"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141636046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"TAILORing Estimates of Late Breast Cancer Recurrence with the RSClin Tool.","authors":"William R Gwin, Nancy E Davidson","doi":"10.1056/EVIDe2400191","DOIUrl":"https://doi.org/10.1056/EVIDe2400191","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 8","pages":"EVIDe2400191"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141749884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acute Proximal Hamstring Tear - Who Will Benefit from Surgical Intervention?","authors":"Maegan Shields, Tim Dwyer","doi":"10.1056/EVIDe2400211","DOIUrl":"https://doi.org/10.1056/EVIDe2400211","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 8","pages":"EVIDe2400211"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141749877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical and Genomic Risk for Late Breast Cancer Recurrence and Survival.","authors":"Joseph A Sparano, Michael Crager, Robert J Gray, Gong Tang, Jess Hoag, Frederick L Baehner, Steven Shak, Della F Makower, Kathy S Albain, Daniel F Hayes, Charles E Geyer, Elizabeth C Dees, Matthew P Goetz, John A Olson, Tracy Lively, Sunil S Badve, Thomas J Saphner, Timothy J Whelan, Virginia G Kaklamani, Norman Wolmark, George W Sledge, Salomon M Stemmer","doi":"10.1056/EVIDoa2300267","DOIUrl":"10.1056/EVIDoa2300267","url":null,"abstract":"<p><strong>Background: </strong>The 21-gene recurrence score (RS) assay (Oncotype DX) is used to guide adjuvant chemotherapy use for patients with hormone receptor-positive, HER2 (human epidermal growth factor receptor 2)-negative, axillary node-negative breast cancer. Its role, however, in providing prognostic information for late distant recurrence when added to clinicopathologic prognostic factors is unknown.</p><p><strong>Methods: </strong>A patient-specific meta-analysis including 10,004 women enrolled in three trials was updated using extended follow-up data from TAILORx, integrating the RS with histologic grade, tumor size, and age at surgery for the RSClin tool. Cox models integrating clinicopathologic factors and the RS were compared by using likelihood ratio (LR) tests. External validation of prognosis for distant recurrence in years 0 to 10 and 5 to 10 was performed in an independent cohort of 1098 women in a real-world registry.</p><p><strong>Results: </strong>RSClin provided significantly more prognostic information than either the clinicopathologic factors (ΔLR chi-square, 86.2; P<0.001) or RS alone (ΔLR chi-square, 131.0; P<0.001). The model was prognostic in an independent cohort for distant recurrence by 10 years after diagnosis (standardized hazard ratio, 1.56; 95% confidence interval, 1.25 to 1.94), was associated with late distant recurrence risk between 5 and 10 years after diagnosis (standardized hazard ratio, 1.78; 95% confidence interval, 1.25 to 2.55), and approximated the observed 10-year distant recurrence risk (Lin concordance, 0.87) and 5- to 10-year distant recurrence risk (Lin concordance, 0.92).</p><p><strong>Conclusions: </strong>The 21-gene RS is prognostic for distant recurrence and overall survival in early breast cancer. A model integrating the 21-gene RS and clinicopathologic factors improved estimates of distant recurrence risk compared with either used individually and stratified late distant recurrence risk. (Funded by the National Cancer Institute, National Institutes of Health [U10CA180820, U10CA180794, UG1CA189859, U10CA180868, and U10CA180822] and others.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 8","pages":"EVIDoa2300267"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11730053/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141749879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}