NEJM evidence最新文献

{"title":"Forty Percent and Rising - Why Every Specialist Must Care about Obesity.","authors":"Christopher N Schmickl, Janna Raphelson, Atul Malhotra","doi":"10.1056/EVIDe2500054","DOIUrl":"10.1056/EVIDe2500054","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDe2500054"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12020774/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702294","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}

{"title":"How Interim Analyses Work.","authors":"Christos Kotanidis, Sarah Gorey, Daniel Müller, Kim Knoper, Adam Straus, Alison Burke, Sharon-Lise Normand, C Corey Hardin, Chana A Sacks","doi":"10.1056/EVIDstat2500047","DOIUrl":"https://doi.org/10.1056/EVIDstat2500047","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDstat2500047"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702295","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":"Preventing Surgical Site Infections with Air Purification - Lessons from the EPOS Trial.","authors":"James Masters, Andrew Hotchen","doi":"10.1056/EVIDe2500006","DOIUrl":"https://doi.org/10.1056/EVIDe2500006","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDe2500006"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702359","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 Randomized Trial of an App-Based Therapeutic for Lower Urinary Tract Symptoms.","authors":"Christian Gratzke, Sandra Schönburg, Sven Eger, Katharina Raude, Markus Grabbert, Sophie Astheimer, Jan Halbich, Dirko Hercher, Waseem Mousa, Ralph Raschke, Bastian Keck, Oleg Krivov, Erik Krieger, Kurt Miller, Laura Wiemer","doi":"10.1056/EVIDoa2400290","DOIUrl":"10.1056/EVIDoa2400290","url":null,"abstract":"<p><strong>Background: </strong>Male lower urinary tract symptoms (LUTS) increase with age and negatively impact quality of life. Conservative treatment with physiotherapeutic approaches and changes in lifestyle are often neglected. App-based therapeutics may have some benefits for patients with LUTS.</p><p><strong>Methods: </strong>In this prospective, two-center, single-blinded trial, men with LUTS were randomly assigned 1:1 to either an intervention group with access to an app-based therapeutic in addition to their usual medical care or a control group receiving only their usual medical care. The primary end point was symptom improvement (change from baseline to week 12) as measured by the International Prostate Symptom Score (IPSS; range 0 to 35, with higher scores indicating more severe symptoms; minimal clinically important difference of 3). Secondary end points included symptom improvement, as measured by the Overactive Bladder Questionnaire - Short Form part 1 (OAB-q-SF symptom bother, six items; range 6 to 36, transformed to a scale from 0 to 100, with higher scores indicating more severe symptoms), and health-related quality of life (HRQOL), as measured with the OAB-q-SF part 2 (13 items; range 13 to 78, transformed to a scale from 0 to 100 with higher scores indicating better HRQOL).</p><p><strong>Results: </strong>A total of 237 patients were randomly assigned, with seven participants subsequently dropping out. The mean age (± standard deviation [SD]) was 58.4 (12.3) years; 46.4% had benign prostatic enlargement alone, 22.4% had benign prostatic enlargement combined with overactive bladder, and 31.2% had overactive bladder alone. Compared with the control group, the intervention group showed significantly greater improvement in the primary end point (least- squares mean [LSM], -7.0 points; 95% confidence interval [CI], -8.1 to -5.9; P<0.001) and the secondary end points OAB-q-SF part 1 (symptom bother, LSM -18.; 95% CI, -22.2 to -15.0; P<0.001) and part 2 (health-related quality of life, LSM +17.2; 95% CI, 14.2 to 20.2; P<0.001). A total of 12 patients (10.7%) had at least one adverse event in the intervention group compared with five patients (4.0%) in the control group. There were five patients (4.5%) with serious adverse events (SAEs) in the intervention group and one patient (0.8%) with SAEs in the control group.</p><p><strong>Conclusions: </strong>This randomized trial demonstrated significant symptom improvement measured by the IPSS for patients with LUTS using app-based therapeutics compared with usual care. Additional symptom scores and quality of life also significantly improved in patients with LUTS with the use of app-based therapeutics. (Funded by Kranus Health GmbH; German Clinical Trials Registry number, DRKS00030935.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDoa2400290"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702281","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":"Can De-Escalation of Adjuvant Therapy Be Considered for Older Adults with Breast Cancer?","authors":"Manjeet Chadha, Julia White, Reshma Jagsi","doi":"10.1056/EVIDtt2300358","DOIUrl":"10.1056/EVIDtt2300358","url":null,"abstract":"<p><p>AbstractThe trimodal approach of lumpectomy, radiotherapy, and endocrine therapy may represent overtreatment for certain older patients with early-stage breast cancer. Treatment guidelines permit adjuvant endocrine monotherapy, based on older randomized trials comparing adjuvant endocrine therapy with radiotherapy versus without radiotherapy. There are limited data on radiotherapy with endocrine therapy versus without endocrine therapy, and therefore, the incremental benefits versus burdens of endocrine therapy, specifically in older (≥70 years of age) women with favorable-risk breast cancer are unknown. With the routine use of molecular genomic assays that identify low-risk breast cancer and advances in radiotherapy delivery that have reduced treatment burden, many older women might consider radiotherapy alone without endocrine therapy if offered. This article reviews the relevant literature and proposes a trial to inform the de-escalation of adjuvant therapy in older patients with estrogen receptor-positive, human epidermal growth factor receptor type 2-negative breast cancer.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDtt2300358"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702263","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":"Effect of Plasma Air Purifiers on Infection Rates in Orthopedic Surgery.","authors":"Anders Persson, Isam Atroshi, Thomas Tyszkiewicz, Nils P Hailer, Stergios Lazarinis, Thomas Eisler, Harald Brismar, Sebastian Mukka, Per-Juan Kernell, Maziar Mohaddes, Olof Sköldenberg, Max Gordon","doi":"10.1056/EVIDoa2400289","DOIUrl":"10.1056/EVIDoa2400289","url":null,"abstract":"<p><strong>Background: </strong>Surgical site infection (SSI) following orthopedic surgery impacts patient outcomes. Airborne transmission is one potential route of infection. Despite their high cost and resource demands, modern ventilation systems have shown limited efficacy in reducing SSI rates. This trial investigated the effectiveness of a low-cost air purifier in reducing SSI rates after orthopedic surgery.</p><p><strong>Methods: </strong>In a nationwide, multicenter, double-blind, cluster-randomized crossover, placebo-controlled superiority trial, we included all patients undergoing orthopedic surgery during the trial period. The intervention group underwent surgery in operating rooms with active Novaerus NV800 air purifiers, while the control group underwent surgery in operating rooms with the same air purifiers that were inactive. The primary end point was SSI within 12 weeks post surgery, defined as a postsurgery infection marker (PSIM), a custom composite outcome based on registry codes for prescribed antibiotics, diagnoses, and surgical procedures. Logistic regression was performed to evaluate the primary outcome.</p><p><strong>Results: </strong>Of the 40,547 patients analyzed, 19,869 were in the intervention group and 20,678 in the control group. The PSIM rate was 9.2% in the invention group, and 9.4% in the control group, with an odds ratio of 0.98 (95% confidence interval, 0.91 to 1.05) for the intervention group. This finding remained consistent across various subgroups based on diagnoses, hospital levels, and ventilation types.</p><p><strong>Conclusions: </strong>In modern operating rooms equipped with standard, midrange airflow ventilation systems, the addition of wall-mounted plasma air purifiers did not reduce the PSIM rate after orthopedic surgery. (Funded by the Swedish Research Council; grant number, 2017-00198; ClinicalTrials.gov number, NCT02695368.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDoa2400289"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702291","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":"Beyond Medications - The Promise of App-Based Digital Therapeutics for Lower Urinary Tract Symptoms.","authors":"Dean Elterman","doi":"10.1056/EVIDe2500055","DOIUrl":"https://doi.org/10.1056/EVIDe2500055","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDe2500055"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702237","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":"Instrumental Variables in Randomized Trials.","authors":"Joshua D Angrist, Carol Gao, Peter Hull, Robert W Yeh","doi":"10.1056/EVIDctw2400204","DOIUrl":"10.1056/EVIDctw2400204","url":null,"abstract":"<p><p>AbstractMany randomized clinical trials fail to play out as intended: some participants assigned to the treatment group remain untreated, while others assigned to the control group cross over and receive treatment. In such settings, intention-to-treat analyses that compare participants by treatment assignment are diluted by noncompliance, while per-protocol analyses that compare participants by treatment received are contaminated by selection bias. Instrumental variables methods can address both problems. We explain the rationale for instrumental variables estimation in clinical trials and illustrate instrumental variables methods through an analysis of the effect of revascularization on quality of life. We argue that instrumental variables analysis should be central to pragmatic trials of all kinds, strategy trials in particular, and emerging \"nudge trials\" that encourage specific health-related behaviors in large populations.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDctw2400204"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702296","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":"Surgical versus Nonsurgical Treatment for Cervical Radiculopathy.","authors":"Mirad Taso, Jon Håvard Sommernes, Jarle Sundseth, Are Hugo Pripp, Siri Bjorland, Kaia B Engebretsen, Frode Kolstad, John Anker Zwart, Jens Ivar Brox","doi":"10.1056/EVIDoa2400404","DOIUrl":"10.1056/EVIDoa2400404","url":null,"abstract":"<p><strong>Background: </strong>Cervical radiculopathy is typically caused by disc herniation or spondylosis. Few trials have compared the efficacy of surgical versus nonsurgical treatment for these conditions.</p><p><strong>Methods: </strong>We conducted two randomized clinical trials among 180 patients presenting to the Oslo University Hospital in Norway with disabling radicular arm pain and cervical disc herniation (trial 1; n=89) or spondylosis (trial 2; n=91) proven by magnetic resonance imaging or computerized tomography. Patients were randomly assigned in a 1:1 ratio to receive either surgical or nonsurgical treatment. Surgery involved anterior cervical discectomy and fusion. Nonsurgical treatment involved three sessions with physical medicine/rehabilitation physicians and three sessions with physiotherapists for functional and cognitive behavioral support. The primary outcome in both trials was the Neck Disability Index (NDI) score (range, 0 to 100; higher scores indicate greater disability; minimal important difference is 15) at 12 months, which was self-reported by the patients.</p><p><strong>Results: </strong>Among the 87 patients in the disc herniation trial with 12-month data (surgical group, n=45; nonsurgical group, n=42), the mean difference in NDI adjusted for baseline was 7.4 (95% confidence interval [CI], 1.6 to 13.3; P=0.01) in favor of surgical treatment. Among the 88 patients in the spondylosis trial with 12-month data (surgical, n=44; nonsurgical, n=44), the mean difference in NDI adjusted for baseline was 2.3 (95% CI, -4.9 to 9.6; P=0.52). In the disc herniation trial, two patients in the nonsurgical group crossed over to have surgery. In the spondylosis trial, 11 patients in the nonsurgical group crossed over to have surgery. There were no serious adverse events.</p><p><strong>Conclusions: </strong>In patients with cervical radiculopathy, we found a statistically significant difference for NDI at 12 months in favor of surgical versus nonsurgical treatment in the disc herniation trial, but no difference in the spondylosis trial. (Funded by the Southern and Eastern Norway Regional Health Authority; HSØ#2017057; ClinicalTrials.gov number, NCT03674619.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDoa2400404"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702363","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 68-Year-Old Man with Urinary Incontinence.","authors":"Connor Lough, Nicholas Lanzotti, Ahmer Farooq, Ahmad M El-Arabi","doi":"10.1056/EVIDmr2400408","DOIUrl":"10.1056/EVIDmr2400408","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 68-year-old man with a history of end-stage renal disease who presented with urinary incontinence following a kidney transplant. Through a structured clinical approach, including targeted history-taking, physical examination, and diagnostic testing, an illness script is constructed, and the differential diagnosis is refined. As the clinical course progresses, additional investigations provide key insights, leading to the final diagnosis.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDmr2400408"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702260","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}