NEJM evidence最新文献

{"title":"Cervical Radiculopathy and the Role of Surgery - \"First, Do No Harm\".","authors":"Jerome Paquet","doi":"10.1056/EVIDe2500008","DOIUrl":"https://doi.org/10.1056/EVIDe2500008","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDe2500008"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702271","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":"Associations between Class I, II, or III Obesity and Health Outcomes.","authors":"Zhiqi Yao, Beverly G Tchang, Michael Albert, Roger S Blumenthal, Khurram Nasir, Michael J Blaha","doi":"10.1056/EVIDoa2400229","DOIUrl":"https://doi.org/10.1056/EVIDoa2400229","url":null,"abstract":"<p><strong>Background: </strong>The burden of obesity-related health conditions remains incompletely explored. Previous studies have been underpowered to study severe obesity, focused on a limited set of health outcomes, and lacked diversity in study populations.</p><p><strong>Methods: </strong>We studied 270,657 participants from the All of Us research program with linked electronic health records and body mass index (the weight in kilograms divided by the square of the height in meters) greater than or equal to 18.5. We investigated the prevalence and incidence of 16 a priori-identified outcomes covering cardiovascular-kidney-metabolic syndrome and others: hypertension, type 2 diabetes mellitus, hyperlipidemia/dyslipidemia, heart failure, atrial fibrillation, atherosclerotic cardiovascular disease, chronic kidney disease, pulmonary embolism, deep vein thrombosis, gout, metabolic dysfunction-associated steatotic liver disease, biliary calculus, obstructive sleep apnea, asthma, gastroesophageal reflux disease, and osteoarthritis. Adjusted hazard ratios were calculated for each BMI category and compared with normal weight. The population-attributable fraction was calculated for different obesity classifications.</p><p><strong>Results: </strong>The included population was 62.0% women and 22.0% Black. Class I, II, and III obesity was observed in 21.2%, 11.3%, and 9.8% of participants, respectively. Obesity was strongly associated with all incident outcomes, with graded associations across higher classes of obesity. Class III obesity was most strongly associated with obstructive sleep apnea, type 2 diabetes mellitus, and metabolic dysfunction-associated steatotic liver disease (hazard ratio [95% confidence interval {CI}], 10.94 [9.97 to 12.00], 7.74 [7.03 to 8.53], and 6.72 [6.01 to 7.50], respectively), with weaker associations for asthma, osteoarthritis, and atherosclerotic cardiovascular disease (hazard ratio [95% CI], 2.14 [1.95 to 2.35], 2.06 [1.94 to 2.19], and 1.96 [1.70 to 2.25], respectively). Associations were consistent across sex and race. The obesity-related population-attributed fraction ranged from 14.0% (osteoarthritis) to 51.5% (obstructive sleep apnea) in this population.</p><p><strong>Conclusions: </strong>Obesity, particularly severe obesity, was strongly associated with the incidence of 16 common health outcomes.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"4 4","pages":"EVIDoa2400229"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702287","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":"Forty Percent and Rising - Why Every Specialist Must Care about Obesity.","authors":"Christopher N Schmickl, Janna Raphelson, Atul Malhotra","doi":"10.1056/EVIDe2500054","DOIUrl":"https://doi.org/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":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702294","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 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":"https://doi.org/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":"https://doi.org/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":"https://doi.org/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":"https://doi.org/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}