NEJM evidence最新文献

{"title":"Efficacy of Smoking Cessation Interventions among People with HIV in Kenya.","authors":"Seth S Himelhoch, Emily Koech, Angela A Omanya, Patience Oduor, Walter Mchembere, Tina W Masai, Melanie E Bennett, Lan Li, Wendy Potts, Sylvia Ojoo, Jonathan Shuter","doi":"10.1056/EVIDoa2400090","DOIUrl":"10.1056/EVIDoa2400090","url":null,"abstract":"<p><strong>Background: </strong>People with human immunodeficiency virus (HIV) smoke at much higher rates than the general population, resulting in higher risk for tobacco-related morbidity and mortality. The efficacy of smoking cessation interventions among people with HIV in lower-middle-income countries remains unclear.</p><p><strong>Methods: </strong>We conducted a randomized, 2 × 2 factorial design trial based in Nairobi, Kenya, to evaluate the efficacy of bupropion versus placebo, and a culturally tailored behavioral cessation therapy, called Positively Smoke Free (PSF), versus standard of care for people with HIV who smoke. The primary outcome was 7-day point prevalence abstinence confirmed by exhaled carbon monoxide <7 ppm at 36 weeks.</p><p><strong>Results: </strong>Between June 2020 and August 2023, 300 participants were randomly assigned. Most participants were men (71.4%) who were moderately dependent on nicotine (Fagerström Test of Cigarette Dependence, mean [SD]: 4.5 [2.3]; range: 0-10; higher scores represent greater physical dependence on nicotine); nearly all participants (99.7%) were taking antiretroviral medication. At 36 weeks, 31.3% of participants who received bupropion were abstinent from smoking, compared with 13.3% in the placebo group (odds ratio, 2.95; 95% confidence interval [CI], 1.64-5.32, P<0.001). Among participants randomized to receive PSF therapy, 29.5% were abstinent from smoking, compared with 14.9% in the standard of care group (odds ratio, 2.39; 95% CI, 1.34-4.25, P=0.003). The combination of bupropion+PSF was associated with increased abstinence compared with either bupropion (38.9% vs. 23.6%; odds ratio, 2.06; 95% CI, 1.00-4.23) or PSF (38.9% vs. 20.3%; odds ratio, 2.50; 95% CI, 1.20-5.24) alone. Participants randomized to receive bupropion were significantly more likely to report excessive sweating compared with placebo (50.7% vs. 37.6%; P=0.024).</p><p><strong>Conclusions: </strong>Both bupropion and PSF cessation counseling were effective in promoting abstinence from smoking at 36 weeks. The combined intervention was associated with higher abstinence rates than either therapy alone. (The National Cancer Institute provided support for this trial through grant R01CA225419.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 11","pages":"EVIDoa2400090"},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142514184","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 Composite Outcomes Work.","authors":"Sarah Gorey, C Corey Hardin, Daniel Muller, Alison Burke, Sharon-Lise Normand, Chana A Sacks","doi":"10.1056/EVIDstat2400347","DOIUrl":"https://doi.org/10.1056/EVIDstat2400347","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 11","pages":"EVIDstat2400347"},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142514186","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":"Prognostic Factors Associated with Mortality in Cardiogenic Shock - A Systematic Review and Meta-Analysis.","authors":"Richard G Jung, Cameron Stotts, Arnav Gupta, Graeme Prosperi-Porta, Shan Dhaliwal, Pouya Motazedian, Omar Abdel-Razek, Pietro Di Santo, Simon Parlow, Emilie Belley-Cote, Alexandre Tran, Sean van Diepen, Lee Harel-Sterling, Vineet Goyal, Melissa Fay Lepage-Ratte, Rebecca Mathew, Jacob C Jentzer, Susanna Price, Srihari S Naidu, Mir B Basir, Navin K Kapur, Holger Thiele, F Daniel Ramirez, George Wells, Bram Rochwerg, Shannon M Fernando, Benjamin Hibbert","doi":"10.1056/EVIDoa2300323","DOIUrl":"10.1056/EVIDoa2300323","url":null,"abstract":"<p><strong>Background: </strong>Cardiogenic shock remains highly associated with early mortality, with mortality often exceeding 50%. We sought to determine the association between prognostic factors and in-hospital and 30-day mortality in cardiogenic shock.</p><p><strong>Methods: </strong>We performed a systematic review and meta-analysis of prognostic factors in cardiogenic shock, searching MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for records up to June 5, 2023. English-language studies that investigated prognostic factors and in-hospital and/or 30-day mortality in cardiogenic shock were included. Studies were excluded if they evaluated the pediatric population, were postmortem studies, or included fewer than 100 patients. The primary aim was to identify modifiable and non-modifiable prognostic factors associated with in-hospital and 30-day mortality in cardiogenic shock.</p><p><strong>Results: </strong>We identified 160 studies, including 2,459,703 patients with a median in-hospital mortality of 41.4% (interquartile range, 33.6% to 49.2%). The majority were retrospective cohort studies. Patient factors potentially associated with an increase in early mortality included an age greater than or equal to 75 years of age, peripheral arterial disease, chronic kidney disease, and female sex. Procedural and presentation factors potentially associated with increased mortality included out-of-hospital cardiac arrest, left main culprit artery, left ventricular ejection fraction less than 30%, dialysis, and need for mechanical circulatory support. Revascularization in the form of coronary artery bypass graft and percutaneous coronary intervention were potentially associated with reduced in-hospital mortality.</p><p><strong>Conclusions: </strong>This analysis quantifies the association between patient, presentation, and treatment-related factors and early mortality in cardiogenic shock. Increased certainty in the association of these prognostic factors with cardiogenic shock outcomes can aid in clinical risk assessment, development of risk tools, and analysis of clinical trials.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 11","pages":"EVIDoa2300323"},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142514204","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":"Lessons Learned from National Heart, Lung, and Blood Institute Covid-19 Clinical Trials.","authors":"Sonia M Thomas, Robert A Harrington, Clyde W Yancy, Diane Nugent, Serpil Erzurum, Gordon R Bernard, Mary Cushman, Judith S Hochman, Paul M Ridker, Thomas L Ortel, Sean P Collins, Clifton W Callaway, Tracy L Nolen, Kelsey N Womack, Samuel M Brown, Annetine Gelijns, Mark Geraci, Adit A Ginde, Nigel S Key, Jerry A Krishnan, Lisa LaVange, Stephen R Wisniewski, Lisa Berdan, Antonello Punturieri, David C Goff, Amy P Patterson","doi":"10.1056/EVIDctcs2300291","DOIUrl":"10.1056/EVIDctcs2300291","url":null,"abstract":"<p><p>AbstractIn response to the Covid-19 pandemic, the National Heart, Lung, and Blood Institute launched five multisite clinical trials testing candidate host tissue-directed medical interventions to hasten recovery, improve function, and reduce morbidity and mortality. Speed, flexibility, and collaboration were essential. This article from the Steering and Executive committees describes the Collaborating Network of Networks for Evaluating Covid-19 and Therapeutic Strategies (CONNECTS) research program that enrolled 6690 participants and evaluated 18 intervention strategies using 10 molecular agents across the care continuum (outpatient, inpatient, and post discharge), and reports lessons learned from this initiative. Successes include rapid trial execution through collaboration and adaptive platform designs. Challenges that impeded efficiency included time required to execute subcontracts, constraints on clinical research workforce, and limited research infrastructure in nonacademic settings.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 11","pages":"EVIDctcs2300291"},"PeriodicalIF":0.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142514203","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":"Sequencing of Checkpoint or BRAF/MEK Inhibitors on Brain Metastases in Melanoma.","authors":"Paolo A Ascierto, Mario Mandalà, Pier Francesco Ferrucci, Massimo Guidoboni, Piotr Rutkowski, Virginia Ferraresi, Ana Arance, Michele Guida, Evaristo Maiello, Helen Gogas, Erika Richtig, Pietro Quaglino, Céleste Lebbé, Hildur Helgadottir, Paola Queirolo, Francesco Spagnolo, Marco Tucci, Michele Del Vecchio, Maria Gonzalez-Cao, Alessandro Marco Minisini, Sabino De Placido, Miguel F Sanmamed, Milena Casula, Jenny Bulgarelli, Marina Pisano, Claudia Piccinini, Luisa Piccin, Antonio Cossu, Domenico Mallardo, Miriam Paone, Maria Grazia Vitale, Ignacio Melero, Antonio M Grimaldi, Diana Giannarelli, Giuseppe Palmieri, Reinhard Dummer, Vanna Chiarion Sileni","doi":"10.1056/EVIDoa2400087","DOIUrl":"10.1056/EVIDoa2400087","url":null,"abstract":"<p><strong>Background: </strong>The impact of the order of treatment with checkpoint inhibitors or BRAF/MEK inhibitors on the development of brain metastases in patients with metastatic unresectable <i>BRAF</i>V600-mutant melanoma is unknown. The SECOMBIT trial examined the impact of the order of receipt of these treatments in such patients.</p><p><strong>Methods: </strong>In this three-arm trial, we reviewed patients without brain metastases who received the BRAF/MEK inhibitors encorafenib and binimetinib until they had progressive disease followed by the immune checkpoint inhibitors ipilimumab and nivolumab (arm A); or treatment with ipilimumab and nivolumab until they had progressive disease followed by encorafenib and binimetinib (arm B); or treatment with encorafenib and binimetinib for 8 weeks followed by ipilimumab and nivolumab until they had progressive disease followed by retreatment with encorafenib arm binimetinib (arm C).</p><p><strong>Results: </strong>Brain metastases were discovered during the trial in 23/69 patients in arm A, 11/69 in arm B, and 9/68 in arm C. At a median follow-up of 56 months, the 60-month brain metastases-free survival rates were 56% for arm A, 80% for arm B (hazard ratio [HR] vs. A: 0.40, 95% confidence interval [CI] 0.23 to 0.58), and 85% for arm C (HR vs. A: 0.35, 95% CI 0.16 to 0.76).</p><p><strong>Conclusions: </strong>In patients with unresectable metastatic melanoma, the treatment sequence of immune checkpoint inhibition followed by BRAF/MEK inhibitors was associated with longer periods of new brain metastases-free survival than the reverse sequence. A regimen in which immune checkpoint inhibition was sandwiched between BRAF/MEK inhibition also appeared to be protective against brain metastases. (ClinicalTrials.gov number NCT02631447.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 10","pages":"EVIDoa2400087"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142309293","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":"Methodological Insights from the ERASe Trial.","authors":"Armando Teixeira-Pinto, Liliana Laranjo","doi":"10.1056/EVIDe2400296","DOIUrl":"10.1056/EVIDe2400296","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 10","pages":"EVIDe2400296"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142309292","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":"Tecovirimat Use under Expanded Access to Treat Mpox in the United States, 2022-2023.","authors":"Patricia A Yu, Riad Elmor, Kalimah Muhammad, Yon C Yu, Agam K Rao","doi":"10.1056/EVIDoa2400189","DOIUrl":"10.1056/EVIDoa2400189","url":null,"abstract":"<p><strong>Background: </strong>During the ongoing outbreak of clade II <i>monkeypox</i> <i>virus</i> (MPXV), many U.S. patients were prescribed tecovirimat, an antiviral drug that was made available under an expanded access Investigational New Drug (EA-IND) program. We evaluated EA-IND data to summarize characteristics of treated patients, outcomes, and serious adverse events (SAEs).</p><p><strong>Methods: </strong>We evaluated data from patients prescribed tecovirimat from May 29, 2022, through July 10, 2023. Baseline patient characteristics, clinical courses, and outcomes were evaluated via intake forms, outcome forms, and patient diaries. Data were summarized in aggregate by human immunodeficiency virus (HIV) status and by comorbidities of special interest. Reported SAEs were also compiled.</p><p><strong>Results: </strong>Tecovirimat was prescribed for over 7100 patients in the United States, most often for lesions in sensitive anatomical areas, such as certain anogenital lesions (83.5%; 5135 out of 6148 patients), and pain (52.5%; 3227 out of 6148 patients). The demographic and clinical characteristics mirrored those of patients worldwide. Among the 7181 patients with returned intake forms, 1626 also had returned outcome forms (22.6%). Many patients with severe immunocompromise (e.g., HIV with CD4 counts <200 cells/μl) received multiple courses of tecovirimat (43.1%; 22 out of 51 patients), including intravenously, and often experienced poor outcomes (35.3%; 18 out of 51 patients). Overall, 223 SAEs and 40 deaths were reported. Most SAEs were among patients who were severely immunocompromised, one of whom experienced hallucinations after tecovirimat was administered at twice the standard dose.</p><p><strong>Conclusions: </strong>Tecovirimat was used extensively. The returned EA-IND data suggest that life-threatening or protracted infections occurred in persons who were severely immunocompromised. SAEs were not commonly reported. The EA-IND data are not definitive; controlled clinical trial data are essential to elucidating if and how tecovirimat should be used.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":" ","pages":"EVIDoa2400189"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11421955/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142302800","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":"Getting Diabetes Technologies into the Hands of Those Who Need Them Most.","authors":"Alanna Weisman","doi":"10.1056/EVIDe2400283","DOIUrl":"10.1056/EVIDe2400283","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 10","pages":"EVIDe2400283"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142309291","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":"Broader Options for Experimental Clinical Research in Melanoma - Time for Adaptive Platform Trials?","authors":"Thomas A Trikalinos","doi":"10.1056/EVIDe2400284","DOIUrl":"10.1056/EVIDe2400284","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 10","pages":"EVIDe2400284"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142309288","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":"Sleep Disorders.","authors":"Rebecca Robbins, Stuart F Quan","doi":"10.1056/EVIDra2400096","DOIUrl":"10.1056/EVIDra2400096","url":null,"abstract":"<p><p>AbstractThere are more than 90 recognized sleep disorders, many of which impair sleep and daytime function and adversely impact heath, well-being, and chronic disease risk. Unfortunately, many sleep disorders are undiagnosed or not managed effectively. This review describes how to identify, evaluate, and treat common sleep disorders.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 10","pages":"EVIDra2400096"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142309294","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}