JAMA Network OpenPub Date : 2025-06-02DOI: 10.1001/jamanetworkopen.2025.14997
Lori Ann Post, Daniel Ciccarone, George Jay Unick, Gail D'Onofrio, Soyang Kwon, Alexander L Lundberg, Shivangi Sharma, Maryann Mason
{"title":"Decline in US Drug Overdose Deaths by Region, Substance, and Demographics.","authors":"Lori Ann Post, Daniel Ciccarone, George Jay Unick, Gail D'Onofrio, Soyang Kwon, Alexander L Lundberg, Shivangi Sharma, Maryann Mason","doi":"10.1001/jamanetworkopen.2025.14997","DOIUrl":"10.1001/jamanetworkopen.2025.14997","url":null,"abstract":"<p><strong>Importance: </strong>Drug overdose deaths (DODs) surged with the advent of fentanyl. Recent US reports indicated a decline, but standard surveillance systems do not account for monthly variability or seasonality and require monthly population data to calculate DOD rates.</p><p><strong>Objective: </strong>To identify when US DOD rates began to decelerate and to examine patterns by census region, drug type, and demographics.</p><p><strong>Design, setting, and participants: </strong>This repeated cross-sectional study of DOD rates was conducted from January 2015 to October 2024, using data from the National Center for Health Statistics and US Census Bureau. Decedents included those whose drug poisoning death was classified as unintentional, intentional (suicide or homicide), or undetermined intent, identified by International Statistical Classification of Diseases and Related Health Problems, 10th Revision codes for external overdose causes and T codes for opioids, cocaine, and psychostimulants (eg, methamphetamine).</p><p><strong>Main outcomes and measures: </strong>The main outcome was change in monthly DOD rates nationally and by drug type (opioids, cocaine, or methamphetamine), census region, and demographics. Joinpoint regression evaluated significant shifts in DOD rates applying the weighted bayesian information criterion and 2-sided z tests (α = .05).</p><p><strong>Results: </strong>A total of 800 645 US residents (68.3% male; median age, 42 years [IQR, 33-54 years]) died of drug overdose between January 2015 and October 2024. The national DOD rate increased from 14.54 (95% CI, 14.52-14.55) per 100 000 population in January 2015 to 33.24 (95% CI, 33.15 to 33.33) per 100 000 population in August 2023. From August 2023 to February 2024, the monthly DOD rate declined by -0.36 (95% CI, -0.46 to -0.27) per 100 000 population, accelerating to -0.84 (95% CI, -0.77 to -0.92) per 100 000 population through October 2024 and reaching 24.29 (95% CI, 24.21-24.37) per 100 000 population. Opioid-related DOD rates declined faster than stimulant-related DOD rates (-0.80 [95% CI, -0.74 to -0.87] vs -0.25 [95% CI, -0.23 to -0.27] per 100 000 population). While the national DOD rate peaked in August 2023, rates peaked in the Northeast, Midwest, and South census regions in October 2022 and the West peaked a year later. By late 2023, death rates continued to accelerate among adults aged 55 years or older (0.07 per 100 000 population) and American Indian or Alaska Native (0.02 per 100 000 population), Black or African American (1.70 per 100 000 population), Hispanic or Latino (0.20 per 100 000 population), and multiracial (0.28 per 100 000 population) populations, though the pace of increase was slowing, suggesting a potential inflection point.</p><p><strong>Conclusions and relevance: </strong>In this cross-sectional study, US DOD rates entered a new wave of sustained deceleration in 2023 after 2 decades of increase. This shift may reflect changes in dru","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 6","pages":"e2514997"},"PeriodicalIF":10.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12163676/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA Network OpenPub Date : 2025-06-02DOI: 10.1001/jamanetworkopen.2025.15213
Shengpu Tang, Stephanie Shepard, Rebekah Clark, Erkin Ötles, Chidimma Udegbunam, Josh Tran, Melinda Seiler, Justin Ortwine, Akbar K Waljee, Jerod Nagel, Sarah L Krein, Jacob E Kurlander, Paul J Grant, Jihoon Baang, Anastasia Wasylyshyn, Krishna Rao, Jenna Wiens
{"title":"Guiding Clostridioides difficile Infection Prevention Efforts in a Hospital Setting With AI.","authors":"Shengpu Tang, Stephanie Shepard, Rebekah Clark, Erkin Ötles, Chidimma Udegbunam, Josh Tran, Melinda Seiler, Justin Ortwine, Akbar K Waljee, Jerod Nagel, Sarah L Krein, Jacob E Kurlander, Paul J Grant, Jihoon Baang, Anastasia Wasylyshyn, Krishna Rao, Jenna Wiens","doi":"10.1001/jamanetworkopen.2025.15213","DOIUrl":"10.1001/jamanetworkopen.2025.15213","url":null,"abstract":"<p><strong>Importance: </strong>Increasingly, artificial intelligence (AI) is being used to develop models that can identify patients at high risk for adverse outcomes. However, the clinical impact of these models remains largely unrealized.</p><p><strong>Objective: </strong>To evaluate the association of an AI-guided infection prevention bundle with Clostridioides difficile infection (CDI) incidence in a hospital setting.</p><p><strong>Design, setting, and participants: </strong>This prospective, single-center quality improvement study evaluated adult inpatient hospitalizations before (September 1, 2021, to August 31, 2022) and after (January 1, 2023, to December 31, 2023) AI implementation. Data analysis was performed from January to August 2024.</p><p><strong>Intervention: </strong>A previously validated institution-specific AI model for CDI risk prediction was integrated into clinical workflows at the study site. The model was used to guide infection prevention practices for reducing pathogen exposure through enhanced hand hygiene and reducing host susceptibility through antimicrobial stewardship.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was CDI incidence rate. Secondary outcomes included antimicrobial use and qualitative assessments of bundle implementation.</p><p><strong>Results: </strong>Pre-AI and post-AI samples included 39 046 (21 645 [55.4%] female; median [IQR] age, 58 [36-70] years) and 40 515 (22 575 [55.7%] female; median [IQR] age, 58 [37-70] years) hospitalizations, respectively. After adjusting for differences in clinical characteristics, there was no significant reduction in CDI incidence (pre-AI period: 5.76 per 10 000 patient-days vs post-AI period: 5.65 per 10 000 patient-days; absolute difference, -0.11; 95% CI, -1.43 to 1.18; P = .85). Relative reductions greater than 10% in normalized antimicrobial days were seen for piperacillin-tazobactam (-9.64; 95% CI, -12.93 to -6.28; P < .001) and clindamycin (-1.04; 95% CI, -1.60 to -0.47; P = .03), especially for high-risk patients alerted by AI (relative reduction for piperacillin-tazobactam, 16.8%; 95% CI, 8.0%-24.6%). On the basis of qualitative assessments via semistructured interviews and field observations, the study found that health care staff's experiences with AI-guided workflows varied. In particular, the enhanced hand hygiene protocols were met with poor adherence, whereas pharmacists consistently engaged with the alerts.</p><p><strong>Conclusions and relevance: </strong>In this quality improvement study, the implementation of an AI-guided infection prevention bundle was not associated with a significant reduction in the already low CDI incidence rate at the study site, but it was associated with reduced CDI-associated antimicrobial use. The results highlight the potential of AI in supporting antimicrobial stewardship. Barriers to implementation, including infrastructure, staff knowledge, and workflow integration, need to be addressed in f","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 6","pages":"e2515213"},"PeriodicalIF":10.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12163649/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA Network OpenPub Date : 2025-06-02DOI: 10.1001/jamanetworkopen.2025.15592
Rayane Haddadj, Anne Lovise Nordstoga, Tom Ivar Lund Nilsen, Eivind Schjelderup Skarpsno, Atle Kongsvold, Mats Flaaten, Jasper Schipperijn, Kerstin Bach, Paul Jarle Mork
{"title":"Volume and Intensity of Walking and Risk of Chronic Low Back Pain.","authors":"Rayane Haddadj, Anne Lovise Nordstoga, Tom Ivar Lund Nilsen, Eivind Schjelderup Skarpsno, Atle Kongsvold, Mats Flaaten, Jasper Schipperijn, Kerstin Bach, Paul Jarle Mork","doi":"10.1001/jamanetworkopen.2025.15592","DOIUrl":"10.1001/jamanetworkopen.2025.15592","url":null,"abstract":"<p><strong>Importance: </strong>Chronic low back pain (LBP) is a prevalent and costly condition, and regular physical activity may reduce its risk. Walking is a common and accessible form of physical activity, but its association with the risk of chronic LBP is unclear.</p><p><strong>Objective: </strong>To examine whether accelerometer-derived daily walking volume and walking intensity are associated with the risk of chronic LBP.</p><p><strong>Design, setting, and participants: </strong>This prospective population-based cohort study used data from the Trøndelag Health (HUNT) Study in Norway, with a baseline in 2017 to 2019 and follow-up in 2021 to 2023. The study included individuals without chronic LBP at baseline and with at least 1 valid day of device-measured walking.</p><p><strong>Exposure: </strong>Daily walking volume (minutes per day) and walking intensity, expressed as metabolic equivalent of task (MET) per minute.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was self-reported chronic LBP at follow-up, defined as pain lasting 3 months or longer in the past 12 months. Poisson regression was used to estimate adjusted risk ratios (RRs) with 95% CIs of chronic LBP according to daily walking volume and mean walking intensity.</p><p><strong>Results: </strong>A total of 11 194 participants aged 20 years or older (mean [SD] age, 55.3 [15.1] years; 6564 women [58.6%]) were included in the analysis. At follow-up (mean [SD] follow-up time, 4.2 [0.3] years), 1659 participants (14.8%) reported chronic LBP. Continuous measures of both walking volume and walking intensity were inversely associated with the risk of chronic LBP using restricted cubic splines models. Compared with participants walking less than 78 minutes per day, those walking 78 to 100 minutes per day had an RR for chronic LBP of 0.87 (95% CI, 0.77-0.98), those walking 101 to 124 minutes per day had an RR of 0.77 (95% CI, 0.68-0.87), and those walking 125 minutes or more per day had an RR of 0.76 (95% CI, 0.67-0.87). Compared with a mean walking intensity of less than 3.00 MET per minute, participants with walking intensity of 3.00 to 3.11 MET per minute had an RR for chronic LBP of 0.85 (95% CI, 0.75-0.96), those with walking intensity of 3.12 to 3.26 MET per minute had an RR of 0.82 (95% CI, 0.72-0.93), and those with walking intensity greater than or equal to 3.27 MET per minute had an RR of 0.82 (95% CI, 0.72-0.93). After mutual adjustment, the association remained largely similar for walking volume but was attenuated for walking intensity.</p><p><strong>Conclusions and relevance: </strong>In this cohort study, daily walking volume and walking intensity were inversely associated with the risk of chronic LBP. The findings suggest that walking volume may have a more pronounced benefit than walking intensity.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 6","pages":"e2515592"},"PeriodicalIF":10.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144284412","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA Network OpenPub Date : 2025-06-02DOI: 10.1001/jamanetworkopen.2025.13293
Misook Kim, Kyungdo Han, Kyuna Lee, Bongseong Kim, Kyuho Kim, Seung-Hyun Ko, Yu-Bae Ahn, Seung Yeon Kim, Seung-Hwan Lee, Jae-Seung Yun
{"title":"Income and Severe Hypoglycemia in Type 2 Diabetes.","authors":"Misook Kim, Kyungdo Han, Kyuna Lee, Bongseong Kim, Kyuho Kim, Seung-Hyun Ko, Yu-Bae Ahn, Seung Yeon Kim, Seung-Hwan Lee, Jae-Seung Yun","doi":"10.1001/jamanetworkopen.2025.13293","DOIUrl":"10.1001/jamanetworkopen.2025.13293","url":null,"abstract":"<p><strong>Importance: </strong>Socioeconomic disparities are increasingly recognized as key factors in health outcomes among patients with type 2 diabetes. Understanding how income level and its changes are associated with severe hypoglycemia risk may inform targeted interventions and policy decisions.</p><p><strong>Objective: </strong>To evaluate the association between income level, including changes in income status, and the risk of severe hypoglycemia, and to assess whether this association varies across key subgroups in middle-aged adults.</p><p><strong>Design, setting, and participants: </strong>This retrospective cohort study included adults aged 40 to 70 years with type 2 diabetes from the Korean National Health Information Database (NHID) who underwent health examinations from 2015 to 2016. Participants aged 40 to 70 years with type 2 diabetes and valid income information were recruited between 2006 and 2010 from the UK Biobank (UKBB) and were included for sensitivity analysis. Data were analyzed from January 2023 to September 2024.</p><p><strong>Exposures: </strong>Participants were categorized into annual income quartiles (NHID) or self-reported income brackets (UKBB). In the NHID, medical aid beneficiaries (ie, those receiving government medical aid due to income below 40% of the median income and limited assets) were identified, and income changes over a 5-year period were assessed.</p><p><strong>Main outcomes and measures: </strong>Severe hypoglycemia requiring medical intervention.</p><p><strong>Results: </strong>Among 1 838 362 adults with type 2 diabetes from the NHID (mean [SD] age, 57.1 [8.1] years; 1 157 263 [63.0%] male) and 17 287 participants from the UKBB (mean [SD] age, 56.9 [6.8] years; 11 522 [66.7%] male), lower income was associated with a higher risk of severe hypoglycemia (NHID: hazard ratio [HR], 2.50; 95% CI, 2.33-2.57; UKBB: HR, 5.38; 95% CI, 1.72-16.85). In the NHID, individuals whose income increased from the lowest quartile or medical aid status to the fourth quartile over 5 years had a significantly lower risk (HR, 0.74; 95% CI, 0.67-0.81; P for trend <.001), whereas receiving medical aid for at least 1 year was associated with a significantly higher risk (HR, 1.71; 95% CI, 1.54-1.89). The association between income and severe hypoglycemia was consistently greater in men, individuals not using insulin, those without chronic kidney disease, and those with a shorter duration of diabetes.</p><p><strong>Conclusions and relevance: </strong>In this cohort study of adults with type 2 diabetes, low income was found to be a significant factor associated with risk for severe hypoglycemia. Addressing socioeconomic disparities and implementing targeted interventions may help reduce the incidence and severity of hypoglycemia.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 6","pages":"e2513293"},"PeriodicalIF":10.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131101/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144199071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA Network OpenPub Date : 2025-06-02DOI: 10.1001/jamanetworkopen.2025.14055
W Richard Burack, Marshall A Lichtman
{"title":"The Complete Blood Count-Time to Assess What Is Impactful and What Is Distracting.","authors":"W Richard Burack, Marshall A Lichtman","doi":"10.1001/jamanetworkopen.2025.14055","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2025.14055","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 6","pages":"e2514055"},"PeriodicalIF":10.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144225516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA Network OpenPub Date : 2025-06-02DOI: 10.1001/jamanetworkopen.2025.13204
Shavano Steadman, Arnav Srivastava
{"title":"Shared Decision-Making in Surgery-The Role of 3D-Printed Models.","authors":"Shavano Steadman, Arnav Srivastava","doi":"10.1001/jamanetworkopen.2025.13204","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2025.13204","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 6","pages":"e2513204"},"PeriodicalIF":10.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144208594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA Network OpenPub Date : 2025-06-02DOI: 10.1001/jamanetworkopen.2025.13548
Radha Sadacharan, Milan F Satcher
{"title":"The Intersection of Community Health and Carceral Health.","authors":"Radha Sadacharan, Milan F Satcher","doi":"10.1001/jamanetworkopen.2025.13548","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2025.13548","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 6","pages":"e2513548"},"PeriodicalIF":10.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144208595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA Network OpenPub Date : 2025-06-02DOI: 10.1001/jamanetworkopen.2025.13772
Stefanie N Hinkle, Chelsea C Okeh, Ernesto Ulloa-Pérez, Ashika Mani, Eve J Higginbotham, Rosemary Thomas, Matthew D Kearney, Corrinne Fahl, Enrique F Schisterman, Shefali S Verma, Roy Hamilton, Sunni L Mumford
{"title":"Perceptions of Institutional Engagement and Inclusion by Sexual Orientation and Gender Identity.","authors":"Stefanie N Hinkle, Chelsea C Okeh, Ernesto Ulloa-Pérez, Ashika Mani, Eve J Higginbotham, Rosemary Thomas, Matthew D Kearney, Corrinne Fahl, Enrique F Schisterman, Shefali S Verma, Roy Hamilton, Sunni L Mumford","doi":"10.1001/jamanetworkopen.2025.13772","DOIUrl":"10.1001/jamanetworkopen.2025.13772","url":null,"abstract":"<p><strong>Importance: </strong>There is a paucity of research regarding the experiences of self-identified lesbian, gay, bisexual, and transgender (LGBT+) individuals in academic medicine.</p><p><strong>Objective: </strong>To examine LGBT+ individuals' perceptions of institutional engagement and workplace inclusivity.</p><p><strong>Design, setting, and participants: </strong>In this survey study, in 2015, 2018, 2021, and 2023, the Diversity Engagement Survey (DES) supplemented with specific questions about LGBT+ visibility and engagement in the workplace was sent to faculty, students and trainees, and staff at a single academic medical center in Pennsylvania.</p><p><strong>Exposures: </strong>Sexual orientation was self-identified as heterosexual; lesbian, gay, or bisexual [LGB]; or other. Gender identity was self-identified as men; transgender, queer, or nonbinary [TQNB]; women; or other or unknown.</p><p><strong>Main outcomes and measures: </strong>Workplace culture inclusivity was assessed using 8 validated DES constructs summarized into 3 scores: perceptions of shared vision and purpose, camaraderie, and appreciation of contributions to the institution. Three questions evaluated statements about institutional welcoming of LGBT+ individuals, comfort working with LGBT+ colleagues, and LGBT+ institutional visibility. Potential attrition was assessed through a question about job change considerations due to inappropriate, disruptive, or unprofessional behavior by a coworker or supervisor. Results were weighted to account for nonresponse.</p><p><strong>Results: </strong>Among 23 708 respondents (15.9% of approximately 149 500 survey recipients), 2068 (8.7%) identified as LGB and 169 (0.7%) as TQNB. Compared with heterosexual respondents, LGB respondents reported lower institutional engagement (vision and purpose: adjusted difference (AD), -1.2 [95% CI, -1.6 to -0.9]; camaraderie: AD, -1.1 [95% CI, -1.3 to -0.9]; appreciation: AD, -0.9 [95% CI, -1.1 to -0.6]) and were less likely to agree with statements of LGBT+ institutional inclusivity (welcoming: adjusted relative ratio [ARR], 0.88 [95% CI, 0.85-0.90]; visibility: ARR, 0.90 [95% CI, 0.86-0.94]). Compared with men, TQNB respondents reported lower engagement (vision and purpose: AD, -4.1 [95% CI, -5.5 to -2.6]; camaraderie: AD, -3.2 [95% CI, -4.1 to -2.3]; appreciation: AD, -2.6 [95% CI, -3.5 to -1.7]) and were less likely to agree with LGBT+ institutional inclusivity statements (welcoming: ARR, 0.65 [95% CI, 0.53-0.80]; visibility: ARR, 0.78 [95% CI, 0.61-1.00]). LGB (vs heterosexual; ARR, 1.26 [95% CI, 1.15-1.38]) and TQNB (vs men; ARR, 1.48 [95% CI, 1.17-1.88]) respondents were more likely to report job change consideration.</p><p><strong>Conclusions and relevance: </strong>In this survey study, the findings demonstrated a need for focused and subgroup-specific intentional initiatives to optimize productivity and improve workplace culture, sense of belonging, and retention for self-identified","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 6","pages":"e2513772"},"PeriodicalIF":10.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12138678/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144215870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JAMA Network OpenPub Date : 2025-06-02DOI: 10.1001/jamanetworkopen.2025.14427
Regina Barragán-Carrillo, Hedyeh Ebrahimi, William S John, Sarah Lucht, Taavy A Miller, Prathamesh Pathak, Emily Bland, Sarah Gordon, JaLyna Laney, Andrew J Klink, Bruce Feinberg, Nisha Singh, Carmelo Alonso, Miraj Y Patel, Lisa Rosenblatt, Xin Yin, Alexander Chehrazi-Raffle
{"title":"Clinical Outcomes in Patients With Muscle-Invasive Urothelial Carcinoma Treated With Nivolumab.","authors":"Regina Barragán-Carrillo, Hedyeh Ebrahimi, William S John, Sarah Lucht, Taavy A Miller, Prathamesh Pathak, Emily Bland, Sarah Gordon, JaLyna Laney, Andrew J Klink, Bruce Feinberg, Nisha Singh, Carmelo Alonso, Miraj Y Patel, Lisa Rosenblatt, Xin Yin, Alexander Chehrazi-Raffle","doi":"10.1001/jamanetworkopen.2025.14427","DOIUrl":"10.1001/jamanetworkopen.2025.14427","url":null,"abstract":"<p><strong>Importance: </strong>Nivolumab is a standard-of-care adjuvant therapy for patients with muscle-invasive urothelial carcinoma (MIUC) at high risk for recurrence after radical resection. However, a better understanding of its use and clinical effectiveness in general patient populations is needed.</p><p><strong>Objective: </strong>To examine treatment patterns and clinical outcomes for patients with MIUC treated with adjuvant nivolumab in a community setting.</p><p><strong>Design, setting, and participants: </strong>This nationwide retrospective medical record review cohort study included patients with clinical stage II to IIIB MIUC who initiated adjuvant nivolumab between September 1, 2021, and November 30, 2022, with at least 6 months follow-up (unless deceased in <6 months). Managing physicians from the Cardinal Health Oncology Provider Extended Network abstracted patient data from electronic records.</p><p><strong>Exposures: </strong>Diagnosis of MIUC and receipt of adjuvant nivolumab.</p><p><strong>Main outcomes and measures: </strong>Disease-free survival (DFS) and overall survival (OS) were estimated using Kaplan-Meier methods.</p><p><strong>Results: </strong>Data from 253 patients were included in this study, with median (IQR) follow-up from adjuvant nivolumab initiation of 12.8 (9.6-15.4) months. The median (IQR) age at MIUC diagnosis was 67.8 (61.5-72.4) years, and most patients were male (169 patients [66.8%]). Overall, 141 patients (55.7%) had received neoadjuvant chemotherapy (NAC). During adjuvant nivolumab, 52 patients (20.6%) experienced an adverse event (AE). At last follow-up, the median (IQR) duration of adjuvant nivolumab was 11.2 (8.4-12.0) months, and 220 patients (87.0%) had discontinued treatment. Discontinuation was primarily due to completion of scheduled therapy duration (163 of 220 patients [74.1%]), while 10 of 220 patients (4.5%) discontinued due to AEs. Median DFS and OS were not reached, and estimates at 12 months after initiation were 86.3% (95% CI, 81.0%-90.2%) for DFS and 90.8% (95% CI, 86.0%-94.0%) for OS. Outcomes were similar in patients who did not receive NAC. At last follow-up, 226 patients (89.3%) were alive, of whom 209 (92.5%) were disease-free.</p><p><strong>Conclusions and relevance: </strong>This retrospective medical record review cohort study of patients with MIUC found clinical outcomes consistent with those observed in the CheckMate 274 trial. These results support the use of adjuvant nivolumab for patient populations in the community, including patients who did not receive NAC. Further research with extended follow-up is needed to elucidate long-term clinical outcomes of adjuvant nivolumab.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 6","pages":"e2514427"},"PeriodicalIF":10.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12150186/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144247933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}