JAMA Network Open最新文献

{"title":"Cost-Effectiveness of Pembrolizumab With Chemoradiotherapy for Locally Advanced Cervical Cancer.","authors":"P Travis Courtney, Puja S Venkat, Ya-Chen Tina Shih, Albert J Chang, Alan Lee, Michael L Steinberg, Ann C Raldow","doi":"10.1001/jamanetworkopen.2025.0033","DOIUrl":"10.1001/jamanetworkopen.2025.0033","url":null,"abstract":"<p><strong>Importance: </strong>The KEYNOTE-A18 trial demonstrated that adding concurrent and adjuvant pembrolizumab to chemoradiotherapy and brachytherapy significantly improved survival in patients with newly diagnosed, locally advanced cervical cancer. However, considering the annual global incidence of 660 000 cases of cervical cancer, including 13 820 in the US in 2024, incorporating this regimen into the standard of care could have substantial health care economic implications for both patients and the health care system.</p><p><strong>Objective: </strong>To determine the cost-effectiveness of adding pembrolizumab to the first-line treatment of newly diagnosed, locally advanced cervical cancer.</p><p><strong>Design, setting, and participants: </strong>This economic evaluation created a Markov model simulating 50-year outcomes to evaluate cost-effectiveness from the payer perspective for patients receiving either pembrolizumab or placebo in addition to chemoradiotherapy plus brachytherapy. Probabilities, including disease progression, survival, and treatment-related toxic effects, were derived from KEYNOTE-A18 clinical trial data in patients with newly diagnosed, locally advanced cervical cancer. Costs and health utilities were obtained from published literature; 1-way, 3-way, and probabilistic sensitivity analyses were used to assess model uncertainty. Data analyses were conducted from April to November 2024.</p><p><strong>Exposure: </strong>Pembrolizumab.</p><p><strong>Main outcomes and measures: </strong>Costs, measured in 2024 US dollars, and effectiveness, measured in quality-adjusted life-years (QALYs) were used to calculate an incremental cost-effectiveness ratio (ICER). A willingness-to-pay threshold of $100 000 per QALY was chosen, below which pembrolizumab would be considered cost-effective.</p><p><strong>Results: </strong>KEYNOTE-A18 enrolled 1060 patients (529 in pembrolizumab group, 531 in placebo group). The median age was 50 years. Pembrolizumab increased costs by $257 000 and effectiveness by 1.40 QALYs, yielding an incremental cost-effectiveness ratio of $183 400 per QALY. The addition of pembrolizumab became cost-effective if its monthly cost was decreased from $16 990 to $9190 (a 45.6% reduction) or its maximum duration of 24 months was decreased to 10 months. The model was insensitive to assumptions about treatment-related toxic effects, progression-free survival, and overall survival. Probabilistic sensitivity analysis indicated that at a willingness-to-pay threshold of $100 000 per QALY, the addition of pembrolizumab was cost-effective 37.3% of the time.</p><p><strong>Conclusions and relevance: </strong>In this economic evaluation of adding concurrent and adjuvant pembrolizumab to first-line treatment of newly diagnosed, locally advanced cervical cancer, this regimen was not cost-effective at current prices despite data demonstrating improved survival with this regimen.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 3","pages":"e250033"},"PeriodicalIF":10.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11880949/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143541967","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}

{"title":"Veterans at High Risk for Post-COVID-19 Suicide Attempts or Other Self-Directed Violence.","authors":"David P Bui, Meike Niederhausen, Alex W Hickok, Diana J Govier, Mazhgan Rowneki, Jennifer C Naylor, Eric Hawkins, Edward J Boyko, Theodore J Iwashyna, Elizabeth M Viglianti, George N Ioannou, Jason I Chen, Denise M Hynes","doi":"10.1001/jamanetworkopen.2025.0061","DOIUrl":"10.1001/jamanetworkopen.2025.0061","url":null,"abstract":"<p><strong>Importance: </strong>US veterans have a higher risk of suicide than the general civilian population. Research suggests that COVID-19 infection is associated with increased risk of suicide attempts or other forms of self-directed violence (SDV) among veterans.</p><p><strong>Objective: </strong>To identify subgroups of veterans with high risk of post-COVID-19 suicide attempts or SDV.</p><p><strong>Design, setting, and participants: </strong>This is a retrospective cohort study conducted using data from the Veteran Health Administration (VHA). Participants included VHA enrollees with a first case of COVID-19 between May 1, 2021, and April 30, 2022, residing in the 50 states or Washington, DC.</p><p><strong>Exposure: </strong>COVID-19 infection.</p><p><strong>Main outcomes and measures: </strong>The main outcome was a suicide attempt or SDV 12 months after COVID-19 infection. Latent class analysis was used to identify subgroups. Outcome rates and 95% CIs per 10 000 veterans were calculated. Multinomial regressions were used to model outcome risk and marginal risk ratios with 99.5% CIs to compare outcome risk across latent classes.</p><p><strong>Results: </strong>The cohort included 285 235 veterans with COVID-19 and was predominantly male (248 118 veterans [87.0%]) and younger than 65 years (171 636 veterans [60.2%]). Chronic pain (152 788 veterans [53.6%]), depression (98 093 veterans [34.4%]), and posttraumatic stress disorder (79 462 veterans [27.9%]) diagnoses were common. The 12-month outcome rate was 73.8 events per 10 000 (95% CI, 70.7-77.0 events per 10 000). Two latent classes with high rates of suicide attempt or SDV were identified. The first high-risk subgroup (46 693 veterans [16.4%]) was older (34 472 veterans [73.8%] aged ≥65 years) and had a high prevalence of physical conditions (43 329 veterans [92.8%] had hypertension, and 36 824 veterans [78.9%] had chronic pain); the 12-month outcome rate was 103.7 events per 10 000 (95% CI, 94.7-113.3 events per 10 000). The second high-risk subgroup (82 309 veterans [28.9%]) was generally younger (68 822 veterans [83.6%] aged <65 years) with a lower prevalence of physical conditions but high prevalence of mental health conditions (61 367 veterans [74.6%] had depression, and 50 073 veterans [60.8%] had posttraumatic stress disorder); the 12-month outcome rate was 162.9 events per 10 000 (95% CI, 154.5-171.8 events per 10 000), and compared with the lowest risk subgroup, the 12-month risk of suicide attempts or SDV was 14 times higher in this subgroup (risk ratio, 14.23; 99.5% CI, 10.22-19.80).</p><p><strong>Conclusions and relevance: </strong>In this cohort study of veterans with COVID-19, 2 veteran subgroups with distinct health profiles had high rates of suicide attempts and SDV, suggesting that different groups may require different approaches to suicide prevention after COVID-19.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 3","pages":"e250061"},"PeriodicalIF":10.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11880954/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542176","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}

{"title":"Hospital Security Searches Among Patients With Substance-Related Encounters.","authors":"Sarah J Nessen, Ashish Thakrar, Jeanmarie Perrone, Lin Xu, Rachel McFadden, Margaret Lowenstein","doi":"10.1001/jamanetworkopen.2025.1068","DOIUrl":"10.1001/jamanetworkopen.2025.1068","url":null,"abstract":"<p><strong>Importance: </strong>Hospital clinicians may request that security personnel search patients' rooms and belongings in response to suspected possession or use of illicit substances. Although searches are intended to protect patient and employee safety, little is known about search outcomes or consequences for clinical care.</p><p><strong>Objective: </strong>To investigate the clinical context and outcomes of room searches among patients with substance-related hospital encounters.</p><p><strong>Design, setting, and participants: </strong>Retrospective cohort study of security incident reports and electronic health record data for patients with substance-related hospital encounters between July 2021 and July 2023 at an urban, academic hospital with approximately 1000 beds in Philadelphia, Pennsylvania. Participants were adults with International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes consistent with substance use disorders, chief concerns of drug overdose or withdrawal, and/or positive verbal screenings for opioid use who had emergency department visits or inpatient hospitalizations.</p><p><strong>Main outcomes and measures: </strong>Primary outcomes were search requests, items confiscated, and patient-directed discharges (PDDs). Secondary measures centered on the clinical context of searches, including location and receipt of medications for opioid use disorder.</p><p><strong>Results: </strong>There were 13 827 total substance-related hospital encounters over the study period involving 6985 unique patients (median [IQR] age, 47 [34-58] years; 3863 [55.3%] male; 3688 [52.7%] Black; 302 [4.3%] Hispanic; 2597 [37.2%] White). Over this time, security reported 576 room search requests, among which 457 (79.3%) were requests for searches among patients with substance-related hospital encounters. Nurses requested most searches (376 searches [82.3%]), and 195 searches (43.6%) resulted in no items confiscated. Confiscated items included syringes and unspecified paraphernalia (129 searches [28.9%]), confirmed or suspected drugs and alcohol (102 searches [22.8%]), tobacco products (54 searches [12.1%]), and pipes and smoking materials (53 searches [11.9%]). Patients who had 1 or more search requests during a substance-related hospital encounter had a statistically significant odds ratio (OR) of having a PDD compared with patients who did not undergo searches (OR, 2.99; 95% CI, 2.32-3.86).</p><p><strong>Conclusions and relevance: </strong>In this cohort study of patients with substance-related hospital encounters, most searches did not result in the confiscation of illicit substances, and searches were associated with PDDs. There is an overall need for clear, patient-centered hospital search protocols that support both staff and patient well-being.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 3","pages":"e251068"},"PeriodicalIF":10.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920837/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657309","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}

{"title":"Errors in Results and Table 1.","authors":"","doi":"10.1001/jamanetworkopen.2025.6345","DOIUrl":"10.1001/jamanetworkopen.2025.6345","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 3","pages":"e256345"},"PeriodicalIF":10.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920835/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657293","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}

{"title":"Treatment and Attrition Trends for Metastatic Clear Cell Renal Cell Carcinoma in the US.","authors":"Zeynep Irem Ozay, Yeonjung Jo, Gliceida Galarza Fortuna, Chadi Hage Chehade, Georges Gebrael, Micah Ostrowski, Nicolas Sayegh, Ethan Anderson, Salvador Jaime-Casas, Miguel Zugman, Vinay Mathew Thomas, Benjamin L Maughan, Neeraj Agarwal, Sumanta K Pal, Umang Swami","doi":"10.1001/jamanetworkopen.2025.1201","DOIUrl":"10.1001/jamanetworkopen.2025.1201","url":null,"abstract":"<p><strong>Importance: </strong>The treatment landscape of metastatic clear cell renal cell carcinoma (ccRCC) has rapidly evolved with the approval of multiple immune checkpoint inhibitor (ICI)-based combinations. However, clinical data on changes in treatment patterns and attrition before and after ICI-based combinations approval are lacking.</p><p><strong>Objective: </strong>To assess treatment patterns and attrition rates in patients with metastatic ccRCC before and after the approval of ICI-based combinations.</p><p><strong>Design, setting, and participants: </strong>This cohort study used patient-level data from a nationwide deidentified electronic health record-derived database, originating from around 280 cancer clinics in the US. Patients diagnosed with metastatic ccRCC who received first-line therapy between January 1, 2011, and January 20, 2023, were included. Those treated for 2 or more malignant neoplasms or enrolled in clinical trials were excluded.</p><p><strong>Exposures: </strong>Line of therapy initiation before and after April 16, 2018.</p><p><strong>Main outcomes measures: </strong>Treatments received in each line of therapy and attrition rate were summarized using frequencies and percentages.</p><p><strong>Results: </strong>Of 12 707 patients with metastatic ccRCC within the database, 8534 were eligible and included (median [IQR] age, 66 [59-74] years; 6032 male [70.7%]; 629 Black [8.1%], 697 Hispanic [9.0%], 5493 White [71.0%]). Before April 16, 2018, the most common first-line therapy was tyrosine kinase inhibitor (TKI) monotherapy (3595 of 4561 patients [78.8%]). Following the approval of ICI-based combinations in 2018, most patients (2392 of 3973 patients [60.2%]) received ICI-based combinations as first-line therapy for metastatic ccRCC. TKI monotherapy remained the most common second- and third-line therapy in patients treated before and after April 16, 2018. Before 2018, 2639 patients (57.9%) and 1458 patients (31.9%) received second-line and third-line therapies, respectively, compared with 1494 (37.6%) and 562 (14.1%) after 2018.</p><p><strong>Conclusions and relevance: </strong>In this cohort study of 8534 patients with metastatic ccRCC, although ICI-based combinations are the preferred first-line therapy due to their proven superiority over TKI monotherapy, many patients were not receiving them; high attrition rates were observed in subsequent lines. These findings highlight the need to optimize treatment selection by implementing current guidelines in clinical practice.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 3","pages":"e251201"},"PeriodicalIF":10.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11926653/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663585","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}

{"title":"Pulmonary Embolism in Patients with End-Stage Kidney Disease Starting Dialysis.","authors":"Kunal N Patel, Wan-Chi Chan, Vivek Bhat, Monil M Majmundar, Harsh Mehta, Cyrus Munguti, Kartik Munshi, Sri G Yarlagadda, Gaurav M Parmar, Aditya M Sharma, Daniella Kadian-Dodov, Lewis G Satterwhite, Jinxiang Hu, Jordan Baker Ms, Kamal Gupta","doi":"10.1001/jamanetworkopen.2025.0848","DOIUrl":"10.1001/jamanetworkopen.2025.0848","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 3","pages":"e250848"},"PeriodicalIF":10.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11915059/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143648614","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}

{"title":"Unmasking Racial and Ethnic Disparities in Prehospital Sedation and Restraint Practices-Beyond the Straps.","authors":"Utsha G Khatri, Samuel E Sondheim","doi":"10.1001/jamanetworkopen.2025.1289","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2025.1289","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 3","pages":"e251289"},"PeriodicalIF":10.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663586","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}

{"title":"The Achilles' Heel of Midline Catheters.","authors":"David Paje","doi":"10.1001/jamanetworkopen.2025.1268","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2025.1268","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 3","pages":"e251268"},"PeriodicalIF":10.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143663506","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}

{"title":"Alcohol Use Disorder Medication Coverage and Utilization Management in Medicaid Managed Care Plans.","authors":"Maureen T Stewart, Sage R Feltus, Christina M Andrews, Andrea Acevedo, Cindy Parks Thomas, Jeffrey Bratberg, Constance M Horgan, Dominic Hodgkin, Rachel Sayko Adams","doi":"10.1001/jamanetworkopen.2025.0695","DOIUrl":"10.1001/jamanetworkopen.2025.0695","url":null,"abstract":"<p><strong>Importance: </strong>Evidence-based, patient-centered treatment for alcohol use disorder (AUD) can include pharmacotherapy with naltrexone, acamprosate, or disulfiram; however, these medications are rarely used. Medicaid managed care plans (MCPs) manage health services for nearly 80% of Medicaid enrollees and are the largest payer for addiction treatment services. Little is known about Medicaid MCP policies for AUD medications.</p><p><strong>Objectives: </strong>To describe Medicaid MCPs' coverage and management of acamprosate, naltrexone, and disulfiram for AUD and examine associations of plan characteristics and state policies with medication coverage.</p><p><strong>Design, setting, and participants: </strong>In this cross-sectional study, a content analysis was performed of 2021 insurance benefit data for 241 comprehensive Medicaid MCPs in states using Medicaid managed care, as well as secondary sources. Data were analyzed from May to August 2024.</p><p><strong>Main outcomes and measures: </strong>Medicaid MCP-reported medication coverage and utilization management requirements (eg, prior authorization, quantity limit requirements) for acamprosate, disulfiram, and oral and injectable naltrexone together and for each medication separately. Independent variables included plan characteristics (profit status, market share) and the state policy environment in which plans are embedded (Section 1115 substance use disorder waiver, state-defined preferred drug list). Regressions examined associations of plan characteristics and state policies with medication coverage.</p><p><strong>Results: </strong>In this cross-sectional content analysis of 241 comprehensive Medicaid MCPs in 2021, 217 (90.0%) covered at least 1 medication for AUD: 132 (54.7%) covered acamprosate, 203 (84.2%) covered oral naltrexone, 175 (72.6%) covered injectable naltrexone, 152 (63.0%) covered disulfiram, and 103 (42.7%) covered all 4 medications. Prior authorization and quantity limits were rarely applied, except for injectable naltrexone, for which 75 plans (42.8%) imposed at least 1 of these utilization management requirements.</p><p><strong>Conclusions and relevance: </strong>This study suggests that efforts to expand AUD medication prescribing may be limited by gaps in health insurance coverage. Medicaid MCPs and states can support AUD medication utilization by covering these medications without applying utilization management strategies.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 3","pages":"e250695"},"PeriodicalIF":10.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11907321/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143624639","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}

{"title":"Probiotics and Fever Duration in Children With Upper Respiratory Tract Infections: A Randomized Clinical Trial.","authors":"Silvia Bettocchi, Anna Comotti, Marina Elli, Valentina De Cosmi, Cristiana Berti, Ilaria Alberti, Alessandra Mazzocchi, Chiara Rosazza, Carlo Agostoni, Gregorio Paolo Milani","doi":"10.1001/jamanetworkopen.2025.0669","DOIUrl":"10.1001/jamanetworkopen.2025.0669","url":null,"abstract":"<p><strong>Importance: </strong>Upper respiratory tract infections (URTIs) are prevalent in children, prompting frequent health care consultations, especially among those with fever. Probiotics show potential as an adjuvant treatment for URTIs, but evidence in children is limited.</p><p><strong>Objective: </strong>To evaluate the efficacy of a probiotic mixture containing Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, and Lactobacillus rhamnosus HN001 in shortening fever duration among children with URTIs.</p><p><strong>Design, setting, and participants: </strong>This randomized clinical trial was conducted between November 19, 2021, and June 20, 2023, at the pediatric emergency department of the Ca' Granda Ospedale Maggiore Policlinico in Milan, Italy. Patients between 28 days and 4 years of age with a fever (≥38.5 °C) and URTI were eligible. Exclusion criteria included recent probiotic use, chronic autoimmune diseases, immunosuppressive treatment, and requirement for hospitalization. Randomization was computer generated and assigned participants to either the intervention (probiotics) or control (placebo) group. Participants, parents or caregivers, and investigators were masked to the group assignments. The primary analysis followed the intention-to-treat approach.</p><p><strong>Interventions: </strong>The probiotic group received daily single dose of 0.5 mL probiotic mixture containing Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, and Lactobacillus rhamnosus HN001 for 14 days. The placebo group received daily single dose of 0.5 mL placebo for 14 days.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was fever duration, defined as the number of days between the first and the last days with fever.</p><p><strong>Results: </strong>Of the 128 patients enrolled (69 males [54%]; mean [SD] age 2.5 [1.3] years), 65 (51%) were randomly assigned to receive placebo and 63 (49%) to receive probiotics. The median (IQR) fever duration was shorter in the probiotic group than the placebo group (median [IQR], 3 [2-4] days vs 5 [4-6] days; adjusted risk ratio, 0.64; 95% CI, 0.51-0.80). Few mild adverse events were reported and did not significantly differ between the probiotic and placebo groups, including constipation (6 [16%] and 6 [12%]; P = .80) and abdominal pain (3 [8%] and 2 [4%]; P = .65).</p><p><strong>Conclusions and relevance: </strong>In this randomized clinical trial, administering a probiotic mixture reduced fever duration by 2 days compared with placebo, with no meaningful safety concerns. The probiotic mixture under investigation could be an effective adjuvant for shortening fever duration in children with URTIs.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT06052540.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"8 3","pages":"e250669"},"PeriodicalIF":10.5,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909606/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143624687","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}