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Error in Funding/Support.
IF 10.5 1区 医学
JAMA Network Open Pub Date : 2024-12-02 DOI: 10.1001/jamanetworkopen.2024.52013
{"title":"Error in Funding/Support.","authors":"","doi":"10.1001/jamanetworkopen.2024.52013","DOIUrl":"10.1001/jamanetworkopen.2024.52013","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"7 12","pages":"e2452013"},"PeriodicalIF":10.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629122/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800781","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}
引用次数: 0
Physical Activity Engagement After Tai Ji Quan Intervention Among Older Adults With Mild Cognitive Impairment or Memory Concerns: A Secondary Analysis of a Randomized Clinical Trial. 对有轻度认知障碍或记忆问题的老年人进行太极拳干预后的体育活动参与度:随机临床试验的二次分析。
IF 10.5 1区 医学
JAMA Network Open Pub Date : 2024-12-02 DOI: 10.1001/jamanetworkopen.2024.50457
Fuzhong Li, Peter Harmer, Elizabeth Eckstrom, Kerri Winters-Stone
{"title":"Physical Activity Engagement After Tai Ji Quan Intervention Among Older Adults With Mild Cognitive Impairment or Memory Concerns: A Secondary Analysis of a Randomized Clinical Trial.","authors":"Fuzhong Li, Peter Harmer, Elizabeth Eckstrom, Kerri Winters-Stone","doi":"10.1001/jamanetworkopen.2024.50457","DOIUrl":"10.1001/jamanetworkopen.2024.50457","url":null,"abstract":"<p><strong>Importance: </strong>The effect of exercise interventions on increasing and sustaining moderate to vigorous physical activity (MVPA) among older adults with mild cognitive impairment (MCI), who are at heightened risk of dementia, remains unclear.</p><p><strong>Objective: </strong>To examine whether participation in a 6-month, supervised, home-based tai ji quan intervention increases MVPA among US community-dwelling older adults at 1 year.</p><p><strong>Design, setting, and participants: </strong>This study was a secondary analysis of a parallel-group, outcome assessor-blinded, randomized clinical trial conducted virtually at participants' homes. Eligible participants were aged 65 years or older, lived independently, and had a baseline Clinical Dementia Rating (CDR) global score of 0.5 or less. Participants were enrolled between October 1, 2019, and June 30, 2022. Final follow-up occurred in May 2023.</p><p><strong>Interventions: </strong>Participants were randomly assigned (1:1:1) to standard tai ji quan, cognitively enhanced tai ji quan, or stretching, and they exercised (via real-time videoconferencing) 1 hour semiweekly for 6 months.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was self-reported time engaged in MVPA (in minutes per week), assessed with the International Physical Activity Questionnaire at baseline and at 4, 6, and 12 months following randomization. The Physical Activity Guidelines for Americans recommend that older adults achieve at least 150 min/wk of MVPA, and the number of participants meeting this recommendation was also assessed. Analyses followed the intention-to-treat principle.</p><p><strong>Results: </strong>Among the 318 participants enrolled, 107 were randomized to standard tai ji quan, 105 to cognitively enhanced tai ji quan, and 106 to stretching. Their mean (SD) age was 76 (5) years, 212 (66.7%) were women, and 247 (77.7%) had a CDR global score of 0.5. A total of 304 participants (95.6%) completed the trial, and 299 (94.0%) had complete data on the primary outcome at the 12-month follow-up. At 12 months, both tai ji quan groups had increased MVPA levels compared with the stretching control group, with mean differences from baseline of 66 min/wk (95% CI, 25-108 min/wk; P = .002) with standard tai ji quan and 65 min/wk (95% CI, 24-108 min/wk; P = .002) with cognitively enhanced tai ji quan. Odds ratios for meeting the recommended amount of MVPA (≥150 min/wk) were 3.11 (95% CI, 1.75-5.53; P < .001) for the standard tai ji quan group and 3.67 (95% CI, 2.02-6.65; P < .001) for the cognitively enhanced tai ji quan group compared with the stretching group.</p><p><strong>Conclusion and relevance: </strong>In this secondary analysis of a randomized clinical trial involving older adults with MCI or self-reported memory concerns, home-based tai ji quan training (delivered via videoconferencing) increased MVPA 6 months following cessation of the intervention compared with stretching. Thes","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"7 12","pages":"e2450457"},"PeriodicalIF":10.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142836444","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}
引用次数: 0
Age at First Fracture and Later Fracture Risk in Older Adults Undergoing Osteoporosis Assessment.
IF 10.5 1区 医学
JAMA Network Open Pub Date : 2024-12-02 DOI: 10.1001/jamanetworkopen.2024.48208
Carrie Ye, Suzanne N Morin, Lisa M Lix, Eugene V McCloskey, Helena Johansson, Nicholas C Harvey, John A Kanis, William D Leslie
{"title":"Age at First Fracture and Later Fracture Risk in Older Adults Undergoing Osteoporosis Assessment.","authors":"Carrie Ye, Suzanne N Morin, Lisa M Lix, Eugene V McCloskey, Helena Johansson, Nicholas C Harvey, John A Kanis, William D Leslie","doi":"10.1001/jamanetworkopen.2024.48208","DOIUrl":"10.1001/jamanetworkopen.2024.48208","url":null,"abstract":"<p><strong>Importance: </strong>Fragility fractures are often defined as those that occur after a certain age (eg, 40-50 years). Whether fractures occurring in early adulthood are equally associated with future fractures is unclear.</p><p><strong>Objective: </strong>To examine whether the age at which a prior fracture occurred is associated with future fracture risk.</p><p><strong>Design, setting, and participants: </strong>This observational, population-based cohort study included individuals from the Manitoba Bone Mineral Density Registry with a first bone mineral density (BMD) measurement between January 1, 1996, and March 31, 2018, with and without prior fracture in adulthood. Data analysis was completed between April 1, and May 31, 2023.</p><p><strong>Exposure: </strong>Individuals with fractures before their first dual-energy x-ray absorptiometry were stratified by the age at first fracture (10-year intervals from 20-29 to ≥80 years of age).</p><p><strong>Main outcomes and measures: </strong>Incident fractures occurring after dual-energy x-ray absorptiometry (index date) and before March 31, 2021, were identified using linked provincial administrative health data.</p><p><strong>Results: </strong>The cohort included 88 696 individuals (80 066 [90.3%] female; mean [SD] age, 64.6 [11.0] years) with a mean (SD) femoral neck T score of -1.4 (1.0). A total of 21 105 individuals (23.8%) had sustained a prior fracture at a mean (SD) age of 57.7 (13.6) years (range, 20.0-102.4 years) at the time of first prior fracture. During a mean (SD) of 9.0 (5.5) years of follow-up, incident fractures occurred in 13 239 individuals (14.6%), including 12 425 osteoporotic fractures (14.0%), 9440 major osteoporotic fractures (MOFs) (10.6%), and 3068 hip fractures (3.5%). The sex- and age-adjusted hazard ratios for all incident fractures, osteoporotic fractures, and MOFs, according to age at first fracture, were all significantly elevated, with point estimates ranging from 1.55 (95% CI, 1.28-1.88) to 4.07 (95% CI, 2.99-5.52). After adjusting for the additional covariates, the effect estimates were similar and remained significantly elevated, with point estimates ranging from fully adjusted hazard ratios of 1.51 (95% CI, 1.42-1.60) to 2.12 (95% CI, 1.67-2.71) across age categories. Sensitivity analyses examining age at last prior fracture and in those with multiple prior fractures showed similar results.</p><p><strong>Conclusions and relevance: </strong>In this cohort study, fractures in adulthood were associated with future fractures regardless of the age at which they occurred. Thus, fractures in early adulthood should not be excluded when assessing an individual's ongoing fracture risk.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"7 12","pages":"e2448208"},"PeriodicalIF":10.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11612869/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769120","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}
引用次数: 0
Improving Prognostication in Hypoxic-Ischemic Encephalopathy.
IF 10.5 1区 医学
JAMA Network Open Pub Date : 2024-12-02 DOI: 10.1001/jamanetworkopen.2024.49197
Daniel G Calame, Kristen S Fisher
{"title":"Improving Prognostication in Hypoxic-Ischemic Encephalopathy.","authors":"Daniel G Calame, Kristen S Fisher","doi":"10.1001/jamanetworkopen.2024.49197","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2024.49197","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"7 12","pages":"e2449197"},"PeriodicalIF":10.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142785692","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}
引用次数: 0
JAMA Network Open.
IF 10.5 1区 医学
JAMA Network Open Pub Date : 2024-12-02 DOI: 10.1001/jamanetworkopen.2024.53628
{"title":"JAMA Network Open.","authors":"","doi":"10.1001/jamanetworkopen.2024.53628","DOIUrl":"https://doi.org/10.1001/jamanetworkopen.2024.53628","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"7 12","pages":"e2453628"},"PeriodicalIF":10.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769163","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}
引用次数: 0
Accuracy in Measurement of Infant Formula Powder and Water by Caregivers With and Without a Crying Baby Present.
IF 10.5 1区 医学
JAMA Network Open Pub Date : 2024-12-02 DOI: 10.1001/jamanetworkopen.2024.47362
Richard R Rosenkranz, Chris Acosta, Ana Gonzalez-Alvarez, Andrew Hooyman, Jose R Hidalgo, Romina Ballesteros-Paniagua, Sara K Rosenkranz
{"title":"Accuracy in Measurement of Infant Formula Powder and Water by Caregivers With and Without a Crying Baby Present.","authors":"Richard R Rosenkranz, Chris Acosta, Ana Gonzalez-Alvarez, Andrew Hooyman, Jose R Hidalgo, Romina Ballesteros-Paniagua, Sara K Rosenkranz","doi":"10.1001/jamanetworkopen.2024.47362","DOIUrl":"10.1001/jamanetworkopen.2024.47362","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"7 12","pages":"e2447362"},"PeriodicalIF":10.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11618465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769025","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}
引用次数: 0
Evaluating Bias-Mitigated Predictive Models of Perinatal Mood and Anxiety Disorders.
IF 10.5 1区 医学
JAMA Network Open Pub Date : 2024-12-02 DOI: 10.1001/jamanetworkopen.2024.38152
Emily F Wong, Anil K Saini, Eynav E Accortt, Melissa S Wong, Jason H Moore, Tiffani J Bright
{"title":"Evaluating Bias-Mitigated Predictive Models of Perinatal Mood and Anxiety Disorders.","authors":"Emily F Wong, Anil K Saini, Eynav E Accortt, Melissa S Wong, Jason H Moore, Tiffani J Bright","doi":"10.1001/jamanetworkopen.2024.38152","DOIUrl":"10.1001/jamanetworkopen.2024.38152","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Importance: &lt;/strong&gt;Machine learning for augmented screening of perinatal mood and anxiety disorders (PMADs) requires thorough consideration of clinical biases embedded in electronic health records (EHRs) and rigorous evaluations of model performance.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To mitigate bias in predictive models of PMADs trained on commonly available EHRs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, and participants: &lt;/strong&gt;This diagnostic study collected data as part of a quality improvement initiative from 2020 to 2023 at Cedars-Sinai Medical Center in Los Angeles, California. The study inclusion criteria were birthing patients aged 14 to 59 years with live birth records and admission to the postpartum unit or the maternal-fetal care unit after delivery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Exposure: &lt;/strong&gt;Patient-reported race and ethnicity (7 levels) obtained through EHRs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcomes and measures: &lt;/strong&gt;Logistic regression, random forest, and extreme gradient boosting models were trained to predict 2 binary outcomes: moderate to high-risk (positive) screen assessed using the 9-item Patient Health Questionnaire (PHQ-9), and the Edinburgh Postnatal Depression Scale (EPDS). Each model was fitted with or without reweighing data during preprocessing and evaluated through repeated K-fold cross validation. In every iteration, each model was evaluated on its area under the receiver operating curve (AUROC) and on 2 fairness metrics: demographic parity (DP), and difference in false negatives between races and ethnicities (relative to non-Hispanic White patients).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among 19 430 patients in this study, 1402 (7%) identified as African American or Black, 2371 (12%) as Asian American and Pacific Islander; 1842 (10%) as Hispanic White, 10 942 (56.3%) as non-Hispanic White, 606 (3%) as multiple races, 2146 (11%) as other (not further specified), and 121 (&lt;1%) did not provide this information. The mean (SD) age was 34.1 (4.9) years, and all patients identified as female. Racial and ethnic minority patients were significantly more likely than non-Hispanic White patients to screen positive on both the PHQ-9 (odds ratio, 1.47 [95% CI, 1.23-1.77]) and the EPDS (odds ratio, 1.38 [95% CI, 1.20-1.57]). Mean AUROCs ranged from 0.610 to 0.635 without reweighing (baseline), and from 0.602 to 0.622 with reweighing. Baseline models predicted significantly greater prevalence of postpartum depression for patients who were not non-Hispanic White relative to those who were (mean DP, 0.238 [95% CI, 0.231-0.244]; P &lt; .001) and displayed significantly lower false-negative rates (mean difference, -0.184 [95% CI, -0.195 to -0.174]; P &lt; .001). Reweighing significantly reduced differences in DP (mean DP with reweighing, 0.022 [95% CI, 0.017-0.026]; P &lt; .001) and false-negative rates (mean difference with reweighing, 0.018 [95% CI, 0.008-0.028]; P &lt; .001) between racial and ethnic groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions and relevance: &lt;/strong&gt;In t","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"7 12","pages":"e2438152"},"PeriodicalIF":10.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11615713/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769150","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}
引用次数: 0
BNT162b2 XBB Vaccine for COVID-19 Among Children 5-17 Years of Age.
IF 10.5 1区 医学
JAMA Network Open Pub Date : 2024-12-02 DOI: 10.1001/jamanetworkopen.2024.49944
Sara Y Tartof, Timothy B Frankland, Laura Puzniak, Jeff M Slezak, Bradley K Ackerson, Vennis Hong, Julie Stern, Joann M Zamparo, Hina Chowdhry, Brigitte Spence, Gregg S Davis, Luis Jodar, John M McLaughlin
{"title":"BNT162b2 XBB Vaccine for COVID-19 Among Children 5-17 Years of Age.","authors":"Sara Y Tartof, Timothy B Frankland, Laura Puzniak, Jeff M Slezak, Bradley K Ackerson, Vennis Hong, Julie Stern, Joann M Zamparo, Hina Chowdhry, Brigitte Spence, Gregg S Davis, Luis Jodar, John M McLaughlin","doi":"10.1001/jamanetworkopen.2024.49944","DOIUrl":"10.1001/jamanetworkopen.2024.49944","url":null,"abstract":"","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"7 12","pages":"e2449944"},"PeriodicalIF":10.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11638790/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813261","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}
引用次数: 0
Resuscitation With Placental Circulation Intact Compared With Cord Milking: A Randomized Clinical Trial. 胎盘循环完好的复苏与脐带挤奶相比:随机临床试验
IF 10.5 1区 医学
JAMA Network Open Pub Date : 2024-12-02 DOI: 10.1001/jamanetworkopen.2024.50476
Simone Pratesi, Martina Ciarcià, Luca Boni, Stefano Ghirardello, Cristiana Germini, Stefania Troiani, Eleonora Tulli, Miria Natile, Gina Ancora, Giovanni Barone, Stefania Vedovato, Federica Bertuola, Francesca Parata, Giovanna Mescoli, Fabrizio Sandri, Roberta Corbetta, Luisa Ventura, Giulia Dognini, Flavia Petrillo, Luigia Valenzano, Raffaele Manzari, Anna Lavizzari, Fabio Mosca, Iuri Corsini, Chiara Poggi, Carlo Dani
{"title":"Resuscitation With Placental Circulation Intact Compared With Cord Milking: A Randomized Clinical Trial.","authors":"Simone Pratesi, Martina Ciarcià, Luca Boni, Stefano Ghirardello, Cristiana Germini, Stefania Troiani, Eleonora Tulli, Miria Natile, Gina Ancora, Giovanni Barone, Stefania Vedovato, Federica Bertuola, Francesca Parata, Giovanna Mescoli, Fabrizio Sandri, Roberta Corbetta, Luisa Ventura, Giulia Dognini, Flavia Petrillo, Luigia Valenzano, Raffaele Manzari, Anna Lavizzari, Fabio Mosca, Iuri Corsini, Chiara Poggi, Carlo Dani","doi":"10.1001/jamanetworkopen.2024.50476","DOIUrl":"10.1001/jamanetworkopen.2024.50476","url":null,"abstract":"<p><strong>Importance: </strong>Among preterm newborns undergoing resuscitation, delayed cord clamping for 60 seconds is associated with reduced mortality compared with early clamping. However, the effects of longer durations of cord clamping with respiratory support are unknown.</p><p><strong>Objective: </strong>To determine whether resuscitating preterm newborns while keeping the placental circulation intact and clamping the cord after a long delay would improve outcomes compared with umbilical cord milking.</p><p><strong>Design, setting, and participants: </strong>This randomized clinical trial (PCI Trial) was conducted at 8 Italian neonatal intensive care units from April 2016 through February 2023 and enrolled preterm newborns born between 23 weeks 0 days and 29 weeks 6 days of gestation from singleton pregnancies.</p><p><strong>Interventions: </strong>Enrolled newborns were randomly allocated to receive at-birth resuscitation with intact placental circulation for 180 seconds or umbilical cord milking followed by an early cord clamping (within 20 seconds of life).</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the composite end point of death, grade 3 to 4 intraventricular hemorrhage, and bronchopulmonary dysplasia at 36 weeks of postconception age. Prespecified secondary end points were the single components of the composite primary outcome. An intention-to-treat analysis was conducted.</p><p><strong>Results: </strong>Of 212 mother-newborn dyads who were randomized, 209 (median [IQR] gestational age, 27 [26-28] weeks; median [IQR] birth weight, 900 [700-1070] g) were enrolled in the intention-to-treat population; 105 were randomized to the placental circulation intact group, and 104 were randomized to the cord milking group. The composite outcome of death, grade 3 to 4 intraventricular hemorrhage, or bronchopulmonary dysplasia occurred in 35 of 105 newborns (33%) in the placental circulation intact group vs 39 of 104 newborns (38%) in the cord milking group (odds ratio, 0.83; 95% CI, 0.47-1.47; P = .53).</p><p><strong>Conclusions and relevance: </strong>In a randomized clinical trial of preterm newborns at 23 to 29 weeks' gestational age, intact placental resuscitation for 3 minutes did not lower the composite outcome of death, grade 3 to 4 intraventricular hemorrhage, or bronchopulmonary dysplasia compared with umbilical cord milking.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov Identifier: NCT02671305.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"7 12","pages":"e2450476"},"PeriodicalIF":10.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11645650/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817900","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}
引用次数: 0
Cannabidiol for Scan-Related Anxiety in Women With Advanced Breast Cancer: A Randomized Clinical Trial. 大麻二酚治疗晚期乳腺癌女性患者与扫描相关的焦虑症:随机临床试验
IF 10.5 1区 医学
JAMA Network Open Pub Date : 2024-12-02 DOI: 10.1001/jamanetworkopen.2024.50391
Manan M Nayak, Peter Chai, Paul J Catalano, William F Pirl, James A Tulsky, Stephanie C Tung, Nancy U Lin, Nicole Andrade, Sabrina Johns, Clint Vaz, Melissa Hughes, Ilana M Braun
{"title":"Cannabidiol for Scan-Related Anxiety in Women With Advanced Breast Cancer: A Randomized Clinical Trial.","authors":"Manan M Nayak, Peter Chai, Paul J Catalano, William F Pirl, James A Tulsky, Stephanie C Tung, Nancy U Lin, Nicole Andrade, Sabrina Johns, Clint Vaz, Melissa Hughes, Ilana M Braun","doi":"10.1001/jamanetworkopen.2024.50391","DOIUrl":"10.1001/jamanetworkopen.2024.50391","url":null,"abstract":"<p><strong>Importance: </strong>Early evidence from studies outside of oncology has suggested that cannabidiol (CBD) may have anxiolytic effects without neuropsychiatric risks. An understanding of oral CBD in patients with cancer-related anxiety is urgently needed.</p><p><strong>Objective: </strong>To determine whether a single 400-mg oral dose of a US Food and Drug Administration-approved CBD improves clinical anxiety in an oncologic population.</p><p><strong>Design, setting, and participants: </strong>This phase II, double-masked, placebo-controlled, randomized clinical trial was performed at the Dana-Farber Cancer Institute's Breast Oncology Center from November 2, 2021, through March 1, 2023. Women aged 18 years or older with advanced breast cancer and baseline clinical anxiety were included.</p><p><strong>Interventions: </strong>Patients were randomized 1:1 to receive oral CBD, 400 mg, vs placebo within 48 hours before a scan assessing tumor burden.</p><p><strong>Main outcomes and measures: </strong>The primary end point was a between-arm comparison of change scores on the afraid subscale of the Visual Analog Mood Scale (VAMS) before and 2 to 4 hours after study drug ingestion. The VAMS scores were converted to T-scores to facilitate interpretation of mood change (>20 indicates a reliable change, >30 indicates both a reliable and clinically significant change). Exploratory outcomes included between-arm comparisons of anxiety levels 2 to 4 hours after study drug ingestion, between-arm comparisons of change scores on other VAMS subscales, and safety.</p><p><strong>Results: </strong>Among the 50 participants, 25 were randomized to the placebo arm (mean [range] age, 57 [37-81] years) and 25 were randomized to the CBD arm (mean [range] age, 60 [30-79] years). The primary end point of VAMS afraid subscale change score, although numerically greater in the CBD arm, was not significantly different between arms (mean [SD]: CBD, -19.1 [15.4]; placebo, -15.0 [10.9]; P = .37). The secondary outcome directly comparing anxiety levels between arms 2 to 4 hours after study drug ingestion demonstrated significantly lower VAMS afraid T-scores for participants who received CBD compared with those receiving placebo (mean [SD]: CBD, 51.5 [12.8]; placebo, 58.0 [11.6]; P = .02). No grade 3 or 4 toxic effects were reported.</p><p><strong>Conclusions and relevance: </strong>The findings of this randomized clinical trial show that CBD can be used safely in women with advanced breast cancer and clinical anxiety. Although the study did not meet its primary end point comparing preingestion vs postingestion anxiety change scores between study arms, anxiety levels in the CBD arm were significantly lower 2 to 4 hours after ingestion, suggesting a possible anxiolytic effect and warranting further investigation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04482244.</p>","PeriodicalId":14694,"journal":{"name":"JAMA Network Open","volume":"7 12","pages":"e2450391"},"PeriodicalIF":10.5,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142828518","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}
引用次数: 0
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