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Nevin Manimala Statistics

Serum Alpha-Linolenic Acid and Long-Term Multiple Sclerosis Activity and Progression

Neurology. 2025 Aug 12;105(3):e213905. doi: 10.1212/WNL.0000000000213905. Epub 2025 Jul 17.

ABSTRACT

BACKGROUND AND OBJECTIVES: Higher dietary intake of alpha-linolenic acid (ALA), a plant-derived omega-3 polyunsaturated fatty acid (PUFA), was associated with a lower risk of multiple sclerosis (MS) in a prospective cohort study and lower risk of new lesions, relapses, and disability progression in a patient cohort. We examined whether serum levels of ALA and other PUFAs predicted MS outcomes up to 11 years after clinical onset.

METHODS: This prospective study was conducted among participants in the BENEFIT clinical trial, who had serum samples collected starting at randomization. Serum fatty acids were measured using gas chromatography. We evaluated the association of individual fatty acids with time to clinically definite MS (CDMS) and other measures of disease activity and progression using Cox, negative binomial, and linear regression.

RESULTS: We followed 468 participants for 5 years, including 278 followed to year 11. At baseline, the median age was 30 years and 71% were women. Higher baseline serum ALA levels were associated with a lower risk of CDMS and relapses during follow-up. The multivariable-adjusted hazard ratios for CDMS comparing top to bottom quartile were 0.60 (95% CI 0.39-0.95) and 0.60 (95% CI 0.37-0.98) after 5 and 11 years, respectively. The multivariable adjusted risk ratios for relapses comparing top to bottom quartile were 0.60 (95% CI 0.38-0.94) and 0.65 (95% CI 0.43-0.99) after 5 and 11 years, respectively. None of the other 35 fatty acids were associated with CDMS risk. Three fatty acids were associated with relapse rate after 5 years, but not 11 years. Higher ALA levels were associated with a slower decline in MS Functional Composite, an assessment of disability, at 5 years. The association was similar at 11 years, but the results did not retain statistical significance. Baseline ALA levels were not associated with subsequent changes in cognitive function, time to confirmed Expanded Disability Status Scale progression, new active lesions, or brain volume loss.

DISCUSSSION: Higher serum ALA levels were associated with a lower risk of CDMS, relapses, and disability progression in a large prospective cohort. The results were null or inconsistent for other fatty acids.

PMID:40674673 | DOI:10.1212/WNL.0000000000213905

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Nevin Manimala Statistics

Proper Definition of Postprostatectomy Prostate-Specific Antigen Persistence-Reply

JAMA Oncol. 2025 Jul 17. doi: 10.1001/jamaoncol.2025.2120. Online ahead of print.

NO ABSTRACT

PMID:40674084 | DOI:10.1001/jamaoncol.2025.2120

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Nevin Manimala Statistics

Risk Factors for COVID-19-Related Hospitalization and Death in Patients With Cancer: The National Cancer Institute COVID-19 in Cancer Patients Study (NCCAPS)

JAMA Oncol. 2025 Jul 17. doi: 10.1001/jamaoncol.2025.2010. Online ahead of print.

ABSTRACT

IMPORTANCE: Retrospective case series have identified having cancer and receiving treatment for cancer as risk factors for inferior COVID-19 outcomes.

OBJECTIVE: To determine risk factors for hospitalization and death in patients with cancer with COVID-19 infection.

DESIGN, SETTING, AND PARTICIPANTS: The National Cancer Institute COVID-19 in Cancer Patients Study (NCCAPS) is a prospective longitudinal natural history cohort study examining the impact of COVID-19 on patients with cancer. Adults were eligible within 14 days of an initial positive SARS-CoV-2 test result if they were receiving active treatment for cancer or had prior stem cell/bone marrow transplant or CAR T-cell treatment. The statistical analysis took place between September 2024 and April 2025.

MAIN OUTCOMES AND MEASURES: The primary objective of the study was to determine patient factors, therapy types, and cancer types associated with COVID-19 severity, defined as hospitalization for or death from COVID-19 within 30 and 90 days after the first positive SARS-CoV-2 test result. Multivariable regressions were performed for COVID-19-specific hospitalization and mortality (proportional hazard and cause-specific hazard models).

RESULTS: Of 1572 eligible adult patients (median [range] age, 60 [18-93] years; 840 female [53.4%]), 1066 (67.8%) had a solid tumor, with 683 (64.0%) having metastatic disease; breast (252 [23.6%]) and lung cancer (148 [13.9%]) were most common. At enrollment, 1013 patients (64.4%) were unvaccinated for SARS-CoV-2. COVID-19-related mortality at 90 days was 3.0% and did not increase at subsequent time points. The cumulative incidence of COVID-19-specific death in the first 90 days was highest in patients with lymphoma, intermediate in patients with acute leukemia and lung cancer, and lowest in patients with other solid tumors and other hematologic cancers. In multivariable analysis, receipt of chemotherapy (hazard ratio [HR], 1.97; 95% CI, 1.52-2.54) and baseline history of stroke, atrial fibrillation, or pulmonary embolism (HR, 1.78; 95% CI, 1.33-2.38) were associated with a higher risk of hospitalization. Vaccination prior to SARS-CoV-2 infection was associated with a lower risk of hospitalization (HR, 0.52; 95% CI, 0.38-0.70). Over 2 years of follow-up, there were 1739 cancer treatment disruptions, of which 881 (50.7%) were attributed to COVID-19, with most disruptions occurring within the first 30 days.

CONCLUSIONS AND RELEVANCE: The results of this prospective cohort study showed that COVID-19 had a significant impact on patients with cancer, including hospitalization, treatment disruptions, and death.

PMID:40674082 | DOI:10.1001/jamaoncol.2025.2010

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COVID-19 Vaccine Booster Uptake and Effectiveness Among US Adults With Cancer

JAMA Oncol. 2025 Jul 17. doi: 10.1001/jamaoncol.2025.2020. Online ahead of print.

ABSTRACT

IMPORTANCE: Persons with cancer are at increased risk of severe COVID-19 infection, but the additional benefit of COVID-19 boosters is unclear.

OBJECTIVE: To assess COVID-19 vaccine effectiveness (VE) and number needed to vaccinate (NNV) among persons with cancer of an additional dose of the monovalent COVID-19 vaccine.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study conducted in 4 health care systems in the US among persons with cancer receiving chemotherapy or immunotherapy. Statistical analysis was conducted between March 2023 and August 2024.

EXPOSURES: Receipt of an additional dose of the monovalent COVID-19 vaccine before January 1, 2022, with follow-up until August 31, 2022, and the bivalent COVID-19 vaccine from September 1, 2022, to August 31, 2023.

MAIN OUTCOMES AND MEASURES: COVID-19 hospitalization, diagnosed COVID-19, and COVID-19-related intensive care unit (ICU) admission.

RESULTS: Among 72 831 persons with cancer (17 922 female individuals [24.6%]), 69% received a monovalent booster by January 1, 2022. During 34 006 person-years of follow-up, the COVID-19 hospitalization rate was 30.5 per 1000 person-years among patients who received a monovalent booster vs 41.9 per 1000 person-years among patients who received the primary series alone, with an adjusted VE of 29.2% (95% CI, 19.9%-37.3%) and NNV to prevent 1 COVID-19 hospitalization of 166 (95% CI, 130-244). There was also significant VE to prevent diagnosed COVID-19 (8.5% [95% CI, 3.7%-13.0%]) and COVID-19-related ICU admission (35.6% [95% CI, 20.0%-48.3%]). Among 88 417 persons with cancer (24 589 female individuals [27.8%]) with 81 027 person-years of follow-up during the bivalent period, patients who received this booster (38%) had a COVID-19 hospitalization rate of 13.4 per 1000 person-years vs 21.7 per 1000 person-years among persons who did not receive a bivalent vaccine, with an adjusted VE of 29.9% (95% CI, 19.4%-39.1%) and NNV to prevent 1 COVID-19 hospitalization of 451 (95% CI, 345-697); the adjusted VE was 30.1% (95% CI, 7.7%-47.0%) to prevent COVID-19-related ICU admission.

CONCLUSIONS AND RELEVANCE: In this retrospective cohort study, COVID-19 booster vaccinations were associated with significant protection against severe COVID-19, with a favorable NNV among persons with cancer. However, uptake of COVID-19 vaccine boosters was low, and interventions are therefore justified to increase COVID-19 uptake in this high-risk population.

PMID:40674059 | DOI:10.1001/jamaoncol.2025.2020

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Homelessness, Patient Navigation, and Lung Cancer Screening in a Health Center Setting: A Subgroup Analysis of a Randomized Clinical Trial

JAMA Netw Open. 2025 Jul 1;8(7):e2519780. doi: 10.1001/jamanetworkopen.2025.19780.

ABSTRACT

IMPORTANCE: Lung cancer is a major cause of death among people who experience homelessness. Patient navigation is an effective strategy for promoting lung cancer screening (LCS) in Health Care for the Homeless (HCH) settings, but little is known about whether the impact of this intervention differs for patients currently vs formerly experiencing homelessness.

OBJECTIVES: To examine the effect of LCS patient navigation on individuals currently vs formerly experiencing homelessness, and to explore how navigation process measures differ for these subgroups.

DESIGN, SETTING, AND PARTICIPANTS: This is a subgroup analysis of the Investigating Navigation to Help Advance Lung Equity (INHALE) pragmatic randomized clinical trial of LCS patient navigation. The INHALE trial was conducted at Boston Health Care for the Homeless Program (BHCHP), a federally qualified health center serving nearly 10 000 patients who have experienced homelessness annually. The study included BHCHP primary care patients with a lifetime history of homelessness who were proficient in English and eligible for LCS under pre-2022 Medicare coverage criteria. The study was conducted between November 20, 2020, and March 29, 2023.

EXPOSURE: Current vs former homelessness, defined by self-reported responses to a detailed residential inventory. Sensitivity analyses further categorized individuals who formerly experienced homelessness as having stable or unstable housing.

MAIN OUTCOMES AND MEASURES: The primary outcome was verified receipt of a 1-time LCS low-dose computed tomography (LDCT) scan within 6 months after randomization. The risk difference (RD) in primary outcome attainment between navigation and usual care within each homelessness subgroup was calculated, and these RDs were compared by testing the interaction between study group and homelessness status in a linear binomial regression model with the identity link.

RESULTS: This study included 260 participants (mean [SD] age, 60.5 [4.7] years; 184 male individuals [70.8%]). At baseline, 84 patients (32.3%) were currently experiencing homelessness and 176 (67.7%) had formerly experienced homelessness. Patient navigation significantly increased LCS LDCT completion among both those currently (15 of 56 [26.8%] vs 2 of 28 [7.1%]; P = .04) and formerly (60 of 117 [51.3%] vs 6 of 59 [10.2%]; P < .001) experiencing homelessness. However, the treatment effect was significantly smaller among participants currently experiencing homelessness (RD, 19.7% vs 41.1%; P = .03), such that a disparity in LCS completion between these subgroups emerged under the navigation condition. Navigation process measures highlighted communication challenges with participants currently experiencing homelessness. In sensitivity analyses, LCS LDCT completion rates and navigation process measures were generally similar for stably vs unstably housed participants who formerly experienced homelessness.

CONCLUSIONS AND RELEVANCE: In this subgroup analysis of a randomized clinical trial, patient navigation increased LCS participation among both patients currently and formerly experiencing homelessness; however, the effect size was smaller for those currently experiencing homelessness. Further improving cancer outcomes among HCH patients may require refinement of the patient navigation intervention, coupled with policy efforts to promote housing attainment among people experiencing homelessness.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04308226.

PMID:40674053 | DOI:10.1001/jamanetworkopen.2025.19780

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Nevin Manimala Statistics

Electronic Health Record Interventions to Reduce Risk of Hospital Readmissions: A Systematic Review and Meta-Analysis

JAMA Netw Open. 2025 Jul 1;8(7):e2521785. doi: 10.1001/jamanetworkopen.2025.21785.

ABSTRACT

IMPORTANCE: Hospital readmissions are associated with significant health care costs and poor patient outcomes. Despite the rapid adoption of electronic health record (EHR) systems, the use of EHR-based interventions to reduce the risk of hospital readmissions is unknown.

OBJECTIVE: To systematically review and estimate the association of EHR-based interventions vs controls with preventing 30-day all-cause hospital readmissions as tested in randomized clinical trials (RCTs).

DATA SOURCES: Ovid MEDLINE, Ovid Embase, CINAHL, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched from database inception to July 5, 2024, using text words with analogous terms within concept areas of “randomized controlled trial,” “hospitalized adults,” and “readmissions.”

STUDY SELECTION: RCTs were included if they evaluated the effect of EHR-based interventions on hospital readmissions compared with a control arm without an EHR-embedded component. Studies were excluded if they involved nonhospitalized, pediatric, obstetric, or psychiatric populations or did not report readmission outcomes. Results were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline.

DATA EXTRACTION AND SYNTHESIS: Data were extracted independently by 3 reviewers in duplicate. A random-effects model was used to pool data, and the quality of studies was assessed using the Cochrane Risk of Bias tool. Heterogeneity was quantified using the I2 statistic and explored with prespecified subgroup analyses and univariable meta-regression by population demographics, intervention complexity, and publication year.

MAIN OUTCOMES AND MEASURES: The primary outcome was 30-day all-cause hospital readmission, and other readmission outcomes (eg, unplanned readmissions and readmissions at 3, 6, 12, and 24 months) were examined as secondary outcomes.

RESULTS: A total of 116 RCTs involving 204 523 participants (weighted mean [SD] males, 56% [16%]; weighted mean [SD] age, 68 [9] years) were included, with telemonitoring (76 studies [66%]) being the most common EHR-based intervention component followed by case management (45 studies [39%]) and medication reconciliation (33 [28%]). EHR-based interventions were associated with a statistically significant reduction in 30-day all-cause readmissions (OR, 0.83 [95% CI, 0.70-0.99]; I2 = 82%; τ = 0.44 [95% CI, 0.30-0.62]; prediction interval [PI], 0.34-2.06) and 90-day all-cause readmissions (OR, 0.72 [95% CI, 0.54-0.96]; I2 = 78%; τ = 0.34 [95% CI, 0.19-1.00]; PI, 0.33-1.55) compared with control arms.

CONCLUSIONS AND RELEVANCE: In this systematic review and meta-analysis of RCTs, the use of EHR-based interventions was associated with a reduction in 30-day and 90-day hospital readmissions. Future research should examine additional components of EHR interventions to understand and account for remaining gaps in effectiveness.

PMID:40674049 | DOI:10.1001/jamanetworkopen.2025.21785

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Nevin Manimala Statistics

Estimated Exposure to Televised Alcohol Advertisements Among Children and Adolescents

JAMA Netw Open. 2025 Jul 1;8(7):e2521819. doi: 10.1001/jamanetworkopen.2025.21819.

ABSTRACT

IMPORTANCE: Alcohol advertising on television in China has the potential to target children and adolescents with harmful content. Understanding the extent of this advertising is critical for informing and improving current regulatory approaches.

OBJECTIVE: To measure the exposure of alcohol advertisements on television channels popular among children and adolescents in Beijing, China.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study of television advertisements used the 4 most popular television channels for viewers aged 3 to 18 years (2 children’s channels and 2 general channels) in Beijing and accessed advertisements recorded from October 19, 2020, to January 17, 2021. Television advertisements were recorded during 4 randomly selected weekdays and 4 randomly selected weekend days (from 6:00 am to 11:59 pm). Data were analyzed from October 1, 2023, to December 31, 2024.

EXPOSURES: Television alcohol advertisements, with food and nonalcoholic beverages (F&B) advertisements classified as not permitted in marketing to children included as comparison.

MAIN OUTCOMES AND MEASURES: Primary outcomes included frequency and distribution of alcohol advertisements, rate per channel-hour, and potential exposure during peak viewing times (PVT). Secondary outcomes included comparison with F&B advertisements classified as not permitted based on the World Health Organization Western Pacific Region Office Nutrient Profile Model integrated with the International Network for Food and Obesity/Non-communicable Diseases Research, Monitoring and Action Support (INFORMAS) food classification system and analysis of 6 marketing strategies.

RESULTS: Among 13 864 total advertisements included in the analysis, 5368 were food advertisements. Among the food advertisements, 321 (6.0%; 95% CI, 5.4%-6.7%) were alcohol advertisements and 2001 (37.3%; 95% CI, 36.0%-38.6%) were F&B advertisements classified as not permitted. On general channels, a mean (SD) of 1.1 (1.7) alcohol advertisements per channel-hour were identified, with significantly higher rates during PVT compared with non-PVT (2.0 [2.4] vs 0.7 [0.9] per channel-hour; P < .001). The highest rate occurred between 9:00 and 9:59 pm, with a mean (SD) of 3.7 (2.8) advertisements per channel-hour and an estimated mean (SD) of 14 303 014 (11 659 096) impressions among children and adolescents. All 321 alcohol advertisements (100%; 95% CI, 98.9%-100%) and 1997 F&B advertisements classified as not permitted (99.8%; 95% CI, 99.5%-99.9%) used at least 1 marketing strategy, predominantly brand benefit claims, which were used in 307 alcohol advertisements (95.6%; 95% CI, 92.8%-97.4%) and 1915 F&B advertisements classified as not permitted (95.7%; 95% CI, 94.7%-96.5%).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of television advertising, alcohol advertisements on general channels exceeded regulatory limits, especially during PVT. These findings suggest that current regulations allow exposure of children and adolescents to alcohol marketing and should be strengthened.

PMID:40674047 | DOI:10.1001/jamanetworkopen.2025.21819

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Acceptability and feasibility of the clinician-administered PTSD Scale for DSM-5 training simulator

Psychol Trauma. 2025 Jul 17. doi: 10.1037/tra0001998. Online ahead of print.

ABSTRACT

OBJECTIVE: The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is regarded as the state-of-the-art method for diagnosing Diagnostic and Statistical Manual of Mental Disorders, fifth edition, posttraumatic stress disorder (PTSD). To address the high demand for training in the CAPS-5, we developed the CAPS-5 Training Simulator (CAPSim), an online program in which learners administer the CAPS-5 to lifelike virtual PTSD patients and receive feedback on their performance.

METHOD: We created three virtual standardized PTSD patients who respond verbally to learners’ spoken or typed prompts. Complexity and availability of in-course feedback varied across patients. The program was then made available to interested learners, and data on program use and user performance were collected to determine acceptability and feasibility.

RESULTS: Over the first 4 years of the program, 4,484 users accessed the training. Of those who started the course (N = 3,022), most (83.6%) completed it. Although CAPS-5 familiarity varied, more than half of the users (58.3%) reported being moderately familiar with the CAPS-5 at baseline. Administration and scoring accuracy varied by virtual patient and by CAPS-5 item, with overall accuracy ranging from near perfect to 77.1% incorrect. Whereas the initial symptom prompts were delivered verbatim 76.2% of the time, in-sequence and additional required prompts were administered with less accuracy (46.0% and 39.2%, respectively).

CONCLUSIONS: The CAPSim is an innovative method for training CAPS-5 learners with various skill levels. The CAPSim can identify specific administrative and scoring challenges and provide personalized feedback in a manner that appears acceptable to learners. The CAPSim has promise to meet the high demand for CAPS-5 training. (PsycInfo Database Record (c) 2025 APA, all rights reserved).

PMID:40674018 | DOI:10.1037/tra0001998

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Do expressive suppression and cognitive reappraisal affect memory?

Emotion. 2025 Jul 17. doi: 10.1037/emo0001562. Online ahead of print.

ABSTRACT

A widely cited idea in the emotion regulation literature holds that expressive suppression impairs memory while cognitive reappraisal has no effect on or may enhance memory relative to control. However, empirical evidence for these effects has been inconsistent. To provide a definitive test, we conducted four well-powered experiments with more than 4,000 participants to examine the effects of reappraisal and suppression of negative emotion (Experiments 1 and 3) and positive emotion (Experiments 2 and 4) on verbal and nonverbal memory. Results showed no consistent evidence for an effect of reappraisal on either type of memory, though expressive suppression of negative emotion consistently impaired verbal memory relative to control. Obtained effect sizes were small given successful emotion regulation manipulations and adequate statistical power (ds < 0.11). Conclusions are constrained to English-speaking online samples, and may not generalize to other types of memory. These findings highlight the need to systematically test widely accepted assumptions as a field. (PsycInfo Database Record (c) 2025 APA, all rights reserved).

PMID:40674016 | DOI:10.1037/emo0001562

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Prenatal stress and infant sleep: The role of maternal emotional distress and sensitive behavior

J Fam Psychol. 2025 Jul 17. doi: 10.1037/fam0001378. Online ahead of print.

ABSTRACT

The association between prenatal stress factors and infant sleep has been examined in the literature, however, the mechanisms explaining this association remain unclear. The present study examined the indirect association between prenatal stress and infant sleep problems via maternal emotional distress and maternal sensitivity in distress-eliciting context in a three-wave longitudinal study that followed 299 mothers from pregnancy until the infants were 6 months old. Expectant mothers reported demographics, prenatal stress (i.e., stressful life events, neighborhood violence, income) and emotional distress (i.e., depressive symptoms, trait anxiety, emotion regulation difficulties, and personality characteristics) Prior to the 2-month laboratory visit, mothers reported their depressive symptoms and state anxiety. During the 2- and 6-month laboratory visits, maternal sensitivity in distress-eliciting context was assessed during the still-face episode of the still-face paradigm. Mothers reported infant sleep problems at 6 months. Consistent with hypotheses, prenatal stress predicted higher perinatal emotional distress which in turn was significantly associated with lower maternal sensitivity. Further, maternal sensitivity was significantly associated with fewer infant sleep problems. The indirect pathway from prenatal stress to infant sleep problems via elevated maternal emotional distress and compromised maternal sensitivity was statistically significant. The findings affirm the need for policies and interventions to better support mothers exposed to prenatal stress and/or experiencing emotional distress to ensure optimal infant sleep outcomes. (PsycInfo Database Record (c) 2025 APA, all rights reserved).

PMID:40674011 | DOI:10.1037/fam0001378