JAMA Network Open最新文献

Importance: Mild traumatic brain injuries (mTBI) involving anxiety and mood, cognitive, migraine and headache, ocular, vestibular, sleep, and autonomic domains can result in chronic symptoms and impairments, thereby increasing morbidity and decreasing quality of life for patients. Timely interventions targeting involved mTBI domains may improve symptoms and impairments and accelerate recovery.

Objective: To evaluate the effectiveness of a targeted multidomain (T-MD) intervention for mTBI in adults.

Design, setting, and participants: This multisite randomized clinical trial (RCT), conducted at 2 specialty concussion clinics from June 2021 to April 2024, involved a 4-week intervention and a total follow-up duration of 3 months. Participants were aged 18 to 49 years and were within 8 days to 6 months of an mTBI.

Intervention: Patients were randomized to T-MD interventions tailored to each domain or a behavioral management control group (control).

Main outcomes and measures: Primary outcomes included changes in the Neurobehavioral Symptom Inventory (NSI) and Patient Global Impression of Change (PGIC) assessed from baseline to 4 weeks. Secondary outcomes included domain-specific symptoms and impairments and adverse events. Least-squares adjusted mean differences (aMDs) and 95% CIs were calculated to assess differences between groups.

Results: Of 1639 patients screened, 745 were eligible and 162 (81 per group) were randomized to T-MD or control (102 female [63%]; 60 male [37%]; mean [SD] age, 29 [8] years). The 2 groups experienced similar improvements over time in NSI symptom severity (aMD, -0.5; 95% CI, -3.6 to 2.6; P = .98) and perceived improvement on the PGIC (odds ratio, 1.18; 95% CI, 0.46-3.04; P = .21). In sensitivity analyses, the T-MD group experienced greater improvement in total (aMD, -4.0; 95% CI, -7.6 to -0.5; P = .045), ocular (aMD, -0.9; 95% CI, -1.7 to -0.1; P = .02), and vestibular (aMD, -0.8; 95% CI, -1.5 to -0.2; P = .01) symptoms; vestibular and ocular motor convergence (aMD, -1.8; 95% CI, -3.2 to -0.3; P = .046); horizontal vestibulo-ocular reflex (aMD, -1.8; 95% CI, -3.2 to -0.3; P = .02); vertical vestibulo-ocular reflex (aMD, -2.2; 95% CI, -3.8 to -0.7; P = .01); visual motion sensitivity (aMD, -2.2; 95% CI, -4.0 to -0.7; P = .01); and cognitive processing speed (aMD, 2.4; 95% CI, 0.6 to 4.2; P = .04). Adverse events were reported by 10 participants (6%).

Conclusions and relevance: In this randomized clinical trial, mTBI symptoms and patients' perception of change improved similarly for the T-MD and control groups. These findings can inform a more effective, efficient, and evidence-based approach to care for mTBI.

Trial registration: ClinicalTrials.gov Identifier: NCT04549532.

Importance: Despite continuous improvements in neonatal resuscitation and stabilization in the last decades, thermal management immediately after birth remains an unresolved issue in preterm infants.

Objective: To compare 2 strategies of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants.

Design, setting, and participants: This multicenter, unblinded, randomized clinical trial was conducted among very preterm infants (birth weight <1500 g and/or gestational age ≤30 weeks 6 days) at 21 tertiary care hospitals in Italy from February 21, 2023, to July 18, 2024.

Interventions: Eligible neonates were randomly allocated to either drying before plastic wrapping in the delivery room (intervention arm) or plastic wrapping without drying (control arm).

Main outcomes and measures: The primary outcome was the proportion of participants with normothermia (36.5-37.5 °C) at admission to the neonatal intensive care unit (NICU). The secondary outcomes included hypothermia (<36.5 °C), moderate to severe hypothermia (<36.0 °C), and hyperthermia (>37.5 °C) at NICU admission, temperature at 1 hour after NICU admission, intraventricular hemorrhage, respiratory distress syndrome, late-onset sepsis, bronchopulmonary dysplasia, and mortality before hospital discharge.

Results: Overall, 354 very preterm infants were randomized (180 [50.8%] female; mean [SD] gestational age, 28.6 [2.5] weeks); all received the allocated intervention and were included in the analysis. Normothermia at NICU admission was achieved in 81 of 177 dried infants (45.8%) and 82 of 177 undried infants (46.3%; risk ratio, 0.99; 95% CI, 0.79-1.24). The mean (SD) neonatal temperature at NICU admission was 36.4 °C (0.8 °C) in dried neonates and 36.5 °C (0.7 °C) in undried neonates (mean difference, -0.1 °C; 95% CI, -0.2 °C to 0.1 °C). In-hospital mortality included 26 of 177 dried neonates (14.7%) and 10 of 177 undried neonates (5.6%) (unadjusted risk ratio, 2.60; 95% CI, 1.29-5.23). The other secondary outcome measures were not different between the 2 arms.

Conclusions and relevance: In this multicenter randomized clinical trial, drying before plastic wrapping provided no benefit to very preterm infants in maintaining normothermia at NICU admission. Most deaths could be expected due to the compromised profile of the neonates, with no pathophysiological explanation related to the trial interventions. Approximately half of the infants were outside the normal thermal range at NICU admission; hence, thermal management remains a challenge requiring further investigations.

Trial registration: ClinicalTrials.gov Identifier: NCT05740072.

Importance: Requests for sexual images are a common but understudied component of adolescent digital interactions. Although image sharing or sexting can be a consensual behavior between peers, when requests for sexual images are coercive it is a form of sexual harassment.

Objective: To examine experiences with coercive requests for sexual images received before the age of 18 years and the incident and respondent characteristics associated with sharing an image in response to coercion.

Design, setting, and participants: This survey study was conducted in the US between June 28, 2023, and April 1, 2024. Survey participants were a sample of 6204 young adults (aged 18-28 years). Screening procedures were designed to oversample individuals with histories of image-based sexual abuse to examine questions related to incident dynamics. Analyses used statistical weighting to improve generalizability to the US population.

Main outcomes and measures: Bivariate and multivariate logistic regression modeling examined whether demographic and incident-level factors were associated with a decision by respondents to share a sexual image in response to coercion, defined as threats or strong pressure, and the impact of sharing on disclosure and mental health outcomes.

Results: A total of 2853 respondents reported 4205 incidents of image-based sexual abuse, including 2003 coercive requests for sexual images that occurred before they were 18 years of age; in 1886 (mean respondent age, 22.8 [95% CI, 22.6-23.1] years; 91.0% female [95% CI, 89.4-92.4]) of these incidents, respondents provided information on whether they did or did not share an image in response, making up the analytic sample for the study. In 1067 coercive request incidents (55.6%; 95% CI, 51.5%-59.6%), adolescents shared an image in response. Sharing was significantly less likely when the perpetrator was someone the adolescent met online vs a dating partner (odds ratio [OR], 0.33; 95% CI, 0.20-0.54; P < .001) and was more likely for incidents lasting longer than month (OR, 3.55; 95% CI, 2.44-5.16; P < .001). Respondents who shared images reported significantly worse mental health outcomes than those who did not (OR, 1.10; 95% CI, 1.04 -1.17; P = .001) and were less likely to disclose the incident (OR, 0.69; 95% CI, 0.48-0.98; P = .04).

Conclusions and relevance: In this survey study of young adults in the US, findings identified significant harms associated with providing sexual images in response to coercive requests during adolescence. Results highlight the importance of providing adolescents with skills to respond to image requests and information about the harmful outcomes of coercive sexual image requests.

Importance: Tranexamic acid (TXA) is associated with improved survival following trauma in prior prehospital trials, shaping clinical practice. The Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport (STAAMP) trial did not find a difference in mortality between TXA and placebo. A bayesian approach that incorporates prior clinical evidence may better characterize the impact of TXA.

Objective: To evaluate the probability of mortality benefit associated with prehospital TXA in trauma.

Design, setting, and participants: This quality improvement study used a post hoc bayesian analysis of data from the STAAMP trial, a prospective, multicenter, double-masked, placebo-controlled, phase 3 randomized clinical trial conducted at level I trauma centers in the US from May 1, 2015, to October 31, 2019. Patients at risk for hemorrhage within approximately 2 hours of injury were randomized to receive prehospital TXA or placebo. The data analysis was performed between January 1, 2024, and December 31, 2025.

Main outcomes and measures: The primary outcome was 30-day mortality assessed using frequentist statistics. Bayesian hierarchical logistic regression models were built to estimate the posterior probability of mortality associated with TXA. The prior distributions were informed by Clinical Randomization of an Antifibrinolytic in Significant Hemorrhage 2 (CRASH-2) and Prehospital Antifibrinolytics for Traumatic Coagulopathy and Hemorrhage (PATCH-Trauma) trial data, and the influence of prior selection, sample size, and varying risk thresholds was also evaluated.

Results: Of 903 STAAMP patients analyzed (median [IQR] age, 39 [26-55] years; 668 male [74.0%]), 447 received TXA and 456 received placebo. The majority of patients (n = 760 [84.2%]) sustained blunt injuries, with a median injury severity score of 12 (IQR, 5-22). In the frequentist analysis, the 30-day mortality rates were 8.1% and 9.9% for the TXA and placebo groups, respectively (hazard ratio, 0.81; 95% CI, 0.59-1.11). Using bayesian models, the estimated posterior risk ratios were 0.91 (95% credible interval [CrI], 0.85-0.97) with a CRASH-2 prior, 0.80 (95% CrI, 0.65-0.97) with a PATCH-Trauma prior, and 0.82 (95% CrI, 0.52-1.23) under a noninformative prior. The results were robust across confounders, site clustering, and alternative priors. The posterior probability that TXA reduced mortality ranged from 84% to 99%.

Conclusions and relevance: This quality improvement study using a post hoc bayesian reanalysis of the STAAMP trial suggested a high probability that prehospital TXA would improve survival. Bayesian methods may offer refined inference and support clinical decision-making in prehospital trauma care.