Importance Since 2023, infants can be protected from respiratory syncytial virus (RSV) through a vaccine (RSVpreF) for pregnant persons or a monoclonal antibody (nirsevimab) for infants. Objective To assess the relative product effectiveness (rPE) of maternal RSVpreF vs infant nirsevimab against RSV infection and hospitalization among infants born in the 2023 to 2025 RSV seasons. Design, Setting, and Participants This retrospective cohort study included full-term infants born at Kaiser Permanente Northern California (KPNC), an integrated health care system with approximately 40 000 births each year, from December 3, 2023, to March 30, 2024, or September 29, 2024, to March 15, 2025. Infants protected by RSVpreF were matched to infants protected with nirsevimab with optimal full matching (up to 1:5), adjusting for birth week, sex, and maternal factors. Each group was also compared with infants with no protection, matching unprotected infants to both RSVpreF and nirsevimab infants (up to 1:10). Exposures Maternal RSVpreF at 32 to 36 weeks’ gestation or infant nirsevimab through age 7 days. Main Outcomes and Measures Polymerase chain reaction (PCR)–confirmed RSV and RSV hospitalization (PCR-confirmed RSV 10 days before to 7 days after hospitalization) in infants aged 8 to 180 days or through RSV season end (April 30 in both seasons). rPE was estimated from age 8 to 180 days using restricted mean time lost. Results Of 15 124 matched infants (7729 [51.1%] male) in the primary analysis, 146 (0.97%) had RSV infection (106 of 11 293 [0.94%] in RSVpreF group and 40 of 3831 [1.04%] in nirsevimab group) and 12 (0.08%) were hospitalized (7 [0.06%] in RSVpreF group and 5 [0.13%] in nirsevimab group). The rPE of RSVpreF vs nirsevimab was −5.3% (95% CI, −44.8% to 23.4%) against infection and 61.5% (95% CI, −10.8% to 86.7%) against hospitalization. Compared with no protection, RSVpreF rPE was 69.3% (95% CI, 59.9% to 76.6%) against infection and 86.4% (95% CI, 66.4% to 94.5%) against hospitalization; nirsevimab rPE was 65.2% (95% CI, 51.0%-75.4%) and 73.8% (95% CI, 33.4%-89.7%), respectively. Conclusion In this cohort study of infants born in the 2023 to 2024 and 2024 to 2025 RSV seasons, no statistically significant difference between maternal RSVpreF and infant nirsevimab in RSV infection or hospitalization was detected. Compared with no protection, both products were associated with fewer infections and hospitalizations. This study supports current US guidelines for either maternal RSVpreF or infant nirsevimab to protect all infants from RSV.
This cohort study examines the prevalence and co-occurrence of autonomic dysregulation and orthostatic intolerance among adults with concussion and explores associated demographic and injury-related factors.
Importance Family-based behavioral treatment (FBT) efficacy decreases in adolescence, a developmental period of gradual maturation and increasing autonomy during which emotion regulation skills develop. Objective To evaluate the feasibility and efficacy of FBT alone compared with FBT plus emotion regulation across 6 months of treatment and 12 months of follow-up on adolescent weight change, emotion regulation, emotional eating, and parent weight change. Design, Setting, and Participants This parallel-group randomized clinical trial of adolescents 13 to 16 years of age with body mass index (BMI) in the 85th percentile or higher but less than the 99.9th percentile was conducted from August 29, 2019, to January 4, 2024, at 2 university clinics. Central randomization was completed by a statistician, and outcome assessors were blinded to treatment condition. The majority of treatments and assessments were delivered remotely via video conference due to the COVID-19 pandemic. Interventions FBT plus emotion regulation vs traditional FBT skills alone for weight loss. FBT included nutrition and physical activity education, behavior change strategies, and parenting skills. Both treatments had 6 months of adolescent and parent groups and behavior coaching sessions. The combined group included FBT skills and added dialectical behavior therapy and emotion-focused therapy. Main Outcomes and Measures The main outcomes were adolescent weight (body mass index [BMI] z score (BMIz) and BMI as a percentage of the 95th BMI percentile [%BMIp95]), emotion regulation skills (measured by Difficulties in Emotion Regulation Scale [DERS] scores), emotional eating behaviors (measured by Emotional Eating Scale [EES] scores), parent weight, and feasibility and acceptability of treatment. Primary outcome analyses used an intention-to-treat approach. Results A total of 166 (FBT plus emotion regulation = 84; FBT = 82) dyads (adolescents: mean [SD] age, 14.3 [1.2] years; 95 [57%] female; mean [SD] BMIz, 2.2 [0.6]; mean [SD] %BMIp95, 120.4 [21.4]; parents: mean [SD] age, 45.3 [6.5] years; 141 [85%] female; mean [SD] BMI, 32.6 [7.0]) were assessed at baseline, midtreatment, posttreatment, and 6- and 12-month follow-up visits. There were no statistically significant differences in posttreatment weight loss among adolescents receiving FBT plus emotion regulation compared with FBT (difference in BMIz, 0.03 [95% CI, −0.05 to 0.10]). However, adolescents in FBT plus emotion regulation did not regain as much weight at the 12-month follow-up (difference in BMIz, −0.09 [95% CI, −0.17 to −0.02]). At the 12-month follow-up, 4% (95% CI, 1%-12%) of adolescents in FBT and 22% (95% CI, 8%-48%) of adolescents in FBT plus emotion regulation lost a clinically significant amount of weight (≥0.20 BMIz). At 12 months’ follow-up, parent weight (difference in BMI, 0.51 [95% CI, −0.03 to 1.05]) and adolescent emotion regulation (difference in DERS scores, −0.06 [95% CI, −0.25 to 0.50]) did not differ by treatment. By contrast, the FBT plus emotion regulation group had lower scores than the FBT group on emotional eating (difference in EES scores, −0.39 [95% CI, −0.63 to −0.15]). Conclusions and Relevance In this randomized clinical trial of 166 parent-adolescent dyads, adding emotion regulation skills to FBT did not improve weight loss during treatment but was associated with less weight regain and lower emotional eating through the 12-month follow-up. These findings suggest that adding emotion regulation skills to an FBT program may attenuate weight regain and decrease emotional eating among adolescents. Trial Registration ClinicalTrials.gov Identifier: NCT03674944
Importance Severe maternal morbidity (SMM) carries serious consequences for pregnant individuals, yet the association between gestational weight gain (GWG) and SMM remains poorly understood. Objective To examine the association between GWG and SMM across prepregnancy body mass index (BMI) categories. Design, Setting, and Participants This retrospective cohort study used linked birth registry data from Better Outcomes Registry & Network Ontario and hospitalization data from the Canadian Institute for Health Information for singleton pregnancies with a hospital delivery at a gestational age of 20 weeks or greater in Ontario, Canada, from April 1, 2012, to March 31, 2022. Data were analyzed from May 1 to November 1, 2025. Exposures Continuous GWG as mean weekly gain in the second and third trimesters and categorical GWG (inadequate, adequate, or excessive) according to the 2009 Institute of Medicine recommendations based on prepregnancy BMI. Main Outcomes and Measures SMM, defined as a composite of 13 indicators per the Canadian Perinatal Surveillance System, occurring during delivery hospitalization. Results Among 1 035 927 pregnancies, 192 731 (18.6%) had inadequate, 296 448 (28.6%) had adequate, and 546 748 (52.8%) had excessive GWG; 15 119 (14.59 per 1000 births) experienced SMM. Compared with adequate GWG, excessive GWG was associated with increased SMM across all BMI categories: underweight (adjusted rate ratio [ARR], 1.33 [95% CI, 1.15-1.53]), normal weight (ARR, 1.24 [95% CI, 1.17-1.31]), overweight (ARR, 1.16 [95% CI, 1.06-1.27]), obesity class I (ARR, 1.21 [95% CI, 1.08-1.35]), obesity class II (ARR, 1.28 [95% CI, 1.07-1.54]), and obesity class III (ARR, 1.24 [95% CI, 1.03-1.48]). Inadequate GWG was associated with increased SMM predominantly among individuals with normal weight (ARR, 1.13 [95% CI, 1.06-1.21]) and overweight (ARR, 1.19 [95% CI, 1.05-1.35]). GWG showed nonlinear associations with SMM across all BMI categories, with risk elevated at both low and high GWG in individuals with underweight, normal weight, and overweight, while in those with obesity classes I to III, risk was concentrated at high GWG values. Estimated SMM rates were lowest at 0.4 kg/wk GWG for underweight through overweight BMI categories and declined across obesity classes to 0.1 kg/wk GWG for the obesity class III category. Conclusions and Relevance In this cohort study of 1 035 927 pregnancies, GWG outside Institute of Medicine–recommended ranges was associated with increased SMM risk, with patterns varying by BMI category. These findings may complement existing evidence informing GWG guidance.
Importance While protein restriction is a cornerstone of chronic kidney disease (CKD) management, its long-term benefits on clinical outcomes in Asian populations, who often have lower body mass and muscle reserves, remain unclear. Objective To investigate the association between daily protein intake (DPI) and the risk of kidney failure requiring replacement therapy (KFRT) and all-cause mortality in patients with non–dialysis-dependent CKD. Design, Setting, and Participants This prospective cohort study used data from the Korean Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD). Participants with CKD at stages ranging from 1 to predialysis 5 were enrolled between 2011 and 2016 from 9 tertiary hospitals in South Korea. The study observation period ended on January 31, 2024. Data analysis was performed from February 2024 to May 2026. Exposures DPI was objectively estimated using 24-hour urinary nitrogen excretion at baseline. The participants were categorized by DPI: less than 0.6, 0.6 to less than 0.8, 0.8 to less than 1.0, 1.0 to less than 1.2, and 1.2 or greater. Main Outcomes and Measures The primary outcome was the onset of KFRT. Secondary outcomes included all-cause mortality and major adverse cardiovascular events (MACEs). Fine-Gray subdistribution hazard models were used to account for the competing risk of death. Results A total of 1861 participants (mean [SD] age, 53.7 [12.0] years; 1304 [61.1%] male) were analyzed, with a median (range) follow-up of 9.3 (0.01-12.37) years. The lowest DPI group (<0.6 g/kg/d) was associated with increased risk of KFRT (subdistribution hazard ratio [sHR], 1.42; 95% CI, 1.09-1.85) as well as all-cause mortality (sHR, 2.17; 95% CI, 1.17-4.03), but not MACEs, compared with the highest DPI group (>1.2 g/kg/d). Furthermore, a nonlinear association was observed, where excessively low protein intake was associated with an increased risk of KFRT. Conclusions and Relevance In this cohort study of 1861 patients with nondialysis CKD, low protein intake was not associated with significant nephroprotection and was associated with a higher risk of KFRT and all-cause mortality. These findings suggest that rigid protein restriction should be balanced with nutritional monitoring to prevent protein-energy wasting, particularly in populations with lower muscle mass, and a more individualized approach to dietary protein management in CKD may be warranted.
