Category: Statistics

JAMA Netw Open. 2025 Oct 1;8(10):e2540559. doi: 10.1001/jamanetworkopen.2025.40559.

ABSTRACT

IMPORTANCE: The routine use of intraoperative transesophageal echocardiography (TEE) during coronary artery bypass graft (CABG) surgery remains controversial. Its benefit across different patient populations is unclear.

OBJECTIVES: To identify patient subgroups with the greatest or least likelihood to benefit from intraoperative TEE during CABG, stratified by hospital surgical volume.

DESIGN, SETTING, AND PARTICIPANTS: This 2-stage, matched retrospective cohort study applied target trial emulation methodologies to the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) to quantify the conditional treatment effect of intraoperative TEE among subpopulations undergoing isolated CABG at low, medium, and high surgical volume hospitals. The study cohort consisted of patients aged 18 years or older who underwent isolated CABG surgery between July 1, 2014, and June 30, 2022. Data analysis was conducted from August 8, 2023, to December 15, 2024.

EXPOSURE: Receipt of an intraoperative TEE during CABG surgery.

MAIN OUTCOMES AND MEASURES: The primary outcome was mortality within 30 days of surgery. Statistical analyses included multivariable logistic regression and multiple TEE vs without TEE matched comparisons stratified by surgical volume and patient subpopulations.

RESULTS: Of 1 266 055 patients who underwent isolated CABG, 963 976 (76.1%) were male, and the mean (SD) age was 65.7 (10.0) years. Among these patients, 61.8% received TEE and 39.0% did not receive TEE. Intraoperative TEE use (vs without TEE) was associated with a significant survival benefit among patients treated at hospitals with low surgical volume (2.47% vs 2.94%; odds ratio [OR], 0.83 [95% CI, 0.78-0.89], P < .001) and medium surgical volume (2.09% vs 2.34%; OR, 0.89 [95% CI, 0.85-0.93], P < .001) but not high surgical volume (1.72% vs 1.77%; OR, 0.97 [95% CI, 0.91-1.03], P = .48). Among patients who underwent isolated CABG at low and medium surgical volume hospitals, TEE provided the greatest survival benefit to subpopulations with greater than 50% (vs ≤50%) left-main coronary stenosis, 3 or more (vs <3) diseased coronaries, and (3) a preoperative inotropic requirement.

CONCLUSIONS AND RELEVANCE: In isolated CABG, intraoperative TEE was associated with survival benefit at low- and medium-volume hospitals, particularly in patients with complex coronary disease or hemodynamic instability, but not at high-volume hospitals. These results highlight persistent equipoise and the need for randomized evaluation.

PMID:41165705 | DOI:10.1001/jamanetworkopen.2025.40559

JAMA Netw Open. 2025 Oct 1;8(10):e2540720. doi: 10.1001/jamanetworkopen.2025.40720.

ABSTRACT

IMPORTANCE: New resistant mutations of respiratory syncytial virus type B (RSV-B) have been observed during the first year of implementation nirsevimab treatment. During the second season of implementation of nirsevimab treatment in France, RSV-B was predominant.

OBJECTIVES: To assess and compare the effectiveness of nirsevimab treatment in preventing RSV bronchiolitis in pediatric emergency departments during the first and second seasons of implementation of treatment in France.

DESIGN, SETTING, AND PARTICIPANTS: This a multicenter test-negative case-control study included 636 infants younger than 1 year who received a diagnosis of a first bronchiolitis episode in 5 pediatric emergency departments in France during the 2 first seasons of implementation of nirsevimab treatment (from October 5, 2023, to February 29, 2024, and from October 15, 2024, to January 31, 2025) and underwent a nasopharyngeal test for RSV.

MAIN OUTCOMES AND MEASURES: The main outcome of the study was the RSV status of the bronchiolitis cases. Multivariable logistic regression was performed with nirsevimab as the explanatory variable, adjusted on age, sex, risk factors of bronchiolitis, type of childcare, month, and center of inclusion. Effectiveness was calculated for each season and compared using the likelihood ratio test. Subgroup analysis by age and severity as well as sensitivity analyses were performed.

RESULTS: The study included 636 patients with bronchiolitis (median age, 3.0 months [IQR, 1.4-5.0 months]; 333 boys [52.4%]). In both seasons, 162 of 636 patients (25.5%) were immunized with nirsevimab. During the first season of implementation, 273 of 384 patients (71.1%) tested positive for RSV; during the second season, 181 of 252 patients (71.8%) tested positive for RSV. The effectiveness of nirsevimab treatment against RSV bronchiolitis was estimated to be 83.2% (95% CI, 68.0%-91.4%) during the first season and 89.3% (95% CI, 77.8%-95.1%) during the second season; no statistically significant difference in effectiveness was found between the 2 seasons (P = .97). Subgroup and sensitivity analyses provided similar results.

CONCLUSIONS AND RELEVANCE: In this test-negative case-control study of nirsevimab treatment, its effectiveness in reducing pediatric emergency department visits for RSV bronchiolitis during the second season of national immunization was high and comparable with that observed in the first season. Although RSV-B resistant strains had been recently identified, it did not appear to have important clinical consequences to date. Continued close monitoring of RSV epidemiology in the context of the widespread nirsevimab use remains essential.

PMID:41165704 | DOI:10.1001/jamanetworkopen.2025.40720

JAMA Oncol. 2025 Oct 30. doi: 10.1001/jamaoncol.2025.4480. Online ahead of print.

ABSTRACT

IMPORTANCE: Hormonal contraceptives are widely used but how breast cancer risk differs by hormonal content remains unclear.

OBJECTIVE: To estimate the difference in breast cancer risk associated with different hormonal contraceptive formulations.

DESIGN, SETTING, AND PARTICIPANTS: This Swedish nationwide, population-based cohort study was conducted using linked national registers. All adolescent girls and women aged 13 to 49 years residing in Sweden as of January 1, 2006, with no history of breast cancer, ovarian cancer, cervical cancer, uterine cancer, bilateral oophorectomy, or infertility treatment were included and followed up from 2006 to 2019. Individuals were censored on meeting an exclusion criterion, reaching age 50 years, or study end, whichever occurred first. Data were analyzed from November 2023 to August 2025.

EXPOSURE: Ever use and duration of use of hormonal contraceptives, categorized by hormone formulations and route of administration.

MAIN OUTCOMES AND MEASURES: Time-dependent Cox regression was used to estimate hazard ratios (HRs) with 95% CIs for incident cases of in situ and invasive breast cancer.

RESULTS: Among 2 095 130 adolescent girls and women (median [IQR] age at diagnosis, 45 [41-48] years) who were followed up for 21 020 846 person-years, 16 385 breast cancer cases occurred. Ever use of any hormonal contraceptive was associated with increased breast cancer risk (HR, 1.24; 95% CI, 1.20-1.28), corresponding to 1 additional case per 7752 (95% CI, 5350-14 070) users, with both combined (HR, 1.12; 95% CI, 1.07-1.17) and progestin-only formulations (HR, 1.21; 95% CI, 1.17-1.25) being associated. Higher risk was associated with oral desogestrel-only formulations (HR, 1.18; 95% CI, 1.13-1.23) and oral desogestrel-combined formulations (HR, 1.19; 95% CI, 1.08-1.31), as well as implants containing etonogestrel, desogestrel’s active metabolite (HR, 1.22; 95% CI, 1.11-1.35), compared to levonorgestrel-containing combined pills (HR, 1.09; 95% CI, 1.03-1.15) and levonorgestrel, 52 mg, intrauterine system (HR, 1.13; 95% CI, 1.09-1.18). No statistically significant increased risk was observed for medroxyprogesterone acetate injection, etonogestrel vaginal ring, or combined oral drospirenone, despite having many users.

CONCLUSIONS AND RELEVANCE: Findings of this cohort study highlight that breast cancer risk varies substantially by progestin content in hormonal contraceptives, providing valuable insights to support more informed contraceptive prescription.

PMID:41165687 | DOI:10.1001/jamaoncol.2025.4480

JAMA Oncol. 2025 Oct 30. doi: 10.1001/jamaoncol.2025.4343. Online ahead of print.

NO ABSTRACT

PMID:41165677 | DOI:10.1001/jamaoncol.2025.4343

Neuromodulation. 2025 Oct 30:S1094-7159(25)01041-4. doi: 10.1016/j.neurom.2025.09.315. Online ahead of print.

ABSTRACT

OBJECTIVES: Deep brain stimulation (DBS) is an effective surgical procedure for the treatment of Parkinson disease (PD) and other movement disorders. Immediate and delayed complications after DBS surgery have been described. Perilead edema (PLE) is a DBS-related complication for which the etiology remains unknown. Moreover, PLE frequency and long-term effects are subjects of ongoing debate. Our study aims to elucidate the long-term clinical and neuropsychologic effects of PLE and to find possible etiologic correlates.

MATERIALS AND METHODS: We retrospectively collected clinical and neuropsychologic data from 51 patients with PD before and 1 year after DBS. PLE visualized on fluid attenuated inversion recovery magnetic resonance imaging (MRI) sequence was manually segmented. Using appropriate statistical tests, continuous and categorical variables were compared in patients with and those without PLE. A multivariate regression model was used to analyze the contribution of clinical variables to edema volume changes.

RESULTS: Overall, 68.62% of patients presented with PLE at the immediate postoperative MRI. Patients with PLE were significantly older (p < 0.001) and had more frequent postoperative confusion episodes (p = 0.025). Furthermore, more microelectrode recording (MER) tracks (p < 0.001) were used in patients with PLE. Multiple MER tracks were directly correlated with edema volume and were the only significant predictors of edema volume changes in a multivariate regression model. No differences were found in other clinical and neuropsychologic variables.

CONCLUSIONS: PLE is a frequent postsurgical event and may cause transient postoperative confusion. It seems linked to older age and multiple MER tracks. Although it does not influence global motor and neuropsychologic outcomes, PLE contributes to postoperative confusion episodes. To avoid PLE sequelae, using multiple MER tracks in older patients should be discouraged.

PMID:41165632 | DOI:10.1016/j.neurom.2025.09.315

J Perianesth Nurs. 2025 Oct 29:S1089-9472(25)00164-9. doi: 10.1016/j.jopan.2025.05.016. Online ahead of print.

ABSTRACT

PURPOSE: To explore the effects of different warming temperatures on the incidence of hypothermia, comfort, and satisfaction of patients after a cesarean section.

DESIGN: A randomized controlled trial.

METHODS: A simple random sampling method was used to select 100 puerpera who underwent cesarean section surgery at the Anesthesia and Operating Department of a 3-class hospital from August 1, 2024 to October 31, 2024. They were randomly divided into a control group (49 cases) and an experimental group (51 cases). Observation indicators: changes in body temperature, comfort level, satisfaction level, incidence and intensity of chills.

FINDINGS: There was no significant difference in baseline data and body temperature between the two groups (P > .05). The incidence of postoperative shivering in the control group was 0%, which was lower than 3.92% in the experimental group. The control group’s comfort score was significantly higher than that of the experimental group, with statistical significance (P < .001). There was no significant difference in satisfaction evaluation or in the incidence of hypothermia between the two groups (P > .05).

CONCLUSIONS: The active and passive composite warming method can effectively prevent the occurrence of hypothermia and shivering in patients after cesarean section and improve their satisfaction. When the warming temperature is set at 38 to 40 ℃, postoperative comfort of patients is the best. However, short-term (30 minutes) postoperative warming has no significant effect on the postoperative body temperature of patients, and some patients still have a decrease in body temperature after short-term warming, suggesting that it is necessary to continue to promote warming measures to ensure the patient’s body temperature recovery after leaving the postanesthesia care unit and entering the ward.

PMID:41165620 | DOI:10.1016/j.jopan.2025.05.016

Rheumatology (Oxford). 2025 Oct 30:keaf578. doi: 10.1093/rheumatology/keaf578. Online ahead of print.

ABSTRACT

OBJECTIVES: This systematic review and meta-analysis examined how axial spondyloarthritis (axSpA), and its specific disease features, impact sexual function.

METHODS: Systematic review of medical literature databases PsycINFO, CINAHL, MEDLINE, Embase, and Cochrane Central from their inception to February 2025. Studies reporting sexual function outcomes in men or women with axSpA were included. After narrative synthesis of included studies, random-effects meta-analysis was used to pool a subset of outcomes. Study quality was assessed using a modified version of the ROBINS-E tool.

RESULTS: From the initial 342 identified studies, 37 were included. Nineteen (50%) examined sexual function in men only, 13 (34%) across both genders, five (13%) in women only, and one (3%) did not specify. Nine studies (24%) reported general sexual dysfunction prevalence in people with axSpA, ranging from 32-71%. A meta-analysis of studies (n = 4) examining the International Index of Erectile Function (IIEF) in men with axSpA found that all domain scores, except sexual desire, were worse compared with controls. In women with axSpA, a meta-analysis (n = 4) of Female Sexual Function Index (FSFI) data revealed significantly poorer total sexual function scores, and arousal, pain, lubrication and desire sub-domain scores compared with controls.

CONCLUSION: Between one- to two-thirds of people with axSpA report a sexual dysfunction. Pooling of data from a small subset of studies demonstrated statistically, and at times clinically, poorer sexual function scores in both men and women compared with controls. This conclusion is constrained by a lack of high-quality research and a notable scarcity of data concerning women.

PMID:41165594 | DOI:10.1093/rheumatology/keaf578

Rheumatology (Oxford). 2025 Oct 30:keaf565. doi: 10.1093/rheumatology/keaf565. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate MyRA, a web-based self-monitoring application for rheumatoid arthritis, on patient empowerment, usability, and perceived usefulness.

METHODS: MyRA was co-developed with patients and used at their own discretion during a 4-month prospective study with patient questionnaires at T0 (baseline), T1 (2 months) and T2 (4 months). The primary outcome was patient empowerment (Patient Activation Measure-13; 0-100). Secondary outcomes included frequency of use, usability (System Usability Scale; 0-100) and perceived usefulness (study specific questions). Descriptive statistics and repeated measures ANOVA were applied with post-hoc subgroup analysis based on frequency of use (subgroup A: 1-7 times; subgroup B: ≥8 times).

RESULTS: Among 548 registered patients (90.1% female, mean age 51.8 (SD 11.9) years, mean disease duration 10.2 (SD 10.1) years), 54 patients never used the application (9.9%), 405 patients were infrequent users (73.9%), and 89 patients were frequent users (16.2%). In the total user group, no statistical difference was found for patient empowerment after 4 months (T0: 55.8, T2: 54.4, p= 0.09). However, subgroup B showed a statistically significant, though not clinically meaningful, decrease (T0: 56.2, T2 53.6, p= 0.04). Subgroup B reported higher usability scores compared with subgroup A (75.9 vs 62.9, p< 0.001) and was more outspoken in perceived usefulness.

CONCLUSION: Despite major patient involvement throughout development, self-monitoring via MyRA did not increase patient empowerment. The study had a considerable decline in application engagement over time, with only a small subgroup of frequent users. These users showed more positive attitudes regarding usability and perceived usefulness of MyRA.

PMID:41165592 | DOI:10.1093/rheumatology/keaf565

Oncologist. 2025 Oct 30:oyaf214. doi: 10.1093/oncolo/oyaf214. Online ahead of print.

ABSTRACT

BACKGROUND: With the adoption of safer outpatient cancer care practices, much of cancer care has transitioned to outpatient settings, decreasing the need for inpatient systemic therapy (IST) which is associated with poorer end-of-life outcomes. We evaluated reasons for IST use, palliative care (PC) utilization, and outcomes among IST recipients to inform guidelines on appropriate IST use.

MATERIALS AND METHODS: We conducted a retrospective chart review of all IST admissions at an academic center from January 2016 to December 2017. Patients were stratified by solid tumor (ST) vs hematological malignancies (HM). We recorded IST urgency, response, mortality, and other variables. Descriptive statistics and odds ratios were estimated from logistic regression models with mixed-effect to account for multiple admissions per patient.

RESULTS: We analyzed 893 admissions (19% ST) among 620 patients. HM patients required frequent elective IST admissions than ST (p<.0001). ST patients more often received IST for non-urgent indications (p = 0.0032) during non-cancer related admissions. ST patients had fewer responses to IST compared to HM (36% vs 70%; p < 0.0001). PC services were more likely utilized for ST vs HM patients (48% vs 14%; p<.0001); and were associated with increased rates of health care proxy assignment, code status change and hospice discharge. Early 60-day mortality was higher for ST vs HM patients (17.3% vs 5.8%; p < 0.001) and most patients (55%) died inpatient during the index admission.

CONCLUSION: IST was overutilized in ST patients with poor response rates and significant early mortality. PC service utilization rates remain low but improved end-of-life transition planning.

PMID:41165589 | DOI:10.1093/oncolo/oyaf214

COPD. 2025 Oct 25;22(1):2579360. doi: 10.1080/15412555.2025.2579360. Epub 2025 Oct 30.

ABSTRACT

PURPOSE: This study investigated whether total serum IgE (T-IgE) can serve as a biomarker to guide personalized inhaled corticosteroid (ICS) therapy in patients with stable chronic obstructive pulmonary disease (COPD).

METHODS: We conducted retrospective (n = 1236) and prospective (n = 540) cohort studies of stable COPD patients. Participants were stratified by baseline T-IgE levels (cutoffs: 100 and 76 IU/mL). Propensity-score matching (PSM) was used to balance confounding factors, and a multivariate negative binomial regression model was constructed to evaluate the effects of ICS on the risks of exacerbations. Additionally, the stability of total serum IgE and its correlation with pulmonary function were analyzed.

RESULTS: In the subgroup with T-IgE ≥ 100 IU/mL, COPD patients had a significantly increased risk of exacerbations, with incidence rate ratios (IRRs) of 1.60 (95% CI 1.11-2.29) for moderate exacerbations, 1.37 (1.03-1.82) for moderate or severe exacerbations, and 1.15 (1.00-1.31) for all exacerbations. In this subgroup, ICS treatment significantly reduced the risk of the aforementioned exacerbations, with corresponding IRRs of 0.62 (0.42-0.91), 0.73 (0.53-1.00), and 0.84 (0.72-0.99). In contrast, in the T-IgE < 100 IU/mL subgroup, the benefits of ICS treatment were not statistically significant. Furthermore, total serum IgE demonstrated better stability than blood eosinophil counts and was negatively correlated with pulmonary function indices. Consistent results were obtained using a cutoff value of 76 IU/mL.

CONCLUSION: The total serum IgE level is closely related to exacerbations of COPD. Patients with high IgE levels can experience a reduced exacerbation rate when treated with ICS.

PMID:41165573 | DOI:10.1080/15412555.2025.2579360