Tag: statistics

JAMA Ophthalmol. 2026 Feb 12. doi: 10.1001/jamaophthalmol.2025.6262. Online ahead of print.

ABSTRACT

IMPORTANCE: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are considered safe, effective medications for type 2 diabetes (T2D) and weight loss, used by millions worldwide. While their cardiometabolic benefits are well established, emerging observations suggest a potential association between GLP-1RA use and new-onset nonarteritic anterior ischemic optic neuropathy (NAION).

OBJECTIVE: To emulate a target trial evaluating the risk of NAION associated with initiation of semaglutide (GLP-1RA), compared with a sodium-glucose cotransporter-2 inhibitor (SGLT2i) as second-line therapy for T2D in a nationwide cohort of US veterans.

DESIGN, SETTING, AND PARTICIPANTS: This study was conducted nationwide using data from the Veterans Health Administration health care system between March 1, 2018, and March 1, 2025. This active-comparator, new-user, target trial emulation used cause-specific hazard ratios (HRs) that were estimated using overlap weighting to account for confounding. Participants included US veterans with T2D, current metformin use, and no prior GLP-1RA or SGLT2i use. Data analysis was conducted from July 2025 through September 2025.

EXPOSURE: Initiation of semaglutide or any SGLT2i.

MAIN OUTCOME AND MEASURE: Incident NAION, identified using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision and Systematized Nomenclature of Medicine codes.

RESULTS: A total of 102 361 US veterans met inclusion criteria, including 11 478 initiators of semaglutide and 90 883 initiators of an SGLT2i. Baseline characteristics were well balanced between treatment groups after overlap weighting (mean [SD] age, 60.1 [11.7] years; body mass index, 37.8 [6.7]; hemoglobin A1c, 7.0% [1.4]; 85.5% male and 14.5% female; 20.7% Black, 8.1% Hispanic, and 61.9% non-Hispanic White). Over a maximum follow-up of 7.5 years, 173 total incident NAION events occurred. The incidence rate of NAION was 123 per 100 000 person-years among semaglutide initiators and 67 per 100 000 person-years among SGLT2i. In 2.1 years of median follow-up, semaglutide initiators had a 2.33-fold higher risk than SGLT2i initiators (hazard ratio, 2.33; 95% CI, 1.54-3.54; P < .001). The overlap weighted incidence rate of NAION was 0.29% for semaglutide initiators and 0.13% for SGLT2i initiators, with a corresponding average treatment effect of 0.16 percentage points.

CONCLUSIONS AND RELEVANCE: In this nationwide cohort of US veterans with T2D, semaglutide initiators had a 2-fold NAION risk than SGLT2i initiators, while the absolute risk was low. Clinicians and patients should be counseled on the rare but evident increased risk of NAION after semaglutide initiation.

PMID:41678180 | DOI:10.1001/jamaophthalmol.2025.6262

JAMA Oncol. 2026 Feb 12. doi: 10.1001/jamaoncol.2025.6448. Online ahead of print.

ABSTRACT

IMPORTANCE: Patients with recurrent prostate cancer after previous radiotherapy typically have poor survival. Those with recurrences prostate confined might be suitable for salvage focal therapy (sFT) or salvage radical prostatectomy (sRP). sFT may offer good cancer control with comparatively less toxic effects, but outcomes beyond 5 years have not been reported, and no study has compared sFT to sRP.

OBJECTIVE: To compare cancer control and perioperative complications among patients after sFT vs sRP.

DESIGN, SETTING, AND PARTICIPANTS: In this international, multicenter cohort study of matched comparison data, patients undergoing sFT were derived from the prospective UK HIFU (high-intensity focused ultrasound) Evaluation and Treatment and International Cryotherapy Evaluation registries (9 centers; 2006-2024) and the prospective UK Focal Recurrent Assessment and Salvage Treatment cohort study (6 centers; 2014-2018). Patients undergoing sRP were derived from an international retrospective registry (12 centers in 8 countries; 2000-2021). Patients with biopsy-confirmed, localized recurrent prostate cancer postradiotherapy, either external beam radiotherapy, brachytherapy, or both, were included. Data were analyzed from March to July 2025.

EXPOSURES: sFT using HIFU or cryotherapy vs sRP.

MAIN OUTCOMES AND MEASURES: The primary outcome was cancer-specific survival up to 10 years. Secondary outcomes were overall survival, any perioperative complications (Clavien-Dindo grades 1-5), and major perioperative complications (Clavien-Dindo grades 3-5). Comparisons were made on matched patients following 1:1 cardinality matching within individual multiply-imputed datasets. Matching variables used were radiotherapeutic treatment, years between primary and salvage treatments, European Association of Urology recurrence risk group, and presalvage age, prostate-specific antigen, prostate volume, grade group, T stage, and androgen-deprivation therapy use.

RESULTS: A total of 923 patients were eligible for matching (419 undergoing sFT and 504 undergoing sRP). Of the patients undergoing sFT, 325 (77.6%) underwent HIFU and the remainder cryotherapy, with 241 (57.5%) treated with quadrant ablation. Of patients treated with sRP, 376 (74.6%) underwent open surgery and the remainder robot-assisted surgery. For sFT vs sRP, 10-year cancer-specific survival was 92% (95% CI, 86%-98%) vs 99% (95% CI, 97%-100%), with no statistically significant difference (restricted mean time lost, -0.09 years; 95% CI, -0.22 to 0.03 years; P = .15; subdistribution hazard ratio, 0.45; 95% CI, 0.05-4.00; P = .47). There was no statistically significant difference in 10-year overall survival (restricted mean survival time, -0.13 years; 95% CI, -0.86 to 0.60 years; P = .72). Undergoing sRP was associated with statistically significant higher odds of any complication (adjusted odds ratio, 24.20; 95% CI, 12.94-45.27; P < .001) and major complication (adjusted odds ratio, 9.31; 95% CI, 3.42-25.36; P < .001).

CONCLUSIONS AND RELEVANCE: In this cohort study, sFT and sRP were effective for treating localized radiorecurrent prostate cancer, while sFT was associated with fewer perioperative complications. sFT may provide a favorable therapeutic ratio for many patients with localized radiorecurrent prostate cancer.

PMID:41678176 | DOI:10.1001/jamaoncol.2025.6448

Clin Exp Rheumatol. 2026 Jan 26. doi: 10.55563/clinexprheumatol/pg971k. Online ahead of print.

ABSTRACT

OBJECTIVES: Fibromyalgia (FM) is a chronic musculoskeletal pain syndrome predominantly affecting women, suggesting possible links with reproductive and hormonal factors. Although reproductive history has been associated with various long-term health conditions, its role in FM remains insufficiently explored. This study aimed to investigate the association between parity, age at first pregnancy, and the presence of fibromyalgia among women of reproductive age.

METHODS: This cross-sectional observational study included 260 women aged 18-50 years with at least one prior live birth, recruited from Physical Medicine and Rehabilitation, Rheumatology, and Gynaecology Outpatient Clinics between March and December 2024. Demographic, clinical, and reproductive data were collected through structured interviews and medical records. FM diagnosis was based on the 2016 revised criteria of the American College of Rheumatology (ACR) using Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) scores; the Global Symptom Score (GSS) was defined as their sum. Statistical analyses included independent-sample t-tests, chi-square tests, and multivariate logistic regression adjusting for age, body mass index, comorbidities, and educational level.

RESULTS: FM was diagnosed in 104 participants (40%). Women with three or more live births had a significantly higher prevalence of FM compared with those with fewer births (p=0.006). In multivariate analysis, grand multiparity remained independently associated with FM (adjusted OR = 2.46, 95% CI = 1.28-4.72, p=0.006). No significant association was found between age at first pregnancy and FM (p>0.05). FM-diagnosed participants reported significantly higher WPI, SSS, and GSS scores (p=0.001 for all), with strong correlations between WPI and both GSS (r=0.782) and SSS (r=0.472).

CONCLUSIONS: Grand multiparity was independently associated with fibromyalgia, suggesting that cumulative hormonal and physiological stress from multiple pregnancies may contribute to chronic pain susceptibility. No association was found between age at first pregnancy and FM. Larger, longitudinal studies are warranted to clarify causal pathways between reproductive history and FM pathogenesis.

PMID:41678172 | DOI:10.55563/clinexprheumatol/pg971k

Clin Exp Rheumatol. 2026 Jan 29. doi: 10.55563/clinexprheumatol/0yu9gm. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the clinical response of Janus kinase inhibitors (JAKi) across subtypes of idiopathic inflammatory myopathies (IIM) in a cohort of patients with refractory disease.

METHODS: We conducted a retrospective analysis of all adult IIM patients treated with JAKi at our centre. Treatment response was assessed based on changes in muscle strength, serum biomarkers of muscle damage and inflammation, pulmonary function, radiological evolution of interstitial lung disease (ILD) and corticosteroid dosage.

RESULTS: Ten IIM patients who were previously or currently receiving JAKi therapy were identified. Six patients were female and the mean age was 52.7 years (standard deviation [SD] 13.91). Anti-synthetase syndrome was the most common subtype (n=5, 50%). At baseline, median manual muscle test 8 score was 136 (interquartile range [IQR] 25.5) and, after therapy, was 147 (IQR 8), representing a statistically significant increase (p<0.05). Corticosteroid dose reduction was also statistically significant (p<0.05), with the median daily dose decreasing from 10mg to 2.5mg. Additionally, four patients were able to discontinue corticosteroid therapy. In six patients with ILD, diffusion capacity for carbon monoxide improved significantly (p<0.01), from 68.33% (IQR 19.31) to 93% (IQR 7.27). No significant changes were observed in serum inflammatory markers, creatine kinase, forced expiratory volume first second or forced vital capacity.

CONCLUSIONS: JAKi therapy appears to be clinically effective, well tolerated, and safe in patients with refractory IIM, with a particular benefit in ILD. The steroid sparing effect was also a major outcome. Future prospective and controlled studies are warranted to confirm these preliminary results and better define the therapeutic potential of JAKi in IIM.

PMID:41678164 | DOI:10.55563/clinexprheumatol/0yu9gm

Eur Geriatr Med. 2026 Feb 12. doi: 10.1007/s41999-025-01363-0. Online ahead of print.

ABSTRACT

PURPOSE: To deliver an effective training intervention to staff in temporary elder care institutions in municipalities.

SETTINGS: A geriatric department at a university hospital in collaboration with 6 surrounding municipalities.

INTERVENTION: The training intervention was planned using self-determination theory as framework. Important elements were relation building, giving nursing staff a choice concerning themes of teaching sessions (supports autonomy) and selection of cases, supporting competence development through case-based discussions. Study design and statistical approach: before and after the intervention, an electronic questionnaire was mailed to staff at care institutions in the municipalities. The questionnaire contained questions drawn from the Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS). Differences concerning competences between before and after the intervention were assessed using Wilcoxon signed-rank test.

KEY FINDINGS: 55 persons answered the BPNSFS before and after the intervention. For all items in BPNSFS, the results after compared to before improved. However, the improvement was significant only for the sum of all items with a mean difference of 0.13, p = 0.05, and for one single item (I feel capable at what I do at work), with a mean difference of 0.15, p = 0.02.

CONCLUSIONS: We have shown that self-determination theory has the potential to provide a theoretical framework for planning training interventions among staff in temporary elder care institutions. It is possible to measure the effect using an instrument developed within the framework of self-determination theory (BPNSFS).

PMID:41678141 | DOI:10.1007/s41999-025-01363-0

Adv Ther. 2026 Feb 12. doi: 10.1007/s12325-026-03504-8. Online ahead of print.

ABSTRACT

INTRODUCTION: Delamanid (Deltyba®), a medicinal product with an orphan designation for the treatment of tuberculosis, received a conditional marketing authorisation in the European Union (EU) based on phase 2 data, while phase 3 trial was ongoing. The list of adverse drug reactions (ADRs) in the original Summary of Product Characteristics (SmPC) contained all adverse events (AEs) considered related by the investigator that were reported in at least one of the 321 patients receiving delamanid. The safety profile observed after completion of the phase 3 clinical trial, post-marketing studies and spontaneous reports from post-marketing appeared different from what the initial SmPC was indicating. A comprehensive analysis was undertaken aiming to provide evidence for identification of a well-substantiated and clinically useful delamanid safety profile.

METHODS: In support of the process of ADR identification, a statistical methodology of data from controlled clinical trials was introduced based on the estimation of risk difference and risk ratio for identification of a potential risk from delamanid in high and low incidence situations. Final medical assessment was supported by this statistical analysis of data from controlled clinical trials, any signal from all other Otsuka-sponsored clinical trials, along with data from post-marketing solicited and unsolicited sources.

RESULTS: ADRs were either retained, added to or removed from the ADR list with the same or modified frequency. Thus, the total number of ADRs listed in the original SmPC was significantly reduced.

CONCLUSION: A combination of statistical parameters and medical judgement should be considered for the selection of undesirable effects for the product label and for the safety risk classification.

PMID:41678139 | DOI:10.1007/s12325-026-03504-8

Eur J Clin Microbiol Infect Dis. 2026 Feb 12. doi: 10.1007/s10096-026-05404-9. Online ahead of print.

ABSTRACT

PURPOSE : Chlamydia psittaci pneumonia (CPP) remains underdiagnosed due to nonspecific clinical manifestations. This study assessed the clinical utility of targeted next-generation sequencing (tNGS) in optimizing CPP diagnosis and antimicrobial stewardship, with a focus on empirical quinolone efficacy.

METHODS: We conducted a retrospective cohort study of 35 CPP patients (November 2022-October 2023) diagnosed by tNGS of respiratory specimens (8 sputum/27 bronchoalveolar lavage fluid [BALF]). Data included epidemiological history, laboratory findings, imaging features, therapeutic interventions, and clinical outcomes. Statistical comparisons between severe and non-severe CPP were performed using Student’s t-test and Mann-Whitney U tests.

RESULTS: Median diagnostic delay post-admission was 4 days (IQR:3-5). Fever predominated as initial presentation (97.1%), with 45.7% reporting avian contact. Leukocyte counts were normal/mildly elevated,, yet neutrophil ratio (83.86 ± 6.17%) and D-dimer (1.31 ± 0.86 mg/L) were notably increased. All patients showed elevated CRP (175.52 ± 87.62 mg/L) and ESR (70.00 ± 22.62 mm/h). Severe CPP cases (n = 8) exhibited higher CRP (p = 0.041) and procalcitonin (p = 0.013) than non-severe cases. Common comorbidities included hepatic dysfunction (68.6%) and pleural effusion (34.3%). Polymicrobial co-infections occurred more frequently in severe CPP cases than in non-severe cases (OR = 21.07, 95% CI:1.11-402.30). tNGS-guided diagnosis prompted antibiotic adjustment in 60.0% of patients (21/35) to targeted quinolone, tetracycline, or combination therapy. Clinical recovery was achieved in 97.1%, with 2.9% mortality.

CONCLUSIONS: tNGS enhances early CPP diagnosis and targeted antimicrobial adjustment. Quinolones demonstrate high efficacy as empirical treatment. The strong association between severe CPP and polymicrobial co-infections necessitates comprehensive pathogen screening. Study limitations include a single-center design and a small sample size, warranting validation through prospective multicenter studies.

PMID:41678126 | DOI:10.1007/s10096-026-05404-9

J Clin Sleep Med. 2026 Jan 5;22(1):10. doi: 10.1007/s44470-025-00014-2.

ABSTRACT

STUDY OBJECTIVES: Evidence of dairy’s association with sleep is limited. Therefore, we evaluated the association between dairy product consumption and self-reported and objective sleep outcomes in U.S. adults.

METHODS: Participants included 23,480 men and women (mean age 46.7 ± 17.3 years) from the 2005-2020 National Health and Nutrition Examination Survey. Dairy intake (total and sub-types) was estimated from two 24-h dietary recalls. We categorized average daily dairy intake as low, moderate, and high based on sex-specific tertiles. Sleep duration (< 7, 7-9 (ref.), ≥ 9 h/day) and trouble sleeping (yes/no) were obtained from questionnaires. Objective sleep measures were derived from accelerometer data in a subsample (n = 4,972). Survey-weighted multivariate logistic and linear regression were used to evaluate dairy intake in relation to self-reported and objective sleep outcomes, respectively.

RESULTS: Mean (SD) total dairy intake was 1.76 (1.34) cup-eq/day. High total dairy intake was associated with 16% and 23% lower odds of short and long sleep duration, respectively (all P-trend ≤ 0.01), and lower odds of trouble sleeping (OR_{high vs. low}=0.86; 95% CI 0.75-1.00; P-trend < 0.05). Similar associations between milk and sleep duration, and high-fat dairy and trouble sleeping were observed (all P-trend < 0.03). Moreover, high vs. low total dairy intake was associated with a higher sleep regularity index, and fermented dairy intake was associated with less variable sleep midpoint, and lower odds of poor sleep (all P-trend < 0.03).

CONCLUSIONS: Dairy consumption is associated with improved odds of adequate sleep, no trouble sleeping, and less variable sleep in U.S. adults. However, additional studies are warranted to assess causality. Current Knowledge/Study Rationale: Emerging research suggests that diet influences sleep health; however, evidence on the specific role of dairy products remains limited. We examined the association between dairy product consumption (total and subtypes) and both self-reported and objective sleep metrics in a nationally representative sample of U.S. adults. Study Impact: Dairy intake, especially of fermented dairy products, is associated with better sleep patterns, via improved odds of having adequate sleep, no trouble sleeping, and less sleep variability. Longitudinal studies and clinical interventions are needed to investigate causal associations and to clarify underlying mechanisms.

PMID:41678097 | DOI:10.1007/s44470-025-00014-2

J Clin Sleep Med. 2026 Feb 6;22(1):28. doi: 10.1007/s44470-025-00028-w.

NO ABSTRACT

PMID:41678095 | DOI:10.1007/s44470-025-00028-w

J Clin Sleep Med. 2025 Dec 22;22(1):7. doi: 10.1007/s44470-025-00019-x.

ABSTRACT

BACKGROUND: Adherence to positive airway pressure (PAP) therapy in obstructive sleep apnoea (OSA) remains suboptimal. Previous cognitive behavioural therapy (CBT) has relied on passive education approaches and has yielded mixed results.

OBJECTIVE: To evaluate whether personalised video footage showing one’s own sleep-disordered breathing events (Self-Viewing of Sleep Apnoea Videos, SVSV) improves PAP adherence.

METHODS: In this randomised controlled trial, 228 treatment-naïve patients with moderate to severe OSA were assigned to either the SVSV or standard CBT-only (control) group. All participants received standard CBT before PAP initiation. The SVSV group additionally viewed video footage of apnoeas from their own diagnostic polysomnography. The primary outcome was good adherence, defined as ≥ 4 h of sleep per night on ≥ 70% of nights for 90 days. Secondary outcomes included the number of days with adequate use, mean daily usage time, and apnoea-hypopnoea index (AHI) during PAP.

RESULTS: Good adherence was achieved in 89.5% of the SVSV and 78.1% of the control group (absolute difference, 11.4%; 95% confidence interval (CI), 1.94% to 20.86%). Compared with the control group, the SVSV group had more days with adequate usage (mean difference of 9.05 days; CI, 2.29 to 15.81) and longer daily usage (mean difference of 0.55 h; CI, 0.13 to 0.98). AHI during PAP therapy was similar between the two groups.

CONCLUSIONS: This study supports the clinical utility of patient-specific visual feedback to improve PAP adherence. SVSV-a simple, low-cost, and scalable strategy-resulted in a higher proportion of patients achieving good adherence and greater usage. 1. Current Knowledge/Study Rationale: Adherence to positive airway pressure therapy in obstructive sleep apnoea is often inadequate, limiting its therapeutic benefit. Previous educational approaches, including video-based cognitive behavioural therapy, have yielded inconsistent effects on adherence. 2. Study Impact: This prospective, randomised controlled trial shows that allowing patients to view video segments of their own sleep-disordered breathing events, extracted from diagnostic polysomnography, significantly improves positive airway pressure adherence. This personalised self-viewing intervention is simple, cost-effective, and easily integrated into existing clinical workflows, with particular value for underserved populations and individuals with limited health literacy.

PMID:41678091 | DOI:10.1007/s44470-025-00019-x