Tag: nevin manimala

Diabetes Obes Metab. 2026 Feb 23. doi: 10.1111/dom.70588. Online ahead of print.

ABSTRACT

AIMS: To investigate sex-stratified associations between 4-year weight loss and risk of incident atrial fibrillation (AF) in a prospective cohort study and the potential benefits of sustained weight management.

MATERIALS AND METHODS: We analysed 60 402 participants from the Kailuan Study free of AF, with body mass index (BMI) and waist circumference (WC) measured in 2006-2007 and 2010-2011. Reductions in BMI, body weight, and WC were used to define weight loss. Cox proportional hazards models assessed the association between weight loss and incident AF, adjusting for relevant covariates.

RESULTS: During a median follow-up of 13.0 years (interquartile range: 12.5-13.3), 582 participants developed AF (484 men, 98 women). In men, BMI reduction >2.5 kg/m² (hazard ratio [HR] 0.663, 95% confidence interval [CI] 0.467-0.940), body weight loss >5 kg (HR 0.662, 95% CI 0.468-0.936), and WC reduction >4 cm (HR 0.768, 95% CI 0.601-0.982) were associated with a lower risk of incident AF. In women, WC reduction >4 cm (HR 0.499, 95% CI 0.279-0.892) was associated with a lower risk. Similar patterns were observed among participants with overweight or obesity. Formal tests for sex interaction were not statistically significant.

CONCLUSIONS: Reductions in BMI, body weight, and WC were associated with lower risk of incident AF, particularly in overweight or obese participants. The magnitude of association differed by anthropometric measure and sex, with BMI change showing stronger associations in men and WC change in women. Anthropometric changes may aid risk stratification and inform prevention efforts in higher-risk groups.

PMID:41725430 | DOI:10.1111/dom.70588

Diabetes Obes Metab. 2026 Feb 23. doi: 10.1111/dom.70596. Online ahead of print.

ABSTRACT

AIMS: To evaluate whether an endocrinology-integrated transplant clinic and differing healthcare delivery models are associated with metabolic outcomes during the first year after kidney transplantation in recipients with pre-existing diabetes.

MATERIALS AND METHODS: We conducted a retrospective longitudinal cohort study of adult kidney transplant recipients with diabetes at a US and a European academic centre. Participants were classified by post-transplant diabetes care model: Cohort 1, endocrinology-led Endocrine Transplant Clinic (ETC; n = 99); Cohort 2, historical standard transplant care at the same US centre (n = 81); and Cohort 3, standard endocrinology care at a Spanish academic centre (n = 40). Pre-specified outcomes included HbA1c, body mass index (BMI), blood pressure, and lipid levels measured at baseline and 3, 6, and 12 months. Linear mixed-effects models adjusted for demographic and clinical covariates were applied. Missing longitudinal data were addressed using multiple imputation with complete-case sensitivity analyses.

RESULTS: Among 220 recipients, adjusted metabolic trajectories were broadly similar across cohorts. HbA1c was unchanged at 3 and 6 months but higher at 12 months; >50% had HbA1c >7% at 1 year. BMI remained stable, with ≥30% meeting obesity criteria throughout follow-up. Blood pressure did not improve, and systolic hypertension (>130 mmHg) remained common (49%-77%). At 12 months, LDL-C ≥70 mg/dL was present in 20.8%, 63.3%, and 42.3% of Cohorts 1-3. Findings were consistent in sensitivity analyses.

CONCLUSIONS: Metabolic control in the first post-transplant year showed stabilisation rather than improvement, with many recipients above cardiometabolic targets. Prospective studies should test whether earlier, protocolised multidisciplinary management improves cardiovascular and graft outcomes.

PMID:41725429 | DOI:10.1111/dom.70596

Leuk Lymphoma. 2026 Feb 23:1-8. doi: 10.1080/10428194.2026.2621822. Online ahead of print.

ABSTRACT

Philadelphia chromosome (Ph) status is a critical prognostic marker in B-cell acute lymphoblastic leukemia (B-ALL). This study evaluates the impact of Ph-positive (Ph+) and Ph-negative (Ph-) status on overall survival (OS) and cancer-specific survival (CSS) while analyzing the role of demographic and treatment variables. A retrospective cohort study involving 14,175 patients diagnosed with B-ALL from 2010 to 2021 was analyzed in this investigation. Primary outcomes were OS and CSS, analyzed using hazard ratios (HRs) with 95% confidence intervals (CIs) and associated p-values. Subgroup analysis by year assessed temporal trends in survival outcomes. Statistical analysis and survival rate (OS and CSS) estimations were performed using SEER*Stat software. The cohort’s mean age was 29.6 years (SD = 26.1), with 54.7% male and 43.6% Caucasian. Ph + patients comprised 7.3% of the cohort. Treatments included chemotherapy (90.9%) and radiation therapy (9.3%). The mean OS for Ph + patients was 49.75 months (95% CI: 47.098-52.402), whereas Ph- patients had a significantly longer OS of 66.541 months (95% CI: 65.715-67.366) (p < .001). Similarly, the mean CSS was 88.2 months (95% CI: 83.3-93) for Ph + patients and 103.2 months (95% CI: 102.1-104.3) for Ph- patients (p < .001). Temporal analysis of the last three years revealed no significant differences in OS (Ph+: 27.7 months vs. Ph-: 26.6 months, p = .145) or CSS (Ph+: 28.1 months vs. Ph-: 29 months, p = .183). Significant predictors of reduced OS and CSS included male sex (OS HR: 1.073, p = .019; CSS HR: 1.070, p = .041), older age (OS HR: 1.039, p < .001; CSS HR: 1.038, p < .001), and lack of chemotherapy (OS HR: 0.617, p < .001; CSS HR: 0.625, p < .001). Race was not a significant predictor of survival outcomes. This study highlights the comparable survival rates in Ph + and Ph- ALL patients in recent years. Demographic factors and treatment modalities, particularly chemotherapy, play significant roles in modulating survival outcomes. These findings underscore the importance of individualized treatment strategies based on Ph status and other prognostic indicators in B-ALL management.

PMID:41725421 | DOI:10.1080/10428194.2026.2621822

J Pediatr Orthop. 2026 Feb 23. doi: 10.1097/BPO.0000000000003226. Online ahead of print.

ABSTRACT

BACKGROUND: Vertebral body tethering (VBT) is a growth-modulating technique in treatment of AIS. While the use of a double row of screws for anchoring of the tether in the apex has been proposed to reduce the risk of tether breakage and improve correction, there is limited evidence supporting this.

METHODS: Patients ≤16 years of age with AIS who underwent anterior VBT with 2-year minimum follow-up were included in the study. We performed 3 separate analyses comparing main thoracic only (T), thoracolumbar only (TL), and combined thoracic/thoracolumbar (T/TL) tether constructs used in either single-row (SRVBT) or double-row VBT (DRVBT). Independent sample t tests and χ2 analyses were performed for comparison of characteristics and main outcomes, including percent surgical correction, rates of tether breakage, and rates of revision.

RESULTS: A total of 227 patients were enrolled in the study (190 SRVBT: 37 DRVBT). Across T, TL, and T/TL cohorts, DRVBT patients were more skeletally mature based on differences in mean Rissers (2.9 vs. 0.7, P<0.05). In our TL cohorts, patients with DRVBT had significantly greater percent correction at early post-op (75% vs. 51%, P=0.003) and better correction at 2 years (DRVBT 50% vs. SRVBT 33%, P=0.279). SRVBT experienced higher rates of revision (39% vs. 7%, P=0.077) and had a higher conversion to fusion rate (23% vs. 0%, P=0.098) compared with DRVBT in the setting of a thoracolumbar tether. In our T analysis, though DRVBT had greater correction at post-op and 2 years, this was not statistically significant (P>0.05). In addition, no significant differences were found in tether breakage (SRVBT 53% vs. DRVBT 50%, P=1.000) or revision (SRVBT 7% vs. DRVBT 0%, P=1.000). In patients with T/TL constructs, 2-year outcomes for correction, tether breakage (DRVBT 85% vs. SRVBT 79%, P=1.000), and revision (DRVBT 15% vs. SRVBT 0%, P=0.206) were statistically nondifferent between groups.

CONCLUSIONS: While results of tether breakage were not statistically different between the SRVBT and DRVBT, DRVBT had greater initial and long-term correction for TL curves along with lower revision and fusion rates.

LEVEL OF EVIDENCE: Level III.

PMID:41725412 | DOI:10.1097/BPO.0000000000003226

Biometrics. 2026 Feb 23:ujag023. doi: 10.1093/biomtc/ujag023. Online ahead of print.

ABSTRACT

Under interference, the treatment of one unit may affect the outcomes of other units. Such interference patterns between units are typically represented by a network. Correctly specifying this network requires identifying which units can affect others-an inherently challenging task. Nevertheless, most existing approaches assume that a known and accurate network specification is given. In this paper, we study the consequences of such misspecification. We derive bounds on the bias arising from estimating causal effects using a misspecified network, showing that the estimation bias grows with the divergence between the assumed and true networks, quantified through their induced exposure probabilities. To address this challenge, we propose a novel estimator that leverages multiple networks simultaneously and remains unbiased if at least one of the networks is correct, even when we do not know which one. Therefore, the proposed estimator provides robustness to network specification. We illustrate key properties and demonstrate the utility of our proposed estimator through simulations and analysis of a social network field experiment.

PMID:41725409 | DOI:10.1093/biomtc/ujag023

J Clin Hypertens (Greenwich). 2026 Feb;28(2):e70222. doi: 10.1111/jch.70222.

ABSTRACT

This study evaluated the accuracy of a variety of home upper-arm oscillometric blood pressure monitors (BPMs) from 448 participants against the FDA-certified XYZ110 auscultatory device using simultaneous measurements. Descriptive statistics were used to summarize the key findings of the study. Device performance was evaluated referencing international standards (ISO 81060-2:2013), where a mean absolute difference of ≤5 mmHg was defined as “Accurate.” In addition, survey questionnaires completed by a subset of participants were analyzed to provide supplementary insights. A total of 448 consecutive outpatient clinical patients attending a routine clinical visit with their BPMs (male 215 and female 233) were eligible to participate in this study. The overall mean age of the participants was 62.35±12.59 years. Most of the BPMs included in this study were of the Omron brand (79.69%, n = 357), followed by Yuwell (5.8%, n = 26) and others. 76.32% of systolic blood pressure (SBP) measurements and 69.89% of diastolic blood pressure (DBP) measurements from BPMs exhibited differences of ≤5 mmHg compared to the reference calibrator. 70.89% (n = 318) were accurate in measuring SBP, and 60.27% (n = 270) were accurate in measuring DBP. Our study revealed that over 20% of BPMs exhibited discrepancies of more than 5 mmHg compared to a reference calibrator. Overall, the Omron U30, HEM-7211, and U10 models demonstrated relatively higher accuracy in blood pressure measurements. Regular patient to patient validation of BPMs is crucial to ensure accurate measurements for daily use.

PMID:41725403 | DOI:10.1111/jch.70222

Nicotine Tob Res. 2026 Feb 23:ntag042. doi: 10.1093/ntr/ntag042. Online ahead of print.

ABSTRACT

INTRODUCTION: Population-level models predicting tobacco use would benefit from inclusion of an accurate anabasine excretion factor. This study aimed to explore the excretion of anabasine in people who use conventional cigarettes (CCs) and nicotine vaping products (NVPs).

METHODS: A total of 72 participants were enrolled: 22 people who smoked CCs, 20 people who used NVPs, and 30 people who had never smoked or vaped. The quantity of CC and NVP use was documented over a 3-day period. Composite 24-hour urine samples were collected on Day 3 and analysed using LC-MS/MS to quantify nicotine, cotinine (COT), 3-hydroxycotinine (3HC), anabasine and anatabine. The anabasine excretion factor was calculated for urine samples containing anabasine.

RESULTS: Nicotine exposure, as the molar sum of nicotine and its metabolites (COT and 3HC) was higher for the NVP group compared to the CC group (p = 0.0460). Anabasine concentrations were low in urine of the NVP group but the difference from the CC group did not reach statistical significance (p = 0.0646). Data from 19 individuals in the CC group was used to calculate anabasine excretion factor, giving a value of 9.02%.

CONCLUSIONS: The excretion factor for anabasine was calculated from 24-hour urine samples for 19 individuals who smoked cigarettes, providing a preliminary estimate that may be incorporated into predictive modelling for population-level tobacco product use. Given the small sample size of this study, future research with larger cohorts is required to provide more reliable estimates.

PMID:41725392 | DOI:10.1093/ntr/ntag042

Aliment Pharmacol Ther. 2026 Feb 23. doi: 10.1111/apt.70578. Online ahead of print.

ABSTRACT

BACKGROUND & AIMS: Highly effective second-line treatments for hepatocellular carcinoma remain an unmet need. The GOING investigator-initiated Phase I/IIa trial evaluated regorafenib plus nivolumab (add-on) in patients who progressed on sorafenib (Cohort-A) or discontinued atezolizumab-bevacizumab (Cohort-B).

METHODS: Patients received regorafenib for two 28-day cycles, adding nivolumab in cycle 3, until unacceptable adverse events, symptomatic progression, withdrawal or death. Primary endpoint was safety. Secondary endpoints included overall survival, time to progression, post-progression survival, objective response rate and incidence of new-extrahepatic-spread.

RESULTS: Of 85 patients screened, 67 were enrolled (75.5% BCLC-C). All experienced adverse events and 9% led to discontinuation. Severe treatment-related adverse events occurred in 28.4% overall, 32.1% in Cohort-A, and 14.3% in Cohort-B. Median overall survival was 20.0 (95% CI 11-37) months, with 40.6% survival at 36 months. In Cohort-A, median overall survival was 25 (95% CI 14-39) months with 45% survival at 36 months, while Cohort-B median overall survival was 8 (95% CI 4-NE) months with 28.6% survival at 24 months. Objective response rate was 16.4%; median time to progression and post-progression survival were 5 (95% CI 4-9) months and 14 (95% CI 8-33) months. Intrahepatic growth was the most common progression pattern, followed by new-extrahepatic-spread.

CONCLUSIONS: The add-on strategy of regorafenib plus nivolumab in second-line had manageable safety and significant clinical activity with a noteworthy median overall survival of 20 months. Among those progressing on sorafenib, 45% were alive at 3 years. These findings support further evaluation with mechanism-guided trials after progression on immunotherapy.

TRIAL REGISTRATION: EudraCT number: 2019-003108-10; https://www.clinicaltrialsregister.eu.

PMID:41725391 | DOI:10.1111/apt.70578

J Bone Miner Res. 2026 Feb 23:zjag039. doi: 10.1093/jbmr/zjag039. Online ahead of print.

ABSTRACT

It is essential to closely monitor the response to oral bisphosphonate therapy for osteoporosis, as many patients are nonadherent. The conventional approach is to monitor whether changes in BMD or bone turnover markers exceed the least significant change. That approach assumed that if a patient were not receiving a treatment, there would be no change in the BMD. We propose an alternative approach, that of expected change. We define this expected change as the change in bone mineral density (BMD) (at 24 months) or bone turnover markers (at three months) that is exceeded in 90% of patients who are adherent with oral bisphosphonate therapy. We studied 108 postmenopausal women (age<85 years) who were randomised to the licensed dose of alendronate, ibandronate or risedronate treatment for two years, along with calcium and vitamin D supplementation. We identified the performance of BMD and bone turnover markers in three ways. We calculated the signal-to-noise ratio, which was lower for BMD [4.1 and 2.1 for lumbar spine BMD (LSBMD) and total hip BMD (THBMD), respectively] compared to bone turnover markers (9.4 and 10.2 for CTX and PINP, respectively). We estimated the response rate as the percentage of women exceeding the least significant change, which was lower for BMD (47% and 24% for LSBMD and THBMD, respectively) than for bone turnover markers (96% and 94% for CTX and PINP, respectively). We estimated the expected change as the 90th (or 10th) percentile of change in adherent patients. We required the expected change to exceed the least significant change, and this was not observed for LS- and THBMD, but it was observed for CTX and PINP (expected changes of 0.233 ng/mL and 12.1 ng/mL, respectively). Thus, the bone turnover markers CTX and PINP showed the best performance as response markers for monitoring oral bisphosphonate treatment, and the new approach is based on a biological rather than a statistical endpoint when using the expected change approach.

PMID:41725388 | DOI:10.1093/jbmr/zjag039

BJU Int. 2026 Feb 23. doi: 10.1111/bju.70140. Online ahead of print.

ABSTRACT

OBJECTIVE: To calculate additional information from urological trials which do not report statistically significant results, and assess whether language manipulation is used when such studies were reported.

MATERIALS AND METHODS: Many randomised controlled trials (RCTs) do not yield statistically significant primary outcomes; such results are challenging to interpret using traditional statistical practices. An alternative approach, the likelihood ratio (LR), uses Bayesian statistical methods to compare the null (no significant effect of treatment) and alternative (significant effect of treatment) hypotheses, and provides quantitative strength of evidence for one compared to the other. A lower LR indicates stronger support for the alternate hypothesis over the null and vice versa. We performed a cross-sectional review of urological RCTs, published in the period 2018-2024, with a primary outcome that did not reach statistical significance. For each outcome, an LR was calculated. For each included article the use of language manipulation (‘spin’) was also analysed.

RESULTS: Eighty-two articles with 98 primary outcomes were identified. For 13% of these outcomes the data provided greater support for the alternative hypothesis compared to the null, as indicated by an LR < 1. This suggests these trials, such as the EVEREST trial (LR = 0.26), should be considered for further investigation. For 36% of results the LR was >100, indicating decisive evidence in favour of the null hypothesis, and suggesting these trials, including SWOG S1011 (LR = 250), need not be repeated. Spin was identified in 41.5% of abstracts. After adjustment, only impact factor and LR <1 were associated with spin use. This study was limited by its analysis of only articles published in high impact factor journals in the past 7 years.

CONCLUSIONS: Many urological RCTs with primary outcomes that were not statistically significant by traditional measures warrant further investigation. Researchers should apply the LR to future trials to aid interpretation of their results.

PMID:41725373 | DOI:10.1111/bju.70140