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The Post-Marketing Real-World Outpatient Clinical Validation of Electronic Blood Pressure Monitors

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

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Exploring anabasine excretion factor in individuals who use tobacco cigarettes: a preliminary estimate

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

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Clinical Trial: Early Nivolumab Addition to Regorafenib in Patients With Hepatocellular Carcinoma in Second-Line (The GOING Trial)

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

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Expected change: a new concept for monitoring patients on oral bisphosphonates

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

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Urological trials without significant results. Can we extract meaning from disappointment?

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

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The feasibility of integrating remote breath alcohol monitoring into ecological momentary assessment of intimate partner violence among young adults with a history of heavy drinking and aggression

Addiction. 2026 Feb 23. doi: 10.1111/add.70357. Online ahead of print.

ABSTRACT

AIMS: We examined the feasibility and acceptability of pairing portable breathalyzers to assess field alcohol use with mobile ecological momentary assessment (EMA) to assess intimate partner violence (IPV; psychological, cyber, physical and sexual aggression) perpetration and victimization among undergraduates who drink heavily and were recently aggressive.

DESIGN, SETTING AND PARTICIPANTS: We assessed EMA/breathalyzer completion rates, drinking captured via breathalyzer versus self-report, number of IPV events captured, procedural acceptability and reactivity to assessment. Sex differences were examined. Undergraduates aged 18-25 (n = 103; M age = 21 years, SD = 2.0; 52% women; 80.6% heterosexual; 64.1% white; 93.2% non-Hispanic) recruited from a large Mid-Atlantic university in the United States completed a baseline survey then a 30-day EMA wherein they were prompted to complete one morning and three evening surveys (7 PM, 9 PM, 11 PM) daily. After each evening survey, participants were prompted to submit a breath alcohol content (BrAC) sample to a breathalyzer linked to surveys. Participants could self-initiate surveys after drinking or IPV outside of assessment periods. Afterward, participants completed an exit survey.

MEASUREMENTS: Outcome variables were self-reported alcohol use and IPV assessed via EMA surveys, and BrAC assessed via breathalyzer. Self-reported procedural acceptability was assessed in the exit survey. Reactivity to assessment was assessed by analyzing daily trends in IPV and drinking by sex using generalized linear mixed effects models.

FINDINGS: Participants completed 80% of surveys and responded to 91% of breathalyzer prompts. BrAC was captured in 89.4% of self-reported drinking events, 91.4% of self-reported non-drinking events and 95.8% of IPV events, with greater responsiveness to breathalyzer prompts as the evening progressed despite increasing intoxication. More IPV events were captured during evening and event triggered (358 combined total events) than morning surveys (245 events). Results were comparable across women and men. Each additional study day was associated with modest declines in odds of experiencing any IPV [odds ratio (OR) = 0.95, 95% confidence interval (CI) = 0.94-0.97, P < 0.001], IPV perpetration (OR = 0.94, 95% CI = 0.92-0.96, P < 0.001), IPV victimization (OR = 0.97, 95% CI = 0.96-0.99, P = 0.004), any drinking (OR = 0.99, 95% CI = 0.98-1.00, P = 0.01) and positive BrAC readings (OR = 0.99, 95% CI = 0.98-1.00, P = 0.052), suggesting minimal reactivity to assessment. Participants reported high overall satisfaction with study components.

CONCLUSIONS: Pairing ecological momentary assessment with portable breathalyzers to capture data on drinking and intimate partner violence across 30 days among US undergraduates who were previously aggressive and who drink heavily appears to be both feasible and acceptable.

PMID:41725361 | DOI:10.1111/add.70357

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The Current State of Peer Review

Emerg Med Australas. 2026 Feb;38(1):e70232. doi: 10.1111/1742-6723.70232.

ABSTRACT

Peer review is a cornerstone of modern scientific publishing, yet its current form is a relatively recent development that became institutionalised in the mid-20th century. While intended to ensure rigour, credibility and quality control, the peer review system now faces mounting pressures. Rapid growth in manuscript submissions, reliance on unpaid reviewer labour, reviewer fatigue and the rise of predatory journals have strained its effectiveness. These challenges contribute to delays, inconsistent review quality and increasing retraction rates, highlighting vulnerabilities that peer review often fails to detect at scale. Evidence from randomised trials suggests that most proposed reforms offer limited benefit, although adding statistical reviewers and adopting elements of open peer review produce modest improvements. Sustainable reform will require evidence-guided changes, better recognition of reviewer contributions, and careful integration of technological tools to preserve the integrity of scientific publishing.

PMID:41725359 | DOI:10.1111/1742-6723.70232

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Adaptive functioning in schizophrenia: Behavioral executive functioning beyond negative symptoms

Appl Neuropsychol Adult. 2026 Feb 23:1-8. doi: 10.1080/23279095.2026.2634178. Online ahead of print.

ABSTRACT

Negative symptoms are among the most robust clinical predictors of adaptive functioning in schizophrenia, particularly in residual or stabilized phases of the disorder. Executive functioning (EF) is also linked to adaptive functioning and partially overlaps with negative symptoms but may capture distinct self-regulatory processes involved in translating intentions into sustained real-world behavior. Most prior evidence relies on performance-based EF measures, which assess executive functioning under highly structured conditions. This study examined whether behavioral ratings of EF provide incremental explanatory value for adaptive functioning beyond negative symptoms in adults with residual-phase schizophrenia. Forty outpatients with residual-phase schizophrenia were assessed using the Life Skills Profile (LSP-39) to measure adaptive functioning, the Scale for the Assessment of Negative Symptoms (SANS), and the informant-report Dysexecutive Questionnaire (DEX). Hierarchical regression models were estimated to test the incremental contribution of behavioral EF beyond negative symptoms, using permutation-based tests for model improvement and bias-corrected and accelerated bootstrap confidence intervals. Behavioral EF ratings showed strong associations with global adaptive functioning and all functional domains. Negative symptoms were also significantly related to functioning, although associations were generally smaller. In hierarchical models, DEX scores accounted for a substantial and statistically significant proportion of additional variance in global adaptive functioning beyond negative symptoms. Similar incremental effects were observed across all LSP-39 subscales, with behavioral EF showing larger standardized coefficients than negative symptoms. These findings indicate that behavioral ratings of executive functioning provide nonredundant and clinically meaningful information about adaptive functioning in residual-phase schizophrenia.

PMID:41725355 | DOI:10.1080/23279095.2026.2634178

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Evaluating the current state of quality measure reporting in the merit-based incentive payment system

Am J Surg. 2026 Feb 17;255:116873. doi: 10.1016/j.amjsurg.2026.116873. Online ahead of print.

ABSTRACT

BACKGROUND: The Merit-Based Incentive Payment System (MIPS) requires physicians to report quality measures along with supplementary metrics that are used to determine an annual percentage adjustment to physician Medicare Part B payments. Unfortunately, during the early years of the MIPS program (2017 to 2020), physicians in non-primary care specialties have had few quality measures to choose from. This has resulted in a disadvantage for physicians of non-primary care specialties to receive a positive Medicare part B adjustment. The aim of this study is to determine if significant variation still exists in the number and characteristics of quality measures in the MIPS program across specialties from 2021 to 2024.

METHODS: This longitudinal quality improvement study uses Centers for Medicare and Medicaid Services (CMS) Quality Payment Program (QPP) public use file data from 2021 to 2024 to collect descriptive statistics about the number and characteristics of MIPS measures and Qualified Clinical Data Registry (QCDR) measures available for reporting within the Traditional MIPS reporting pathway. Primary outcomes included the number of measure-and-collection-type combinations, number of unique MIPS measures, number of QCDRs, and number of QCDR measures available for reporting within each medical specialty. Secondary outcomes included quality measure characteristics such as each measure’s Donabedian class, topped out status, and capped status. All outcomes were established prior to data collection.

RESULTS: The average number of unique quality measures and measure-and-collection-type combinations available for reporting by non-primary care specialties is significantly lower than that for primary care specialties (p < 0.001, p < 0.001, respectively). Process measures outnumber outcome and structure measures within all specialties except neurosurgery, orthopedic surgery, and vascular surgery. A large percentage (40.9%) of all measure-and-collection-type combinations in 2024 are topped out and therefore fail to stratify physician performance effectively.

CONCLUSION: In this longitudinal study of MIPS and QCDR quality measures, results show that significant variability still exists in the number of quality measures available for reporting in 2024, with non-primary care specialties having the lowest number of reportable measures. Policymakers should ensure that future modifications to the MIPS program provide equal opportunity for physicians to achieve a positive Medicare Part B payment adjustment.

PMID:41723892 | DOI:10.1016/j.amjsurg.2026.116873

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Impact of Allergic Contact Dermatitis on Health-Related Quality of Life: A Cross-Sectional Case-Control Study in a Spanish Population

Contact Dermatitis. 2026 Feb 22. doi: 10.1111/cod.70116. Online ahead of print.

ABSTRACT

BACKGROUND: Allergic contact dermatitis (ACD) is a chronic inflammatory skin disorder associated with substantial impairment in quality of life (QoL). Few studies have comprehensively assessed the multidimensional impact of ACD using validated QoL instruments and healthy controls.

OBJECTIVES: To evaluate the impact of ACD on QoL compared to a control group and to explore the association between clinical variables and patient-reported outcomes.

METHODS: This cross-sectional study included 225 patients with confirmed ACD (positive and clinically relevant patch tests) and 225 healthy controls. All participants completed the Dermatology Life Quality Index (DLQI), the EuroQoL-5D (EQ-5D-5L) and the Skindex-29. Disease severity was assessed using the modified Investigator’s Global Assessment (mIGA). Statistical analyses included nonparametric Mann-Whitney U tests for between-group comparisons, correlation analyses, and multivariate linear and ordinal regression models to identify predictors of quality-of-life impairment.

RESULTS: Patients with ACD showed significantly greater impairment across all QoL measures compared to controls (p < 0.001). Pruritus was the most frequently reported symptom (45.0%), and emotional distress and functional limitations were prominent. Higher mIGA scores were significantly associated with poorer QoL across all instruments.

CONCLUSIONS: ACD has a marked negative impact on multiple dimensions of QoL, comparable to that observed in other chronic dermatoses. These findings underscore the importance of integrating standardised QoL assessments into the routine management of ACD and support the adoption of multidimensional approaches in both clinical evaluation and therapeutic decision-making, while also highlighting the relevance of psychosocial screening as an essential component of comprehensive patient care.

PMID:41723879 | DOI:10.1111/cod.70116