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Nevin Manimala Statistics

Identifying Clinical Characteristics of Young People with Treatment-Resistant Schizophrenia Undergoing Community Initiation of Clozapine

Schizophr Bull. 2026 Apr 10;52(3):sbag071. doi: 10.1093/schbul/sbag071.

ABSTRACT

BACKGROUND AND HYPOTHESIS: The requirement for hospital admission to initiate clozapine presents a health-systems-related barrier to clozapine prescription and contributes to its underutilization in treatment-resistant schizophrenia (TRS). This study aimed to examine the clinicodemographic characteristics associated with treatment settings for clozapine initiation within a first-episode psychosis (FEP) cohort attending an early intervention in psychosis service.

STUDY DESIGN: Secondary analysis of a retrospective cohort study of 1220 young people presenting with FEP to the Early Psychosis Prevention and Intervention Centre (EPPIC) in Melbourne between 2011 – 2017.

STUDY RESULTS: Ninety-one cases of TRS were identified and included in the analysis, with 70 commencing clozapine, of whom 67 had a commencement setting identified. Over half (n = 36, 53.7%) commenced clozapine in the community. When compared to the hospital initiation group, the community initiation group were less likely to have had a hospital admission at baseline (odds ratio (OR) 0.26, 95%CI, 0.09-0.87) or an involuntary admission during the 2 year episode of care with EPPIC (OR 0.25, 95%CI, 0.09-0.70). The community initiated group had presented with less severe delusion scores on short form Scale for Assessment of Positive Symptoms at baseline (mean 3.08 vs 3.94, P = .031). First generation migrants were less likely to initiate clozapine in the community (OR 0.29, 95%CI, 0.09-0.97). The community initiation group also had reduced odds of clozapine discontinuation until discharge from EPPIC (OR 0.22, 95%CI, 0.06-0.76).

CONCLUSION: Community initiation provides an alternative route to clozapine treatment and may be associated with a reduced rate of clozapine discontinuation.

PMID:42104793 | DOI:10.1093/schbul/sbag071

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The Geography of Disconnection: Rural and Urban Gaps in Post-Pandemic Telehealth Use

Health Serv Res. 2026 Jun;61(3):e70126. doi: 10.1111/1475-6773.70126.

ABSTRACT

OBJECTIVE: To examine rural-urban disparities in telehealth utilization during the post-pandemic period and assess whether these disparities persist after adjusting for individual-level characteristics.

STUDY SETTING AND DESIGN: We used multivariable logistic regression and propensity score matching to estimate differences in telehealth use by rurality and examined self-reported reasons for non-use.

DATA SOURCES AND ANALYTIC SAMPLE: We analyzed 2022 and 2024 Health Information National Trends Survey (HINTS) data, a nationally representative survey of noninstitutionalized US adults. The analytic sample included 11,106 respondents after excluding missing observations.

PRINCIPAL FINDINGS: Overall, 38.7% of adults reported telehealth use in the past 12 months. After adjusting for covariates, rural residents were significantly less likely to use telehealth than urban core residents; remote rural residence was associated with a 10-percentage point lower probability (95% CI, -16.2 to -2.8; p < 0.01). Propensity score analyses yielded similar results (-7.7% points; 95% CI, -16.2 to -2.8; p < 0.01). Among non-users, rural respondents were more likely to report not being offered telehealth.

CONCLUSIONS: We observed significant rural-urban disparities in telehealth use in the post-pandemic period. Rural non-users were more likely to report not being offered telehealth, indicating delivery-side barriers.

PMID:42104788 | DOI:10.1111/1475-6773.70126

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Association of regional fat distribution indicators with infertility in women: insights from the 2013-2018 NHANES

Gynecol Endocrinol. 2026 Dec 31;42(1):2670809. doi: 10.1080/09513590.2026.2670809. Epub 2026 May 9.

ABSTRACT

BACKGROUND: Female infertility is multifactorial, with adiposity and regional fat distribution hypothesized as contributors, though evidence using detailed fat measures is limited. This study aims to examine the association between fat distribution indicators and female infertility in a nationally representative sample.

METHODS: This retrospective cross-sectional study analyzed NHANES 2013-2018 data from 2,531 women aged 20-45. Infertility was defined by self-reported difficulty conceiving ≥ 12 months or seeking fertility care. Exposures included body mass index (BMI) and DXA-based measures: total percent fat (TPF), android percent fat (APF), gynoid percent fat (GPF), android fat/gynoid fat ratio (AGR), visceral fat/total fat (VPF), subcutaneous fat/total fat (SPF), and visceral fat/subcutaneous fat ratio (VSR). Multivariable logistic regression was used to assess associations, and sensitivity analyses were performed to evaluate robustness.

RESULTS: In multivariable-adjusted models, TPF, APF, AGR, and BMI were modestly associated with higher odds of infertility (TPF: OR = 1.02, 95%CI: 1.00-1.05; APF: OR = 1.03, 95%CI: 1.01-1.04; AGR: OR = 1.02, 95%CI: 1.01-1.03; BMI: OR = 1.02, 95%CI: 1.01-1.04). Smooth curve fitting suggested a generally monotonic positive pattern for these associations. Associations were broadly similar across subgroups, although some subgroup interactions were observed.

CONCLUSION: In this analysis, TPF, APF, AGR, and BMI showed modest associations with infertility, which should not be interpreted causally. Although associations were generally consistent across subgroups, subgroup-specific heterogeneity cannot be excluded.

PMID:42104773 | DOI:10.1080/09513590.2026.2670809

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Effect of Ultrasound-Guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures: A Randomized Controlled Noninferiority Trial

Acta Anaesthesiol Scand. 2026 Jul;70(6):e70246. doi: 10.1111/aas.70246.

ABSTRACT

BACKGROUND: Closed reduction of distal radius fractures is painful, and current analgesic strategies may be inadequate. Ultrasound-guided lateral infraclavicular brachial plexus block may offer complete analgesia and muscle relaxation, potentially improving patient comfort and reduction quality. However, benefits and challenges regarding anesthetic agents for this procedure remain unclear.

METHODS: In this randomized, controlled, blinded, noninferiority trial, 63 adults with distal radius fractures requiring closed reduction received a lateral infraclavicular block with either 30 mL of ropivacaine 0.5%, lidocaine 1% with epinephrine, or ropivacaine 0.2%. The primary outcome was block success at 45 min, defined as complete sensory and extensive motor block of the radial, musculocutaneous, ulnar, and median nerves. Noninferiority was assessed using a margin of 20%. Exploratory outcomes included sensory and motor block assessments, time to pain relief, block duration, pain during reduction, patient satisfaction, quality of closed reduction, fracture treatments, and safety.

RESULTS: Ropivacaine 0.2% was statistically inferior to ropivacaine 0.5% in achieving block success at 45 min (risk ratio (RR) 0.63, 97.5% CI 0.40-0.99). Lidocaine 1% with epinephrine did not meet the predefined noninferiority criteria for block success (RR 0.95, 97.5% CI 0.73-1.22) but did provide comparable analgesia with a shorter block duration. Pain scores during reduction were low across all groups, with a significant decrease in pain from baseline. Patient satisfaction was high in all groups. No significant differences were found in the quality of closed reduction, safety, or fracture treatments.

CONCLUSION: Lateral infraclavicular block with ropivacaine 0.2% failed to demonstrate noninferiority for block success and was statistically inferior to ropivacaine 0.5%. Inferiority testing should be interpreted cautiously within the context of a noninferiority design, although the results suggest reduced effectiveness for distal radius fracture reduction. Lidocaine 1% with epinephrine yielded inconclusive results for noninferiority on block success, but provided a shorter block duration without compromising analgesia, patient satisfaction, or quality of reduction.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT06379490 (released April 23, 2024); https://clinicaltrials.gov/study/NCT06379490; EUCT Identifier 2024-510,572-20-00; https://euclinicaltrials.eu/ctis-public/view/2024-510572-20-00.

PMID:42104772 | DOI:10.1111/aas.70246

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Effect of Nutrition Care Process on Surgical Timing in Infants with Cleft Lip and Palate in North Karnataka, India

Cleft Palate Craniofac J. 2026 May 9:10556656261449340. doi: 10.1177/10556656261449340. Online ahead of print.

ABSTRACT

ObjectiveTo study the effect of nutrition care process (NCP) on cleft repair timing.DesignQuasi-experimental design.SettingTertiary care hospital with an operational cleft unit.Participants47 mothers of infants aged 0-6 months with cleft lip and palate who fulfilled the eligibility criteria.InterventionsDuring the baseline visit, anthropometric measurements of the infant were recorded, and World Health Organization (WHO) Z scores were plotted to identify their nutritional status. Nutritional education according to NCP was imparted to the mothers. In subsequent visits, growth of infants was monitored by anthropometry, education was reiterated and errors rectified. Right surgical timing was classified as on time or delayed according to age in months at surgery. Data collected were analyzed in SPSS software.Main Outcome Measure(s)Nutritional status, timely surgical readiness, educational level regarding nutrition, and feeding techniques.ResultsAmong the 47 infants, malnutrition improved from 55.3% mild, 29.8% moderate, and 14.9% severe at the first visit to 66% mild at lip surgery and 70.2% mild at palate surgery, with 68.1% and 70.2% infants respectively achieving timely surgical readiness. Infants with cleft showed consistently lower mean weights than the WHO standards at birth, lip, and palate surgery which was statistically significant (p = .001) indicating persistent growth faltering that was more pronounced among males. Mother’s education level was significantly associated with timely surgery (χ2 = 7.964, p = .047).ConclusionNutrition education effectively assisted infants in attaining the weight necessary for corrective surgery.

PMID:42104755 | DOI:10.1177/10556656261449340

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Clinical and cost-effectiveness of negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention: the SWHSI 2 pragmatic RCT

Health Technol Assess. 2026 May;30(32):1-50. doi: 10.3310/GJIC1716.

ABSTRACT

BACKGROUND: Surgical wounds healing by secondary intention occur if a surgical wound is not closed or dehisces following primary closure. Surgical wounds healing by secondary intention are common and adversely affect patients’ quality of life. Treatment is often prolonged, complex and expensive. Negative pressure wound therapy applies a controlled vacuum to the wound and is increasingly used to promote surgical wound healing by secondary intention despite limited rigorous evidence for the clinical and cost-effectiveness of negative pressure wound therapy to augment surgical wound healing by secondary intention.

OBJECTIVE: Assess the clinical and cost-effectiveness of negative pressure wound therapy versus usual care (no negative pressure wound therapy) in treating surgical wounds healing by secondary intention.

DESIGN AND METHODS: A pragmatic, two-arm, parallel-group, randomised controlled superiority trial. Twenty-eight UK NHS Trusts randomised adult patients with a surgical wounds healing by secondary intention to receive negative pressure wound therapy or usual care (no negative pressure wound therapy). The planned sample size was 696 participants. Participants were followed up for 12 months via weekly telephone contact to collect the primary outcome (time to healing: full cover with no scab in days since randomisation) and clinical secondary outcomes: wound healing, surgical site infection, pain, hospital re-admission, current treatment and reasons for treatment change (if applicable), reoperation, amputation, antibiotic use, death. Patient-reported outcomes (pain, health-related quality of life and resource use) were collected by postal questionnaire at 3, 6 and 12 months. Validation of the Bluebelle Wound Healing Questionnaire, a patient-reported measure of surgical site infection, was also undertaken. A cost-effectiveness decision model considering all available evidence, and a within-trial cost-utility analysis, was also undertaken to evaluate the cost-effectiveness of negative pressure wound therapy against usual care. Neither participants nor the investigators were blind to treatment allocation.

RESULTS: Between 15 May 2019 and 13 January 2023, 686 participants were recruited, randomised and included in the analysis (negative pressure wound therapy n = 349; usual care n = 337). Most participants had a single surgical wound healing by secondary intention (n = 622, 90.7%), located on the foot (n = 551, 80.3%) or leg (n = 69, 10.1%) arising following vascular surgery (n = 619, 90.2%). Most participants had comorbidities; diabetes (n = 549, 80.0%), cardiovascular disease (n = 446, 65.0%) and/or peripheral vascular disease (n = 349, 50.9%). Median time to healing was 187 days (negative pressure wound therapy) versus 195 days (usual care), with no evidence that negative pressure wound therapy reduced the time to wound healing compared to usual care (hazard ratio 1.08, 95% CI 0.88 to 1.32; p = 0.47). Odds of re-admission, reoperation, surgical site infection and antibiotic use were slightly higher, and odds of amputation or death slightly lower for negative pressure wound therapy participants. These results were not clinically or statistically significant. Bluebelle Wound Healing Questionnaire, quality of life and wound pain scores were not statistically significantly different at any time point. Serious adverse events were rare (nine negative pressure wound therapy vs. five usual-care participants). Both cost-effectiveness analyses concluded that negative pressure wound therapy generates higher costs and marginally higher quality-adjusted life-years than usual care, although findings were statistically insignificant. The probability of negative pressure wound therapy being cost-effective was under the recommended National Institute for Health and Care Excellence cost-effectiveness thresholds. The Bluebelle Wound Healing Questionnaire was acceptable to participants, had low levels of missing data and demonstrated good levels of sensitivity and specificity in the detection of surgical site infection in surgical wounds healing by secondary intention.

LIMITATIONS: The trial included a high proportion of diabetic participants with foot wounds, which may affect study generalisability. Negative pressure wound therapy use for ‘wound management’, common in certain surgical specialties, was not assessed in this study.

CONCLUSIONS: Negative pressure wound therapy is not clinically or cost-effective in augmenting healing in patients with surgical wounds healing by secondary intention, particularly those with comorbidities.

FUTURE WORK: Evaluation of methods to treat or prevent infection of surgical wounds healing by secondary intention and evaluation of negative pressure wound therapy for ‘wound management’ are recommended.

FUNDING: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/42/94.

PMID:42104753 | DOI:10.3310/GJIC1716

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Time Windows Used When Identifying Current Drug Use and Polypharmacy

Pharmacoepidemiol Drug Saf. 2026 May;35(5):e70384. doi: 10.1002/pds.70384.

ABSTRACT

PURPOSE: The length of the time window used to assess “current drug use” or “number of medications used” will influence the estimates hereof; however, no consensus exists on the optimal width of such time windows. We aimed to explore how the estimated prevalence of drug use in general, and of polypharmacy in particular, is affected by definitions used.

METHODS: We conducted a drug-utilization study divided into two parts. In the first part, we focused on current drug use. Using population-based registries from Denmark, we identified adults (i.e., individuals aged ≥ 18) during 2020-2022, and among them, current use of different drugs, including those with typically chronic or episodic patterns of use. The second part of the study focused on polypharmacy. We estimated its prevalence, based on different definitions, using population-based registries from Denmark in a cohort of older adults (i.e., individuals aged ≥ 65) in 2022. We also evaluated the accuracy of different criteria for predicting polypharmacy using simulations.

RESULTS: Evaluating current drug use, the proportion of individuals classified as exposed increased with the length of the time window for all drugs, reaching a plateau considering a 120-150-day window for statins, glucose-lowering drugs, and selective serotonin reuptake inhibitors, and a 180-300-day window for opioids, whereas no plateau was reached for non-steroidal anti-inflammatory drugs within 360 days. The prevalence of polypharmacy ranged from 21% (10 different 4th level Anatomical Therapeutic Chemical (ATC) groups in 1 year) to 92% (two different 4th level ATC groups in 1 year) depending on the applied definition. In the simulation, the best criterion for identifying polypharmacy required at least two dispensations during the one-year study period for each of at least five drugs, with sensitivity ranging between 0.93 and 1.0, and specificity between 0.72 and 1.0.

CONCLUSIONS: Time windows up to 120 days are too short to identify baseline drug use in the Danish setting. How polypharmacy is defined significantly influences its estimate, suggesting a need to use multiple definitions in each study.

PMID:42104746 | DOI:10.1002/pds.70384

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Heart Rate Variability as a Novel Indicator for Predicting Postoperative Urinary Retention in Benign Prostatic Hyperplasia: Development and Internal Validation of a Predictive Nomogram

Arch Esp Urol. 2026 Apr;79(3):469-475. doi: 10.56434/j.arch.esp.urol.20267903.55.

ABSTRACT

OBJECTIVE: To develop and internally validate a heart rate variability (HRV)-based predictive model for estimating the risk of postoperative urinary retention (POUR) in patients with benign prostatic hyperplasia (BPH).

METHODS: We retrospectively reviewed clinical data from 237 patients with confirmed BPH who received surgical treatment. Among them, 36 patients (15.2%) developed POUR. Variables showing statistical significance (p < 0.05) in univariate analysis were subsequently entered into a multivariate logistic regression to determine factors independently associated with POUR. Based on the corresponding regression coefficients, a graphical risk prediction tool (nomogram) was constructed. The predictive capability of the model was evaluated through receiver operating characteristic (ROC) analysis, calibration assessment, and decision curve analysis (DCA), and its robustness was further tested using bootstrap-based internal validation.

RESULTS: Multivariate analysis identified age, prostate volume, standard deviation of normal-to-normal intervals (SDNN), and root mean square of successive differences (RMSSD) as independent predictors of POUR. The HRV-based nomogram exhibited strong discriminative performance, achieving an area under the ROC curve (AUC) of 0.894 (95% CI: 0.833-0.956), with sensitivity and specificity of 0.861 and 0.806, respectively. Internal validation showed a comparable AUC of 0.884, indicating good model stability. The calibration curve indicated close alignment between predicted and actual outcomes (χ2 = 11.801) and a Brier score of 0.075, confirming precise calibration. DCA demonstrated that the model provided a favourable net clinical benefit over a broad range of probability thresholds.

CONCLUSIONS: The HRV-based nomogram established in this study accurately predicts POUR in patients with BPH. By integrating autonomic function indicators with clinical parameters, the model demonstrates strong predictive power and clinical utility, offering an effective tool for early identification and individualised management of patients.

PMID:42104701 | DOI:10.56434/j.arch.esp.urol.20267903.55

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Genetically Predicted Gut Microbiota and Bladder Cancer Risk: A Mendelian Randomisation Analysis

Arch Esp Urol. 2026 Apr;79(3):431-439. doi: 10.56434/j.arch.esp.urol.20267903.51.

ABSTRACT

BACKGROUND: Gut microbiota (GM) has been increasingly implicated in cancer development through immune modulation, metabolic regulation, and systemic inflammatory pathways. Although observational studies have suggested a potential link between GM dysbiosis and bladder cancer (BC), these findings remain susceptible to confounding and reverse causation. To our knowledge, few studies have applied a Mendelian randomisation (MR) framework to systematically evaluate the gut-bladder axis from a genetic perspective.

METHODS: We performed a two-sample MR analysis to examine associations between genetically predicted GM composition and BC risk. Genetic instruments for 119 GM taxa were obtained from the MiBioGen consortium. Summary-level genetic association data for BC were derived from the UK Biobank. The inverse variance weighted (IVW) method was used as the primary analytical approach, complemented by Mendelian randomisation-Egger regression (MR-Egger) and weighted median methods. Sensitivity analyses were conducted to assess heterogeneity and horizontal pleiotropy. Instrumental variants were further mapped to host genes to perform exploratory functional annotation and pathway enrichment analyses.

RESULTS: In the primary IVW analysis, five GM taxa demonstrated nominal associations with BC risk. Higher genetically predicted abundance of Oscillibacter (OR = 0.706, 95% CI: 0.564-0.883) and Oscillospira (OR = 0.668, 95% CI: 0.490-0.910) was associated with lower risk, whereas Lachnospiraceae (FCS020 group) was associated with increased risk (OR = 1.406, 95% CI: 1.070-1.847). However, none of the associations remained statistically significant after Bonferroni correction for multiple testing. Sensitivity analyses revealed no evidence of significant heterogeneity or directional pleiotropy, and estimates were broadly consistent across MR methods.

CONCLUSIONS: In this MR study, we identified nominal associations between genetically predicted GM composition and BC risk. As none of the findings remained statistically significant after correction for multiple testing, these results should be interpreted with caution. Further replication in independent cohorts and mechanistic investigations into the role of candidate taxa are warranted to clarify the potential involvement of the gut-bladder axis in bladder carcinogenesis.

PMID:42104697 | DOI:10.56434/j.arch.esp.urol.20267903.51

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A 15-Year Google Trends Analysis of Surgical Treatment Modalities for Benign Prostatic Hyperplasia in the United States

Arch Esp Urol. 2026 Apr;79(3):415-421. doi: 10.56434/j.arch.esp.urol.20267903.49.

ABSTRACT

BACKGROUND: Background: To evaluate temporal trends in public interest regarding surgical treatments for benign prostatic hyperplasia (BPH) in the United States using Google Trends (GT) data from 2010-2025.

METHODS: Relative search volume (RSV) data for Holmium Laser Enucleation of the Prostate (HoLEP), Rezūm®, UroLift, Aquablation, and Prostatic Arterial Embolization (PAE) were extracted from GT between January 2010 and August 2025. Annual mean RSV values were analyzed using descriptive statistics, linear regression, and Pearson correlation. Statistical significance was defined as p < 0.05.

RESULTS: HoLEP demonstrated a robust and statistically significant upward trajectory throughout the study period (R2 = 0.762; β = 0.873; p < 0.001), reflecting sustained growth in public interest. Rezūm® similarly exhibited a strong and consistent increasing trend (R2 = 0.799; β = 0.894; p < 0.001), indicating a notable expansion in online engagement over time. Aquablation showed a moderate but significant rise in search activity (R2 = 0.549; β = 0.741; p < 0.001), although its overall magnitude of interest remained comparatively lower than other modalities. UroLift demonstrated a significant temporal association (R2 = 0.637; β = 0.798; p = 0.001), despite fluctuations in interest during later years of the study. PAE demonstrated a strong but non-significant upward trend (R2 = 0.788; β = 0.888; p = 0.051), suggesting a more variable pattern of public attention. Correlation analyses further revealed strong inter-modality relationships, particularly between HoLEP and Aquablation (r = 0.948) and between HoLEP and PAE (r = 0.916).

CONCLUSIONS: Rezūm® and Aquablation have experienced rapid growth in recent years, while HoLEP has consistently maintained its importance. UroLift and PAE have exhibited more variable trends. Digital trend analysis is a valuable tool for understanding evolving patient preferences and informing clinical and policy decisions.

PMID:42104695 | DOI:10.56434/j.arch.esp.urol.20267903.49