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Nevin Manimala Statistics

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

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Nevin Manimala Statistics

Assessing infection rates in field-collected Culicoides populations: Example of a large-scale study on bluetongue and epizootic hemorrhagic disease viruses in Culicoides species (Diptera: Ceratopogonidae) in Reunion Island, Indian ocean

Med Vet Entomol. 2026 May 8. doi: 10.1111/mve.70082. Online ahead of print.

ABSTRACT

Characterising the vector role of a species is critical to understand and quantify host-vector-pathogen interactions. This role has to be assessed for each suspected vector species, but also at the population level. Indeed, different populations of the same species can exhibit biological and ecological variability that can amplify or limit their epidemiological role in transmitting pathogens to human and/or animal populations. In this work, we characterise the spatio-temporal dynamics of two major viruses of veterinary interest (bluetongue virus [BTV] and epizootic hemorrhagic disease virus [EHDV]) in the five species of Culicoides (Diptera: Ceratopogonidae) present in Reunion Island, located in the Indian Ocean. Our aim is to quantify the infection rates of the two viruses in field-collected Culicoides over a 2-year period. A total of 33,358 individuals comprising 11,504 pools were molecularly screened to detect the presence of both viruses. Our work applied an original statistical approach based on the use of Bayesian inference and showed that all five Culicoides species could be involved in the transmission of the two viruses with different levels of infection. EHDV circulated within Culicoides populations for only 4 months over the study period, while BTV circulated within the same populations throughout the entire 2-year period. We hypothesized that although both viruses are transmitted by the same Culicoides species, they exhibit distinct epidemiological patterns: BTV displays enzootic circulation in Reunion Island, whereas EHDV shows an epizootic pattern.

PMID:42104528 | DOI:10.1111/mve.70082

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Nevin Manimala Statistics

Assessing infection rates in field-collected Culicoides populations: Example of a large-scale study on bluetongue and epizootic hemorrhagic disease viruses in Culicoides species (Diptera: Ceratopogonidae) in Reunion Island, Indian ocean

Med Vet Entomol. 2026 May 8. doi: 10.1111/mve.70082. Online ahead of print.

ABSTRACT

Characterising the vector role of a species is critical to understand and quantify host-vector-pathogen interactions. This role has to be assessed for each suspected vector species, but also at the population level. Indeed, different populations of the same species can exhibit biological and ecological variability that can amplify or limit their epidemiological role in transmitting pathogens to human and/or animal populations. In this work, we characterise the spatio-temporal dynamics of two major viruses of veterinary interest (bluetongue virus [BTV] and epizootic hemorrhagic disease virus [EHDV]) in the five species of Culicoides (Diptera: Ceratopogonidae) present in Reunion Island, located in the Indian Ocean. Our aim is to quantify the infection rates of the two viruses in field-collected Culicoides over a 2-year period. A total of 33,358 individuals comprising 11,504 pools were molecularly screened to detect the presence of both viruses. Our work applied an original statistical approach based on the use of Bayesian inference and showed that all five Culicoides species could be involved in the transmission of the two viruses with different levels of infection. EHDV circulated within Culicoides populations for only 4 months over the study period, while BTV circulated within the same populations throughout the entire 2-year period. We hypothesized that although both viruses are transmitted by the same Culicoides species, they exhibit distinct epidemiological patterns: BTV displays enzootic circulation in Reunion Island, whereas EHDV shows an epizootic pattern.

PMID:42104528 | DOI:10.1111/mve.70082

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Indigenous knowledge of traditional medicinal plants in Gondar City Administration, Amhara National Regional State, northwest Ethiopia

Trop Med Health. 2026 May 8. doi: 10.1186/s41182-026-00965-z. Online ahead of print.

ABSTRACT

INTRODUCTION: Ethiopian people possess deep knowledge of how to use plant resources and are dependent on plant values mainly for traditional medicine. However, most ethnobotanical studies are restricted to rural areas, leaving urban centers poorly documented, which implies the need for further study. Thus, this study was conducted in Gondar City Administration, aimed at investigating medicinal plants to fill the traditional knowledge documentation gap.

METHODS: The study was conducted from February 2024 to January 2025 in 12 kebeles selected purposively based on vegetation cover, availability of knowledgeable practitioners and representation of both urban and rural settings. Data were collected using interviews, focus group discussions, guided field walks, and market surveys with 120 randomly selected general informants and 60 purposively selected key informants. Descriptive statistics were used to analyze the basic ethnobotanical data. An independent sample t-test and two-way ANOVA were used to analyze socio-demographic effects of informants on their indigenous knowledge. Different ethnobotanical ranking and clustering methods, Rahman’s similarity index (RSI) and Jaccard’s coefficient of similarity were also used.

RESULTS: A total of 109 medicinal plants distributed across 95 genera and 54 families were recorded to treat 76 ailment types. Asteraceae was the foremost family with 9 (8.26%) species. Shrub was the dominant habit (39.45%) and leaves were the most valuable plant parts used for 33.80% of remedy preparations. Remedies were prepared mainly from fresh forms (76.39%) by crushing (20.37%) and administered through the dermal route (41.20%). Significant knowledge variation on medicinal plants was observed between key and general informants (P = 0.000), rural and urban kebeles (P = 0.001), and between age groups (P = 0.013). Informant type (general vs. key informant) and age had a highly significant interaction effect on the medicinal plant knowledge (P = 0.000). About 14.68% of all recorded species were reported to treat hepatitis. From those, Clutia lanceolata was the most preferred. The highest informant consensus factor value (98%) was associated with respiratory conditions. The RSI ranged from 0.5 to 13.79%, and the JSI ranged from 3.5 to 36%. After a systematic search was performed across various reputable databases (Scopus, PubMed, EMBASE, Web of Science, and Google Scholar), unique ethnobotanical information on the therapeutic roles of 12 medicinal plant species that have not been reported previously was documented.

CONCLUSION: This finding indicates that the rich diversity of medicinal plants in Gondar City, along with unique ethnomedicinal findings, is an indicator of alternative use of traditional medicine by urban inhabitants for their healthcare system. However, urban ethnobotany is a distinct field in which is expected to evolve knowledge systems influenced by migration. So, these knowledge systems could experience an accelerated loss due to urbanization-related factors unless prior documentation is made.

PMID:42104521 | DOI:10.1186/s41182-026-00965-z

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A rapid multiplex platform for simultaneous detection of chikungunya virus, dengue virus, and dengue serotyping based on isothermal amplification and lateral flow dipsticks

Infect Dis Poverty. 2026 May 9;15(1):52. doi: 10.1186/s40249-026-01450-9.

ABSTRACT

BACKGROUND: The expeditious and precise diagnosis of dengue virus (DENV) and chikungunya virus (CHIKV) is paramount for effective patient management and the control of outbreaks. In this study, a duplex reverse transcription multi-enzyme isothermal amplification (RT-MIRA) assay was established for the simultaneous detection of DENV and CHIKV, followed by a nested RT-MIRA assay for DENV serotyping (DENV-1 to -4).

METHODS: Specific primers and probes targeting the DENV 3′-UTR, CHIKV E1 gene, and four DENV serotypes were designed. The duplex RT-MIRA and nested DENV RT-MIRA serotyping reaction systems were optimized at 39 °C with portable fluorescence or lateral flow dipstick readouts. For methodological validation, specificity was evaluated against 35 related pathogens, and the 95% limit of detection (LOD95) was determined via probit regression. For clinical validation, serum samples from 236 suspected patients were tested, benchmarking against RT-qPCR and serology. Statistical analyses included the Wilson score method for calculating 95% confidence intervals (CIs) and Cohen’s kappa (κ). For external verification, 12 CHIKV-positive clinical samples and 5 artificially simulated co-infection samples were retrospectively analyzed to validate assay accuracy.

RESULTS: The duplex RT-MIRA assay exhibited no cross-reactivity with other pathogens. The LOD95 values were 13.47 copies/μl for DENV and 10.49 copies/μl for CHIKV. Clinical validation demonstrated sensitivities of 96.15% (95% CI: 89.28%-98.67%) for DENV and 88.89% (95% CI: 67.20%-96.90%) for CHIKV. Specificity was 100% (95% CI: 92.87%-100%) for both. Agreement with RT-qPCR was strong for DENV (κ = 0.96) and CHIKV (κ = 0.92). The nested RT-MIRA serotyping assay showed high sensitivity (LOD95: 1.6-18.7 copies/μl) without cross-reactivity, accurately differentiating 75 DENV-positive samples into 71 DENV-1 and 4 DENV-2. In the external verification, the assay accurately detected 10 CHIKV mono-infections and 2 CHIKV/DENV co-infections, and distinguished four DENV serotypes in simulated matrices.

CONCLUSIONS: A rapid and sensitive integrated method has been developed that combines duplex RT-MIRA for detecting DENV and CHIKV, and nested RT-MIRA for serotyping DENV. The simplicity and speed of the amplification and detection steps demonstrate this platform’s potential for use in point-of-care testing and surveillance in areas with limited resources, particularly when used alongside portable extraction methods.

PMID:42104518 | DOI:10.1186/s40249-026-01450-9