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Nevin Manimala Statistics

Cost-effectiveness analysis of pembrolizumab as an adjuvant treatment of early-stage non-small cell lung cancer following complete resection and platinum-based chemotherapy in Canada

J Med Econ. 2025 Jul 14:1-25. doi: 10.1080/13696998.2025.2530862. Online ahead of print.

ABSTRACT

AIM: To assess the cost-effectiveness of adjuvant pembrolizumab (Keytruda) versus routine observation of adult patients with stage IB (T2a ≥ 4 cm) -IIIA with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) <50% who have undergone complete resection and platinum-based chemotherapy from the Canadian public healthcare payer perspective.

MATERIALS AND METHODS: A Markov model was constructed to capture clinical and economic outcomes across four health states: disease-free (DF), local-regional recurrence (LR), distant metastases (DM) and death. Transition probabilities (TPs) from the DF state were populated using clinical trial data from KEYNOTE-091. TPs from the LR state were from real-world evidence (RWE). Clinical trial and network meta-analysis output populated transitions from DM. TPs from LR and DM were calibrated to fit the KEYNOTE-091 survival data. Costs were reported in 2023 Canadian dollars and utilities were based on data from KEYNOTE-091 and metastatic NSCLC clinical trials.

RESULTS: Pembrolizumab extended life years (LYs) (1.55) and quality-adjusted life years (QALYs) (1.19). Costs increased by $84,050, resulting in an incremental cost-effectiveness ratio (ICER) per additional LY of $54,219 and per additional QALY of $70,725, below the willingness-to-pay threshold of $100,000. Survival gains associated with pembrolizumab were attributed to more time spent in the DF health state. Higher costs for pembrolizumab were due to adjuvant treatment costs but were partially offset by lower subsequent treatment costs in downstream health states, reflecting a lower risk of recurrence associated with pembrolizumab. The model results remained robust across scenario and sensitivity analyses.

LIMITATIONS: Due to lack of transition probabilities starting from the LR and DM states from the KEYNOTE-091 trial, TPs from the LR and DM states were estimated using non-trial sources.

CONCLUSIONS: Adjuvant pembrolizumab was found to be cost-effective compared to routine observation from the public healthcare payer perspective in Canada.

PMID:40654114 | DOI:10.1080/13696998.2025.2530862

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Nevin Manimala Statistics

Development of a personalized visualization and analysis tool to improve clinical care in complex multisystem diseases with application to scleroderma

Arthritis Care Res (Hoboken). 2025 Jul 14. doi: 10.1002/acr.25613. Online ahead of print.

ABSTRACT

BACKGROUND: In complex diseases, it is challenging to assess a patient’s disease state, trajectory, treatment exposures, and risk of multiple outcomes simultaneously, efficiently and at the point of care.

METHODS: We developed an interactive patient-level data visualization and analysis tool (VAT) that automates illustration of a scleroderma patient’s trajectory across multiple organs and illustrates this relative to a reference population, including patient subgroups who share risk factors with the index patient, to improve estimation of disease state. We conducted VAT usability testing with patients and clinicians. We then embedded results from internally cross-validated, Bayesian multivariate mixed models that calculate an individual’s risk of critical events, utilizing baseline risk factors, patient-level information in past trajectories in multiple dimensions, and known outcomes from the entire population and relevant subgroups.

RESULTS: The web-based application aggregates complex, longitudinal data to illustrate patient-, subgroup- and population-level health trajectories across multiple organ systems. Patients (N=7) exposed to the VAT reported increased knowledge about their disease and confidence in medical decision-making. Rheumatologists (N=4) were able to access 8.6-times more data in 81.5% of the time using 2/3 fewer clicks using the VAT compared to the EMR. Statistical modeling was successfully embedded in the VAT, enabling real-time estimation of a patient’s risks of multiple complications.

CONCLUSIONS: Systematic analysis and visualization of individual- and population-level data in a complex disease has potential to improve medical decision-making and warrants further study. Individualized risk estimation disseminated at the point of care may enable targeted screening and early intervention in high-risk patients.

PMID:40654109 | DOI:10.1002/acr.25613

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Diagnostic performance of immunohistochemistry and rapid urease test in detecting Helicobacter pylori, emphasizing bacterial localization and mucosal changes: a retrospective cross-sectional study

J Yeungnam Med Sci. 2025;42:41. doi: 10.12701/jyms.2025.42.41. Epub 2025 Jul 13.

ABSTRACT

BACKGROUND: Accurate detection of Helicobacter pylori is essential for the diagnosis and management of gastritis and related gastrointestinal disorders. This study aimed to evaluate the diagnostic performance of the rapid urease test (RUT) and immunohistochemistry (IHC) using four antibodies (from BioGenex, Tokyo Medical and Dental University [TMDU], Cell Marque, and Dako), with a focus on bacterial localization (surface vs. subepithelial) and associated mucosal changes.

METHODS: Gastric biopsy specimens from patients who underwent upper endoscopy at Vajira Hospital between June and December 2022 were retrospectively analyzed. Histological evaluations included hematoxylin and eosin staining, RUT, and IHC. The sensitivity of each antibody for detecting H. pylori was compared, with special attention paid to subepithelial colonization and histopathological patterns.

RESULTS: The BioGenex antibody exhibited the highest sensitivity in detecting H. pylori, followed by TMDU, Cell Marque, and Dako antibodies. RUT demonstrated the lowest sensitivity, particularly in cases of chronic nonactive gastritis or minimal mucosal changes. Among the IHC antibodies, BioGenex detected the greatest number of subepithelial H. pylori cases, many of which were missed by the other antibodies and RUT. Subepithelial colonization typically presented as dot-like signals suggestive of coccoid forms or bacterial remnants. The BioGenex antibody identified all subepithelial cases detected by the TMDU antibody, highlighting the former’s superior sensitivity. Statistical analysis confirmed the significantly higher diagnostic accuracy of the BioGenex antibody across multiple histological subgroups (p<0.05).

CONCLUSION: Subepithelial H. pylori colonization is clinically relevant and often undetected by RUT or less sensitive IHC antibodies. The BioGenex antibody was the most effective in identifying H. pylori in both surface and subepithelial regions. Patients with suspected subepithelial infection, particularly those without detectable surface bacteria, should undergo further evaluation using urea breath tests or stool antigen assays, in accordance with current clinical guidelines.

PMID:40654104 | DOI:10.12701/jyms.2025.42.41

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Worker studies and their interpretation

J Radiol Prot. 2025 Jul 14;45(3). doi: 10.1088/1361-6498/ade68e.

ABSTRACT

A recent commentary on epidemiological studies of nuclear workers notes that these studies can provide radiation risk estimates that complement those derived from the study of Japanese atomic bomb survivors. The author asserts that the results from some nuclear worker studies are difficult to interpret due to the fact that ERR/Gy estimates vary across subcohorts, and subcohort-specific estimates are not always equal to estimates obtained in the overall study population. We discuss settings in which it is reasonable to expect that an estimate of association in a subcohort should be similar to an estimate obtained in the full cohort and settings in which a subcohort analysis may differ from the estimate obtained in a full cohort analysis. Focusing on the INWORKS study, we describe some of the steps taken to understand variation in estimates of ERR/Gy between subgroups and upon restrictions, as well as interpretation of estimates of external dose-mortality associations in the total study population.

PMID:40654101 | DOI:10.1088/1361-6498/ade68e

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Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data

J Cosmet Dermatol. 2025 Jul;24(7):e70197. doi: 10.1111/jocd.70197.

ABSTRACT

BACKGROUND: Hybrid cooperative complex hyaluronic acid (HCC HA) is a novel, widely used injectable developed using the patented NAHYCO Hybrid Technology for the treatment of the face and body, respectively.

AIM: To examine the safety profile of HCC HA from global post-marketing surveillance data.

METHODS: Post-marketing adverse events (AEs) reported for HCC HA injected to the face (Profhilo, HCC-HAPROF, IBSA Farmaceutici Italia Srl, Italy) from January 1, 2018 to October 31, 2023 and to the body (Profhilo Body, HCC-HAPROF-B, IBSA Farmaceutici Italia Srl, Italy) from January 1, 2020 to October 31, 2023 were analyzed. Patient exposure and the proportion of exposed patients with a safety complaint were also estimated.

RESULTS: The total number of patients exposed to HCC-HAPROF and HCC-HAPROF-B globally was projected to be 1 091 956 and 27 692, respectively. There was a total of 371 AEs recorded for HCC-HAPROF, and 11 AEs reported for HCC-HAPROF-B, corresponding to 0.034% and 0.040% of the patients, respectively. The most common AEs were edema, erythema, and discomfort, which are consistent with the manner and location of administration, and the AEs are frequently reported following treatment. The proportion of exposed patients with a safety complaint was low, with 0.026%-0.050% and 0%-0.013% of patients exposed to HCC-HAPROF or HCC-HAPROF-B experiencing a safety complaint, respectively.

CONCLUSIONS: Post-marketing surveillance indicated favorable safety profiles for HCC-HAPROF and HCC-HAPROF-, with the most common AEs expected and/or related to the method or site of administration.

PMID:40654100 | DOI:10.1111/jocd.70197

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Provider Perspectives on Use of Nighttime and Full-time Bracing to Treat Adolescent Idiopathic Scoliosis

J Pediatr Orthop. 2025 Jul 14. doi: 10.1097/BPO.0000000000003056. Online ahead of print.

ABSTRACT

BACKGROUND: For patients with adolescent idiopathic scoliosis (AIS), full-time scoliosis braces are effective in preventing curve progression but are a source of stress for patients and families. Nighttime hypercorrective braces have minimal impact on daily life, but there is little evidence to guide prescription. It is not known how providers with expertise in scoliosis incorporate nighttime bracing into their routine clinical practice. The aim of this study is to assess provider perspectives and recommendations regarding the use of nighttime and full-time scoliosis bracing for patients with AIS.

METHODS: Providers engaged in nonoperative scoliosis management were invited to complete an online survey that included 12 scoliosis case scenarios. For each case scenario, respondents were asked to indicate their bracing recommendation and their willingness to randomize each case into a hypothetical clinical trial. The survey also queried respondents’ use of nighttime and full-time bracing in their practice. Descriptive statistics were used to summarize findings; a linear mixed effects model was used to determine patient characteristics related to bracing recommendations and willingness to randomize.

RESULTS: A total of 214 respondents completed the survey; most had been in practice for >15 years (58%) and dedicate the majority of their practice to pediatric spine (57%). Just over half (54%) currently prescribe nighttime braces. Across case scenarios, most respondents recommended full-time bracing (70% to 92%); recommendations varied by curve type, curve magnitude, and skeletal maturity. For providers who use nighttime braces, the most important factors that led providers to prescribe nighttime over full-time braces were patient willingness to wear the brace (58%), skeletal maturity (57%), and curve type (56%).

CONCLUSIONS: Most providers preferred to prescribe full-time over nighttime braces. Providers were more willing to recommend a nighttime brace for patients with lumbar/thoracolumbar curves and those who were at lower risk for curve progression (ie, more skeletally mature and smaller curve magnitudes). Ultimately, results provide insights into current practice and will inform eligibility criteria and feasibility for a future study comparing nighttime and full-time braces.

LEVEL OF EVIDENCE: Expert opinion.

PMID:40654097 | DOI:10.1097/BPO.0000000000003056

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Evaluation and Predictive Value of Placental Thickness in Fetal Biometric Assessment and Doppler Indices of the Uterine and Umbilical Arteries

J Clin Ultrasound. 2025 Jul 14. doi: 10.1002/jcu.70009. Online ahead of print.

ABSTRACT

OBJECTIVE: The placenta plays a critical role in fetal development by facilitating the exchange of oxygen and nutrients from maternal blood while removing carbon dioxide and metabolic waste. It also acts as a protective barrier against infections and maintains pregnancy by producing key hormones. As the first organ to reflect pathological changes during pregnancy, placental evaluation can aid in the early detection of pregnancy complications. The primary objective of this study was to assess the correlation between placental thickness (PT) and fetal biometric parameters during the second-trimester anomaly screening, aiming to facilitate earlier detection of pregnancy outcomes.

MATERIALS AND METHODS: This cross-sectional study included 300 healthy pregnant women with gestational ages between 18 and 22 weeks, determined by last menstrual period or first-trimester ultrasound. Participants underwent routine biometric ultrasound assessments, including biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC), femur length (FL), estimated fetal weight (EFW), and Doppler evaluations of the umbilical and uterine arteries. PT was measured perpendicularly to the uterine wall at the site of cord insertion. Statistical analyses included descriptive statistics, Pearson correlation coefficients, and independent t-tests, with statistical significance set at p < 0.001.

RESULTS: The mean placental thickness (PT) was 23.45 ± 3.99 mm. Statistically significant (p < 0.001) but weak positive correlations were observed between PT and the following fetal growth parameters: estimated fetal weight (EFW) (r = 0.29), abdominal circumference (AC) (r = 0.33), head circumference (HC) (r = 0.21), biparietal diameter (BPD) (r = 0.27), and femur length (FL) (r = 0.29). Gestational age showed a weak positive correlation with PT (r = 0.32). Correlations between PT and Doppler indices, including the umbilical artery pulsatility index (PI) and uterine artery PI, were trivial (r = -0.16 and r = 0.06, respectively). No significant differences in PT were observed based on fetal gender.

CONCLUSION: PT demonstrates statistically significant correlations with fetal biometric parameters and gestational age, suggesting its potential utility as a marker for fetal growth and development. However, its association with Doppler indices is trivial, indicating limited utility in vascular assessments. These findings highlight the need for further investigation into PT as a noninvasive marker for prenatal assessment, particularly in larger cohorts and during the third trimester.

PMID:40654094 | DOI:10.1002/jcu.70009

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Comparative Analysis of King Vision aBlade Video Laryngoscopy and Direct Laryngoscopy for Endotracheal Intubation in Paediatric Age Group: a Prospective Randomized Study

Turk J Anaesthesiol Reanim. 2025 Jul 14. doi: 10.4274/TJAR.2025.251902. Online ahead of print.

ABSTRACT

OBJECTIVE: Paediatric airway management is challenging due to anatomical differences, making effective endotracheal intubation crucial during surgery. While direct laryngoscopy (DL) has been the standard method, video laryngoscopy (VL) has emerged as a promising alternative. This study compared the effectiveness of King Vision aBlade non-channeled VL with Miller/Macintosh DL for intubation in children.

METHODS: In this prospective, randomized, single-blinded study, 150 children aged 2-10 years undergoing elective surgery were randomly assigned to either Group DL (n = 75) or Group KVL (n = 75). Data was collected on intubation success, time, glottic view, external maneuvers, and hemodynamic parameters [heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), peripheral oxygen saturation (SpO2)] at various intervals.

RESULTS: The mean age of patients was similar in both groups (P=0.15). The DL group had a higher success rate on the first attempt (P < 0.001) and shorter intubation times (9.97±3.12 sec vs. 14.35±2.99 sec, P < 0.001) compared to King Vision aBlade VL (KVL). Although KVL provided a better glottic view, this difference was not statistically significant (P=0.059). Hemodynamic parameters (SBP, DBP) were significantly higher in the DL group post-intubation (P < 0.05), with no significant differences in HR or SpO2 between groups. The DL group required more external maneuvers for intubation (P=0.022).

CONCLUSION: DL showed a higher success rate, faster intubation times, and greater hemodynamic stability compared to KVL. While KVL offered better glottic views, it had longer intubation times and lower success rates. Further studies with larger sample sizes are recommended to validate these findings.

PMID:40654062 | DOI:10.4274/TJAR.2025.251902

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Polypharmacy and Depressive Symptoms in Older Adults: Does Gender Matter?

Clin Gerontol. 2025 Jul 14:1-11. doi: 10.1080/07317115.2025.2532526. Online ahead of print.

ABSTRACT

OBJECTIVES: This study examined the relationship between polypharmacy and depressive symptoms among U.S. community-dwelling older adults and whether it varied by gender.

METHODS: We conducted a retrospective population-based analysis of 3,354 adults aged 65 and older using data from the 2009 Health and Retirement Study Health and Well-Being Study. Polypharmacy was defined as the use of five or more prescription medications. Depressive symptoms were measured using the 8-item Center for Epidemiologic Studies Depression Scale (CESD-8). Negative binomial regression models assessed associations between polypharmacy and depressive symptoms and whether the relationship varied by gender.

RESULTS: Over 40% of participants reported polypharmacy. In unadjusted models, polypharmacy was positively related to depressive symptoms (Incidence Rate Ratio [IRR] = 1.44, p < .01). In models adjusting for demographic and health characteristics, there was no statistically significant relationship between polypharmacy and depressive symptoms (Adjusted Incidence Rate Ratio [AIRR] = 0.99, p > .05). There were no significant gender differences in unadjusted or adjusted models in the relationship between polypharmacy and depressive symptoms.

CONCLUSIONS: Polypharmacy was not related to depressive symptoms among older women or men.

CLINICAL IMPLICATIONS: Interventions to address physical health may be more salient to depression management than polypharmacy regardless of gender.

PMID:40654053 | DOI:10.1080/07317115.2025.2532526

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Non-Linear Socioeconomic Inequality in the Distribution of Food Outlets in Metropolitan Melbourne and Regional Victoria, Australia

Health Promot J Austr. 2025 Jul;36(3):e70074. doi: 10.1002/hpja.70074.

ABSTRACT

ISSUE ADDRESSED: Socioeconomic disparities in food environments significantly impact diet quality and health outcomes, yet comparative evidence between metropolitan and regional areas remains limited. We examined spatial and temporal changes in food outlet availability in Victoria, Australia from 2019 to 2023.

METHODS: Geospatial data from OpenStreetMap was used to classify food outlets into healthy, less healthy, and unhealthy categories. Outlet densities were calculated within 500 m (walkable) and 2000 m (short driving) buffers from Statistical Area Level 1 centroids. Socioeconomic disparities were assessed using the Index of Relative Socio-economic Advantage and Disadvantage quintiles. Gini coefficients quantified inequality, while Kruskal-Wallis tests, Dunn’s post hoc tests, and k-means clustering identified socio-spatial patterns.

RESULTS: In metropolitan Melbourne, both highly disadvantaged (quintile 1) and affluent areas (quintiles 4-5) had significantly higher densities of food outlets (e.g., 2.3 vs. 2.7 healthy outlets per 1000 people within 500 m in 2023), while mid-range socioeconomic areas (quintiles 2-3) had notably lower availability. Regional Victoria exhibited similar trends, with mid-range areas consistently underserved. From 2019 to 2023, Melbourne’s Gini coefficients for healthy outlet access improved slightly (0.45-0.43), whereas regional areas worsened (0.52-0.55). Clustering revealed limited healthy food availability in disadvantaged rural clusters and high densities of unhealthy options in urban regional centres.

CONCLUSIONS: Food outlet availability in Victoria shows distinct non-linear socioeconomic disparities, disproportionately disadvantaging mid-range socioeconomic areas.

SO WHAT: Strategic urban planning and targeted policy interventions in underserved suburban and regional locations are essential for mitigating inequalities and promoting healthier communities.

PMID:40653608 | DOI:10.1002/hpja.70074