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Nevin Manimala Statistics

The Cost-Effectiveness of the Cancer Home-Life Intervention: An Economic Evaluation Alongside a Randomized Clinical Trial with a Six-Month Time Frame

J Palliat Med. 2025 Sep 16. doi: 10.1177/10966218251374527. Online ahead of print.

ABSTRACT

Background: People with advanced cancer often face significant challenges in everyday activities, especially within their home environments, where they spend most of their time. The Cancer Home-Life Intervention is an occupational therapy-based program supporting everyday activities in people with advanced cancer living at home. Aim: To examine the cost-utility and cost-effectiveness of the Cancer Home-Life Intervention compared to usual care over six months. Methods: This economic evaluation with a societal perspective was conducted alongside a randomized controlled trial (ClinicalTrials.gov: NCT02356627). Quality-adjusted life years (QALYs) and activities of daily living motor ability accounted for the outcome. Costs included primary and secondary health care, domestic care, assistive devices, and participants’ out-of-pocket costs. A total of 242 adults with advanced cancer were included from two Danish University Hospitals and randomized 1:1 to the Cancer Home-Life Intervention or usual care. Primary analysis included 172 participants alive at six months follow-up. Results: The intervention showed no statistically significant improvement in either QALYs or activities of daily living motor ability compared to usual care. However, the cost-utility analysis revealed a 72% probability of the intervention being cost-effective, regardless of the willingness-to-pay threshold per QALY gained. The probability of cost-effectiveness for activities of daily living motor ability started at 26% and increased to 58%. Sensitivity analyses supported these findings. Conclusion: The Cancer Home-Life Intervention showed limited potential for cost-effectiveness compared to usual practice. The cost-utility analysis revealed a 72% probability of cost-effectiveness. However, these findings should be interpreted cautiously due to small, nonstatistically significant improvements in QALYs.

PMID:40955537 | DOI:10.1177/10966218251374527

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The effect of non-surgical periodontal treatment on Dickkopf-1 and secreted Frizzled-Related Protein 5 levels

J Periodontol. 2025 Sep 16. doi: 10.1002/jper.70005. Online ahead of print.

ABSTRACT

BACKGROUND: Recent advancements in bone tissue biomarker research have identified 2 promising molecules: Dickkopf-1 and secreted Frizzled-Related Protein 5. This study aims to evaluate the levels of these biomarkers in gingival crevicular fluid in periodontal health, gingivitis, and periodontitis and to assess the effects of non-surgical periodontal treatment on these biomarkers.

METHODS: A total of 99 adult subjects were included in this study, divided into 3 groups: 33 periodontally healthy individuals, 33 with gingivitis, and 33 with periodontitis. Patients in the gingivitis and periodontitis groups received non-surgical periodontal treatment. Periodontal clinical parameters were recorded, and gingival crevicular fluid levels of biomarkers were analyzed by enzyme-linked immunosorbent assay at baseline and 6-8 weeks post-treatment.

RESULTS: Pre-treatment Dickkopf-1 levels were found to be highest in the periodontitis group (p < 0.001). Conversely, secreted Frizzled-Related Protein 5 levels were highest in the healthy group (p < 0.001). Post-treatment, a statistically significant reduction in Dickkopf-1 levels was observed in the gingivitis (p = 0.015) and periodontitis (p < 0.001) groups, while secreted Frizzled-Related Protein 5 levels significantly increased (respectively, p = 0.008 and p < 0.001). A statistically significant weak negative correlation was identified between total Dickkopf-1 and secreted Frizzled-Related Protein 5 levels (τ = -0.117, p = 0.027). Receiver operating characteristic curve analysis to assess diagnostic performance between periodontal health and periodontitis revealed an area under the curve of 0.938 for Dickkopf-1 and 0.803 for secreted Frizzled-Related Protein 5.

CONCLUSIONS: These biomarkers could serve as valuable biomarkers in the pathogenesis of periodontal disease. Non-surgical periodontal treatment significantly affects the levels of these biomarkers, indicating their potential utility in monitoring therapeutic outcomes.

PLAIN LANGUAGE SUMMARY: In the human body, bone tissue is in a state of constant balance of production and destruction. This balance supports the maintenance of the mechanical integrity of the skeleton and the regulation of calcium and phosphorus levels. Bone markers have been developed to monitor various bone diseases and the effect of treatments without any interventional procedures. Dickkopf-1 (Dkk-1) and secreted Frizzled-Related Protein 5 (sFRP5) are two of the current bone markers that play a role in the balance of bone formation and destruction in the human body. The presence of these molecules in periodontal diseases, which cause inflammation and bone destruction in the gingiva surrounding the teeth, is not yet clear. In this study, Dkk-1 and sFRP5 levels were investigated in periodontal diseases, and the effect of treatment of periodontal diseases on these molecules was evaluated. In the transition from periodontal disease to health, Dkk-1 levels decreased while sFRP5 levels increased. Consistent with these results, Dkk-1 levels decreased in all groups after treatment, while sFRP5 levels increased. In conclusion, Dkk-1 and sFRP5 may serve as valuable markers for the early diagnosis of periodontal disease, and non-surgical periodontal treatment may significantly affect the levels of these markers, demonstrating their potential utility in monitoring treatment outcomes.

PMID:40955531 | DOI:10.1002/jper.70005

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Peri-operative outcomes of open, laparoscopic and robotic simple prostatectomy

BJU Int. 2025 Sep 16. doi: 10.1111/bju.16928. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare peri-operative outcomes and trends in open (OSP), laparoscopic (LSP) and robot-assisted simple prostatectomy (RASP).

MATERIALS AND METHODS: We used German Nationwide Inpatient Data (GRAND), provided by the Research Data Centre of the Federal Bureau of Statistics, and performed multiple patient-level analyses.

RESULTS: Between 2013 and 2023, 46 234 simple prostatectomies were performed in Germany for benign prostatic hyperplasia without concomitant bladder stones. Of these, 44 194 (96%) were performed with an open, 724 (1%) with a laparoscopic, and 1335 (3%) with a robotic approach. Among patients undergoing OSP, 11 755 (27%) cases were performed with a transcapsular and 32 439 (73%) with a transvesical approach. We compared transcapsular OSP vs RASP and LSP. The adoption of RASP increased exponentially during the period studied, while the use of OSP gradually declined, and that of LSP remained stable. In multivariable regression analyses, in-hospital transfusions were lower for LSP (6.5%; odds ratio [OR] 0.46, 95% confidence interval [CI] 0.34-0.62, P < 0.001) and RASP (7.3%; OR 0.58, 95% CI 0.47-0.72, P < 0.001) compared to OSP (13%). In-hospital urinary retention was significantly less frequent after LSP (4.6%; OR 0.46, 95% CI 0.32-0.65, P < 0.001) and RASP (6.4%; OR 0.68, 95% CI 0.54-0.85, P < 0.001) compared to OSP (9.3%). The median (interquartile range) hospital stay was 9 (8-12) days for OSP, 7 (6-9) days for RASP (P < 0.001) and 4 (4-7) days for LSP (P < 0.001). Transcapsular OSP was associated with a lower risk of intensive care unit admission (P < 0.001) and shorter hospital stay (P < 0.001) compared to transvesical OSP.

CONCLUSION: Our results showed that RASP is rapidly growing and offers better peri-operative outcomes compared to OSP.

PMID:40955513 | DOI:10.1111/bju.16928

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Medial and Lateral Column Load Distribution After In Situ Subtalar/Talonavicular Fusion With and Without Calcaneocuboid Fusion: A Cadaveric Study

Foot Ankle Int. 2025 Sep;46(9):1025-1029. doi: 10.1177/10711007251344916. Epub 2025 Sep 16.

ABSTRACT

BACKGROUND: Previous investigations have speculated that stiffening the lateral column of the hindfoot in triple arthrodesis can increase lateral plantar pressure with resulting lateral column pain. It is unclear whether sparing of the calcaneocuboid joint in hindfoot arthrodesis yields lower lateral column plantar forefoot pressures vs triple arthrodesis including the calcaneocuboid joint.

METHODS: Tendon loading and axial pressure were applied to 9 cadaveric legs according to standard cadaveric models. Medial and lateral forefoot pressures were recorded using a pressure-sensitive plate. Specimens were tested in native state, after sequential subtalar and talonavicular fixation, and after added calcaneocuboid fixation. All fixation was performed in situ in a neutral foot position. Testing was performed both on a neutral sensor plate and on a plate with 10 degrees of lateral slope.

RESULTS: In neutral position, pressure under the fifth metatarsal increased significantly from 31.0 ± 22.4 kPa in the native state to 63.1 ± 33.0 kPa (P = .018) after CC-sparing fusion and to 54.7 ± 27.9 kPa (P = .023) after triple arthrodesis. In the everted position, there was no significant difference in pressure under the fifth metatarsal from 56.8 ± 31.8 kPa in the native state to 89.7 ± 55.4 kPa (P = .134) after CC-sparing fusion and to 78.9 ± 42.9 kPa (P = .111) after triple fusion. No statistically significant pressure differences under the fifth metatarsal were found between the arthrodesis groups with loading on a neutral (P = .687) or sloped (P = .393) surface.

CONCLUSION: In our in situ fusion cadaveric model, both traditional triple arthrodesis and the calcaneocuboid-sparing procedure resulted in significantly higher lateral forefoot plantar pressure compared with the native state, but there was no significant difference in lateral pressure between the procedures on both a flat and a laterally inclined surface. These findings should be interpreted in light of limitations including small sample size, static loading conditions, intact cartilage, and lack of formal radiographic assessment of hindfoot alignment.

CLINICAL RELEVANCE: Although other considerations may warrant sparing the calcaneocuboid joint during hindfoot fusion, its preservation did not reduce lateral column overload in this model.

PMID:40955505 | DOI:10.1177/10711007251344916

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Impact of Extended Lens-Induced Myopia on Retinal Structure and Function in Mice

Curr Eye Res. 2025 Sep 16:1-9. doi: 10.1080/02713683.2025.2557590. Online ahead of print.

ABSTRACT

PURPOSE: To investigate time-dependent structural and functional retinal alterations in a mouse model of prolonged lens-induced myopia.

METHODS: Myopia was induced in male C57BL/6J mice by fitting -30 D lenses on both eyes starting at postnatal week 3. Mice were assigned to either a long-term induction group (3-9 weeks of age) or a short-term induction group (3-6 weeks of age). Separate groups fitted with 0 D lenses served as controls. Ocular parameters, including refraction, axial length, choroidal thickness, and retinal thickness were measured at weeks 3, 6, and 9 using an infrared photorefractor and spectral-domain optical coherence tomography. Retinal function was assessed by dark-adapted electroretinography at week 9 for the long-term group and at week 6 for the short-term group. Statistical analyses included two-way repeated-measures ANOVA followed by Bonferroni’s post hoc test for comparisons across groups and time points, and two-tailed unpaired t-test or one-way ANOVA with Fisher’s LSD post hoc test for group comparisons at individual time points.

RESULTS: After 6 weeks of myopia induction, the long-term myopia group exhibited significant reduction in refraction, axial length elongation, and choroidal thickness thinning. Inner retinal thickness was markedly reduced, and electroretinography revealed attenuated amplitudes and delayed implicit times of the oscillatory potentials.

CONCLUSION: Prolonged lens-induced myopia in mice induces time-dependent structural and functional retinal alterations, particularly in the inner layers. This model underscores the significance of early retinal monitoring under long-term myopic conditions and serves as a platform for investigating retinal vulnerability and developing preservation strategies over time.

PMID:40955491 | DOI:10.1080/02713683.2025.2557590

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Analysis of the body composition of patients with impaired carbohydrate metabolism

Vopr Pitan. 2025;94(4):76-85. doi: 10.33029/0042-8833-2025-94-4-76-85. Epub 2025 Jul 21.

ABSTRACT

The prevalence of carbohydrate metabolism disorders, such as type 2 diabetes mellitus and insulin resistance, associated with the global obesity pandemic, makes modern healthcare necessary to improve diagnostic tools aimed at early detection and further evaluation of the effectiveness of therapeutic measures. Bioimpedance is a modern diagnostic tool in dietetics and endocrinology. Differences in body composition, as well as the accumulation of fat mass in patients with impaired carbohydrate metabolism, become an urgent issue to study. The purpose of the study was to conduct a comparative analysis of the body composition of patients with type 2 diabetes mellitus (DM2) and insulin resistance (IR).

MATERIAL AND METHODS: The analysis of medical records of 1003 patients who received individual consultations from a dietitian and an endocrinologist at the bases of medical, preventive and diagnostic organizations in Samara has been carried out. The patients were divided into three groups depending on the disease history: with diagnosed DM2 (288 people); with clinically established IR (319 people) and without carbohydrate metabolism disorders (396 people). The data of the morbidity history and the results of bioimpedance have been analyzed.

RESULTS: A significant difference in the component composition between patients with DM2, insulin resistance and without impaired carbohydrate metabolism was revealed in all parameters, except for active cellular and musculo-skeletal mass in kilograms and basal metabolism in women and except for the percentage of fat mass in men. DM2 patients were found to have the highest median values of body weight and body mass index (BMI), fat mass, total body water, and the lowest values of active cellular and skeletal muscle mass relative to lean body mass, as well as the current metabolic rate (specific basal metabolic rate and phase angle). The results of the component composition in patients of different sexes had a statistically significant difference (p<0.001) in patients with IR and DM2 for all indicators except body fat mass in kilograms and BMI. At the same time, in the group of patients without carbohydrate metabolism disorders, statistically significant differences were not found for any of the indicators, except for the phase angle and fat mass in kilograms, which may indicate the presence of certain gender-specific characteristics of the influence of carbohydrate metabolism disorders on the component composition of the body. Significant differences in fat mass and proportion of fat mass were found for patients with and without carbohydrate metabolism disorders depending on the body mass index. There were also significant differences in fat mass and the fat mass available for patients with and without impaired carbohydrate metabolism, depending on BMI.

CONCLUSION: Bioelectrical impedance analysis as a method of analyzing the body structure and nutritional status of patients is an effective and easy-to-use tool capable of detecting abnormalities in the accumulation of adipose tissue and metabolic processes in patients with impaired carbohydrate metabolism. Differences in the fat component of body composition in individuals with excess body weight and obesity in the presence and absence of DM2 and IR confirm the need to assess the body composition in patients of dietary and endocrinological profiles for early detection of these disorders and their control in view of the diabetogenic effect of adipose tissue.

PMID:40955487 | DOI:10.33029/0042-8833-2025-94-4-76-85

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Evaluating health impacts of exposure to PFAS mixtures: a systematic review of epidemiological studies using mixture methods

Crit Rev Toxicol. 2025 Sep 16:1-19. doi: 10.1080/10408444.2025.2546427. Online ahead of print.

ABSTRACT

Per- and polyfluoroalkyl substances (PFAS) continue to be an emerging chemical class of concern due to their long half-lives in nature and in the human body. There have been many epidemiology studies published in the scientific literature on PFAS and various health effects. Until recently, these studies have focused on assessing exposure to individual PFAS rather than exposure to mixtures of PFAS. Over the past two decades, mixture methods-statistical methods for investigating the association of mixtures-have been developed, making it possible to more accurately assess the risk of adverse health effects associated with exposure to PFAS. To help provide a resource for the overall evaluation of potential health effects of PFAS mixtures, we applied a consistent set of examination methods and criteria for all epidemiology studies that examined the potential relationship between exposure to PFAS mixtures and various types of health outcomes. We identified 233 cohort studies, 39 case-control studies, and 89 cross-sectional studies that evaluated general background-level exposures, exposure from contaminated sites, and occupational exposure to PFAS mixtures and health outcomes including metabolic, cardiovascular, and immune system effects, fetal development, pregnancy outcomes, reproductive effects, liver function, and respiratory effects. We extracted study characteristics and results in a systematic manner and performed a formal study quality evaluation and classified studies into tiers based on their methodological strengths and weaknesses. We found 42 prospective cohort studies, five nested case-control studies, and one traditional case-control study that qualified for inclusion in the highest tier of quality (Tier I). Overall, the weight of evidence from this systematic review indicates that the available epidemiology studies currently support an association between exposure to PFAS mixtures and adiposity, increased total cholesterol, and hypertension, while the evidence for all other health outcomes is suggestive or limited.

PMID:40955472 | DOI:10.1080/10408444.2025.2546427

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Ventilator-Associated Pneumonia in Trauma Patients with Splenic Injuries: Does Splenectomy Increase the Risk?

Surg Infect (Larchmt). 2025 Sep 16. doi: 10.1177/10962964251380366. Online ahead of print.

ABSTRACT

Background: The impact of splenectomy on immune function and infection risk in trauma patients remains debated. Severely ill trauma patients are known to have a high risk for ventilator-associated pneumonia (VAP). We hypothesize that trauma patients undergoing splenectomy do not have a higher incidence of VAP compared with those managed with splenic preservation. Patients and Methods: We conducted a retrospective review of trauma registry data for patients admitted with splenic injuries from 2017 to 2023. Exclusions included patients who died within 48 h, had an Injury Severity Score (ISS) <25, or required <3 ventilator days. Only patients admitted to the surgical intensive care unit (ICU) with confirmed splenic injuries were included. The American Association for the Surgery of Trauma splenic injury scale was used to grade injury severity. VAP was defined per the 2024 National Trauma Data Standard by the American College of Surgeons. We collected data on ISS, Abbreviated Injury Scale for chest, abdomen-pelvis, and head, demographics, hospital, ICU length of stay, ventilator days, mechanism of injury, microbiology, vaccination status, and splenic injury grade. Patients were stratified into splenectomy and splenic preservation groups, which included embolization, splenorrhaphy, or observation. VAP incidence was compared across groups. Results: Among 140 patients, 64 (46%) underwent splenectomy, and 76 (54%) had splenic preservation. Uni-variable analysis showed higher VAP rates in the splenic preservation group (32.9% vs. 18.8%), but this was not statistically significant (p = 0.059). Multi-variable regression confirmed that longer ventilator days increased VAP risk (OR: 1.13, p < 0.001). Splenectomy itself was not associated with a higher VAP incidence (OR: 0.42, p = 0.054). Conclusion: In this study, splenectomy was not substantially associated with VAP, whereas prolonged ventilator duration remained the strongest predictor. Larger studies are needed to clarify whether splenectomy influences pneumonia risk.

PMID:40955467 | DOI:10.1177/10962964251380366

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Nevin Manimala Statistics

Methods for Estimating the Exposure-Response Curve to Inform the New Safety Standards for Fine Particulate Matter

J R Stat Soc Ser A Stat Soc. 2025 Jan 16:qnaf004. doi: 10.1093/jrsssa/qnaf004. Online ahead of print.

ABSTRACT

Exposure to fine particulate matter (PM2.5) poses significant health risks and accurately determining the shape of the relationship between PM2.5 and health outcomes has crucial policy implications. Although various statistical methods exist to estimate this exposure-response curve (ERC), few studies have compared their performance under plausible data-generating scenarios. This study compares seven commonly used ERC estimators across 72 exposure-response and confounding scenarios via simulation. Additionally, we apply these methods to estimate the ERC between long-term PM2.5 exposure and all-cause mortality using data from over 68 million Medicare beneficiaries in the United States. Our simulation indicates that regression methods not placed within a causal inference framework are unsuitable when anticipating heterogeneous exposure effects. Under the setting of a large sample size and unknown ERC functional form, we recommend utilizing causal inference methods that allow for nonlinear ERCs. In our data application, we observe a nonlinear relationship between annual average PM2.5 and all-cause mortality in the Medicare population, with a sharp increase in relative mortality at low PM2.5 concentrations. Our findings suggest that stricter limits on PM2.5 could avert numerous premature deaths. To facilitate the utilization of our results, we provide publicly available, reproducible code on Github for every step of the analysis.

PMID:40955424 | PMC:PMC12433667 | DOI:10.1093/jrsssa/qnaf004

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Interventions for Prolonged Grief Disorder in Children and Adolescents: A Systematic Review

J Child Adolesc Trauma. 2025 Mar 12;18(3):517-527. doi: 10.1007/s40653-024-00677-8. eCollection 2025 Sep.

ABSTRACT

Prolonged Grief Disorder (PGD) was added as a new diagnosis to the Diagnostic and Statistical Manual of Mental Disorders 5 Text Revision (DSM-5-TR). Research on treatment interventions for PGD has focused primarily on adults. However, due to developmental differences, children and adolescents may experience grief differently than adults. There is a need to tailor interventions to children and adolescent populations, but there is a lack of consensus on best practices for treating PGD in these populations. The purpose of this study was to review existing interventions for PGD in children and adolescents to better inform clinicians working with this population. A systematic review was conducted through Google Scholar, APAPsychNet, and by following citations. Studies were reviewed for participant age, prolonged grief symptoms or diagnosis, intervention, and outcomes. Ten studies were included for review with eight interventions identified. Results for each intervention were found to be generally positive in reducing PGD symptoms. Interventions were grouped by modality including group treatments, hybrid treatments (combined group or individual therapy with family therapy), family treatment, and individual treatment. Cognitive Behavior Therapy (CBT), Attachment Theory and Multidimensional Grief Theory were common theoretical bases for interventions and all shared elements of psychoeducation and integrating knowledge about the loss with existing knowledge. Involvement of surviving parents in treatment was found to be a common element across most child and adolescent interventions and was not included in PGD treatment for adults. This review was limited in scope due to lack of research on child and adolescent populations for PGD treatment and heterogeneity of intervention types. However, preliminary findings support the efficacy of interventions for PGD in children and adolescents and highlight a key difference in treatment for these populations.

PMID:40955395 | PMC:PMC12433411 | DOI:10.1007/s40653-024-00677-8