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Nevin Manimala Statistics

Housing and Support Intervention and Mortality Among Homeless Adults With Mental Illnesses: A Secondary Analysis of a Randomized Clinical Trial

JAMA Netw Open. 2025 Jul 1;8(7):e2524302. doi: 10.1001/jamanetworkopen.2025.24302.

ABSTRACT

IMPORTANCE: Homelessness is an important risk factor for premature death, with individuals experiencing homelessness having substantially higher mortality rates than the general population.

OBJECTIVE: To assess the association of housing and support interventions with mortality among individuals experiencing homelessness and mental illnesses.

DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of a randomized clinical trial included 2255 homeless adults with mental illnesses. The study was conducted in 5 Canadian cities (Vancouver, Winnipeg, Toronto, Montreal, and Moncton). Recruitment took place from October 2009 to July 2011; mortality data were collected until March 30, 2019. Due to the complexity of accessing health administrative data, analyses were conducted and completed between February 2021 and December 2023.

EXPOSURE: Participants were randomized to receive either the Housing First (HF) intervention, which provided immediate permanent, scattered-site housing and support through intensive case management or assertive community treatment to chronically homeless individuals, or treatment as usual (TAU).

MAIN OUTCOMES AND MEASURES: Mortality rate ratios were ascertained at each site using health administrative databases. Adjusted hazard ratios were computed using Cox proportional hazard survival models. Random-effects meta-analysis was used to calculate pooled effect sizes across sites.

RESULTS: Of the 2255 total participants, 2108 (93.5%) were successfully linked with health administrative data; among them, 1434 (68.0%) were male, with a mean (SD) age of 40.6 (11.5) years. Mortality rates were not different in the HF compared with TAU groups (pooled log mortality rate ratio, -0.07; 95% CI, -0.36 to 0.22). The pooled adjusted hazard ratio comparing mortality in the HF and TAU groups was 0.83 (95% CI, 0.43-1.22).

CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial, the HF intervention was not directly associated with mortality risk. Research is needed to determine whether adjunctive interventions could reduce mortality among homeless individuals with mental illnesses.

TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN42520374.

PMID:40742585 | DOI:10.1001/jamanetworkopen.2025.24302

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Characteristics, Regional Evaluation, and D-Antigen in Transfusions by Emergency Medical Services

JAMA Netw Open. 2025 Jul 1;8(7):e2524368. doi: 10.1001/jamanetworkopen.2025.24368.

ABSTRACT

IMPORTANCE: Prehospital transfusion (PHT) of blood products by emergency medical services (EMS) has become common in civilian settings. However, variability exists in practices across the US. There are few large-scale data describing US civilian PHT with regard to blood products administered, potential exposure of females of childbearing potential to D-positive blood, or the proportion of PHT cases occurring in EMS transports of short duration.

OBJECTIVE: To evaluate nationwide PHT trends, regional differences, and potential risks, particularly for D-positive blood administration in females of childbearing potential.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study, Characteristics, Regional Evaluation, and D-Antigen in Transfusions by EMS (CREDIT-EMS), assessed data collected from January 1, 2020, to October 31, 2024 (before hypothesis generation), in trauma and nontrauma patients of all ages treated in 48 states in the US.

EXPOSURE: Prehospital-initiated transfusion of blood products.

MAIN OUTCOMES AND MEASURES: Age, sex, blood product characteristics (including blood type), and transport time. Comparative analyses were conducted using Pearson χ2, Wilcoxon rank sum, and nonparametric trend tests. Proportions were reported with binomial exact 95% CIs.

RESULTS: The study analyzed 10 444 patients (median [IQR] age, 45 [29-63] years; 7302 of 10 439 [70.0%] male) who received 18 177 units of blood products. The proportion of transfused units that were whole blood (WB) increased from 10.0% in 2020 to 30.8% in 2024 (P < .001). Regional variations in PHT were identified, with the Northeast having the highest proportion of WB use (33.2% of PHT). A total of 1589 (15.2%; 95% CI, 14.5%-15.9%) of the study patients were females of childbearing potential (aged 12-50 years), with an increasing number receiving D-positive blood products over time (73 of 169 [43.2%] in 2020 to 372 of 497 [74.9%] in 2024) (P < .001). Prehospital times were 20 minutes or less in only 255 of 10 343 cases (2.5%; 95% CI, 2.2%-2.8%).

CONCLUSIONS AND RELEVANCE: This cohort study of civilian PHT practices in the US found geographic and temporal variability. There was increasing adoption of WB and significant implications for females of childbearing potential who are increasingly likely to receive D-positive PHT. Cases of PHT uncommonly involved short prehospital duration. These findings highlight the need for standardized protocols and further evaluation of risk-benefit considerations.

PMID:40742584 | DOI:10.1001/jamanetworkopen.2025.24368

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Impact of the MISSION Act on Quality and Outcomes of Major Cardiovascular Procedures Among Veterans

JAMA. 2025 Jul 31. doi: 10.1001/jama.2025.11661. Online ahead of print.

ABSTRACT

IMPORTANCE: The Department of Veterans Affairs (VA) Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act expanded opportunities for veterans to obtain care outside the VA. However, the impact on health care outcomes is uncertain.

OBJECTIVE: To measure the MISSION Act’s impact on travel times and outcomes of percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), and aortic valve replacement (AVR).

DESIGN, SETTING, AND PARTICIPANTS: This retrospective difference-in-differences cohort study included veterans receiving nonemergent/nonurgent PCI, CABG, or AVR between October 2016 and September 2022 in non-VA hospitals under MISSION Act coverage or in VA hospitals in the 48 contiguous US states or the District of Columbia. Analyses were conducted in 2023-2024.

EXPOSURES: Veterans eligible for non-VA care under the MISSION Act by living far from ( >60 minutes) the nearest VA medical center vs veterans living near (≤60 minutes) a VA medical center.

MAIN OUTCOMES AND MEASURES): Major adverse cardiovascular events (MACE), defined as rehospitalization for cardiovascular cause or mortality within 30 days of the procedure, and travel times for care were the primary outcomes.

RESULTS: The cohort comprised veterans receiving PCI (n = 43 000; 42 066 [98%] male; mean [SD] age, 69 [8.8] years), CABG (n = 23 301; 22 197 [98%] male; mean [SD] age, 69 [7.7] years), or AVR (n = 14 682; 14 336 [98%] male; mean [SD] age, 74 [9.6] years). After MISSION implementation, mean PCI travel times increased by 1.3 minutes for near patients and decreased by 29.2 minutes for far patients (difference in differences, -30.5 minutes; P < .001). Mean CABG travel times increased by 9.4 minutes for near patients and decreased by 18.1 minutes for far patients (difference in differences, -27.4 minutes; P < .001). Mean travel times for AVR increased by 10.0 minutes for near patients and decreased by 23.0 minutes for far patients (difference in differences, -33.1 minutes; P < .001). After MISSION implementation, mean PCI MACE rates decreased by 0.5 percentage points for near patients and increased by 2.3 percentage points for far patients (difference in differences, 2.8 percentage points; P <.001). Mean CABG MACE rates decreased by 6.5 percentage points for near patients and increased by 1.6 percentage points for far patients (difference in differences, 8.1 percentage points; P < .001). AVR MACE rates were not statistically different between the groups (P = .45).

CONCLUSIONS AND RELEVANCE: MISSION Act implementation was associated with substantial decreases in travel times among veterans who became geographically eligible for non-VA care. For these patients undergoing PCI or CABG, MISSION Act implementation was also associated with worsened 30-day MACE rates.

PMID:40742582 | DOI:10.1001/jama.2025.11661

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Total shoulder arthroplasty in patients with degenerative cervical spine disease: Does cervical spine surgery affect outcomes?

Eur J Orthop Surg Traumatol. 2025 Jul 31;35(1):332. doi: 10.1007/s00590-025-04456-5.

ABSTRACT

BACKGROUND: Rates of both total shoulder arthroplasty (TSA) and cervical spine surgery for degenerative cervical spine disease (DCSD) are increasing. However, it is still unknown if prior cervical spine surgery for DCSD impact outcomes following TSA. This study aims to compare the risk of complications and revisions in patients undergoing TSA with DCSD between patients with and without prior cervical spine surgery.

METHODS: This study is a retrospective review of the PearlDiver Mariner Database. Based on whether or not patients had prior cervical spine surgery, the patients with DCSD and undergoing TSA were divided into 2 groups: patients with DCSD and cervical spine surgery, and patients with DCSD and without cervical spine surgery. The two groups were matched based on age, gender, the Charlson comorbidity index (CCI), and obesity. Surgical complications and revisions with regards to their TSA at 1 through 5 years post-operatively were compared between the groups.

RESULTS: The TSA with DCSD and no cervical spine surgery cohort were older (63.7 ± 8.4 vs 61.2 ± 8.4 years, p < .001), had higher CCI (1.2 ± 1.7 vs 1.0 ± 1.6, p < .001), had a higher proportion of males (47.8% vs 41.8%, p = 0.01), and had a lower % of patients with obesity (50.9% vs 53.3%, p = 0.01). After matching, 2899 patients remained in each group. The group with prior cervical spine surgery had higher rates of mechanical loosening at 5 years post-operatively (1.2% vs 1.8%, p = 0.05), and lower rates of periprosthetic fractures at 3 and 4 years post-operatively (0.4% vs < 10, p = 0.01; 0.5% vs < 10, p = 0.02 respectively). No difference in the remaining surgical complications or revisions was seen between the two groups.

CONCLUSION: This study highlights an increase in risk of mechanical loosening after TSA in patients with prior cervical spine surgery. Additionally, patients with DCSD without prior cervical spine surgery had an increased risk of sustaining periprosthetic fractures after TSA, potentially due to untreated myelopathy and related falls.

PMID:40742568 | DOI:10.1007/s00590-025-04456-5

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Pre-radiotherapy multidisciplinary survivorship care and patient-reported outcomes in head and neck cancer survivors

Support Care Cancer. 2025 Jul 31;33(8):734. doi: 10.1007/s00520-025-09797-9.

ABSTRACT

PURPOSE: This study aims to evaluate the association between receiving pre-radiotherapy multidisciplinary survivorship care and patient-reported outcomes measures (PROMs) pertaining to quality of life (QOL), symptom burden, and psychological distress at one-year post-radiotherapy among head and neck cancer (HNC) survivors.

METHODS: Survivors who underwent radiotherapy from 2017-2022 and completed PROMs during their one-year post-radiotherapy visit at a multidisciplinary HNC survivorship clinic were included. Survivors with recurrent disease, second primary tumor, and/or distant metastasis were excluded. Differences in PROMs between propensity score matched survivors who did and did not have a pre-radiotherapy visit were analyzed using multivariable regression models controlling for covariates.

RESULTS: 310 survivors were included (mean [SD] age, 61.09 [9.58] years; 238 [76.8%] male; 159 [51.3%] pre-radiotherapy visit; 163 [52.6%] oropharyngeal; 161 [54.9%] early T stage; 159 [51.5%] early N stage). Compared to survivors without a pre-radiotherapy visit, survivors with a pre-radiotherapy visit had higher physical (+ 7.26 points, 95% CI [3.35, 11.18], p < 0.001) and social-emotional (+ 5.93 points, 95% CI [1.58, 10.29], p = 0.008) QOL scores and lower depression (-1.31 points, 95% CI [-2.61, -0.01], p = 0.048), anxiety (-1.18 points, 95% CI [-2.23, -0.13], p = 0.027), dysphagia (-3.77 points, 95% CI [-6.36, -1.19], p = 0.004), insomnia (-2.76 points, 95% CI [-4.61, -0.92], p = 0.004), and neck disability (-2.28 points, 95% CI [-4.41, -0.16], p = 0.035) scores one-year post-radiotherapy.

CONCLUSIONS: Receiving pre-radiotherapy multidisciplinary survivorship care was associated with higher QOL and lower symptom burden and psychological distress among HNC survivors. These findings support implementing proactive survivorship care in clinical practice to improve health outcomes in HNC.

PMID:40742566 | DOI:10.1007/s00520-025-09797-9

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Family-based cognitive behavioral therapy versus family-based psychoeducation and relaxation training for obsessive-compulsive disorder in children and adolescents: a randomized clinical trial (TECTO)

Eur Child Adolesc Psychiatry. 2025 Jul 31. doi: 10.1007/s00787-025-02797-4. Online ahead of print.

ABSTRACT

Few randomized clinical trials (RCTs) have compared cognitive behavioral therapy (CBT) versus active control interventions for pediatric obsessive-compulsive disorder (OCD), and the range of investigated outcomes has been limited. We investigated benefits and harms of family-based CBT with exposure and response prevention (FCBT) versus family-based psychoeducation and relaxation training (FPRT) in pediatric OCD. This single-center RCT was investigator-initiated, independently funded, including participants with OCD aged 8-17 years with a Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) entry score ≥ 16. We randomized participants 1:1 to 14 sessions of FCBT versus FPRT. Allocation was masked to assessors and statisticians. The primary outcome was CY-BOCS end-of-treatment-score (week-16) analyzed by intention-to-treat. Adverse events were reported by the Negative Effects Questionnaire (NEQ-20). One-hundred-and-thirty participants were randomized, 52.3% females; mean age 13.3 (SD = 2.9) years; mean CY-BOCS total score 25.8 (SD = 4.9); n = 64 to FCBT versus n = 66 to FPRT. Sixteen participants dropped out (four from FCBT, 12 from FPRT). The mean CY-BOCS total score at end-of-treatment was significantly lower for FCBT (15.9, SD = 8.7) versus FPRT (19.9, SD = 8.1), estimate – 3.89, 95%CI [-6.83, – 0.96), p = 0.01, effect size = 0.47, 95% CI [0.09, 0.85]. This difference was below our predefined minimal clinically important difference of four points. The average weekly NEQ frequency score showed no significant group differences. FCBT was associated with significantly larger symptom reduction than FPRT, but with a modest effect. FCBT and FPRT appeared comparably tolerable. A rigorous methodology enabled the counteraction of several biases. Limitations included missing self-reported data and inability of masking participants and treatment providers.

PMID:40742552 | DOI:10.1007/s00787-025-02797-4

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Incidence and clinical predictors of postoperative ileus following non-abdominal surgery in Ethiopia: a prospective cohort study

Langenbecks Arch Surg. 2025 Jul 31;410(1):236. doi: 10.1007/s00423-025-03808-3.

ABSTRACT

BACKGROUND: Postoperative ileus (POI) is a common consequence following abdominal surgeries; however, its incidence and risk factors in non-abdominal procedures remain unknown. Identifying clinical indicators of POI in this population is essential for early detection and treatment.

OBJECTIVE: This study aims to assess the incidence and determinants of postoperative ileus (POI) in patients undergoing non-abdominal surgeries at Debre Tabor Comprehensive Specialized Hospital.

METHODS: A prospective cohort study was conducted between September 1, 2024, and January 30, 2025. Demographic characteristics, comorbidities, surgical details, and perioperative parameters were recorded. Data were analyzed using SPSS version 27, with continuous and categorical variables summarized using descriptive statistics. Independent predictors of postoperative ileus (POI) were identified through bivariate and multivariate logistic regression analyses.

RESULTS: Among the 400 patients who underwent elective non-abdominal surgery, 31 (7.75%) developed postoperative ileus (POI). Significant predictors included opioid use (OR = 3.28 [95% CI, 2.25-7.12], P < 0.01), neuromuscular blockers (OR = 2.33 [95% CI, 2.01-5.12], P < 0.01), poor postoperative functional status (OR = 5.67 [95% CI, 3.41-8.91], P < 0.01), and delayed postoperative mobility (OR = 4.45 [95% CI, 2.05-8.17], P < 0.01).

RECOMMENDATION AND CONCLUSION: POI occurs in a significant proportion of patients undergoing non-abdominal surgery. Implementing targeted perioperative strategies may reduce the incidence of POI and enhance postoperative outcomes.

PMID:40742541 | DOI:10.1007/s00423-025-03808-3

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Robotic Sacrocolpopexy With Versus Without Supracervical Hysterectomy

Int Urogynecol J. 2025 Jul 31. doi: 10.1007/s00192-025-06253-4. Online ahead of print.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: After the age of 80, the cumulative incidence of surgery of pelvic organ prolapse (POP) exceeds 15%. While concomitant supracervical hysterectomy (SCH) is very popular at the time of sacrocolpopexy in some parts of the world, it is rarely performed in many European countries. The aim of the present study was to compare the outcomes of robotic sarcrocolpopexy with or without SCH.

METHODS: The charts of all consecutive patients who underwent minimally invasive sacrocolpopexy for POP at a single center between 2013 and 2023 were included in a retrospective study. The remaining patients were included for analysis and divided in two groups: with (HYST) vs. without (no HYST) supracervical hysterectomy.

RESULTS: Out of 197 minimally invasive sacrocolpopexy, 88 were included in the present analysis: 39 in the HYST group and 49 in the no-HYST group. The only statistically significant difference at baseline between the two groups was the higher proportion of grade 3 or 4 uterine prolapse in the HYST group (35.1% vs. 10.2%; p = 0.01). The postoperative complications rates were similar in both groups (16.7% vs. 18.4%; p = 0.84). After a median follow-up of 12 months, the subjective success rate was similar (96.6% vs. 92.2%; p = 0.44). Most outcomes were not significantly different.

CONCLUSIONS: In the present study, we did not demonstrate a benefit for SCH at the time of sacrocolpopexy. However, we did not observe an increased morbidity in the HYST group, suggesting that it may not exist anymore beyond the learning curve in the robotic era.

PMID:40742532 | DOI:10.1007/s00192-025-06253-4

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Simulated Dosing Regimens of Subcutaneous Infliximab in Adults and Children with Inflammatory Bowel Disease: Exploring Switch and Initiation Strategies

Eur J Drug Metab Pharmacokinet. 2025 Jul 31. doi: 10.1007/s13318-025-00959-y. Online ahead of print.

ABSTRACT

INTRODUCTION: An increasing number of patients in clinical practice are transitioning from intravenous (IV) to subcutaneous (SC) dosing of infliximab. In this simulation study, we evaluated hypothetical dosing scenarios both for typical adults and adults with obesity and for children switching from steady-state IV to SC infliximab, as well as those initiating SC infliximab therapy.

METHODS: By combining two previous published infliximab models, we were able to simulate both IV and SC dosing in adults and children. Various dosing regimens were simulated using a large virtual population. In each scenario, the distribution of trough concentrations and area under the plasma concentration-time curve (AUC) was calculated.

RESULTS: Peak levels were higher after IV dosing compared with SC dosing, while trough levels were higher after SC dosing, leading to more stable infliximab levels over time. Overall exposure remained largely similar when switching from a standard IV to SC dosing regimen. Patients with a high body mass index and those on high-frequency IV dosing regimens of infliximab demonstrated reduced exposure when transitioned to the fixed SC dose. Paediatric patients exhibited higher exposure on the fixed SC dose. Simulation of SC induction schemes demonstrated early achievement of steady-state plasma levels.

CONCLUSION: Infliximab exposure (AUC) remains largely similar when transitioning from standard IV to SC dosing. Current dosing regimens may not be optimal for patients with severe obesity, paediatric patients and patients on high-frequency infliximab regimens. These findings provide a foundation for future clinical research to refine SC infliximab dosing in these populations.

PMID:40742528 | DOI:10.1007/s13318-025-00959-y

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Predictive Modelling of Solvent Effects on Drug Incorporation into Polymeric Nanocarriers: A Machine Learning Approach

Macromol Rapid Commun. 2025 Jul 31:e00251. doi: 10.1002/marc.202500251. Online ahead of print.

ABSTRACT

This study aimed to identify solvent characteristics that enhance drug loading in polymeric micelles. Polyethylene glycol-block-polystyrene (PEG-b-PS) and curcumin were used as model compounds to investigate the impact of 40 different solvent mixtures on drug loading during flow-based assembly. We tested five algorithms: Random Forest (RF), Gradient Boosting (GP), XGBoost, Support Vector Regression (SVR), and Multilayer Perceptron (MLP), with the MLP model proving to be the most effective among them. To explain the model’s predictions, we utilized SHapley Additive exPlanations (SHAP) values to identify solvent properties that contribute to high drug loading. Of the nine descriptors examined-curcumin solubility, polarity, Hildebrand solubility parameters, dipole moment, dielectric constants, viscosity, and Hansen solubility parameters (δD, δP, and δH)-solubility emerged as the most critical factor. Therefore, to achieve optimal drug loading, researchers should prioritize solvents with the highest solubility.

PMID:40742525 | DOI:10.1002/marc.202500251