Categories
Nevin Manimala Statistics

Stoma-Free Intersphincteric Resection in Low Rectal Cancer Without Radiotherapy: A Prospective Cohort Study on Safety and Recovery

Dis Colon Rectum. 2025 Oct 29. doi: 10.1097/DCR.0000000000004002. Online ahead of print.

ABSTRACT

BACKGROUND: Although defunctioning stoma creation is routine during intersphincteric resection for low rectal cancer, it carries significant complication risks and necessitates reoperation for closure. Defunctioning stoma omission in intersphincteric resection could avoid these complications; however, its feasibility remains unproven.

OBJECTIVE: This study aims to compare Grade C anastomotic leakage and secondly evaluate postoperative complications and economic impact of stoma-free vs. defunctioning stoma-intersphincteric resection procedures.

DESIGN: A prospective non-randomized cohort design.

SETTING: This study was conducted at a single tertiary referral center.

PATIENTS: Patients diagnosed with low rectal cancer, scheduled for intersphincteric resection from 2023 to 2025, were recruited, with those who received neoadjuvant radiotherapy excluded. The cohort was stratified by stoma free vs defunctioning stoma, which was dependent on patient decision.

MAIN OUTCOME MEASURES: Grade C anastomotic leakage.

RESULTS: A total of 101 patients were enrolled in this study, with 79 and 22 patients in the stoma-free and defunctioning stoma cohorts, respectively. Baseline demographic characteristics, tumor profiles, and preoperative comorbidities showed no statistically significant intergroup differences. Intraoperative parameters, including lymph node yield [13.00 (IQR 10.00-17.00) vs. 14.50 (IQR 10.75-17.00), p = 0.59] and intraoperative blood loss [20.00 (IQR 20.00-50.00) vs. 30.00 (IQR 20.00-50.00) mL, p = 0.10], were similar. Within 30 days, safety outcomes were comparable: Grade C anastomotic leakage (1.3% vs. 4.5%, p = 0.39) and overall complications (Clavien-Dindo I-IV, p = 0.46). Notably, the stoma-free group had shorter hospital stays (5 days [IQR 4-6] vs. 6 days [IQR 5-9], p = 0.004) and lower hospitalization costs (CNY 29,598 [IQR 26,803-33,863] vs CNY 49,734 [IQR 36,731-65,018], p < 0.001).

LIMITATIONS: This study was conducted at a single tertiary referral center with a limited patient population.

CONCLUSIONS: Under standardized perioperative protocols, stoma-free intersphincteric resection surgery exhibits comparable Grade C leak rates to defunctioning stoma procedures, along with lower medical costs in patients with low rectal cancer without neoadjuvant radiotherapy. See Video Abstract.

PMID:41160071 | DOI:10.1097/DCR.0000000000004002

Categories
Nevin Manimala Statistics

Sampling Challenges of MM/PBSA Binding Energy Calculations

J Phys Chem B. 2025 Oct 29. doi: 10.1021/acs.jpcb.5c04908. Online ahead of print.

ABSTRACT

The accuracy of the MM/PBSA binding free energy calculation depends on both the employed force field and the statistical quality of sampling. However, the impact of sampling sufficiency has often been underestimated in previous studies. Here, we systematically analyze multiple protein-ligand systems using conventional and enhanced molecular dynamics simulations of different lengths. Our results show that short simulations may sometimes give the illusion of convergence while failing to capture slow conformational transitions that affect the computed free energies. Longer or enhanced simulations can reveal these hidden motions but do not always improve agreement with experiments, indicating that force-field limitations may dominate once statistical convergence is achieved. From a theoretical perspective, sufficient sampling is the fundamental requirement for converging thermodynamic quantities such as ΔΔG, independent of the simulation length. Practically, the degree of sampling sufficiency depends on system-specific dynamics and research goals. This work highlights the importance of recognizing sampling sufficiency as a statistical prerequisite rather than equating it with long simulations and calls for more adaptive strategies to balance efficiency and reliability in MM/PBSA analyses.

PMID:41160056 | DOI:10.1021/acs.jpcb.5c04908

Categories
Nevin Manimala Statistics

Optimal Cutoffs for the Ratio of Arterial Oxygen Partial Pressure to Inspired Oxygen Fraction in Categorizing Respiratory Impairment Severity in Organ Failure Scores

Acta Anaesthesiol Scand. 2026 Jan;70(1):e70137. doi: 10.1111/aas.70137.

ABSTRACT

BACKGROUND: The ratio of arterial oxygen partial pressure to fraction of inspired oxygen (PaO2/FiO2, hereafter P/F ratio) is a key component of the Sequential Organ Failure Assessment (SOFA) score. It reflects the severity of hypoxaemic respiratory failure. The ongoing revision of the SOFA score requires data-driven cutoffs for P/F ratio as well as rational criteria for respiratory support. In this study, we aimed to determine the optimal P/F ratio cutoffs for determining respiratory failure categories in the revised SOFA score and examined whether advanced respiratory support should be a prerequisite for the most severe categories.

METHODS: We used the database of the intensive care unit of Kuopio University Hospital, Finland, for cutoff derivation and the eICU database, a multicenter U.S. intensive care registry, for external validation. We identified cutoffs most discriminative for hospital mortality using the log-rank statistic test with the Contal and O’Quigley method. In external validation, these cutoffs were compared with those in the current respiratory SOFA score.

RESULTS: Optimal cutoffs were identified as follows: P/F ratio > 40 kPa (normal), 30-40 kPa (mild impairment), 20-30 kPa (moderate impairment), 10-20 kPa (severe impairment), and ≤ 10 kPa (critical impairment). These cutoffs resulted in clear separation of the severity categories (chi-square for log-rank statistic 356.9). They outperformed the current respiratory SOFA score cutoffs in the validation cohort (AUROC 0.615, 95% CI 0.607-0.622 vs. AUROC 0.610, 95% CI 0.603-0.618, p < 0.001). Advanced respiratory support was associated with higher mortality, but its inclusion as a prerequisite improved discrimination only in the moderately impaired respiratory function category, not in the severely or critically impaired categories.

CONCLUSION: P/F ratio cutoffs using 10 kPa (75 mmHg) intervals were identified to be optimal for distinguishing stages of respiratory failure severity. The impact of respiratory support on P/F ratio-mortality associations suggests the need to calibrate any P/F ratio-based score by support level, but optimal calibration methods require further study.

EDITORIAL COMMENT: In this study, the cut-off values for the partial pressure of arterial oxygen to the fraction of inspired oxygen (P/F ratio) were investigated in a large Finnish intensive care database and validated externally with the US intensive care registry. The aim was to support a revision of the cut-off values for the P/F ratio in the Sequential Organ Failure Assessment (SOFA) score. The results showed that incremental changes in the P/F ratio of 10 kPa are better than 13 kPa and emphasize the need for critical assessment of the current SOFA score.

PMID:41160043 | DOI:10.1111/aas.70137

Categories
Nevin Manimala Statistics

Active Rash, Interstitial Lung Disease, and Neutrophil to Lymphocyte Ratio and Mortality in Dermatomyositis

JAMA Dermatol. 2025 Oct 29. doi: 10.1001/jamadermatol.2025.4161. Online ahead of print.

ABSTRACT

IMPORTANCE: Dermatomyositis (DM) is associated with increased rates of hospitalization and mortality. However, characteristics present at the time of admission that are associated with in-hospital mortality remain poorly defined in the US.

OBJECTIVE: To evaluate whether features of DM present at admission, including active rash and muscle disease, interstitial lung disease (ILD), elevated neutrophil to lymphocyte ratio (NLR), myositis-specific autoantibody status, and baseline treatment regimens, are associated with in-hospital mortality among patients admitted with DM.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included adults with pre-existing DM (confirmed by documentation by a dermatologist or rheumatologist) who were admitted for any cause at a single tertiary referral center from January 2013 to May 2024. Data were analyzed from August 2024 to August 2025.

EXPOSURES: Clinical, serologic, and laboratory features of DM at the time of admission as well as baseline treatment prior to hospitalization.

MAIN OUTCOMES AND MEASURES: The primary outcome was in-hospital mortality. Statistical analyses included descriptive statistics and multivariable logistic regression with the Firth correction, adjusting for demographics and DM subtype. Bonferroni correction was applied to control for multiple comparisons.

RESULTS: Among 153 patients with DM (113 females [73.9%]; mean [SD] age, 56.5 [14.3] years), 16 (10.5%) died during hospitalization. Deceased patients were more likely than survivors to have active rash (13 of 16 [81.3%] vs 47 of 137 [34.3%]), ILD (14 of 16 [87.5%] vs 57 of 137 [41.6%]), and elevated NLR (mean [SD], 12.5 [7.43] vs 4.90 [3.82]). Myositis prevalence did not differ significantly between deceased patients and survivors. In multivariable analysis, active rash (odds ratio [OR], 12.13; 95% CI, 3.18-46.28; P = .003), ILD (OR, 6.43; 95% CI, 1.78-23.13; P = .04), and NLR (OR per 1-unit increase, 1.29 [95% CI, 1.16-1.44]; P < .001) were independently associated with mortality. No association with baseline intravenous immunoglobulin use was observed among patients who died after Bonferroni correction.

CONCLUSIONS AND RELEVANCE: In this study, active rash, ILD, and elevated NLR were independently associated with in-hospital mortality in patients with DM, regardless of disease subtype or myositis-specific autoantibody status. Recognizing these high-risk features may guide inpatient management and support future risk stratification strategies.

PMID:41160039 | DOI:10.1001/jamadermatol.2025.4161

Categories
Nevin Manimala Statistics

Health-Related Social Needs Among LGB+ Veterans

JAMA Netw Open. 2025 Oct 1;8(10):e2539986. doi: 10.1001/jamanetworkopen.2025.39986.

ABSTRACT

IMPORTANCE: Veterans identifying as lesbian, gay, bisexual, additional orientations, or not sure (LGB+) may have unique health-related social needs. By addressing social needs, health systems can take steps to alleviate persistent health disparities in this population.

OBJECTIVE: To evaluate associations between sexual orientation and need for support for social needs among primary care patients served by the Veterans Health Administration (VHA).

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from a national sample of VHA primary care patients seen in January or February 2023 who were invited to participate in a survey online or by mail. Data collection occurred from March 2 through May 9, 2023.

EXPOSURE: Self-reported sexual orientation (straight or LGB+).

MAIN OUTCOMES AND MEASURES: Unadjusted prevalence ratios (PRs) and adjusted PRs (APRs) of need for support across 13 health-related social domains.

RESULTS: Of 38 759 veterans invited to participate in the survey, 7095 (18.3%) responded and 6296 (16.2%) with complete data were included. Weighted responses represented 903 714 veterans. The unweighted number (weighted percentage) identifying as straight was 5874 (94.2%) and as LGB+ was 422 (5.8%); 3585 (89.1%) were male. In unadjusted comparisons, LGB+ veterans had a higher prevalence of need for support for feeling socially isolated (PR, 1.40; 95% CI, 1.04-1.87), feeling lonely (PR, 1.59; 95% CI, 1.20-2.09), finding or keeping work (PR, 1.71; 95% CI, 1.07-2.75), paying for food (PR, 1.71; 95% CI, 1.19-2.46), paying for basics such as housing, medical care, and heating (PR, 1.89; 95% CI, 1.29-2.75), managing experiences of discrimination (PR, 2.31; 95% CI, 1.54-3.48), and getting or maintaining housing (PR, 2.41; 95% CI, 1.40-4.15). After adjusting for age and for a combined race, ethnicity, and sex variable, LGB+ veterans had higher prevalence of need for support for managing experiences of discrimination (APR, 1.79; 95% CI, 1.21-2.64) and getting or maintaining housing (APR, 1.91; 95% CI, 1.10-3.34).

CONCLUSIONS AND RELEVANCE: This cross-sectional study found that LGB+ veterans reported a higher prevalence of social needs related to managing experiences of discrimination and housing instability compared with their straight counterparts. Expansion of support systems to address social needs in general and to ensure that systems are tailored for groups that more often experience certain needs should be considered.

PMID:41160026 | DOI:10.1001/jamanetworkopen.2025.39986

Categories
Nevin Manimala Statistics

Postacute Care Use and Outcomes Among Medicare Advantage vs Traditional Medicare Beneficiaries

JAMA Netw Open. 2025 Oct 1;8(10):e2540347. doi: 10.1001/jamanetworkopen.2025.40347.

ABSTRACT

IMPORTANCE: Postacute care expenditures exceed $57.3 billion annually for traditional Medicare (TM) and drive regional spending variation. Medicare Advantage (MA) plans, with financial incentives to optimize postacute care, offer a compelling alternative. With more than half of Medicare beneficiaries now enrolled in MA, understanding postacute care use and outcomes across these groups is increasingly critical for policy and practice.

OBJECTIVE: To analyze the association of MA enrollment with postacute care use and patient outcomes compared with TM.

DESIGN, SETTING, AND PARTICIPANTS: This cross-temporal cohort study using a difference-in-differences approach matched 2021 MA beneficiaries to 2015 TM beneficiaries with a high propensity of enrolling in MA. The study included Medicare beneficiaries aged 66 years or older discharged alive from acute care in 2015 or 2021 and subsequently admitted to a skilled nursing facility (SNF) or to home health care. The data were analyzed between April 1, 2023, and August 28, 2025.

EXPOSURE: Enrollment in MA plans.

MAIN OUTCOMES AND MEASURES: The main outcomes were the proportion of beneficiaries discharged to an SNF or home health, length of stay in an SNF or home health, 100-day hospital readmission and mortality rates, total days in the community, and changes in functional status. Difference-in-differences analyses were conducted using linear probability models for binary outcomes, and linear regression models were used for continuous outcomes. Doubly robust models included the same covariates as the propensity score models to adjust for residual imbalances in the matching.

RESULTS: The study included 7 294 038 patients hospitalized in 2015 and 2021, with 2 687 009 (36.8%) enrolled in MA at some point. The final analytic sample included 1 081 103 MA beneficiaries enrolled in 2021 matched to 221 119 MA beneficiaries enrolled in 2015 (n = 1 302 222; mean [SD] age, 77.3 [7.9] years; 54.6% female) and 1 625 316 TM beneficiaries enrolled in 2021 matched to 534 607 TM beneficiaries enrolled in 2015 (n = 2 159 923; mean [SD] age, 78.4 [8.2] years; 53.9% female). The MA beneficiaries exhibited greater reductions in postacute care use compared with TM beneficiaries, including 6.3 fewer days in SNFs (95% CI, -6.8 to -5.8 days) and 3.6 fewer days in home health (95% CI, -4.3 to -2.9 days). Medicare Advantage enrollees also experienced a 1.5-percentage point lower probability of readmission (95% CI, -1.8 to -1.2 percentage points) and spent more time in the community in the first 100 days after hospital discharge (difference, 1.9 days; 95% CI, 1.7-2.2 days) than TM beneficiaries. Medicare Advantage beneficiaries also experienced a slightly lower mortality (difference, -0.3 percentage points; 95% CI, -0.6 to -0.1 percentage points) compared with TM beneficiaries, as well as modest functional gains (difference in 30-day activities of daily living improvement, 2.5 percentage points; 95% CI, 1.7-3.4 percentage points).

CONCLUSIONS AND RELEVANCE: These findings suggest that reductions in postacute care in comparable MA and TM beneficiaries were not associated with worse outcomes.

PMID:41160023 | DOI:10.1001/jamanetworkopen.2025.40347

Categories
Nevin Manimala Statistics

Physical Performance in Young Adult Women With High Femoral Anteversion

J Strength Cond Res. 2025 Oct 30. doi: 10.1519/JSC.0000000000005279. Online ahead of print.

ABSTRACT

Tuncer, D, Altay, E, and Furuncu, B. Physical performance in young adult women with high femoral anteversion. J Strength Cond Res XX(X): 000-000, 2025-Women with high femoral anteversion (HFA) demonstrate significantly increased hip internal rotation and anteversion angles than controls, which may affect lower extremity biomechanics. This cross-sectional observational study aimed to evaluate the impact of HFA on physical performance in young adult women. Twenty-two women with HFA (age 21.36 ± 1.89 years) and 22 age-matched controls (age 22.23 ± 2.05 years) were assessed. Femoral anteversion was assessed using both the Craig test and goniometric measurements of hip internal and external rotation. Physical performance was evaluated using sit-and-reach flexibility test, hand-grip strength, back-leg-chest dynamometry, double- and single-leg horizontal jump tests, and 6-minute walk test. The HFA group exhibited significantly increased internal rotation and decreased external rotation ranges of motion, along with higher femoral anteversion angles as determined by the Craig test (p < 0.001). No statistically significant differences were found between groups for most physical performance measures (p > 0.05), although back-leg-chest strength tended to be lower in the HFA group (p = 0.05, moderate effect size). These findings suggest that despite marked anatomical differences, physical performance in young adult women with HFA is largely comparable with controls. Future research should investigate symptomatic individuals and the potential functional impact of higher anteversion angles.

PMID:41160019 | DOI:10.1519/JSC.0000000000005279

Categories
Nevin Manimala Statistics

The emerging promise of induced pluripotent stem cells in clinical studies: a systematic scoping review of the literature and registered clinical trials

Cytotherapy. 2025 Sep 26:S1465-3249(25)00846-1. doi: 10.1016/j.jcyt.2025.09.008. Online ahead of print.

ABSTRACT

BACKGROUND AIMS: Induced pluripotent stem cells (iPSCs) are a promising cell-based therapy given their ability to differentiate into various cell types for therapeutic use. Although clinical trials using these cells have recently emerged, such trials are small, heterogenous in design, and examine a broad range of diseases. A systematic scoping review of published clinical studies and registered trials is needed to understand important aspects of study design and identify barriers to greater clinical adoption.

METHODS: A systematic search of published clinical studies was conducted in MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (1946 to January 29, 2025) and ongoing registered clinical trials in Clinical Trials.Gov and the World Health Organization International Clinical Trials Registry Platform (January 29, 2025). Descriptive statistics were used for data analysis. Meta-analysis was not performed given the small number and size of included studies.

RESULTS: We identified 10 published clinical studies and 22 ongoing registered trials utilizing iPSCs to treat a wide range of diseases, including cardiac conditions, ocular disorders, cancer, graft-versus-host disease, and as a source of platelets for transfusion. Published studies were mostly small (only 2 studies reported on more than 4 patients) and uncontrolled, with a total of 115 patients treated. While iPSC characterization was generally aligned with criteria established by the International Society for Stem Cell Research, considerable variability was observed in terms of study design, medical conditions examined, and cell source used for iPSC generation. Moreover, a broad range of iPSC-derived cell products were administered. Variability among studies and ongoing trials may complicate and delay our understanding of the safety and efficacy of iPSC-based therapies.

CONCLUSIONS: iPSCs are poised to have a significant impact on clinical care for patients with conditions such as cardiac disease, cancer, and ocular disorders. We anticipate a period of several more years before the safety and efficacy of iPSC-based therapies can be definitively determined. Standardized study protocols and adherence to iPSC-derived product characterization criteria could facilitate more accelerated approval of iPSC-based therapies.

PMID:41160002 | DOI:10.1016/j.jcyt.2025.09.008

Categories
Nevin Manimala Statistics

Development of the TEACH Study: A Culturally Responsive Nutrition Intervention Program for Montessori Teachers

J Nutr Educ Behav. 2025 Oct 28:S1499-4046(25)00427-0. doi: 10.1016/j.jneb.2025.09.004. Online ahead of print.

ABSTRACT

OBJECTIVE: To describe the intervention and research methods of the Teacher Education and Classroom Habits (TEACH) study, a social cognitive theory-based virtual nutrition intervention program for Montessori teachers to enhance teachers’ personal and classroom nutrition beliefs and behaviors.

DESIGN: This 12-week study will employ a cluster-randomized control design with a delayed intervention for the control group.

SETTING: Montessori schools across the US with early childhood programs.

PARTICIPANTS: Early childhood teachers will be recruited from approximately 29 Montessori schools across the US and randomized at the school level.

INTERVENTION: The TEACH study will provide culturally focused nutrition education for Montessori teachers over 6 weeks, consisting of 4 program components, including an interactive online platform, live virtual education sessions, a Montessori-based nutrition curriculum, and parent education handouts.

MAIN OUTCOME MEASURES: Using validated survey measures, changes in teachers’ nutrition knowledge, nutrition self-efficacy, nutrition teaching self-efficacy, cultural competence, classroom eating behaviors, classroom food practices, nutrition teaching practices, and teacher-parent communication will be assessed at 3 timepoints (i.e., baseline, week 6, and week 12).

ANALYSIS: Stepwise linear regressions will be used to assess relationships between baseline variables. Multilevel modeling will be used to determine the impact of the intervention. Statistical significance set at P ≤ 0.05.

PMID:41159997 | DOI:10.1016/j.jneb.2025.09.004

Categories
Nevin Manimala Statistics

Comparison of Perioperative Management Effort and Work Relative Value Units in the Management of Distal Humerus and Distal Radius Fractures

J Hand Surg Am. 2025 Oct 28:S0363-5023(25)00473-3. doi: 10.1016/j.jhsa.2025.08.017. Online ahead of print.

ABSTRACT

PURPOSE: Open reduction and internal fixation (ORIF) of distal humerus fractures (DHFs) has nearly identical work relative value unit (wRVU) compensation compared with distal radius fractures (DRFs). The purpose of this study was to compare perioperative work effort, surgical times, complications, and the frequency of postoperative follow-up care for ORIF DRF and DHF cases.

METHODS: All isolated cases of ORIF DHF and intra-articular DRF in adult patients between 2010 and 2024 from a single, large health care system were reviewed. Baseline demographics, surgical characteristics, complications/reoperations, and postoperative visits/communication were recorded. Work relative value units per minute of surgery (wRVU/min) were calculated for each case relative to their current procedural terminology (CPT) codes and assigned wRVUs: (1) CPT 24545: ORIF extra-articular DHF (13.15 wRVU), (2) CPT 24546: ORIF intra-articular DHF (14.91wRVU), (3) CPT 25608: ORIF intra-articular DRF, two fragments (11.07 wRVU), and (4) CPT 25609: ORIF intra-articular DRF, ≥3 fragments (14.38 wRVU). A 1:1 matched cohort was constructed to make comparisons between groups.

RESULTS: A total of 75 DHF and 74 DRF cases were included. Baseline demographics were similar. Distal humerus fractures had significantly longer mean surgical times (183 minutes) compared with DRFs (92 minutes). Distal humerus fracture cases had a mean wRVU/min of 0.093/min compared with DRF (0.154/min), and this difference was statistically significant. Distal humerus fracture cases also demonstrated significantly higher complication/reoperation rates (23% and 21%) compared with DRFs (6.8% and 6.8%). Both groups had similar frequencies of postoperative visits (mean = 3.0), and ORIF DHF cases had significantly more postoperative phone calls (mean = 2.6) compared with DRF cases (mean = 1.0).

CONCLUSIONS: Considering the longer surgical times and complication rates, upper-extremity surgeons are not proportionally compensated from a wRVU perspective for DHF management compared with DRFs.

CLINICAL RELEVANCE: These data should be used in future analyses and advocacy efforts related to wRVU adjustments for DHFs.

PMID:41159988 | DOI:10.1016/j.jhsa.2025.08.017