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Nevin Manimala Statistics

Improved prediction and flagging of extreme random effects for non-Gaussian outcomes using weighted methods

Biometrics. 2025 Jul 3;81(3):ujaf094. doi: 10.1093/biomtc/ujaf094.

ABSTRACT

Investigators often focus on predicting extreme random effects from mixed effects models fitted to longitudinal or clustered data, and on identifying or “flagging” outliers such as poorly performing hospitals or rapidly deteriorating patients. Our recent work with Gaussian outcomes showed that weighted prediction methods can substantially reduce mean square error of prediction for extremes and substantially increase correct flagging rates compared to previous methods, while controlling the incorrect flagging rates. This paper extends the weighted prediction methods to non-Gaussian outcomes such as binary and count data. Closed-form expressions for predicted random effects and probabilities of correct and incorrect flagging are not available for the usual non-Gaussian outcomes, and the computational challenges are substantial. Therefore, our results include the development of theory to support algorithms that tune predictors that we call “self-calibrated” (which control the incorrect flagging rate using very simple flagging rules) and innovative numerical methods to calculate weighted predictors as well as to evaluate their performance. Comprehensive numerical evaluations show that the novel weighted predictors for non-Gaussian outcomes have substantially lower mean square error of prediction at the extremes and considerably higher correct flagging rates than previously proposed methods, while controlling the incorrect flagging rates. We illustrate our new methods using data on emergency room readmissions for children with asthma.

PMID:40736765 | DOI:10.1093/biomtc/ujaf094

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Nevin Manimala Statistics

Quality of life following ileostomy takedown: single-centre, retrospective clinical trial-does closure time matter?

Tech Coloproctol. 2025 Jul 30;29(1):154. doi: 10.1007/s10151-025-03196-2.

ABSTRACT

AIM: This study aimed to assess whether early closure of loop ileostomy reduces the rate of postoperative complications related to ileostomy closure and improves patients’ quality of life, as measured by the Low Anterior Resection Syndrome (LARS) and Wexner questionnaires.

METHODS: All patients who underwent low anterior resection + ileostomy with subsequent reversal between January 2019 and May 2023 were included in the study. Patients were divided into two groups: early (< 3 months) and late closure (> 3 months). There were 46 (43%) patients in the early closure group and 61 (57%) in late closure. In this study, patients’ demographics and complication rate (categorised by severity using the Clavien-Dindo scale) were assessed.

RESULTS: We assessed and contacted 180 patients. Of these, 107 (59%) completed the LARS and Wexner questionnaires. Of the 107 patients, 51 were male (47.7%) and 56 female (52.3%). The time to ileostomy closure ranged between 0.5 and 28 months, with a median of 5. In the early and late closure groups, postoperative complications were observed in 4.3% vs. 14.8% (p = 0.08) of patients and postoperative ileus occurred in 6.5% vs. 4.9% (p = 0.72) of patients respectively. Median LARS score was 25 vs. 20 (p = 0.99) and Wexner’s 2.5 vs. 2 (p = 0.82), respectively. The previously discussed indicators (postoperative ileostomy complications, postoperative ileus rate, LARS and Wexner scores) were not statistically significantly different.

CONCLUSION: In our small retrospective study, early ileostomy closure did not affect postoperative complications related to ileostomy closure and bowel dysfunction rates compared to late closure.

TRIAL REGISTRATION: This study was a secondary analysis of the prospective trial registered at ClinicalTrials.gov no. NCT03607370, 01.07.2017.

PMID:40736758 | DOI:10.1007/s10151-025-03196-2

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Nevin Manimala Statistics

Source analysis of soil selenium and evaluation of soil environmental quality and safety in the eastern area of Zichuan District, Shandong Province

Environ Monit Assess. 2025 Jul 30;197(8):968. doi: 10.1007/s10661-025-14372-0.

ABSTRACT

Zichuan District is a selenium (Se)-rich area discovered in Shandong Province. This study analyzed the source of soil Se in the eastern area of Zichuan District with using multivariate statistical analysis methods and considering the contribution of exogenous input for the first time. Additionally, the environmental quality of soil was evaluated using single factor index methods and comprehensive evaluation methods. Finally, the safety of crops and the health risks of human ingestion were assessed. The results showed that: the background value of Se in the study area was 0.43 mg/kg, significantly higher than that in Shandong Province and Chinese soil (Layer A). The F1 of R-type factor analysis revealed that the black sedimentary parent material was the material basis and initial source of soil Se enrichment, while pedogenic geochemical processes and the properties of Se contribute to the continuous accumulation of soil Se, but the exogenous input was low. Cd, Hg, and Pb exhibited the most severe pollution levels in soils. Most soils in the area were none or slightly polluted, but a small portion showed moderate or intense pollution. The MPI of 45 wheat grains was all below 1, confirming the absence of heavy metal (HM) contamination. However, the Hazard Index (HI) of HMs in 3 out of the 45 wheat grains was greater than 1, indicating potential health risks from ingestion. In contrast, the Hazard Quotient (HQ) of Se in crops was all less than 1, suggesting no harm to human health.

PMID:40736754 | DOI:10.1007/s10661-025-14372-0

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Nevin Manimala Statistics

Enhanced consent and patient counselling using virtual reality for patients undergoing shockwave lithotripsy: prospective outcomes from a university teaching hospital

World J Urol. 2025 Jul 30;43(1):461. doi: 10.1007/s00345-025-05847-3.

ABSTRACT

OBJECTIVE: To discover the effectiveness of VR in improving patient understanding and enhancing the consent procedure for patients undergoing extracorporeal shockwave lithotripsy (SWL). The primary outcomes measured include patient knowledge, pain perception, and emotional well-being.

METHODS: For this prospective study (ERGO: 92019), patients with kidney stone disease (KSD) undergoing SWL were given a VR headset before their treatment. The VR glasses visually explained the SWL process (3 min) and its success and complications through an audio explanation linked to a 3D animation. The content followed the patient information leaflet (PIL) from European and British associations. Participants were provided with three questionnaires that covered pain, anxiety, and patient understanding of SWL via the VR enhanced consent (one questionnaire each).

RESULTS: 100 patients completed all three questionnaires. 68 patients reported an improved understanding of SWL with VR, and the overall improvement in patient understanding was statistically significant (p < 0.001). Participants also found the VR headset significantly more helpful and accessible and felt more confident explaining the procedure. 66 participants preferred VR to current teaching methods, and 81 firmly favoured using VR for future procedures. Findings also demonstrated a positive emotional impact, with participants reporting more positive and fewer negative emotions after VR use.

CONCLUSION: Our study showed that incorporating VR into the consent process effectively improves patient understanding and experience, with widespread approval. VR improved the psychological well-being of patients undergoing surgical procedures, highlighting the potential for VR to play a significant role in enhancing consent.

PMID:40736751 | DOI:10.1007/s00345-025-05847-3

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Nevin Manimala Statistics

Variation, Overlap, and Stability in Defining Safety Net Hospitals

JAMA Netw Open. 2025 Jul 1;8(7):e2523923. doi: 10.1001/jamanetworkopen.2025.23923.

ABSTRACT

IMPORTANCE: The lack of universally accepted definitions for safety net hospitals (SNHs) has made it difficult to effectively design policies to support these hospitals and the populations they serve.

OBJECTIVE: To evaluate the overlap, variation, and consistency across different definitions for SNH status.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used a hospital year-level dataset on short-term acute care US hospitals from 2014 to 2022. Hospital-level and area-level measures were used to define SNHs. Hospital characteristics under each definition, overlap across definitions, and stability of SNH samples produced by each definition from were described. Data analyses were performed from August 2024 to June 2025.

EXPOSURE: Nine hospital-level and 4 area-level SNH definitions.

MAIN OUTCOMES AND MEASURES: Hospital characteristics under each definition, overlap across definitions, and stability of SNH samples over time. Hospital-level definitions included Medicare Disproportionate Share Hospital (DSH) index, Medicare inpatient day share, dual-eligible or low-income subsidy (DLIS) inpatient day share, Medicaid inpatient day share, Medicare Safety-Net Index, teaching status, public ownership, uncompensated care share, and operating margins. Area-level measures included Area Deprivation Index, Social Vulnerability index, proportion Hispanic population, and proportion Black population. Safety net status was assigned based on quartiles defined nationally (or within a state for Medicaid-specific definitions). For a subset of measures, this quartile-based approach was compared between the absolute number of inpatient days attributed to each patient group and the relative number (or share) of inpatient days.

RESULTS: Among 4531 short-term acute care hospitals, between 992 (21.9%) and 1326 (29.3%) were SNHs in 2022, depending on definition. SNHs defined based on the absolute level of inpatient days or absolute level of DLIS populations were often large (51% [242 of 476] or 67% [537 of 801]) and were not often rural (9% [45 of 476] or 2% [17 of 801]). Meanwhile, SNHs defined based on relative level of Medicaid inpatient days or relative level of DLIS patients were more often small (63% [298 of 476] and 82% [660 of 801]) and rural (48% [228 of 476] and 69% [555 of 801]) hospitals. The largest overlap across definitions was between a hospital’s Medicaid inpatient day share and Medicare DSH index (55% overlap [808 of 1466 hospitals]), which tended to represent large, teaching hospitals. Public ownership, teaching status, and Medicare DSH index produced the most stable definitions of SNHs over time from 2014 to 2022, with 83% (862 of 1043), 74% (1000 of 1354), and 60% (809 of 1358) of similar hospitals, respectively, meeting safety net criteria. The least stable definitions were based on low operating margins, high uncompensated care share, and high DLIS day share, with only 15% (263 of 1796), 20% (362 of 1823), and 25% (436 of 1725) of similar hospitals, respectively, meeting safety net criteria in 2014, 2018, and 2022.

CONCLUSIONS AND RELEVANCE: In this cohort study of US hospitals, different SNH definitions produced different samples, and candidate measures had variable overlap and stability over time. These findings highlight the trade-offs when considering different options to define SNHs.

PMID:40736736 | DOI:10.1001/jamanetworkopen.2025.23923

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Nevin Manimala Statistics

Stroke Center Certification and Within-Hospital Racial Disparities in Treatment

JAMA Netw Open. 2025 Jul 1;8(7):e2524027. doi: 10.1001/jamanetworkopen.2025.24027.

ABSTRACT

IMPORTANCE: Despite improvements in access to stroke technology, it remains unclear whether Black and White patients with stroke experience similar benefits after a hospital becomes stroke certified and whether stroke center expansion has changed disparities between Black and White patients over time.

OBJECTIVE: To examine the association of hospital stroke center certification with receipt of acute ischemic stroke treatments and health outcomes between Black and White patients with stroke.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study implemented a linear probability model with hospital fixed effects to evaluate changes in outcomes for Black and White patients, comparing outcomes before and after a hospital was certified as a stroke center (treatment group) relative to changes in outcomes at hospitals that did not acquire stroke certification (control group). Participants included patients with acute ischemic stroke who were covered by Medicare fee-for-service, who lived in urban communities, and who were admitted to hospitals between January 1, 2009, and December 31, 2019. Data were analyzed from September 1, 2024, to April 30, 2025.

EXPOSURE: Admission to a certified stroke center.

MAIN OUTCOMES AND MEASURES: Probability of (1) receipt of thrombolytic therapy, (2) receipt of mechanical thrombectomy, and (3) being home at 90 days and (4) 1-year mortality.

RESULTS: Among 2 109 075 million admissions of patients with stroke included in the analysis, 15.3% were Black, 84.7% were White, 56.8% were female, 15.3% were 65 to 69 years of age, 16.4% were 70 to 74 years of age, 17.7% were 75 to 79 years of age, 18.8% were 80 to 84 years of age, and 31.9% were 85 years or older. Among White patients, the probability of receiving thrombolytic therapy increased by 1.70 (95% CI, 1.19-2.21) percentage points when a hospital became a primary stroke center (PSC) and 3.76 (95% CI, 2.89-4.62) percentage points when a hospital became a thrombectomy-capable or comprehensive stroke center (TSC or CSC), relative to White patients at non-stroke-certified hospitals. Among Black patients, the probability of receiving thrombolytic therapy did not change when admitted to a new PSC or a new TSC or CSC compared with Black patients at non-stroke-certified hospitals. For thrombectomy, a new TSC or CSC was associated with an increase of 3.74 (95% CI, 3.02-4.45) percentage points for White patients and 0.97 (95% CI, 0.03-1.90) for Black patients. No improvements in being home at 90 days or in 1-year mortality were observed.

CONCLUSIONS AND RELEVANCE: In this cohort study, the likelihood of receiving stroke treatments increased for White but not Black patients within the same facility after the center was stroke certified as a PSC or a TSC or CSC. These within-hospital racial differences serve as sobering evidence that racial disparities in stroke care persist despite increased access to care.

PMID:40736735 | DOI:10.1001/jamanetworkopen.2025.24027

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Nevin Manimala Statistics

Transgender-Affirming Hormone Therapies, QT Prolongation, and Cardiac Repolarization

JAMA Netw Open. 2025 Jul 1;8(7):e2524124. doi: 10.1001/jamanetworkopen.2025.24124.

ABSTRACT

IMPORTANCE: Transgender women (assigned male at birth) usually take antiandrogens associated with estrogens (or are castrated) to induce feminization, whereas transgender men (assigned female at birth) take testosterone to induce masculinization. However, the cardiovascular outcomes of these gender-affirming hormone therapies (GAHTs) remain poorly studied.

OBJECTIVE: To examine the association between GAHT intake and cardiac repolarization alterations on electrocardiography in transgender individuals.

DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, data from a prospective cohort of adult transgender individuals from a single center in France were collected from January 1, 2021, to January 1, 2023. GAHT consisted of injectable testosterone in transgender men and transdermal estradiol with mostly oral cyproterone acetate as antiandrogens in transgender women.

MAIN OUTCOMES AND MEASURES: Electrocardiographic features, including QTc, T-wave maximal amplitude (TAmp), and QT peak (QTp; distance between Q onset and T peak), were studied. Circulating sex hormones, including total testosterone, estradiol, progesterone, and gonadotrophins, were assessed concomitantly to electrocardiographic intake.

RESULTS: In the overall cohort of 120 transgender individuals (mean [SD] age, 29.7 [11.9] years; 64 transgender men and 56 transgender women), mean (SD) QTc was similar between 35 transgender women receiving GAHT (406 [20] milliseconds) and 23 transgender men before GAHT (400 [16] milliseconds) but prolonged vs 41 transgender men receiving GAHT (378 [19] milliseconds) (P < .001) or 21 transgender women before receiving GAHT (384 [21] milliseconds) (P < .001). The start of GAHT in 15 transgender women was associated with increased QTc (mean [SD], 20 [12] milliseconds vs before receiving GAHT; P < .001) and decreased QTc in 18 transgender men (mean [SD], -17 [16] milliseconds vs before receiving GAHT; P < .001). No participant had a QTc greater than 480 milliseconds or QTc change greater than 60 milliseconds after the start of GAHT in this study. Nonlinear mixed models (eg, integrating age, calcemia, relevant circulating hormones levels, and torsadogenic drug intake) showed that QTc was associated with total testosterone in transgender men (mean [SD] estimate, -1.6 [0.6] ms/ng/mL; P = .007) and prolactin (mean [SD], 0.4 [0.1] ms/ng/mL; P < .001). In transgender women, QTc was associated with total testosterone (mean [SD] estimate, -3.5 [0.8] ms/ng/mL; P < .001). Variation of QTp and TAmp observed after the start of GAHT and associated hormonal alteration were globally associated with those observed with QTc, although in opposite directions for transgender women and transgender men.

CONCLUSIONS AND RELEVANCE: In this cohort study, testosterone use in transgender men was associated with QTc and QTp shortening and increased TAmp. Androgen deprivation in transgender women was associated with opposite observations. The magnitude of QTc sexual dimorphism seen in cisgender adults was also observed in the transgender population. This work highlights that potential GAHT effects on cardiac repolarization warrant attention in the exponentially increasing transgender population, which is often exposed to coprescribed drugs prolonging QTc and at risk of TdP.

PMID:40736733 | DOI:10.1001/jamanetworkopen.2025.24124

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Nevin Manimala Statistics

Early Cardiac Rehabilitation for Critically Ill Patients With Acute Decompensated Heart Failure: A Randomized Clinical Trial

JAMA Netw Open. 2025 Jul 1;8(7):e2524141. doi: 10.1001/jamanetworkopen.2025.24141.

ABSTRACT

IMPORTANCE: The optimal timing and approach for initiating cardiac rehabilitation (CR) in critically ill patients during the acute phase of acute decompensated heart failure (ADHF) remains uncertain.

OBJECTIVE: To evaluate the effects of CR on physical function and rehospitalization for critically ill patients with ADHF admitted to the cardiac intensive care unit (CICU).

DESIGN, SETTING, AND PARTICIPANTS: In this single-center, single-blind randomized clinical trial conducted in China, critically ill patients with severe ADHF admitted to the CICU were recruited between March 26, 2021, and September 1, 2022. All patients were followed up for 6 months, and investigators were blinded to the group assignment.

INTERVENTIONS: After short-term therapy, participants were randomized 1:1 to an early progressive and personalized CR program for patients with ADHF (AHF-CR program) that was administered exclusively during the patients’ CICU stay or to usual care.

MAIN OUTCOMES AND MEASURES: The primary outcomes were Short Physical Performance Battery (SPPB) score at hospital discharge and 6-month all-cause rehospitalization rates. These outcomes were analyzed using an intention-to-treat approach including all patients after randomization. The Perme Intensive Care Unit Mobility (PERME) score was incorporated as an exploratory outcome during analysis to assess mobility status in critically ill patients.

RESULTS: This study included 120 patients (mean [SD] age, 68.6 [12.3] years; 80 [66.7%] male). At randomization, pulmonary crackles were observed in 49 patients in the control group (81.7%) and 43 patients in the intervention group (71.7%). Additionally, 62 patients (51.7%) had an arterial partial pressure of oxygen to fraction of inspired oxygen ratio below 300 mm Hg. A total of 40 patients (33.3%) received intravenous vasoactive medications, and 87 (72.5%) received intravenous loop diuretics. The median difference in SPPB scores between groups was 1.0 (95% CI, 0-2.0; P = .16), which was not significant. Six-month rehospitalization rates were comparable between the control and intervention groups (16 [26.6%] vs 17 [28.3%]; hazard ratio, 1.00 [95% CI, 0.51-1.99]; P = .99). Exploratory analysis revealed that the intervention group had higher PERME scores, with a median between-group difference of 2.76 (95% CI, 0.77-4.74; adjusted P = .04).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of critically ill patients with ADHF, the AHF-CR program did not significantly improve SPPB scores or rehospitalization rates. However, it may offer potential physical benefits, including enhanced mobility.

TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2100050151.

PMID:40736732 | DOI:10.1001/jamanetworkopen.2025.24141

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Nevin Manimala Statistics

State E-Cigarette Flavor Restrictions and Tobacco Product Use in Youths and Adults

JAMA Netw Open. 2025 Jul 1;8(7):e2524184. doi: 10.1001/jamanetworkopen.2025.24184.

ABSTRACT

IMPORTANCE: Seven states have policies restricting the sale of flavored e-cigarettes. Limited evidence exists regarding these policies’ association with the use of tobacco products across age groups.

OBJECTIVE: To evaluate associations of e-cigarette flavor restriction policies with e-cigarette and cigarette use by age group over multiple years.

DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study, annual state-level prevalences of e-cigarette and cigarette use in the US between 2015 and 2023 were separately estimated among youths (high school age) using data from the Youth Risk Behavior Survey (YRBS) and young adults (ages 18-24 years) and adults (ages ≥25 years) using the Behavioral Risk Factor Surveillance System (BRFSS). Six policy states had multiple years of postpolicy data available; other states were control states. Associations between policy and prevalence of e-cigarette and cigarette use in each postpolicy year were estimated annually using difference-in-differences analysis, setting 2019 as the prepolicy year and 2020 to 2023 as postpolicy years.

EXPOSURE: Statewide policy restricting sales of non-tobacco flavored e-cigarettes.

MAIN OUTCOMES AND MEASURES: State annual prevalence of past 30-day (YRBS) and current (BRFSS) e-cigarette and cigarette use.

RESULTS: Prevalence data were obtained for 186 (YRBS) and 386 (BRFSS) state-years for e-cigarettes and 191 (YRBS) and 456 (BRFSS) state-years for cigarettes. In recent years, e-cigarette use prevalence decreased among youths (eg, the change in mean prevalence from 2019 to 2023 was 24.1% to 14.0% for policy states and 24.6% to 17.2% for control states) but increased in control states among young adults (eg, mean prevalence, 17.0% in 2019 to 20.4% in 2023). Cigarette use prevalence decreased in policy and control states, although policy states exhibited lower prepolicy prevalence and attenuated postpolicy decreases (eg, mean prevalence, 6.7% in 2019 to 3.8% in 2023 among young adults) relative to control states (eg, mean prevalence, 12.1% in 2019 to 6.3% in 2023 among young adults). Flavor policies were associated with reduced e-cigarette use among young adults in 2022 (average treatment effect among the treated [ATT], -6.7 percentage points; 95% CI, -1.3 to -12.1 percentage points) and adults aged 25 years or older in 2023 (ATT, -1.2 percentage points; 95% CI, -2.0 to -0.4 percentage points) and increased cigarette use among youths in 2021 (ATT, 1.8 percentage points; 95% CI, 0.7 to 2.9 percentage points) and young adults in 2021 (ATT, 3.7 percentage points; 95% CI, 2.2 to 5.2 percentage points), 2022 (ATT, 2.7 percentage points; 95% CI, 1.4 to 4.1 percentage points), and 2023 (ATT, 3.2 percentage points; 95% CI, 0.9 to 5.5 percentage points).

CONCLUSIONS AND RELEVANCE: In this study, flavor restriction policies were associated with some reductions in e-cigarette use but also unintended increases in cigarette use, highlighting a need for further work evaluating potential substitution outcomes and prevention of tobacco use among youths.

PMID:40736731 | DOI:10.1001/jamanetworkopen.2025.24184

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Nevin Manimala Statistics

Biomimetic management of orthodontic white spot lesions

J Mater Chem B. 2025 Jul 30. doi: 10.1039/d5tb00306g. Online ahead of print.

ABSTRACT

Objectives: white spot lesions (WSLs) may develop in patients with inadequate oral hygiene during orthodontic treatment. This study aimed to develop a natural remineralization agent by creating artificial WSLs in vitro. Materials/methods: WSLs were created in teeth with orthodontic buttons in vitro. The teeth were divided into the following groups: P11-4 (group 1), Nano-HA solution before sintering (group 2), Nano-HA solution after sintering (group 3), P11-4 and Nano-HA mixture before sintering (group 4), P11-4 and Nano-HA mixture after sintering (group 5), boron-containing Nano-HA mixture before sintering (group 6), boron-containing Nano-HA mixture after sintering (group 7), CPP-ACP (group 8), and artificial saliva (group 9). Measurements were taken before and after demineralization, and at the 7th, 14th, 21st, and 28th days of remineralization. Images were recorded using DIAGNOcam and VistaCamIX, area measurements were made using ImageJ, and SEM was used for remineralization assessment. Results: all groups except group 9 showed a reduction in the WSL area, with statistically significant results. SEM analysis revealed the lowest remineralization in groups 8 and 9, while the other groups exhibited more intense remineralization. Conclusions: the most successful groups for WSL remineralization were those containing pure Nano-HA (groups 2 and 3), with the other groups showing varying levels of remineralization.

PMID:40735869 | DOI:10.1039/d5tb00306g