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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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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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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

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Validation of the Fitbit Charge 5 for the Detection of Heart Rate and Electrodermal Activity

Psychophysiology. 2025 Aug;62(8):e70116. doi: 10.1111/psyp.70116.

ABSTRACT

Wearable devices are increasingly used to evaluate psychophysiological markers of anxiety for continuous health monitoring. Consumer-grade wearable devices, such as Fitbits, have the potential for widespread use and dissemination given their affordability and accessibility for both research and clinical settings. However, the validation of consumer-grade devices against research-grade devices is required. This study aimed to evaluate and compare the accuracy of the Fitbit Charge 5 against a research-grade wearable device, the Equivital EQ02, in measuring psychophysiological parameters of anxiety, specifically heart rate (HR) and electrodermal activity (EDA). Fifty-five undergraduate students (Mage = 19.4, SDage = 1.6, 46% female) wore both Fitbit and Equivital devices whilst completing social stressor and reading tasks. Statistical analyses demonstrated significant moderate correlations between the two devices for heart rate (HR) estimates (rs = 0.45-0.58) and low to moderate correlations for electrodermal activity (EDA) estimates (rs = 0.42-0.50). Intraclass correlations were moderate for both HR (ICCs = 0.53-0.72) and EDA (ICCs = 0.46-0.64) across conditions (ps < 0.05). Furthermore, Bland-Altman analyses revealed that the Fitbit showed a pattern of underestimation of HR (ranging from 24 to 32 bpm) and overestimation of EDA (ranging from -12.92 to 10.29 μS) compared to the Equivital. These findings highlight potential reliability concerns with the Fitbit Charge 5 in measuring physiological data. While the device may have some utility in assessing HR and EDA, it is crucial to approach the interpretation of data from consumer-grade wearable devices with caution due to potential accuracy limitations.

PMID:40735859 | DOI:10.1111/psyp.70116

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Data Resource Profile: EULAT Eradicate GBC: the European-Latin American Research Consortium towards Eradication of Preventable Gallbladder Cancer

Int J Epidemiol. 2025 Jun 11;54(4):dyaf127. doi: 10.1093/ije/dyaf127.

NO ABSTRACT

PMID:40735836 | DOI:10.1093/ije/dyaf127

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Disease outcomes following lateral switch among different CD20-antibodies in active multiple sclerosis

Mult Scler. 2025 Jul 30:13524585251361330. doi: 10.1177/13524585251361330. Online ahead of print.

ABSTRACT

BACKGROUND: Ocrelizumab (OCR) and ofatumumab (OFA)are approved and their differences in dosing route and interval allow personalized treatment. However, there are no data on whether lateral switches between both substances affect treatment effectiveness or safety.

METHODS: We screened our local cohort of MS patients, who began OCR since 09/2020 or OFA since 09/2021. Patients with a lateral switch were matched to controls who continuously received initial B-cell depleting therapy (BCT). We compared disease courses including effectiveness outcomes as well as peripheral CD19+ B-cell counts and serum IgG levels.

RESULTS: From 09/2020 to 03/2024, 713 patients were subjected to BCT (OCR: 396; OFA: 317 [as in Fig.1]). The matched OCR cohort included 38 switchers and 149 controls. The OFA cohort consisted of 24 switchers and 83 controls. Effectiveness outcomes were comparable among switchers and controls. B cell depletion appeared slightly pronounced following a switch. Serum IgG levels declined faster among switchers compared to controls (OCR: 9.7 vs 9.0 g/L; p = 0.007; manifest hypogammaglobulinemia (HGG) in 13.2% vs 6.0%; OFA: 9.7 vs 8.4 g/L; p = 0.016; manifest HGG in 8.3% vs 2.4%).

CONCLUSIONS: Lateral switching between BCT does not abate effectiveness in this matched real-world cohort. Our observation of increased loss of IgG warrants further validation, but may indicate niche-specific immunological effects of OFA and OCR.

PMID:40735835 | DOI:10.1177/13524585251361330

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Lifestyle Behaviours and Future Healthcare Utilisation for Musculoskeletal Pain in Young Adults: A Cohort Study of Norwegian University Students With Three-Year Follow-Up

Eur J Pain. 2025 Sep;29(8):e70087. doi: 10.1002/ejp.70087.

ABSTRACT

BACKGROUND: It is unclear whether lifestyle behaviours influence use of healthcare for musculoskeletal pain in young adults. This study examined if lifestyle behaviours among college/university students were associated with future healthcare utilisation for musculoskeletal pain.

METHODS: Data from the Students’ Health and Wellbeing Study (SHoT2018) were linked with the Norwegian Registry for Primary Health Care, comprising 31,358 college/university students. We analysed associations of physical activity level, sleep duration, alcohol consumption, smoking, illicit drug use and cumulative adverse lifestyle behaviours with healthcare utilisation for musculoskeletal pain over the following three years, including ‘any use’, ‘high use’ and for back and neck pain specifically.

RESULTS: High physical activity levels, compared to recommended levels, were associated with a higher risk of ‘any’ healthcare utilisation for musculoskeletal pain (females: RR 1.14, 99% CI [1.04-1.25]; males: RR 1.20, 99% CI [1.07-1.36]); below recommended physical activity levels were associated with a lower risk (females: RR 0.90, 99% CI [0.85-0.96]; males: RR 0.84, 99% CI [0.76-0.93]). Illicit drug use was associated with a lower risk of healthcare utilisation for neck pain in females (RR 0.77, 99% CI [0.62-0.97]). Four or more adverse lifestyle behaviours, compared to ≤ 1, were associated with a lower risk of high healthcare utilisation for musculoskeletal pain (females: RR 0.66, 99% CI [0.48-0.90]; males: RR 0.68, 99% CI [0.48-0.97]) and a lower risk of healthcare utilisation for neck pain in females (RR 0.63, 99% CI [0.41-0.97]).

CONCLUSIONS: Associations between college/university students’ lifestyle behaviours and healthcare utilisation for musculoskeletal pain were identified, but with some unexpected patterns. Future research should explore long-term effects of these behaviours on healthcare utilisation for musculoskeletal pain.

SIGNIFICANCE: High levels of physical activity among college and university students were associated with a greater risk of seeking healthcare for musculoskeletal pain within the following three years. Illicit drug use was associated with a lower risk of seeking healthcare for neck pain in females. Surprisingly, the presence of many adverse lifestyle behaviours appeared to be associated with a lower risk of healthcare utilisation for musculoskeletal pain, particularly healthcare contacts for neck pain in females and repeated healthcare contacts for musculoskeletal pain in general.

PMID:40735830 | DOI:10.1002/ejp.70087