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Nevin Manimala Statistics

Engagement in Hypertension and Diabetes Clinical Trials at Federally Qualified Health Centers: A Systematic Review

JAMA Netw Open. 2025 Apr 1;8(4):e255258. doi: 10.1001/jamanetworkopen.2025.5258.

ABSTRACT

IMPORTANCE: Federally qualified community health centers (FQHCs) are potential partners in the quest to increase diversity in clinical trials. Despite this opportunity, there is limited knowledge about FQHC engagement in clinical trials.

OBJECTIVE: To assess levels of FQHC engagement in hypertension and type 2 diabetes (T2D) clinical trials and identify FQHC characteristics associated with engagement in the US.

EVIDENCE REVIEW: Six literature databases were searched for protocols and reports of clinical trials addressing hypertension or T2D among adults at FQHCs in the US, published between January 1, 2013, and November 6, 2023. Guided by a framework on community-engaged research, 4 levels of FQHC engagement in clinical trials were defined, ranging from level 1 (FQHC informed) to level 4 (FQHC driven). An ordinal regression analysis was conducted to investigate the association between FQHC organizational and patient demographic characteristics and levels of engagement in hypertension and T2D clinical trials using the publicly available data from Uniform Data System (UDS) for all identifiable FQHCs.

FINDINGS: The initial literature search identified 4552 articles. Following deduplication, title and abstract screening, full-text review, data extraction, and matching with available information in UDS, a total of 33 clinical trials were included. Together, these clinical trials engaged 67 FQHCs. In most cases, FQHC engagement occurred at level 1 (15 clinical trials engaging 19 FQHCs) or level 2 (8 clinical trials engaging 38 FQHCs). A higher ratio of full-time equivalent physicians to patients was associated with 54% (odds ratio [OR], 1.54; 95% CI, 1.06-2.23) higher odds of having a higher level of FQHC engagement in hypertension and T2D clinical trials. A higher ratio of full-time community and patient education specialists to patients was associated with 41% (OR, 1.41; 95% CI, 1.03-1.94) higher odds of having a higher level of FQHC engagement in hypertension and T2D clinical trials.

CONCLUSIONS AND RELEVANCE: In this systematic review of FQHC engagement in clinical trials, lower levels of engagement in hypertension and T2D clinical trials were found. Further research is required to identify clinical trial design and implementation strategies that promote FQHC participation in clinical trials and research capacity building.

PMID:40232717 | DOI:10.1001/jamanetworkopen.2025.5258

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Nevin Manimala Statistics

Plastic Waste and COVID-19 Incidence Among Hospital Staff After Deescalation in PPE Use

JAMA Netw Open. 2025 Apr 1;8(4):e255264. doi: 10.1001/jamanetworkopen.2025.5264.

ABSTRACT

IMPORTANCE: In September 2023, the Singapore Ministry of Health revised the national personal protective equipment (PPE) guideline for health care personnel (HCP) attending to suspected or confirmed patients with COVID-19, recommending the use of N95 respirators alone. However, data on the associations between PPE deescalation, staff COVID-19 incidence, and sustainability outcomes are limited.

OBJECTIVE: To evaluate the associations between PPE deescalation guidelines on staff COVID-19 incidence and the environmental sustainability outcomes of the measure.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective quality improvement study of hospital PPE usage using data from Tan Tock Seng Hospital and the National Centre for Infectious Diseases (NCID), analyzing monthly COVID-19 incidence rates among HCP (all medical staff, allied health care workers, ancillary staff, and administrative staff from the hospital campus) and in the community over 12 months before and after PPE deescalation measures (October 2021 to September 2022 and October 2022 to September 2023).

MAIN OUTCOMES AND MEASURES: COVID-19 incidence rates among HCP and in the community; economic and environmental outcomes of removing single-use gowns from routine COVID-19 care, including reductions in carbon footprint, plastic waste generation, and cost savings.

RESULTS: The mean (SD) monthly number of HCP was 10 774 (79) (range, 10 636-10 891) preimplementation and 11 099 (200) (range, 10 864-11 449) postimplementation. Our analysis revealed PPE deescalation was not associated with an increase in monthly COVID-19 infections among hospital staff, with the trends aligning with population infection rates. The median (IQR) staff COVID-19 infection rate relative to the community COVID-19 infection rate was 2.6 (1.9-3.6) preimplementation compared with 1.5 (0.9-3.1) postimplementation. An estimated 4 gowns per patient-day were saved, totaling 440 532 gowns over 12 months. This equated to an estimated reduction in health care costs by SGD 453 748 (approximately USD 333 970) and reductions of 398 681.46 kg carbon dioxide equivalent in carbon emissions and 66 080 kg of plastic waste.

CONCLUSIONS AND RELEVANCE: This quality improvement study of hospital PPE usage observed that the national PPE deescalation guidelines corresponded with the reductions in protective gown use, associated costs, carbon footprint, and plastic waste generation with no apparent compromise to staff safety and health.

PMID:40232716 | DOI:10.1001/jamanetworkopen.2025.5264

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Nevin Manimala Statistics

Screening History, Stage at Diagnosis, and Mortality in Screen-Detected Breast Cancer

JAMA Netw Open. 2025 Apr 1;8(4):e255322. doi: 10.1001/jamanetworkopen.2025.5322.

ABSTRACT

IMPORTANCE: Screening mammography promotes early detection of breast cancer and is associated with reduced breast cancer mortality. Screening history prior to diagnosis may impact stage at diagnosis and breast cancer mortality but has not been comprehensively examined within a diverse US cohort.

OBJECTIVE: To determine whether having a prior screening is associated with earlier stage at breast cancer diagnosis and lower breast cancer-specific mortality.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used linked Surveillance, Epidemiology, and End Results-Medicare data of women aged at least 70 years, diagnosed with estrogen receptor-positive or human epidermal growth factor receptor 2-negative breast cancer from 2010 to 2017, and enrolled in fee-for-service Medicare Parts A and B from 5 years prior to through 1 year after diagnosis. Data were analyzed from March 1 to September 18, 2024.

EXPOSURE: Presence of 1 or more screening mammograms during the 5 years prior to the mammogram at breast cancer diagnosis.

MAIN OUTCOMES AND MEASURES: Outcomes of interest were stage of breast cancer at diagnosis, dichotomized into very early (T1N0) vs later stage (T2+ or N1+) and breast cancer-specific mortality.

RESULTS: Among 13 028 included women, most had at least 1 prior screening (10 094 women [77.5%]) and were aged between 70 and 79 years (9034 women [69.4%]) and not dual-eligible for Medicare and Medicaid (11 475 women [88.1%]). Additionally, 3812 women (29.3%) were diagnosed with later-stage disease (T2+ or N1+) at the time of diagnosis. In multivariable analyses, prior screening was associated with 54% lower odds of later-stage breast cancer diagnosis (adjusted odds ratio, 0.46; 95% CI, 0.42-0.50) and 36% lower hazard of breast cancer-specific death (adjusted hazard ratio, 0.63; 95% CI, 0.52-0.76) compared with no prior screenin. In the adjusted Cox proportional hazards model, having 3 or 4 prior screenings was associated with 37% reduced hazard of breast cancer-specific mortality compared with having 1 prior screening (adjusted hazard ratio, 0.63; 95% CI, 0.44-0.89).

CONCLUSIONS AND RELEVANCE: In this cohort study of older women with screen-detected estrogen receptor-positive or human epidermal growth factor receptor 2-negative breast cancer, prior screening mammography was associated with earlier stage at breast cancer diagnosis and lower breast cancer mortality. These findings support the potential for routine screening to improve breast cancer outcomes. As with all observational studies, this study is limited by the potential effects of other differences between the screening and nonscreening groups.

PMID:40232715 | DOI:10.1001/jamanetworkopen.2025.5322

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Nevin Manimala Statistics

Optimal visual search with highly heuristic decision rules

J Vis. 2025 Apr 1;25(4):5. doi: 10.1167/jov.25.4.5.

ABSTRACT

Visual search is a fundamental natural task for humans and other animals. We investigated the decision processes that humans use in covert (single fixation) search with briefly presented displays having well-separated potential target locations. Performance was compared with the Bayesian-optimal decision process under the assumption that the information from the different potential target locations is statistically independent. Surprisingly, humans performed slightly better than optimal, despite humans’ substantial loss of sensitivity in the fovea (“foveal neglect”) and the implausibility of the human brain replicating the optimal computations. We show that three factors can quantitatively explain these seemingly paradoxical results. Most importantly, simple and fixed heuristic decision rules reach near optimal search performance. Second, foveal neglect primarily affects only the central potential target location. Finally, spatially correlated neural noise can cause search performance to exceed that predicted for independent noise. These findings have broad implications for understanding visual search tasks and other identification tasks in humans and other animals.

PMID:40232706 | DOI:10.1167/jov.25.4.5

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Nevin Manimala Statistics

Measurement Invariance of the Conjoint Community Resiliency Assessment Measure-10 in South Korea

J Community Psychol. 2025 Mar;53(3):e70008. doi: 10.1002/jcop.70008.

ABSTRACT

Interest in resilience at both the individual and group levels is increasing in response to disasters. The Conjoint Community Resiliency Assessment Measure-10 (CCRAM10), actively utilized in disaster-related research, is a shortened 10-item scale developed to measure community resilience. This study aims to explore the factor structure of CCRAM10 and to verify its measurement invariance. Data were collected from 1200 Korean adults, and factor analysis along with measurement invariance for gender and age groups was conducted. The analysis indicated that, like the original scale, CCRAM10 appropriately consists of five subfactors and has secured measurement invariance, confirming its usefulness for community resilience research.

PMID:40232685 | DOI:10.1002/jcop.70008

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Nevin Manimala Statistics

Overlap of ‘disorders of gut-brain interaction’ and their impact on quality of life and somatization in a tertiary care center- A cross-sectional study

Indian J Gastroenterol. 2025 Apr 15. doi: 10.1007/s12664-025-01770-y. Online ahead of print.

ABSTRACT

BACKGROUND: Disorders of gut-brain interaction (DGBIs) constitute a global health challenge. Overlapping DGBIs amplify the clinical severity and have a profound impact on health-related quality of life (HRQoL) and somatization. Data on the prevalence and overlap of all individual DGBIs and their clinical ramifications remains limited. This study sought to elucidate these aspects within a northern Indian tertiary healthcare setting.

METHODS: This prospective cross-sectional study enrolled patients meeting Rome IV criteria for DGBIs and healthy controls (HC). Participants underwent elaborative assessments, including socio-demographic profiling, HRQoL evaluation (PROMIS Global-10) and somatization quantification (PHQ-12). Statistical analyses compared prevalence rates, overlap patterns and associated clinical outcomes between various groups.

RESULTS: Of the 2538 patients screened, 1044 (41.1%) with DGBIs (age 41.7 ± 12.6 years, 51.9% males) were enrolled; along with 1021 age and gender-matched HCs. Most common gastrointestinal region involved was gastroduodenal (49.9%), followed by bowel (39.7%) and esophageal (33.3%). Most common DGBIs were functional dyspepsia (FD; 44.4%), functional esophageal disorders (FEsD;32.4%), functional constipation (FC;18%), irritable bowel syndrome (IBS;16.1%). Overlapping DGBIs were present in 40.3% patients, with FD-FEsD (23.9%) and FD-FC(22.1%) and FD-IBS (52;12.4%) overlaps being the most common. Compared to HC, DGBI patients had significantly poorer HRQoL scores (19.1 ± 0.7 vs. 13.52 ± 3.39; p < 0.001) and significantly increased somatization scores (2.5 ± 1.7 vs. 18.5 ± 0.7; p < 0.001). Further, patients with overlapping DGBIs had significantly poorer HRQoL and significantly increased somatization scores compared to non-overlapping counterparts.

CONCLUSIONS: This study provides novel data on the clinical burden and the entire spectrum of overlapping and non-overlapping DGBIs, while studying their impact on HRQoL and somatization. DGBI patients had significantly poorer HRQoL and heightened somatization compared to HCs; with further detriments observed in those with overlapping DGBIs. These findings emphasize the need for an integrated multidisciplinary approach for the evaluation of possible overlaps and for assessment of HRQoL in all patients with DGBIs to improve clinical outcomes.

PMID:40232666 | DOI:10.1007/s12664-025-01770-y

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Nevin Manimala Statistics

Effects of SGLT2 inhibitors on health-related quality of life and functional capacity in patients with heart failure with and without diabetes: a meta-analysis of randomized controlled trials

Int J Clin Pharm. 2025 Apr 15. doi: 10.1007/s11096-025-01908-0. Online ahead of print.

ABSTRACT

BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce major cardiovascular events among individuals with heart failure regardless the ejection fraction. The effect of SGLT2 inhibitors on health-related quality of life (HRQoL) and physical capacity are still unclear.

AIM: To investigate the effects of SGLT2 inhibitors on HRQoL and physical capacity in patients with heart failure.

METHOD: We systematically searched PubMed, Embase, and Cochrane Central databases for randomized controlled trials (RCTs) comparing SGLT2 inhibitors to placebo in this population. The outcomes analyzed were mean changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) score and its domains: total symptoms score (TSS), physical limitations score (PLS), clinical summary score (CSS) and overall summary score (OSS), as well as the six-minute walk test (6MWT) and peak oxygen uptake (peak VO2).

RESULTS: Eighteen RCTs with 23,848 participants were included. There was a statistical significant improvement in KCCQ TSS (MD: 3.33; 95% CI 1.84 to 4.81; p < 0.001) in HFrEF, HFpEF and non-diabetic subgroups. Consistent findings were found in KCCQ PLS, KCCQ CSS, and KCCQ OSS. The distance covered in the 6MWT was significant higher (MD: 12.8; 95% CI 1.06 to 24.54; p = 0.03) and peak VO2 was increased (MD: 1.06; 95% CI 0.57 to 1.55; p < 0.001).

CONCLUSION: SGLT2 inhibitors improve HRQoL and functional capacity in patients with HF regardless the ejection fraction and co-diagnosis of diabetes.

PMID:40232664 | DOI:10.1007/s11096-025-01908-0

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Nevin Manimala Statistics

Statistics of Primary Malignant Spine Tumors in Japan: A Retrospective Study Using the Bone and Soft Tissue Tumor Registry in Japan

Spine (Phila Pa 1976). 2025 Apr 15. doi: 10.1097/BRS.0000000000005361. Online ahead of print.

ABSTRACT

STUDY DESIGN: A retrospective registry-based study.

OBJECTIVE: To elucidate the nationwide epidemiology, treatment patterns, and prognosis of primary malignant spine tumors (PMST) using the Japanese Orthopaedic Association’s Bone and Soft Tissue Tumor (BSTT) Registry.

SUMMARY OF BACKGROUND DATA: PMSTs are rare, comprising a small proportion of primary malignant bone tumors. The surrounding anatomical structures make complete resection challenging, leading to poor prognoses. Studies using the Surveillance, Epidemiology, and End Results database have provided valuable epidemiological insights; however, limitations in the granularity and diversity of histological subtypes persist, leaving detailed knowledge of PMSTs insufficiently clarified.

METHODS: We analyzed 288 PMST cases from the BSTT Registry (2006-2019), evaluating patient demographics, tumor characteristics, treatment details, and prognostic outcomes. Kaplan-Meier methods estimated disease-specific survival (DSS), and Cox proportional hazards models identified prognostic factors.

RESULTS: PMSTs accounted for 3.3% of primary malignant bone tumors. Common histological subtypes included osteosarcoma (21.9%), chondrosarcoma (16.3%), chordoma (13.9%), and undifferentiated pleomorphic sarcoma (13.9%). Surgery was performed in 46.2% of cases, with intralesional margins in 54.1%. Chemotherapy and radiotherapy were administered in 42.0% and 54.9% of cases, respectively. The 5-year DSS was 47.5%. Adjusted analysis revealed favorable prognoses for chondrosarcoma (hazard ratio [HR]: 0.23, 95% confidence interval [CI]: 0.06-0.87, P=0.031), chordoma (HR: 0.27, 95% CI: 0.09-0.84, P=0.024), and Ewing sarcoma (HR: 0.42, 95% CI: 0.18-0.98, P=0.044) compared to osteosarcoma. Adults (40-64 years) had better outcomes than the elderly (≥65 years; HR: 0.43, 95% CI: 0.24-0.76, P=0.015). Advanced TNM stage (IVA + IVB) was an adverse prognostic factor (HR: 7.60, 95% CI: 1.85-31.18, P=0.005).

CONCLUSIONS: PMSTs are rare and present diverse histological subtypes with poor prognoses. This study emphasizes the need for further investigations to optimize PMST management and improve prognoses.

LEVEL OF EVIDENCE: 2b.

PMID:40231408 | DOI:10.1097/BRS.0000000000005361

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Nevin Manimala Statistics

Addressing the stiffness-toughness conflict in hybrid double-network hydrogels through a design of experiments approach

Soft Matter. 2025 Apr 15. doi: 10.1039/d4sm01470g. Online ahead of print.

ABSTRACT

An open challenge in soft matter science is the ability to create hydrogels that are soft but also have high fracture energy. A possible solution to this stiffness-toughness conflict has arisen through a class of material known as hybrid double-network hydrogels, which combine two polymeric networks with diametrically opposed chain stiffness and with both covalent and physical crosslinking. The vast parameter space inherent to such a system means it is difficult to identify the precise compositional parameters that lead to both high toughness and low stiffness. In this work, we address this challenge through a design of experiments (DoE) framework used to establish the statistical relationship between factors and mechanical properties of a hybrid double-network hydrogel. The crosslinking density of the networks is noted to play a prominent role in determining the stiffness of the hydrogel, while the network characteristics of the ductile network determine the toughness of the hydrogel. We also report that contrary to observations in current literature, it is possible to toughen the hydrogel without stiffening it. Therefore, the present experimentation and optimization exercise provides a hands-on guide for the use of DoE to determine the conditions for optimised mechanical properties of thin hybrid double-network hydrogels for various applications.

PMID:40231401 | DOI:10.1039/d4sm01470g

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Nevin Manimala Statistics

Changes in the Alignment of the Spine and Lower Limb in Children With Achondroplasia Treated With Vosoritide: A Single-center, 1-year Follow-up Prospective Study

J Pediatr Orthop. 2025 Apr 15. doi: 10.1097/BPO.0000000000002980. Online ahead of print.

ABSTRACT

BACKGROUND: Achondroplasia (ACH) is the most common skeletal dysplasia and is characterized by a short-limbed short stature, sagittal spinal malalignment, and genu varum. Vosoritide promotes longitudinal bone growth in children with ACH; however, its effects on various disease-specific complications, other than short stature, are unknown. This study aimed to investigate the therapeutic effects of vosoritide on spinal and lower limb malalignment in children with ACH.

METHODS: This single-center, open-label, prospective study included patients with ACH aged younger than or equal to 15 years who received vosoritide treatment and had a minimum follow-up period of 1 year. To evaluate alignment after vosoritide treatment, radiologic parameters were measured from sagittal radiographs of the spine and anteroposterior radiographs of the bilateral lower limbs before the administration of vosoritide and 12 months after treatment. Paired t tests were used to compare parameters before and after vosoritide treatment.

RESULTS: Seventeen patients (mean age, 7.6±2.7 y) were included. After 1-year treatment of vosoritide, the mean height increased by 5.4±1.3 cm. Changes in spinal alignment after 1 year of vosoritide treatment were 1.5 degrees for cervical lordosis, -1.3 degrees for thoracic kyphosis, -2.8 degrees for thoracolumbar kyphosis, -5.2 degrees for lumbar lordosis (LL), -2.2 degrees for pelvic tilt, -2.6 degrees for pelvic incidence, -0.4 degrees for sacral slope, and 2.6 mm for C7 sagittal vertical axis. Alignment changes in the lower limbs were -3.4 degrees for mechanical axis angle (MAA), 1.7 degrees for mechanical lateral proximal femoral angle (mLPFA), -2.8 degrees for mechanical lateral distal femoral angle (mLDFA), -0.2 degrees for medial proximal tibial angle, and -0.5 degrees for lateral distal tibial angle. The LL, MAA, mLPFA, and mLDFA levels showed statistically significant changes towards the normal range after treatment.

CONCLUSIONS: One-year treatment of vosoritide decreased the exaggerated LL and improved genu varum deformity in children with ACH. Vosoritide therapy may not only increase longitudinal bone growth but also improve spinal and lower limb malalignment in children with ACH.

LEVEL OF EVIDENCE: Level II: prospective comparative study.

PMID:40231376 | DOI:10.1097/BPO.0000000000002980