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Nevin Manimala Statistics

Effectiveness and Implementation Outcomes of an mHealth App Aimed at Promoting Physical Activity and Improving Psychological Distress in the Workplace Setting: Cluster-Level Nonrandomized Controlled Trial

JMIR Mhealth Uhealth. 2025 May 6;13:e70473. doi: 10.2196/70473.

ABSTRACT

BACKGROUND: Encouraging physical activity improves mental health and is recommended in workplace mental health guidelines. Although mobile health (mHealth) interventions are promising for physical activity promotion, their impact on mental health outcomes is inconsistent. Furthermore, poor user retention rates of mHealth apps pose a major challenge.

OBJECTIVE: This study aimed to examine the effectiveness and implementation outcomes of the smartphone app ASHARE in Japanese workplace settings, leveraging a deep learning model to monitor depression and anxiety through physical activity.

METHODS: This hybrid effectiveness-implementation trial was a 3-month nonrandomized controlled trial conducted from October 2023 to September 2024. Work units and employees were recruited and allocated to the intervention or active control group based on preference. The intervention group installed the ASHARE app, whereas the control group participated in an existing multicomponent workplace program promoting physical activity. Changes in physical activity and psychological distress levels were compared between the groups. User retention rates, participation rates, acceptability, appropriateness, feasibility, satisfaction, and potential harm were also assessed.

RESULTS: A total of 84 employees from 7 work units participated (67 from 5 units in the intervention group and 17 from 2 units in the control group). In total, 78 employees completed the 3-month follow-up survey (follow-up rate: 93%). Both groups showed increased physical activity, and the intervention group showed reduced psychological distress; however, the differences between groups were not statistically significant (P=.20; P=.36). In a sensitivity analysis of protocol-compliant employees (n=21), psychological distress levels were significantly reduced in the intervention group compared with the control group (coefficient=-3.68, SE 1.65; P=.03). The app’s 3-month user retention rate was 20% (12/61), which was lower than the participation rate in each component of the control programs. Implementation outcomes evaluated by employees were less favorable in the intervention group than in the control group, whereas health promotion managers found them to be similar.

CONCLUSIONS: The ASHARE app did not show superior effectiveness compared with an existing multicomponent workplace program for promoting physical activity. An implementation gap may exist between health promotion managers and employees, possibly contributing to the app’s low user retention rate. Future research should focus on examining the effectiveness of strategies to get engagement from managers and from segments of employees with favorable responses in the workplace at an early stage.

PMID:40327360 | DOI:10.2196/70473

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Nevin Manimala Statistics

Casting vs Surgical Treatment of Children With Medial Epicondyle Fractures: A Randomized Clinical Trial

JAMA Netw Open. 2025 May 1;8(5):e258479. doi: 10.1001/jamanetworkopen.2025.8479.

ABSTRACT

IMPORTANCE: Displaced pediatric medial humeral epicondyle fractures are traditionally treated nonoperatively with casting. However, the use of surgical treatment has increased despite limited high-level evidence supporting its benefits.

OBJECTIVE: To determine whether open surgical reduction and internal fixation improve functional outcomes compared with long arm casting in children with displaced medial humeral epicondyle fractures at 12 months post injury.

DESIGN, SETTING, AND PARTICIPANTS: This noninferiority randomized clinical trial was conducted in 4 university hospitals in Finland between August 30, 2019, and August 22, 2023, with a 12-month follow-up completed August 20, 2024. Participants included children (aged 7-16 years) with nonincarcerated medial humeral epicondyle fractures and more than 2 mm of displacement. Data analysis was based on intention to treat.

INTERVENTIONS: Open reduction and fixation, followed by a long arm cast for 4 weeks, or long arm cast without reduction for 4 weeks.

MAIN OUTCOME AND MEASURE: The primary outcome was the Quick Disabilities of the Arm, Shoulder, and Hand (QDASH) score at 12 months (range, 0-100 points, with 0 denoting no disability and 100 extreme disability; prespecified noninferiority margin was 6.8 points).

RESULTS: Seventy-two patients were randomized (43 [59.7%] female; mean [SD] age, 12.1 [2.1] years; range, 7.9-15.9 years), with 37 (19 [51.4%] female) to the surgery group (mean [SD] age, 12.2 [2.3] years; range, 7.9-15.9 years) and 35 (24 [68.6%] female) to the cast group (mean [SD] age, 11.9 [2.0] years; range 7.9-15.9 years). At 12 months, the mean QDASH score was 1.73 (95% CI, 0.65-2.81) in the surgery group and 2.71 (95% CI, 0.52-4.90) in the cast group, showing noninferiority (mean difference, -0.98 [95% CI, -2.95 to 0.98] points). The cosmetic visual analog scale favored the cast group, with a statistically significant between-group difference of -8.9 points (95% CI, -16.6 to -1.2 points; P < .001). Nonunion occurred in 1 of 37 surgically treated patients (2.7%) and 24 of 35 cast-treated patients (68.6%). No crossovers from casting to surgery occurred.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of displaced medial epicondyle fractures, treatment with casting alone was noninferior at 12 months to surgical reduction and internal fixation followed by casting. Findings support nonoperative care as effective at 1 year; longer-term outcomes remain to be studied.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04531085.

PMID:40327343 | DOI:10.1001/jamanetworkopen.2025.8479

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Nevin Manimala Statistics

Combined sedentarism and high-fat diet induce early signs of kidney injury in C57BL/6J mice

Am J Physiol Renal Physiol. 2025 May 6. doi: 10.1152/ajprenal.00259.2024. Online ahead of print.

ABSTRACT

Chronic kidney disease (CKD) is a progressive disorder marked by a decline in kidney function. Obesity and sedentary behavior contribute to the development of CKD, though mechanisms by which this occurs are poorly understood. This knowledge gap is worsened by the lack of a reliable murine CKD model that does not rely on injury, toxin, or gene deletion to induce a reduction in kidney function. High-fat diet (HFD) feeding alone is insufficient to cause reduced kidney function until later in life. Here, we employed a small mouse cage (SMC), a recently developed mouse model of sedentariness, to study its effect on kidney function. Wildtype C57BL/6J male mice were housed in sham or SMC housing for six months with HFD in room (22°C) or thermoneutral (30°C) conditions. Despite hyperinsulinemia induced by the SMC+HFD intervention, kidneys from these mice displayed normal glomerular filtration rate (GFR). However, the kidneys showed early signs of kidney injury, including increases in Col1a1 and NGAL transcripts, as well as fibrosis by histology, primarily in the inner medullary/papilla region. High-resolution respirometry and fluorometry experiments showed no statistically significant changes in the capacities for respiration, ATP synthesis, or electron leak. These data confirm the technical challenge in modeling human CKD. They further support the notion that obesity and a sedentary lifestyle make the kidneys more vulnerable, but additional insults are likely required for the pathogenesis of CKD.

PMID:40327334 | DOI:10.1152/ajprenal.00259.2024

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Manifestations of Anti-Black Racism and Worry About Pregnancy and Birthing While Black: A Cross-sectional Secondary Analysis of Giving Voice to Mothers

J Racial Ethn Health Disparities. 2025 May 6. doi: 10.1007/s40615-025-02461-2. Online ahead of print.

ABSTRACT

INTRODUCTION: Pregnancy and childbirth traditionally bring worry or a sense of anxiety and distress, particularly among Black women that face historical and contemporary anti-Black racism. We employed two frameworks to assess manifestations of anti-Black racism, structural racism and obstetric racism, as predictors of worry about pregnancy and birth within the Black reproducing community.

METHODS: In a secondary cross-sectional analysis, we analyzed data from Black women in the Giving Voice to Mothers study who completed all relevant items (n = 260). We conducted descriptive analyses and logistic regression models to explore how worry about pregnancy and birth for the Black reproducing community varies with experiences of obstetric racism and different manifestations of structural racism.

RESULTS: Approximately 71% of the sample worried about pregnancy and birth for themselves and their community. Black women who experienced obstetric racism were statistically significantly more likely to be worried about pregnancy and birth experiences compared to Black women who did not. Furthermore, when structural racism was manifested and measured as hidden resources, among Black women reporting fewer pregnancy and birthing care options for women of color, those who experienced obstetric racism during care were 15.6 times more likely to worry about pregnancy and birthing experiences than those who did not (OR 15.667; 95% CI 1.348-182.058).

CONCLUSION: The findings demonstrate the complexity of racialized harm enacted against Black women during the perinatal period and underscore the ways in which obstetric racism and contexts of structural racism powerfully shape the meaning and subsequent emotional impact of pregnancy and birthing while Black.

PMID:40327291 | DOI:10.1007/s40615-025-02461-2

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One-Year Efficacy of Guselkumab Versus Advanced Therapies for the Treatment of Moderately to Severely Active Crohn’s Disease: A Network Meta-Analysis

Adv Ther. 2025 May 6. doi: 10.1007/s12325-025-03183-x. Online ahead of print.

ABSTRACT

INTRODUCTION: This study used network meta-analysis (NMA) to evaluate the comparative efficacy of available advanced therapies for moderately to severely active Crohn’s disease (CD) versus the IL-23 inhibitor guselkumab.

METHODS: A systematic literature review was conducted to identify randomized controlled trials (RCTs) of advanced therapies in moderately to severely active CD. Bayesian NMAs were conducted for outcomes of clinical response, clinical remission, endoscopic response, and a combined outcome of clinical remission with endoscopic response, at the end of the maintenance phase (up to 1 year). Primary analyses included patients with varied prior inadequate treatment responses, with additional analyses conducted for specific subgroups. Re-randomized trials were normalized in several cases to mimic a standard treat-through design, incorporating data from additional sources, when necessary, for patients who had an inadequate response or experienced a delayed response following induction.

RESULTS: Of the 58 RCTs identified, 13 with maintenance endpoint data were ultimately included in the NMAs. Guselkumab 100 mg and 200 mg were more likely to be effective versus several comparators. Guselkumab 200 mg demonstrated significantly greater efficacy versus infliximab 10 mg/kg every 8 weeks and upadacitinib 30 mg daily for clinical response and clinical remission. For endoscopic response, guselkumab 200 mg showed significantly greater efficacy than ustekinumab, adalimumab, and upadacitinib. Significance was also noted versus ustekinumab on the combined outcome of clinical remission with endoscopic response. Similarly, guselkumab 100 mg demonstrated efficacy versus comparators across analyses. Guselkumab achieved higher rankings based on surface under the cumulative ranking curve. Findings of primary analyses within mixed populations were generally corroborated by subpopulation analyses.

CONCLUSION: Results of this NMA in moderately to severely active CD indicate a higher likelihood of guselkumab achieving each clinical and endoscopic endpoint analyzed at the end of the maintenance phase versus other advanced therapies assessed.

PMID:40327280 | DOI:10.1007/s12325-025-03183-x

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Performance of Adherence Measures for Oral, Tenofovir-Based HIV Pre-Exposure Prophylaxis: A Systematic Review

AIDS Behav. 2025 May 6. doi: 10.1007/s10461-025-04741-8. Online ahead of print.

ABSTRACT

Accurate adherence measures to HIV pre-exposure prophylaxis (PrEP) are essential for identifying individuals with low adherence and providing tailored support. This systematic review summarizes evidence on the performance of PrEP indirect adherence measures and explores their potential use in clinical practice. Following a registered protocol (PROSPERO: CRD42020144733) we searched PubMed, Embase, LILACS and Web of Science until December 2024. We included studies that assessed PrEP adherence among individuals using daily oral PrEP with tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC). The reference standard involved quantifying PrEP in dried blood spots or plasma, and index tests included self-reported adherence, pill counts, pharmacy records, electronic monitoring, or composite measures. We used QUADAS-2 to assess the risk of bias and applicability concerns. Twenty-three studies, which included 6649 individuals, fulfilled the inclusion criteria. Most were observational studies (n = 17, 73.9%), and the most common measure was self-report (n = 18, 78.3%). The performance of indirect measures was reported through accuracy statistics in 12 studies (52.2%), concordance in two (8.7%), correlation in eight (34.8%), and proportions in one (4.3%). The risk of bias and applicability concerns were generally low or unclear due to unclear reporting. This review underscores the wide heterogeneity of indirect measures used to assess PrEP adherence, with self-reports being the most frequently utilized. Despite some correlation with direct measures, these methods showed mixed evidence of accuracy, with studies reporting moderate discriminatory capacity for identifying high protective levels of TFV-DP. This finding limits the broader applicability of the measures and underscores the need for further research.

PMID:40327271 | DOI:10.1007/s10461-025-04741-8

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Trainee Awareness of US Preventive Services Task Force (USPSTF) Colorectal Cancer Screening Guidelines

J Cancer Educ. 2025 May 6. doi: 10.1007/s13187-025-02638-7. Online ahead of print.

ABSTRACT

In 2021, the US Preventive Services Task Force (USPSTF) issued a final recommendation to lower the initial age for colorectal cancer (CRC) screening to 451. At many institutions, trainees play a critical role in the implementation of CRC screening guidelines. The aim of the current study is to assess trainee awareness of recent changes to CRC screening guidelines. Trainees in surgical and non-surgical residency and fellowship programs at a single academic medical center were surveyed, in February of 2023, regarding awareness of recent changes to CRC screening guidelines. Additional information regarding trainee recommendations for various types of screening modalities and their perceptions of patient awareness was obtained. A total of 116 trainees responded to the survey, reflecting a 39% response rate. Of trainees recommending CRC screening, 75% recommended screening to be initiated at age 45, 13% at age 50, 6% at age 40, and 2% at age greater than 50. Trainee knowledge of screening guidelines came from medical school learning (70.7%) and USPSTF guidelines (82%). The most recommended screening modalities were colonoscopy (87%), fecal immunochemical testing (FIT) (31%), and fecal occult blood testing (FOBT) (15%). In comparing trainees who perform colonoscopies versus trainees from primary care specialties, there was no statistical difference between groups regarding knowledge on current screening guideline recommendations. Most trainees recommended CRC screening during their training. Unfortunately, many trainees were unaware of recent changes to CRC screening guidelines. These results revealed an important knowledge gap to be addressed among surgical and non-surgical trainees.

PMID:40327250 | DOI:10.1007/s13187-025-02638-7

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Oral GnRH antagonists for ovulation suppression during ovarian stimulation protocols: systemic review and meta-analysis

J Assist Reprod Genet. 2025 May 6. doi: 10.1007/s10815-025-03496-4. Online ahead of print.

ABSTRACT

PURPOSE: The impact of oral GnRH antagonists on IVF treatment outcomes remains unclear. The aim of the study is to investigate the impact of GnRH antagonist over the outcomes of IVF.

METHODS: We performed an electronic search using MEDLINE® with the OvidSP interface PUBMED, Embase, Web of Science, and Cochrane Library up to December 16, 2024. We included experimental and non-experimental studies, assessing the role of oral GnRH during controlled ovarian stimulation protocols. Our main outcomes were cycle cancelation rate and mean number of mature oocytes retrieved at oocyte pickup (OPU) day.

RESULTS: We included four studies comprising 813 patients, of whom 452 women received oral GnRH antagonists and 294 received injectable subcutaneous GnRH antagonists. No statistical differences were noted in the meta-analysis between each outcome measured (cycle cancelation, mean overall and mature oocytes, fertilization rate, and blastulation rate). Using the GRADE criteria, the overall quality of the existing evidence was determined as moderate.

CONCLUSIONS: This is the first systemic review and meta-analysis to examine the usage of oral GnRH antagonists for ovulation suppression during IVF treatments. Our findings suggest the use of oral GnRH antagonists may be beneficial in infertility treatments; however, caution should be taken, as robust establishment of their effectivity and safety in clinical practice is still pending.

TRIAL REGISTRATION: Registration Number: PROSPERO study ID: CRD42024599730.

PMID:40327246 | DOI:10.1007/s10815-025-03496-4

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Nevin Manimala Statistics

Improved quality of life in cystic fibrosis patients observed up to 36 months after starting Elexacaftor/Tezacaftor/Ivacaftor treatment

J Patient Rep Outcomes. 2025 May 6;9(1):48. doi: 10.1186/s41687-025-00879-0.

ABSTRACT

BACKGROUND: Elexacaftor/Tezacaftor/Ivacaftor (ETI) is a therapy approved for cystic fibrosis (CF) that has given improved clinical outcomes in patients carrying the F508del mutation. There are few published data regarding ETI’s effects on patients’ quality of life (QoL). This study aims to (fill the data gap in current literature by assessing) evaluate the long-term effects of ETI on QoL.

METHODOLOGY: A prospective observational study was conducted with thirty-seven severe patients that received ETI for compassionate use (group A), 184 received it for on-label use (group B). All carried one F508del mutation. Patients were assessed using the CFQ-R (Cystic Fibrosis Questionnaire-Revised). The evaluation time-points were pre-treatment (T0), and after 12 (T1) and 24 months (T2); group A was also assessed after 36 months (T3). Twenty-five patients completed 3 years of treatment and 65 patients completed 2 years of treatment, in groups A and B respectively.

RESULTS: At T1, median values for almost all areas of CFQ-R statistically significant increased in group A, particularly Physical Functioning (+ 25.0), Respiratory (+ 22.2) and Health Perception (+ 22.2).The Social Functioning area statistically significant increased at T2 (+ 5.6). At T3, these improvements remained stable. At T1, all areas of CFQ-R statistically significant increased in group B, particularly the Health Perception (+ 22,2) heading. At T2, these improvements remained stable. For both groups, the changes identified at the last follow-up showed no major differences by gender, age or genetic status.

CONCLUSIONS: Treatment with ETI significantly improved patients’ QoL in both groups at 12-24 months, these improvements remaining stable in patients tested at 36 months.

PMID:40327240 | DOI:10.1186/s41687-025-00879-0

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Distinctive and Shared Health Needs of Minority Communities by Immigrant Status

J Immigr Minor Health. 2025 May 6. doi: 10.1007/s10903-025-01672-3. Online ahead of print.

ABSTRACT

To identify distinct and shared health barriers, priorities, and desired information within minority communities by immigrant status. Health needs assessment surveys were conducted at three different health fairs in San Antonio from October 22, 2022 to January 14, 2023. Data was compared using descriptive statistics by immigration status. Among 59 US-born and 55 non-US-born respondents, nutrition and mental health were the highest health priorities. Time was a greater barrier among US-born respondents (p =.007) while lack of insurance was a greater barrier among non-US-born respondents (p =.008). Although the US-born group had higher rates of insurance (74%) compared to the non-US-born group (64%) (p =.019), both had similar rates of having a primary care provider. The US-born group had a higher number of emergency department (ED) visits (p =.030). There are multiple commonalities and differences among health needs in ethnically diverse communities in South Texas. Future health interventions targeted toward minority communities should consider nutrition and mental health while also addressing unique barriers. Multiple factors such as access to free clinics, personal safety, language, and health insurance status are integral to minority group health.

PMID:40327238 | DOI:10.1007/s10903-025-01672-3