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Nevin Manimala Statistics

A 12-week randomized, double-blind, placebo-controlled exploratory pilot study of HFN2-008 (heat-treated Bifidobacterium longum HN001) for adiposity reduction in overweight adults

BMC Nutr. 2026 Jul 11. doi: 10.1186/s40795-026-01417-x. Online ahead of print.

ABSTRACT

BACKGROUND: Excessive accumulation of body fat, particularly abdominal and visceral fat, is a major risk factor for metabolic abnormalities and chronic diseases. This study evaluated the safety and effects of 12-week HFN2-008 supplementation on body fat distribution and abdominal fat in adults.

METHODS: A 12-week randomized, double-blind, placebo-controlled exploratory pilot study was conducted in 100 adult men and women. Participants were randomly assigned to receive either HFN2-008, a formulation containing heat-treated Bifidobacterium longum HN001 dried culture powder, or a placebo. Body fat mass and percentage were assessed using dual-energy X-ray absorptiometry, whereas abdominal fat areas were assessed using computed tomography.

RESULTS: After 12 weeks of supplementation, the HFN2-008 group demonstrated significantly greater decreases in trunk and total body fat mass and percentage compared with the placebo group. Computed tomography further revealed significant decreases in visceral and subcutaneous fat areas in the HFN2-008 group compared with the placebo group. No significant between-group differences were observed in lean body mass or circulating metabolic biomarkers. No serious adverse events were reported, indicating a favorable safety profile.

CONCLUSIONS: HFN2-008 effectively decreases body and abdominal fat without loss of lean body mass and appears to be a safe functional ingredient for body fat management in adults.

TRIAL REGISTRATION: Registry: Clinical Research Information Service, TRN: KCT0011178, Registration date: 19 November 2025.

PMID:42436590 | DOI:10.1186/s40795-026-01417-x

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Nevin Manimala Statistics

Development and validation of the breastfeeding resilience scale (BRS) among employed mothers after returning to work

Int Breastfeed J. 2026 Jul 11. doi: 10.1186/s13006-026-00870-5. Online ahead of print.

ABSTRACT

BACKGROUND: The increasing number of employed mothers in the workforce is an inevitable trend in China. Employed mothers may stop breastfeeding due to work-related stressors. However, many mothers overcome these challenges and continue breastfeeding after returning to work. This study aimed to develop and validate a tool to understand employed mothers’ experiences with continuing breastfeeding after returning to work, based on Kumpfer’s Resilience Framework, in China.

METHODS: The study comprised three phases. Phase 1 involved item pool generation through a literature review, focus groups, and a Delphi survey, followed by pre-testing with 15 mothers to finalize the breastfeeding resilience scale (BRS) trial version. In Phase 2, the trial BRS was administered in a cross-sectional survey of employed mothers from 18 provincial-level regions of China who were recruited using purposive sampling, and valid responses from 172 participants were included in item analysis and exploratory factor analysis (EFA) to develop the provisional BRS. In Phase 3, the provisional BRS and the Connor-Davidson Resilience Scale (CD-RISC) were administered in a cross-sectional survey of employed mothers from 23 provincial-level regions of China who had returned to work, using purposive sampling. Valid responses from 200 participants were included to evaluate reliability and validity and develop the formal BRS. Reliability was examined using internal consistency and split-half coefficients. Validity was assessed through content, construct, convergent, discriminant, and criterion-related validity analyses.

RESULTS: The formal BRS contains 24 items across five dimensions. Cronbach’s α was 0.897 (95% CI: 0.875-0.916) for the overall scale, and Cronbach’s α coefficients for the five dimensions ranged from 0.750 (95% CI: 0.683-0.805) to 0.875 (95% CI: 0.847-0.900). Split-half reliability was 0.787. EFA yielded five factors explaining 63.139% of the variance, with all item loadings exceeding 0.50. Confirmatory factor analysis (CFA) showed that most fit indices met the recommended criteria, with χ²/df = 1.654, RMSEA = 0.057, CFI = 0.923, IFI = 0.924, TLI = 0.912, although GFI = 0.860 and NFI = 0.828 were below the 0.90 cutoff. Average variance extracted (AVE) values ranged from 0.441 to 0.570, with the social dimension having an AVE of 0.441, and composite reliability (CR) values ranged from 0.755 to 0.876. Correlation coefficients among the dimensions were below 0.50, and the square roots of the AVE values for each dimension ranged from 0.663 to 0.755. Correlations between BRS dimensions and the total score on the CD-RISC criterion scale ranged from 0.410 to 0.629, all statistically significant.

CONCLUSIONS: This study developed and validated a Breastfeeding Resilience Scale for employed mothers after returning to work. It may provide healthcare workers engaged in breastfeeding promotion with an assessment tool to identify employed mothers’ intrinsic motivation and psychological resilience throughout their breastfeeding journey.

CLINICAL TRIAL NUMBER: Not applicable.

PMID:42436581 | DOI:10.1186/s13006-026-00870-5

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Multimodal model for predicting exercise-induced pulmonary hypertension validated by invasive exercise hemodynamics: a prospective study

Respir Res. 2026 Jul 11. doi: 10.1186/s12931-026-03814-z. Online ahead of print.

ABSTRACT

BACKGROUND: Exercise-induced pulmonary hypertension (EiPH) represents an early stage of pulmonary vascular disease that remains challenging to identify noninvasively, particularly in patients with borderline resting haemodynamics. We aimed to develop and validate a multimodal non-invasive model integrating clinical characteristics, exercise echocardiography, and cardiopulmonary exercise testing (CPET) to accurately predict invasively confirmed EiPH.

METHODS: This prospective cohort study consecutively enrolled adult patients who presented with exercise limitation following chronic pulmonary artery thrombosis or who exhibited increased tricuspid regurgitation velocity on transthoracic echocardiography. All patients underwent comprehensive clinical evaluation, stress echocardiography, CPET, and invasive exercise right heart catheterization as the diagnostic gold standard. To minimize the impact of physiological variability on the results, all three tests were conducted at the same time. Feature selection was conducted sequentially using Spearman correlation analysis, statistical testing, and LASSO regression to identify core features associated with EiPH. Subsequently, a logistic regression model with elastic net regularization was used. Five-fold cross-validation and grid search were employed to optimize model parameters and evaluate the diagnostic performance of different models. In addition, the DeLong test was used to assess whether the AUC differed significantly between models. Finally, subgroup analyses were performed to validate the robustness of the model.

RESULTS: The study included a total of 78 patients, comprising 34 cases of EiPH and 44 cases without EiPH. Patients in the EiPH group were significantly older (68.5 vs. 51.5 years, P < 0.001) and demonstrated reduced exercise capacity, impaired pulmonary function, abnormal right ventricular function, and increased pulmonary vascular resistance. After integrating multimodal data from clinical features, stress echocardiography, and cardiopulmonary exercise testing, the Clinical+Echo+CPET model achieved the best performance, with an AUC of 0.951 (95% CI: 0.902-0.987), an accuracy of 0.871, and a Brier score of 0.128, indicating strong discriminative ability and good calibration. The model maintained high stability in the internal validation cohort, with an AUC of 0.900, a sensitivity of 0.833, and a specificity of 0.700. The DeLong test showed that the multimodal model (Clinical+Echo+CPET) had superior discriminative performance compared with the unimodal models (Clinical, Echo, or CPET). Subgroup analysis demonstrated that the model maintained good diagnostic performance across different age and sex groups.

CONCLUSIONS: A non-invasive multimodal model integrating clinical indicators, exercise echocardiography, and cardiopulmonary metabolic parameters can reliably identify EiPH.

PMID:42436574 | DOI:10.1186/s12931-026-03814-z

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Pinpointing precision: axial length and refraction in paediatric myopia trials-a mixed methods study

Trials. 2026 Jul 11. doi: 10.1186/s13063-026-09884-0. Online ahead of print.

ABSTRACT

PURPOSE: Most paediatric myopia intervention trials report two primary outcomes: axial length and cycloplegic autorefraction. Having one single primary outcome would increase trial efficiency, reduce participant burden, and may improve trial retention. This article aims to evaluate precision of axial length and cycloplegic autorefraction and to explore eye care professionals’ and young people’s views of cycloplegia.

METHODS: Mixed methods study with meta-analysis of axial length and cycloplegic spherical equivalent measurements reported by paediatric myopia treatment trials; interviews with eye care professionals; engagement/involvement discussion with children and young people.

RESULTS: In the meta-analysis, mean effect size (standard error, SE) was -0.52 (0.12, p < 0.001, 95% confidence interval (CI) -0.76 to -0.29) for axial length and 0.49 (0.11, p < 0.001, CI 0.27 to 0.71) for cycloplegic spherical equivalent refraction. Difference in mean point estimates was 0.033, SE of the difference 0.164 (CI -0.29 to +0.535). With t-statistic (mean difference/SE of mean difference) of 0.20, two-tailed p value was 0.84. Eye care professionals report that children dislike cycloplegia, describing discomfort, distress, and potential refusal to attend follow-up appointments. Children and young people describe pain and discomfort, remember prolonged effects such as blurred vision and light sensitivity, and complain about receiving insufficient information about adverse effects.

CONCLUSIONS: Whilst the precision of axial length and cycloplegic autorefraction spherical equivalent measurements is similar, cycloplegic autorefraction requires longer study visits and inflicts more discomfort. In the design of future trials, researchers, funders, and regulators should consider increasing trial efficiency by selecting axial length as primary outcome and removing cycloplegic refraction from follow-up assessments.

PMID:42436573 | DOI:10.1186/s13063-026-09884-0

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Nevin Manimala Statistics

Academic distress and help-seeking behavior among first year university students: A correlational study of domestic and international students in the Ethiopian higher education ecosystem

BMC Psychol. 2026 Jul 11. doi: 10.1186/s40359-026-05100-5. Online ahead of print.

ABSTRACT

Transitions to a new educational ecosystem result in students’ academic distress, particularly at the university level. Thus, this study aimed to examine academic distress and help-seeking practices among first-year domestic and international university students in the fields of Engineering and Health Sciences. The study mainly focused on academic distress and help- seeking behavior abided by the help-seeking process model and mind sponge mechanism. A quantitative correlational research design was used. A total of 361 students were selectedusing simple random sampling. Standardized questionnaires were used to measure the variables. Descriptive statistics and Multivariate Analysis of Variance (MANOVA) were used to achieve the study objectives. The results revealed that University students had moderate levels of help-seeking behavior and academic distress. Moreover, male students had higher academic help-seeking behavior and lower academic distress than their female counterparts; whereas academic help-seeking behavior and academic distress were lower for female students. Statistically significant sex differences were also noted in academic distress. Based on the mind sponge theory, measures for the prevention of academic distress should be targeted at the optimization of help-seeking behavior with a special focus on female students who manifest a high vulnerability to academic distress. Moreover, ways such as digital-based interventions that assist in addressing a large number of students at once also merit attention.

PMID:42436567 | DOI:10.1186/s40359-026-05100-5

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Mental tasks induce common modulations of oscillations in cortex and spinal cord

J Neuroeng Rehabil. 2026 Jul 11;23(1):214. doi: 10.1186/s12984-026-02041-3.

ABSTRACT

BACKGROUND: Spike trains from spinal motor neurons contain low-frequency components that modulate muscle force, and higher-frequency components (above 10 Hz) that do not. The functional role of these higher-frequency components in motor control is still debated. We investigated whether mental tasks that modulate the power of cortical oscillations produce corresponding modulations in spinal motor neuron activity above 10 Hz without affecting force output. Such coupling would indicate that some higher-frequency components are not merely arising as a byproduct of force generation nor indirectly contributing to motor control, but simply reflect cortical oscillations propagating to spinal motor neurons. If voluntary power modulations of these higher-frequency oscillations do not affect force output, they could potentially serve as control signals for neural interface applications such as movement augmentation or motor neuroprostheses.

METHODS: We recruited 15 human participants and recorded high-density electromyography signals (HD-EMG) from the tibialis anterior muscle, as well as electroencephalography (EEG) signals. The cumulative spike train (CST) was computed from the activity of spinal motor neurons decoded from HD-EMG signals. The participants performed sustained dorsiflexion concurrent with foot motor imagery, hand motor imagery, mental arithmetic, or no specific mental task. We analysed the bandpower correlation between EEG and CST signals as well as evaluated the task discriminability of CST bandpower signals with a linear classifier.

RESULTS: At the intra-muscular coherence peak, we found statistically significant power correlations between CST and EEG in two separate analyses: first, when correlating across individual trials regardless of the mental task, and second, when correlating across the four mental tasks (Kendall’s τ coefficient [Formula: see text], [Formula: see text] respectively; mean ± std. dev.). To evaluate the potential of the CST as a control signal, we classified the mental tasks based on CST bandpower and obtained classification accuracies slightly but significantly above chance level ([Formula: see text]; chance level = 25%).

CONCLUSION: These results show that mental tasks can simultaneously modulate the power of cortical and spinal oscillations. This supports the notion that cortical oscillations not contributing to ongoing force control can propagate to the spinal level. We further demonstrate that mental tasks can be classified from CST bandpower, but classification performance is limited by the low signal-to-noise ratio.

PMID:42436562 | DOI:10.1186/s12984-026-02041-3

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Nevin Manimala Statistics

Psychological distress and quality of life in women with infertility due to polycystic ovarian syndrome versus unexplained infertility: a cross-sectional study with phenotype-based analysis

J Ovarian Res. 2026 Jul 11. doi: 10.1186/s13048-026-02186-8. Online ahead of print.

ABSTRACT

BACKGROUND: Infertility is associated with significant psychological distress and impaired quality of life (QoL) in women. Polycystic Ovarian Syndrome (PCOS), a common cause of infertility, is frequently associated with metabolic and psychological symptoms. However, limited evidence directly compares psychological symptom burden and QoL between women with PCOS-related infertility and unexplained infertility, including across PCOS phenotypes.

METHODS: This cross-sectional observational study included 240 women aged 18-40 years with infertility due to PCOS or unexplained causes, conducted at a tertiary care center between October 2019 and March 2021. PCOS was diagnosed using revised Rotterdam criteria, and unexplained infertility was defined after exclusion of known causes. Psychological outcomes were assessed using validated screening instruments (PHQ-9, BDI, BAI, and GAD-7), representing symptom severity rather than clinical psychiatric diagnoses. QoL was assessed using WHOQOL-BREF. Statistical analysis included group comparisons using appropriate parametric and non-parametric tests, with p < 0.05 considered statistically significant.

RESULTS: Women with PCOS demonstrated significantly higher screening-based depressive symptom burden (60% vs. 14%, p < 0.001) and anxiety symptom burden (63% vs. 21%, p < 0.001) compared to women with unexplained infertility. QoL scores were significantly lower in the PCOS group (66.8% vs. 85.1%, p < 0.001), particularly in psychological and social domains. Among PCOS phenotypes, hyperandrogenic phenotypes (B and C) showed relatively higher psychological symptom burden and lower QoL scores compared to other phenotypes. The PCOS group also demonstrated higher BMI and androgen levels.

CONCLUSION: Infertility associated with PCOS is linked to higher screening-based psychological symptom burden and reduced quality of life compared to unexplained infertility. Hyperandrogenic PCOS phenotypes appear to be more affected. These findings support the integration of routine psychological screening and multidisciplinary support into infertility care for women with PCOS.

PMID:42436557 | DOI:10.1186/s13048-026-02186-8

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Is clinical experience associated with lower perceived resuscitation stress in emergency nurses? Psychometric validation of the Chinese Perceived Stress during Resuscitation Scale and comparison of novice, intermediate, and expert practitioners

BMC Nurs. 2026 Jul 11. doi: 10.1186/s12912-026-05030-y. Online ahead of print.

ABSTRACT

BACKGROUND: Resuscitation imposes substantial psychological stress on emergency nurses, potentially impairing clinical performance and patient outcomes. Whether cumulative clinical experience is associated with lower perceived resuscitation stress remains empirically unresolved, and no validated Chinese instrument exists to measure resuscitation-specific perceived stress. This study aimed to translate the Perceived Stress during Resuscitation Scale (PSDRS) into Chinese, psychometrically evaluate its properties, and test its known-groups validity by comparing scores across novice, intermediate, and expert emergency nurses.

METHODS: A multicenter cross-sectional study was conducted across seven tertiary hospitals in Liaoning Province, China, from June 2025 to February 2026. Following the Brislin translation model, the original PSDRS was translated, back-translated, and culturally adapted through expert panel review and pilot testing. A convenience sample of 434 emergency nurses completed the Chinese PSDRS. Participants were stratified by clinical experience: novice (< 2 years, n = 52), intermediate (2-10 years, n = 202), and expert (≥ 10 years, n = 180). Psychometric evaluation included content validity (S-CVI), construct validity via exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) on randomly split subsamples, internal consistency reliability (Cronbach’s α), test-retest reliability (ICC), and known-groups validity tested through one-way ANOVA.

RESULTS: The Chinese PSDRS demonstrated robust psychometric properties. Content validity was excellent (S-CVI = 0.926). A randomly split subsample for EFA (n = 210) extracted a seven-factor structure explaining 75.17% of total variance. CFA on the validation subsample (n = 224) confirmed satisfactory model fit (χ²/df = 1.295, RMSEA = 0.036, CFI = 0.958, TLI = 0.951). Internal consistency was satisfactory (Cronbach’s α = 0.815) and test-retest reliability was acceptable (ICC = 0.774). Known-groups validity was supported, with expert nurses reporting lower PSDRS scores (M = 2.31, SD = 0.42) than intermediate (M = 2.48, SD = 0.45) and novice nurses (M = 2.67, SD = 0.49; F = 24.36, P < 0.001, η²=0.102). Post-hoc analyses confirmed all pairwise comparisons were statistically significant (all P < 0.01).

CONCLUSIONS: The Chinese PSDRS is a reliable and valid instrument. A significant dose-response gradient was observed, with greater clinical experience associated with lower perceived resuscitation stress. This pattern is consistent with theoretical perspectives such as the stress-inoculation hypothesis and professional development frameworks; however, these mechanisms were not directly tested, and causal inferences cannot be drawn given the cross-sectional design. This tool can facilitate early identification of at-risk novice nurses and inform experience-tailored stress management interventions.

TRIAL REGISTRATION: Not applicable.

PMID:42436553 | DOI:10.1186/s12912-026-05030-y

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A mixed-methods exploration of stakeholder experiences and perspectives on integrating polygenic breast cancer risk scores into Swedish clinical practice

BMC Health Serv Res. 2026 Jul 11;26(1):948. doi: 10.1186/s12913-026-15116-7.

ABSTRACT

OBJECTIVE: To explore women’s experiences following polygenic risk score (PRS) testing for breast cancer risk and to assess the knowledge, attitudes, practices (KAP), and implementation perspectives of medical professionals and healthcare decision-makers in Sweden.

METHODS: Convergent mixed-methods study combining quantitative survey data with qualitative thematic analysis of survey open-ended responses and focus group discussion (FGD) notes.

SETTING: Swedish healthcare context.

PARTICIPANTS: 400 women receiving PRS results for a first Participants Feedback Survey; 289 women for the second Participants Feedback Survey, and 6 medical professionals/decision-makers for a KAP survey and FGD. Women completed two sequential online feedback surveys post-PRS result disclosure. Professionals completed a KAP survey and participated in an FGD. Quantitative survey data were analysed using descriptive statistics. Qualitative data from open-ended survey questions and FGD notes were analysed using thematic analysis.

RESULTS: Participants valued participation in PRS testing and receiving PRS-test results, with 87% finding results interesting and 82% finding them valuable. Although most participants found the explanations understandable (approximately 75% in Survey 1 and 82% in Survey 2), qualitative comments indicated that some had difficulty interpreting probabilistic risk information, including participants who self-identified as highly educated or medically trained. Negative emotional impact was generally minimal (85% felt calm), though some women with high PRS risk experienced anxiety. Major unmet needs included clearer explanations, actionable guidance, and better access to follow-up support from healthcare. Professionals were cautiously positive: in the KAP survey, 5 of 6 were familiar with the concept of PRS, but confidence in the health system’s readiness to integrate it was limited. The main barriers raised were the absence of clinical guidelines and the need for evidence of clinical utility.

CONCLUSIONS: Breast cancer PRS testing holds potential for enhancing risk assessment in Sweden. Key challenges for clinical integration include clinician readiness, the development of clear guidelines, and improved participant comprehension and communication. PRS tests should be accompanied with clinical decision support both for patients as well for medical professionals. Addressing these will require person-centered communication tools, robust evidence of clinical utility, well-defined clinical pathways, investments in provider education, and equitable implementation strategies within the Swedish healthcare system.

CLINICAL TRIAL NUMBER: Not applicable.

PMID:42436550 | DOI:10.1186/s12913-026-15116-7

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Nevin Manimala Statistics

Safety of the harmonic scalpel versus conventional “clamp-and-tie” approach for intraoperative bleeding control during thyroidectomy: a surgeon’s experience in 60 consecutive cases

Patient Saf Surg. 2026 Jul 11. doi: 10.1186/s13037-026-00501-2. Online ahead of print.

ABSTRACT

BACKGROUND: Post-thyroidectomy complications including hypocalcemia, recurrent laryngeal nerve injury, and cervical hematoma remain important safety concerns. Although the harmonic scalpel improves operative efficiency, evidence regarding its impact on patient safety outcomes remains limited.

METHODS: In this prospective observational cohort study, 60 patients undergoing open thyroidectomy were allocated to harmonic scalpel (n = 30) or clamp and tie (n = 30) groups. The primary endpoints were safety outcomes, including hypocalcemia, recurrent laryngeal nerve injury, postoperative hematoma, surgical site infection, and composite complication rates. Secondary endpoints included operative time, intraoperative blood loss, drain output, postoperative pain, and length of hospital stay. Statistical significance was defined as p < 0.05.

RESULTS: Use of the harmonic scalpel was associated with a significant reduction in overall complications compared with the conventional technique (13.3% vs. 33.3%, p = 0.04). Transient hypocalcemia occurred less frequently in the harmonic scalpel group, accompanied by significantly higher postoperative calcium levels at 24 and 48 h. No recurrent laryngeal nerve injury or postoperative hematoma was observed in the harmonic scalpel group, although differences were not statistically significant. In addition to improved safety outcomes, harmonic scalpel use resulted in shorter operative duration, substantially reduced intraoperative blood loss, lower postoperative drain volumes, decreased pain scores, and reduced length of hospital stay.

CONCLUSION: The harmonic scalpel was associated with improved operative efficiency and a lower overall complication burden without increasing major safety-related complications. Larger randomized multicenter studies are required to confirm these findings.

CLINICAL TRIAL NUMBER: Not applicable.

PMID:42436548 | DOI:10.1186/s13037-026-00501-2