Category: Nevin Manimala

SoftwareX. 2025 Sep;31:102288. doi: 10.1016/j.softx.2025.102288. Epub 2025 Aug 7.

ABSTRACT

Stepped wedge cluster randomized trials (SWCRTs) have become increasingly popular across various disciplines, particularly in public health and clinical research, as they allow evaluations of interventions rolled out sequentially across clusters. SWCRTsimulator is a user-friendly, web-based RShiny application designed to facilitate sample size and statistical power estimation for an interval-censored time-to-event outcome in a SWCRT. Leveraging Monte Carlo simulations, the platform accommodates various study design features, including heterogeneity in intervention effect across different clusters, to provide a more accurate and reliable statistical approach to sample size and power estimates as compared to the approximate methods based on study design features when a closed-form solution is not feasible. SWCRTsimulator provides customizable visualizations for simulation results. We also illustrate the practical application of this platform using the Sankofa 2 trial, an active multi-clinic SWCRT of a pediatric HIV disclosure intervention in Ghana, underscoring the importance of accounting for real-world complexities in the design and analysis of such trials.

PMID:41036414 | PMC:PMC12483528 | DOI:10.1016/j.softx.2025.102288

BMC Psychiatry. 2025 Oct 1;25(1):908. doi: 10.1186/s12888-025-07391-1.

ABSTRACT

BACKGROUND: Motivational Interviewing (MI) is a counseling approach that promotes behavior change by eliciting “change talk” and minimizing “sustain talk.” Traditional methods for assessing MI quality, such as manual coding, are labor-intensive, subjective, and difficult to scale. This study introduces an automated framework integrating large language models (LLMs) and Hidden Markov Models (HMMs) for evaluation of MI session quality.

AIMS: This study evaluates the effectiveness of an LLM-HMM framework in predicting MI session quality and examines motivational state transitions in high- and low-quality sessions.

METHOD: A dataset of 40 MI sessions was analyzed. Client utterances were classified and numerically scored by an LLM based on their intention toward or away from change. With HMMs, we used these scores to examine the motivational state transitions across each session. Differences between high- and low-quality sessions were quantified by comparing transition matrices using Frobenius norms. Statistical significance was assessed via a permutation test. Predictive performance was evaluated using logistic regression with leave-one-out cross-validation (LOOCV), where transition matrix elements served as independent variables and interview quality as the dependent variable.

RESULTS: High-quality MI sessions exhibited fluid transitions between motivational states, whereas low-quality sessions showed persistence in resistance-oriented states. A statistically significant difference in transition matrices was observed between session groups (p < 0.001). The framework achieved a mean LOOCV accuracy of 0.80, demonstrating strong predictive performance in identifying MI session quality.

CONCLUSIONS: This study presents a scalable, objective alternative to manual MI evaluation. Future applications may include real-time therapist support, training, and prognosis prediction, pending further validation on field-collected data.

PMID:41034852 | DOI:10.1186/s12888-025-07391-1

BMC Musculoskelet Disord. 2025 Oct 1;26(1):899. doi: 10.1186/s12891-025-09034-8.

ABSTRACT

BACKGROUND: Idiopathic scoliosis is a three-dimensional spinal deformity that typically develops during childhood or adolescence but may affect individuals across the lifespan. Regular monitoring is often necessary to detect progression and assess treatment effectiveness. Radiography remains the clinical gold standard; however, repeated ionizing radiation exposure is associated with increased cancer risks, highlighting the need for reliable, non-invasive, and radiation-free assessment methods. This systematic review and meta-analysis evaluated the diagnostic accuracy and criterion validity of emerging radiation-free scoliosis monitoring techniques compared to radiographic standards.

METHODS: A comprehensive literature search across six databases (Cochrane, EMBASE, IEEE Xplore, PUBMED, Scopus, Web of Science) identified 56 eligible studies involving 4,774 patients diagnosed with idiopathic scoliosis (median number of patients per study: 38; range: 5 to 952, mean patient age: 15.2 years, female-to-male ratio: 3:1). Criterion validity was assessed by pooling Pearson correlation coefficients between radiographic and non-ionizing measurements. Measurement accuracy was assessed by pooling their mean absolute differences in Cobb angles. Additionally, sensitivity and specificity for detecting deformity progression were assessed. Statistical analyses employed multilevel linear mixed-effects models, introducing moderators to explain study heterogeneity.

RESULTS: Ultrasonography demonstrated the highest overall validity, consistently correlating strongly (r≈0.9) with radiographic Cobb angles. Surface topography also showed robust correlation (r > 0.8), although evidence remains insufficient for patients with higher body mass indices or more severe spinal curvatures for both methods. Magnetic resonance imaging exhibited a very strong correlation (r = 0.93) with radiographic measurements; however, correlation varied significantly depending on patient positioning. Upright MRI provided more consistent results compared to supine positioning.

CONCLUSIONS: Ultrasonography and surface topography represent promising radiation-free alternatives that could significantly reduce radiographic assessment frequency, minimizing radiation exposure, particularly in suitable patient groups. While MRI also demonstrates excellent validity, its broader clinical applicability remains constrained by substantial costs, limited availability, and extended examination durations. Although these non-ionizing modalities are not yet viable replacements for routine radiography, their demonstrated validity and accuracy supports their potential as complementary technologies, particularly for screening or supplementary monitoring of scoliosis.

PMID:41034849 | DOI:10.1186/s12891-025-09034-8

BMC Geriatr. 2025 Oct 1;25(1):753. doi: 10.1186/s12877-025-06361-2.

ABSTRACT

BACKGROUND: The SUGAR Handshake is a pharmacist-led educational intervention to prevent hypoglycaemia in elderly people with type 2 diabetes mellitus (T2DM). A process evaluation was conducted alongside the ROSE-ADAM pragmatic randomized controlled trial (RCT) to assess the implementation of the intervention and study procedures, explore mechanisms of impact, and examine future scalability.

METHODS: This mixed-methods process evaluation was nested within a single-centre RCT conducted at outpatient clinics in a Jordanian hospital. Routine monitoring quantitative data assessed adherence to the intervention components and study activities, and estimated reach. Qualitative data, collected through semi-structured interviews with 12 purposively selected participants on Days 45 and 90 of enrolment, captured experiences with the intervention and usual care. Thematic analysis was used for qualitative data; descriptive statistics and inferential tests were applied to quantitative data.

RESULTS: The intervention was well implemented: 104 of 106 participants (98.11%) continued the full intervention, with a 100% reach to those enrolled in the trial. Participants showed high adherence to study activities (mean ± SD: 88.07 ± 9.33 documented days on diaries; 77.97 ± 18.87 fasting blood glucose measurements). Intervention reach was 100%. Participants described the intervention as informative, easy to follow, and helpful in avoiding hypoglycaemia and the side-effects of antidiabetic medications. Key facilitators included trust in pharmacists, altruism, and social support. Reported barriers were people’s health status, age-related conditions, and stress.

CONCLUSIONS: This process evaluation highlights the SUGAR Handshake’s potential for broader implementation and scale-up. By addressing identified barriers, future educational interventions may enhance adherence, improve patient outcomes, and advance hypoglycaemia management in diabetes care.

TRIAL REGISTRATION: Clinicaltrials.gov (NCT04081766), registration date 4,920,219.

PMID:41034834 | DOI:10.1186/s12877-025-06361-2

BMC Musculoskelet Disord. 2025 Oct 1;26(1):904. doi: 10.1186/s12891-025-09129-2.

ABSTRACT

BACKGROUND: Exploring the effect of sarcopenia on the clinical outcome of delta large-channel endoscopic treatment of elderly patients with lumbar spinal stenosis.

METHODS: Data were collected from 87 patients who underwent delta large-channel endoscopy between January 2022 and June 2023 at the First Affiliated Hospital of Ningbo University. Skeletal muscle index at the L3 level SMI < 36 cm²/m² (males) and SMI < 29 cm²/m² (females) were used as diagnostic thresholds for sarcopenia. We divided patients who met the inclusion criteria into a sarcopenia group (41) and a non-sarcopenia group (46). Patients’ age, gender, BMI, responsible segment, procedure-related parameters (intraoperative bleeding, operative time, hospitalization time, and complication occurrence), and clinical outcomes (Visual Analog Scale for Pain (VAS) scores, JOA scores, Oswestry Dysfunction Index (ODI) scores, and MacNab scores at the time of final follow-up) were recorded and compared.

RESULTS: There were no significant differences in gender, age, BMI, intraoperative bleeding, operative time, hospitalization time, and complication occurrence between the two groups (P > 0.05). Surgery was successfully completed in both groups. Clinical outcomes, such as lumbar VAS scores was not significant different between the two groups (P > 0.05). While comparing the lumbar VAS scores between the two groups at 6 months and 12 months postoperatively, the scores of the non- sarcopenia group were lower than those of the sarcopenia group, and the difference was statistically significant (P < 0.05). In addition, in the postoperative follow-up at 3 months, 6 months and 12 months, the comparison of ODI scores and JOA scores between the sarcopenia group and the non-sarcopenia group was statistically significant (P < 0.05), in which the ODI scores of the non-sarcopenia group were significantly lower than those of the sarcopenia group, and the JOA scores of the non-sarcopenia group were significantly higher than those of the sarcopenia group.

CONCLUSION: Functional recovery after delta large-channel endoscopic decompression was better in non-sarcopenia patients than in the sarcopenia group, and sarcopenia had a greater impact on long-term postoperative outcomes in older patients. We need to emphasize the diagnosis and intervention of sarcopenia in patients to reduce the impact of sarcopenia on postoperative clinical outcomes. Whether sarcopenia affects the stability of lumbar spine in endoscopic patients requires a longer follow-up period and later studies.

PMID:41034829 | DOI:10.1186/s12891-025-09129-2

BMC Public Health. 2025 Oct 1;25(1):3278. doi: 10.1186/s12889-025-24539-6.

ABSTRACT

BACKGROUND: In recent years, with rapid societal changes and increasing educational pressures, the mental health of primary and secondary school students has garnered significant attention. Psychological resilience, as a core capacity for coping with adversity, and emotional competence, as a foundation for emotional regulation in social adaptation, are crucial for student development, with family functioning being a primary environmental factor closely associated with them. Research suggests that healthy family functioning may be associated with higher psychological resilience and emotional competence, while family dysfunction may be linked to increased psychological distress. However, the interconnected mechanisms among family functioning, psychological resilience, and emotional competence, as well as the roles of factors such as gender, urban-rural differences, and grade level, still require further exploration.

OBJECTIVES: To explore the associations between family functioning, psychological resilience, and emotional competence among primary and secondary school students in Chengdu, Sichuan Province, and their underlying mechanisms. The study aims to provide a scientific basis for educators and parents to develop targeted mental health interventions.

DESIGN: Multicenter cross-sectional study.

METHODS: A cluster sampling method was employed to survey 7,937 students from grades 1 to 9 across five schools in Chengdu. Data were collected using the Chinese Family Assessment Instrument (C-FAI, assessing family mutual support, communication, and conflict harmony), the Resilience Subscale and Emotional Competence Subscale of the Chinese Positive Youth Development Scale (CPYDS, measuring adaptation and recovery under stress, and the ability to perceive, understand, and manage emotions, respectively). Data were double-entered and verified using Epidata 3.1. SPSS 26.0 was used for descriptive statistics, correlation analysis, and difference tests (independent samples t-test, Welch t-test, one-way ANOVA, or Welch ANOVA based on data distribution, with Games-Howell post-hoc tests). Partial correlation analysis controlled for gender, urban/rural residence, and grade. Structural equation modeling was conducted using AMOS 26.0 to analyze the associations and mediating effects among family functioning, psychological resilience, and emotional competence, and to evaluate model fit. Harman’ s single-factor test was applied to detect common method bias. The significance level was set at α=0.05.

RESULTS: Family functioning showed significant differences across gender, urban/rural location, and grade level (P<0.05): male students (1.97±0.74), rural students (1.97±0.73), and students in grades 7-9 reported more severe family dysfunction. Psychological resilience was significantly positively correlated with emotional competence (r=0.646,P<0.001), and both were negatively correlated with family dysfunction (r=-0.394 and r=-0.376, respectively, P<0.001). The structural equation model demonstrated a good fit (CMIN/DF=6.988,RMSEA=0.027). Path analysis from the model indicated that psychological resilience may be indirectly associated with emotional competence through family functioning. The mediating effect of this path was 0.089, accounting for 9.2% of the total effect (95% CI: 0.667-0.726, P<0.001).

CONCLUSIONS: Family dysfunction is significantly negatively correlated with the psychological resilience and emotional competence of primary and secondary school students, with psychological resilience indirectly associated with emotional competence through family functioning. Boys, rural students, and those in grades 7-9 exhibit more severe family dysfunction, warranting focused attention. It is recommended to implement interventions such as “Parent-Child Co-Creation Day,” communication training, and “Father’ s Role Workshop” to optimize family functioning, thereby supporting the mental health of primary and secondary school students.

PMID:41034824 | DOI:10.1186/s12889-025-24539-6

BMC Med Res Methodol. 2025 Oct 1;25(1):225. doi: 10.1186/s12874-025-02667-2.

ABSTRACT

The ATR-FTIR spectral data represent a valuable source of information in a wide range of pathologies, including neurological disorders, and can be used for disease discrimination. To this end, the identification of the potential spectral biomarkers among all possible candidates is needed, but the amount of information characterizing the spectral dataset and the presence of redundancy among data could make the selection of the more informative features cumbersome. Here, a novel approach is proposed to perform feature selection based on redundant information among spectral data. In particular, we consider the Partition Around Medoids algorithm based on a dissimilarity matrix obtained from mutual information measure, in order to obtain groups of variables (wavenumbers) having similar patterns of pairwise dependence. Indeed, an advantage of this grouping algorithm with respect to other more widely used clustering methods, is to facilitate the interpretation of results, since the centre of each cluster, the so-called medoid, corresponds to an observed data point. As a consequence, the obtained medoid can be considered as representative of the whole wavenumbers belonging to the same cluster and retained in the subsequent statistical methods for disease prediction. An application on real data is finally reported to show the ability of the proposed approach in discriminating between patients affected by multiple sclerosis and healthy subjects.

PMID:41034819 | DOI:10.1186/s12874-025-02667-2

BMC Pregnancy Childbirth. 2025 Oct 1;25(1):1000. doi: 10.1186/s12884-025-08176-w.

ABSTRACT

BACKGROUND: Worldwide, preeclampsia continued to be one of a leading cause of maternal and perinatal morbidity and mortality. Indeed, developing countries like Ethiopia face significant public health challenges because of scarce data and limited applications of determinants of preeclampsia. Therefore, the aim of this research was to identify determinants of preeclampsia among pregnant and laboring mothers who came for antenatal care and labor and delivery services.

METHODS: We conducted an unmatched case-control study among women diagnosed with preeclampsia and admitted to Wolaita Sodo University Comprehensive Specialized Hospital. Two hundred seventy women with case to control ratio of 1:2 were participated. We computed descriptive statistics like frequencies, percentages, mean, and standard deviation. An independent sample t-test was computed to compare the difference in means of cases and controls. Chi-squared test was used to compare categorical variables between cases and controls. To assess the association between dependent and independent variables, we carried out bivariable and multivariable logistic regressions. Variables whose p-value < 0.05 were considered as having strong association and strength of association was measured using an odds ratio (OR) with its corresponding 95% confidence level (CI).

RESULTS: Pre-pregnancy overweight (OR = 6.7; 95%CI: 1.1-41.3 p = 0.0035), hypertension in the family member (OR = 3.1, 95%CI: 1.4-6.8, p = 004), multifetal gestation (OR = 5.4, 95% CI: 1.1-26, p = 003) and increased mid-gestation diastolic blood pressure of ≥ 80mmgh (OR = 7.6, 95%CI: 2.54-22.7, p = 0.002) were determinants of preeclampsia. Drinking coffee during pregnancy (OR = 0.27, 95%CI: 0.07, 0.94, p = 0.015) and iron and folic acid supplementation during pregnancy (OR = 0.48, 95%CI: 0.25-0.96, p = 0.041) were identified as protective factors.

CONCLUSION: Odds of preeclampsia was higher in women with pre-pregnancy overweight, family history of hypertension, multifetal gestation, and high mid-gestation diastolic blood pressure, whereas supplementation of iron and folic acid lowers the risk of preeclampsia. Therefore, health care providers should emphasis on preconception care and thorough clinical evaluation during pregnancy, which may provide opportunity to detect women likely to develop preeclampsia. Nutritional intervention and conducting further research on protective factors like coffee intake is recommended to clarify the inconsistent findings.

PMID:41034809 | DOI:10.1186/s12884-025-08176-w

BMC Cancer. 2025 Oct 1;25(1):1485. doi: 10.1186/s12885-025-14861-y.

ABSTRACT

OBJECTIVE: This study investigates the sensory and cognitive impact of cancer and its treatment, focusing on possible chemotherapy-induced hearing and olfactory impairment, and cognitive function. The primary aim is to evaluate the effectiveness and feasibility of an extended test battery for assessing sensory and cognitive function in cancer patients, providing foundational knowledge for a larger study. A secondary aim is to examine associations between chemotherapy types and sense-neurodegenerative function.

DESIGN: An observational cross-sectional, pilot study evaluated hearing, olfactory function, and cognitive function in first-line chemotherapy patients without prior brain injuries and ototoxic or otological histories. Self-reported outcomes on communication strategies, tinnitus and olfaction were collected. Data analysis applied descriptive statistics with t-tests, and Fisher´s exact tests to compare auditory, olfactory, and cognitive performance between treatment groups.

STUDY SAMPLE: Thirteen cancer survivors (n = 13), six (n = 6) females and seven (n = 7) males who received two different types of chemotherapy.

RESULTS: No significant differences were observed between the chemotherapy groups in audiological and olfactory tests, cognitive assessment, or self-reported outcomes. However, among those receiving platinum-based chemotherapy, participants reported greater use of communication strategies in specific areas.

CONCLUSION: No significant differences in hearing, olfactory, cognitive, and self-reported outcomes were found when examining cancer patients receiving two different chemotherapy types. The study highlights the need for advanced diagnostic tools to detect hearing, olfactory, and cognitive function in cancer survivors.

PMID:41034807 | DOI:10.1186/s12885-025-14861-y

BMC Cancer. 2025 Oct 1;25(1):1475. doi: 10.1186/s12885-025-14786-6.

ABSTRACT

BACKGROUND: There are limited real-world data on the prevalence of brain metastases (BM) in metastatic breast cancer (mBC) across the treatment pathway, especially when stratified by human epidermal growth factor receptor 2-positive (HER2+) or HER2-negative (HER2-) status. The goals of this study were to estimate the prevalence of BM at metastatic diagnosis and at the start of each line of systemic therapy (LOT), and to describe treatment patterns and overall survival (OS) in patients with and without BM.

METHODS: This retrospective cohort study included adult patients in the US with mBC diagnosed between January 2013 – May 2020, with known HER2 status from an electronic health record-derived, deidentified database. Patients were followed from mBC diagnosis to last activity date or death. Descriptive statistics were used for BM prevalence, patient characteristics, and treatment patterns. OS was estimated using the Kaplan-Meier method.

RESULTS: Of 12,644 patients with mBC in the database, 1923 (HER2+) and 9693 (HER2-) were included. The prevalence of BM at mBC diagnosis was 12.5% (HER2+) and 1.7% (HER2-). An NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) recommended systemic treatment for BM was received by 25.0% of patients with BM (HER2+) versus 12.8% (HER2-) during first-line treatment. The prevalence of BM (documented before or within the same month of LOT start) was 11.2%, 22.8%, and 33.0% in those with HER2+ diseases who had at least one, two, and three prior LOTs, respectively. The prevalence of BM among patients with HER2- disease was 1.6%, 2.0%, and 2.8% in those who had at least one, two, and three prior LOTs, respectively. Median OS from mBC diagnosis among patients with versus without BM was 24 versus 37 months (HER2+) and 12 versus 27 months (HER2-).

CONCLUSIONS: In this real-world study of patients receiving care in US oncology clinics, the prevalence of BM in patients with mBC increased by LOT, and most were not receiving NCCN Guideline^®-recommended systemic therapies. OS was poorer in patients with BM versus without BM, especially in the HER2- population. These results highlight a need for more effective treatments for patients with mBC and BM.

PMID:41034805 | DOI:10.1186/s12885-025-14786-6