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Nevin Manimala Statistics

Statistical documentation for multi-disease, multi-domain platform trials: our experience with the Staphylococcus aureus Network Adaptive Platform trial

Trials. 2025 Feb 11;26(1):49. doi: 10.1186/s13063-024-08684-8.

ABSTRACT

Platform trials have become widely adopted across multiple disease areas over recent years, however, guidelines for operationalising these trials have not kept pace. We outline a series of documents that summarise the statistical components, and implicit processes, of the Staphylococcus aureus Network Adaptive Platform (SNAP) trial to provide an informal template for other researchers and reviewers of platform trials. We briefly summarise the content and role of the core protocol, statistical appendix, domain-specific appendices, simulation report, statistical implementation guides, data safety and monitoring committee (DSMC) reports, and domain-specific statistical analysis plans and final reports, and a transparent governance structure that ensures separate blinded and unblinded statistical teams. In the absence of guidelines or checklists for platform trial statistical documents, we hope to provide useful guidance to others in terms of what has worked so far for the SNAP trial, stimulate discussion, and inform a future consensus.Trial registration NCT05137119 . Registered on 30 November 2021.

PMID:39934879 | DOI:10.1186/s13063-024-08684-8

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Nevin Manimala Statistics

Perceived teacher support and student engagement among higher education students – a systematic literature review

BMC Psychol. 2025 Feb 11;13(1):112. doi: 10.1186/s40359-025-02412-w.

ABSTRACT

BACKGROUND: Research on student engagement has garnered significant interest from educators and practitioners because of its direct impact on academic success and achievement. Engaged students tend to perform better academically and exhibit fewer undesirable study behaviors, thereby enhancing academic outcomes.

OBJECTIVE: This systematic literature review consolidates research on the impact of perceived teacher support on student engagement in higher education. This study emphasizes the association between teacher support in improving students’ academic performance, motivation, and retention. Furthermore, the review explores key theoretical frameworks, such as self-determination theory and social cognitive theory, alongside methodological tools such as measurement instruments and statistical analyses. The goal is to equip psychologists and educational researchers with insights into the relevant frameworks, tools, and methods for advancing future studies within the context of higher education.

METHODS: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology. We conducted a comprehensive search for academic studies published in English within databases such as APA PsycNet, Scopus, ERIC, EBSCOHost, ProQuest, and PubMed to identify eligible studies published between 2014 and 2024.

RESULTS: A review of 13 selected articles revealed that both students’ personal characteristics and school environment factors mediate and moderate the relationship between perceived teacher support and student engagement. The students’ personal characteristics factors include self-efficacy, the fulfillment of psychological needs, and motivation, whereas school environment factors involve the learning environment and the quality of teacher-student and peer relationships. Our findings show a lack of studies prior to 2020, with most research conducted in China and limited contributions from Malaysia and Vietnam. The reviewed articles predominantly used cross-sectional quantitative designs and self-report questionnaires, employing statistical methods like path analysis and structural equation modeling. Theoretical frameworks on student engagement mostly followed Fredricks et al.’s model, while teacher support theories varied, with three main patterns identified: direct influence, mediation through basic psychological needs, and social cognitive perspectives. This review emphasizes the crucial role of teacher support in enhancing student engagement in higher education and urges further exploration in this under-researched area.

CONCLUSION: In conclusion, this review underscores the significant role of teacher support in enhancing student engagement in higher education. It highlights key theoretical frameworks and research methodologies, offering valuable insights for future studies aimed at advancing teacher support and student engagement in this context.

PMID:39934874 | DOI:10.1186/s40359-025-02412-w

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Nevin Manimala Statistics

Efficacy and safety of mesenchymal stromal cell transplantation in the treatment of autoimmune and rheumatic immune diseases: a systematic review and meta-analysis of randomized controlled trials

Stem Cell Res Ther. 2025 Feb 11;16(1):65. doi: 10.1186/s13287-025-04184-x.

ABSTRACT

OBJECTIVE: This study aims to assess the effectiveness and safety of mesenchymal stem cell (MSC) transplantation in the treatment of autoimmune and rheumatic immune diseases through randomized controlled trials (RCTs).

METHODS: Two researchers conducted a comprehensive search of Chinese and English databases from their inception until Dec. 2023. The literature screening and data extraction were then performed. Statistical analysis was carried out using RevMan 5.4 software.

RESULTS: A total of 42 relevant RCTs, involving 2,183 participants, were ultimately included in this study. These RCTs encompassed four types of rheumatic immune and bone diseases, namely rheumatoid arthritis (RA), osteoarthritis (OA), spondyloarthritis, systemic sclerosis arthritis, systemic lupus erythematosus (SLE), inflammatory bowel disease, multiple sclerosis, primary Sjögren’s syndrome (PSS). The systematic review indicates that MSC transplantation may improve spondyloarthritis, RA, PSS. The meta-analysis reveals that MSC transplantation significantly improved symptoms in patients with OA [VAS (visual analogue scale): bone marrow: SMD = – 0.95, 95% CI – 1.55 to – 0.36, P = 0.002; umbilical cord: SMD = – 1.25, 95% CI – 2.04 to – 0.46, P = 0.002; adipose tissue: SMD = -1.26, 95% CI -1.99 to – 0.52, P = 0.0009)], SLE [Systemic lupus erythematosus disease activity index (SLEDAI): SMD = – 2.32, 95% CI – 3.59 to – 1.06, P = 0.0003], inflammatory bowel disease [clinical efficacy: RR = 2.02, 95% CI 1.53 to 2.67, P < 0.00001]. However, MSC transplantation may not improve the symptoms of multiple sclerosis and systemic sclerosis (Ssc). Importantly, MSC transplantation did not increase the incidence of adverse events (OA: RR = 1.23, 95% CI 0.93 to 1.65, P = 0.15; SLE: RR = 0.83, 95% CI 0.28 to 2.51, P = 0.76; Inflammatory bowel disease: RR = 0.99, 95% CI 0.81 to 1.22, P = 0.96; Multiple sclerosis: RR = 1.12, 95% CI 0.81 to 1.53, P = 0.50), supporting its safety profile across the included studies. These findings suggest that MSC transplantation holds promise for several rheumatic and autoimmune diseases while highlighting areas where further research is warranted.

CONCLUSION: MSC transplantation may have the potential to treat autoimmune and rheumatic immune diseases. Moreover. MSC transplantation appears to be relatively safe and could be considered as a viable alternative treatment option for autoimmune and rheumatic immune diseases.

PMID:39934871 | DOI:10.1186/s13287-025-04184-x

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Nevin Manimala Statistics

The relationship between biological aging and psoriasis: evidence from three observational studies

Immun Ageing. 2025 Feb 11;22(1):6. doi: 10.1186/s12979-025-00500-4.

ABSTRACT

BACKGROUND: The relationship between psoriasis and aging remains unclear. Biological age is considered as a tool for strong association with aging, but there is a lack of reports on the relationship between biological age and psoriasis. Therefore, this study aimed to explore the relationship between biological age and psoriasis.

METHODS: Patients with psoriasis and non-psoriasis were recruited from National Health and Nutrition Examination Survey (NHANES) (12,973 cases), Medical Information Mart for Intensive Care (MIMIC-IV) (558 cases) and The First Clinical Medical College of Zhejiang Chinese Medical University (206 cases). Biological age was calculated using Klemera-Doubal method age (KDM-age) and phenotypic age (PhenoAge). Linear regression and logistic regression were used to explore the association between psoriasis and biological age advance. Cox regression was used to investigate the association between biological age advance and mortality. Finally, biological age advance was used to predict the death of psoriasis patients.

RESULTS: In NHANES, linear regression showed that psoriasis led to a 0.54 advance in PhenoAge (Adjust Beta: 0.54, 95CI: 0.12-0.97, p = 0.018). The KDM-age advance due to psoriasis was not statistically significant (p = 0.754). Using data from China, we came to the new conclusion that for every unit rise in Psoriasis Area and Severity Index, PhenoAge advance rose by 0.12 (Beta: 0.12, 95CI: 0.01-0.22, p = 0.031). Using NHANES data, cox regression shows for every unit rise in PhenoAge advance patients had an 8% rise in mortality (Adjust hazard ratio: 1.08, 95CI: 1.04-1.12, p < 0.001). Using MIMIC-IV, logistic regression showed a 13% increase in mortality within 28 days of admission for every 1 unit rise in PhenoAge advance (odds ratio: 1.13, 95CI: 1.09-1.18, P < 0.001). Finally, we used PhenoAge advance to predict death, with an AUC of 0.71 in the NHANES, an ACU of 0.79 for predicting death within 1 years in the general ward of MIMIC-IV. In the ICU of MIMIC-IV, the AUC for predicting death within 28 days was 0.71.

CONCLUSION: Psoriasis leads to accelerated biological aging in patients, which is associated with the severity of psoriasis and more comorbidities. In addition, PhenoAge has the potential to monitor the health status of patients with psoriasis.

PMID:39934868 | DOI:10.1186/s12979-025-00500-4

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Nevin Manimala Statistics

Improving the sexual health of couples with diabetes: study protocol of an action research study

Reprod Health. 2025 Feb 12;22(1):21. doi: 10.1186/s12978-025-01964-9.

ABSTRACT

BACKGROUND: One of the most serious problems that threatens the sexual health of couples is diabetes. Diabetes is a global public health crisis affecting more than 0.5 billion adults worldwide. Inefficiency in implementing family planning or childbearing, sexually transmitted infections and sexual disorders in these patients can lead to psychological problems such as feelings of inadequacy, despair, loss of self-esteem and psychological consequences. Action research has the dual purpose of action, to bring about change in society or an organization or program, and research to increase the understanding of the researcher or the people involved with the problem, or both, in the wider community. Therefore, this study was designed with the aim of improving the sexual health of couples with diabetes with an action research approach.

METHODS: This study will be done with an action research approach in four phases and several steps. In the first phase (planning), which includes 4 steps, during which the needs and challenges of sexual health of couples with diabetes are explained ([with a qualitative and quantitative approach), the literature review of databases, the explanation of suitable and practical solutions, the prioritization of strategy improve sexual health Diabetic couples and development of sexual health promotion program for diabetic couples and Identifying sexual function and sexual satisfaction before implementing the program [before action]will be done. In the second phase (action), the program resulting from the first phase will be implemented, and in the third and fourth phases, the program will be continuously observed and reflected in order to adjust and improve the program. Qualitative data analysis using conventional content analysis method, quantitative data analysis will be done with SPSS 27 statistical software.

CONCLUSION: Since diabetes affects the sexual health and marital satisfaction of couples, and considering that providing sexual health is one of the duties of reproductive health practitioners, and considering that the study of strategic action research is accepted to change attitudes, behavior and performance in the system. It seems that the application of the technical action research method opens the field for the entry of a research team consisting of various relevant experts to implement the plan resulting from It is the participants’ own needs and strategy open.

PMID:39934859 | DOI:10.1186/s12978-025-01964-9

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Nevin Manimala Statistics

Establishment of an ex vivo cartilage damage model by combined collagenase treatment and mechanical loading

Arthritis Res Ther. 2025 Feb 11;27(1):30. doi: 10.1186/s13075-025-03499-7.

ABSTRACT

BACKGROUND: There is a substantial need for ex vivo cartilage damage models to assess new emerging cartilage repair strategies. Ex vivo cartilage explant models have the advantages of achieving standardized and reproducible experimental conditions while maintaining the cells in their native tissue environment. This study aimed to establish a bovine cartilage damage model to evaluate the safety and efficacy of novel cartilage repair therapies. We hypothesized that combining transient exposure to matrix-degrading enzymes with mechanical loading on bovine cartilage would simulate cartilage damage.

METHODS: Prior to mechanical load, bovine osteochondral plugs underwent a brief 5-minutes treatment with collagenase to induce mild cartilage damage by disrupting the collagen network. To induce a moderate cartilage damage, aggrecanase 1 and aggrecanase 2 were additionally applied to the cartilage for 40 min post-collagenase treatment to degrade aggrecan. Data was analyzed using ANOVA or the Friedman test.

RESULTS: Observations revealed a statistically significant loss of sulphated glycosaminoglycan (sGAG) using both Collagenase Treatment (CT) and Collagenase and Aggrecanase Treatment (CAT), while chondrocytes viability was maintained. Both treatments resulted in a significantly elevated release of inflammation markers during the initial two days, including IL6 and nitric oxide. Collagenase treatment also significantly increased neo-epitopes of aggrecan compared to the untreated plugs at day 7, suggesting endogenous aggrecanase activation upon collagen network disruption. The additional effect of mechanical loading on cartilage degeneration was also explored in the CT group. Mildly damaged cartilage treated solely with collagenase could withstand 1 h per day of cyclical load, at 10-20% compression of cartilage thickness combined with interfacial shear at 25 degrees. However, higher compression levels (20-40% of cartilage thickness) with the same shear stress regimen led to a significant increase in surface chondrocyte death, with no evidence of TUNEL staining.

CONCLUSIONS: This study establishes a promising model for evaluating cartilage repair strategies, and screening anti-catabolic drugs, particularly overload-related cartilage damage.

PMID:39934857 | DOI:10.1186/s13075-025-03499-7

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Nevin Manimala Statistics

Death by p-value: the overreliance on p-values in critical care research

Crit Care. 2025 Feb 11;29(1):73. doi: 10.1186/s13054-025-05307-9.

ABSTRACT

The p-value has changed from a versatile tool for scientific reasoning to a strict judge of medical information, with the usual 0.05 cutoff frequently deciding a study’s significance and subsequent clinical use. Through an examination of five critical care interventions that demonstrated meaningful treatment effects yet narrowly missed conventional statistical significance, this paper illustrates how rigid adherence to p-value thresholds may obscure therapeutically beneficial findings. By providing a clear, step-by-step illustration of a basic Bayesian calculation, we demonstrate that clinical importance can remain undetected when relying solely on p-values. These observations challenge current statistical paradigms and advocate for hybrid approaches-including both frequentist and Bayesian methodologies-to provide a more comprehensive understanding of clinical data, ultimately leading to better-informed medical decisions.

PMID:39934845 | DOI:10.1186/s13054-025-05307-9

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Nevin Manimala Statistics

Androgen receptor expression and clinical significance in breast cancer

World J Surg Oncol. 2025 Feb 11;23(1):48. doi: 10.1186/s12957-025-03673-w.

ABSTRACT

PURPOSE: This study aimed to investigate the expression and clinical relevance of the androgen receptor (AR) in breast cancer.

METHODS: This retrospective study examined the expression of AR in breast cancer and its correlation with patients’ clinicopathological and immunohistochemical characteristics. A total of 521 patient records were gathered and assessed. Patients were categorized as either positive or negative for AR expression, and statistical analyses were conducted using the chi-square test, logistic regression in SPSS 26.0, and Kaplan-Meier analysis.

RESULTS: AR was detected in 83.7% of the 521 patients studied. There was a statistically significant difference in the prevalence of AR positivity among different molecular subtypes, estrogen receptor (ER) status, progesterone receptor (PR) status, human epidermal growth factor receptor 2 (HER2) status, and epidermal growth factor receptor (EGFR) (P < 0.05). Logistic regression analysis further revealed that ER and PR positivity were identified as risk factors for AR expression, and Kaplan-Meier curve analysis demonstrated the potential of AR as a prognostic indicator for breast cancer outcomes. Additionally, AR positivity was associated with a favorable prognosis.

CONCLUSIONS: The results suggest a strong correlation between AR expression and ER and PR co-expression in breast cancer. Additionally, AR positivity in the absence of ER and PR expression is associated with a favorable prognosis, indicating potential therapeutic value as a novel target in breast cancer treatment. Particularly in endocrine resistance or triple-negative breast cancer (TNBC), AR may serve as a significant prognostic indicator, warranting further investigation.

PMID:39934842 | DOI:10.1186/s12957-025-03673-w

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Nevin Manimala Statistics

Diversity competence in medical education: short-term effectiveness of an interprofessional diversity-specific undergraduate learning

BMC Med Educ. 2025 Feb 12;25(1):226. doi: 10.1186/s12909-025-06824-5.

ABSTRACT

BACKGROUND: Diversity competence, diversity itself, and a corresponding awareness of possible (intersectional) discrimination mechanisms have not been anchored in the German National Competence based Learning Objectives Catalogue for Medicine 2.0 (Nationaler Kompetenzbasierter Lernzielkatalog 2.0., NKLM) yet, highlighting a systemic gap in national competency frameworks. We present our first experience with a prospective diversity-specific intervention in medical students to assess its short-term impact on students’ diversity acceptance (DA) and to develop actionable recommendations for integrating diversity into medical education.

METHODS: We designed a prospective cohort study using a control group (CG) and intervention group (IG) design. The IG absolved a five-day diversity-specific intervention (50 h; field trip; seminar). Quantitative data were collected using the validated DWD-O5 scale at baseline (T0), three months (T3), and six months (T6), complemented by qualitative responses (diversity issues in the medical curriculum; perceptions and criticisms) categorized using Mayring’s content analysis. Descriptive and non-parametric statistics were performed.

RESULTS: Thirty-one medical students (n = 10, IG vs n = 21, CG) were enrolled. The IG demonstrated a short-term improvement in diversity competence (+ 9.72%) across all DWD-O5 factors during the intervention. While scores slightly declined at T6, they remained above baseline levels. 35% (CG) vs. 56% (IG) have experienced discrimination in context of medical studies on their own. Participants in both groups stressed the importance of integrating diversity criteria into curricula at an early stage (100% agreement). Findings revealed three key themes: perceived inadequacies in current curricula, self-reported discrimination experiences, and a strong desire for practical diversity training, such as simulation-based learning.

CONCLUSION: The intervention shows promise as an initial step toward addressing diversity gaps in medical education. By combining historical, cultural, and experiential learning approaches, the program fosters essential competencies such as empathy, self-reflection, and bias recognition. More broadly, sustained improvements in diversity competence require longitudinal integration of diversity training across curricula and systemic reforms to national frameworks like the NKLM. Future research should explore the long-term impact of such interventions and strategies for institutionalizing equity-focused medical education.

PMID:39934836 | DOI:10.1186/s12909-025-06824-5

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Nevin Manimala Statistics

Comparison of maternal and neonatal outcomes of midwifery-led care with routine midwifery care: a retrospective cohort study

BMC Nurs. 2025 Feb 11;24(1):158. doi: 10.1186/s12912-025-02789-4.

ABSTRACT

INTRODUCTION: Globally, the management of low-risk pregnancies by midwives often leads to a more natural childbirth process, which enhances physical and psychological outcomes for mothers and their babies. Midwives implement various models of maternal care in practice. This study investigates and compares maternal and neonatal outcomes associated with midwifery-led care versus routine midwifery care in private hospitals in Iran.

METHODS: This retrospective cohort study was conducted in Iran in 2022. The study population consisted of two groups including 387 women in the Routine Care Group (RCG) and 397 women in the Private Care Group (PCG). Participants were selected through continuous sampling in accordance with the inclusion criteria. The two groups were compared in terms of some maternal and neonatal outcomes. The research data collection tool was a researcher-made checklist with variables adjusted according to the ‘Iman’ system of the Iran Ministry of Health. Based on this tool, the data were extracted from the mentioned system and analyzed with SPSS software.

FINDINGS: The results indicated no significant difference between the two groups in terms of the type of delivery (p = 0.999), the use of forceps or vacuum (P = 0.5) and transferring the mother to the operating room (OR) or the intensive care unit (ICU) immediately after delivery (P = 0.744). However, there was a statistically significant difference between the two groups in terms of labor pain control (P < 0.001), induction of labor (P < 0.001), and the use of episiotomy (P < 0.001). Regarding neonatal outcomes, there was no statistically significant difference between the two groups in relation to the average infant weight (P = 0.46), Apgar score (P = 0.75), need for resuscitation (P = 0.999), skin-to-skin contact (P = 0.626), initiation of breastfeeding (P = 0.241) and admission to the neonatal intensive care units (NICU) (P = 0.66).

CONCLUSION: Given the positive impact of private care on key maternal outcomes, it is recommended that health policymakers create the conditions necessary for establishing a continuous midwifery care model in both governmental and private hospitals. Besides, more quantitative, qualitative, and especially mixed methods research should be conducted to explore the challenges and facilitators of this model across various settings.

PMID:39934823 | DOI:10.1186/s12912-025-02789-4