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Nevin Manimala Statistics

Efficacy and cost-effectiveness of an ACT and compassion-based intervention for women with breast cancer: study protocol of two randomised controlled trials {1}

Trials. 2025 Jan 3;26(1):5. doi: 10.1186/s13063-024-08626-4.

ABSTRACT

BACKGROUND: Breast cancer is the most diagnosed cancer in women worldwide and carries a considerable psychosocial burden. Interventions based on Acceptance and Commitment Therapy (ACT) and compassion-based approaches show promise in improving adjustment and quality of life in people with cancer. The Mind programme is an integrative ACT and compassion-based intervention tailored for women with breast cancer, which aims to prepare women for survivorship by promoting psychological flexibility and self-compassion. A pilot study of the Mind programme has shown acceptability and preliminary efficacy in improving quality of life and psychological health. This paper presents the study protocol of two randomised controlled trials that aim to test the efficacy and cost-effectiveness of an optimised version of the Mind programme in women with breast cancer.

METHODS: Participants will be women diagnosed with breast cancer randomly assigned to the Mind programme or a support group intervention (active control) in a 1:1 ratio for study 1, while study 2 includes one more arm (treatment as usual; inactive control) and a 2:2:1 ratio. Both interventions will be delivered weekly via an 8-session face-to-face or online group format. Data will be collected at baseline, post-treatment and 6-month follow-up. The efficacy and cost-effectiveness of the two interventions will be assessed. Treatment outcomes will comprise cancer-specific quality of life (primary outcome), anxiety and depressive symptoms, psychological flexibility, self-compassion, health-related quality of life, resource use, and intervention’s acceptability and feasibility. Study 1 will also include immunological and epigenetic markers associated with breast cancer prognosis and mental health. Outcome assessors will be blind to group allocation. Statistical analyses will be conducted using an intention-to-treat approach. Analyses of moderators and mediators of change will also be performed.

DISCUSSION: These trials examine the efficacy and cost-effectiveness of an integrative ACT and compassion-based intervention tailored for women with breast cancer. Greater improvements in psychosocial, biological and resource use are expected in the Mind group, when compared to the control group(s). Results will likely support the potential benefits of the Mind programme for breast cancer patients and highlight the clinical relevance of integrative and holistic interventions in oncology. TRIALS REGISTRATION {2A, 2B}: ClinicalTrials.gov NCT05642897 and NCT06212414. Registered on December 8, 2022, and January 18, 2024.

PMID:39754194 | DOI:10.1186/s13063-024-08626-4

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Risk analysis of cardiovascular toxicity in patients with lymphoma treated with CD19 CAR T cells

J Transl Med. 2025 Jan 4;23(1):8. doi: 10.1186/s12967-024-06035-4.

ABSTRACT

BACKGROUND: Anti-CD19 chimeric antigen receptor (CAR) T cell therapy is a common, yet highly efficient, cellular immunotherapy for lymphoma. However, many recent studies have reported on its cardiovascular (CV) toxicity. This study analyzes the cardiotoxicity of CD19 CAR T cell therapy in the treatment of lymphoma for providing a more valuable reference for clinicians.

METHODS: The PubMed, Embase, Cochrane library, and Web of Science databases were comprehensively searched from the time of their establishment to May 2024. The ClinicalTrials.gov English database is a comprehensive repository of the original studies of CD19 CAR T cell therapy and associated adverse outcomes, such as arrhythmia, CV events, and hypotension, in patients with lymphoma. The Cochrane Collaboration tool and the Newcastle-Ottawa Scale (NOS) were used to assess the quality of the included original studies. For RCTs, the Cochrane Collaboration tool was used to assess the risk of bias. For non-randomized studies, the risk of bias was assessed using the NOS quality assessment scale.

RESULTS: A risk analysis of two randomized controlled trials and nine cohort studies, totaling 1379 patients with lymphoma receiving CD19 CAR-T, is conducted. The incidences for all-cause mortality, CV events, and hypotension were found to be 17.8%, 17.8%, and 52.8%, respectively. Additionally, the incidences of heart failure (HF), cardiomyopathy, cardiac arrest, and other CV events are 3%, 0.6%, 1.3%, and 2.5%, respectively. In addition to cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) as adverse events, patients treated with CD19 CAR T cells are also at risk of CV events. The most common CV events are arrhythmia and HF. Our further analysis showed that the incidence of CV events was 28.7% in the elderly and 13.5% in adults. The incidence of CV events in the elderly was higher than that in adults, and it was statistically significant. Furthermore, the incidence of CV events and hypotension is strongly associated with patients with CRS.

CONCLUSION: Therefore, clinicians should pay close attention to the occurrence of such CV events and take timely prevention and intervention measures to further improve the safety of CD19 CAR T cell therapy.

PMID:39754193 | DOI:10.1186/s12967-024-06035-4

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Association between remnant cholesterol (RC) and endometriosis: a cross-sectional study based on NHANES data

Lipids Health Dis. 2025 Jan 4;24(1):2. doi: 10.1186/s12944-024-02422-4.

ABSTRACT

BACKGROUND: Prior research indicates a potential link between dyslipidemia and endometriosis (EMs). However, the relationship between remnant cholesterol (RC) and EMs has not been thoroughly investigated. Consequently, looking into and clarifying the connection between RC and EMs was the primary goal of this study.

METHODS: Following the screening of participants from the NHANES dataset spanning 2001 to 2006, a total of 1,840 individuals were incorporated into this research. A weighted multivariable logistic regression analysis was first performed to investigate the relation between RC and the likelihood of encountering EMs. To assess the degree of consistency in the link between RC and EMs across different populations, additional subgroup analyses were performed. In addition, the researchers used the extreme gradient boosting (XGBoost) technique and the area under the receiver operating characteristic curve (ROC) to evaluate how well RC recognized EMs. Lastly, both linear and nonlinear relationships were validated using generalized additive models (GAM), while dose-response connections were investigated through restricted cubic spline models.

RESULTS: After accounting for all potential confounders, a strong correlation between RC and EMs was identified. In particular, an increase of one unit in RC was linked to a 135% rise in the likelihood of developing EMs. Analyses of subgroups revealed that these relationships remained stable across the majority of subgroups (interaction P-value > 0.05). Multivariable logistic regression demonstrated RC’s independent predictive value, maintaining statistical significance after adjusting for confounders. The AUC of 0.614 suggests RC’s moderate ability to discriminate EMs, outperforming traditional markers like LDL-C in sensitivity and specificity. Furthermore, XGBoost analysis identified RC as the most critical predictor among lipid-related and demographic variables. The relationship was further validated through GAM, which visually confirmed a linear trend, and RCS, which provided statistical evidence of linearity.

CONCLUSION: This study reveals a clear connection between RC and the likelihood of having EMs within the US population, suggesting RC as a potential marker for further investigation in understanding endometriosis risk.

PMID:39754185 | DOI:10.1186/s12944-024-02422-4

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Knowledge, awareness and attitudes among a group of Turkish dental students regarding molar incisor hypomineralization: a cross-sectional study

BMC Oral Health. 2025 Jan 3;25(1):14. doi: 10.1186/s12903-024-05401-4.

ABSTRACT

BACKGROUND: Molar incisor hypomineralization (MIH) is estimated to affect more than 800 million people worldwide. The clinical management of MIH can be challenging. For dentists, to provide effective and high-quality dental care to people affected by MIH, it is essential that they improve their awareness, ability to describe the clinical situation, and knowledge of treatment modalities. Previous surveys conducted with students showed that only a limited number are confident in diagnosing MIH. The aim of the study was to assess the clinical knowledge and perceptions of 4th- and 5th-year dental students regarding the distribution, severity, etiology and treatment modalities of MIH.

METHODS: In this cross-sectional study, a total of 194 students studying in the 4th- (85 students) and 5th- (109 students) years participated in the survey. The survey had 23 questions and two sections, the first of which was intended to gather demographic information about the students. The second part consisted of questions about the diagnosis, etiology, and treatment of MIH. The independent t test and the chi-square test was used to compare qualitative data.

RESULTS: The majority of students (78.87%) stated that they had known about MIH. 5th-year students had known about MIH at a statistically significantly higher rate compared to 4th-year students (p = 0.0001). While only 19.69% of the participants stated that they could diagnose a patient with MIH, the proportion of 5th-year students who could make such a diagnosis was statistically significantly higher (p = 0.0001). The majority of the participants (96.39%) stated that they wanted MIH-related practices to be included more in their clinical education. The most desired topic to be included was diagnosis (91.98%).

CONCLUSIONS: The current study showed that students have some knowledge about MIH, but this knowledge is not sufficient, especially in terms of diagnosis and treatment. The students clearly wanted to develop their knowledge of MIH both theoretically and practically.

PMID:39754180 | DOI:10.1186/s12903-024-05401-4

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Extensible lateral approach versus sinus tarsi approach for sanders type II and III calcaneal fractures osteosynthesis: a randomized controlled trial of 186 fractures

J Orthop Surg Res. 2025 Jan 3;20(1):8. doi: 10.1186/s13018-024-05345-z.

ABSTRACT

AIMS: Which is the best extensile lateral (ELA) or sinus tarsi (STA) approach for osteosynthesis displaced intraarticular calcaneal fracture (DIACF) is still debatable. The current RCT’s primary objective was to compare the complications incidence after open reduction and internal fixation of DIACFs through STA vs. ELA. The secondary objectives were the differences in intraoperative radiation exposure, time to fracture union, functional and radiological outcomes.

METHODS: Between August 2020 and February 2023, 157 patients with Sanders type II and III fractures were randomly assigned to either ELA (81 patients with 95 fractures) or STA (76 patients with 91 fractures). The primary outcome was the incidence of complications. The secondary outcomes were Böhler’s and Gissane angles angle, fracture union, and American Orthopaedic Foot and Ankle Society (AOFAS) score.

RESULTS: No statistical differences between both groups regarding basic demographic data, injury characteristics, and fracture classification; however, patients in the STA group were operated upon significantly earlier (4.43 ± 7.37 vs. 7 ± 6.42 days, p = 0.001). STA’s operative time was significantly shorter (55.83 ± 7.35 vs. 89.66 ± 7.12 min, p < 0.05), and no statistical difference regarding intraoperative radiation exposure. The time to fracture union was significantly shorter in STA (6.33 ± 0.8 vs. 7.13 ± 0.7 weeks, p = 0.000). Skin complications (superficial or deep infection) and Subtalar osteoarthritis were significantly higher in ELA (18.9% vs. 3.3%, p = 0.001) and (32.6% vs. 9.9%, p = 0.001), respectively. The radiological parameters were significantly better in STA postoperatively and at the last follow up. The AOFAS scores were significantly better in STA (83.49 ± 7.71 vs. 68.62 ± 7.05, respectively, p = 0.000).

CONCLUSION: During osteosynthesis of Sanders type II and III DIACFs, STA is superior to ELA in terms of operating earlier, shorter operative time, fewer complications, and better radiological and functional outcomes.

PMID:39754179 | DOI:10.1186/s13018-024-05345-z

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Nevin Manimala Statistics

Psychometric properties of the Iranian version of the dissociative experiences measure, Oxford (DEMO)

BMC Psychiatry. 2025 Jan 3;25(1):8. doi: 10.1186/s12888-024-06399-3.

ABSTRACT

BACKGROUNDS: Dissociative experiences are described as crucial psychological mechanisms involving the organism’s responses to severe psychological traumas and unpleasant past experiences. This research was conducted to examine the psychometric properties of the Dissociative Experiences Measure, Oxford (DEMO) in the Iranian general population.

METHODS: This study used cross-sectional correlation, and the statistical population consisted of Iranians over 15 years old. Among them, 712 subjects were chosen as the study sample using the convenience sampling technique. Data were acquired between February and April 2022 using DEMO, Dissociative Experiences Scale II (DES-II), and Depression Anxiety and Stress Scale (DASS-21). In order to determine DEMO’s psychometric properties, Confirmatory Factor Analysis (CFA) was used to investigate the factorial structure, Cronbach’s alpha analyses to examine the internal consistency reliability, and Pearson correlation analyses to examine the relationships between DEMO’s subscales and the subscales of DES-II and DASS-21, indicating convergent validity. In order to analyze the data, LISREL 8.0 and SPSS-26 were used.

RESULTS: Based on the results of the CFA, the proposed five-factor structure of DEMO showed an acceptable fit to the data (χ² = 1939.81, SRMR = 0.078, CFI = 0.96, RMSEA = 0.074). The internal reliability was satisfactory for the total scale (Cronbach’s alpha = 0.93) and the five subscales (Cronbach’s alpha = 0.89 for unreality, 0.87 for numb and disconnected, 0.80 for memory blanks, 0.85 for zoned out, and 0.79 for vivid internal world). The CFA results indicated that the five factors explained 60.69% of the variance. Significant correlations were observed between the DEMO subscales and the respective subscales of DES-II and DASS-21, confirming the measure’s convergent validity.

CONCLUSION: It can be concluded from the results of this study that the DEMO has high reliability and validity among the Iranian general population.

PMID:39754178 | DOI:10.1186/s12888-024-06399-3

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KDM6A facilitates Xist upregulation at the onset of X inactivation

Biol Sex Differ. 2025 Jan 3;16(1):1. doi: 10.1186/s13293-024-00683-3.

ABSTRACT

BACKGROUND: X chromosome inactivation (XCI) is a female-specific process in which one X chromosome is silenced to balance X-linked gene expression between the sexes. XCI is initiated in early development by upregulation of the lncRNA Xist on the future inactive X (Xi). A subset of X-linked genes escape silencing and thus have higher expression in females, suggesting female-specific functions. One of these genes is the highly conserved gene Kdm6a, which encodes a histone demethylase that removes methyl groups at H3K27 to facilitate gene expression. KDM6A mutations have been implicated in congenital disorders such as Kabuki Syndrome, as well as in sex differences in development and cancer.

METHODS: Kdm6a was knocked out (KO) using CRISPR/Cas9 gene editing in hybrid female mouse embryonic stem (ES) cells derived either from a 129 × Mus castaneus (cast) cross or a BL6 x cast cross. In one of the lines a transcriptional stop signal inserted in Tsix results in completely skewed X silencing upon differentiation. The effects of both homozygous and heterozygous Kdm6a KO on Xist expression during the onset of XCI were measured by RT-PCR and RNA-FISH. Changes in gene expression and in H3K27me3 enrichment were investigated using allele-specific RNA-seq and Cut&Run, respectively. KDM6A binding to the Xist gene was characterized by Cut&Run.

RESULTS: We observed impaired upregulation of Xist and reduced coating of the Xi during early stages of differentiation in Kdm6a KO cells, both homozygous and heterozygous, suggesting a threshold effect of KDM6A. This was associated with aberrant overexpression of genes from the Xi after differentiation, indicating loss of X inactivation potency. Consistent with KDM6A having a direct role in Xist regulation, we found that the histone demethylase binds to the Xist promoter and KO cells show an increase in H3K27me3 at Xist, consistent with reduced expression.

CONCLUSIONS: These results reveal a novel female-specific role for the X-linked histone demethylase, KDM6A in the initiation of XCI through histone demethylase-dependent activation of Xist during early differentiation. X chromosome inactivation is a female-specific mechanism that evolved to balance sex-linked gene dosage between females (XX) and males (XY) by silencing one X chromosome in females. X inactivation begins with the upregulation of the long noncoding RNA Xist on the future inactive X chromosome. While most genes become silenced on the inactive X chromosome some genes escape inactivation and thus have higher expression in females compared to males, suggesting that escape genes may have female-specific functions. One such gene encodes the histone demethylase KDM6A which function is to turn on gene expression by removing repressive histone modifications. In this study, we investigated the role of KDM6A in the regulation of Xist expression during the onset of X inactivation. We found that KDM6A binds to the Xist gene to remove repressive histone marks and facilitate its expression in early development. Indeed, depletion of KDM6A prevents upregulation of Xist due to abnormal persistence of repressive histone modifications. In turn, this results in aberrant overexpression of genes from the inactive X chromosome. Our findings point to a novel mechanism of Xist regulation during the initiation of X inactivation, which may lead to new avenues of treatment to alleviate congenital disorders such as Kabuki syndrome and sex-biased immune disorders where X-linked gene dosage is perturbed.

PMID:39754175 | DOI:10.1186/s13293-024-00683-3

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How does integrating ‘disaster nursing’ into nursing curricula impact nursing students’ perception of disaster literacy and preparedness?

BMC Nurs. 2025 Jan 3;24(1):1. doi: 10.1186/s12912-024-02478-8.

ABSTRACT

BACKGROUND: Disaster nursing involves systematic and professional care provided to communities affected by natural or man-made disasters. With limited resources in global disaster settings, nurses play a crucial role in disaster management. The aim of this study is to investigate the impact of integrating ‘Disaster Nursing’ into nursing curricula on nursing students’ perceptions of disaster literacy and preparedness.

METHODS: This quasi-experimental one-group pretest-posttest study was conducted at a public university in Izmir, Turkey. The pre-test took place on September 27, 2021, and the post-test on January 7, 2022. The study population comprised 66 nursing students enrolled in the elective “Disaster Nursing” course, with 62 volunteering for participation. Data collection tools included an individual introduction form, the Disaster Literacy Scale, and the Perception of Disaster Preparedness in Nurses Scale. The 14-week “Disaster Nursing” course served as the intervention. Data were collected online and analyzed using descriptive statistics, paired sample t-tests, and Pearson correlation.

RESULTS: Of the students, 51.6% were aged 22-23, and 62.9% were female. Additionally, 54.8% reported previous disaster experience. The mean pre-test score on the Disaster Literacy Scale was 32.97 ± 6.47, which increased significantly to 40.58 ± 5.95 post-test (p < 0.05). The mean pre-test score on the Perception of Disaster Preparedness in Nurses Scale was 81.66 ± 4.61, rising significantly to 90.64 ± 6.25 post-test (p < 0.05). A statistically significant positive correlation was found between the total scores of the Disaster Literacy and Disaster Preparedness in Nurses scales (r = 0.79).

CONCLUSIONS: The integration of “Disaster Nursing” into nursing curricula positively enhanced the disaster literacy and preparedness perceptions of nursing students. The results demonstrated that higher levels of disaster literacy were associated with increased disaster preparedness among nurses. These findings can inform the development of educational policies for disaster nursing education in Turkey.

PMID:39754162 | DOI:10.1186/s12912-024-02478-8

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The effect of an app-based dietary education on dietary intake and cardiometabolic risk markers in people with type 2 diabetes: results from a randomized controlled trial

Nutr J. 2025 Jan 4;24(1):2. doi: 10.1186/s12937-024-01069-2.

ABSTRACT

BACKGROUND: mHealth, i.e. mobile-health, strategies may be used as a complement to regular care to support healthy dietary habits in primary care patients. We evaluated the effect of a 12-week smartphone-based dietary education on overall diet quality (primary outcome), and dietary intake and cardiometabolic risk markers (secondary outcomes) in people with type 2 diabetes.

METHODS: In this two-armed randomized clinical trial, people with type 2 diabetes were recruited within a primary care setting and randomized 1:1 to a smartphone-delivered dietary education for 12 weeks or a control group receiving regular care only. Dietary intake and cardiometabolic risk markers were measured at baseline and after 3 months. Diet was assessed using a 4-day dietary record and a food frequency questionnaire (FFQ). Overall diet quality was estimated with a Nordic Nutrition Recommendation (NNR) score and specific dietary intake was estimated for 13 food groups/nutrients. We used linear regression models to examine differences in change from baseline to the 3-month follow-up between the intervention and control group, adjusted for baseline values of each outcome variable.

RESULTS: The study included 129 participants (67 in the intervention group and 62 controls), of whom 61% were men. At baseline, mean age was 63.0 years and mean body mass index was 29.8 kg/m2. When analyzing dietary record data, we found no effect of the intervention on diet quality or intake, however, the control group had increased their score by 1.6 points (95%CI: -2.9, -0.26) compared to the intervention group. In the analyses of FFQ data, the intervention group had lowered their daily intake in grams of saturated (β = -4.1, 95%CI: -7.9, -0.2) and unsaturated (mono- and polyunsaturated) (β = -6.9, 95%CI: -13.5, -0.4) fat more than the control group. The intervention group also presented lower serum triglycerides levels than the controls (β = -0.33, 95%CI: -0.60, -0.05). No statistical differences were found in any other dietary variables or cardiometabolic risk markers.

CONCLUSION: While we found no effect on overall diet quality, our findings suggest that a smartphone-based dietary education might impact dietary fat intake and corresponding cardiometabolic risk markers in people with type 2 diabetes. Our results should be considered hypothesis-generating and need to be confirmed in future studies.

TRIAL REGISTRATION: Registered at ClinicalTrials.gov ( NCT03784612 ). Registered 24 December 2018.

PMID:39754157 | DOI:10.1186/s12937-024-01069-2

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Joint analysis of blood pressure changes over time and survival of hypertensive patients under treatment at Sawula hospital in Southern Ethiopia

BMC Public Health. 2025 Jan 3;25(1):23. doi: 10.1186/s12889-024-21176-3.

ABSTRACT

INTRODUCTION: Hypertension is among the most significant non-communicable public health issues worldwide. High blood pressure, or hypertension, has been associated with severe health consequences, including death, aneurysms, stroke, chronic renal disease, eye damage, heart attack, heart failure, peripheral artery disease, and vascular dementia. Consequently, this study aimed to investigate the predictors linked to survival time and the progression of blood pressure measurements in hypertensive patients.

METHODS: This study on retrospective cohort analysis was conducted among hypertensive patients receiving follow-up treatment. A total of 200 hypertensive patients were screened during their follow-up at Sawula General Hospital. Multivariate joint models typically combine a multivariate linear mixed-effects model for repeated measurements with a Cox model for time-to-event outcomes.

RESULT: The baseline characteristics of patients indicated that, out of 200 hypertensive patients, the majority were male, totaling 116 (58%). Regarding alcohol consumption, 72 (36%) of the hypertensive patients reported using alcohol, while 128 (64%) did not. The multivariate joint model emerged as the most effective model in this study. The analysis revealed that observation time, economic status, sex, place of residence, baseline FBS, and age significantly influenced log FBS, while visiting time, age, sex, pulse rate, place of residence, and baseline DBP were identified as significant factors for log diastolic blood pressure.

CONCLUSION: The multivariate joint model exhibited superior performance. Hypertension continues to be a non-communicable disease and a public health issue in Sawula and Ethiopia, deserving greater attention.

PMID:39754151 | DOI:10.1186/s12889-024-21176-3