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Nevin Manimala Statistics

Tele-patient-reported outcome measures (telePROM) in follow-up of endometriosis: a validity and test-retest reliability study of an endometriosis-specific questionnaire (EQ)

Curr Med Res Opin. 2025 Mar 3:1-10. doi: 10.1080/03007995.2025.2470749. Online ahead of print.

ABSTRACT

OBJECTIVE: Patient-Reported Outcome (PRO) measures supported by a severity algorithm may serve as a decision aid for triage and consultation in follow-up of patients with endometriosis. In a new follow-up regime, patients filled out an endometriosis-specific questionnaire (EQ) at home before outpatient consultation (tele-Patient-Reported Outcome Measures; telePROM). A severity algorithm was assigned patients’ answers using a color code thereby reflecting the need of clinical attention. Our study aimed to assess the test-retest reliability of the severity algorithm and of the single items as well as to evaluate the face- and content validity of the EQ.

METHODS: The study was carried out in a referral endometriosis clinic at a Danish University Hospital. The validation was based on an initial version of the EQ, which was adjusted simultaneously with its severity algorithm, to meet the purpose of this study. Reliability was assessed by a test-retest setting of the questionnaire including patients with endometriosis, ≥ 18 years and Danish speaking. Kappa statistics and interclass correlation analyses were applied to assess test-retest reliability. Face- and content validity was explored by focus group interviewing of patients.

RESULTS: In total, 14 patients answered the questionnaire twice. Results indicate that the EQ demonstrated substantial reliability in three out of five domain indicators in the severity algorithm and 65% of items with kappa values above 0.60. Further, focus-group interview of five patients resulted in adding an open-ended question regarding important issues to discuss at the consultation.

CONCLUSION: TelePROM in outpatient follow-up of endometriosis is feasible as patients viewed the questionnaire relevant for their clinical follow-up. Yet, due to the small sample size results should be interpreted with caution. Further validation of the EQ is recommended.

PMID:40025888 | DOI:10.1080/03007995.2025.2470749

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Epigenomic mechanisms of dietary prescriptions for obesity therapy

Epigenomics. 2025 Mar 2:1-12. doi: 10.1080/17501911.2025.2473309. Online ahead of print.

ABSTRACT

Dietary modification is a cornerstone and a primary goal for weight loss, whose effects may be related to epigenetic phenomena. In this literature review, a comprehensive search without time restriction was performed in PubMed/Medline, Cochrane, SciELO, and Scopus databases to identify epigenetic signatures related to obesity outcomes upon dietary advice. In this context, experimental studies and clinical trials have identified certain DNA methylation marks, miRNA expression profiles and histone modifications putatively associated with adiposity outcomes after different nutritional interventions. These include traditional dietary patterns, diets with different macronutrient compositions, and supplementation with fatty acids, amino acids and derivatives, methyl donors, vitamins and minerals, probiotics and prebiotics, and bioactive food compounds. Some of these epigenetic signatures have been mapped to genes involved in food intake control, adipogenesis, lipolysis, fatty acid oxidation, body fat deposition, and gut microbiota modulation. However, additional studies are still required to address dosage and follow-up variability, validation of epigenetic marks, genome-wide approaches, and appropriate statistical settings. Although more investigation is required, these insights may contribute to the characterization of epigenetic biomarkers of body weight regulation toward the prescription of tailored dietary strategies targeting the epigenome for a more precise obesity management and control.

PMID:40025880 | DOI:10.1080/17501911.2025.2473309

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People Living with HIV’s Worry That the COVID-19 Health Crisis Could Impact Long-Term HIV Care: Lessons From the French Context for Future Disease Epidemics

J Int Assoc Provid AIDS Care. 2025 Jan-Dec;24:23259582251320127. doi: 10.1177/23259582251320127.

ABSTRACT

Background: In 2020, people living with HIV (PLHIV) in France were worried that the COVID-19 health crisis would lead to long-term changes in their HIV care. Using data from the anonymous, online, cross-sectional survey ACOVIH, which was completed by PLHIV between July and September 2020, this study explored factors associated with worry about long-term changes to HIV care after the end of the first lockdown (17 March-11 May 2020). Methods: Using multivariate logistic regression, we compared participants who declared they were worried about long-term changes with those who did not, in terms of their demographic, behavioral, and socioeconomic characteristics, as well as their experience of the COVID-19 crisis and access to care. Results: Among the 249 respondents, 61.5% (n = 153) declared having worries about long-term changes to HIV care. Specifically, after adjustment for gender and age, PLHIV born outside of France (adjusted odds ratios (aOR) [95%CI] = 2.57[1.44;6.76]), those whose financial situation deteriorated since the beginning of the pandemic (4.87[1.97;13.20]), those with a history of HIV opportunistic infections (3.27[1.53;7.32]), and respondents who took psychotropic drugs (3.21[1.50;7.22]) were all more likely to declare having worries. In terms of related determinants, a deterioration in communication with their HIV medical team (3.47[1.61;7.94]), having worries about COVID-19 (1.36[1.14;1.62]), and believing that HIV treatment increased the risk of COVID-19 infection (1.52[1.15;2.03]), were all significantly associated with having worries about long-term changes to HIV care. Conclusion: In the context of future disease epidemics, taking into account the profiles of individual PLHIV, and providing clearer, targeted information on HIV care, could help reduce worry in this population about the continuity of HIV care and could foster efficient communication with care providers.

PMID:40025868 | DOI:10.1177/23259582251320127

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Nevin Manimala Statistics

Medical Racism and Physician Trust Impressions of African-American Breast Cancer Patients Enrolled on the Navigator-Assisted Hypofractionation (NAVAH) Phase I Clinical Trial

Am J Clin Oncol. 2025 Mar 3. doi: 10.1097/COC.0000000000001183. Online ahead of print.

ABSTRACT

OBJECTIVES: The historical distrust between the African-American community and the medical system, rooted in systemic racism, continues to affect health care outcomes today. Although Caucasian women have the largest incidence of breast cancer diagnoses, African-American women have the highest mortality rate. Furthermore, studies show African-American women are less likely to receive hypofractionated radiation therapy (RT). The Navigation-Assisted Hypofractionation (NAVAH) program was designed to identify the barriers preventing equal access to adjuvant hypofractionated RT while also addressing the inequities by utilizing patient navigation services to improve breast cancer survivorship in African-American women. This study explored patients’ perceptions of racism in medicine, offering new insights into this critical, yet understudied aspect of health care disparities.

METHODS: This is a prospective study of African-American breast cancer patients enrolled in the ongoing NAVAH phase I clinical trial. Following consent to receive RT, pretreatment surveys were administered. Surveys assessed participants’ distrust of medical professionals and if care was impacted as a result. Each patient answered a series of questions with responses on a scale from strongly agree to strongly disagree. The significance of patients’ views on medical racism and physician trust was evaluated using the Kendall tau correlation. A P-value of ≤0.05 was considered statistically significant.

RESULTS: The Kendall tau test was used to analyze the data accounting for the possible nonlinear, monotonic nature of the data. Patients believing harmful events have taken place at medical centers were significantly less likely to trust doctors (P=0.03). Of the remaining sets of questions assessed, only the correlation between the belief that African-Americans receive the same care as other patients and the likelihood of following hospital-given advice approached statistical significance (P=0.055).

LESSONS: Patients’ perception of treatment within the medical system can greatly impact their decision to seek care and adhere to treatment, which in return can have a substantial impact on oncologic outcomes. Our findings indicate that patient trust in physicians is significantly impacted by patient perceptions of the likelihood of harmful event occurrence at medical centers, with the correlation of perceived medical racism and obeying hospital-given advice trending towards significance.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05978232.

PMID:40025854 | DOI:10.1097/COC.0000000000001183

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Evaluation of the performance of ChatGPT-4 and ChatGPT-4o as a learning tool in endodontics

Int Endod J. 2025 Mar 2. doi: 10.1111/iej.14217. Online ahead of print.

ABSTRACT

AIMS: The aim of this study was to evaluate the accuracy and consistency of responses given by two different versions of Chat Generative Pre-trained Transformer (ChatGPT), ChatGPT-4, and ChatGPT-4o, to multiple-choice questions prepared from undergraduate endodontic education topics at different times of the day and on different days.

METHODOLOGY: In total, 60 multiple-choice, text-based questions from 6 topics of undergraduate endodontic education were prepared. Each question was asked to ChatGPT-4 and ChatGPT-4o 3 times a day (morning, noon, and evening) and for 3 consecutive days. The accuracy and consistency of AIs were compared using SPSS and R programs (p < .05, 95% confidence interval).

RESULTS: The accuracy rate of ChatGPT-4o (92.8%) was significantly higher than that of ChatGPT-4 (81.7%; p < .001). The question groups affected the accuracy rates of both AIs (p < .001). The times at which the questions were asked did not affect the accuracy of either AI (p > .05). There was no statistically significant difference in the consistency rate between ChatGPT-4 and ChatGPT-4o (p = .123). The question groups did not affect the consistency of either AI, too (p > .05).

CONCLUSIONS: According to the results of this study, the accuracy of ChatGPT-4o was better than that of ChatGPT-4. These findings demonstrate that AI chatbots can be used in dental education. However, it is also necessary to consider the limitations and potential risks associated with AI.

PMID:40025853 | DOI:10.1111/iej.14217

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Prospective Validation of An Inpatient Metastatic Spine Neoplasm Score To Assess the Optimal Radiation Therapy Intervention Modality

Am J Clin Oncol. 2025 Mar 3. doi: 10.1097/COC.0000000000001184. Online ahead of print.

ABSTRACT

OBJECTIVES: Metastatic spine disease is typically treated with conventional external beam radiation therapy (EBRT) or stereotactic body radiation therapy (SBRT). Recently, an inpatient metastatic spine score evaluated retrospectively produced promising results in selecting patients with prognoses favorable enough to benefit from the durability advantages of SBRT over EBRT, with scores of 0 to 3 warranting recommendation of SBRT over EBRT compared with scores of 4 to 7 yielding median survival <90 days. This study represents a prospective evaluation of this algorithm to further assess its potential utility.

METHODS: From July to November 2023, 11 spine metastases referred for inpatient radiation oncology consultation were prospectively assessed according to the inpatient metastatic spine score: scores of 0 to 3 were recommended for SBRT, and 4 to 7 for EBRT or no radiation therapy. The timeframe from consultation to death/hospice was correlated with the cumulative score.

RESULTS: The median age was 68.5 years. Patients with a score of 0 to 3 (n=5) had a median survival of 278 days, compared with scores of 4 to 7 (n=6) having a median survival of 37.5 days; this difference was statistically significant (P=0.0146).

CONCLUSIONS: Prospective validation of the inpatient metastatic spine score reveals the prognosis of patients with scores of 4 to 7 have median survival too brief to benefit from the durability advantages of SBRT over EBRT, while scores of 0 to 3 have a prognosis long enough to benefit from SBRT. These results concur with previous retrospective evaluation, and indicate that the inpatient metastatic spine score is a reliable tool for determining which inpatients with spine metastases are appropriate for SBRT over EBRT.

PMID:40025847 | DOI:10.1097/COC.0000000000001184

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The role of ubiquitin C-terminal hydrolase (UCH-L1) and protein S100B in differentiating patients with epileptic and psychogenic non-epileptic seizures – Pilot study

Epilepsia Open. 2025 Mar 2. doi: 10.1002/epi4.13130. Online ahead of print.

ABSTRACT

OBJECTIVE: Psychogenic non-epileptic seizures (PNES) are functional neurological disorders that are often misdiagnosed and treated as epileptic seizures (ES). Video-electroencephalography (v-EEG) is the gold standard for differentiating ES from PNES. However, blood biomarkers provide a faster and more accessible methodology, particularly for unwitnessed events. Ubiquitin C-terminal hydrolase L1 (UCH-L1) and protein S100B are key biomarkers released following neuronal and glial damage. Previous experimental and clinical studies have shown increased postictal serum and cerebrospinal fluid (CSF) levels of UCH-L1 and S100B in patients with ES.

METHODS: This prospective cohort pilot study compared postictal serum levels of UCH-L1 and S100B proteins in subjects with ES to those with PNES, aiming to identify specific biomarkers for distinguishing these conditions. To exclude confounding factors, the inclusion criteria required normal magnetic resonance (MR) findings of the brain. Strict timing of blood sampling and v-EEG monitoring were used for diagnosing PNES. The study included 32 subjects with epilepsy, 36 with PNES, and 30 healthy controls.

RESULTS: A significant difference in postictal UCH-L1 levels was observed among the groups. Subjects with ES had significantly higher postictal UCH-L1 levels (pg/mL) compared to those with PNES (p = 0.049) and healthy controls (p = 0.029). No significant differences were found between PNES subjects and healthy controls (p = 0.756). Postictal protein S100B levels did not differ significantly between the groups (p = 0.515).

SIGNIFICANCE: This study confirms the potential of postictal UCH-L1 levels as a biomarker for distinguishing ES from PNES. However, it also raises questions about the utility of protein S100B as a biomarker in epilepsy. Given the pilot nature of this study, UCH-L1 cannot yet be adopted for clinical use due to the small sample size, as statistical significance may have been driven by a subset of eight patients.

PLAIN LANGUAGE SUMMARY: This study evaluated two potential biomarkers, UCH-L1 and S100B, to differentiate ES from PNES in clinical practice. Our findings showed elevated postictal UCH-L1 levels in subjects with epilepsy compared to those with PNES, while no significant differences in S100B levels were observed among the groups.

PMID:40025842 | DOI:10.1002/epi4.13130

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Exploration of Using an Open-Source Large Language Model for Analyzing Trial Information: A Case Study of Clinical Trials With Decentralized Elements

Clin Transl Sci. 2025 Mar;18(3):e70183. doi: 10.1111/cts.70183.

ABSTRACT

Despite interest in clinical trials with decentralized elements (DCTs), analysis of their trends in trial registries is lacking due to heterogeneous designs and unstandardized terms. We explored Llama 3, an open-source large language model, to efficiently evaluate these trends. Trial data were sourced from Aggregate Analysis of ClinicalTrials.gov, focusing on drug trials conducted between 2018 and 2023. We utilized three Llama 3 models with a different number of parameters: 8b (model 1), fine-tuned 8b (model 2) with curated data, and 70b (model 3). Prompt engineering enabled sophisticated tasks such as classification of DCTs with explanations and extracting decentralized elements. Model performance, evaluated on a 3-month exploratory test dataset, demonstrated that sensitivity could be improved after fine-tuning from 0.0357 to 0.5385. Low positive predictive value in the fine-tuned model 2 could be improved by focusing on trials with DCT-associated expressions from 0.5385 to 0.9167. However, the extraction of decentralized elements was only properly performed by model 3, which had a larger number of parameters. Based on the results, we screened the entire 6-year dataset after applying DCT-associated expressions. After the subsequent application of models 2 and 3, we identified 692 DCTs. We found that a total of 213 trials were classified as phase 2, followed by 162 phase 4 trials, 112 phase 3 trials, and 92 phase 1 trials. In conclusion, our study demonstrated the potential of large language models for analyzing clinical trial information not structured in a machine-readable format. Managing potential biases during model application is crucial.

PMID:40025837 | DOI:10.1111/cts.70183

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Elevated atherogenic index of plasma is associated with increased cardiorenal syndrome prevalence: a cross-sectional study

Ren Fail. 2025 Dec;47(1):2472037. doi: 10.1080/0886022X.2025.2472037. Epub 2025 Mar 2.

ABSTRACT

PURPOSE: Cardiorenal syndrome (CRS) is a complex clinical condition characterized by the simultaneous dysfunction of the heart and kidneys. The atherogenic index of plasma (AIP), calculated as the logarithm of the ratio of triglycerides (TG) to high-density lipoprotein cholesterol (HDL-C), has emerged as a potential biomarker for cardiovascular risk. This study investigates the association between AIP and CRS, aiming to explore the potential linkage between AIP and CRS.

METHODS: Data were sourced from the National Health and Nutrition Examination Survey spanning 2005-2018, involving 35,365 participants after applying exclusion criteria. The primary exposure variable was AIP, categorized into quartiles, while the primary outcome variable was CRS, defined by the coexistence of cardiovascular disease (CVD) and chronic kidney disease (CKD). Statistical analyses, considering sample weights, included ANOVA, Chi-square tests, logistic regression models, and restricted cubic spline (RCS) analysis to examine nonlinear relationships.

RESULTS: The weighted logistic regression analysis showed a positive correlation between AIP and CRS across all models. In the fully adjusted model, the highest AIP quartile had a significantly increased odds ratio (OR) for CRS (Q4: OR = 1.62; 95% CI: 1.21-2.15). RCS analysis confirmed a positive correlation between AIP and CRS, with TG positively and HDL-C negatively correlated with CRS. Subgroup analysis indicated a significant interaction with hypertension, showing a stronger association in non-hypertensive individuals.

CONCLUSION: Higher AIP levels are associated with an increased prevalence of CRS, with a notable hypertension-specific interaction indicating a higher effect in individuals without hypertension.

PMID:40025821 | DOI:10.1080/0886022X.2025.2472037

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The association of pre-COVID-19 social isolation and functional social support with loneliness during COVID-19: a longitudinal analysis of the Canadian Longitudinal Study on Aging

Aging Ment Health. 2025 Mar 2:1-10. doi: 10.1080/13607863.2025.2472888. Online ahead of print.

ABSTRACT

OBJECTIVES: We evaluated the association between two measures of social connection prior to COVID-19-social isolation and functional social support-and loneliness during the pandemic.

METHOD: The study was a retrospective longitudinal analysis of 20,129 middle-aged and older adults enrolled in the Canadian Longitudinal Study on Aging (CLSA). We drew upon two waves of CLSA data spanning three years and the supplemental COVID-19 Questionnaire Study of eight months to conduct our analysis.

RESULTS: Social isolation prior to COVID-19 was associated with loneliness during COVID-19 only among persons who were lonely before the pandemic (adjusted odds ratio [aOR]: 1.17; 95% confidence interval [CI]: 1.02, 1.35). Higher functional social support prior to COVID-19 was inversely associated with loneliness during the pandemic, when adjusting for pre-COVID-19 loneliness (aOR: 0.37; 95%CI: 0.34, 0.41) and when assessing incident loneliness during the pandemic (adjusted relative risk: 0.59; 95% CI: 0.55, 0.63).

CONCLUSION: Policies are needed to identify people who are both socially isolated and lonely, and provide them with functional social support, to prevent worsening loneliness during public health crises.

PMID:40025804 | DOI:10.1080/13607863.2025.2472888