Nevin Manimala

Arthritis Res Ther. 2025 Dec 4. doi: 10.1186/s13075-025-03697-3. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate maternal-fetal outcomes and therapeutic efficacy in Takayasu arteritis (TA)-complicated pregnancies through integrated retrospective analysis and meta-analytic synthesis.

METHODS: A dual-design study was conducted: (1) retrospective analysis of 20 pregnancies (17 patients) at West China Second Hospital (2012-2024), stratifying TA phases (acute/prolonged/stable); (2) systematic review with random-effects meta-analysis of 16 studies (568 pregnancies globally). Clinical data encompassed maternal-fetal profiles, TA-specific variables, laboratory metrics (hematologic/coagulation parameters), and therapies (glucocorticoids /immunosuppressants /antihypertensives). Outcomes were compared against normative standards using t-tests, Wilcoxon, chi-square, and meta-regression.

RESULTS: Among 20 pregnancies (median maternal age 28.5 years), 50% had at least one obstetric complication, with arterial stenosis (80%) and hypertension (40%) predominant. Meta-analysis revealed 42.6% adverse outcomes: gestational hypertension (26.1%), fetal growth restriction (17.7%), and preterm delivery (13.6%). Hematological analysis (n = 20) showed elevated WBC, PCT, TT, fibrinogen, urinary protein, and ALT (all P < 0.05), alongside reduced PT, albumin, and bilirubin (P < 0.05). Regarding the analysis results of inflammatory indicators, CRP (prepartum) (95%CI = 0.969-1.034, OR = 1.001), CRP (postpartum) (95%CI = 0.920-1.217, OR = 1.058), and ESR (95%CI = 0.952-1.101, OR = 1.024) showed no statistically significant association with pregnancy outcomes. Neither pre-pregnancy nor gestational glucocorticoids (prednisone vs methylprednisolone) or immunosuppressants significantly reduced complications (all RR 95% CI crossed 1; P > 0.05). Antihypertensive therapy showed no correlation with preeclampsia (P > 0.05).

CONCLUSION: TA significantly elevates maternal-fetal risks, driving hypertension, growth restriction, and preterm birth via vasculopathic-inflammatory pathways. Postpartum hypercoagulability (↑fibrinogen, ↓prothrombin time) necessitates multidisciplinary coagulation monitoring and mandatory thromboprophylaxis.

PMID:41345710 | DOI:10.1186/s13075-025-03697-3

BMC Psychol. 2025 Dec 4. doi: 10.1186/s40359-025-03780-z. Online ahead of print.

ABSTRACT

BACKGROUND: Serious complications affecting burn patients include reduced body image satisfaction, which can negatively influence their mental health. At the same time, resilience is a key factor in promoting psychological well-being. Therefore, the present study aimed to examine the relationship between body image satisfaction and resilience among burn patients in 2022-2023.

METHODS: In this descriptive cross-sectional study, 106 burn patients from Hamadan were enrolled using stratified quota sampling. The study instruments included a demographic information questionnaire, the Connor-Davidson Resilience Scale, and the Souto and Garcia Body Image Satisfaction Questionnaire. Data were analyzed using STATA version 14, employing descriptive statistics and Spearman’s correlation coefficient.

RESULTS: The results showed that the mean ± standard deviation for body image satisfaction was 59.83 ± 16.98, and for resilience, 56.26 ± 17.61. Furthermore, analysis indicated a strong, positive, and statistically significant correlation between body image satisfaction and resilience among these patients (r = 0.614, P < 0.001).

CONCLUSION: This study found that burn patients reported moderate levels of body image satisfaction and resilience. A significant positive correlation was observed between these two variables, suggesting that patients with higher body image satisfaction tend to exhibit greater resilience in coping with the physical and psychological challenges of burn injuries. These findings highlight the importance of integrating psychological care targeting body image into rehabilitation programs, as addressing body image concerns may help enhance resilience and improve overall well-being among burn survivors.

PMID:41345708 | DOI:10.1186/s40359-025-03780-z

BMC Sports Sci Med Rehabil. 2025 Dec 5. doi: 10.1186/s13102-025-01409-7. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to comparatively evaluate the scientific approach, accuracy, and practical applicability of different versions of ChatGPT in generating training programs.

METHOD: Adopting a mixed-methods design, the study employed seven distinct instruction sets, each developed with input from seven experts possessing a minimum of 10 years of professional experience (Certified Strength and Conditioning Specialists (CSCS), academicians holding PhDs in Sports Sciences with research focus on exercise physiology and training methodology) in their respective fields. Using these instruction sets, three versions of ChatGPT (ChatGPT-3.5, ChatGPT-4o, and ChatGPT-4.1) were tasked with generating 12-week resistance training programs for a hypothetical, healthy young adult male with a moderate training background. Using a rubric scoring scale, the generated programs were systematically evaluated and scored separately based on the following criteria: compliance with the initial program request, inclusion of literature references, adherence to exercise variety and progressive loading principles, individualization of progression and justification, program modifications, inclusion of warm-up and cool-down components, injury risk considerations, presence of incorrect recommendations and practical applicability, and accessibility.To determine whether differences in mean scores were statistically significant, the Friedman non-parametric test was applied. When significant differences were identified, pairwise comparisons were conducted using the Wilcoxon signed-rank test to determine which groups accounted for these differences. In addition, qualitative data analysis was performed to explore expert evaluations in depth, employing both content analysis and descriptive analysis techniques.

RESULTS: Statistically significant differences were identified among the ChatGPT versions examined in this study: between ChatGPT-4o and ChatGPT-3.5 (p = .018), ChatGPT-4.1 and ChatGPT-3.5 (p = .018), and ChatGPT-4.1 and ChatGPT-4o (p = .018). Expert content analysis further indicated that ChatGPT-4.1 produced responses that were more detailed, internally consistent, and better supported by scientific literature compared to the other versions.

CONCLUSION: Although the ChatGPT versions examined in this study exhibited certain limitations, they demonstrated the potential to deliver structured exercise programs aligned with established training principles and relevant scientific literature. Nonetheless, to ensure that AI-assisted training plans provide safe, evidence-based, and individualized content, the involvement of qualified human expertise remains essential.

TRIAL REGISTRATION: No official trial registration number was assigned.

PMID:41345701 | DOI:10.1186/s13102-025-01409-7

Trials. 2025 Dec 4;26(1):561. doi: 10.1186/s13063-025-09358-9.

ABSTRACT

BACKGROUND: The two-period randomised crossover design can be advantageous over the parallel-group randomised controlled design with two study arms, yielding greater statistical power and requiring smaller sample sizes. However, a general assumption of the crossover design is that study participants return to their stable baseline state after the experimental treatment has been withdrawn, either immediately or following a wash-out period.

MAIN BODY: In this article, we describe an alternative paradigm for the crossover design, which assumes that participants do not return to their baseline after the experimental treatment has discontinued-in other words, a paradigm under which a persistent carry-over effect is anticipated and even desired after intervention cessation. Such a paradigm is suitable, for example, when investigating behaviour change interventions that aim to establish long-lasting health behaviours through, for example, patient education or counselling. We present sample size calculations and statistical simulations to illustrate that under this alternative paradigm, the randomised crossover design can still maintain greater power than the parallel-group randomised controlled design. Statistical simulations show that, under realistic assumptions of partial or full carry-over, the crossover design can maintain equal or greater power than the parallel-group design, particularly when between-subject heterogeneity is non-negligible.

CONCLUSION: Trialists may consider this approach when the nature or intention of the experimental treatment is contrary to the assumption of return to baseline.

PMID:41345689 | DOI:10.1186/s13063-025-09358-9

Int J Health Geogr. 2025 Dec 4;24(1):39. doi: 10.1186/s12942-025-00431-9.

ABSTRACT

BACKGROUND: Equitable access to general practitioner services remains a persistent challenge for health systems and is critical for reducing health inequalities, particularly between urban and rural regions. Understanding the spatial and temporal dynamics of primary care provision is vital for informed healthcare planning and policy.

METHODS: Spatial and temporal disparities in the supply of general practitioners across Lower Saxony, Germany, were assessed over a 21-year period (2000-2021). Data from the Association of Statutory Health Insurance Physicians and municipal population statistics were used to develop the General Practitioner Regional Index – a composite measure incorporating both the availability and accessibility of general practitioners. Non-parametric statistical tests were applied to identify significant trends at the municipal level.

RESULTS: Pronounced geographic inequities in general practitioner supply were identified. More than 40% of the population resides in areas with declining supply, while only 5% experience improvements. Urban centres and their peripheries consistently exhibited higher and mostly stable levels of general practitioner supply. In contrast, rural small towns and villages demonstrated both lower baseline accessibility and more frequent negative trends. The primary driver of supply losses in affected areas was physician retirement, while relocation played a secondary role and typically occurred within similar regional types, thereby limiting redistribution effects.

CONCLUSIONS: The results underscore the persistence of urban-rural disparities in general practitioner availability and highlight physician retirements as the principal factor behind declining supply, with limited offsetting effects from physician migration. The findings indicate a need for spatially sensitive, succession-focused workforce strategies and innovative primary care models to mitigate rural undersupply and promote health equity.

TRIAL REGISTRATION: Not applicable. This study does not report the results of a health care intervention on human participants.

PMID:41345667 | DOI:10.1186/s12942-025-00431-9

Ann Gen Psychiatry. 2025 Dec 4. doi: 10.1186/s12991-025-00607-4. Online ahead of print.

ABSTRACT

PURPOSE: Transcranial direct current stimulation (tDCS) is a novel non-invasive brain stimulation therapy that is a potential treatment for major depressive disorder (MDD). Acceptability impacts patient preference, treatment adherence and outcomes, however, it has typically been assessed through measures of attrition, self-reported satisfaction levels, or adverse events. We sought to explore participant acceptability using structured questionnaires and individual interviews.

METHODS: Acceptability was assessed in a fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of a 10-week course of home-based tDCS for MDD. Questionnaires were conducted at baseline and at the 10-week end of treatment. Participants were 174 adults (120 women) with MDD in a current depressive episode of at least moderate severity. Active or sham tDCS was self-administered over 10 weeks with remote supervision at regular intervals. A thematic analysis was conducted.

RESULTS: Four themes were revealed: acceptability, ease of use, side effects, and trial participation. The themes indicated generally high acceptability of tDCS as a treatment of MDD in both the active and sham treatment groups. Some participants noted concerns about the technical functionality of the device and the impact of side effects.

CONCLUSIONS: The first three themes are central to understanding participant perspectives of tDCS and its feasibility as a treatment option. In addition, the theme of trial participation highlights the value of participant support when introducing a new treatment, which may underscore treatment options in general. Furthermore, acceptability is a dynamic concept as participant views changed during treatment.

TRIAL REGISTRATION: NCT05202119, registered on 9th January 2022.

PMID:41345653 | DOI:10.1186/s12991-025-00607-4

BMC Med Educ. 2025 Dec 4. doi: 10.1186/s12909-025-08316-y. Online ahead of print.

ABSTRACT

BACKGROUND: Biomedical graduate education requires systematic reform, as traditional lecture-based approaches do not meet the interdisciplinary and clinically oriented demands of the field. This study aims to develop the education systems in biomedical science using the RPISD to design a data-driven aligned with the needs of learners and instructors.

METHODS: A comprehensive literature review, current state analysis, and relevant case analysis were conducted. Additionally, 100 learner surveys were analyzed using descriptive statistics, and 36 learner and 15 instructor interviews were examined through thematic analysis. A usability test was also performed in alignment with the RPISD phases to validate the framework.

RESULTS: The study identified 12 educational principles and 18 strategies for the Department of Biomedical Sciences. Specifically, six educational principles and seven educational strategies were developed with respect to the curriculum, four educational principles and five educational strategies in regard to teaching methods, and four educational principles and six educational strategies in relation to the educational environment.

CONCLUSION: This framework contributes to higher education by offering a structured model that differs from existing approaches through its emphasis on contextual adaptability and learner-centered design. It provides guidelines for institutions seeking to reform or improve their graduate education systems.

PMID:41345643 | DOI:10.1186/s12909-025-08316-y

Bull Menninger Clin. 2025 Fall;89(4):262-281. doi: 10.1521/bumc.2025.89.4.262.

ABSTRACT

Cultural competence is crucial for achieving health equity in mental health care, as systemic barriers and sociocultural factors significantly impact access, diagnosis, and treatment. This paper examines cultural competence and related concepts, including cultural humility, cultural safety, and structural competence, while addressing critiques and misconceptions. We examine its applications at micro, meso, and macro levels, emphasizing its role in diverse clinical settings. In mental health assessment, frameworks like the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision’s (DSM-5-TR) Outline for Cultural Formulation and the Contextual Formulation highlight the importance of understanding patients’ cultural identities and values. In psychotherapy, cultural adaptations, including mindfulness-based interventions such as acceptance and commitment therapy (ACT), can enhance effectiveness. At the systemic level, we advocate for inclusive organizational practices, ongoing training, and policies that address structural inequities. Integrating cultural competence into mental health care enables clinicians and institutions to better serve diverse populations.

PMID:41343231 | DOI:10.1521/bumc.2025.89.4.262

JAMA Netw Open. 2025 Dec 1;8(12):e2544515. doi: 10.1001/jamanetworkopen.2025.44515.

ABSTRACT

IMPORTANCE: Preexposure prophylaxis (PrEP) is highly effective at preventing HIV-1 when taken as prescribed; however, barriers to uptake persist.

OBJECTIVE: To assess clinical practice formulary coverage and PrEP uptake barriers and the association between those factors and cumulative HIV-1 incidence.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective observational cohort study from January 2021 to December 2023 using US pharmacy claims data from HIV-1-negative adults who received daily oral brand emtricitabine and tenofovir disoproxil fumarate (F/TDF), generic F/TDF (gF/TDF), or emtricitabine and tenofovir alafenamide fumarate (F/TAF), or intramuscular injection of cabotegravir every 2 months, for PrEP (after a 180-day washout period for previous PrEP use).

EXPOSURES: Formulary coverage evaluated by claim rejection reasons, dispensing status (dispensed, rejected, or abandoned), payer types, and copayment costs.

MAIN OUTCOMES AND MEASURES: HIV-1 incidence was described based on PrEP dispensing status. Logistic regression was used to estimate odds ratios (ORs) and 95% CIs of dispensing PrEP claims across key demographic and formulary characteristics.

RESULTS: Overall, 399 902 individuals with 2 680 545 PrEP claims were analyzed. A total of 348 773 (87.2%) were male; 281 452 (70.4%) were aged 18 to 39 years; 42 549 10.6%] lived in predominantly Hispanic neighborhoods, 4114 [1.0%] lived in predominantly non-Hispanic Asian and Pacific Islander neighborhoods, 20 214 [5.1%] lived in predominantly non-Hispanic Black neighborhoods, and 238 292 [59.6%] lived in predominantly non-Hispanic White neighborhoods). Of 265 833 individuals with 12 or more months of follow-up, 238 271 (89.6%) had 1 or more PrEP claims dispensed (DISP), 17 917 (6.7%) never had PrEP dispensed with 50% or more of claims rejected by payer (ND-R), and 9645 (3.6%) never had PrEP dispensed with more than 50% of claims abandoned (ND-A). Individuals in the ND-R and ND-A groups had higher HIV-1 incidence (662 [3.7%] and 270 [2.8%], respectively) vs the DISP group (4811 [2.0%]). In the DISP group, a 1- to 7-day dispensation delay was associated with higher odds of acquiring HIV-1 (OR, 1.29; 95% CI, 1.13-1.47). Most claims were for gF/TDF (1 400 389 claims [52.2%]); compared with gF/TDF, the likelihood of claims being dispensed was lower for other PrEP regimens (brand F/TDF: OR, 0.36; 95% CI, 0.36-0.37; cabotegravir: OR, 0.52; 95% CI, 0.49-0.55; F/TAF: OR, 0.93; 95% CI, 0.91-0.95). As cost sharing increased, the likelihood of dispensation decreased. The most common reason for claim rejection was that the product was not covered by the formulary (49 690 rejected claims [29.2%]).

CONCLUSIONS AND RELEVANCE: In this cohort study, HIV-1 incidence was higher in individuals with abandoned or rejected PrEP claims compared with those with dispensed claims. These findings highlight the importance of targeted strategies to improve PrEP claim dispensation and remove payer barriers to reduce HIV-1 transmission.

PMID:41343217 | DOI:10.1001/jamanetworkopen.2025.44515

JAMA Netw Open. 2025 Dec 1;8(12):e2546517. doi: 10.1001/jamanetworkopen.2025.46517.

ABSTRACT

IMPORTANCE: The US Food and Drug Administration (FDA) has recommended, but not required, age ranges for pediatric age labeling in devices, despite regulation existing for drugs, and this policy perpetuates off-label use of devices and creates several issues in practice for safety and monitoring. Proper device labeling is an important regulatory component that impacts risk stratification, clinical use, marketing, and reimbursement.

OBJECTIVE: To evaluate the variability in pediatric medical device age labeling among all pediatric class III devices approved by the FDA from 2008 to 2017 and their adherence to nonbinding FDA age range recommendations, and to review the device type, clinical use, and whether the pediatric population was included in clinical trials.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cross-sectional study reviewed data from public databases to understand pediatric age labeling practices. Data included in the 2008 to 2017 Reports to Congress: Premarket Approval of Pediatric Uses of Devices were reviewed in 2022. Additional data were extracted from the FDA Databases. Two physicians independently reviewed the data and assigned clinical descriptors to each device. Descriptive analysis was performed.

EXPOSURE: Device approval by the FDA from 2008 to 2017.

MAIN OUTCOMES AND MEASURES: The primary outcomes were whether approved devices had age labeling, whether they described the approved pediatric population, and whether pediatric populations were included in clinical studies of the devices. Pairwise comparison was done with Student t test and P < .05 to indicate statistically significant differences.

RESULTS: Of 101 unique devices, 26 (25.7%) did not include any specific age ranges and among the remaining 75 devices, 51 (50.5%) were not indicated for patients younger than 18 years. There was significant variation in age labeling, with only 4 devices using fully structured age ranges (eg, 2 to 17 years). Only 8 (7.9%) devices used the FDA recommended pediatric age ranges. The review of clinical trials evaluating device safety and efficacy revealed that 60 (59.4%) included pediatric patients (aged 0 to <22 years); however, only 33 (32.7%) included patients younger than 18 years. In contrast, the Indications For Use statements for the same devices indicate 52 (51.5%) did not include any specific age ranges and 29 (28.7%) were indicated for adults 18 years or older.

CONCLUSIONS AND RELEVANCE: In this cross-sectional analysis of devices included the 2008 to 2017 Reports to Congress, most high-risk devices were not evaluated or specifically indicated for children younger than 18 years. This poses substantial problems for clinical use, reimbursement, research, and policy evaluation. To address this gap, the FDA should establish pediatric labeling requirements that consider age and other relevant factors.

PMID:41343216 | DOI:10.1001/jamanetworkopen.2025.46517