Category: Nevin Manimala

JAMA Netw Open. 2025 Aug 1;8(8):e2528264. doi: 10.1001/jamanetworkopen.2025.28264.

ABSTRACT

IMPORTANCE: Prenatal intensive behavioral therapy (IBT) interventions that promote adequate gestational weight gain (GWG) have had variable and mostly modest effects on clinically relevant maternal and infant outcomes. It is unknown whether different maternal obesity metabolic phenotypes underlie the heterogeneity in response.

OBJECTIVE: To examine GWG, adverse perinatal outcomes, substrate changes, and differential changes in each in a prenatal IBT intervention conducted among pregnant individuals with 2 identified obesity phenotypes.

DESIGN, SETTING, AND PARTICIPANTS: The Lifestyle Interventions for Expectant Moms (LIFE-Moms) trial was a consortium of 7 independent but collaborative multicenter randomized clinical trials that took place between November 1, 2012, and December 31, 2017, and evaluated a prenatal IBT intervention on GWG and perinatal outcomes among women with overweight and obesity. Statistical analysis for the present preplanned secondary analysis was conducted from March 29, 2023, to June 4, 2025. Participants (n = 1150) had a confirmed viable singleton pregnancy and no previous diagnosis of cardiometabolic diseases. This analysis was limited to those with obesity. Participants were classified into 2 groups: obesity with no additional qualifying cardiometabolic disease risk factors (metabolically healthy obesity [MHO]) or obesity with 2 qualifying risk factors (metabolically unhealthy obesity [MUO]) in early pregnancy.

INTERVENTION: A behavioral lifestyle intervention incorporating diet and physical activity was delivered to increase adherence to the National Academy of Medicine GWG guidelines.

MAIN OUTCOMES AND MEASURES: GWG (total and adherence to guidelines), adverse perinatal outcomes, substrate changes, and infant body composition. Analysis was conducted on an intent-to-treat basis.

RESULTS: The mean (SD) age of the 640 participants was 30.2 (5.6) years, and the participants presented in early pregnancy with a mean (SD) body mass index of 35.2 (4.1). Participants in the MUO (n = 172) and MHO (n = 228) groups did not differ in response to treatment in weight outcomes, adverse perinatal outcomes, or substrate changes, with the exception that patients in the intervention group experienced smaller mean (SE) triglyceride increases more in the MUO group than in the MHO group (90.3% [7.4%] vs 81.8% [8.3%]; P = .02). After adjustment for maternal baseline demographics and treatment group, individuals with MUO had lower GWG (0.30 [0.23] kg/wk) compared with individuals with MHO (0.41 [0.27] kg/wk; P < .001), a 36.7% difference, and had a lower proportion exceed weight gain guidelines (57.0% [98 of 172] vs 68.0% [155 of 228]; P = .03). Participants with MUO had a higher incidence of gestational diabetes (23.8% [41 of 172] vs 9.8% [22 of 228]; P = .001) and had infants with a higher proportion of adiposity (mean [SD], 12.5% [3.9%] vs 11.7% [3.7%] fat; P = .05) compared with participants with MHO.

CONCLUSIONS AND RELEVANCE: In this preplanned secondary analysis of a randomized clinical trial of an IBT on GWG among pregnant individuals, those with MUO experienced less GWG, had a higher incidence of gestational diabetes, and had infants with a higher proportion of adiposity compared with those who MHO. Data supported that the maternal obesity metabolic phenotype has a greater clinical effect on adverse maternal and infant clinical outcomes compared with GWG alone and did not contribute to a differential response to a lifestyle intervention. Future interventions should identify methods to better optimize the maternal metabolic milieu as early in pregnancy as possible to reduce the intergenerational transmission of metabolic disease.

TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT01545934, NCT01616147, NCT01771133, NCT01631747, NCT01768793, NCT01610752, NCT01812694.

PMID:40839263 | DOI:10.1001/jamanetworkopen.2025.28264

Support Care Cancer. 2025 Aug 21;33(9):804. doi: 10.1007/s00520-025-09842-7.

ABSTRACT

OBJECTIVE: Cancer-associated anemia is multifactorial, resulting from both the malignancy itself and its treatment. It is frequently accompanied by absolute or functional iron deficiency. While intravenous (IV) iron is a well-established treatment in outpatients, evidence is lacking in cancer patients hospitalized for acute complications. We conducted a feasibility study to evaluate the practicality of administering intravenous ferric carboxymaltose (FCM) in this population.

METHODS: This feasibility study includes cancer patients who have been hospitalized for acute cancer complications and biological evidence of iron deficiency. Exclusion criteria apply to patients with hemoglobin levels below 7 g/dL, active bleeding or contraindications to iron carboxymaltose. Participants received a single IV infusion of FCM (1000 mg). Primary objectives were to assess feasibility and characterize anemia etiology; secondary objectives were hemoglobin response, transfusion requirements within 4 weeks, and exploratory predictive biomarkers.

RESULTS: Of 55 enrolled patients, 51 received FCM. Response rates-defined as a hemoglobin increase ≥1 g/dL were 33% at week 2 and 39% at week 4. Transfusion rates reached 15% by day 28. No reliable predictive biomarkers were identified.

CONCLUSION: Our results suggest that a single dose of IV FCM is effective in increasing hemoglobin levels. No predictive biomarkers were identified, likely due to the modest sample size, advanced disease, and complex inpatient status. IV iron supplementation trials in this population are feasible; multicentric trials are needed to enroll larger samples. Furthermore, quality-of-life endpoints should be incorporated, which were difficult to capture here.

PMID:40839228 | DOI:10.1007/s00520-025-09842-7

Tech Coloproctol. 2025 Aug 21;29(1):165. doi: 10.1007/s10151-025-03203-6.

ABSTRACT

BACKGROUND: Neoadjuvant chemoradiotherapy (nCRT) is key for low rectal cancer but raises the risk of anastomotic leakage (AL). This study examines how fluorescence laparoscopic (FL) surgery reduces AL after intersphincteric resection (ISR), especially in nCRT patients.

METHODS: This real-world multicenter cohort study included 533 patients undergoing laparoscopic ISR for ultra-low rectal adenocarcinoma from January 2012 to July 2023. Patients were categorized into FL and non-FL groups. Propensity score matching (PSM) was used at a 1:2 ratio to adjust for baseline differences. The primary endpoint was the incidence of AL within 6 months postoperatively. Secondary endpoints included anastomotic site perfusion, intraoperative blood loss, lymph node retrieval, perioperative complications, and postoperative recovery metrics. Subgroup analyses were conducted on the basis of nCRT status.

RESULTS: After PSM, 393 patients were analyzed (131 FL versus 262 non-FL). The FL group showed a significantly lower AL incidence (3.1% versus 11.5%, P = 0.005), with fewer severe symptomatic AL cases (0.8% versus 6.1%, P = 0.014). Intraoperative blood loss was reduced (45.2 ± 58.9 mL versus 65.3 ± 73.1 mL, P = 0.004), and lymph node yield was higher (21.2 ± 11.4 versus 16.6 ± 7.3, P < 0.001) in the FL group. Postoperative recovery was accelerated, with earlier return of bowel function and shorter hospital stays (9.5 ± 3.1 versus 10.7 ± 3.8 days, P = 0.012). In subgroup analyses, FL significantly reduced AL rates in patients without nCRT (1.9% versus 7.2%, P = 0.045) and demonstrated a strong trend toward reduction in AL for patients receiving nCRT (13.0% versus 35.9%, P = 0.051). FL also increased the proportion of patients achieving benchmark lymph node retrieval, including those post-nCRT.

CONCLUSIONS: Fluorescence-guided laparoscopic surgery reduces anastomotic leakage and improves outcomes in low rectal cancer, especially after chemoradiotherapy, by enhancing surgical precision and recovery.

PMID:40839222 | DOI:10.1007/s10151-025-03203-6

J Reprod Infant Psychol. 2025 Aug 21:1-14. doi: 10.1080/02646838.2025.2550992. Online ahead of print.

ABSTRACT

AIMS: To evaluate the effects of a mobile programme on infertility stress, anxiety, infertility self-efficacy, marital relationship, social support, and fertility quality of life in couples undergoing intrauterine insemination.

METHODS: This quasi-experimental study was conducted over three weeks with a non-equivalent control group and a non-synchronised pre-test – post-test design. Fifty couples participated: 26 in the experimental group and 24 in the control group. The experimental group received a couple-based mobile programme, while the control group received conventional care. Data were analysed using descriptive statistics and the chi-squared, Fisher’s exact, Wilcoxon rank-sum, Mann – Whitney U, and t-tests. Prior scores of the individual variables were controlled through an analysis of covariance, and the differences in the pre- and post-intervention mean values between the groups were compared. The main outcome measures were infertility stress, anxiety, infertility self-efficacy, marital relationship, social support, and fertility quality of life.

RESULTS: The couple-based mobile programme effectively reduced infertility stress (F = 18.88, p < .001) and anxiety (F = 19.87, p < .001), and it improved infertility self-efficacy (F = 38.68, p < .001), marital relationship (F = 30.64, p < .001), and fertility quality of life (F = 21.08, p < .001).

CONCLUSION: The couple-based mobile programme can be used as an intervention to improve the quality of life for couples diagnosed with infertility who are undergoing intrauterine insemination. The results could form the basis for further development of interventions and strategies to improve the quality of life for couples considering ART.

PMID:40839218 | DOI:10.1080/02646838.2025.2550992

Ther Innov Regul Sci. 2025 Aug 21. doi: 10.1007/s43441-025-00863-2. Online ahead of print.

ABSTRACT

Medical devices used in health care should fulfill the requirements of the technical regulations to protect patient health. Difficulties in enforcing stricter rules in the new medical device regulations may negatively affect the continuity of care. This study examines the status of manufacturers’ compliance with medical device regulations, based on predefined criteria, and proposes a collaborative action plan and an approach to verify regulatory compliance. We conducted a nationwide survey comprising questions grouped by criteria to understand the status of the manufacturers in terms of compliance with the Medical Device Regulation. Four hundred sixty-seven manufacturers participated in the survey. We achieved a Cronbach’s alpha of 0.77, which indicates that the survey is statistically reliable. We applied the independent samples t-test to the responses to determine significant features per question and employed factor analysis to investigate the relationships of the questions. The results of independent samples t-tests showed statistically significant differences across groups in replies to several survey items (p < 0.05), indicating that participants’ opinions varied based on their demographic characteristics. We applied Exploratory Factor Analysis to introduce the relationships between the questions. The analysis revealed that manufacturers continue to face substantial challenges in acquiring sufficient knowledge and operational capability to meet MDR requirements. In light of these findings, we focused on the person responsible for regulatory compliance, who plays a central role in maintaining regulatory compliance within manufacturing organizations. We proposed an action plan at the macro level to introduce more effective action plans in cooperation with other stakeholders, including healthcare providers, and a verification approach for regulatory compliance to enhance the Person Responsible for Regulatory Compliance’s competence. Manufacturers should implement effective postmarketing clinical follow-up plans involving device-oriented parameters for monitoring in the healthcare system, especially in collaboration with health professionals.

PMID:40839208 | DOI:10.1007/s43441-025-00863-2

Environ Monit Assess. 2025 Aug 21;197(9):1033. doi: 10.1007/s10661-025-14446-z.

ABSTRACT

This study focuses on the rarely ventured assessment of the flood-induced heavy metal contamination in the water sources in a flood-prone region in India, emphasizing human health risks using average daily dose (ADD), hazard quotient (HQ), hazard index (HI), and carcinogenic risk (CR). Results showed children were more vulnerable to exposure than adults, and ingestion was the main route of exposure, followed by dermal and inhalation. The contribution of Cd to the cumulative HI for children was the highest, exceeding the maximum acceptable risk level of 1.0 × 10^-4. The values of single HI were elevated after flooding, but did not exceed the critical value of 1. The highest CR contributor was Cr, followed by Cd, Ni, and Pb, with lifetime CR within the acceptable limit of 10^-6-10^-4. Heavy metal pollution index (HPI) was found to be > 100 for both river and groundwater, indicating “severe” contamination status with Cd, Mn, and Fe being the prime contributors. The paired t-static revealed significant differences in the metal concentrations before and after floods. Factors extracted by principal components analysis (PCA) indicated the influence of floods as a source of metal contamination integrated with anthropogenic and geogenic sources. The findings form an important database for monitoring, mitigating, and remediating flood-induced contaminations and human health effects in riverine systems.

PMID:40839204 | DOI:10.1007/s10661-025-14446-z

Clin Rheumatol. 2025 Aug 21. doi: 10.1007/s10067-025-07630-6. Online ahead of print.

ABSTRACT

OBJECTIVE: Understand the willingness and preference of patients with knee osteoarthritis for biological treatment, and the current status of knee osteoarthritis treatment.

METHODS: KOA patients with grades 1-4 Kellgren-Ray (K-L) in the knee of our imaging department from November 1, 2022, solstice May 1, 2023, were included in this single-center cross-sectional survey. The questionnaire was designed through the online questionnaire platform, and 502 questionnaires were completed, of which 393 were eligible for this study.

RESULTS: (1) Basic information: 66.67% (262/393), female, male 33.33% (131/393), male: 1:2; patients aged 45-69 years 89.06% (350/393); 28.50% (112/393); first degree relatives’ osteoarthritis 6.87% (27/393); hyperlipidemia 10.94% (43/393); hypertension 30.79% (121/393); diabetes 9.16% (36/393). (2) Disease assessment: the patients had a significant negative relationship between Lysholm score and WOMAC score, with a correlation coefficient of – 0.632, p < 0.01. Using the Kruskal-Wallis test statistic, the Lysholm score showed different K-L grade samples for the WOMAC score (p < 0.01). (3) Classical treatment: 84.99% of the subjects had no attempted basic treatment for osteoarthritis. 94.40% had not tried 4 exercise therapies for osteoarthritis. 96.95% had not attempted physical therapy for osteoarthritis. 98.73% did not try exercise aids for osteoarthritis. 67.94% had not tried TCM treatment for osteoarthritis, accounting for 18.58%, two accounted for 10.69%, three accounted for 2.04%, and four accounted for 0.76%. 77.35% did not try nonsteroidal anti-inflammatory drugs for osteoarthritis, 16.03%, 6.36%, and six 0.25%. 87.02% had not tried non-class NSAIDs analgesic drugs for osteoarthritis, using weak opioid analgesics 10.69% and strong opioid analgesics 2.29%. 95.93% denied previous use of glucocorticoids for osteoarthritis, 16 but not consistently. 85.75% had not tried using slow-acting drugs (SYSADOAs) to relieve OA symptoms, 11.45% and 2.80%, respectively. 99.24% denied taking antidepressant anxiety medication for osteoarthritis. 92.37% denied attempted knee cavity injection (sodium hyaluronate, glucocorticoids), 25 had sodium hyaluronate injection in the joint cavity, 6.36%, and 5 had glucocorticoid injection, 1.27%. (4) Biological therapy situation: 96.44% did not know the biological therapy of the knee cavity for osteoarthritis. 96.69% were not recommended for knee cavity biological treatment, 13 people were recommended, accounting for 3.31%, of which 11 were recommended by doctors, accounting for 84.62% (11/13), and relatives recommended for 15.38% (11/13). In the Likert5 scoring method of joint cavity biological treatment, 10 people in this study were very reluctant, accounting for 2.54%; 37 preferred unwilling, accounting for 9.41%; 264, average, accounting for 67.18%; 40 preferred, accounting for 10.18%; 42, very willing, accounting for 10.69%. The stepwise regression analysis of the factors affecting the willingness to treat joint cavity biotherapy, the previous treatment with sodium hyaluronate or corticosteroid knee cavity injection, WOMAC score will have a significant positive effect on the willingness score of joint cavity biotherapy. In addition, age had a significant negative effect on the willingness to treat the joint cavity. (5) The analysis was performed by MaxDiff: efficacy, course of treatment, side effects, medical expenses, and administration pathways (oral, external use, and intra-articular injection), subject preference for choosing a joint cavity biotherapy. The preferred shares are, respectively. Efficacy > side effect > medical expenses > course of treatment > administration pathways, 69.42% > 15.85% > 6.39% > 4.93% > 3.41%.

CONCLUSION: In this study, KOA subjects, most had not received osteoarthritis-related standard treatment, and the proportion of TCM treatment was relatively high. The low awareness rate of knee biological therapy, the joint cavity injection treatment, high WOMAC score, and age have an impact on the treatment intention of biologics. Efficacy is the most important factor in patient preference for KOA treatment. Key Points • The low awareness rate of knee biological therapy, the joint cavity injection treatment, high WOMAC score, and age have an impact on the treatment intention of biologics. • Efficacy is the most important factor in patient preference for KOA treatment.

PMID:40839199 | DOI:10.1007/s10067-025-07630-6

Int J Dermatol. 2025 Aug 21. doi: 10.1111/ijd.70025. Online ahead of print.

ABSTRACT

BACKGROUND: Secukinumab, a fully human, monoclonal antibody targeting interleukin-17A, is approved for moderate-to-severe HS in adults. This study evaluated pharmacokinetics (PK), high-sensitivity C-reactive protein (hsCRP) changes, and safety of secukinumab over 52 weeks in SUNSHINE and SUNRISE Phase 3 trials.

METHODS: An exploratory analysis of pooled Phase-3 trials evaluated serum PK and safety of secukinumab 300 mg every 2 (SECQ2W) or 4 weeks (SECQ4W). A population PK model assessed the effects of body weight, disease severity, and baseline hsCRP on secukinumab serum concentration. Exposure-response analysis assessed the relationship between predicted PK and HS clinical response [HiSCR]. No confirmatory statistical testing was performed.

RESULTS: Mean serum trough concentration at Weeks 16, 24, and 52 was ~2-fold higher with SECQ2W vs. SECQ4W. At Week 16, exposure overlap was high, with an estimated numerical increase in HiSCR of ~3% for SECQ2W over SECQ4W. At Week 52, HiSCR levels plateaued. At Week 16, hsCRP decreased from 18.6 ± 26.3 mg/L to 12.8 ± 18.0 mg/L (SECQ2W), 15.9 ± 27.6 mg/L to 11.5 ± 18.4 mg/L (SECQ4W), and remained unchanged with placebo (14.4 ± 22.5 mg/L to 14.7 ± 23.8 mg/L); reductions were sustained through Week 52. Higher body weight, disease severity, and baseline hsCRP were associated with lower secukinumab serum concentrations. Secukinumab immunogenicity was low (< 1%), with no new safety signals.

CONCLUSION: Secukinumab serum concentrations in patients with HS varied with body weight, disease severity, and baseline hsCRP. SECQ2W may benefit certain patients. Secukinumab reduced hsCRP through Week 52. The safety profile of secukinumab was consistent with other approved indications, with no apparent dose-response relationship observed.

TRIAL REGISTRATION: NCT03713619 (Novartis study code CAIN457M2301). NCT03713632 (Novartis study code CAIN457M2302).

PMID:40839197 | DOI:10.1111/ijd.70025

J Robot Surg. 2025 Aug 21;19(1):503. doi: 10.1007/s11701-025-02666-x.

ABSTRACT

While robotic surgery has been dominated by a single platform in the United States for over 25 years, the introduction of new robotic systems may have an impact on subjective workload. Therefore, we aimed to establish baseline workload measurements for operating room team members using the DaVinci surgical robot during robotic hernia procedures, providing reference points for evaluating team adaptation as new robotic platforms are introduced. Within the operating room, subjective workload refers to the physical, cognitive, and temporal demands experienced during surgical procedures. We prospectively collected NASA-TLX surveys from surgeons, circulators, and scrub staff performing robotic hernia repairs between February-December 2024. Baseline demographics and prior robotic experience were collected for each participant. Surveys assessed subjective workload across six NASA-TLX domains and surgeon assessment of case complexity relative to other procedures (Easiest 1/3, Average, Hardest 1/3). Case-specific information was extracted from the electronic medical record. We used linear mixed-effects models (LMMs) to analyze role-based and complexity-related workload, which accounts for within-subject correlation from repeated measurements collected from the same individuals across different surgical cases. A total of 131 post-operative surveys were analyzed from 14 participants across 72 robotic hernia cases. Robotic OR team members reported similar baseline workload with the highest overall workload reported by circulators (mean 30.6, 95% CI 22.1-39.2), followed by scrub staff (mean 25.1, 95% CI 16.5-33.7). Surgeons experienced the lowest overall workload (mean 24.4, 95% CI 10.2-38.6), however, demonstrated a significant stepwise increase in workload with increasing case complexity (mean 11.4 to 41.5, Cohen’s d = 3.41, 95% CI [2.31, 4.51], p < 0.0001), while circulators and scrub staff were unaffected. Comparisons across NASA-TLX domains showed that circulators reported significantly worse self-assessed performance (mean difference vs. surgeons: 14.97, 95% CI [8.84, 21.10], p = 0.001; vs. scrub staff: 9.60, 95% CI [4.21, 14.99], p = 0.002) and higher effort compared to other team members (mean difference vs scrub staff: 11.07, 95% CI [3.20, 18.94], p = 0.017). These findings provide one of the first role-specific benchmarks for intraoperative workload in robotic hernia surgery, representing essential reference metrics against which new robotic platforms can be evaluated. Further exploration of these role-specific challenges is needed to determine if there are opportunities to optimize workload to improve patient safety, team efficiency, and staff well-being as new platforms are adopted.

PMID:40839192 | DOI:10.1007/s11701-025-02666-x

Curr Opin Oncol. 2025 Aug 12. doi: 10.1097/CCO.0000000000001184. Online ahead of print.

ABSTRACT

PURPOSE OF REVIEW: Immunotherapy has transformed the management of several malignancies, yet its role in rare breast cancer histologies remains poorly defined due to limited research and few dedicated clinical trials. This review critically assesses current knowledge and emerging opportunities for immunotherapy in these uncommon breast cancer subtypes.

RECENT FINDINGS: Rare breast cancer histologies exhibit heterogeneous immunogenicity, including variable expression of programmed death-ligand 1 (PD-L1), differing levels of tumor-infiltrating lymphocytes (TILs), and distinct mutational burdens. Recent studies highlight potential immunotherapy responsiveness in metaplastic, invasive lobular, apocrine, and other rare breast cancer types, though predictive biomarkers like PD-L1 and tumor mutational burden (TMB) alone appear insufficient. Currently, only two clinical trials specifically target rare breast cancer histologies, emphasizing significant knowledge gaps.

SUMMARY: The effectiveness of immunotherapy in rare breast cancer histologies remains limited, likely due to inadequate patient selection using current biomarkers such as PD-L1 and TMB. Further research must focus on refining predictive biomarkers to better identify patients likely to from immunotherapy and enhance outcomes in these challenging clinical settings.

PMID:40838334 | DOI:10.1097/CCO.0000000000001184