Nevin Manimala

Musculoskelet Surg. 2025 Feb 5. doi: 10.1007/s12306-025-00884-y. Online ahead of print.

ABSTRACT

PURPOSE: Magnetic resonance imaging (MRI) is often used to evaluate patients with patellar dislocations to facilitate diagnosis and management strategies. Many radiological parameters have been described in the literature. The aim of this study was to assess the significance of tibial-tubercle trochlear groove distance (TT-TG) distance and other MRI measurements in patients with and without patellar instability.

METHODS: This case-control study included 41 patients with recurrent patellar instability and 50 patients with stable knees, all of whom underwent MRI scans. A total of 19 radiological parameters were measured in both groups.

RESULTS: All measured MRI parameters had statistically significant differences between both groups (p < 0.05) apart from trochlear cartilage length. TT-TG distance. 20 mm had the strongest association with patellar instability (OR 53.3, p = 0.006, 95%CI [3.1- 927.4]) and the highest specificity (100%) but had the lowest sensitivity (34%) out of all the measured parameters. TT-TG. 13 mm had a higher sensitivity (68%) but lower specificity (72%) and weaker association with patellar instability (OR 5.5, p < 0.001, 95%CI [2.2. 13.7]). TT-TG/trochlear articular cartilage width ratio also had a strong association with patellar instability (OR 14.7, p < 0.001, 95%CI [4.5. 48.5]) with high specificity (92%) but lower sensitivity (56%).

CONCLUSION: The cut-off values for TT-TG distance at 13 mm and 20 mm both had advantages and disadvantages which supports the concept of using patient-individualised ratios. Patellar instability is associated with many radiological abnormalities demonstrated on MRI scans. Selection of the most appropriate measurement is dependent on the philosophy and preference of the treating clinician.

PMID:39907984 | DOI:10.1007/s12306-025-00884-y

Drug Saf. 2025 Feb 5. doi: 10.1007/s40264-025-01521-0. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Standardised procedures for performing and reporting safety monitoring studies investigating medications use in pregnancy may help improve data quality and the speed of data generation. The objective of this study was to provide recommendations on the statistical analysis and reporting of single-arm pregnancy medication safety studies using primary source datasets.

METHODS: A Delphi consensus-setting protocol was used to acquire agreement on recommendations from experts with extensive knowledge and experience in conducting studies investigating medication safety in pregnancy. A series of recommendations, along with their scientific justifications and examples of how to calculate and describe exposure and outcome incidences, were critiqued and improved through a series of online Delphi review rounds. Agreement to inclusion scoring was assessed using a five-point Likert scale. Recommendations with a median Likert-scale score of at least 4, where ≥ 80% of the expert panel scored the recommendation at level 4 or higher, was used as the threshold for inclusion.

RESULTS: The Delphi consensus methodology produced a set of 30 recommendations spread over five themes. These included descriptions of (1) study sample, (2) medication exposure, (3) maternal outcomes, (4) pregnancy and birth outcomes, and (5) fetal and neonatal outcomes. Of the 30 recommendations, 19 were strongly advised while 11 were included for consideration where their implementation may be beneficial for supplementing data communication.

CONCLUSION: Use of the finalised set of recommendations should be encouraged to help standardise published evidence around medication use in pregnancy.

PMID:39907983 | DOI:10.1007/s40264-025-01521-0

Obes Surg. 2025 Feb 5. doi: 10.1007/s11695-025-07707-w. Online ahead of print.

ABSTRACT

BACKGROUND: Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are common bariatric procedures, with GERD being a frequent obesity-associated disease among individuals undergoing these surgeries. RYGB is recommended for patients with GERD due to the increased control of GERD symptoms. This study examines RYGB and SG use in this population and factors influencing procedure choice.

METHODS: This study analyzed 2016-2022 data from the MBSAQIP database comprising patients with GERD who underwent SG or RYGB. Statistical analysis included univariate and multivariable logistic regression to identify factors associated with procedure receipt.

RESULTS: RYGB rates are rising annually but remain lower than SG for GERD. Compared to White individuals, Hispanics are 14% less likely, and African Americans are 19% less likely, to receive RYGB.

CONCLUSIONS: The study notes a research gap in choosing RYGB or SG for patients with GERD, despite consensus favoring RYGB. It highlights a disparity between recommendations and practice, with GERD predicting the use of RYGB but SG being more prevalent in this population overall. The analysis links race to procedure choice, showing African American and Hispanic patients are less likely to undergo RYGB, indicating potential disparities in access and decision-making.

PMID:39907982 | DOI:10.1007/s11695-025-07707-w

Am J Cardiovasc Drugs. 2025 Feb 5. doi: 10.1007/s40256-025-00721-4. Online ahead of print.

ABSTRACT

BACKGROUND: Semaglutide has emerged as an effective medication for treating type 2 diabetes mellitus (DM). However, the cardiovascular effects and safety of this agent in patients with heart failure with preserved ejection fraction (HFpEF) are unclear.

OBJECTIVE: This systematic review and meta-analysis aimed to assess the clinical and laboratory effects of semaglutide compared to placebo in patients with HFpEF.

METHODS: We systematically searched EMBASE, PubMed, and Cochrane databases for randomized controlled trials (RCTs) and non-randomized cohorts, from inception to July 2024, comparing semaglutide versus placebo in patients with HFpEF. Statistical analyses were performed using R Studio 4.3.2. Mean difference (MD) and odds ratio (OR) with 95% confidence intervals (CIs) were pooled across trials.

RESULTS: This meta-analysis included three studies, two RCTs and one non-randomized cohort, reporting data on 1463 patients. The follow-up time of the studies was 52 weeks. Compared to placebo, the use of semaglutide was associated with a significant increase in the 6-min walk distance (MD 16.20; 95% CI 10.19-22.21; p < 0.01; I² = 0%). Additionally, reductions were observed in systolic blood pressure (MD -2.22; 95% CI -3.60 to -0.83; p < 0.01; I² = 0%), C-reactive protein level (MD 0.59; 95% CI 0.49-0.70; p < 0.01; I² = 51%), and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels (MD 0.81; 95% CI 0.74-0.89; p < 0.01; I² = 0%).

CONCLUSION: These findings suggest that the use of semaglutide is associated with clinical and laboratory benefits in patients with HFpEF.

PMID:39907981 | DOI:10.1007/s40256-025-00721-4

CJEM. 2025 Feb 5. doi: 10.1007/s43678-024-00849-3. Online ahead of print.

ABSTRACT

OBJECTIVES: Emergency physicians have the highest rates of burnout among all medical specialties. There is a need for accurate and reliable burnout assessment tools to monitor changes and assess the effects of interventions. However, existing tools are typically long and/or costly. We sought to validate an abbreviated Copenhagen Burnout Inventory among emergency physicians and trainees in Canada.

METHODS: We conducted a planned secondary analysis of a national, cross-sectional survey of emergency physicians and trainees in Canada. Exploratory factor analysis was performed followed by confirmatory factor analysis. Kaiser’s eigenvalues rule, a scree plot, and Horn’s parallel analysis guided the number of factors to extract. Structural validity fit indices and internal consistency were compared to pre-specified cutoffs. Criterion validity was assessed compared to the full Copenhagen Burnout Inventory (burnout defined as mean ≥ 50/100).

RESULTS: One hundred eighty-two responses were randomly split into separate cohorts for exploratory factor analysis and confirmatory factor analysis. Data were confirmed to be statistically suitable for factor analysis. Using exploratory factor analysis, a ten-item, two-factor abbreviated Copenhagen Burnout Inventory was reached after removing items based on over correlation (≥ 0.80), cross-loading (≥ 75%), and low factor loading (< 0.60). In confirmatory testing, the abbreviated inventory had a good Comparative Fit Index (0.91) though did not meet cutoffs for the remaining fit indices. Internal consistency was 0.92 (95%CI 0.90-0.95). Using a cutoff of 33/50, sensitivity was 0.99, specificity was 0.82, and area under the ROC curve was 0.86.

CONCLUSION: With further validation, an abbreviated ten-item Copenhagen Burnout Inventory has potential to serve as a short, freely available burnout assessment tool among Canadian emergency physicians and trainees. This abbreviated inventory has evidence to support its internal consistency and criterion validity, albeit with inconsistent structural validity. Future validation with larger samples is required, with special attention paid to content validity, test-retest reliability, and correlation with important outcomes.

PMID:39907968 | DOI:10.1007/s43678-024-00849-3

Clin Pharmacokinet. 2025 Feb 5. doi: 10.1007/s40262-025-01481-9. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Aficamten, a small-molecule, selective cardiac myosin inhibitor, is under development for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten is primarily eliminated by hepatic metabolism with renal excretion playing a minor role. The objective of this investigation was to evaluate the pharmacokinetics (PK) of aficamten in moderate hepatic impairment or mild to moderate renal impairment to inform dosing recommendations in HCM patients with mild or moderate hepatic impairment or mild to moderate renal impairment.

METHODS: The impact of hepatic impairment on the PK of single-dose aficamten 20 mg was evaluated in a phase 1 single-dose, open-label, parallel-group study, in healthy participants with moderate (n = 8) hepatic impairment (Child-Pugh B classification) versus participants with normal hepatic function (n = 8). Safety was monitored throughout. The effect of renal impairment on aficamten PK was assessed using population PK (PopPK) modelling of phase 2/3 clinical data in patients with oHCM.

RESULTS: Aficamten PK was similar in participants with moderate hepatic impairment and those with normal hepatic function. No serious or severe treatment-emergent adverse events or clinically significant laboratory abnormalities were reported. There were no clinical meaningful differences in aficamten exposure in patients with oHCM with mild or moderate renal impairment and those with normal renal function.

CONCLUSIONS: No clinically relevant changes in aficamten PK were observed in participants with moderate hepatic impairment. Population PK analysis indicated mild or moderate renal impairment and had no statistically or clinically significant impact on aficamten PK in patients with oHCM. Aficamten dose adjustment may not be necessary in patients with mild or moderate hepatic or renal impairment.

PMID:39907965 | DOI:10.1007/s40262-025-01481-9

EJNMMI Phys. 2025 Feb 5;12(1):13. doi: 10.1186/s40658-025-00720-z.

ABSTRACT

PURPOSE: ¹⁸F-labelled somatostatin receptor tracers have recently gained popularity due to their better spatial resolution, longer half-life and lower costs compared to ⁶⁸Ga-labeled tracers. The aim of this study was to evaluate the impact and limitations of reduced administered activities of [¹⁸F]SiTATE on image quality, lesion detectability and quantitative PET parameters in a long axial field-of-view (LAFOV) PET/CT scanner.

METHODS: Twenty-four patients with histologically confirmed neuroendocrine tumor, who underwent clinically indicated [¹⁸F]SiTATE PET/CT examination (3.0 MBq/kg, 5 min PET scan time) on a Siemens Biograph Vision Quadra LAFOV PET/CT, were included retrospectively in this study. PET list-mode data were rebinned for shorter frame durations to simulate 5 min scans with lower activities of injected radiotracer. A comparison of image reconstruction in high sensitivity (HS) and ultra-high sensitivity mode (UHS) mode was performed. Subjective image quality, noise and lesion detectability of n = 122 lesions were rated using a 5-point Likert scale. The molecular tumor volume (MTV), signal-to-noise ratio (SNR), tumor-to-liver activity concentration ratio (TLR) and standardized uptake values (SUV) were analyzed.

RESULTS: Subjective image quality decreased with simulated reduction of injected activity with generally superior ratings in the UHS mode compared to the HS mode. Despite a reduction to 1 MBq/kg of [¹⁸F]SiTATE all lesions were still detected while at 0.25 MBq/kg lesion detectability decreased to 70% (HS) and 93% (UHS). Only minor changes in SUV_mean and TLR were detected with reduced activity. However, reduced activities led to an increase in SUV_SD, which in turn caused a decrease in SNR (at 1 MBq/kg: 7.3 in HS and 9.0 in UHS mode and an increase in deviation of the MTV.

CONCLUSION: Reducing the administered activity of injected [¹⁸F]SiTATE by 66% to 1 MBq/kg (HS & UHS) is feasible in a LAFOV PET/CT scanner, maintaining clinically diagnostic image quality without statistically significant deviations in PET uptake parameters and MTV. Furthermore, in low activity [¹⁸F]SiTATE PET/CT, the UHS mode improves image quality and noise as well as lesion detectability compared to HS mode, further reinforcing the clinical benefits of this recently introduced reconstruction mode.

PMID:39907960 | DOI:10.1186/s40658-025-00720-z

J Autism Dev Disord. 2025 Feb 5. doi: 10.1007/s10803-025-06727-w. Online ahead of print.

ABSTRACT

PURPOSE: The study of effective measures to improve emotional regulation and social responsiveness in children with Autism Spectrum Disorder (ASD) is of significant importance for the adaptation of this group of children. The aim of this research was to evaluate the impact of a 6-month drawing therapy program on preschool-aged children with ASD.

METHOD: It employed a quasi-experimental design with two groups: an experimental group participating in drawing therapy and a control group receiving no intervention. Emotional regulation was assessed using pre-test and post-test measures on the Social Responsiveness Scale (SRS).

RESULTS: The results indicated a significant improvement in social responsiveness in the experimental group post-intervention, as evidenced by paired and independent sample t-tests, indicating statistically significant differences between pre- and post-testing scores in the experimental group, as well as between the experimental and control groups. This study concludes that art therapy can significantly enhance the emotional-social responsiveness of children with ASD, highlighting its potential for practical application in therapeutic settings.

CONCLUSIONS: The findings suggest the necessity of incorporating drawing-based therapeutic strategies into intervention programs for children with ASD, offering meaningful opportunities to enhance their social skills and overall quality of life.

PMID:39907929 | DOI:10.1007/s10803-025-06727-w

Intern Emerg Med. 2025 Feb 5. doi: 10.1007/s11739-025-03881-y. Online ahead of print.

ABSTRACT

OBJECTIVES: This study investigates the impact of Familial Mediterranean Fever (FMF) and its treatment on male infertility, and the paternal effect of FMF on pregnancy outcomes or complications.

METHODS: We enrolled 282 adult male FMF patients and excluded 102 for never attempting pregnancy. Demographic and clinical data, including MEFV mutation status and treatment history, were collected. Fertility status and pregnancy outcomes were assessed through interviews and medical records. Statistical analysis was performed using Fisher’s exact test, with significance set at p < 0.05.

RESULTS: Among the 180 patients who attempted pregnancy, 177 (98.3%) achieved pregnancy. Only 3 (1.7%) were infertile. A total of 452 pregnancies were conceived, with 85.0% resulting in live births. Miscarriages occurred in 11.9%, stillbirths in 0.9%, and ectopic pregnancies in 0.9%. The most common complication was preterm birth (4.2%), followed by gestational diabetes (2.1%). Eleven patients with amyloidosis achieved 39 pregnancies, with no cases of infertility.

CONCLUSION: FMF does not lead to decreased male fertility or adverse pregnancy outcomes. Colchicine is safe for use during conception. Male FMF patients and their partners do not need additional precautions during pregnancy attempts and follow-up.

PMID:39907917 | DOI:10.1007/s11739-025-03881-y

Clin Transl Oncol. 2025 Feb 5. doi: 10.1007/s12094-025-03847-8. Online ahead of print.

ABSTRACT

BACKGROUND: Breast cancer remains a leading cause of morbidity and mortality among women worldwide. According to the recent statistics by World Health Organization (WHO), it is the leading cause of death from cancer in women worldwide and it is the most frequently diagnosed cancer. This meta-analysis aims to systematically evaluate the efficacy and safety of S-ketamine in patients undergoing modified radical mastectomy.

METHOD: We searched five databases; PubMed, Scopus, Science Direct, Web of Science, and Medline Plus. We included six studies. The applicable outcomes for meta-analysis about efficacy and safety of S-ketamine in patients undergoing modified radical mastectomy.

RESULTS: Six RCTs included in our meta-analysis found that Esketamine group had a statistically significant lower VAS score after 4 h, after 6 h, after 24 h, after 48 h; (MD = -1.54; 95% CI [-1.65, -1.42], P < 0.00001), (MD = -0.55; 95% CI [-0.66, -0.45], P < 0.00001), (MD = -0.75; 95% CI [-0.84, -0.66], P < 0.00001,), (MD = -0.26; 95% CI [-0.48, -0.03], P = 0.03) P < 0.00001), respectively.

CONCLUSION: We conclude that S-ketamine is valuable for reducing pain and safe in patients undergoing modified radical mastectomy.

PMID:39907885 | DOI:10.1007/s12094-025-03847-8