Tag: pubmed

JAMA Netw Open. 2025 Feb 3;8(2):e2458059. doi: 10.1001/jamanetworkopen.2024.58059.

ABSTRACT

IMPORTANCE: Cognitive processing therapy (CPT) is an evidence-based treatment for posttraumatic stress disorder (PTSD). However, there is little evidence on the efficacy of CPT in East Asia.

OBJECTIVE: To evaluate whether CPT is effective in treating PTSD among outpatients in a Japanese medical setting.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial used a 16-week, single-center, assessor-blinded, parallel-group superiority design to examine the efficacy of CPT in conjunction with treatment as usual (CPT-TAU) vs waiting list with TAU (WL-TAU) from April 2016 through December 2022. The trial included adult patients with PTSD at a national psychiatric referral hospital in Tokyo, Japan. Analysis was based on intention to treat and per protocol and was performed from February 1 to April 30, 2024.

INTERVENTIONS: Participants were randomized 1:1 to CPT-TAU (n = 29), which consisted of 12 weekly individual CPT sessions, or WL-TAU (n = 31), which consisted of clinical monitoring and/or pharmacotherapy.

MAIN OUTCOMES AND MEASURES: The primary outcome was the Clinician-Administered PTSD Scale (CAPS-5) score for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) at 17 weeks. Secondary outcomes included self-reported PTSD symptoms assessed by the PTSD Checklist-5 and responder status at 17 weeks. Adverse events were evaluated using the Japanese version of the Common Terminology Criteria for Adverse Events, version 4.0.

RESULTS: Among 60 eligible participants (all included in the intention-to-treat analysis), mean (SD) age was 36.9 (9.9) years; 54 (90.0%) were women. The CPT-TAU group showed a mean (SE) reduction in CAPS-5 scores of 14.00 (1.92) points, with a low dropout rate (2 of 29 [6.9%]). Patients in the CPT-TAU group showed superiority in all secondary and other outcomes. The mean change difference was observed in depression (8.83; 95% CI, 6.00-11.66), suicidal ideation (6.73; 95% CI, 1.25-12.22), disability (8.16; 95% CI, 3.90-12.43), clinical global impression (0.84; 95% CI, 0.41-1.26), and loss of principal PTSD diagnosis (59.09; 95% CI, 37.19-81.00). There were no serious adverse events in the CPT-TAU group and 3 serious adverse events in the WL-TAU group during the intervention period.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in East Asian populations.

TRIAL REGISTRATION: Umin.Uc.Jp/Ctr Identifier: UMIN000021670.

PMID:39908018 | DOI:10.1001/jamanetworkopen.2024.58059

JAMA Netw Open. 2025 Feb 3;8(2):e2458141. doi: 10.1001/jamanetworkopen.2024.58141.

ABSTRACT

IMPORTANCE: In 2024, the US Preventive Services Task Force (USPSTF) reversed a 2009 policy recommending only females aged 50 to 74 years complete a biennial mammogram. Understanding whether females facing heterogeneous breast cancer risks responded to the 2009 guidance may illuminate how they may respond to the latest policy update.

OBJECTIVE: To evaluate whether the 2009 policy was associated with changes in mammography screening in females no longer recommended to complete a biennial mammogram and whether these changes varied by factors associated with breast cancer risk.

DESIGN, SETTING, AND PARTICIPANTS: The difference-in-differences design compared biennial mammogram trends in the exposed groups (aged 40-49 and ≥75 years) with trends of the unexposed groups (aged 50-64 and 65-74 years), before and after the 2009 update. Population-based, repeated cross-sectional survey data came from the Behavioral Risk Factor Surveillance System (BRFSS) biennial cancer screening module (2000-2018). The sample was restricted to females between ages 40 and 84 years. Data were analyzed from March 1 to June 30, 2024.

MAIN OUTCOMES AND MEASURES: The outcome was a binary variable indicating whether the respondent reported a mammogram in the past 2 years (biennial). After 2009, females aged 40 to 49 and 75 or older years were exposed to the policy update, as a complete biennial mammogram was recommended. Subgroup analyses included race and ethnicity, educational level, household income, smoking history, current binge drinking status, and state of residence.

RESULTS: The sample included 1 594 834 females; 75% reported a biennial mammogram. In those aged 40 to 49 years, the USPSTF update was associated with a 1.1 percentage-point (95% CI, -1.8% to -0.3 percentage points) decrease in the probability of a biennial mammogram, with the largest decreases in the non-Hispanic Black population (-3.0 percentage points; 95% CI, -5.5% to -0.5 percentage points). In the aged 75 years or older group, the USPSTF update was associated with a 4.8 percentage-point decrease (95% CI, -6.3% to -3.5 percentage points) in the probability of a biennial mammogram, with significant heterogeneity by race and ethnicity, binge drinking status, and state residence.

CONCLUSIONS AND RELEVANCE: In this study, socioeconomic factors were associated with differences in how females responded to the 2009 USPSTF mammography recommendation. Whether the 2024 update considered such differences is unclear. These findings suggest that including risk assessment into future USPSTF policy updates may improve adoption of risk-reducing interventions and shorten the time to diagnosis and treatment for high-risk patients.

PMID:39908017 | DOI:10.1001/jamanetworkopen.2024.58141

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