Tag: pubmed

J Clin Psychiatry. 2024 Apr 22;85(2):23m15078. doi: 10.4088/JCP.23m15078.

ABSTRACT

Objective: Major depressive disorder (MDD) is common, but current treatment options have significant limitations in terms of access and efficacy. This study examined the effectiveness of transcranial alternating current stimulation (tACS) for the acute treatment of MDD.

Methods: We performed a triple-blind, fully remote, randomized controlled trial comparing tACS with sham treatment. Adults aged 21-65 years meeting DSM 5 criteria for MDD and having a score on the Beck Depression Inventory, Second Edition (BDI-II), between 20 and 63 were eligible to participate. Participants utilized tACS or sham treatment for two 20-minute treatment sessions daily for 4 weeks. The primary outcome was change in BDI-II score from baseline to the week 2 time point in an intent-to treat analysis, followed by analyses of treatment-adherent participants. Secondary analyses examined change at the week 1 and 4 time points, responder rates, subgroup analyses, other self-report mood measures, and safety. The study was conducted from April to October 2022.

Results: A total of 255 participants were randomized to active or sham treatment. Improvement in intent-to-treat analysis was not statistically significant at week 2 (P= .056), but there were significant effects in participants with high adherence (P= .005). Significantly greater improvement at week 1 (P= .020) and greater response at week 4 (P= .028) occurred following tACS. Improvements were significantly larger for female participants. There were no significant effects on secondary mood measures. Side effects were minimal and mild.

Conclusions: Rapid, clinically significant improvement in depression in adults with MDD was associated with tACS, particularly for women. Compared to other depression therapies, tACS has 3 key advantages: rapid, clinically significant treatment effect, the ability of patients to use the treatment on their own at home, and the rarity and low impact of adverse events.

Trial Registration: ClinicalTrials.gov identifier: NCT05384041.

PMID:38696220 | DOI:10.4088/JCP.23m15078

Invest Ophthalmol Vis Sci. 2024 May 1;65(5):6. doi: 10.1167/iovs.65.5.6.

ABSTRACT

PURPOSE: Thyroid eye disease (TED) is characterized by proliferation of orbital tissues and complicated by compressive optic neuropathy (CON). This study aims to utilize a deep-learning (DL)-based automated segmentation model to segment orbital muscle and fat volumes on computed tomography (CT) images and provide quantitative volumetric data and a machine learning (ML)-based classifier to distinguish between TED and TED with CON.

METHODS: Subjects with TED who underwent clinical evaluation and orbital CT imaging were included. Patients with clinical features of CON were classified as having severe TED, and those without were classified as having mild TED. Normal subjects were used for controls. A U-Net DL-model was used for automatic segmentation of orbital muscle and fat volumes from orbital CTs, and ensemble of Random Forest Classifiers were used for volumetric analysis of muscle and fat.

RESULTS: Two hundred eighty-one subjects were included in this study. Automatic segmentation of orbital tissues was performed. Dice coefficient was recorded to be 0.902 and 0.921 for muscle and fat volumes, respectively. Muscle volumes among normal, mild, and severe TED were found to be statistically different. A classification model utilizing volume data and limited patient data had an accuracy of 0.838 and an area under the curve (AUC) of 0.929 in predicting normal, mild TED, and severe TED.

CONCLUSIONS: DL-based automated segmentation of orbital images for patients with TED was found to be accurate and efficient. An ML-based classification model using volumetrics and metadata led to high diagnostic accuracy in distinguishing TED and TED with CON. By enabling rapid and precise volumetric assessment, this may be a useful tool in future clinical studies.

PMID:38696188 | DOI:10.1167/iovs.65.5.6

JAMA Netw Open. 2024 May 1;7(5):e249435. doi: 10.1001/jamanetworkopen.2024.9435.

NO ABSTRACT

PMID:38696173 | DOI:10.1001/jamanetworkopen.2024.9435

JAMA Netw Open. 2024 May 1;7(5):e249305. doi: 10.1001/jamanetworkopen.2024.9305.

ABSTRACT

IMPORTANCE: Sodium-glucose cotransporter-2 (SGLT2) inhibitors have been shown to have benefits when used in patients with heart failure. The comparative outcomes of SGLT2 inhibitors relative to each other has not been well defined and may impact medication selection.

OBJECTIVE: To determine the comparative outcomes of empagliflozin and dapagliflozin on reducing the composite of all-cause mortality and hospitalizations in patients with heart failure.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter retrospective cohort study included patients with heart failure from August 18, 2021, and December 6, 2022, in the TriNetX Research Collaborative, a centralized database of deidentified electronic medical record data from a network of 81 health care organizations. Eligible patients had a diagnosis of heart failure, had never received an SGLT2 inhibitor previously, and were newly started on empagliflozin or dapagliflozin. Patients were followed up for 1 year.

EXPOSURE: Initiation of dapagliflozin or empagliflozin.

MAIN OUTCOMES AND MEASURES: The primary outcome was the time to the composite of all-cause mortality or hospitalization between study days 1 to 365. Kaplan-Meier analyses, hazard ratios (HRs), and 95% CIs were used to assess the primary outcome.

RESULTS: Among 744 914 eligible patients, 28 075 began empagliflozin (15 976 [56.9%]) or dapagliflozin (12 099 [43.1%]). After nearest-neighbor matching for demographics, diagnoses, and medication use, there were 11 077 patients in each group. Of patients who received empagliflozin, 9247 (57.9%) were male, 3130 (19.6%) were Black individuals, and 9576 (59.9%) were White individuals. Similarly, of those who received dapagliflozin, 7439 (61.5%) were male, 2445 (20.2%) were Black individuals, and 7131 (58.9%) were White individuals. Patients receiving empagliflozin were less likely to experience the composite of all-cause mortality or hospitalization compared with those initiated on dapagliflozin (3545 [32.2%] vs 3828 [34.8%] events; HR, 0.90 [95% CI, 0.86-0.94]) in the year following SGLT2 inhibitor initiation and less likely to be hospitalized (HR, 0.90 [95% CI, 0.86-0.94]). All-cause mortality did not differ between exposure groups (HR, 0.91 [95% CI, 0.82-1.00]). There was no difference in mean hemoglobin A1c or adverse events between groups.

CONCLUSIONS AND RELEVANCE: In this cohort study, patients who initiated empagliflozin were less likely to experience the composite of all-cause mortality or hospitalization compared with patients who started dapagliflozin. Additional studies are needed to confirm these finding.

PMID:38696170 | DOI:10.1001/jamanetworkopen.2024.9305

JAMA Netw Open. 2024 May 1;7(5):e249312. doi: 10.1001/jamanetworkopen.2024.9312.

ABSTRACT

IMPORTANCE: Nursing home (NH) transfers to hospitals are common and have been associated with cognitive decline; approximately 45% of NH hospital transfers are potentially avoidable hospitalizations (PAHs).

OBJECTIVE: To determine PAH incidence for historically marginalized NH residents with severe cognitive impairment compared with non-Hispanic White residents.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study merged 2018 Centers for Medicaid & Medicare Services datasets and LTCFocus, a public dataset on US NH care, for US NH residents aged 65 years and older who had a hospitalization. Analyses were performed from January to May 2022.

EXPOSURE: Race and ethnicity of NH residents.

MAIN OUTCOMES AND MEASURES: Racial and ethnic differences in resident-level annual rates of PAHs were estimated for residents with and without severe cognitive impairment (measured using the Cognitive Function Scale), controlling for resident characteristics, comorbidities, dual eligibility, and time at risk. PAHs were defined as NH hospital transfers that resulted from neglectful NH care or for which NH treatment would have been appropriate.

RESULTS: Of 2 098 385 NH residents nationwide included in the study, 7151 (0.3%) were American Indian or Alaska Native, 39 873 (1.9%) were Asian, 229 112 (10.9%) were Black or African American, 99 304 (4.7%) were Hispanic, 2785 (0.1%) were Native Hawaiian or Pacific Islander, 1 713 670 (81.7%) were White, and 6490 (0.3%) were multiracial; 1 355 143 (64.6%) were female; 128 997 (6.2%) were severely cognitively impaired; and the mean (SD) age was 81.8 (8.7) years. PAH incidence rate ratios (IRRs) were significantly greater for residents with severe cognitive impairment compared with those without. In unadjusted analyses comparing historically marginalized residents with severe cognitive impairment vs non-Hispanic White residents with severe cognitive impairment, American Indian or Alaska Native residents had a 49% higher PAH incidence (IRR, 1.49 [95% CI, 1.10-2.01]), Black or African American residents had a 64% higher incidence (IRR, 1.64 [95% CI, 1.48-1.81]), and Hispanic residents had a 45% higher incidence (IRR, 1.45 [95% CI, 1.29-1.62]). Higher incidences persisted for historically marginalized residents with severe cognitive impairment vs non-Hispanic White residents with severe cognitive impairment in adjusted analyses. Asian residents had a 24% higher PAH incidence (IRR, 1.24 [95% CI, 1.06-1.45]), Black or African American residents had a 48% higher incidence (IRR, 1.48 [95% CI, 1.36-1.60]), and Hispanic residents had a 27% higher incidence (IRR, 1.27 [95% CI, 1.16-1.39]).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of PAHs, compared with non-Hispanic White NH residents, historically marginalized residents had increased PAH incidence. In the presence of severe cognitive impairment, incidence rates increased significantly compared with rates for residents without severe cognitive impairment. These results suggest that identification of residents with severe cognitive impairment and proper NH care may help prevent further cognitive decline by avoiding PAHs.

PMID:38696169 | DOI:10.1001/jamanetworkopen.2024.9312

JAMA Netw Open. 2024 May 1;7(5):e249429. doi: 10.1001/jamanetworkopen.2024.9429.

ABSTRACT

IMPORTANCE: Cancer is a leading cause of death among children worldwide. Treatments used for medically assisted reproduction (MAR) are suspected risk factors because of their potential for epigenetic disturbance and associated congenital malformations.

OBJECTIVE: To assess the risk of cancer, overall and by cancer type, among children born after MAR compared with children conceived naturally.

DESIGN, SETTING, AND PARTICIPANTS: For this cohort study, the French National Mother-Child Register (EPI-MERES) was searched for all live births that occurred in France between January 1, 2010, and December 31, 2021 (and followed up until June 30, 2022). The EPI-MERES was built from comprehensive data of the French National Health Data System. Data analysis was performed from December 1, 2021, to June 30, 2023.

EXPOSURE: Use of assisted reproduction technologies (ART), such as fresh embryo transfer (ET) or frozen ET (FET), and artificial insemination (AI).

MAIN OUTCOMES AND MEASURES: The risk of cancer was compared, overall and by cancer type, among children born after fresh ET, FET, or AI and children conceived naturally, using Cox proportional hazards regression models adjusted for maternal and child characteristics at birth.

RESULTS: This study included 8 526 306 children with a mean (SD) age of 6.4 (3.4) years; 51.2% were boys, 96.4% were singletons, 12.1% were small for gestational age at birth, and 3.1% had a congenital malformation. There were 260 236 children (3.1%) born after MAR, including 133 965 (1.6%) after fresh ET, 66 165 (0.8%) after FET, and 60 106 (0.7%) after AI. A total of 9256 case patients with cancer were identified over a median follow-up of 6.7 (IQR, 3.7-9.6) years; 165, 57, and 70 were born after fresh ET, FET, and AI, respectively. The overall risk of cancer did not differ between children conceived naturally and those born after fresh ET (hazard ratio [HR], 1.12 [95% CI, 0.96 to 1.31]), FET (HR, 1.02 [95% CI, 0.78 to 1.32]), or AI (HR, 1.09 [95% CI, 0.86 to 1.38]). However, the risk of acute lymphoblastic leukemia was higher among children born after FET (20 case patients; HR 1.61 [95% CI, 1.04 to 2.50]; risk difference [RD], 23.2 [95% CI, 1.5 to 57.0] per million person-years) compared with children conceived naturally. Moreover, among children born between 2010 and 2015, the risk of leukemia was higher among children born after fresh ET (45 case patients; HR, 1.42 [95% CI, 1.06 to 1.92]; adjusted RD, 19.7 [95% CI, 2.8 to 43.2] per million person-years).

CONCLUSIONS AND RELEVANCE: The findings of this cohort study suggest that children born after FET or fresh ET had an increased risk of leukemia compared with children conceived naturally. This risk, although resulting in a limited number of cases, needs to be monitored in view of the continuous increase in the use of ART.

PMID:38696167 | DOI:10.1001/jamanetworkopen.2024.9429

JAMA Netw Open. 2024 May 1;7(5):e249474. doi: 10.1001/jamanetworkopen.2024.9474.

ABSTRACT

IMPORTANCE: The National Cancer Institute comprehensive cancer centers (CCCs) lack spatial and temporal evaluation of their self-designated catchment areas.

OBJECTIVE: To identify disparities in cancer stage at diagnosis within and outside a CCC’s catchment area across a 10-year period using spatial and statistical analyses.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional, population-based study conducted between 2010 and 2019 utilized cancer registry data for the Johns Hopkins Sidney Kimmel CCC (SKCCC). Eligible participants included patients with cancer in the contiguous US who received treatment for cancer, a diagnosis of cancer, or both at SKCCC. Patients were geocoded to zip code tabulation areas (ZCTAs). Individual-level variables included sociodemographic characteristics, smoking and alcohol use, treatment type, cancer site, and insurance type. Data analysis was performed between March and July 2023.

EXPOSURES: Distance between SKCCC and ZCTAs were computed to generate a catchment area of the closest 75% of patients and outer zones in 5% increments for comparison.

MAIN OUTCOMES AND MEASURES: The primary outcome was cancer stage at diagnosis, defined as early-stage, late-stage, or unknown stage. Multinomial logistic regression was used to determine associations of catchment area with stage at diagnosis.

RESULTS: This study had a total of 94 007 participants (46 009 male [48.94%] and 47 998 female [51.06%]; 30 195 aged 22-45 years [32.12%]; 4209 Asian [4.48%]; 2408 Hispanic [2.56%]; 16 004 non-Hispanic Black [17.02%]; 69 052 non-Hispanic White [73.45%]; and 2334 with other or unknown race or ethnicity [2.48%]), including 47 245 patients (50.26%) who received a diagnosis of early-stage cancer, 19 491 (20.73%) who received a diagnosis of late-stage cancer , and 27 271 (29.01%) with unknown stage. Living outside the main catchment area was associated with higher odds of late-stage cancers for those who received only a diagnosis (odds ratio [OR], 1.50; 95% CI, 1.10-2.05) or only treatment (OR, 1.44; 95% CI, 1.28-1.61) at SKCCC. Non-Hispanic Black patients (OR, 1.16; 95% CI, 1.10-1.23) and those with Medicaid (OR, 1.65; 95% CI, 1.46-1.86) and no insurance at time of treatment (OR, 2.12; 95% CI, 1.79-2.51) also had higher odds of receiving a late-stage cancer diagnosis.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of CCC data from 2010 to 2019, patients residing outside the main catchment area, non-Hispanic Black patients, and patients with Medicaid or no insurance had higher odds of late-stage diagnoses. These findings suggest that disadvantaged populations and those living outside of the main catchment area of a CCC may face barriers to screening and treatment. Care-sharing agreements among CCCs could address these issues.

PMID:38696166 | DOI:10.1001/jamanetworkopen.2024.9474

JAMA Netw Open. 2024 May 1;7(5):e249531. doi: 10.1001/jamanetworkopen.2024.9531.

ABSTRACT

IMPORTANCE: Pregnancy represents a window of opportunity for vaccination due to established maternal and fetal benefits of vaccination. Little is known about receipt of routinely recommended vaccines in pregnancy, specifically tetanus, diphtheria, plus acellular pertussis (Tdap) and influenza, among pregnant people living with HIV (PLHIV).

OBJECTIVE: To estimate prevalence of vaccination receipt among pregnant people with HIV (PLHIV) and identify demographic and clinical characteristics associated with vaccination.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter cohort study included women participating in Women’s Health Study (WHS) of the Surveillance Monitoring for ART Toxicities (SMARTT) Study of the Pediatric HIV/AIDS Cohort Study. The network has been enrolling pregnant PLHIV at 22 US sites since 2007. Participants for this study enrolled between December 2017 and July 2019. Data analysis was conducted from October 2021 to March 2022.

EXPOSURE: Data on vaccination in pregnancy were collected through medical record abstraction.

MAIN OUTCOMES AND MEASURES: Vaccination receipt was defined as Tdap vaccination received at less than 36 weeks’ gestation and influenza vaccination at any gestational age, based on current guidelines. Log-binomial and modified Poisson regression models with generalized estimating equations were fit to identify factors associated with successful receipt of (1) Tdap, (2) influenza, and (3) both vaccinations.

RESULTS: A total of 310 pregnancies among 278 people participating in the WHS were included (mean [SD] age, 29.5 [6.1] years; 220 [71%] Black, 77 [25%] Hispanic, and 77 [25%] race and ethnicity other than Black; 64 [21%] with perinatally acquired HIV). Less than one-third of pregnancies were vaccinated as recommended (Tdap, 32.6% [95% CI, 27.4%-38.1%]; influenza, 31.6% [95% CI, 26.5%-37.1%]; both, 22.6% [95% CI, 18.0%-27.6%]). People living with perinatally acquired HIV, those who did not identify as Black, or those who were multiparous had adjusted risk ratios (aRRs) less than 1, while older PLHIV had aRRs greater than 1, but these differences did not reach statistical significance (perinatally acquired HIV: adjusted risk ratio [aRR], 0.46; 95% CI, 0.21-1.02; race other than Black: aRR, 0.53; 95% CI, 0.26-1.08; multiparous: aRR, 0.59; 95% CI, 0.35-1.00; age 24-29 years: aRR, 2.03; 95% CI, 0.92-4.48).

CONCLUSIONS AND RELEVANCE: In this diverse, multicenter cohort of pregnant PLHIV, receipt of recommended vaccinations was low. Identifying and addressing barriers to vaccination receipt is urgently needed for pregnant people with HIV.

PMID:38696165 | DOI:10.1001/jamanetworkopen.2024.9531

Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(4. Vyp. 2):92-99. doi: 10.17116/jnevro202412404292.

ABSTRACT

OBJECTIVE: To study the efficacy and safety of the use of annual course therapy of choline alfoscerate (CA) as a drug potentially capable of slowing or preventing the transition of amnesic type mild cognitive impairment (aMCI) into clinically pronounced dementia in a three-year open comparative study, as well as to explore the possibility of predicting the preventive effect of such therapy based on a number of clinical and biological parameters.

MATERIAL AND METHODS: The study included 100 patients with aMCI, randomly divided into 2 groups: the therapeutic group consisted of 50 patients who received CA course therapy once a year for 3 years (20 intravenous infusions of 1000 mg (4 ml) in 100 ml of saline solution for 4 weeks) and a comparison group of 50 patients who underwent an annual examination at the center and did not receive therapy. Clinical and psychopathological, psychometric, immunological, follow-up, and statistical methods were used.

RESULTS: A comparative three-year prospective study conducted in a group of aMCI patients treated with annual course therapy of CA for 3 years and aMCI patients who did not receive therapy with similar initial demographic, diagnostic, psychometric and immunological characteristics showed a lower progression of cognitive deficits (12.2% and 39.1%, respectively) and a lower conversion rate (8.2% and 26.1%, respectively) to dementia in the therapeutic group compared with the comparison group. The differences between the initial and final (after 1, 2 and 3 years of follow-up) cognitive functioning indicators in the therapeutic group and the comparison group were significant (p<0.05) on all scales and tests in favor of the therapeutic group throughout the entire follow-up period.

CONCLUSION: The results allow us to consider CA as a possible model of preventive dementia therapy aimed at preventing the progression of cognitive deficits and the development of dementia in people at high risk of developing AD – patients with aMCI.

PMID:38696157 | DOI:10.17116/jnevro202412404292

Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(4. Vyp. 2):64-71. doi: 10.17116/jnevro202412404264.

ABSTRACT

OBJECTIVE: To establish the characteristics of clinical manifestations and cognitive tests in patients with schizophrenia, with a predominance of cognitive and negative disorders.

MATERIAL AND METHODS: We examined 76 patients, 66 in the main group, 10 in the comparison group, who were treated in Psychiatric Hospital No. 1 and Psychiatric Hospital No. 4 (Moscow). Clinical-psychopathological, psychometric and statistical methods were used. Features of cognitive functioning were studied using the Frontal Assessment Battery (FAB) and the Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis (ALS) Screen (ECAS). Emotional intelligence scores were assessed using the Ekman Face Emotion Recognition (EFER) test.

RESULTS: Patients with schizophrenia showed dominance of one of 3 types of deficit symptoms: cognitive, emotional, and volitional. Cognitive functions were significantly reduced in patients with schizophrenia when compared with the comparison group (mean FAB score (M±SD) 13.44±2.97 in patients with schizophrenia vs. 16.10±1.70 in the comparison group; t=4.10; p<0.001). Cognitive functions were particularly reduced in patients with volitional deficit (mean EFER total score 42.40±9.0 in patients with volitional deficit vs. 47.21±633 in patients with cognitive deficit; t=2.12; p=0.039; mean FAB score 12.83±3.29 in patients with volitional deficit vs. 16.10±1.70 in the comparison group; t=4.24; p<0.001; mean ECAS score specific to ALS 78.80±9.07 in patients with volitional deficit vs. 84.50±6.71 in the comparison group; t=2.18; p=0.034).

CONCLUSION: The greatest contribution to the development of cognitive disorders in schizophrenia is made by dysfunction of frontal (especially) and temporal cortex. Executive functions, speech skills and verbal fluency are most severely damaged.

PMID:38696153 | DOI:10.17116/jnevro202412404264