Nevin ManimalaCategory Added in a WPeMatico Campaign
J Clin Oncol. 2024 Jun 25:JCO2400539. doi: 10.1200/JCO.24.00539. Online ahead of print.
ABSTRACT
Unlocking the full potential of clinical trials through comprehensive CSR and IPD sharing can revolutionize cancer care, enhance safety evaluations, and reduce bias in systematic reviews. It is time for all stakeholders to embrace transparency and advance patient-centered outcomes.
PMID:38917375 | DOI:10.1200/JCO.24.00539
J Clin Psychiatry. 2024 Jun 17;85(3):24m15265. doi: 10.4088/JCP.24m15265.
ABSTRACT
Objective: To test esmethadone (REL-1017) as adjunctive treatment in patients with major depressive disorder (MDD) and inadequate response to standard antidepressants.
Methods: In this phase 3, double-blind, placebo-controlled trial, outpatients with MDD (DSM-5) were randomized to daily oral esmethadone (75 mg on day 1, followed by 25 mg daily on days 2 through 28) or placebo between December 2020 and December 2022. The primary efficacy measure was change from baseline (CFB) to day 28 in the Montgomery-Asberg Depression Rating Scale (MADRS) score. The intent-to-treat (ITT) population included all randomized participants. The per-protocol (PP) population included completers without major protocol deviations impacting assessment. Post hoc analyses included participants with severe depression (baseline MADRS score ≥35).
Results: For the ITT analysis (n = 227), mean CFB was 15.1 (SD 11.3) for esmethadone (n = 113) and 12.9 (SD 10.4) for placebo (n = 114), with a mean difference (MD) of 2.3, which was not statistically significant (P = .154; Cohen effect size [ES] = 0.21). Remission rates were 22.1% and 13.2% (P = .076), and response rates were 39.8% and 27.2% (P = .044) with esmethadone and placebo, respectively. For the PP analysis (n = 198), mean CFB was 15.6 (SD 11.2) for esmethadone (n = 101) and 12.5 (SD 9.9) for placebo (n = 97), with an MD of 3.1 (P = .051; ES =0.29). In post hoc analyses of patients with baseline MADRS ≥35 in the ITT population (n = 112), MD was 6.9; P = .0059; ES = 0.57, and for the PP population (n = 98), MD was 7.9; P = .0015; ES = 0.69. Adverse events (AEs) were predominantly mild or moderate and transient, with no significant differences between groups.
Conclusions: The primary end point was not met. Esmethadone showed stronger efficacy in PP than in ITT analyses, with the discrepancy not attributable to AEs impacting treatment adherence. Significant efficacy occurred in post hoc analyses of patients with severe depression. Esmethadone was well tolerated, consistent with prior studies.
Trial Registration: ClinicalTrials.gov identifier: NCT04688164.
PMID:38917366 | DOI:10.4088/JCP.24m15265
J Clin Psychiatry. 2024 Jun 19;85(3):23m15136. doi: 10.4088/JCP.23m15136.
ABSTRACT
Abstract.
Background: Sex differences in suicide attempts have been widely recognized across domains such as depression and rumination. The relationship between depression, rumination, and suicide attempts in mood disorders has been studied before; however, how they interact across sexes remains unclear. This study aimed to examine the sex differences in the relationship between depression, rumination, and suicide attempts in Chinese adolescents with mood disorders.
Methods: We recruited 681 adolescents with mood disorders who met ICD-10 criteria for having unipolar or bipolar depression with a current depressive episode at the time of the study and collected demographic and clinical data.
Results: The prevalence of suicide attempts in female adolescents with mood disorders (64.36%) was significantly higher than that in male adolescents with mood disorders (49.47%), with an odds ratio of 1.84 (95% CI, 1.31-2.59). Regression analysis showed that PHQ-9 was independently associated with suicide attempts among male adolescents with mood disorders, while in female adolescents with mood disorders, total scores of PHQ-9 and RRS-10 were independently associated with suicide attempts. Importantly, in female adolescents with mood disorders, the mediating effect of RRS-10 total score on the relationship between PHQ-9 and suicide attempts was significant (standardized β = 0.005, P = 0.003, 95% CI, 0.002-0.008), the mediating effect accounted for 31.25% of the total effect of depressive symptoms on suicide attempts.
Conclusions: Our study suggests that there are sex differences in depression, rumination, and suicide attempts and in the interaction between them in adolescents with mood disorders. These sex differences may have important clinical implications, both for improving strategies to detect suicidal behaviors and for developing better early intervention programs for this population.
PMID:38917361 | DOI:10.4088/JCP.23m15136
Adv Clin Exp Med. 2024 Jun 25. doi: 10.17219/acem/176892. Online ahead of print.
ABSTRACT
INTRODUCTION: Proton pump inhibitors (PPIs) and histamine type-2 receptor antagonists (H2RAs) are generally effective in preventing delayed bleeding and healing artificial wounds after endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). This study aimed to review the therapeutic effects of PPIs and H2RAs on damage caused by EMR and ESD.
MATERIAL AND METHODS: Thirteen articles were collected between 2002 and 2022 by searching Medlib, ScienceDirect, PubMed, International Scientific Indexing (ISI), Embase, and Scopus databases using valid keywords. The main inclusion criteria were delayed wound healing, bleeding, epigastric pain, intraoperative bleeding, and perforation. The odds ratio (OR) and 95% confidence interval (95% CI) were evaluated using a random or fixed effects model. Data analysis was performed using Stata v. 14.2.
RESULTS: A total of 13 articles including 1,483 patients were analyzed. The results showed that delayed bleeding was significantly less frequent in the PPI group than in the H2RA group (OR = 0.6; 95% CI: 0.39-0.92). Subgroup analysis showed that PPI was more effective in preventing delayed bleeding than H2RA for ESD wounds (OR = 0.65; 95% CI: 0.44-1.08). There was no statistically significant difference between both groups regarding the incidence of epigastric pain, intraoperative bleeding, wound healing, and perforation after endoscopic treatments.
CONCLUSION: The meta-analysis results reveal that PPI is more effective than H2RA in preventing delayed bleeding after endoscopic treatment, particularly in patients treated with ESD. However, there was no significant difference between PPI and H2RA in terms of intraoperative bleeding, epigastric pain, wound healing, and perforation from endoscopic therapy.
PMID:38917321 | DOI:10.17219/acem/176892
R I Med J (2013). 2024 Jul 1;107(7):39-43.
ABSTRACT
While the burden of COVID-19 in Rhode Island has diminished since 2020, Rhode Islanders’ health continues to be severely impacted. We compared COVID-19 hospitalization rates among Rhode Islanders who did and did not receive the latest COVID-19 vaccination for the 2022-2023 and 2023-2024 COVID-19 seasons (November through March). Crude and age-adjusted rate ratios were calculated for each season comparing hospitalization rates of unvaccinated and vaccinated individuals. During the 2022-2023 season, individuals who were not vaccinated with the bivalent COVID-19 vaccine were 3.6 times (95% CI=2.8-4.6) more likely to be hospitalized for COVID-19 than individuals who received the vaccine, whereas during the 2023-2024 season, not receiving the updated vaccine was associated with a 2.4 times (95% CI=1.8-3.3) higher risk of hospitalization. The study provides the first assessment of the protection from hospitalization provided by COVID-19 vaccinations among Rhode Islanders and highlights the importance of continued vaccination for COVID-19.
PMID:38917315
R I Med J (2013). 2024 Jul 1;107(7):22-27.
ABSTRACT
OBJECTIVE: This study examined if emergency department (ED) operational metrics, such as wait time or length of stay, are associated with interest in substance use disorder (SUD) treatment referral among patients at high risk of opioid overdose.
METHODS: In this observational study, 648 ED patients at high risk of opioid overdose completed a baseline questionnaire. Operational metrics were summarized using electronic health record data. The association between operational metrics and treatment interest was estimated with multivariable logistic regression.
RESULTS: Longer time to room (adjusted odds ratio [AOR]=1.12, 95% confidence interval [CI]=1.01-1.25) and length of stay (AOR=1.02, 95% CI=1.00-1.05) were associated with treatment referral interest. Time to provider and number of treating providers showed no significant association.
CONCLUSION: Longer rooming wait times and longer ED visits were associated with increased SUD treatment referral interest. This suggests patients who wait for longer periods may be motivated for treatment and warrant further resource investment.
PMID:38917311
AIDS Educ Prev. 2024 Jun;36(3):216-228. doi: 10.1521/aeap.2024.36.3.216.
ABSTRACT
HIV testing is the point of entry for linkage to treatment and prevention and is critically important to ending the HIV epidemic. HIV self-testing (HST) is an acceptable, user-controlled tool that can address testing barriers, which is especially important for populations who need to test frequently, like women who exchange or trade sex for money or other needed resources (WES) and women who use drugs. HST is feasible and acceptable among WES, but research among WES who also use drugs is limited, particularly in places like Kazakhstan, where HIV rates remain high and where scale-up of HST and pre-exposure prophylaxis (PrEP) is in process. To develop effective programming, there is a need to develop tailored services for WES and/or use drugs that address key barriers. We discuss opportunities to increase HST and linkage to services among WES and/or use drugs in Kazakhstan, with a focus on stigma reduction.
PMID:38917303 | DOI:10.1521/aeap.2024.36.3.216
AIDS Educ Prev. 2024 Jun;36(3):182-197. doi: 10.1521/aeap.2024.36.3.182.
ABSTRACT
This analysis examined correlates of HIV testing among Asian immigrant female sex workers in massage parlors. We interviewed 69 Chinese and Korean immigrant women who provided sexual services in massage parlors in New York City or Los Angeles County (2014-2016). Multivariable logistic regression results showed that participants who were younger, have lived in the U.S. for a longer period of time, had greater English proficiency, perceived higher HIV risk, or were living with an intimate partner were more likely to have had an HIV test. Disclosing sex work to a close friend was also positively associated with HIV testing at p < .1. These correlates may reflect differential access to information, systems, and social networks that would facilitate HIV testing, highlighting the importance of reducing social isolation and increasing HIV education, especially for older women who have come to the U.S. more recently. As the literature has indicated that Asian immigrant female sex workers experience high rates of intersectional stigma, efforts to mitigate these intersecting stigmas could further these objectives.
PMID:38917302 | DOI:10.1521/aeap.2024.36.3.182
AIDS Educ Prev. 2024 Jun;36(3):155-167. doi: 10.1521/aeap.2024.36.3.155.
ABSTRACT
Transgender women are disproportionately impacted by HIV infection. We report herein the findings of a pre-post evaluation of the TransLife Care (TLC) project in Chicago, Illinois, on behaviors associated with HIV transmission among transgender women. Participants who received any TLC component versus those who did not were compared using mixed-effects logistic regression with random intercepts across follow-up time points. Ninety-seven participants aged 18 to 59 (median age 24) enrolled; 76.3% were transgender women of color. There was a decrease in condomless sex without consistent PrEP use at 8 months, which was not significantly different between those who did and did not receive the TLC intervention, controlling for calendar time. Evidence does not indicate that the TLC reduces condomless sex without PrEP protection among urban transgender women. However, given the preponderance of evidence of the influence of structural barriers on condomless sex, future research should continue to test the efficacy of structural interventions.
PMID:38917300 | DOI:10.1521/aeap.2024.36.3.155
Pharmacogenet Genomics. 2024 Jun 18. doi: 10.1097/FPC.0000000000000541. Online ahead of print.
ABSTRACT
OBJECTIVE: This study aims to understand patient and healthcare provider perspectives on the integration and application of pharmacogenetics (PGx) testing in routine clinical practice.
METHODS: Two anonymous online surveys were distributed globally for healthcare providers and patients respectively on the Qualtrics platform (version 3.24). The surveys were distributed through social platforms, email, and posters with QR codes from 27 October 2023 to 7 March 2024. The surveys evaluated participant familiarity with PGx, previous experience with PGx testing, perceived implementation challenges, and opinions on point-of-care (PoC) PGx testing devices.
RESULTS: This study collected 78 responses from healthcare providers and 98 responses from patients. The results revealed that 64% of healthcare providers had some level of familiarity with PGx, however, PGx testing in clinical practice was low. The primary challenges identified by healthcare providers included limited access to testing and lack of knowledge on PGx test interpretation. In contrast, 52% of patient respondents were aware of PGx testing, with a significant association between awareness and positive opinions toward PGx. Both healthcare providers and patients recognized the value of PoC PGx testing devices, with 98% of healthcare providers and 71% of patients believing PoC devices would improve the accessibility and implementation of PGx testing. Comparative analysis revealed a statistically significant difference in PGx awareness between healthcare providers and patients, with providers being more informed.
CONCLUSION: Improved PGx awareness, training, clinical guidelines, and PoC PGx testing devices may help promote the implementation of PGx-guided treatments in routine clinical practice.
PMID:38917295 | DOI:10.1097/FPC.0000000000000541