Tag: pubmed

J Med Internet Res. 2025 Aug 8;27:e72637. doi: 10.2196/72637.

ABSTRACT

BACKGROUND: Attitude-targeted interventions are important approaches for promoting vaccination. Educational approaches alone cannot effectively cultivate positive vaccine attitudes. Artificial intelligence (AI)-driven chatbots and motivational interviewing (MI) techniques show high promise in improving vaccine attitudes and facilitating readiness for vaccination.

OBJECTIVE: This study aimed to evaluate the effectiveness of a theory and evidence-based, MI-oriented AI digital assistant in improving COVID-19 vaccine attitudes among adults in Hong Kong.

METHODS: This 2 parallel-armed randomized controlled trial was conducted from October 2022 to June 2024. Hong Kong adults (N=177) who were vaccine-hesitant were randomly assigned into 2 study groups. The intervention group (n=91) interacted with the AI digital assistant over 5 weeks, including receiving a web-based education program comprising 5 educational modules and communicating with an AI-driven chatbot equipped with MI techniques. The control group (n=86) received WhatsApp (Meta) messages directing them to government websites for COVID-19 vaccine information and knowledge, with the same dosage as the intervention group. Primary outcomes included vaccine hesitancy. Secondary outcomes included vaccine readiness, confidence, trust in government, and health literacy. Outcomes were measured at baseline, postintervention, 3-month, and 6-month follow-up. Focus group interviews were conducted postintervention. Intervention effects were analyzed using the generalized estimating equation model. Interview data were content analyzed.

RESULTS: Decreases in vaccine hesitancy were observed while no statistically significant time-by-group interaction effects were found. The intervention showed significant time-by-group interaction effects on vaccine readiness (P=.04), confidence (P=.02), and trust in government (P=.04). Significant between-group differences with medium effect sizes were identified for vaccine readiness (Cohen d=0.52) and trust in government (Cohen d=0.54) postintervention, respectively. Increases in vaccine-related health literacy were observed, and a significant time effect was found (P=.01). In total, three categories were summarized from interview data: (1) improved vaccine literacy, confidence, and trust in government; (2) hesitancy varied while readiness improved; and (3) facilitators, barriers, and recommendations of modifications on the intervention.

CONCLUSIONS: The intervention indicated promising yet significant effects on vaccine readiness while the effects on vaccine hesitancy require further confirmation. The qualitative findings; however, further consolidate the significant effects on participants’ attitudes toward vaccines. The findings provide novel evidence to encourage the adoption and refinement of a MI-oriented AI digital assistant in vaccine promotion.

PMID:40779743 | DOI:10.2196/72637

J Clin Oncol. 2025 Aug 8:JCO2500618. doi: 10.1200/JCO-25-00618. Online ahead of print.

ABSTRACT

PURPOSE: New therapies for glioblastoma are needed, especially MGMT-unmethylated (uMGMT) disease. NRG Oncology BN002 (phase I) demonstrated safety and suggested efficacy of ipilimumab (ipi) with nivolumab (nivo) in newly diagnosed glioblastoma, leading to this phase II/III trial.

METHODS: Adults with newly diagnosed uMGMT glioblastoma and Karnofsky performance status (KPS) ≥70 were randomly assigned to radiotherapy with either immunotherapy (ipi and nivo) or temozolomide (TMZ), stratified by recursive partitioning analysis (RPA) class and intention to use tumor treating fields. With 95% power to detect a hazard ratio (HR) ≤0.58 for progression-free survival (PFS) at a one-sided significance level (P) of .15, superior PFS with immunotherapy in phase II would lead to phase III overall survival (OS) testing. Corticosteroids were disallowed when starting immunotherapy. Diagnosis, biomarkers, and PFS were centrally assessed.

RESULTS: One hundred fifty-nine participants were randomly assigned (79 immunotherapy and 80 TMZ). Arms were well balanced for age (median 60 years, range, 28-79), sex (male n = 105, 66%), KPS (90-100 n = 97, 61%), resection extent (gross total, n = 103, 65%), and RPA class (III, n = 16, 10%; IV, n = 116, 73%; V, n = 27, 17%). A preplanned analysis of phase II data conducted after 100 centrally determined PFS events showed no significant PFS improvement for ipi and nivo versus TMZ (median 7.7 months v 8.5 months, HR, 1.47 [70% CI, 1.19 to 1.83]; one-sided P = .96 [95% CI, 0.98 to 2.2]). OS is immature (>50% alive) but with no observed difference between arms (median approximately 13 months each, HR, 0.95 [95% CI, 0.61 to 1.49]; P = .36).

CONCLUSION: Ipi and nivo did not improve PFS among patients with newly diagnosed uMGMT glioblastoma versus TMZ. Accrual closed permanently; the trial will not proceed to phase III. No new safety signals were identified. Molecular correlative analyses and survival follow-up are ongoing.

PMID:40779733 | DOI:10.1200/JCO-25-00618

Am J Speech Lang Pathol. 2025 Aug 8:1-17. doi: 10.1044/2025_AJSLP-25-00029. Online ahead of print.

ABSTRACT

PURPOSE: Reading proficiency is an important life skill that contributes to improved quality of life and becoming an active member in society. This pilot randomized clinical trial tested the effects of a functional literacy intervention in young adults with intellectual and/or developmental disabilities (IDDs).

METHOD: Participants included 44 young adults with IDD between 18 and 26 years old. Participants were randomly assigned to the Functional Reading Activities to Motivate and Empower (FRAME) treatment group or a “business-as-usual” control group. Participants participated in 24 twice-weekly sessions in which they were taught reading comprehension strategies in the context of functional text stimuli or activities of daily living that require reading (e.g., text messages, e-mails). The primary outcome measure was the number of reading comprehension strategies used. Secondary outcomes included (a) multiple-choice comprehension questions, (b) text message response, (c) e-mail response, (d) summarization, and (e) verbal responses to functional text samples.

RESULTS: Young adults with IDD in the treatment group made statistically significant gains in use of reading comprehension strategies (d = 1.09, p = .002) and multiple-choice comprehension questions (d = 0.79, p = .038) as compared with the control group. There were no statistically significant differences on the remaining outcome measures.

CONCLUSIONS: This study provides preliminary support for the short-term effects of the FRAME intervention for young adults with IDD, with particular emphasis on explicit reading comprehension strategy instruction within a functional context. Therapeutic services typically end during the transition period for young adults with disabilities. However, it is essential that evidence-based literacy supports are available as this is a skill that continues to develop throughout the lifespan and has the potential to transform an individual’s transition to adulthood and independence. Future research should include a larger clinical trial and evaluate mediators of intervention effects.

PMID:40779715 | DOI:10.1044/2025_AJSLP-25-00029

J Bras Nefrol. 2025 Oct-Dec;47(4):e20250037. doi: 10.1590/2175-8239-JBN-2025-0037en.

ABSTRACT

INTRODUCTION: Infections represent a major cause of morbidity and mortality in kidney transplant recipients. Preservation fluid (PF) contamination is considered a potential infectious source; however, its clinical relevance remains controversial.

AIM: To evaluate whether PF contamination acts as a source of early post-transplant infections (within 30 days) and its association with acute rejection, graft loss, and mortality within 90 days.

METHODS: This was a retrospective, observational, and descriptive study based on medical records of patients aged ≥18 years who underwent kidney transplantation between January 2021 and December 2023. Collected variables included demographic, clinical, and post-transplant outcome data.

RESULTS: Among 246 recipients with available PF culture data, 27.6% (68/246) presented with PF contamination. Gram-positive cocci accounted for 64.7% of isolates, Gram-negative bacilli, for 35.3%, and fungi, for 2.9%. Coagulase-negative staphylococci (CoNS) were the most frequent isolate (36.8%). Microbiological concordance between PF isolates and pathogens responsible for early infection were observed in 13.23% (9/68) of cases, with Klebsiella pneumoniae being the predominant pathogen (66.6%). Although the infection rate was higher among patients with positive PF cultures (72%) compared to those with negative cultures (64%), this difference was not statistically significant (p = 0.2992). No significant associations were found with mortality (p = 1.000), graft loss (p = 0.8199), or acute rejection (p = 0.5635).

CONCLUSION: PF contamination was frequent and may contribute to early post-transplant infections, reinforcing the importance of microbiological surveillance and preventive strategies.

PMID:40779694 | DOI:10.1590/2175-8239-JBN-2025-0037en

J Bras Nefrol. 2025 Oct-Dec;47(4):e20250028. doi: 10.1590/2175-8239-JBN-2025-0028en.

ABSTRACT

INTRODUCTION: Stress hyperglycemia in patients with sepsis has not been consistently associated with an increased risk of acute kidney injury (AKI).

OBJECTIVE: To evaluate the effect of blood glucose levels on the occurrence of AKI requiring dialysis in critically ill patients with sepsis.

METHODS: Retrospective cohort study of patients with sepsis admitted to the ICU of a private hospital between December 2017 and August 2021. Clinical, laboratory, and severity variables were collected. Mean blood glucose levels in the first week of ICU stay (primary exposure variable) were stratified into tertiles. The effect of blood glucose on the occurrence of dialysis-requiring AKI was assessed using multivariate logistic regression.

RESULTS: Of the 1,317 patients evaluated, 86.6% had clinical conditions as the underlying cause of sepsis. AKI requiring hemodialysis occurred in 12.2% of the sample. Patients with mean blood glucose levels above the third tertile (≥160 mg/dl), compared to those with mean blood glucose levels below the first two tertiles (<160 mg/dl), had a higher prevalence of diabetes (69.1% vs. 7.1%; p < 0.001). Patients with mean blood glucose levels ≥160 mg/dl had a 62% higher odds of developing AKI requiring dialysis compared to those with mean blood glucose levels < 160 mg/dl (crude OR = 1.62; 95% CI 1.16-2.26; p = 0.005). After adjustment for other variables, mean blood glucose levels ≥180 mg/dl did not increase the likelihood of AKI (OR = 1.27; 95% CI 0.76-2.12; p = 0.359).

CONCLUSION: In this patient group, sepsis and mean blood glucose levels ≥160 mg/dl were not independently associated with the occurrence of dialysis-requiring AKI.

PMID:40779693 | DOI:10.1590/2175-8239-JBN-2025-0028en

Clin Drug Investig. 2025 Aug 8. doi: 10.1007/s40261-025-01470-7. Online ahead of print.

ABSTRACT

BACKGROUND: SHR7280 is an oral small-molecule gonadotropin-releasing hormone (GnRH) antagonist that can be developed as therapeutic agent for the treatment of hormone-dependent pathologies, including prostate, breast, and ovarian cancers. SHR7280 dry suspension formulation is being developed to provide an alternative mode of administration for order patients, those using nutritional tubes, and those unable to swallow solid dosage forms.

OBJECTIVE: This study evaluated the relative bioavailability, pharmacokinetics (PK), and safety of SHR7280 dry suspension and tablets administered in a single dose in healthy Chinese volunteers.

METHODS: A randomized, open, two-preparation, two-sequence, two-cycle, double-crossover design was used in this study. The plasma drug concentration was determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The main PK parameters of the two formulations of SHR7280 were calculated by noncompartmental analysis using Phoenix WinNonlin (version 8.3.4) software. A total of 16 healthy participants were randomized to receive SHR7280 (200 mg) as tablets (n = 8) or dry suspension (n = 8) formulation.

RESULTS: The geometric least squares mean ratio (90% confidence interval [CI]) for maximum concentration of drug in blood plasma (C_max) and area under the plasma concentration-time curve from time 0 to t (AUC_0-t) and from time 0 to infinity (AUC_0-∞) between the dry suspension of SHR7280 and its tablets were calculated as follows: C_max-101.90% (90% CI 79.50-130.62), AUC_0-t-111.58% (90% CI 91.71-135.76), and AUC_0-∞-111.44% (90% CI 91.70-135.43). A total of nine (56.3%) subjects experienced treatment-emergent adverse events (TEAEs).

CONCLUSIONS: The bioavailability of SHR7280 tablets was found to be comparable to that of dry suspension. The safety profile of two formulations was favorable. No serious adverse events or adverse drug reactions were reported.

TRIAL REGISTRATION: ClinicalTrials.gov (NCT05868057; 22 May 2023).

PMID:40779283 | DOI:10.1007/s40261-025-01470-7

Obes Surg. 2025 Aug 8. doi: 10.1007/s11695-025-08155-2. Online ahead of print.

ABSTRACT

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) has been shown to be effective for inducing weight loss. Liraglutide, a glucagon-like peptide-1 agonist, has been successfully used for weight loss and remission of comorbidities in patients with obesity. So far, there are no clinical studies comparing short-term outcomes in patients treated with ESG or Liraglutide. The aim of the study is to assess the efficacy and safety of ESG versus Liraglutide in patients with obesity over a 12 months follow-up period.

METHODS: A prospective, randomized controlled, monocentric study was performed. A total of 43 patients with class I and II obesity were included in the study. Twenty-three patients underwent ESG, and 20 patients were treated with Liraglutide. All participants received standardized follow-up protocols with assessments by both surgeon and nutritionist in the bariatric ambulatory setting. Weight loss outcomes, including the percentage of excess weight loss (%EWL), total weight loss (%TWL), and resolution of obesity-related comorbidities were assessed at 3, 6, and 12 months post-intervention.

RESULTS: After 3 and 6 months, %EWL and %TWL were greater in the ESG group (P = 0.001). However, at 12 months, these differences were no longer statistically significant, suggesting that the ESG group was experiencing some weight regain, while the Liraglutide group had a slower but more consistent weight loss. Regarding the resolution of comorbidities, there were no statistically significant differences at 3, 6 and 12 months between the two groups. None of the patients had major complications or significant side effects.

CONCLUSIONS: Both ESG and Liraglutide guarantee weight loss and remission of comorbidities in class I and II obesity patients. However, ESG induces a more rapid weight loss in the first six months, after which two patients seem experience weight regain. Liraglutide provides a slower weight loss in terms of %EWL and %TWL but patients continue losing weight also after six months. Larger samples with a longer follow-up are needed to confirm our results.

PMID:40779281 | DOI:10.1007/s11695-025-08155-2

Obes Surg. 2025 Aug 8. doi: 10.1007/s11695-025-08144-5. Online ahead of print.

ABSTRACT

BACKGROUND: Roux-en-Y gastric bypass (RYGB) has long been established as one of the most efficient therapeutic options for patients with obesity and associated medical conditions. However, the impact of concurrent vagal transection during pouch creation on postoperative outcomes remains underreported.

METHODS: This retrospective cohort study examined patients who underwent RYGB between January 2011 and December 2023, with 1 to 5 years of follow-up. Patients were stratified into two groups: vagal sparing RYGB (VS) and non-vagal sparing RYGB (NVS). Data collected included postoperative complications, intraoperative characteristics, weight trajectories, resolution of obesity-related medical conditions, and mortality. Statistical analysis methods included paired t-tests, multivariate regression, and Cox regression models.

RESULTS: Out of 1521 patients, 374 (24.6%) underwent VS-RYGB and 1147 (75.4%) had NVS-RYGB. Patients were predominantly female (80.8%), with a mean age of 47.6 ± 12.1 years and body mass index (BMI) of 46.0 ± 7.7 kg/m². NVS had significantly longer operative times (p < 0.001) and a higher lysis of adhesions rate (p < 0.001). Marginal ulcer rate was also significantly higher in NVS compared to VS (p = 0.03). In contrast, the rate of dumping syndrome (p = 0.13) and cholelithiasis (p = 0.65) was not significantly different between groups. While overall weight outcomes were similar, VS reached maximum percentage of total weight loss (%TWL) earlier (p = 0.02). Both groups showed comparable obesity-related condition outcomes.

CONCLUSION: NVS-RYGB was associated with higher operative time. Additionally, vagal transection was significantly associated with marginal ulcer occurrence. Our findings support the potential advantage of vagal-sparing RYGB.

PMID:40779279 | DOI:10.1007/s11695-025-08144-5

JAMA Netw Open. 2025 Aug 1;8(8):e2525252. doi: 10.1001/jamanetworkopen.2025.25252.

ABSTRACT

IMPORTANCE: Clostridioides difficile is a leading cause of health care-associated infections. Understanding the association among C difficile carriage, antibiotic use, and infection hazard is essential for infection prevention.

OBJECTIVE: To evaluate the hazard of C difficile infection (CDI) among asymptomatic carriers vs noncarriers of C difficile and whether it is associated with antibiotic exposure.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study conducted between June 18, 2017, and June 21, 2023, analyzed hospitalizations from Sheba Medical Center in Ramat Gan, Israel, which routinely screens for C difficile in high-risk patients admitted to internal medicine. Adult patients (aged >18 years) without active CDI at admission were included.

EXPOSURE: Antibiotic exposure during hospitalization, including specific classes.

MAIN OUTCOMES AND MEASURES: The primary outcome was the development of CDI, as confirmed by laboratory testing for C difficile. Antibiotic exposure was assessed as a time-varying variable.

RESULTS: The study included 33 756 hospitalizations among 23 001 patients (median [IQR] age, 78 [68-87] years; 52.8% men). C difficile infection occurred in 67 of 1624 hospitalizations (4.1%) with positive screening results and in 47 of 32 132 hospitalizations (0.1%) with negative screening results. A positive C difficile screening result at admission was associated with a high hazard of infection (hazard ratio [HR], 27.5; 95% CI, 18.7-40.3). Antibiotic exposure was associated with an increased hazard for CDI (HR, 1.98; 95% CI, 1.24-3.16). Piperacillin and tazobactam showed the most pronounced hazard for CDI (HR, 2.18; 95% CI, 1.41-3.36). Among asymptomatic carriers, antibiotic exposure was not significantly associated with a further increase in CDI hazard (HR, 1.07; 95% CI, 0.73-1.58).

CONCLUSIONS AND RELEVANCE: In this cohort study, carriers of C difficile had a substantially higher baseline hazard for hospital-onset CDI. Antibiotic exposure was associated with an increased hazard among noncarriers but was not significantly associated with additional hazard among carriers. These findings suggest that while antibiotic stewardship may reduce CDI risk in noncarriers, additional strategies may be needed for carriers given their elevated baseline risk.

PMID:40779269 | DOI:10.1001/jamanetworkopen.2025.25252

JAMA Netw Open. 2025 Aug 1;8(8):e2525809. doi: 10.1001/jamanetworkopen.2025.25809.

ABSTRACT

IMPORTANCE: Suicide is a leading cause of death in the US. Suicide-specific cognitive behavior therapy (CBT) is effective for reducing suicide attempts but is difficult to implement.

OBJECTIVE: To evaluate the efficacy of a smartphone-based digital therapeutic intervention designed to deliver suicide-focused CBT in reducing suicidal behavior among patients hospitalized for a suicide attempt or suicidal ideation.

DESIGN, SETTING, AND PARTICIPANTS: This multisite, double-blind, randomized clinical trial was conducted in 6 psychiatric inpatient units across the US. Adult patients admitted with elevated suicide risk from April 2022 to April 2024 were included. Participants completed a baseline assessment and were randomly assigned to either the digital therapeutic group or control application group. The trial was stopped early by the Data Management Safety Board because it surpassed the prespecified futility boundary for the primary end point. Statistical analysis followed the intention-to-treat principle.

INTERVENTIONS: The digital therapeutic intervention includes 12 sessions of smartphone-based educational modules (lasting 10-15 minutes each) drawn from CBT for suicide prevention. The active control is a 12-session smartphone-based application that delivers safety planning and psychoeducation about suicide. For both interventions, the first session was completed prior to hospital discharge and the remaining self-paced sessions could be completed after discharge. All participants also received treatment as usual, which included suicide risk assessment, supportive listening, crisis resources, clinician assessment, safety planning, and referral to outpatient treatment.

MAIN OUTCOMES AND MEASURES: The primary end point was time (days) to first actual suicide attempt during follow-up. The secondary end points were change in suicidal ideation from baseline to week 24 (quantified as a change in the Scale for Suicide Ideation total score) and clinician-rated clinical improvement at week 24. The nonprespecified sensitivity analysis end point for suicide attempts was the rate of suicide attempts (actual, aborted, and interrupted). Prespecified subgroup analyses were also conducted to examine treatment effects among patients with vs without prior suicide attempts.

RESULTS: A total of 339 participants (mean [SD] age, 27.9 [10.7] years; 224 females [66.1%]) were included. Follow-up data were available from 266 participants (78.5%). Time to first actual suicide attempt, the primary end point, was not significantly different across treatment groups (log-rank χ21 = 3.6; P = .06). Among the 170 participants with prior suicide attempts, nonprespecified sensitivity analyses indicated that the adjusted rate of follow-up suicide attempts was 58.3% lower in the digital therapeutic group than the control application group (0.70 vs 1.68 attempts per person-year; rate ratio [RR], 0.42 [95% CI, 0.18-0.95]; P = .04), and the odds of clinical improvement were higher in the digital therapeutic group than the control application group (97.9% vs 87.5%; odds ratio, 7.59; 95% CI, 1.14-153.62; P = .04). Trajectories of suicidal ideation significantly differed between the digital therapeutic and control application groups (F3,206 = 2.9, P = .04), with decreased suicidal ideation through week 24 in the digital therapeutic group, but in the control application group, suicidal ideation decreased through week 12 and then increased at week 24. Nonprespecified dose-response analyses indicated the suicide attempt rate among patients with a prior suicide attempt decreased by 14.0% for every digital therapeutic module completed (adjusted RR, 0.86; 95% CI, 0.76-0.98; P = .02).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the digital therapeutic intervention did not change the time to first actual suicide attempt but helped to sustain reductions in suicidal ideation among inpatients with elevated suicide risk. However, among patients with prior suicide attempts, the digital therapeutic intervention helped reduce recurrent suicide attempts and increased the percentage of inpatients with clinician-rated clinical improvement.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05144685.

PMID:40779267 | DOI:10.1001/jamanetworkopen.2025.25809