BACKGROUND: Gaming disorder (GD) is a new official diagnosis in the International Classification of Diseases, 11th Revision, and with its recognition, the need to offer treatment for the condition has become apparent. More knowledge is needed about the type of treatment needed for this group of patients.
OBJECTIVE: This study aims to evaluate the effectiveness and acceptability of a novel module-based psychological treatment for GD based on cognitive behavioral therapy and family therapy.
METHODS: This study is a nonrandomized intervention study, with a pretest, posttest, and 3-month follow-up design. It will assess changes in GD symptoms, psychological distress, and gaming time, alongside treatment satisfaction, working alliance, and a qualitative exploration of patients\' and relatives\' experiences of the treatment.
RESULTS: This study started in March 2022 and the recruitment is expected to close in August 2024.
CONCLUSIONS: This study evaluates the effectiveness and acceptability of a psychological treatment for patients with problematic gaming behavior and GD. It is an effectiveness trial and will be conducted in routine care. This study will have high external validity and ensure that the results are relevant for a diverse clinical population with psychiatric comorbidity.
BACKGROUND: ClinicalTrials.gov NCT06018922; https://clinicaltrials.gov/study/NCT06018922.
UNASSIGNED: DERR1-10.2196/56315.

Purpose: This study aims to assess the effectiveness of ChatGPT in remote learning among medical students. Methods: This cross-sectional survey study recruited 386 medical students from three public universities in Saudi Arabia. Participants completed an online questionnaire designed to assess perceptions of ChatGPT\'s effectiveness in remote learning. The questionnaire included Likert scale questions to evaluate various aspects of ChatGPT\'s support in remote learning, such as personalized learning, language and communication skills, and interactive quizzing. Data were analyzed using SPSS, employing descriptive statistics, independent samples t-tests, one-way ANOVA, and Cronbach\'s alpha to evaluate reliability. Results: Participants mostly used ChatGPT on a weekly (43.2%) or daily (48.7%) basis, primarily on personal computers (62.5%). Mean scores for ChatGPT\'s support in remote learning were high for personalized learning (4.35), language and communication skills (4.23), and interactive quizzing and assessments (4.01). Statistically significant differences were found based on gender for interactive quizzing (p = .0177) and continuity of education (p = .0122). Conclusion: Despite certain challenges and variations in perceptions based on gender and education level, the overwhelmingly positive attitudes toward ChatGPT highlight its potential as a valuable tool in medical education.

OBJECTIVE: To assess the effects of an evidence-based family caregiver training program (implementation of Helping Invested Families Improve Veteran Experiences Study [iHI-FIVES]) in the Veterans Affairs healthcare system on Veteran days not at home and family caregiver well-being.
METHODS: Participants included Veterans referred to home- and community-based services with an identified caregiver across 8 medical centers and confirmed family caregivers of eligible Veterans.
METHODS: In a stepped wedge cluster randomized trial, sites were randomized to a 6-month time interval for starting iHI-FIVES and received standardized implementation support. The primary outcome, number of Veteran \"days not at home,\" and secondary outcomes, changes over 3 months in measures of caregiver well-being, were compared between pre- and post-iHI-FIVES intervals using generalized linear models including covariates.
METHODS: Patient data were extracted from the electronic health record. Caregiver data were collected from 2 telephone-based surveys.
RESULTS: Overall, n = 898 eligible Veterans were identified across pre-iHI-FIVES (n = 327) and post-iHI-FIVES intervals (n = 571). Just under one fifth (17%) of Veterans in post-iHI-FIVES intervals had a caregiver enroll in iHI-FIVES. Veteran and caregiver demographics in pre-iHI-FIVES intervals were similar to those in post-iHI-FIVES intervals. In adjusted models, the estimated rate of days not at home over 6-months was 42% lower (rate ratio = 0.58 [95% confidence interval: 0.31-1.09; p = 0.09]) post-iHI-FIVES compared with pre-iHI-FIVES. The estimated mean days not at home over a 6-month period was 13.0 days pre-iHI-FIVES and 7.5 post-iHI-FIVES. There were no differences between pre- and post-iHI-FIVES in change over 3 months in caregiver well-being measures.
CONCLUSIONS: Reducing days not at home is consistent with effectiveness because more time at home increases quality of life. In this study, after adjusting for Veteran characteristics, we did not find evidence that implementation of a caregiver training program yielded a reduction in Veteran\'s days not at home.

BACKGROUND: For a decade, despite results from many studies, telemedicine systems have suffered from a lack of recommendations for chronic heart failure (CHF) care because of variable study results. Another limitation is the hospital-based architecture of most telemedicine systems. Some systems use an algorithm based on daily weight, transcutaneous oxygen measurement, and heart rate to detect and treat acute heart failure (AHF) in patients with CHF as early on as possible.
OBJECTIVE: The aim of this study is to determine the efficacy of a telemonitoring system in detecting clinical destabilization in real-life settings (out-of-hospital management) without generating too many false positive alerts.
METHODS: All patients self-monitoring at home using the system after a congestive AHF event treated at a cardiology clinic in France between March 2020 and March 2021 with at least 75% compliance on daily measurements were included retrospectively. New-onset AHF was defined by the presence of at least 1 of the following criteria: transcutaneous oxygen saturation loss, defined as a transcutaneous oxygen measurement under 90%; rise of cardiac frequency above 110 beats per minute; weight gain of at least 2 kg; and symptoms of congestive AHF, described over the phone. An AHF alert was generated when the criteria reached our definition of new-onset acute congestive heart failure (HF).
RESULTS: A total of 111 consecutive patients (n=70 men) with a median age of 76.60 (IQR 69.5-83.4) years receiving the telemonitoring system were included. Thirty-nine patients (35.1%) reached the HF warning level, and 28 patients (25%) had confirmed HF destabilization during follow-up. No patient had AHF without being detected by the telemonitoring system. Among incorrect AHF alerts (n=11), 5 patients (45%) had taken inaccurate measurements, 3 patients (27%) had supraventricular arrhythmia, 1 patient (9%) had a pulmonary bacterial infection, and 1 patient (9%) contracted COVID-19. A weight gain of at least 2 kg within 4 days was significantly associated with a correct AHF alert (P=.004), and a heart rate of more than 110 beats per minute was more significantly associated with an incorrect AHF alert (P=.007).
CONCLUSIONS: This single-center study highlighted the efficacy of the telemedicine system in detecting and quickly treating cardiac instability complicating the course of CHF by detecting new-onset AHF as well as supraventricular arrhythmia, thus helping cardiologists provide better follow-up to ambulatory patients.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is a critical biomedical strategy to prevent HIV transmission among cisgender women. Despite its proven effectiveness, Black cisgender women remain significantly underrepresented throughout the PrEP care continuum, facing barriers such as limited access to care, medical mistrust, and intersectional racial or HIV stigma. Addressing these disparities is vital to improving HIV prevention outcomes within this community. On the other hand, nurse practitioners (NPs) play a pivotal role in PrEP utilization but are underrepresented due to a lack of awareness, a lack of human resources, and insufficient support. Equipped with the rapid evolution of artificial intelligence (AI) and advanced large language models, chatbots effectively facilitate health care communication and linkage to care in various domains, including HIV prevention and PrEP care.
OBJECTIVE: Our study harnesses NPs\' holistic care capabilities and the power of AI through natural language processing algorithms, providing targeted, patient-centered facilitation for PrEP care. Our overarching goal is to create a nurse-led, stakeholder-inclusive, and AI-powered program to facilitate PrEP utilization among Black cisgender women, ultimately enhancing HIV prevention efforts in this vulnerable group in 3 phases. This project aims to mitigate health disparities and advance innovative, technology-based solutions.
METHODS: The study uses a mixed methods design involving semistructured interviews with key stakeholders, including 50 PrEP-eligible Black women, 10 NPs, and a community advisory board representing various socioeconomic backgrounds. The AI-powered chatbot is developed using HumanX technology and SmartBot360\'s Health Insurance Portability and Accountability Act-compliant framework to ensure data privacy and security. The study spans 18 months and consists of 3 phases: exploration, development, and evaluation.
RESULTS: As of May 2024, the institutional review board protocol for phase 1 has been approved. We plan to start recruitment for Black cisgender women and NPs in September 2024, with the aim to collect information to understand their preferences regarding chatbot development. While institutional review board approval for phases 2 and 3 is still in progress, we have made significant strides in networking for participant recruitment. We plan to conduct data collection soon, and further updates on the recruitment and data collection progress will be provided as the study advances.
CONCLUSIONS: The AI-powered chatbot offers a novel approach to improving PrEP care utilization among Black cisgender women, with opportunities to reduce barriers to care and facilitate a stigma-free environment. However, challenges remain regarding health equity and the digital divide, emphasizing the need for culturally competent design and robust data privacy protocols. The implications of this study extend beyond PrEP care, presenting a scalable model that can address broader health disparities.
UNASSIGNED: PRR1-10.2196/59975.

UNASSIGNED: To evaluate the safety and effectiveness of baloxavir marboxil (baloxavir) and oseltamivir in pediatric influenza patients in China.
UNASSIGNED: Patients filling a prescription for baloxavir or oseltamivir within 48 h following an influenza-related outpatient visit were identified in Children\'s Hospital of Fudan University in China between March 2023 and December 2023. Outcomes were assessed after antiviral treatment and included the incidence of adverse reactions and the duration of fever and other flu symptoms.
UNASSIGNED: A total of 1430 patients infected with influenza A were collected and 865 patients (baloxavir: n = 420; oseltamivir: n = 445) finally included. The incidence of adverse reactions of nausea and vomiting was significantly different between the baloxavir group (2.38%) and the oseltamivir group (12.13%) [P < 0.001, OR = 4.2526, 95%CI (2.0549, 9.6080)]. No differences in other adverse reactions were observed between the two groups. The mean duration of fever in baloxavir group (1.43d) was significantly shorter than that in oseltamivir group (2.31d) [P < 0.001, 95%CI (0.7815, 0.9917)]. There were no differences in the mean duration of nasal congestion and runny nose, sore throat, cough, and muscle soreness between two groups.
UNASSIGNED: The incidence of nausea and vomiting is lower with baloxavir compared to oseltamivir, and the duration for complete fever reduction is shorter with baloxavir than with oseltamivir. The results indicate that baloxavir is well tolerated and effective in Chinese children.

BACKGROUND: The NHS (National Health Service) COVID-19 app was a digital contact tracing app (DCTA) used in England in response to the COVID-19 pandemic. The aim of which was to limit the spread of COVID-19 by providing exposure alerts. At the time of the pandemic, questions were raised regarding the effectiveness and cost of the NHS COVID-19 app and whether DCTAs have a role in future pandemics.
OBJECTIVE: This study aims to explore key barriers to DCTAs in England during the COVID-19 pandemic.
METHODS: This is a qualitative study using semistructured video interviews conducted with professionals in public health, digital health, clinicians, health care law, and health executives who had an active role in the COVID-19 pandemic. These interviews aimed to explore the perspective of different experts involved in the pandemic response and gauge their opinions on the key barriers to DCTAs in England during the COVID-19 pandemic. The initial use of maximum variation sampling combined with a snowball sampling approach ensured diversity within the cohort of interviewees. Interview transcripts were then analyzed using Braun and Clarke\'s 6 steps for thematic analysis.
RESULTS: Key themes that acted as barriers to DCTAs were revealed by interviewees such as privacy concerns, poor communication, technological accessibility, digital literacy, and incorrect use of the NHS COVID-19 app. Interviewees believed that some of these issues stemmed from poor governmental communication and a lack of transparency regarding how the NHS COVID-19 app worked, resulting in decreased public trust. Moreover, interviewees highlighted that a lack of social support integration within the NHS COVID-19 app and delayed app notification period also contributed to the poor adoption rates.
CONCLUSIONS: Qualitative findings from interviews highlighted barriers to the NHS COVID-19 app, which can be applied to DCTAs more widely and highlight some important implications for the future use of DCTAS. There was no consensus among interviewees as to whether the NHS COVID-19 app was a success; however, all interviewees provided recommendations for improvements in creating and implementing DCTAs in the future.

BACKGROUND: Objective monitoring of self-directed physical activity (PA) is a common approach used in both fitness and health settings to promote exercise behavior, but adherence has been poor. Newer mobile health (mHealth) technologies could be a cost-effective approach to broadening accessibility and providing support for PA behavior change; yet, the optimal method of delivery of such interventions is still unclear.
OBJECTIVE: This study aimed to determine the feasibility and acceptability of an mHealth exercise intervention delivered in combination with objective monitoring in 3 ways: health education emails, asynchronous exercise videos, or synchronous videoconference exercise classes.
METHODS: Physically inactive (<30 min/wk) adults (cisgender women aged 31.5, SD 11.3 years, cisgender men aged 34.1, SD 28.9 years, and nonbinary individuals aged 22.0, SD 0 years) were randomized (1:1:1) to 8 weeks of increasing PA behavioral support: level 1 (health education+objective monitoring, n=26), level 2 (asynchronous contact, level 1+prerecorded exercise videos, n=30), or level 3 (synchronous contact, level 1+videoconference group exercise, n=28). Participants used a heart rate monitor during exercise and a mobile app for interaction. Primary outcomes were feasibility (accrual, retention, and adherence) and acceptability (user experience survey). Secondary outcomes assessed at baseline and 8 weeks included resting heart rate, self-reported PA, and quality of life. The exercise dose was evaluated throughout the intervention.
RESULTS: Between August 2020 and August 2021, 204 adults were screened for eligibility. Out of 135 eligible participants, 84 (62%) enrolled in the study. Retention was 50% (13/26) in level 1, 60% (18/30) in level 2 and 82% (23/28) in level 3, while adherence was 31% (8/26) in level 1, 40% (12/30) in level 2 and 75% (21/28) in level 3. A total of 83% (70/84) of the study sample completed the intervention, but low response rates (64%, 54/84) were observed postintervention at week-8 assessments. Program satisfaction was highest in participants receiving exercise videos (level 2, 80%, 8/10) or exercise classes (level 3, 80%, 12/15), while only 63% (5/8) of level 1 reported the program as enjoyable. Level 3 was most likely to recommend the program (87%, 13/15), compared to 80% (8/10) in level 2 and 46% (5/8) in level 1. Self-reported PA significantly increased from baseline to intervention in level 3 (P<.001) and level 2 (P=.003), with no change in level 1. Level 3 appeared to exercise at higher doses throughout the intervention.
CONCLUSIONS: Only the videoconference exercise class intervention met feasibility criteria, although postintervention response rates were low across all groups. Both videoconference and prerecorded videos had good acceptability, while objective monitoring and health education alone were not feasible or acceptable. Future studies are needed to examine the effectiveness of videoconference exercise interventions on health-related outcomes during nonpandemic times and how asynchronous interventions might maximize adherence.
BACKGROUND: ClinicalTrials.gov NCT05192421; https://clinicaltrials.gov/study/NCT05192421.

The present study aimed to evaluate the effectiveness of two doses of CoronaVac in preventing SARS-CoV-2 symptomatic disease with virological confirmation, as well as in the prevention of COVID-19 moderate and severe cases. A test-negative unmatched case-control design was used, in which cases were patients with suspected COVID-19 (presenting at least two of the following symptoms: fever, chills, sore throat, headache, cough, runny nose, olfactory or taste disorders) with virological confirmation, and controls were those whose SARS-CoV-2 test was negative. As for exposure, participants were classified as unvaccinated, or vaccinated with a complete schedule. Suspected COVID-19 cases were identified from March to November 2021, in two cities located in the State of São Paulo, Brazil. All participants signed the Informed Consent Form before enrollment. RT-PCR results and vaccination data were obtained from the local surveillance systems. Up to two phone calls were made to obtain information on the outcome of the cases. A total of 2981 potential participants were screened for eligibility, of which 2163 were included, being 493 cases and 1670 controls. Vaccination, age, the reported contact with a COVID-19 suspected or confirmed case in the 14 days before symptoms onset, and the educational level were the variables independently associated with the outcome. The adjusted vaccine effectiveness for symptomatic COVID-19 (AVE) was 39.0 % (95 % CI 6.0-60.0 %). The AVE in the prevention of moderate and severe disease was 91.0 % (95 % CI 76.0-97.0 %). Our results were influenced by the waning of the Gamma variant, in the second trimester of 2021, followed by the increase in vaccination coverage, and a drop in the number of cases in the second half of the year. The study demonstrated the high effectiveness of CoronaVac in preventing moderate/severe COVID-19 cases.

UNASSIGNED: Vortioxetine has demonstrated safety and efficacy in improving symptoms of major depressive disorder (MDD), including overall functioning in real-world settings. This is the first study in a real-life clinical setting in India to evaluate effectiveness and safety of vortioxetine in patients with MDD.
UNASSIGNED: This interventional, open-label study consisted of a 12-week treatment period with flexible doses of vortioxetine (5-20 mg/day) in adult patients (aged 18-65 years) with a confirmed MDD diagnosis. Effectiveness outcomes included change from baseline to week 12 in Patient Health Questionnaire-9 (PHQ-9) and Clinical Global Impression-Severity (CGI-S) scores, along with CGI-Improvement (CGI-I) scores at week 12, using a mixed model for repeated measures. Adverse events (AEs) were recorded for safety outcome assessments.
UNASSIGNED: Of 395 patients who received vortioxetine, 42.3% were women mean age 38.9 years; 322 patients completed the study. Significant improvement in depressive symptoms was observed in change from baseline to week 12 least squares (LS) mean (SE) PHQ-9 total score (-9.36 [0.276]; p<.0001) and CGI-S score (-2.14 [0.065]; p<.0001). LS mean (SE) CGI-I score showed significant improvement at week 12 (1.93 [0.067]; p<.0001). Subgroup analysis across age, sex, disease severity, and body mass index showed significant improvements in depression symptoms and severity. A total of 35.4% (n = 140) of patients experienced treatment-emergent AEs (mostly mild-moderate); nausea and pruritus were the most frequent (6.6%, n = 26 each).
UNASSIGNED: Safety and effectiveness of vortioxetine in improving symptoms of MDD over a 12-week period was demonstrated in a real-life clinical setting in India.
UNASSIGNED: Open-label, flexible-dose study of vortioxetine in patients with major depressive disorder in India; Clinical Trials.gov ID: NCT04288895; https://www.clinicaltrials.gov/study/NCT04288895.