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.

Gastrointestinal function plays a pivotal role in nutrient absorption and overall digestive health. Abnormal gastric emptying is closely linked to type 2 diabetes, impacting blood glucose regulation and causing gastrointestinal symptoms. This study aims to investigate and compare segmental transit times, motility indices, and micromilieu between Greenlandic Inuit and Danish individuals with and without type 2 diabetes. We included forty-four Greenlandic Inuit, twenty-three of whom had type 2 diabetes, and age and gender-matched Danish individuals. Segmental transit time, motility, and luminal environment were measured using the SmartPill®. Greenlandic controls displayed shorter gastric emptying time (GET) (163 min), higher gastric median pH (2.0 pH) and duodenal median contractions (18.2 mm Hg) compared to Greenlanders with type 2 diabetes (GET: 235 min, pH:1.9, median duodenal contraction 18.4 mm Hg) and Danish controls (GET: 190, pH:1.2 median duodenal contraction 17.5 mmHg). Despite similar anti-diabetic management efforts, variations in gastrointestinal physiology were evident, highlighting the complexity of diabetes and its interaction with ethnicity, suggesting potential dietary or even genetic influences, emphasising the necessity for personalised diabetes management approaches. Finally, the study opens possibilities for future research, encouraging investigations into the underlying mechanisms linking genetics, diet, and gastric physiology, as an understanding of factors can lead to more effective, tailored strategies for diabetes care and improved digestive health in diverse populations.

OBJECTIVE: Although both urachal (U) and nonurachal (NU) bladder adenocarcinomas (adenoCas) share several histologic similarities, they differ in location and sometimes in therapeutic options. We analyzed the differences in genomic alterations (GAs) between these tumor entities, with the aim of identifying potential therapeutic targets for clinical trials.
METHODS: Overall, 133 U and 328 NU adenoCas were analyzed. Hybrid capture-based comprehensive genomic profiling (CGP) was performed to evaluate all classes of GA. Germline status of GA was predicted using a validated somatic-germline computational method. CGP was performed using the FoundationOne and FoundationOne CDx assays (Foundation Medicine, Inc).
RESULTS: The most frequent GA in both U and NU cohorts included TP53 (86.5% v 81.1%) and KRAS (34.6% v 27.7%). GAs characteristic of colorectal adenoCa, such as SMAD4 (P = .069) and GNAS (P = .071), were more common in U versus NU. Conversely, TERT (P < .01) and RB1 (P = .071) were more prevalent in NU adenoCa. Notably, both U and NU adenoCas exhibited possibly targetable GA in PIK3CA (7.5% v 7.9%) and ERBB2 (6.8% v 7.6%). Biomarkers associated with potential benefit from anti-PD-1/L1 were infrequent. Median tumor mutational burden was 2.6 and 3.5 mutations per megabase for U and NU, respectively, and PD-L1 expression >1% was rare. Genomic ancestry and genomic signature distribution were similar in both tumor types. GAs were most commonly of somatic nature. Limitations include lack of clinical data, tumor heterogeneity, and retrospective nature.
CONCLUSIONS: U and NU adenoCAs revealed differences in GA, with PIK3CA and ERBB2 being identified as putative therapeutic targets. Biomarkers of response to anti-PD-(L)1 were uncommon. Results highlight the potential of CGP to personalize treatment options of bladder adenoCa and inform clinical trial designs.

OBJECTIVE: We examined the one-year test re-test reliability and validity criterion of survey-assessed sleep duration collected from two separate questions.
METHODS: The Activity Validation Sub Study included 751 participants of the Cancer Prevention Study-3 study to further investigate rest/activity cycles. Sleep duration was collected using three methods: survey, Daysimeter device, and sleep diary. Survey-assessed sleep duration was collected using 2 different questions, each with different response options (categorical and continuous). Selected participants (n = 170) were asked to wear a Daysimeter device for seven consecutive days for two non-consecutive quarters. Participants were excluded from the current study due to incomplete/implausible survey or device data or reported working night shift. We calculated reliability of pre- and post-survey sleep duration for both survey question using Spearman correlation. We used the method of triads to estimate the validity coefficient (VC) between the three sleep duration measurements in the present study and the \"true\" latent sleep duration measure, and bootstrapping methods to calculate the 95% confidence intervals (95%CI).
RESULTS: Of 119 participants included in the study (52.10% male), test-retest correlation showed strong and moderate correlations for sleep duration collected continuously and categorically, respectively. The VC for survey-assessed continuous sleep duration was 0.82 (95%CI 0.71, 0.90) for weekday and 0.68 (95%CI 0.46, 0.83) for weekend. Performance of the VC was slightly weaker for survey-assessed categorical sleep duration (weekday VC = 0.57 95%CI 0.42, 0.71; weekend VC = 0.47 95%CI 0.29, 0.62).
CONCLUSIONS: The two survey-assessed sleep duration questions used in the AVSS and CPS-3 cohorts are valid approximations of sleep duration.

BACKGROUND: This study examined manual therapy business owners\' perception of official recommendations during the COVID-19 pandemic and the impact on their clinics\' economic performance, including clinic activity hours and business turnover.
METHODS: In a longitudinal study design, data were collected in November 2021 (baseline), and after three months, six months, and 12 months. Participants were manual therapists who were business owners. A growth curve model was used to analyze differences in clinical activity trajectories. Multinomial logistic regression analysis was used to assess the relationship between perceived disruptions in business and turnover. Qualitative text analysis was used to examine participants\' responses to open-ended questions concerning economic measures taken to sustain their business during the pandemic.
RESULTS: This study of 443 manual therapy business owners found that clinics were initially active with minimal variation, but activity changed following COVID-19 recommendations. Business owners perceived that the disruptions had no significant impact on turnover during the initial stages of the official recommendations. Economic support and the previous decrease in turnover increased the likelihood of experiencing a decreased turnover at 12 months. Business owners implemented cost-cutting measures and diversified income sources to navigate COVID-19 challenges and sustain their businesses.
CONCLUSIONS: The official recommendations in Sweden had an impact on manual therapists\' businesses as the COVID-19 pandemic lingered. Some business owners were concerned at the early stages about lower turnover but showed financial resilience by cutting costs and finding new revenue sources to overcome COVID-19 challenges.

BACKGROUND: Globally, 7 million people with HIV (PWH) aged over 50 years exist. 5 million of them live in sub-Saharan Africa, the epicenter of the HIV epidemic. In Ghana, every 1 in 6 PWH is aged over 50 years. However, access to geriatric health care is grossly limited in Ghana and the sub-Saharan Africa region. This has resulted in a lack of focus on geriatric syndromes, a multi-factorial clinical condition common in older PWH, that do not fit discrete disease categories. Consequently, this gap threatens the life expectancy for aging PWH, necessitating the need to promptly fill it. The KNUST Aging and HIV Outcomes (KAHO) study will help identify priorities and opportunities for developing an effective integrated model of HIV and geriatric healthcare in Ghana.
METHODS: The KAHO study will recruit 151 PWH aged 50 years and older at the Infectious Disease Unit (IDU) of the University Hospital, Kwame Nkrumah University of Science and Technology (KNUST). The study will be conducted over a 2-year period and participants will be seen at months 0, 6 and 12. Participants at each visit will be taken through assessments and questionnaires on geriatric health, cognition, social vulnerability, HIV-related conditions and they will provide biospecimens for laboratory testing. We will also conduct semi-structured qualitative interviews of PWH, healthcare providers, policy makers and study research assistants. Quantitative data will be analyzed using one sample proportion test and linear regression models appropriately. The Levesque\'s framework will be used as a guide to analyze qualitative data.

Dental caries and periodontal disease are typical oral diseases frequently observed in patients with renal diseases. Tooth loss is an outcome of dental caries and periodontal disease, and the number of existing teeth is an indicator of oral health status. However, the association between the number of existing teeth and end-stage kidney disease (ESKD) has not been investigated in detail. This study aimed to investigate the association between oral health status, expressed by the number of existing teeth, and ESKD. We analyzed data from the second survey of the Longitudinal Evaluation of Multi-phasic, Odontological, and Nutritional Associations in Dentists, a cohort study conducted among members of the Japan Dental Association. From August 2016 to July 2017, self-administered questionnaires were mailed to 16,128 male dentists and 8,722 responded. Among them, 7,479 men with complete data on age, number of existing teeth, and ESKD were included in the analysis. Multivariate logistic regression analysis was conducted, with ESKD as the dependent variable and the number of existing teeth (≥23 teeth and <23 teeth) as the independent variable. Subgroup analysis by age (<65 years and ≥65 years) was also conducted. The <23 teeth group had a significantly higher rate of ESKD than did the ≥23 teeth group. After adjusting for age, body mass index, smoking habits, hypertension, and diabetes mellitus, there was no significant association between having <23 teeth and ESKD in all participants. However, the subgroup analysis revealed a significant association after adjustment for covariates in participants aged <65 years but not in those aged ≥65 years. In conclusion, having <23 teeth was associated with the risk of requiring maintenance dialysis therapy among Japanese men aged <65 years. Therefore, tooth loss may be associated with renal function decline.

OBJECTIVE: To evaluate the effectiveness of pelvic floor muscle training (PFMT) on pelvic floor muscle (PFM) function and quality of life (QoL) in women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
METHODS: This study will be a randomized, controlled, parallel, and blinded clinical trial. The final sample will consist of 32 women diagnosed with SUI and cystocele (stage I and II). All volunteers will be assessed and reassessed using the same protocol: assessment form, gynecological examination, functional evaluation of PFM, and questionnaires to assess quality of life, urinary function, and sexual function. All volunteers will be evaluated for satisfaction levels post-treatment. The intervention will be PFMT, totaling 16 sessions to be conducted twice a week. Reevaluation will take place at the end of treatment and 1 month after completion of PFMT. Descriptive analysis and repeated measures ANOVA will be used for result analysis. A significance level of p<0.05 will be considered for all statistical tests.
BACKGROUND: This study has been submitted to the Ethics in Research Committee of the Federal University of Rio Grande do Norte and approved under protocol number 5.826.563. It has been registered with the Brazilian Clinical Trials Registry ReBec (RBR-49p6g3t). It is expected that these studies will provide a deeper understanding of the efficacy of PFMT in women with SUI and cystocele. Additionally, it aims to provide more insights into the efficacy of PFMT prior to surgery.

BACKGROUND: Schizophrenia (SCZ) is characterized by cognitive deficits that are linked to prefrontal cortex dysfunction. While transcranial direct current stimulation (tDCS) shows promise for improving cognition, the effects of intensified 3mA tDCS protocols on brain physiology are unknown. This project aims to elucidate the neurophysiological and cognitive effects of an intensified prefrontal tDCS protocol in SCZ.
METHODS: The study is designed as a randomized, double-blind, 2-arm parallel-group, sham-controlled, trial. Forty-eight participants with SCZ and cognitive impairment (measured via a set of executive functions tests) will be randomly allocated to receive either a single session of active (n = 24) or sham (n = 24) tDCS (20-min, 3-mA). The anodal and cathodal electrodes are positioned over the left and right DLPFC respectively. The stimulation occurs concurrently with the working memory task, which is initiated precisely 5 minutes after the onset of tDCS. Structural and resting-state (rs-fMRI) scans are conducted immediately before and after both active and sham tDCS using a 3 Tesla scanner (Siemens Prisma model) equipped with a 64-channel head coil. The primary outcome will be changes in brain activation (measures vis BOLD response) and working memory performance (accuracy, reaction time).
CONCLUSIONS: The results of this study are helpful in optimizing tDCS protocols in SCZ and inform us of neurocognitive mechanisms underlying 3 mA stimulation. This study will additionally provide initial safety and efficacy data on a 3 mA tDCS protocol to support larger clinical trials. Positive results could lead to rapid and broader testing of a promising tool for debilitating symptoms that affect the majority of patients with SCZ. The results will be made available through publications in peer-reviewed journals and presentations at national and international conferences.

BACKGROUND: Noncommunicable diseases (NCDs), particularly diabetes and chronic kidney diseases, pose a significant health burden in Thailand, especially among socioeconomically disadvantaged populations. The existing primary health care system faces challenges in providing optimal care for NCDs due to inadequate primary care workforce. The SMARThealth program offers a technology-based solution to enhance NCD management through task-sharing among nonphysician health care workers.
OBJECTIVE: This study aims to adapt and implement the SMARThealth Diabetes program in rural Thailand to improve diabetes management. The main objectives are to (1) adapt, validate, and integrate the SMARThealth Diabetes program for improving the management of type 2 diabetes mellitus at the primary health care level; and (2) to determine the feasibility and acceptability of the SMARThealth Diabetes program in rural communities of Thailand.
METHODS: A pragmatic, type 2 hybrid effectiveness or implementation, parallel-group cluster randomized controlled trial of 12 months duration and involving 51 subdistrict health offices in rural communities of Kamphaeng Phet province, Thailand, will be conducted. The intervention arm will receive the SMARThealth Diabetes program, including workforce restructuring, clinical decision support system, and continuous performance monitoring, while the control arm will continue with usual practice. Data will be collected using the SMARThealth platform and will be stored on a server in Thailand. The primary outcome measure will be the change in mean hemoglobin A1c (HbA1c) measured at randomization and 12 months from randomization between the intervention and control clusters. Secondary outcomes will include the difference in change in albuminuria status, estimated glomerular filtration rate, systolic blood pressure, and low-density lipoprotein cholesterol level. The analysis for change in HbA1c between baseline and end of study will be performed using linear mixed models. Any imbalances between the 2 arms will be addressed by sensitivity analyses. Additionally, a mixed methods process evaluation will be conducted to assess the implementation process, that will include in-depth interviews and focus group discussions, in addition to the quantitative data collected during the implementation process. The qualitative data will be thematically analyzed to explore factors that promote or inhibit the implementation and maintenance of the program.
RESULTS: The data collection commenced in November 2022, and the results will be ready for publication by the first quarter of 2025. Effectiveness of the intervention package will be assessed by change in mean HbA1c measures, and detailed feasibility, barriers, and enablers for the implementation of the intervention will be documented through a detailed process evaluation.
CONCLUSIONS: The study protocol outlines a novel approach to enhancing diabetes management in rural Thailand through digital technology-based interventions that will facilitate task-sharing among health care workers. This can help inform future strategies for improving NCD care in low-resource settings globally.
BACKGROUND: Thai Clinical Trials Registry TCTR20200322006; https://www.thaiclinicaltrials.org/show/TCTR20200322006.
UNASSIGNED: DERR1-10.2196/59266.