Prevalence of hazardous drinking and suspected alcohol dependence in Japanese primary care settings.

OBJECTIVE: We aimed to assess the prevalence of hazardous drinking and potential alcohol dependence among Japanese primary care patients, and their readiness to change and awareness of others' concerns. METHODS: From July to August 2023, we conducted a multi-site cross-sectional study as a screening survey for participants in a cluster randomized controlled trial. The trial included outpatients aged 20-74 from primary care clinics. Using the Alcohol Use Disorders Identification Test (AUDIT) alongside a self-administered questionnaire, we evaluated the prevalence of hazardous drinking and suspected alcohol dependence, patients' readiness to change, and their awareness of others' concerns. RESULTS: Among the 1388 participants from 18 clinics, 22% (95% confidence interval (CI): 20% to 24%) were identified as engaging in hazardous drinking or suspected of being alcohol dependent. As the AUDIT scores increased, so did their readiness to change. However, only 22% (95%CI: 16% to 28%) of those with scores ranging from 8 to 14 reported that others, including physicians, had expressed concerns about their drinking during the past year. For those with scores of 15 or higher, the figure was 74%. CONCLUSIONS: This study underscores the need for universal or high-risk alcohol screening and brief intervention in Japanese primary care settings. Trial registry UMIN-CTR (https://www.umin.ac.jp/ctr/) (UMIN000051388).

Efficacy and safety of alcohol reduction pharmacotherapy according to treatment duration in patients with alcohol dependence or alcohol use disorder: A systematic review and network meta-analysis.

BACKGROUND AND AIMS: Relapse is common in alcohol dependence (AD) and alcohol use disorder (AUD), so alcohol reduction therapy should be measured over as long a period as possible; however, existing reviews do not consider the duration of treatment and therefore alcohol reduction therapy may not have been appropriately evaluated. This review evaluated the efficacy and safety of alcohol reduction pharmacotherapy in patients with AD or AUD according to the duration of treatment. METHODS: We conducted a systematic review and network meta-analysis of randomized controlled trials (RCTs) that assessed 15 pharmacological agents. MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Trials, the ClinicalTrials.gov and the International Clinical Trials Registry Platform were searched for eligible trials through to May 2021. Outcomes were heavy drinking days (HDD), total alcohol consumption (TAC), any adverse event and days without drinking. RESULTS: Fifty-five RCTs (n = 8891) were included. Nalmefene was superior to placebo for reducing HDD (standard mean difference [SMD] -0.28, 95% confidence interval [CI] -0.37, -0.18) and TAC (SMD -0.25, 95% CI -0.35, -0.16) in the long-term, but not in the short-term. Topiramate was superior to placebo for reducing HDD (SMD -0.35, 95% CI -0.59, -0.12) and days without drinking (SMD 0.46, 95% CI 0.11, 0.82), and baclofen was superior for reducing TAC (SMD -0.70, 95% CI -1.29, -0.11), in the short-term. The frequency of adverse events was higher with nalmefene and topiramate than with placebo. CONCLUSION: Nalmefene, topiramate and baclofen may be effective as alcohol reduction pharmacotherapy; however, only nalmefene has demonstrated long-term efficacy, and nalmefene and topiramate have a significantly higher frequency of adverse events compared with placebo.

Guided versus unguided chatbot-delivered cognitive behavioral intervention for individuals with moderate-risk and problem gambling: A randomized controlled trial (GAMBOT2 study).

BACKGROUND: Internet-based interventions can be a promising option for individuals with problem gambling facing barriers to seeking help. This study aimed to directly compare the effects of therapist-guided Internet interventions with unguided ones on gambling-related behavior, cognition, and stage of change including help-seeking intention. METHODS: We conducted a participant-blinded randomized controlled trial of therapist-guided versus unguided groups with a 12-week follow-up. Both groups received self-help chatbot-delivered cognitive behavioral therapy. Additionally, at baseline and weeks 1, 2, 3, and 4, the guided group received personalized feedback messages from therapists based on their gambling diary and questionnaire responses. The unguided group received reminders of assessments from research assistants. The primary outcome was the change in scores on the Gambling Symptoms Assessment Scale (G-SAS) over 12 weeks. Secondary outcomes included the stage of change including help-seeking intention, money wagered, gambling frequency, and gambling-related cognitions. RESULTS: We included 139 participants with a mean Problem Gambling Severity Index total score of 14.6 and a mean G-SAS total score of 27.0 who sought information about gambling problems. Both groups demonstrated substantial decreases in their G-SAS scores from baseline to week 12 (-10.2, 95% CI: -7.67 to -12.7 for the guided group, and 11.7, 95% CI: -9.05 to -14.3 for the unguided group). However, we did not find a significant between-group difference (1.49, 95% CI: -2.20 to 5.17). Regarding the stage of change including help-seeking intention, there were also no between-group differences. CONCLUSIONS: Minimum therapist support did not have an additive effect on the self-help chatbot intervention on gambling symptoms, behavior, and the stage of change including help-seeking intention.

Effect of smoking habits and concomitant valproic acid use on relapse in patients with treatment-resistant schizophrenia receiving clozapine: A 1-year retrospective cohort study.

INTRODUCTION: No study has investigated the impact of smoking habits and concomitant valproic acid (VPA) use on clinical outcomes in maintenance treatment with clozapine. Thus, we aimed to examine the effect of smoking habits and concomitant VPA use on relapse during the first year after discharge in patients with treatment-resistant schizophrenia (TRS) receiving clozapine. METHODS: This retrospective cohort study included patients with TRS who were initiated on clozapine during hospitalization and discharged between April 2012 and January 2021 in two tertiary psychiatric hospitals in Japan. Relapse was defined as rehospitalization due to psychiatric exacerbation during the first year after discharge. A multivariable Cox proportional hazards regression analysis was performed to analyze the effect of smoking habits and concomitant VPA use on relapse. Subgroup analyses were also conducted to examine potential interactions between smoking habits and concomitant VPA use. RESULTS: Among the included 192 patients, 69 (35.9%) met the criteria of relapse. While smoking habits (adjusted hazard ratio [aHR], 2.27; 95% confidence interval [CI], 1.28-4.01; p < 0.01) independently increased the risk of relapse, a significant interaction for relapse risk was found between smoking habits and concomitant VPA use (p-interaction = 0.015). Concomitant VPA use may be an effective modifier of the increased relapse risk associated with smoking habits. Among patients who smoked, those using VPA concomitantly exhibited a higher risk of relapse (aHR, 5.32; 95% CI, 1.68-16.9; p < 0.01) than those not using VPA (aHR, 1.41; 95% CI, 0.73-2.70; p = 0.30). CONCLUSION: The findings suggest that the combination of smoking habits and concomitant VPA use may increase the risk of relapse after discharge. Future studies are required to elucidate the mechanisms underlying these findings, such as a decrease in clozapine blood levels.

An open competition involving thousands of competitors failed to construct useful abstract classifiers for new diagnostic test accuracy systematic reviews.

There are currently no abstract classifiers, which can be used for new diagnostic test accuracy (DTA) systematic reviews to select primary DTA study abstracts from database searches. Our goal was to develop machine-learning-based abstract classifiers for new DTA systematic reviews through an open competition. We prepared a dataset of abstracts obtained through database searches from 11 reviews in different clinical areas. As the reference standard, we used the abstract lists that required manual full-text review. We randomly splitted the datasets into a train set, a public test set, and a private test set. Competition participants used the training set to develop classifiers and validated their classifiers using the public test set. The classifiers were refined based on the performance of the public test set. They could submit as many times as they wanted during the competition. Finally, we used the private test set to rank the submitted classifiers. To reduce false exclusions, we used the Fbeta measure with a beta set to seven for evaluating classifiers. After the competition, we conducted the external validation using a dataset from a cardiology DTA review. We received 13,774 submissions from 1429 teams or persons over 4 months. The top-honored classifier achieved a Fbeta score of 0.4036 and a recall of 0.2352 in the external validation. In conclusion, we were unable to develop an abstract classifier with sufficient recall for immediate application to new DTA systematic reviews. Further studies are needed to update and validate classifiers with datasets from other clinical areas.

The Usefulness of a Smartphone App-Based Smoking Cessation Program for Conventional Cigarette Users, Heated Tobacco Product Users, and Dual Users: Retrospective Study.

BACKGROUND: Heated tobacco products (HTPs) are widespread in Japan, and smoking cessation of such products has become an important issue owing to the spread of harmful effects from HTPs. The efficacy of online digital therapy has been reported in smoking cessation treatment; however, we have limited evidence of online smoking cessation programs for HTP users. OBJECTIVE: In this study, we evaluate the usefulness of the Ascure program for HTP users (defined as exclusive HTP use or dual use of HTP and cigarettes) compared with exclusive cigarette users. METHODS: This was a retrospective study. We recruited adult smokers participating in the Ascure online smoking cessation program in Japan from June 2019 to February 2021. The Ascure smartphone app provided four elements: (1) educational video tutorials to enhance the understanding of nicotine dependence, (2) a personalized to-do list for behavior change, (3) a digital diary for record keeping, and (4) interactive chat sessions for relief from cravings or withdrawal symptoms. The primary outcome was the continuous abstinence rate (CAR) at weeks 21 to 24, biochemically validated using salivary cotinine testing. We considered those who dropped out of the program as smoking cessation failures. We analyzed the primary outcome using inverse probability weighting against tobacco product type estimated by multinomial propensity scores. We also assessed CAR at weeks 9 to 12 and program adherence. RESULTS: We analyzed data from 2952 participants, including 52% (1524/3478) in the cigarette group, 35% (1038/3478) in the HTP group, and 13% (390/3478) in the dual-use group, who had a mean age of 43.4 (SD 10.8) years and included 17% (513/2952) women. CAR at weeks 21 to 24 showed that exclusive HTP users were more likely to stop tobacco use than exclusive cigarette smokers (CAR 52.6% for cigarette users vs CAR 64.8% for HTP users; odds ratio [OR] 1.17, 95% CI 1.12-1.22; P<.001). There was no significant difference between the exclusive cigarette users and the dual users (CAR 52.6% for cigarette users vs CAR 48.7% for dual users; OR 0.99, 95% CI 0.93-1.05; P=.77). CAR at weeks 9 to 12 was 56.7% (95% CI 54.2%-59.2%) for the exclusive cigarette users, 68.3% (95% CI 65.5%-71.1%) for the exclusive HTP users, and 58.2% (95% CI 53.3%-63.1%) for the dual users. The program adherence rate at week 24 was 70.7% overall (68.4% for cigarette users, 75% for HTP users, and 67.9% for dual users). CONCLUSIONS: Exclusive HTP users had higher CARs and adherence compared with exclusive cigarette users, indicating a higher affinity for the Ascure online smoking cessation program. This program might be a useful smoking cessation option for HTP users, as well as for cigarette smokers.

Gender Biases Toward People With Difficulty in Balancing Work and Family Due to ADHD: Two Case Vignette Randomized Studies Featuring Japanese Laypersons and Psychiatrists.

Objective The gender gap in labor force participation is likely larger in adults with attention deficit hyperactivity disorder (ADHD) than that in the general population. Thus, we investigated whether gender affected the perception toward persons displaying ADHD symptoms and experiencing difficulty in balancing work and family. Methods Both Japanese laypersons and psychiatrists were recruited for web-based surveys in March and October 2020 via an online survey company, Cross Marketing Inc., and the secretariat of the Japanese Society of Psychiatry and Neurology, respectively. The participants were randomly assigned to read either a male or female case vignette. The vignettes were identical, except for the gender of the patient in the case. The primary and secondary outcomes were the respondents' opinions on the seriousness of the case and the degree to which the case's wish should be maintained, using sliding scales of 0-100. Results We included 560 laypersons and 585 psychiatrists. Neither cohort differed in most outcomes between the groups assigned to the male and female case vignettes. Among laypersons, the average score of seriousness was 58.8 in the female-vignette group and 58.6 in the male-vignette group (mean difference, 0.15; 95% confidence interval, -4.9 to 5.2). Among psychiatrists, the average score of seriousness was 53.9 in the female-vignette group and 53.7 in the male-vignette group (mean difference, 0.18; 95% confidence interval, -3.1 to 3.4). Similarly, between-group differences in the opinions on the degree to which the case's wish should be maintained were 1.2 in laypersons and 0.63 in psychiatrists. We found no significant interaction between the gender of the case and the respondent's gender in any of the outcomes. Conclusion Our results did not support the hypothesis that women were more likely to be pressured to prioritize family over work than men were when there was difficulty balancing work and family due to ADHD symptoms.

Strong chu-hai, a Japanese ready-to-drink high-alcohol-content beverage, and hazardous alcohol use: A nationwide cross-sectional study.

BACKGROUND: A new ready-to-drink premixed high-alcohol-content beverage, called strong chu-hai, was launched in Japan, and more recently, in Taiwan and Australia. We aimed to examine the popularity and association of strong chu-hai with individual alcohol use, both of which remained unclear. METHODS: We conducted a cross-sectional study using data from the Japan "Society and New Tobacco" Internet Survey conducted from February 1 to 28, 2022, in Japan. We enrolled 27,993 respondents (aged 15 to 81 years; male 48.5%), including 15,083 current alcohol users. Using inverse probability weighting of data from the 2016 Comprehensive Survey of Living Conditions on Health and Welfare, we estimated the weighted proportions of strong chu-hai users among all respondents and constructed multivariable logistic regression models to estimate the weighted odds ratios (OR) and 95% confidence intervals (CI) of strong chu-hai use for hazardous and harmful alcohol use, defined as a score ≥8 of the Alcohol Use Disorder Identification Test, among current alcohol users. RESULTS: Among all respondents, 56.2% (weighted proportions: past, 35.9%; and current, 20.3%) drank strong chu-hai. Among drinkers, both past and current strong chu-hai use, compared to never use, were associated with hazardous and harmful alcohol use (past, OR 1.73, 95% CI 1.42 to 2.12; current, OR 2.19, 95% CI 1.79 to 2.69). CONCLUSIONS: Our study found that more than half of the respondents experienced strong chu-hai consumption, suggesting that it is widely used in Japan. In addition, both past and current strong chu-hai use were associated with hazardous and harmful alcohol use among current alcohol users.

Long-term Weight Loss as a Predictor of Mortality in Hemodialysis Patients.

BACKGROUND: Serial weight decrease can be a prognostic predictor in chronic hemodialysis (HD) patients. We investigated the impact of long-term post-HD body weight (BW) changes on all-cause mortality among HD patients. METHODS: This longitudinal cohort study and post-hoc analysis evaluated participants of a previous randomized controlled trial conducted between 2006 and 2011 who were followed up until 2018. Weight change slopes were generated with repeated measurements every 6 months during the trial for patients having ≥5 BW measurements. Participants were categorized into four groups based on quartiles of weight change slopes; the median weight changes per 6 months were -1.02 kg, -0.25 kg, +0.26 kg, and +0.86 kg for first, second, third, and fourth quartile, respectively. Cox proportional hazard regression was used to evaluate differences in subsequent survival among the four groups. BW trajectories were plotted with a backward time-scale and multilevel regression analysis to visualize the difference in BW trajectories between survivors and non-survivors. RESULTS: Among the 461 patients, 404 were evaluated, and 168 (41.6%) died within a median follow-up period of 10.2 years. The Cox proportional hazard regression adjusted for covariates and baseline BW showed that a higher rate of weight loss was associated with higher mortality. The hazard ratios were 2.02 (95% confidence interval [CI], 1.28-3.20), 1.77 (95% CI, 1.10-2.85), 1.00 (reference), and 1.11 (95% CI, 0.67-1.83) for the first, second, third (reference), and fourth quartiles, respectively. BW trajectories revealed a significant decrease in BW in non-survivors. CONCLUSION: Weight loss elucidated via serial BW measurements every 6 months is significantly associated with higher mortality among HD patients.

Prevalence of gambling disorder and its correlates among homeless men in Osaka city, Japan.

Internationally, the prevalence of gambling disorder has been reported to be higher among homeless people than the general population; however, little is known about the factors associated with gambling disorder in this population. The present study aimed to investigate the prevalence of gambling disorder and its associated factors among homeless men using shelters in Osaka City. A cross-sectional survey was conducted from 30 to 2018 to 4 January 2019, using the 2017 Japanese National Survey of Gambling (JNSG) questionnaire, supplemented with questions about homeless experiences, drinking, and smoking. Using the South Oaks Gambling Screen, the presence of gambling disorder was determined by a score ≥ 5 out of 20. Multivariate logistic regression was conducted to explore factors associated with lifetime gambling disorder. Lifetime and past-year prevalence of gambling disorder among 103 participants was 43.7% (95% confidence interval [CI]: 34.5-53.3) and 3.9% (95% CI: 1.5-9.6), respectively, which are higher than the 6.7% and 1.5% found among men in the 2017 JNSG. Reasons reported for currently gambling less were primarily financial. Factors associated with lifetime GD included "more than 20 years since the first incidence of homelessness" (adjusted odds ratio [AOR]: 4.97, 95% CI: 1.50-16.45) and "more than five incidences of homelessness" (AOR: 4.51, 95% CI: 1.06-19.26). When homeless individuals with gambling disorder try to rebuild and stabilize their lives, the presence or resurgence of gambling disorder may hinder the process and pose a risk of recurring homelessness. Comprehensive support services for homeless individuals with gambling disorder are required. (250 words).

Longitudinal changes in clozapine dose in patients with treatment-resistant schizophrenia: a 5-year retrospective cohort study.

This retrospective cohort study aimed to investigate the longitudinal changes in clozapine dose over a 5-year period in patients with treatment-resistant schizophrenia (TRS). Patients with TRS who were administered clozapine at a hospital between April 2012 and December 2016 and continued treatment with clozapine for at least 1 year were included. Clozapine doses were compared at the dose-fixation point, defined as when the same regimen of clozapine had been continued for 8 weeks or longer, and the post-dose-fixation phase, at 12, 36 and 60 months after clozapine initiation. We included 103 patients and found no significant differences in clozapine dose between the dose-fixation point and post-dose-fixation phase. Approximately half of the patients were categorized into an unchanged group at 12 months after clozapine initiation, whereas approximately 40% of patients were categorized into either the decreased or increased group at 60 months. Multivariable regression analysis revealed that the change in clozapine dose between the dose-fixation point and 60 months after clozapine initiation was negatively associated with clozapine dose at the dose-fixation point. On average, the clozapine dose was unchanged during long-term treatment in patients with TRS, although the dose was decreased or increased in approximately 40% of the patients.

Patients' acceptability and implementation outcomes of a case management approach to encourage participation in colorectal cancer screening for people with schizophrenia: a qualitative secondary analysis of a mixed-method randomised clinical trial.

OBJECTIVES: We examined the efficacy of case management (CM) interventions to encourage participation in colorectal cancer screening for patients with schizophrenia. This study aimed to clarify patients' acceptability of the intervention and the helpful components of the intervention. Simultaneously, the study aimed to determine the acceptability, appropriateness and feasibility of the intervention from the perspective of psychiatric care providers. STUDY DESIGN AND SETTING: This study was a secondary qualitative analysis of a mixed-method randomised controlled trial that evaluated the efficacy of the CM approach to encourage participation in cancer screening for people with schizophrenia. The intervention comprised education and patient navigation for colorectal cancer screening. Interviews were conducted with patients who received the intervention and staff from two psychiatric hospitals in Japan who delivered the intervention. PARTICIPANTS: Of the 172 patients with schizophrenia who participated in the trial, 153 were included. In addition, three out of six providers were included. DATA COLLECTION AND ANALYSIS: Using a structured interview, the case manager asked participants about patient acceptability and the helpful components of the intervention. Content analysis was conducted for the responses obtained, and the number of responses was tabulated by two researchers. For the interviews with the providers, opinions obtained from verbatim transcripts were extracted and summarised. RESULTS: Forty-three of the 56 patients perceived that the intervention was acceptable. For the intervention component, inperson counselling with an explanation of the screening process by psychiatric care providers was most frequently reported by the patients as helpful (48 of the 68 respondents). Psychiatric care providers evaluated the intervention as acceptable, appropriate and easy to understand and administer. However, providing the intervention to all patients simultaneously was considered difficult with the current human resources. CONCLUSIONS: This study showed that the CM intervention was perceived as acceptable by patients and acceptable and appropriate by psychiatric care providers. TRIAL REGISTRATION NUMBER: UMIN000036017.

Changes in Plasma Clozapine Levels after Smoking Cessation in Japanese Inpatients with Schizophrenia: A Retrospective Cohort Study.

Although reported for Caucasians, changes in plasma clozapine levels after smoking cessation in East Asians remain unclear. We here investigated plasma clozapine levels before and after smoking cessation in Japanese inpatients with schizophrenia. We conducted a retrospective chart review of 14 inpatients with schizophrenia who were being treated with clozapine between June 1, 2019, and July 31, 2019 and who were smokers as of July 1, 2019, the day on which a smoking ban was instituted in the tertiary public psychiatric hospital. The primary outcome was individual differences in plasma clozapine levels between before and after the smoking ban, which were compared using paired t-tests. The mean plasma clozapine level was significantly increased, by 213.4 ng/mL (95% CI 119.9-306.8; p<0.01) or 53.2%. Four of the 14 inpatients experienced clinically significant side effects, such as myoclonus, drooling, and amnesia, due to the development of high plasma clozapine levels. Our findings indicated that close monitoring of plasma clozapine levels before and after smoking cessation and prior dose adjustment of clozapine may be necessary, to prevent a significant risk of developing high plasma clozapine levels, even in Japanese patients.

A randomized controlled trial of the web-based drinking diary program for problem drinking in multi workplace settings.

OBJECTIVES: To assess the effectiveness of a web-based brief intervention (BI) program to record daily drinking among people with problem drinking in workplace settings. METHODS: A two-armed, parallel-group, randomized controlled trial were conducted at six workplaces in Japan. After obtaining written consent to participate in the study, workers with an Alcohol Use Disorders Identification Test (AUDIT) score of 8 or higher were randomly assigned into two groups. The participants allocated to the intervention group recorded their daily alcohol consumption for 4 weeks using the program, while those allocated to the control group received no intervention. Outcome measures included the amount of alcohol consumption in past 7 days using the Timeline Follow-Back method in the program at baseline, 8th week, and 12th week and written AUDIT score at baseline and 12th week. RESULTS: Hundred participants were assigned to either the intervention group (n = 50) or control group (n = 50). The results of two-way repeated measures ANOVA showed a statistically significant interaction between the group and the week factors in the two primary outcomes (number of alcohol-free days, total drinks) and secondary outcomes (AUDIT score) (p = .04, .02, and .03, respectively). The between-group effect sizes (Hedges' g; 95% CI) of the outcomes at 12th week were 0.53; 0.13-0.93 (total drinks), 0.44; 0.04-0.84 (AUDIT score), 0.43; 0.03-0.83 (number of alcohol-free days). CONCLUSIONS: The web-based BI program for problem drinking was considered to be effective in reducing alcohol consumption and the AUDIT score in workplace settings.