Association of night-shift work with gambling and problem gambling among workers in Japan: A nationwide cross-sectional study.

BACKGROUND AND AIMS: Night-shift work disturbs sleep and is associated with poor health conditions among workers. We aimed to investigate the association between night-shift work and gambling among workers and the association between night-shift work and problem gambling in working and gambling participants. METHODS: This cross-sectional study used data from an online survey conducted between February 6 and 27, 2023 in Japan. A total of 21,134 workers participated in this study, including 9,739 respondents who had gambled in the past year. We estimated the association between night-shift work and gambling among workers and the association between night-shift work and problem gambling among those who gambled at the survey. We defined problem gambling as a score ≥ 8 on the Problem Gambling Severity Index. All estimates were weighted using a nationally representative survey in Japan. We fitted multivariable weighted logistic regression models after adjusting for 14 confounders. RESULTS: The weighted prevalence of gambling among non-night and night-shift workers was 42.1 % and 55.4 %, respectively. When focusing on workers gambling in the survey, the prevalence of problem gambling among non-night and night-shift workers was 8.8 % and 24.2 %, respectively. The weighted multivariable logistic regression analyses showed that night-shift work was associated with gambling participation among workers (adjusted odds ratio [aOR], 1.39, 95 % confidence interval [CI] 1.25-1.53, p < 0.001). In addition, night-shift work was associated with problem gambling among those who gambled (aOR 1.94, 95 % CI 1.57-2.40, p < 0.001). CONCLUSIONS: Night-shift work was associated with gambling among workers and with problem gambling among those who gambled.

Cost-Effectiveness Analysis of Nivolumab Plus Ipilimumab Combination Therapy as First-line Treatment for Advanced Renal Cell Carcinoma in Japan.

OBJECTIVES: The purpose of this study is to examine the cost-effectiveness of nivolumab (NIVO) plus ipilimumab (IPI) combination therapy (NIVO + IPI) compared with the sunitinib (SUN) therapy for Japanese patients with advanced renal cell carcinoma from the perspective of a Japanese health insurance payer. METHODS: A lifetime horizon was applied, and 2% per annum was set as the discount rate. The threshold was set as $ 75 000 per quality-adjusted life-year (QALY) gained. For the analytical method, we used a partitioned survival analysis model to estimate the incremental cost-effectiveness ratio (ICER), which is calculated by dividing incremental costs by incremental QALYs. Progression-free survival, progressive disease, and death were set as health states. Additionally, cost parameters and utility weights were set as key parameters. We set the intermediate/poor-risk population as the base case. Scenario analysis was conducted for the intention-to-treat population and the favorable risk population. Furthermore, one-way sensitivity analysis and probabilistic sensitivity analysis were conducted for each population. RESULTS: In the base-case analysis, the QALYs of NIVO + IPI and SUN were 4.32 and 2.99, respectively. NIVO + IPI conferred 1.34 additional QALYs. Meanwhile, the total costs in the NIVO + IPI and SUN were $692 288 and $475 481, respectively. As a result, the ICER of NIVO + IPI compared with SUN was estimated to be $162 243 per QALY gained. The parameter that greatly affected the ICER was the utility weight of progression-free survival in NIVO + IPI. CONCLUSIONS: NIVO + IPI for advanced renal cell carcinoma seems to be not cost-effective compared with the SUN in the Japanese healthcare system.

Bladder training for treating overactive bladder in adults.

BACKGROUND: Overactive bladder (OAB) is a common chronic and bothersome condition. Bladder training is widely prescribed as a first-line treatment for OAB, but the efficacy has been systematically evaluated for urinary incontinence rather than OAB alone. OBJECTIVES: To evaluate the benefits and harms of bladder training for treating adults with OAB compared to no treatment, anticholinergics, ß3-adrenoceptor agonists, or pelvic floor muscle training (PFMT) alone or in combination. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 6 November 2022. SELECTION CRITERIA: We included randomized controlled trials involving adults aged 18 years or older with non-neurogenic OAB. We excluded studies of participants whose symptoms were caused by factors outside the urinary tract (e.g. neurologic disorders, cognitive impairment, gynecologic diseases). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. participant-reported cure or improvement, 2. symptom- and condition-related quality of life (QoL), and 3. ADVERSE EVENTS: Secondary outcomes included 4. participant-reported satisfaction, 5. number of incontinence episodes, 6. number of urgency episodes, and 7. number of micturition episodes. For the purpose of this review, we considered two time points: immediately after the treatment (early phase) and at least two months after the treatment (late phase). We used GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We included 15 trials with 2007 participants; participants in these trials were predominantly women (89.3%). We assessed the risk of bias of results for primary and secondary outcomes, which across all studies was similar and predominantly of high risk of bias, and none were at low risk of bias. The certainty of evidence was low to very low, with some moderate, across measured outcomes. Bladder training versus no treatment: three studies involving 92 participants compared bladder training to no treatment. The evidence is very uncertain about the effects of bladder training on cure or improvement at the early phase (risk ratio (RR) 17.00, 95% confidence interval (CI) 1.13 to 256.56; 1 study, 18 participants; very low-certainty evidence). Bladder training may reduce the number of incontinence episodes (mean difference (MD) -1.86, 95% CI -3.47 to -0.25; 1 study, 14 participants; low-certainty evidence). No studies measured symptom- and condition-related QoL, number of adverse events, participant-reported satisfaction, number of urgency episodes, or number of micturition episodes in the early phase. Bladder training versus anticholinergics: seven studies (602 participants) investigated the effects of bladder training versus anticholinergic therapy. Bladder training may be more effective than anticholinergics on cure or improvement at the early phase (RR 1.37, 95% CI 1.10 to 1.70; 4 studies, 258 participants; low-certainty evidence). The evidence is very uncertain about the effects of bladder training on symptom- and condition-related QoL (standardized mean difference (SMD) -0.06, 95% CI -0.89 to 0.77; 2 studies, 117 participants; very low-certainty evidence). Although the evidence is very uncertain, there were fewer adverse events in the bladder training group than in the anticholinergics group (RR 0.03, 95% CI 0.01 to 0.17; 3 studies, 187 participants; very low-certainty evidence). The evidence is very uncertain about the effects of the number of incontinence episodes per 24 hours (MD 0.36, 95% CI -0.27 to 1.00; 2 studies, 117 participants; very low-certainty evidence), the number of urgency episodes per 24 hours (MD 0.70, 95% CI -0.62 to 2.02; 2 studies, 92 participants; very low-certainty evidence), and the number of micturition episodes per 24 hours (MD -0.35, 95% CI -1.90 to 1.20; 3 studies, 175 participants; very low-certainty evidence). No studies measured participant-reported satisfaction in the early phase. Bladder training versus PFMT: three studies involving 203 participants compared bladder training to PFMT. The evidence is very uncertain about the different effects between bladder training and PFMT on symptom- and condition-related QoL at the early phase (SMD 0.10, 95% CI -0.19 to 0.40; 2 studies, 178 participants; very low-certainty evidence). There were no adverse events in either group at the early phase (1 study, 97 participants; moderate-certainty evidence). The evidence is uncertain about the effects of the number of incontinence episodes per 24 hours (MD 0.02, 95% CI -0.35 to 0.39, 1 study, 81 participants; low-certainty evidence) and very uncertain about the number of micturition episodes per 24 hours (MD 0.10, 95% CI -1.44 to 1.64; 1 study, 81 participants; very low-certainty evidence). No studies measured cure or improvement, participant-reported satisfaction, or number of urgency episodes in the early phase. Although we were interested in studies examining bladder training versus ß3-adrenoceptor agonists, in combination with ß3-adrenoceptor agonists versus ß3-adrenoceptor agonists alone, and in combination with PFMT versus PFMT alone, we did not identify any eligible studies for these comparisons. AUTHORS' CONCLUSIONS: This review focused on the effect of bladder training to treat OAB. However, most of the evidence was low or very-low certainty. Based on the low- or very low-certainty evidence, bladder training may cure or improve OAB compared to no treatment. Bladder training may be more effective to cure or improve OAB than anticholinergics, and there may be fewer adverse events. There may be no difference in efficacy or safety between bladder training and PFMT. More well-designed trials are needed to reach a firm conclusion.

Global Trends in Highly Cited Studies in COVID-19 Research.

Importance: Since the onset of the COVID-19 outbreak, an extremely high number of studies have been published worldwide, with variable quality. Research trends of highly cited papers may enable identification of influential research, providing insights for new research ideas; it is therefore important to investigate trends and focus on more influential publications in COVID-19-related studies. Objective: To examine research trends of highly cited studies by conducting a bibliometric analysis of highly cited studies in the previous 2 months about COVID-19. Design, Setting, and Participants: In this cross-sectional study, Essential Science Indicators (ESI) and Web of Science (WOS) Core Collection were used to find studies with a focus on COVID-19 that were identified as highly cited studies from Clarivate Analytics. Highly cited studies were extracted from the ESI database bimonthly between January 2020 and December 2022. Bibliographic details were extracted from WOS and combined with ESI data using unique accession numbers. The number of highly cited studies was counted based on the fractional counting method. Data were analyzed from January through July 2023. Main Outcomes and Measures: The number of publications by research field, country, and institutional affiliation. Results: The number of published COVID-19-related highly cited studies was 14 studies in January to February 2020, peaked at 1292 studies in November to December 2021, and showed a downward trend thereafter, reaching 649 studies in November to December 2022. China had the highest number of highly cited studies per 2-month period until July to August 2020 (138.3 studies vs 103.7 studies for the US, the second highest country), and the US had the greatest number of highly cited studies afterward (159.9 studies vs 157.6 studies for China in September to October 2020). Subsequently, the number of highly cited studies per 2-month period published by China declined (decreasing from 179.7 studies in November to December 2020 to 40.7 studies in September to October 2022), and the UK produced the second largest number of such studies in May to June 2021 (171.3 studies). Similarly, the top 5 institutional affiliations in May to June 2020 by highly cited studies per 2-month period were from China (Huazhong University: 14.7 studies; University of Hong Kong: 6.8 studies; Wuhan University: 4.8 studies; Zhejiang University: 4.5 studies; Fudan University: 4.5 studies), while in November to December 2022, the top 5 institutions were in the US and UK (Harvard University: 15.0 studies; University College London: 11.0 studies; University of Oxford: 10.2 studies; University of London: 9.9 studies; Imperial College London: 5.8 studies). Conclusions and Relevance: This study found that the total number of highly cited studies related to COVID-19 peaked at the end of 2021 and showed a downward trend until the end of 2022, while the origin of these studies shifted from China to the US and UK.

Detection bias in open-label trials of anticancer drugs: a meta-epidemiological study.

OBJECTIVES: In anticancer clinical trials, particularly open-label trials, central reviewers are recommended to evaluate progression-free survival (PFS) and objective response rate (ORR) to avoid detection bias of local investigators. However, it is not clear whether the bias has been adequately identified, or to what extent it consistently distorts the results. Therefore, the objective of this study was to evaluate the detection bias in oncological open-label trials by confirming whether local investigators overestimate the PFS and ORR compared with the findings of central reviewers. DESIGN: Meta-epidemiological study. DATA SOURCES: MEDLINE via PubMed from 1 January 2010 to 30 June 2021. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Open-label, parallel-group superiority, randomised trials of anticancer drugs that adjudicated PFS or ORR by both central reviewers and local investigators. REVIEW METHODS: We assessed the values for the same outcome (PFS and ORR) adjudicated by both central reviewers and local investigators. A random-effects model was used to estimate the ratio of HR (RHR) for PFS and the ratio of OR (ROR) for ORR between central reviewers and local investigators. An RHR lower than 1 and an ROR higher than 1 indicated an overestimation of the effect estimated by local investigators. RESULTS: We retrieved 1197 records of oncological open-label trials after full-text screening. We identified 171 records (PFS: 149 records, ORR: 136 records) in which both central reviewers and local investigators were used, and included 114 records (PFS: 92 records, ORR: 74 records) for meta-analyses. While the RHR for PFS was 0.95 (95% CI 0.91 to 0.98), the ROR of ORR was 1.00 (95% CI 0.91 to 1.09). The results remained unchanged in the prespecified sensitivity analysis. CONCLUSIONS: This meta-epidemiological study found that overestimation of local investigators has a small impact on evaluating PFS and ORR in oncological open-label trials. However, a limitation of this study is that it did not include data from all trials; hence, the results may not fully evaluate detection bias. The necessity of central reviewers in oncological open-label trials needs to be assessed by further studies that overcome this limitation. TRIAL REGISTRATION NUMBER: CTR-UMIN000044623.

Social Isolation/Loneliness and Tooth Loss in Community-Dwelling Older Adults: The Sukagawa Study.

Background and Objectives: The relationship between social isolation/loneliness and oral health is unclear. This study investigated the association between social isolation/loneliness and tooth loss in older Japanese adults. Research Design and Methods: This was a cross-sectional study of a population-based cohort (the Sukagawa Study); 5,490 cohort study participants aged ≥75 years and who were independent answered a self-administered questionnaire in 2018. Social isolation was defined based on the 6-item Japanese version of the Lubben Social Network Scale. Loneliness was measured by the 3-item Japanese version of the University of California, Los Angeles (UCLA) Loneliness Scale version 3. The primary outcome was tooth loss, defined as having fewer than 20 teeth. The secondary outcomes were decreased toothbrushing frequency and diminished ability to chew food. Prevalence ratios (PRs) were estimated using a modified Poisson regression analysis in 2 models-Model 1, which adjusted for age, gender, smoking status, alcohol consumption, low annual income, and short education period, and Model 2, which added history of depression, history of diabetes mellitus, history of stroke, and cognitive impairment to Model 1. Results: The primary analysis included 4,645 participants. Adjusted PRs of social isolation and loneliness for tooth loss (Model 1) were 0.97 (95% confidence interval [CI] 0.92-1.01) and 1.06 (95% CI 1.01-1.12), respectively; those for decreased toothbrushing frequency were 1.13 (95% CI 0.95-1.36) and 1.56 (95% CI 1.26-1.92), respectively; and those for chewing difficulty were 1.61 (95% CI 1.06-2.43) and 2.94 (95% CI 1.91-4.53), respectively. The adjusted PRs in Model 2 demonstrated results similar to that of Model 1. Discussion and Implications: Loneliness is associated with tooth loss among older adults, whereas social isolation is not. Our findings can inform plans for policymakers, professionals, and organizations to identify lonely older adults and provide social prescriptions to improve their access to oral health care services.

Phase II study of biweekly cetuximab plus mFOLFOX6 or mFOLFIRI as second-line treatment for metastatic colorectal cancer and exploratory analysis of associations between DNA methylation status and the efficacy of the anti-EGFR antibody: T-CORE1201.

Background: Little is known about the biweekly combined use of cetuximab and chemotherapy as second-line treatment of metastatic colorectal cancer (mCRC). Recently, DNA methylation status has been reported to be a new possible predictor of the efficacy from the anti-epidermal growth factor receptor (EGFR) antibody treatment. The purpose of this study was to examine the efficacy and safety of biweekly cetuximab plus mFOLFOX6 or mFOLFIRI as a second-line treatment for KRAS exon 2 wild-type mCRC. We also investigated the predictability of DNA methylation status on the efficacy of the EGFR antibody-containing treatment. Methods: Patients who were refractory or intolerant to the first-line chemotherapy were enrolled and received biweekly cetuximab plus mFOLFOX6 or mFOLFIRI. The primary endpoint was progression-free survival (PFS). Tumor evaluations were performed every 2 months using Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Adverse events (AEs) were evaluated according to the Common Terminology Criteria for Adverse Events version 4.0. DNA methylation status of colorectal cancer cells was defined by a modified MethyLight assay. Results: Sixty-six cases were enrolled. The median PFS (mPFS) was 5.1 [95% confidence interval (CI), 3.8-7.6] months. The median overall survival (mOS) was 12.7 (95% CI, 7.5-15.3) months. Grade 3 or higher neutropenia occurred in 53.0% of patients, whereas skin disorders with a grade 3 or higher occurred in <15% of patients. In multivariate analysis, DNA methylation status could not be an independent predictor of PFS [hazard ratio (HR), 1.43; P=0.39] and OS (HR, 2.13; P=0.086). However, in RAS/BRAF wild-type patients, the mPFS and mOS in the low-methylated colorectal cancer (LMCC) group was numerically better than those in the highly-methylated colorectal cancer (HMCC) group, although the difference was not statistically significant [mPFS: 8.5 (95% CI, 6.1-10.9) vs. 3.3 (95% CI, 1.2-not reached) months, P=0.79; ΔmPFS, 5.2 months; mOS: 15.3 (95% CI, 11.9-23.5) vs. 6.5 (95% CI, 3.1-not reached) months, P=0.53; ΔmOS, 8.8 months]. Conclusions: Biweekly cetuximab plus mFOLFOX6 or mFOLFIRI is a useful second-line therapy for mCRC. DNA methylation status warrants further exploration as a predictive biomarker for anti-EGFR efficacy in mCRC.

Longitudinal Association of Working From Home on Work Functioning Impairment in Desk Workers During COVID-19 Pandemic: A Nationwide Cohort Study.

OBJECTIVE: This study clarifies the longitudinal association between working from home and work functioning impairment among desk workers. METHODS: Nationwide surveys were conducted from 2020 to 2022, analyzing 3532 desk workers who never worked from home before the COVID-19 pandemic. RESULTS: The adjusted hazard ratio (95% confidence intervals) of working from home at least once a month or more with the composite result (incidence of work functioning or reduced work participation) was 1.22 (1.04-1.43). The cause-specific hazard ratios of work functioning impairment and reduced work participation were 1.30 (1.04-1.61) and 1.13 (0.86-1.47). CONCLUSIONS: Working from home could be longitudinally associated with work functioning impairment, especially for workers who are in higher positions. Workers and policy makers should be aware of the potential risk of working from home regarding presenteeism.

Differences in attitude toward COVID-19 based on internet and social media usage among community-dwelling older adults during the first state of emergency.

AIM: In order to understand the digital divide among older adults during the coronavirus disease 2019 (COVID-19) pandemic, we investigated the association between internet use and compliance with COVID-19 preventive behaviors during the first state of emergency in Japan. METHODS: A total of 8952 community-dwelling citizens aged 75 years and above were asked about their preventive behaviors during the first state of emergency using a paper-based questionnaire. Among them, 51% responded and were divided into internet users and non-users. We used multivariable logistic regression models to estimate the adjusted odds ratios and 95% confidence intervals of internet use for compliance with preventive behaviors. RESULTS: Approximately 40% of the respondents used the internet, and 9.29% used social media to collect COVID-19-related information. Internet usage was independently associated with compliance with using hand sanitizers, avoiding going out, avoiding eating out, avoiding traveling, getting vaccinated, and getting tested for COVID-19; the adjusted odds ratios (95% confidence intervals) were 1.21 (1.05-1.38), 1.19 (1.04-1.37), 1.20 (1.05-1.38), 1.32 (1.15-1.52), 1.30 (1.11-1.53), and 1.23 (1.07-1.41), respectively. Exploratory subgroup analyses demonstrated that social media users might have shown early adaptation to newly recommended preventive behaviors during the first state of emergency. CONCLUSIONS: Results suggest that a digital divide exists, as evidenced by the varied compliance with preventive behaviors depending on internet use. Additionally, social media use may be associated with early adaptation to newly recommended preventive behaviors. Therefore, future studies regarding the digital divide among older adults should investigate differences depending on the types and content of internet resources. Geriatr Gerontol Int 2023; 23: 289-296.

Association between exposure to secondhand aerosol from heated tobacco products and respiratory symptoms among current non-smokers in Japan: a cross-sectional study.

OBJECTIVES: To investigate the association between secondhand-aerosol exposure from heated tobacco products (HTPs) and respiratory symptoms among current non-smokers. DESIGN: Cross-sectional study. SETTING: Internet survey conducted between 8 and 26 February 2021 in Japan. PARTICIPANTS: Non-smoking respondents at the survey aged 15-80 years. EXPOSURE: Self-reported secondhand-aerosol exposure. PRIMARY AND SECONDARY OUTCOMES: We defined asthma/asthma-like symptoms as a primary outcome and persistent cough as a secondary outcome. We examined the association between secondhand-aerosol exposure from HTPs and respiratory symptoms (asthma attacks/asthma-like symptoms and persistent cough). The prevalence ratio (PR) and 95% CI were calculated by using weighted, multivariable 'modified' Poisson regression models. RESULTS: Of the 18 839 current non-smokers, 9.8% (95% CI 8.2% to 11.7%) and 16.7% (95% CI 14.8% to 18.9%) of those who were exposed to secondhand aerosols reported asthma attacks/asthma-like symptoms and persistent cough, whereas 4.5% (95% CI 3.9% to 5.2%) and 9.6% (95% CI 8.4% to 11.0%) of those who were not, respectively. Secondhand-aerosol exposure was associated with respiratory symptoms (asthma attacks/asthma-like symptoms: PR 1.49, 95% CI 1.21 to 1.85; persistent cough: PR 1.44, 95% CI 1.21 to 1.72) after adjusting for covariates. CONCLUSION: Secondhand-aerosol exposure from HTPs was associated with both asthma attacks/asthma-like symptoms and persistent cough. These results provide policymakers with meaningful information in the regulation of HTP use for the protection of current non-smokers.