Interactive assistance via eHealth for small- and medium-sized enterprises' employer and health care manager teams on tobacco control (eSMART-TC): protocol for a cluster randomized hybrid type II trial (N-EQUITY2101/J-SUPPORT2102).

BACKGROUND: Tobacco control should be a higher public health priority in Japan. Some workplaces provide smoking cessation support and connect employees to effective smoking cessation treatments such as outpatient clinics. However, tobacco control measures have not been sufficiently implemented in Japan, especially in small- and medium-sized enterprises (SMEs), where resources are limited. Organizational commitment and consistent leadership are crucial to facilitate implementation, but research on whether supporting organizational leaders leads to health behavior changes among employees is limited. METHODS: This hybrid type II cluster randomized effectiveness implementation trial (eSMART-TC) aims to examine the effects of interactive assistance for SME management on health and implementation outcomes. We will provide interactive assistance to employers and health managers for 6 months, aiming to promote the utilization of reimbursed smoking cessation treatments by public health insurance and to implement smoke-free workplaces. The intervention will consist of three strategies: supporting employees through campaigns, tailored ongoing facilitation, and ensuring executive engagement and support. The primary health and implementation outcomes will be salivary cotinine-validated 7-day point-prevalence abstinence rate, and the adoption of two recommended measures (promoting utilization of smoking cessation treatment and implementing smoke-free workplaces) 6 months after the initial session, respectively. Other outcomes for implementation (e.g., penetration of smoking cessation clinic visits), health (e.g., salivary cotinine-validated 7-day point-prevalence abstinence rate at 12 months), and process (e.g., adherence and potential moderating factors) will be collected via questionnaires, interviews, logbooks, and interventionists' notes at 6 and 12 months. An economic analysis will be undertaken to assess the cost-effectiveness of the implementation interventions at 12 months. DISCUSSION: This will be the first cluster randomized controlled trial to evaluate the effectiveness of an implementation intervention with interactive assistance for employers and health managers in SMEs on smoking cessation and implementation of evidence-based tobacco control measures in SMEs. The findings of this trial targeting management in SMEs have the potential to accelerate the implementation of evidence-based smoking cessation methods as well as abstinence rates among employees in SMEs across Japan. TRIAL REGISTRATION: The study protocol has been registered in the UMIN Clinical Trials Registry (UMIN-CTR; ID: UMIN000044526). Registered on 06/14/2021.

Study Profile: The Japan "Society and New Tobacco" Internet Survey (JASTIS): A Longitudinal Internet Cohort Study of Heat-Not-Burn Tobacco Products, Electronic Cigarettes, and Conventional Tobacco Products in Japan.

BACKGROUND: Japan became the first country where heat-not-burn tobacco products were sold. Therefore, there was no information for actual status on the actual use status or the harms of heat-not-burn tobacco products. The objectives of the study profile are to generate data that can be freely available to external researchers, and to create collaborative research projects in the future. METHODS: The Japan "Society and New Tobacco" Internet Survey (JASTIS) is a longitudinal internet cohort study which investigates perception, attitude, and use of heat-not-burn tobacco, electronic cigarettes (e-cigarettes), and conventional tobacco products in Japan. The survey also includes demographic, health-related, and socioeconomic factors. Participants were randomly selected and invited from internet panelists. The baseline survey was closed when the target number of respondents who had answered the questionnaire was met. RESULTS: The study includes three cohorts (1-3) from the 2015 baseline survey and a cohort (4) from the 2017 baseline survey: cohorts 1 and 4 were recruited based on sex and age: men and women aged 15-69 years (n = 8,240 for cohort 1 and n = 5,897 for cohort 4); cohorts 2 and 3 were created using status-based recruiting: e-cigarette and/or heat-not-burn tobacco ever users (n = 2,188; cohort 2) and combustible cigarette smokers without e-cigarette/heat-not-burn tobacco experience (n = 724; cohort 3). The completion rates were 8.5% to 9.9%. All subjects were followed and assessed annually. Response rates for the follow-up survey were 65.5% in 2016, 55.3% in 2017, and 50.9% in 2018. Because Internet-based responders are not a representative sample of the general population of Japan, we conducted adjustment to account for "being an internet survey respondent" and reported tobacco product use in Japan. A recent JASTIS study reported that prevalence of IQOS current-use among Japanese adults had rapidly increased from 0.3% in 2015 to 3.6% in 2017. CONCLUSION: The JASTIS study provides the first estimates for heat-not-burn tobacco use in the world and e-cigarette use in Japan. For information on collaboration, please contact the corresponding author.

[Awareness of harm to others from secondhand smoke and smokers' interest in smoking cessation].

Objectives　Because smoking presents various health hazards, smoking cessation is important for health promotion. It is known that awareness of the harm of smoking to smokers themselves is associated with attempts to quit. However, the association between smoking cessation and awareness of harm to others from secondhand smoke has not been well examined. Therefore, in this research, we examined the association between smokers' awareness of the harm to others from secondhand smoke and their interest in smoking cessation, focusing on current smokers in an Internet survey of the general population of Japan.Methods　We conducted a cross-sectional Internet survey of the general population of Japan between January 27 and March 13, 2017. A total of 1,586 respondents aged 15-71 years (1,128 men and 458 women) who were current smokers were analyzed. We used multivariable-adjusted logistic regression to examine the association among awareness of smoking's harm to smokers themselves, awareness of harm to others from secondhand smoke, and the smokers' interest in smoking cessation.Results　Of current smokers, 81.6% of men and 88.2% of women were aware of the harm caused to others by secondhand smoke; 52.7% of men and 64.6% of women were interested in smoking cessation. Using awareness of harm to smokers themselves and awareness of harm to others from secondhand smoke as predictor variables in multivariable-adjusted logistic regression, odds ratios were 2.53 and 2.92, respectively. In the model using both awareness of harm to smokers themselves and harm to others from secondhand smoke, both have a significant independent positive association with smokers' interest in quitting.Conclusions　Current smokers aware of the harm caused to others by secondhand smoke were more interested in quitting than those who were not. Awareness of the harm caused to smokers themselves by smoking and awareness of the harm caused to others by secondhand smoke have a significant independent positive association with smokers' interest in quitting. Although this study is a cross-sectional study and did not investigate causal relationships, the findings suggest that raising awareness of the harm to other people from secondhand smoke may lead to more interest in smoking cessation, and the data can be used to promote tobacco control in the future.

Tobacco Price Increase and Smoking Cessation in Japan, a Developed Country With Affordable Tobacco: A National Population-Based Observational Study.

BACKGROUND: Longitudinal assessment of the impact of tobacco price on smoking cessation is scarce. Our objective was to investigate the effect of a price increase in October 2010 on cessation rates according to gender, age, socioeconomic status, and level of tobacco dependence in Japan. METHODS: We used longitudinal data linkage of two nationally representative studies and followed 2702 smokers for assessment of their cessation status. The odds ratios (ORs) for cessation were calculated using logistic regression. To estimate the impact of the 2010 tobacco price increase on cessation, data from 2007 were used as a reference category. RESULTS: Overall cessation rates significantly increased from 2007 to 2010, from 3.7% to 10.7% for men and from 9.9% to 16.3% for women. Cessation rates were 9.3% for men who smoked 1-10 cigarettes per day, 2.7% for men who smoked 11-20 cigarettes per day, and 2.0% for men who smoked more than 20 cigarettes per day in 2007. These rates increased to 15.5%, 10.0%, and 8.0%, respectively, in 2010. The impact was stronger among subjects who smoked more than 11 cigarettes per day than those who smoked 1-10 cigarettes per day in both sexes: ORs for 2010 were 4.04 for those smoking 11-20 cigarettes per day, 4.26 for those smoking more than 20 cigarettes per day, and 1.80 for those smoking 1-10 cigarettes per day in the main model in men. There were no obvious differences in the relationship between tobacco price increase and smoking cessation across age and household expenditure groups. CONCLUSIONS: The tobacco price increase in Japan had a significant impact on smoking cessation in both sexes, especially among heavy smokers, with no clear difference in effect by socio-demographic status.

'Only Fathers Smoking' Contributes the Most to Socioeconomic Inequalities: Changes in Socioeconomic Inequalities in Infants' Exposure to Second Hand Smoke over Time in Japan.

BACKGROUND: Exposure to second hand smoke (SHS) is one of the major causes of premature death and disease among children. While socioeconomic inequalities exist for adult smoking, such evidence is limited for SHS exposure in children. Thus, this study examined changes over time in socioeconomic inequalities in infants' SHS exposure in Japan. METHODS: This is a repeated cross-sectional study of 41,833 infants born in 2001 and 32,120 infants born in 2010 in Japan from nationally representative surveys using questionnaires. The prevalence of infants' SHS exposure was determined and related to household income and parental education level. The magnitudes of income and educational inequalities in infants' SHS exposure were estimated in 2001 and 2010 using both absolute and relative inequality indices. RESULTS: The prevalence of SHS exposure in infants declined from 2001 to 2010. The relative index of inequality increased from 0.85 (95% confidence interval [CI], 0.80 to 0.89) to 1.47 (95% CI, 1.37 to 1.56) based on income and from 1.22 (95% CI, 1.17 to 1.26) to 2.09 (95% CI, 2.00 to 2.17) based on education. In contrast, the slope index of inequality decreased from 30.9 (95% CI, 29.3 to 32.6) to 20.1 (95% CI, 18.7 to 21.5) based on income and from 44.6 (95% CI, 43.1 to 46.2) to 28.7 (95% CI, 27.3 to 30.0) based on education. Having only a father who smoked indoors was a major contributor to absolute income inequality in infants' SHS exposure in 2010, which increased in importance from 45.1% in 2001 to 67.0% in 2010. CONCLUSIONS: The socioeconomic inequalities in infants' second hand smoke exposure increased in relative terms but decreased in absolute terms from 2001 to 2010. Further efforts are needed to encourage parents to quit smoking and protect infants from second hand smoke exposure, especially in low socioeconomic households that include non-smoking mothers.

Difference in bias approach for commutability assessment: application to frozen pools of human serum measured by 8 direct methods for HDL and LDL cholesterol.

BACKGROUND: We used a difference in bias approach to evaluate the commutability of 4 frozen serum pools for 8 direct methods for measurement of HDL and LDL cholesterol (HDLC and LDLC). METHODS: Freshly collected nonfrozen sera from 138 diseased and 37 nondiseased patients and 4 frozen pools from the CDC Lipid Standardization Program were measured by direct methods and by the beta-quantification reference measurement procedure of the CDC. We used an error components model to estimate the difference in the bias component of error plus its uncertainty for frozen pools vs patient samples between the direct method and the reference procedure. Frozen pools with bias differences less than a critical value determined by either medical requirements for bias or the random error components of the measurement procedures were considered commutable. RESULTS: On the basis of medical requirement criteria, 1 of the 4 frozen pools was commutable for most of the HDLC methods for both diseased and nondiseased patients, and none was commutable for LDLC methods. On the basis of random error criteria, all of the frozen pools were generally commutable for all of the HDLC methods for both diseased and nondiseased patients, and 1 of the 4 frozen pools was generally commutable for most of the LDLC methods for both diseased and nondiseased patients. CONCLUSIONS: Commutability was assessed as the closeness of agreement of the difference in bias between a reference material and a set of patient samples. Criteria for commutability could be based on fixed medical requirements for bias or on random error components.

The economic effects of smoking restriction within casual dining chain restaurants in Japan.

OBJECTIVES: One of the popular casual dining chain restaurants running 255 outlets under the same brand name adopted the separation policy, mandating the differentiation of smoking and non-smoking zone in 2000. Following this, they started renovating the outlets' interiors because two thirds of them are dated. Going a step further, they have decided to implement stricter countermeasures against secondhand smoke. This includes the introduction of smoking prohibition outside the designated smoking room where foods are not served, and in some cases the separation of the smoking zone with glass walls and automatic doors. This study examined the economic effects of the smoking prohibition within a non-designated smoking zone of casual dining chain restaurants in Japan. METHODS: We selected 59 outlets that prohibited smoking outside of the designated smoking room (prohibition group), and 17 outlets that separated the smoking zone with glass walls and automatic doors (separation group), all of which were renovated during the same time period, that is, February to December 2009. We compared the relative change in monthly sales of each restaurant two years before the renovation (24~13 months, 12~1 months) and one year after the renovation (1~12 months) in order to exclude the effects of social economic regression and usual seasonal changes. Eighty-two outlets were not renovated during the observation period; hence, they were treated as the control group. For comparison purposes, the relative monthly sales of each outlet was collected and compared to the sales in January 2007, using a two-way repeated measures ANOVA and post-hoc analysis (Scheffé test) using SAS ver. 9.3. RESULTS: There was a significant difference among three groups across three different periods, P for group×time<0.0001. Relative sales of the prohibition group was significantly increased after the renovation (P<0.001); however, there was no significant increase in the relative sales of the separation group. CONCLUSION: Prohibition of smoking outside of the designated rooms in casual dining chain restaurants increased sales, while separation of the smoking zone did not.

[The effect of increasing tobacco tax on tobacco sales in Japan].

OBJECTIVES: Since the special tobacco tax was established in 1998, the tobacco tax and price of tobacco have increased thrice, in 2003, 2006, and 2010, respectively. We evaluated the effect of increases in tax on the consumption and sales of tobacco in Japan using the annual data on the number of tobacco products sold and the total sales from Japan Tobacco, Inc. METHODS: We applied the number of tobacco products sold and the total sales per year to a joinpoint regression model to examine the trends in the data. This model could help identify the year in which a decrease or increase was apparent from the data. In addition, we examined the effect of each tax increase while also considering other factors that may have caused a decrease in the levels of tobacco consumption using the method proposed by Hirano et al. RESULTS: According to the joinpoint regression analysis, the number of tobacco products sold started decreasing in 1998, and the trends of decrease accelerated to 5% per year, from 2005. Owing to the tax increase, tobacco sales reduced by -2.4%, -2.9%, and -10.1% (corrected for the effect of the Tohoku Great Earthquake), and price elasticity was estimated as -0.30, -0.27, and -0.28 (corrected) in 2003, 2006, and 2010, respectively. The effect of tobacco tax increase on the decrease in tobacco sales was greatest in 2010, while the price elasticity remained almost the same as it was during the previous tax increase. CONCLUSION: The sharp hike in tobacco tax in 2010 decreased the number of tobacco products sold, while the price elasticity in 2010 was similar to that in 2003 and 2006. Our findings suggest that further increase in tobacco tax is needed to reduce the damage caused by smoking in the people of Japan.

[Health insurance coverage for smoking cessation treatment in Japan: current status and future issues].

In Japan, nicotine dependence treatment service for outpatients at registered medical institutions has been started under health insurance coverage since 2006. The reimbursed treatment program consists of five treatment sessions over 12 week duration. Nicotine patch or varenicline can be prescribed under health insurance coverage during the treatment period. The surveys conducted in 2007 and 2009 have proved the effectiveness of the service. However, the accessibility and utilization of smoking cessation treatment are not sufficient, considering the fact that the percentage of smokers who underwent smoking cessation treatment in Japan remained low compared with other countries. Future challenges call for implementing effective measures to improve the accessibility and utilization of the service, while maintaining a satisfactory level of treatment quality.

Establishment of long-term monitoring system for blood chemistry data by the national health and nutrition survey in Japan.

AIM: We established a monitoring system for the annual follow-up of blood chemistry data obtained by the National Health and Nutrition Survey in Japan. METHODS: Blood chemistry testing has been entrusted to SRL Inc. We used two external quality control assurance programs established by the Japan Medical Association (JMA) and by CDC/CRMLN during the previous 8-year period. Ten analytes were measured: total cholesterol, HDL cholesterol, triglycerides, urea nitrogen, uric acid, creatinine, AST (GOT), ALT (GPT), gamma-GT (gamma-GTP), and glucose. Total error (TE) was calculated from accuracy by the JMA program and precision by internal quality control of SRL. The permissible range of TE values was determined to be 50% of the evaluation limit on one side in the evaluation criteria of the College of American Pathologists (CAP). When TE fell within the permissible range, the follow-up of annual changes was considered possible. RESULTS: Annual follow-up of blood chemistry data was considered possible for all the analytes except urea nitrogen. Based on this study, new permissible TE ranges are proposed. CONCLUSION: We confirmed the functioning of the monitoring system for the annual follow-up of blood chemistry data obtained by the National Health and Nutrition Survey in Japan.

Effectiveness of a low-intensity intra-worksite intervention on smoking cessation in Japanese employees: a three-year intervention trial.

To test the effectiveness of a low-intensity intervention program for smoking cessation targeting the worksite environment in employees who had a low readiness to quit, we conducted an intervention trial at six intervention and six control worksites in Japan. A total of 2,307 smokers at baseline who remained at their worksite throughout the three-year study period were analyzed (1,017 in intervention and 1,290 in control groups). The multi-component program at the worksites consisted of (1) presenting information on the harms of tobacco smoking and the benefits of cessation by posters, websites, and newsletters; (2) smoking cessation campaigns for smokers; (3) advice on designation of smoking areas; and (4) periodic site-visits of the designated smoking areas by an expert researcher. At baseline, the intervention and control groups each had high prevalence of immotive or precontemplation, that reflected low readiness to quit (71.5% and 73.2%, respectively). The smoking cessation rate, as not having smoked for the preceding six months or longer, assessed at 36 months after the baseline survey by a self-administered questionnaire was significantly higher in the intervention group than the control group (12.1%, vs. 9.4%, p=0.021). The intervention program still had a significant effect on the smoking cessation rate after multiple logistic regression analysis adjusted for sex, age, type of occupation, age of starting smoking, quit attempts in the past, number of cigarettes per day, and readiness to quit (odds ratio: 1.38, 95% confidence interval: 1.05-1.81, p=0.02). The cost per additional quitter due to the intervention was calculated to be Yen 70,080. These findings indicate that this program is effective and can be implemented in similar workplaces where the prevalence of smoking is high and smokers' readiness to cease smoking is low.