A feasibility study of provider-level implementation strategies to improve access to colorectal cancer screening for patients with schizophrenia: ACCESS2 (N-EQUITY 2104) trial.

BACKGROUND: People with schizophrenia have a lower colorectal screening rate than the general population. A previous study reported an intervention using case management to encourage colorectal cancer screening for patients with schizophrenia in psychiatric outpatient settings. In this feasibility study, we developed provider-level implementation strategies and evaluated the feasibility of conducting a definitive trial in terms of the penetration of the intervention assessed at the patient level. Additionally, we examined the fidelity of strategies to implement the intervention at the provider level in a routine clinical psychiatric setting. METHODS: This was a multicenter, single-arm feasibility study with medical staff at psychiatric hospitals in Japan. The provider-level implementation strategies developed in this study included three key elements (organizing an implementation team appointed by the facility director, interactive assistance using a clear guide that outlines who in the hospital should do what, and developing accessible educational materials) to overcome major barriers to implementation of the intervention and four additional elements (progress monitoring, joint meetings and information sharing among participating sites, adaptation of encouragement methods to specific contexts, and education of on-site staff), with reference to the elements identified in the Expert Recommendations for Implementing Change (ERIC). The feasibility of the strategies was evaluated by the proportion of patients who were eligible for encouragement (patients with schizophrenia aged 40, 50, or 60) who received encouragement. We set the goal of providing encouragement to at least 40% of eligible patients at each site. RESULTS: Two public and four private psychiatric hospitals in Okayama and Shimane prefectures participated in this study. Regarding fidelity, all elements of the strategies were conducted as planned. Following the procedures in the guide, each team prepared and provided encouragement according to their own facility and region. Penetration, defined as the proportion of eligible patients who received encouragement, ranged from 33.3 to 100%; five of the six facilities achieved the target proportion. CONCLUSIONS: The provider-level implementation strategies to implement encouragement were feasible in terms of penetration of the intervention assessed at the patient level. The results support the feasibility of proceeding with a future definitive trial of these strategies. TRIAL REGISTRATION: jRCT, jRCT1060220026 . Registered on 06/04/2022.

Smoking cessation interventions and implementations across multiple settings in Japan: a scoping review and supplemental survey.

BACKGROUND: Smoking is the leading risk factor for death worldwide. In Japan, although several evidence-based interventions (EBIs) for smoking cessation have been disseminated or adopted, there is a gap between scientific evidence and the actual implementation. This scoping review aimed to describe the knowledge gaps in local-level smoking cessation interventions in Japan, their implementation outcomes, implementation barriers and facilitators, and the use of implementation strategies. METHODS: This study comprised two approaches: (1) a comprehensive scoping review of primary and grey literature, and (2) a supplemental survey of organizations in the grey literature. For the scoping review, we included original studies or reports on smoking cessation interventions targeting adults aged 18 years and older, or providers of cessation support at various settings (community, workplace, school, and clinical settings) in Japan. The extracted data included basic characteristics, intervention categories, implementation outcomes, factors influencing implementation, and implementation strategies for each intervention. Responses to the supplemental survey were extracted same used for the scoping review. To gain a deeper understanding, semi-structured interviews were conducted with some of the organizations in the survey. RESULTS: A total of 600 interventions with 691 intervention components, based on EBIs in the 2020 US Surgeon General Report, from 498 articles were included in the data extraction; 32 of the 88 organizations responded to the survey. Regarding the overall knowledge about smoking cessation intervention components, behavioral counseling, and cessation medication in clinical settings were mostly reported (34.7%). Implementation outcomes were measured in 18 articles (3.0%) and penetration was mostly reported. Regarding influential factors, "available resources," and "knowledge and beliefs about the intervention" for barriers, and "relative priority" for facilitators were mostly reported. Implementation strategies were measured in 29 articles (4.8%), and "Train and educate stakeholders" was mostly reported. CONCLUSIONS: Most EBIs reported in the Japanese literature included smoking cessation treatments in clinical settings. While a few articles focused on the implementation indicators in Japan, significant knowledge and experience were extracted from the grey literature, especially in the workplace and community settings. Future research should focus more on implementation to reduce the knowledge gap regarding smoking cessation interventions.

Age, gender and socioeconomic disparities in human papillomavirus (HPV) awareness and knowledge among Japanese adults after a 7-year suspension of proactive recommendation for the HPV vaccine: A nationally representative cross-sectional survey.

The Japanese government's 2013 suspension of its proactive recommendation for Human papillomavirus (HPV) vaccination resulted in low HPV vaccination coverage and was unique. However, data on awareness and knowledge of HPV vaccines in the general population was limited. Here, to investigate more recent awareness and knowledge of HPV vaccines by age, gender, and socioeconomic status, we used data from the INFORM Study 2020, a nationally representative cross-sectional survey of self-administered questionnaires with 1,998 Japanese individuals aged 20 to 59 years. We found that 47.5% of females and 21.0% of males had heard of HPV, and 33.6% of females and 16.8% of males had knowledge of HPV vaccine efficacy. After adjusting for potential confounders, females aged 50-54 years were more likely to be aware of HPV than females aged 20-24 (AOR, 2.02, 95%CI: 1.12-3.65). Females (AOR, 2.13, 95%CI: 1.48-3.07) and males (AOR, 1.64, 95%CI: 1.03-2.59) with higher education had more awareness than those with less education. Females with higher education had more knowledge about HPV vaccine efficacy than those with less education (AOR, 1.70; 95%CI: 1.16-2.50). We found a generally low level of awareness and knowledge about HPV vaccines in Japan, which might be attributable to the suspension of proactive recommendations. Additionally, we identified disparities in awareness and knowledge by age, gender, socioeconomic status, and health literacy. Enhancing HPV awareness and understanding of HPV vaccines and implementing targeted efforts for specific subpopulations within Japan after the resumption of proactive recommendation for HPV vaccines, are imperative.

Barriers and facilitators to implementing geriatric assessment in daily oncology practice in Japan: A qualitative study using an implementation framework.

INTRODUCTION: Various guidelines recommend geriatric assessment (GA) for older adults with cancer, but it is not widely implemented in daily practice. This study uses an implementation framework to comprehensively and systematically identify multi-level barriers and facilitators to implementing GA in daily oncology practice. MATERIALS AND METHODS: We conducted 16 semi-structured interviews with healthcare providers in 10 designated cancer hospitals in Japan, using purposive and convenience sampling. The Consolidated Framework for Implementation Research (CFIR) was used to guide collection and analysis of interview data following a deductive content analysis approach with consensual qualitative research methods. After coding the interview data, ratings were assigned to each CFIR construct for each case, reflecting the valence and strength of each construct relative to implementation success. Then, those constructs that appeared to distinguish between high-implementation hospitals (HI) where GA is routinely performed in daily practice and low-implementation hospitals (LI) where GA is performed only for research purposes or not at all were explored. RESULTS: Of the 24 CFIR constructs assessed in the interviews, 15 strongly distinguished between HI and LI. In HI, GA was self-administered (Adaptability), or administered via a mobile app with interpretation (Design Quality and Packaging). In HI, healthcare providers were strongly aware of the urgent need to change practice for older adults (Tension for Change) and recognized that GA was compatible with existing workflow as part of their jobs (Compatibility), whereas in LI, they did not realize the need to change practice, and dismissed GA as an extra burden on their heavy workload. In HI, usefulness of GA was widely recognized by healthcare providers (Knowledge & Beliefs about the Intervention), GA had a high priority (Relative Priority) and had strong support from hospital directors, managers, and nursing chiefs (Leadership Engagement), and multiple stakeholders were successfully engaged, including nurses (Key Stakeholders), peer doctors (Opinion Leaders), and those who drive implementation of GA (Champions). DISCUSSION: These findings suggest that successful implementation of GA should focus on not only individual beliefs about the usefulness of GA and the complexity of GA itself, but also organizational factors related to hospitals and the engagement of multiple stakeholders.

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.

Effects of work-family life support program on the work-family interface and mental health among Japanese dual-earner couples with a preschool child: A randomized controlled trial.

OBJECTIVES: This study examined the effectiveness of a newly developed work-family life support program on the work-family interface and mental health indicators among Japanese dual-earner couples with a preschool child(/ren) using a randomized controlled trial with a waitlist. METHODS: Participants who met the inclusion criteria were randomly allocated to the intervention or the control groups (n = 79 and n = 85, respectively). The program comprised two 3-h sessions with a 1-month interval between them and provided comprehensive skills by including self-management, couple management, and parenting management components. The program sessions were conducted on weekends in a community center room with 3-10 participants. Outcomes were assessed at baseline, 1-month, and 3-month follow-ups. Primary outcomes were work-family balance self-efficacy (WFBSE), four types of work-family spillovers (i.e., work-to-family conflict, family-to-work conflict, work-to-family facilitation, and family-to-work facilitation), psychological distress, and work engagement reported by the participants. RESULTS: The program had significantly pooled intervention effects on WFBSE (P = .031) and psychological distress (P = .014). The effect sizes (Cohen's d) were small, with values of 0.22 at the 1-month follow-up and 0.24 at the 3-month follow-up for WFBSE, and -0.36 at the 3-month follow-up for psychological distress. However, the program had nonsignificant pooled effects on four types of work-family spillovers and work engagement. CONCLUSIONS: The program effectively increased WFBSE and decreased psychological distress among Japanese dual-earner couples with a preschool child(/ren).

Using implementation mapping to develop strategies for preventing non-communicable diseases in Japanese small- and medium-sized enterprises.

Introduction: Workplace programs to prevent non-communicable diseases (NCDs) in the workplace can help prevent the incidence of chronic diseases among employees, provide health benefits, and reduce the risk of financial loss. Nevertheless, these programs are not fully implemented, particularly in small- and medium-sized enterprises (SMEs). The purpose of this study was to develop implementation strategies for health promotion activities to prevent NCDs in Japanese SMEs using Implementation Mapping (IM) to present the process in a systematic, transparent, and replicable manner. Methods: Qualitative methods using interviews and focus group discussions with 15 SMEs and 20 public health nurses were conducted in a previous study. This study applied the Consolidated Framework for Implementation Research and IM to analyze this dataset to develop implementation strategies suitable for SMEs in Japan. Results: In task 2 of the IM, we identified performance objectives, determinants, and change objectives for each implementation stage: adoption, implementation, and maintenance; to identify the required actors and actions necessary to enhance implementation effectiveness. Twenty-two performance objectives were identified in each implementation stage. In task 3 of the IM, the planning group matched behavioral change methods (e.g., modeling and setting of graded tasks, framing, self-re-evaluation, and environmental re-evaluation) with determinants to address the performance objectives. We used a consolidated framework for implementation research to select the optimal behavioral change technique for performance objectives and determinants and designed a practical application. The planning team agreed on the inclusion of sixteen strategies from the final strategies list compiled and presented to it for consensus, for the overall implementation plan design. Discussion: This paper provides the implementation strategies for NCDs prevention for SMEs in Japan following an IM protocol. Although the identified implementation strategies might not be generalizable to all SMEs planning implementation of health promotion activities, because they were tailored to contextual factors identified in a formative research. However, identified performance objectives and implementation strategies can help direct the next steps in launching preventive programs against NCDs in SMEs.

Factors affecting the implementation of guideline-based prophylactic antiemetic therapy for chemotherapy-induced nausea and vomiting in Japan: a protocol for a hospital-based qualitative study.

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) decrease patients' quality of life and negatively impact treatment outcomes. Although standard prophylactic antiemetic therapy for acute CINV recommended by guidelines is effective, poor guideline implementation is a worldwide problem. In Japan, prophylactic antiemetic therapy is relatively well implemented for chemotherapy associated with high emetogenic risk, while implementation gaps are observed for that with low emetogenic risk.Although most reports on factors influencing appropriate antiemetic prescription focus on physicians' attitudes and behaviours, a more comprehensive exploration is needed since chemotherapy is expected to involve pharmacists, nurses and eventually hospital directors. The purpose of this qualitative study is to comprehensively explore the factors that influence the implementation of appropriate prophylactic antiemetic procedures at cancer care hospitals in Japan. METHODS AND ANALYSIS: This study is a hospital-based qualitative study using semistructured individual interviews. The target population will be hospital directors, and chiefs (including proxies) of departments of oncology and/or chemotherapy, pharmacy and nursing, working in the hospitals, selected by purposive sampling. We will obtain information on antiemetics in chemotherapy regimens, antiemetic routine use and awareness of guidelines using prequestionnaires. Interviews will then be conducted online using an interview guide. The Consolidated Framework for Implementation Research will be used to collect and analyse the interview data. We will also create new codes inductively, as required. In addition, we will refer to the aggregate results of the Quality Indicator survey to determine the implementation of recommended antiemetic prescriptions for each hospital and discuss the relationship with influencing factors. ETHICS AND DISSEMINATION: This study has been approved by the National Cancer Centre Ethics Approval Committee (approval number: 2020-305). The study findings will be disseminated via peer-reviewed journal publications and presentations to academics, policy-makers, and clinicians at scientific conferences.

Barriers and facilitative factors in the implementation of workplace health promotion activities in small and medium-sized enterprises: a qualitative study.

BACKGROUND: There is an immense difference between large companies and small and medium-sized enterprises (SMEs) in implementation of evidence-based interventions (EBIs). Previous literature reveals various barriers that SMEs face during implementation, such as a lack of time, accessibility, and resources. However, few studies have comprehensively examined those influential factors at multi-levels. This study aims to identify the factors influencing the implementation of non-communicable disease prevention activities (tobacco, alcohol, diet, physical activity, and health check-up) in SMEs using Consolidated Framework for Implementation Research (CFIR). METHODS: We conducted 15 semi-structured interviews with health managers and/or employers in 15 enterprises with less than 300 employees, and four focus groups among public health nurses/nutritionists of health insurers who support SMEs in four prefectures across Japan. A qualitative content analysis by a deductive directed approach was performed. After coding the interview transcript text into the CFIR framework constructs by two independent researchers, the coding results were compared and revised in each enterprise until an agreement was reached. RESULTS: Of the 39 CFIR constructs, 25 were facilitative and 7 were inhibitory for workplace health promotion implementation in SMEs, which were across individual, internal, and external levels. In particular, the leadership engagement of employers in implementing the workplace health promotion activities was identified as a fundamental factor which may influence other facilitators, including "access to knowledge and information," "relative priority," "learning climate," at organizational level, and "self-efficacy" at the health manager level. The main barrier was the beliefs held by the employer/manager that "health management is one's own responsibility." CONCLUSIONS: Multi-level factors influencing the implementation of non-communicable diseases prevention activities in SMEs were identified. In resource-poor settings, strong endorsement and support, and positive feedback from employers would be important for health managers and employees to be highly motivated and promote or participate in health promotion. Future studies are needed to develop context-specific strategies based on identified barriers and facilitative factors, and empirically evaluate them, which would contribute to narrowing the differences in worksite health promotion implementation by company size.

Smoking cessation interventions and implementations in Japan: a study protocol for a scoping review and supplemental survey.

INTRODUCTION: Despite various tobacco control measures in Japan, smoking remains a leading cause of mortality. This manuscript outlines proposed methodology for scoping review that aims to describe the knowledge gaps for local-level smoking cessation interventions in Japan, their implementation barriers and facilitators, and the use of implementation strategies. METHODS AND ANALYSIS: A scoping review will be conducted using the updated guidelines of Preferred Reporting Items for Systematic Reviews and Meta-Analyses-extension for Scoping Reviews to systematically search peer-reviewed journal articles and grey literature to identify studies on smoking cessation interventions in Japan. The six-stage scoping review model will involve (1) identifying the research question; (2) identifying relevant studies; (3) selecting studies; (4) charting data; (5) collating, summarising and reporting the results; and (6) consultation exercise. Since there is little information available on the implementation context in the literature, we will use grey literature to identify organisations implementing smoking cessation interventions and conduct a cross-sectional survey among them to supplement the information gap. Based on a literature review, findings will be organised on smoking cessation interventions in local settings (ie, communities, workplaces, schools and hospitals) at the population, provider and individual levels in Japan to understand knowledge gaps. We will adopt the consolidated framework for implementation research to identify implementation barriers and facilitators, and the expert recommendations for implementing change to identify implementation strategies. ETHICS AND DISSEMINATION: This study does not require ethical committee approval. The scoping review method will be robust in searching available smoking cessation interventions in Japan. The findings of this study will be compiled as case studies of best practices on smoking cessation interventions and disseminated to relevant stakeholders at the public and private levels through publications, presentations in conferences and stakeholder meetings.

Effectiveness of a Cancer Risk Prediction Tool on Lifestyle Habits: A Randomized Controlled Trial.

BACKGROUND: Risk prediction models offer a promising approach to lifestyle modification. We evaluated the effect of personalized advice based on cancer risk prediction in improving five lifestyle habits (smoking, alcohol consumption, salt intake, physical activity, and body mass index) compared with standard advice without risk prediction among a Japanese general population with at least one unhealthy lifestyle habit. METHODS: In a parallel-design, single-blind, randomized controlled trial between February 2018 and July 2019, 5984 participants aged 40-64 years with unhealthy lifestyle habits were recruited from persons covered under a life insurance policy. They were randomly assigned to an intervention or control group and received personalized or standard advice, respectively. They were also sent an invitation to participate in a lifestyle modification program aimed at improving lifestyle. Primary outcome was an improvement in lifestyle, defined as an increase in healthy lifestyle habits within 6 months. RESULTS: The proportion of participants who improved their lifestyle within 6 months in the intervention group did not significantly differ from that in the control group (18.4% vs. 17.7%; P = 0.488). Among participants with low health literacy and two or fewer of five healthy habits, the proportion of participants subscribing to the lifestyle modification program was higher in the intervention group than in the control group. CONCLUSIONS: Compared with standardized advice, personalized advice based on cancer risk prediction had no effect on improving lifestyle. IMPACT: Provision of predicted cancer risk information did not induce change in unhealthy lifestyle.

Real-Time Assessment of the Effect of Biofeedback Therapy with Migraine: A Pilot Study.

BACKGROUND: Biofeedback therapy has been reported to be effective in the treatment of migraine. However, previous studies have assessed its effectiveness using paper-and-pencil diaries, which are not very reliable. PURPOSE: The objective of the present pilot study was to investigate the feasibility of using computerized ecological momentary assessment (EMA) for evaluating the efficacy of BF treatment for migraine in a randomized controlled trial. METHOD: The subjects comprised one male and 26 female patients with migraine. They were randomly assigned to either biofeedback or wait-list control groups. Patients were asked to carry a palmtop-type computer to record momentary symptoms for 4 weeks before and after biofeedback treatment. The primary outcome measure was headache intensity. The secondary outcome measures included psychological stress, anxiety, irritation, headache-related disability and the frequency (number of days per month) of migraine attack and of headache of at least moderate intensity (pain rating ≥50). RESULTS: Headache intensity showed significant main effects of period (before vs. after therapy, p = 0.02) and group (biofeedback vs. control groups, p = 0.42) and a significant period × group interaction (p < 0.001). Biofeedback reduced the duration of headaches by 1.9 days, and the frequency of days when headache intensity was ≥50 by 2.4 times. In addition, headache-related disability, psychological stress, depression, anxiety, and irritation were significantly improved. CONCLUSION: The present study used computerized EMA to show that biofeedback could improve the symptoms of migraine, including psychological stress and headache-related disability.