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Study DesignTwo-year, prospective cohort data from the Japan epidemiological research of occupation-related back pain study in urban settings were used for this analysis.ObjectiveTo examine the association between aggravated low back pain and psychosocial factors among Japanese workers with mild low back pain.Summary of Background DataAlthough psychosocial factors are strongly indicated as yellow flags of low back pain (LBP) leading to disability, the association between aggravated LBP and psychosocial factors has not been well assessed in Japanese workers.MethodsAt baseline, 5,310 participants responded to a self-administered questionnaire including questions about individual characteristics, ergonomic work demands, and work-related psychosocial factors (response rate: 86.5%), with 3,811 respondents completing the 1-year follow-up questionnaire. The target outcome was aggravation of mild LBP into persistent LBP during the follow-up period. Incidence was calculated for the participants with mild LBP during the past year at baseline. Logistic regression was used to explore risk factors associated with persistent LBP.ResultsOf 1,675 participants who had mild LBP during the preceding year, 43 (2.6%) developed persistent LBP during the follow-up year. Multivariate analyses adjusted for individual factors and an ergonomic factor found statistically significant or almost significant associations of the following psychosocial factors with persistent LBP: interpersonal stress at work [adjusted odds ratio (OR): 1.96 and 95% confidence interval (95%CI): 1.00–3.82], job satisfaction (OR: 2.34, 95%CI: 1.21–4.54), depression (OR: 1.92, 95%CI: 1.00–3.69), somatic symptoms (OR: 2.78, 95%CI: 1.44–5.40), support from supervisors (OR: 2.01, 95%CI: 1.05–3.85), previous sick-leave due to LBP (OR: 1.94, 95%CI: 0.98–3.86) and family history of LBP with disability (OR: 1.98, 95%CI: 1.04–3.78).ConclusionsPsychosocial factors are important risk factors for persistent LBP in urban Japanese workers. It may be necessary to take psychosocial factors into account, along with physical work demands, to reduce LBP related disability.

In Japan, an increasing interest in real-world evidence for hypothesis generation and decision-making has emerged in order to overcome limitations and restrictions of clinical trials. We sought to characterize the context and concrete considerations of when to use Medical Data Vision (MDV) and JMDC databases, the main Japanese real-world data (RWD) sources accessible by pharmaceutical companies. Use cases for these databases, and related issues and considerations, were identified and summarized based on a literature search and experience-based knowledge. Studies conducted using MDV or JMDC were mostly descriptive in nature, or explored potential risk factors by evaluating associations with a target outcome. Considerations such as variable ascertainment at different time points, including issues relating to treatment identification and missing data, were highlighted for these two databases. Although several issues were commonly shared (e.g., only month of event occurrence reported), some database-specific issues were also identified and need to be accounted for. In conclusion, MDV and JMDC present limitations that are relatively typical of RWD sources, though some of them are unique to Japan, such as the identification of event occurrence and the inability to track patients visiting different healthcare settings. Addressing study design and careful result interpretation with respect to the specificities and uniqueness of the Japanese healthcare system is of particular importance. This aspect is especially relevant with respect to the growing global interest of conducting RWD studies in Japan.

To investigate the associations between psychosocial factors and the development of chronic disabling low back pain (LBP) in Japanese workers. A 1 yr prospective cohort of the Japan Epidemiological Research of Occupation-related Back Pain (JOB) study was used. The participants were office workers, nurses, sales/marketing personnel, and manufacturing engineers. Self-administered questionnaires were distributed twice: at baseline and 1 yr after baseline. The outcome of interest was the development of chronic disabling LBP during the 1 yr follow-up period. Incidence was calculated for the participants who experienced disabling LBP during the month prior to baseline. Logistic regression was used to assess risk factors for chronic disabling LBP. Of 5,310 participants responding at baseline (response rate: 86.5%), 3,811 completed the questionnaire at follow-up. Among 171 eligible participants who experienced disabling back pain during the month prior to baseline, 29 (17.0%) developed chronic disabling LBP during the follow-up period. Multivariate logistic regression analysis implied reward to work (not feeling rewarded, OR: 3.62, 95%CI: 1.17–11.19), anxiety (anxious, OR: 2.89, 95%CI: 0.97–8.57), and daily-life satisfaction (not satisfied, ORs: 4.14, 95%CI: 1.18–14.58) were significant. Psychosocial factors are key to the development of chronic disabling LBP in Japanese workers. Psychosocial interventions may reduce the impact of LBP in the workplace.

Both ergonomic and work-related psychosocial factors may predict the development of LBP with disability among previously asymptomatic Japanese workers. Thus, workplace interventions aimed at reducing the incidence of LBP should focus on both ergonomic and psychosocial stress.