Handling missing data in an FFQ: multiple imputation and nutrient intake estimates.

OBJECTIVE: We aimed to examine missing data in FFQ and to assess the effects on estimating dietary intake by comparing between multiple imputation and zero imputation. DESIGN: We used data from the Okazaki Japan Multi-Institutional Collaborative Cohort (J-MICC) study. A self-administered questionnaire including an FFQ was implemented at baseline (FFQ1) and 5-year follow-up (FFQ2). Missing values in FFQ2 were replaced by corresponding FFQ1 values, multiple imputation and zero imputation. SETTING: A methodological sub-study of the Okazaki J-MICC study.ParticipantsOf a total of 7585 men and women aged 35-79 years at baseline, we analysed data for 5120 participants who answered all items in FFQ1 and at least 50% of items in FFQ2. RESULTS: Among 5120 participants, the proportion of missing data was 3·7%. The increasing number of missing food items in FFQ2 varied with personal characteristics. Missing food items not eaten often in FFQ2 were likely to represent zero intake in FFQ1. Most food items showed that the observed proportion of zero intake was likely to be similar to the probability that the missing value is zero intake. Compared with FFQ1 values, multiple imputation had smaller differences of total energy and nutrient estimates, except for alcohol, than zero imputation. CONCLUSIONS: Our results indicate that missing values due to zero intake, namely missing not at random, in FFQ can be predicted reasonably well from observed data. Multiple imputation performed better than zero imputation for most nutrients and may be applied to FFQ data when missing is low.

Assessment of potential risk factors for new onset disabling low back pain in Japanese workers: findings from the CUPID (cultural and psychosocial influences on disability) study.

BACKGROUND: Most studies of risk factors for new low back pain (LBP) have been conducted in Western populations, but because of cultural and environmental differences, the impact of causal factors may not be the same in other countries. We used longitudinal data from the Cultural and Psychosocial Influences on Disability (CUPID) study to assess risk factors for new onset of disabling LBP among Japanese workers. METHODS: Data came from a 1-year prospective follow-up of nurses, office workers, sales/marketing personnel, and transportation workers, initially aged 20-59 years, who were employed in or near Tokyo. A baseline questionnaire included items on past history of LBP, personal characteristics, ergonomic work demands, and work-related psychosocial factors. Further information about LBP was collected at follow-up. Analysis was restricted to participants who had been free from LBP during the 12 months before baseline. Logistic regression was used to assess baseline risk factors for new onset of disabling LBP (i.e. LBP that had interfered with work) during the 12 months of follow-up. RESULTS: Among 955 participants free from LBP during the 12 months before baseline, 58 (6.1%) reported a new episode of disabling LBP during the 12-month follow-up period. After mutual adjustment in a multivariate logistic regression analysis, which included the four factors that showed associations individually (p < 0.1) in analyses adjusted only for gender and age, the highest odds ratio (OR) was for past history of LBP (2.8, 95% [confidence interval {CI}]: 1.6-4.9), followed by working ≥60 h per week (1.8, 95% CI: 1.0-3.5) and lifting weights ≥25 kg by hand (1.6, 95% CI: 0.9-3.0). When past history of LBP was excluded from the model, ORs for the remaining risk factors were virtually unchanged. CONCLUSIONS: Our findings suggest that among Japanese workers, as elsewhere, past history of LBP is a major risk factor for the development of new episodes of disabling back pain. They give limited support to the association with occupational lifting that has been observed in earlier research, both in Japan and in Western countries. In addition, they suggest a possible role of long working hours, which merits further investigation.

Development of the Japanese Version of the Leeds Assessment of the Neuropathic Symptoms and Signs Pain Scale: Diagnostic Utility in a Clinical Setting.

OBJECTIVE: We aimed to assess the diagnostic utility of the linguistically validated Japanese version of the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS-J) as a screening tool for neuropathic pain in the clinical setting. METHODS: Patients with neuropathic pain or nociceptive pain who were 20 to 85 years of age were included. Sensitivity and specificity using the original cutoff value of 12 were assessed to evaluate the diagnostic utility of the LANSS-J. Sensitivity and specificity with possible cutoff values were calculated, along with area under the receiver operating characteristic curve. We then evaluated agreement regarding assessment of the LANSS-J by two investigators. We used the intraclass correlation coefficient (ICC) for the total score and Cohen's kappa coefficient for each item. RESULTS: Data for patients with neuropathic pain (n = 30) and those with nociceptive pain (n = 29) were analyzed. With a cutoff of 12, the sensitivity was 63.3% (19/30) and the specificity 93.1% (27/29). Sensitivity improved substantially with a cutoff of ≤ 11 (≥ 83.3%, 25/30). High specificity (93.1%, 27/29) was sustained with a cutoff of 9 to 12. The ICC for the total score was 0.85, indicating sufficient agreement. Kappa coefficients ranged from 0.68 to 0.84. CONCLUSIONS: The LANSS-J is a valid screening tool for detecting neuropathic pain. Our results suggest that employing the original cutoff value provides high specificity, although a lower cutoff value of 10 or 11 (with its high specificity maintained) may be more beneficial when pain attributed to neuropathic mechanisms is suspected in Japanese patients.

Can standing back extension exercise improve or prevent low back pain in Japanese care workers?

BACKGROUND: We suggested a standing back extension exercise 'One Stretch' based on the McKenzie method, to examine the ability to improve or prevent low back pain (LBP) in Japanese care workers. METHODS: We conducted a single-center, non-randomized, controlled study in Japan. Care workers in an intervention group received an exercise manual and a 30-minute seminar on LBP and were encouraged with a group approach, while care workers in a control group were given only the manual. All care workers answered questionnaires at the baseline and end of a 1-year study period. The subjective improvement of LBP and compliance with the exercise were evaluated. RESULTS: In all, 64 workers in the intervention group and 72 in the control group participated in this study. More care workers in the intervention group exercised regularly and improved or prevented LBP than in the control group (P = 0·003 and P<0·0001, respectively). In the intervention group, none had a first medical consultation or were absent from disability for LBP by the end of the study period. CONCLUSION: The exercise 'One Stretch' would be effective to improve or prevent LBP in care workers. Our group approach would lead to better compliance with the exercise.

Psychometric properties of the Japanese version of the Fear-Avoidance Beliefs Questionnaire (FABQ).

BACKGROUND: The Fear-Avoidance Beliefs Questionnaire (FABQ) is useful for measuring fear-avoidance beliefs in patients with low back pain (LBP); however, no psychometrically validated Japanese version is available. The objective of this study was to evaluate reliability and validity of the Japanese version of the FABQ for use with Japanese workers with LBP. METHODS: This was conducted as a web-based survey. Both confirmatory and exploratory factor analysis were performed to examine domain structure of the Japanese version of the FABQ. For reliability, internal consistency was assessed with Cronbach's alpha coefficient. For concurrent validity, correlation coefficients between the FABQ and the Pain Catastrophizing Scale (PCS) were calculated. For known-group validity, the relationship between FABQ score and clinical variables such as pain and depression was examined. RESULTS: Analyses were based on responses of 1,786 adult Japanese workers with LBP. Factor analysis using the principal factor method with promax rotation revealed two factors, work and physical activity, in accordance with the domain structure of the original version of the scale. For reliability, acceptable internal consistency was demonstrated with Cronbach's alpha coefficient of 0.882 and 0.783 for each subscale. For concurrent validity, significantly moderate correlations were demonstrated between FABQ subscales and PCS subscales (r = 0.30-0.39). For known-group validity, as hypothesized, significantly higher FABQ subscale scores were observed in workers who had stronger pain, who experienced routine work disability with sick leave, who experienced recurrence of LBP, and who had depressed mood. CONCLUSIONS: This analysis showed that the Japanese version of the FABQ is psychometrically reliable and valid to detect fear-avoidance beliefs in Japanese workers with LBP.

[Risk factors for low back pain and katakori: a new concept].

Low back pain (LBP) is a common musculoskeletal health problem in industrialized countries and one of the worst leading specific causes of years lived with disability. We conducted a cohort study specifically targeting Japanese workers. Results suggest that psychosocial factors such as low job satisfaction, little social support, depression, and somatization are important risk factors for aggravating LBP and are consistent with foreign studies despite cultural differences. Additionally, neck and shoulder discomfort ("katakori" in Japanese) is common among Japanese adults, especially females. Psychosocial stress is likely to trigger brain dysfunction, leading to depression and somatization. Our data suggests a new concept of LBP and "katakori" as a form of somatization, possibly derived from psychological stress.

Validity, reliability and responsiveness of the Japanese version of the Neck Disability Index.

BACKGROUND: The Neck Disability Index (NDI) is one of the most widely used questionnaires for neck pain. The purpose of this study was to validate the Japanese NDI. METHODS: We performed two surveys with an 8-week interval in 130 patients with neck pain, radiculopathy and myelopathy. We asked patients to answer two versions of the Japanese NDI: the original NDI, which had been completed by a forward-backward translation procedure, and the modified NDI, which has the phrase "because of neck pain" to the phase "because of neck pain or numbness in the arm." The other parameters examined were the strength of pain and numbness, the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire, the Hospital Anxiety and Depression Scale, and Short Form 36. Attending surgeons judged the symptom severity. Patients were asked to report the patient global impression of change (PGIC) at the second survey. The internal consistency, criterion-related and discriminative validity, and reliability were evaluated. RESULTS: The original NDI and the modified NDI were 26.9 ± 17.1 and 29.9 ± 15.5, respectively. The Cronbach α values of the original NDI and the modified NDI were 0.92 and 0.89, respectively. Both versions of the NDI had good to excellent correlative coefficients with the related domains. The modified NDI had a higher validity for numbness and mental health-related QOL. The symptom severity was significantly correlated with the modified NDI. The intraclass correlation coefficients of the two surveys of the modified and original NDI were comparable. The effect sizes of the modified and the original NDI were 0.64 and 0.55, respectively. Spearman's ρ between the change of the NDI and the PGIC was 0.47 in the original NDI and 0.59 in the modified NDI. CONCLUSIONS: We demonstrated the validity, reliability and responsiveness of the Japanese NDI. The modified NDI was more strongly correlated with numbness and mental health-related QOL.

Exploring Changes in Attitudes, Behaviors, and Self-Measured Health Data Through Lifestyle Modification Support by Community Pharmacists: Suito-Ogaki Selfcare (SOS) Trial.

Purpose: Contributing to public health by supporting people's health is the social mission of community pharmacists. This multicenter, prospective case series study aimed to evaluate changes in people's behavior and health states through community pharmacists' self-care support for healthy lifestyles. Methods: The participants were recruited from voluntary adults aged ≥20 years who agreed to participate in the study, at community pharmacies in Gifu, Japan, between June and September 2021. Participants self-managed their lifestyles for six months while recording their health data, including blood pressure (BP), daily using devices (home BP monitor, body composition monitor, and activity meter) and a diet-recording app. They received lifestyle modification support at pharmacies at least once per month. Participants' subjective health status, attitudes, and behavioral changes were evaluated using self-report questionnaires. Due to the exploratory nature of this study, data were primarily analyzed descriptively. Results: Fifty-four participants aged 20 to 77 (mean age: 49.6 years; female participant proportion: 55.6%) participated in this study. Their mean weekly BP shifted almost horizontally from baseline to week 24 (systolic BP: 118.8 to 121.5 mmHg; diastolic BP: 76.1 to 77.5 mmHg). At six months, 38.9% and 35.2% of the participants reported better overall health and mental health, respectively, than at baseline. Over 85% of the participants became more proactive in improving their lifestyles regarding salt intake, diet, weight loss, and exercise, although drinking and smoking habits were more challenging to change. All the participants reported that they intended to continue to improve their lifestyle. Conclusion: The participants' responses suggested that community pharmacists' support helped increase participants' health awareness and promote their health-enhancing behaviors. However, its impact on health parameters should be further examined in future studies. More vigorous, tailored self-care support may be worth considering in developing a more effective, community-fitted health/well-being support system in Japan.

Effect of donepezil for dementia prevention in Parkinson's disease with severe hyposmia (The DASH-PD study): A randomized long-term placebo-controlled trial.

Background: Dementia greatly contributes to poor prognosis in patients with Parkinson's disease (PD). We previously reported that severe olfactory dysfunction may be a good predictor of Parkinson's disease dementia (PDD). In this trial, we investigated whether early administration of donepezil to patients with severe hyposmia can reduce the development of PDD. Methods: This was a multi-centre, randomized, double-blind, parallel group, placebo-controlled trial in patients with non-demented PD with severe hyposmia (The Donepezil Application for Severe Hyposmic Parkinson's Disease [DASH-PD] study). A total of 201 patients were randomly allocated to receive donepezil or placebo in addition to standard therapy for PD. Patients were followed up every 6 months until the onset of PDD or for a maximum of 4 years. The primary endpoint was the onset of dementia. The secondary endpoint was cognitive impairment measured by Addenbrooke's Cognitive Examination-Revised (ACE-R) and the Clinical Dementia Rating (CDR).(UMIN000009958: February 2013 to May 2019). Findings: A total of 201 hyposmic patients with PD were randomly assigned to a treatment: 103 to donepezil and 98 to placebo. Overall, 141 (70%) patients completed the 4-year intervention. During follow-up, 7 of 103 (6.8%) patients in the donepezil group and 12 of 98 (12.2%) patients in the placebo group developed PDD; however, the hazard ratio of PDD incidence was not statistically significant (hazard ratio (HR), 0.609; 95% confidence interval, 0.240 to 1.547; p = 0.2969). At week 208, the patients in the donepezil group had better scores on the ACE-R (p < 0.005) and the CDR (p < 0.005) than those taking placebo. Interpretation: Administration of donepezil to PD patients with severe olfactory dysfunction for 4 years did not change the incidence of dementia but had a beneficial effect on neuropsychological function, with good tolerability. Funding: The Ministry of Health Labour and Welfare and the Japan Agency for Medical Research and Development provided funding for this study.

Context and Considerations for Use of Two Japanese Real-World Databases in Japan: Medical Data Vision and Japanese Medical Data Center.

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.

Bisphosphonate Use May Reduce the Risk of Urolithiasis in Astronauts on Long-Term Spaceflights.

Long-duration spaceflight is associated with an increased risk of urolithiasis, and the pain caused by urinary calculi could result in loss of human performance and mission objectives. The present study investigated the risk of urolithiasis in astronauts during 6 months on the International Space Station, and evaluated whether the suppression of bone resorption by the bisphosphonate, alendronate (ALN), can reduce the risk. A total of 17 astronauts were included into the analysis: exercise using the advanced resistive exercise device (ARED) plus weekly oral 70 mg alendronate (ARED+ALN group, n = 7) was compared to resistive exercise alone (ARED group, n = 10). Urine volume decreased in both groups during spaceflight but recovered after return. The ARED group showed increased urinary calcium excretion from the 15th to 30th day of spaceflight, whereas urinary calcium was slightly decreased in the ARED+ALN group. Urinary N-terminal telopeptide (NTX) and helical peptide (HP) of type I collagen, as bone resorption markers, were elevated in the ARED group during and until 0 days after spaceflight, while there was no elevation in these parameters in the ARED+ALN group. Urinary oxalate and uric acid excretion tended to be higher in the ARED group than in the ARED+ALN group during spaceflight. These results demonstrate that astronauts on long-duration spaceflights may be at high risk for the formation of urinary calcium oxalate and calcium phosphate stones through increased urinary excretion of oxalate and uric acid, from degraded type I collagen, as well as of calcium from enhanced bone resorption. Our findings suggest that increased bone resorption during spaceflight, as a risk factor for urinary calculus formation, could be effectively prevented by an inhibitor of bone resorption. © 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Intraepithelial CD8+ lymphocytes as a predictive diagnostic biomarker for the remission of oral lichen planus.

Oral lichen planus (OLP) is an autoimmune inflammatory disease of the oral mucosa whose etiology remains unknown. Moreover, the possibility of OLP being a premalignant change is under debate. Various types of immune cells infiltrate the OLP lesion and affect its clinicopathological features. However, the diversity of infiltrating immune cells has not been fully clarified in relation to OLP diagnosis. In this study, we quantitatively examined CD8+ lymphocyte infiltration by immunohistochemistry, which is the principal effector of cytotoxic immune reaction in 123 cases of OLP specimens. Our examination revealed that high-grade intraepithelial CD8+ lymphocyte infiltration was associated with a high remission rate. Evaluation of the infiltration of T-bet+ and FoxP3+ lymphocytes, which corresponded to the Th1 and Treg CD4+ subsets, respectively, showed that intraepithelial CD8+ lymphocytes were associated with the remission rate in the subgroup with a higher T-bet/FoxP3 subset balance that is inducible for cytotoxic immunity. We also investigated the cutoff value of CD8+ lymphocyte infiltration for histopathological diagnosis. By microscopic counting, 16 cells/high-power field, which was also confirmed in the validation cohort, was established as the cutoff value for intraepithelial CD8+ lymphocyte infiltration for predicting the remission of OLP. Remitting OLP might be different from refractory OLP in terms of etiology and clinical behavior. Thus, intraepithelial CD8+ lymphocytes may serve not only as a predictive biomarker for remission but also as an area for further biomedical research regarding the etiology and premalignant potential of OLP.

Diagnostic significance of intratumoral CD8+ tumor-infiltrating lymphocytes in medullary carcinoma.

Invasive ductal carcinomas of breast with marked stromal lymphocytic infiltration have come to be classified as lymphocyte-predominant breast cancer (LPBC) because it obtains high pathological complete response rates with neoadjuvant chemotherapy. Medullary carcinoma (MC), which is independent from LPBC, is a rare histological subtype of invasive breast carcinoma accompanied by abundant lymphoplasmacytic infiltration as LPBC. Although MC shows marked cellular and structural atypia, it usually has a favorable outcome. It is occasionally difficult to distinguish MC from LPBC because both subtypes have nonspecific morphological features according to the present diagnostic criteria. Herein, we adopted multiplexed fluorescent immunohistochemistry to perform quantitative and simultaneous analyses of tumor-infiltrating lymphocytes (TILs) considering their spatial distribution and examined focal immune reaction differences between MC and LPBC. We found that CD8+ TILs are predominant in the intratumoral region, whereas CD4+ TILs are less common in MC. In non-luminal-type cancers, the numbers of stromal and intratumoral CD8+ TILs were significantly higher in MC than in LPBC. Stratified analyses by CD4+ TIL subsets showed robust infiltration of intratumoral CD8+ TILs in non-luminal-type MC even in suppressive environments, such a low T helper 1-to-regulatory T cell ratio. Our results suggest that extensive intratumoral CD8+ TIL infiltration might well be a promising biomarker for distinguishing MC from LPBC, especially in non-luminal-type cancers. Intratumoral CD8+ TILs and nonluminal intrinsic subtypes may serve as diagnostic characteristics allowing reliable histological criteria to be established for reproducibly diagnosing MC.

Psychometric assessment of the Japanese version of the Revised Fibromyalgia Impact Questionnaire: reliability and validity.

AIM: To assess the psychometric properties of the Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) in fibromyalgia (FM) patients. METHOD: The reliability and validity of the JFIQR were assessed using online data collected from Japanese FM patients. Reliability was evaluated based on test-retest reliability results and internal consistency; validity was evaluated on the basis of concurrent and known-group validity. RESULTS: A total of 105 patients completed the online questionnaire. Intra-class correlation coefficients for test-retest were 0.91 for the JFIQR total score with a range of 0.84-0.90 in three domains: function, overall impact and symptoms. Internal consistency results indicated a Cronbach's alpha of 0.90 for the total score with a range of 0.83 and 0.85 for the domains. Concurrent validity results showed that the total score was correlated to all external criteria (Japanese version of the Fibromyalgia Impact Questionnaire, Fibromyalgia Activity Scale-31, Medical Outcomes Study 36-item Short-Form health survey) from a moderate to strong degree with most indicating a strong correlation. Results of known-group validity showed that the JFIQR total score is capable of discriminating between FM and the other groups, such as rheumatic arthritis and no chronic pain (P < 0.0001 for all pairwise comparisons). CONCLUSION: The current psychometric assessment of the JFIQR demonstrated that it is a reliable and valid questionnaire in Japanese patients with FM. Usefulness of the JFIQR in clinical studies and medical practice for Japanese-speaking populations is expected.

Assessment of psychosocial risk factors for the development of non-specific chronic disabling low back pain in Japanese workers-findings from the Japan Epidemiological Research of Occupation-related Back Pain (JOB) study.

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.

Potential risk factors of persistent low back pain developing from mild low back pain in urban Japanese workers.

STUDY DESIGN: Two-year, prospective cohort data from the Japan epidemiological research of occupation-related back pain study in urban settings were used for this analysis. OBJECTIVE: To examine the association between aggravated low back pain and psychosocial factors among Japanese workers with mild low back pain. SUMMARY OF BACKGROUND DATA: Although 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. METHODS: At 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. RESULTS: Of 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). CONCLUSIONS: Psychosocial 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.

Central nervous system effects of the second-generation antihistamines marketed in Japan--review of inter-drug differences using the proportional impairment ratio (PIR)-.

BACKGROUND: Second-generation antihistamines (AHs) have, in general, fewer sedative effects than the first-generation. However, important inter-drug differences remain in the degree of cognitive and/or psychomotor impairment. The extent to which a particular compound causes disruption can be conveniently compared, to all other AHs, using the Proportional Impairment Ratio (PIR). Although the PIR can differentiate the relative impairment caused by individual drugs, there is no indication of the reliability of the ratios obtained. OBJECTIVE: To calculate the PIRs -together with 95% confidence intervals (CIs), as an index of reliability- and compare AHs currently, or soon to be, available in Japan, with respect to their intrinsic capacity to cause impairment. METHODS: Results from studies of cetirizine, desloratadine, ebastine, fexofenadine, levocetirizine, loratadine, mequitazine, and olopatadine were included in the PIR calculations. All data utilised came from crossover studies in healthy volunteers which were randomised and placebo and positive-internal controlled. Existing databases from studies reporting the sedative effects of AHs on objective (speed, accuracy, memory) and subjective (feeling) psychometrics were augmented, via results from suitable studies published after the previous reviews. The null value for a PIR was one. RESULTS: A total of 45 studies were finally included for this review. Of the AHs assessed, fexofenadine, ebastine, and levocetirizine showed a PIR for objective tests of 0. However, only fexofenadine (PIR = 0.49) had an upper limit of the 95% CI of less than 1. Fexofenadine, levocetirizine, desloratadine, olopatadine, loratadine, and mequitazine all had a PIR for subjective ratings of 0, but the upper limits of the 95% CIs were all in excess of 1, although fexofenadine (PIR = 2.57) was the lowest. CONCLUSIONS: The results show that there are differences between second-generation AHs in the extent of sedation produced. However, subjective ratings indicate that patients may not necessarily be aware of this.

Identification of risk factors for new-onset sciatica in Japanese workers: findings from the Japan epidemiological research of Occupation-related Back pain study.

STUDY DESIGN: Two-year, prospective cohort data collected for the Japan epidemiological research of Occupation-related Back pain study were used for the analysis. OBJECTIVE: To identify potential risk factors for the development of new-onset sciatica in initially symptom-free Japanese workers with no history of sciatica. SUMMARY OF BACKGROUND DATA: Although the associations between individual and occupational factors and cases of new-onset sciatica are established, the effect of psychosocial factors on the development of sciatica has still not been adequately clarified. METHODS: In total, 5310 participants responded to a self-administered baseline questionnaire (response rate: 86.5%). Furthermore, 3194 (60.2%) completed both 1- and 2-year follow-up questionnaires. The baseline questionnaire assessed individual characteristics, ergonomic work demands, and work-related psychosocial factors. The outcome of interest was new-onset sciatica with or without low back pain during the 2-year follow-up period. Incidence was calculated for participants who reported no low back pain in the preceding year and no history of lumbar radicular pain (sciatica) at baseline. Logistical regression assessed risk factors associated with new-onset sciatica. RESULTS: Of 765 eligible participants, 141 (18.4%) reported a new episode of sciatica during the 2-year follow-up. In crude analysis, significant associations were found between new-onset sciatica and age and obesity. In adjusted analysis, significant associations were found for obesity and mental workload in a qualitative aspect after controlling for age and sex. Consequently, in multivariate analysis with all the potential risk factors, age and obesity remained statistically significant (odds ratios: 1.59, 95% confidence interval: 1.01-2.52; odds ratios: 1.77, 95% confidence interval: 1.17-2.68, respectively). CONCLUSION: In previously asymptomatic Japanese workers, the risk of developing new-onset sciatica is mediated by individual factors. Our findings suggest that the management of obesity may prevent new-onset sciatica. LEVEL OF EVIDENCE: 3.

Potential risk factors for new onset of back pain disability in Japanese workers: findings from the Japan epidemiological research of occupation-related back pain study.

STUDY DESIGN: Two-year, prospective cohort data from the Japan epidemiological research of occupation-related back pain study were used for this analysis. OBJECTIVE: To examine the association between a new onset of low back pain (LBP) with disability and potential risk factors among initially symptom-free Japanese workers. SUMMARY OF BACKGROUND DATA: Despite strong evidence that psychosocial issues may influence LBP onset among symptom-free persons, these and other LBP risk factors have not been well investigated in the Japanese workplace. METHODS: Of 5310 participants responding to a self-administered baseline questionnaire (response rate: 86.5%), 3194 (60.2%) completed both 1- and 2-year follow-up questionnaires. The baseline questionnaire assessed individual characteristics, ergonomic work demands, and work-related psychosocial factors. The outcome of interest was new-onset LBP with disability during the follow-up period. Incidence was calculated for the participants who reported no LBP during the past year at baseline. Logistic regression was used to explore risk factors associated with new-onset LBP with disability. RESULTS: Of 836 participants who were symptom-free during the preceding year, 33 (3.9%) reported LBP with disability during the 2-year follow-up. In univariate analyses, "history of LBP," "frequent lifting," "interpersonal stress at workplace," and "monotonous tasks" were all significant predictors of LBP incidence. All of these factors remained statistically significant or almost significant in the multivariate analysis adjusting for the other variables as well as age and sex: adjusted odds ratio (OR) and 95% confidence interval (95% CI) for history of LBP (OR: 3.25, 95% CI: 1.53-6.91), frequent lifting (OR: 3.77, 95% CI: 1.16-12.3), interpersonal stress at workplace (OR: 2.42, 95% CI: 1.08-5.43), and monotonous tasks (OR: 2.21, 95% CI: 0.99-4.94). CONCLUSION: 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.

Comparison of physician's advice for non-specific acute low back pain in Japanese workers: advice to rest versus advice to stay active.

To assess the effects of physician's advice on non-specific acute low back pain (ALBP) in Japanese workers, existing data from a prospective, epidemiological study of Japanese workers were analyzed. Among workers who had had low back strain during the past year at baseline and responded to the 1-yr follow-up survey (n=475), those who obtained medical care (n=255) and received advice either to rest (n=68 for the rest group) or to stay active (n=32 for the active group) were examined. The rest group seemed to have a higher risk of ALBP than the active group after adjusting for age, gender, history of low back strain, type of physical activity at work, and severity of LBP during the past month at baseline (adjusted OR for the rest group vs. the active group: 3.65, 95%CI: 0.96-13.8). Compared to the active group, low back strain was more likely to occur repeatedly and to become chronic in the rest group. These findings suggest that advice to rest may not be better than advice to stay active for preventing future episodes of ALBP in Japanese workers, which is consistent with previous studies or guidelines for the management of ALBP in Western countries.