The impact of different anti-vascular endothelial growth factor treatment regimens on reducing burden for caregivers and patients with wet age-related macular degeneration in a single-center real-world Japanese setting.

OBJECTIVE: To describe the burden associated with different anti-vascular endothelial growth factor (VEGF) treatment strategies for wet age-related macular degeneration (wAMD) in a real-word setting in Japan. METHODS: Single-center, cross-sectional survey of caregivers of patients with wAMD performed in a hospital in Mito-City, a rural area in Japan. Caregiver burden was evaluated using the Burden Index of Caregivers (BIC-11), and depressive symptoms were assessed by the Center for Epidemiologic Studies Depression scale. Retrospective medical chart review was conducted to monitor resource use and visual acuity outcomes in patients. The productivity loss of caregivers accompanying patients on hospital visits was estimated using the human capital method. RESULTS: Seventy-one patient-caregiver pairs were included. Most caregivers were female (74.6%), spouse/partner (54.9%), employed (46.5%), and the primary caregiver (85.9%). Patients received anti-VEGF treatment as follows: treat-and-extend (T&E; n = 42), switch (from as-needed [PRN] to T&E; n = 18), PRN (n = 10), and other (n = 1). Caregiver-related burden (total BIC-11 scores) were 4.29 (T&E) 4.60 (PRN), and 5.33 (switch) (p = NS). The mean number of hospital visits was lower with T&E than PRN (7.88 vs. 14.0 [p = 0.00674] in year 1 and 5.68 vs. 9.0 in year 2). For patients who switched from PRN to T&E, the mean number of hospital visits decreased from 13.21 to 7.43 (p<0.0001) in the first year after switch. The productivity loss associated with accompanying patients to the hospital was lower for caregivers of patients receiving T&E than PRN (mean differences: 74,456.04 JPY [p = 0.00284] in year 1 and 40843.14 JPY in year 2), and was also reduced for caregivers of patients who switched from PRN to T&E. CONCLUSION: wAMD treatment with anti-VEGF agents via T&E reduced hospital visits compared with PRN, where associated monitoring visits are necessary to provide good patient outcomes. T&E was associated with a reduction trend in caregiver burden, including time and costs.

Estimated risk for chronic pain determined using the generic STarT Back 5-item screening tool.

OBJECTIVE: The generic STarT Back 5-item screening tool (STarT-G) is used to manage chronic pain in the lower back and elsewhere. This study evaluated the validity of the Japanese version of this generic screening tool. MATERIALS AND METHODS: Japanese participants between the ages of 20 and 64 years completed online surveys regarding pain. Survey reliability was assessed with internal consistency, as calculated using Cronbach's alpha coefficients. Spearman's correlation coefficients were used to evaluate concurrent validity between the STarT-G score and standard reference questionnaires. Associations between STarT-G scores and the presence of a disability due to chronic pain (DCP) were analyzed using receiver operator characteristic (ROC) curves. RESULTS: Analyses ultimately included data obtained from 52,842 Japanese participants (54.4% male) with a mean (standard deviation) age of 47.7 (9.4) years. Approximately 1.5% of participants had DCP, and the mean STarT-G score was 1.2 (1.4). The Cronbach's alpha coefficient was 0.71, indicating an acceptable reliability. The STarT-G score moderately correlated with the pain numerical rating scale (NRS) score (Spearman's correlation coefficient: r = 0.34). When the STarT-G threshold was set at 4, the sensitivity and specificity of the DCP predictive model were 65.8% and 82.4%, respectively, and the area under the ROC was 0.808. CONCLUSION: The STarT-G was internally consistent and was able to distinguish between subjects with and without a DCP. Therefore, the STarT-G can reliably be used in the Japanese population to identify patients with DCP.

Perceived Stress and Colorectal Cancer Incidence: The Japan Collaborative Cohort Study.

Colorectal cancer is the third most common cancer worldwide, and many risk factors for colorectal cancer have been established. However, it remains uncertain whether psychological stress contributes to the onset of colorectal cancer. Therefore, we conducted a large-scale prospective cohort study to confirm the association between perceived stress and colorectal cancer incidence. We identified 680 cases of colon cancer and 330 cases of rectal cancer during a maximum of 21-year follow-up of 61,563 Japanese men and women. Cox regression analysis adjusted for potential confounders revealed a significant association of perceived stress with rectal cancer incidence but not with colon cancer incidence. This finding is partly consistent with that from only one previous study that addressed an association between perceived stress and the risk of colorectal cancer. However, studies on this topic are sparse and warrant further exploration.

The Japanese version of the STarT Back Tool predicts 6-month clinical outcomes of low back pain.

BACKGROUND: The STarT Back Tool classifies patients into low-, medium-, or high-risk groups according to risk for chronic low back pain. The Japanese version of the STarT Back Tool (STarT-J) has been translated and psychometrically validated. The present analysis investigated the predictive ability of the STarT-J. METHODS: Baseline data were collected through an online survey conducted with Japanese patients with low back pain. Long-term outcomes were assessed in a 6-month follow-up survey. Clinical outcomes at 6 months were evaluated with a pain numerical rating scale, the Roland-Morris Disability Questionnaire, and the EuroQol 5 Dimension. Differences in these scores among the three STarT-J risk groups were analyzed. Participants' perceived changes in low back pain and overall health status were examined to determine associations between the chronicity of low back pain at 6 months and STarT-J risk groups. RESULTS: Data of 1228 volunteers who responded to the baseline and follow-up surveys were included in this analysis. Mean ± standard deviation (SD) scores for the pain numerical rating scale and the Roland-Morris Disability Questionnaire were highest in the high-risk group (5.6 ± 1.9 and 9.6 ± 7.5) and lowest in the low-risk group (3.9 ± 1.6 and 2.1 ± 3.5). Mean ± SD EuroQol 5 Dimension index scores were lowest in the high-risk group (0.66 ± 0.20) and highest in the low-risk group (0.86 ± 0.14). A small percentage of high-risk patients (5.3%) perceived improvement in low back pain at the 6-month follow-up. CONCLUSIONS: The STarT-J predicted 6-month pain and disability outcomes. The STarT-J is an easy-to-use tool to screen for patients who are more likely to have chronic low back pain, and may be useful to initiate stratified care in primary care settings.

The influence of personality and perceived stress on the development of breast cancer: 20-year follow-up of 29,098 Japanese women.

Breast cancer is the most common cancer in women. However, it remains unproven whether psychological factors have an influence on breast cancer incidence. In our earlier study, subjects possessing two personality traits, decisiveness and "ikigai" (a Japanese word meaning something that makes one's life worth living), showed a significantly lower risk of developing breast cancer, although no psychological factors have been convincingly demonstrated to have an influence on breast cancer development in other studies. Therefore, we conducted this follow-up analysis to confirm the association between breast cancer incidence and psychological traits, using the final dataset of a large-scale prospective cohort study in Japan. We identified 209 cases of incident breast cancer out of a maximum 21-year follow-up of 29,098 Japanese women. Cox proportional hazard regression analysis, adjusted for the same potential confounders used in our previous study, did not reveal any significant relationships between breast cancer incidence and four psychological traits: having "ikigai", decisiveness, ease of anger arousal, and perceived stress. Our finding is consistent with previous studies, and suggests that the psychological traits are unlikely to be an important risk factor for breast cancer.

Psychometric Assessment of the Japanese Version of the Zurich Claudication Questionnaire (ZCQ): Reliability and Validity.

PURPOSE: The Zurich Claudication Questionnaire (ZCQ) is a self-administered measure to evaluate symptom severity, physical function, and surgery satisfaction in lumbar spinal stenosis (LSS). The purpose of this study is to assess the psychometric properties of the Japanese ZCQ in LSS patients. METHODS: LSS patients who are scheduled to undergo surgery were recruited from 12 facilities. Responses to several questionnaires, including the Japanese ZCQ; the visual analogue scale (VAS) to evaluate the degree of pain in the buttocks/legs, numbness in the buttocks/legs, and low back pain; the Oswestry Disability Index (ODI); and the SF-36v2, were collected before surgery and again 3 months after surgery (the post-surgery ZCQ was administered twice for test-retest reliability). For reliability, test-retest reliability was evaluated using the intra-class coefficient (ICC) and internal consistency was evaluated using Cronbach's alpha coefficient. Concurrent validity was assessed using Spearman's correlation coefficients between the Japanese ZCQ and other questionnaires. Effect size (ES) and standard response mean were calculated for responsiveness. All analyses were performed individually for the Japanese ZCQ symptom, function, and satisfaction domains. RESULTS: Data from 180 LSS patients were used in this analysis. The ICCs were 0.81, 0.89, and 0.88 and Cronbach's alpha coefficients were 0.78, 0.84, and 0.92 for the Japanese ZCQ symptom, function, and satisfaction domains, respectively. Regarding the concurrent validity, strong correlations (±0.5) were demonstrated between the Japanese ZCQ domains and the VAS leg pain, ODI, and SF-36v2 physical functioning or bodily pain, whereas correlations were approximately 0.3 in scales measuring other symptoms that are less related to symptom, function, or satisfaction domains. ESs showed high values for the ZCQ symptom and function domains (-1.73 for both). CONCLUSIONS: These psychometric assessments demonstrate that the Japanese ZCQ is a psychometrically reliable and valid measure in LSS. The Japanese ZCQ can evaluate both multi-dimensional aspects and the level of surgery satisfaction.

Psychometric Properties of the Japanese Version of the STarT Back Tool in Patients with Low Back Pain.

BACKGROUND AND OBJECTIVE: The STarT Back Tool uses prognostic indicators to classify patients with low back pain into three risk groups to guide early secondary prevention in primary care. The present study aimed to evaluate the psychometric properties of the Japanese version of the tool (STarT-J). METHODS: An online survey was conducted among Japanese patients with low back pain aged 20-64 years. Reliability was assessed by examining the internal consistency of the overall and psychosocial subscales using Cronbach's alpha coefficients. Spearman's correlation coefficients were used to evaluate the concurrent validity between the STarT-J total score/psychosocial subscore and standard reference questionnaires. Discriminant validity was evaluated by calculating the area under the curves (AUCs) for the total and psychosocial subscale scores against standard reference cases. Known-groups validity was assessed by examining the relationship between low back pain-related disability and STarT-J scores. RESULTS: The analysis included data for 2000 Japanese patients with low back pain; the mean (standard deviation [SD]) age was 47.7 (9.3) years, and 54.1% were male. The mean (SD) STarT-J score was 2.2 (2.1). The Cronbach's alpha coefficient was 0.75 for the overall scale and 0.66 for the psychosocial subscale. Spearman's correlation coefficients ranged from 0.30 to 0.59, demonstrating moderate to strong concurrent validity. The AUCs for the total score ranged from 0.65 to 0.83, mostly demonstrating acceptable discriminative ability. For known-groups validity, participants with more somatic symptoms had higher total scores. Those in higher STarT-J risk groups had experienced more low back pain-related absences. CONCLUSIONS: The overall STarT-J scale was internally consistent and had acceptable concurrent, discriminant, and known-groups validity. The STarT-J can be used with Japanese patients with low back pain.

Psychometric properties of the Japanese version of the Tampa Scale for Kinesiophobia (TSK-J) in patients with whiplash neck injury pain and/or low back pain.

BACKGROUND: Although the Tampa Scale for Kinesiophobia (TSK) is useful for measuring fear of movement in patients with musculoskeletal pain, no psychometrically validated Japanese version is available. We evaluated the reliability and validity of the Japanese version of the TSK-J (original 17-item version and shorter 11-item version). METHODS: The data subset used in this psychometric testing was derived from a survey previously conducted to collect information on musculoskeletal pain due to motor vehicle accident. For reliability, internal consistency was assessed via Cronbach's alpha coefficient. For concurrent validity, Pearson correlation coefficients of the TSK-J with the pain catastrophizing scale (PCS), euroqol 5 dimension (EQ-5D), and numerical rating scales (NRSs) for pain in the neck and back were calculated. For known-group validity, the relationship between variables (e.g., depression, somatic symptoms, treatment period) and the TSK-J score was examined. RESULTS: Data from 956 persons who had suffered from a motor vehicle accident were used in this analysis. For reliability, internal consistency was demonstrated, with Cronbach's alpha statistics of 0.850 (TSK-J17) and 0.919 (TSK-J11). For concurrent validity, significantly strong correlations were demonstrated between the TSK-J versions and PCS total score and subscales (r = 0.602-0.680). For known-group validity, as hypothesized, significantly higher TSK-J scores were observed in persons with depressive mood, somatic symptoms, and longer treatment period. CONCLUSIONS: The present analysis showed that the Japanese versions of the TSK-J17 and TSK-J11 were psychometrically reliable and valid for detecting fear of movement in the Japanese population suffering from neck to back pain due to a motor vehicle accident.

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.

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.

Workaholism as a risk factor for depressive mood, disabling back pain, and sickness absence.

OBJECTIVES: Although it is understood that work-related factors, including job demands, job control, and workplace support, are associated with workers' health and well-being, the role played by personal characteristics, especially workaholism, has not been fully investigated. This study examined workaholism's associations with psychological ill health, low back pain with disability, and sickness absence among Japanese workers. METHODS: A cross-sectional Internet survey was conducted using self-administered questionnaires. Data from 3,899 Japanese workers were analyzed. Workaholism was measured using the Dutch Workaholism Scale (DUWAS). Scores were divided into tertiles, where respondents were classified into three groups (high, middle, and low). Depressive mood as a measure of psychological ill health was assessed using the SF-36 mental health subscale, and low back pain using a standardized question. Sickness absence, except that due to physical injuries, was categorized either as absence due to mental health problems or to physical/somatic problems including the common cold. Multiple logistic regression analyses were conducted to examine the association between workaholism and depressive mood, low back pain with disability, and sickness absence, adjusting for demographic characteristics, job demand, job control, and workplace support. RESULTS: Compared to the low workaholism group, the middle and high workaholism groups had significantly higher odds for depressive mood (Odds ratio (OR) = 1.93 and 3.62 for the middle and high groups, respectively), disabling back pain (ORs = 1.36 and 1.77 for the middle and high groups, respectively). Workaholism was more strongly associated with sickness absence due to mental health problems than that for other reasons (ORs = 1.76 vs. 1.21 for the middle group and 3.52 vs. 1.37 for the high groups). CONCLUSIONS: Workaholism is significantly associated with poor psychological health, disabling back pain, and sickness absence, particularly from mental health problems. Therefore, workaholism must be considered when addressing well-being of workers.