Clinical Study Support Inc.

Chikusa ku, Japan

Clinical Study Support Inc.

Chikusa ku, Japan
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PubMed | Iwate Medical University, Clinical Study Support Inc, Hokkaido University, Sapporo Medical University and Aichi Medical University
Type: | Journal: Scientific reports | Year: 2016

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 ones 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.


PubMed | Hokkaido University, Kyoto Prefectural University of Medicine, Clinical Study Support Inc. and Aichi Medical University
Type: | Journal: Scientific reports | Year: 2017

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.


PubMed | Juntendo University, Clinical Study Support Inc. and Eisai Co.
Type: Journal Article | Journal: Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society | Year: 2016

There have been very few long-term studies involving a large study population; existing studies usually have no more than a few hundred patients with Alzheimers disease. For these reasons, there are no detailed investigations regarding changes in activities of daily living evaluated by the Functional Assessment Staging Test (FAST).A long-term, large-scale observational study of donepezil hydrochloride (Aricept(); Eisai Co., Ltd, Tokyo, Japan) is currently in progress. Its objective is to investigate disease state changes associated with the long-term administration of this drug and its safety in patients with Alzheimers disease. In this report, data collected over a maximum of 24 months were compiled. Efficacy was assessed using FAST and a cognitive function test (Mini-Mental State Examination or the Hasegawas Dementia Scale-Revised).The percentages of patients whose FAST stage improved or remained the same compared to at the start of donepezil hydrochloride administration (baseline) were 91.1% at 6 months, 83.0% at 12 months, 79.5% at 18 months, and 74.8% at 24 months. Multivariate logistic regression analysis was conducted to investigate factors that affect the improvement and maintenance or exacerbation of FAST at 24 months. Independence level in the daily life of elderly with dementia and duration of illness were identified as variables that affected the improvement and maintenance or exacerbation of FAST. Cognitive function improved significantly at 12 weeks and at 6 months compared to baseline, maintained baseline levels at 12 months and at 18 months, and decreased significantly at 24 months compared to baseline.This is the largest prospective study involving Alzheimers disease patients in Japan, and we believe it is an important study that shows the reality of daily clinical practice.


Matsudaira K.,Kanto Rosai Hospital | Kikuchi N.,Clinical Study Support Inc. | Murakami A.,Clinical Study Support Inc. | Isomura T.,Clinical Study Support Inc.
Journal of Orthopaedic Science | Year: 2014

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. © The Japanese Orthopaedic Association 2013.


Matsudaira K.,Kanto Rosai Hospital | Matsudaira K.,Tokyo Medical University | Konishi H.,Nagasaki Rosai Hospital | Miyoshi K.,Yokohama Rosai Hospital | And 4 more authors.
PLoS ONE | Year: 2014

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. © 2014 Matsudaira et al.


Matsudaira K.,Kanto Rosai Hospital | Konishi H.,Nagasaki Rosai Hospital | Miyoshi K.,Yokohama Rosai Hospital | Isomura T.,CLINICAL STUDY SUPPORT INC. | And 4 more authors.
Spine | Year: 2012

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. Copyright © 2012 Lippincott Williams & Wilkins.


PubMed | Nagoya City University, University of Toyama and Clinical Study Support Inc.
Type: Review | Journal: European journal of clinical nutrition | Year: 2016

There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Although many randomized controlled trials (RCTs) of green tea extracts have been reported in the literature, the systematic reviews published to date were only based on subjective assessment of case reports. To more objectively examine the liver-related safety of green tea intake, we conducted a systematic review of published RCTs. A systematic literature search was conducted using three databases (PubMed, EMBASE and Cochrane Central Register of Controlled Trials) in December 2013 to identify RCTs of green tea extracts. Data on liver-related adverse events, including laboratory test abnormalities, were abstracted from the identified articles. Methodological quality of RCTs was assessed. After excluding duplicates, 561 titles and abstracts and 119 full-text articles were screened, and finally 34 trials were identified. Of these, liver-related adverse events were reported in four trials; these adverse events involved seven subjects (eight events) in the green tea intervention group and one subject (one event) in the control group. The summary odds ratio, estimated using a meta-analysis method for sparse event data, for intervention compared with placebo was 2.1 (95% confidence interval: 0.5-9.8). The few events reported in both groups were elevations of liver enzymes. Most were mild, and no serious liver-related adverse events were reported. Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare.


PubMed | University of Tokyo, Tokyo Medical University, Clinical Study Support Inc. and Aichi Medical University
Type: | Journal: Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association | Year: 2016

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.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.Data of 1228 volunteers who responded to the baseline and follow-up surveys were included in this analysis. Meanstandard deviation (SD) scores for the pain numerical rating scale and the Roland-Morris Disability Questionnaire were highest in the high-risk group (5.61.9 and 9.67.5) and lowest in the low-risk group (3.91.6 and 2.13.5). MeanSD EuroQol 5 Dimension index scores were lowest in the high-risk group (0.660.20) and highest in the low-risk group (0.860.14). A small percentage of high-risk patients (5.3%) perceived improvement in low back pain at the 6-month follow-up.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.


PubMed | Tokyo Medical University, Clinical Study Support Inc. and University of Tokyo
Type: Journal Article | Journal: PloS one | Year: 2016

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).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 Cronbachs alpha coefficients. Spearmans 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.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 Cronbachs alpha coefficient was 0.75 for the overall scale and 0.66 for the psychosocial subscale. Spearmans 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.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.

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