Comparison of the specimen quality of endobronchial ultrasound-guided intranodal forceps biopsy using standard-sized forceps versus mini forceps for lung cancer: A prospective study.

BACKGROUND AND OBJECTIVE: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a diagnostic procedure with adequate performance; however, its ability to provide specimens of sufficient quality and quantity for treatment decision-making in advanced-stage lung cancer may be limited, primarily due to blood contamination. The use of a 0.96-mm miniforceps biopsy (MFB) permits true histological sampling, but the resulting small specimens are unsuitable for the intended applications. Therefore, we introduced a 1.9-mm standard-sized forceps biopsy (SFB) and compared its utility to that of MFB. METHODS: We prospectively enrolled patients from three institutions who presented with hilar/mediastinal lymphadenopathy and suspected advanced-stage lung cancer, or those who were already diagnosed but required additional tissue specimens for biomarker analysis. Each patient underwent MFB followed by SFB three or four times through the tract created by TBNA using a 22-gauge needle on the same lymph node (LN). Two pathologists assessed the quality and size of each specimen using a virtual slide system, and diagnostic performance was compared between the MFB and SFB groups. RESULTS: Among the 60 enrolled patients, 70.0% were diagnosed with adenocarcinoma. The most frequently targeted sites were the lower paratracheal LNs, followed by the interlobar LNs. The diagnostic yields of TBNA, MFB and SFB were 91.7%, 93.3% and 96.7%, respectively. The sampling rate of high-quality specimens was significantly higher in the SFB group. Moreover, the mean specimen size for SFB was three times larger than for MFB. CONCLUSION: SFB is useful for obtaining sufficient qualitative and quantitative specimens.

Vimentin expression correlates with immune checkpoint inhibitor efficacy in non-small cell lung cancer.

BACKGROUND: Although vimentin is often expressed in non-small cell lung cancer (NSCLC), the association between vimentin expression and immune-checkpoint inhibitor (ICI) efficacy remains unclear. METHODS: This retrospective multicenter study enrolled patients with NSCLC who received ICI treatment between December 2015 and July 2020. The authors constructed tissue microarrays and performed immunohistochemical staining with vimentin. They analyzed the relationship between vimentin expression rate and objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). RESULTS: Immunohistochemically evaluable specimens on microarray blocks were available for 397 patients, of whom 343 (86%) were negative (<10%), 30 (8%) were positive (10%-49%), and 24 (6%) were highly positive (≥50%) for vimentin expression. Both rates of programmed death-ligand 1 (PD-L1) tumor proportion score ≥1% and ≥50% were significantly higher in the vimentin-positive group (≥10%) than the vimentin-negative group (<10%) (96% vs. 78%, p = .004; 64% vs. 42%, p = .006, respectively). In patients treated with ICI monotherapy, ORR, PFS, and OS were significantly better in the vimentin-positive group (10%-49%) than in the vimentin-negative group (<10%) (54% vs. 25%, p = .003, median = 7.9 vs. 3.2 months, p = .011; median = 27.0 vs. 13.6 months, p = .015, respectively), whereas there was no significant difference in PFS and OS between the vimentin highly positive group (≥50%) and the vimentin-negative group (<10%) (median = 3.4 vs. 3.2 months, p = .57; median = 7.2 vs. 13.6 months, p = .086, respectively). CONCLUSIONS: Vimentin expression correlated with PD-L1 expression and ICI efficacy. PLAIN LANGUAGE SUMMARY: We constructed tissue microarrays and performed immunohistochemical staining with vimentin on 397 patients with advanced non-small cell lung cancer who were treated with immune-checkpoint inhibitor (ICI). The vimentin-positive group who were treated with ICI monotherapy showed significantly better objective response rate, progression-free survival, and overall survival than the vimentin negative group. The measurement of vimentin expression will aid in determining appropriate immunotherapy strategies.

Vascular endothelial growth factor receptor 2 expression and immunotherapy efficacy in non-small cell lung cancer.

It is unclear whether tumor vascular endothelial growth factor receptor 2 expression affects the therapeutic efficacy of immune-checkpoint inhibitors and antiangiogenic agents. This retrospective, multicenter study included patients with advanced non-small cell lung cancer who were treated with immune-checkpoint inhibitors. We constructed tissue microarrays and performed immunohistochemistry with an anti-vascular endothelial growth factor receptor 2 antibody. We analyzed immune and tumor cell staining separately in order to determine their correlation with the objective response rate, progression-free survival, and overall survival in patients receiving immune-checkpoint inhibitors. Of 364 patients, 37 (10%) expressed vascular endothelial growth factor receptor 2 in immune cells and 165 (45%) in tumor cells. The objective response rate, progression-free survival, and overall survival were significantly worse in patients treated with immune checkpoint inhibitor monotherapy who expressed vascular endothelial growth factor receptor 2 in immune cells than those who did not (10% vs 30%, p = 0.028; median = 2.2 vs 3.6 months, p = 0.012; median = 7.9 vs 17.0 months, p = 0.049, respectively), while there was no significant difference based on tumor cell expression (24% vs 30%, p = 0.33; median = 3.1 vs 3.5 months, p = 0.55; median = 13.6 vs 16.8 months, p = 0.31). There was no significant difference in overall survival between patients treated with and without antiangiogenic agents in any treatment period based on vascular endothelial growth factor receptor 2 expression. Immune checkpoint inhibitor efficacy was limited in patients expressing vascular endothelial growth factor receptor 2 in immune cells.

Impact of tumor microenvironment on the efficacy of epidermal growth factor receptor-tyrosine kinase inhibitors in patients with EGFR-mutant non-small cell lung cancer.

We retrospectively investigated the impact of the tumor microenvironment (TME) on the efficacy of epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) as first-line treatment in 70 patients with advanced EGFR-mutant non-small cell lung cancer and who were seen at Osaka City University Hospital (Osaka, Japan) between August 2013 and December 2017. Using immunohistochemical staining with 28-8 and D7U8C Abs, the tumor proportion score was assessed for programmed cell death-1 ligand-1 (PD-L1), as high (50% or more) or low (less than 50%), and ligand-2 (PD-L2) expression, respectively. The extent of CD8+ tumor-infiltrating lymphocytes was evaluated on a scale of 0-3, with 0-1 as low and 2-3 as high. The TME of the 52 evaluable pretreatment specimens was categorized into 4 subtypes, according to the respective PD-L1 tumor proportion and CD8+ scores, as follows: (a) high/high (13.5%, n = 7); (b) low/low (42.3%, n = 22); (c) high/low (17.3%, n = 9); and (d) low/high (26.9%, n = 14). Expression of PD-L2 was significantly the highest in type 1 (57.1% vs 4.5% vs 11.1% vs 7.1%, respectively; P = .0090). Response rate was significantly the lowest in type 1 (14.3% vs 81.8% vs 66.7% vs 78.6%, respectively; P = .0085). Progression-free survival was the shortest in type 1 and the longest in type 4 (median, 2.4 vs 11.3 vs 8.4 vs 17.5 months, respectively; P = .00000077). The efficacy of EGFR-TKIs differed according to the TME, and the phenotype with high PD-L1 and CD8+ expression might be the subset that would poorly benefit from such treatment.

Japanese orthopaedic association cervical myelopathy evaluation questionnaire (JOACMEQ): Part 5. Determination of responsiveness.

BACKGROUND: In 1999, the Japanese Orthopaedic Association decided to develop a new Cervical Myelopathy Evaluation Questionnaire (JOACMEQ). The final version of the JOACMEQ, comprising 24 questions and five domains (cervical spine function (CF); upper extremity function (UF); lower extremity function (LF); bladder function (BF); and quality of life (QOL)), was established after three nationwide investigations. The fourth investigation, reported in this paper, was performed to confirm the responsiveness of the questionnaire. METHODS: A total of 137 patients with cervical myelopathy were included in the study. Each patient was interviewed twice using the JOACMEQ before and after treatment. At the second interview, the patients self-rated their condition in five domains for "worse," "somewhat worse," "no change," "somewhat better," or "better," and these scores were defined as the external assessment rating. The difference of the points in five domains between the first and the second interview was calculated against each external assessment. Based on the results, substantial clinical benefit (SCB) thresholds for the JOACMEQ were determined. RESULTS: The statistically significant median values of the acquired points were 17.5 for CF, 16.0 and 21.0 for UF, 27.0 and 20.5 for LF, 13.0 for BF, and 29.0 for QOL. After consideration of the results, the committee decided that an acquired point ≥20 could be interpreted as representing an SCB threshold for the JOACMEQ. CONCLUSION: We have concluded that a treatment can be judged to be effective for a patient if 1) The patient give all answers for the questions necessary to calculate the functional score of a domain and an increase of ≥20 points is obtained for that score, or 2) The functional score after treatment is > 90 points even if the answer for the unanswered questions was supposed to be the worst possible choice.

Low-dose irradiation of mouse embryos increases Smad-p21 pathway activity and preserves pluripotency.

PURPOSE: To study the outcomes of mouse preimplantation embryos irradiated with low doses of X-rays (≤ 1 Gy) and investigate apoptosis and pluripotency of the irradiated embryos. METHODS: Mouse embryos at the 2-cell stage were collected for in vitro culture. After reaching the 8-cell stage, embryos were irradiated with various low doses of X-rays (0-1 Gy). Blastocysts with a normal appearance were transferred into a pseudopregnant uterus. The developmental rate to blastocysts and the survival rate following embryo transfer were examined. Expression levels of p21, Smad2, Foxo1, Cdx2, Oct4, and Nanog genes were measured by RT-PCR. Apoptotic cells in mouse blastocysts were examined immunofluorescently by staining for cleaved caspase-3. RESULTS: More than 90% of non-irradiated and low-dose X-ray-irradiated preimplantation embryos developed to morphologically normal blastocysts that could be implanted and survive in the uterus. However, embryos irradiated with X-rays had more apoptotic cells in a dose-dependent manner. Expression of p21, Smad2, and Foxo1 genes in X-ray-irradiated embryos was increased significantly, while expression of Cdx2, Oct4, and Nanog genes was maintained in comparison with non-irradiated embryos. CONCLUSIONS: Although irradiated embryos contained apoptotic cells, the low doses of irradiation did not disturb development of 8-cell stage embryos to blastocysts or their survival in utero. The underlying mechanisms might involve anti-apoptotic systems, including the Smad-p21 pathway, and preservation of pluripotency.

Effect of Oral Alfacalcidol on Clinical Outcomes in Patients Without Secondary Hyperparathyroidism Receiving Maintenance Hemodialysis: The J-DAVID Randomized Clinical Trial.

Importance: Patients with chronic kidney disease have impaired vitamin D activation and elevated cardiovascular risk. Observational studies in patients treated with hemodialysis showed that the use of active vitamin D sterols was associated with lower risk of all-cause mortality, regardless of parathyroid hormone levels. Objective: To determine whether vitamin D receptor activators reduce cardiovascular events and mortality in patients without secondary hyperparathyroidism undergoing hemodialysis. Design, Setting, and Participants: Randomized, open-label, blinded end point multicenter study of 1289 patients in 207 dialysis centers in Japan. The study included 976 patients receiving maintenance hemodialysis with serum intact parathyroid hormone levels less than or equal to 180 pg/mL. The first and last participants were enrolled on August 18, 2008, and January 26, 2011, respectively. The final date of follow-up was April 4, 2015. Interventions: Treatment with 0.5 µg of oral alfacalcidol per day (intervention group; n = 495) vs treatment without vitamin D receptor activators (control group; n = 481). Main Outcomes and Measures: The primary outcome was a composite measure of fatal and nonfatal cardiovascular events, including myocardial infarctions, hospitalizations for congestive heart failure, stroke, aortic dissection/rupture, amputation of lower limb due to ischemia, and cardiac sudden death; coronary revascularization; and leg artery revascularization during 48 months of follow-up. The secondary outcome was all-cause death. Results: Among 976 patients who were randomized from 108 dialysis centers, 964 patients were included in the intention-to-treat analysis (median age, 65 years; 386 women [40.0%]), and 944 (97.9%) completed the trial. During follow-up (median, 4.0 years), the primary composite outcome of cardiovascular events occurred in 103 of 488 patients (21.1%) in the intervention group and 85 of 476 patients (17.9%) in the control group (absolute difference, 3.25% [95% CI, -1.75% to 8.24%]; hazard ratio, 1.25 [95% CI, 0.94-1.67]; P = .13). There was no significant difference in the secondary outcome of all-cause mortality between the groups (18.2% vs 16.8%, respectively; hazard ratio, 1.12 [95% CI, 0.83-1.52]; P = .46). Of the 488 participants in the intervention group, 199 (40.8%) experienced serious adverse events that were classified as cardiovascular, 64 (13.1%) experienced adverse events classified as infection, and 22 (4.5%) experienced malignancy-related serious adverse events. Of 476 participants in the control group, 191 (40.1%) experienced cardiovascular-related serious adverse events, 63 (13.2%) experienced infection-related serious adverse events, and 21 (4.4%) experienced malignancy-related adverse events. Conclusions and Relevance: Among patients without secondary hyperparathyroidism undergoing maintenance hemodialysis, oral alfacalcidol compared with usual care did not reduce the risk of a composite measure of select cardiovascular events. These findings do not support the use of vitamin D receptor activators for patients such as these. Trial Registration: UMIN-CTR Identifier: UMIN000001194.

Verification of the sensitivity of functional scores for treatment results - Substantial clinical benefit thresholds for the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ).

BACKGROUND: Validity and reliability of the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) had already been verified as the patients' self-rating assessment of low back pain and lumbar spinal disease and, the present study demonstrated the responsiveness of this measure. METHODS: 192 subjects who were determined by medical instructors of the Japanese Society for Spine Surgery and Related Research were analyzed. They had completed a series of treatment and both surveys before and after the treatment. Authors investigated rates of concordance between assessment by physicians and subjective assessment by patients. The mean, standard deviation, minimum, 25th percentile, median, 75th percentile and maximum values for pre-treatment, post-treatment, and acquired points were calculated, and then, we also investigated the trend between subjective assessment by patients and mean acquired points for each JOABPEQ domain and substantial clinical benefit thresholds for the JOABPEQ. RESULTS: Symptom changes as assessed by physicians did not coincide with those by patients, and acquired points in each JOABPEQ domain were significantly increased with improved self-rating by patients. In addition, patients who rated symptom changes as "slightly improved" showed a mean acquired points of ≥20, and those reporting "improved" showed a 25th percentile points of the acquired points of ≥20 approximately. CONCLUSION: A significant correlation was noted between the self-rating of patients and acquired points JOABPEQ, suggesting that ≥20 acquired points can be interpreted as substantial clinical benefit thresholds for the JOABPEQ.

Inverse Analysis of the Relationship between Ocular Refraction and Birth Month Using Matrix Equations.

Purpose: To find which kind of light exposure and what sensitivity patterns in infancy influence the relationship between ocular refraction and birth month. Methods: We studied 13,757 children whose cycloplegic refraction could be tested during their initial visit to a children's hospital. After dividing subjects into four groups based on refractive degree, the risk ratio for each birth month was calculated from the cases for that month and the results were adjusted using the national birth/month. We then inversely assessed the risk ratio according to the birth month in each group using simply modeling matrix equations. Results: When results were calculated based on the possible effect of the day length, there was a wide variation in the degree of sensitivity depending on the number of months passed since birth at time of investigation, the statistical results falling into insignificant bimodal peaks. In contrast, when based on the assumption the effect was associated with deviations from the yearly average of the day length, far less variation was observed and there was a single natural sensitivity peak at around five months of age in all four refractive groups. Conclusion: Assuming that the peak stage of influence deviation from the yearly average of the day length has on the infant's refraction is at five month, there is a relationship between the refractive degree and the month of birth.

Estimation of habitual iodine intake in Japanese adults using 16 d diet records over four seasons with a newly developed food composition database for iodine.

Although habitual seaweed consumption in Japan would suggest that iodine intake in Japanese is exceptionally high, intake data from diet records are limited. In the present study, we developed a composition database of iodine and estimated the habitual intake of iodine among Japanese adults. Missing values for iodine content in the existing composition table were imputed based on established criteria. 16 d diet records (4 d over four seasons) from adults (120 women aged 30-69 years and 120 men aged 30-76 years) living in Japan were collected, and iodine intake was estimated. Habitual intake was estimated with the Best-power method. Totally, 995 food items were imputed. The distribution of iodine intake in 24 h was highly skewed, and approximately 55 % of 24 h values were < 300 µg/d. The median iodine intake in 24 h was 229 µg/d for women and 273 µg/d for men. All subjects consumed iodine-rich foods (kelp or soup stock) on one or more days of the sixteen survey days. The mean (median) habitual iodine intake was 1414 (857) µg/d for women and 1572 (1031) µg/d for men. Older participants had higher intake than younger participants. The major contributors to iodine intake were kelp (60 %) and soup stock (30 %). Habitual iodine intake among Japanese was sufficient or higher than the tolerable upper intake level, particularly in older generations. The association between high iodine intake as that observed in the present study and thyroid disease requires further study.

Designing optimal food intake patterns to achieve nutritional goals for Japanese adults through the use of linear programming optimization models.

BACKGROUND: Simultaneous dietary achievement of a full set of nutritional recommendations is difficult. Diet optimization model using linear programming is a useful mathematical means of translating nutrient-based recommendations into realistic nutritionally-optimal food combinations incorporating local and culture-specific foods. We used this approach to explore optimal food intake patterns that meet the nutrient recommendations of the Dietary Reference Intakes (DRIs) while incorporating typical Japanese food selections. METHODS: As observed intake values, we used the food and nutrient intake data of 92 women aged 31-69 years and 82 men aged 32-69 years living in three regions of Japan. Dietary data were collected with semi-weighed dietary record on four non-consecutive days in each season of the year (16 days total). The linear programming models were constructed to minimize the differences between observed and optimized food intake patterns while also meeting the DRIs for a set of 28 nutrients, setting energy equal to estimated requirements, and not exceeding typical quantities of each food consumed by each age (30-49 or 50-69 years) and gender group. RESULTS: We successfully developed mathematically optimized food intake patterns that met the DRIs for all 28 nutrients studied in each sex and age group. Achieving nutritional goals required minor modifications of existing diets in older groups, particularly women, while major modifications were required to increase intake of fruit and vegetables in younger groups of both sexes. Across all sex and age groups, optimized food intake patterns demanded greatly increased intake of whole grains and reduced-fat dairy products in place of intake of refined grains and full-fat dairy products. Salt intake goals were the most difficult to achieve, requiring marked reduction of salt-containing seasoning (65-80%) in all sex and age groups. CONCLUSION: Using a linear programming model, we identified optimal food intake patterns providing practical food choices and meeting nutritional recommendations for Japanese populations. Dietary modifications from current eating habits required to fulfil nutritional goals differed by age: more marked increases in food volume were required in younger groups.

Characteristic differences and reference ranges for mitral, tricuspid, aortic, and pulmonary Doppler velocity waveforms during fetal life.

OBJECTIVES: We aimed to construct reference ranges for time intervals of each component of cardiac flow velocity waveforms in normal fetuses, comparing those variables between right and left ventricles. METHODS: In 359 fetuses at the gestational age of 17-38 weeks, the durations of atrioventricular (AV) valve opening (AVVO), AV valve closure (AVVC), total E- (total-E) and A- (total-A) waves, total ejection time (total-ET), acceleration time (acc-E for E-wave, acc-A for A-wave, and acc-ET for ejection time), and deceleration time (dec-E for E-wave, dec-A for A-wave, and dec-ET for ejection time) were studied cross sectionally. RESULTS: Both right and left acc-E showed the strongest correlations with gestational age (r = 0.478 and r = 0.519, respectively). Left AVVO showed a stronger correlation (r = 0.474) than right AVVO (r = 0.282) and, conversely, right AVVC showed a stronger correlation (r = 0.399) than left AVVC (r = 0.195) with gestational age. Significant differences (all P values <0.001) were observed for all right and left parameters other than total-A and acc-E. CONCLUSIONS: Characteristic differences between right and left ventricles were found in the reference ranges, suggesting the developmental properties of the fetal heart. © 2014 John Wiley & Sons, Ltd.

Higher proportion of total and fat energy intake during the morning may reduce absolute intake of energy within the day. An observational study in free-living Japanese adults.

BACKGROUND: Although the distribution of energy intake throughout the day appears to impact overall daily energy intake, little is known about the ad libitum distribution of energy intake. OBJECTIVE: Our aim was to investigate associations between the distribution of energy intake during the day and subsequent or overall energy intake, and food choice in free-living adults. DESIGN: A total of 119 women and 116 men completed 16-day semi-weighed dietary records. The longitudinal dietary intake data for each participant were analyzed using a mixed model to examine the effect of energy intake at various times of day on subsequent or overall energy intake. RESULTS: Mean proportion of total energy intake in the morning (4:00 a.m.-10:29 a.m.), afternoon (10:30 a.m.-4:59 p.m.) and evening (5:00 p.m.-3:59 a.m.) meal was 22.6%, 33.8% and 43.6% in men, and 24.7%, 36.5%, 38.8% in women, respectively. Proportion of energy intake (%) in the morning meal was significantly and negatively associated with energy intake (kcal) in the subsequent afternoon and evening meals, and consequently in the whole day in both sexes. This significant and negative association was also observed for proportion of energy intake (%) of fat, but not of carbohydrate or protein, in both sexes. Proportion of energy intake (%) in the morning meal was negatively associated with overall energy intake (kcal) from the group of meats, fish, and eggs in both sexes, and from the group of confectioneries and soft drinks in women. CONCLUSIONS: More energy in the morning meal may reduce energy intake, especially that from fat, in the subsequent meals, and consequently in the whole day.

Japanese orthopaedic association back pain evaluation questionnaire (JOABPEQ) as an outcome measure for patients with low back pain: reference values in healthy volunteers.

BACKGROUND: In 2007, the Japanese orthopaedic association back pain evaluation questionnaire (JOABPEQ) was established to overcome the limitations of the original JOA scoring system developed in 1986. Although this new self-administered questionnaire is a more accurate outcome measure for evaluating patients with low back pain, physicians were unable to as certain the exact status of a patient at a single time point because of a lack of reference values. This study aimed to establish the reference values of JOABPEQ in different age and gender groups using data obtained from healthy volunteers. METHODS: This study was conducted in 21 university hospitals and affiliated hospitals from October 2012 to July 2013. The JOABPEQ includes 25 questions that yield five domains to evaluate individuals with low back pain from five different perspectives. A total of 1,456 healthy volunteers (719 men, 737 women; age range, 20-89 years) answered the questionnaire. The differences in scores according to age and gender were examined by non-parametric tests. RESULTS: The JOABPEQ scores significantly decreased with age in the domains of lumbar spine dysfunction, gait disturbance, and social life dysfunction. In these three domains, the median scores approached the 100 possible points in individuals aged 20-70 for both genders. However, the median scores for lumbar spine dysfunction and social life dysfunction decreased to 83.0 and 65.0-78.0 points, respectively, in individuals in their 80 s and 70-80 s, respectively; and the scores for gait disturbance decreased to 93.0 and 71.0 points for males and females in their 80 s. Overall, the median scores for pain-related and psychological disorders were 100 and 60.0-72.0 points, respectively. CONCLUSION: The reference values for JOABPEQ according to age and gender were established herein. Patients with low back pain should be evaluated with this new self-administered questionnaire taking these reference values into account.

Effect of seasonality on the estimated mean value of nutrients and ranking ability of a self-administered diet history questionnaire.

BACKGROUND: We examined the effect of seasonality on the validity (ability to estimate the mean intake of a group and ranking ability) of nutrient intakes estimated with a comprehensive self-administered diet history questionnaire (DHQ) developed for the assessment of Japanese diets during the preceding one month, using semi-weighed dietary records (DRs) as a reference method. METHODS: This study was conducted in three areas in Japan (Osaka, Nagano, and Tottori). The study population included 92 Japanese men aged 32-76 years and 92 Japanese women aged 31-69 years (30 from Osaka, 31 from Nagano, and 31 from Tottori for each sex). A DHQ and a four-day DR were completed four times at 3-month intervals, once per season. The effect of seasonality was examined by the level of agreement among seasons using mean nutrient intake and correlation coefficients. RESULTS: Significant differences in estimated energy-adjusted intakes of 42 selected nutrients between the average of DRs administered 16 times throughout a year and that of the DHQ administered four times in each season (fall, winter, spring, and summer) were observed for 30, 29, 30, and 31 nutrients for men and 21, 28, 30, and 31 nutrients for women, respectively. Pearson correlation coefficients between the DRs and the DHQs for energy-adjusted intakes of the 42 nutrients showed significant inter-season differences in 11 nutrients for men and 13 nutrients for women. Particularly, correlation coefficients of fat, monounsaturated fat, polyunsaturated fat, n-6 polyunsaturated fat, α-linolenic acid, and cholesterol in spring and cryptoxanthin in summer for men, and fat, saturated fat, and monounsaturated fat in spring and summer and thiamin and iron in summer for women were markedly altered by seasonality. CONCLUSIONS: Mean nutrient intake estimated by the DHQ varied by season, indicating that any consideration of nutrient intake estimated by the DHQ as a yearly average intake may be problematic. In contrast, the effect of seasonality on the ranking ability of the DHQ was relatively small, and thus the use of a DHQ to rank individuals by nutrient intake is acceptable for epidemiological studies, regardless of season.

An outcome measure for patients with cervical myelopathy: the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): an average score of healthy volunteers.

BACKGROUND: An outcome measure to evaluate the neurological function of patients with cervical myelopathy was proposed by the Japanese Orthopaedic Association (JOA score) and has been widely used in Japan. However, the JOA score does not include patients' satisfaction, disability, handicaps, or general health, which can be affected by cervical myelopathy. In 2007, a new outcome measure, the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ), which is a self-administered questionnaire, was developed. However, the influence of age and gender on the scores has not been fully examined. The purpose of this study was to establish the standard value of the JOACMEQ by age using healthy volunteers. METHODS: This study was conducted in 23 university hospitals and their affiliated hospitals from September to December 2011. The questionnaire included 24 questions for evaluation of physical function of the cervical spine and spinal cord. A total of 1,629 healthy volunteers were recruited for the study. The ages ranged from 20 to 89 years old. RESULTS: The volunteers comprised 798 men and 831 women. In the elderly healthy volunteers, the JOACMEQ scores decreased with age. In general, the scores for cervical spine function and upper/lower extremity function were retained up to the 60s, then decreased in the 70s and 80s. The scores for quality of life were retained up to the 70s; however, the score for bladder function was retained up to the 40s, then declined with age from the 50s to 80s. CONCLUSION: The standard values of the JOACMEQ by age were established. Differences in the scores were found among different generations. Patients with cervical myelopathy should be evaluated with this new self-administered questionnaire taking into account the standard values according to different ages.

Home visitors' needs and perceptions of the benefits of a home visiting program for childcare support in Japan: A qualitative study of home visitors.

BACKGROUND: The Home Visiting Program for Childcare Support (HV-CCS; "Yoiku Shien Homon Jigyo" in Japanese) has targeted families in need of parenting support and those at risk of child maltreatment in Japan. OBJECTIVE: The aim of this study was to explore the needs and perceptions of benefits of home visitors in HV-CCS. PARTICIPANTS AND SETTING: Sixteen home visitors agreed to participate in the interview. METHODS: This study conducted 1-hour semi-structured interviews with 16 home visitors and analyzed approximately 18 h of interview data using thematic analysis. RESULTS: The findings suggested that home visitors required training to enhance individual skills and knowledge about mental health of caregivers or children. Additionally, they required environmental support, particularly for transportation expenses and parking places. Multidisciplinary communicative support is also necessary, as well as system to improve the process of support. Home visitor perceived the HV-CCS as beneficial in preventing child maltreatment by improving parenting skills and home environment, providing psychological support for mothers, and entering families' intimate spaces. CONCLUSIONS: To ensure the continuity and improvement of home visits for parents and children in Japan, it is essential to address the identified needs of home visitors.

Validity and Reproducibility of a Food Frequency Questionnaire for Dietary Assessment in Japanese People.

A 76-item food frequency questionnaire (FFQ) was developed to investigate nutritional epidemiology in urban residents in Japan. The authors prepared two food models-a life-size three-dimensional model and a life-size two-dimensional photograph-to assess the FFQ portion size. The validity of the FFQ was verified using the two food models by comparing them with 16-d weighted dietary records (WDRs). Validation was conducted by comparing the FFQ1 findings with those obtained with the WDR, which is regarded as the gold standard, and reproducibility was verified by comparing the findings from FFQ2 and FFQ1. After completion of the WDR, the participants were randomized into two groups. In one group, the FFQ was conducted using life-size three-dimensional models (3D-FFQ) to estimate the portion size. In the other group, the FFQ was administered using life-size photo collection (2D-FFQ). Regarding validity, the median values (range) of Pearson's correlation coefficients for the energy and nutrient intake of the 32 items by the WDR and FFQ1 were r=0.53 (0.30-0.68) in the 3D-FFQ and r=0.57 (0.33-0.87) in the 2D-FFQ. When FFQs with 2D or 3D food models and two different portion sizes were compared with regard to the intake of certain food groups, energy, and nutrients, both the 2D-FFQ and 3D-FFQ provided good correlation coefficients with the WDR.

Within- and between-individual variation in energy and nutrient intake in Japanese adults: effect of age and sex differences on group size and number of records required for adequate dietary assessment.

BACKGROUND: Information on within- and between-individual variation in energy and nutrient intake is critical for precisely estimating usual dietary intake; however, data from Japanese populations are limited. METHODS: We used dietary records to examine within- and between-individual variation by age and sex in the intake of energy and 31 selected nutrients among Japanese adults. We also calculated the group size required to estimate mean intake for a group and number of days required both to rank individuals within a group and to assess an individual's usual intake, all with appropriate arbitrary precision. A group of Japanese women (younger: 30-49 years, n = 58; older: 50-69 years, n = 63) and men (younger: 30-49 years, n = 54; older: 50-76 years, n = 67) completed dietary records for 4 nonconsecutive days in each season (16 days in total). RESULTS: Coefficients of within-individual variation and between-individual variation were generally larger in the younger group than in the older group and in men as compared with women. The group size required to estimate a group's mean intake, and number of days required to assess an individual's usual intake, were generally larger for the younger group and for men. In general, a longer period was required to rank women and older adults. CONCLUSIONS: In a group of Japanese adults, coefficients of within-individual variation and between-individual variation, which were used to estimate the group size and number of records required for adequate dietary assessment, differed by age, sex, and nutrient.

Theoretical risk of anterior femoral cortex notching in total knee arthroplasty using a navigation system.

Two important requirements for navigation systems in total knee arthroplasty (TKA), perpendicular cut from the distal femoral condyle to the femoral mechanical axis and prevention of notching of the anterior femoral cortex, might be difficult to meet simultaneously. The potential risk of notching was investigated using three-dimensional (3D) computed tomography data of 50 entire lower extremities of 50 female Japanese candidates for TKA and a 3D template system. Navigation systems for TKA carry the potentially higher risk of notching of the anterior femoral cortex (34% to 51%) than conventional technique (11%) (P<0.001). More anterior setting of the reference point for navigation systems on the distal femur and more external setting of the femoral component were risk factors for notching (P<0.001).