Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2- and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study.

PURPOSE: Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate consisting of a humanized antitrophoblast cell-surface antigen 2 (TROP2) monoclonal antibody linked to a potent, exatecan-derived topoisomerase I inhibitor payload via a plasma-stable, selectively cleavable linker. PATIENTS AND METHODS: TROPION-PanTumor01 (ClinicalTrials.gov identifier: NCT03401385) is a phase I, dose-escalation, and dose-expansion study evaluating Dato-DXd in patients with previously treated solid tumors. The primary study objective was to assess the safety and tolerability of Dato-DXd. Secondary objectives included evaluation of antitumor activity and pharmacokinetics. Results from patients with advanced/metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer (BC) or triple-negative BC (TNBC) are reported. RESULTS: At data cutoff (July 22, 2022), 85 patients (HR+/HER2- BC = 41, and TNBC = 44) had received Dato-DXd. The objective response rate by blinded independent central review was 26.8% (95% CI, 14.2 to 42.9) and 31.8% (95% CI, 18.6 to 47.6) for patients with HR+/HER2- BC and TNBC, respectively. The median duration of response was not evaluable in the HR+/HER2- BC cohort and 16.8 months in the TNBC cohort. The median progression-free survival in patients with HR+/HER2- BC and TNBC was 8.3 and 4.4 months, respectively. All-cause treatment-emergent adverse events (TEAEs; any grade, grade ≥3) were observed in 100% and 41.5% of patients with HR+/HER2- BC and 100% and 52.3% of patients with TNBC. Stomatitis was the most common TEAE (any grade, grade ≥3) in both HR+/HER2- BC (82.9%, 9.8%) and TNBC (72.7%, 11.4%) cohorts. CONCLUSION: In patients with heavily pretreated advanced HR+/HER2- BC and TNBC, Dato-DXd demonstrated promising clinical activity and a manageable safety profile. Dato-DXd is currently being evaluated in phase III studies.

Development and validation of the gratitude for food scale for Japanese adults.

Gratitude for food is a concept associated with various aspects of healthy and sustainable diet and originates from Buddhism and Shintoism in Japan. Against this background, a scale specifically targeting adults is essential for boosting studies concerning gratitude for food. This study aimed to adapt the Gratitude for Food Scale (GFS), originally developed for Japanese children, to Japanese adults and to examine the reliability and validity of GFS for adults (GFS-A). This cross-sectional study used baseline and one-week follow-up data from a longitudinal survey. The analysis included 1800 Japanese adults at baseline and 1380 at the one-week follow-up based on completion of self-administered questionnaires in February 2023. Construct validity was confirmed using exploratory and confirmatory factor analyses. Further, Spearman's and intraclass correlation coefficients and Cronbach's alpha were calculated to confirm criterion validity and reliability (test-retest and internal consistency). Participants' mean (SD) age was 40.2 (11.2) years (women: n = 900, 50.0%) at baseline. The analysis revealed a one-factor structure comprising five items with good model fit. Criterion validity was confirmed by the correlation coefficients between the total GFS score and the gratitude questionnaire and the sub-score of awareness and appreciation for food, which represents a subscale of the expanded mindful eating scale. Moreover, test-retest reliability and internal consistency were confirmed. From this study's results, we can see that the developed GFS-A is an appropriate scale with good reliability and validity for measuring Japanese adults' gratitude for food.

First-in-Human, Phase I Dose-Escalation and Dose-Expansion Study of Trophoblast Cell-Surface Antigen 2-Directed Antibody-Drug Conjugate Datopotamab Deruxtecan in Non-Small-Cell Lung Cancer: TROPION-PanTumor01.

PURPOSE: This first-in-human, dose-escalation and dose-expansion study evaluated the safety, tolerability, and antitumor activity of datopotamab deruxtecan (Dato-DXd), a novel trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate in solid tumors, including advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Adults with locally advanced/metastatic NSCLC received 0.27-10 mg/kg Dato-DXd once every 3 weeks during escalation or 4, 6, or 8 mg/kg Dato-DXd once every 3 weeks during expansion. Primary end points were safety and tolerability. Secondary end points included objective response rate (ORR), survival, and pharmacokinetics. RESULTS: Two hundred ten patients received Dato-DXd, including 180 in the 4-8 mg/kg dose-expansion cohorts. This population had a median of three prior lines of therapy. The maximum tolerated dose was 8 mg/kg once every 3 weeks; the recommended dose for further development was 6 mg/kg once every 3 weeks. In patients receiving 6 mg/kg (n = 50), median duration on study, including follow-up, and median exposure were 13.3 and 3.5 months, respectively. The most frequent any-grade treatment-emergent adverse events (TEAEs) were nausea (64%), stomatitis (60%), and alopecia (42%). Grade ≥3 TEAEs and treatment-related AEs occurred in 54% and 26% of patients, respectively. Interstitial lung disease adjudicated as drug-related (two grade 2 and one grade 4) occurred in three of 50 patients (6%). The ORR was 26% (95% CI, 14.6 to 40.3), and median duration of response was 10.5 months; median progression-free survival and overall survival were 6.9 months (95% CI, 2.7 to 8.8 months) and 11.4 months (95% CI, 7.1 to 20.6 months), respectively. Responses occurred regardless of TROP2 expression. CONCLUSION: Promising antitumor activity and a manageable safety profile were seen with Dato-DXd in heavily pretreated patients with advanced NSCLC. Further investigation as first-line combination therapy in advanced NSCLC and as monotherapy in the second-line setting and beyond is ongoing.

Sensory profile of picky eaters among college female students.

Picky eaters are at risk of an unbalanced diet, which is critical for women of reproductive age. A sensory profile, which is a potential factor in picky eating, has not been well researched. This study assessed the differences in sensory profile and dietary intake according to the picky eating status among female Japanese undergraduate college students. Cross-sectional data were obtained from the Ochanomizu Health Study conducted in 2018. The questionnaire included items regarding demographic characteristics, picky eating status, sensory profile, and dietary intake. Sensory profile was assessed using the Adult/Adolescent Sensory Profile questionnaire, and dietary intakes were calculated using a brief-type self-administered diet history questionnaire. Among the 111 participants, 23% were picky eaters and 77% were non-picky eaters. The age, body mass index and household status did not differ between the picky eaters and non-picky eaters. Being a picky eater was associated with higher scores on sensory sensitivity and sensation avoiding, and lower thresholds for taste and smell, touch, and auditory stimuli than being a non-picky eater. Of the picky eaters, 58% and 100% were at a high risk for folate and iron deficiencies, respectively, compared to 35% and 81% of non-picky eaters. Nutrition education for picky eaters in reproductive age to increase vegetable dishes comfortably in their diet is suggested to prevent anemia during their future pregnancy.

Integrated consumers' sustainable and healthy dietary behavior patterns: Associations between demographics, psychological factors, and meal preparation habits among Japanese adults.

The consumers' Sustainable and Healthy Dietary Behaviors (SHDBs) links sustainable behaviors related to eating (e.g., choosing, cooking, eating, and disposing of foods) with the level of "dietary behavior." It was hypothesized that SHDBs will vary depending on consumers' meal preparation habits, such as food selection, cooking frequency, and skill. This study examined (1) some of the behavioral patterns of SHDBs and (2) independent predictors of each pattern. In total, 508 Japanese adults who completed cross-sectional self-administered questionnaire surveys in December 2021 were included in the study. Principal component analysis (PCA) was used to identify the behavioral patterns of the 30-item SHDBs developed previously by the authors. Additionally, independent predictors of each component score were analyzed using multiple linear regression models, which included demographics, psychological factors concerning SHDBs (pros and cons for the decisional balance of SHDBs and number of environmental issues of interest), and meal preparation habits. Participants' median age was 41 (18-59) years (women: n = 259, 51.0%). Five SHDB patterns with several independent predictors were identified: amalgamation of all SHDBs, healthy food choices but unsustainable cooking, sustainable disposal, avoiding plastic products, and sustainable behaviors regarding expiry date. The multiple linear regression analysis demonstrated the independent predictors of the amalgamation of all SHDBs, such as being a man (ß = -0.105), greater pros (ß = 0.134), higher cooking frequency (ß = 0.443) and skill (ß = 0.244). Greater pros and/or smaller cons were associated with four of the five SHDB patterns, including an amalgamation of all SHDBs, healthy food choice and unsustainable cooking, avoiding disposal, and avoiding plastic products. Sustainable and healthy diet education must be implemented to ensure the adoption of all SHDBs.

Association of healthy eating literacy and resident status with energy, nutrients, and food consumption among lean and normal-weight female university students.

BACKGROUND & AIMS: This study aimed to describe the association of healthy eating literacy (HEL) with energy, nutrients, and food consumption in young women who had normal and lean weight at a Japanese university, considering their resident status. METHODS: Cross-sectional data from the Ochanomizu Health Study were used in this study. Participants answered a self-administered, two-part, anonymous survey in 2018 and 2019. A total of 203 female undergraduate students with lean and normal body mass index (BMI) were included in the analysis. Single and stepwise multiple linear regression analysis was used to examine the association of HEL and resident status with healthy food consumption, such as vegetables, fish, and shellfish. The dependent variables were HEL and resident status, and the covariates were age, BMI, and the total metabolic equivalents. RESULTS: The median (25th and 75th percentiles) age, BMI, and total HEL score were 20 (19, 21) years, 20.2 (18.9, 21.3) kg/m 2, and 18 (16, 20), respectively. Resident status and HEL were independently associated with vegetables, fish, and shellfish intake. Participants who had higher total HEL scores and lived in their family home consumed significantly more vegetables (ß = 0.17 and -0.34, p < 0.05) and fish and shellfish (ß = 0.24, -0.28, p < 0.001). CONCLUSION: This study provides an insight into the association between HEL and dietary consumption in young women with normal and lean BMI.

The relationship between traditional and common Japanese childhood education and adulthood towards avoiding food waste behaviors.

Japanese parents and educators teach children to refrain from leaving food in their plates. Their teachings have direct (advising children to refrain from leaving food uneaten) and indirect (meal-related rituals before and after mealtimes) influence in enhancing gratitude for food in daily life. This cross-sectional study aimed to examine 1) the interaction of direct and indirect approaches to avoiding food waste behaviors and 2) the mediation of gratitude for food by preventing such behaviors. Overall, 400 Japanese adults (female: n = 200) responded to a self-administrated anonymous questionnaire survey measuring: the present food waste avoiding behaviors; current gratitude for food; direct and indirect childhood approaches for avoiding food waste behaviors. Participants' mean (standard deviation) age and body mass index were 40.0 (11.6) and 21.9 (3.9), respectively. A significant main effect of the indirect approach and the interaction of direct and indirect approaches were obtained by adjusting the participants' background. Moreover, through mediation analyses with percentile-corrected bootstrap confidence intervals, it was observed that gratitude for food mediated the association between direct and indirect childhood approaches and avoiding food waste behaviors. Despite no information on the current meal-related rituals of the respondents, this study suggests the potential of these approaches in enhancing gratitude for food as a new approach to reduce food waste worldwide.

Later chronotype is associated with unhealthful plant-based diet quality in young Japanese women.

BACKGROUND: Having a late chronotype, that is, the tendency to go to sleep and wake up at later hours, influences an individual's physical and mental health. Despite a few studies noting the association of chronotype with healthy dietary patterns, this relationship remains unclear. PURPOSE: This study aimed to describe the association of chronotype with healthful and unhealthful plant-based diet quality in female Japanese undergraduate students. DESIGN: Cross-sectional. PARTICIPANTS AND SETTING: A total of 218 female university students in Tokyo, Japan. MAIN OUTCOME MEASURES: Healthful and unhealthful plant-based dietary index-Japanese version (hPDI-J and uPDI-J), calculated using the validated brief-type self-administered diet history questionnaire. STATISTICAL ANALYSES PERFORMED: A five-model stepwise multiple linear regression analysis was conducted. Independent variables were hPDI-J and uPDI-J scores, and dependent variables were various lifestyle habits related to the circadian rhythm and demographic characteristics. RESULTS: Mean (standard deviation) sleep duration, midpoint of sleep, sleep latency time, and social jetlag were 411 (60) min, 03:56 (00:57), 21 (27) min, and 50 (39) min, respectively. Chronotype and several variables, such as residential status, energy and alcohol intake, and nutritional knowledge, were associated with healthful and unhealthful plant-based diet quality. Individuals who had higher hPDI-J scores were more likely to have an earlier chronotype (ß = -0.168, P = 0.019) and better nutritional knowledge (ß = 0.164, P = 0.022) than those with lower hPDI-J scores. Individuals were more likely to have higher uPDI-J scores if they were living alone (ß = -0.301, P < 0.001), had a later chronotype (ß = 0.181, P = 0.001), higher frequency of snacking (ß = 0.164, P = 0.019), lower total energy (ß = -0.445, P < 0.001), and worse nutritional knowledge (ß = -0.172, P = 0.001). CONCLUSION: This study provided new evidence as to the relationship between sleep and dietary habits, the interaction of which may affect women's health.

Is mindful eating sustainable and healthy? A focus on nutritional intake, food consumption, and plant-based dietary patterns among lean and normal-weight female university students in Japan.

PURPOSE: This study aimed to investigate the correlation between mindful eating and nutritional intake, food consumption, and healthful and unhealthful plant-based dietary patterns in young Japanese women. METHODS: The sample comprised 215 female undergraduates who responded to a two-questionnaire anonymous survey conducted in Tokyo, Japan in 2018 and 2019 from November to December. We measured mindful eating status using the Expanded Mindful Eating Scale (EMES) and used Japanese plant-based dietary indices to determine plant-based dietary patterns. Partial correlation analyses were conducted to determine the correlation of mindful eating with energy and nutrient intake, food consumption, and plant-based dietary patterns, after adjusting for demographics and body mass index. RESULTS: Participants with higher sub-scores in "health of the planet" and "awareness and appreciation for food" ate higher quantities of several micronutrients and plant-based foods and were more likely to have a healthful plant-based dietary pattern. They were also less likely to have an unhealthful plant-based dietary pattern. In contrast, participants with higher scores in "non-judgmental awareness" ate less protein, whole grains, and vegetables, and were likely to have an unhealthful plant-based dietary pattern. CONCLUSION: This study is the first to show that young Japanese women with normal or lean body weight were more likely to consume healthful plant-based foods when they ate mindfully. LEVEL V: Opinions of respected authorities, based on descriptive studies, narrative reviews, clinical experience, or reports of expert committees.

Modified model for predicting early C-reactive protein levels after gastrointestinal surgery: A prospective cohort study.

BACKGROUND: Postoperative serum concentration of C-reactive protein (CRP) is one of the objective quantitative indices integrating the effects of preoperative and intraoperative variables. Higher levels of CRP after gastrointestinal surgery are associated with major postoperative complications. To develop a model for predicting CRP levels on postoperative day (POD) 1 in surgical patients both with and without serious conditions and comorbidities, we modified the previous formula for prediction of CRP levels on POD1, and assessed the accuracy of our modified predictive formula for CRP levels. MATERIAL AND METHODS: Consecutive patients of all ages undergoing gastrointestinal surgery under general anesthesia were enrolled in this single-institution prospective cohort study. We developed a modified predictive formula in a calculation cohort. Next, associations between measured CRP levels on POD1, predicted CRP levels on POD1 using the previous and modified models, and major complications after surgery were examined in a validation cohort. RESULTS: We obtained the following model in the calculation cohort (n = 222): Modified model for predicting CRP levels on POD1 (mg•dL-1) = -10.13 + 0.0025 Duration of surgery (min) + 15.9 Mean Nociceptive Response (NR) + 0.66 Preoperative CRP level (mg•dL-1). In the validation cohort (n = 440), there was a significant association between measured and predicted CRP levels on POD1 (P < 0.001) No significant difference between the measured and predicted CRP levels using the modified model was observed (P = 0.847). There were also significant associations between the predicted CRP levels and major complications after surgery. CONCLUSION: CRP levels predicted using duration of surgery, mean NR, and preoperative CRP levels are likely identical to measured CRP levels on POD1, being associated with major complications after gastrointestinal surgery.

Development and validation of the Expanded Mindful Eating Scale.

PURPOSE: To develop and validate the Expanded Mindful Eating Scale (EMES), an expanded mindful eating model created for the promotion of health and sustainability. DESIGN/METHODOLOGY/APPROACH: A cross-sectional study using self-administered questionnaire surveys on Ochanomizu Health Study (OHS) was conducted. The survey was provided to 1,388 female university students in Tokyo, Japan. Exploratory factor analysis (EFA), confirmatory factor analysis (CFA) and a partial correlation analysis were used to confirm construct and criterion validity. Internal consistency of the EMES was confirmed to calculate Cronbach's alpha. FINDINGS: The response rate was 38.7 % (n = 537). Mean BMI was 20.21 ± 2.12, and 18.8% of them were classified as "lean" (BMI < 18.5). The authors listed 25 items and obtained a final factor structure of five factors and 20 items, as a result of EFA. Through CFA, the authors obtained the following fit indices for a final model: GFI = 0.914, AGFI = 0.890, CFI = 0.870 and RMSEA = 0.061. The total EMES score was significantly correlated with BMI, mindfulness, body dissatisfaction, drive for thinness and life satisfaction (r = -0.138, -0.315, -0.339, -0.281 and 0.149, p < 0.01, respectively). Cronbach's alpha for all items in this scale was 0.687. PRACTICAL IMPLICATIONS: The authors suggest the possibility that practitioners and researchers of mindful eating that includes this new concept can use authors' novel scale as an effective measurement tool. ORIGINALITY/VALUE: The EMES, which can multidimensionally measure the concept of the expanded model of mindful eating was first developed in this study.

Effects of Simulation Study of High Neuraxial Block During Epidural Analgesia for Labor Pain on Pre/Posttest Evaluation in Junior Clinical Trainees.

BACKGROUND: Since a high neuraxial block is one of the serious complications in obstetric anesthesia, simulation training is required for the education of rapid diagnosis and treatment of this complication. OBJECTIVES: This study aimed to evaluate the effects of a simulation study of the high neuraxial block during epidural analgesia for labor pain on pre- and post-simulation tests in junior clinical trainees, who had graduated a medical school within one or two years and being under a two-month program for anesthesia during the Japanese Postgraduate Medical Education. METHODS: Twenty-two junior clinical trainees participated in this study from September 2016 to May 2017. Before the simulation training, the participants answered a pretest, providing written responses on "how to approach and treat the rapid spread of anesthesia (high neuraxial block) in painless epidural delivery" in a bullet-point form. The number of correct answers to 12 items was counted for each participant. These items were as follows: mask ventilation, preparation for tracheal intubation, oxygenation, supraglottic airway placement, checking the breathing, checking oxygen saturation using pulse oximetry, checking blood pressure, ephedrine injection, checking epidural tube, assessing the level of sensory block, assessing the level of consciousness, and left uterine displacement. After performing our original training, all participants were debriefed and written responses were obtained to a posttest containing the same content as the pretest. RESULTS: The percentage of correct answers significantly increased from 8.3 to 16.7% (P = 0.041) after training. The response rates for "mask ventilation" and "check epidural tube" significantly increased from 13.6 to 54.5% (P = 0.004) and from 4.5 to 27.3% (P = 0.039), respectively, after training. CONCLUSIONS: Simulation training is likely an effective method for junior clinical trainees on studying diagnosis and treatment of high neuraxial block during epidural analgesia in parturient patients.

Appreciation for food, an important concept in mindful eating: association with home and school education, attitude, behavior, and health status in Japanese elementary school children.

BACKGROUND: Appreciating food is an important concept in mindful eating, mentioned by advocates of an expanded model of mindful eating in 2016. With the exception of Japan, this concept is not common in many countries. OBJECTIVE: We aimed to describe the role that appreciation for food has in the health of children from two perspectives: 1) association between children's appreciation for food and their backgrounds, such as home and school educational experiences related to food, and 2) association between their appreciation for food and outcomes, such as attitude toward food, eating behaviors, and health status. DESIGN: Cross-sectional. METHODS: Data were obtained from self-administered anonymous questionnaires sent to 2070 elementary school students in Tokyo, Japan, during October and December 2006. They contained several question items pertaining to the characteristics of participants: home and school educational experiences related to food, attitudes towards food (including level of appreciation for food), eating behaviors, and health status. T-test, Pearson's correlation coefficient, and simple and multiple linear regression analyses were used to compare the total score of appreciation for food with other factors. RESULTS: Surveys were completed by 1994 children (response rate: 96.3%) and significant correlations were indicated by gender, educational experiences at home and school, attitudes toward healthy food, recommended food preferences, breakfast consumption, and body mass index. CONCLUSIONS: We concluded that appreciation for food plays an important role in children's health.

Differences in characteristics of raters who use the visual estimation method in hospitals based on their training experiences.

BACKGROUND & AIMS: Despite a clinical need, only a few studies have provided information concerning visual estimation training for raters to improve the validity of their evaluations. This study aims to describe the differences in the characteristics of raters who evaluated patients' dietary intake in hospitals using the visual estimation method based on their training experiences. METHODS: We collected data from three hospitals in Tokyo from August to September 2016. The participants were 199 nursing staff members, and they completed a self-administered questionnaire on demographic data; working career; training in the visual estimation method; knowledge, attitude, and practice associated with nutritional care; and self-evaluation of method validity of and skills of visual estimation. We classified participants into two groups, experienced and inexperienced, based on whether they had received training. Square test, Mann-Whitney U test, and univariable and multivariable logistic regression analysis were used to describe the differences between these two groups in terms of their characteristics; knowledge, attitude, and practice associated with nutritional care; and self-evaluation of method validity and tips used in the visual estimation method. RESULTS: Of the 158 staff members (79.4%) (118 nurses and 40 nursing assistants) who agreed to participate in the analysis, thirty-three participants (20.9%) were trained in the visual estimation method. Participants who had received training had better knowledge (2.70 ± 0.81, score range was 1-5) than those who had not received any training (2.34 ± 0.74, p = 0.03). Score of self-evaluation of method validity of the visual estimation method was higher in the experienced group (3.78 ± 0.61, score range was 1-5) than the inexperienced group (3.40 ± 0.66, p < 0.01). Mean total scores of using tips in the visual estimation method in the experienced and inexperienced groups were 19.6 ± 1.76 and 17.9 ± 2.28, respectively (score range was 6-24), differing significantly between the two groups (p < 0.01). Multivariable logistic regression revealed that participants who had been trained had adequate knowledge (OR: 2.78, 95% CI: 1.05-7.35) and frequently used tips in visual estimation (OR: 1.85, 95% CI: 1.26-2.73). CONCLUSION: Trained participants had more required knowledge and they used visual estimation tips more frequently than participants who had not been trained in the visual estimation method. This study provides new evidence for the importance of training clinical staff members to use the visual estimation method appropriately and makes suggestions to improve the validity of the visual estimation method.

Differences in the validity of a visual estimation method for determining patients' meal intake between various meal types and supplied food items.

BACKGROUND & AIMS: The aim of this study was to examine differences in the validity of a visual estimation method for determining patients' meal intake between various meal types and supplied food items in hospitals and to find factors influencing the validity of a visual estimation method. METHODS: There are two procedures by which we obtained the information on dietary intake of the patients in these hospitals. These are both by visual assessment from the meal trays at the time of their clearing, by the attending nursing staff and by weighing conducted by researchers. The following criteria are set for the target trays: A) standard or therapeutic meals, which are monitored by a doctor, for energy and/or protein and/or sodium; B) regular, bite-sized, minced and pureed meal texture, and C) half-portion meals. Visual assessment results were tested for their validity by comparing with the corresponding results of weighing. Differences between these two methods indicated the estimated and absolute values of nutrient intake. RESULTS: A total of 255 (76.1%) trays were included in the analysis out of the 335 possible trays and the results indicated that the energy consumption estimates by visual or weighing procedures are not significantly different (412 ± 173 kcal, p = 0.15). However, the mean protein consumption was significantly different (16.3 ± 6.7 g/tray, p < 0.01) between the two procedures. Compared with standard meals (38 ± 45 kcal, 1.9 ± 2.5 g/tray), raters significantly misestimated the energy and protein intake of half-portion meals (78 ± 65 kcal, 2.8 ± 2.2 g/tray, p = 0.01) but accurately estimated the protein intake of protein controlled meals (0.5 ± 0.6 g/tray, p = 0.03). Trays adding supplied food items were significantly misestimated for energy intake (66 ± 58 kcal/tray) compared to trays with no additions (32 ± 39 kcal/tray, p < 0.01). Moreover, the results of multivariable analysis demonstrated that supplied food items were significantly associated with increased odds of a difference between the two methods (OR: 3.84; 95% confidence interval [CI]: 1.07-13.85). CONCLUSIONS: There were high correlations between the visual estimation method and the weighing method measuring patients' dietary intake for various meal types and textures, except for meals with added supplied food items. Nursing staff need to be attentive to supplied food items.

Carbohydrate intake during early pregnancy is inversely associated with abnormal glucose challenge test results in Japanese pregnant women.

BACKGROUND: In East Asian countries, which have a high prevalence of underweight individuals, there is little information about the association between dietary factors and abnormal glucose tolerance during pregnancy. We examined the association between carbohydrate intake and moderately abnormal glucose tolerance in Japanese pregnant women. METHODS: We conducted a prospective study on 325 Japanese pregnant women without a diagnosis of diabetes mellitus prior to pregnancy. Dietary carbohydrate intake (% of total energy intake) was assessed using a 3-day dietary record during weeks 8-15 of pregnancy. Glucose tolerance was assessed by the 50 g glucose challenge test (GCT) during weeks 24-28 of pregnancy. A positive GCT result was defined by a 1-hour plasma concentration ≥ 7.8 mmol/L. Odds ratios of a positive GCT were calculated for the top and middle tertile categories of carbohydrate intake using the bottom category as reference. RESULTS: Mean (standard deviation) body mass index at the first prenatal visit was 19.7 (1.9) kg/m2 , and 95 women were underweight. Seventy-four women had positive GCT results. Carbohydrate intake was negatively associated with a positive GCT result after adjusting for age, parity, body mass index at first prenatal visit, family history of diabetes mellitus, rate of gestational weight gain, energy intake, and dietary fiber intake (odds ratio for top category: 0.46 [95% CI, 0.23-0.93]). CONCLUSIONS: These findings suggest that high carbohydrate intake was negatively associated with moderately abnormal glucose tolerance in a population with a high prevalence of underweight individuals.

Barriers to accurately measuring patients' dietary intake in hospitals using the visual estimation method.

Purpose Visual estimation, an easy-to-perform technique, is commonly used in hospitals to assess dietary intake in patients. The authors performed a qualitative study where the authors interviewed nurses and dietitians about their perceptions of barriers to accurately measuring patients' dietary intake in hospitals using the visual estimation method. The paper aims to discuss these issues. Design/methodology/approach Ten dietitians and ten clinical nurses responded to 30-minute individual interviews in Tokyo, Japan, in September 2014. Each interview was conducted using a common protocol of open-ended questions focusing on the challenges of the visual estimation method and barriers to accurately measuring patients' dietary intake as part of their routine work. The tape-recorded interviews were transcribed and analyzed based on grounded theory. Findings Five main categories emerged: hospitals, meals, colleagues, raters, and patients. Various individual barriers such as skill, attitude, knowledge, and others that had not been considered in previous studies also emerged. External barriers that were out of the raters' control, such as shortage of time, human resources, financial ability, and others, emerged from the "hospitals" category. Research limitations/implications Research participants were all females and many of them had less than ten years of experience. Practical implications In addition to standardizing the visual estimation process, medical staff need to overcome various other internal and external barriers to accurate measurements. Originality/value This is the first study to articulate some important barriers that influence reliability and validity when measuring patients' dietary intake by visual estimation methods in typical clinical settings.

Criterion validity of the visual estimation method for determining patients' meal intake in a community hospital.

BACKGROUND & AIMS: The accuracy of the visual estimation method is unknown, even though it is commonly used in hospitals to measure the dietary intake of patients. We aimed to compare the difference in the validity of visual estimation according to the raters' job categories and tray divisions, and to demonstrate associations between meal characteristics and validity of visual estimation in a usual clinical setting in a community hospital. METHODS: We collected patients' dietary intake data in usual clinical settings for each tray in 3 ways: visual estimation by nursing assistants, visual estimation by dietitians, and weighing by researchers (reference method). Dietitians estimated the dietary intake using 2 divisions, namely, whole tray and food items. Then we compared the weights and visual estimation data to evaluate the validity of the visual estimation method. RESULTS: Mean nutrient consumption of target trays was significantly different when using the visual estimation of target trays than when using the weighed method (visual estimation by nursing assistants [589 ± 168 kcal, 24.3 ± 7.0 g/tray, p < 0.01], dietitians' whole trays [561 ± 171 kcal, 23.0 ± 6.9 g/tray, p < 0.05], food items [562 ± 171 kcal/tray, p < 0.05], and dietitians' food items [23.4 ± 7.3 g/tray, p = 0.63]). Spearman's correlations for both methods were very high for energy (ρ = 0.91-0.98, p < 0.01) and protein intakes (ρ = 0.88-0.96, p < 0.01), respectively. The limits of agreement in the Bland-Altman plot for both dietary intake categories were -121 kcal to 147 kcal/tray and -6.4 g to 7.0 g/tray (nursing assistants, whole division), -122 kcal-106 kcal/tray and -6.7 g to 5.5 g/tray (dietitians, whole divisions), and -82 kcal to 66 kcal/tray and -4.3 g to 3.9 g/tray (dietitians, food items divisions). High intake rate of grains was significantly associated with decreased odds of a difference between two methods based on the nursing assistant's whole tray evaluation (odds ratio [OR]: 0.85; 95% confidence interval [CI]: 0.76-0.94) and the dietitians' whole tray (OR: 0.80; 95% CI: 0.72-0.89) and food items evaluations (OR: 0.64; 95% CI: 0.56-0.73), respectively. In addition, minced meals were also associated with a difference between two methods, for the nursing assistants' whole tray (OR: 3.53; 95% CI: 1.66-7.51) and dietitians' food items (OR: 2.92; 95% CI: 1.37-6.22). CONCLUSIONS: Visual estimation by nursing assistants and dietitians correlated highly with the weighing method although the limits of agreement were wide. Nursing assistants and dietitians should pay attention to low consumption and modified texture meals when evaluating dietary intake using the visual estimation method.