In this study, we conducted interviews with staff members who had experience in discharge coordination to clarify the characteristics and efforts of discharge coordination for patients with pediatric cancer toward end-of-life. Focus group interviews were conducted with 11 individuals, including six medical social workers and five nurses (acceptance rate: 84.6%) and a qualitative inductive analysis was conducted. Seven categories were identified as characteristics of discharge coordination for patients with pediatric cancer toward the end-of-life, such as “few home physicians and home health care nurses who could accept terminally ill children” and “a small number of cases and lack of accumulated experience”. Seven categories were identified as efforts of discharge coordination, including “maintaining connections with the community” in three situations: coordination with home physicians and home-visit nursing care, coordination with children and their families, and coordination in hospitals. The number of children who spend their end-of-life days at home is increasing, and we believe that it is necessary to consider expanding the role of pediatric cancer base hospitals in the future, such as collecting information in the community and sharing good practices.

Background: Prompt awakening and sufficient recovery of psychomotor and equilibrium functions are important for day surgery. Flumazenil accelerates recovery of consciousness after remimazolam anesthesia, but its effects on psychomotor and equilibrium functions are not well known. The purpose of this study was to determine whether flumazenil improves time to recovery, psychomotor, and equilibrium functions in subjects undergoing remimazolam anesthesia. Methods: The design was a single-center, double-blind, randomized, controlled trial. Inclusion criteria were patients aged 18–64 years scheduled for oral surgery under remimazolam anesthesia, with American Society of Anesthesiologists physical status I or II. The predictor variable was the use of a reversal agent (flumazenil group) versus placebo (non-flumazenil group). The primary outcome variable was recovery from sedation measured using the Modified Observer’s Alertness/Sedation (MOAA/S) scale for wakefulness. Secondary outcome variables were psychomotor function measured using the Trieger Dot Test (number of dots missed [NDM], maximum distance of dots missed [MDDM]), and the digit symbol substitution test (DSST), as well as equilibrium function measured using the timed up and go test (TUG), and gravimetric area and speed. Statistical analyses were performed using the Mann-Whitney U test, χ² test, Student’s t-test, two-way ANOVA, and Bonferroni correction. P-values < 0.05 were considered significant. Results: Sixty-eight subjects were included (male: 33, female: 35). The mean time from extubation to an MOAA/S score of 5 (minutes) was 6.5 (1.5–10.5) in the flumazenil group and 13.5 (6.8–19.3) in the non-flumazenil group (P = 0.01). There was no significant difference in the recovery of psychomotor and balance functions between the two groups. However, the following measurements were significantly increased compared to baseline: NDM (P < 0.001) and DSST (P < 0.001) at 30 minutes, MDDM (P < 0.001), TUG (P < 0.001), and gravimetric speed (P < 0.001) at 60 minutes, and gravimetric area (P = 0.03) at 90 minutes. Conclusion Administration of flumazenil after remimazolam anesthesia resulted in faster recovery of consciousness, but it did not affect the recovery of psychomotor and equilibrium functions. The time until patients were safe to return home was 120 minutes. Flumazenil did not improve the time until it was safe for patients to return home.

Background: Prompt awakening and sufficient recovery of psychomotor and equilibrium functions are important for day surgery. Flumazenil accelerates recovery of consciousness after remimazolam anesthesia, but its effects on psychomotor and equilibrium functions are not well known. The purpose of this study was to determine whether flumazenil improves time to recovery, psychomotor, and equilibrium functions in subjects undergoing remimazolam anesthesia. Methods: The design was a single-center, double-blind, randomized, controlled trial. Inclusion criteria were patients aged 18–64 years scheduled for oral surgery under remimazolam anesthesia, with American Society of Anesthesiologists physical status I or II. The predictor variable was the use of a reversal agent (flumazenil group) versus placebo (non-flumazenil group). The primary outcome variable was recovery from sedation measured using the Modified Observer’s Alertness/Sedation (MOAA/S) scale for wakefulness. Secondary outcome variables were psychomotor function measured using the Trieger Dot Test (number of dots missed [NDM], maximum distance of dots missed [MDDM]), and the digit symbol substitution test (DSST), as well as equilibrium function measured using the timed up and go test (TUG), and gravimetric area and speed. Statistical analyses were performed using the Mann-Whitney U test, χ² test, Student’s t-test, two-way ANOVA, and Bonferroni correction. P-values < 0.05 were considered significant. Results: Sixty-eight subjects were included (male: 33, female: 35). The mean time from extubation to an MOAA/S score of 5 (minutes) was 6.5 (1.5–10.5) in the flumazenil group and 13.5 (6.8–19.3) in the non-flumazenil group (P = 0.01). There was no significant difference in the recovery of psychomotor and balance functions between the two groups. However, the following measurements were significantly increased compared to baseline: NDM (P < 0.001) and DSST (P < 0.001) at 30 minutes, MDDM (P < 0.001), TUG (P < 0.001), and gravimetric speed (P < 0.001) at 60 minutes, and gravimetric area (P = 0.03) at 90 minutes. Conclusion Administration of flumazenil after remimazolam anesthesia resulted in faster recovery of consciousness, but it did not affect the recovery of psychomotor and equilibrium functions. The time until patients were safe to return home was 120 minutes. Flumazenil did not improve the time until it was safe for patients to return home.

Background: Prompt awakening and sufficient recovery of psychomotor and equilibrium functions are important for day surgery. Flumazenil accelerates recovery of consciousness after remimazolam anesthesia, but its effects on psychomotor and equilibrium functions are not well known. The purpose of this study was to determine whether flumazenil improves time to recovery, psychomotor, and equilibrium functions in subjects undergoing remimazolam anesthesia. Methods: The design was a single-center, double-blind, randomized, controlled trial. Inclusion criteria were patients aged 18–64 years scheduled for oral surgery under remimazolam anesthesia, with American Society of Anesthesiologists physical status I or II. The predictor variable was the use of a reversal agent (flumazenil group) versus placebo (non-flumazenil group). The primary outcome variable was recovery from sedation measured using the Modified Observer’s Alertness/Sedation (MOAA/S) scale for wakefulness. Secondary outcome variables were psychomotor function measured using the Trieger Dot Test (number of dots missed [NDM], maximum distance of dots missed [MDDM]), and the digit symbol substitution test (DSST), as well as equilibrium function measured using the timed up and go test (TUG), and gravimetric area and speed. Statistical analyses were performed using the Mann-Whitney U test, χ² test, Student’s t-test, two-way ANOVA, and Bonferroni correction. P-values < 0.05 were considered significant. Results: Sixty-eight subjects were included (male: 33, female: 35). The mean time from extubation to an MOAA/S score of 5 (minutes) was 6.5 (1.5–10.5) in the flumazenil group and 13.5 (6.8–19.3) in the non-flumazenil group (P = 0.01). There was no significant difference in the recovery of psychomotor and balance functions between the two groups. However, the following measurements were significantly increased compared to baseline: NDM (P < 0.001) and DSST (P < 0.001) at 30 minutes, MDDM (P < 0.001), TUG (P < 0.001), and gravimetric speed (P < 0.001) at 60 minutes, and gravimetric area (P = 0.03) at 90 minutes. Conclusion Administration of flumazenil after remimazolam anesthesia resulted in faster recovery of consciousness, but it did not affect the recovery of psychomotor and equilibrium functions. The time until patients were safe to return home was 120 minutes. Flumazenil did not improve the time until it was safe for patients to return home.

In response to the outbreak of coronavirus disease 2019 (COVID-19) in Japan, a national COVID-19 cluster taskforce (comprising governmental and nongovernmental experts) was established to support the country’s Ministry of Health, Labour and Welfare in conducting daily risk assessment. The assessment was carried out using established infectious disease surveillance systems; however, in the initial stages of the pandemic these were not sufficient for real-time risk assessment owing to limited accessibility, delay in data entry and inadequate case information. Also, local governments were publishing anonymized data on confirmed COVID-19 cases on their official websites as daily press releases. We developed a unique database for nationwide real-time risk assessment that included these case lists from local government websites and integrated all case data into a standardized format. The database was updated daily and checked systematically to ensure comprehensiveness and quality. Between 15 January 2020 and 15 June 2021, 776 459 cases were logged in the database, allowing for analysis of real-time risk from the pandemic. This semi-automated database was used in daily risk assessments, and to evaluate and update control measures to prevent community transmission of COVID-19 in Japan. The data were reported almost every week to the Japanese Government Advisory Panel on COVID-19 for public health responses.

Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Results: Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37). Conclusions This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Results: Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37). Conclusions This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

Background/Aims: Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings. Methods: This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI). Results: The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks. Conclusions Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

Chinese Medicine Questionnaire (CCMQ-J) consists of sixty independent questionnaires and 9 physical constitutions called subscales. One type is balanced constitution (i.e., gentleness), and the following eight types represent unbalanced constitution: Qi-deficiency constitution, Yang-deficiency constitution, Yin-deficiency constitution, Phlegm-dampness constitution, Damp-heat constitution, Stagnant Blood constitution, Stagnant Qi constitution, and Inherited Special constitution. In this study, we proposed to determine optimal number of groups in 851 participants recruited from crowdsourcing answered CCMQ-J questionnaire consisting of 60 questions. In the present study, we applied k-means clustering with gap statistics to the questionnaire data and the number of optimal groups was estimated by five. The five groups are mainly characterized by 3 subscales in CCMQ-J, i.e. (i) two subscales corresponding to Yang-deficiency and Qi-depress, (ii) three subscales corresponding to gentleness, Yang-deficiency and Qi-depress (iii) Yang-deficiency, (iv) gentleness, and (v) Qi-depress. In the crowdsourcing survey, two subscales, Yang-deficient and Qi-depress are the most frequently occurred in current Japanese people.

In this study, we proposed an approach to interpret the classification of body constitution based on the Japanese Version of Constitution in Chinese Medicine Questionnaire (CCMQ-J) in terms of an augmented questionnaire combining seven independent questionnaires. The augmented questionnaire consists of 254 questions in terms of seven categories of attributes, which are the (i) basic information (BI), (ii) disease (DI), (iii) social factors (SO), (iv) mental factors (ME), (v) dietary habits (DH), (vi) sleeping state (SL), and (vii) sub-health (SH). The partial least square (PLS) regression has been adopted to model the correlations between the scores of body constitutions and the questions, and their results show that the body constitution can be represented by the linear combination of the questions substantially (correlation coefficients between the true and predicted constitutions are all above 0.7). Moreover, by using the crowdsourcing technique in data collection, a total of 851 samples (350 males and 501 females between 20 and 85 years old) samples with diverse geographical backgrounds in Japan have been collected, from which new medical implications have been extracted through the discussion in a Traditional Chinese Medicine standpoint. This study serves as a crucial step for validating the philosophy of ancient Chinese medicine by the state-of-the-art information science techniques and facilitating the use of the CCMQ-J in public healthcare.