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Background: Families raising children with disabilities assume risks to their health and lives. Therefore, it is necessary to support these families to improve family empowerment, which is the ability of these families to control their own lives and to promote the collaborative raising of children with disabilities. This is the first online intervention program focusing on the empowerment of families raising children with disabilities who live at home in Japan. Method: The program consists of four online peer-based group sessions. Moreover, the families engage in several activities in stages wherein they discover their own issues, find measures to resolve them, and take action, while visualizing interfamily relationships, including social resources, and the status of their family life, with facilitators and other peer members. This study is a non-randomized, waitlist-controlled trial. It compares the results of the intervention group (early group) and the waitlist-controlled group (delayed group). The participants are allocated to the early or delayed group in the order of their applications. The main outcome is family empowerment. Other outcomes are the caregiver burden, self-reported capability to use social resources, self-compassion, and the quality of life (QOL) of primary caregivers. The timeline of the online outcome evaluation is as follows: the initial evaluation (Time 1 [T1]) is conducted before the start of the first early group program, and post-intervention evaluation (Time 2 [T2]) is conducted immediately (within 1 week) after the early group completes all four sessions (4 weeks) of the program. Follow-up evaluation (Time 3 [T3]) is conducted 4 weeks after the post-intervention evaluation. This timing is the same in the delayed group, but the delayed group will attend the program after a 4-week waiting period, compared to the early group. Discussion: The intention is to evaluate whether the provision of the program developed in this study and the evaluation test design are feasible and to verify the efficacy of this program. Trial registration: The UMIN Clinical Trials Registry (UMIN000044172), registration date: May 19, 2021. [ABSTRACT FROM AUTHOR]

Background: PedsQL Infant Scales (PedsQL-I) are used to assess parent-reported health-related quality of life for children younger than 2 years. We determined the feasibility, reliability, and validity of the Japanese version of the PedsQL-I. Methods: A total of 183 participants (parents) with infants aged 1–30 months were recruited from 8 day care centers and one pediatric clinic. Participants completed the PedsQL-I (infants aged 1–18 months), the PedsQL-I and the PedsQL-Toddler version (infants aged 19–30 months), and the Kessler-6 psychological distress scale (all participants). We determined feasibility, internal consistency, test–retest reliability, concurrent validity, convergent and discriminant validity, known-groups validity with regard to acute and chronic illness, and relative and transitional validity with PedsQL-Toddler for the use in infants aged 25–30 months. Results: All subscales were internally consistent (Cronbach's alpha for 1–12 months: 0.88–0.98 and for 13–24 months: 0.85–0.97); test–retest reliability was acceptable (intra-class correlation coefficients > 0.40); and all scales were concurrently valid with the PedsQL-Toddler version (Pearson's product-moment correlation coefficient for the total score = 0.74). The scales' convergent and discriminant validity were acceptable (scaling success rate > 80%). Validation for known-groups showed that the Physical Health Summary score was sensitive to acute and chronic disease, the Psychosocial Health Summary score was sensitive to neither acute nor chronic disease, and the total score was sensitive to acute disease. Relative validity showed a ratio of 1.74 for the squared t values for the total score. Conclusions: The PedsQL-I is suitable for assessing health-related quality of life in infants aged 1–24 months in prospective studies. [ABSTRACT FROM AUTHOR]

Aim: Nurses are expected to have a role in the transition of care from pediatric to adult medical practices for adolescents and young adults with childhood‐onset chronic diseases. This study compares the experience, knowledge, and perceptions regarding the ideal care among adult unit and pediatric nurses regarding the transition to adult care for those with childhood‐onset chronic diseases. Methods: A cross‐sectional study using self‐report questionnaires was conducted with nurses in a tertiary hospital in Tokyo. Questions were generated based on a literature review and expert discussion. Data from 1,064 participants were analyzed (adult unit nurses: n = 959, 90.1%; pediatric nurses: n = 105, 9.9%). Results: Among 623 adult unit nurses who had care experience for adult patients with a childhood‐onset chronic disease, 458 nurses (73.6%) were unaware of the concept of transitional care. As the obstructive factors for transition, pediatric nurses recognized problems in healthcare providers' attitudes and lack of transitional care coordinators, while the adult unit nurses emphasized the patients' wishes to continue to receive pediatric healthcare. Most adult unit nurses expected pediatric nurses to function as transitional care coordinators. Conclusion: Adult unit and pediatric nurses had different perceptions of the barriers in transitioning children with chronic diseases to adult care. It is important to have educational programs focusing on transitional care for all nurses, both to enable pediatric nurses to improve transition readiness of children with chronic diseases and to offer adult patients with a childhood‐onset chronic disease continuing support through adult unit nurses. [ABSTRACT FROM AUTHOR]

Background: Reducing non-completion of quality-of-life assessment in clinical trials is an important challenge in obtaining accurate data and unbiased interpretation of patients' quality-of-life for each regimen. We evaluated the effect of changing our questionnaire distribution procedure in a multicenter phase II/III trial on the response rate to a quality-of-life questionnaire. Methods: In the trial, we distributed 1767 questionnaires and 1045 were returned. We adopted a regression discontinuing design and estimated the change in response rate between pre-intervention (quality-of-life questionnaires were sent to each center soon after patient registration) and post-intervention (a set of tailored questionnaires was sent just before the first quality-of-life assessment). Results: The post-intervention response rate was higher (odds ratio = 1.62) than the pre-intervention response rate. Conclusions: A simple logistic intervention reduced the non-completion of QOL assessment in this case, suggesting that a simple change can contribute to improving clinical trial accomplishment. [ABSTRACT FROM AUTHOR]

Aim: The present study aimed to examine the associations among behavioral and psychological symptoms of dementia (BPSD) of persons with dementia (PWD), care burden and family‐to‐work conflict (FWC) of employed family caregivers. Method: A cross‐sectional study was carried out with employed adult daughter or son (or in‐law) caregivers for PWD from two rural cities in Japan. FWC, care burden and the degree of BPSD were evaluated by the Survey Work‐Home Interaction‐NijmeGen, Zarit Burden Scale‐Short Version and Dementia Behavior Disturbance Scale, respectively. Of the 200 questionnaires distributed, 130 were returned. A total of 53 respondents were not employed, and seven questionnaires had missing data for demographic variables, Survey Work‐Home Interaction‐NijmeGen, Zarit Burden Scale‐Short Version or Dementia Behavior Disturbance Scale. Thus, complete data from 70 respondents were analyzed through structural equation modeling. Results: The mean age of employed family caregivers was 56 years, and 34 (48.5%) were men. The mean age of PWD was 84 years, and there were 68 (68.6%) men. The path model with a good fit was shown (root mean square error of approximation 0.136, comparative fit index 0.960 and goodness of fit index 0.965). The path model showed that BPSD affected FWC, and that the association was partially mediated by care burden. Conclusions: The results show that a decrease in not only care burden, but also BPSD, of PWD is important for employed family caregivers to reduce their FWC and maintain their work–life balance. Geriatr Gerontol Int 2019; 19: 51–55. [ABSTRACT FROM AUTHOR]

Abstract: Background: Health‐related quality of life (HRQOL) is an important outcome in solid organ transplantation. This study evaluated and explored the factors of generic and transplant‐specific HRQOL in Japanese pediatric and adolescent patients with biliary atresia (BA) after living donor liver transplant (LDLT). Methods: A cross‐sectional survey using anonymous questionnaires was completed between April and July 2015. Patient medical records were accessed. The Japanese version of Pediatric Quality of Life InventoryTM Generic Core Scales and Transplant Modules (child self‐report and parent proxy‐report) was administered. Results: Participants consisted of 75 patients (mean age at survey, 9.6 years) and 74 parents. Japanese patients reported higher generic and transplant‐specific HRQOL (total score) than that reported by US patients with BA after LT (US I; age at survey, 7.2 years) and by US patients after solid organ transplant (US II; age at survey, 11.3 years; LT, 53.8%; effect size, 0.55–0.96). Japanese parents, however, rated their children's generic HRQOL (total score) similar to that rated by the US I and II parents (0.13 and 0.30, respectively) and reported lower transplant‐specific HRQOL (total score) than that reported by US II (0.26). Although the number of types of prescribed drugs was a common factor in HRQOL, most demographic and medical factors (e.g. child's age at survey and consultation frequency) varied with reporter (i.e. patients and parents). Conclusions: The levels and factors of generic and transplant‐specific HRQOL of Japanese pediatric and adolescent patients with BA after LDLT varied with reporter (i.e. patients or parents). [ABSTRACT FROM AUTHOR]

Objective: The present study clarified factors related to mother-child communication openness when fathers suffer neurobehavioural sequelae after stroke or traumatic brain injury. Research design: A cross-sectional study using self-report anonymous questionnaires was conducted. Methods and procedures: Forty-one mothers with 6-22-year-old children participated. The questionnaire examined personal factors (mother's psychological distress), social/family factors (family support functioning), illness-related factors (father's time at home and neurobehavioural sequelae severity) and mother's perceived level of open communication. Multiple regression was used to analyse factors related to mother-child communication openness. Results:Mother-child open communication was explained by family support functioning (β = 0.449), father's time at home (β = -0.325) and mother's psychological distress (β = -0.303). Neurobehavioural sequelae severity was not associated with mother-child open communication. Conclusions: Personal, social/family and illness-related factors were related to mother-child communication about paternal illness. Professionals should promote optimal family support functioning, connect families with external resources and assess families' interaction processes. [ABSTRACT FROM AUTHOR]

Background Health-related quality of life ( HRQOL) is an important outcome in pediatric solid organ transplantation. Considering the emerging problems after transplantation, an evaluation of transplant-specific aspects of HRQOL is essential, but no validated HRQOL measure is available in Japan. The aim of this study was therefore to develop the Japanese version of the Pediatric Quality of Life Inventory™ (Peds QL) Transplant Module Child Self-Report and to investigate its feasibility, reliability, and validity. Methods Based on the Peds QL linguistic validation process, the Japanese version of the Peds QL Transplant Module was developed through translation and cognitive interviews (patient testing). The scale's reliability and validity were investigated, using statistical analyses of field tests of the target population. Results Eighty-seven pairs of pediatric liver-transplant recipients and their parents participated in the field test. The pediatric patients completed the measure in 3-7 min, and the rate of missing items was low (0.27%). Excellent internal consistency and test-retest reliability were confirmed. Known-groups validity, concurrent validity, and convergent and discriminant validity also were confirmed. Conclusions Excellent feasibility, reliability, and validity of this Japanese self-report version of the Peds QL Transplant Module Child Self-Report were verified. As a measure of transplant-specific aspects of HRQOL in Japanese pediatric patients who have undergone organ transplants, the Japanese version of the Peds QL Transplant Module is appropriate for use in clinical and research settings. [ABSTRACT FROM AUTHOR]

This study aimed to identify self-care strategies and assess physical and psychosocial factors associated with premenstrual distress among high school students. A cross-sectional survey of 217 adolescent girls aged 15 to 18 years was conducted in October 2009. Most (84.3 percent) had at least one or more symptoms of premenstrual distress. Premenstrual distress interfered with normal school activity in 51.2 percent. Most participants (57.1 percent) did not perform any self-care strategies for premenstrual distress. A hierarchical multiple linear regression analysis was conducted. Comprehension of one’s own physical and mental states during premenstrual phases mediated the relationship between neuroticism and premenstrual distress. Activity restrictions due to menstrual distress mediated the relationship between the family’s understanding of one’s behavior during premenstrual phases and premenstrual distress. Findings suggest that, even if girls have neuroticism, it will be important to teach them to address the comprehension of one’s own physical and mental states so that perceptions of both premenstruation and menstruation become more positive. Findings also suggest that the family’s understanding was associated with alleviation of premenstrual distress. This study suggests the need for education to help adolescent girls and their families manage premenstrual distress and increase awareness of the benefit of managing its associated symptoms. [ABSTRACT FROM PUBLISHER]

Purpose: The purpose of the study is to develop a Japanese version of the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales Young Adult Version (PedsQL-YA-J) and determine the feasibility, reliability, and validity of the scales. Methods: Translation equivalence and content validity were verified using back-translation and cognitive debriefing tests. A total of 428 young adults recruited from one university, two vocational schools, or five companies completed questionnaires. We determined questionnaire feasibility, internal consistency, and test-retest reliability; checked concurrent validity against the Center for Epidemiologic Studies Depression Scale (CES-D); determined convergent and discriminant validity with the Medical Outcome Study 36-item Short Form Health Survey (SF-36); described known-groups validity with regard to subjective symptoms, illness or injury requiring regular medical visits, and depression; and verified factorial validity. Results: All scales were internally consistent (Cronbach's coefficient alpha = 0.77-0.86); test-retest reliability was acceptable (intraclass correlation coefficient = 0.57-0.69); and all scales were concurrently valid with depression (Pearson's correlation coefficient = 0.43-0.57). The scales convergent and discriminant validity with the SF-36 and CES-D were acceptable. Evaluation of known-groups validity confirmed that the Physical Functioning scale was sensitive for subjective symptoms, the Emotional Functioning scale for depression, and the Work/School Functioning scale for illness or injury requiring regular medical visits. Exploratory factor analysis found a six-factor structure consistent with the assumed structure (cumulative proportion = 57.0 %). Conclusions: The PedsQL-YA-J is suitable for assessing health-related quality of life in young adults in education, employment, or training, and for clinical trials and epidemiological research. [ABSTRACT FROM AUTHOR]

Primary CNS germ cell tumors (GCTs) are rare neoplasms predominantly observed in the pediatric and young adult populations. In line with the hypothesis that the primordial germ cell is the cell-of-origin, histopathological examinations for this pathology involve a diverse range of components mirroring the embryogenic developmental dimensions. Chemotherapy and radiotherapy are the mainstays of treatment, with surgery having a limited role for diagnosis and debulking of residual tissue after treatment. While better management has been achieved over recent decades by modifying radiation coverage and selecting appropriate chemotherapy, standardization of treatment remains challenging, partly due to the low volume of cases encountered in each institution. As the incidence is higher in East Asia, including Japan, the Japan Society for Neuro-Oncology established a multidisciplinary task force to create an evidence-based guideline for CNS GCTs. This guideline provides recommendations for multiple dimensions of clinical management for CNS GCTs, with particular focus on diagnostic measures including serum markers, treatment algorithms including surgery, radiotherapy, and chemotherapy, and under-investigated but important areas such as treatment for recurrent cases, long-term follow-up protocols, and long-term sequelae. This guideline serves the purpose of helping healthcare professionals keep up to date with current knowledge and standards of management for patients with this rare disease in daily clinical practice, as well as driving future translational and clinical research by recognizing unmet needs concerning this tumor., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

A nationwide cross-sectional survey was conducted in long-term survivors of allogeneic hematopoietic stem cell transplantation (HSCT) in childhood to investigate the effect of chronic graft-versus-host disease (cGVHD) on quality of life (QOL) and differences in QOL assessments between raters. QOL was evaluated by a visual analogue scale (VAS). Assessments were compared between the survivor, guardian, and attending pediatrician for those aged 15 years or younger, and between the survivor and attending pediatrician for those aged 16 years or older. For cGVHD, severity scores were obtained by organ and their association with the VAS score was analyzed. The average pediatrician-rated VAS score was higher than that of other raters for both patient age groups (< 15 years and > 16 years). By organ, involvement of the skin, digestive organs, and joints in GVHD affected the VAS scores. A high joint score was associated with a low VAS score, and conversely, a high lung score was associated with a low pediatrician-rated VAS score. Our results indicate that differences between raters must be considered when evaluating QOL of HSCT survivors, because patients appeared to experience grater inconvenience and difficulties due to joint GVHD than their pediatricians perceived., (© 2021. Japanese Society of Hematology.)

Background: The evaluation of transition readiness is indispensable for long-term follow-ups of adolescent patients with childhood-onset chronic diseases (CCD). We developed a Japanese version of the TRANSITION-Q (TRANSITION-Q-J) and used it to assess Japanese patients with CCD., Methods: The TRANSITION-Q-J was developed through forward and backward translations followed by cognitive interviews with five adolescent patients. The field test was conducted with 125 adolescent patients, and a retest was conducted with 113 adolescent patients., Results: Confirmatory factor analysis supported the two-factor analysis model including F1 (communication and self-management) and F2 (examination behavior). Sufficient internal consistency and test-retest reliability were demonstrated among the total 14 items, F1, and F2 (Cronbach's α > 0.80, intraclass correlation coefficient > 0.85). Convergent and discriminant validity for the 14 items and F1 were acceptable; however, F2 did not correlate significantly with the Rosenberg Self-Esteem Scale and Independent Consciousness Scale. Regarding known-groups validity, the older group had a significantly higher mean TRANSITION-Q-J score (50.05) than the younger group (43.28; P = 0.04). The same results were found for both F1 and F2., Conclusions: The TRANSITION-Q-J for adolescent patients with CCD was developed and its reliability and validity were verified. This scale is easy to administer. In addition to being a tool for transition period support, it could be used to verify effective factors and in program outcome evaluation, including intervention studies., (© 2020 Japan Pediatric Society.)

Aim: This study aimed to develop a Japanese version of the Caregiving Interface Work Scale (J-CIWS) for use with employed Japanese family caregivers., Methods: Permission was obtained from the developer of the original CIWS. The CIWS contains 20 items: 10 measuring care interface work (CIW) and 10 measuring work interface care (WIC). Responses are measured on a five-point Likert scale. The J-CIWS was developed through forward- and back-translation and cognitive interviews of employed family caregivers. An internet survey was conducted with 116 employed family caregivers, and 78 participants answered a retest. Questionnaire items included the J-CIWS and demographic factors. Factor analysis was conducted to determine the J-CIWS factor structure. Validity was assessed based on known-groups, convergent and discriminant validity. Internal consistency was examined by calculating Cronbach's α. Test-retest reliability was examined by calculating the Pearson's correlation coefficient., Results: The mean participant age was 50.3 years; 74 (63.8%) were male. The average weekly working and caregiving hours were 41.6 and 12.1 h, respectively. Confirmatory factor analysis supported the original two-factor model. High internal consistency (Cronbach's alpha >0.90) and sufficient test-retest reliability (weighted κ score >0.45) were demonstrated for both subscales. Convergent and discriminant validity were acceptable for the two subscales (CIW and WIC)., Conclusions: This study confirmed the usefulness of the CIWS within a Japanese context. The J-CIWS may be useful for evaluating the extent of the conflict between work and care among employed family caregivers. Geriatr Gerontol Int 2021; 21: 254-261., (© 2020 Japan Geriatrics Society.)

Objective: The MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) module is a widely used instrument for measuring symptom burden and interference of daily activities in brain tumor patients. This study aims to develop and validate its Japanese version (MDASI-BT-Japanese)., Methods: Following forward and backward translation of the original MDASI-BT into Japanese, understandability and feasibility were assessed by cognitive debriefing. Subsequently, patients with brain tumors were asked to fill out MDASI-BT-Japanese and European Quality of Life-5 Dimensions (EQ-5D). Feasibility, reliability and validity of MDASI-BT-Japanese were assessed., Results: Cognitive debriefing confirmed overall ease of completion and good understandability. The study population composed of 140 patients with brain tumors (most commonly gliomas). The mean symptom severity score and mean interference score were 1.9 ± 1.7 and 2.8 ± 2.7, respectively. The top items included distress and drowsiness for symptom severity and general activity and work for interference. The median time required was 4 minutes (range, 0.5-30), and missing values were seen in 1%. Internal consistency was proven by excellent Cronbach's coefficient alpha (0.94 for symptom severity, 0.92 for interference). Test-retest reliability was assessed with acceptable intra-class correlation coefficient (mean, 0.76). Correlation efficient ranged between 0.7 and 0.9 for convergent validity. Known-group validity was confirmed by significantly different mean symptom severity score and mean interference score among patients with different performance status. As evidence of concurrent validity, MDASI-BT-Japanese correlated with EQ-5D in the hypothesized magnitude and direction., Conclusions: The newly developed MDASI-BT-Japanese has demonstrated feasibility, reliability and validity in evaluation of clinical benefit in Japanese-speaking brain tumor patients., (© The Author(s) 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Patients with childhood cancer and their families frequently experience psychosocial distress associated with cancer and its treatment. We thus examined the reliability and validity of a Japanese version of the Psychosocial Assessment Tool, which was designed to screen for psychosocial risk factors among families of children with cancer., Methods: Forward-backward translation was used to develop the Japanese version of the Psychosocial Assessment Tool. We conducted a cross-sectional study. Mothers (N = 117), who were the primary caregivers of children with cancer, completed the Japanese version of the Psychosocial Assessment Tool and other measures to establish validity. The internal consistency and 2-week test-retest reliability of the Japanese version of the Psychosocial Assessment Tool were also examined., Results: The internal consistency of the Japanese version of the Psychosocial Assessment Tool total score was sufficient (Kuder-Richardson 20 coefficient = 0.84); however, the subscales 'structure and resources,' 'stress reactions' and 'family beliefs' were less than optimal (Kuder-Richardson 20 coefficients = 0.03, 0.49 and 0.49, respectively). The test-retest reliability for the Japanese version of the Psychosocial Assessment Tool total score was sufficient (intraclass correlation coefficient = 0.92). Significant correlations with the criteria measures indicated the validity of the Japanese version of the Psychosocial Assessment Tool total score. The optimal cut-off score for screening mothers with high psychosocial risk was 0.9/1.0, which was associated with 92% sensitivity and 63% specificity., Conclusions: This study indicated that the Japanese version of the Psychosocial Assessment Tool is a valid and reliable tool to screen mothers for elevated distress., (© Crown copyright 2019.)

ABSTRACTBackground:The aim of the study was to develop a family conflict scale for family caregivers of persons with dementia in long-term care facilities and to explore the relationship between family conflicts and family support., Methods: The scale was developed through forward- and back-translations, interviews with 12 staff members in long-term care facilities, and cognitive interviews with 12 family caregivers who met operational definitions in this study. The test was conducted with 334 family caregivers and a retest was conducted with 318 family caregivers who had indicated willingness to participate further., Results: The internal consistency was relatively high for all subscales (Cronbach's α >0.87); sufficient retest reliability was demonstrated for all subscales (intraclass correlation coefficient >0.69). Confirmatory factor analysis supported a three-factor model. Convergent and discriminant validity for each of the family conflict scale subscales, family APGAR, and the Symptom Check List-90 Items-Revised were acceptable. Family caregivers who received no family assistance for caregiving perceived more conflict in their family than those receiving family assistance., Conclusions: The Japanese version of the family conflict scale for family caregivers of persons with dementia in long-term care facilities was developed. The reliability and validity of the scale were verified. When providing support to family caregivers in long-term care facilities, it is necessary to consider the family from multiple viewpoints, including family conflicts and support conditions from other family members.

Background: Survivors of pediatric brain tumors are often affected by late effects, such as motility disturbance of limb(s), seizure, ocular/visual impairment, endocrine abnormality, and higher brain dysfunction, resulting from the disease and its treatment. Appropriate provision of supportive care will require understanding the effects of these experiences on survivors' health-related quality of life (HRQOL)., Objective: The aim of this study was to identify the relationships between late effects and specific aspects of the HRQOL of pediatric brain tumor survivors., Methods: We distributed questionnaires for measuring HRQOL to 138 survivors and their parents at 8 hospitals and 1 clinic in Japan and simultaneously surveyed late effects using information provided by the survivors' attending physicians. We compared the HRQOL of survivors with and survivors without specific late effects., Results: A total of 106 survivors and their parents returned the questionnaires to the researchers. The HRQOL of survivors 18 years or older was negatively affected by all 5 late effects, indicating that their higher impairment was associated with diminished HRQOL. The HRQOL of survivors aged 12 to 17 years was negatively affected by 2 late effects (ocular/visual impairment and motility disturbance of the limbs). A part of the HRQOL subdomain (motor and cognitive functioning) of survivors aged 12 to 17 years was positively related to ocular/visual impairment., Conclusions: Five late effects influenced the HRQOL of pediatric brain tumor survivors., Implications for Practice: Nurses and other health professionals should provide specific care designed to support aspects of HRQOL affected by late effects. For example, survivors with ocular/visual impairment may be expected to require additional emotional support, and those with seizures or endocrine abnormalities may be expected to require additional support for sleep disorders.

Background: The Pediatric Quality of Life Inventory (PedsQL) is a widely-used modular instrument for measuring health-related quality of life in children aged 2 to 18 years. The PedsQL Brain Tumor Module is comprised of six scales: Cognitive Problems, Pain and Hurt, Movement and Balance, Procedural Anxiety, Nausea, and Worry. In the present study, we developed the Japanese version of the PedsQL Brain Tumor Module and investigated its feasibility, reliability, and validity among Japanese children and their parents., Methods: Translation equivalence and content validity were verified using the standard back-translation method and cognitive debriefing tests. Participants were recruited from 6 hospitals in Japan and the Children's Cancer Association of Japan, and questionnaires were completed by 137 children with brain tumors and 166 parents. Feasibility of the questionnaire was determined based on the amount of time required to complete the form and the percentage of missing values. Internal consistency was assessed using Cronbach's coefficient alpha. Test-retest reliability was assessed by retesting 22 children and 27 parents. Factorial validity was verified by exploratory factor analyses. Known-groups validity was described with regard to whole brain irradiation, developmental impairment, infratentorial tumors, paresis, and concurrent chemotherapy. Convergent and discriminant validity were determined using Generic Core Scales and State-Trait Anxiety Inventory for children., Results: Internal consistency was relatively high for all scales (Cronbach's coefficient alpha > 0.70) except the Pain and Hurt scale for the child-report, and sufficient test-retest reliability was demonstrated for all scales (intraclass correlation coefficient = 0.45-0.95). Factorial validity was supported through exploratory factor analysis (factor-item correlation = 0.33-0.96 for children, 0.55-1.00 for parents). Evaluation of known-groups validity confirmed that the Cognitive Problems scale was sensitive for developmental impairment, the Movement and Balance scale for infratentorial tumors or paresis, and the Nausea scale for a patient currently undergoing chemotherapy. Convergent and discriminant validity with the PedsQL Generic Core Scales and State-Trait Anxiety Inventory for children were acceptable., Conclusions: The Japanese version of the PedsQL Brain Tumor Module is suitable for assessing health-related quality of life in children with brain tumors in clinical trials and research studies.