title: Development of the Japanese version of the Pediatric Quality of Life Inventory Brain Tumor Module.
abstract: 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.
authors.affiliation: Department of Family Nursing, Graduate School of Health Sciences and Nursing, Faculty of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
authors.forename: Iori
authors.initials: I
authors.lastname: Sato
authors.forename: Akiko
authors.initials: A
authors.lastname: Higuchi
authors.forename: Takaaki
authors.initials: T
authors.lastname: Yanagisawa
authors.forename: Akitake
authors.initials: A
authors.lastname: Mukasa
authors.forename: Kohmei
authors.initials: K
authors.lastname: Ida
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Sawamura
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Sugiyama
authors.forename: Nobuhito
authors.initials: N
authors.lastname: Saito
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Kumabe
authors.forename: Mizuhiko
authors.initials: M
authors.lastname: Terasaki
authors.forename: Ryo
authors.initials: R
authors.lastname: Nishikawa
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Ishida
authors.forename: Kiyoko
authors.initials: K
authors.lastname: Kamibeppu
mesh_terms: D000293:Adolescent; D001932:Brain Neoplasms; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007564:Japan; D010290:Parents; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires
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