Development of the Japanese version of the Pediatric Quality of Life Inventory Brain Tumor Module.
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.
Sato
Iori
I
Department of Family Nursing, Graduate School of Health Sciences and Nursing, Faculty of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Higuchi
Akiko
A
Yanagisawa
Takaaki
T
Mukasa
Akitake
A
Ida
Kohmei
K
Sawamura
Yutaka
Y
Sugiyama
Kazuhiko
K
Saito
Nobuhito
N
Kumabe
Toshihiro
T
Terasaki
Mizuhiko
M
Nishikawa
Ryo
R
Ishida
Yasushi
Y
Kamibeppu
Kiyoko
K
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
Childs Nerv Syst. 2007 Jan;23(1):47-57
16960733
J Pediatr Psychol. 2008 Oct;33(9):939-55; discussion 956-7
18024983
Med Care. 2001 Aug;39(8):800-12
11468499
Dev Med Child Neurol. 2005 Sep;47(9):592-7
16138665
Med Care. 2002 Dec;40(12):1186-95
12458301
Pediatr Int. 2010 Feb;52(1):80-8
19496977
Recent Results Cancer Res. 1988;111:231-49
2459750
Neuropediatrics. 2005 Dec;36(6):357-65
16429375
Prog Neurol Surg. 2009;23:130-139
19329867
Cancer. 2004 Nov 1;101(9):2116-25
15389475
Nurs Res. 2005 Sep-Oct;54(5):354-62
16224322
J Clin Oncol. 2003 Apr 1;21(7):1347-51
12663725
Qual Life Res. 1996 Feb;5(1):139-50
8901377
J Clin Oncol. 2007 Sep 20;25(27):4239-45
17878477
J Pain Symptom Manage. 2000 May;19(5):363-77
10869877
Psychol Rep. 1966 Aug;19(1):3-11
5942109
Stat Med. 1998 Jan 15;17(1):101-10
9463853
Cancer. 1995 Mar 1;75(5):1151-61
7850714
Pediatr Blood Cancer. 2007 Sep;49(3):287-93
16991131
Med Care. 1999 Mar;37(3 Suppl):MS10-21
10098555
Dev Med Child Neurol. 2004 Apr;46(4):220-9
15077699
Health Technol Assess. 2001;5(4):1-157
11262421
N Engl J Med. 1996 Mar 28;334(13):835-40
8596551
J Anxiety Disord. 2003;17(4):427-46
12826090
Pediatr Blood Cancer. 2006 May 1;46(5):637-44
16421901
Med Pediatr Oncol. 2003 Jan;40(1):26-34
12426683
Clin Psychol Rev. 2002 May;22(4):547-85
12094511
CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66
17237035
Child Care Health Dev. 2003 Mar;29(2):95-102
12603354