Abstract
BackgroundThe 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.MethodsTranslation 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.ResultsInternal 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.ConclusionsThe 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.
Highlights
The Pediatric Quality of Life InventoryTM (PedsQLTM) is a widely-used modular instrument for measuring health-related quality of life in children aged 2 to 18 years
We can determine from these previous studies that indices for endpoints secondary to survival are necessary to improve quality of life among these patients, and to this end, clinicians and researchers have turned their focus to health-related quality of life (HRQOL) [11]
To facilitate the sharing of data across international borders, we developed the Japanese version of the PedsQLTM Brain Tumor Module and investigated its feasibility, reliability, and validity
Summary
The Pediatric Quality of Life InventoryTM (PedsQLTM) is a widely-used modular instrument for measuring health-related quality of life in children aged 2 to 18 years. Several widelyused measurements specific to assessing HRQOL in patients with brain tumors have been developed already, including Functional Assessment of Cancer Therapy Brain Subscale [13] and European Organisation for Research and Treatment Center Quality of Life Questionnaire - Brain Caner Module [14], but these methods are not suitable for use on children. To measure HRQOL among children with brain tumors, we have used the Pediatric Quality of Life InventoryTM (PedsQLTM) Generic Core Scales [15], which contain general domains but no brain tumor-specific domains. Taking into account this need for a more appropriate measurement, the PedsQLTM Brain Tumor Module [16] was developed as a PedsQLTM disease-specific module
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