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<p>Abstract</p> <p>Background</p> <p>This study aimed to investigate the reliability and validity of the Iranian version of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0) Generic Core Scales in children.</p> <p>Methods</p> <p>A standard forward and backward translation procedure was used to translate the US English version of the PedsQL™ 4.0 Generic Core Scales for children into the Iranian language (Persian). The Iranian version of the PedsQL™ 4.0 Generic Core Scales was completed by 503 healthy and 22 chronically ill children aged 8-12 years and their parents. The reliability was evaluated using internal consistency. Known-groups discriminant comparisons were made, and exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were conducted.</p> <p>Results</p> <p>The internal consistency, as measured by Cronbach's alpha coefficients, exceeded the minimum reliability standard of 0.70. All monotrait-multimethod correlations were higher than multitrait-multimethod correlations. The intraclass correlation coefficients (ICC) between the children self-report and parent proxy-reports showed moderate to high agreement. Exploratory factor analysis extracted six factors from the PedsQL™ 4.0 for both self and proxy reports, accounting for 47.9% and 54.8% of total variance, respectively. The results of the confirmatory factor analysis for 6-factor models for both self-report and proxy-report indicated acceptable fit for the proposed models. Regarding health status, as hypothesized from previous studies, healthy children reported significantly higher health-related quality of life than those with chronic illnesses.</p> <p>Conclusions</p> <p>The findings support the initial reliability and validity of the Iranian version of the PedsQL™ 4.0 as a generic instrument to measure health-related quality of life of children in Iran.</p>