Initial validation of the Argentinean Spanish version of the PedsQL™ 4.0 Generic Core Scales in children and adolescents with chronic diseases: acceptability and comprehensibility in low-income settings

BACKGROUND To validate the Argentinean Spanish version of the PedsQL 4.0 Generic Core Scales in Argentinean children and adolescents with chronic conditions and to assess the impact of socio-demographic characteristics on the instrument's comprehensibility and acceptability. Reliability, and known-groups, and convergent validity were tested. METHODS Consecutive sample of 287 children with chronic conditions and 105 healthy children, ages 2-18, and their parents. Chronically ill children were: (1) attending outpatient clinics and (2) had one of the following diagnoses: stem cell transplant, chronic obstructive pulmonary disease, HIV/AIDS, cancer, end stage renal disease, complex congenital cardiopathy. Patients and adult proxies completed the PedsQL 4.0 and an overall health status assessment. Physicians were asked to rate degree of health status impairment. RESULTS The PedsQL 4.0 was feasible (only 9 children, all 5 to 7 year-olds, could not complete the instrument), easy to administer, completed without, or with minimal, help by most children and parents, and required a brief administration time (average 5-6 minutes). People living below the poverty line and/or low literacy needed more help to complete the instrument. Cronbach Alpha's internal consistency values for the total and subscale scores exceeded 0.70 for self-reports of children over 8 years-old and parent-reports of children over 5 years of age. Reliability of proxy-reports of 2-4 year-olds was low but improved when school items were excluded. Internal consistency for 5-7 year-olds was low (alpha range = 0.28-0.76). Construct validity was good. Child self-report and parent proxy-report PedsQL 4.0 scores were moderately but significantly correlated (rho = 0.39, p < 0.0001) and both significantly correlated with physician's assessment of health impairment and with child self-reported overall health status. The PedsQL 4.0 discriminated between healthy and chronically ill children (72.72 and 66.87, for healthy and ill children, respectively, p = 0.01), between different chronic health conditions, and children from lower socioeconomic status. CONCLUSION Results suggest that the Argentinean Spanish PedsQL 4.0 is suitable for research purposes in the public health setting for children over 8 years old and parents of children over 5 years old. People with low income and low literacy need help to complete the instrument. Steps to expand the use of the Argentinean Spanish PedsQL 4.0 include an alternative approach to scoring for the 2-4 year-olds, further understanding of how to increase reliability for the 5-7 year-olds self-report, and confirmation of other aspects of validity.