Purpose of the Study
To develop, pretest, and validate a questionnaire to measure quality of life in children with seasonal allergic rhinoconjunctivitis (SAR).
Children, ages 6 to 12 years, with a history of SAR and troublesome symptoms during the previous month.
Two studies in different locations were conducted to develop the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ). Study 1 was the “development” phase in which PRQLQ questions were developed and modified in 34 children with SAR. Forty-eight items in 8 initial domains were reduced to 23 questions in 5 domains (nose symptoms, eye symptoms, other symptoms, practical problems, and activity limitations) to establish the final PRQLQ. Ten children were pretested with the PRQLQ using a 7-point response option scale. Study 2 was the “validation” phase in which 83 children with SAR were tested with the PRQLQ in a 3-week, single cohort study conducted during the fall pollen season of 1996. Children were seen at enrollment and after 1 and 3 weeks. Subjects completed a symptom diary twice daily for 1 week before each visit. At the 1-week visit, medication was prescribed for the child's symptoms. The PRQLQ was given at each visit and results analyzed with symptom profiles.
Study 1 established the PRQLQ format of 23 questions in 5 domains. Study 2 tested the instrument in 83 children. Of the 83 children enrolled, 75 children completed the analysis with a mean age of 9.8 years (40% female, 76% white, 11% black). The reliability and validity of the PRQLQ were found to be very consistent in the population tested. Good evidence was found for cross-sectional correlations between quality of life and diary symptom scores. The PRQLQ was also able to detect difference in those subjects who remained clinically stable and those who changed clinically. Responsiveness data showed that children did not have trouble understanding the 7-point scale used. The only problem encountered was the apparent difficulty of some children understanding the time specification. Some younger children had problems understanding the concept of “during the last week.”
The PRQLQ can be completed reliably in children 6 to 12 years old. The instrument demonstrates good measurement properties and can be used with confidence in clinical studies.
Once again, Juniper and colleagues have developed a validated, reliable quality of life instrument for children with chronic disease. This tool will be useful in the assessment of children with rhinoconjunctivitis, especially with regard to clinical studies. The authors recognize some limitation to their study, primarily that the instrument development was conducted in one population and validated in another. This problem was minimized by inclusion of a wide range of disease severity in the test population. Further use of the PRQLQ in pediatric patients will be helpful and will likely strengthen these findings.