Patient-reported outcome (PRO) instruments are increasingly common in both clinical practice and research. The data obtained from these instruments can be used to help inform decision making and policy-making decisions. The methodological approaches undertaken in developing PROs is not frequently reported. Literature on the development of the descriptive systems for PROs is sparse in comparison with that on the assessment of the psychometric properties of such instruments. The purpose of this study is to describe the results of qualitative interviews conducted to identify potential themes for the Child Amblyopia Treatment Questionnaire (CAT-QoL), a pediatric disease-specific health-related quality of life instrument for amblyopia designed for children aged 4 to 7 years. Semistructured interviews were undertaken with 59 children (aged 3 years 9 months to 9 years 11 months; average, 6 years 3 months) with amblyopia. The interviews were transcribed verbatim and imported into QSR NVivo 8. Interview transcripts were analyzed to identify potential items to be included in the descriptive system. Thematic content analysis was undertaken using Framework. Eleven potential themes were identified for inclusion in the CAT-QoL instrument, namely, physical sensation of the treatment, pain, being able to play with other children, how other children have treated them, ability to undertake schoolwork, ability to undertake other tasks, sad or unhappy, cross, worried, frustrated, and feelings toward family members. Children are able to identify their thoughts and opinions of their own health and to describe what impact their amblyopia treatment has had on their daily lives. Themes for the draft descriptive system for a pediatric self-reported amblyopia QoL instrument have been identified. A draft version of the CAT-QoL instrument has been developed. Further research is required to refine and assess the psychometric properties of the instrument.
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