Development of the PedsQL™ sickle cell disease module items: qualitative methods

Purpose The objective of this qualitative study was to develop the items and support the content validity of the PedsQL (TM) Sickle Cell Disease Module for pediatric patients with sickle cell disease (SCD). Methods The iterative process included multiphase qualitative methodology. A literature review on SCD was conducted to generate domains of interest for the individual in-depth interviews. Ten healthcare experts with clinical experience in SCD participated in the development of the conceptual framework. A total of 13 pediatric patients with SCD ages 5-18 and 18 parents of patients ages 2-18 participated in the individual in-depth interviews. A total of 33 pediatric patients with SCD ages 5-18 and 39 parents of patients ages 2-18 participated in individually conducted cognitive interviews that included both think aloud and cognitive debriefing techniques to assess the interpretability and readability of the item stems. Results Six domains were derived from the qualitative methods involving patient/parent interviews and expert opinion, with content saturation achieved, resulting in 48 items. The six domains consisted of items measuring Pain Intensity/Location (9 items), Pain Interference (11 items), Worry (7 items), Emotions (3 items), Disease Symptoms/Treatment, (12 items), and Communication (6 items). Conclusions Qualitative methods involving pediatric patients and parents in the item development process support the content validity for the PedsQL (TM) SCD Module. The PedsQL (TM) SCD Module is now undergoing national multisite field testing for the psychometric validation phase of instrument development.