Development of the PedsQL™ Sickle Cell Disease Module items: qualitative methods

Area of Science:

• Pediatric Health
• Sickle Cell Disease Research
• Health Outcomes Measurement

Background:

• Sickle cell disease (SCD) significantly impacts pediatric quality of life.
• Validated instruments are crucial for assessing health-related outcomes in children with SCD.
• Existing measures may not fully capture the multifaceted experiences of pediatric SCD patients.

Purpose of the Study:

• To develop items for the PedsQL™ Sickle Cell Disease Module.
• To establish content validity of the module for pediatric patients with SCD.
• To ensure the module accurately reflects patient and parent perspectives.

Main Methods:

• Qualitative, multiphase methodology including literature review and expert interviews.
• Individual in-depth interviews with 13 pediatric patients (ages 5-18) and 18 parents (ages 2-18).
• Cognitive interviews with 33 pediatric patients and 39 parents using think-aloud and debriefing techniques.

Main Results:

• Six key domains identified: Pain Intensity/Location, Pain Interference, Worry, Emotions, Disease Symptoms/Treatment, and Communication.
• Content saturation achieved, resulting in 48 items for the module.
• Items demonstrated interpretability and readability through cognitive testing.

Conclusions:

• Qualitative item development involving pediatric patients and parents supports the content validity of the PedsQL™ SCD Module.
• The PedsQL™ SCD Module is currently undergoing national multisite field testing for psychometric validation.
• This module aims to improve the assessment of health-related quality of life in children with sickle cell disease.