Qualitative development of the ‘Questionnaire on Pain caused by Spasticity (QPS),’ a pediatric patient‐reported outcome for spasticity‐related pain in cerebral palsy

PURPOSE: To develop a patient-reported outcome measure for spasticity-related pain in children/adolescents (age 2–17 years) with cerebral palsy (CP), the ‘Questionnaire on Pain caused by Spasticity (QPS).’ METHODS: Using a semi-structured interview guide, concept elicitation interviews on spasticity-related pain in upper and lower limbs were conducted in 21 children and caregiver pairs. Data were used to modify initial QPS modules and develop six draft modules, which were subsequently refined and finalized in four consecutive cognitive interview waves (12 children and caregiver pairs). RESULTS: To accommodate the broad range in the children’s communication skills, QPS child/adolescent modules were developed in both interviewer-administered and self-administered formats. With the additional parent modules, three QPS modules were developed for each of the upper and lower limb applications. Information gained from the parent/caregiver modules complements the child/adolescent assessment. Parents report observed signs and frequency of pain in the same situations used to capture the child/adolescent reports of pain severity (e.g., rest, usual daily activities, active mobilization, and physically difficult activities). Participating children/adolescents and parents/caregivers reported that the final QPS instruments were comprehensive, relevant to the child’s spasticity-related experience, and easy to understand and complete. CONCLUSIONS: The QPS is a novel instrument for the assessment of spasticity-related pain in children/adolescents with CP that was developed with direct patient input. Its modules allow the use of this instrument in children/adolescents with varied levels of impairment and communication skills.