Development of the Pediatric Quality of Life Inventory™ Spinal Cord Injury (PedsQL™ SCI) module: qualitative methods.

Study Design: It is a qualitative study.

Objectives: To develop the items and support content validity for the Pediatric Quality of Life Inventory™ (PedsQL™) Spinal Cord Injury Module for youth and emerging adults with spinal cord injury (SCI).

Setting: Community and children's hospital.

Methods: A comprehensive literature review was conducted in pediatric and SCI-specific health-related quality-of-life (HRQoL) measures to create an item bank. A multidisciplinary panel of experts convened to discuss the conceptual framework of the module, reviewed the item bank, and generated a core set of items through a process of "binning-and-winnowing". International clinicians and researchers participated in iterative rounds of a Modified Delphi survey, until 90% agreement was reached on all items of the core set, resulting in the construction of a preliminary module. Cognitive interviews were conducted on individuals with SCI and their parents to determine the relevance of items and age-appropriate wording of the preliminary module. The research team regularly reviewed transcriptions of the interviews, and incorporated participant feedback to modify the modules. This process was repeated until content saturation was achieved.

Results: A total of 43 participants completed the cognitive interviews. Following five iterations of cognitive interviews and modifications based on participant input, the PedsQL™ SCI Module was generated. It comprised 67 items in the 12 domains of Daily Activities, Mobility, Bladder Function, Bowel Function, Muscle Spasms, Pressure Injury, Pain, Orthostatic Hypotension, Autonomic Dysreflexia, Participation, Worry, and Emotions.

Conclusions: The PedsQL™ SCI Module was developed using well-established qualitative methods. Internet-based field testing is underway to finalize its development and validation.