Developing a contemporary patient-reported outcomes measure for spinal cord injury

Abstract

Objective: To develop a spinal cord injury (SCI)-specific patient-reported outcome (PRO) measure of health-related quality of life (QOL) covering multiple domains of functioning, including physical, emotional, and social health.

Design: Focus groups.

Setting: Four SCI Model Systems rehabilitation hospitals.

Participants: Individuals with SCI (n=65) and clinicians (n=42).

Interventions: Not applicable.

Main outcome measure: Spinal Cord Injury Quality of Life Measurement System (SCI-QOL).

Results: Qualitative analysis yielded 3 domains of primary importance: physical-medical health, emotional health, and social participation. Results were used to guide domain and item decisions in the development of the SCI-QOL PRO measurement system. Qualitative data were used to develop item pools with item content specific to individuals with SCI across a wide spectrum of functioning. When possible, items from other major measurement initiatives were included verbatim in the item pools to link the measurement systems and facilitate cross-study and cross-population comparisons.

Conclusions: Issues that affect individuals' QOL after SCI are varied and several issues are unique to individuals who have had a traumatic injury. From these qualitative data, 3 major domains and 18 subdomains of functioning were identified. Item pools were developed in each of these 18 areas to measure functioning related to physical-medical issues, emotional status, and social participation.