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EuroQol 5-Dimension 5-Level Index Value Changes Associated With Clinically Important Functional Improvement in
Takayuki Sasaki1, Kazuhiro Miyata2, Ryuichiro Koga1
1Department of Rehabilitation Medicine, Japan Organization of Occupational Health and Safety, Spinal Injuries Center, Iizuka, Japan.
Objective:
To quantify changes in the EuroQol 5-Dimension (EQ-5D) index value associated with clinically important functional improvement in patients with traumatic spinal cord injury (SCI).
Design:
Secondary longitudinal analysis.
Setting:
SCI center in Japan using data from the Japan Single-Center Study for Spinal Cord Injury Database.
Participants:
Patients with traumatic SCI (N=163) registered in the Japan Single-Center Study for Spinal Cord Injury Database between 2015 and 2024.
Interventions:
Not applicable.
Main Outcome Measures:
The primary patient-reported outcome was the EQ-5D index value from the EuroQol 5-Dimension 5-Level questionnaire at 2 weeks and 3 months after injury. As reference measures, we used previously reported minimal important change thresholds for the Spinal Cord Independence Measure version III (SCIM-III) subscale scores to compare EQ-5D index value changes between improvement and nonimprovement groups. Patients were classified into improvement and nonimprovement groups for the Walking Index for SCI version II and for upper and lower extremity motor scores derived from the International Standards for Neurological Classification of SCI motor score, based on established smallest real difference values; these were evaluated as supportive indices. Using these classifications, receiver operating characteristic analyses identified EQ-5D index value change thresholds.
Results:
In patients with cervical SCI (American Spinal Injury Association Impairment Scale C/D), analyses using previously reported Spinal Cord Independence Measure version III subscale minimal important change thresholds yielded EQ-5D index value change thresholds of 0.182 (95% confidence interval, 0.112-0.253) for "self-care" and 0.173 (95% confidence interval, 0.107-0.284) for "respiration and sphincter management." Other functional measures did not meet criteria for anchor validity and were not used to identify EQ-5D thresholds.
Conclusions:
In patients with cervical SCI with incomplete motor paralysis, this study quantitatively demonstrated the extent to which functional recovery is reflected in changes in EQ-5D index values. The findings provide reference thresholds to support clinical interpretation of EQ-5D index changes in the SCI field.
