Reaching minimal clinically important difference in adult spinal deformity surgery: a comparison of patients from North America and Japan

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  • 1 Norton Leatherman Spine Center, Louisville, Kentucky;
  • 2 Department of Orthopedic Surgery, University of Louisville School of Medicine, Louisville, Kentucky;
  • 3 Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan;
  • 4 Washington University in St. Louis, Missouri;
  • 5 Department of Orthopedic Surgery, Keio University School of Medicine, Tokyo, Japan; and
  • 6 Department of Orthopaedic Surgery, Dokkyo Medical University, Tochigi, Japan
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OBJECTIVE

The Scoliosis Research Society-22r questionnaire (SRS-22r) has been shown to be reliable, valid, and responsive to change in patients with adult spinal deformity (ASD) undergoing surgery. The minimal clinically important difference (MCID) is the smallest difference in a health-related quality of life score that is considered to be worthwhile or clinically important to the individual. The authors hypothesized that the proportion of patients with ASD achieving an MCID in the SRS-22r score would be different between two culturally different cohorts. The purpose of this study was to compare the proportion of patients with ASD achieving MCID for the SRS-22r domains in North American (NA) and Japanese cohorts.

METHODS

A total of 137 patients from North America (123 women, mean age 60.0 years) and 60 patients from Japan (56 women, mean age 65.5 years) with at least 2 years of follow-up after corrective spine surgery for ASD were included. Except for self-image, published Japanese MCID values of SRS-22r for ASD were higher (function = 0.90, pain = 0.85, self-image = 1.05, subtotal = 1.05) than the published NA MCID values (function = 0.60, pain = 0.40, self-image = 1.23, subtotal = 0.43).

RESULTS

There was a statistically significant improvement in all SRS-22r domain scores at 2 years compared to baseline in both cohorts. Except for mental health (NA = 0.32, Japanese = 0.72, p = 0.005), the mean improvement from baseline to 2 years was similar between the NA and Japanese cohorts. The proportion of patients achieving MCID was higher in North America for function (NA = 51%, Japanese = 30%, p = 0.006), pain (NA = 80%, Japanese = 47%, p < 0.001), and subtotal (NA = 72%, Japanese = 35%, p < 0.001), while there was no significant difference for self-image (NA = 53%, Japanese = 58%, p = 0.454).

CONCLUSIONS

Despite similar improvements in SRS-22r domain scores from baseline to 2 years postoperatively, the proportion of patients reaching SRS-22r MCID for function, pain, and subtotal after ASD surgery was higher in the NA cohort than in the Japanese cohort. This may imply that patients in North America and Japan may value observed changes in clinical status differently.

ABBREVIATIONS ADLs = activities of daily living; ASD = adult spinal deformity; HRQOL = health-related quality of life; LL = lumbar lordosis; MCID = minimal clinically important difference; NA = North American; PI = pelvic incidence; PRO = patient-reported outcome; PT = pelvic tilt; SRS-22r = Scoliosis Research Society-22r questionnaire; SVA = sagittal vertical axis; UIV = upper instrumented vertebra.

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Contributor Notes

Correspondence Hideyuki Arima: Norton Leatherman Spine Center, Louisville, KY. arihidee@gmail.com.

INCLUDE WHEN CITING Published online January 31, 2020; DOI: 10.3171/2019.12.SPINE19593.

Disclosures Dr. Glassman reports being an employee of Norton Healthcare; being a consultant for K2M and Medtronic; receiving royalties from Medtronic; receiving clinical or research support for the study from NuVasive; and being a patent holder for Medtronic. Dr. Carreon reports being an employee of Norton Healthcare; receiving funds for travel from the University of Southern Denmark and the University of Louisville; that her institution received research funds from OREF, NIH, ISSG, SRS, TSRH, Pfizer, LifeSciences Corp., IntelliRod, Cerapedics, Medtronic, Empirical Spine, and the NeuroPoint Alliance; being a member of the Editorial Advisory Board of Spine Deformity, The Spine Journal, and Spine; and being a member of the University of Louisville IRB and the Research Committee of the SRS.

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