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. 2018 Mar;28(3):268-279.
doi: 10.3171/2017.7.SPINE17661. Epub 2018 Jan 5.

Validation of Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests in cervical spine surgery

Barrett S Boody  1 , Surabhi Bhatt  1 , Aditya S Mazmudar  1 , Wellington K Hsu  1 , Nan E Rothrock  2 , Alpesh A Patel  1
Affiliations

Validation of Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests in cervical spine surgery

Barrett S Boody et al. J Neurosurg Spine. 2018 Mar.

Abstract

OBJECTIVE The Patient-Reported Outcomes Measurement Information System (PROMIS), which is funded by the National Institutes of Health, is a set of adaptive, responsive assessment tools that measures patient-reported health status. PROMIS measures have not been validated for surgical patients with cervical spine disorders. The objective of this project is to evaluate the validity (e.g., convergent validity, known-groups validity, responsiveness to change) of PROMIS computer adaptive tests (CATs) for pain behavior, pain interference, and physical function in patients undergoing cervical spine surgery. METHODS The legacy outcome measures Neck Disability Index (NDI) and SF-12 were used as comparisons with PROMIS measures. PROMIS CATs, NDI-10, and SF-12 measures were administered prospectively to 59 consecutive tertiary hospital patients who were treated surgically for degenerative cervical spine disorders. A subscore of NDI-5 was calculated from NDI-10 by eliminating the lifting, headaches, pain intensity, reading, and driving sections and multiplying the final score by 4. Assessments were administered preoperatively (baseline) and postoperatively at 6 weeks and 3 months. Patients presenting for revision surgery, tumor, infection, or trauma were excluded. Participants completed the measures in Assessment Center, an online data collection tool accessed by using a secure login and password on a tablet computer. Subgroup analysis was also performed based on a primary diagnosis of either cervical radiculopathy or cervical myelopathy. RESULTS Convergent validity for PROMIS CATs was supported with multiple statistically significant correlations with the existing legacy measures, NDI and SF-12, at baseline. Furthermore, PROMIS CATs demonstrated known-group validity and identified clinically significant improvements in all measures after surgical intervention. In the cervical radiculopathy and myelopathic cohorts, the PROMIS measures demonstrated similar responsiveness to the SF-12 and NDI scores in the patients who self-identified as having postoperative clinical improvement. PROMIS CATs required a mean total of 3.2 minutes for PROMIS pain behavior (mean ± SD 0.9 ± 0.5 minutes), pain interference (1.2 ± 1.9 minutes), and physical function (1.1 ± 1.4 minutes) and compared favorably with 3.4 minutes for NDI and 4.1 minutes for SF-12. CONCLUSIONS This study verifies that PROMIS CATs demonstrate convergent and known-groups validity and comparable responsiveness to change as existing legacy measures. The PROMIS measures required less time for completion than legacy measures. The validity and efficiency of the PROMIS measures in surgical patients with cervical spine disorders suggest an improvement over legacy measures and an opportunity for incorporation into clinical practice.

Keywords: CAT = computer adaptive test; MCID = minimally important clinical difference; MCS = mental component score; NDI = Neck Disability Index; ODI = Oswestry Disability Index; PB = pain behavior; PCS = physical component score; PF = physical function; PI = pain interference; PRO = patient-reported outcome; PROMIS; PROMIS = Patient-Reported Outcomes Measurement Information System; cervical spine; patient-reported outcomes.

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Figures

FIG. 1.
FIG. 1.
Overall group analysis showing the PROMIS T-scores at baseline (general population mean 50 points).
FIG. 2.
FIG. 2.
PROMIS T-scores by work and activity limitations.
FIG. 3.
FIG. 3.
SF-12 scores by work and activity limitations.
FIG. 4.
FIG. 4.
Change in PROMIS T-scores over the assessment period by subgroup. A: Effect sizes for the PROMIS scores versus NDI by subgroup. B: Effect sizes for the PROMIS scores versus NDI for the myelopathy subgroup. C: Effect sizes for the PROMIS scores versus NDI for the radiculopathy subgroup.
FIG. 5.
FIG. 5.
Floor and ceiling effects of the PROMIS PF scores.
FIG. 6.
FIG. 6.
Floor and ceiling effects of the PROMIS PI scores.
FIG. 7.
FIG. 7.
Floor and ceiling effects of the PROMIS PB scores.
See this image and copyright information in PMC

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