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Alvaro Ibaseta, Rafa Rahman, Nicholas S. Andrade, Richard L. Skolasky, Khaled M. Kebaish, Daniel M. Sciubba, and Brian J. Neuman

OBJECTIVE

The aim of this study was to determine the concurrent validity, discriminant ability, and responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) in adult spinal deformity (ASD) and to calculate minimal clinically important differences (MCIDs) for PROMIS scores.

METHODS

The authors used data obtained in 186 surgical patients with ASD. Concurrent validity was determined through correlations between preoperative PROMIS scores and legacy measure scores. PROMIS discriminant ability between disease severity groups was determined using the preoperative Oswestry Disability Index (ODI) value as the anchor. Responsiveness was determined through distribution- and anchor-based methods, using preoperative to postoperative changes in PROMIS scores. MCIDs were estimated on the basis of the responsiveness analysis.

RESULTS

The authors found strong correlations between PROMIS Pain Interference and ODI and the Scoliosis Research Society 22-item questionnaire Pain component; PROMIS Physical Function and ODI; PROMIS Anxiety and Depression domains and the 12-Item Short Form Health Survey version 2, Physical and Mental Components, Scoliosis Research Society 22-item questionnaire Mental Health component (anxiety only), 9-Item Patient Health Questionnaire (anxiety only), and 7-Item Generalized Anxiety Disorder questionnaire; PROMIS Fatigue and 9-Item Patient Health Questionnaire; and PROMIS Satisfaction with Participation in Social Roles (i.e., Social Satisfaction) and ODI. PROMIS discriminated between disease severity groups in all domains except between none/mild and moderate Anxiety, with mean differences ranging from 3.7 to 8.4 points. PROMIS showed strong responsiveness in Pain Interference; moderate responsiveness in Physical Function and Social Satisfaction; and low responsiveness in Anxiety, Depression, Fatigue, and Sleep Disturbance. Final PROMIS MCIDs were as follows: –6.3 for Anxiety, –4.4 for Depression, –4.6 for Fatigue, –5.0 for Pain Interference, 4.2 for Physical Function, 5.7 for Social Satisfaction, and –3.5 for Sleep Disturbance.

CONCLUSIONS

PROMIS is a valid assessment of patient health, can discriminate between disease severity levels, and shows responsiveness to changes after ASD surgery. The MCIDs provided herein may help clinicians interpret postoperative changes in PROMIS scores, taking into account the fact that they are pending external validation.

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Rafa Rahman, Alvaro Ibaseta, Jay S. Reidler, Nicholas S. Andrade, Richard L. Skolasky, Lee H. Riley III, David B. Cohen, Daniel M. Sciubba, Khaled M. Kebaish, and Brian J. Neuman

OBJECTIVE

The authors conducted a study to analyze associations between changes in depression/anxiety before and 12 months after spine surgery, as well as changes in scores using the Patient-Reported Outcomes Measurement Information System (PROMIS) at the same time points.

METHODS

Preoperatively and 12 months postoperatively, the authors assessed PROMIS scores for depression, anxiety, pain, physical function, sleep disturbance, and satisfaction with participation in social roles among 206 patients undergoing spine surgery for deformity correction or degenerative disease. Patients were stratified according to preoperative/postoperative changes in depression and anxiety, which were categorized as persistent, improved, newly developed postoperatively, or absent. Multivariate regression was used to control for confounders and to compare changes in patient-reported outcomes (PROs).

RESULTS

Fifty patients (24%) had preoperative depression, which improved in 26 (52%). Ninety-four patients (46%) had preoperative anxiety, which improved in 70 (74%). Household income was the only preoperative characteristic that differed significantly between patients whose depression persisted and those whose depression improved. Compared with the no-depression group, patients with persistent depression had less improvement in all 4 domains, and patients with postoperatively developed depression had less improvement in pain, physical function, and satisfaction with social roles. Compared with the group of patients with postoperatively improved depression, patients with persistent depression had less improvement in pain and physical function, and patients with postoperatively developed depression had less improvement in pain. Compared with patients with no anxiety, those with persistent anxiety had less improvement in physical function, sleep disturbance, and satisfaction with social roles, and patients with postoperatively developed anxiety had less improvement in pain, physical function, and satisfaction with social roles. Compared with patients with postoperatively improved anxiety, patients with persistent anxiety had less improvement in pain, physical function, and satisfaction with social roles, and those with postoperatively developed anxiety had less improvement in pain, physical function, and satisfaction with social roles. All reported differences were significant at p < 0.05.

CONCLUSIONS

Many spine surgery patients experienced postoperative improvements in depression/anxiety. Improvements in 12-month PROs were smaller among patients with persistent or postoperatively developed depression/anxiety compared with patients who had no depression or anxiety before or after surgery and those whose depression/anxiety improved after surgery. Postoperative changes in depression/anxiety may have a greater effect than preoperative depression/anxiety on changes in PROs after spine surgery. Addressing the mental health of spine surgery patients may improve postoperative PROs.

CLASSIFICATION OF EVIDENCE Type of question: causation; study design: prospective cohort study; evidence: class III.