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• By Author: Sciubba, Daniel M.
• By Author: Kebaish, Khaled M.
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## Determining validity, discriminant ability, responsiveness, and minimal clinically important differences for PROMIS in adult spinal deformity

### 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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## Changes in patients’ depression and anxiety associated with changes in patient-reported outcomes after spine surgery

### 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.

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## Paraspinal muscle size as an independent risk factor for proximal junctional kyphosis in patients undergoing thoracolumbar fusion

### OBJECTIVE

Proximal junctional kyphosis (PJK) is a structural complication of spinal fusion in 5%–61% of patients treated for adult spinal deformity. In nearly one-third of these cases, PJK is progressive and requires costly surgical revision. Previous studies have suggested that patient body habitus may predict risk for PJK. Here, the authors sought to investigate abdominal girth and paraspinal muscle size as risk factors for PJK.

### METHODS

All patients undergoing thoracolumbosacral fusion greater than 2 levels at a single institution over a 5-year period with ≥ 6 months of radiographic follow-up were considered for inclusion. PJK was defined as kyphosis ≥ 20° between the upper instrumented vertebra (UIV) and two supra-adjacent vertebrae. Operative and radiographic parameters were recorded, including pre- and postoperative sagittal vertical axis (SVA), sacral slope (SS), lumbar lordosis (LL), pelvic tilt, pelvic incidence (PI), and absolute value of the pelvic incidence–lumbar lordosis mismatch (|PI-LL|), as well as changes in LL, |PI-LL|, and SVA. The authors also considered relative abdominal girth and the size of the paraspinal muscles at the UIV.

### RESULTS

One hundred sixty-nine patients met inclusion criteria. On univariate analysis, PJK was associated with a larger preoperative SVA (p < 0.001) and |PI-LL| (p = 0.01), and smaller SS (p = 0.004) and LL (p = 0.001). PJK was also associated with more positive postoperative SVA (p = 0.01), ΔSVA (p = 0.01), Δ|PI-LL| (p < 0.001), and ΔLL (p < 0.001); longer construct length (p = 0.005); larger abdominal girth–to-muscle ratio (p = 0.007); and smaller paraspinal muscles at the UIV (p < 0.001). Higher postoperative SVA (OR 1.1 per cm), smaller paraspinal muscles at the UIV (OR 2.11), and more aggressive reduction in |PI-LL| (OR 1.03) were independent predictors of radiographic PJK on multivariate logistic regression.

### CONCLUSIONS

A more positive postoperative global sagittal alignment and smaller paraspinal musculature at the UIV most strongly predicted PJK following thoracolumbosacral fusion.

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## US regional variations in rates, outcomes, and costs of spinal arthrodesis for lumbar spinal stenosis in working adults aged 40–65 years

### OBJECTIVE

It is important to identify differences in the treatment of common diseases over time and across geographic regions. Several studies have reported increased use of arthrodesis to treat lumbar spinal stenosis (LSS). The purpose of this study was to investigate geographic variations in the treatment of LSS by US region.

### METHODS

The authors reviewed inpatient and outpatient medical claims from 2010 to 2014 using the MarketScan Commercial Claims and Encounters database (Truven Health Analytics), which includes data on commercially insured members younger than 65 years. ICD-9 code 724.02 was used to identify patients aged ≥ 40 and < 65 years who underwent surgery for “spinal stenosis of the lumbar region” and for whom LSS was the only principal diagnosis. The primary outcome was the performance of spinal arthrodesis as part of the procedure. Geographic regions were based on patient residence and defined according to the US Census Bureau as the Northeast, Midwest, South, and West.

### CONCLUSIONS

From 2010 to 2014, the proportion of adults undergoing decompression with arthrodesis versus decompression only for the treatment of LSS increased, especially in the South and Midwest regions of the US. A greater proportion of these fusions were complex and were associated with more complications, higher costs, and a greater likelihood of being discharged to a skilled nursing facility.

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## The use of patient-reported preoperative activity levels as a stratification tool for short-term and long-term outcomes in patients with adult spinal deformity

### OBJECTIVE

Given the recent shift in health care toward quality reporting requirements and a greater emphasis on a cost-quality approach, patient stratification with respect to long-term outcomes and the use of health care resources is of increasing value. Stratification tools may be effective if they are simple and evidence based. The authors hypothesize that preoperative patient-reported activity levels might independently predict postoperative outcomes in patients with adult spinal deformity.

### METHODS

This is a retrospective cohort. A total of 575 patients in a prospective adult spinal deformity surgical database were identified with complete data regarding the preoperative level of activity. Answers to question 5 of the Scoliosis Research Society-22r Patient Questionnaire (SRS-22r) were used to stratify patients into active and inactive groups. Outcomes were length of hospital stay (LOS), level of activity, and reaching the minimum clinically important difference (MCID) for SRS-22r domains and the Physical Component Summary (PCS) of the SF-36 at 2 years postoperatively. The 2 groups were compared with respect to several potential confounders. Covariates with p < 0.1 were controlled for. The impact of activity on LOS was assessed using multivariate negative binomial regression analysis. Multivariate logistic regression models additionally controlling for the respective baseline health-related quality of life (HRQOL) scores were used to assess the association between preoperative activity levels and reaching the MCID at 2 years postoperatively.

### RESULTS

A total of 420 (73%) of the 575 patients who met the inclusion criteria had complete data at 2 years postoperatively. The inactive group was more likely to be significantly older, have a higher Charlson Comorbidity Index, worse baseline radiographic deformity, and greater correction of most radiographic parameters. After controlling for possible confounders, the active group had a significantly shorter LOS (incidence risk ratio 0.91, p = 0.043). After adding respective baseline HRQOL scores to the models, active patients were significantly more likely to reach the MCID for the SRS-22r pain domain (OR 1.72, p = 0.026) and PCS (OR 1.94, p = 0.013). Active patients were also significantly more likely to be active at 2 years postoperatively on multivariate analysis (OR 8.94, p < 0.001).

### CONCLUSIONS

The authors’ results show that patients who belong to the inactive group are likely to have a longer LOS and lower odds of reaching the MCID in HRQOL or being active at 2 years postoperatively. Inquiring about patients’ preoperative activity levels might be a reliable and simple stratification tool in terms of long- and short-term outcomes in ASD patients.

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## An assessment of frailty as a tool for risk stratification in adult spinal deformity surgery

### OBJECTIVE

The goal of this study was to analyze the value of an adult spinal deformity frailty index (ASD-FI) in preoperative risk stratification. Preoperative risk assessment is imperative before procedures known to have high complication rates, such as ASD surgery. Frailty has been associated with risk of complications in trauma surgery, and preoperative frailty assessments could improve the accuracy of risk stratification by providing a comprehensive analysis of patient factors that contribute to an increased risk of complications.

### METHODS

Using 40 variables, the authors calculated frailty scores with a validated method for 417 patients (enrolled between 2010 and 2014) with a minimum 2-year follow-up in an ASD database. On the basis of these scores, the authors categorized patients as not frail (NF) (< 0.3 points), frail (0.3–0.5 points), or severely frail (SF) (> 0.5 points). The correlation between frailty category and incidence of complications was analyzed.

### RESULTS

The overall mean ASD-FI score was 0.33 (range 0.0–0.8). Compared with NF patients (n = 183), frail patients (n = 158) and SF patients (n = 109) had longer mean hospital stays (1.2 and 1.6 times longer, respectively; p < 0.001). The adjusted odds of experiencing a major intraoperative or postoperative complication were higher for frail patients (OR 2.8) and SF patients ( 4.1) compared with NF patients (p < 0.01). For frail and SF patients, respectively, the adjusted odds of developing proximal junctional kyphosis (OR 2.8 and 3.1) were higher than those for NF patients. The SF patients had higher odds of developing pseudarthrosis (OR 13.0), deep wound infection (OR 8.0), and wound dehiscence (OR 13.4) than NF patients (p < 0.05), and they had 2.1 times greater odds of reoperation (p < 0.05).

### CONCLUSIONS

Greater patient frailty, as measured by the ASD-FI, was associated with worse outcome in many common quality and value metrics, including greater risk of major complications, proximal junctional kyphosis, pseudarthrosis, deep wound infection, wound dehiscence, reoperation, and longer hospital stay.

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## Incidence of perioperative medical complications and mortality among elderly patients undergoing surgery for spinal deformity: analysis of 3519 patients

### OBJECTIVE

Using 2 complication-reporting methods, the authors investigated the incidence of major medical complications and mortality in elderly patients after surgery for adult spinal deformity (ASD) during a 2-year follow-up period.

### METHODS

The authors queried a multicenter, prospective, surgeon-maintained database (SMD) to identify patients 65 years or older who underwent surgical correction of ASD from 2008 through 2014 and had a minimum 2 years of follow-up (n = 153). They also queried a Centers for Medicare & Medicaid Services claims database (MCD) for patients 65 years or older who underwent fusion of 8 or more vertebral levels from 2005 through 2012 (n = 3366). They calculated cumulative rates of the following complications during the first 6 weeks after surgery: cerebrovascular accident, congestive heart failure, deep venous thrombosis, myocardial infarction, pneumonia, and pulmonary embolism. Significance was set at p < 0.05.

### RESULTS

During the perioperative period, rates of major medical complications were 5.9% for pneumonia, 4.1% for deep venous thrombosis, 3.2% for pulmonary embolism, 2.1% for cerebrovascular accident, 1.8% for myocardial infarction, and 1.0% for congestive heart failure. Mortality rates were 0.9% at 6 weeks and 1.8% at 2 years. When comparing the SMD with the MCD, there were no significant differences in the perioperative rates of major medical complications except pneumonia. Furthermore, there were no significant intergroup differences in the mortality rates at 6 weeks or 2 years. The SMD provided greater detail with respect to deformity characteristics and surgical variables than the MCD.

### CONCLUSIONS

The incidence of most major medical complications in the elderly after surgery for ASD was similar between the SMD and the MCD and ranged from 1% for congestive heart failure to 5.9% for pneumonia. These complications data can be valuable for preoperative patient counseling and informed consent.

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## Patient and operative factors associated with complications following adolescent idiopathic scoliosis surgery: an analysis of 36,335 patients from the Nationwide Inpatient Sample

### OBJECTIVE

The aim of this study was to investigate the incidence of and factors associated with complications following idiopathic scoliosis surgery in adolescents.

### METHODS

The Nationwide Inpatient Sample database was used to identify patients 10–18 years of age who had undergone spinal fusion for adolescent idiopathic scoliosis (AIS) from 2002 to 2011. Twenty-three unique in-hospital postoperative complications, including death, were examined. A series of logistic regressions was used to determine if any demographic, comorbid, or surgical parameter was associated with complication development. Results of multiple logistic regression analyses were reported as odds ratios with 95% confidence intervals. All analyses were performed after the application of discharge weights to produce national estimates.

### RESULTS

A total of 36,335 patients met the study inclusion criteria, 7.6% of whom (95% CI 6.3%–8.9%) developed at least one in-hospital complication. The 3 most common complications were respiratory failure (3.47%), reintubation (1.27%), and implant related (1.14%). Major complications such as death, pancreatitis, disseminated intravascular coagulation, visual loss, spinal cord injury, cardiac arrest, sepsis, nerve root injury, deep vein thrombosis, pulmonary embolism, shock, malignant hyperthermia, myocardial infarction, and iatrogenic stroke each had an incidence ≤ 0.2%. On multiple logistic regression analysis, an increasing age (OR 0.80) was associated with significantly lower odds of complication development; patients who were male (OR 1.80) or who had anemia (OR 2.10), hypertension (OR 2.51), or hypothyroidism (OR 2.27) or underwent revision procedures (OR 5.55) were at a significantly increased risk for complication development. The rates of postoperative complications for posterior, anterior, and combined approaches were 6.7%, 10.0%, and 19.8%, respectively (p < 0.001). Length of fusion (< 8 vs ≥ 8 levels) was not associated with complication development (p = 0.311).

### CONCLUSIONS

Analysis of 36,335 patients who had undergone surgery for AIS revealed that younger patients, male patients, patients with a history of anemia, hypertension, or hypothyroidism, as well as those undergoing revision or anterior or combined approaches may have higher rates of postoperative complications. However, the overall complication rate was low (7.6%), and major complications had a rate ≤ 0.2% for each event. These findings suggest that surgery for AIS remains relatively safe, and future prospective investigations may further help to decrease the postoperative morbidity rate.

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## Inpatient morbidity and mortality after adult spinal deformity surgery in teaching versus nonteaching hospitals

### OBJECTIVE

The goal of this study was to compare inpatient morbidity and mortality after adult spinal deformity (ASD) surgery in teaching versus nonteaching hospitals in the US.

### METHODS

The Nationwide Inpatient Sample was used to identify surgical patients with ASD between 2002 and 2011. Only patients > 21 years old and elective cases were included. Patient characteristics, inpatient morbidity, and inpatient mortality were compared between teaching and nonteaching hospitals. A multivariable logistic regression analysis was performed to examine the effect of hospital teaching status on surgical outcomes.

### RESULTS

A total of 7603 patients were identified, with 61.2% (n = 4650) in the teaching hospital group and 38.8% (n = 2953) in the nonteaching hospital group. The proportion of patients undergoing revision procedures was significantly different between groups (5.2% in teaching hospitals vs 3.9% in nonteaching hospitals, p = 0.008). Likewise, complex procedures (defined as fusion of 8 or more segments and/or osteotomy) were more common in teaching hospitals (27.3% vs 21.7%, p < 0.001). Crude overall complication rates were similar in teaching hospitals (47.9%) compared with nonteaching hospitals (49.8%, p = 0.114). After controlling for patient characteristics, case complexity, and revision status, patients treated at teaching hospitals were significantly less likely to develop a complication when compared with patients treated at a nonteaching hospital (OR 0.89; 95% CI 0.82–0.98). The mortality rate was 0.4% in teaching hospitals and < 0.4% in nonteaching hospitals (p = 0.210).

### CONCLUSIONS

Patients who undergo surgery for ASD at a teaching hospital may have significantly lower odds of complication development compared with patients treated at a nonteaching hospital.