Search

In recent years, the incidence of spinal epidural abscesses (SEA) has tripled in number and nonoperative management has risen in popularity. While there has been a shift towards reserving surgical intervention for patients with focal neurologic deficits, a third of patients will still fail medical management and require surgical intervention. Failure to understand long-term quality of life and functional outcomes hinders effective decision making and prognostication. To describe patterns and associated factors impacting long-term quality of life following treatment of spinal epidural abscess. Multicenter cohort study at two urban academic tertiary referral centers and two community centers. Adult patients treated for a spinal epidural abscess. EuroQoL 5-Dimension 5L (EQ5D), Neuro-Quality of Life Lower Extremity – Mobility (Short Form; NeuroQoL-LE), Patient-Reported Outcomes Measurement Information System Physical Function (short form 4a; PROMIS PF), and PROMIS Global Mental Health score (PROMIS Mental). Eligible patients were enrolled and administered questionnaires. Multivariable analysis assessed the influence of ambulatory status on HRQL, adjusting for covariates including age, biologic sex, Charlson comorbidity index, intravenous drug use, management approach, and ASIA grade on presentation. Sixty-one patients were enrolled (mean age 60.5 years, 46% male). Thirty-four patients (58%) underwent operative management. Mean standard deviation (SD) results for HRQL measures were: EQ5D 0.51 (0.37), EQ5D visual analogue scale 60.34 (25.11), NeuroQoL Lower extremity 41.47 (10.64), PROMIS physical function 39.49 (10.07), and PROMIS Global Mental Health 44.23 (10.36). Adjusted analysis demonstrated ambulatory status at presentation, and at 1 year, to be important drivers of HRQL, irrespective of other factors including IVDU and ASIA grade. Patients with independent ambulatory function at 1 year had mean EQ5D utility of 0.65 (95% CI 0.55, 0.75), whereas those requiring assistive devices saw a 49% decrease with mean EQ5D utility of 0.32 (0.14, 0.51). Ambulatory status was associated with global and physical function but did not impact overall health self-assessment or mental health scores. We found that ambulatory status was the most important factor associated with long-term HRQL regardless of other factors such as ASIA grade or IVDU. Given prior literature demonstrating the protective effect of operative intervention on ambulatory function, this highlights ambulatory dysfunction as a potential indication for surgery and a marker of poor long-term prognosis, even in the absence of focal neurologic deficits. Our work also highlights the importance of optimized long-term rehabilitation strategies aimed to preserve ambulatory function in this high-risk population. Level III, cohort study [ABSTRACT FROM AUTHOR]

Various total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. The primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. Propensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. At 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both). Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes. [ABSTRACT FROM AUTHOR]

Little information is available about the minimal clinically important differences (MCIDs) for objective physical measurements in people with lumbar spinal stenosis (LSS). To use disorder-specific anchor and, multiple anchor-, and distribution-based approaches to determine the MCIDs for walking capacity and physical activity in patients with LSS receiving nonsurgical treatment. Secondary analysis of a randomized controlled trial. Sixty-nine patients with neurogenic claudication caused by LSS receiving outpatient physical therapy. Zurich claudication questionnaire (ZCQ), self-paced walking test (SPWT), and number of daily steps measured by pedometry. All patients completed the ZCQ, SPWT, and pedometry at the baseline and after 6 weeks. For the anchor-based approach, ZCQ symptom severity, physical function, and satisfaction subscales were used as the external anchors. Using the receiver-operating characteristic (ROC) curve, the MCIDs were determined based on the optimal cutoff points for changes in the SPWT or daily steps. For the distribution-based approach, the MCIDs were estimated from the standard deviations (SDs) of the baseline scores of the SPWT and daily steps. In the anchor-based approach, only the ZCQ satisfaction subscale for the SPWT (0.73), and ZCQ symptom severity subscale for daily steps (0.71) exceeded the area under the ROC curve value of 0.7, which is considered acceptable. When using these subscales as anchors, the ROC curves and optimal cutoff points indicated MCIDs of 151 m for the SPWT and 1,149 steps for daily steps. The distribution-based approach estimated the MCIDs as 280 m for the SPWT and 1,274 steps for daily steps, and had a moderate effect size (0.5 SD). The anchor-based approach had limited external responsiveness when the ZCQ was used as the anchor. However, this information may be helpful for interpreting walking capacity and physical activity in patients with LSS receiving nonsurgical treatment and for estimating power and sample size when planning new trials. [ABSTRACT FROM AUTHOR]

The lateral approach to lumbar fusion surgery provides access to the spine without needing to use a transperitoneal pathway thus reducing the incidence of morbidity compared to the anterior approach. Therefore, the frequency in which this approach has been utilized has grown warranting increased need for evaluating patient reported outcomes for this particular surgical technique. The utilization of patient-reported outcome measures (PROMs) administered as surveys is a standard procedure now in spine surgery. These surveys are used to evaluate from the patient's perspective the success of the surgery in alleviating the preoperative symptoms. More information is needed to correlate PROMs with their legacy counterparts in the context of individual pathologies and surgeries. The goal of this study is to correlate Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) scores with Short Form-12 Physical Component Score (SF-12 PCS) and Veterans RAND-12 Physical Component Score (VR-12 PCS) to assess physical function in individuals undergoing Lateral Lumbar Interbody Fusion (LLIF). This study is a retrospective review. Electronic medical records of a single spine surgeon were searched for individuals undergoing primary, elective LLIF. Excluded cases were related to cancer, infection, trauma, or individuals missing the PROMs of interest. A total of 86 patients were included in the final study. Outcome measures included perioperative characteristics, minimal clinically important difference (MCID) achievement rate, and PROMs of SF-12 PCS, Oswestry Disability Index (ODI), VR-12 PCS, and PROMIS-PF. Demographics, perioperative characteristics, and PROMs were collected both preoperatively and postoperatively at six weeks, 12 weeks, six-months, one year, and two years. As we look to compare "legacy" PROMs to the newer generation of measurements, we will use SF-12 PCS, VR-12, and ODI to represent the legacy PROMs. The newer generation will be represented by PROMIS-PF. Pearson's Correlation Coefficient was used to establish the relationship between the legacy PROM values and PROMIS-PF. All PROMs other than ODI showed improvements in the mean score at each consecutive follow-up time point. PROMIS-PF showed a statistically significant Pearson's Correlation Coefficient with SF-12 PCS, VR-12 PCS, and ODI at all time points measured (p<0.05, all). The Pearson's correlation coefficient for 12-week SF-12 PCS until 2-years is reported as strongly correlated (0.500<|r|, r=0.765, r=0.824, r=0.772, r=0.757, respectively). The correlation coefficients of SF-12 PCS for the preoperative and six-week timepoints were considered moderately strong positive correlation (0.300<|r|≤0.500; r = 0.467, and 0.373, respectively). The correlation coefficients of VR-12 for the preoperative and six weeks were considered strongly positive (0.500<|r|; r = 0.576 and 0.536, respectively). The 12 weeks through 2-year timepoints for VR-12 were considered strongly positive (0.500<|r|; r = 0.770, 0.835, 0.838, 0.817, respectively). The correlation coefficient for ODI from preoperative through 2-year follow-up were all considered strongly negative (0.500<|r| for all). PROMIS-PF demonstrated a strong positive correlation with VR-12 PCS, and SF-12 PCS, and a strong negative correlation with ODI in our patient sample. These results suggest PROMIS-PF can be used as an accurate measure of physical function in patients undergoing LLIF. Therefore, the use of PROMIS-PF as a singular survey for patients may be an accurate measure of patient-reported outcomes in spine surgery. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

The outcomes of revision minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and lateral lumbar interbody fusion (LLIF) have not been compared in the literature thus far. The purpose of this study is to compare perioperative and patient-reported outcome (PRO) data of revision MIS-TLIF and LLIF. This study is a retrospective cohort study. Patients undergoing elective revision MIS-TLIF and LLIF were identified from a prospective single surgeon registry and grouped into cohorts based on surgical approach. Only patients undergoing fusions at spinal levels accessible through both MIS-TLIF and LLIF were included. In total, 102 patients were included, with 29 MIS-TLIF patients and 73 LLIF patients. Outcome measures were perioperative data, minimal clinically important difference (MCID) achievement rates), and PROs including Veterans Rand-12 Physical and Mental Composite Score (VR-12 PCS, MCS), Patient-Reported Outcome Measurement Information System-physical function (PROMIS-PF), Patient-Health Questionnaire-9 (PHQ-9), Visual Analog Scale-Back and Leg Pain (VAS-BP, LP), and Oswestry Disability Index (ODI). Demographics, perioperative data, and PROs were obtained from the registry and compared through independent samples t-tests or chi-square tests. Improvements in PROs by six weeks and final follow-up were tabulated. Postoperative PROs and changes in PROs were compared through multivariable linear regression to account for age differences. MCID achievement rates were calculated for each group by comparing changes in PROs to thresholds reported in prior literature. MCID achievement rates were then compared between groups using multivariable logistic regression. Patients undergoing LLIF were significantly older (58.7 years) than patients undergoing MIS-TLIF (54.0 years) (p=0.047), but there were no other demographic differences between groups (p≥0.111, all). LLIF patients consumed more narcotics on postoperative day 0 (p=0.035), while there were no other differences in perioperative data. There were no significant differences in baseline PROMs (p≥0.059, all). When controlling for differences in age, there were no differences in 6-week postoperative and final follow-up PROMs (p≥ 0.061, all). The LLIF group reported greater average improvement in VAS-LP scores by six weeks postoperatively compared to the MIS-TLIF group (p=0.049), while other outcomes were statistically similar (p≥0.098, all). The LLIF group also reported greater average final follow-up improvements in PROMIS-PF scores (p=0.003), and similar final follow-up improvements otherwise (p≥0.086, all). There were no significant differences in MCID achievement of any outcome overall (p≥0.052, all). When controlling for age, revision LLIF patients reported earlier and greater reduction in leg pain by six weeks, with similar magnitudes of improvement by final follow-up and greater improvement in physical function at final follow-up. Overall, there were no differences in patients achieving clinically significant improvements in any outcomes. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

In recent years, mental health has increasingly been recognized as an influential determinant of patient outcomes after surgery across many specialties. Patients with back pain, a common manifestation of spine pathology, experience high concomitant rates of depression. Roughly a quarter of patients undergoing spine surgery are regularly taking antidepressant medication, which has been associated with longer hospitals stays and increased cost. Discharge to rehab facilities can contribute significantly to overall cost of care. Recent research has focused on associations between surgical spine patients and nonhome discharge in an effort to identify potential risk factors. In recent years, mental health has increasingly been recognized as an influential determinant of patient outcomes after surgery across many specialties. Patients with back pain, a common manifestation of spine pathology, experience high concomitant rates of depression. Roughly a quarter of patients undergoing spine surgery are regularly taking antidepressant medication, which has been associated with longer hospitals stays and increased cost. Discharge to rehab facilities can contribute significantly to overall cost of care. Recent research has focused on associations between surgical spine patients and nonhome discharge in an effort to identify potential risk factors. The goal of this study was to investigate the association between antidepressant use and discharge disposition, as well as inpatient physical therapy performance. This was a retrospective cohort study. Our patient sample consisted of 1,775 patients undergoing elective lumbar fusion between 2017 and 2021 at a single, academic, teritary care center. Our primary outcome measure was discharge disposition. Secondary outomces included short-term surgical outcomes such as complications and readmission. We also used inpatient physical therapy performance as a secondary outcome, as it is often plays a role in determining discharge disposition. After approval was obtained by the Institutional Review Board, patients undergoing primary 1-3 level lumbar fusion at a single, tertiary care institution from 2017-2021 were retrospectively identified. Patient characteristics, surgical details, and surgical outcomes were collected via chart review. Medications were collected based on active medication lists at the patient's preoperative and first postoperative appointment. A patient was deemed to be taking antidepressants if they were active medication at both the preoperative and follow-up appointment. Inpatient physical therapy metrics including session distance and AMPAC (Activity Measure for Post Acute Care) scores were collected via chart review. Statistical analysis was performed to identify differences between the "antidepressant" and "no antidepressant" groups. A total of 493 patients (27.7%) were taking antidepressants perioperatively. Patients in the antidepressant group were more likely to be female (p<0.001), current smokers (p=0.012), and have a higher Elixhauser comorbidity index (p<0.001). On regression analysis, the antidepressant group was associated with discharge to rehab after surgery (p=0.026). Age (p<0.001), length of stay (p<0.001), 1st session distance (p<0.001), and improvement in gait distance (p<0.001) were associated with nonhome discharge. Antidepressant use was independently associated with discharge to a rehabilitation facility. These patients were still discharged to these facilities without performing significantly worse in in their inpatient physical therapy sessions. These findings suggest that psychosocial factors may play an important role in disposition discharge after spine surgery and patients with depression/anxiety may require additional resources while in the hospital to be discharged safely home. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Low early postoperative mobility (LEPOM) has been shown to be associated with increased length of hospital stay, complication rates, and likelihood of nonhome discharge. However, few studies have examined preoperative characteristics associated with LEPOM in adult spinal deformity (ASD) patients. To investigate which preoperative patient characteristics may be associated with LEPOM after ASD surgery. Retrospective review. Included were 86 ASD patients with fusion of ≥5 levels for whom immediate-postoperative AM-PAC Basic Mobility Inpatient Short Form (6-Clicks) scores had been obtained. The primary outcome of this study was the likelihood of LEPOM, defined as an AM-PAC score ≤15, which is associated with inability to stand for more than 1 minute. Significant cutoffs for preoperative characteristics associated with LEPOM were determined via threshold linear regression. Multivariable logistic regression was used to assess the impact of preoperative characteristics on the likelihood of LEPOM. LEPOM was recorded in 38 patients (44.2%). Threshold regression identified the following cutoffs to be associated with LEPOM: preoperative Patient Reported Outcomes Measurement Information System (PROMIS) scores of ≥68 for Pain, <28.3 for Physical Function, and ≥63.4 for Anxiety; preoperative Oswestry disability index (ODI) score of ≥60; and body mass index (BMI) of ≥35.2. On multivariate analysis, preoperative PROMIS scores of ≥68 for Pain (odds ratio [OR] 5.3, confidence interval [CI] 1.2–22.8, p=.03), <28.3 for Physical Function (OR 10.1, CI 1.8–58.2, p=.01), and ≥63.4 for Anxiety (OR 4.7, CI 1.1–20.8, p=.04); preoperative ODI score ≥60 (OR 38.8, CI 4.0–373.6, p=.002); BMI ≥35.2 (OR 14.2, CI 1.3–160.0, p=.03), and male sex (OR 5.4, CI 1.2–23.7, p=.03) were associated with increased odds of LEPOM. Preoperative PROMIS Pain, Physical Function, and Anxiety scores; ODI score; BMI; and male sex were associated with LEPOM. Several of these characteristics are modifiable risk factors and thus may be candidates for optimization before surgery. III [ABSTRACT FROM AUTHOR]

Patient-reported outcomes (PROs) are increasingly utilized to evaluate the efficacy and value of spinal procedures. Among patients with cervical myelopathy, the modified Japanese Orthopaedic Association (mJOA) remains the standard instrument, with Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and patient satisfaction also frequently assessed. These outcomes have not all been directly compared using a large spine registry at 2 years follow-up for cervical myelopathic patients undergoing surgery. To determine the correlation and association of PROMIS PF, mJOA, and patient satisfaction outcomes in patients undergoing surgery for cervical myelopathy. Retrospective review of a multicenter spine registry database. Adult patients with cervical myelopathy who underwent cervical spine surgery between 2/26/2018 and 4/17/2021. PROMIS PF, mJOA, and North American Spine Society (NASS) patient satisfaction index. The MSSIC database was accessed to gather pre- and postoperative outcome data on patients with cervical myelopathy. Spearman's correlation coefficients relating mJOA and PROMIS PF were quantified up to 2 years postoperatively. The correlations between patient satisfaction with mJOA and PROMIS were determined. Kappa statistics were used to evaluate for agreement between those reaching the minimum clinically important difference (MCID) for mJOA and PROMIS PF. Odds ratios were calculated to determine the association between patient satisfaction and those reaching MCID for mJOA and PROMIS PF. Support for MSSIC is provided by BCBSM and Blue Care Network as part of the BCBSM Value Partnerships program. Data from 2,023 patients were included. Moderate to strong correlations were found between mJOA and PROMIS PF at all time points (p<.001). These outcomes had fair agreement at all postoperative time points when comparing those who reached MCID. Satisfaction was strongly related to changes from baseline for both mJOA and PROMIS PF at all time points (p<.001). Odds ratios associating satisfaction with PROMIS PF MCID were higher at all time points compared with mJOA, although the differences were not significant. PROMIS PF has a strong positive correlation with mJOA up to 2 years postoperatively in patients undergoing surgery for cervical myelopathy, with similar odds of achieving MCID with both instruments. Patient satisfaction is predicted similarly by these outcome measures by 2 years postoperatively. These results affirm the validity of PROMIS PF in the cervical myelopathic population. Given its generalizability and ease of use, PROMIS PF may be a more practical outcome measure for clinical use compared with mJOA. [ABSTRACT FROM AUTHOR]

• The novel lifting disability test is correlated with low back pain questionnaires. • This novel test and 5 repetition sit-to-stand (5R-STS) can measure intervention effectiveness. • Both tests have high test-retest and inter-rater reliability, not considered painful or difficult. • Questionnaire screening for moderately disabled will yield more significant correlation. Lifting disability commonly affects patients with chronic low back pain (CLBP) and may not correlate with the existing lifting-related physical assessment tests, such as the loaded forward reach (LFR) test. The Lift and Place (LAP) test was developed to assess lifting disability in CLBP based on known risk factors. The LAP test was compared with established physical assessment test, including the LFR test and self-reported disability questionnaires. This cross-sectional study measured self-reported disability questionnaires along with LAP and other physical assessment test results Eighty three CLBP and 82 asymptomatic participants aged 18 to 55 with normal BMI according to WHO classification. Oswestry disability index (ODI), Roland–Morris disability questionnaire (RMDQ), Numerical Pain Rating Scale, Trunk Extensor Endurance test, 5 Repetition Sit-To-Stand test, LAP and LFR test. Physical assessment test scores were compared between the two groups. The correlation of assessment test scores with ODI and RMDQ in patients with CLBP was calculated. Receiver operating characteristic (ROC) curve analysis was performed to calculate the area under the curve (AUC) of each assessment tests. Assessment tests, ODI, and RMDQ were measured twice for CLBP patients on separate days to calculate the test-retest intraclass correlation (ICC) reliability. Two researchers scored the assessment tests independently to calculate the inter-rater ICC. Patients with CLBP were slower in the LAP test (CLBP vs asymptomatic: 21.6±4.9 s vs 18.6±3.6 s) and had shorter reach in the LFR test (CLBP vs asymptomatic: 33.6±6.0 cm vs 36.3±6.6 cm). The LAP was correlated with both ODI (r=0.418) and RMDQ (r=0.390), while the LFR was not. In the ROC analysis, the LAP and LFR bore AUCs of 0.685 and 0.379, respectively. Their test-retest ICCs were 0.913 and 0.858, and their inter-rater ICCs were 0.997 and 0.969, respectively. The LAP test demonstrated higher reliability and significant correlation with the ODI and RMDQ, indicating its potential as performance assessment for lifting disability in CLBP. Further studies should investigate the use of LAP and other physical assessments for rapid CLBP screening. [ABSTRACT FROM AUTHOR]

• Preoperative patient activation is an independent predictor of minimum clinically important difference (MCID) for PROMIS pain at 1-year follow-up. • Preoperative patient activation is an independent predictor of MCID for PROMIS physical function at 1-year follow-up. • Routine preoperative assessment of patient activation may help identify patients at risk for poor clinical outcomes. Patient activation is a patient's willingness to take independent actions to manage their own health care. The goal of this study is to determine whether preoperative patient activation measure (PAM) predicts minimum clinically important difference (MCID) for Patient-Reported Outcomes Measurement Information System (PROMIS) pain, physical function, depression, and anxiety for patients undergoing elective spine surgery. Retrospective review. A single-institution, academic database of patients undergoing elective spine surgery. MCID at 1-year follow-up for PROMIS pain, physical function, depression and anxiety. We retrospectively reviewed a single-institution, academic database of patients undergoing elective spine surgery. Preoperative patient activation was evaluated using the PAM-13 survey, which was used to stratify patients into four activation stages. Primary outcome variable was achieving MCID at 1-year follow-up for PROMIS pain and physical function. Multivariable logistic regression analysis was used to determine impact of patient activation on PROMIS pain and the physical function. Of the 430 patients, 220 (51%) were female with a mean age of 58.2±16.8. Preoperatively, 34 (8%) were in activation stage 1, 45 (10%) in stage 2, 98 (23%) in stage 3, and 253 (59%) in stage 4. At 1-year follow up, 248 (58%) achieved MCID for PROMIS physical function, 256 (60%) achieved MCID for PROMIS pain, 151 (35.28%) achieved MCID for PROMIS depression, and 197 (46%) achieved MCID for PROMIS anxiety. For PROMIS physical function, when compared to patients at stage 1 activation, patients at stage 2 (aOR:3.49, 95% CI:1.27, 9.59), stage 3 (aOR:3.54, 95% CI:1.40, 8.98) and stage 4 (aOR:7.88, 95% CI:3.29, 18.9) were more likely to achieve MCID. For PROMIS pain, when compared against patients at stage 1, patients at stage 3 (aOR:2.82, 95% CI:1.18, 6.76) and stage 4 (aOR:5.44, 95% CI:2.41, 12.3) were more likely to achieve MCID. For PROMIS depression, when compared against patients at stage 1, patients at stage 4 were more likely to achieve MCID (Adjusted Odds Ratio (aOR):2.59, 95% CI:1.08–6.19). For PROMIS anxiety, when compared against patients at stage 1, stage 3 (Adjusted Odds Ratio (aOR):3.21, 95% CI:1.20–8.57), and stage 4 (aOR:5.56, 95% CI:2.20–14.01) were more likely to achieve MCID. Patients at higher stages of activation were more likely to achieve MCID for PROMIS pain, physical function, depression, and anxiety at 1-year follow-up. Routine preoperative assessment of patient activation may help identify patients at risk of poor outcomes. [ABSTRACT FROM AUTHOR]

Patient-reported outcome measures (PROMs) are increasingly being used in clinical care, research, and to inform policy decisions. Prior studies have demonstrated that non-English speaking patients and those of African American race and lower socioeconomic status are less likely to complete PROMs. In spine surgery populations, these groups have been shown to present with worse physical and mental health, and these disparities persist postoperatively. However, few studies have examined trends in PROMs completion rates and baseline function for spine patients broadly, including those managed nonoperatively. As the use of PROMs expands, it is pivotal that disparities in both completion rates and scores be identified, as these may bias clinical decision making, research, and policy decisions. The purpose of this study was to evaluate disparities in PROM completion rates and baseline function scores among newly presenting spine patients. Retrospective review of new patients presenting to a single multidisciplinary spine clinic from June 2020 to September 2022. A total of 10,803 consecutive new patients. The primary outcomes of interest were whether patients completed PROMs at their clinic visit, and the PROMIS Physical Function (PF), Pain Interference, and Pain Intensity t-scores reported by respondents. Chi-square and two-sided independent samples t-tests were performed to compare demographics, social vulnerability (measured using the Centers for Disease Control Social Vulnerability Index [SVI]), and diagnoses between patients who did and did not complete PROMs at the first visit. Multivariate logistic regression was used to assess likelihood of PROMs completion by race, ethnicity, and SVI, after adjusting for age, sex, body mass index (BMI), and diagnosis type. Multivariate linear regression was performed to assess the impact of race, ethnicity, and SVI on PROMIS scores in the responder group, after controlling for the same factors. Overall, 7392/10803 (68.4%) patients completed PROMs at the first clinic visit. During the study period, 783 (7.2%) underwent surgery; the remaining 10020 (92.8%) were managed nonoperatively. Patients of nonwhite race (61.4 vs 71.8%, p<0.001), Hispanic ethnicity (56.5 vs 69.5%, p<0.001), and a diagnosis other than cervical-only or lumbar-only pathology (52.9 vs 76.8%, p<0.001) were less likely to complete PROMs. Further, nonresponders resided in areas of higher social vulnerability (SVI 0.35 ± 0.26 vs 0.31 ± 0.24, p<0.001). Age, BMI, and sex were not associated with statistically significant differences in PROMs completion rates. After adjusting for these factors and diagnosis type, patients of nonwhite race (OR=0.661, 95% CI: 0.599-0.729), Hispanic ethnicity (OR=0.569, 95% CI: 0.448-0.721), and increased social vulnerability (OR=0.608, 95% CI: 0.511-0.723) remained less likely to complete PROMs (all p<0.001). In the multivariate models assessing PROMIS scores by race, ethnicity, and SVI, patients of nonwhite race reported lower levels of physical function (PROMIS PF β=-6.5, p=0.032) and higher levels of pain intensity (β=0.6, p=0.005). Hispanic ethnicity and increased social vulnerability were each associated with increased pain intensity (Hispanic β=1.5, p=0.004; SVI β=1.1, p=0.002) but no significant differences in baseline physical function were observed. Race, ethnicity, and SVI were not associated with any statistically significant differences in pain interference scores. Our study highlights disparities in PROM completion rates and suggests that nonwhite patients, those of Hispanic ethnicity, and those at increased social vulnerability may be underrepresented in spine patient-reported outcomes. As these subpopulations may also have worse physical function or pain intensity, additional strategies are needed to better capture patient reported health status in order to avoid bias in clinical care, outcomes research and health policy. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

The impact of sarcopenia on surgical outcomes has been well-documented, but its specific influence on the posterior lumbar interbody fusion (PLIF) surgery requires further exploration. In this context, the present aims to investigate the impact of sarcopenia on clinical outcomes following one or two-level PLIF. Additionally, the present study also aims to evaluate if muscle indices, including gluteal muscle index, derived from CT scans, can predict clinical outcomes. Prospective observational study. A total of 115 patients who underwent one or two-level PLIF from December 2021 to December 2022 were enrolled and analyzed prospectively. Sarcopenia diagnosis, muscle indices, and demographic data were analyzed using regression analysis to identify predictive factors for the Oswestry Disability Index (ODI) 12-month postoperatively. Sarcopenia was defined according to the 2018 Asian Working Group for Sarcopenia (AWGS) guidelines. Appendicular skeletal muscle mass (ASM) was measured using a full-body DEXA scan, with low ASM defined as < 7.0 kg/m² in men and < 5.4 kg/m² in women. Muscle strength was assessed using handgrip strength (HGS), with thresholds of 29 kg for men and 18 kg for women. Poor physical performance was identified using physical performance test, including 6-meter walk speed of less than 1.0 m/s or sit-to-stand time of 12 seconds or more. Muscle indices, including psoas muscle index (PMI), paraspinal muscle index (PaMI), and gluteal muscle index (GMI), were derived from CT scans. Out of 115 patients, 77 (65.2%) were diagnosed with sarcopenia according to the AWGS criteria. The sarcopenia group had statistically significantly lower BMI, ASM, PaMI, GMI, and poor preoperative ODI compared to the normal group. RM-ANOVA analysis showed significant differences in ODI scores between groups at 3-, 6-, and 12-months postoperatively, with the sarcopenia group exhibiting significant poorer outcomes at 12-months (sarcopenia vs normal group, 0.183 ± 0.149 vs 0.107 ± 0.055, P < 0.001). Multivariate regression analysis identified poor sit-to-stand test results, weak HGS, lower ASM, and lower GMI as poor predictive factors for ODI 12-month postoperatively. Patients diagnosed with sarcopenia exhibited poorer clinical outcomes 12-months postoperatively. In our study cohort, poor sit-to-stand test results, weak HGS, lower ASM, and lower GMI were identified as predictive factors for poor outcomes. Therefore, the presence of sarcopenia in patients considering fusion surgery necessitates careful consideration, as it may predispose them to poorer clinical outcomes. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Patients undergoing anterior/posterior lumbar fusion surgery can undergo either a single-stage or multi-stage operation depending on surgeon preference. There is limited evidence directly comparing outcomes between single- and multi-stage lumbar fusion surgery. To assess differences in outcomes between patients who underwent single- versus multi-stage lumbar fusion procedures in a multi-center setting. Not Applicable Not Applicable Not Applicable The Michigan Spine Surgery Improvement Collaborative database was queried for lumbar fusion surgeries between July 2018 and January 2022. Patients who underwent single-stage and multi-stage procedures were included. Primary outcomes included postoperative complications and improvement in patient-reported outcomes (PROs) which include: NASS patient satisfaction, PROMIS Physical Function, and EQ-5D. Propensity matching was conducted followed by Poisson generalized estimating equation models for multivariate analyses. Following propensity matching, 355 patients underwent single-stage procedures and 355 patients underwent multi-stage procedures. Patients undergoing multi-stage procedures had more complications, less patient satisfaction after 1 year, and were less likely to experience improvement in back pain after 90 days and at 2 years (1.17[1.02-1.34, p = 0.026], 0.83[0.74-0.93, p < 0.001], 0.86[0.75-0.99, p = 0.039], and 0.76[0.60-0.96, p = 0.023], respectively). On a matched cohort of patients undergoing lumbar 360 fusion, we observed that patients who undergo a multi-stage approach have higher postoperative complication rates and lower patient satisfaction compared to those who underwent single-stage procedures. Our findings suggest that single-stage lumbar 360 fusion surgery is tolerated well, if not better, than the multi-staged approach. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

There is a paucity of literature comparing clinical outcomes by specific cervical level. To compare clinical outcomes through patient-reported outcome measures (PROMs) and minimum clinically important difference (MCID) achievement for patients undergoing 1-level anterior cervical discectomy and fusion (ACDF) or cervical disc replacement (CDR) at each individual cervical level. Retrospective Review. Patients undergoing 1-level ACDF or CDR. Patient-Reported Outcomes Measurement Information System Physical. Function (PROMIS-PF), Visual Analog Scale (VAS) Neck, VAS Arm, and Neck Disability Index (NDI). Patients undergoing 1-level ACDF or CDR were separated into 5 different cohorts depending on surgical level: C3-C4, C4-C5, C5-C6, C6-C7, and C7-T1. Patient demographics, perioperative characteristics, and PROMs were collected. PROMs of Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF), Visual Analog Scale (VAS) Neck, VAS Arm, and Neck Disability Index (NDI) were collected at preoperative and up to 2-year postoperative time points. MCID achievement was calculated by comparing deltaPROM to previously established values. Univariate analysis was utilized for demographics, perioperative characteristics, and preoperative PROMs. Multivariable linear and logistic regression accounting for demographic and perioperative characteristics were utilized for postoperative PROM comparison and MCID achievement, respectively. A total of 437 patients, with 25 patients undergoing surgery at C3-C4, 57 at C4-C5, 208 at C5-C6, 138 at C6-C7, and 9 at C7-T1. The mean postoperative follow-up was 9.81±7.87 months. Patients undergoing surgery at C3-C4 demonstrated inferior PROMIS-PF at the 6-week postoperative time point (p=0.009). Patients undergoing surgery at C7-T1 demonstrated superior VAS Neck at the final postoperative follow-up (p=0.009). No significant differences were reported in magnitude of postoperative improvement or MCID achievement. Patients undergoing ACDF or CDR demonstrated similar postoperative improvement in most PROMs. Magnitude of postoperative improvement and MCID achievement were similar regardless of operated level. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Steroid injections have gained prominence in the management of lumbosacral canal stenosis, a condition characterized by narrowing of the spinal canal in the lower back. This nonsurgical approach aims to alleviate pain and inflammation, providing relief for patients experiencing symptoms such as back pain, leg pain, and numbness. The injections deliver anti-inflammatory medication directly to the affected area, offering a targeted therapeutic option for those seeking conservative treatment for lumbosacral canal stenosis. N/A N/A N/A N/A A systematic review and meta analysis were done by searching the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE (including MEDLINE InProcess) (OvidSP), Web of Science, Embase (OvidSP), and Scopus databases. ROB2 Cochrane Tools Assessment for RCTs. In the analysis, we used RevMan Cochrane software. Our comprehensive analysis included 22 studies, 18 randomized clinical trials, and 4 observational studies. The pooled analysis revealed a significant improvement in ODI score (mean difference [MD]: 5.83, 95% confidence interval [CI]: 1.58 to 10.08, p = 0.007, I2 = 99%) and VAS score (MD: 1.52, 95% CI: 0.30 to 2.74, p = 0.01, I2 = 96%) in patients who received placebo/control when compared to the patients who got steroid injection. No statistically significant differences were found in the NRS score, adverse events, weight change, Roland Morris disability score, SF-36 physical functioning change, or opioid intake between the two groups. However, a substantial enhancement in walking distance was noted among patients who received a steroid injection. Steroid injections offer a valuable adjunct in the management of lumbosacral canal stenosis. They provide effective short-term relief from pain and inflammation, allowing patients to engage in rehabilitation. However, their role as a long-term solution is limited. Combining injections with comprehensive treatment strategies can yield optimal results. Regular evaluation and personalized approaches are essential for achieving sustained relief and improving the quality of life for individuals with lumbosacral canal stenosis. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Modic changes have been linked to vertebrogenic chronic low back pain (CLBP). Vertebral endplates are innervated by the basivertebral nerve, making it a promising target for basivertebral nerve ablation (BVNA). This study aimed to evaluate the long-term efficacy and safety of BVNA for CLBP with Modic changes (ClinicalTrials.gov Ref #NCT05692440). This is a small-scale longitudinal series performed in a community practice setting. BVNA was performed by a single surgeon (WS) using the INTRACEPT® device (Relievant Medsystems, Inc.). Fifty-six patients with CLBP (pain persisting for ≥ 6 months) were recruited for BVNA, and 26 of them completed their 12 months follow-up. At baseline the average age was 71.9±9.3, 69.6% (N=39) were male, and 62.5% (N=35) experienced CLBP for over five years. Clinical improvements were recorded using the Oswestry Disability Index (ODI), the Visual Analog Scale (VAS) scale, the SF-36 Physical Component Summary (SF-36 PCS) and Mental Component Summary (MCS), at baseline, 1-month, 3-months, 6-months, and 12-months. The BVNA procedure was performed by a single surgeon (WS) using the INTRACEPT® device (Relievant Medsystems, Inc.). ODI pain intensity declined by 21.1 percent [95% CI: 14.7,27.5] at 1 month, 21.2 percent [95% CI: 14.7,27.6] at 3 months, 22.9 percent [95% CI: 16.4,29.3] at 6 months, and 22.9 percent [95% CI: 16.5,29.4] at 12 months from baseline. VAS pain intensity was reduced by 2.6 [95% CI: 1.5,3.7] at 1 month, 2.5 [95% CI: 1.4,3.6] at 3 months, 2.7 [95% CI: 1.6,3.8] at 6 months, and 3.0 [95% CI: 1.9,4.1] at 12 months from baseline. SF-36 PCS improved by 10.9 [95% CI: 7.3,14.5] at 1 month, 11.5 [95% CI: 7.9,15.1] at 3 months, and 12.3 [95% CI: 8.7,15.9] at 6 months, and 11.3 [95% CI: 7.7,15.0] at 12 months from baseline. SF-36 MCS improved by 6.0 [95% CI: 2.3,9.7] at 1 month, 6.7 [95% CI: 3.0,10.4] at 3 months, 7.4 [95% CI: 3.7,11.1] at 6 months, and 7.6 [95% CI: 3.9,11.3] at 12 months from baseline. All the measurements at every timepoint were significantly improved compared to baseline at a significance level of 5%. This study provides independent evidence that BVNA performed with the INTRACEPT® device in a community practice setting effectively improves pain, physical function, and mental function in CLBP patients. Further research with larger cohorts and longer follow-up periods is warranted to solidify the long-term benefits and potential limitations of BVNA for CLBP patients. To our knowledge, this is the first independently funded US study on basivertebral nerve ablation and the first independently funded study on an FDA-cleared device, the INTRACEPT® device. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Background: Lumbar disc herniations (LDH) are among the most common spinal conditions. Despite increased appreciation for the importance of social determinants of health, the role that these factors play in patients with lumbar disc herniations is poorly defined.Purpose: To elucidate the association between insurance status and baseline patient reported outcome measures (PROMs) in the setting of lumbar disc herniations.Study Design/setting: Retrospective cohort study PATIENT SAMPLE: Baseline patient-reported outcome measures (PROMS) were reviewed from 924 adult patients presenting for treatment of lumbar disc herniation within our institutional healthcare system (2015-2020).Outcome Measures: The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, PROMIS Global-Physical, and visual analogue scale (VAS) for back and leg pain were assessed.Methods: PROMIS scores at presentation were defined at the primary outcome and insurance status as the primary predictor. Differences in clinical and sociodemographic characteristics between our cohorts, stratified by insurance status, were evaluated using Wilcoxon rank-sum or chi-squared testing. We used multivariable negative binomial regression modeling to adjust for potential confounders including age, gender, race, language, ethnicity, comorbidity index, and median geospatial household income.Results: We included 924 patients, with mean age of 58.4 +/- 15.2 years and 52.6% male prevalence. Patients insured through Medicaid were more likely to be Black, Hispanic, and non-English speaking patients compared with the commercially insured. The Charlson Comorbidity index was significantly higher in the Medicare group. Following adjusted analysis, patients with Medicaid insurance had significantly worse PF10a (IRR, 0.90, 95% CI 0.85-0.96), as well as PROMIS Global-Physical score (IRR 0.88, 95% CI 0.82-0.94), and VAS low back pain (IRR 1.20, 95% CI 1.04-1.40) when compared to the commercially insured.Conclusions: We encountered worse physical function, mental, and pain-related patient-reported outcomes for those with Medicaid insurance in a population of patients presenting for evaluation of lumbar disc herniation. These findings, including worse depression, anxiety, and higher axial back pain scores, merit further investigation into potential health system asymmetries, and should be accounted for by treating providers. [ABSTRACT FROM AUTHOR]

Background Context: Sacroiliac (SI) joint pain causes significant disability and impairment to quality of life (QOL). Minimally invasive SI joint fusion is increasingly used to relieve chronic SI joint pain among patients who do not respond to nonsurgical treatment.Purpose: To systematically review the existing literature to assess the effectiveness and safety of minimally invasive SI joint fusion.Study Design/setting: Systematic review.Data Sources: PubMed, Embase, Cochrane, and a clinical trial registry from database inception to June 30, 2021.Study Selection: Eligible studies were primary research studies published in the English language, enrolled adults with SI joint pain, and compared SI joint fusion to nonsurgical interventions or alternative minimally invasive procedures. We included randomized controlled trials (RCTs) or controlled cohort studies (CCSs) that reported effectiveness (pain, physical function, QOL, opioid use) or safety outcomes (adverse events [AEs], revision surgeries) and uncontrolled studies that reported safety outcomes.Data Abstraction and Synthesis: Data were abstracted into structured forms; two independent reviewers assessed risk of bias using standard instruments; certainty of evidence was rated using GRADE.Results: Forty studies (2 RCTs, 3 CCSs, and 35 uncontrolled studies) were included. Minimally invasive SI joint fusion with the iFuse Implant System appeared to result in larger improvements in pain (two RCTs: mean difference in visual analog scale -40.5 mm, 95% CI, -50.1 to -30.9; -38.1 mm, p<.0001) and larger improvements in physical function (mean difference in Oswestry Disability Index -25.4 points, 95% CI, -32.5 to -18.3; -19.8 points, p<.0001) compared to conservative management at 6 months. Improvements in pain and physical function for the RCTs appeared durable at 1- and 2-year follow-up. Findings were similar in one CCS. The two RCTs also found significant improvements in QOL at 6 months and 1 year. Opioid use may be improved at 6 months and 1 to 2 years. AEs appeared higher in the fusion group at 6 months. The incidence of revision surgery varied by study; the highest was 3.8% at 2 years. Two CCSs compared the effectiveness of alternative minimally invasive fusion procedures. One CCS compared iFuse to the Rialto SI Fusion System and reported no differences in pain, function, QOL, and revision surgeries from 6 months to 1 year. One CCS compared iFuse to percutaneous screw fixation and reported significantly fewer revisions among iFuse participants (mean difference -61.0%, 95% CI, -78.4% to -43.5%). The 35 uncontrolled studies had serious limitations and reported heterogeneous safety outcomes. Two of the larger studies reported a 13.2% incidence of complications from minimally invasive SI joint fusion at 90 days using an insurance claims database and a 3.1% incidence of revision surgery over 2.5 years using a postmarket surveillance database.Conclusions: Among patients meeting diagnostic criteria for SI joint pain and who have not responded to conservative care, minimally invasive SI joint fusion is probably more effective than conservative management for reducing pain and opioid use and improving physical function and QOL. Fusion with iFuse and Rialto appear to have similar effectiveness. AEs appear to be higher for minimally invasive SI joint fusion than conservative management through 6 months. Based on evidence from uncontrolled studies, serious AEs from minimally invasive SI joint fusion may be higher in usual practice compared to what is reported in trials. The incidence of revision surgery is likely no higher than 3.8% at 2 years. Limited evidence is available that compares different minimally invasive devices. [ABSTRACT FROM AUTHOR]

Background Context: Physical inactivity has been described as both a cause and a consequence of low back pain (LBP) largely based on self-reported measures of daily activity. A better understanding of the connections between routine physical activity and LBP may improve LBP interventions.Purpose: In this study, we aim to objectively characterize the free-living physical activity of people with low back pain in comparison to healthy controls using accelerometers, and we aim to derive a set of LBP-specific physical activity minutes thresholds that may be used as targets for future physical activity interventions.Study Design: Cross-sectional.Patient Sample: A total of 22 low back pain patients and 155 controls.Outcome Measures: Accelerometry derived physical activity measures.Methods: Twenty-two people with LBP were compared to 155 age and gender-matched healthy controls. All subjects wore an ActiGraph accelerometer on the right hip for 7 consecutive days. Accelerometry-based physical activity features (count-per-minute CPM) were derived using Freedson's intervals and physical performance intervals. A random forest machine learning classifier was trained to classify LBP status using a leave-one-out cross-validation procedure. An interpretation algorithm, the SHapley Additive exPlanations (SHAP) algorithm was subsequently applied to assess the feature importance and to establish LBP-specific physical activity thresholds.Results: The LBP group reported mild to moderate disability (average ODI=18.5). The random forest classifier identified a set of 8 features (digital biomarkers) that achieved 88.1% accuracy for distinguishing LBP from controls. All of the top distinguishing features were related to differences in the sedentary and light activity ranges (<800 CPM), whereas moderate to vigorous physical activity was not discriminative. In addition, we identified and ranked physical activity thresholds that are associated with LBP prediction that can be used in future studies of physical activity interventions for LBP.Conclusions: We describe a set of physical activity features from accelerometry data associated with LBP. All of the discriminating features were derived from the sedentary and light activity range. We also identified specific activity intensity minutes thresholds that distinguished LBP subjects from healthy controls. Future examination on the digital markers and thresholds identified through this work can be used to improve physical activity interventions for LBP treatment and prevention by allowing the development of LBP-specific physical activity guidelines. [ABSTRACT FROM AUTHOR]

Background Context: Preliminary evidence has suggested favorable correlation between National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) assessments and traditional ("legacy") patient reported outcome measures (PROMs) in spine surgery. There has been a significant increase in PROMIS research with regards to spinal conditions.Purpose: The purpose of this systematic review is to provide an assessment of PROMIS Physical Function (PF) measures in this patient population.Study Design/setting: Systematic review.Methods: A systematic search of the PubMed/MEDLINE and Embase databases was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to identify published articles that referenced the various PROMIS PF measures. Two authors independently reviewed selected studies. The search returned 1,060 studies, 124 of which were selected for independent review by two authors. Of these, 37 were selected for inclusion. Mixed linear models were performed to assess for differences between legacy PROMs and PROMIS measures.Results: The combined sample size of all included studies yielded 10,296 total patients. Overall, PROMIS Physical Function (PF) measures demonstrated strong correlations with legacy PROMs when evaluating spine patients (weighted Pearson correlation, 0.589, standard error [SE]=0.023; weighted Spearman correlation, 0.702, SE=0.028). PROMIS questionnaires had significantly fewer questions than did legacy PROMs (4.2±0.30 vs. 9.53±0.82, p=.015). In spine studies, the PROMIS PF forms were completed in significantly less time than legacy PROMs (48.1±2.9 vs. 174.7±12.6 seconds, p<.001). The differences for the reliability measures and the floor and ceiling effects were not significant.Conclusions: Patient-Reported Outcomes Measurement Information System PF forms compare favorably with legacy PROMs with regard to correlations, ease of use, and quality criteria in the field of spine surgery. PROMIS PF scores correlate strongly with commonly used legacy PROMs, particularly in spine patients. Patient-Reported Outcomes Measurement Information System PF forms can be administered efficiently and to a broad patient population while remaining highly reliable. [ABSTRACT FROM AUTHOR]

Background Context: When different health care providers use different patient-reported outcome (PRO) instruments, it is challenging to integrate findings that describe particular patient groups or to establish treatment effectiveness across studies. It is therefore critical to develop accurate ways to convert scores between various instruments for clinicians and researchers to make comparisons across health outcomes.Purpose: To develop a common metric so that scores on the Oswestry Disability Index (ODI) and scores on the PROMIS Physical Function can be converted interchangeably.Study Design/setting: Data were collected from a prospective study. A single-group linking design was used.Patient Sample: The study population included 9020 patients presented to an orthopedic spine clinic from November 2013 to March 2019.Outcome Measures: Patients completed the ODI and the PROMIS Pain Interference scale delivered by Computerized Adaptive Testing (CAT) at the same time prior to their visit with a spine clinician.Methods: Equipercentile linking methods based on log-linear smoothing approach and non-smoothing approach were used to establish a common metric across the two measures.Results: The two measures assess the similar contruct of pain. The correlation between the scores of the ODI and the PROMIS PI was 0.81. The standardized Root Expected Mean Square Difference (REMSD) values for gender, ethnic, and racial groups ranged from 3.55% to 4.81%. Hence, the assumptions for the equipercentile linking method were met. The crosswalk derived linked scores based on the log-linear smoothing method yielded small deviations (Δ = 0.09) from the observed scores. We then identified linked PROMIS-PI scores corresponding to the benchmark ODI scores for the five disability levels and for various categories of patients.Conclusions: This study is the first to create crosswalks to interchangeably convert scores between the ODI to the PROMIS-PI in a large population of spine patients using the equipercentile linking method. The results of this study provide confidence in the validity and usefulness of the derived crosswalks based on the equipercentile linking approach. The crosswalks are helpful for comparing new and old studies on the two measures and identifying benchmark scores for various diseases and disability levels. [ABSTRACT FROM AUTHOR]

Background: The ability to preoperatively predict which patients will achieve a minimal clinically important difference (MCID) after lumbar spine decompression surgery can help determine the appropriateness and timing of surgery. Patient-Reported Outcome Measurement Information System (PROMIS) scores are an increasingly popular outcome instrument.Purpose: The purpose of this study was to develop algorithms predictive of achieving MCID after primary lumbar decompression surgery.Patient Sample: This was a retrospective study at two academic medical centers and three community medical centers including adult patients 18 years or older undergoing one or two level posterior decompression for lumbar disc herniation or lumbar spinal stenosis between January 1, 2016 and April 1, 2019.Outcome Measures: The primary outcome, MCID, was defined using distribution-based methods as one half the standard deviation of postoperative patient-reported outcomes (PROMIS physical function, pain interference, pain intensity).Methods: Five machine learning algorithms were developed to predict MCID on these surveys and assessed by discrimination, calibration, Brier score, and decision curve analysis. The final model was incorporated into an open access digital application.Results: Overall, 906 patients completed at least one PROMs survey in the 90 days before surgery and at least one PROMs survey in the year after surgery. Attainment of MCID during the study period by PROMIS instrument was 74.3% for physical function, 75.8% for pain interference, and 79.2% for pain intensity. Factors identified for preoperative prediction of MCID attainment on these outcomes included preoperative PROs, percent unemployment in neighborhood of residence, comorbidities, body mass index, private insurance, preoperative opioid use, surgery for disc herniation, and federal poverty level in neighborhood of residence. The discrimination (c-statistic) of the final algorithms for these outcomes was 0.79 for physical function, 0.74 for pain interference, and 0.69 for pain intensity with good calibration. The open access digital application for these algorithms can be found here: https://sorg-apps.shinyapps.io/promis_pld_mcid/ CONCLUSION: Lower preoperative PROMIS scores, fewer comorbidities, and certain sociodemographic factors increase the likelihood of achieving MCID for PROMIS after lumbar spine decompression. [ABSTRACT FROM AUTHOR]

Background Context: Positive psychosocial factors early after surgery, such as resilience and self-efficacy, may be important characteristics for informing individualized postoperative care.Purpose: To examine the association of early postoperative resilience and self-efficacy on 12-month physical function, pain interference, social participation, disability, pain intensity, and physical activity after lumbar spine surgery.Study Design/setting: Pooled secondary analysis of prospectively collected trial data from two academic medical centers.Patient Sample: Two hundred and forty-eight patients who underwent laminectomy with or without fusion for a degenerative lumbar condition.Outcome Measures: Physical function, pain inference, and social participation (ability to participate in social roles and activities) were measured using the Patient Reported Outcomes Measurement Information System. The Oswestry Disability Index, Numeric Rating Scale, and accelerometer activity counts were used to measure disability, pain intensity, and physical activity, respectively.Methods: Participants completed validated outcome questionnaires at 6 weeks (baseline) and 12 months after surgery. Baseline positive psychosocial factors included resilience (Brief Resilience Scale) and self-efficacy (Pain Self-Efficacy Questionnaire). Multivariable linear regression analyses were used to assess the associations between early postoperative psychosocial factors and 12-month outcomes adjusting for age, sex, study site, randomized group, fusion status, fear of movement (Tampa Scale for Kinesiophobia), and outcome score at baseline. This study was funded by Patient-Centered Outcomes Research Institute and Foundation for Physical Therapy Research. There are no conflicts of interest.Results: Resilience at 6 weeks after surgery was associated with 12-month physical function (unstandardized beta=1.85 [95% confidence interval [CI]: 0.29; 3.40]), pain interference (unstandardized beta=-1.80 [95% CI: -3.48; -0.12]), social participation (unstandardized beta=2.69 [95% CI: 0.97; 4.41]), and disability (unstandardized beta=-3.03 [95% CI: -6.04; -0.02]). Self-efficacy was associated with 12-month disability (unstandardized beta=-0.21 [95% CI: -0.37; -0.04].Conclusions: Postoperative resilience and pain self-efficacy were associated with improved 12-month patient-reported outcomes after spine surgery. Future work should consider how early postoperative screening for positive psychosocial characteristics can enhance risk stratification and targeted rehabilitation management in patients undergoing spine surgery. [ABSTRACT FROM AUTHOR]

Of Background Data: Surgery for degenerative lumbar spondylolisthesis (DLS) has traditionally been indicated for patients with neurogenic claudication. Surgery improves patients' disability and lower extremity symptoms, but less is known about the impact on back pain.Objective: To evaluate changes in back pain after surgery and identify factors associated with these changes in surgically-treated DLS.Study Design: Retrospective review of prospectively collected data.Methods: There were 486 consecutive patients with surgically-treated DLS who were enrolled in the Canadian Spine Outcomes Research Network prospective registry and identified for this study. Patients had demographic data, clinical information, disability (Oswestry Disability Index), and back pain rating scores collected prospectively at baseline, and 12 months follow-up RESULTS: Of the 486 DLS patients, 376 (77.3%) were successfully followed at 12 months. Mean age at baseline was 66.7 (standard deviation [SD] 9.2) years old, and 63% were female. Back pain improved significantly at 12 months, compared with baseline (p<.001). Improvement in Numeric Rating Scale (NRS)-back pain ratings was on average 2.97 (SD 2.5) points at one year and clinically significant improvement in back pain was observed in 75% of patients (minimal clinically important difference (MCID) NRS-Pain 1.2 points). Multivariable logistic regression revealed five factors associated with meeting MCID NRS-back pain at 12 month follow up: higher baseline back pain, better baseline physical function (higher SF-12 Physical Component Score), symptoms duration less than 1 to 2 years, and having no intraoperative adverse events.Conclusions: Back pain improved significantly for patients treated surgically for DLS at 1-year follow-up. [ABSTRACT FROM AUTHOR]

Background Context: Many different pain and functional outcomes are used to determine progress after surgical intervention for lumbar spinal stenosis (LSS); it is unknown how these different outcomes correlate, or whether timing of pain measurement is important.Purpose: The goal was to determine whether method and timing of pain measurement is important in the context of LSS surgical outcomes.Study Design/setting: Cohort study.Patient Sample: LSS patients (N=21).Outcome Measures: Self-report measures.Methods: Each patient completed the 36-item Short Form, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire 1 week presurgery and 6 months postsurgery. Objective function was measured using the Self-Paced Walking Test (SPWT). Low back and leg pain were assessed by visual analogue scale both immediately before the SPWT (prewalking pain) and at the symptom-limited endpoint (provoked pain). Pain was also assessed before and after surgery using the pain subscales of 36-item Short Form pain, Oswestry Disability Index, and Swiss Spinal Stenosis Questionnaire.Results: Patients averaged 65.3 years of age with 15 being female. After surgery, all outcome measures improved significantly. Postwalking pain (provoked pain) demonstrating a strong relationship with objectively measured function (SPWT). Pain (visual analogue scale prewalk and postwalk) showed little correlation with reported changes in disability, general health or physical function.Conclusions: Our results suggest that for patients with LSS, the context of the pain measurement matters, and it is important to measure pain after walking (provoked pain). Results also suggest that when examining the relationship between pain and function, objective measures of function are preferable (eg, a walking test). Finally, given the lack of association between measures of pain, it is important to understand that each pain measure is addressing a different pain construct. Therefore, when conducting outcomes studies, it is imperative to compare the exact same pain measures across time points. [ABSTRACT FROM AUTHOR]

Neurogenic claudication due to lumbar spinal stenosis (LSS) is a growing health problem in older adults. Our 2013 Cochrane systematic review assessing the effectiveness of nonoperative treatments for neurogenic claudication found only low and very low-quality evidence. Therefore, no conclusions could be made on the effectiveness of nonoperative treatment for neurogenic claudication. The purpose of this study is to update the evidence for nonoperative treatments for neurogenic claudication due to LSS. Our specific research question was: What nonoperative interventions are effective in improving outcomes in patients with neurogenic claudication due to LSS? This systematic review was registered with PROSPERO registration number CRD42020191860 and was conducted and reported according to the PRISMA guidelines. The population of interest was individuals with imaging confirming LSS and neurogenic claudication. Neurogenic claudication was defined as buttock or leg pain and/or aching, numbness, tingling, weakness or fatigue with or without back pain, precipitated by standing or walking and improved with stooping forward and/or sitting. There were no age restrictions. Outcomes included at least one of the following measures: walking ability, pain intensity, physical function, quality of life, or global improvement. We replicated and updated our original electronic database search to July 22, 2020. The search was performed in CENTRAL (Cochrane Library 2011 issue1), Medline, EMBASE, CINAHL and Index to Chiropractic Literature. We only included RCTs published in English where at least one arm provided data on nonoperative treatment and included participants diagnosed with neurogenic claudication with imaging confirmed LSS. The interventions of interest included all nonoperative treatments and the comparison was any treatment including surgery. Two independent reviewers extracted data and assessed risk of bias using the Cochrane Risk of Bias Tool One. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) was used for evidence synthesis. Of 15,200 citations screened, 156 were assessed and 23 new trials were identified. There is moderate quality evidence from three trials that: manual therapy and exercise provide superior and clinically important short-term improvement in symptoms and function compared to medical care or community-based group exercise; manual therapy, education and exercise delivered using a cognitive-behavioral approach, demonstrate superior and clinically important improvements in walking distance in the immediate to long-term compared to self-directed home exercises; glucocorticoid plus lidocaine injection is more effective than lidocaine alone in improving statistical, but not clinically important improvements in pain and function in the short-term. The remaining 20 new trials demonstrated low or very low-quality evidence for all comparisons and outcomes, like the findings of our original review. There is moderate quality evidence that a multimodal approach which includes manual therapy and exercise, with or without education is an effective treatment, and that epidural steroids are not effective for the management of LSS with neurogenic claudication. All other nonoperative interventions provided insufficient quality evidence to make conclusions on their effectiveness This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Numerous studies have reported the interplay between spinal deformity and pelvis compensatory mechanisms, but little data exist evaluating the contribution of lower extremity compensation (LE) to maintain upright posture. We hypothesis that hip, knee and ankle compensation is proportional to the severity of the spinal deformity and varies by demographics. Evaluate the association between spinal alignment and lower limbs compensation. Multicenter, prospective cohort. This study included 288 patients treated for complex adult spinal deformity (ASD) with full body images available. Pelvic retroversion (PT), hip extension (SFA), knee flexion (KA), ankle dorsiflexion (AA), pelvic translation (P.Shift) and patient reported outcomes (ODI, PROMIS and SRS-22). Surgical ASD patients were enrolled into a prospective study based on three criteria: deformity severity (PI-LL>25°, TPA>30°, SVA>15cm, TCobb>70° or TLCobb>50°), procedure complexity (>12 levels fused, 3CO or ACR) and/or age (>65 and >7 levels fused). Associations between lower extremity compensation (hip extension, knee flexion, and ankle dorsiflexion) and the magnitude of spinal deformity, patient demographics, patient frailty, and patient-reported outcomes (ODI, SRS, PROMIS-CAT) were assessed via regressions and partial correlations. A total of 288/329 patients met inclusion criteria (60±15yo, 70.5% female), had moderate to severe spinal deformity (PI-LL:15±24, TPA:24±14, SVA:65±69mm, lumbar Cobb:34±24), and reported high pain (PROMIS pain interference; PI=62.7±7.8) and reduced physical function (PROMIS physical function; PF=35.6±7.6). Lower extremity compensation included pelvic retroversion (PT:24.1± 11.8), hip extension (SFA: 203±10.5), knee flexion (KA:5.5± 9.6), ankle dorsiflexion (AA: 5.3±4.5), and posterior pelvic translation (P.Shift: 30±51mm). Overall, lower extremity compensation increased with age (all p <0.001), BMI and frailty (all p <0.001, except SFA). For a similar PT, women had greater hip extension than men (SFA: 206 vs 200, p <0.001), with less KA (3.6 vs. 10.1, p <0.001), AA, and P.Shift. Lower extremity compensation increased with PI (r=0.2-0.45, p <0.001), TPA (r=0.5-0.9, p <0.001) and correlated with PROMS (ODI:0.26 - 0.37, PROMIS PF: -0.28 - -0.39, SRS Acti.: -0.20 - -0.33). When controlling for deformity severity and PI, most associations between lower limbs compensation and PROMS were lost. However, P.Shift and SFA remained weakly correlated with physical scores (ODI and PROMIS PF). The recruitment of LE compensation is overall proportional to the severity of adult spinal deformity, with different patterns observed between men and women. Patients achieved similar PT by recruiting different patterns of LE compensation. Hip extension and posterior pelvic translation are independently associated with impairment in patient-reported outcomes. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Pelvic incidence (PI) serves as the cornerstone for many deformity classifications and realignment schema to create a more individualized realignment target for each patient. Yet, previous literature has linked high PI to problematic outcomes following corrective surgery, including mechanical complications and hip pathologies. Investigate if patients with high pelvic incidence have increased risk for complications and poor clinical outcomes following ASD surgery. Retrospective. A total of 689 ASD patients. Clinical Outcomes (ODI, SF-36 PCS, MCS), mechanical failure, surgical details. ASD patients with 2-year (2Y) data included. Groups: PI >65° (HighPI) versus PI < 65° (NormPI). Means comparison tests assessed differences in demographics, surgical details and outcomes between groups. Multivariate analysis controlling for baseline age, frailty, baseline PI-LL, and history of prior fusion, analyzed complication rates and clinical improvement between groups. Included: 445 ASD patients. There were 94 (21%) patients presented with a BL pelvic incidence greater than 65° (HighPI). HighPI patients were older (63 yrs), shorter, with higher BMI and frailty (all p<.05). HighPI were more likely to have had a prior fusion (OR: 1.9, [1.2-3.1]). HighPI were more likely to present with lower physical functioning scores, and severe pelvic compensation (OR: 5.5, [3.4-8.9]) and global deformity (OR: 3.5, [2.2-5.6]). During surgery, HighPI underwent more 3COs (OR: 1.8,[1.1-3.1]) and fusion to pelvis (OR: 2.1,[1.1-3.9]). Upon correction, adjusted analysis revealed HighPI were more likely to be undercorrected in each age-adjusted parameter compared to LowPI (OR: 4.8, [2.9-7.8]). Yet, HighPI patients were less likely to deteriorate within in-construct PI-based alignment (relative lordosis and lordosis distribution) (OR: 0.3,[0.1-0.9]). While not different at six weeks, HighPI were more likely to deteriorate in PI-based global alignment and pelvic compensation from six weeks to two years (OR: 3.2, [1.6-6.5]). This translated to a higher likelihood of developing a major or mechanical complication by 2Y (OR: 1.6, [1.04-2.6]) via adjusted analysis. High pelvic incidence is associated with increased frailty, decreased physical functioning, and more severe lumbopelvic and global deformity upon presentation for adult spinal deformity correction. These patients are more often undercorrected by age-adjusted standards and deteriorate in out-of-construct alignment over time even when adequately corrected, leading to higher mechanical complications by two years. Despite our focus on PI-adjusted alignment, we have still not optimized treatment for the patient with high pelvic incidence. Further research should target which surgical techniques and strategies can achieve better results in this population. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Few studies have investigated how neck pain and disability improve differently among patients with symptoms of both myelopathy and radiculopathy. To determine how neck pain and disability improve following anterior cervical discectomy and fusion (ACDF) among patients with myeloradiculopathy. Retrospective cohort. This study included 187 eligible patients undergoing primary, elective, single or multilevel ACDF. Demographics, perioperative information, and patient-reported outcome measures (PROM) were collected. PROMs included visual analog scale (VAS) neck and arm, neck disability index (NDI), 12-Item Short Form physical composite score (SF-12 PCS), Patient-Reported Outcomes Measurement Information System physical function (PROMIS PF), and Patient Health Questionnaire 9 (PHQ-9). A surgical database was reviewed for primary, elective, single or multilevel ACDF. Demographics, perioperative information, and patient-reported outcome measures (PROM) were collected. PROMs included visual analog scale (VAS) neck and arm, neck disability index (NDI), 12-Item Short Form physical composite score (SF-12 PCS), Patient-Reported Outcomes Measurement Information System physical function (PROMIS PF), and Patient Health Questionnaire 9 (PHQ-9). PROMs were collected preoperatively and postoperatively. Patients were categorized according to preoperative symptom severity: High VAS arm (>7); High NDI (>55); High VAS arm and NDI; and moderate symptoms. Demographics and perioperative information for groups were tested for independence using chi-squared analysis or t-test. Impact of preoperative symptom severity on PROM scores and magnitude of change were assessed using linear regression. Achievement of a minimum clinically important difference (MCID) was calculated for all groups using established values. Impact of preoperative symptoms on MCID achievement was determined using logistic regression. Alpha value was adjusted for multiple testing using a Bonferroni correction. Of 187 eligible patients, there were 14 with High NDI, 46 with High VAS arm, 29 with High NDI and VAS arm, and 98 with neither high VAS arm or NDI. Mean age was 50.2 years, average BMI was 29.4 and 61.0% were male. Insurance collected was the only significant demographic between groups (p=0.014). No significant differences in perioperative characteristics were demonstrated. Preoperative VAS neck, VAS arm, NDI, SF-12 PCS, PROMIS PF, and PHQ-9 significantly differed by group (all p<0.001). Symptom severity had a significant impact on postoperative VAS neck (all time points; p<0.002), VAS arm (6-weeks; p=0.007), NDI (6 weeks to 6 months; p<0.001), SF-12 PCS (6 months; p=0.004), PROMIS PF (6 weeks; p=0.007), and PHQ-9 (6 weeks and 6 months; p<0.001). Magnitude of improvement at all postoperative time points differed by severity groups for VAS arm, NDI, and VAS neck, except at 1 year (all p<0.002). Overall MCID achievement differed by symptom severity for VAS neck and arm, and NDI (p<0.005). MCID achievement demonstrated significant differences between groups at intermittent timepoints for VAS arm (all time points), VAS neck (6 weeks), and NDI (6 months) (all p<0.002). MCID achievement for physical function PROMs and PHQ-9 were not significantly different. Patients with myeloradiculopathy demonstrated significant differences in PROM scores based on severity of preoperative symptoms. PROM improvement and MCID achievement for neck disability, neck pain, and arm pain were the only values that differed based on symptom severity. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

A number of previous studies have demonstrated the significance of preoperative mental health scores, such as the Patient-Health Questionnaire-9 and the 12-Item Short Form Mental Composite Score (SF-12 MCS), as predictors of postoperative patient-reported outcome measures (PROMs) for physical health. However, these measures have not yet been compared as predictors of physical health outcomes following spine surgery. To assess the predictive value of PHQ-9 and SF-12 MCS in patients undergoing minimally invasive lumbar decompression (MIS LD). Retrospective cohort. This study included 416 patients undergoing primary, elective, single- or multilevel MIS LD procedures for degenerative spinal pathology. Demographic and perioperative characteristics, Patient Health Questionnaire-9 (PHQ-9), Short Form 12 Mental Composite Score (SF-12 MCS), Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF), SF-12 Physical Composite Score (PCS), visual analog scale (VAS) back, VAS leg, and Oswestry Disability Index (ODI). A prospectively maintained surgical database was retrospectively reviewed for patients who underwent primary, elective, single- or multilevel MIS LD procedures for degenerative spinal pathology. Patient demographics, baseline characteristics, pre-existing spinal pathology, and perioperative outcomes were collected. PROMs including PHQ-9, SF-12 MCS, Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF), SF-12 Physical Composite Score (PCS), Visual analog scale (VAS) back, VAS leg, and Oswestry Disability Index (ODI) were administered preoperatively and at postoperative timepoints. Descriptive statistics were performed for baseline and perioperative variables. Paired Student's t-test was used to assess postoperative improvement in PROM scores from preoperative baseline. PHQ-9 and SF-12 MCS were assessed as predictors of postoperative scores in other PROMs using linear regression analysis at each timepoint. Post-hoc estimations were performed using standardized beta coefficients to compare PHQ-9 and SF-12 MCS as predictors of postoperative PROM scores. A total of 416 MIS LD patients were included with a mean age of 45.7. A majority were male (69.0%), and non-obese (58.2%). Mean preoperative PHQ-9 and SF-12 MCS scores were 5.8 ± 5.5 and 48.8 ± 11.8, respectively. PROMIS PF, SF-12 PCS, VAS back, VAS leg, and ODI demonstrated significant improvements from preoperative baseline at all postoperative timepoints (all p<0.001). PHQ-9 was a significant predictor of PROMIS PF and SF-12 at preoperative, 6-week, 12-week, and 2-year timepoints (all p≤0.045), VAS back at all timepoints except 1-year (all p≤0.047), VAS leg at preoperative, 6-week, 12-week, and 1-year timepoints (all p≤0.021), and ODI from preoperative through 1-year timepoints (all p≤0.005). SF-12 MCS was a significant predictor of PROMIS PF at preoperative, 6-week, 12-week, and 2-year timepoints (all p≤0.016), SF-12 PCS at 6-week, 12-week, and 2-year timepoints (all p≤0.022), VAS back at preoperative, 12-week, and 6-month timepoints (all p≤0.017), and VAS leg and ODI at all timepoints except 2-years (all p≤0.025). Significant differences in effect size as predictor variables were demonstrated between PHQ-9 and SF-12 MCS at all timepoints except 6-months and 1-year for PROMIS PF and SF-12 PCS (all p≤0.027), 1-year for VAS back (all p≤0.015), and 2-years for VAS leg (all p≤0.014). Both PHQ-9 and SF-12 MCS were demonstrated as significant predictors of physical function, pain, and disability PROMs at most timepoints. However, significant differences in the effect sizes of these predictive models were demonstrated. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Engaging in physical activity early after lumbar spine surgery has promising effects on long-term postoperative recovery, including improved physical function. However, whether this effect is mediated through improvement in psychosocial factors is yet to be established. The purpose of this study was to investigate the longitudinal postoperative relationship between physical activity, psychosocial factors, and physical function in patients undergoing lumbar spine surgery. Secondary analysis from randomized controlled trial. This study included 248 participants (mean ± SD; age=62.2±11.9 years; BMI=32.4±6.6 kg/m2 and 51% females) who underwent surgery for a degenerative lumbar spine condition. Physical activity, defined as steps per day, was measured using a triaxial accelerometer (Actigraph GT3X) worn for >10 hours for >1 day(s) at 6 weeks (6wk), 6 months (6M), 12 months (12M) and 24 months (24M) following spine surgery. Physical function, measured with Patient-Reported Outcomes Measurement Information System, and psychosocial factors pain self-efficacy [Pain Self-Efficacy Questionnare], depression [Patient Health Questionnaire-9] and fear of movement [Tampa Scale for Kinesiophobia]) were assessed at preoperative visit and 6wk, 6M, 12M and 24M after surgery. Structural equation modeling (SEM) was used to analyze data and compute standardized coefficients to determine the effects of physical activity, function and psychosocial factors. Multiple imputation accounted for missing data and pooled coefficients and p-values were calculated using Rubin's approach. The mediation effect of each psychosocial factor on the effect of physical activity on physical function were computed by dividing the direct effects with the indirect effects. All SEM models controlled for age, employment, comorbidities, prior spine surgery, and preoperative pain self-efficacy, depression, fear of movement, physical function, and back and leg pain. Each SEM models was tested for model fit by assessing the established fit indexes. The overall standardized direct effect of physical activity (ie, steps per day) on physical function ranged from 0.08 to 0.19 (p<0.05), while the overall effect of physical function on physical activity ranged from non-existent to 0.14 (p<0.01 to 0.3). The effect of physical activity on physical function remained consistent after accounting for psychosocial factors in each of the mediation models. Pain self-efficacy did not mediate but depression and fear of movement at 6M mediated 3.4% and 5.4% of the effect of physical actvity at 6Wk on physical function at 12M, respectively. The findings of this study support the use of early postoperative strategies to address physical activity in order to improve long-term physical function. Pain self-efficacy did not have a mediating effect while depression and fear of movement had a very small mediating effect; therefore, additional work is needed to investigate other potential mediating factors such as pain catastrophizing, resilience and exercise self-efficacy. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

A previous study utilized normative alignment to determine overcorrections and predict mechanical complications in adult spinal deformity (ASD) surgery. Other studies have recommended alignment targets that optimize age-appropriate physical function. The difference in functional outcomes and mechanical complications between these prescribed alignment targets has not been explored. This study utilizes a component angle of the T1 pelvic angle (TPA) within the fusion to compare normative and age-pelvic incidence (PI) optimal alignment in terms of proximal junctional kyphosis (PJK), proximal junctional failure (PJF) and health related quality of life measures (HRQL). Using the component of TPA within the fusion, the T4-pelvic angle (T4PA), allows for the measurement spinopelvic alignment separate from that of the unfused thoracic spine and any PJK that may occur postoperatively. To compare ASD patients corrected to normative alignment vs age-PI optimal alignment in terms of PJK/PJF and outcomes. Retrospective analysis of a prospective multicenter ASD database and a database of asymptomatic subjects. This study included 1,916 ASD patients and 118 asymptomatic subjects for formula development; 288 ASD patients with 2-year X-ray and HRQL follow-up. SF36-PCS, ODI, SRS-22, NRS back/leg, PJK (change in UIV to UIV+2 >10°), PJF (defined as severe PJK with change >21.6°, or UIV olisthesis, or proximal junctional fracture). Baseline relationships between age, PI and T4PA, were analyzed in the ASD patients and compared to the asymptomatic subjects. Linear regression modeling was used to determine alignment based on PI and age in asymptomatic subjects (normative alignment), and in ASD patients, alignment corresponding to age-appropriate functional status (optimal alignment). ASD patients with UIV above T4 were grouped based on their corrections: normative vs optimal. Extreme over or under corrected patients were excluded (greater than or less than 2SD from mean postop T4PA). For each group, the rate of PJK and PJF were determined. In the multilinear regression analysis of the 119 asymptomatic subjects, T4PA correlated with age and PI, r=.713, p<.0001. 1916 ASD patients were included in the optimal formula development. In the 288 ASD patients included in the pre- to postop analysis (137 normative, 151 optimal), there was no difference in baseline alignment or HRQL between the groups. At 6 weeks, the normative aligned group had smaller T4PA (4.45 vs 14.1) and PI-LL (-7.24 vs 7.4), all p<.0001. Normative aligned patients had the higher PJK rate (40% vs 27.2%, p=.03) compared with optimal; and a higher PJF rate (17% vs 6.8%, p=.008). PJF patients had -1.2°of T4PA offset from normative alignment and -5.2°of offset from optimal alignment. By contrast, no PJF patients had 3.8° of T4PA offset from normative alignment and -0.42° of offset from optimal alignment. There was a trend toward worse 2-year SF36-PCS in patients who suffered PJF (37.7 vs 41.6, p=.09). Both the Normative and Optimal groups improved in outcomes from baseline to 2-year (p<.001) with no difference in 2-year HRQL. Correcting ASD patients to normative alignment resulted in higher rates of PJK and PJF without improvements in HRQL. ASD patients should not be corrected to match the alignment of their asymptomatic unfused peers, rather they should be realigned optimally to match age-appropriate physical function. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Previous studies have compared outcomes of anterior cervical discectomy and fusion (ACDF) with stand-alone interbody cage versus interbody cage with an anterior cervical plate. However, the impact of cervical plating has not been explored in terms of achievement of a minimum clinically important difference (MCID). To compare the impact of cervical plating on achievement of MCID up to 2-years following ACDF. Retrospective Cohort. A total of 197 patients undergoing primary, single-level ACDF procedures with 102 receiving anterior cervical plating with interbody cage and 95 receiving a stand-alone cage. Patient demographic characteristics, preoperative spinal diagnoses, perioperative information, Patient-Reported Outcomes Measurement Information System physical function (PROMIS-PF), the 12-Item Short Form physical component summary (SF-12 PCS), Visual Analogue Scale (VAS) neck and VAS arm and Neck Disability Index (NDI). A database was queried for primary, single-level ACDF procedures. Patients were grouped based on whether their procedure included application of an anterior, intervertebral plate. Patient demographic characteristics, preoperative spinal diagnoses, and perioperative information were recorded. PROMs including Patient-Reported Outcomes Measurement Information System physical function (PROMIS-PF), the 12-Item Short Form physical component summary (SF-12 PCS), Visual Analogue Scale (VAS) neck and VAS arm, and Neck Disability Index (NDI) were administered at preoperative and postoperative timepoints. Demographics, preoperative spinal diagnoses, and perioperative characteristics were compared between plating groups using chi squared and t-tests for categorical and continuous variables, respectively. Improvement in PROM scores was calculated as the difference between preoperative scores and each postoperative score. Achievement of an MCID was assessed using the following previously established thresholds: PROMIS-PF 4.5, SF-12 PCS 8.1, VAS neck 2.6, VAS arm 4.1, NDI 8.5. Rates of MCID achievement were compared between groups using a chi squared test. Of 197 patients, 102 received plating and 95 received no plating. The mean cohort age was 47.2 years, 58.8% were male, and 47.2% were obese. Plating status was significantly associated with Charlson Comorbidity Index (p=0.003) and insurance status (p=0.014). Operative length and estimated blood loss were significantly greater for the plating group (p<0.001). The no-plating group demonstrated significant improvements at all postoperative timepoints for VAS neck, VAS arm, and NDI (all p≤0.004), through 1-year forSF-12 PCS (all p≤0.48), and at 12-weeks (p=0.005), 6-months (p=0.022), and 2-years (p=0.030) for PROMIS-PF. In the plating group, significant improvements were demonstrated in VAS neck through 1-year (all p ≤0.025), VAS arm through 6-months (all p<0.001), NDI at 12-weeks and 6-months (both p<0.001), and SF-12 PCS and PROMIS-PF from 12-weeks through 2-years (all p≤0.027). Significant intergroup differences in PROM improvement were demonstrated only for VAS neck and NDI at 6-weeks (p=0.011, p=0.010). Rates of MCID achievement differed significantly between groups for PROMIS-PF at 6-months (p=0.009), VAS neck overall (p=0.006), and NDI at 6-weeks (p=0.033), 12-weeks (p=0.020), and overall (p=0.004). Patients improved significantly in terms of pain, disability and physical function, regardless of plating status, and with the exception of early neck pain and disability, these improvements were similar between groups. However, patients that underwent plating as part of their ACDF procedure achieved an MCID for neck pain and disability at lower rates. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Patient-Reported Outcomes Measurement Information System (PROMIS) has been well validated as a tool for assessing patient reported outcomes in spine surgery. However, as with any self-reported survey, PROMIS is vulnerable to response bias. There is currently a dearth of literature assessing differences in patients who do and do not complete PROMIS surveys. To characterize differences in patient reported outcome measure (PROM) scores between patients who do and do not complete PROMIS physical function (PF) surveys following lumbar spine surgery. Retrospective cohort. A total of 983 patients undergoing primary lumbar spine procedures. Demographic and perioperative characteristics, Patient Health Questionnaire (PHQ-9), visual analog score (VAS) back and leg, Oswestry Disability Index (ODI) and 12-Item Short Form Physical Composite Summary (SF-12 PCS) A prospectively maintained surgical database was retrospectively reviewed for primary lumbar spine procedures from May 2015 to July 2020. Procedures indicated for traumatic, infectious, or malignant etiologies were excluded. Patient demographic and operative data were collected. Outcome measures for PHQ-9, VAS back and leg, ODI and SF-12 PCS were recorded at both pre- and postoperative (6-week, 12-week, 6-month, 1-year, 2-year) timepoints. Completion rates for PROMIS PF surveys were recorded for each of the above timepoints. PROMIS PF survey dates that were before or after the window when patients could have potentially completed the survey (eg, ≤1 year after study start or before study end for 1-year PROMIS surveys) were excluded from this analysis. Descriptive statistics were performed for demographic and operative variables. Patients were categorized into groups at each timepoint based on whether or not PROMIS PF was completed. A t-test for independent samples was used to determine differences in mean scores for each PROM at each timepoint between groups. A total of 983 patients were included in this study with an average age of 48.8 years. A majority were male (66.5%), had a body mass index <30 kg/m2 (60.0%), and were nonsmokers (88.3%). The most common spinal pathology was recurrent herniated nucleus pulposus at 53.2%. Means values for operative variables were 86.6 minutes for operative time, 42.8mL for estimated blood loss, and 18.0 hours for length of stay. No significant differences were observed for all outcome measures between PROMIS completion groups at the preoperative timepoint. PHQ-9 and VAS back scores differed significantly between groups through 1-year (all p<0.05). Significant differences in VAS leg and ODI scores were demonstrated through 6-months (all p<0.05), but not at 1-year. SF-12 PCS differed significantly between PROMIS completion groups only at 6-weeks (p=0.018). Patients who did not complete PROMIS PF surveys had significantly poorer outcomes than those that did in terms of postoperative depressive symptoms, pain, and disability. These results suggest that patents completing PROMIS questionnaires may represent a healthier cohort than the overall lumbar spine population. Interestingly, these differences were not observed for preoperative scores and to a lesser extent for physical function. This finding may be reassuring, since PROMIS PF's primary function is to assess patient physical function. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Risk stratification is essential for informed decision-making and patient counseling. The PROMIS physical function computer adaptive test (PFCAT) and pain interference (PI) scales directly evaluate physical function and limitation due to pain with low question burden and may be clinically relevant predictors of adverse outcomes in spine patients. To evaluate whether preoperative PROMIS PFCAT or PI scores are important predictors of unplanned readmission in adults undergoing lumbar arthrodesis. Retrospective analysis of a spine patient registry at a Level I academic center. A total of 1,782 patients who underwent lumbar arthrodesis between 2015 and 2020 were included. Primary outcome measures was unplanned hospital readmission. All cases with unplanned hospital readmission were adjudicated by manual chart review. We performed random forest prediction modeling to identify variables with the greatest predictive importance to unplanned hospital readmission risk using the mean decrease in Gini index. Mean patient age was 62.8 (12.8) years. Mean BMI was 30.2 (6.4) kg/m2. Mean preoperative PFCAT was 33.8 (6.6) and mean PI was 66.5 (6.5). Preop CCI mean was 2.0 (2.5). Of 1,782 patients included, 146 patients (8.19%) had unplanned readmissions after surgery. In both model PFCAT and model pain interference, BMI had the greatest importance (68.9, 63.3, respectively). In model PFCAT, PFCAT had the second highest predictive importance (61.3), while in model pain interference PROMIS PI had the second greatest predictive importance (50.1). In both models, age (49.5, 46.7, respectively) and CCI (32.0, 28.7) were the third and fourth most important predictive variables for unplanned readmission, respectively. Random forest modeling is a more flexible modeling technique than linear regression techniques, and therefore, can identify under-explored risk factors. Our analysis using random forest modeling identified BMI as the most important predictive variable for unplanned readmission, with PROMIS PFCAT and PROMIS PI demonstrating the next greatest predictive importance in respective models. Both models also included age and CCI as predictive variables of lesser importance. While traditionally used to assess post-treatment outcomes, PROMIS PFCAT and PI are stronger independent predictors of postoperative readmission than age or CCI. Further research to develop risk-stratification tools incorporating PROMIS measures and random forest models is warranted. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Surgeons may preferentially limit fusion levels for younger vs older ASD patients to maintain motion segments and optimize postoperative function. Few data exist comparing the functional impact of upper thoracic (UT) vs thoracolumbar (TL) upper instrumented vertebra (UIV) in younger vs older ASD patients undergoing long fusion to the pelvis. Evaluate patient reported functional impact of UT vs TL UIV in younger vs older ASD patients undergoing long fusion to the pelvis. Propensity score matched (PSM) analysis of ASD patients prospectively enrolled into a multicenter study. Surgically treated ASD patients prospectively enrolled into multicenter study. Numeric rating scale (NRS) back and leg pain, Scoliosis Research Society-22r questionnaire (SRS-22r), Short Form-36v2 questionnaire (SF-36), Oswestry Disability Index (ODI), estimated blood loss, duration of hospital stay, postoperative complications, revision spine surgery. Surgically treated ASD patients prospectively enrolled into a multicenter ASD study were divided into 2 age groups (younger= <65 years, older= > 65 years) and separated according to UIV (TL= L2-T7; UT= T6-T1). Study inclusion criteria; 1) surgery for Lumbar (L), Sagittal (S), or Mixed (M) deformities (as per SRS-Schwab ASD classification), 2) fusion to the pelvis, 3) minimum 5 levels fused, and 4) minimum 2 year postop follow up. Surgery for double major or thoracic scoliosis were excluded. PSM was used to match preop patient demographics, scoliosis, and sagittal spinopelvic parameters including PI-LL, TK, SVS, and TPA. Surgical data evaluated and impact of UIV upon patient reported functional outcomes compared for UT vs TL for younger vs older. From 2008-2018, 435 of 717 eligible surgically treated patients were evaluated; younger (n=193; mean age 57.6 years) and older (n=242; mean age 72.3 years), mean levels fused UT=17.4, TL=10.7 (p<0.05). Preop spine deformity, demographics, and performance of osteotomies were similar for matched UT vs TL in younger and older (p>0.05). Surgical blood loss, duration of SICU and hospital stay was greater for UT vs TL in younger and older (p<0.05). UT had more revision surgery than TL due to implant failures in younger (20% vs 3%) and older (16% vs 1%), respectively (p<0.05). Older UT had more major complications than older TL (65% vs 30%). At minimum 2 year postoperative follow up spine deformity correction and all PROMs (including improvements and final values) including SRS-22r activity, SF-36 physical function, SF-36 role physical, SF-36 social function and SF-36 vitality were similar UT vs TL in younger and older (p>0.05). Younger ASD patients fused to the pelvis do not report more physical restrictions for UT vs TL UIV compared to older ASD patients, however blood loss, SICU and hospital stay and complications were greater for UT vs TL in younger and older cohorts. When deciding upon UIV for ASD patients, the minimal impact of UT vs TL UIV upon patient reported outcomes must be offset by cognizance of a longer hospital stay and potential for greater postoperative complications for UT fusions especially in older patients. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Predicting which patients will benefit from cervical spine surgery remains a clinical challenge. While a number of studies have examined postoperative improvement in degenerative cervical disease, the proportion of patients who return to normal remains unknown. To assess whether preoperative patient-reported outcomes (PROs) can be used to predict which patients return to normative levels after cervical spine surgery. Prospective cohort. Adult patients undergoing cervical spine surgery, excluding those undergoing surgery for instability due to trauma. Correlation of baseline PROs with achieving postoperative normative and acceptable symptoms states. Patients undergoing cervical spine surgery between 2016-2018 were prospectively enrolled, completing questionnaires (Neck Disability Index [NDI] and Patient Reported Outcomes Measurement Information System [PROMIS] Pain Interference [PI] and Physical Function [PF]) preoperatively and at 6 months postoperatively. Logistic regression analysis was used to determine the association between preoperative outcome measures and achieving postoperative patient acceptable symptom state (PASS) for NDI and the normative mean (50) for PROMIS. A total of 139 patients met inclusion criteria, with a mean age of 56.4 years and diagnoses of myelopathy (n=36), radiculopathy (n=48) and myeloradiculopathy (n=49). Overall, NDI and PROMIS PF demonstrated a statistically significant correlation between worse baseline scores and achieving postoperative PASS (NDI) and the PROMIS normative mean, while the association for PROMIS PI did not reach statistical significance. For NDI, a one-point worsening in the preoperative score resulted in OR of achieving PASS (NDI ≤ 17) of 0.96 (p<0.001). This association held true for patients with radiculopathy (OR 0.96; p=0.022) but did not reach statistical significance for patients with myelopathy (OR 0.98; p=0.35). For PROMIS PF, a one-point increase in the preoperative score resulted in OR of achieving the normative mean (PROMIS ≥ 50) of 1.10 (p<0.001). This association held true for patients with radiculopathy (OR 1.14; p=0.033) but did not reach statistical significance for patients with myelopathy (OR 1.03; p=0.515). When stratified by baseline level of disability, the proportion of patients reaching PASS was 83%, 100%, 80%, 57%, and 52% for baseline NDI 0-4, 5-15, 15-24, 25-34, and >34, respectively. For PROMIS PF, the proportion of patients reaching the normative threshold was 62%, 46%, 30%, 33%, and 26% for baseline PF 47.7-66.2, 43.3-47.2, 40.1-43.1, 34.7-40.0, and 23.5-34.6, respectively. Preoperative PROs can predict postoperative benefit for patients undergoing cervical spine surgery, with worse baseline function associated with a lower likelihood of attaining PASS for NDI and the PROMIS PF normative mean. PROMIS PI did not demonstrate this correlation and may not be as useful as a predictor of postoperative outcome. These data will better enable surgeons and patients to estimate prognosis after cervical spine surgery. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Patient activation refers to the extent with which patients play an active, engaged role in their own health care. An increasing number of studies in spine and broader orthopedic literature have found patient activation to be both modifiable and an independent predictor of clinical outcomes, including satisfaction. No prior studies, however, have explored the impact of patient activation on whether patients achieve minimal clinical improvement difference (MCID) for PROMIS pain and physical function at 1-year follow-up. To determine whether patient activation, a modifiable risk factor, predicts MCID for PROMIS pain and physical function for patients undergoing elective cervical or thoracolumbar spine surgery. Retrospective review of single, academic institution database. A total of 430 patients were identified who had undergone elective spine surgery and had minimum 1-year follow-up. The primary outcome measure was whether patients achieved MCID for PROMIS pain and physical function at 1-year follow-up. We retrospectively reviewed a single-institution, academic database of patients undergoing elective cervical or thoracolumbar spine surgery. Inclusion criteria was (1) age 18 or older, and (2) minimum 1-year follow-up. We assessed patient activation using the validated Patient Activation Measures-13 (PAM-13) survey. Using the PAM-13 survey, we can numerically quantify patient activation and stratify patients into one of four stages of activation (I, II, III, IV), with a higher stage indicating greater activation. Primary outcome variable was achieving MCID at 1-year follow-up for PROMIS pain and physical function. Multivariable logistic regression analysis was used to determine impact of patient activation on MCID for PROMIS pain and physical function while controlling for demographics (age, sex), income and education. Of the 430 patients meeting inclusion criteria, 210 (49%) were female with a mean age of 58.2 ± 16.8. Preoperatively, 34 (8%) were in activation stage 1, 45 (10%) in stage 2, 98 (23%) in stage 3, and 253 (59%) in stage 4. At 1-year postoperative follow up, 248 (58%) achieved MCID for PROMIS function and 256 (60%) achieved MCID for PROMIS pain. Using multivariable logistic regression, patients at higher stages of activation were more likely to achieve MCID for both PROMIS pain and physical function, compared to patients at stage 1 activation. With regards to PROMIS physical function, when compared to patients at stage 1 activation, patients at stage 2 (aOR:3.40, 95% CI: 1.25, 9.30), stage 3 (aOR:3.39, 95% CI: 1.34, 8.56) and stage 4 (aOR:7.63, 95% CI: 3.19, 18.3) were far more likely to achieve MCID. With regards to PROMIS pain, when compared against patients at stage 1, patients at stage 3 (aOR:2.78, 95% CI: 1.17, 6.63) and stage 4 (aOR:5.49, 95% CI: 2.43, 12.4) were far more likely to achieve MCID. Of note, for PROMIS pain, no difference in achieving MCID were observed between patients at stage 1 and 2. We found patient activation to be an independent predictor of MCID for both PROMIS pain and physical function for patients undergoing elective spine surgery. Given our findings, we recommend routine assessment of patient activation. And, for patients found to be at the lowest stage of activation, they should be counseled regarding the increased risk of poor outcomes, and interventions to increase activation should be considered. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Patients receiving workers' compensation (WC) demonstrate a propensity for poorer postoperative outcomes. This study determined rates of minimum clinically important difference (MCID) achievement in patients receiving WC following transforaminal interbody lumbar fusion (TLIF). Retrospective cohort. A total of 121 patients, out of 634, undergoing primary, single level TLIF with 29 receiving WC and 92 that were non-WC. Visual analog score (VAS) for back and leg, Oswestry Disability Index (ODI), 12-Item Short Form Physical Component Summary (SF-12 PCS), and Patient Reported Outcome Measurement Information System (PROMIS) A retrospective review of a prospective surgical registry for patients undergoing primary, single level TLIF from 2015 to 2020 was performed. Patient reported outcome measures (PROM) were collected pre- and postoperatively as VAS for back and leg, ODI, SF-12 PCS and PROMIS. Patients were separated into two groups based on insurance collected: WC or Non-WC. To account for differences in demographic characteristics between groups and types of procedures, a propensity score match was performed. Postoperative improvement was assessed for all PROMs using paired t-test and intergroup differences were determined by linear regression. Achievement of MCID was calculated by comparison of the difference in preoperative and postoperative PROM scores with established values and any intergroup differences assessed using Chi-squared analysis. Following propensity score matching, a total of 121 patients, out of 634, were included with 29 receiving WC and 92 that were non-WC. Mean age was 53.5 years with majority being male (63.6%). Groups differed in spinal diagnosis of isthmic spondylolisthesis (p=0.044). Following propensity score matching groups differed only in age, gender, and ethnicity (all p<0.05). WC patients demonstrated significantly poorer PROM values at all timepoints except for preoperative VAS back (p=0.297) and VAS leg (p=0.475). Groups differed in MCID achievement for VAS back and leg at 12-weeks (both p<0.05), ODI at 12-weeks (p=0.013) and 6-months (p=0.024), and SF-12 PCS at 6-months (p<0.001). Overall achievement of MCID was significantly lower for the WC cohort for VAS back (p=0.040), ODI (p=0.001), SF-12 PCS (p=0.010), and PROMIS PF (p=0.039). Workers' compensation patients demonstrated poorer postoperative outcomes at majority of timepoints. Additionally, a significantly lower rate of MCID achievement for back pain, disability, and physical function was observed overall and at intermittent timepoints for WC patients. WC patients may require alternative preoperative counseling regarding expectations for improvement following TLIF. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Patient-Reported Outcomes Measurement Information System (PROMIS) tools offer alternatives to legacy outcome measures. The National Institutes of Health Task Force on Research Standards for Chronic Low Back Pain has encouraged use of PROMIS domains. Recent study findings suggest PROMIS tools may be appropriate for long-term outcome assessment in spine surgery populations. However, the dissemination of PROMIS into clinical practice has been limited and more work showing longitudinal congruence between PROMIS and spine legacy measures may increase adoption of PROMIS measures to assess patient reported outcomes. To compare the trajectory of patient reported outcomes (PROs) as reported by PROMIS to other legacy measures of disability and pain over time. To better understand the timelines for healing in patients with different lumbar procedures, we reported the outcome trajectories of laminectomy decompression with fusion vs without fusion. Secondary analysis from a randomized controlled trial comparing postoperative cognitive-behavioral based physical therapy (n=124) and an education program (n=124). A total of 248 patients were included. Of them, 164 (66%) patients had laminectomy with fusion and 84 (34%) had laminectomy without fusion. PROMIS CAT Physical Function (PF) and Pain Interference (PI); Oswestry Disability Index (ODI); Numeric Rating Scale leg (NRS-LP) and back pain (NRS-BP), Brief Pain Inventory (BPI). Participants completed PROs preoperatively, 6 weeks, 6-, 12-, and 24-months after surgery. Mean scores were plotted at each time point for all outcomes and patients were stratified by fusion status. T-scores were reported for PROMIS measures which are standardized with a mean of 50 (SD=10). Pearson's correlations across measures were done within each timepoint. The general pattern of trajectories for all outcomes showed significant improvements from preop to 6-weeks (p<0.001) and from 6-weeks to 6-months (p<0.001) with very little change between 6 and 24 months after surgery. Between preoperative and 24-months, PROMIS PF T-scores for both fusion (33±6 at baseline to 43±7 at 24mo) and decompression (34±6 at baseline to 43±7 at 24mo) groups improved from scores indicating moderate to mild problem. For PROMIS PI T-scores, fusion (66±6 at baseline to 53±7 at 24mo) and decompression (66±7 at baseline to 53±8 at 24mo) patients both improved from scores indicating moderate problems to normal levels. For both PROMIS outcomes, the fusion group showed less improvement at 6 weeks, but both groups had similar scores by 6 months after surgery and remained similar at 12 and 24 months. The ODI and pain score trajectories showed a similar pattern of responses over time. Correlations within timepoint ranged from r=-0.84 to -0.67 for PF and ODI and r=0.69 to 0.78 for PI with BPI. Back and leg pain correlations with PI were weaker (r=0.30 to 0.70). All correlations were significant (p<0.001). PROMIS PF and PI showed similar 24-month trajectories to ODI, NRS pain measures, and BPI following lumbar spine surgery with most change occurring in the first 6 months. Fusion patients tend to have slightly worse scores than decompression at 6 weeks but both groups have similar scores by 6 months postoperatively and remain similar through 24 months. These results support the use of PROMIS measures to assess outcomes in a degenerative spine population. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Several previous randomized controlled trials have documented the success of cervical disc replacement (CDR) in treating radiculopathy and/or myelopathy, but many did not systematically compare outcomes of patients with radiculopathy versus those with myelopathy. Currently, there is still controversy about whether CDR utilization in patients with components of myelopathy can result in equivalent outcomes when compared to its use in patients with only radiculopathy. The purpose of the present study was to compare the minimally clinically important difference (MCID) across multiple patient-reported outcomes (PROs) in patients undergoing CDR for cervical spondylotic radiculopathy versus myeloradiculopathy. Retrospective review of prospectively collected data. Patients who underwent one or two-level CDR with radiculopathy versus myeloradiculopathy. Neck Disability Index (NDI), VAS-Neck, VAS-Arm, Short Form-12 Health Survey (SF-12) Physical Component Score (PCS), SF-12 Mental Component Score (MCS), PROMIS Physical Function (PF). Demographic variables and operative characteristics were analyzed for differences between patients with radiculopathy versus myeloradiculopathy. PROs were assessed for differences between the two diagnosis groups as well as improvements within each group following surgery. An MCID analysis of PROs for each diagnosis group was performed and the percentage of patients achieving the MCID was compared between the two diagnosis groups. A total of 85 patients were included in the present study, of which 48 (56%) had radiculopathy and 37 (44%) had myeloradiculopathy. Average follow-up was 13.4 months. There were no significant differences in preoperative demographic variables, or the number and distribution of cervical levels treated between the two diagnosis groups. There were no significant differences in preoperative NDI, Neck-VAS, Arm-VAS, SF-12 PCS, SF-12 MCS, and PROMIS PF scores between the two groups. At the final postoperative visit, there was no significant difference in each PRO assessed between the radiculopathy and myeloradiculopathy groups and both groups demonstrated statistically significant improvement in each PRO compared to preoperative values (P<0.02).MCID analysis demonstrated that at 6-week, 12-week, and final postoperative follow-up there was no significant difference in the percentage of patients with radiculopathy or myeloradiculopathy achieving the MCID for each PRO assessed. In both diagnosis groups the percentage of patients achieving the MCID for each PRO continued to increase from the 6-week to final postoperative follow-up except for the SF-12 MCS in patients with myeloradiculopathy. This is the first study to compare the MCID across various PROs in patients with radiculopathy versus myelopathy undergoing CDR. The percentage of patients achieving the MCID was not significantly different at each postoperative period assessed in the radiculopathy and myeloradiculopathy groups. In addition, the percentage of patients achieving the MCID continued to increase from 6-weeks to final follow-up in both groups for almost all PROs assessed. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

The 12-Item Veterans RAND physical composite score (VR-12 PCS) has been assessed for use at short-term and intermediate timepoints for lumbar fusion populations. However, it has not been validated at long-term timepoints and relevant minimum clinically important difference (MCID) values have not yet been established. This study assesses the long-term validity and establishes potential MCID values of VR-12 PCS in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). Retrospective cohort. A total of 74 patients undergoing primary, elective, single-level MIS TLIF procedures with posterior instrumentation were included. Demographic characteristics, perioperative characteristics, VR-12 PCS, 12-Item Short Form (SF-12) PCS, and Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF). A surgical database was retrospectively reviewed for primary, elective, single-level MIS TLIF procedures with posterior instrumentation. Patients were excluded if preoperative and 2-year postoperative VR-12 PCS survey data was unavailable or if procedures were indicated due to trauma, infection, or malignancy. VR-12 PCS, 12-Item Short Form (SF-12) PCS, and Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) measures were recorded at preoperative, 6-week, 12-week, 6-month, 1-year, and 2-year postoperative timepoints. Responsiveness of the VR-12 measure was assessed in 2 ways: mean postoperative scores were compared to preoperative baseline values and MCID values were calculated using distribution- and anchor-based methods and used to assess improvement in VR-12 at 2-years. Convergent validity was assessed by the correlation of VR-12 PCS scores with SF-12 PCS and PROMIS PF scores at each timepoint. Floor and ceiling effects were assessed based on the total range of VR-12 PCS scores at each timepoint. A total of 74 patients were included. VR-12 PCS demonstrated significant postoperative improvements at all timepoints from 12-weeks to 2-years. Distribution-based MCID was calculated as 3.0 (⅓ SD) with an achievement rates of 73.0%. Anchor-based MCIDs were calculated as 7.8, 8.7 (cross-sectional) (p=.049 and p=<.001), and 8.1 (longitudinal) (p=.040) with achievement rates of 52.7%, 50.0%, and 52.7%, respectively. Strong correlations of VR-12 PCS with SF-12 PCS and PROMIS PF were demonstrated at all timepoints. No significant floor or ceiling effects were detected. VR-12 PCS demonstrated good responsiveness, excellent convergent validity, and no significant floor or ceiling effects up to 2-years following MIS TLIF. Therefore, we recommend VR-12 PCS as a valid measure of long-term physical function in patients undergoing MIS TLIF. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

Patient-centered goal setting is an important component of behavioral interventions for chronic pain. Limited data exist on the relationship between goal attainment during cognitive-behavioral based physical therapy (CBPT) and pain-related outcomes. The purpose of this study was to examine the relationship between CBPT goal attainment and pain-related outcomes in a cohort of patients who completed a 6-week telephone-based CBPT intervention after lumbar spine surgery. Secondary analysis from a randomized trial comparing postoperative CBPT and an education program. The primary results of the trial showed superiority of CBPT in an intervention completers only analysis. This study included 108 participants (mean ± SD age = 63.5 ± 11.3 years, 54 [50%] female, 92 [85%] White) who completed the CBPT intervention were included. Six and 12-month outcomes included physical function (PROMIS), pain interference (PROMIS), and back and leg pain intensity (Brief Pain Inventory). At each session, CBPT participants used goal attainment scaling (GAS) to set goals and report goal attainment from the previous session. The number and type of goals and percentage of goals met were recorded. A GAS t-score for achievement of goals across all sessions was computed for each patient. Patients were grouped as high or low goal attainment based on a GAS t-score of 50, which indicates goals were met as expected. Outcome differences between groups at each follow-up time point were examined using linear regression analyses controlling for baseline outcome score. Alpha was set at the 0.05 level for statistical significance. Participants set a median of 3 goals (range: 1 to 6) at each CBPT session. The most common goals were related to participating in a physical/recreational activity (36%), adopting a cognitive or behavioral strategy (28%), exercising (11%), or performing activities of daily living (11%). The least common goals related to social activities (2%). Forty-six (43%) participants met criteria for high goal attainment (mean % goals met = 87% compared to 64% in the low goal attainment group, p<0.001). Greater improvements in the high goal attainment group were observed in physical function at 6 (unstandardized beta = 4.2, p < 0.05) and 12 months (unstandardized beta = 3.5, p < 0.05) and back pain intensity at 12 months (unstandardized beta = -0.9 p < 0.05). The attainment of personalized goals within a CBPT intervention was an important factor related to improvements in physical functioning after spine surgery. Implementing a structured process for setting personalized goals and tracking goal attainment may be an essential aspect of a biopsychosocial approach for addressing functional impairment following surgery. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]