Archer, Kristin R.

BACKGROUND AND OBJECTIVES: Although risk factors for unplanned readmission after cervical spine surgery have been widely reported, less is known about how readmission itself affects patient-reported outcome measures (PROMs). Using the Quality Outcomes Database registry of patients undergoing elective cervical spine surgery, we sought to (1) determine the impact of unplanned readmission on PROMs and (2) compare the effect of specific readmission reasons on PROMs. METHODS: An observational study was performed using a multi-institution, retrospective registry for patients undergoing cervical spine surgery. The occurrence of 90-day unplanned readmission classified into medical, surgical, pain only, and no readmissions was the exposure variable. Outcome variables included 12-month PROMs of Neck Disability Index (NDI), Numeric Rating Scale (NRS)-neck/arm pain, EuroQol-5D (EQ-5D), and patient dissatisfaction. Multivariable models predicting each PROM were built using readmission reasons controlling for demographics, clinical characteristics, and preoperative PROMs. RESULTS: Data from 13 355 patients undergoing elective cervical spine surgery (82% anterior approach and 18% posterior approach) were analyzed. Unplanned readmission within 90 days of surgery occurred in 3.8% patients, including medical (1.6%), surgical (1.8%), and pain (0.3%). Besides medical reasons, wound infection/dehiscence was the most common reason for unplanned readmission for the total cohort (0.5%), dysphagia in the anterior approach (0.6%), and wound infection/dehiscence in the posterior approach (1.5%). Based on multivariable regression, surgical readmission was significantly associated with worse 12-month NDI, NRS-neck pain, NRS-arm pain, EQ-5D, and higher odds of dissatisfaction. Pain readmissions were associated with worse 12-month NDI and NRS-neck pain scores, and worse dissatisfaction. For specific readmission reasons, pain, surgical site infection/wound dehiscence, hematoma/seroma, revision surgery, deep vein thrombosis, and pulmonary embolism were significantly associated with worsened 12-month PROMs. CONCLUSION: In patients undergoing elective cervical spine surgery, 90-day unplanned surgical and pain readmissions were associated with worse 12-month PROMs compared with patients with medical readmissions and no readmissions.

Study Design. Retrospective review. Objective. The aim was to compare outcomes at 3 and 12 months for patients with lumbar spondylolisthesis treated with direct decompression (DD) versus indirect decompression (ID) techniques. Summary of Background Data. Debate persists regarding the optimal surgical strategy to treat lumbar spondylolisthesis. Novel techniques relying on ID have shown superior radiographic outcomes compared to DD, however, doubt remains regarding their effectiveness in achieving adequate decompression. Currently, there is a paucity of data comparing the clinical efficacy of DD to ID. Methods. The Quality Outcomes Database (QOD), a national, multicenter prospective spine registry, was queried for patients who underwent DD and ID between April 2013 and January 2019. Propensity scores for each treatment were estimated using logistic regression dependent on baseline covariates potentially associated with outcomes. The propensity scores were used to exclude nonsimilar patients. Multivariable regression analysis was performed with the treatment and covariate as independent variables and outcomes as dependent variables. Results. A total of 4163 patients were included in the DD group and 86 in the ID group. The ID group had significantly lower odds of having a longer hospital stay and for achieving 30% improvement in back and leg pain at 3 months. These trends were not statistically significant at 12 months. There were no differences in ED5D scores or Oswestry disability index 30% improvement scores at 3 or 12 months. ID patient had a significantly higher rate of undergoing a repeat operation at 3 months (4.9% vs. 1.5%, P =0.015). Conclusion. Our study suggests that both DD and ID for the treatment of lumbar spondylolisthesis result in similar clinical outcomes, with the exception that those treated with ID experienced a lower reduction in back and leg pain at 3 months and a higher 3-month reoperation rate. This data can provide surgeons with additional information when counseling patients on the pros and cons of ID versus DD surgery.

Study Design. Retrospective analysis on prospectively collected data. Objective. To determine the effectiveness of elective spine surgery in patients with Parkinson disease (PD). Background Context. PD has become increasingly prevalent in an aging population. While surgical treatment for degenerative spine pathology is often required in this population, previous literature has provided mixed results regarding its effectiveness. Methods. Data from the Quality Outcomes Database (QOD) was queried between April 2013 and January 2019. Three surgical groups were identified: (1) elective lumbar surgery, (2) elective cervical surgery for myelopathy, (3) elective cervical surgery for radiculopathy. Patients without PD were propensity matched against patients with PD in a 5:1 ratio without replacement based on American Society of Anesthesiology grade, arthrodesis, surgical approach, number of operated levels, age, and baseline Oswestry Disability Index, Numerical Rating Scale (NRS) extremity pain, NRS back pain, and EuroQol 5-Dimensions (EQ-5D). The mean difference was calculated for continuous outcomes (Oswestry Disability Index, NRS leg pain, NRS back pain, and EQ-5D at 3 and 12 mo after surgery) and the risk difference was calculated for binary outcomes (patient satisfaction, complications, readmission, reoperation, and mortality). Results. For the lumbar analysis, PD patients had a higher rate of reoperation at 12 months (risk difference=0.057, P=0.015) and lower mean EQ-5D score at 12 months (mean difference=−0.053, P=0.005) when compared with patients without PD. For the cervical myelopathy cohort, PD patients had lower NRS neck pain scores at 3 months (mean difference=−0.829, P=0.005) and lower patient satisfaction at 3 months (risk difference=−0.262, P=0.041) compared with patients without PD. For the cervical radiculopathy cohort, PD patients demonstrated a lower readmission rate at 3 months (risk difference=−0.045, P=0.014) compared with patients without PD. Conclusion. For the matched analysis, in general, patients with and without PD had similar patient-reported outcomes and complication, readmission, and reoperation rates. These results demonstrate that a diagnosis of PD alone should not represent a major contraindication to elective spine surgery.

Study Design: This was an observational study. Objectives: This study aims to determine the correlation between patient-reported outcomes (PROs) pulled from a national spine registry and physician ratings from physician review websites (PRWs). Summary of Background Data: PRWs are frequently utilized by patients to make health care decisions; however, many PRWs appear to incorporate subjective experiences unrelated to a surgeon’s clinical performance into ratings. As such, their utility as a health care decision-making tool remains unclear. Materials and Methods: This study evaluated 8834 patients from the Quality Outcomes Database (QOD) who underwent 1-level elective lumbar spine surgery. The lumbar module of QOD was queried to rank 124 surgeons using PROs (Oswestry Disability Index, EuroQOL, Numerical Rating Scale—back/leg pain, and patient satisfaction). The QOD PRO-ranking system was compared against PRWs including Healthgrades, Vitals, WebMD, and Google. The Spearman correlation coefficients, Kruskal-Wallis tests, and multiple linear regression models were used for statistical comparison. The primary outcome was the correlation between PRW scores and PROs. Results: Surgeon PRO-derived ranking showed high intercorrelational congruence with coefficients between the 3 PROs (Oswestry Disability Index, EuroQOL, Numerical Rating Scale back/leg) ranging between 0.70 and 0.88. Low correlations were observed between PRO-derived rankings and PRWs, ranging from 0.23 to 0.37. Healthgrades performed most similarly to PRO-derived rankings, correlating best with patient satisfaction, though the correlation was low (ρ=0.37). Conclusions: While PRWs are often used to evaluate surgeon competency, these results demonstrate they poorly correlate with a surgeon’s clinical ability measured by PROs. PRWs should be used with caution when making health care decisions by patients, payers, and administrators. Level of Evidence: Level III.

OBJECTIVE The development of new treatment approaches for degenerative lumbar spondylolisthesis (DLS) has introduced many questions about comparative effectiveness and long-term outcomes. Patient registries collect robust, longitudinal data that could be combined or aggregated to form a national and potentially international research data infrastructure to address these and other research questions. However, linking data across registries is challenging because registries typically define and capture different outcome measures. Variation in outcome measures occurs in clinical practice and other types of research studies as well, limiting the utility of existing data sources for addressing new research questions. The purpose of this project was to develop a minimum set of patient- and clinician-relevant standardized outcome measures that are feasible for collection in DLS registries and clinical practice. METHODS Nineteen DLS registries, observational studies, and quality improvement efforts were invited to participate and submit outcome measures. A stakeholder panel was organized that included representatives from medical specialty societies, health systems, government agencies, payers, industries, health information technology organizations, and patient advocacy groups. The panel categorized the measures using the Agency for Healthcare Research and Quality’s Outcome Measures Framework (OMF), identified a minimum set of outcome measures, and developed standardized definitions through a consensus-based process. RESULTS The panel identified and harmonized 57 outcome measures into a minimum set of 10 core outcome measure areas and 6 supplemental outcome measure areas. The measures are organized into the OMF categories of survival, clinical response, events of interest, patient-reported outcomes, and resource utilization. CONCLUSIONS This effort identified a minimum set of standardized measures that are relevant to patients and clinicians and appropriate for use in DLS registries, other research efforts, and clinical practice. Collection of these measures across registries and clinical practice is an important step for building research data infrastructure, creating learning healthcare systems, and improving patient management and outcomes in DLS.

Study Design. Retrospective analysis of prospectively collected registry data. Objective. The aim of this study was to compare the performance of 30% reduction to established absolute point-change values for measures of disability and pain in patients undergoing elective cervical spine surgery. Summary of Background Data. Recent studies recommend using a proportional change from baseline instead of an absolute point-change value to define minimum clinically important difference (MCID). Methods. Analyses included 13,179 patients who underwent cervical spine surgery for degenerative disease between April 2013 and February 2018. Participants completed a baseline and 12-month follow-up assessment that included questionnaires to assess disability (Neck Disability Index [NDI]), neck and arm pain (Numeric Rating Scale [NRS-NP/AP], and satisfaction [NASS scale]). Participants were classified as met or not met 30% reduction from baseline in each of the respective measures. The 30% reduction in scores at 12 months was compared to a wide range of established absolute point-change MCID values using receiver-operating characteristic curves, area under the receiver-operating characteristic curve (AUROC), and logistic regression analyses. These analyses were conducted for the entire patient cohort, as well as for subgroups based on baseline severity and surgical approach. Results. Thirty percent reduction in NDI and NRS-NP/AP scores predicted satisfaction with more accuracy than absolute point-change values for the total population and ACDF and posterior fusion procedures (P < 0.05). The largest AUROC differences, in favor of 30% reduction, were found for the lowest disability (ODI 0–20%: 16.8%) and bed-bound disability (ODI 81%–100%: 16.6%) categories. For pain, there was a 1.9% to 11% and 1.6% to 9.6% AUROC difference for no/mild neck and arm pain (NRS 0–4), respectively, in favor of a 30% reduction threshold. Conclusion. A 30% reduction from baseline is a valid method for determining MCID in disability and pain for patients undergoing cervical spine surgery. Level of Evidence: 3

Study Design. Retrospective analysis of prospectively collected registry data. Objective. To develop and validate prediction models for 12-month patient-reported outcomes of disability, pain, and myelopathy in patients undergoing elective cervical spine surgery. Summary of Background Data. Predictive models have the potential to be utilized preoperatively to set expectations, adjust modifiable characteristics, and provide a patient-centered model of care. Methods. This study was conducted using data from the cervical module of the Quality Outcomes Database. The outcomes of interest were disability (Neck Disability Index:), pain (Numeric Rating Scale), and modified Japanese Orthopaedic Association score for myelopathy. Multivariable proportional odds ordinal regression models were developed for patients with cervical radiculopathy and myelopathy. Patient demographic, clinical, and surgical covariates as well as baseline patient-reported outcomes scores were included in all models. The models were internally validated using bootstrap resampling to estimate the likely performance on a new sample of patients. Results. Four thousand nine hundred eighty-eight patients underwent surgery for radiculopathy and 2641 patients for myelopathy. The most important predictor of poor postoperative outcomes at 12-months was the baseline Neck Disability Index score for patients with radiculopathy and modified Japanese Orthopaedic Association score for patients with myelopathy. In addition, symptom duration, workers’ compensation, age, employment, and ambulatory and smoking status had a statistically significant impact on all outcomes (P < 0.001). Clinical and surgical variables contributed very little to predictive models, with posterior approach being associated with higher odds of having worse 12-month outcome scores in both the radiculopathy and myelopathy cohorts (P < 0.001). The full models overall discriminative performance ranged from 0.654 to 0.725. Conclusions. These predictive models provide individualized risk-adjusted estimates of 12-month disability, pain, and myelopathy outcomes for patients undergoing spine surgery for degenerative cervical disease. Predictive models have the potential to be used as a shared decision-making tool for evidence-based preoperative counselling. Level of Evidence: 2.

Abstract BACKGROUND The impact of symptom characteristics on outcomes of spine surgery remains elusive. OBJECTIVE To determine the impact of symptom location, severity, and duration on outcomes following lumbar spine surgery. METHODS We queried the Quality Outcomes Database (QOD) for patients undergoing elective lumbar spine surgery for lumbar degenerative spine disease. Multivariable regression was utilized to determine the impact of preoperative symptom characteristics (location, severity, and duration) on improvement in disability, quality of life, return to work, and patient satisfaction at 1 yr. Relative predictor importance was determined using an importance metric defined as Wald χ 2 penalized by degrees of freedom. RESULTS A total of 22 022 subjects were analyzed. On adjusted analysis, we found patients with predominant leg pain were more likely to be satisfied ( P < .0001), achieve minimum clinically important difference (MCID) in Oswestry Disability Index (ODI) ( P = .002), and return to work ( P = .03) at 1 yr following surgery without significant difference in Euro-QoL-5D (EQ-5D) ( P = .09) [ref = predominant back pain]. Patients with equal leg and back pain were more likely to be satisfied ( P < .0001), but showed no significant difference in achieving MCID ( P = .22) or return to work ( P = .07). Baseline numeric rating scale-leg pain and symptom duration were most important predictors of achieving MCID and change in EQ-5D. Predominant symptom was not found to be an important determinant of return to work. Worker's compensation was found to be most important determinant of satisfaction and return to work. CONCLUSION Predominant symptom location is a significant determinant of functional outcomes following spine surgery. However, pain severity and duration have higher predictive importance. Return to work is more dependent on sociodemographic features as compared to symptom characteristics.

OBJECTIVE Patient satisfaction with treatment outcome is gaining an increasingly important role in assessing the value of surgical spine care delivery. Nationwide data evaluating the predictors of patient satisfaction in elective cervical spine surgery are lacking. The authors sought to decipher the impacts of the patient, surgical practice, and surgeon on satisfaction with outcome following anterior cervical discectomy and fusion (ACDF). METHODS The authors queried the Quality Outcomes Database for patients undergoing 1- to 2-level ACDF for degenerative spine disease since 2013. Patient satisfaction with the surgical outcome as measured by the North American Spine Society (NASS) scale comprised the primary outcome. A multivariable proportional odds logistic regression model was constructed with adjustments for baseline patient characteristics and surgical practice and surgeon characteristics as fixed effects. RESULTS A total of 4148 patients (median age 54 years, 48% males) with complete 12-month NASS satisfaction data were analyzed. Sixty-seven percent of patients answered that “surgery met their expectations” (n = 2803), while 20% reported that they “did not improve as much as they had hoped but they would undergo the same operation for the same results” (n = 836). After adjusting for a multitude of patient-specific as well as hospital- and surgeon-related factors, the authors found baseline Neck Disability Index (NDI) score, US geographic region of hospital, patient race, insurance status, symptom duration, and Workers’ compensation status to be the most important predictors of patient satisfaction. The discriminative ability of the model was satisfactory (c-index 0.66, overfitting-corrected estimate 0.64). CONCLUSIONS The authors’ results found baseline NDI score, patient race, insurance status, symptom duration, and Workers’ compensation status as well as the geographic region of the hospital to be the most important predictors of long-term patient satisfaction after a 1- to 2-level ACDF. The findings of the present analysis further reinforce the role of preoperative discussion with patients on setting treatment goals and realistic expectations.

Abstract BACKGROUND Degenerative cervical myelopathy (DCM) is a progressive disease resulting from cervical cord compression. The modified Japanese Orthopaedic Association (mJOA) is commonly used to grade myelopathic symptoms, but its persistent postoperative improvement has not been previously explored. OBJECTIVE To utilize the Quality Outcomes Database (QOD) to evaluate the trajectory of outcomes in those operatively treated for DCM. METHODS This study is a retrospective analysis of prospectively collected data. The QOD was queried for patients undergoing elective surgery for DCM. Patients were divided into mild (≥14), moderate (9-13), or severe (<9) categories for their baseline severity of myelopathic symptoms (mJOA scores). A parsimonious multivariable logistic regression model was fitted with 2 points improvement on mJOA from 3- to 12-mo follow-up as the outcome of interest. RESULTS A total of 2156 patients who underwent elective surgery for DCM and had complete 3- and 12-mo follow-up were included in our analysis. Patients improved significantly from baseline to 3-mo on their mJOA scores, regardless of their baseline mJOA severity. After adjusting for the relevant preoperative characteristics, the baseline mJOA categories had significant impact on outcome of whether a patient keeps improving in mJOA score from 3 to 12 mo postsurgery. Patient with severe mJOA score at baseline had a higher likelihood of improvement in their myelopathic symptoms, compared to patients with mild mJOA score in. CONCLUSION Most patients achieve improvement on a shorter follow-up; however, patients with severe symptoms keep on improving until after a longer follow-up. Preoperative identification of such patients helps the clinician settling realistic expectations for each follow-up timepoint.