Devin, Clinton J.

Study Design. Delphi method. Objective. To gain consensus on the following questions: (1) When should anticoagulation/antiplatelet (AC/AP) medication be stopped before elective spine surgery?; (2) When should AC/AP medication be restarted after elective spine surgery?; (3) When, how, and in whom should venous thromboembolism (VTE) chemoprophylaxis be started after elective spinal surgery? Summary of Background Data. VTE can lead to significant morbidity after adult spine surgery, yet postoperative VTE prophylaxis practices vary considerably. The management of preoperative AC/AP medication is similarly heterogeneous. Materials and Methods. Delphi method of consensus development consisting of three rounds (January 26, 2021, to June 21, 2021). Results. Twenty-one spine surgeons were invited, and 20 surgeons completed all rounds of questioning. Consensus (>70% agreement) was achieved in 26/27 items. Group consensus stated that preoperative Direct Oral Anticoagulants should be stopped two days before surgery, warfarin stopped five days before surgery, and all remaining AC/AP medication and aspirin should be stopped seven days before surgery. For restarting AC/AP medication postoperatively, consensus was achieved for low-risk/medium-risk/high-risk patients in 5/5 risk factors (VTE history/cardiac/ambulation status/anterior approach/operation). The low/medium/high thresholds were POD7/POD5/POD2, respectively. For VTE chemoprophylaxis, consensus was achieved for low-risk/medium-risk/high-risk patients in 12/13 risk factors (age/BMI/VTE history/cardiac/cancer/hormone therapy/operation/anterior approach/staged separate days/staged same days/operative time/transfusion). The one area that did not gain consensus was same-day staged surgery. The low-threshold/medium-threshold/high-threshold ranges were postoperative day 5 (POD5) or none/POD3-4/POD1-2, respectively. Additional VTE chemoprophylaxis considerations that gained consensus were POD1 defined as the morning after surgery regardless of operating finishing time, enoxaparin as the medication of choice, and standardized, rather than weight-based, dose given once per day. Conclusions. In the first known Delphi study to address anticoagulation/antiplatelet recommendations for elective spine surgery (preoperatively and postoperatively); our Delphi consensus recommendations from 20 spine surgeons achieved consensus on 26/27 items. These results will potentially help standardize the management of preoperative AC/AP medication and VTE chemoprophylaxis after adult elective spine surgery.

OBJECTIVE Spine surgery represents an ideal target for healthcare cost reduction efforts, with outpatient surgery resulting in significant cost savings. With an increased focus on value-based healthcare delivery, lumbar decompression surgery has been increasingly performed in the outpatient setting when appropriate. The aim of this study was to compare clinical and patient-reported outcomes following outpatient and inpatient lumbar decompression surgery. METHODS The Quality Outcomes Database (QOD) was queried for patients undergoing elective one- or two-level lumbar decompression (laminectomy or laminotomy with or without discectomy) for degenerative spine disease. Patients were grouped as outpatient if they had a length of stay (LOS) < 24 hours and as inpatient if they stayed in the hospital ≥ 24 hours. Patients with ≥ 72-hour stay were excluded from the comparative analysis to increase baseline comparability between the two groups. To create two highly homogeneous groups, optimal matching was performed at a 1:1 ratio between the two groups on 38 baseline variables, including demographics, comorbidities, symptoms, patient-reported scores, indications, and operative details. Outcomes of interest were readmissions and reoperations at 30 days and 3 months after surgery, overall satisfaction, and decrease in Oswestry Disability Index (ODI), back pain, and leg pain at 3 months after surgery. Satisfaction was defined as a score of 1 or 2 in the North American Spine Society patient satisfaction index. Noninferiority of outpatient compared with inpatient surgery was defined as risk difference of < 1.5% at a one-sided 97.5% confidence interval. RESULTS A total of 18,689 eligible one- and two-level decompression surgeries were identified. The matched study cohorts consisted of 5016 patients in each group. Nonroutine discharge was slightly less common in the outpatient group (0.6% vs 0.3%, p = 0.01). The 30-day readmission rates were 4.4% and 4.3% for the outpatient and inpatient groups, respectively, while the 30-day reoperation rates were 1.4% and 1.5%. The 3-month readmission rates were 6.3% for both groups, and the 3-month reoperation rates were 3.1% for the outpatient cases and 2.9% for the inpatient cases. Overall satisfaction at 3 months was 88.8% for the outpatient group and 88.4% for the inpatient group. Noninferiority of outpatient surgery was documented for readmissions, reoperations, and patient-reported satisfaction from surgery. CONCLUSIONS Outpatient lumbar decompression surgery demonstrated slightly lower nonroutine discharge rates in comparison with inpatient surgery. Noninferiority in clinical outcomes at 30 days and 3 months after surgery was documented for outpatient compared with inpatient decompression surgery. Additionally, outpatient decompression surgery performed noninferiorly to inpatient surgery in achieving patient satisfaction from 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 With the expanding indications for and increasing popularity of minimally invasive surgery (MIS) for lumbar spinal fusion, large-scale outcomes analysis to compare MIS approaches with open procedures is warranted. METHODS The authors queried the Quality Outcomes Database for patients who underwent elective lumbar fusion for degenerative spine disease. They performed optimal matching, at a 1:2 ratio between patients who underwent MIS and those who underwent open lumbar fusion, to create two highly homogeneous groups in terms of 33 baseline variables (including demographic characteristics, comorbidities, symptoms, patient-reported scores, indications, and operative details). The outcomes of interest were overall satisfaction, decrease in Oswestry Disability Index (ODI), and back and leg pain, as well as hospital length of stay (LOS), operative time, reoperations, and incidental durotomy rate. Satisfaction was defined as a score of 1 or 2 on the North American Spine Society scale. Minimal clinically important difference (MCID) in ODI was defined as ≥ 30% decrease from baseline. Outcomes were assessed at the 3- and 12-month follow-up evaluations. RESULTS After the groups were matched, the MIS and open groups consisted of 1483 and 2966 patients, respectively. Patients who underwent MIS fusion had higher odds of satisfaction at 3 months (OR 1.4, p = 0.004); no difference was demonstrated at 12 months (OR 1.04, p = 0.67). Lumbar stenosis, single-level fusion, higher American Society of Anesthesiologists Physical Status Classification System grade, and absence of spondylolisthesis were most prominently associated with higher odds of satisfaction with MIS compared with open surgery. Patients in the MIS group had slightly lower ODI scores at 3 months (mean difference 1.61, p = 0.006; MCID OR 1.14, p = 0.0495) and 12 months (mean difference 2.35, p < 0.001; MCID OR 1.29, p < 0.001). MIS was also associated with a greater decrease in leg and back pain at both follow-up time points. The two groups did not differ in operative time and incidental durotomy rate; however, LOS was shorter for the MIS group. Revision surgery at 12 months was less likely for patients who underwent MIS (4.1% vs 5.6%, p = 0.032). CONCLUSIONS In patients who underwent lumbar fusion for degenerative spinal disease, MIS was associated with higher odds of satisfaction at 3 months postoperatively. No difference was demonstrated at the 12-month follow-up. MIS maintained a small, yet consistent, superiority in decreasing ODI and back and leg pain, and MIS was associated with a lower reoperation rate.

OBJECTIVE The impact of the type of pain presentation on outcomes of spine surgery remains elusive. The aim of this study was to assess the impact of predominant symptom location (predominant arm pain vs predominant neck pain vs equal neck and arm pain) on postoperative improvement in patient-reported outcomes. METHODS The Quality Outcomes Database cervical spine module was queried for patients undergoing 1- or 2-level anterior cervical discectomy and fusion (ACDF) for degenerative spine disease. RESULTS A total of 9277 patients were included in the final analysis. Of these patients, 18.4% presented with predominant arm pain, 32.3% presented with predominant neck pain, and 49.3% presented with equal neck and arm pain. Patients with predominant neck pain were found to have higher (worse) 12-month Neck Disability Index (NDI) scores (coefficient 0.24, 95% CI 0.15–0.33; p < 0.0001). The three groups did not differ significantly in odds of return to work and achieving minimal clinically important difference in NDI score at the 12-month follow-up. CONCLUSIONS Analysis from a national spine registry showed significantly lower odds of patient satisfaction and worse NDI score at 1 year after surgery for patients with predominant neck pain when compared with patients with predominant arm pain and those with equal neck and arm pain after 1- or 2-level ACDF. With regard to return to work, all three groups (arm pain, neck pain, and equal arm and neck pain) were found to be similar after multivariable analysis. The authors’ results suggest that predominant pain location, especially predominant neck pain, might be a significant determinant of improvement in functional outcomes and patient satisfaction after ACDF for degenerative spine disease. In addition to confirmation of the common experience that patients with predominant neck pain have worse outcomes, the authors’ findings provide potential targets for improvement in patient management for these specific populations.

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

OBJECTIVENational databases collect large amounts of clinical information, yet application of these data can be challenging. The authors present the NeuroPoint Alliance and Institute for Healthcare Improvement (NPA-IHI) program as a novel attempt to create a quality improvement (QI) tool informed through registry data to improve the quality of care delivered. Reducing the length of stay (LOS) and readmission after elective lumbar fusion was chosen as the pilot module.METHODSThe NPA-IHI program prospectively enrolled patients undergoing elective 1- to 3-level lumbar fusions across 8 institutions. A three-pronged approach was taken that included the following phases: 1) Research Phase, 2) Development Phase, and 3) Implementation Phase. Primary outcomes were LOS and readmission. From January to June 2017, a learning system was created utilizing monthly conference calls, weekly data submission, and continuous refinement of the proposed QI tool. Nonparametric tests were used to assess the impact of the QI intervention.RESULTSThe novel QI tool included the following three areas of intervention: 1) preoperative discharge assessment (location, date, and instructions), 2) inpatient changes (LOS rounding checklist, daily huddle, and pain assessments), and 3) postdischarge calls (pain, primary care follow-up, and satisfaction). A total of 209 patients were enrolled, and the most common procedure was a posterior laminectomy/fusion (60.2%). Seven patients (3.3%) were readmitted during the study period. Preoperative discharge planning was completed for 129 patients (61.7%). A shorter median LOS was seen in those with a known preoperative discharge date (67 vs 80 hours, p = 0.018) and clear discharge instructions (71 vs 81 hours, p = 0.030). Patients with a known preoperative discharge plan also reported significantly increased satisfaction (8.0 vs 7.0, p = 0.028), and patients with increased discharge readiness (scale 0–10) also reported higher satisfaction (r = 0.474, p < 0.001). Those receiving postdischarge calls (76%) had a significantly shorter LOS than those without postdischarge calls (75 vs 99 hours, p = 0.020), although no significant relationship was seen between postdischarge calls and readmission (p = 0.342).CONCLUSIONSThe NPA-IHI program showed that preoperative discharge planning and postdischarge calls have the potential to reduce LOS and improve satisfaction after elective lumbar fusion. It is our hope that neurosurgical providers can recognize how registries can be used to both develop and implement a QI tool and appreciate the importance of QI implementation as a separate process from data collection/analysis.

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.