Timelines for Return to Different Sports Types After Eight Cervical Spine Fractures in Recreational and Elite Athletes: A Survey of the Association for Collaborative Spine Research.

STUDY DESIGN: Prospective cross-sectional survey. OBJECTIVE: To identify timelines for when athletes may be considered safe to return to varying athletic activities after sustaining cervical spine fractures. BACKGROUND: While acute management and detection of cervical spine fractures have been areas of comprehensive investigation, insight into timelines for when athletes may return to different athletic activities after sustaining such fractures is limited. METHODS: A web-based survey was administered to members of the Association for Collaborative Spine Research that consisted of surgeon demographic information and questions asking when athletes (recreational vs elite) with one of 8 cervical fractures would be allowed to return to play noncontact, contact, and collision sports treated nonoperatively or operatively. The third part queried whether the decision to return to sports was influenced by the type of fixation or the presence of radiculopathy. RESULTS: Thirty-three responses were included for analysis. For all 8 cervical spine fractures treated nonoperatively and operatively, significantly longer times to return to sports for athletes playing contact or collision sports compared with recreational and elite athletes playing noncontact sports, respectively (P< 0.05), were felt to be more appropriate. Comparing collision sports with contact sports for recreational and elite athletes, similar times for return to sports for nearly all fractures treated nonoperatively or operatively were noted. In the setting of associated radiculopathy, the most common responses for safe return to play were "when only motor deficits resolve completely" and "when both motor and sensory deficits resolve completely." CONCLUSIONS: In this survey of spine surgeons from the Association for Collaborative Spine Research, reasonable timeframes for return to play for athletes with 8 different cervical spine fractures treated nonoperatively or operatively varied based on fracture subtype and level of sporting physicality.

Patient-level patterns in daily prescribed opioid dosage in single level lumbar fusion are associated with postoperative opioid dosage and adverse events: a retrospective analysis of claims data.

BACKGROUND: Patients undergoing lumbar spine surgery have high rates of preoperative opioid use, which is associated with inferior outcomes and higher risks for opioid dependency postoperatively. PURPOSE: Determine whether there are identifiable subgroups of patients that follow distinct patterns in pre- and postoperative opioid dosing. Examine how preoperative patterns in opioid dosing relate to postoperative opioid patterns, opioid cessation, and the risk for adverse events. STUDY DESIGN/SETTING: Retrospective analysis of an administrative claims database (MeritiveTM Marketscan® Research Databases 2007-2015). PATIENT SAMPLE: The 9,768 patients undergoing primary single level lumbar fusion. OUTCOME MEASURES: Primary: daily morphine milligram equivalent (MME) opioid dosing calculated from prescriptions dispensed for 1 year before and after surgery; secondary: 90-day all-cause readmission and complications, 90-day acute postoperative pain, 90-day and 1-year reoperation, surgical costs, length of stay, and discharge disposition. METHODS: Distinct patient subgroups defined by patterns of daily MME pre- and postoperatively were identified via group-based trajectory modeling. Associations between these groups and outcomes were assessed with multivariable logistic regression with risk adjustment for patient and surgical factors. RESULTS: Among primary single level lumbar fusion patients, 59.5% filled an opioid prescription in the 3 months preceding surgery, whereas 40.5% were opioid naïve (Naïve). Five distinct subgroups of daily MME were identified among those filling opioids preoperatively: (1) Naïve to 3m (21.2% of patients): no opioids until 3 months preoperatively, escalating to 15 MME/day; (2) Low to 3m (11.4%): very low or as needed dose until 3 months preoperatively, escalating to 15 MME/day; (3) 6m Rise (6.9%): no opioids until 6 months preoperatively, escalating to >30 MME/day; (4) Medium (9.8%): increased linearly from 10 to 25 MME/day across the year before surgery; (5) High (10.0%): increased linearly from 60 to >80 MME/day across the year before surgery. These five preoperative opioid groups were related to postoperative opioids filled in a dose-response manner. The two preoperative patient groups with chronic Medium to High-dose opioid dosing were associated with increased adverse events, including all-cause readmission, reoperation, and pneumonia, whereas a low baseline group with a large, earlier preoperative rise in opioid dosing (6m Rise) had increased encounters for acute postoperative pain. Postoperatively, only 9.5% of patients did not fill an opioid prescription. Five distinct postoperative subgroups were identified based on their patterns in daily MME: Two groups ceased filling opioids within the year following surgery (33.6% of patients), and three groups declined in opioid dosage following surgery but plateaued at low (0-5 MME/day, 29.1%), medium (10-15 MME/day, 12.0%), or high (70-75 MME/day), 13.1%) doses by 1 year. Patients within the higher preoperative opioid groups were more likely to belong to the postoperative groups that were unable to cease filling opioids. CONCLUSIONS: Identification of a patient's pre-operative time trend in daily opioid use may provide significant prognostic value and help guide pain management and risk reduction efforts. LEVEL OF EVIDENCE: III.

Polymethyl methacrylate augmentation and proximal junctional kyphosis in adult spinal deformity patients.

BACKGROUND: Proximal junctional kyphosis (PJK) is a complication following surgery for adult spinal deformity (ASD) possibly ameliorated by polymethyl methacrylate (PMMA) vertebroplasty of the upper instrumented vertebrae (UIV). This study quantifies PJK following surgical correction bridging the thoracolumbar junction ± PMMA vertebroplasty. METHODS: ASD patients from 2013 to 2020 were retrospectively reviewed and included with immediate postoperative radiographs and at least one follow-up radiograph. PMMA vertebroplasty at the UIV and UIV + 1 was performed at the surgeons' discretion. RESULTS: Of 102 patients, 56% received PMMA. PMMA patients were older (70 ± 8 vs. 66 ± 10, p = 0.021), more often female (89.3% vs. 68.2%, p = 0.005), and had more osteoporosis (26.8% vs. 9.1%, p = 0.013). 55.4% of PMMA patients developed PJK compared to 38.6% of controls (p = 0.097), and the rate of PJK development was not different between groups in univariate survival models. There was no difference in PJF (p > 0.084). Reoperation rates were 7.1% in PMMA versus 11.4% in controls (p = 0.501). In multivariable models, PJK development was not associated with the use of PMMA vertebroplasty (HR 0.77, 95% CI 0.38-1.60, p = 0.470), either when considered overall in the cohort or specifically in those with poor bone quality. PJK was significantly predicted by poor bone quality irrespective of PMMA use (HR 3.81, p < 0.001). CONCLUSIONS: In thoracolumbar fusions for adult spinal deformity, PMMA vertebroplasty was not associated with reduced PJK development, which was most highly associated with poor bone quality. Preoperative screening and management for osteoporosis is critical in achieving an optimal outcome for these complex operations. LEVEL OF EVIDENCE: 4, retrospective non-randomized case review.

Is outpatient spine surgery associated with new, persistent opioid use in opioid-naïve patients? A retrospective national claims database analysis.

BACKGROUND CONTEXT: Although spine procedures have historically been performed inpatient, there has been a recent shift to the outpatient setting for selected cases due to increased patient satisfaction and reduced cost. Effective postoperative pain management while limiting over-prescribing of opioids, which may lead to persistent opioid use, is critical to performing spine surgery in the outpatient setting. PURPOSE: To assess if there is an increased risk for new, persistent opioid use between inpatient and outpatient spine procedures. STUDY DESIGN: Retrospective analysis using national administrative claims database. PATIENT SAMPLE: A total of 390,049 opioid-naïve patients with a perioperative opioid prescription who underwent an inpatient or outpatient spine surgery. OUTCOME MEASURES: Patients with perioperative opioid prescriptions who filled ≥ 1 opioid prescription between 90- and 180-days following surgery were defined as new, persistent opioid users. METHODS: We utilized a claims database to identify opioid-naïve patients who underwent lumbar or cervical fusion, total disc arthroplasty, or decompression procedures. We constructed a multivariable logistic regression to evaluate the association between inpatient versus outpatient surgery and the development of new, persistent opioid use while adjusting for several patient factors. RESULTS: A total of 19,205 (11.7%) inpatient and 18,546 (8.2%) outpatient patients developed new, persistent opioid use. Outpatient lumbar and cervical spine surgery patients were significantly less likely to develop new, persistent opioid use following surgery compared to inpatient spine surgery patients (OR = 0.71 [95% confidence interval {CI}: 0.69, 0.73], p < .001). Average morphine milligram equivalents (MMEs) (inpatient = 1,476 MME +/- 22.7, outpatient = 1,072 MME +/- 18.5, p < .001) and average MMEs per day (inpatient = 91.6 MME +/- 0.32, outpatient = 77.7 MME +/- 0.28, p < .001) were lower in the outpatient cohort compared to the inpatient. CONCLUSION: Our results support the shift from inpatient to outpatient spine procedures, as outpatient procedures were not associated with an increased risk for new, persistent opioid use. As more patients become candidates for outpatient spine surgery, predictors of new, persistent opioid use should be considered during risk stratification. LEVEL OF EVIDENCE: Level III Prognostic Study. MINI ABSTRACT: We utilized a national administrative claims database to identify opioid-naïve patients who underwent common spine procedures. Outpatient lumbar and cervical spine surgery patients were significantly less likely to be new, persistent opioid users following surgery compared to inpatient spine surgery patients. Our results support the shift to outpatient spine procedures.

A Stepwise Replicable Approach to Negotiating Value-driven Supply Chain Contracts for Orthobiologics.

INTRODUCTION: Orthobiologics are increasingly used to augment healing of tissues. Despite growing demand for orthobiologic products, many health systems do not enjoy substantial savings expected with high-volume purchases. The primary goal of this study was to evaluate an institutional program designed to (1) prioritize high-value orthobiologics and (2) incentivize vendor participation in value-driven contractual programs. METHODS: A three-step approach was used to reduce costs through optimization of orthobiologics supply chain. First, surgeons with orthobiologics expertise were engaged in key supply chain purchasing decisions. Second, eight orthobiologics formulary categories were defined. Capitated pricing expectations were established for each product category. Capitated pricing expectations were established for each product using institutional invoice data and market pricing data. In comparison with similar institutions, products offered by multiple vendors were priced at a lower benchmark (10th percentile of market price) than more rare products priced at the 25th percentile of the market price. Pricing expectations were transparent to vendors. Third, a competitive bidding process required vendors to submit pricing proposals for products. Clinicians and supply chain leaders jointly awarded contracts to vendors that met pricing expectations. RESULTS: Compared with our projected estimate of $423,946 savings using capitated product prices, our actual annual savings was $542,216. Seventy-nine percent of savings came from allograft products. Although the number of total vendors decreased from 14 to 11, each of the nine returning vendors received a larger, three-year institutional contract. Average pricing decreased across seven of the eight formulary categories. DISCUSSION: This study demonstrates a three-step replicable approach to increase institutional savings for orthobiologic products, engaging clinician experts, and strengthening relationships with select vendors. Vendor consolidation permits a symbiotic win-win relationship: Health systems achieve increased value by reducing unnecessary complexity of multiple contracts, and vendors obtain larger contracts with increased market share. LEVEL OF EVIDENCE: Level IV study.

Patient-level payment patterns prior to single level lumbar decompression are associated with resource utilization, postoperative payments, and adverse events.

BACKGROUND: Understanding patient-specific trends in costs and healthcare resource utilization (HCRU) surrounding lumbar spine surgery is critically needed to better inform surgical decision making and the development of targeted interventions. PURPOSE: 1) Identify subgroups of patients following distinct patterns in direct healthcare payments pre- and postoperatively, 2) determine whether these patterns are associated with patient and surgical factors, and 3) examine whether preoperative payment patterns are related to postoperative payments, healthcare resource utilization (HCRU), and adverse events. STUDY DESIGN/SETTING: Retrospective analysis of an administrative claims database (IBM Marketscan Research Databases 2007-2015). PATIENT SAMPLE: Adults undergoing primary single-level decompression surgery for lumbar stenosis (n=12,394). OUTCOME MEASURES: Direct healthcare payments, HCRU payments (15 categories), 90-day complications and all-cause readmission, 2-year reoperation METHODS: Group-based trajectory modeling is an application of finite mixture modeling that is able to identify meaningful subgroups within a population that follow distinct developmental trajectories over time. We used this technique to identify subgroups of patients following distinct profiles in preoperative direct healthcare payments. A separate analysis was performed to identify distinct profiles in payments postoperatively. Patient and surgical factors associated with these payment profiles were assessed with multinomial logistic regression, and associations with adverse events were assessed with risk-adjusted multivariable logistic regression. RESULTS: We identified 4 preoperative patient payment subgroups following distinct profiles in payments: Pre-Low (5.8% of patients), Pre-Early-Rising (4.8%), Pre-Medium (26.1%), and Pre-High (63.3%). Postoperatively, 3 patient subgroups were identified: Post-Low (8.9%), Post-Medium (29.6%), and Post-High (61.4%). Patients following the higher-cost pre- and postoperative payment profiles were older, more likely female, and had a greater physical and mental comorbidity burden. With each successively higher preoperative payment profile, patients were increasingly likely to have high postoperative payments, use more HCRU (particularly high-cost services such as inpatient admissions, ER, and SNF/IRF care), and experience postoperative adverse events. Following risk adjustment for patient and surgical factors, patients following the Pre-High payment profile had 209.5 (95% CI: 144.2, 309.7; p<.001) fold greater odds for following the Post-High payment profile, 1.8 (1.3, 2.5; p=.003) fold greater odds for 90-day complications, and 1.7 (1.2, 2.6; p=.035) fold greater odds for 2-year reoperation relative to patients following the Pre-Low payment profile. CONCLUSIONS: There are identifiable subgroups of patients who follow distinct profiles in direct healthcare payments surrounding lumbar decompression surgery. These payment profiles are related to patient age, sex, and physical and mental comorbidities. Notably, preoperative payment profiles may provide prognostic value, as they are associated with postoperative costs, HCRU, and adverse events. LEVEL OF EVIDENCE: III.

Catastrophic acute failure of pelvic fixation in adult spinal deformity requiring revision surgery: a multicenter review of incidence, failure mechanisms, and risk factors.

OBJECTIVE: There are few prior reports of acute pelvic instrumentation failure in spinal deformity surgery. The objective of this study was to determine if a previously identified mechanism and rate of pelvic fixation failure were present across multiple institutions, and to determine risk factors for these types of failures. METHODS: Thirteen academic medical centers performed a retrospective review of 18 months of consecutive adult spinal fusions extending 3 or more levels, which included new pelvic screws at the time of surgery. Acute pelvic fixation failure was defined as occurring within 6 months of the index surgery and requiring surgical revision. RESULTS: Failure occurred in 37 (5%) of 779 cases and consisted of either slippage of the rods or displacement of the set screws from the screw tulip head (17 cases), screw shaft fracture (9 cases), screw loosening (9 cases), and/or resultant kyphotic fracture of the sacrum (6 cases). Revision strategies involved new pelvic fixation and/or multiple rod constructs. Six patients (16%) who underwent revision with fewer than 4 rods to the pelvis sustained a second acute failure, but no secondary failures occurred when at least 4 rods were used. In the univariate analysis, the magnitude of surgical correction was higher in the failure cohort (higher preoperative T1-pelvic angle [T1PA], presence of a 3-column osteotomy; p < 0.05). Uncorrected postoperative deformity increased failure risk (pelvic incidence-lumbar lordosis mismatch > 10°, higher postoperative T1PA; p < 0.05). Use of pelvic screws less than 8.5 mm in diameter also increased the likelihood of failure (p < 0.05). In the multivariate analysis, a larger preoperative global deformity as measured by T1PA was associated with failure, male patients were more likely to experience failure than female patients, and there was a strong association with implant manufacturer (p < 0.05). Anterior column support with an L5-S1 interbody fusion was protective against failure (p < 0.05). CONCLUSIONS: Acute catastrophic failures involved large-magnitude surgical corrections and likely resulted from high mechanical strain on the pelvic instrumentation. Patients with large corrections may benefit from anterior structural support placed at the most caudal motion segment and multiple rods connecting to more than 2 pelvic fixation points. If failure occurs, salvage with a minimum of 4 rods and 4 pelvic fixation points can be successful.

Leadership Principles in Uncertain Times. Presidential Address to the AOA, June 10, 2021: AOA Critical Issues.

ABSTRACT: One of the core foundations of leadership is communication. This past pandemic year gave us lessons in how to improve communication during uncertain times as well as examples of strong leadership in the public sphere. The AOA has formulated important Leadership Principles to guide future educational offerings. I will discuss the importance of these Leadership Principles and give examples of how we can apply these principles.

Healthcare resource utilization and costs 2 years pre- and post-lumbar spine surgery for stenosis: a national claims cohort study of 22,182 cases.

BACKGROUND CONTEXT: Improved understanding of the pre- and postoperative trends in costs and healthcare resource utilization (HCRU) is needed to better inform patient expectations and aid in the development of strategies to minimize the significant healthcare burden associated with lumbar spine surgery. PURPOSE: Examine the time course of costs and HCRU in the 2 years preceding and following elective lumbar spine surgery for stenosis in a large national claims cohort. STUDY DESIGN/SETTING: Retrospective analysis of an administrative claims database (IBM® Marketscan® Research Databases 2007-2015). PATIENT SAMPLE: Adult patients undergoing elective primary single-level lumbar surgery for stenosis with at least 2 years of continuous health plan enrollment pre- and postoperatively. OUTCOME MEASURES: Functional measures, including monthly rates of HCRU (15 categories), monthly gross covered payments (including payments made by the health plan and deductibles and coinsurance paid by the patient) overall, by HCRU category, and by spine versus non-spine-related. METHODS: All available patients were utilized for analysis of HCRU. For analysis of payments, only patients on noncapitated health plans providing accurate financial information were analyzed. Payments were converted to 2015 United States dollars using the medical care component of the consumer price index. Trends in payments and HCRU were plotted on a monthly basis pre- and post-surgery and assessed with regression models. Relationships with demographics, surgical factors, and comorbidities were assessed with multivariable repeated measures generalized estimating equations. RESULTS: Median monthly healthcare payments 2 years prior to surgery were $275 ($22, $868). Baseline HCRU at 2 years preoperatively was stable or only gradually rising (office visits, prescription drug use), but began an increasingly steep rise in many categories 6 to 12 months prior to surgery. Monthly payments began an increasingly steep rise 6 months prior to surgery, reaching a peak of $1,402 ($634, $2,827) in the month prior to surgery. This was driven by an increase in radiology, office visits, PT, injections, prescription medications, ER encounters, and inpatient admissions. Payments dropped dramatically immediately following surgery. Over the remainder of the 2 years, the median total payments declined only slightly, as a continued decline in spine-related payments was offset by gradually increased non-spine related payments as patients aged. By 2 years postoperatively, the percentage of patients using PT and injections returned to within 1% of the baseline levels observed 2 years preoperatively; however, spine-related prescription medication use remained elevated, as did other categories of HCRU (radiology, office visits, lab/diagnostic services, and also rare events such as inpatient admissions, ER encounters, and SNF/IRF). Patients with a fusion component to their surgeries had higher payments and HCRU preoperatively, and this did not resolve postoperatively. Variations in payments and HCRU were also evident among plan types, with patients on comprehensive medical plans-predominantly employer-sponsored supplemental Medicare coverage-utilizing more inpatient, ER, and inpatient rehabilitation & skilled nursing facilities. Patients on high-deductible plans had fewer payments and HCRU across all categories; however, we are unable to distinguish whether this is because they used fewer of these services or if they were paying for these services out of pocket without submitting to the payer. By 2 years postoperatively, 51% of patients had no spine-related monthly payments, while 33% had higher and 16% had lower monthly payments relative to 2 years preoperatively. CONCLUSIONS: This is the first study to characterize time trends in direct healthcare payments and HCRU over an extended period preceding and following spine surgery. Differences among plan types potentially highlight disparities in access to care and plan-related financial mediators of patients' healthcare resource utilization.

Factors Affecting the Decision to Initiate Anticoagulation After Spine Surgery: Findings From the AOSpine Anticoagulation Global Initiative.

STUDY DESIGN: Cross-sectional, international survey. OBJECTIVES: To identify factors influencing pharmacologic anticoagulation initiation after spine surgery based on the AOSpine Anticoagulation Global Survey. METHODS: This survey was distributed to the international membership of AOSpine (n = 3805). A Likert-type scale described grade practice-specific factors on a scale from low (1) to high (5) importance, and patient-specific factors a scale from low (0) to high (3) importance. Analysis was performed to determine which factors were significant in the decision making surrounding the initiation of pharmacologic anticoagulation. RESULTS: A total of 316 spine surgeons from 64 countries completed the survey. In terms of practice-specific factors considered to initiate treatment, expert opinion was graded the highest (mean grade ± SD = 3.2 ± 1.3), followed by fellowship training (3.2 ± 1.3). Conversely, previous studies (2.7 ± 1.2) and unspecified guidelines were considered least important (2.6 ± 1.6). Patient body mass index (2.0 ± 1.0) and postoperative mobilization (2.3 ± 1.0) were deemed most important and graded highly overall. Those who rated estimated blood loss with greater importance in anticoagulation initiation decision making were more likely to administer thromboprophylaxis at later times (hazard ratio [HR] = 0.68-0.71), while those who rated drain output with greater importance were likely to administer thromboprophylaxis at earlier times (HR = 1.32-1.43). CONCLUSION: Among our global cohort of spine surgeons, certain patient factors (ie, patient mobilization and body mass index) and practice-specific factors (ie, expert opinion and fellowship training) were considered to be most important when considering anticoagulation start times.

Delayed Ejaculation After Lumbar Spine Surgery: A Claims Database Analysis.

STUDY DESIGN: Retrospective cohort. OBJECTIVES: Delayed ejaculation (DE) is a distressing condition characterized by a notable delay in ejaculation or complete inability to achieve ejaculation, and there are no existing reports of DE following lumbar spine surgery. Inspired by our institutional experience, we sought to assess national rates of DE following surgery of the lumbar spine. METHODS: We queried the Optum De-identified Clinformatics Database for adult men undergoing surgery of the lumbar spine between 2003 and 2017. The primary outcome was the development of DE within 2 years of surgery. Multivariable logistic regression was performed to identify factors associated with the development of DE. RESULTS: We identified 117 918 men who underwent 162 646 lumbar spine surgeries, including anterior lumbar interbody fusion (ALIF), posterior lumbar fusion (PLF), and more. The overall incidence of DE was 0.09%, with the highest rate among ALIF surgeries at 0.13%. In multivariable analysis, the odds of developing DE did not vary between anterior/lateral lumbar interbody fusion, PLF, and other spine surgeries. A history of tobacco smoking (OR = 1.47, 95% CI 1.00-2.16, P = .05) and obesity (OR = 1.56, 95% CI 1.00-2.44, P = .05) were associated with development of DE. CONCLUSIONS: DE is a rare but distressing complication of thoracolumbar spine surgery, and patients should be queried for relevant symptoms at postoperative visits when indicated.

Advanced Age Does Not Impact Outcomes After 1-level or 2-level Lateral Lumbar Interbody Fusion.

STUDY DESIGN: This was a retrospective comparative study. OBJECTIVE: The objective of this study was to assess the effect of increased age on perioperative and postoperative complication rates, reoperation rates, and patient-reported pain and disability scores after lateral lumbar interbody fusion (LLIF). SUMMARY OF BACKGROUND DATA: LLIF was developed to minimize soft tissue trauma and reduce the risk of vascular injury; however, there is little evidence regarding the effect of advanced age on outcomes of LLIF. METHODS: Patients who underwent LLIF from 2009 to 2019 at one institution with a minimum 6-month follow-up were retrospectively reviewed. Patients less than 18 years old with musculoskeletal tumor or trauma were excluded. The primary outcome was the preoperative to postoperative change in the Numeric Pain Rating Scale (NPRS) for back pain. Operative time, estimated blood loss, length of stay, perioperative and 90-day complications, unplanned readmissions, reoperations, and change in Oswestry Disability Index were also evaluated. Relationships with age were assessed both with age as a continuous variable and segmenting by age below 70 versus 70+. RESULTS: In total, 279 patients were included. The median age was 65±13 years and 159 (57%) were female. Age was not related to improvements in back NPRS and Oswestry Disability Index. Operative time, estimated blood loss, length of stay, perioperative and 90-day complications, unplanned readmissions, reoperations, and radiographic fusion rate also were not related to age. After multivariable risk adjustment, increasing age was associated with greater improvements in back NPRS. The decrease in back NPRS was 0.68 (95% confidence interval: 0.14, 1.22; P=0.014) points greater for every 10-year increase in age. Age was not associated with rates of complication, readmission, or reoperation. CONCLUSIONS: LLIF is a safe and effective procedure in the elderly population. Advanced age is associated with larger improvements in preoperative back pain. Surgeons should consider the benefits of LLIF and other minimally invasive techniques when evaluating elderly candidates for lumbar fusion. LEVEL OF EVIDENCE: Level III.

A framework to make PROMs relevant to patients: qualitative study of communication preferences of PROMs.

PURPOSE: Patient-reported outcome measures are tools for evaluating symptoms, magnitude of limitations, baseline health status, and outcomes from the patient's perspective. Healthcare professional organizations and payers increasingly recommend PROMs for clinical care, but there lacks guidance regarding effective communication of PROMs with orthopedic surgery patients. This qualitative study aimed to identify (1) patient attitudes toward the use and communication of PROMs, and (2) what patients feel are the most relevant or important aspects of PROM results to discuss with their physicians. METHODS: Participants were recruited from a multispeciality orthopedic clinic. Three PROMs: the EuroQol-5 Dimension, the Patient-Specific Functional Scale, and the Patient-Reported Outcome Measurement Information System Physical Function Computer Adaptive Test were shown and a semi-structured interview was conducted to elicit PROMs attitudes and preferences. Interviews were transcribed and inductive-deductively coded. Coded excerpts were aggregated to (1) identify major themes and (2) analyze how themes interacted. RESULT: Three themes emerged: (1) Beliefs toward the purpose of PROMs, (2) PROMs as a reflection of self, and (3) PROMs to facilitate communication and guide healthcare decisions. These themes informed a framework outlining the patient perspective on communicating PROMs during clinical care. CONCLUSION: Patient attitudes toward the use and communication of PROMs start with the incorporation of patient beliefs, which can facilitate or act as a barrier to engagement. Patients should ideally believe that PROMs are an accurate reflection of personal health state before incorporation into care. Clinicians should endeavor to communicate the purpose of a chosen PROM in line with a patient's unique needs and what they feel is most relevant to their own care. Aspects of PROMs results which may be helpful to address include providing context for what scores mean and how they are calculated, and using scores as a way to weigh risks and benefits of treatment and tracking progress over time. Future research can focus on the effect of communication strategies on patient outcomes and engagement in care.

Is Uncontrolled Diabetes Mellitus Associated with Incidence of Complications After Posterior Instrumented Lumbar Fusion? A National Claims Database Analysis.

BACKGROUND: Previous research has shown that diabetes mellitus (DM) is associated with postoperative complications, including surgical site infections (SSIs). However, evidence for the association between diabetes control and postoperative complications in patients with DM is mixed. Prior studies relied on a single metric for defining uncontrolled DM, which does not account for glycemic variability, and it is unknown whether a more comprehensive assessment of diabetes control is associated with postoperative complications. QUESTIONS/PURPOSES: (1) Is there a difference in the incidence of SSI after lumbar spine fusion in patients with uncontrolled DM, defined with a comprehensive assessment of glycemic control, compared with patients with controlled DM? (2) Is there a difference in the incidence of other select postoperative complications after lumbar spine fusion in patients with uncontrolled DM compared with patients with controlled DM? (3) Is there a difference in total reimbursements between these groups? METHODS: We used the PearlDiver Patient Records Database, a national administrative claims database that provides access to the full continuum of perioperative care. We included 46,490 patients with DM undergoing posterior lumbar fusion with instrumentation. Patients were required to be continuously enrolled in the database for at least 1 year before and 90 days after the index procedure. Patients were divided into uncontrolled and controlled DM cohorts, as defined by ICD-9 diagnostic codes. These are based on a comprehensive assessment of glycemic control, including consideration of patient self-monitoring of blood glucose levels, hemoglobin A1c, and the presence/severity of diabetes-related comorbidities. The cohorts differed only by age, insurance type, and Elixhauser comorbidity score. The primary outcome was the incidence of SSI, divided into superficial and deep, within 90 days postoperatively. Secondary complications included the incidence of cerebrovascular events, acute kidney injury, pulmonary embolism, pneumonia, urinary tract infection, blood transfusion, and total reimbursements. These are the sum of reimbursements occurring within 90 days of surgery, which capture the total professional and facility cost burden to the health payer (such as the insurer). We constructed multivariable logistic regression models to adjust for the effects of age, insurance type, and comorbidities. RESULTS: After adjusting for potentially confounding variables including age, insurance type, and comorbidities, we found that patients with uncontrolled DM had an odds ratio for deep SSI of 1.52 (95% confidence interval 1.16 to 1.95; p = 0.002). Similarly, patients with uncontrolled DM had adjusted odds ratios of 1.25 (95% CI 1.01 to 1.53; p = 0.03) for cerebrovascular events, 1.36 (95% CI 1.18 to 1.57; p < 0.001) for acute kidney injury, 1.55 (95% CI 1.16 to 2.04; p = 0.002) for pulmonary embolism, 1.30 (95% CI 1.08 to 1.54; p = 0.004) for pneumonia, 1.33 (95% CI 1.19 to 1.49; p < 0.001) for urinary tract infection, and 1.27 (95% CI 1.04 to 1.53; p = 0.02) for perioperative transfusion. Patients with uncontrolled DM had higher median 90-day total reimbursements than patients with controlled DM: USD 27,915 (interquartile range 5472 to 63,400) versus USD 10,263 (IQR 4101 to 49,748; p < 0.001). CONCLUSION: Our findings encourage surgeons to take a full diabetic history beyond the HbA1c value, including any self-monitoring of glucose measurements, time in acceptable range for continuous glucose monitors, and/or consideration of the presence/severity of diabetes-related complications before lumbar spine fusion, as HbA1c does not fully capture glycemic control or variability. We emphasize that uncontrolled DM is a clinical, rather than laboratory, diagnosis. Comprehensive diabetes histories should be incorporated into existing preoperative diabetes care pathways and elective surgery could be deferred to improve glycemic control. Future development of an index measure incorporating multidimensional measures of diabetes control (such as continuous or self-glucose monitoring, diabetes-related comorbidities) is warranted. LEVEL OF EVIDENCE: Level III, therapeutic study.

Rod-Screw Constructs Composed of Dissimilar Metals Do Not Affect Complication Rates in Posterior Fusion Surgery Performed for Adult Spinal Deformity.

STUDY DESIGN: This was a retrospective cohort study. OBJECTIVE: The objective of this study was to compare implant-related complications between mixed-metal and same-metal rod-screw constructs in patients who underwent posterior fusion for adult spinal deformity. SUMMARY OF BACKGROUND DATA: Contact between dissimilar metals is discouraged due to potential for galvanic corrosion, increasing the risk for metal toxicity, infection, and implant failure. In spine surgery, titanium (Ti) screws are most commonly used, but Ti rods are notch sensitive and likely more susceptible to fracture after contouring for deformity constructs. Cobalt chrome (CC) and stainless steel (SS) rods may be suitable alternatives. No studies have yet evaluated implant-related complications among mixed-metal constructs (SS or CC rods with Ti screws). METHODS: Adults with spinal deformity who underwent at least 5-level thoracic and/or lumbar posterior fusion or 3-column osteotomy between January 2013 and May 2015 were reviewed, excluding neuromuscular deformity, tumor, acute trauma or infection. Implant-related complications included pseudarthrosis, proximal junctional kyphosis, hardware failure (rod fracture, screw pullout or haloing), symptomatic hardware, and infection. RESULTS: A total of 61 cases met inclusion criteria: 24 patients received Ti rods with Ti screws (Ti-Ti, 39%), 31 SS rods (SS-Ti, 51%), and 6 CC rods (CC-Ti, 9.8%). Median follow-up was 37-42 months for all groups. Because of the limited number of cases, the CC-Ti group was not included in statistical analyses. There were no differences between Ti-Ti and SS-Ti groups with regard to age, body mass index, or smokers. Implant-related complications did not differ between the Ti-Ti and SS-Ti groups (P=0.080). Among the Ti-Ti group, there were 15 implant-related complications (63%). In the SS-Ti group, there were 12 implant-related complications (39%). There were 3 implant-related complications in the CC-Ti group (50%). CONCLUSION: We found no evidence that combining Ti screws with SS rods increases the risk for implant-related complications.

Preoperative epidural steroid injections are not associated with increased rates of infection and dural tear in lumbar spine surgery.

PURPOSE: The study objectives were to use a large national claims data resource to examine rates of preoperative epidural steroid injections (ESI) in lumbar spine surgery and determine whether preoperative ESI or the timing of preoperative ESI is associated with rates of postoperative complications and reoperations. METHODS: A retrospective longitudinal analysis of patients undergoing lumbar spine surgery for disc herniation and/or spinal stenosis was undertaken using the MarketScan® databases from 2007-2015. Propensity-score matched cohorts were constructed to compare rates of complications and reoperations in patients with and without preoperative ESI. RESULTS: Within the year prior to surgery, 120,898 (46.4%) patients had a lumber ESI. The median time between ESI and surgery was 10 weeks. 23.1% of patients having preoperative ESI had more than one level injected, and 66.5% had more than one preoperative ESI treatment. Patients with chronic pain were considerably more likely to have an ESI prior to their surgery [OR 1.62 (1.54, 1.69), p < 0.001]. Patients having preoperative ESI within in close proximity to surgery did not have increased rates of infection, dural tear, neurological complications, or surgical complications; however, they did experience higher rates of reoperations and readmissions than those with no preoperative ESI (p < 0.001). CONCLUSION: Half of patients undergoing lumbar spine surgery for stenosis and/or herniation had a preoperative ESI. These were not associated with an increased risk for postoperative complications, even when the ESI was given in close proximity to surgery. Patients with preoperative ESI were more likely to have readmissions and reoperations following surgery.

Anterior Lumbar Interbody Fusion With Cage Retrieval for the Treatment of Pseudarthrosis After Transforaminal Lumbar Interbody Fusion: A Single-Institution Case Series.

BACKGROUND: The treatment of pseudarthrosis after transforaminal lumbar interbody fusion (TLIF) can be challenging, particularly when anterior column reconstruction is required. There are limited data on TLIF cage removal through an anterior approach. OBJECTIVE: To assess the safety and efficacy of anterior lumbar interbody fusion (ALIF) as a treatment for pseudarthrosis after TLIF. METHODS: ALIFs performed at a single academic medical center were reviewed to identify cases performed for the treatment of pseudarthrosis after TLIF. Patient demographics, surgical characteristics, perioperative complications, and 1-yr radiographic data were collected. RESULTS: A total of 84 patients were identified with mean age of 59 yr and 37 women (44.0%). A total of 16 patients (19.0%) underwent removal of 2 interbody cages for a total of 99 implants removed with distribution as follows: 1 L2/3 (0.9%), 6 L3/4 (5.7%), 37 L4/5 (41.5%), and 55 L5/S1 (51.9%). There were 2 intraoperative venous injuries (2.4%) and postoperative complications were as follows: 7 ileus (8.3%), 5 wound-related (6.0%), 1 rectus hematoma (1.1%), and 12 medical complications (14.3%), including 6 pulmonary (7.1%), 3 cardiac (3.6%), and 6 urinary tract infections (7.1%). Among 58 patients with at least 1-yr follow-up, 56 (96.6%) had solid fusion. There were 5 cases of subsidence (6.0%), none of which required surgical revision. Two patients (2.4%) required additional surgery at the level of ALIF for pseudarthrosis. CONCLUSION: ALIF is a safe and effective technique for the treatment of TLIF cage pseudarthrosis with a favorable risk profile.

Relationship between industry royalty and licensing payments and patent authorship among orthopedic spine surgeons.

BACKGROUND CONTEXT: The Physician Payments Sunshine Act requires manufacturers of drugs, medical devices, medical supplies, and biologics to record all financial relationships with physicians in the Open Payments database with the goal of increasing transparency for patients and the general public. The majority of total money going to orthopedic surgeons has been found to go to a small number of surgeons in the form of royalties and licensing payments. This category of payment is intended to compensate physicians for use of their intellectual property. However, little research has been done to investigate the degree to which these physicians own intellectual property. PURPOSE: To the authors' knowledge, the association between patents and industry payments to orthopedic surgeons has not been explored. We quantify the association between the patents and academic productivity of orthopedic spine surgeons and the amount of royalty and licensing fees they receive. We then compared this with the associations observed for other categories of payments. STUDY DESIGN: Cross-sectional study METHODS: Top royalty and licensing earners, defined as those who collectively earned 50% of all royalty and licensing payments over the period August 2013-December 2018, were identified. The h-index, publication count, and patent count of this group were compared with top earners of other payment categories using the Mann-Whitney U test. The association between (1) earnings and patent counts, (2) earnings and manuscript counts, and (3) earnings and h-index among the top royalty and licensing earners was assessed using Spearman correlation. RESULTS: Top royalty and licensing earners had significantly more patents than every comparison group except the top earners of money derived from ownership in a biomedical company. For this one exception, there was a trend toward the top eight royalty and licensing earners having more patents (p=.054). The top royalty and licensing earners had significantly more manuscripts than three of the five comparison groups and significantly higher h-indices than four of the five comparison groups. Among the top royalty and licensing earners, receiving more royalty and licensing payments was associated with holding more patents, but not with publishing more papers or having higher h-indices. CONCLUSIONS: There is a strong association between the number of patents authored by individual orthopedic spine surgeons and the amount of royalty and licensing fees they receive from industry. This supports the hypothesis that these payments serve as compensation to inventor-surgeons for their intellectual property. CLINICAL SIGNIFICANCE: Our findings provide new, important context for the largest category of industry payments to orthopedic spine surgeons and suggests that physicians' patents should be considered when evaluating financial transactions between industry and physicians.

A Cost-Effectiveness Analysis of Smoking-Cessation Interventions Prior to Posterolateral Lumbar Fusion.

BACKGROUND: Smoking cessation represents an opportunity to reduce both short and long-term effects of smoking on complications after lumbar fusion and smoking-related morbidity and mortality. However, the cost-effectiveness of smoking-cessation interventions prior to lumbar fusion is not fully known. METHODS: We created a decision-analytic Markov model to evaluate the cost-effectiveness of 5 smoking-cessation strategies (behavioral counseling, nicotine replacement therapy [NRT], bupropion or varenicline monotherapy, and a combined intervention) prior to single-level, instrumented lumbar posterolateral fusion (PLF) from the health payer perspective. Probabilities, costs, and utilities were obtained from published sources. We calculated the costs and quality-adjusted life years (QALYs) associated with each strategy over multiple time horizons and accounted for uncertainty with probabilistic sensitivity analyses (PSAs) consisting of 10,000 second-order Monte Carlo simulations. RESULTS: Every smoking-cessation intervention was more effective and less costly than usual care at the lifetime horizon. In the short term, behavioral counseling, NRT, varenicline monotherapy, and the combined intervention were also cost-saving, while bupropion monotherapy was more effective but more costly than usual care. The mean lifetime cost savings for behavioral counseling, NRT, bupropion monotherapy, varenicline monotherapy, and the combined intervention were $3,291 (standard deviation [SD], $868), $2,571 (SD, $479), $2,851 (SD, $830), $6,767 (SD, $1,604), and $34,923 (SD, $4,248), respectively. The minimum efficacy threshold (relative risk for smoking cessation) for lifetime cost savings varied from 1.01 (behavioral counseling) to 1.15 (varenicline monotherapy). A PSA revealed that the combined smoking-cessation intervention was always more effective and less costly than usual care. CONCLUSIONS: Even brief smoking-cessation interventions yield large short-term and long-term cost savings. Smoking-cessation interventions prior to PLF can both reduce costs and improve patient outcomes as health payers/systems shift toward value-based reimbursement (e.g., bundled payments) or population health models. LEVEL OF EVIDENCE: Economic Level II. See Instructions for Authors for a complete description of levels of evidence.

The effect of anterior lumbar interbody fusion staging order on perioperative complications in circumferential lumbar fusions performed within the same hospital admission.

OBJECTIVE: Anterior lumbar interbody fusion (ALIF) is a powerful technique that provides wide access to the disc space and allows for large lordotic grafts. When used with posterior spinal fusion (PSF), the procedures are often staged within the same hospital admission. There are limited data on the perioperative risk profile of ALIF-first versus PSF-first circumferential fusions performed within the same hospital admission. In an effort to understand whether these procedures are associated with different perioperative complication profiles, the authors performed a retrospective review of their institutional experience in adult patients who had undergone circumferential lumbar fusions. METHODS: The electronic medicals records of patients who had undergone ALIF and PSF on separate days within the same hospital admission at a single academic center were retrospectively analyzed. Patients carrying a diagnosis of tumor, infection, or traumatic fracture were excluded. Demographics, surgical characteristics, and perioperative complications were collected and assessed. RESULTS: A total of 373 patients, 217 of them women (58.2%), met the inclusion criteria. The mean age of the study cohort was 60 years. Surgical indications were as follows: degenerative disease or spondylolisthesis, 171 (45.8%); adult deformity, 168 (45.0%); and pseudarthrosis, 34 (9.1%). The majority of patients underwent ALIF first (321 [86.1%]) with a mean time of 2.5 days between stages. The mean number of levels fused was 2.1 for ALIF and 6.8 for PSF. In a comparison of ALIF-first to PSF-first cases, there were no major differences in demographics or surgical characteristics. Rates of intraoperative complications including venous injury were not significantly different between the two groups. The rates of postoperative ileus (11.8% vs 5.8%, p = 0.194) and ALIF-related wound complications (9.0% vs 3.8%, p = 0.283) were slightly higher in the ALIF-first group, although the differences did not reach statistical significance. Rates of other perioperative complications were no different. CONCLUSIONS: In patients undergoing staged circumferential fusion with ALIF and PSF, there was no statistically significant difference in the rate of perioperative complications when comparing ALIF-first to PSF-first surgeries.