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 preoperative time trend in daily opioid use may provide significant prognostic value and help guide pain management and risk reduction efforts. LEVEL OF EVIDENCE: III.

Moral Injury: How It Affects Us and Tools to Combat It.

Introduction: Moral injury comprises feelings of guilt, despair, shame, and/or helplessness from having one's morals transgressed. Those underrepresented in health care are more likely to experience moral injury arising from micro- and macroaggressions. This workshop was designed for interprofessional health care providers ranging from students to program leadership to raise awareness about moral injury and provide tools to combat it. Methods: This 75-minute interactive workshop explored moral injury through a health care lens. It included components of lecture, case-based learning, small-group discussion, and individual reflection. Participants completed anonymous postworkshop evaluations, providing data on satisfaction and intention to change practice. We used descriptive statistics to analyze the quantitative data and applied content analysis to the qualitative data. Results: The workshop was presented at two local academic conferences. Data were collected from 34 out of 60 participants, for a response rate of 57%. Ninety-seven percent of participants felt the workshop helped them define and identify moral injury and was a valuable use of their time, as well as indicating they would apply the information learned in their daily life. One hundred percent would recommend the workshop to a friend or colleague. Almost half felt they could implement strategies to address moral injury after participating in the workshop. Discussion: This workshop proved to be a valuable tool to define and discuss moral injury. The materials can be adapted to a broad audience.

Invasive Treatments for Low Back Disorders.

OBJECTIVE: This abbreviated version of the American College of Occupational and Environmental Medicine's Low Back Disorders guideline reviews the evidence and recommendations developed for invasive treatments used to manage low back disorders. METHODS: Comprehensive systematic literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel and extensive peer-review to develop evidence-based guidance. Consensus recommendations were formulated when evidence was lacking and often relied on analogy to other disorders for which evidence exists. A total of 47 high-quality and 321 moderate-quality trials were identified for invasive management of low back disorders. RESULTS: Guidance has been developed for the invasive management of acute, subacute, and chronic low back disorders and rehabilitation. This includes 49 specific recommendations. CONCLUSION: Quality evidence should guide invasive treatment for all phases of managing low back disorders.

Non-Invasive and Minimally Invasive Management of Low Back Disorders.

OBJECTIVE: This abbreviated version of the American College of Occupational and Environmental Medicine's (ACOEM) Low Back Disorders Guideline reviews the evidence and recommendations developed for non-invasive and minimally invasive management of low back disorders. METHODS: Systematic literature reviews were accomplished with article abstraction, critiquing, grading, evidence table compilation, and guideline finalization by a multidisciplinary expert panel and extensive peer-review to develop evidence-based guidance. Consensus recommendations were formulated when evidence was lacking. A total of 70 high-quality and 564 moderate-quality trials were identified for non-invasive low back disorders. Detailed algorithms were developed. RESULTS: Guidance has been developed for the management of acute, subacute, and chronic low back disorders and rehabilitation. This includes 121 specific recommendations. CONCLUSION: Quality evidence should guide treatment for all phases of managing low back disorders.

Does the presence of the fibronectin-aggrecan complex predict outcomes from lumbar discectomy for disc herniation?

BACKGROUND CONTEXT: Protein biomarkers associated with lumbar disc disease have been studied as diagnostic indicators and therapeutic targets. Recently, a cartilage degradation product, the fibronectin-aggrecan complex (FAC) identified in the epidural space, has been shown to predict response to lumbar epidural steroid injection in patients with radiculopathy from herniated nucleus pulposus (HNP). PURPOSE: Determine the ability of FAC to predict response to microdiscectomy for patients with radiculopathy due to lumbar disc herniation STUDY DESIGN/SETTING: Single-center prospective consecutive cohort study. PATIENT SAMPLE: Patients with radiculopathy from HNP with concordant symptoms to MRI who underwent microdiscectomy. OUTCOMES MEASURES: Oswestry disability index (ODI) and visual analog scores (VAS) were noted at baseline and at 3-month follow-up. Primary outcome of clinical improvement was defined as patients with both a decrease in VAS of at least 3 points and ODI >20 points. METHODS: Intraoperative sampling was done via lavage of the excised fragment by ELISA for presence of FAC. Funding for the ELISA was provided by Cytonics, Inc. RESULTS: Seventy-five patients had full complement of data and were included in this analysis. At 3-month follow-up, 57 (76%) patents were "better." There was a statistically significant association of the presence of FAC and clinical improvement (p=.017) with an 85% positive predictive value. Receiver-operating-characteristic (ROC) curve plotting association of FAC and clinical improvement demonstrates an area under the curve (AUC) of 0.66±0.08 (p=.037). Subset analysis of those with weakness on physical examination (n=48) plotting the association of FAC and improvement shows AUC on ROC of 0.81±0.067 (p=.002). CONCLUSIONS: Patients who are "FAC+" are more likely to demonstrate clinical improvement following microdiscectomy. The data suggest that the inflammatory milieu plays a significant role regarding improvement in patients undergoing discectomy for radiculopathy in lumbar HNP, even in those with preoperative weakness. The FAC represents a potential target for treatment in HNP.

Effect of an Annular Closure Device (Barricaid) on Same-Level Recurrent Disk Herniation and Disk Height Loss After Primary Lumbar Discectomy: Two-year Results of a Multicenter Prospective Cohort Study.

STUDY DESIGN: A prospective cohort study. OBJECTIVE: To evaluate whether an annular closure device could be implanted safely to reduce same-level recurrent disk herniation, or attenuate disk height loss and improve the outcome after lumbar discectomy. SUMMARY OF BACKGROUND DATA: Same-level recurrent disk herniation, disk height loss, and progressive degeneration are common complications and sequelae after lumbar discectomy. Techniques to reduce these consequences may improve outcomes. METHODS: Forty-six consecutive patients undergoing lumbar discectomy for single-level herniated disk at 2 institutions were followed prospectively with clinical and radiographic evaluations at 6 weeks and 3, 6, 12, and 24 months (control cohort). A second consecutive cohort of 30 patients undergoing 31 lumbar discectomies with implantation of an annular closure device was followed similarly. Incidence of recurrent disk herniation, disk height loss, the leg and back pain visual analog scale (VAS), and the Oswestry Disability Index were assessed at each follow-up. RESULTS: Cohorts were well matched at baseline. By 2 years of follow-up, symptomatic recurrent same-level disk herniation occurred in 3 (6.5%) patients in the control cohort versus 0 (0%) patients in the annular repair cohort (P=0.27). A trend of greater preservation of disk height was observed in the annular repair versus the control cohort 3 months (7.9 vs. 7.27 mm, P=0.08), 6 months (7.81 vs. 7.18 mm, P=0.09), and 12 months (7.63 vs. 6.9 mm, P=0.06) postoperatively. The annular closure cohort reported less leg pain (VAS-LP: 5 vs. 16, P<0.01), back pain (VAS-BP: 13 vs. 22, P<0.05), and disability (Oswestry Disability Index: 16 vs. 22, P<0.05) 1 year postoperatively. CONCLUSIONS: Implantation of a novel annular repair device was associated with greater maintenance of disk height and improved 1-year leg pain, back pain, and low-back disability. Recurrent disk herniation did not occur in any patient after annular repair. Closure of annular defect after lumbar discectomy may help preserve the physiological disk function and prevent long-term disk height loss and associated back and leg pain.

Does provocative discography cause clinically important injury to the lumbar intervertebral disc? A 10-year matched cohort study.

BACKGROUND CONTEXT: Provocative discography, an invasive diagnostic procedure involving disc puncture with pressurization, is a test for presumptive discogenic pain in the lumbar spine. The clinical validity of this test is unproven. Data from multiple animal studies confirm that disc puncture causes early disc degeneration. A recent study identified radiographic disc degeneration on magnetic resonance imaging (MRI) performed 10 years later in human subjects exposed to provocative discography. The clinical effect of this disc degeneration after provocative discography is unknown. PURPOSE: The aim of this study was to investigate the clinical effects of lumbar provocative discography on patients subjected to this evaluation method. STUDY DESIGN/SETTING: A prospective, 10-year matched cohort study. PATIENT SAMPLE: Subjects (n=75) without current low back pain (LBP) problems were recruited to participate in a study of provocative discography at the L3-S1 discs. A closely matched control cohort was simultaneously recruited to undergo a similar evaluation except for discography injections. OUTCOME MEASURES: The primary outcome variables were diagnostic imaging events and lumbar disc surgery events. The secondary outcome variables were serious LBP events, disability events, and medical visits. METHODS: The discography subjects and control subjects were followed by serial protocol evaluations at 1, 2, 5, and 10 years after enrollment. The lumbar disc surgery events and diagnostic imaging (computed tomography (CT) or MRI) events were recorded. In addition, the interval and cumulative lumbar spine events were recorded. RESULTS: Of the 150 subjects enrolled, 71 discography subjects and 72 control subjects completed the baseline evaluation. At 10-year follow-up, 57 discography and 53 control subjects completed all interval surveillance evaluations. There were 16 lumbar surgeries in the discography group, compared with four in the control group. Medical visits, CT/MRI examinations, work loss, and prolonged back pain episodes were all more frequent in the discography group compared with control subjects. CONCLUSION: The disc puncture and pressurized injection performed during provocative discography can increase the risk of clinical disc problems in exposed patients.

From Anzac to Afghanistan: have 100 years taught us nothing about the devastation of war?

Commentary On: Atkinson Brigadier (Ret'd) RN, Fraser RD. 100 years-Anzac, Vietnam to now. Spine J 2015:15:2454-6 (in this issue). Robertson PA. Gallipoli 100 years on: a New Zealand perspective. Spine J 2015:15:2457-8 (in this issue).

Cancer risk after use of recombinant bone morphogenetic protein-2 for spinal arthrodesis.

BACKGROUND: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is a growth factor known to have in vitro effects on the growth and invasiveness of cancer. It has been approved by the U.S. Food and Drug Administration in limited doses for single-level anterior spinal arthrodesis, but it is commonly used off-label and at high doses. The effect of rhBMP-2 on the risk of cancer has been a concern. We sought to evaluate the risk of new cancers in patients receiving high-dose rhBMP-2. METHODS: We used publicly available data from a pivotal, multicenter, randomized controlled trial of patients with degenerative lumbar spine conditions who underwent a single-level instrumented posterolateral arthrodesis with either high-dose rhBMP-2 in a compression-resistant matrix (CRM) (rhBMP-2/CRM; n = 239) or autogenous bone graft (control group; n = 224). We compared the risks of new cancers in the rhBMP-2/CRM and control groups at two and five years after surgery. RESULTS: At two years, with 86% follow-up, there were fifteen new cancer events in eleven patients in the rhBMP-2/CRM group compared with two new cancer events in two patients in the control group treated with autogenous bone graft. The incidence rate of new cancer events per 100 person-years was 3.37 (95% confidence interval [CI], 1.89 to 5.56) in the rhBMP-2/CRM group at two years compared with 0.50 (95% CI, 0.06 to 1.80) in the control group. The incidence rate ratio was 6.75 (95% CI, 1.57 to 60.83; p = 0.0026) at two years. Calculated in terms of the number of patients with one or more cancer events two years after the surgery, the incidence rate per 100 person-years was 2.54 (95% CI, 1.27 to 4.54) in the rhBMP-2/CRM group compared with 0.50 (95% CI, 0.06 to 1.82) in the control group at two years; the incidence rate ratio was 5.04 (95% CI, 1.10 to 46.82; p = 0.0194). At five years, there was a 37% loss of follow-up, but a significantly greater incidence of cancer events was still observed in the rhBMP-2/CRM group. CONCLUSIONS: A high dose of 40 mg of rhBMP-2/CRM in lumbar spinal arthrodesis was associated with an increased risk of new cancer.

Does a fibronectin and aggrecan complex play a role in painful vertebral disks?

OBJECTIVE: To determine the presence of a fibronectin-aggrecan complex (FAC) in the disk space of persons with chronic low back pain as relates to provocative diskography. DESIGN: A single-center prospective consecutive case series. SETTING: A single private practice setting. PATIENTS: Thirty-seven patients with symptomatic degenerative disk disease of the cervical, thoracic, or lumbar spine undergoing provocative diskography to identify a source of pain. METHODS: Diskographic lavage for analysis was simultaneously performed at each disk level injected during diskography. MAIN OUTCOME MEASURES: Visual analog scale (VAS) pain scores, Pfirrmann magnetic resonance imaging grade, and biochemical analysis of disk material were statistically analyzed. RESULTS: A total of 105 levels in 37 patients had a complete set of data (mean age 43.2 ± 11.9 years; 15 male/22 female). The FAC was present in 43 of 108 levels and in at least one level in 25 of 37 patients. The Pfirrmann magnetic resonance imaging grade did not differ between complex-positive and negative levels (P = .125), nor did the intraoperative VAS (IO-VAS) score for pain by level (P = .206). A significant but loose correlation was found between Pfirrmann grade and IO-VAS (R(2) = 0.4, P < .001), but no significant correlation was found between VAS or IO-VAS and complex concentration (R(2) = 0.08, P = .11 and R(2) = 0.003, P = .5). CONCLUSIONS: The FAC was identified in some painful disks by diskography. There was no significant correlation between the Pfirrmann grade or pre/intraoperative pain scores during diskography and complex concentrations within the disk measured by disk lavage.