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.

A Regional Analysis of Low Back Pain Treatments in the Military Health System.

STUDY DESIGN: Claims-based analysis of cohorts of TRICARE Prime beneficiaries. OBJECTIVE: To compare rates of utilization of 5 low back pain (LBP) treatments (physical therapy (PT), manual therapy, behavioral therapies, opioid, and benzodiazepine prescription) across catchment areas and assess their association with the resolution of LBP. SUMMARY OF BACKGROUND: Guidelines support focusing on nonpharmacologic management for LBP and reducing opioid use. Little is known about patterns of care for LBP across the Military Health System. PATIENTS AND METHODS: Incident LBP diagnoses were identified data using the International Classification of Diseases ninth revision before October 2015 and 10th revision after October 2015; beneficiaries with "red flag" diagnoses and those stationed overseas, eligible for Medicare, or having other health insurance were excluded. After exclusions, there were 159,027 patients remained in the final analytic cohort across 73 catchment areas. Treatment was defined by catchment-level rates of treatment to avoid confounding by indication at the individual level; the primary outcome was the resolution of LBP defined as an absence of administrative claims for LBP during a 6 to 12-month period after the index diagnosis. RESULTS: Adjusted rates of opioid prescribing across catchment areas ranged from 15% to 28%, physical therapy from 17% to 39%, and manual therapy from 5% to 26%. Multivariate logistic regression models showed a negative and marginally significant association between opioid prescriptions and LBP resolution (odds ratio: 0.97, 95% CI: 0.93-1.00; P = 0.051) but no significant association with physical therapy, manual therapy, benzodiazepine prescription, or behavioral therapies. When the analysis was restricted to the subset of only active-duty beneficiaries, there was a stronger negative association between opioid prescription and LBP resolution (odds ratio: 0.93, 95% CI: 0.89-0.97). CONCLUSIONS: We found substantial variability across catchment areas within TRICARE for the treatment of LBP. Higher rates of opioid prescription were associated with worse outcomes.

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.

Quality-of-life outcomes in patients who underwent subcutaneous immunotherapy and sublingual immunotherapy in a real-world clinical setting.

OBJECTIVE: To compare changes in quality of life (QOL) that resulted from sublingual immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) in a real-world clinical setting. BACKGROUND: SLIT is established as a viable alternative to SCIT for the treatment of allergic rhinitis. Although comparative trials are increasingly available, few studies have examined QOL outcomes between these two treatments. METHODS: One hundred and five participants who underwent immunotherapy for airborne allergies were enrolled in this prospective, single-center study. Forty participants completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at initiation of therapy, after 6 months, and after 1 year of therapy. Only patients with complete time points were included in the ultimate analysis. Twenty-nine of these participants underwent SCIT and 11 underwent SLIT. The effects of age, sex, and asthma history were also examined. RESULTS: The participants in both groups demonstrated improvements in QOL regarding allergic rhinoconjunctivitis over the study period. However, the change in the RQLQ score from both baseline to 6 months and baseline to 1 year was only statistically significant in the SCIT group (p = 0.002, 6 months and 1 year). The participants in the SCIT group also demonstrated statistically significant improvement from baseline to 1 year in the specific domains of practical and emotional functioning, nasal symptoms, non-nasal/eye symptoms, and sleep. After 1 year, both SCIT and SLIT demonstrated a minimally important difference from baseline in the overall RQLQ score. Age <35 years in the SCIT group had a significant positive impact on QOL improvement (p = 0.038). CONCLUSION: Although improvements in QOL were noted in both groups, changes in overall scores and the majority of domains only achieved statistical significance in the SCIT group. A small study population and difficulties adhering to immunotherapy dosing schedules in the SLIT group may be contributing factors.

Poland's Syndrome: When there is no breast.

Poland's Syndrome is rare, therefore, clinicians may not be familiar with all that potentially defines this disorder. Much of the literature that exists regarding Poland's Syndrome focuses on the surgical correction of breast asymmetry for cosmesis. Inspired by a patient at our institution, this paper reviews this rare breast disorder and its associated findings within the context of the whole woman with special attention to breast cancer in this cohort.

Ribosomal PCR assay of excised intervertebral discs from patients undergoing single-level primary lumbar microdiscectomy.

PURPOSE: To determine the presence of infectious microorganisms in the herniated discs of immunocompetent patients, using methodology that we hoped would be of higher sensitivity and specificity than has been reported in the past. Recent studies have demonstrated a significant rate of positive cultures for low virulent organisms in excised HNP samples (range 19-53%). These studies have served as the theoretical basis for a pilot trial, and then, a well done prospective randomized trial that demonstrated that systemic treatment with antibiotics may yield lasting improvements in a subset of patients with axial back pain. Whether the reported positive cultures in discectomy specimens represent true positives is as yet not proven, and critically important if underlying the basis of therapeutic approaches for chronic low back pain. METHODS: This consecutive case series from a single academic center included 44 patients with radiculopathy and MRI findings of lumbar HNP. Patients elected for lumbar microdiscectomy after failure of conservative management. All patients received primary surgery at a single spinal level in the absence of immune compromise. Excised disc material was analyzed with a real-time PCR assay targeting the 16S ribosomal RNA gene followed by amplicon sequencing. No concurrent cultures were performed. Inclusion criteria were as follows: sensory or motor symptoms in a single lumbar nerve distribution; positive physical examination findings including positive straight leg raise test, distributional weakness, and/or a diminished deep tendon reflexes; and magnetic resonance imaging of the lumbar spine positive for HNP in a distribution correlating with the radicular complaint. RESULTS: The PCR assay for the 16S rRNA sequence was negative in all 44 patients (100%). 95% CI 0-8%. CONCLUSIONS: Based on the data presented here, there does not appear to be a significant underlying rate of bacterial disc infection in immunocompetent patients presenting with radiculopathy from disc herniation.

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.

Surgical Versus Nonsurgical Treatment for Lumbar Spinal Stenosis.

STUDY DESIGN: A systematic review. OBJECTIVES: The aim of this study is to evaluate the effectiveness of different types of surgery compared with different types of nonsurgical interventions in adults with symptomatic lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND DATA: LSS is a debilitating condition associated with degeneration of the spine with aging. People with LSS experience a range of symptoms, including back pain, leg pain, numbness and tingling in the legs, and reduced physical function. Main treatment options are surgery, physical therapy, exercise, braces, and injections into the spine. METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, five other databases, and two trials registries up to February 2015, reference lists, and conference proceedings related to treatment of the spine. Randomized controlled trials (RCTs) compared surgical versus nonoperative treatments in participants with LSS.Outcomes included quality of life, disability, function, pain, complication rates, and side effects. RESULTS: From the 12,966 citations screened, we included five RCTs (643 participants).Three studies compared spine surgery versus various types of nonsurgical treatment. It is difficult to draw conclusions from these studies because nonsurgical treatments were inadequately described. One study that compared surgery versus bracing and exercise found no differences in pain. Another study compared surgery versus spinal injections and found better physical function with injections, and better pain relief with surgery at six weeks. Still another trial compared surgery with an implanted device versus nonsurgical care. This study reported favorable outcomes of surgery for symptoms and physical function. CONCLUSION: We cannot conclude on the basis of this review whether surgical or nonsurgical treatment is better for individuals with LSS. Nevertheless, we can report on the high rate of effects reported in three of five surgical groups, ranging from 10% to 24%. No side effects were reported for any of the conservative treatment options. LEVEL OF EVIDENCE: 1.

Surgical versus non-surgical treatment for lumbar spinal stenosis.

BACKGROUND: Lumbar spinal stenosis (LSS) is a debilitating condition associated with degeneration of the spine with aging. OBJECTIVES: To evaluate the effectiveness of different types of surgery compared with different types of non-surgical interventions in adults with symptomatic LSS. Primary outcomes included quality of life, disability, function and pain. Also, to consider complication rates and side effects, and to evaluate short-, intermediate- and long-term outcomes (six months, six months to two years, five years or longer). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, five other databases and two trials registries up to February 2015. We also screened reference lists and conference proceedings related to treatment of the spine. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing surgical versus non-operative treatments in participants with lumbar spinal stenosis confirmed by clinical and imaging findings. DATA COLLECTION AND ANALYSIS: For data collection and analysis, we followed methods guidelines of the Cochrane Back and Neck Review Group (Furlan 2009) and those provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). MAIN RESULTS: From the 12,966 citations screened, we assessed 26 full-text articles and included five RCTs (643 participants).Low-quality evidence from the meta-analysis performed on two trials using the Oswestry Disability Index (pain-related disability) to compare direct decompression with or without fusion versus multi-modal non-operative care showed no significant differences at six months (mean difference (MD) -3.66, 95% confidence interval (CI) -10.12 to 2.80) and at one year (MD -6.18, 95% CI -15.03 to 2.66). At 24 months, significant differences favoured decompression (MD -4.43, 95% CI -7.91 to -0.96). Low-quality evidence from one small study revealed no difference in pain outcomes between decompression and usual conservative care (bracing and exercise) at three months (risk ratio (RR) 1.38, 95% CI 0.22 to 8.59), four years (RR 7.50, 95% CI 1.00 to 56.48) and 10 years (RR 4.09, 95% CI 0.95 to 17.58).Low-quality evidence from one small study suggested no differences at six weeks in the Oswestry Disability Index for patients treated with minimally invasive mild decompression versus those treated with epidural steroid injections (MD 5.70, 95% CI 0.57 to 10.83; 38 participants). Zurich Claudication Questionnaire (ZCQ) results were better for epidural injection at six weeks (MD -0.60, 95% CI -0.92 to -0.28), and visual analogue scale (VAS) improvements were better in the mild decompression group (MD 2.40, 95% CI 1.92 to 2.88). At 12 weeks, many cross-overs prevented further analysis.Low-quality evidence from a single study including 191 participants favoured the interspinous spacer versus usual conservative treatment at six weeks, six months and one year for symptom severity and physical function.All remaining studies reported complications associated with surgery and conservative side effects of treatment: Two studies reported no major complications in the surgical group, and the other study reported complications in 10% and 24% of participants, including spinous process fracture, coronary ischaemia, respiratory distress, haematoma, stroke, risk of reoperation and death due to pulmonary oedema. AUTHORS' CONCLUSIONS: We have very little confidence to conclude whether surgical treatment or a conservative approach is better for lumbar spinal stenosis, and we can provide no new recommendations to guide clinical practice. However, it should be noted that the rate of side effects ranged from 10% to 24% in surgical cases, and no side effects were reported for any conservative treatment. No clear benefits were observed with surgery versus non-surgical treatment. These findings suggest that clinicians should be very careful in informing patients about possible treatment options, especially given that conservative treatment options have resulted in no reported side effects. High-quality research is needed to compare surgical versus conservative care for individuals with lumbar spinal stenosis.

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.

Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.

This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.

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).