Cervical fusion for treatment of degenerative conditions: development of appropriate use criteria.

BACKGROUND CONTEXT: High quality evidence is difficult to generate, leaving substantial knowledge gaps in the treatment of spinal conditions. Appropriate use criteria (AUC) are a means of determining appropriate recommendations when high quality evidence is lacking. PURPOSE: Define appropriate use criteria (AUC) of cervical fusion for treatment of degenerative conditions of the cervical spine. STUDY DESIGN/SETTING: Appropriate use criteria for cervical fusion were developed using the RAND/UCLA appropriateness methodology. Following development of clinical guidelines and scenario writing, a one-day workshop was held with a multidisciplinary group of 14 raters, all considered thought leaders in their respective fields, to determine final ratings for cervical fusion appropriateness for various clinical situations. OUTCOME MEASURES: Final rating for cervical fusion recommendation as either "Appropriate," "Uncertain" or "Rarely Appropriate" based on the median final rating among the raters. METHODS: Inclusion criteria for scenarios included patients aged 18 to 80 with degenerative conditions of the cervical spine. Key modifiers were defined and combined to develop a matrix of clinical scenarios. The median score among the raters was used to determine the final rating for each scenario. The final rating was compared between modifier levels. Spearman's rank correlation between each modifier and the final rating was determined. A multivariable ordinal regression model was fit to determine the adjusted odds of an "Appropriate" final rating while adjusting for radiographic diagnosis, number of levels and symptom type. Three decision trees were developed using decision tree classification models and variable importance for each tree was computed. RESULTS: Of the 263 scenarios, 47 (17.9 %) were rated as rarely appropriate, 66 (25%) as uncertain and 150 (57%) were rated as appropriate. Symptom type was the modifier most strongly correlated with the final rating (adjusted ρ2 = 0.58, p<.01). A multivariable ordinal regression adjusting for symptom type, diagnosis, and number of levels and showed high discriminative ability (C statistic = 0.90) and the adjusted odds ratio (aOR) of receiving a final rating of "Appropriate" was highest for myelopathy (aOR, 7.1) and radiculopathy (aOR, 4.8). Three decision tree models showed that symptom type and radiographic diagnosis had the highest variable importance. CONCLUSIONS: Appropriate use criteria for cervical fusion in the setting of cervical degenerative disorders were developed. Symptom type was most strongly correlated with final rating. Myelopathy or radiculopathy were most strongly associated with an "Appropriate" rating, while axial pain without stenosis was most associated with "Rarely Appropriate."

Commentary on Classification of patients with incident non-specific low back pain: implications for research.

COMMENTARY ON: Norton G, McDonough CM, Cabral HJ, Shwartz M, Burgess JF Jr. Classification of patients with incident non-specific low back pain: implications for research. Spine J 2016;16:567-76 (in this issue).

The Spine Surgical Care and Outcomes Assessment Program (Spine SCOAP): a surgeon-led approach to quality and safety.

STUDY DESIGN: Prospective registry of spine surgery. OBJECTIVE: To identify variation in utilization, processes of care, and outcomes in spine surgery to improve statewide quality and safety. SUMMARY OF BACKGROUND DATA: Variability in the utilization and outcomes of elective spine surgery across different regions in the United States and internationally has become a growing focus of critical evaluation. In 2011, surgeons in Washington State created the Spine Surgical Care and Outcomes Assessment Program to address variability in use, process, and outcome of spine surgery. METHODS: Prospective cohort study from consecutive spine fusion cases and 30% sampling of other spine procedures from up to 20 hospitals (2011-2013). Logistic regression models were developed using data from 10 quarters to determine factors associated with combined adverse events inclusive of index hospital death, reintervention, and adverse events not requiring intervention, and then applied to patients in the last 2 quarters. RESULTS: A total of 10,166 (58.9 ± 13.4 yr, 52.2% females) underwent surgery including 3767 (37%) lumbar and 6399 (63%) cervical procedures. Of the total, 75.3% of the cohort had a spine fusion and among those, neurological symptoms were described in 92.5% of patients, with baseline limb pain numeric rating scale (NRS) scores of 5.9 among those classified as having neurological symptoms. The NRS mean score for back pain was 5.9 with a mean Oswestry Disability Index/Neck Disability Index of 44. There was significant intersite variation in rates of cigarette smoking among patients undergoing fusion surgery (range, 0%-40%) and rates of combined adverse events with 10 hospitals having a significantly lower observed/expected ratio and 3 having a significantly greater observed to expected ratio. CONCLUSION: Spine Surgical Care and Outcomes Assessment Program identified significant variability in the indications, process of care, and outcomes related to spine surgery. This variability indicates the need for continued surveillance initiatives and point to opportunities for quality improvement and research. LEVEL OF EVIDENCE: 2.

Safeguards to prevent neurologic complications after epidural steroid injections: consensus opinions from a multidisciplinary working group and national organizations.

BACKGROUND: Epidural corticosteroid injections are a common treatment for radicular pain caused by intervertebral disc herniations, spinal stenosis, and other disorders. Although rare, catastrophic neurologic injuries, including stroke and spinal cord injury, have occurred with these injections. METHODS: A collaboration was undertaken between the U.S. Food and Drug Administration Safe Use Initiative, an expert multidisciplinary working group, and 13 specialty stakeholder societies. The goal of this collaboration was to review the existing evidence regarding neurologic complications associated with epidural corticosteroid injections and produce consensus procedural clinical considerations aimed at enhancing the safety of these injections. U.S. Food and Drug Administration Safe Use Initiative representatives helped convene and facilitate meetings without actively participating in the deliberations or decision-making process. RESULTS: Seventeen clinical considerations aimed at improving safety were produced by the stakeholder societies. Specific clinical considerations for performing transforaminal and interlaminar injections, including the use of nonparticulate steroid, anatomic considerations, and use of radiographic guidance are given along with the existing scientific evidence for each clinical consideration. CONCLUSION: Adherence to specific recommended practices when performing epidural corticosteroid injections should lead to a reduction in the incidence of neurologic injuries.

Comparison of four different analgesic discogram protocols comparing the incidence of reported pain relief following local anesthetic injection into concordantly painful lumbar intervertebral discs.

OBJECTIVE: To compare the incidence of pain relief following injection of local anesthetic (LA) into lumbar discs that caused concordant pain during provocation testing. DESIGN: Prospective collected data review from two centers and compare with published results. OUTCOME MEASURES: We compared subjective reported pain relief following provocative testing using the following protocols at three separate facilities: 23 patients undergoing routine provocative discography using contrast alone (PD); 47 patients undergoing provocative discography performed using an equal combination of LA and contrast (CPD); 120 patients injected with LA following routine PD (ADPD); 33 patients undergoing stand-alone analgesic discography (SAAD); and 28 patients injected with LA through a catheter (FAD) placed during provocative discogaphy testing. RESULTS: Pressure-controlled PD showed a positive response rate of 34% per disc in patients with a clinical diagnosis of discogenic pain. None of the PD group without LA had pain relief and less than 10% of the CPD group reported pain relief. Forty percent of the SAAD group with positive pain reproduction reported ≥50% relief and 20% reporting ≥80% relief. Forty-six percent of the ADPD group reported ≥50% relief and 30% reporting ≥80% relief. The FAD group had a greater 80% patients reporting ≥50% pain relief although fewer 26% reporting more convincing ≥80% relief. CONCLUSIONS: If the criterion standard to confirm painful annular tears is concordant pain provocation and 80% or greater pain relief following LA injected into lumbar discs, the SAAD, ADPD, and FAD protocols show statistically similar 20% to 30% prevelance.

Evidence-informed management of chronic low back pain with intradiscal electrothermal therapy.

The management of chronic low back pain (CLBP) has proven very challenging in North America, as evidenced by its mounting socioeconomic burden. Choosing among available nonsurgical therapies can be overwhelming for many stakeholders, including patients, health providers, policy makers, and third-party payers. Although all parties share a common goal and wish to use limited health-care resources to support interventions most likely to result in clinically meaningful improvements, there is often uncertainty about the most appropriate intervention for a particular patient. To help understand and evaluate the various commonly used nonsurgical approaches to CLBP, the North American Spine Society has sponsored this special focus issue of The Spine Journal, titled Evidence-Informed Management of Chronic Low Back Pain Without Surgery. Articles in this special focus issue were contributed by leading spine practitioners and researchers, who were invited to summarize the best available evidence for a particular intervention and encouraged to make this information accessible to nonexperts. Each of the articles contains five sections (description, theory, evidence of efficacy, harms, and summary) with common subheadings to facilitate comparison across the 24 different interventions profiled in this special focus issue, blending narrative and systematic review methodology as deemed appropriate by the authors. It is hoped that articles in this special focus issue will be informative and aid in decision making for the many stakeholders evaluating nonsurgical interventions for CLBP.

Evidence-informed management of chronic low back pain with minimally invasive nuclear decompression.

The management of chronic low back pain (CLBP) has proven very challenging in North America, as evidenced by its mounting socioeconomic burden. Choosing among available nonsurgical therapies can be overwhelming for many stakeholders, including patients, health providers, policy makers, and third-party payers. Although all parties share a common goal and wish to use limited health-care resources to support interventions most likely to result in clinically meaningful improvements, there is often uncertainty about the most appropriate intervention for a particular patient. To help understand and evaluate the various commonly used nonsurgical approaches to CLBP, the North American Spine Society has sponsored this special focus issue of The Spine Journal, titled Evidence Informed Management of Chronic Low Back Pain Without Surgery. Articles in this special focus issue were contributed by leading spine practitioners and researchers, who were invited to summarize the best available evidence for a particular intervention and encouraged to make this information accessible to nonexperts. Each of the articles contains five sections (description, theory, evidence of efficacy, harms, and summary) with common subheadings to facilitate comparison across the 24 different interventions profiled in this special focus issue, blending narrative and systematic review methodology as deemed appropriate by the authors. It is hoped that articles in this special focus issue will be informative and aid in decision making for the many stakeholders evaluating nonsurgical interventions for CLBP.

Comparative effectiveness of cervical transforaminal injections with particulate and nonparticulate corticosteroid preparations for cervical radicular pain.

OBJECTIVES: Cervical transforaminal epidural injections of corticosteroids have been used in the treatment of radicular pain. Particulate agents have been associated with rare adverse neurological outcomes. It is unknown whether nonparticulate preparations are any less effective than particulate preparations. Therefore, a study was designed to determine whether there is a basis for promoting a theoretically safer nonparticulate corticosteroid preparation. DESIGN: Volunteer patients were randomized to receive a single cervical transforaminal epidural injection with one of two corticosteroid preparations. SETTING: This study was undertaken in a private practice setting. PATIENTS: Those with single-level, unilateral radicular pain with advanced imaging demonstrating single-level neural compression. INTERVENTIONS: Patients received a single cervical transforaminal epidural injection with either dexamethasone or triamcinolone. OUTCOME MEASURES: Ratings were obtained by an independent unbiased assessor at 4 weeks via a telephone interview. A visual analog pain scale was used preprocedurally and a verbal integer scale was used at 4 weeks to assess the severity of the patient's radicular pain. As a secondary outcome measure, a patient-specified functional outcome measure was obtained. RESULTS: Both groups exhibited statistically and clinically significant improvements in pain at 4 weeks. Although the triamcinolone group exhibited a somewhat greater improvement, the difference between groups was not significantly different. CONCLUSION: The study found that the effectiveness of dexamethasone was slightly less than that of triamcinolone, but the difference was neither statistically nor clinically significant. A theoretically safer nonparticulant agent appears to be a valid alternative to particulate agents that have been used to date, and which have been associated with hazard.

Cervical transforaminal injection of corticosteroids into a radicular artery: a possible mechanism for spinal cord injury.

Spinal cord injury has been recognized as a complication of cervical transforaminal injections, but the mechanism of injury is uncertain. In the course of a transforaminal injection, an observation was made after the initial injection of contrast medium. The contrast medium filled a radicular artery that passed to the spinal cord. The procedure was summarily abandoned, and the patient suffered no ill effects. This case demonstrates that despite using careful and accurate technique, it is possible for material to be injected into a radicular artery. Consequently, inadvertent injection of corticosteroids into a radicular artery may be the mechanism for spinal cord injury following transforaminal injections. This observation warns operators to always perform a test injection of contrast medium, and carefully check for arterial filling using real-time fluoroscopy with digital subtraction.