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."

Management of degenerative spondylolisthesis: development of appropriate use criteria.

BACKGROUND CONTEXT: Outcomes of treatment in care of patients with spinal disorders are directly related to patient selection and treatment indications. However, for many disorders, there is absence of consensus for precise indications. With the increasing emphasis on quality and value in spine care, it is essential that treatment recommendations and decisions are optimized. PURPOSE: The purpose of the North American Spine Society Appropriate Use Criteria was to determine the appropriate (ie reasonable) multidisciplinary treatment recommendations for patients with degenerative spondylolisthesis across a spectrum of more common clinical scenarios. STUDY DESIGN: A Modified Delphi process was used. METHODS: The methodology was based on the Appropriate Use Criteria development process established by the Research AND Development Corporation. The topic of degenerative spondylolisthesis was selected by the committee, key modifiers determined, and consensus reached on standard definitions. A literature search and evidence analysis were completed by one work group simultaneously as scenarios were written, reviewed, and finalized by another work group. A separate multidisciplinary rating group was assembled. Based on the literature, provider experience, and group discussion, each scenario was scored on a nine-point scale on two separate occasions, once without discussion and then a second time following discussion based on the initial responses. The median rating for each scenario was then used to determine if indications were rarely appropriate (1 - 3), uncertain (4-6), or appropriate (7-9). Consensus was not mandatory. RESULTS: There were 131 discrete scenarios. These addressed questions on bone grafting, imaging, mechanical instability, radiculopathy with or without neurological deficits, obesity, and yellow flags consisting of psychosocial and medical comorbidities. For most of these, appropriateness was established for physical therapy, injections, and various forms of surgical intervention. The diagnosis of spondylolisthesis should be determined by an upright x-ray. Scenarios pertaining to bone grafting suggested that patients should quit smoking prior to surgery, and that use of BMP should be reserved for patients who had risk factors for non-union. Across all clinical scenarios, physical therapy (PT) had an adjusted mean of 7.66, epidural steroid injections 5.76, and surgery 4.52. Physical therapy was appropriate in most scenarios, and most appropriate in patients with back pain and no neurological deficits. Epidural steroid injections were most appropriate in patients with radiculopathy. Surgery was generally more appropriate for patients with neurological deficits, higher disability scores, and dynamic spondylolisthesis. Mechanical back pain and presence of yellow flags tended to be less appropriate, and obesity in general had relatively little influence on decision making. Decompression alone was more strongly considered in the presence of static versus dynamic spondylolisthesis. On average, posterior fusion with or without interbody fusion was similarly appropriate, and generally more appropriate than stand-alone interbody fusion which was in turn more appropriate than interspinous spacers. CONCLUSIONS: Multidisciplinary appropriate treatment criteria were generated based on the Research AND Development methodology. While there were consistent and significant differences between surgeons and non-surgeons, these differences were generally very small. This document provides comprehensive evidence-based recommendations for evaluation and treatment of degenerative spondylolisthesis. The document in its entirety will be found on the North American Spine Society website (https://www.spine.org/Research-Clinical-Care/Quality-Improvement/Appropriate-Use-Criteria).

Commentary on the significance of pain catastrophizing in clinical manifestations of patients with lumbar spinal stenosis: mediation analysis with bootstrapping.

COMMENTARY ON: Kim HJ, Cho CH, Kang KT, Chang BS, Lee CK, Yeom JS. The significance of pain catastrophizing in clinical manifestations of patients with lumbar spinal stenosis: mediation analysis with bootstrapping. Spine J 2015;15:238-46 (in this issue).

Ghost and guest authors: you can't always trust who you read.

Clinicians and educators rely on the published medical information. They trust that original research and narrative or systematic reviews are reliable and the authorship is transparent, but this is not always the case. Disclosure of conflicts of interest by authors is required by most journals, disclosure will not detect ghost or guest authorship. Ghosting or guesting is of more than academic interests because it can directly or indirectly affect patient care. Therefore it is important for readers to be aware of this issue, and to be alert to suggestions that particular works may be at increased risk for ghost or guest authors. It is important to take a proactive stance against these practices. Industry, universities, research centers, and professional medical associations should be clear and unequivocal in condeming these practices. Processes need to be in place to investigate and, if need be, deal with violations. Clearly, we must all participate in this endeavor for professional, ethical, and most importantly, best patient care reasons.

Conflict of interest and professional medical associations: the North American Spine Society experience.

BACKGROUND CONTEXT: Recently the financial relationships between industry and professional medical associations have come under increased scrutiny because of the concern that industry ties may create real or perceived conflicts of interest. Professional medical associations pursue public advocacy as well as promote medical education, develop clinical practice guidelines, fund research, and regulate professional conduct. Therefore, the conflicts of interest of a professional medical association and its leadership can have more far-reaching effects on patient care than those of an individual physician. PURPOSE: Few if any professional medical associations have reported their experience with implementing strict divestment and disclosure policies, and among the policies that have been issued, there is little uniformity. We describe the experience of the North American Spine Society (NASS) in implementing comprehensive conflicts of interest policies. STUDY DESIGN: A special feature article. METHODS: We discuss financial conflicts of interest as they apply to professional medical associations rather than to individual physicians. We describe the current policies of disclosure and divestment adopted by the NASS and how these policies have evolved, been refined, and have had no detrimental impact on membership, attendance at annual meetings, finances, or leadership recruitment. No funding was received for this work. The authors report no potential conflict-of-interest-associated biases in the text. RESULTS: The NASS has shown that a professional medical association can manage its financial relationships with industry in a manner that minimizes influence and bias. CONCLUSIONS: The NASS experience can provide a template for other professional medical associations to help manage their own possible conflicts of interest issues.

The medical-industrial complex, professional medical associations, and continuing medical education.

Financial relationships among the biomedical industries, physicians, and professional medical associations (PMAs) can be professional, ethical, mutually beneficial, and, most importantly, can lead to improved medical care. However, such relationships, by their very nature, present conflicts of interest (COIs). One of the greatest concerns regarding COI is continuing medical education (CME), especially because currently industry funds 40-60% of CME. COIs have the potential to bias physicians in practice, educators, and those in leadership positions of PMAs and well as the staff of a PMA. These conflicts lead to the potential to bias the content and type of CME presentations and thereby influence physicians' practice patterns and patient care. Physicians are generally aware of the potential for bias when industry contributes funding for CME, but they are most often unable to detect the bias. This may because it is very subtle and/or the educators themselves may not realize that they have been influenced by their relationships with industry. Following Accreditation Council for Continuing Medical Education guidelines and mandating disclosure that is transparent and complete have become the fallback positions to manage COIs, but such disclosure does not really mitigate the conflict. The eventual and best solutions to ensure evidence-based education are complete divestment by educators and leaders of PMAs, minimal and highly controlled industry funding of PMAs, blind pooling of any industry contributions to PMAs and CME, strict verification of disclosures, clear separation of marketing from education at CME events, and strict oversight of presentations for the presence of bias.

Structural etiology of chronic low back pain due to motor vehicle collision.

OBJECTIVE: To estimate prevalence rates of discogenic, facet, and sacroiliac joint pain, and describe clinical features of chronic low back pain patients whose symptoms were initiated by motor vehicle collisions. DESIGN: Retrospective chart review. SETTING: Academic spine center. PATIENTS: Twenty-seven motor vehicle collision-induced chronic low back pain patients were included after undergoing diagnostic procedures. INTERVENTIONS: Lumbar provocation discography, dual diagnostic facet joint blocks, and intra-articular sacroiliac joint injections. METHODS: Enrolled patients underwent diagnostic procedures based on clinical presentation until the pain source was identified. The prevalence of each source of low back pain was estimated. Clinical, categorical, and continuous characteristics within the source groups were calculated with SAS v.9.2 (SAS Institute Inc., Cary, NC). OUTCOME MEASURES: Etiology and prevalence were analyzed for each diagnosis group. RESULTS: Of the 27 patients, 15/27 (56%) were diagnosed with discogenic pain, 7/27 (26%) with sacroiliac joint pain, and 5/27 (19%) with facet joint pain. Seventy-eight percent were female. Mean age was 42.5 years (standard deviation = 10.4) with median duration of symptoms of 24 months (interquartile range = 6-48). CONCLUSIONS: Our study is the first to demonstrate that diagnostic spinal injections can identify particular spinal structures, namely the intervertebral disc, facet joint, and sacroiliac joint, as the specific source of chronic low back pain due to inciting motor vehicle collisions. The most common source of motor vehicle collision-induced chronic low back pain appears to be the disc followed by the sacroiliac and facet joints.

Expert opinion and controversies in musculoskeletal and sports medicine: conflict of interest.

Standaert CJ, Schofferman JA, Herring SA. Expert opinion and controversies in musculoskeletal and sports medicine: conflict of interest. Medical providers are faced with conflicts of interest (COIs) on a routine basis, but there is growing concern over the effects of COIs on medical care, medical education, research, product development, and other aspects of the health care system. The data clearly indicate that medical providers are subconsciously influenced by interactions with representatives of pharmaceutical and device manufacturers and that they are not very good at assessing the extent of this influence upon themselves. The data are also clear that potential bias arising from COIs is present in medical education and research. A number of professional medical associations have developed guidelines regarding interactions between medical providers and industry, and requirements for disclosure have become commonplace. The impact of these regulations and of disclosure on managing COI is unclear, however, and it is extremely important that providers manage the conflicts present on their own. A broad awareness of the effects of COIs and disclosure is necessary if providers are going to be able to offer the best care for their patients.

Serial therapeutic sacroiliac joint injections: a practice audit.

OBJECTIVE: To determine the long-term response to serial sacroiliac joint (SIJ) corticosteroid injections. Design. Retrospective practice audit. SETTING AND PATIENTS: Tertiary care spine center. Review of charts of all patients in a single practice who underwent diagnostic and therapeutic fluoroscopically guided SIJ injections with combined local anesthetic, long-acting corticosteroid, and contrast. MEASURES: Response was evaluated at 1 hour and again at follow-up clinic visits. Response to injection was graded as positive if there was > or =50% relief of the targeted pain during the local anesthetic phase and at least 2 weeks of > or =50% relief afterward. If pain recurred, patients had to have been sufficiently satisfied with the relief to request repeat injection. RESULTS: There were 164 patients; 5 had incomplete records, 4 had <2 year follow-up. Of the 155 patients, 120 (77%) were positive responders; 45 were men and 75 were women; and the mean age was 48 (27-91) years. Sixty-nine had prior lumbar surgery. Mean duration of follow-up was 44 months (26-101). Two were lost to follow-up. The 118 positive responders received a mean of 2.7 injections per patient. Forty patients required 1 injection only, 29 required two, 22 required three, and 27 required four or more. The mean duration of response for those receiving >1 injection was 9.3 months per injection (1-58). There were no adverse events. CONCLUSIONS: SIJ corticosteroid injections appear to be an effective palliative treatment for selected patients with SIJ pain. Most patients whose pain is responsive to SIJ steroid injections improved sufficiently and remained well after 1 to 3 injections, but some required frequent injections on a long-term basis.

Effectiveness of repeated radiofrequency neurotomy for cervical facet joint pain.

STUDY DESIGN: Retrospective chart review. OBJECTIVES: To determine the success rate and duration of relief of repeat radiofrequency neurotomy (RFN) for cervical facet joint pain. SUMMARY OF BACKGROUND DATA: RFN is an effective but temporary management of cervical facet pain. When pain recurs, RFN is usually repeated, but the outcomes for repeat RFN are not well established. METHODS: Record review of consecutive patients who had an initial successful RFN, recurrence of pain, and then one or more repeat RFN. Responses of repeat RFN were compared with initial RFN for success rates and duration of relief. Success was defined as >/=50% relief of targeted pain and patient sufficiently satisfied with prior RFN to have RFN repeated. RESULTS: There were 14 women and 8 men. Mean age was 47 years (range, 34 to 66 y). Sixty-four RFNs were performed. Mean duration of relief after initial RFN was 12.5 months (range, 3 to 25 mo). Forty-two RFNs were performed after the initial RFN. Forty-one of the 42 RFNs were available to follow-up (98%). Thirty-nine of the 41 RFNs were successful (95%). To date, 11 patients had a series of 2 RFNs performed, 7 had 3, 2 had 4, 1 had 6, and 1 had 7. Twenty-two patients had a second RFN, which was successful in 20 of the 21 available to follow-up (95%) but unsuccessful in 1 (5%). The mean duration of relief in these patients was 12.7 months (range, 3 to 30 mo) and the relief is continuing in 2 patients. Eleven patients had a third RFN, of which 10 (91%) were successful and 1 (9%) was unsuccessful. The mean duration of relief in 8 patients was 9.5 months (range, 3 to 16 mo), and the relief is continuing in the other 2. Four patients had a fourth RFN, which was successful in all 4. The mean duration of relief was 8.75 months (range, 4 to 12 mo). Two patients had a fifth RFN with both having a mean duration of relief of 9 months (11 and 7 mo, respectively). There were 2 patients with a sixth RFN, both were successful, 1 lasted 18 months and in the other relief is continuing. There was 1 patient with a successful seventh RFN, and relief is continuing. The frequency of success and durations of relief remained consistent after each subsequent RFN. CONCLUSIONS: In a carefully selected group of patients with cervical facet joint pain who have been responsive to previous RFN, repeat RFNs are usually successful.

Evidence-informed management of chronic low back pain with opioid analgesics.

The management of chronic low back pain (CLBP) has proven to be 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.

Chronic whiplash and whiplash-associated disorders: an evidence-based approach.

Whiplash is neck pain experienced as a result of a motor vehicle collision or similar trauma. Following a motor vehicle collision, 15% to 40% of patients with acute neck pain develop chronic neck pain. The cervical facet joint is the most common source of chronic neck pain after whiplash injury, followed by disk pain. Some patients experience pain from both structures. Initial management recommendations need not be directed toward an exact structural cause, but treatment includes advising the patient to remain active, prescribing medications when necessary, and providing advice regarding the generally favorable outcome. When neck pain persists, the physician should recommend medial branch blocks of the dorsal rami of the spinal nerves that supply the putative painful facet joint or joints; this is done to determine whether the facet joints are the cause of pain. When significant relief occurs on two occasions, radiofrequency neurotomy typically provides substantial relief for approximately 8 to 12 months and can be repeated indefinitely as needed. Occasionally, long-term treatment with medication may be indicated. Anterior cervical diskectomy and fusion is necessary on rare occasions.

Opinions and testimony of expert witnesses and independent medical evaluators.

OBJECTIVE: To clarify the guidelines and responsibilities of expert witnesses and independent medical evaluators (IMEs). DESIGN: Literature review and personal opinion. SETTING: There have been concerns about the objectivity of expert witnesses and IMEs due to potential financial conflicts of interest. RESULTS: Medical-legal work such as expert witness testimony and independent medical evaluations are a recognized part of the practice of medicine. As such, the opinions and testimony of expert witnesses and IMEs should be held to the same scientific and ethical standards as clinical practice. The concept of "expert" differs when used by the legal system vs when used by physicians. Expert testimony should be based on the best available evidence and standards of care, which requires that experts stay current in their field of expertise, and revise old opinions as new information is published. Personal experience alone is rarely sufficient. A medical expert should be in active practice caring for the type of patient involved in the legal action or, alternatively, be able to demonstrate competence to provide an opinion in the specific area of interest. CONCLUSIONS: Testimony should be honest and evidence-based. Testimony and reports should be accurate, impartial, and relevant. Both should be based on current scientific evidence, and avoid the role of advocate for the party. The physician should testify as if the opinions and their bases are subject to peer review.