Comparative Effectiveness of Treatments for Chronic Low Back Pain: A Multiple Treatment Comparison Analysis.

STUDY DESIGN: A systematic review and network meta-analysis. OBJECTIVE: To determine current treatment options of chronic low back pain (LBP) as defined by randomized controlled trials (RCTs) and to compare effectiveness of those treatments using a mixed-treatment comparison (MTC). SUMMARY OF BACKGROUND DATA: It is important to provide an evidence-based assessment of the treatment options that exist for LBP. METHODS: A systematic search of RCTs was conducted in MEDLINE and the Cochrane Collaboration Library from 1990 to 2014. From the selected studies, we extracted preoperative and postoperative ODI and VAS back pain scores, additional surgeries, and complications. Standard and network meta-analytic techniques were used. RESULTS: Twelve RCTs were included in the analysis: 5 total disk replacement (TDR) versus fusion; 1 TDR versus exercise and cognitive behavioral therapy (CBT); 5 fusion versus exercise and CBT; and 1 fusion versus physical therapy (PT). On the basis of MTC, with respect to ODI change scores, the pooled mean difference favoring fusion over exercise and CBT was 2.0 points (95% CI, -1.2 to 4.8). The pooled mean difference favoring TDR over exercise and CBT was 6.4 points (95% CI, 3.2-9.3). The pooled mean difference favoring fusion over PT was 8.8 points (95% CI, 4.1-13.6). The pooled mean differences favoring TDR over fusion was 4.4 points (95% CI, 2.37-6.63). For PT versus structured exercise with CBT, the pooled mean difference favoring exercise with CBT over PT was 6.8 points (95% CI, 1.5-12.8). For TDR versus PT, the pooled mean difference favoring TDR over PT was 13.2 points (95% CI, 8.0-18.4). Additional surgery rates were similar between treatment options. CONCLUSIONS: All 4 treatments provided some benefit to patients with chronic LBP. According to the MTC analysis, TDR may be the most effective treatment and PT the least effective treatment for chronic LBP. This review is based on a limited number of RCT studies and does not support any 1 treatment modality for all patients.

Radiological Determination of Postoperative Cervical Fusion: A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVE: To determine best criteria for radiological determination of postoperative subaxial cervical fusion to be applied to current clinical practice and ongoing future research assessing fusion to standardize assessment and improve comparability. SUMMARY OF BACKGROUND DATA: Despite availability of multiple imaging modalities and criteria, there remains no method of determining cervical fusion with absolute certainty, nor clear consensus on specific criteria to be applied. METHODS: A systematic search in MEDLINE/Cochrane Collaboration Library (through March 2014). Included studies assessed C2 to C7 via anterior or posterior approach, at 12 weeks or more postoperative, with any graft or implant. Overall body of evidence with respect to 6 posited key questions was determined using Grading of Recommendations Assessment, Development and Evaluation and Agency for Healthcare Research and Quality precepts. RESULTS: Of plain radiographical modalities, there is moderate evidence that the interspinous process motion method (<1 mm) is more accurate than the Cobb angle method for assessing anterior cervical fusion. Of the advanced imaging modalities, there is moderate evidence that computed tomography (CT) is more accurate and reliable than magnetic resonance imaging in assessing anterior cervical fusion. There is insufficient evidence regarding the optimal modality and criteria for assessing posterior cervical fusions and insufficient evidence to support a single time point after surgery as being optimal for determining fusion, although some evidence suggest that reliability of radiography and CT improves with increasing time postoperatively. CONCLUSION: We recommend using less than 1-mm motion as the initial modality for determining anterior cervical arthrodesis for both clinical and research applications. If further imaging is needed because of indeterminate radiographical evaluation, we recommend CT, which has relatively high accuracy and reliability, but due to greater radiation exposure and cost, it is not routinely suggested. We recommend that plain radiographs also be the initial method of determining posterior cervical fusion but suggest a lower threshold for obtaining CT scans because dynamic radiographs may not be as useful if spinous processes have been removed by laminectomy. LEVEL OF EVIDENCE: 1.

Lumbar Lateral Interbody Fusion (LLIF): Comparative Effectiveness and Safety versus PLIF/TLIF and Predictive Factors Affecting LLIF Outcome.

STUDY DESIGN: Systematic review. STUDY RATIONALE: The surgical treatment of adult degenerative lumbar conditions remains controversial. Conventional techniques include posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF). A new direct approach known as lumbar lateral interbody fusion (LLIF), or extreme lateral interbody fusion (XLIF(®)) or direct lateral interbody fusion (DLIF), has been introduced. Objectives The objective of this article is to determine the comparative effectiveness and safety of LLIF, at one or more levels with or without instrumentation, versus PLIF or TLIF surgery in adults with lumbar degenerative conditions, and to determine which preoperative factors affect patient outcomes following LLIF surgery. MATERIALS AND METHODS: A systematic review of the literature was performed using PubMed and bibliographies of key articles. Articles were reviewed by two independent reviewers based on predetermined inclusion and exclusion criteria. Each article was evaluated using a predefined quality rating scheme. RESULTS: The search yielded 258 citations and the following met our inclusion criteria: three retrospective cohort studies (all using historical cohorts) (class of evidence [CoE] III) examining the comparative effectiveness and safety of LLIF/XLIF(®)/DLIF versus PLIF or TLIF surgery, and one prospective cohort study (CoE II) and two retrospective cohort studies (CoE III) assessing factors affecting patient outcome following LLIF. Patients in the LLIF group experienced less estimated blood loss and a lower mortality risk compared with the PLIF group. The number of levels treated and the preoperative diagnosis were significant predictors of perioperative or early complications in two studies. CONCLUSION: There is insufficient evidence of the comparative effectiveness of LLIF versus PLIF/TLIF surgery. There is low-quality evidence suggesting that LLIF surgery results in fewer complications or reoperations than PLIF/TLIF surgery. And there is insufficient evidence that any preoperative factors exist that predict patient outcome after LLIF surgery.

Surgical correction of scoliosis in children with spastic quadriplegia: benefits, adverse effects, and patient selection.

STUDY RATIONALE: Cerebral palsy (CP) is a group of nonprogressive syndromes of posture and motor impairment associated with lesions of the immature brain. Spastic quadriplegia is the most severe form with a high incidence of scoliosis, back pain, respiratory compromise, pelvic obliquity, and poor sitting balance. Surgical stabilization of the spine is an effective technique for correcting deformity and restoring sitting posture. The decision to operate in this group of patients is challenging. OBJECTIVES: The aim of this study is to determine the benefits of surgical correction of scoliosis in children with spastic quadriplegia, the adverse effects of this treatment, and what preoperative factors affect patient outcome after surgical correction. MATERIALS AND METHODS: A systematic review was undertaken to identify studies describing benefits and adverse effects of surgery in spastic quadriplegia. Factors affecting patient outcome following surgical correction of scoliosis were assessed. Studies involving adults and nonspastic quadriplegia were excluded. RESULTS: A total of 10 case series and 1 prospective and 3 retrospective cohort studies met inclusion criteria. There was significant variation in the overall risk of complications (range, 10.9-70.9%), mortality (range, 2.8-19%), respiratory/pulmonary complications (range, 26.9-57.1%), and infection (range, 2.5-56.8%). Factors associated with a worse outcome were a significant degree of thoracic kyphosis, days in the intensive care unit, and poor nutritional status. CONCLUSION: Caregivers report a high degree of satisfaction with scoliosis surgery for children with spastic quadriplegia. There is limited evidence of preoperative factors that can predict patient outcome after scoliosis. There is a need for well-designed prospective studies of scoliosis surgery in spastic quadriplegia.

Role of prospective registries in defining the value and effectiveness of spine care.

STUDY DESIGN: Literature review and case example. OBJECTIVE: Describe methodological considerations of spine surgery registries. Review existing spine surgery registries. Describe the Vanderbilt Prospective Spine Registry (VPSR) as a case example and demonstrate its impact on comparative effectiveness research, value analysis, quality improvement, and practice-based learning. SUMMARY OF BACKGROUND DATA: To bend the cost curve and ultimately achieve sustainability in health care, medical providers and surgical treatments of the highest quality and effectiveness must be preferentially used and purchased. As the current US health care environment continues to evolve, it will be essential for all spine clinicians to understand and be facile with the principles of evidence-based health care reform. METHODS: We describe the methodological considerations of spine surgery registries, review the literature to describe existing spine surgery registries, and discuss the VPSR as a case example. RESULTS: We were able to obtain detailed information on 13 existing spine surgery registries through various internet-based resources. Of the 13, 2 registries had start dates before 2000, 3 between 2001 and 2005, 5 starting in 2006, and 3 were indeterminate. Follow-up rates were in the range from 22% to 79%, with longer follow-up times consistently producing lower follow-up rates. CONCLUSION: Prospective, longitudinal, patient-reported outcomes registries are powerful tools that allow measurement of cost, safety, effectiveness, and health care value across clinically meaningful episodes of care. Registries entirely based on claims or billing data, safety measures alone, process measures, or other proxies of outcome offer valuable insights, but do not provide comprehensive data to drive patient-centered value-based reform. As more spine-focused registries emerge and their integration into the US health care delivery evolve, the evidence to power value-based reform will be enabled.