Evidence-Based Medicine Summary Statement

Over the past decade, evidence-based medicine (EBM) has evolved from an academic curiosity to a movement shaping both the future of medical care and health policy. A Medline search of “evidence-based medicine” in 1993 revealed 6 citations, but by 2007, the number had grown to 24,692. Even the lay media has embraced the term, with “evidence-based medicine” being identified as one of the ideas that made a difference in 2001 by The New York Times Magazine.1 Given the dramatic growth and increased awareness of EBM, it is imperative that both the underlying concepts and the appropriate applications of EBM be clearly understood to ensure excellence in clinical practice and fairness in health policy advocacy. The Executive Board of the Scoliosis Research Society and the Editors of Spine recognize the growing significance of EBM. This SRS-Spine Focus issue on Evidence Based Medicine in Spinal Deformity is the beginning of the society’s effort to move toward greater emphasis on evidence-based care in spinal deformity. For many physicians, EBM remains an ill-defined concept. This issue will introduce the methodology of EBM and also provide an analysis of the present state of EBM in spine deformity. The contributing authors all combine an understanding of complex spine care with an appreciation of the principles of public health, epidemiology, and healthcare research. After reading this issue of Spine, the SRS hopes that its members will be more familiar with this rapidly evolving discipline, and also be better positioned to contribute new and meaningful research in deformity related EBM. In the lead article, the principles and some of the pitfalls of EBM are examined, and methods are introduced both to evaluate the quality of research papers and to assess the strength of treatment recommendations arising from the research. This article demonstrates the critical nature of formulating the research “question” in EBM and helps the reader to appreciate that research design does not necessarily correlate with strong treatment recommendations. The traditional “medical” model of EBM is not fully applicable to a surgical practice due to the unique aspects of surgical research. Specifically, standardization of surgical procedures is difficult (as opposed to a medication), blinding the treating physician is impossible, and placebo treatment introduces new complexity. These challenges do not make good EBM surgical research impossible but do raise the bar for the investigator. Finally, the critical, and often neglected, role of both the clinician’s knowledge of prior experiences, and also the assessment of patient’s preferences and values in the delivery of EBM is emphasized. As a cautionary note, this paper merits particularly close study as there is a trend among physicians and policy makers alike to pursue higher “levels of evidence” simply by the numerical attribution without the necessary and all important assessment of quality. Many physicians treating spinal deformity concentrate their efforts on children and adolescents. The current status of patient-based outcomes research instruments for pediatric spine is reviewed. There are differences between the traditional “technical” outcomes with which surgeons are familiar (e.g., radiograph interpretation) and the possibly more relevant “clinical” outcomes (e.g., health status measures). Evaluating the result of procedures in children and adolescents is complex because pain is rarely the reason for intervention, and the ultimate result may only be known many years in the future. Some of the inherent weaknesses of the health status measures are reviewed, and the importance of developing short-term assessments (measures), which could have long-term predictive value for spinal deformity patients, is emphasized. EBM techniques have been used to analyze 3 timely topics in adolescent idiopathic scoliosis (AIS). The surgical rate in patients who have been braced for AIS is a surrogate measure of brace success. This information is important for shared decision-making with patients regarding brace treatment but needs confirmation from randomized trials of bracing. There is a paucity of quality of life (QOL) assessment in populations of AIS patients undergoing surgery. There remains a critical need to establish the clinical implication of statistically significant measured differences of health-related quality of life (HRQOL) in spine surgery. As might be expected from clinical experience, surgery for AIS does not significantly impact QOL measures in either the short term or the long term. It remains unclear whether this is due to shortcomings in the sensitivity and specificity of the current instruments. An EBM analysis of the literature concerning “all pedicle screw constructs” in AIS does not demonstrate clear cut evidence in favor of this technique at this time; however, this potentially is an instance where a surgeon’s experience may be the tipping point in EBM decision-making. Surgeons need to measure utilities (Health Utility Index, Euroqol) as part of the assessment of modern spinal reconstruction techniques, so that formal cost-effectiveness studies may be performed in the future. There is an absence of natural history studies in Scheuermann’s kyphosis, and there is particular uncertainty concerning the future of curves in the 70° to 100° degree range. Brace treatment in the skeletally immature appears ineffective. Clearly, surgery results in improvement in the deformity, but whether this results in improved function and well-being is unknown. The literature provides modest guidance on the treatment of high-grade spondylolisthesis. When the chosen outcome is deformity or fusion, reduction seems best. When it is short-term pain relief, arthrodesis in situ appears equivalent. An EBM analysis of the literature concerning 3 distinct neuromuscular spine deformities: cerebral palsy, Duchenne muscular dystrophy, and spina bifida/myelomeningocele leads to the conclusion that there is weak support for spinal fusion in cerebral palsy and Duchenne muscular dystrophy, and weak recommendation against fusion in spina bifida. Individual patients with these deformities are all different, which makes EBM difficult. A systematic literature review of the nonoperative treatment methods commonly used in adult spinal deformity patients with pain reveals a lack of studies for any method resulting in weak treatment recommendations. This is an area for future study. There is a paucity of evidence for surgical treatment of adult spinal deformity. To address this gap in knowledge, a novel pathway for funding is needed. The federal government, professional societies, and industry should cooperate to address this important topic.2 There has been a particularly rapid expansion of treatment options for children with early-onset scoliosis. Growth of the spine, chest wall, and lungs is interrelated. Improved measures of pulmonary function are being developed; however, correlation with long-term function has not been established. Bracing has been suggested to alter progression in infantile scoliosis. Prediction of progression of congenital scoliosis is imperfect. Spinal fusion and resection with instrumentation have been shown to be effective in congenital deformity. Chest wall expansion is now a treatment option for deformities of the rib cage and the spine. A better understanding of the natural history of these deformities is required to guide the selection of patients for this treatment. This focus issue also contains important reference materials, including Article Plus links to the pediatric QOL instruments, links to the 1999 Spine focus issue on Outcomes3 that contains the adult HRQOL assessment instruments, and information regarding the CONSORT criteria for evaluating clinical trials. EBM is increasingly important for clinicians, researchers, and policy makers. It behooves spinal deformity surgeons and physicians managing these patients by other means to educate themselves regarding the basic techniques and the weaknesses of EBM. Current practice is weakly supported by EBM. Future research is needed to meet the increasing demand for evidence to support treatment decisions.

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