Journal of comparative effectiveness research
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Degenerative spine disorders are a significant cause of patient morbidity and are a prominent factor in healthcare costs in many countries. Pressure for healthcare cost control and the desire for improved outcomes have led to an expanding emphasis on evidence-based medicine methodologies in spine research. ⋯ Spine surgery professional organizations have recently taken a prominent role in assembling procedural- and diagnosis-based registries, specifically addressing therapeutic outcomes for spine patients. As healthcare systems continue to evolve, comparative effectiveness research driven by spine registries may better elucidate the appropriate clinical choices for patients with these challenging illnesses.
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Traditional randomized controlled trials are the 'gold standard' for evaluating health interventions and are typically designed to maximize internal validity, often at the cost of limited generalizability. Pragmatic randomized controlled trials should be designed with a conscious effort to generate evidence with a greater external validity by making the research question as similar as possible to the questions faced by clinical decision-makers (i.e., patients and their families, physicians, policy makers and administrators) and then answer that question with rigor. Clarity and transparency about the specifics of the research question are the keys to designing, as well as interpreting, any clinical trial.