Clinical Study Design

作者: Daniel B. Carr , Anthony Eidelman

DOI: 10.1016/B978-0-12-374248-3.00008-2

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摘要: Publisher Summary This chapter explores the clinical trial design, with a particular focus on investigations of neuromodulation. The current hierarchy study design stratifies scientific literature based upon its type and quality. It should be considered general framework rather then an absolute ranking system, clinicians consider results best available evidence while making evidence-based decisions. Randomized, double-blinded, controlled trials (RCT) are historically least biased method for assessing efficacy medical interventions. However, in evaluating interventional therapies, including neuromodulation, blinding is more challenging to accomplish. In fact, double-blinded spinal cord stimulation not feasible because paresthesiae normally present during such treatment. situations where RCTs practical or feasible, observational that rigorously designed may appropriate alternative determining therapeutic efficacy. Although generally supports use neurostimulation, there paucity high quality literature. therefore essential those involved especially chronic pain management, develop innovative studies improved methodological order determine value this emerging therapy.

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