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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Review Comparative Study
Drug-eluting versus bare-metal coronary stents: where are we now?
Drug-eluting stents have dramatically reduced the risk of restenosis, but concerns of an increased risk of stent thrombosis have provided uncertainty about their use. Recent studies have continued to show improved procedural and clinical outcomes with drug-eluting stents both in the setting of acute coronary syndromes and stable coronary artery disease. Newer generation drug-eluting stents (especially everolimus-eluting stents) have been shown to be not only efficacious but also safe with reduced risk of stent thrombosis when compared with bare-metal stents, potentially changing the benchmark for stent safety from bare-metal stents to everolimus-eluting stents. While much progress is being made in the development of bioabsorbable polymer stents, nonpolymer stents and bioabsorbable stent technology, it remains to be seen whether these stents will have superior safety and efficacy outcomes compared with the already much improved rates of revascularization and stent thrombosis seen with newer generation stents (everolimus-eluting stents and resolute zotarolimus-eluting stents).
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Clinical trials have largely focused on whether an intervention can work. To ensure valid and powerful testing of this hypothesis, trials attempt to maximize the effect of the intervention of interest, controlling other factors that can confound comparisons. ⋯ Minimizing biases in this pragmatic context remains a very difficult task, however. This paper reviews some of these challenges and highlights specific aspects of design that must be approached with a pragmatic attitude.
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Comparative effectiveness research (CER) includes pragmatic clinical trials (PCTs) to address 'real-world' effectiveness. CER interest would be expected to stimulate biopharmaceutical manufacturer PCT investment; however, this does not seem to be the case. In this article we identify all industry-sponsored PCT studies from 1996 to 2010; analyze them across a variety of characteristics, including sponsor, research question, design, comparators and results; and suggest methodological and policy changes to spur future manufacturer PCT investment. ⋯ Of seven that evaluated utilization or costs, six reported no differences and four of five studies comparing brand-generic drugs reported no difference. Whereas private investment in PCTs is in the public interest, manufacturers apparently have not yet seen the business case. To induce investment, we propose several methodological and regulatory policy innovations designed to reduce business risk by decreasing outcome variability and increasing trial efficiency, flexibility and market applicability.