Los ensayos clínicos pragmáticos – Guías para una mejor atención al paciente?

5 05 2011

Ware J,  Hamel MB. Pragmatic Trials — Guides to Better Patient Care?.  N Engl J Med 2011; 364:1685-1687

Although randomized clinical trials provide essential, high-quality evidence about the benefits and harms of medical interventions, many such trials have limited relevance to clinical practice. The investigations are often framed in ways that fail to address patients’ and clinicians’ actual questions about a given treatment. For example, placebo-controlled trials of a new migraine medication help to establish its efficacy, but they may not help clinicians and patients choose between the new medication and other available treatments. Moreover, since most randomized clinical trials are efficacy trials, researchers enroll a homogeneous patient population, define treatment regimens carefully and require that they be followed assiduously, and inform neither patients nor study personnel about treatment assignments. Thus, although these trials are conducted in clinical settings, their enrolled populations and management approach don’t reflect the complexity and diversity of actual clinical practice. Because of concerns about real-world applicability and about improving the quality and value of health care, “pragmatic” or “practical” trials are attracting increasing attention.

Descargar http://www.nejm.org/doi/pdf/10.1056/NEJMp1103502

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