作者: Philip D. Home
DOI: 10.1016/S0168-8227(10)00192-0
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摘要: Randomized controlled trials (RCTs) are rightly considered to provide the highest quality, first-level information in evidence-based medicine, because their inherent design limits bias and confounding. However, a number of aspects conduct mean that they do not always accurately reflect actual clinical practice [1]: these include highly selected patient populations, treatment specialist centers, intensive supervision follow-up. Observational studies wide range study designs (cohort, case control, cross-sectional), common feature which is non-interventional, although participants often on basis having previously had specific intervention course routine practice. Such observational may prospective data ascertainment, used assess performance therapies post-licensing period. Here, ‘noninterventional’ means people only enrolled into once have been started particular therapy. Because randomized, susceptible confounding, and, while likely biases can be compensated for and/or statistical analysis, unknown factors also influence results [2]. Another limiting factor many lack control population. With reservations, from complement those RCTs by providing an insight how treatments perform dayto-day more clinically representative populations. cost resource advantages applicable larger diverse The first article this supplement will examine different types trials, differ RCTs, relevance provide. Additionally, roles healthcare professionals, health authorities, industry planning such examined [3].