Bellomo Rinaldo, Bagshaw Sean M
Department of Intensive Care, Austin Hospital, Studley Rd, Heidelberg, Victoria 3084, Australia.
Crit Care. 2006;10(5):232. doi: 10.1186/cc5045.
The current approach to assessing the quality of evidence obtained from clinical trials focuses on three dimensions: the quality of the design (with double-blinded randomised controlled trials representing the highest level of such design); the statistical power (beta) and the level of significance (alpha). While these aspects are important, we argue that other significant aspects of trial quality impinge upon the truthfulness of the findings: biological plausibility, reproducibility and generalisability. We present several recent studies in critical care medicine where the design, beta and alpha components of the study are seemingly satisfactory but where the aspects of biological plausibility, reproducibility and generalisability show serious limitations. Accordingly, we argue for more reflection, definition and consensus on these aspects of the evaluation of evidence.
设计质量（双盲随机对照试验代表此类设计的最高水平）；统计功效（β）和显著性水平（α）。虽然这些方面很重要，但我们认为试验质量的其他重要方面会影响研究结果的真实性：生物学合理性、可重复性和可推广性。我们展示了危重病医学领域最近的几项研究，这些研究的设计、β和α部分看似令人满意，但生物学合理性、可重复性和可推广性方面却存在严重局限性。因此，我们主张在证据评估的这些方面进行更多的思考、定义和共识。
