Freedman L S
MRC Clinical Oncology and Radiotherapeutics Unit, MRC Centre, Cambridge.
Br J Radiol. 1987 Nov;60(719):1071-81. doi: 10.1259/0007-1285-60-719-1071.
The designs of studies to evaluate and compare imaging techniques are reviewed. Thirteen principles for the design of studies of diagnostic accuracy are given. Because of the "independence principle" these studies are not able directly to evaluate the contribution of a technique to clinical management. For the latter, the "clinical value" study design is recommended. A classification of study designs is proposed in parallel with the standard classification of clinical trials. Studies of diagnostic accuracy are analogous to Phase II, whereas studies evaluating the contribution to clinical management correspond to the Phase III category. Currently the majority of published studies employ the Phase II design. More emphasis on Phase III studies is required.
本文回顾了评估和比较成像技术的研究设计。给出了诊断准确性研究设计的十三条原则。由于“独立性原则”，这些研究无法直接评估一项技术对临床管理的贡献。对于后者，推荐采用“临床价值”研究设计。本文提出了一种与临床试验标准分类并行的研究设计分类方法。诊断准确性研究类似于II期试验，而评估对临床管理贡献的研究则对应于III期试验类别。目前，大多数已发表的研究采用II期设计。需要更加强调III期研究。
