Estimating diagnostic accuracy without a gold standard: A continued controversy.

There is a wide body of literature in biostatistics and epidemiology literature about estimating diagnostic accuracy, such as sensitivity and specificity of a binary test, without a gold standard. This methodology is very attractive since obtaining gold standard information is impossible, difficult, or very expensive in some situations. Although there are many proponents of these approaches, there have also been some serious criticisms. We review important methodological developments as well as discuss problems with the approaches. We propose alternative designs that may be less controversial and present ideas for future research. Lastly, we provide recommendations about how these methods should be used in practice.