Gellerstedt M, Bengtsson U, Niggemann B
Department of Informatics, University West, Trollhättan, Sweden.
J Investig Allergol Clin Immunol. 2007;17(6):350-6.
The standard of reporting in diagnostic studies has generally been low. Fortunately, this issue has begun to be addressed in recent years through the discussion of important methodological issues in educational series, textbooks, and checklists. Double-blind, placebo-controlled, oral food challenges (DBPCFC) are considered to be the gold standard for diagnosis of food allergy. However, there is no consensus regarding how to interpret the outcome and how to define positive and negative provocations in DBPCFC. Furthermore, since most theories on the diagnosis of food allergy rely on the assumption that the DBPCFC has a high accuracy, this accuracy must be formally statistically evaluated. In this review, we discuss essential methodological issues for diagnostic accuracy studies in general and for oral food challenges in particular and discuss the importance of methodological issues as a guide for forthcoming studies of diagnostic procedures.
诊断性研究的报告标准总体上一直较低。幸运的是，近年来通过教育系列、教科书和清单中对重要方法学问题的讨论，这个问题已开始得到解决。双盲、安慰剂对照口服食物激发试验（DBPCFC）被认为是食物过敏诊断的金标准。然而，对于如何解读DBPCFC的结果以及如何定义阳性和阴性激发试验，目前尚无共识。此外，由于大多数关于食物过敏诊断的理论都依赖于DBPCFC具有高准确性这一假设，因此必须对这种准确性进行正式的统计学评估。在本综述中，我们讨论了一般诊断准确性研究尤其是口服食物激发试验的基本方法学问题，并讨论了方法学问题作为即将开展的诊断程序研究指南的重要性。
