Department of Pediatrics, Martini Hospital, Groningen, The Netherlands.
Department of Pediatric Pulmonology and Pediatric Allergology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Pediatr Allergy Immunol. 2022 Jan;33(1):e13654. doi: 10.1111/pai.13654. Epub 2021 Sep 9.
It is of major importance to diagnose food allergy accurately. Current guidelines support the use of oral food challenges to do so. The double-blind placebo-controlled food challenge (DBPCFC) has been regarded as the 'gold standard' for decades. However, DBPCFCs are costly, and time- and resource-intensive procedures. Structural implementation of less demanding open food challenges will only find support if research demonstrates that their outcome is comparable to DBPCFC, yet this has been proven difficult to investigate.
We performed a literature review to investigate the diagnostic accuracy of oral food challenges and interviewed 19 parents of children with proven or suspected food allergy about the design of a trial to study this.
An overview of the dilemma of diagnosing food allergy using oral food challenges, and the methodological issues and parents' opinions to study this. No comparative studies have been performed using the latest guidelines on oral food challenges.
There is an urgent need to investigate the diagnostic accuracy of different oral food challenge protocols. We present the rationale and design of the ALDORADO trial (ALlergy Diagnosed by Open oR DOuble-blind food challenge) that has been set up to investigate whether the outcome of the open food challenge is comparable to DBPCFC.
准确诊断食物过敏至关重要。目前的指南支持使用口服食物挑战来进行诊断。双盲安慰剂对照食物挑战（DBPCFC）已被视为数十年的“金标准”。然而，DBPCFC 既昂贵又费时费力。只有当研究证明其结果与 DBPCFC 相当时，结构上实施要求较低的开放式食物挑战才会得到支持，但事实证明这很难进行调查。
我们进行了文献综述，以调查口服食物挑战的诊断准确性，并采访了 19 名患有确诊或疑似食物过敏的儿童的家长，了解他们对这项研究设计的看法。
概述了使用口服食物挑战诊断食物过敏的困境，以及研究这一问题的方法学问题和家长的意见。目前还没有使用最新的口服食物挑战指南进行比较研究。
迫切需要调查不同口服食物挑战方案的诊断准确性。我们介绍了 ALDORADO 试验（通过开放或双盲食物挑战诊断过敏）的基本原理和设计，该试验旨在研究开放食物挑战的结果是否与 DBPCFC 相当。
