BackgroundDouble‐blind placebo‐controlled food challenge (DBPCFC) is widely regarded as the “gold standard” to diagnose food allergy. Maximum efforts are made to reduce bias, yet DBPCFCs are costly, time‐, and resource‐intensive. Less demanding open food challenges are increasingly used in clinical practice. However, recommendations regarding the use of these challenges are based on low certainty of evidence, and no comparative studies have been performed using the most recent international food challenge guidelines. We hypothesised that the open food challenge is non‐inferior to DBPCFC in children suspected of allergy to cashew nuts, hazelnuts or peanuts.MethodsA total of 63 children, aged 4 years and older, were included if referred for suspected IgE‐mediated allergy to cashew nut, hazelnut, or peanut. All study participants underwent DBPCFC first, followed by an open food challenge for the same food. Challenge outcomes were assessed by predefined criteria into positive, negative, or inconclusive.ResultsDBPCFC and open food challenge outcomes were the same for 36/41 (87.8%) patients. Sensitivity and specificity of the open food challenge were 0.91 (95% CI 0.79, 1.03) and 0.83 (95% CI 0.63, 1.01), respectively, with an AUC value of 0.87. Eliciting and stop doses were not significantly different between both food challenges.ConclusionThe Diagnostic accuracy of open food challenge is non‐inferior to that of DBPCFC. This finding implies less demanding open food challenges can be implemented for children from the age of 4 years suspected to be cashew nut, hazelnut, or peanut allergic. Further research is necessary to validate our findings and to investigate the diagnostic accuracy for other major food allergens.

中文翻译：

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双盲和开放食物挑战诊断儿童食物过敏的比较：ALDORADO 研究


背景双盲安慰剂对照食物激发试验 （DBPCFC） 被广泛认为是诊断食物过敏的“金标准”。人们尽最大努力减少偏倚，但 DBPCFC 成本高昂、耗时且耗费资源。要求较低的开放式食品挑战越来越多地用于临床实践。然而，关于使用这些激发剂的建议是基于低质量证据，并且尚未使用最新的国际食品激发试验指南进行比较研究。我们假设在怀疑对腰果、榛子或花生过敏的儿童中，开放食物激发试验不劣于 DBPCFC。方法共纳入 63 名 4 岁及以上的儿童，如果因疑似 IgE 介导的腰果、榛子或花生过敏而被转诊。所有研究参与者首先接受了 DBPCFC，然后是针对相同食物的开放食物激发试验。通过预定义的标准将激发结果评估为阳性、阴性或不确定。结果36/41 （87.8%） 患者的 DBPCFC 和开放食物激发结果相同。开放食物攻击的敏感性和特异性分别为 0.91 （95% CI 0.79， 1.03） 和 0.83 （95% CI 0.63， 1.01），AUC 值为 0.87。两种食物激发剂之间的诱导剂量和停止剂量没有显著差异。结论开放食物激发的诊断准确性不劣于 DBPCFC。这一发现意味着可以对 4 岁以上怀疑对腰果、榛子或花生过敏的儿童实施要求较低的开放食品挑战。需要进一步的研究来验证我们的发现并调查其他主要食物过敏原的诊断准确性。