The dilemma of open or double‐blind food challenges in diagnosing food allergy in children: Design of the ALDORADO trial

Weger, Wouter W de; Sprikkelman, A. B.; Herpertz, Catherina E M; Meulen, Gerbrich N van der; Vonk, Judith M.; Kamps, Arvid W A; Koppelman, Gerard H.

doi:10.1111/pai.13654

Cited by 11 publications

(14 citation statements)

References 51 publications

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“…Thus, a significant number of patients may remain incorrectly labeled as having DH after assessment in a specialized unit, so developing strategies to reduce this possibility would be desirable. In the case of a food challenge, some authors have proposed additional efforts to make the interpretation of the test as objective as possible, especially in the research setting 70,71 . In routine clinical practice, it may be more useful to verify an initial positive DPT with a second test a few weeks or months later, especially when the reaction is mild and involves a beta‐lactam antibiotic.…”

Section: Possible Approaches To Reduce False‐positive Dpt Results: Re...mentioning

confidence: 99%

“…In the case of a food challenge, some authors have proposed additional efforts to make the interpretation of the test as objective as possible, especially in the research setting. 70,71 In routine clinical practice, it may be more useful to verify an initial positive DPT with a second test a few weeks or months later, especially when the reaction is mild and involves a beta-lactam antibiotic. Since there are few patients with a possibly positive DPT, and the reactions observed are usually mild, the effort and risk taken to perform a second confirmatory test may be outweighed by the increased diagnostic accuracy, allowing a larger number of children to be delabeled and avoiding the pernicious effect of an incorrect diagnosis.…”

Section: P Oss Ib Le Approache S To Reduce Fal S E-p Os Itive Dp T Re...mentioning

confidence: 99%

“…Many issues related to performing and interpreting a DPT with drugs are similar to those that occur with the food challenge. 52,[69][70][71] The F I G U R E 2 A 6-year-old boy was referred for a generalized maculopapular erythematous rash, with involvement of the palms, after 7 days of treatment with amoxicillin. The episode had occurred 1 year prior to consultation.…”

Section: P Oss Ib Le Approache S To Reduce Fal S E-p Os Itive Dp T Re...mentioning

confidence: 99%

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Drug provocation tests in children: All that glitters is not gold

Moral,

Mori

2023

Pediatric Allergy Immunology

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A proper allergy work‐up, based on the gold standard drug provocation test (DPT), usually rules out suspected drug hypersensitivity in children. These tests are generally open, given their high efficiency compared with double‐blind placebo‐controlled DPTs. Although their negative predictive value is excellent, no studies have calculated their positive predictive value, highly dependent on the prevalence of the disease. Most studies have found a rate of <5%–10% of true beta‐lactam hypersensitivity in children. Given this low prevalence (pre‐test probability), a few false‐positive results can significantly reduce the estimated positive predictive value. False positives may arise from the nocebo effect during the test, including nocebo by proxy, or from observer bias, which depends on professional expertise and organizational circumstances. Some studies have found a high rate of tolerance on a second DPT in children who failed the first, but these results may be affected by the interval between the two tests, of a year or more in most cases, reflecting a loss of hypersensitivity over time. Taking into account the low rate of positive DPTs, with commonly mild reactions, we suggest confirming nonsevere positive DPTs with a second provocation performed soon after the first, especially in the case of beta‐lactam antibiotics, in order to improve the diagnostic accuracy, de‐label more patients, and achieve a better estimation of true drug hypersensitivity prevalence. In case of mild immediate reactions, the potential benefits of a second DPT should be carefully weighed against the risk of anaphylaxis.

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Section: Possible Approaches To Reduce False‐positive Dpt Results: Re...mentioning

confidence: 99%

Section: P Oss Ib Le Approache S To Reduce Fal S E-p Os Itive Dp T Re...mentioning

confidence: 99%

Section: P Oss Ib Le Approache S To Reduce Fal S E-p Os Itive Dp T Re...mentioning

confidence: 99%

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Drug provocation tests in children: All that glitters is not gold

Moral,

Mori

2023

Pediatric Allergy Immunology

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“…The age, basic economic condition, or geographical region could be the factors that influence the prevalence of wheat allergy, and they are worthwhile for further investigation. The DBPCFC is the ‘Gold Standard’ for diagnosing food allergy [ 80 ]. The included studies in this meta-analysis were rarely used for food challenges to diagnose wheat allergy, and they would lead to the prevalence of wheat allergies in this analysis, deviating from the real world.…”

Section: Discussionmentioning

confidence: 99%

A Meta-Analysis of the Prevalence of Wheat Allergy Worldwide

Liu

Wang

et al. 2023

Nutrients

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Wheat allergy is a primary disease of food allergy, and its global prevalence is unclear. This study aimed to characterize the latest worldwide prevalence of wheat allergy based on five different diagnostic methods. Study searches were conducted in Web of Science, PubMed, Ovid LWW, and Cochrane database, with a time limit of 1 January 2007 to 1 September 2022. The review and screening of the articles was undertaken by two independent reviewers. The statistical analysis was conducted by R. A total of 56 articles were finally included. The prevalence of wheat allergy was 0.63% (95% CI: 0.43–0.87%) for self-reported, 0.70% (95% CI: 0.18–1.22%) for self-reported physician-diagnosed, 0.22% (95%CI: 0.07–0.65%) for skin prick test positive, 0.97% (95% CI: 0.43–2.20%) for specific immunoglobulin E positive, and 0.04% (95% CI: 0–0.16%) for food challenge. However, food challenge can be largely subjective, and the results were only based two countries, so the prevalence of wheat allergy confirmed by food challenge may be not entirely trustworthy. In conclusion, investigating the prevalence of wheat allergy in the real world as accurately as possible will contribute to the prevention, management, and risk assessment of wheat allergy.

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“…Similar questions and problems to these have been considered regarding food challenges. [17][18][19] Positive predictive values of diagnostic tests are known to be influenced by the prevalence of the tested condition in the population that is being tested. 20 Given the low prevalence of BLA hypersensitivity in children, the likelihood of a false positive DPT is significant for different reasons.…”

Section: Discussionmentioning

confidence: 99%

Positive drug provocation with beta-lactam antibiotics in children: A single test may not be enough

Moral

Latorre

Toral

et al. 2022

Allergol Immunopathol

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Background: Drug provocation tests (DPTs) are considered the gold standard for diagnosing betalactam allergy. However, positive results tend to be mild and difficult to interpret. This study aimed to describe pediatric patients with a presumedly positive or inconclusive DPT, assess the decision to repeat the DPT, and describe its outcome. Methods: Retrospective review of all presumedly positive or inconclusive DPTs performed in six pediatric allergy clinics from 2017 to 2019. We describe the interpretation of results, focusing on the decision to repeat the DPT and its outcome. Results: Of 439 children challenged with a betalactam, 26 (5.9%) with a presumedly positive or inconclusive result were included in this study. Most were girls (n = 16, 61.5%), and the median age was 5 years (range 1–13). The initial DPT used amoxicillin (n = 13, 50.0%), amoxicillin-clavulanic acid (n = 12, 46.2%), or cefadroxil (n = 1, 3.8%). Reactions were early (n = 11, 42.3 %), delayed (n = 14, 53.8 %), or not registered (n = 1, 3.8 %), but mild in all cases. A second confirmatory DPT was proposed in 19 patients (73.1%) and performed in 17 patients (65.4%). Nine DPTs were performed from 1 day to 4 months after the first DPT, and the remaining eight took place 6 months to 2 years later. Fifteen children tolerated the drug in the second DPT: 88.2% of those reevaluated and 57.5% of the whole study group. Conclusion: The positive predictive value of DPT may be lower than expected. Given the mildness of observed reactions, a second confirmatory DPT is warranted within a few weeks or months.

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The dilemma of open or double‐blind food challenges in diagnosing food allergy in children: Design of the ALDORADO trial

Cited by 11 publications

References 51 publications

Drug provocation tests in children: All that glitters is not gold

Drug provocation tests in children: All that glitters is not gold

A Meta-Analysis of the Prevalence of Wheat Allergy Worldwide

Positive drug provocation with beta-lactam antibiotics in children: A single test may not be enough

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