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• W4377030761 abstract "Food allergy studies often define the outcome of treatment by comparing the threshold of reaction, sometimes referred to as dose-limiting symptoms (DLSs) or stopping criteria, between the baseline and postintervention oral food challenge (OFC). It is important to strive for the most accurate stopping criteria, especially when establishing the threshold. In this issue of the Journal of Allergy and Clinical Immunology, Turner et al1Turner P.J. Patel N. Blumchen K. Berkes S. Sampson H.A. Beyer K. Impact of using less objective symptoms to define tolerated dose during food challenges: a data-driven approach.J Allergy Clin Immunol. 2023; 152: 145-154Abstract Full Text Full Text PDF Scopus (2) Google Scholar present an analysis of OFCs that illustrates the potential impact of varied stopping criteria. Different stopping criteria were applied to individual-level data from 592 participants’ baseline OFCs and 223 repeat OFCs derived from 2 oral immunotherapy (OIT) trials, 1 epicutaneous immunotherapy (EPIT) trial, and 1 trial analyzing the effect of cofactors (exercise and sleep deprivation) on the allergic threshold. The stopping criteria compared were the PRACTALL consensus criteria,2Sampson H.A. Gerth van Wijk R. Bindslev-Jensen C. Sicherer S. Teuber S.S. Burks A.W. et al.Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report.J Allergy Clin Immunol. 2012; 130: 1260-1274Abstract Full Text Full Text PDF PubMed Scopus (530) Google Scholar Consortium for Food Allergy Research version 3 (CoFAR v3)3Chinthrajah R.S. Jones S.M. Kim E.H. Sicherer S.H. Shreffler W. Lanser B.J. et al.Updating the CoFAR Grading Scale for Systemic Allergic Reactions in Food Allergy.J Allergy Clin Immunol. 2022; 149: 2166-2170.e1Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar with at least 1 moderate- or severe-grade symptom, or CoFAR v33Chinthrajah R.S. Jones S.M. Kim E.H. Sicherer S.H. Shreffler W. Lanser B.J. et al.Updating the CoFAR Grading Scale for Systemic Allergic Reactions in Food Allergy.J Allergy Clin Immunol. 2022; 149: 2166-2170.e1Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar with at least 2 mild symptoms occurring in 2 different organ symptoms. The authors demonstrate that mild symptoms respond well to desensitization, and applying the least possible objective criteria from CoFAR v3 would result in an overestimate of the increase in reaction threshold. Furthermore, they suggest that these criteria would lead to an increase in placebo reactions (2.9% if moderate symptoms from CoFAR v3 and 6.6% if mild symptoms from CoFAR v3 were used, as compared with 0% for PRACTALL), and reduce reproducibility. Remarkably, their analysis suggests that there is no significant reduction in the rate of anaphylaxis by applying milder criteria, or by applying a longer duration of observation between doses, a rather unexpected finding. Therefore, the reduction in precision and accuracy cannot be justified by a gain in safety. Another key finding is that gastrointestinal discomfort with objectively observed decreased activity appears to be a valid DLS. Using the data, Turner et al propose a slightly modified version of CoFAR v3 with the goal to maintain its simplicity, but reduce its subjectivity. There are multiple valuable insights from this analysis. First, it reveals that few trials met criteria for this data-driven analysis because of the omission of sufficient description of the utilized OFC stopping criteria, despite the recommendation back in 2012 that investigators make individual-level data available.2Sampson H.A. Gerth van Wijk R. Bindslev-Jensen C. Sicherer S. Teuber S.S. Burks A.W. et al.Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report.J Allergy Clin Immunol. 2012; 130: 1260-1274Abstract Full Text Full Text PDF PubMed Scopus (530) Google Scholar Furthermore, the analysis raises the question on whether double-blinding is required in an OFC using clear objective stopping criteria. There are some considerations in interpreting the results. In the few studies available for inclusion, the OFC indication and protocols differed significantly. For example, one of the trials used 2 hours between doses rather than 20 to 30 minutes. In the future, pooling more studies with universally agreed-upon protocols would facilitate combining data to move the field forward faster. It is also notable that this analysis focused on peanut only, and other food allergens may yield differing results. The data Turner et al present in their Fig 2 demonstrate that much of the differences between the DLSs from applying the 3 criteria are found at low doses and the scoring systems converge as the doses increase. Therefore, applying differing criteria would most affect the baseline threshold, but if the efficacy outcome in an interventional trial is tolerance of the 600-mg protein dose or more compared with placebo,4Vickery B.P. Vereda A. Casale T.B. Beyer K. du Toit G. et al.Palisade Group of Clinical InvestigatorsAR101 Oral immunotherapy for peanut allergy.N Engl J Med. 2018; 379: 1991-2001Crossref PubMed Scopus (405) Google Scholar the scoring systems would have minimal impact on the outcome. There is an additional limitation to this post hoc retrospective analysis. The data analyzed were recorded under a different set of stopping rules, which cannot be completely extricated from the data. Symptoms measured at the time did not count as DLS, but in this reanalysis they do. Specifically, Turner et al1Turner P.J. Patel N. Blumchen K. Berkes S. Sampson H.A. Beyer K. Impact of using less objective symptoms to define tolerated dose during food challenges: a data-driven approach.J Allergy Clin Immunol. 2023; 152: 145-154Abstract Full Text Full Text PDF Scopus (2) Google Scholar highlight as a concern that moderate, isolated single-organ subjective symptoms are criteria for positive OFC in CoFAR v3, citing the moderate symptoms of “throat tightness without hoarseness” or “more than a few areas of erythema.” However, this analysis assumes that the data are hard facts with no role for individual investigator’s judgment, which may not be a true reflection of real-life events. As an example, for throat-related symptoms, the investigator evaluating a well-looking, playing child who endorses throat tightness early in a challenge may report this as “tightness,” if that classification is not a stopping criterion, but they may have recorded this symptom as the CoFAR v3 mild symptom of “discomfort” if “tightness” was considered a stopping criterion. If the child appears distressed, the investigator may use “tightness” to end the challenge. Therefore, symptoms documented according to the scale of the included studies may have been documented differently if the investigator was prospectively reporting with the CoFAR v3 scale. The other symptom combination of concern raised by Turner et al is the stopping criteria of 2 mild symptoms. In CoFAR v3, “a single episode of vomiting due to gagging (for example, as a result of taste aversion) would be considered a DLS if occurring in combination with another subjective symptom.”1Turner P.J. Patel N. Blumchen K. Berkes S. Sampson H.A. Beyer K. Impact of using less objective symptoms to define tolerated dose during food challenges: a data-driven approach.J Allergy Clin Immunol. 2023; 152: 145-154Abstract Full Text Full Text PDF Scopus (2) Google Scholar It is recognized that the most permissive criteria possible in CoFAR v3 were used to illustrate the misclassifications that could occur. However, CoFAR v33Chinthrajah R.S. Jones S.M. Kim E.H. Sicherer S.H. Shreffler W. Lanser B.J. et al.Updating the CoFAR Grading Scale for Systemic Allergic Reactions in Food Allergy.J Allergy Clin Immunol. 2022; 149: 2166-2170.e1Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar states that mild symptoms are typically not dose limiting and interpreting 2 or more mild symptoms as DLS (and therefore stopping criteria) requires physician discretion. Thus, it may be more accurate to say that this symptom combination could (not would) be considered a DLS if occurring in combination with another subjective symptom. Many decisions in a research trial require physician opinion. Physicians determine capacity to consent, adjudicate adverse events for their relatedness to the treatment, and make many other expert decisions. Especially in regulated trials designed for market approval of pharmaceuticals, investigators are chosen on the basis of their experience and expertise. The possibility that symptoms during OFC could have been recorded differently under different stopping criteria, or that multiple mild symptoms are subject to physician discretion, further supports the position of Turner et al that objective measures are needed where possible. For example, PRACTALL2Sampson H.A. Gerth van Wijk R. Bindslev-Jensen C. Sicherer S. Teuber S.S. Burks A.W. et al.Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report.J Allergy Clin Immunol. 2012; 130: 1260-1274Abstract Full Text Full Text PDF PubMed Scopus (530) Google Scholar also has subjectivity within the skin rating with the mild criteria of “few areas of faint erythema” versus the moderate symptoms of “areas of erythema,” although with the important distinction that this 1 moderate symptom would not lead to stopping criteria. In both PRACTALL and CoFAR v3 scoring systems, one consideration for improvement in the erythema determination would be to always apply a percent skin involvement to distinguish between mild and moderate categories to anchor the assessment. There are additional approaches to mitigate bias in addition to OFC stopping criteria, which only represent one measure, albeit important, to approximate the truth in a trial. In blinded interventional trials, the outcome of both placebo and investigational agent participants will be subject to the same OFC limitations. The recognition that even with strict PRACTALL criteria, there can be a one-half log variability5Patel N. Adelman D.C. Anagnostou K. Baumert J.L. Blom W.M. Campbell D.E. et al.Using data from food challenges to inform management of consumers with food allergy: a systematic review with individual participant data meta-analysis.J Allergy Clin Immunol. 2021; 147: 2249-2262.e7Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar,6Turner P.J. Patel N. Campbell D.E. Sampson H.A. Maeda M. Katsunuma T. et al.Reproducibility of food challenge to cow’s milk: systematic review with individual participant data meta-analysis.J Allergy Clin Immunol. 2022; 150: 1135-1143.e8Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar is a reminder that multiple measures are required for validity. Fig 1 summarizes considerations of varied stopping criteria. In the future, emerging tools such as the basophil activation test may reduce the need for OFCs, but it is likely that OFCs will remain the cornerstone for diagnosis and response to treatment, especially in regulated trials, for the next decade at least.7Patel N. Shreffler W.G. Custovic A. Santos A.F. Will oral food challenges still be part of allergy care in 10 years’ time?.J Allergy Clin Immunol Pract. 2023; 11: 988-996Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar Although the retrospective data approach has some limitations, the findings of Turner et al are valuable for our field and highlight that revisions to the standardized stopping criteria for OFCs in research trials should follow an evidence-based approach. It is likely that any future stopping criteria will continue to require physician insight and expertise, as well as ongoing attention to other trial procedures, such as randomization and blinding of the intervention, for the greatest precision and accuracy. We hope that this thought-provoking work will encourage further data sharing among investigators in diverse settings and parts of the world. Disclosure of potential conflict of interest: J. Upton reports research support/grants from Novartis, Regeneron, ALK Abello, DBV Technologies, CIHR, and SickKids Food Allergy and Anaphylaxis Program; fees from Pfizer, ALK Abello, Bausch Health, and Astra Zeneca; and serves as an Associate Editor for Allergy, Asthma and Clinical Immunology, on the Board of Directors of Canadian Society of Allergy and Clinical Immunology, and on the Healthcare Advisory Board of Food Allergy Canada, all outside the submitted work. A. Anagnostou reports research support from Novartis and Aimmune Therapeutics and consultation fees from ALK and DBV Technologies. A. Nowak-Wegrzyn receives research support from Alladapt Immunotherapeutics, DBV Technologies, Siolta Therapeutics, and Regeneron; speaking fees from Nestle, Danone, and Thermofisher; royalties from UpToDate; and serves as an Associate Editor for the Annals of Allergy, Asthma and Immunology, as Director of the AAAAI Board, and as the Chair of the Medical Advisory Board of the International FPIES Association. Impact of using less objective symptoms to define tolerated dose during food challenges: A data-driven approachJournal of Allergy and Clinical ImmunologyVol. 152Issue 1PreviewFood challenges (FCs) form the basis for assessing efficacy outcomes in interventional studies of food allergy; however, different studies have used a variety of similar but not identical criteria to define a challenge reaction, including subjective (nonobjective) symptoms occurring in a single-organ system as dose limiting. Full-Text PDF Open Access" @default.
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• W4377030761 title "Oral food challenges: Measuring what counts" @default.
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