Linus B Grabenhenrich1,2, Andreas Reich3, Doreen McBride4, Aline Sprikkelman5, Graham Roberts6, Kate E C Grimshaw7, Alessandro G Fiocchi8, Photini Saxoni-Papageorgiou9, Nikolaos G Papadopoulos10, Ana Fiandor11, Santiago Quirce11, Marek L Kowalski12, Sigurveig T Sigurdardottir13, Ruta Dubakiene14, Jonathan O B Hourihane15, Leonard Rosenfeld16, Bodo Niggemann16, Thomas Keil17, Kirsten Beyer16. 1. Department for Infectious Disease Epidemiology, Robert Koch Institute, Berlin, Germany. 2. Department of Dermatology, Venerology and Allergology, Charité - Universitätsmedizin Berlin, Berlin, Germany. 3. German Rheumatism Research Center, Berlin, Germany. 4. HTA Health Economics Strategy and Research, RTI International, Manchester, UK. 5. Department of Pediatric Pulmonology & Pediatric Allergology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 6. University Child Health, University of Southampton, Southampton, Hampshire, UK. 7. Clinical Experimental Sciences, University of Southampton, Southampton, Hampshire, UK. 8. Department of Paediatrics, Paediatric Hospital Bambino Gesù, Rome, Italy. 9. Department of Allergy and Clinical Immunology, 2nd Pediatric Clinic, National & Kapodistrian University of Athens, Athens, Greece. 10. Division of Infection Immunity & Respiratory Medicine, University of Manchester, Manchester, UK. 11. Alergia Infantil, Hospital Universitario La Paz, Madrid, Spain. 12. Department of Immunology, Rheumatology and Allergy, Medical University, Lodz, Poland. 13. Department of Immunology, Landspitali - The National University Hospital of Iceland, Reykjavik, Iceland. 14. Faculty of Medicine, Vilnius University, Vilnius, Lithuania. 15. Paediatrics and Child Health, University College, Cork, Ireland. 16. Department of Paediatric Pneumology and Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany. 17. Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Abstract
BACKGROUND: Blinded food challenges are considered the current gold standard for the diagnosis of food allergies. We used data from a pan-European multicenter project to assess differences between study centers, aiming to identify the impact of subjective aspects for the interpretation of oral food challenges. METHODS: Nine study centers of the EuroPrevall birth cohort study about food allergy recruited 12 049 newborns and followed them for up to 30 months in regular intervals. Intensive training was conducted and every center visited to ensure similar handling of the protocols. Suspected food allergy was clinically evaluated by double-blind, placebo-controlled food challenges using a nine dose escalation protocol. The primary challenge outcomes based on physician's appraisal were compared to documented signs and symptoms. RESULTS: Of 839 challenges conducted, study centers confirmed food allergy in 15.6% to 53.6% of locally conducted challenges. Centers reported 0 to 16 positive placebo challenges. Worsening of eczema was the most common sign when challenged with placebo. Agreement between documented objective signs and the challenge outcome assigned by the physician was heterogeneous, with Cohen's kappa spanning from 0.42 to 0.84. CONCLUSIONS: These differences suggest that the comparison of food challenge outcomes between centers is difficult despite common protocols and training. We recommend detailed symptom assessment and documentation as well as objective sign-based challenge outcome algorithms to assure accuracy and comparability of blinded food challenges. Training and supervision of staff conducting food challenges is a mandatory component of reliable outcome data.
BACKGROUND: Blinded food challenges are considered the current gold standard for the diagnosis of food allergies. We used data from a pan-European multicenter project to assess differences between study centers, aiming to identify the impact of subjective aspects for the interpretation of oral food challenges. METHODS: Nine study centers of the EuroPrevall birth cohort study about food allergy recruited 12 049 newborns and followed them for up to 30 months in regular intervals. Intensive training was conducted and every center visited to ensure similar handling of the protocols. Suspected food allergy was clinically evaluated by double-blind, placebo-controlled food challenges using a nine dose escalation protocol. The primary challenge outcomes based on physician's appraisal were compared to documented signs and symptoms. RESULTS: Of 839 challenges conducted, study centers confirmed food allergy in 15.6% to 53.6% of locally conducted challenges. Centers reported 0 to 16 positive placebo challenges. Worsening of eczema was the most common sign when challenged with placebo. Agreement between documented objective signs and the challenge outcome assigned by the physician was heterogeneous, with Cohen's kappa spanning from 0.42 to 0.84. CONCLUSIONS: These differences suggest that the comparison of food challenge outcomes between centers is difficult despite common protocols and training. We recommend detailed symptom assessment and documentation as well as objective sign-based challenge outcome algorithms to assure accuracy and comparability of blinded food challenges. Training and supervision of staff conducting food challenges is a mandatory component of reliable outcome data.
Authors: Wouter W de Weger; Aline B Sprikkelman; Catherina E M Herpertz; Gerbrich N van der Meulen; Judith M Vonk; Arvid W A Kamps; Gerard H Koppelman Journal: Pediatr Allergy Immunol Date: 2021-09-09 Impact factor: 5.464
Authors: Vincenzo Fierro; Rocco L Valluzzi; Claudia Banzato; Ma A Plaza; Montserrat Bosque; Marcel Íbero; Luis A Z Echeverría; Maurizio Mennini; Lamia Dahdah; Roser de Castellar; Gloria Tort; Jesus Jiménez Journal: Immun Inflamm Dis Date: 2020-02-28