A new framework for the documentation and interpretation of oral food challenges in population-based and clinical research.
BACKGROUND
The conduct of oral food challenges as the preferred diagnostic standard for food allergy (FA) was harmonized over the last years. However, documentation and interpretation of challenge results, particularly in research settings, are not sufficiently standardized to allow valid comparisons between studies. Our aim was to develop a diagnostic toolbox to capture and report clinical observations in double-blind placebo-controlled food challenges (DBPCFC).


METHODS
A group of experienced allergists, paediatricians, dieticians, epidemiologists and data managers developed generic case report forms and standard operating procedures for DBPCFCs and piloted them in three clinical centres. The follow-up of the EuroPrevall/iFAAM birth cohort and other iFAAM work packages applied these methods.


CONCLUSIONS
A set of newly developed questionnaire or interview items capture the history of FA. Together with sensitization status, this forms the basis for the decision to perform a DBPCFC, following a standardized decision algorithm. A generic form including details about severity and timing captures signs and symptoms observed during or after the procedures. In contrast to the commonly used dichotomous outcome FA vs no FA, the allergy status is interpreted in multiple categories to reflect the complexity of clinical decision-making.


CONCLUSIONS
The proposed toolbox sets a standard for improved documentation and harmonized interpretation of DBPCFCs. By a detailed documentation and common terminology for communicating outcomes, these tools hope to reduce the influence of subjective judgment of supervising physicians. All forms are publicly available for further evolution and free use in clinical and research settings.
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany.
L B
LB
Grabenhenrich
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany.
A
A
Reich
Department of Paediatric Pneumology and Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
J
J
Bellach
Department of Paediatric Pneumology and Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
V
V
Trendelenburg
Department of Pediatric Pulmonology & Pediatric Allergology, University Medical Center Groningen, Groningen, The Netherlands.
A B
AB
Sprikkelman
Clinical and Experimental Sciences Academic Units, Faculty of Medicine, University of Southampton, Southampton, UK.
G
G
Roberts
Clinical and Experimental Sciences Academic Units, Faculty of Medicine, University of Southampton, Southampton, UK.|Department of Nutrition and Dietetics, Southampton Children's Hospital, Southampton, UK.
K E C
KE
Grimshaw
Department of Immunology, Landspitali - The National University Hospital of Iceland, Reykjavik, Iceland.
S
S
Sigurdardottir
Department of Clinical Immunology and Allergy, University of Łódź, Łódź, Poland.
M L
ML
Kowalski
Institute of Human Development, University of Manchester, Manchester, UK.|Allergy Department, 2nd Paediatric Clinic, University of Athens, Athens, Greece.
N G
NG
Papadopoulos
Department of Allergy, Hospital La Paz Institute for Health Research, Madrid, Spain.
S
S
Quirce
Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
R
R
Dubakiene
Department of Paediatric Pneumology and Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
B
B
Niggemann
Allergy Department, Hospital Clinico San Carlos IdISSC, Madrid, Spain.
M
M
Fernández-Rivas
Allergy Unit, Department of Dermatology, University Hospital, Zürich, Switzerland.
B
B
Ballmer-Weber
Departments of Experimental Immunology and of Otorhinolaryngology, Academic Medical Center, Amsterdam, The Netherlands.
R
R
van Ree
German Allergy and Asthma Association, Mönchengladbach, Germany.
S
S
Schnadt
Institute of Inflammation and Repair, University of Manchester, Manchester, UK.
E N C
EN
Mills
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany.
T
T
Keil
Department of Paediatric Pneumology and Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.|Icahn School of Medicine at Mount Sinai, New York, NY, USA.
K
K
Beyer
D000284:Administration, Oral; D000485:Allergens / Q000008:administration & dosage / Q000276:immunology*; D035843:Biomedical Research / Q000379:methods / Q000592:standards; D000066491:Clinical Decision-Making; D000068456:Clinical Studies as Topic / Q000379:methods / Q000592:standards; D003429:Cross Reactions / Q000276:immunology; D004282:Documentation; D005502:Food / Q000009:adverse effects*; D005512:Food Hypersensitivity / Q000175:diagnosis* / Q000453:epidemiology / Q000276:immunology*; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D057566:Self Report; D012882:Skin Tests / Q000379:methods / Q000592:standards; D011795:Surveys and Questionnaires
D000485:Allergens; D007073:Immunoglobulin E
decision-making; double-blind method; food hypersensitivity; oral food challenge; symptom assessment
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