Assessment of the Cow's Milk-related Symptom Score (CoMiSS) as a diagnostic tool for cow's milk protein allergy: a prospective, multicentre study in China (MOSAIC study).

Fecha de publicación: 17/02/2022 Fecha Ahead of Print: 17/02/2022

Autores de IIS La Fe

Carmen Ribes Koninckx

Autor

Participantes ajenos a IIS La Fe

Vandenplas Y
Zhao ZY
Mukherjee R
Dupont C
Eigenmann P
Kuitunen M
Szajewska H
von Berg A
Bajerová K
Meyer R
Salvatore S
Shamir R
Järvi A
Heine RG
MOSAIC Study Investigator Group

Grupos

Enfermedad celíaca e Inmunopatología digestiva

Leader

Carmen Ribes Koninckx

Abstract

OBJECTIVES: The MOSAIC study aimed to evaluate if the Cow's Milk-related Symptom Score (CoMiSS) can be used as a stand-alone diagnostic tool for cow's milk protein allergy (CMPA). DESIGN: Single-blinded, prospective, multicentre diagnostic accuracy study. SETTING: 10 paediatric centres in China. PARTICIPANTS: 300 non-breastfed infants (median age 16.1 weeks) with suspected CMPA. INTERVENTIONS: After performing the baseline CoMiSS, infants commenced a cow's milk protein elimination diet with amino acid-based formula for 14 days. CoMiSS was repeated at the end of the elimination trial. Infants then underwent an open oral food challenge (OFC) with cow's milk-based formula (CMF) in hospital. Infants who did not react during the OFC also completed a 14-day home challenge with CMF. A diagnosis of CMPA was made if acute or delayed reactions were reported. PRIMARY OUTCOME MEASURES: A logistic regression model for CoMiSS to predict CMPA was fitted and a receiver-operator characteristic (ROC) curve generated. An area under the curve (AUC) of =0.75 was deemed adequate to validate CoMiSS as a diagnostic tool (target sensitivity 80%-90% and specificity 60%-70%). RESULTS: Of 254 infants who commenced the OFC, 250 completed both challenges, and a diagnosis of CMPA made in 217 (85.4%). The median baseline CoMiSS in this group fell from 8 (IQR 5-10) to 5 (IQR 3-7) at visit 2 (p<0.000000001), with a median change of -3 (IQR -6 to -1). A baseline CoMiSS of =12 had a low sensitivity (20.3%), but high specificity (87.9%) and high positive predictive value (91.7%) for CMPA. The ROC analysis with an AUC of 0.67 fell short of the predefined primary endpoint. CONCLUSIONS: The present study did not support the use of CoMiSS as a stand-alone diagnostic tool for CMPA. Nevertheless, CoMiSS remains a clinically useful awareness tool to help identify infants with cow's milk-related symptoms. TRIAL REGISTRATION NUMBER: NCT03004729; Pre-results.

Datos de la publicación

ISSN/ISSNe:: 2044-6055, 2044-6055
Tipo:: Article
Páginas:: -
DOI:: 10.1136/bmjopen-2021-056641
Factor de Impacto:: 0,982 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Filiaciones

Vandenplas Y:: Vrije Universiteit Brussel, UZ Brussel, KidZ Health Castle, Brussels, Belgium
Zhao ZY:: Children's Hospital Zhejiang, University School of Medicine, Zhejiang University, Hangzhou, China
Mukherjee R:: Cytel Inc, Waltham, Massachusetts, USA
Dupont C:: Department of Paediatrics, Hôpital Necker-Enfants Malades, Paris, France
Eigenmann P:: Department of Infants and Adolescents, University Hospitals Geneva, Geneva, Switzerland
Kuitunen M:: New Children's Hospital, Helsinki University Central Hospital, Helsinki, Finland
Ribes Koninckx C:: Paediatric Gastroenterology, La Fe University and Polytechnic Hospital, Valencia, Spain
Szajewska H:: Department of Paediatrics, Medical University of Warsaw, Warszawa, Poland
von Berg A:: Research Institute, Department of Paediatrics, Marien-Hospital Wesel, Wesel, Germany
Bajerová K:: Research Institute, Department of Paediatrics, Marien-Hospital Wesel, Wesel, Germany
Meyer R:: Department of Paediatrics, Imperial College London, London, UK
Salvatore S:: Department of Paediatrics, Hospital 'F. Del Ponte', University of Insubria, Varese, Italy
Shamir R:: Institute for Gastroenterology, Nutrition and Liver Disease, Schneider Children's Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
Järvi A:: Nestlé Health Science, Vevey, Switzerland
Heine RG:: Nestlé Health Science, Vevey, Switzerland