Evidence map›Paper›PMID 35177461›Full record

ArticleBMJ open2022

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).

Yvan Vandenplas, Zheng-Yan Zhao, Rajat Mukherjee, Christophe Dupont, Philippe Eigenmann, Mikael Kuitunen, Carmen Ribes Koninckx, Hania Szajewska, Andrea von Berg, Kateřina Bajerová and 6 more

Registry-linked trialOpen access · goldAbstract readMulticenter Study
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03004729 (Symptoms Based Awareness Confirmation Study - CoMiSS Validation), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03004729 nacompletednot on this map

Symptoms Based Awareness Confirmation Study - CoMiSS Validation

TypeinterventionalSponsorSociété des Produits Nestlé (SPN)Ran2016 to 2018Enrolled300ConditionsCow Milk AllergyArmsCoMiSS questionnaire
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  4. Observational
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  7. The Naples pediatric food allergy (NAPFA) score: A multivariable model for the prediction of food allergy in children.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2025
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 13 institutions in 12 countries.

Yvan VandenplasVrije Universiteit Brussel, UZ Brussel, KidZ Health Castle, Brussels, Belgium.
Zheng-Yan ZhaoChildren's Hospital Zhejiang, University School of Medicine, Zhejiang University, Hangzhou, China zhaozy@zju.edu.cn.
Rajat MukherjeeCytel Inc, Waltham, Massachusetts, USA.
Christophe DupontDepartment of Paediatrics, Hôpital Necker-Enfants Malades, Paris, France.
Philippe EigenmannDepartment of Infants and Adolescents, University Hospitals Geneva, Geneva, Switzerland.
Mikael KuitunenNew Children's Hospital, Helsinki University Central Hospital, Helsinki, Finland.
Carmen Ribes KoninckxPaediatric Gastroenterology, La Fe University and Polytechnic Hospital, Valencia, Spain.
Hania SzajewskaDepartment of Paediatrics, Medical University of Warsaw, Warszawa, Poland.
Andrea von BergResearch Institute, Department of Paediatrics, Marien-Hospital Wesel, Wesel, Germany.
Kateřina BajerováResearch Institute, Department of Paediatrics, Marien-Hospital Wesel, Wesel, Germany.
Rosan MeyerDepartment of Paediatrics, Imperial College London, London, UK.
Silvia SalvatoreDepartment of Paediatrics, Hospital 'F. Del Ponte', University of Insubria, Varese, Italy.
Raanan ShamirInstitute for Gastroenterology, Nutrition and Liver Disease, Schneider Children's Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Anette JärviNestlé Health Science, Vevey, Switzerland.
Ralf G HeineNestlé Health Science, Vevey, Switzerland.ORCID 0000-0002-3343-0379
MOSAIC Study Investigator Group
Marien Hospital Wesel · DENestlé (Switzerland) · CHChildren's Hospital of Zhejiang University · CNCytel (United States) · USHelsinki University Hospital · FIHôpital Necker-Enfants Malades · FRHospital Universitari i Politècnic La Fe · ESImperial College London · GBMedical University of Warsaw · PLTel Aviv University · ILUniversity Hospital of Geneva · CHUniversity of Insubria · ITVrije Universiteit Brussel · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe 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).

designSingle-blinded, prospective, multicentre diagnostic accuracy study.

setting10 paediatric centres in China.

participants300 non-breastfed infants (median age 16.1 weeks) with suspected CMPA.

interventionsAfter 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%).

resultsOf 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.

conclusionsThe 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.

Indexed as

Milk HypersensitivityAllergensAnimalsArea Under CurveCattleChildFemaleHumansInfantMilkProspective StudiesAllergensallergycommunity child healthpaediatric dermatologypaediatric gastroenterology

Identifiers

PMID35177461
PMCPMC8860045
OpenAlexW4213090299

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.