Dataset Information

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).

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.

SUBMITTER: Vandenplas Y

PROVIDER: S-EPMC8860045 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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).

Vandenplas Yvan Y Zhao Zheng-Yan ZY Mukherjee Rajat R Dupont Christophe C Eigenmann Philippe P Kuitunen Mikael M Ribes Koninckx Carmen C Szajewska Hania H von Berg Andrea A Bajerová Kateřina K Meyer Rosan R Salvatore Silvia S Shamir Raanan R Järvi Anette A Heine Ralf G RG

BMJ open 20220217 2

<h4>Objectives</h4>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).<h4>Design</h4>Single-blinded, prospective, multicentre diagnostic accuracy study.<h4>Setting</h4>10 paediatric centres in China.<h4>Participants</h4>300 non-breastfed infants (median age 16.1 weeks) with suspected CMPA.<h4>Interventions</h4>After performing the baseline CoMiSS, infants commenced a cow's milk pro ...[more]

PMID: 35177461

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Project description:The Cow's Milk-related Symptom Score (CoMiSS) is an awareness tool for evaluating cow's milk-related symptoms. Previous studies have focused on providing CoMiSS values for healthy and symptomatic infants aged 0-6 months. However, there is a notable gap in the literature concerning CoMiSS values for infants older than 6 months. This cross-sectional study aimed to determine CoMiSS values in presumed healthy infants who have completed 6 months and are up to 12 months old, hereafter referred to as 6 to 12 months old. Physicians from six European countries prospectively determined CoMiSS values in infants attending well-child clinics. Exclusion criteria included preterm delivery, acute or chronic disease, and the consumption of a therapeutic formula, dietary supplements (except vitamins), or medication. The following information was collected: gestational age, gender, age, type of feed (breast milk or infant formula), and complementary feeding. Descriptive statistics were summarized with mean and standard deviation for normally distributed continuous variables, median and IQR for non-normally distributed variables, and differences in CoMiSS values were analyzed with appropriate tests. Data from 609 infants were obtained. The overall median (Q1-Q3) CoMiSS values were 3 (1-5). Significant differences were found across age groups (p < 0.001), but not across groups based on gender (p = 0.551) or feeding type (p = 0.880). Conclusions: This study provided CoMiSS values in presumed healthy infants aged 6-12 months. Additional studies should be conducted to establish the use of CoMiSS to assess cow's milk-related symptoms in infants 6 months and older. What is Known: • The Cow's Milk-related Symptom Score (CoMiSS) is an awareness tool for evaluating symptoms related to cow's milk. • CoMiSS values for presumed healthy infants aged 0-6 months infants are already available. What is New: • CoMiSS values in European infants aged 6-12 months are provided. • These CoMiSS values differed across various age groups but not across groups based on gender or feeding type.

Project description:INTRODUCTION:The symptoms of cow's milk protein allergy (CMPA) in infancy can be non-specific which may delay a correct diagnosis and cause adverse clinical outcomes. The diagnosis of non-IgE-mediated CMPA is particularly complex as it involves a 2 to 4 week elimination diet followed by oral food challenge (OFC). The Cow's Milk-related Symptom Score (CoMiSS) is a clinical resource for primary healthcare providers which aims to increase awareness of CMPA symptoms to facilitate an earlier diagnosis. The aim of the present study is to assess if the CoMiSS can be used as a potential diagnostic tool in infants with suspected CMPA. METHODS AND ANALYSIS:Exclusively formula-fed infants aged 0-6 months presenting with symptoms suggestive of CMPA will be included in this prospective, multicentre trial which will be conducted in 10 centres in China. All infants will commence a 2-week trial of an amino acid-based formula (AAF) while eliminating all cow milk protein from their diets. After the AAF treatment period, infants will undergo an open OFC in hospital with standard cow's milk formula, followed by an open home challenge for another 2 weeks. Clinical symptoms will be documented on standardised symptom scorecards. The CoMiSS will be determined at study entry (CoMiSS 1, before the start of the AAF), after 2 weeks (CoMiSS 2, before the OFC) and after a further period of 2 weeks or when symptoms suggestive of CMPA reappear (CoMiSS 3). Weight and length will be measured at each visit. The difference between CoMiSS 1 and 2 as a predictor of the OFC outcome will also be assessed. The diagnostic accuracy of the baseline CoMiSS will be calculated. ETHICS AND DISSEMINATION:The study was approved by the Hunan Children's Hospital Medical Ethics Committee, Hunan, China. The findings of this trial will be submitted for publication in a peer-reviewed journal in paediatric nutrition or gastroenterology. Abstracts will be submitted to the relevant national and international conferences. TRIAL REGISTRATION NUMBER:NCT03004729; Pre-results.

Project description:BackgroundCow's milk is a food allergen of public health importance both in the United States and globally. Its natural history and epidemiology have been most studied among infants and young children, but the public health burden it places on adults and older pediatric populations remains unclear. This study comprehensively characterizes the US population-level burden of cow's milk allergy (CMA), including its prevalence, severity, health care utilization, psychosocial impact, natural history, and other associated factors-including ability to tolerate extensively heated milk products-within a large, nationally-representative survey sample of US households.MethodsA cross-sectional survey was administered via web and telephone. Population level inference was based on data collected from participants recruited from National Opinion Research Center (NORC) at the University of Chicago's probability-based AmeriSpeak panel. Established dual-sample complex survey calibration methods were used to augment this sample with additional participants recruited through Survey Sampling International to increase the precision of the resulting estimates. In total, surveys were administered to a nationally representative sample of 51 819 US households from October 1, 2015, through September 31, 2016. Self-report responses from 40 453 adults and parent-proxy report for 38 408 children were analyzed.ResultsAnalyzing survey responses from 78 851 individuals, an estimated 4.7% (95% CI, 4.4%-4.9%) of the US population reported current CMA, whereas 1.9% (95% CI, 1.8%-2.1%) met symptom-report criteria for convincing IgE-mediated allergy. An estimated 0.9% (95% CI, 0.8%-1.0%) had CMA that met convincing symptom-report criteria and was physician diagnosed. Female and White respondents were more likely to report outgrowing CMA relative to males and those reporting other races and ethnicities. Individuals with CMA who reported tolerance to baked milk products were less likely to report severe reaction histories (33.5% vs 42.7%; p = .03), a lifetime history of food allergy-related emergency department visits (43.4% vs. 55.8%; p = .005), and treating a milk-allergic reaction with epinephrine (10.6 vs. 18.9%; p = .003). These individuals also exhibited less psychosocial burden on the validated Food Allergy Independent Measure (FAIM) than their counterparts with CMA who were allergic to baked forms of milk.ConclusionThese data indicate a discrepancy in reported rates of allergy to cow's milk among the US general population ranging from approximately 1 in 20 with reported CMA to fewer than 1 in 50 with physician-confirmed CMA. However, they suggest a substantial population-level burden of CMA, including substantial healthcare utilization, psychosocial burden and nutritional impacts-particularly among the approximately 30% of individuals with CMA who cannot tolerate baked forms of milk.

Dataset Information

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).

Objectives

Design

Setting

Participants

Interventions

Primary outcome measures

Results

Conclusions

Trial registration number

Publications

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).

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