title: Pooled Analysis of the Cow's Milk-related-Symptom-Score (CoMiSS™) as a Predictor for Cow's Milk Related Symptoms.
abstract: OBJECTIVE
  The diagnosis of cow's milk (CM) allergy is a challenge. The Cow's Milk-related-Symptom-Score (CoMiSS™) was developed to offer primary health care providers a reliable diagnostic tool for CM related symptoms. The predictive prospective value of the CoMiSS™ was evaluated in three clinical trials.
  
  
  METHODS
  Pooled analyses of the three studies were conducted based on regressing the results of the month-1 challenge test on the month-1 CoMiSS™, adjusting for baseline CoMiSS™ using a logistic regression model. In addition a logistic regression model was also fitted to the month-1 challenge test result with the change in CoMiSS™ from baseline as a predictor.
  
  
  RESULTS
  Results suggest that infants having a low CoMiSS™ (median, 5) after 1 month dietary treatment free from intact CM protein have a significant risk of having a positive challenge test (odds ratio, 0.83; 95% confidence interval, 0.75-0.93;p=0.002). Pooled data suggest that the change in CoMiSS™ from baseline to month-1 can predict CM related symptoms as a confirmed diagnosis according to the challenge test at month-1. However, in order to validate such a tool, infants without CM related symptoms would also need to be enrolled in a validation trial. A concern is that it may not be ethical to expose healthy infants to a therapeutic formula and a challenge test.
  
  
  CONCLUSIONS
  Pooled data analysis emphasizes that the CoMiSS™ has the potential to be of interest in infants suspected to have CM-related-symptoms. A prospective validation trial is needed.
authors.affiliation: Department of Pediatrics, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
authors.forename: Yvan
authors.initials: Y
authors.lastname: Vandenplas
authors.affiliation: Nestlé Health Science, Vevey, Switzerland.
authors.forename: Philippe
authors.initials: P
authors.lastname: Steenhout
authors.affiliation: Nestlé Health Science, Vevey, Switzerland.
authors.forename: Anette
authors.initials: A
authors.lastname: Järvi
authors.affiliation: United Pharmaceuticals/Novalac, Paris, France.
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Garreau
authors.affiliation: Cytel, Cambridge, MA, USA.
authors.forename: Rajat
authors.initials: R
authors.lastname: Mukherjee
keywords: Cow's milk protein allergy; Cow's milk-related-symptom-score extensive hydrolysate