Cow Milk Allergy — Symptoms Based Awareness Confirmation Study - CoMiSS Validation
Citation(s)
Bock SA Prospective appraisal of complaints of adverse reactions to foods in children during the first 3 years of life. Pediatrics. 1987 May;79(5):683-8.
Høst A, Halken S A prospective study of cow milk allergy in Danish infants during the first 3 years of life. Clinical course in relation to clinical and immunological type of hypersensitivity reaction. Allergy. 1990 Nov;45(8):587-96.
Høst A Cow's milk protein allergy and intolerance in infancy. Some clinical, epidemiological and immunological aspects. Pediatr Allergy Immunol. 1994;5(5 Suppl):1-36. Review.
Sampson HA Food allergy. Part 1: immunopathogenesis and clinical disorders. J Allergy Clin Immunol. 1999 May;103(5 Pt 1):717-28. Review.
Vandenplas Y; Althera Study Group, Steenhout P, Grathwohl D A pilot study on the application of a symptom-based score for the diagnosis of cow's milk protein allergy. SAGE Open Med. 2014 Feb 13;2:2050312114523423. doi: 10.1177/2050312114523423. eCollection 2014.
Symptoms Based Awareness Confirmation Study - CoMiSS Validation
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
