The CONSORT statement checklist in allergen-specific immunotherapy: a GA2LEN paper.
The methodology of randomized clinical trials is essential for the critical assessment and registration of therapeutic interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement was developed to alleviate the problems arising from the inadequate reporting of randomized controlled trials. The present article reflects on the items that we believe should be included in the CONSORT checklist in the context of conducting and reporting trials in allergen-specific immunotherapy. Only randomized, blinded (in particular blinding of patients, health care providers, and outcome assessors), placebo-controlled Phase III studies in this article. Our analysis focuses on the definition of patients' inclusion and exclusion criteria, allergen standardization, primary, secondary and exploratory outcomes, reporting of adverse events and analysis.
Département de Biostatistique, Epidémiologie Clinique Santé Publique et Information Médicale, Groupe Hospitalo-Universtaire Carémeau, Nîmes Cedex, France.
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D000485:Allergens / Q000276:immunology*; D004311:Double-Blind Method; D006801:Humans; D007167:Immunotherapy / Q000379:methods* / Q000592:standards; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D012015:Reference Standards
D000485:Allergens