| Literature DB >> 19860788 |
P J Bousquet1, J Brozek, C Bachert, T Bieber, S Bonini, P Burney, M Calderon, G W Canonica, E Compalati, J P Daures, L Delgado, P Demoly, R Dahl, S R Durham, M L Kowalski, H J Malling, H Merk, N Papadopoulos, G Passalacqua, H U Simon, M Worms, U Wahn, T Zuberbier, H J Schünemann, J Bousquet.
Abstract
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.Entities:
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Year: 2009 PMID： 19860788 DOI： 10.1111/j.1398-9995.2009.02232.x
Source DB: PubMed Journal: Allergy ISSN： 0105-4538 Impact factor: 13.146