The Consolidated Standards of Reporting Trials (CONSORT) Statement applied to allergen-specific immunotherapy with inhalant allergens: A Global Allergy and Asthma European Network (GA(2)LEN) article

• Type: Article in International Scientific Journal
• Date: 2011

Authors

Bousquet, PJ (Author) Other; Calderon, MA (Author) Other; Demoly, P (Author) Other; Larenas, D (Author) Other; Passalacqua, G (Author) Other; Bachert, C (Author) Other; Brozek, J (Author) Other; Canonica, GW (Author) Other; Casale, T (Author) Other; Fonseca, J (Author) FMUP; Dahl, R (Author) Other; Durham, SR (Author) Other; Merk, H (Author) Other; Worm, M (Author) Other; Wahn, U (Author) Other; Zuberbier, T (Author) Other; Schuenemann, HJ (Author) Other; Bousquet, J (Author) Other

Journal

Title: Journal of Allergy and Clinical Immunology

Vol. 127 No. 1

Pages: 49-U511

ISSN: 0091-6749

Publisher: Elsevier

Indexing

ISI Web of Knowledge - 41 Citations

Scopus - 46 Citations

Scientific classification

FOS: Medical and Health sciences > Other medical sciences

Other information

Authenticus ID: P-002-YWJ

DOI: 10.1016/j.jaci.2010.09.017

Abstract (EN): Background: Randomized trials provide evidence to inform treatment decisions. The Consolidated Standards of Reporting Trials (CONSORT) Statement is a set of recommendations for the reporting of trials. Objective: We sought to assess the quality of reporting allergen-specific immunotherapy trials according to CONSORT criteria. Methods: The reporting of the procedure, randomization, dropouts, strict conduct of intention-to-treat (ITT) analysis, and sample size calculation according to CONSORT were assessed in the 46 subcutaneous and 48 sublingual immunotherapy (SLIT) blind, placebo-controlled randomized trials published between 1996 and 2009 in English. Results: One subcutaneous immunotherapy (2.2%) and 3 SLIT (6.6%) trials met CONSORT Statement criteria. These were used for the registration of sublingual tablets to the European Medicines Agency. In subcutaneous immunotherapy, 16 (35%) studies reported a CONSORT flow chart, and 12 (26%) provided a description of dropouts. Adequate randomization was reported in 9 (35%) studies, and incomplete randomization was reported in 15 (33%). Power analysis was reported in 15 (33%) studies. In SLIT, 20 (42%) studies reported a CONSORT flow chart, and 16 (32%) a description of dropouts. ITT analysis was carried out in 1 (2.2%) SLIT study, and a modified ITT analysis was used in 1 (2.2%) subcutaneous immunotherapy study and 2 (4.4%) SLIT studies. Adequate randomization was reported in 6 (12%) studies, and incomplete randomization was reported in 16 (32%). Power analysis was reported in 15 (27%) studies. Conclusion: As in other areas of medicine, the quality of reporting of most immunotherapy trials is low, and only 4.2% of SLIT randomized controlled trials met all of the criteria of the CONSORT Statement. Use of the CONSORT criteria should be encouraged. (J Allergy Clin Immunol 2011;127:49-56.)

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 19