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.
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.


CONCLUSIONS
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.
Department of Respiratory Diseases, University Hospital of Montpellier, Montpellier, France. jean.bousquet@inserm.fr
Philippe J
PJ
Bousquet
Moisés A
MA
Calderón
Pascal
P
Demoly
Désirée
D
Larenas
Giovanni
G
Passalacqua
Claus
C
Bachert
Jan
J
Brozek
G Walter
GW
Canonica
Thomas
T
Casale
Joao
J
Fonseca
Ronald
R
Dahl
Stephen R
SR
Durham
Hans
H
Merk
Margitta
M
Worm
Ulrich
U
Wahn
Torsten
T
Zuberbier
Holger J
HJ
Schünemann
Jean
J
Bousquet
D000485:Allergens / Q000276:immunology*; D001249:Asthma / Q000276:immunology*; D003888:Desensitization, Immunologic / Q000379:methods / Q000592:standards*; D006801:Humans; D006967:Hypersensitivity / Q000276:immunology*; D011785:Quality Assurance, Health Care; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*
D000485:Allergens