The CONSORT statement checklist in allergen-specific immunotherapy: a GA2LEN paper

被引：46

作者：

Bousquet, P. J. ^{[1
]}

Brozek, J. ^{[2
]}

Bachert, C. ^{[3
]}

Bieber, T. ^{[4
]}

Bonini, S. ^{[5
]}

Burney, P.

Calderon, M. ^{[6
]}

Canonica, G. W. ^{[7
]}

Compalati, E. ^{[7
]}

Daures, J. P. ^{[1
]}

Delgado, L. ^{[8
]}

Demoly, P. ^{[9
,10
]}

Dahl, R. ^{[11
]}

Durham, S. R. ^{[6
]}

Kowalski, M. L. ^{[12
]}

Malling, H. J. ^{[13
]}

Merk, H. ^{[14
]}

Papadopoulos, N. ^{[15
]}

Passalacqua, G. ^{[7
]}

Simon, H. U. ^{[16
]}

Worms, M. ^{[17
]}

Wahn, U. ^{[18
]}

Zuberbier, T. ^{[17
]}

Schuenemann, H. J. ^{[2
]}

Bousquet, J. ^{[9
,19
]}

机构：

[1] Grp Hosp Univ Caremeau, Dept Epidemiol Clin Biostat Sante Publ & Informat, F-3002 Nimes 9, France

[2] McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada

[3] Univ Ghent, ENT Dept, Ghent, Belgium

[4] Univ Bonn, Dermatol Clin, D-5300 Bonn, Germany

[5] Univ Naples 2, Naples, Italy

[6] Univ London Imperial Coll Sci Technol & Med, Allergy Unit, London, England

[7] Univ Genoa, DIMI, I-16126 Genoa, Italy

[8] Univ Porto, Fac Med, Dept Immunol, P-4100 Oporto, Portugal

[9] Univ Hosp, Montpellier, France

[10] INSERM, U652, F-75654 Paris 13, France

[11] Aarhus Univ, DK-8000 Aarhus C, Denmark

[12] Univ Lodz, PL-90131 Lodz, Poland

[13] Natl Univ Hosp, Copenhagen, Denmark

[14] Univ Aachen, Dept Dermatol, Aachen, Germany

[15] Univ Athens, Dept Pediat, GR-10679 Athens, Greece

[16] Univ Bern, CH-3012 Bern, Switzerland

[17] Charit Hosp, Dept Dermatol, Berlin, Germany

[18] Charit Hosp, Dept Pediat, Berlin, Germany

[19] INSERM, U780, F-75654 Paris 13, France

来源：

ALLERGY | 2009年 / 64卷 / 12期

关键词：

Consort; Ga2len; specific immunotherapy; randomized controlled trial; POLLEN INDUCED RHINOCONJUNCTIVITIS; RANDOMIZED CONTROLLED-TRIAL; GA(2)LEN GLOBAL ALLERGY; HOUSE-DUST MITES; SUBLINGUAL IMMUNOTHERAPY; DOUBLE-BLIND; COST-EFFECTIVENESS; CLINICAL-TRIALS; EFFICACY; ASTHMA;

D O I：

10.1111/j.1398-9995.2009.02232.x

中图分类号：

R392 [医学免疫学];

学科分类号：

100108 [医学免疫学];

摘要：

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.

引用

页码：1737 / 1745

页数：9

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