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

Authors

  • P. J. Bousquet,

    1. Département de Biostatistique, Epidémiologie Clinique Santé Publique et Information Médicale, Groupe Hospitalo-Universtaire Carémeau, Nîmes Cedex, France
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • J. Brozek,

    1. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
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  • C. Bachert,

    1. ENT Department, Ghent University, Belgium
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • T. Bieber,

    1. Dermatology Clinic, Bonn University, Germany
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • S. Bonini,

    1. Second University of Naples, Italy
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • P. Burney,

    1. Epidemiology and Public Health Medicine, Imperial College, London, UK
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • M. Calderon,

    1. Allergy Unit, Imperial College, London, UK
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • G. W. Canonica,

    1. Allergy and Respiratory Diseases, DIMI, University of Genoa
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • E. Compalati,

    1. Allergy and Respiratory Diseases, DIMI, University of Genoa
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • J. P. Daures,

    1. Département de Biostatistique, Epidémiologie Clinique Santé Publique et Information Médicale, Groupe Hospitalo-Universtaire Carémeau, Nîmes Cedex, France
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  • L. Delgado,

    1. Department of Immunology, Faculdade de Medicina, Universidade do Porto, Porto, Portugal
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • P. Demoly,

    1. University Hospital, Montpellier, France and INSERM U652
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • R. Dahl,

    1. Aarhus University, Denmark
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • S. R. Durham,

    1. Allergy Unit, Imperial College, London, UK
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • M. L. Kowalski,

    1. Lodz University, Denmark
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • H. J. Malling,

    1. National University Hospital, Copenhagen, Denmark
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  • H. Merk,

    1. Dermatology Department, Aachen University, Germany
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  • N. Papadopoulos,

    1. Pediatric Department, Athens University, Greece
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • G. Passalacqua,

    1. Allergy and Respiratory Diseases, DIMI, University of Genoa
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • H. U. Simon,

    1. Bern University, Switzerland
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  • M. Worms,

    1. Dermatology Department, Charit Hospital, Berlin, Germany
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • U. Wahn,

    1. Pediatric Department, Charit Hospital, Berlin, Germany
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • T. Zuberbier,

    1. Dermatology Department, Charit Hospital, Berlin, Germany
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.

  • H. J. Schünemann,

    1. Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
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  • J. Bousquet

    1. University Hospital Montpellier, France and INSERM U 780
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      Member of GA2LEN (Global Allergy and Asthma European Network), supported by EU Framework program for research, contract n° FOOD-CT-2004-506378.


Dr Philippe J Bousquet
Département d’Epidémiologie Clinique
Biostatistique
Santé Publique et Information Médicale
Groupe Hospitalo-Universtaire Carémeau
Place du Professeur Robert Debré
30 02 Nîmes Cedex 9
France

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.

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