The Consolidated Standards of Reporting Trials (CONSORT) Statement applied to allergen-specific immunotherapy with inhalant allergens: A Global Allergy and Asthma European Network (GA2LEN) article - 10/08/11
, Moisés A. Calderón, MD, PhD b, , Pascal Demoly, MD, PhD a, c, , Désirée Larenas, MD d, Giovanni Passalacqua, MD e, , Claus Bachert, MD, PhD f, , Jan Brozek, MD, PhD g, , G. Walter Canonica, MD e, , Thomas Casale, MD h, Joao Fonseca, MD, PhD i, , Ronald Dahl, MD, DrMedSci j, , Stephen R. Durham, MD b, , Hans Merk, MD k, , Margitta Worm, MD l, , Ulrich Wahn, MD m, , Torsten Zuberbier, MD, PhD l, , Holger J. Schünemann, MD, PhD, MSc g, , Jean Bousquet, MD, PhD a, n, ⁎ 
Reprint request: Jean Bousquet, MD, PhD, Hôpital Arnaud de Villeneuve, Service des Maladies Respiratoires, 34295 Montpellier, France.Abstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : Subcutaneous immunotherapy, sublingual immunotherapy, allergen, CONSORT, randomized clinical trial
Abbreviations used : CONSORT, DBPC, EMA, ITT, PP, RCT, SCIT, SIT, SLIT
Plan
| This study was exclusively funded by the Global Allergy and Asthma European Network, supported by the European Union Framework program for research, contract no. FOOD-CT-2004-506378) and was initiated during a GA2LEN workshop held in Rome on July 12, 2009. |
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| Disclosure of potential conflict of interest: P. Demoly has received honoraria from ALK-Abelló and Stallergenes. D. Larenas has received research support from ALK-Abelló, Stallergenes, and Alerquim; is the Chair of the Immunotherapy Committee of the Colegio Mexicano de Alergia and the American Academy of Allergy, Asthma & Immunology; and is Secretary of the Immunotherapy Dosing Task Force of the European Academy of Allergy and Clinical Immunology. G. W. Canonica is a consultant for MSD, Nycomed, Stallergenes, ALK-Abelló, and HAL and has received research support from Chiesi and CoPharma. T. Casale has received research support from Allergy Therapeutics, Schering-Plough, and Stallergenes. J. Fonseca has received research support from Bial-Aristegui. R. Dahl has lectured for or is on the advisory board of Boehringer-Ingelheim, AstraZeneca, GlaxoSmithKline, Almirall, UCB, ALK-Abelló, Airsonett, MSD, and Novartis; and has received research support from ALK-Abelló, Stallergenes, Pfizer, Boehringer-Ingelheim, AstraZeneca, Novartis, and Almirall; is Chairman of the Danish Respiratory Society and Interasma; and is Vice-Chair of the Global Alliance against chronic respiratory diseases. S. R. Durham has received lecture and consultancy fees from ALK-Abelló, Hørsholm Denmark, and GlaxoSmithKline; is a consultant for Merck, Greer Laboratories, and Ono Pharma (United Kingdom); and has received research support from ALK-Abelló, Hørsholm Denmark, and GlaxoSmithKline. H. Merk is a consultant for Stallergenes and ALK-Abelló. M. Worm has received honoraria from Stallergenes, Actelion, Basilea, Beta Pharma, Essex Pharma, ALK-Abelló, and AllergoPharma. T. Zuberbier is a consultant for Schering-Plough, Novartis, Leri, Stallergenes, Bayer Schering, Ansell Kryolan, UCB, MSD, DST, Sanofi-Aventis, and Procter & Gamble; is on the Editorial Board of the Journal of Allergy; is on the Scientific Advisory Board of the German Federal Ministry of Consumer Protection; is Chairman of the European Academy of Allergology and Clinical Immunology (EAACI) Dermatology Section; is Head of European Centre for Allergy Research Foundation (ECARF); is a committee member of the WHO-Initiative Allergy Rhinitis and its Impact on Asthma (ARIA); is a member of the World Allergy Organization Communications Council; and is Secretary General of the Global Allergy and Asthma European Network (GA2LEN). J. Bousquet has received honoraria from Stallergenes, Actelion, Almirall, AstraZeneca, Chiesi, GlaxoSmithKline, Merck, MSD, Novartis, OM Pharma, Sanofi-Aventis, Schering-Plough, TEVA, and Uriach. The rest of the authors have declared that they have no conflict of interest. |
Vol 127 - N° 1
P. 49 - janvier 2011 Retour au numéro
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