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
| Autor: | João Fonseca, Stephen R. Durham, Torsten Zuberbier, Jan Brozek, Ronald Dahl, Holger J. Schünemann, Hans F. Merk, Thomas B. Casale, Ulrich Wahn, Moises A. Calderon, Philippe J. Bousquet, Claus Bachert, Pascal Demoly, G. Walter Canonica, Désirée Larenas, Jean Bousquet, Margitta Worm, Giovanni Passalacqua |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
medicine.medical_specialty
Allergy Randomization Quality Assurance Health Care Immunology law.invention Randomized controlled trial law Internal medicine medicine Hypersensitivity Immunology and Allergy Humans Asthma Randomized Controlled Trials as Topic Intention-to-treat analysis business.industry Specific immunotherapy Consolidated Standards of Reporting Trials Allergens medicine.disease humanities Surgery Sample size determination Desensitization Immunologic Research Design business |
| Zdroj: | Bousquet, P J, Calderón, M A, Demoly, P, Larenas, D, Passalacqua, G, Bachert, C, Brozek, J, Canonica, G W, Casale, T, Fonseca, J, Dahl, R, Durham, S R, Merk, H, Worm, M, Wahn, U, Zuberbier, T, Schünemann, H J & Bousquet, J 2011, ' 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 ', Journal of Allergy and Clinical Immunology, vol. 127, no. 1, pp. 49-56, 56.e1-11 . https://doi.org/10.1016/j.jaci.2010.09.017 |
| DOI: | 10.1016/j.jaci.2010.09.017 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|