期刊
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
卷 127, 期 1, 页码 49-U511出版社
MOSBY-ELSEVIER
DOI: 10.1016/j.jaci.2010.09.017
关键词
Subcutaneous immunotherapy; sublingual immunotherapy; allergen; CONSORT; randomized clinical trial
资金
- EU [FOOD-CT-2004-506378]
- Global Allergy and Asthma European Network
- ALK-Abello
- Stallergenes
- Chiesi and CoPharma
- Allergy Therapeutics
- Schering-Plough
- Bial-Aristegui
- Pfizer
- Boehringer-Ingelheim
- AstraZeneca
- Novartis
- Horsholm Denmark
- GlaxoSmithKline
- Medical Research Council [G1000758B, G1000758] Funding Source: researchfish
- National Institute for Health Research [NF-SI-0508-10212] Funding Source: researchfish
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. (J Allergy Clin Immunol 2011;127:49-56.)
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