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

被引：45

作者：

Bousquet, Philippe J. ^{[1
]}

Calderon, Moises A. ^{[2
]}

Demoly, Pascal ^{[1
]}

Larenas, Desiree ^{[3
]}

Passalacqua, Giovanni ^{[5
]}

Bachert, Claus ^{[6
]}

Brozek, Jan ^{[7
,8
]}

Canonica, G. Walter ^{[5
]}

Casale, Thomas ^{[9
]}

Fonseca, Joao ^{[10
,11
,14
]}

Dahl, Ronald ^{[12
]}

Durham, Stephen R. ^{[2
]}

Merk, Hans ^{[13
]}

Worm, Margitta ^{[15
]}

Wahn, Ulrich ^{[16
]}

Zuberbier, Torsten ^{[15
]}

Schuenemann, Holger J. ^{[7
,8
]}

Bousquet, Jean ^{[1
,4
,17
]}

机构：

[1] Univ Hosp Montpellier, Dept Resp Dis, Montpellier, France

[2] Univ London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, Sect Allergy & Clin Immunol, London SW7 2AZ, England

[3] Hosp Med Sur, Dept Allergy, Mexico City, DF, Mexico

[4] Hop Arnaud Villeneuve, Serv Malad Resp, Inserm U657, F-34295 Montpellier, France

[5] Univ Genoa, Dept Internal Med, I-16126 Genoa, Italy

[6] Ghent Univ Hosp, Upper Airways Res Lab URL, B-9000 Ghent, Belgium

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

[8] McMaster Univ, Dept Med, Hamilton, ON, Canada

[9] Creighton Univ, Dept Med, Div Allergy & Immunol, Omaha, NE 68178 USA

[10] Univ Porto, Biostat & Med Informat Dept, P-4100 Oporto, Portugal

[11] Univ Porto, Div Allergy, P-4100 Oporto, Portugal

[12] Aarhus Univ Hosp, Dept Resp Dis, DK-8000 Aarhus, Denmark

[13] Univ Aachen, Dept Dermatol, D-5100 Aachen, Germany

[14] Univ Porto, CINTESIS, P-4100 Oporto, Portugal

[15] Charite, Dept Dermatol, Allergy Ctr Charite, D-13353 Berlin, Germany

[16] Charite Hosp, Dept Pediat, Berlin, Germany

[17] Inserm 1018, CESP, Villejuif, France

来源：

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY | 2011年 / 127卷 / 01期

关键词：

Subcutaneous immunotherapy; sublingual immunotherapy; allergen; CONSORT; randomized clinical trial; SUBLINGUAL-SWALLOW IMMUNOTHERAPY; HOUSE-DUST-MITE; PLACEBO-CONTROLLED EVALUATION; RANDOMIZED CONTROLLED-TRIAL; ENZYME-POTENTIATED DESENSITIZATION; PARIETARIA-JUDAICA EXTRACT; GRASS-POLLEN IMMUNOTHERAPY; SHORT-TERM IMMUNOTHERAPY; DOUBLE-BLIND; CLINICAL-EFFICACY;

D O I：

10.1016/j.jaci.2010.09.017

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

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.)

引用

页码：49 / U511

页数：19

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