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. Copyright Â
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. Copyright Â
Authors: Oliver Pfaar; Tobias Ankermann; Matthias Augustin; Petra Bubel; Sebastian Böing; Randolf Brehler; Peter A Eng; Peter J Fischer; Michael Gerstlauer; Eckard Hamelmann; Thilo Jakob; Jörg Kleine-Tebbe; Matthias Volkmar Kopp; Susanne Lau; Norbert Mülleneisen; Christoph Müller; Katja Nemat; Wolfgang Pfützner; Joachim Saloga; Klaus Strömer; Peter Schmid-Grendelmeier; Antje Schuster; Gunter Johannes Sturm; Christian Taube; Zsolt Szépfalusi; Christian Vogelberg; Martin Wagenmann; Wolfgang Wehrmann; Thomas Werfel; Stefan Wöhrl; Margitta Worm; Bettina Wedi; Susanne Kaul; Vera Mahler; Anja Schwalfenberg Journal: Allergol Select Date: 2022-09-06
Authors: Giorgio Walter Canonica; Linda Cox; Ruby Pawankar; Carlos E Baena-Cagnani; Michael Blaiss; Sergio Bonini; Jean Bousquet; Moises Calderón; Enrico Compalati; Stephen R Durham; Roy Gerth van Wijk; Désirée Larenas-Linnemann; Harold Nelson; Giovanni Passalacqua; Oliver Pfaar; Nelson Rosário; Dermot Ryan; Lanny Rosenwasser; Peter Schmid-Grendelmeier; Gianenrico Senna; Erkka Valovirta; Hugo Van Bever; Pakit Vichyanond; Ulrich Wahn; Osman Yusuf Journal: World Allergy Organ J Date: 2014-03-28 Impact factor: 4.084
Authors: Moises A Calderon; Pascal Demoly; Roy Gerth van Wijk; Jean Bousquet; Aziz Sheikh; Anthony Frew; Glenis Scadding; Claus Bachert; Hans J Malling; Rudolph Valenta; Beatrice Bilo; Antonio Nieto; Cezmi Akdis; Jocelyne Just; Carmen Vidal; Eva M Varga; Emilio Alvarez-Cuesta; Barbara Bohle; Albrecht Bufe; Walter G Canonica; Victoria Cardona; Ronald Dahl; Alain Didier; Stephen R Durham; Peter Eng; Montserrat Fernandez-Rivas; Lars Jacobsen; Marek Jutel; Jörg Kleine-Tebbe; Ludger Klimek; Jan Lötvall; Carmen Moreno; Ralph Mosges; Antonella Muraro; Bodo Niggemann; Giovanni Pajno; Giovanni Passalacqua; Oliver Pfaar; Sabina Rak; Gianenrico Senna; Gabriela Senti; Erkka Valovirta; Marianne van Hage; Johannes C Virchow; Ulrich Wahn; Nikolaos Papadopoulos Journal: Clin Transl Allergy Date: 2012-10-30 Impact factor: 5.871