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How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement

(2011) ALLERGY. 66(6). p.765-774
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Abstract
P>Specific immunotherapy (SIT) is one of the treatments for allergic rhinitis. However, for allergists, nonspecialists, regulators, payers, and patients, there remain gaps in understanding the evaluation of randomized controlled trials (RCTs). Although treating the same diseases, RCTs in SIT and pharmacotherapy should be considered separately for several reasons, as developed in this study. These include the severity and persistence of allergic rhinitis in the patients enrolled in the study, the problem of the placebo, allergen exposure (in particular pollen and mite), the analysis and reporting of the study, the level of symptoms of placebo-treated patients, the clinical relevance of the efficacy of SIT, the need for a validated combined symptom-medication score, the differences between children and adults and pharmacoeconomic analyses. This statement reviews issues raised by the interpretation of RCTs in sublingual immunotherapy. It is not possible to directly extrapolate the rules or parameters used in medication RCTs to SIT. It also provides some suggestions for the research that will be needed. Interestingly, some of the research questions can be approached with the available data obtained from large RCTs.
Keywords
subcutaneous, sublingual, randomized controlled trials, immunotherapy, symptom score, FUROATE NASAL SPRAY, POLLEN INDUCED RHINOCONJUNCTIVITIS, QUALITY-OF-LIFE, GRASS-POLLEN, SUBLINGUAL-SWALLOW IMMUNOTHERAPY, DOUBLE-BLIND, FLUTICASONE FUROATE, TABLET IMMUNOTHERAPY, rhinitis, CLINICAL-EFFICACY, COST-EFFECTIVENESS

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Chicago
Bousquet, J, HJ Schünemann, PJ Bousquet, Claus Bachert, GW Canonica, TB Casale, P Demoly, et al. 2011. “How to Design and Evaluate Randomized Controlled Trials in Immunotherapy for Allergic Rhinitis: An ARIA-GA2LEN Statement.” Allergy 66 (6): 765–774.
APA
Bousquet, J, Schünemann, H., Bousquet, P., Bachert, C., Canonica, G., Casale, T., Demoly, P., et al. (2011). How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement. ALLERGY, 66(6), 765–774.
Vancouver
1.
Bousquet J, Schünemann H, Bousquet P, Bachert C, Canonica G, Casale T, et al. How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement. ALLERGY. 2011;66(6):765–74.
MLA
Bousquet, J, HJ Schünemann, PJ Bousquet, et al. “How to Design and Evaluate Randomized Controlled Trials in Immunotherapy for Allergic Rhinitis: An ARIA-GA2LEN Statement.” ALLERGY 66.6 (2011): 765–774. Print.
@article{1232812,
  abstract     = {P{\textrangle}Specific immunotherapy (SIT) is one of the treatments for allergic rhinitis. However, for allergists, nonspecialists, regulators, payers, and patients, there remain gaps in understanding the evaluation of randomized controlled trials (RCTs). Although treating the same diseases, RCTs in SIT and pharmacotherapy should be considered separately for several reasons, as developed in this study. These include the severity and persistence of allergic rhinitis in the patients enrolled in the study, the problem of the placebo, allergen exposure (in particular pollen and mite), the analysis and reporting of the study, the level of symptoms of placebo-treated patients, the clinical relevance of the efficacy of SIT, the need for a validated combined symptom-medication score, the differences between children and adults and pharmacoeconomic analyses. This statement reviews issues raised by the interpretation of RCTs in sublingual immunotherapy. It is not possible to directly extrapolate the rules or parameters used in medication RCTs to SIT. It also provides some suggestions for the research that will be needed. Interestingly, some of the research questions can be approached with the available data obtained from large RCTs.},
  author       = {Bousquet, J and Sch{\"u}nemann, HJ and Bousquet, PJ and Bachert, Claus and Canonica, GW and Casale, TB and Demoly, P and Durham, S and Carlsen, K-H and Malling, H-J and Passalacqua, G and Simons, FER and Anto, J and Baena-Cagnani, CE and Bergmann, K-C and Bieber, T and Briggs, AH and Brozek, J and Calderon, MA and Dahl, R and Devillier, P and Gerth van Wijk, R and Howarth, P and Larenas, D and Papadopoulos, NG and Schmid-Grendelmeier, P and Zuberbier, Torsten},
  issn         = {0105-4538},
  journal      = {ALLERGY},
  language     = {eng},
  number       = {6},
  pages        = {765--774},
  title        = {How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement},
  url          = {http://dx.doi.org/10.1111/j.1398-9995.2011.02590.x},
  volume       = {66},
  year         = {2011},
}

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