Study design and quality of reporting of randomized controlled trials of chronic idiopathic or autoimmune urticaria: review.

<h4>Background</h4>The recommended first-line therapy of chronic urticaria is second-generation antihistamines, but the modalities of treatment remains unclear. Numerous recommendations with heterogeneous conclusions have been published. We wondered whether such heterogeneous conclusions...

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Autores principales:	Elodie Le Fourn, Bruno Giraudeau, Olivier Chosidow, Marie-Sylvie Doutre, Gérard Lorette
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2013
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/ceb2e86d36954d6fa07d74cdb6c50945
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spelling	oai:doaj.org-article:ceb2e86d36954d6fa07d74cdb6c509452021-11-18T09:01:16ZStudy design and quality of reporting of randomized controlled trials of chronic idiopathic or autoimmune urticaria: review.1932-620310.1371/journal.pone.0070717https://doaj.org/article/ceb2e86d36954d6fa07d74cdb6c509452013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23940632/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>The recommended first-line therapy of chronic urticaria is second-generation antihistamines, but the modalities of treatment remains unclear. Numerous recommendations with heterogeneous conclusions have been published. We wondered whether such heterogeneous conclusions were linked to the quality of published studies and their reporting.<h4>Objective</h4>To review the study design and quality of reporting of randomized control trials investigating pharmacological treatment of autoimmune or idiopathic chronic urticaria.<h4>Methodology/principal findings</h4>MEDLINE and EMBASE were searched for pharmacological randomized controlled trials involving patients with chronic autoimmune or idiopathic urticaria, with the main outcome being treatment efficacy. Data were collected on general characteristics of the studies, internal validity, studied treatments, design of the trial, outcome measures and "spin" strategy in interpreting results. Spin was defined as use of specific reporting strategies to highlight that the experimental treatment is beneficial, despite statistically nonsignificant results. We evaluated 52 articles that met our criteria. Patients were reported as blinded in 42 articles (81%) and the outcome assessor was blinded in 37 (71%). A placebo was the only comparator in 13 (25%) studies. The study duration was <8 weeks in 39 articles (75%), with no follow-up after discontinuation of treatment in 37 (71%). In 4 articles (8%), blinding was clear because they described blinding of the outcome assessor, the treatment was not recognizable (identical or double-dummy) or had no major secondary effects, and computed randomization was centralized. The primary outcome was specified in 33 articles (63%) and was a score in 31. In total, 15 different scores were used. A spin strategy was used for 10 of 12 studies with a nonsignificant primary outcome.<h4>Conclusion</h4>For establishing guidelines in treatment of chronic urticaria, studies should focus on choosing clinically relevant and reproducible primary outcomes, long-term follow-up, limited use of placebo and avoiding spin strategies.Elodie Le FournBruno GiraudeauOlivier ChosidowMarie-Sylvie DoutreGérard LorettePublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 8, p e70717 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Elodie Le Fourn Bruno Giraudeau Olivier Chosidow Marie-Sylvie Doutre Gérard Lorette Study design and quality of reporting of randomized controlled trials of chronic idiopathic or autoimmune urticaria: review.
description	<h4>Background</h4>The recommended first-line therapy of chronic urticaria is second-generation antihistamines, but the modalities of treatment remains unclear. Numerous recommendations with heterogeneous conclusions have been published. We wondered whether such heterogeneous conclusions were linked to the quality of published studies and their reporting.<h4>Objective</h4>To review the study design and quality of reporting of randomized control trials investigating pharmacological treatment of autoimmune or idiopathic chronic urticaria.<h4>Methodology/principal findings</h4>MEDLINE and EMBASE were searched for pharmacological randomized controlled trials involving patients with chronic autoimmune or idiopathic urticaria, with the main outcome being treatment efficacy. Data were collected on general characteristics of the studies, internal validity, studied treatments, design of the trial, outcome measures and "spin" strategy in interpreting results. Spin was defined as use of specific reporting strategies to highlight that the experimental treatment is beneficial, despite statistically nonsignificant results. We evaluated 52 articles that met our criteria. Patients were reported as blinded in 42 articles (81%) and the outcome assessor was blinded in 37 (71%). A placebo was the only comparator in 13 (25%) studies. The study duration was <8 weeks in 39 articles (75%), with no follow-up after discontinuation of treatment in 37 (71%). In 4 articles (8%), blinding was clear because they described blinding of the outcome assessor, the treatment was not recognizable (identical or double-dummy) or had no major secondary effects, and computed randomization was centralized. The primary outcome was specified in 33 articles (63%) and was a score in 31. In total, 15 different scores were used. A spin strategy was used for 10 of 12 studies with a nonsignificant primary outcome.<h4>Conclusion</h4>For establishing guidelines in treatment of chronic urticaria, studies should focus on choosing clinically relevant and reproducible primary outcomes, long-term follow-up, limited use of placebo and avoiding spin strategies.
format	article
author	Elodie Le Fourn Bruno Giraudeau Olivier Chosidow Marie-Sylvie Doutre Gérard Lorette
author_facet	Elodie Le Fourn Bruno Giraudeau Olivier Chosidow Marie-Sylvie Doutre Gérard Lorette
author_sort	Elodie Le Fourn
title	Study design and quality of reporting of randomized controlled trials of chronic idiopathic or autoimmune urticaria: review.
title_short	Study design and quality of reporting of randomized controlled trials of chronic idiopathic or autoimmune urticaria: review.
title_full	Study design and quality of reporting of randomized controlled trials of chronic idiopathic or autoimmune urticaria: review.
title_fullStr	Study design and quality of reporting of randomized controlled trials of chronic idiopathic or autoimmune urticaria: review.
title_full_unstemmed	Study design and quality of reporting of randomized controlled trials of chronic idiopathic or autoimmune urticaria: review.
title_sort	study design and quality of reporting of randomized controlled trials of chronic idiopathic or autoimmune urticaria: review.
publisher	Public Library of Science (PLoS)
publishDate	2013
url	https://doaj.org/article/ceb2e86d36954d6fa07d74cdb6c50945
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Study design and quality of reporting of randomized controlled trials of chronic idiopathic or autoimmune urticaria: review.

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