Rhinosinusitis: Developing guidance for clinical trials.
Otolaryngol Head Neck Surg
; 135(5 Suppl): S31-80, 2006 Nov.
Article
em En
| MEDLINE
| ID: mdl-17081855
ABSTRACT
The Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication, "Rhinosinusitis Establishing definitions for clinical research and patient care" and provides templates for clinical trials in antimicrobial, anti-inflammatory, and symptom-relieving therapies for the following (1) acute presumed bacterial rhinosinusitis, (2) chronic rhinosinusitis (CRS) without nasal polyps, (3) CRS with nasal polyps, and (4) classic allergic fungal rhinosinusitis. In addition to the templates for clinical trials and proposed study designs, the Rhinosinusitis Initiative has developed 6 appendices, which address (1) health outcomes, (2) nasal endoscopy and staging of CRS, (3) radiologic imaging, (4) microbiology, (5) laboratory measures, and (6) biostatistical methods.
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MEDLINE
Assunto principal:
Sinusite
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Rinite
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Ensaios Clínicos como Assunto
Tipo de estudo:
Diagnostic_studies
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Guideline
Limite:
Humans
Idioma:
En
Revista:
Otolaryngol Head Neck Surg
Ano de publicação:
2006
Tipo de documento:
Article