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Rhinosinusitis: Developing guidance for clinical trials.

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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  • Authors+Show Affiliations

    ,

    Allergy and Asthma Medical Group and Research Center Department of Pediatrics, University of California, San Diego, San Diego, California.

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    Source

    MeSH

    Chronic Disease
    Clinical Trials as Topic
    Endoscopy
    Humans
    Nasal Polyps
    Rhinitis
    Sinusitis

    Pub Type(s)

    Journal Article
    Practice Guideline

    Language

    eng

    PubMed ID

    17081855

    Citation

    Meltzer, Eli O., et al. "Rhinosinusitis: Developing Guidance for Clinical Trials." Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, vol. 135, no. 5 Suppl, 2006, pp. S31-80.
    Meltzer EO, Hamilos DL, Hadley JA, et al. Rhinosinusitis: Developing guidance for clinical trials. Otolaryngol Head Neck Surg. 2006;135(5 Suppl):S31-80.
    Meltzer, E. O., Hamilos, D. L., Hadley, J. A., Lanza, D. C., Marple, B. F., Nicklas, R. A., ... Winther, B. (2006). Rhinosinusitis: Developing guidance for clinical trials. Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, 135(5 Suppl), pp. S31-80.
    Meltzer EO, et al. Rhinosinusitis: Developing Guidance for Clinical Trials. Otolaryngol Head Neck Surg. 2006;135(5 Suppl):S31-80. PubMed PMID: 17081855.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Rhinosinusitis: Developing guidance for clinical trials. AU - Meltzer,Eli O, AU - Hamilos,Daniel L, AU - Hadley,James A, AU - Lanza,Donald C, AU - Marple,Bradley F, AU - Nicklas,Richard A, AU - Adinoff,Allen D, AU - Bachert,Claus, AU - Borish,Larry, AU - Chinchilli,Vernon M, AU - Danzig,Melvyn R, AU - Ferguson,Berrylin J, AU - Fokkens,Wytske J, AU - Jenkins,Stephen G, AU - Lund,Valerie J, AU - Mafee,Mahmood F, AU - Naclerio,Robert M, AU - Pawankar,Ruby, AU - Ponikau,Jens U, AU - Schubert,Mark S, AU - Slavin,Raymond G, AU - Stewart,Michael G, AU - Togias,Alkis, AU - Wald,Ellen R, AU - Winther,Birgit, AU - ,, PY - 2006/11/4/pubmed PY - 2007/4/20/medline PY - 2006/11/4/entrez SP - S31 EP - 80 JF - Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery JO - Otolaryngol Head Neck Surg VL - 135 IS - 5 Suppl N2 - 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. SN - 0194-5998 UR - https://www.unboundmedicine.com/medline/citation/17081855/Rhinosinusitis:_Developing_guidance_for_clinical_trials_ L2 - http://journals.sagepub.com/doi/full/10.1016/j.otohns.2006.09.014?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -