1. Rhinosinusitis: Developing guidance for clinical trials
Eli O. Meltzer, MD, Daniel L. Hamilos, MD, James A. Hadley, MD, Donald C. Lanza, MD, Bradley F. Marple, MD, Richard A. Nicklas, MD, Allen D. Adinoff, MD, Claus Bachert, MD, PhD, Larry Borish, MD, Vernon M. Chinchilli, PhD, Melvyn R. Danzig, PhD, Berrylin J. Ferguson, MD, Wytske J. Fokkens, MD, PhD, Stephen G. Jenkins, PhD, Valerie J. Lund, MD, Mahmood F. Mafee, MD, Robert M. Naclerio, MD, Ruby Pawankar, MD, PhD, Jens U. Ponikau, MD, Mark S. Schubert, MD, PhD, Raymond G. Slavin, MD, Michael G. Stewart, MD, MPH, Alkis Togias, MD, Ellen R. Wald, MD, Birgit Winther, MD 
Journal of Allergy and Clinical Immunology 
Volume 118, Issue 5, Pages S17-S61 (November 2006)
DOI: /j.jaci
Copyright © 2006 American Academy of Allergy, Asthma and Immunology and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. Terms and Conditions

2. Fig 1
The rationale for the illustrated study design is to determine the effect of a treatment intervention on the clinical course of ABRS, as measured by time to resolution of symptoms. Patient symptoms, QOL, or both are measured on the y-axis, and time is measured on the x-axis. The therapeutic intervention that is to be tested can be compared with either placebo or a comparator intervention. Success of the treatment intervention is based on a statistically significant difference in rate of symptom (or QOL) resolution between the comparator interventions. This graph is intended to convey the conceptual aspects of the type of study design. Therefore variables, such as timing of intervention, duration of treatment, type of intervention, and end of study, can be modified based on the specifics of the proposed study.
Journal of Allergy and Clinical Immunology  , S17-S61DOI: ( /j.jaci )
Copyright © 2006 American Academy of Allergy, Asthma and Immunology and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. Terms and Conditions

3. Fig 2
The rationale for the illustrated study design is to determine the effect of a short-term treatment intervention on the clinical course of CRS (CRSwNP, CRSsNP, or AFRS), as measured by improvement and duration of symptoms experienced by the patient. Patient symptoms, QOL, or both are measured on the y-axis, and time is measured on the x-axis. The therapeutic intervention that is to be tested can be compared with either placebo or a comparator intervention. Success of the treatment intervention is based on a statistically significant difference in rate of symptom (or QOL) resolution or change from baseline symptom scores. This graph is intended to convey the conceptual aspects of the type of study design (as in Fig 1).
Journal of Allergy and Clinical Immunology  , S17-S61DOI: ( /j.jaci )
Copyright © 2006 American Academy of Allergy, Asthma and Immunology and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. Terms and Conditions

4. Fig 3
The rationale for the illustrated study design is to determine the effect of a long-term treatment intervention on the clinical course of CRS (CRSwNP, CRSsNP, or AFRS), as measured by improvement and duration of symptoms experienced by the patient. Patient symptoms, QOL, or both are measured on the y-axis, and time is measured on the x-axis. The therapeutic intervention that is to be tested can be compared with either placebo or a comparator intervention. Success of the treatment intervention is based on a statistically significant difference in rate of symptom (or QOL) resolution or change from baseline symptom scores. This graph is intended to convey the conceptual aspects of the type of study design (as in Fig 1).
Journal of Allergy and Clinical Immunology  , S17-S61DOI: ( /j.jaci )
Copyright © 2006 American Academy of Allergy, Asthma and Immunology and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. Terms and Conditions

5. Fig 4
The rationale for the illustrated study design is to determine the ability of a treatment intervention to attenuate recurrence of CRS (CRSwNP, CRSsNP, or AFRS) after a preceding intervention (eg, surgery and long-term systemic corticosteroids). Patient symptoms, QOL, or both are measured on the y-axis, and time is measured on the x-axis. The therapeutic intervention that is to be tested can be compared with either placebo or a comparator intervention. Success of the treatment intervention is based on a statistically significant difference in the rate of symptom recurrence, as measured by worsening symptom score or diminishing QOL. This graph is intended to convey the conceptual aspects of the type of study design (as in Fig 1).
Journal of Allergy and Clinical Immunology  , S17-S61DOI: ( /j.jaci )
Copyright © 2006 American Academy of Allergy, Asthma and Immunology and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. Terms and Conditions

6. Fig 5 Examples of endoscopic images.
Journal of Allergy and Clinical Immunology  , S17-S61DOI: ( /j.jaci )
Copyright © 2006 American Academy of Allergy, Asthma and Immunology and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. Terms and Conditions

7. Fig 6
Polyp grading system: 0, no visible NPs; 1, small amount of polypoid disease confined within the middle meatus; 2, multiple polyps occupying the middle meatus; 3, polyps extending beyond the middle meatus, within the sphenoethmoid recess but not totally obstructing, or both; 4, polyps completely obstructing the nasal cavity.
Journal of Allergy and Clinical Immunology  , S17-S61DOI: ( /j.jaci )
Copyright © 2006 American Academy of Allergy, Asthma and Immunology and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. Terms and Conditions

8. Fig 7
Polyp side rating.
Journal of Allergy and Clinical Immunology  , S17-S61DOI: ( /j.jaci )
Copyright © 2006 American Academy of Allergy, Asthma and Immunology and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. Terms and Conditions

9. Journal of Allergy and Clinical Immunology 2006 118, S17-S61DOI: (10
Journal of Allergy and Clinical Immunology  , S17-S61DOI: ( /j.jaci )
Copyright © 2006 American Academy of Allergy, Asthma and Immunology and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. Terms and Conditions

10. Journal of Allergy and Clinical Immunology 2006 118, S17-S61DOI: (10
Journal of Allergy and Clinical Immunology  , S17-S61DOI: ( /j.jaci )
Copyright © 2006 American Academy of Allergy, Asthma and Immunology and American Academy of Otolaryngology–Head and Neck Surgery Foundation, Inc. Terms and Conditions