Adult patients (≥ 18 years of age) with a current diagnosis of medically
refractory CRS were prospectively enrolled into an ongoing, multi-institutional,
observational, cohort study to compare the effectiveness of treatment outcomes for this
chronic disease process. Preliminary findings from this cohort have been previously
described.2 (link),6 –9 (link) The diagnosis of CRS
was defined by the 2007 Adult Sinusitis Guideline,10 (link) with prior treatment with oral, broad spectrum, or culture directed
antibiotics (≥ 2 weeks duration) and either topical nasal corticosteroid sprays
(≥ 3 week duration) or a 5-day trial of systemic steroid therapy necessary for
enrollment. Enrollment sites consisted of four academic, tertiary care rhinology practices
as part of the Oregon Health & Science University (OHSU, Portland, OR, USA), the
Medical Univeristy of South Carolina (Charleston, SC, USA), Stanford University (Palo
Alto, CA, USA), and the University of Calgary (Calgary, Alberta, Canada). The
Institutional Review Board at each enrollment location provided oversight and annual
review of the informed consent process and all investigational protocols, while central
review and coordination services were conducted at OSHU (eIRB
#7198).
Treatment modality selection was not randomized or assigned for study purposes at
any time point. Participants either selected continued, non-standardized medical therapy
for control of symptoms associated with CRS or subsequent ESS based on individual disease
processes and intraoperative clinical judgement of the enrolling physician at each site.
Participants were either primary or revision surgery cases in both treatment groups.
Surgical procedures consisted of either unilateral or bilateral maxillary anstrostomy,
partial or total ethmoidectomy, sphenoidotomy, frontal sinus procedures (Draf I, IIa/b, or
III), with or without septoplasty and inferior turbinate reduction.
refractory CRS were prospectively enrolled into an ongoing, multi-institutional,
observational, cohort study to compare the effectiveness of treatment outcomes for this
chronic disease process. Preliminary findings from this cohort have been previously
described.2 (link),6 –9 (link) The diagnosis of CRS
was defined by the 2007 Adult Sinusitis Guideline,10 (link) with prior treatment with oral, broad spectrum, or culture directed
antibiotics (≥ 2 weeks duration) and either topical nasal corticosteroid sprays
(≥ 3 week duration) or a 5-day trial of systemic steroid therapy necessary for
enrollment. Enrollment sites consisted of four academic, tertiary care rhinology practices
as part of the Oregon Health & Science University (OHSU, Portland, OR, USA), the
Medical Univeristy of South Carolina (Charleston, SC, USA), Stanford University (Palo
Alto, CA, USA), and the University of Calgary (Calgary, Alberta, Canada). The
Institutional Review Board at each enrollment location provided oversight and annual
review of the informed consent process and all investigational protocols, while central
review and coordination services were conducted at OSHU (eIRB
#7198).
Treatment modality selection was not randomized or assigned for study purposes at
any time point. Participants either selected continued, non-standardized medical therapy
for control of symptoms associated with CRS or subsequent ESS based on individual disease
processes and intraoperative clinical judgement of the enrolling physician at each site.
Participants were either primary or revision surgery cases in both treatment groups.
Surgical procedures consisted of either unilateral or bilateral maxillary anstrostomy,
partial or total ethmoidectomy, sphenoidotomy, frontal sinus procedures (Draf I, IIa/b, or
III), with or without septoplasty and inferior turbinate reduction.
