Table 2. Study objectives and endpoints in prospective observation study in adults with cystic fibrosis and comorbid chronic rhinosinusitis.

Objective	Endpoint	Assessments
1) Determine whether ESS outperforms CMT for CF-related CRS using measures in pulmonary function, the rate of PEx, and antibiotic use in over 12 months follow-up	Change in percent of predicted expiratory volume in the first second (ppFEV1) at initial visit and months 3,6,9, and 12.	NA
	Rate of PEx, and antibiotic utilization for exacerbations compared between treatment groups.
2) Delineate changes in CF-specific quality of life and sinus-related comorbidities for subjects who undergo ESS through 12 months of follow-up and assess if ESS outperforms CMT in these areas.	Descriptive summary of CF-specific QOL, CRS-specific QOL, sleep quality, depression, headache, cognition, and olfaction; and improvement in scores and comparisons between groups from baseline through 12 months post-treatment.	CFQ-R (CF QOL), SNOT-22 (CRS QOL), PSQI (Sleep), PHQ-9-revised (Depression), HIT-6 (Headache), CFQ (Cognitive function), QOD (Olfaction), SIT (Smell Identification Test)
3) Delineate changes in productivity loss and health utility value for subjects who undergo ESS through 12 months of follow-up and evaluate if ESS outperforms CMT in these areas.	Descriptive summary of productivity and health utility value; and improvement in scores and comparisons between groups from baseline through 12 months post-treatment.	WPAI (Productivity), EQ-5D (Health Utility Value)

ESS, endoscopic sinus surgery; CMT, continued medical therapy; CF, cystic fibrosis, QOL, quality of life; ppFEV₁, percent of predicted expiratory volume in the first second; PEx, pulmonary exacerbation; QOL, quality of life; CFQ-R, Cystic Fibrosis Questionnaire-Revised; SNOT-22, 22-question Sino-Nasal Outcome Test; PHQ-9-revised, Patient Health Questionnaire-9-revised; PSQI, Pittsburgh Sleep Quality Index; CFQ, Cognitive Failures Questionnaire; HIT-6, Headache Impact Test; QOD, Questionnaire of Olfactory Disorders; SIT, Smell Identification Test; WPAI, Work Productivity and Activity Impairment-Specific Health Problem; HUV, EQ-5D, 5-dimensional EuroQol questionnaire.