Table 3. Data collection time points in months.
Data collection time points | Baseline | 3 | 6 | 9 | 12 |
---|---|---|---|---|---|
History and physical, computed tomography | x | ||||
Disease and socio-demographic factors | x | ||||
Nasal endoscopy | x | x | |||
Treatment option: ESS vs. CMT | x | ||||
Medication, CFTR modulator, cross-over data | x | x | x | x | x |
PFTs, PEx data, antibiotic use | x | x | x | x | x |
CFQ-R, SNOT-22, QOD, PSQI, PHQ-9-revised, CFQ, SIT, HIT-6, WPAI, HUV | x | x | x | x | x |
Nasal mucus sponge, nasal microbiome swab | x | x | x | x | x |
Blood, excised ethmoid sinus tissue* | x |
ESS, endoscopic sinus surgery; CMT, continued medical therapy; PwCF+CRS, people with cystic fibrosis and comorbid chronic rhinosinusitis; CF, cystic fibrosis, QOL, quality of life; CFTR, cystic fibrosis transmembrane receptor; PFT, pulmonary function test; PEx, pulmonary exacerbation; 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, health utility value; EQ-5D, 5-dimensional EuroQol questionnaire.
*These are for surgical cases only. Centers which routinely perform blood draws during clinic visits may also collect blood specimens at multiple follow up visits.