Evaluating metrics of responsiveness using patient-reported outcome measures in chronic rhinosinusitis

Abstract

Background: Responsiveness, or sensitivity to clinical change, is important when selecting patient-reported outcome measures (PROMs) for research and clinical applications. This study compares responsiveness of PROMs used in chronic rhinosinusitis (CRS) to inform the future development of a highly responsive instrument that accurately portrays CRS patients' symptom experiences.

Methods: Adult CRS patients initiating medical therapy (MT; n = 143) or undergoing endoscopic sinus surgery after failing MT (ESS; n = 123) completed the 22-item Sino-Nasal Outcome Test (SNOT-22), European Position Statement on Rhinosinusitis (EPOS) visual analog scale (VAS), and 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29) at baseline and 3 months after treatment. Cohen's d and paired t statistics were used to evaluate the responsiveness of each measure.

Results: Fifty-two (36.4%) subjects and 42 (34.1%) subjects in the MT and ESS groups, respectively, completed baseline and 3-month questionnaires. Subjects with and without 3-month data were similar with respect to baseline demographics, VAS scores, and SNOT-22 scores (p > 0.05). In MT patients, CRS-specific measures, like VAS (d = -0.58, p < 0.01; t = -1.81, p > 0.05) and SNOT-22 (d = -0.70, p < 0.01; t = -3.29, p < 0.05) scores, were more responsive than PROMIS-29 general health domains (p > 0.05 for Cohen's d). In ESS patients, VAS (d = -1.97; t = -9.63, both p < 0.01) and SNOT-22 (d = -1.56; t = -9.99, both p < 0.01) scores were similarly more responsive, although changes in PROMIS-29 domains of Fatigue (d = -0.82, p = 0.01; t = -4.63, p < 0.01), Sleep Disturbance (d = -0.83; t = -3.77, both p < 0.01), and Pain Intensity (d = -1.0; t = -5.67, both p < 0.01) were significant. All 22 individual SNOT-22 items differed significantly after surgery, whereas only 8 items were consistently responsive after MT.

Conclusions: For both MT and ESS patients, CRS-specific PROMs are more responsive to posttreatment clinical changes than general health measures. Still, the SNOT-22 contains items that likely decrease its overall responsiveness. Our findings also indicate that existing PROMs had a greater response to ESS than MT.

Keywords: FESS; SNOT-22; chronic rhinosinusitis; medical therapy of rhinosinusitis; paranasal sinus diseases; patient-reported outcome measure; sinus surgery.