Responsiveness of Patient-Reported Outcomes to Treatment Among Patients With Type 2 Diabetes Mellitus and OSA.

<bold>Background: </bold>The Patient-Reported Outcomes Measurement Information System (PROMIS) includes two instruments to quantify sleep symptoms (sleep disturbance [SDA] and sleep-related impairment [SRI]) in diverse populations across a wide symptom spectrum. However, the responsiveness of PROMIS measures to treatment of sleep disorders is unknown. We examined the responsiveness of the PROMIS sleep scales to the treatment of OSA.<bold>Methods: </bold>We collected SDA, SRI, and Epworth Sleepiness Scale (ESS) before and after initiation of positive airway pressure (PAP) in patients with type 2 diabetes newly diagnosed with OSA. To compare responsiveness, we compared effect sizes and classifications of symptom improvement using both the reliable change method and thresholds of minimum important difference (MID).<bold>Results: </bold>A total of 103 patients completed assessments pre- and post-PAP. SDA, SRI, and ESS scores all declined significantly with PAP therapy. We observed the largest effect size for SDA (-0.64; 95% CI, -0.86 to -0.42), followed by SRI (-0.43; 95% CI, -0.63 to -0.23), and ESS (-0.28; 95% CI, -0.42 to -0.15). More patients experienced the reliable change category of symptom remission categorized by the PROMIS measures (SDA: 23.3%; SRI: 31.1%) relative to the ESS (5.8%) (P < .001 for both). Using the MID, SDA and SRI also classified more patients as improved (SDA: 54.4%; SRI: 49.5%) relative to the ESS (35.0%) (P < .001 for both pairwise comparisons).<bold>Conclusions: </bold>PROMIS sleep measures were more likely than the ESS to detect an improvement with PAP therapy. Incorporating PROMIS measures into research and clinical care may provide a more sensitive assessment of symptomatic response to OSA treatment. [ABSTRACT FROM AUTHOR]