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

Abstract

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. 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). 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). 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.