Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea.

PURPOSE: This study estimated thresholds for clinically important responses and minimally important differences for two indicators of improvement for the 10-item version of the functional outcomes of sleep questionnaire (FOSQ-10). METHODS: Participants with excessive daytime sleepiness with narcolepsy or obstructive sleep apnea received 12 weeks of solriamfetol treatment. Participants completed the FOSQ-10 and other patient-reported outcome measures, including the single-item patient global impression of change (PGI-C) assessment. Clinicians completed the single-item clinician global impression of change (CGI-C) for each participant. Data from the two studies were analyzed separately, both without regard to treatment assignment. In total, 690 participants (47% female, mean age 48 years, 77% Caucasian, 91% from North America) were enrolled. Two clinically important changes, defined as a minimally important difference and a clinically important response, were determined using distribution and anchor-based analyses. A receiver operating characteristic analysis was used to determine the optimal FOSQ-10 change threshold. RESULTS: Spearman correlations between change in FOSQ-10 scores and PGI-C and CGI-C were - 0.57 and - 0.49 for participants with narcolepsy and - 0.42 and - 0.37 for participants with obstructive sleep apnea. Receiver operating characteristic analysis suggested minimally important difference and clinically important response estimates of 1.7 and 2.5 and 1.8 and 2.2 points in narcolepsy and obstructive sleep apnea, respectively. CONCLUSIONS: Minimally important difference and clinically important response estimates for the FOSQ-10 for adults with excessive daytime sleepiness in narcolepsy or obstructive sleep apnea will be helpful for interpreting changes over time and defining a clinical responder. CLINICALTRIALS. GOV IDENTIFIERS: NCT02348593 (first submitted January 15, 2015) and NCT02348606 (first submitted January 15, 2015).

Association Between Spending and Survival of Chronic Heart Failure Across Veterans Affairs Medical Centers.

Importance: The US Department of Veterans Affairs (VA) provides health care to more than 2 000 000 veterans with chronic cardiovascular disease, yet little is known about how expenditures vary across VA Medical Centers (VAMCs), or whether VAMCs with greater health expenditures are associated with better health outcomes. Objectives: To compare expenditures for patients with chronic heart failure (CHF) across the nation's VAMCs and examine the association between health care spending and survival. Design, Setting, and Participants: Retrospective cohort study using existing administrative data sets from the VA's Corporate Data Warehouse and each veteran's Medicare enrollment information and claims history for fee-for-service clinicians outside of the VA from 265 714 patients diagnosed with CHF between April 1, 2010, and December 31, 2013, who received care at any of 138 VAMCs or affiliated outpatient clinics nationwide. Patients were followed up through September 30, 2014. Data were analyzed from April 1, 2010, through September 30, 2014. Main Outcomes and Measures: Main outcomes were patient deaths per calendar quarter and aggregate VA costs per calendar quarter. Hierarchical generalized linear models with hospital-level random effects were estimated to calculate both risk-standardized annual health care expenditures and risk-standardized annual survival rates for veterans with CHF at each VAMC. The association between VAMC-level expenditures and survival was then modeled using local and linear regression. Results: Of the 265 714 patients included, 261 132 (98.7%) were male; 224 353 (84.4%) were white; 41 110 (15.5%) were black, Asian, Pacific Islander, American Indian, or Alaskan Native; and 251 (0.1%) did not report race. Mean (SD) age of the patients included was 74 (10) years. Across 138 VAMCs, mean (95% CI) annual expenditures for veterans with CHF varied from $21 300 ($20 300-$22 400) to $52 800 ($49 400-$54 300) per patient, whereas annual survival varied between 81.4% to 88.9%. There was a modest V-shaped association between spending and survival such that adjusted survival was 1.7 percentage points higher at the minimum level of spending compared with the inflection point of $34 100 per year (P = .001) and 1.9 percentage points higher at the maximum level of spending compared with the inflection point (P = .006). Conclusions and Relevance: Despite marked differences in mean annual expenditures per veteran, only a modest association was found between CHF spending and survival at the VAMC level, with slightly higher survival observed at the extremes of the spending range. Hospitals with high expenditures may be less efficient than their peer institutions in producing optimal health outcomes.