Development and Initial Validation of a Self-Scored COPD Population Screener Questionnaire (COPD-PS)

COPD has a profound impact on daily life, yet remains underdiagnosed and undertreated. We set out to develop a brief, reliable, self-scored questionnaire to identify individuals likely to have COPD. COPD-PS™ development began with a list of concepts identified for inclusion using expert opinion from a clinician working group comprised of pulmonologists (n = 5) and primary care clinicians (n = 5). A national survey of 697 patients was conducted at 12 practitioner sites. Logistic regression identified items discriminating between patients with and without fixed airflow obstruction (AO, postbronchodilator FEV1/FVC < 70%). ROC analyses evaluated screening accuracy, compared scoring options, and assessed concurrent validity. Convergent and discriminant validity were assessed via COPD-PS and SF-12v2 score correlations. For known-groups validation, COPD-PS differences between clinical groups were tested. Test-retest reliability was evaluated in a 20% sample. Of 697 patients surveyed, 295 patients met expert review criteria for spirometry performance; 38% of these (n = 113) had results indicating AO. Five items positively predicted AO (p < 0.0001): breathlessness, productive cough, activity limitation, smoking history, and age. COPD-PS scores accurately classified AO status (area under ROC curve = 0.81) and reliable (r = 0.91). Patients with spirometry indicative of AO scored significantly higher (6.8, SD = 1.9; p < 0.0001) than patients without AO (4.0, SD = 2.3). Higher scores were associated with more severe AO, bronchodilator use, and overnight hospitalization for breathing problems. With the prevalence of COPD in the studied cohort, a score on the COPD-PS of greater than five was associated with a positive predictive value of 56.8% and negative predictive value of 86.4%. The COPD-PS accurately classified physician-reported COPD (AUC = 0.89). The COPD-PS is a brief, accurate questionnaire that can identify individuals likely to have COPD

The Burden of Restless Legs Syndrome: An Assessment of Work Productivity, Sleep, Psychological Distress, and Health Status Among Diagnosed and Undiagnosed Individuals in an Internet-Based Panel

Background: Restless legs syndrome (RLS) affects approximately 10-15% of the general population and has deleterious effects on sleep and subsequent daytime performance. The disorder may also give rise to long-term complications such as psychological distress and diminished quality of life. The condition is often unrecognized or misdiagnosed, and the magnitude of the effects of RLS on the sizeable proportion of undiagnosed (and therefore untreated) individuals has not previously been evaluated. Objectives: This study examined the impact of RLS on overall health status, sleep, psychological functioning, work productivity, and daily activities in individuals with diagnosed and in those with undiagnosed (self-reported) RLS. Methods: An internet-based survey was conducted on a multimillion-member panel of US adults. Eligible participants were currently experiencing RLS symptoms as determined using established diagnostic criteria. Participants provided information related to self-reported RLS diagnosis, treatment, symptom frequency and severity, and responses to validated instruments (Medical Outcomes study [MOS] Short Form 12, version 2 [SF-12v2], MOS Sleep Scale, Center for Epidemiological Studies Depression Scale [CES-D], Work Productivity and Activity Impairment - General Health Questionnaire [WPAI-GH] and Work Limitations Questionnaire [WLQ]). Analysis of co-variance (ANCOVA) models were developed to evaluate the relationships among symptom severity, diagnosis status, age, and sex, and the impact of RLS. Results: Participants included 702 adults with RLS symptoms. Means for the SF-12v2 scores (physical component score_=_35.6, mental component score_=_42.6) were at least 1 standard deviation lower than sex- and age-adjusted general population norms. Participants reported poorer sleep quality scores across each MOS Sleep Scale domain, with differences from published norms of >16 points on 100-point scales, as well as approximately 1 hour less sleep per night on average. A majority (64%) met the cut-off score for depression. Compared with population norms, the sample reported greater limitations in time management, physical demands, mental/interpersonal demands, general work output, and usual activities. Symptom intensity and frequency were shown to be the primary predictors of RLS impact on the various outcomes. Conclusion: These results support previous reports that RLS often goes undiagnosed or misdiagnosed. The results of this survey also suggest that regardless of whether RLS is recognized, the burden of the disorder is substantial, implying a need for improved diagnosis and management of RLS. DOI: 10.2165/1312067-200801030-00007Productivity-costs, Quality-of-life, Restless-legs-syndrome

Comparison of effectiveness and safety of treatment with apixaban vs. other oral anticoagulants among elderly nonvalvular atrial fibrillation patients

Objective: To compare the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) of elderly (≥65 years of age) nonvalvular atrial fibrillation (NVAF) patients initiating apixaban vs. rivaroxaban, dabigatran, or warfarin. Methods: NVAF patients with Medicare Advantage coverage in the US initiating oral anticoagulants (OACs, index event) were identified from the Humana database (1 January 2013–30 September 2015) and grouped into cohorts depending on OAC initiated. Propensity score matching (PSM), 1:1, was conducted among patients treated with apixaban vs. each other OAC, separately. Rates of S/SE and MB were evaluated in the follow-up. Cox regressions were used to compare the risk of S/SE and MB between apixaban and each of the other OACs during the follow-up. Results: The matched pairs of apixaban vs. rivaroxaban (n = 13,620), apixaban vs. dabigatran (n = 4654), and apixaban vs. warfarin (n = 14,214) were well balanced for key patient characteristics. Adjusted risks for S/SE (hazard ratio [HR] vs. rivaroxaban: 0.72, p =.003; vs. warfarin: 0.65,

Effect of Apixaban Versus Warfarin Use on Health Care Resource Utilization and Costs Among Elderly Patients with Nonvalvular Atrial Fibrillation

BACKGROUND: The clinical trial ARISTOTLE showed that apixaban was superior to warfarin in reducing the risks of stroke and bleeding among patients with nonvalvular atrial fibrillation (NVAF). Further study of the effect of apixaban versus warfarin use on health care resource utilization (HCRU) and associated costs in the real-world setting is warranted, especially among elderly patients who are at higher risk of stroke and bleeding

All-Cause, Stroke/Systemic Embolism-, and Major Bleeding-Related Health-Care Costs Among Elderly Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants

In this study, all-cause, stroke/systemic embolism (SE)-related, and major bleeding (MB)-related health-care costs among elderly patients with nonvalvular atrial fibrillation (NVAF) initiating treatment with different oral anticoagulants (OACs) were compared. Patients ≥65 years of age initiating OACs, including apixaban, rivaroxaban, dabigatran, and warfarin, were identified from the Humana Research Database between January 1, 2013, and September 30, 2015. Propensity score matching was used to separately match the different OAC cohorts with the apixaban cohort. All-cause health-care costs and stroke/SE-related and MB-related medical costs per patient per month (PPPM) were compared using generalized linear or 2-part regression models. Compared to apixaban, rivaroxaban was associated with significantly higher all-cause health-care costs (US$2234 vs US$1846 PPPM, P < .001) and MB-related medical costs (US$106 vs US$47 PPPM, P < .001), dabigatran was associated with significantly higher all-cause health-care costs (US$1980 vs US$1801 PPPM, P = .007), and warfarin was associated with significantly higher all-cause health-care costs (US$2386 vs US$1929 PPPM, P < .001), stroke/SE-related medical costs (US$42 vs US$18 PPPM, P < .001), and MB-related medical costs (US$132 vs US$51 PPPM, P < .001). Among elderly patients with NVAF, other OACs were associated with higher all-cause health-care costs than apixaban