Prescription Drug Prices: An AAN Position Statement.

This position statement serves to establish the AAN's stance on the methods to address the cost of prescription drugs being considered by state and federal policymakers so that the AAN can continue to advocate effectively for its members. Neurologists seek to provide high-value care for patients with neurologic diseases at the lowest cost possible. However, many therapies for neurologic diseases are among the most expensive in the United States. The 3 major cost challenges include (1) unjustified increases in the pricing for drugs used to treat neurologic disorders, (2) the high cost of medications used to treat rare diseases where there are limited or no therapeutic options available, and (3) the high cost of noninnovative (already FDA-approved) therapies that used accelerated FDA approval pathways or Orphan Drug Act designated to expedite approvals in neurologic disorders. In each of these cases, AAN is concerned that the high cost does not deliver sufficient value to patients or society. The AAN's position is that action must be taken to ensure that effective prescription medications are accessible for patients with complex, chronic neurologic conditions. Potential solutions should be affordable, simple, and transparent. Cost-containment efforts must also address the burden on the entire healthcare system because high prescription drug prices may be shifted and absorbed in ways that negatively affect patient and prescriber access to important medications. AAN supports price negotiations, the cost saving potential of generics and biosimilars, development of novel therapeutics, price transparency, and importation.

Cluster Headache: Clinical Characteristics and Opportunities to Enhance Quality of Life.

PURPOSE OF REVIEW: Cluster headache is a highly disabling primary headache disorder characterized by severe pain and autonomic features. We present the existing body of literature on psychological factors associated with cluster headache and recommendations to address gaps in current clinical care with regards to psychological treatments for cluster headache. RECENT FINDINGS: People with cluster headache often endorse depressive symptoms, are more likely than the general population to report suicidal ideation and behaviors, and experience significantly decreased quality of life. Psychological treatments such as Acceptance and Commitment Therapy may be particularly valuable for patients with cluster headache given that they are transdiagnostic in nature and can therefore simultaneously address the disease burden and common psychiatric comorbidities that present. Greater understanding of the debilitating nature of cluster headache and behavioral interventions that seek to reduce the burden of the disease and improve the quality of life of people with cluster headache is paramount.

Assessment of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) Program for Improving Quality of Care for Transient Ischemic Attack: A Nonrandomized Cluster Trial.

Importance: Patients with transient ischemic attack (TIA) are at high risk of recurrent vascular events. Timely management can reduce that risk by 70%; however, gaps in TIA quality of care exist. Objective: To assess the performance of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) intervention to improve TIA quality of care. Design, Setting, and Participants: This nonrandomized cluster trial with matched controls evaluated a multicomponent intervention to improve TIA quality of care at 6 diverse medical centers in 6 geographically diverse states in the US and assessed change over time in quality of care among 36 matched control sites (6 control sites matched to each PREVENT site on TIA patient volume, facility complexity, and quality of care). The study period (defined as the data period) started on August 21, 2015, and extended to May 12, 2019, including 1-year baseline and active implementation periods for each site. The intervention targeted clinical teams caring for patients with TIA. Intervention: The quality improvement (QI) intervention included the following 5 components: clinical programs, data feedback, professional education, electronic health record tools, and QI support. Main Outcomes and Measures: The primary outcome was the without-fail rate, which was calculated as the proportion of veterans with TIA at a specific facility who received all 7 guideline-recommended processes of care for which they were eligible (ie, anticoagulation for atrial fibrillation, antithrombotic use, brain imaging, carotid artery imaging, high- or moderate-potency statin therapy, hypertension control, and neurological consultation). Generalized mixed-effects models with multilevel hierarchical random effects were constructed to evaluate the intervention associations with the change in the mean without-fail rate from the 1-year baseline period to the 1-year intervention period. Results: Six facilities implemented the PREVENT QI intervention, and 36 facilities were identified as matched control sites. The mean (SD) age of patients at baseline was 69.85 (11.19) years at PREVENT sites and 71.66 (11.29) years at matched control sites. Most patients were male (95.1% [154 of 162] at PREVENT sites and 94.6% [920 of 973] at matched control sites at baseline). Among the PREVENT sites, the mean without-fail rate improved substantially from 36.7% (58 of 158 patients) at baseline to 54.0% (95 of 176 patients) during a 1-year implementation period (adjusted odds ratio, 2.10; 95% CI, 1.27-3.48; P = .004). Comparing the change in quality at the PREVENT sites with the matched control sites, the improvement in the mean without-fail rate was greater at the PREVENT sites than at the matched control sites (36.7% [58 of 158 patients] to 54.0% [95 of 176 patients] [17.3% absolute improvement] vs 38.6% [345 of 893 patients] to 41.8% [363 of 869 patients] [3.2% absolute improvement], respectively; absolute difference, 14%; P = .008). Conclusions and Relevance: The implementation of this multifaceted program was associated with improved TIA quality of care across the participating sites. The PREVENT QI program is an example of a health care system using QI strategies to improve performance, and may serve as a model for other health systems seeking to provide better care. Trial Registration: ClinicalTrials.gov Identifier: NCT02769338.

Polysomnography Utilization in Veterans Presenting Acutely with Ischemic Stroke or Transient Ischemic Attack.

INTRODUCTION: Obstructive sleep apnea (OSA) is an independent cerebrovascular risk factor and highly prevalent in patients with ischemic stroke and transient ischemic attack (TIA). Timely diagnosis and treatment of OSA is important as clinical data suggest that treatment of OSA in the setting of acute ischemic stroke improves functional outcomes. We aimed to assess polysomnography (PSG) utilization in US. Veterans with acute stroke or TIA over a 2-year period. METHODS: Veterans with acute ischemic stroke or TIA presenting to a Veterans Administration Medical Center (VAMC) between October 1, 2015, and June 30, 2017, were included. Demographic, clinical data, and PSG within 12 months of hospital discharge were obtained from the VA Corporate Data Warehouse to determine the rate of PSG testing among those with acute ischemic stroke or TIA. Fisher's exact test and two-sample t tests were used to compare demographic and clinical characteristics for those receiving and not receiving PSG. Mixed effect logistic regression was used to model the association of clinical and demographic characteristics with PSG receipt. RESULTS: In fiscal years (FYs) 2016 and 2017, 9,200 Veterans were admitted to a VAMC with ischemic stroke (6,011) or TIA (3,089). Veterans were elderly (70.5 ± 11.1 years), predominantly male (95.7%), and largely Caucasian (68.0% Caucasian, 26.3% African-American). Just 6.0% of Veterans underwent PSG within 1 year of acute ischemic stroke or TIA in FY 2016, compared to 6.2% in FY 2017 (p = 0.72). Compared to Veterans ≥80 years, those <60 had adjusted OR of 6.73 (4.10-11.05), those 60-69 had OR 4.29 (2.73-6.74), and those 70-79 had OR 2.63 (1.66-4.18) of having PSG. Veterans with diabetes or heart failure had significantly higher odds, whereas those with dementia had significantly lower odds of receiving PSG. CONCLUSION: PSG utilization among US Veterans is low and stable over time, despite recent guidelines recommending PSG among those having stroke or TIA. Older Veterans and those with dementia were unlikely to get PSG, representing especially vulnerable populations.

American Academy of Neurology members' preparedness to treat sexual and gender minorities.

OBJECTIVE: To measure the attitudes and knowledge of American Academy of Neurology (AAN) member neurologists in caring for sexual and gender minority (SGM) patients (e.g., those who identify in the lesbian, gay, bisexual, transgender, queer, or questioning [LGBTQ+] spectrum) to inform future educational offerings. METHODS: A questionnaire was created in an iterative process by the LGBTQ+ Survey Task Force, consisting of 21 questions examining self-reported knowledge, attitudes, and clinical preparedness in caring for SGM patients. Participants responded to each statement with a 5-point Likert scale ("strongly disagree" to "strongly agree"). The survey was distributed via electronic and conventional mail to a random, representative sample of 1,000 AAN members. RESULTS: The response rate was 13.5% (n = 135). Most respondents (60%-66%) were aware of local and national barriers that inhibit SGM individuals from using health care services; the majority (73%-91%) felt comfortable assessing SGM patients. Over half believed sexual orientation (SO) and gender identity (GI) to be social determinants of health (61% and 57%, respectively). Yet a third would not tailor neurologic care based on a patient's SGM identity, and 43% believed that SO/GI has no bearing on the management of neurologic illness. CONCLUSIONS: Most neurologists surveyed were aware of overarching barriers to care experienced by SGM individuals; however, a minority of respondents recognized the intersection of SGM identity with neurologic health. Our results highlight awareness gaps that could be addressed via targeted educational opportunities, ensuring that neurologists provide high-quality neurologic care to patients of all sexual orientations and gender identities.

Association of neurologist care with headache expenditures: A population-based, longitudinal analysis.

Objective To assess the association of neurologist ambulatory care with healthcare utilization and expenditure in headache. Methods This was a longitudinal cohort study from two-year duration panel data, pooled from 2002-2013, of adult respondents identified with diagnostic codes for headache in the Medical Expenditure Panel Survey. Those with a neurologist ambulatory care visit in year one of panel participation were compared with those who did not for the change in annual aggregate direct headache-related health care costs from year one to year two of panel participation, inflated to 2015 US dollars. Results were adjusted via multiple linear regression for demographic and clinical variables, utilizing survey variables for accurate estimates and standard errors. Results Eight hundred and eighty-seven respondents were included, with 23.3% (207/887) seeing a neurologist in year one. The neurologist group had higher year-one mean headache-related expenditures ($3032 vs. $1636), but nearly equal mean year-two expenditures compared to controls ($1900 vs. $1929). Adjusted association between neurologist care and difference in mean annual expenditures from year two to year one was -$1579 (95% CI -$2468, -$690, p < 0.001). Conclusion Among headache sufferers, particularly those with higher headache-related healthcare expenditures, neurologist care is associated with a significant reduction in costs over two years.

Development, Validation, and Assessment of an Ischemic Stroke or Transient Ischemic Attack-Specific Prediction Tool for Obstructive Sleep Apnea.

BACKGROUND: Screening instruments for obstructive sleep apnea (OSA), as used routinely to guide clinicians regarding patient referral for polysomnography (PSG), rely heavily on symptomatology. We sought to develop and validate a cerebrovascular disease-specific OSA prediction model less reliant on symptomatology, and to compare its performance with commonly used screening instruments within a population with ischemic stroke or transient ischemic attack (TIA). METHODS: Using data on demographic factors, anthropometric measurements, medical history, stroke severity, sleep questionnaires, and PSG from 2 independently derived, multisite, randomized trials that enrolled patients with stroke or TIA, we developed and validated a model to predict the presence of OSA (i.e., Apnea-Hypopnea Index ≥5 events per hour). Model performance was compared with that of the Berlin Questionnaire, Epworth Sleepiness Scale (ESS), the Snoring, Tiredness, Observed apnea, high blood Pressure, Body mass index, Age, Neck circumference, and Gender instrument, and the Sleep Apnea Clinical Score. RESULTS: The new SLEEP Inventory (Sex, Left heart failure, ESS, Enlarged neck, weight [in Pounds], Insulin resistance/diabetes, and National Institutes of Health Stroke Scale) performed modestly better than other instruments in identifying patients with OSA, showing reasonable discrimination in the development (c-statistic .732) and validation (c-statistic .731) study populations, and having the highest negative predictive value of all in struments. CONCLUSIONS: Clinicians should be aware of these limitations in OSA screening instruments when making decisions about referral for PSG. The high negative predictive value of the SLEEP INventory may be useful in determining and prioritizing patients with stroke or TIA least in need of overnight PSG.

Diagnosis and Treatment of Sleep Apnea in patients' homes: the rationale and methods of the "GoToSleep" randomized-controlled trial.

BACKGROUND: The "Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease" (GoToSleep) study is evaluating a strategy to improve the diagnosis and treatment of sleep apnea among veterans with stroke or transient ischemic attack (TIA) who also have hypertension. Specifically, the GoToSleep study was designed to overcome some of the barriers that exist within the Veterans Health Administration (VHA) to the timely diagnosis and treatment of sleep apnea by using ambulatory home-based polysomnography and auto-titrating continuous positive airway pressure (CPAP) to reduce the reliance on laboratory-based sleep studies. METHODS: The GoToSleep study is a prospective, multi-site, randomized, controlled strategy trial among an expected 318 veterans with cerebrovascular disease and hypertension who are assigned to an intervention group or a control group. Patients in the intervention group receive unattended polysomnography at baseline, and those with sleep apnea receive auto-titrating CPAP therapy for up to one year. Patients in the control group receive usual care and unattended polysomnography at the end of the study to identify the rate of undiagnosed sleep apnea. The primary objectives of the GoToSleep study are to determine whether a diagnostic and therapeutic intervention strategy among veterans with cerebrovascular disease and hypertension improves: (1) detection of sleep apnea; (2) appropriate treatment for sleep apnea; and (3) control of hypertension. Twenty-four-hour blood pressure assessments are made at baseline and at the end of the one-year study period for both groups. Antihypertensive medications and their doses are recorded at the time of the 24-hour blood pressure measurements. DISCUSSION: This manuscript provides the rationale for 4 key components of the design of the GoToSleep trial: the inclusion of patients with cerebrovascular disease and hypertension without the use of a measure of daytime sleepiness as an eligibility criterion; the use of portable polysomnography and auto-titrating CPAP in patients' homes rather than using sleep laboratory polysomnography with fixed pressure CPAP; the analytic approach to evaluating change in blood pressure in the context of change in antihypertensive medications; and the use of a usual care control group.