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Introduction/Aims: Riluzole improves survival in amyotrophic lateral sclerosis (ALS), but optimal time and duration of treatment are unknown. The aim of this study was to examine if timing of riluzole initiation and duration of treatment modified its effect on survival. Methods: Patients from the PRO‐ACT dataset with information on ALS Functional Rating Scale, time from onset to enrollment (TFOE), and riluzole use were selected for analysis. Survival from enrollment was the outcome. Multivariable Cox proportional hazard models were examined for interactions between riluzole and TFOE. Inverse probability of treatment weighting (IPTW) was used to assess average treatment effect. Results: Of 4778 patients, 3446 (72.1%) had received riluzole. In unadjusted analyses, riluzole improved median survival significantly (22.6 vs. 20.2 months, log‐rank p < 0.001). In multivariable analyses, no significant interaction between TFOE and riluzole was found. Riluzole effect was uniform during follow‐up. By IPTW, estimated riluzole hazard ratio was 0.798 (95% confidence interval 0.686–0.927). Delaying riluzole initiation by 1 y (6 to 18 months from onset) may translate to reducing median survival from onset by 1.9 months (40.1 to 38.2 months). Discussion: Riluzole appears to reduce risk of death uniformly, regardless of time from onset to treatment, and duration of treatment. Earlier treatment with riluzole may be associated with greater absolute survival gain from onset. Early diagnosis of ALS will facilitate early treatment and is expected to improve survival. [ABSTRACT FROM AUTHOR]

Background and purpose: There is concern that the Patient Health Questionnaire‐9 (PHQ‐9) depression scale may be impacted by the presence of somatic symptoms (differential item functioning [DIF]) in patients with neurological conditions. We evaluated the PHQ‐9 for the presence and impact of DIF in large clinical samples of neurological patients. Methods: We conducted a cross‐sectional study of patients seen at the Cleveland Clinic Cerebrovascular, Headache, Movement Disorder, and Neuromuscular clinics who completed the PHQ‐9 and patient‐reported disease severity measures as part of standard care between 29 July 2008 and 21 February 2013. We evaluated PHQ‐9 items for DIF with respect to disease‐specific severity for each condition. Salient DIF impact was characterized as a difference between DIF‐adjusted and unadjusted PHQ‐9 scores. Results: Included in the study were 2112 patients with stroke, 8221 with migraine, 440 with amyotrophic lateral sclerosis (ALS), and 5022 with Parkinson disease (PD). Several PHQ‐9 items demonstrated DIF with respect to disease‐specific severity, although salient DIF was present in very few patients (stroke, n = 0; migraine, n = 1; ALS, n = 13; PD, n = 1). Conclusions: PHQ‐9 items function consistently across disease severity, with salient levels of DIF impact found only for a very small proportion of people. These results suggest that the PHQ‐9 provides a consistent measure of depression severity among people with neurological conditions associated with somatic symptoms that overlap with depression. [ABSTRACT FROM AUTHOR]

Background: Home‐based primary care promotes aging in place but is not immediately responsive to urgent needs. Community paramedicine leverages emergency medical services clinicians to expedite in‐home care, though limited evidence supports this model. We evaluated the primary care and acute care use of older adults evaluated urgently by a community paramedic with telemedicine physician compared to a physician home visit model. Methods: This prospective cohort study enrolled older adults in home‐based primary care who requested an urgent evaluation. We allocated participants to the physician home visit model or physician home visit plus community paramedic model by ZIP code. We observed primary care and acute care use for 6 months following enrollment. The primary outcome was the median number of primary care and acute care visits per participant. Secondary outcomes included 30‐day readmission rates, median wait times, and physician productivity. Data analysis included descriptive statistics, comparison of means and proportions, and negative binomial regression modeling reported as incidence rate ratios (IRR). Results: We screened 255 participants, determined 203 eligible, allocated 199, and completed observation for 167 (84 community paramedicine, 83 physician home visit). Participants were mostly female, age 76–86 years, with 3–5 comorbidities, living in a home/apartment. Community paramedic participants had 29% more primary care visits (IRR 1.29, 95% confidence interval [CI] 1.06–1.57) and shorter wait times for urgent evaluations (1 vs. 5 days, p < 0.001) without increasing acute care use (IRR 0.75, 95% CI 0.48–1.18) or 30‐day readmissions (IRR 1.32, 95% CI 0.49–3.55). Physician productivity increased 81% (40 vs. 22 visits/week, p < 0.001). Conclusion: Older adults evaluated by a community paramedic for urgent needs were seen sooner, used acute care similarly to patients evaluated by a physician home visit, and nearly doubled physician efficiency. This suggests that older adults may benefit from combining emergency medical services and primary care resources for urgent evaluations. [ABSTRACT FROM AUTHOR]

Introduction: Rate of decline of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score is a common outcome measure and a powerful predictor of mortality in ALS.Methods: Observed rate of decline (postslope) of ALSFRS-R, its linearity, and its relationship to decline at first visit (preslope) were examined in the Pooled Resource Open-Access ALS Clinical Trials cohort by using longitudinal mixed effects models.Results: Mean ALSFRS-R postslope in 3,367 patients was -0.99 points/month. Preslope and postslope were correlated and had powerful effects on survival. ALSFRS-R trajectories were slightly accelerated overall, but slope and direction/degree of curvature varied. Subscore decline was sequential by site of onset. Respiratory subscore decline was the least steep.Discussion: Variable curvilinearity of ALSFRS-R trajectories confounds interpretation in clinical studies that assume linear decline. Subscore trajectories recapitulate phenotypic diversity and topographical progression of ALS. ALSFRS-R is better used as a multidimensional measure. Muscle Nerve 57: 937-945, 2018. [ABSTRACT FROM AUTHOR]

Background & Aims: Non-alcoholic steatohepatitis (NASH) is an independent risk factor for cardiovascular disease (CVD) morbidity after liver transplantation, but its impact on CVD mortality is unknown. We sought to assess the impact of NASH on CVD mortality after liver transplantation and to predict which NASH recipients are at highest risk of a CVD-related death following a liver transplant. Methods: Using the Organ Procurement and Transplantation Network database, we examined associations between NASH and post-liver transplant CVD mortality, defined as primary cause of death from thromboembolism, arrhythmia, heart failure, myocardial infarction or stroke. A physician panel reviewed cause of death. Results: Of 48 360 liver transplants (2/2002-12/2011), 5057 (10.5%) were performed for NASH cirrhosis. NASH recipients were more likely to be older, female, obese, diabetic and have history of renal failure or prior CVD vs. non-NASH (P < 0.001 for all). Although there was no difference in overall all-cause mortality (log-rank P = 0.96), both early (30-day) and long-term CVD-specific mortality was increased among NASH recipients (Odds ratio = 1.30, 95% Confidence interval (CI): 1.02-1.66; Hazard ratio = 1.42, 95% CI: 1.07-1.41 respectively). These associations were no longer significant after adjustment for pretransplant diabetes, renal impairment or CVD. A risk score comprising age ≥55, male sex, diabetes and renal impairment was developed for prediction of post-liver transplant CVD mortality (c-statistic 0.60). Conclusion: NASH recipients have an increased risk of CVD mortality after liver transplantation explained by a high prevalence of comorbid cardiometabolic risk factors that in aggregate identify those at highest risk of post-transplant CVD mortality. [ABSTRACT FROM AUTHOR]

Objective: To describe differences in clinical and demographic characteristics between patients with episodic migraine (EM) or chronic migraine (CM) and determine the effect of migraine subtype on patient‐reported outcome measures (PROM). Background: Prior studies have characterized migraine in the general population. While this provides a basis for our understanding of migraine, we have less insight into the characteristics, comorbidities, and outcomes of migraine patients who present to subspecialty headache clinics. These patients represent a subset of the population that bears the greatest burden of migraine disability and are more representative of migraine patients who seek medical care. Valuable insights can be gained from a better understanding of CM and EM in this population. Methods: We conducted a retrospective observational cohort study of patients with CM or EM seen in the Cleveland Clinic Headache Center between January 2012 and June 2017. Demographics, clinical characteristics, and patient‐reported outcome measures (3‐Level European Quality of Life 5‐Dimension [EQ‐5D‐3L], Headache Impact Test‐6 [HIT‐6], Patient Health Questionnaire‐9 [PHQ‐9]) were compared between groups. Results: Eleven thousand thirty‐seven patients who had 29,032 visits were included. More CM patients reported being on disability 517/3652 (14.2%) than EM patients 249/4881 (5.1%) and had significantly worse mean HIT‐6 (67.3 ± 7.4 vs. 63.1 ± 7.4, p < 0.001) and median [interquartile range] EQ‐5D‐3L (0.77 [0.44–0.82] vs. 0.83 [0.77–1.00], p < 0.001), and PHQ‐9 (10 [6–16] vs. 5 [2–10], p < 0.001). Conclusions: There are multiple differences in demographic characteristics and comorbid conditions between patients with CM and EM. After adjustment for these factors, CM patients had higher PHQ‐9 scores, lower quality of life scores, greater disability, and greater work restrictions/unemployment. [ABSTRACT FROM AUTHOR]

Objectives: To compare clinical characteristics among outpatient headache clinic patients who do and do not self‐report visiting the emergency department for headache. Background: Headache is the fourth most common reason for emergency department visits, compromising 1%–3% of visits. Limited data exist about patients who are seen in an outpatient headache clinic but still opt to frequent the emergency department. Clinical characteristics may differ between patients who self‐report emergency department use and those who do not. Understanding these differences may help identify which patients are at greatest risk for emergency department overutilization. Methods: This observational cohort study included adults treated at the Cleveland Clinic Headache Center between October 12, 2015 and September 11, 2019, who completed self‐reported questionnaires. Associations between self‐reported emergency department utilization and demographics, clinical characteristics, and patient‐reported outcome measures (PROMs: Headache Impact Test [HIT‐6], headache days per month, current headache/face pain, Patient Health Questionnaire‐9 [PHQ‐9], Patient‐Reported Outcomes Measurement Information System [PROMIS] Global Health [GH]) were evaluated. Results: Of the 10,073 patients (mean age 44.7 ± 14.9, 78.1% [7872/10,073] female, 80.3% [8087/10,073] White patients) included in the study, 34.5% (3478/10,073) reported visiting the emergency department at least once during the study period. Characteristics significantly associated with self‐reported emergency department utilization included younger age (odds ratio = 0.81 [95% CI = 0.78–0.85] per decade), Black patients (vs. White patients) (1.47 [1.26–1.71]), Medicaid (vs. private insurance) (1.50 [1.29–1.74]), and worse area deprivation index (1.04 [1.02–1.07]). Additionally, worse PROMs were associated with greater odds of emergency department utilization: higher (worse) HIT‐6 (1.35 [1.30–1.41] per 5‐point increase), higher (worse) PHQ‐9 (1.14 [1.09–1.20] per 5‐point increase), and lower (worse) PROMIS‐GH Physical Health T‐scores (0.93 [0.88–0.97]) per 5‐point increase. Conclusion: Our study identified several characteristics associated with self‐reported emergency department utilization for headache. Worse PROM scores may be helpful in identifying which patients are at greater risk for utilizing the emergency department. [ABSTRACT FROM AUTHOR]