Contemporary treatment utilization among women diagnosed with symptomatic uterine fibroids in the United States.

BACKGROUND: This study evaluated treatment patterns among women diagnosed with symptomatic uterine fibroids (UF) in the United States. Data were retrospectively extracted from the IBM Watson Health MarketScan® Commercial Claims and Encounters and Medicaid Multi-State databases. METHODS: Women aged 18-64 years with ≥1 medical claim with a UF diagnosis (primary position, or secondary position plus ≥1 associated symptom) from January 2010 to June 2015 (Commercial) and January 2009 to December 2014 (Medicaid) were eligible; the first UF claim during these time periods was designated the index date. Data collected 12 months pre- and 12 and 60 months post-diagnosis included clinical/demographic characteristics, pharmacologic/surgical treatments, and surgical complications. Prevalence (2015) and cumulative incidence (Commercial, 2010-2015; Medicaid, 2009-2015) of symptomatic UF were estimated. RESULTS: 225,737 (Commercial) and 19,062 (Medicaid) women had a minimum of 12 months post-index continuous enrollment and were eligible for study. Symptomatic UF prevalence and cumulative incidence were: 0.57, 1.23% (Commercial) and 0.46, 0.64% (Medicaid). Initial treatments within 12 months post-diagnosis were surgical (Commercial, 36.7%; Medicaid, 28.7%), pharmacologic (31.7%; 53.0%), or none (31.6%; 18.3%). Pharmacologic treatments were most commonly non-steroidal anti-inflammatory drugs and oral contraceptives; hysterectomy was the most common surgical treatment. Of procedures of abdominal hysterectomy, abdominal myomectomy, uterine artery embolization, and ablation in the first 12 months post-index, 14.9% (Commercial) and 24.9% (Medicaid) resulted in a treatment-associated complication. Abdominal hysterectomy had the highest complication rates (Commercial, 18.5%; Medicaid, 31.0%). CONCLUSIONS: Off-label use of pharmacologic therapies and hysterectomy for treatment of symptomatic UF suggests a need for indicated non-invasive treatments for symptomatic UF.

Development of a bedside tool to predict the probability of drug-resistant pathogens among hospitalized adult patients with gram-negative infections.

BACKGROUND: We developed a clinical bedside tool to simultaneously estimate the probabilities of third-generation cephalosporin-resistant Enterobacteriaceae (3GC-R), carbapenem-resistant Enterobacteriaceae (CRE), and multidrug-resistant Pseudomonas aeruginosa (MDRP) among hospitalized adult patients with Gram-negative infections. METHODS: Data were obtained from a retrospective observational study of the Premier Hospital that included hospitalized adult patients with a complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI), hospital-acquired/ventilator-associated pneumonia (HAP/VAP), or bloodstream infection (BSI) due to Gram-negative bacteria between 2011 and 2015. Risk factors for 3GC-R, CRE, and MDRP were ascertained by multivariate logistic regression, and separate models were developed for patients with community-acquired versus hospital-acquired infections for each resistance phenotype (N = 6). Models were converted to a singular user-friendly interface to estimate the probabilities of a patient having an infection due to 3GC-R, CRE, or MDRP when ≥ 1 risk factor was present. RESULTS: Overall, 124,068 patients contributed to the dataset. Percentages of patients admitted for cUTI, cIAI, HAP/VAP, and BSI were 61.6, 4.6, 16.5, and 26.4%, respectively (some patients contributed > 1 infection type). Resistant infection rates were 1.90% for CRE, 12.09% for 3GC-R, and 3.91% for MDRP. A greater percentage of the resistant infections were community-acquired relative to hospital-acquired (CRE, 1.30% vs 0.62% of 1.90%; 3GC-R, 9.27% vs 3.42% of 12.09%; MDRP, 2.39% vs 1.59% of 3.91%). The most important predictors of having an 3GC-R, CRE or MDRP infection were prior number of antibiotics; infection site; infection during the previous 3 months; and hospital prevalence of 3GC-R, CRE, or MDRP. To enable application of the six predictive multivariate logistic regression models to real-world clinical practice, we developed a user-friendly interface that estimates the risk of 3GC-R, CRE, and MDRP simultaneously in a given patient with a Gram-negative infection based on their risk (Additional file 1). CONCLUSIONS: We developed a clinical prediction tool to estimate the probabilities of 3GC-R, CRE, and MDRP among hospitalized adult patients with confirmed community- and hospital-acquired Gram-negative infections. Our predictive model has been implemented as a user-friendly bedside tool for use by clinicians/healthcare professionals to predict the probability of resistant infections in individual patients, to guide early appropriate therapy.

Assessing Physician-Patient Dialogues About Chronic Migraine During Routine Office Visits.

OBJECTIVE: To assess physician-patient communication and identify the frequency of use of specific communication techniques by analyzing recordings of routinely scheduled medical encounters for patients with clinician-identified chronic migraine. BACKGROUND: Chronic migraine is an under-diagnosed, under-treated, and highly burdensome disease. Effective medical communication is integral to optimal medical care, including providing accurate diagnoses, creating effective treatment plans, and enhancing patient adherence. Communication patterns during office visits may be a target for intervention to improve outcomes for people with chronic migraine. DESIGN: This was a prospective, observational study based on analysis of audio recordings collected during neurologist-patient chronic migraine dialogues. METHODS: Twenty neurologists from a US neurology panel maintained by Verilogue, Inc., a research organization specializing in healthcare dialogues, were invited to identify patients with chronic migraine and record clinical encounters with their patients. Both new patient visits and follow-up visits were included in this analysis. Neurologist-patient dialogues were audio-recorded, anonymized, transcribed, and analyzed by a sociolinguist for the presence of prespecified communication parameters, strategies, and specific language indicative of optimal migraine-related medical care. RESULTS: Fourteen out of the 20 invited neurologists (70.0%) accepted the study invitation and recorded 35 encounters with patients eligible for the study. The patient sample was 91.4% female (n = 32/35), with a mean age of 46 years. On average, there were 17 headache-related questions per visit; 82.0% of questions were closed-ended (n = 369/450). Headache/migraine frequency was elicited in 77.1% of the dialogues (n = 27/35), but headache days per month was assessed in only a single dialogue. Only one neurologist utilized the ask-tell-ask technique. Headache-related disability was discussed in 22.9%of the dialogues (n = 8/35), with only one using open-ended questions. None of the dialogues discussed ictal vs interictal headache-related disability. Chronic migraine was mentioned in 8.6% of dialogues (n = 3/35) and treatment plans were discussed in 37.1% of the dialogues (n = 13/35). CONCLUSIONS: Results from this preliminary study showed that the majority of the neurologist-chronic migraine patient dialogues did not assess elements crucial for diagnosis and treatment (eg, headache days per month and headache related disability) or use standard communication techniques (eg, open-ended questions, ask-tell-ask). We recommend intervention studies designed to assess the benefits of improved communication on diagnostic accuracy, treatment decisions, and patient reported outcomes.

A systematic review of the association between delayed appropriate therapy and mortality among patients hospitalized with infections due to Klebsiella pneumoniae or Escherichia coli: how long is too long?

BACKGROUND: Temporal relationships between the time to appropriate antibiotic therapy and outcomes are not well described. METHODS: A systematic literature review and meta-analysis was performed to examine this relationship in patients hospitalized with Klebsiella pneumoniae or Escherichia coli infections. RESULTS: Twenty identified studies contained data for patients who received delayed appropriate therapy (DAT) versus appropriate antibiotic therapy for these pathogens. Of the 20 included studies, the majority (19/20) focused on patients with bloodstream infections, and only 1 study evaluated patients with pneumonia. When all DAT results were combined (any delay > 24 h from culture collection or any delay after culture and susceptibility reporting [C& SR]), there was an increased risk of mortality (odds ratio [OR], 1.60 [95% CI, 1.25-2.50]). The risk of mortality was greater when DAT > 48 h from culture collection or DAT > C&SR results were combined (OR, 1.76 [95% CI, 1.27-2.44]). CONCLUSIONS: Our findings suggest there is a need to shift current treatment practices away from antibiotic escalation strategies that contribute to delayed appropriate therapy and toward early, relatively aggressive and comprehensive, antibiotic therapy, especially among patients with bloodstream infections due to K. pneumoniae or E. coli.

Persistence and switching patterns of oral migraine prophylactic medications among patients with chronic migraine: A retrospective claims analysis.

Background Migraine prevention guidelines recommend oral prophylactic medications for patients with frequent headache. This study examined oral migraine preventive medication (OMPM) treatment patterns by evaluating medication persistence, switching, and re-initiation in patients with chronic migraine (CM). Methods A retrospective US claims analysis (Truven Health MarketScan® Databases) evaluated patients ≥18 years old diagnosed with CM who had initiated an OMPM between 1 January, 2008 and 30 September, 2012. Treatment persistence was measured at six and 12 months' follow-up. Time-to-discontinuation was assessed for each OMPM and compared using Cox regression models. Among those who discontinued, the proportion that switched OMPMs within 60 days or re-initiated treatment between 61 to 365 days, and their associated persistence rates, were also assessed. Results A total of 8707 patients met the inclusion/exclusion criteria. Persistence to the initial OMPM was 25% at six months and 14% at 12 months. Based on Kaplan-Meier curves, a sharp decline of patients discontinuing was observed by 30 days, and approximately half discontinued by 60 days. Similar trends in time-to-discontinuation were seen following the second or third OMPM. Amitriptyline, gabapentin, and nortriptyline had significantly higher likelihood of non-persistence compared with topiramate. Among patients who discontinued, 23% switched to another prophylactic and 41% re-initiated therapy within one year. Among patients who switched, persistence was between 10 to 13% and among re-initiated patients, persistence was between 4 to 8% at 12 months. Conclusions Persistence to OMPMs is poor at six months and declines further by 12 months. Switching between OMPMs is common, but results indicate that persistence worsens as patients cycle through various OMPMs.

Comparative effectiveness of onabotulinumtoxinA versus oral migraine prophylactic medications on headache-related resource utilization in the management of chronic migraine: Retrospective analysis of a US-based insurance claims database.

BACKGROUND: Migraine, especially chronic migraine (CM), causes substantial disability; however, health care utilization has not been well characterized among patients receiving different migraine prophylactic treatments. METHODS: Using a large, US-based, health care claims database, headache-related health care utilization was evaluated among adults with CM treated with onabotulinumtoxinA or oral migraine prophylactic medications (OMPMs). Headache-related health care utilization was assessed at six, nine, and 12 months pre- and post-treatment. The primary endpoint was the difference between pre- and post-index headache-related health care utilization. A logistic regression model was created to test the difference between onabotulinumtoxinA and OMPM-treated groups for headache-related emergency department (ED) visits and hospitalizations. RESULTS: Baseline characteristics were comparable between groups. The proportion of patients with ED visits or hospitalizations for a headache-related event decreased after starting onabotulinumtoxinA, but increased after starting an OMPM, for all three cohorts. Regression analyses showed that the odds of having a headache-related ED visit were 21%, 20%, and 19% lower and hospitalization were 47%, 48%, and 56% lower for the onabotulinumtoxinA group compared to the OMPM group for the six-month, nine-month, and 12-month post-index periods, respectively. CONCLUSIONS: When compared with similar patients who initiated treatment with OMPM, onabotulinumtoxinA was associated with a significantly lower likelihood of headache-related ED visits and hospitalizations.

OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program.

BACKGROUND: Chronic migraine (CM) is associated with high impact and reduced health-related quality of life (HRQoL). METHODS: Patients with CM from PREEMPT (Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy) were randomized (1:1) to receive onabotulinumtoxinA or placebo for two 12-week cycles in the double-blind (DB) phase, followed by three 12-week cycles of open-label (OL) onabotulinumtoxinA (onabotulinumtoxinA/onabotulinumtoxinA (O/O) and placebo/onabotulinumtoxinA (P/O) groups, respectively). HRQoL endpoints were assessed over 56 weeks using the Headache Impact Test (HIT-6) and the Migraine-Specific Quality of Life Questionnaire (MSQ). HIT-6 score reductions ≥2.3 and ≥5 denoted between-group minimally important difference and within-patient clinically meaningful response, respectively. RESULTS: A total of 1236 participants (O/O, n = 607; P/O, n = 629) participated in both phases. The DB phase showed significantly reduced HIT-6 and MSQ for onabotulinumtoxinA versus placebo (all p < 0.001). The OL phase showed significantly reduced HIT-6 for O/O versus P/O at weeks 28, 36, and 48, but not 56. All three MSQ domains showed improved HRQoL relative to baseline, but only the role restrictive domain showed a significant difference between O/O and P/O at week 56. CONCLUSIONS: Benefits of onabotulinumtoxinA on HRQoL versus baseline persisted throughout the OL phase. Statistical superiority in favor of O/O was demonstrated for HIT-6 through 48 weeks and for MSQ (role restrictive) at 56 weeks.

Improving the detection of chronic migraine: Development and validation of Identify Chronic Migraine (ID-CM).

BACKGROUND: Migraine, particularly chronic migraine (CM), is underdiagnosed and undertreated worldwide. Our objective was to develop and validate a self-administered tool (ID-CM) to identify migraine and CM. METHODS: ID-CM was developed in four stages. (1) Expert clinicians suggested candidate items from existing instruments and experience (Delphi Panel method). (2) Candidate items were reviewed by people with CM during cognitive debriefing interviews. (3) Items were administered to a Web panel of people with severe headache to assess psychometric properties and refine ID-CM. (4) Classification accuracy was assessed using an ICHD-3ß gold-standard clinician diagnosis. RESULTS: Stages 1 and 2 identified 20 items selected for psychometric validation in stage 3 (n = 1562). The 12 psychometrically robust items from stage 3 underwent validity testing in stage 4. A scoring algorithm applied to four symptom items (moderate/severe pain intensity, photophobia, phonophobia, nausea) accurately classified most migraine cases among 111 people (sensitivity = 83.5%, specificity = 88.5%). Augmenting this algorithm with eight items assessing headache frequency, disability, medication use, and planning disruption correctly classified most CM cases (sensitivity = 80.6%, specificity = 88.6%). DISCUSSION: ID-CM is a simple yet accurate tool that correctly classifies most individuals with migraine and CM. Further testing in other settings will also be valuable.

Adherence to oral migraine-preventive medications among patients with chronic migraine.

BACKGROUND: Chronic migraine (CM) is a disabling disorder characterized by ≥15 headache days per month that has been shown to significantly reduce quality of life. Migraine-prevention guidelines recommend preventive medications as the standard of care for patients with frequent migraine. The aim of this study was to assess adherence to 14 commonly prescribed oral migraine-preventive medications (OMPMs) among patients with CM. METHODS: Retrospective claims analysis of a US claim database (Truven MarketScan® Databases) was queried to identify patients who were at least 18 years old, diagnosed with CM, and initiated an OMPM (antidepressants, beta blockers, or anticonvulsants) between January 1, 2008 and September 30, 2012. Medication possession ratios (MPR) and proportion of days covered (PDC) were calculated for each patient. A cutoff of ≥80% was used to classify adherence. The odds of adherence between OMPMs were compared using logistic regression models. RESULTS: Of the 75,870 patients identified with CM, 8688 met the inclusion/exclusion criteria. Adherence ranged between 26% to 29% at six months and 17% to 20% at 12 months depending on the calculation used to classify adherence (PDC and MPR, respectively). Adherence among the 14 OMPMs was similar except for amitriptyline, nortriptyline, gabapentin, and divalproex, which had significantly lower odds of adherence when compared to topiramate. CONCLUSION: Adherence to OMPMs is low among the US CM population at six months and worsens by 12 months.

The negative impact of spasticity on the health-related quality of life of stroke survivors: a longitudinal cohort study.

BACKGROUND: Spasticity often leads to symptomatic and functional problems that can cause disability for stroke survivors. We studied whether spasticity has a negative impact on health-related quality of life (HRQoL). METHODS: As part of the Greater Cincinnati/Northern Kentucky Stroke Study (NCT00642213), 460 ischemic stroke patients were interviewed during hospitalization and then followed over time. HRQoL was measured by the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the Short Form-12 (SF-12), EuroQol-5 dimension (EQ-5D), and Stroke-Specific Quality of Life (SSQOL) instruments, with lower scores indicating worse health. HRQoL differences between stroke survivors with and without spasticity were compared, adjusting for age, race, stroke severity, pre-stroke function, and comorbidities. RESULTS: Of the 460 ischemic stroke patients, 328 had spasticity data available 3 months after their stroke (mean age of 66 years, 49% were female, and 26% were black). Of these patients, 54 (16%) reported having spasticity. Three months following their stroke, patients who reported spasticity had lower mean scores on the PCS (29.6 ± 1.4 vs 37.3 ± 0.6; P < .001), EQ-5D (0.59 ± 0.03 vs 0.71 ± 0.01; P < .001), and SSQOL (3.57 ± 0.08 versus 3.78 ± 0.03; P = .03) compared with patients who did not report spasticity. Lower HRQoL scores were also observed at the 1-year (PCS, EQ-5D, and SSQOL) and 2-year (EQ-5D and SSQOL) interviews in those with spasticity compared with those without spasticity. CONCLUSIONS: Statistically and clinically meaningful differences in HRQoL exist between stroke survivors with and without spasticity.

Treatment persistence and switching in triptan users: a systematic literature review.

OBJECTIVE: To conduct a systematic review to evaluate persistence to and switching of triptan therapy for the acute treatment of migraine. BACKGROUND: Migraine affects over 12% of adults in Western countries and an estimated 36 million people in the United States. Triptans are an abortive treatment option in patients with moderate to severe migraine. Despite the safety and efficacy of triptans reported in clinical trials, observational studies have consistently demonstrated low persistence to therapy and frequent switching among products over time. METHODS: The following databases were researched: Medline, CENTRAL, and EMBASE. Detailed inclusion and exclusion criteria were specified a priori before conducting abstract and full-text screening. Included studies were required to: (1) report triptan use for migraine treatment; (2) report measures of persistence and/or switching patterns; (3) study migraineurs aged 18 years or older; and (4) conduct an observational study. Studies were excluded if they (1) incorporated interventional study design; (2) lack information or relevance to outcome of interest; (3) were not original research; (4) did not clearly state the results; and (5) were not written in English. Abstracts and full-text articles were reviewed independently by two investigators. RESULTS: Out of 595 studies identified, 380 studies were included for abstract screening. A total of 12 articles met the eligibility criteria after full-text screening of 44 studies, including four studies from reference search. The proportion of patients that remained persistent up to six refills of an index triptan ranged from 3.2% to 12.6% and the proportion of patients that never refilled their index triptan ranged from 38% to 65.8%. In addition to those patients who discontinued, several studies reported that 5-9% of newly initiating triptan users switch to a different triptan before refilling their original medication. Finally, several studies reported the 1-year probability of discontinuation among a general group of triptan users (not limited to treatment naïve patients) to be between 30% and 60%. CONCLUSIONS: Triptans can be a valuable option for acute treatment of migraine. However, studies have shown that treatment persistence is low. This, along with frequent switching behaviors, suggests that a significant unmet clinical need remains despite the wide availability of triptans.

Anxiety and depression associated with caregiver burden in caregivers of stroke survivors with spasticity.

OBJECTIVE: To investigate the relationship between anxiety/depression and caregiver burden in informal caregivers of stroke survivors with spasticity. DESIGN: Data were collected via online surveys from informal caregivers 18 years or older who cared for stroke survivors. SETTING: Internet-based survey. PARTICIPANTS: 2007 through 2009 U.S. National Health and Wellness Survey database or Lightspeed Research general panel respondents (N=153). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Anxiety and depression were self-reported by the caregiver as a physician diagnosis. Depression severity was measured by the Patient Health Questionnaire-9 (PHQ-9). Caregiver burden was measured by the Oberst Caregiving Burden Scale (OCBS) and the Bakas Caregiving Outcomes Scale (BCOS). Logistic regression analyses were conducted with anxiety, depression, and the PHQ-9 depression severity categories as a result of each caregiver burden scale. RESULTS: Data were analyzed for 153 informal caregivers; they were mostly women (70.6%) and white (78.4%), with a mean age of 51.6 years. For every 1-point increase in the OCBS Difficulty Scale, the odds of anxiety or depression were 2.57 times as great (P<.001) and 1.88 times as great (P=.007), respectively. The odds of PHQ-9 severe depression versus all other categories combined were 2.48 times as great (P<.001). For every 1-point decrease in the BCOS, the odds of anxiety or depression were 2.43 times as great (P<.001) and 2.27 times as great (P=.002), respectively. The odds of PHQ-9 severe depression versus all other categories combined were 4.55 times as great (P<.001). CONCLUSIONS: As caregiver burden increases, caregivers are more likely to have anxiety and depression. Depression severity also increases. Providing treatment to stroke survivors with spasticity that lessens the time and more importantly, the difficulty of caregiving may lead to a reduction in caregiver anxiety and depression.

Development of a poststroke checklist to standardize follow-up care for stroke survivors.

BACKGROUND: Long-term care for stroke survivors is fragmented and lacks an evidence-based, easy-to-use tool to identify persistent long-term problems among stroke survivors and streamline referral for treatment. We sought to develop a poststroke checklist (PSC) to help health care professionals identify poststroke problems amenable to treatment and subsequent referral. METHODS: An instrument development team, supported by measurement experts, international stroke experts, and poststroke care stakeholders, was created to develop a long-term PSC. A list of long-term poststroke problem areas was generated by an international, multidisciplinary group of stroke experts, the Global Stroke Community Advisory Panel. Using Delphi methods, a consensus was reached on which problem areas on the list were most important and relevant to include in a PSC. The instrument development team concurrently created the actual checklist, which provided example language about how to ask about poststroke problem areas and linked patient responses to a specific referral process. RESULTS: Eleven long-term poststroke problem areas were rated highly and consistently among stroke experts participating in the Delphi process (n = 12): secondary prevention, activities of daily living, mobility, spasticity, pain, incontinence, communication, mood, cognition, life after stroke, and relationship with caregiver. These problem areas were included in the long-term PSC. CONCLUSIONS: The PSC was developed to be a brief and easy-to-use tool, intended to facilitate a standardized approach for health care providers to identify long-term problems in stroke survivors and to facilitate appropriate referrals for treatment.

Total healthcare cost savings through improved bipolar I disorder identification using the Rapid Mood Screener in patients diagnosed with major depressive disorder.

INTRODUCTION: Misdiagnosis of bipolar I disorder (BP-I) as major depressive disorder (MDD) leads to increased healthcare resource utilization and costs. The cost-effectiveness of the Rapid Mood Screener (RMS), a tool to identify BP-I in patients with depressive symptoms, was assessed in patients diagnosed with MDD presenting with depressive episodes. METHODS: A decision-tree model of a hypothetical cohort of 1000 patients in a US health plan was used to estimate the number of correct diagnoses and overall total, direct healthcare costs over a 3-year timeframe for RMS-screened versus unscreened patients. Model inputs included the prevalence of BP-I in patients diagnosed with MDD, RMS sensitivity/specificity, and the cost of misdiagnosing BP-I as MDD. RESULTS: Screening with the RMS resulted in 171, 159, and 143 additional correct BP-I or MDD diagnoses at Years 1, 2, and 3, respectively. Total healthcare plan cost savings were $1279 per patient in Year 1. Cumulative cost savings per patient for RMS screening versus no RMS screening were $2307 over 2 years and $3011 over 3 years. Scenario analyses showed that the RMS would remain cost-saving assuming a lower prevalence of BP-I (20% or 10%) versus the base case (24.3%). CONCLUSION: The RMS is a cost-effective tool to identify BP-I in patients who would otherwise be misdiagnosed with MDD. Screening with the RMS resulted in cost-savings over 3 years, with model results remaining robust even with lower prevalence of BP-I and reduced RMS sensitivity assumptions.

Healthcare resource utilization and costs among patients with post-stroke spasticity before and after spasticity management including onabotulinumtoxina.

BACKGROUND: Real-world data regarding the impact of onabotulinumtoxinA on healthcare resource utilization and costs for post-stroke spasticity are scarce. OBJECTIVE: To compare differences in 12-month healthcare resource utilization and costs before and after post-stroke spasticity management including onabotulinumtoxinA. METHODS: This retrospective claims analysis of IBM MarketScan Commercial and Medicare Supplemental databases included adults with ≥ 1 onabotulinumtoxinA claim for post-stroke spasticity (1 January 2010 to 30 June 2018) and continuous enrolment for ≥ 12 months pre- and post-index (first onabotulinumtoxinA claim date). All-cause and spasticity-related healthcare resource utilization and costs were compared 12 months pre- and post-index (McNemar's χ2 test or paired t-test). A subgroup analysis assessed effect of stroke-to-index interval on costs. RESULTS: Among 735 patients, mean (standard deviation) stroke-date-to-index-date interval was 284.5 (198.8) days. Decreases were observed post-index for mean all-cause outpatient (62.9 vs 60.5; p ≤ 0.05) and emergency department visits (1.1 vs 0.8; p ≤ 0.0001), and hospital admissions (1.5 vs 0.4; p ≤ 0.0001). Increase in prescription fills (43.0 vs 53.7) was seen post-index. Post-index decreases in all-cause (-66%) and spasticity-related (-51%) costs were driven by reduced inpatient care costs. Findings were consistent regardless of stroke-date-to-index-date interval. CONCLUSION: Significant reductions in healthcare resource utilization and costs were observed after 1 year of post-stroke spasticity management including onabotulinumtoxinA. Long-term studies are needed to establish causality.

Cost-effectiveness of overactive bladder treatments from a US commercial and payer perspective.

Aim: The cost-effectiveness of treatment options (anticholinergics, ß3-adrenoceptor agonists, onabotulinumtoxinA, sacral nerve stimulation and percutaneous tibial stimulation [the latter two including new rechargeable neurostimulators]) for the management of overactive bladder (OAB) were compared with best supportive care (BSC) using a previously published Markov model. Materials & methods: Cost-effectiveness was evaluated over a 15-year time horizon, and sensitivity analyses were performed using 2- and 5-year horizons. Discontinuation rates, resource utilization, and costs were derived from published sources. Results: Using Medicare and commercial costs over a 15-year time period, onabotulinumtoxinA 100U had incremental cost-effectiveness ratios (ICERs) gained of $39,591/quality-adjusted life-year (QALY) and $42,255/QALY, respectively, versus BSC, which were the lowest ICERs of all assessed treatments. The sensitivity analyses at 2- and 5-year horizons also showed onabotulinumtoxinA to be the most cost-effective of all assessed treatments versus BSC. Conclusion: OnabotulinumtoxinA 100U is currently the most cost-effective treatment for OAB.

Place of care and costs associated with acute episodes and remission in schizophrenia.

BACKGROUND: Schizophrenia imposes significant economic burden on patients, families, caregivers, and society. To our knowledge, place of care and associated costs of acute schizophrenia episodes have not been well characterized. OBJECTIVE: To describe the care settings and costs associated with likely acute episodes and untreated remission periods among patients with schizophrenia. METHODS: Adults with schizophrenia were identified using the IBM MarketScan Commercial and Medicare Supplemental databases (2009-2018); claims for capitated benefits plans were excluded. Acute episode index date was defined as at least 1 inpatient schizophrenia claim or outpatient schizophrenia claim (frequency of claim dependent on visit type, such as hospitalization, emergency department, private practice, clinic, urgent care, or laboratory). Mental health-related medical costs (health plan+patient) associated with acute episodes were collected over a 2-month follow-up period and stratified by setting (inpatient vs outpatient); acute episode data were reported in subgroups of patients without or with prior clozapine use, as an indication of disease severity. Remission index date was defined as at least 1 outpatient claim with a schizophrenia diagnosis with no acute episode and no oral or injectable antipsychotic therapy. Remission costs were assessed over a 3-month period. All data were analyzed descriptively. RESULTS: A total of 14,824 patients with schizophrenia met criteria for an acute episode (12,896 [87.0%] without prior clozapine use; 1,427 [9.6%] with prior clozapine use). Most acute episodes were treated in an outpatient setting (all patients, 76.3%; without prior clozapine use, 74.5%; with prior clozapine use, 87.1%). When treated inpatient, mean (SD) episode medical costs were $17,045 ($28,101) for all patients, $16,060 ($22,786) for those without prior clozapine use, and $22,827 ($55,860) for those with prior clozapine use. When treated outpatient, mean (SD) medical costs for acute episodes were $2,478 ($6,961) for all patients, $2,609 ($7,068) for those without prior clozapine use, and $1,770 ($6,560) for those with prior clozapine use. For all patients with acute episodes, regardless of clozapine use, patient-incurred out-of-pocket costs were approximately 30% of total medical costs. For an untreated period of remission, 6,950 patients with schizophrenia met criteria. Total medical costs were $2,399 for these patients over a 3-month period. CONCLUSIONS: The majority of acute schizophrenia episodes were treated in the outpatient setting. For episodes that required inpatient care, inpatient episodes were approximately 7 times more costly than episodes treated in outpatient-only settings. For acute episodes and remission periods, health plans covered most costs; however, there were additional patient-incurred out-of-pocket costs. DISCLOSURES: All authors met the International Committee of Medical Journal Editors authorship criteria. Neither honoraria nor payments were made for authorship. Dr McIntyre has received research grant support from CIHR/GACD/National Natural Science Foundation of China (NSFC) and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, AbbVie, Atai Life Sciences. Dr McIntyre is a CEO of Braxia Scientific Corp. Mr Doan, Dr Amari, and Mr Mercer are employees of Genesis Research, which was funded to perform the study. Ms Higa, Dr Gillard, and Dr Harrington were employees of AbbVie at the time of the study and may hold stock. This study was sponsored by AbbVie.

Real-world persistence and costs among patients with chronic migraine treated with onabotulinumtoxinA or calcitonin gene-related peptide monoclonal antibodies.

BACKGROUND: Chronic migraine (CM) is a common neurologic disorder that imposes substantial burden on payers, patients, and society. Low rates of persistence to oral migraine preventive medications have been previously documented; however, less is known about persistence and costs associated with innovative nonoral migraine preventive medications. OBJECTIVE: To evaluate real-world persistence and costs among adults with CM treated with onabotulinumtoxinA (onabotA) or calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs). METHODS: This was a retrospective, longitudinal, observational study analyzing the IBM MarketScan Commercial and Medicare databases. The study sample included adults with CM initiating treatment with either onabotA or a CGRP mAb on or after January 1, 2018. Persistence and costs over 12 months after treatment initiation were evaluated using chi-square and Student's t-tests. Persistence to onabotA was compared with CGRP mAbs as a weighted average of the class and by individual CGRP mAbs. Mean pharmacy (acute and preventive), medical (inpatient, emergency department, and outpatient), and total costs are reported. Multivariate regression analyses were conducted to generate adjusted estimates of persistence and costs after controlling for potential confounders (age, sex, region, insurance type, number of baseline comorbidities, Charlson Comorbidity Index, and number of previously used oral migraine preventive medications). RESULTS: Of 66,303 individuals with onabotA or CGRP mAb claims, 2,697 with CM met the inclusion/exclusion criteria. In the total population, individuals were primarily female (85.5%), lived in the South (48.5%), and had a mean (SD) age of 44 (12) years, which was consistent across the onabotA and CGRP mAb cohorts. Common comorbid conditions included anxiety (23.9%), depression (18.2%), hypertension (16.5%), and sleep disorders (16.9%). After adjusting for potential confounding variables, persistence to onabotA during the 12-month follow-up period was 40.7% vs 27.8% for CGRP mAbs (odds ratio [OR] = 0.683; 95% CI = 0.604-0.768; P < 0.0001). Persistence to erenumab, fremanezumab, and galcanezumab was 25.5% (OR = 0.627; 95% CI = 0.541-0.722; P < 0.0001), 30.3% (OR = 0.746; 95% CI = 0.598-0.912; P = 0.0033), and 33.7% (OR = 0.828; 95% CI = 0.667-1.006; P = 0.058). All-cause ($18,292 vs $18,275; P = 0.9739) and migraine-related ($8,990 vs $9,341; P = 0.1374) costs were comparable between the onabotA and CGRP mAb groups. CONCLUSIONS: Among adults with CM receiving onabotA and CGRP mAbs, individuals initiating onabotA treatment had higher persistence compared with those receiving CGRP mAbs. Total all-cause and migraine-related costs over 12 months were comparable between those receiving onabotA and CGRP mAbs. DISCLOSURES: This study was sponsored by Allergan (prior to its acquisition by AbbVie), they contributed to the design and interpretation of data and the writing, reviewing, and approval of final version. Writing and editorial assistance was provided to the authors by Dennis Stancavish, MS, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and was funded by AbbVie. The opinions expressed in this article are those of the authors. The authors received no honorarium/fee or other form of financial support related to the development of this article. Dr Schwedt serves on the Board of Directors for the American Headache Society and the American Migraine Foundation. Within the prior 12 months he has received research support from Amgen, Henry Jackson Foundation, Mayo Clinic, National Institutes of Health, Patient-Centered Outcomes Research Institute, SPARK Neuro, and US Department of Defense. Within the past 12 months, he has received personal compensation for serving as a consultant or advisory board member for AbbVie, Allergan, Axsome, BioDelivery Science, Biohaven, Collegium, Eli Lilly, Ipsen, Linpharma, Lundbeck, and Satsuma. He holds stock options in Aural Analytics and Nocira. He has received royalties from UpToDate. Dr Lee and Ms Shah are employees of AbbVie and may hold AbbVie stock. Dr Gillard was an employee of AbbVie and may hold AbbVie stock. Dr Knievel has served as a consultant for AbbVie, Amgen, Eli Lilly, and Biohaven; conducted research for AbbVie, Amgen, and Eli Lilly; and is on speaker programs for AbbVie and Amgen. Dr McVige has served as a speaker and/or received research support from Allergan (now AbbVie Inc.), Alder, Amgen/Novartis, Avanir, Biohaven, Eli Lilly, Lundbeck, and Teva. Ms Wang and Ms Wu are employees of Genesis Research, which provides consulting services to AbbVie. Dr Blumenfeld, within the past 12 months, has served on advisory boards for Allergan, AbbVie, Aeon, Alder, Amgen, Axsome, BDSI, Biohaven, Impel, Lundbeck, Lilly, Novartis, Revance, Teva, Theranica, and Zosano; as a speaker for Allergan, AbbVie, Amgen, BDSI, Biohaven, Lundbeck, Lilly, and Teva; as a consultant for Allergan, AbbVie, Alder, Amgen, Biohaven, Lilly, Lundbeck, Novartis, Teva, and Theranica; and as a contributing author for Allergan, AbbVie, Amgen, Biohaven, Novartis, Lilly, and Teva. He has received grant support from AbbVie and Amgen. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (eg, protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. Data requests can be submitted at any time after approval in the United States and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvieclinicaltrials.com/hcp/data-sharing/.

Healthcare resource utilization and costs for patients with postoperative atrial fibrillation in the United States.

BACKGROUND: Postoperative atrial fibrillation (POAF) is one of the most common complications following cardiac surgery. POAF is associated with increased hospitalization costs, but its long-term economic burden is not well defined. OBJECTIVE: To assess 30-day and 1-year incremental healthcare resource utilization (HRU) and costs associated with POAF in the United States (US). METHODS: This retrospective cohort study used claims data from the IBM Watson MarketScan database. A cohort of US adults aged 55--90 years who underwent open-heart surgery between 1 January 2017 and 31 December 2018 was used to compare patients who experienced POAF versus patients who did not (controls). The outcomes of interest were incremental HRU and costs, which were assessed during the index hospitalization and 30-day and 1-year postdischarge time periods. Inverse probability weighting was used to adjust for differences in baseline characteristics. RESULTS: A total of 8,020 patients met the study inclusion criteria with 5,765 patients in the control cohort (mean age, 63.4 years) and 2,255 patients in the POAF cohort (mean age, 65.8 years). After adjustment, patients with POAF had an index hospitalization that was 1.9 days longer (99% CI, 1.3-2.4 days; p < 0.001) and cost $13,919 more (99% CI, $2,828-$25,011; p < 0.001) than for patients without POAF. POAF patients also had significantly higher HRU at 30 days and 1-year postdischarge with incremental costs of $4,649 (99% CI, $1,479-$7,819; p < 0.001) and $10,671 (99% CI, $2,407-$18,935; p < 0.001), respectively. CONCLUSION: POAF following open-heart surgery poses a significant economic burden up to 1 year postdischarge.

Mapping from disease-specific measures to health-state utility values in individuals with migraine.

OBJECTIVE: The objective of this study was to develop empirical algorithms that estimate health-state utility values from disease-specific quality-of-life scores in individuals with migraine. METHODS: Data from a cross-sectional, multicountry study were used. Individuals with episodic and chronic migraine were randomly assigned to training or validation samples. Spearman's correlation coefficients between paired EuroQol five-dimensional (EQ-5D) questionnaire utility values and both Headache Impact Test (HIT-6) scores and Migraine-Specific Quality-of-Life Questionnaire version 2.1 (MSQ) domain scores (role restrictive, role preventive, and emotional function) were examined. Regression models were constructed to estimate EQ-5D questionnaire utility values from the HIT-6 score or the MSQ domain scores. Preferred algorithms were confirmed in the validation samples. RESULTS: In episodic migraine, the preferred HIT-6 and MSQ algorithms explained 22% and 25% of the variance (R(2)) in the training samples, respectively, and had similar prediction errors (root mean square errors of 0.30). In chronic migraine, the preferred HIT-6 and MSQ algorithms explained 36% and 45% of the variance in the training samples, respectively, and had similar prediction errors (root mean square errors 0.31 and 0.29). In episodic and chronic migraine, no statistically significant differences were observed between the mean observed and the mean estimated EQ-5D questionnaire utility values for the preferred HIT-6 and MSQ algorithms in the validation samples. CONCLUSIONS: The relationship between the EQ-5D questionnaire and the HIT-6 or the MSQ is adequate to use regression equations to estimate EQ-5D questionnaire utility values. The preferred HIT-6 and MSQ algorithms will be useful in estimating health-state utilities in migraine trials in which no preference-based measure is present.