Publications

2017

Kabiri, Mina, Jagpreet Chhatwal, Julie M Donohue, Mark S Roberts, Everette James, Michael A Dunn, and Walid F Gellad. (2017) 2017. “Long-Term Disease and Economic Outcomes of Prior Authorization Criteria for Hepatitis C Treatment in Pennsylvania Medicaid.”. Healthcare (Amsterdam, Netherlands) 5 (3): 105-11. https://doi.org/10.1016/j.hjdsi.2016.11.001.

BACKGROUND: Several highly effective but costly therapies for hepatitis C virus (HCV) are available. As a consequence of their high price, 36 state Medicaid programs limited treatment coverage to patients with more advanced HCV stages. States have only limited information available to predict the long-term impact of these decisions.

METHODS: We adapted a validated hepatitis C microsimulation model to the Pennsylvania Medicaid population to estimate the existing HCV prevalence in Pennsylvania Medicaid and estimate the impact of various HCV drug coverage policies on disease outcomes and costs. Outcome measures included rates of advanced-stage HCV outcomes and treatment and disease costs in both Medicaid and Medicare.

RESULTS: We estimated that 46,700 individuals in Pennsylvania Medicaid were infected with HCV in 2015, 33% of whom were still undiagnosed. By expanding treatment to include mild fibrosis stage (Metavir F2), Pennsylvania Medicaid will spend an additional $273 million on medications in the next decade with no substantial reduction in the incidence of liver cancer or liver-related death. Medicaid patients who are not eligible for treatment under restricted policies would get treatment once they transition to the Medicare program, which would incur 10% reduction in HCV-related costs due to early treatment in Medicaid. Further expanding treatment to patients with early fibrosis stages (F0 or F1) would cost Medicaid an additional $693 million during the next decade but would reduce the number of individuals in need of treatment in Medicare by 46% and decrease Medicare treatment costs by 23%. In some scenarios, outcomes could worsen with eligibility expansion if there is inadequate capacity to treat all patients.

CONCLUSIONS AND RELEVANCE: Expansion of HCV treatment coverage to less severe stages of liver disease may not substantially improve liver related outcomes for patients in Pennsylvania Medicaid in scenarios in which coverage through Medicare is widely available.

Progovac, Ana M, Julie M Donohue, Karen A Matthews, Chung-Chou H Chang, Elizabeth B Habermann, Lewis H Kuller, Juliann Saquib, et al. (2017) 2017. “Optimism Predicts Sustained Vigorous Physical Activity in Postmenopausal Women.”. Preventive Medicine Reports 8: 286-93. https://doi.org/10.1016/j.pmedr.2017.10.008.

Optimism and cynical hostility are associated with health behaviors and health outcomes, including morbidity and mortality. This analysis assesses their association with longitudinal vigorous physical activity (PA) in postmenopausal women of the Women's Health Initiative (WHI). Subjects include 73,485 women nationwide without history of cancer or cardiovascular disease (CVD), and no missing baseline optimism, cynical hostility, or PA data. The Life Orientation Test-Revised Scale measured optimism. A Cook Medley questionnaire subscale measured cynical hostility. Scale scores were divided into quartiles. Vigorous PA three times or more per week was assessed via self-report at study baseline (1994-1998) and through follow-up year 6. Descriptive analysis mapped lifetime trajectories of vigorous PA (recalled at ages 18, 25, 50; prospectively assessed at baseline, and 3 and 6 years later). Hierarchical generalized linear mixed models examined the prospective association between optimism, cynical hostility, and vigorous PA over 6 years. Models adjusted for baseline sociodemographic variables, psychosocial characteristics, and health conditions and behaviors. Vigorous PA rates were highest for most optimistic women, but fell for all women by approximately 60% between age 50 and study baseline. In adjusted models from baseline through year 6, most vs. least optimistic women were 15% more likely to exercise vigorously (p < 0.001). Cynical hostility was not associated with lower odds of longitudinal vigorous PA after adjustment. Results did not differ by race/ethnicity or socioeconomic status. Higher optimism is associated with maintaining vigorous PA over time in post-menopausal women, and may protect women's health over the lifespan.

Joyce, Nina R, Haiden A Huskamp, Scott E Hadland, Julie M Donohue, Shelly F Greenfield, Elizabeth A Stuart, and Colleen L Barry. (2017) 2017. “The Alternative Quality Contract: Impact on Service Use and Spending for Children With ADHD.”. Psychiatric Services (Washington, D.C.) 68 (12): 1210-12. https://doi.org/10.1176/appi.ps.201700143.

In 2009, Blue Cross-Blue Shield of Massachusetts (BCBSMA) implemented the alternative quality contract (AQC), which pays provider organizations a global payment for all services used by enrollees. BCBSMA claims for 2006-2011 were used to compare youths enrolled in provider organizations participating in the AQC (7,407 person-years [PYs]) with those not participating (45,398 PYs). Difference-in-differences models estimated changes in mental health and substance abuse treatment service utilization and spending attributable to the AQC. The AQC was associated with small increases in the probability of any outpatient visits and in the probability and number of medication management visits among children with attention-deficit hyperactivity disorder (ADHD). Spending did not change, and there was no evidence of reductions in service utilization or spending for children with ADHD in the first three years of AQC implementation.

Almutairi, Abdulaali R, Lili Zhou, Walid F Gellad, Jeannie K Lee, Marion K Slack, Jennifer R Martin, and Wei-Hsuan Lo-Ciganic. (2017) 2017. “Effectiveness and Safety of Non-Vitamin K Antagonist Oral Anticoagulants for Atrial Fibrillation and Venous Thromboembolism: A Systematic Review and Meta-Analyses.”. Clinical Therapeutics 39 (7): 1456-1478.e36. https://doi.org/10.1016/j.clinthera.2017.05.358.

PURPOSE: The findings from the observational studies comparing the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) for atrial fibrillation (AF) and venous thromboembolism (VTE) are inconsistent. We conducted separate meta-analyses examining the efficacy/effectiveness and safety of NOACs versus VKAs by disease (AF vs VTE), study design (randomized controlled trials [RCTs] vs observational studies), and NOAC (dabigatran, rivaroxaban, apixaban, and edoxaban).

METHODS: The main data sources included PubMed/MEDLINE, EMBASE, Web of Science, CINAHL, and Scopus from January 1, 2005, to February 15, 2016. We searched for Phase III RCTs and observational studies comparing NOACs versus VKAs. The primary outcomes were stroke/systemic embolism (SE) for AF; recurrent VTE/fatal pulmonary embolism (PE) for VTE; and major bleeding for both conditions. Secondary outcomes included stroke and myocardial infarction (MI) for AF, recurrent deep vein thrombosis (DVT)/PE for VTE, and mortality, intracranial hemorrhage (ICH), and gastrointestinal bleeding for both conditions. Pooled hazard ratios (HRs) were reported by using inverse variance-weighted random effects models.

FINDINGS: A total of 13 RCTs and 27 observational studies (AF, n = 32; VTE, n = 8) were included. For AF, dabigatran and VKAs were comparable for stroke/SE risk in 1 RCT (HR, 0.77 [95% CI, 0.57-1.03]) and 6 observational studies (HR, 1.03 [95% CI, 0.83-1.27]). Rivaroxaban had a 20% decreased risk of stroke/SE in 3 RCTs (HR, 0.80 [95% CI, 0.67-0.95]) compared with VKA, but the effect was nonsignificant in 3 observational studies (HR, 0.78 [95% CI, 0.59-1.04]). Apixaban decreased stroke/systemic embolism risk (HR, 0.79 [95% CI, 0.66-0.95]) compared with VKA in 1 RCT, but edoxaban was comparable to VKA (HR, 0.99 [95% CI, 0.77-1.28]) in 1 RCT (no observational studies available for apixaban/edoxaban). Dabigatran, apixaban, and edoxaban decreased the risk of hemorrhagic stroke, mortality, major bleeding, and ICH by 10% to 71% compared with VKAs but not rivaroxaban. For VTE, NOACs and VKAs were comparable for recurrent VTE/fatal PE/DVT/PE risk in 7 RCTs and 1 observational study. The 7 RCTs demonstrated a 32% to 69% decreased risk of major bleeding for dabigatran, rivaroxaban, and apixaban compared with VKAs. No difference was shown in 1 rivaroxaban observational study (HR, 0.77 [95% CI, 0.40-1.49]) and 1 edoxaban RCT (HR, 0.84 [95% CI, 0.59-1.20]). Except for dabigatran, the NOACs had a 61% to 86% decreased risk of ICH and gastrointestinal bleeding.

IMPLICATIONS: Overall, NOACs were comparable or superior to VKAs. Although no observational studies are currently available for apixaban/edoxaban, a few notable inconsistencies exist for dabigatran (ischemic stroke, MI) and rivaroxaban (stroke/SE, major bleeding in VTE) between RCTs and observational studies. Individualizing NOAC/VKA therapy based on benefit/safety profiles and patient characteristics is suggested.

Cochran, Gerald, Adam J Gordon, Walid F Gellad, Chung-Chou H Chang, Wei-Hsuan Lo-Ciganic, Carroline Lobo, Evan Cole, et al. (2017) 2017. “Medicaid Prior Authorization and Opioid Medication Abuse and Overdose.”. The American Journal of Managed Care 23 (5): e164-e171.

OBJECTIVES: The US opioid medication epidemic has resulted in serious health consequences for patients. Formulary management tools adopted by payers, specifically prior authorization (PA) policies, may lower the rates of opioid medication abuse and overdose. We compared rates of opioid abuse and overdose among enrollees in plans that varied in their use of PA from "High PA" (ie, required PA for 17 to 74 opioids), with "Low PA" (ie, required PA for 1 opioid), and "No PA" policies for opioid medications.

STUDY DESIGN: Retrospective cohort study of patients initiating opioid treatment in Pennsylvania Medicaid from 2010 to 2012.

METHODS: Generalized linear models with generalized estimating equations were employed to assess the relationships between the presence of PA policies and opioid medication abuse and overdose, as measured in Medicaid claims data, adjusting for demographics, comorbid health conditions, benzodiazepine/muscle relaxant use, and emergency department use.

RESULTS: The study cohort included 297,634 enrollees with a total of 382,828 opioid treatment episodes. Compared with plans with No PA, enrollees in High PA (adjusted rate ratio [ARR], 0.89; 95% confidence interval [CI], 0.85-0.93; P <.001) and Low PA plans (ARR, 0.93; 95% CI, 0.87-1.00; P = .04) had lower rates of abuse. Enrollees in the Low PA plan had a lower rate of overdose than those within plans with No PA (ARR, 0.75; 95% CI, 0.59-0.95; P = .02). High PA plan enrollees were also less likely than No PA enrollees to experience an overdose, but this association was not statistically significant (ARR, 0.88; 95% CI, 0.76-1.02; P = .08).

CONCLUSIONS: Enrollees within Medicaid plans that utilize PA policies appear to have lower rates of abuse and overdose following initiation of opioid medication treatment.

Cochran, Gerald, Adam J Gordon, Wei-Hsuan Lo-Ciganic, Walid F Gellad, Winfred Frazier, Carroline Lobo, Chung-Chou H Chang, Ping Zheng, and Julie M Donohue. (2017) 2017. “An Examination of Claims-Based Predictors of Overdose from a Large Medicaid Program.”. Medical Care 55 (3): 291-98. https://doi.org/10.1097/MLR.0000000000000676.

BACKGROUND: Health systems may play an important role in identification of patients at-risk of opioid medication overdose. However, standard measures for identifying overdose risk in administrative data do not exist.

OBJECTIVE: Examine the association between opioid medication overdose and 2 validated measures of nonmedical use of prescription opioids within claims data.

RESEARCH DESIGN: A longitudinal retrospective cohort study that estimated associations between overdose and nonmedical use.

SUBJECTS: Adult Pennsylvania Medicaid program 2007-2012 patients initiating opioid treatment who were: nondual eligible, without cancer diagnosis, and not in long-term care facilities or receiving hospice.

MEASURES: Overdose (International Classification of Disease, ninth edition, prescription opioid poisonings codes), opioid abuse (opioid use disorder diagnosis while possessing an opioid prescription), opioid misuse (a composite indicator of number of opioid prescribers, number of pharmacies, and days supplied), and dose exposure during opioid treatment episodes.

RESULTS: A total of 372,347 Medicaid enrollees with 583,013 new opioid treatment episodes were included in the cohort. Opioid overdose was higher among those with abuse (1.5%) compared with those without (0.2%, P<0.001). Overdose was higher among those with probable (1.8%) and possible (0.9%) misuse compared with those without (0.2%, P<0.001). Abuse [adjusted rate ratio (ARR), 1.52; 95% confidence interval (CI), 1.10-2.10), probable misuse (ARR, 1.98; 95% CI, 1.46-2.67), and possible misuse (ARR, 1.76; 95% CI, 1.48-2.09) were associated with significantly more events of opioid medication overdose compared with those without.

CONCLUSIONS: Claims-based measures can be used by health systems to identify individuals at-risk of overdose who can be targeted for restrictions on opioid prescribing, dispensing, or referral to treatment.

Lo-Ciganic, W-H, L Floden, J K Lee, E L Ashbeck, L Zhou, C Chinthammit, A W Purdy, and C K Kwoh. (2017) 2017. “Analgesic Use and Risk of Recurrent Falls in Participants With or at Risk of Knee Osteoarthritis: Data from the Osteoarthritis Initiative.”. Osteoarthritis and Cartilage 25 (9): 1390-98. https://doi.org/10.1016/j.joca.2017.03.017.

OBJECTIVE: Few studies have compared the risk of recurrent falls across different types of analgesic use, and with limited adjustment for potential confounders (e.g., pain/depression severity). We assessed analgesic use and the subsequent risk of recurrent falls, among participants with or at risk of knee osteoarthritis (OA).

METHODS: A longitudinal analysis included 4231 participants aged 45-79 years at baseline with 4-year follow-up from the Osteoarthritis Initiative (OAI) cohort study. We grouped participants into six mutually exclusive subgroups based on annually assessed analgesic use in the following hierarchical order of analgesic/central nervous system (CNS) potency: use of (1) opioids, (2) antidepressants, (3) other prescription pain medications, (4) over-the-counter (OTC) pain medications, (5) nutraceuticals, and (6) no analgesics. We used multivariable modified Poisson regression models with a robust error variance to estimate the effect of analgesic use on the risk of recurrent falls (≥2) in the following year, adjusted for demographics and health status/behavior factors.

RESULTS: Opioid use increased from 2.7% at baseline to 3.6% at the 36-month visit (>80% using other analgesics/nutraceuticals), while other prescription pain medication use decreased from 16.7% to 11.9% over this time period. Approximately 15% of participants reported recurrent falls. Compared to those not using analgesics, participants who used opioids and/or antidepressants had a 22-25% increased risk of recurrent falls (opioids: RRadjusted = 1.22, 95% CI = 1.04-1.45; antidepressants: RRadjusted = 1.25, 95% CI = 1.10-1.41).

CONCLUSION: Participants with or at risk of knee OA who used opioids and antidepressants with/without other analgesics/nutraceuticals may have an increased risk of recurrent falls after adjusting for potential confounders. Use of opioids and antidepressants warrants caution.

Frazier, Winfred, Gerald Cochran, Wei-Hsuan Lo-Ciganic, Walid F Gellad, Adam J Gordon, Chung-Chou H Chang, and Julie M Donohue. (2017) 2017. “Medication-Assisted Treatment and Opioid Use Before and After Overdose in Pennsylvania Medicaid.”. JAMA 318 (8): 750-52. https://doi.org/10.1001/jama.2017.7818.

This study uses Medicaid data to compare prescription opioid use, duration of opioid use, and rates of medication-assisted treatment (buprenorphine, methadone, or naltrexone) among enrollees before and after an overdose event.

Fulkerson, Justin S, Heather M Moore, Tristan S Anderson, and Robert F Lowe. (2017) 2017. “Ultrasonography in the Preoperative Difficult Airway Assessment.”. Journal of Clinical Monitoring and Computing 31 (3): 513-30. https://doi.org/10.1007/s10877-016-9888-7.

To evaluate the utility of ultrasound for detection of the difficult intubation in a preoperative setting. PubMed, Ovid, CINAHL Plus Full Text, and Google Scholar searches using ["difficult airway" OR "difficult intubation" OR "difficult laryngoscopy" OR "difficult ventilation"] AND [ultrasonography OR sonography OR ultrasound] without date limitations. Abstracts without publications, case reports, letters, textbooks, unrelated topics, or foreign language articles were excluded. Ancestry references were included from the reviewed articles. Two reviewers independently performed the query. Each study was reviewed using the STARD checklist to assess blinding, incomplete data reporting, subject attrition, and selection of appropriate statistical tests. Ten studies were included. All used convenience sampling of adult subjects requiring direct laryngoscopy in elective surgical settings. One study is retrospective and nine are prospective observational. Populations included non-obese, obese, pregnant, and thyroidectomy patients in the United States, Turkey, Israel, Canada, Portugal, and China. Airway locations scanned are variable using different protocols and patient positioning. The outcome variable is uniformly the Cormack-Lehane Grade. 114 of the 681 total subjects had difficult laryngoscopies. Significance for sonographic prediction of difficult laryngoscopy occurred at three locations: hyomental distance [52.6 ± 5.8 mm (p < 0.01)], anterior tissue at the hyoid bone [16.9 mm (95 % CI 11.9-21.9) and 15.9 ± 2.7 mm (p < 0.0001)], and the thyrohyoid membrane [34.7 mm (95 % CI 28.8-40.7) and 23.9 ± 3.4 mm (p < 0.0001) and 28.25 ± 4.43 mm (p < 0.001)]. The vocal cords and sternal notch levels have conflicting significance. Limitations include the heterogeneous populations and lack of standard scanning protocols.