Publications

2015

Alvarez, Carlos A, Eric M Mortensen, Una E Makris, Dan R Berlowitz, Laurel A Copeland, Chester B Good, Megan E Amuan, and Mary Jo Pugh V. (2015) 2015. “Association of Skeletal Muscle Relaxers and Antihistamines on Mortality, Hospitalizations, and Emergency Department Visits in Elderly Patients: A Nationwide Retrospective Cohort Study.”. BMC Geriatrics 15: 2. https://doi.org/10.1186/1471-2318-15-2.

BACKGROUND: High-risk medication exposure in the elderly is common and associated with increased mortality, hospitalizations, and emergency department (ED) visits. Skeletal muscle relaxants and antihistamines are high-risk medications commonly prescribed in elderly patients. The objective of this study was to determine the association between skeletal muscle relaxants or antihistamines and mortality, hospitalizations, and emergency department visits.

METHODS: This study used a new-user, retrospective cohort design using national Veteran Affairs (VA) data from 128 hospitals. Veterans ≥65 years of age on October 1, 2005 who received VA inpatient/outpatient care at least once in each of fiscal year (FY) 2005 and FY 2006 were included. Exposure to skeletal muscle relaxants and antihistamines was defined by the National Committee for Quality Assurance Healthcare Effectiveness Data and Information Set measures for high-risk medications in the elderly. Primary outcomes identified within one year of exposure were death, ED visit, or hospitalization; ED visits or hospitalizations due to falls and fracture were also assessed. Propensity score matching (1 to 1 match) was used to balance covariates between exposed patients and non-exposed patients.

RESULTS: In this cohort of 1,807,404 patients 55,566 patients were included in the propensity-matched cohort for skeletal muscle relaxants and 60,058 patients were included in the propensity-matched cohort for anti-histamines. Mortality was lower in skeletal muscle relaxants-exposed patients (adjusted odds ratio [AOR] 0.87, 95% CI 0.81-0.94), but risk of emergency care (AOR 2.25, 95% CI 2.16-2.33) and hospitalization (AOR 1.56, 95% CI 1.48-1.65) was higher for patients prescribed skeletal muscle relaxants. Similar findings were observed for emergency and hospital care for falls or fractures. Mortality (AOR 1.93, 95% CI 1.82-2.04), ED visits (AOR 2.35, 95% CI 2.27-2.43), and hospitalizations (AOR 2.21, 95% CI 2.11-2.32) were higher in the antihistamine-exposed group, with similar findings for falls and fractures outcomes.

CONCLUSION: Skeletal muscle relaxants and antihistamines are associated with an increased risk of ED visits and hospitalizations in elderly patients. Antihistamines were also associated with an increased risk of death, further validating the classification of these drug classes as "high risk".

Gellad, Walid F, Xinhua Zhao, Carolyn T Thorpe, Maria K Mor, Chester B Good, and Michael J Fine. (2015) 2015. “Dual Use of Department of Veterans Affairs and Medicare Benefits and Use of Test Strips in Veterans With Type 2 Diabetes Mellitus.”. JAMA Internal Medicine 175 (1): 26-34. https://doi.org/10.1001/jamainternmed.2014.5405.

IMPORTANCE: Self-monitoring of blood glucose is a costly component of care for diabetes mellitus, with unclear benefits for patients not taking insulin. Veterans with dual Department of Veterans Affairs (VA) and Medicare benefits have access to test strips through both systems, raising the potential for overuse.

OBJECTIVES: To examine the patterns of test strip receipt among older veterans with diabetes and determine whether receipt of strips from dual health care systems is associated with overuse.

DESIGN, SETTING, AND PARTICIPANTS: We performed a cross-sectional, retrospective cohort study using national VA administrative data linked to Medicare Parts A, B, and D claims for fiscal years 2008 and 2009. A total of 363,996 community-dwelling veterans 65 years or older with diabetes who used the VA health care system and received test strips in fiscal year 2009 were included in the study.

EXPOSURES: Receipt of test strips from the VA only, Medicare only, or both the VA and Medicare; covariates included sociodemographics, comorbidity, diabetes complications, and hemoglobin A1c level.

MAIN OUTCOMES AND MEASURES: Quantity of test strips dispensed and overuse of test strips, defined as more than 1 strip per day (>365 strips per year) among those taking no diabetes medications, oral diabetes medications alone, or long-acting insulin without short-acting insulin or more than 4 strips per day (>1460 strips per year) among those taking short-acting insulin.

RESULTS: Overall, 260,688 older veterans (71.6%) with diabetes received strips from the VA only, 82,826 (22.8%) from Medicare only, and 20,482 (5.6%) from the VA and Medicare. Veterans receiving strips from both the VA and Medicare received more strips (median, 600; interquartile range [IQR], 350-1000) than the Medicare only (median, 400; IQR, 200-700) and VA only (median, 200; IQR, 100-500) groups (P < .001) and had substantially greater odds of overuse than the VA only group (55.4% vs 15.8%) (adjusted odds ratio [OR], 16.3; 95% CI, 14.6-18.1 for no medications; 55.3% vs 6.0%; OR, 19.8; 95% CI, 18.9-20.8 for oral medications; 87.4% vs 65.5%; OR, 3.69; 95% CI, 3.30-4.14 for long-acting insulin; and 32.8% vs 13.5%; OR, 3.24; 95% CI, 3.05-3.45 for short-acting insulin). Patterns were similar when using more conservative thresholds of overuse.

CONCLUSIONS AND RELEVANCE: Veterans who receive glucose test strips through both the VA and Medicare use more strips and are more likely to potentially overuse strips. These results illustrate the profound importance of understanding dual VA and Medicare coverage and are emblematic of waste and inefficiency.

Anderson, Timothy S, Chester B Good, and Walid F Gellad. (2015) 2015. “Prevalence and Compensation of Academic Leaders, Professors, and Trustees on Publicly Traded US Healthcare Company Boards of Directors: Cross Sectional Study.”. BMJ (Clinical Research Ed.) 351: h4826. https://doi.org/10.1136/bmj.h4826.

OBJECTIVE: To identify the prevalence, characteristics, and compensation of members of the boards of directors of healthcare industry companies who hold academic appointments as leaders, professors, or trustees.

DESIGN: Cross sectional study.

SETTING: US healthcare companies publicly traded on the NASDAQ or New York Stock Exchange in 2013.

PARTICIPANTS: 3434 directors of pharmaceutical, biotechnology, medical equipment and supply, and healthcare provider companies.

MAIN OUTCOME MEASURES: Prevalence, annual compensation, and beneficial stock ownership of directors with affiliations as leaders, professors, or trustees of academic medical and research institutions.

RESULTS: 446 healthcare companies met the study search criteria, of which 442 (99%) had publicly accessible disclosures on boards of directors. 180 companies (41%) had one or more academically affiliated directors. Directors were affiliated with 85 geographically diverse non-profit academic institutions, including 19 of the top 20 National Institute of Health funded medical schools and all of the 17 US News honor roll hospitals. Overall, these 279 academically affiliated directors included 73 leaders, 121 professors, and 85 trustees. Leaders included 17 chief executive officers and 11 vice presidents or executive officers of health systems and hospitals; 15 university presidents, provosts, and chancellors; and eight medical school deans or presidents. The total annual compensation to academically affiliated directors for their services to companies was $54,995,786 (£35,836,000; €49,185,900) (median individual compensation $193,000) and directors beneficially owned 59,831,477 shares of company stock (median 50,699 shares).

CONCLUSIONS: A substantial number and diversity of academic leaders, professors, and trustees hold directorships at US healthcare companies, with compensation often approaching or surpassing common academic clinical salaries. Dual obligations to for profit company shareholders and non-profit clinical and educational institutions pose considerable personal, financial, and institutional conflicts of interest beyond that of simple consulting relationships. These conflicts have not been fully addressed by professional societies or academic institutions and deserve additional review, regulation, and, in some cases, prohibition when conflicts cannot be reconciled.

Thorpe, Carolyn T, Walid F Gellad, Chester B Good, Sijian Zhang, Xinhua Zhao, Maria Mor, and Michael J Fine. (2015) 2015. “Tight Glycemic Control and Use of Hypoglycemic Medications in Older Veterans With Type 2 Diabetes and Comorbid Dementia.”. Diabetes Care 38 (4): 588-95. https://doi.org/10.2337/dc14-0599.

OBJECTIVE: Older adults with diabetes and dementia are at increased risk for hypoglycemia and other adverse events associated with tight glycemic control and are unlikely to experience long-term benefits. We examined risk factors for tight glycemic control in this population and use of medications associated with a high risk of hypoglycemia in the subset with tight control.

RESEARCH DESIGN AND METHODS: This retrospective cohort study of national Veterans Affairs (VA) administrative/clinical data and Medicare claims for fiscal years (FYs) 2008-2009 included 15,880 veterans aged ≥ 65 years with type 2 diabetes and dementia and prescribed antidiabetic medication. Multivariable regression analyses were used to identify sociodemographic and clinical predictors of hemoglobin A1c (HbA1c) control (tight, moderate, poor, or not monitored) and, in patients with tight control, subsequent use of medication associated with a high risk of hypoglycemia (sulfonylureas, insulin).

RESULTS: Fifty-two percent of patients had tight glycemic control (HbA1c <7% [53 mmol/mol]). Specific comorbidities, older age, and recent weight loss were associated with greater odds of tight versus moderate control, whereas Hispanic ethnicity and obesity were associated with lower odds of tight control. Among tightly controlled patients, 75% used sulfonylureas and/or insulin, with higher odds in patients who were male, black, or aged ≥ 75 years; had a hospital or nursing home stay in FY2008; or had congestive heart failure, renal failure, or peripheral vascular disease.

CONCLUSIONS: Many older veterans with diabetes and dementia are at high risk for hypoglycemia associated with intense diabetes treatment and may be candidates for deintensification or alteration of diabetes medications.

Aspinall, Sherrie L, Chester B Good, Xinhua Zhao, Francesca E Cunningham, Bernadette B Heron, Mark Geraci, Vida Passero, et al. (2015) 2015. “Adjuvant Chemotherapy for Stage III Colon Cancer: Relative Dose Intensity and Survival Among Veterans.”. BMC Cancer 15: 62. https://doi.org/10.1186/s12885-015-1038-y.

BACKGROUND: Given the paucity of information on dose intensity, the objective of this study is to describe the use of adjuvant chemotherapy for stage III colon cancer, focusing on relative dose intensity (RDI), overall survival (OS) and disease-free survival (DFS).

METHODS: Retrospective cohort of 367 patients diagnosed with stage III colon cancer in 2003-2008 and treated at 19 VA medical centers. Kaplan-Meier curves summarize 5-year OS and 3-year DFS by chemotherapy regimen and RDI, and multivariable Cox proportional hazards regression was used to model these associations.

RESULTS: 5-fluorouracil/leucovorin (FU/LV) was the most commonly initiated regimen in 2003 (94.4%) and 2004 (62.7%); in 2005-2008, a majority of patients (60%-74%) was started on an oxaliplatin-based regimen. Median RDI was 82.3%. Receipt of >70% RDI was associated with better 5-year OS (p < 0.001) and 3-year DFS (P = 0.009) than was receipt of ≤70% RDI, with 5-year OS rates of 66.3% and 50.5%, respectively and 3-year DFS rates of 66.1% and 52.7%, respectively. In the multivariable analysis of 5-year OS, oxaliplatin + 5-FU/LV (versus 5-FU/LV) (HR = 0.55; 95% CI = 0.34-0.91), >70% RDI at the first year (HR = 0.58; 95% CI = 0.37-0.89) and married status (HR = 0.66; 95% CI = 0.45-0.97) were associated with significantly decreased risk of death, while age ≥75 (versus 55-64) (HR = 2.06; 95% CI = 1.25-3.40), Charlson Comorbidity Index (HR = 1.17; 95% CI = 1.06-1.30), T4 tumor status (versus T1/T2) (HR = 5.88; 95% CI = 2.69-12.9), N2 node status (HR = 1.68; 95% CI = 1.12-2.50) and bowel obstruction (HR = 2.32, 95% CI = 1.36-3.95) were associated with significantly increased risk. Similar associations were observed for DFS.

CONCLUSION: Patients with stage III colon cancer who received >70% RDI had improved 5-year OS. The association between RDI and survival needs to be examined in studies of adjuvant chemotherapy for colon cancer outside of the VA.

Costa, Deena Kelly, Courtney Colonna Kuza, and Jeremy M Kahn. (2015) 2015. “Differences Between Nurse- and Physician-Assessed ICU Characteristics Using a Standardized Survey.”. International Journal for Quality in Health Care : Journal of the International Society for Quality in Health Care 27 (5): 344-8. https://doi.org/10.1093/intqhc/mzv062.

OBJECTIVE: Surveys are often used to assess intensive care unit (ICU) organizational characteristics for quality improvement. Typically these surveys target ICU nurse managers and/or physician directors. However, it is unclear whether these providers' assessments differ. We sought to determine whether differences existed in nurse- and physician-assessed ICU characteristics using a standardized survey.

DESIGN: We administered a previously developed survey to nurse managers and medical directors in adult ICUs within a single healthcare system in 2013. The survey asked about interprofessional staffing and evidence-based protocols. We examined differences between nurse managers' and medical directors' responses using McNemar's test and assessed concordance using the kappa statistic.

SETTING: Twenty-three ICUs in 10 hospitals in Southwestern Pennsylvania.

RESULTS: Sixteen (69%) were specialty ICUs. The median number of ICU beds was 34. Concordance was moderate for high- vs. low-intensity physician staffing (κ = 0.60) and almost perfect on questions related to interprofessional staffing (κ = 0.83 nurse practitioners/physician assistants; 1.0 respiratory therapists; 0.83 physical therapists). However, concordance was slight to fair with regard to the presence of these providers on rounds (κ = 0.20-0.21) and poor to slight for protocols for liberation from mechanical ventilation (κ = 0.19), sedation (κ = -0.03) and central line insertion (κ = -0.03).

CONCLUSIONS: Despite a standardized survey, we found substantial disagreement on ICU characteristics when assessed by the nurse manager or physician director. This study raises questions about the use of surveys to examine ICU organizational characteristics and suggests that differences in nurse managers' and medical directors' assessments could be helpful in guiding future ICU quality improvement projects.

Marcum, Zachary A, Julia Driessen, Carolyn T Thorpe, Julie M Donohue, and Walid F Gellad. (2015) 2015. “Regional Variation in Use of a New Class of Antidiabetic Medication Among Medicare Beneficiaries: The Case of Incretin Mimetics.”. The Annals of Pharmacotherapy 49 (3): 285-92. https://doi.org/10.1177/1060028014563951.

BACKGROUND: When incretin mimetic (IM) medications were introduced in 2005, their effectiveness compared with other less-expensive second-line diabetes therapies was unknown, especially for older adults. Physicians likely had some uncertainty about the role of IMs in the diabetes treatment armamentarium. Regional variation in uptake of IMs may be a marker of such uncertainty.

OBJECTIVE: To investigate the extent of regional variation in the use of IMs among beneficiaries and estimate the cost implications for Medicare.

METHODS: This was a cross-sectional analysis of 2009-2010 claims data from a nationally representative sample of 238 499 Medicare Part D beneficiaries aged ≥65 years, who were continuously enrolled in fee-for-service Medicare and Part D and filled ≥1 antidiabetic prescription. Beneficiaries were assigned to 1 of 306 hospital-referral regions (HRRs) using ZIP codes. The main outcome was adjusted proportion of antidiabetic users in an HRR receiving an IM.

RESULTS: Overall, 29 933 beneficiaries (12.6%) filled an IM prescription, including 26 939 (11.3%) for sitagliptin or saxagliptin and 3718 (1.6%) for exenatide or liraglutide. The adjusted proportion of beneficiaries using IMs varied more than 3-fold across HRRs, from 5th and 95th percentiles of 5.2% to 17.0%. Compared with non-IM users, IM users faced a 155% higher annual Part D plan ($1067 vs $418) and 144% higher patient ($369 vs $151) costs for antidiabetic prescriptions.

CONCLUSION: Among older Part D beneficiaries using antidiabetic drugs, substantial regional variation exists in the use of IMs, not accounted for by sociodemographics and health status. IM use was associated with substantially greater costs for Part D plans and beneficiaries.

Cochran, Gerald, Bongki Woo, Wei-Hsuan Lo-Ciganic, Adam J Gordon, Julie M Donohue, and Walid F Gellad. (2015) 2015. “Defining Nonmedical Use of Prescription Opioids Within Health Care Claims: A Systematic Review.”. Substance Abuse 36 (2): 192-202. https://doi.org/10.1080/08897077.2014.993491.

BACKGROUND: Health insurance claims data may play an important role for health care systems and payers in monitoring the nonmedical use of prescription opioids (NMPO) among patients. However, these systems require valid methods for identifying NMPO if they are to target individuals for intervention. Limited efforts have been made to define NMPO using administrative data available to health systems and payers. We conducted a systematic review of publications that defined and measured NMPO within health insurance claims databases in order to describe definitions of NMPO and identify areas for improvement.

METHODS: We searched 8 electronic databases for articles that included terms related to NMPO and health insurance claims. A total of 2613 articles were identified in our search. Titles, abstracts, and article full texts were assessed according to predetermined inclusion/exclusion criteria. Following article selection, we extracted general information, conceptual and operational definitions of NMPO, methods used to validate operational definitions of NMPO, and rates of NMPO.

RESULTS: A total of 7 studies met all inclusion criteria. A range of conceptual NMPO definitions emerged, from concrete concepts of abuse to qualified definitions of probable misuse. Operational definitions also varied, ranging from variables that rely on diagnostic codes to those that rely on opioid dosage and/or filling patterns. Quantitative validation of NMPO definitions was reported in 3 studies (e.g., receiver operating curves or logistic regression), with each study indicating adequate validity. Three studies reported qualitative validation, using face and content validity. One study reported no validation efforts. Rates of NMPO among the studies' populations ranged from 0.75% to 10.32%.

CONCLUSIONS: Disparate definitions of NMPO emerged from the literature, with little uniformity in conceptualization and operationalization. Validation approaches were also limited, and rates of NMPO varied across studies. Future research should prospectively test and validate a construct of NMPO to disseminate to payers and health officials.

Lo-Ciganic, Wei-Hsuan, Subashan Perera, Shelly L Gray, Robert M Boudreau, Janice C Zgibor, Elsa S Strotmeyer, Julie M Donohue, et al. (2015) 2015. “Statin Use and Decline in Gait Speed in Community-Dwelling Older Adults.”. Journal of the American Geriatrics Society 63 (1): 124-9. https://doi.org/10.1111/jgs.13134.

OBJECTIVES: To examine the association between statin use and objectively assessed decline in gait speed in community-dwelling older adults.

DESIGN: Longitudinal cohort study.

SETTING: Health, Aging and Body Composition (Health ABC) Study.

PARTICIPANTS: Two thousand five participants aged 70-79 at baseline with medication and gait speed data at 1998-99, 1999-2000, 2001-02, and 2002-03.

MEASUREMENTS: The independent variables were any statin use and their standardized daily doses (low, moderate, high) and lipophilicity. The primary outcome measure was decline in gait speed of 0.1 m/s or more in the following year of statin use. Multivariable generalized estimating equations were used, adjusting for demographic characteristics, health-related behaviors, health status, and access to health care.

RESULTS: Statin use increased from 16.2% in 1998-99 to 25.6% in 2002-03. The overall proportions of those with decline in gait speed of 0.1 m/s or more increased from 22.2% in 1998 to 23.9% in 2003. Statin use was not associated with decline in gait speed of 0.1 m/s or more (adjusted odds ratio (AOR) = 0.90, 95% confidence interval (CI) = 0.77-1.06). Similar nonsignificant trends were also seen with the use of hydrophilic or lipophilic statins. Users of low-dose statins were found to have a 22% lower risk of decline in gait speed than nonusers (AOR = 0.78, 95% CI = 0.61-0.99), which was mainly driven by the results from 1999-2000 follow-up.

CONCLUSION: These results suggest that statin use did not increase decline in gait speed in community-dwelling older adults.

Donohue, Julie M, Eros Papademetriou, Rochelle R Henderson, Sharon Glave Frazee, Christine Eibner, Andrew W Mulcahy, Ateev Mehrotra, et al. (2015) 2015. “Early Marketplace Enrollees Were Older And Used More Medication Than Later Enrollees; Marketplaces Pooled Risk.”. Health Affairs (Project Hope) 34 (6): 1049-56. https://doi.org/10.1377/hlthaff.2015.0016.

Little is known about the health status of the 7.3 million Americans who enrolled in insurance plans through the Marketplaces established by the Affordable Care Act in 2014. Medication use may provide an early indicator of the health needs and access to care among Marketplace enrollees. We used data from January-September 2014 on more than one million Marketplace enrollees from Express Scripts, the largest pharmacy benefit management company in the United States. We compared the characteristics and medication use between early and late Marketplace enrollees and between all Marketplace enrollees and enrollees with employer-sponsored insurance. Among Marketplace enrollees, we found that those who enrolled earlier (October 2013-February 2014) were older and used more medication than later enrollees. Marketplace enrollees, as a whole, had lower average drug spending and were less likely to use most medication classes than the employer-sponsored comparison group. However, Marketplace enrollees were more likely to use medicines for hepatitis C and particularly for HIV.