Clinical burden of asynchrony in patients with asthma when using metered-dose inhalers for control.

Background: Asynchrony, or lack of coordination between inhalation and actuation when using a pressurized metered-dose inhaler (MDI), could theoretically impact the delivery of inhaled medications and treatment efficacy. Objective: To assess the real-world association between asynchrony and clinical outcomes among patients with asthma who receive controller therapy delivered by MDIs. Methods: A cohort of patients was assembled via electronic health records. The patients were aged ≥12 years, with one or more documentations of an asthma diagnosis, no diagnosis of chronic obstructive pulmonary disease, and two or more prescriptions for an inhalation aerosol corticosteroid alone or with long-acting beta-2-agonist delivered via MDI. Their inhaler technique, demonstrated by using a placebo MDI, was evaluated at a clinic visit by study nurses who used a standardized 10-step checklist. Asynchrony was defined as any gap in timing between inhalation and actuation. Clinical outcomes were assessed via electronic health records during the 6 months before the clinic visit and were compared between patients with and patients without asynchrony by using multivariable regression analyses adjusted for age, gender, asthma severity proxy, and baseline comorbidities. Results: Of the total 254 eligible patients, mean age of 49.3 years, 90 males (35.4%), 32 (12.6%) had asynchrony. Patients with asynchrony had higher odds of an asthma exacerbation (adjusted odds ratio, 2.99; p = 0.009), and lower odds of risk domain asthma control (adjusted odds ratio, 0.41; p = 0.04) compared with patients without asynchrony. Conclusion: This study provided real-world evidence that asynchrony in MDI use among patients with asthma who were treated with controller MDIs was associated with clinical burden in terms of asthma exacerbations and control.

Mixed Incontinence Masked as Stress Induced Urgency Urinary Incontinence.

PURPOSE: We sought to understand variations in the expression and temporal relation of bladder control episodes among women with mixed urinary incontinence. MATERIALS AND METHODS: A random sample of women 40 years old or older with mixed urinary incontinence on GLOBE-UI (General Longitudinal Overactive Bladder Evaluation-Urinary Incontinence) was recruited in a digital daily diary study using a smartphone application. When a bladder control event occurred, women were instructed to answer episode specific questions. Episodes were defined as urgency, and urinary incontinence with and urinary incontinence without urgency. Women and episodes were compared by the type of activity preceding each episode. Urinary incontinence episodes were further defined as stress urinary incontinence, urgency urinary incontinence, stress induced urgency urinary incontinence and other. The chi-square and Wilcoxon tests were used for categorical and continuous variables, respectively. RESULTS: Of 40 women with a mean age of 65.5 years 35 provided complete 30-day diary data. Of the 950 bladder control episodes reported 25% were urgency only, 55% were urinary incontinence with urgency and 19% were urinary incontinence without urgency. Of the urinary incontinence episodes without urgency 82% occurred after a stress activity (eg coughing or sneezing). Notably, a stress activity also occurred just before 52.5% of the urgency urinary incontinence episodes (p <0.001). A total of 24 women (69%) reported at least 1 episode of stress induced urgency urinary incontinence, which was the most prevalent urinary incontinence subtype episode, followed by urgency urinary incontinence and stress urinary incontinence (29% vs 27% and 16%, respectively). The mean number of daily episodes was 1 or 2 across all groups. CONCLUSIONS: Women with mixed urinary incontinence express a heterogeneous set of bladder control episodes with stress induced urgency urinary incontinence as the dominant type.

The impact of free trial acceptance on demand for alternative nicotine products: evidence from experimental auctions.

OBJECTIVES: This study explored the relationship between product trials and consumer demand for alternative nicotine products (ANP). METHODS: An experimental auction was conducted with 258 adult smokers, wherein participants were randomly assigned to one of four experimental conditions. The participants received the opportunity to try, but did not have to accept, one of three relatively novel ST products (i.e., snus, dissolvable tobacco, or medicinal nicotine), or they were placed into a control group (i.e., no trial). All the participants then bid on all three of these products, as well as on cigarettes. We assessed interest in using ANP based on both trial of the product and bids placed for the products in the experimental auction. RESULTS: Fewer smokers were willing to try snus (44%) than dissolvable tobacco (64%) or medicine nicotine (68%). For snus, we find modest evidence suggesting that willingness to try is associated with greater demand for the product. For dissolvable tobacco or medicinal nicotine, we find no evidence that those who accept the product trial have higher demand for the product. CONCLUSIONS: Free trials of a novel ANP were not strongly associated with product demand, as assessed by willingness to pay. Given the debate over the potential for ANP to reduce the harm from smoking, these results are important in understanding the impact of free trial offers on adoption of ST product as a strategy to reduce harm from tobacco use.

The impact of product information and trials on demand for smokeless tobacco and cigarettes: evidence from experimental auctions.

INTRODUCTION: Epidemiological and toxicological evidence suggests lower risk of smokeless tobacco (ST) products compared to cigarettes. Less is known, however, about consumer perceptions and use of novel forms of ST, including snus and dissolvable tobacco. METHODS: In this study, we conducted in-person experimental auctions in Buffalo, NY, Columbia, SC, and Selinsgrove, PA with 571 smokers to test the impact of information and product trials on smokers' preferences. Auctions were conducted between November 2010-November 2011. RESULTS: We found no evidence of an impact of product trials on demand in our auctions. Anti-ST information increased demand for cigarettes when presented alone, but when presented with pro-ST information it decreased demand for cigarettes. It did not decrease demand for ST products. Anti-smoking information increased demand for ST products, but did not affect cigarette demand. CONCLUSIONS: These findings suggest that credible and effective communications about tobacco harm reduction should reinforce the negative effects of smoking.

Quantifying Sex Differences in Cardiovascular Care Among Patients Evaluated for Suspected Ischemic Heart Disease.

Background: Cardiovascular care sex differences are controversial. We examined sex differences in management and clinical outcomes among patients undergoing noninvasive testing for ischemic heart disease (IHD). Methods: In a rural integrated healthcare system, we identified adults age 40-79 without diagnosed IHD who underwent initial evaluation with a cardiac stress test with imaging or coronary computed tomographic angiography (CTA), 2013-2014. We assessed sex differences in statin/aspirin therapy, revascularization, and adverse cardiovascular events. The 2013 American College of Cardiology/American Heart Association statin guidelines and U.S. Preventive Services Task Force aspirin guidelines were applied. Results: Among 2213 patients evaluated for IHD, median age was 57 years, 48.8% were women, and 9% had a positive stress test/CTA. Women were more likely to be missing lipid values than men (p < 0.001). Mean ASCVD risk score at baseline was 7.2% in women versus 12.4% in men (p < 0.001). There was no significant sex difference in statin therapy at baseline or 60-day follow-up. Women were less likely than men to be taking aspirin at baseline (adj. diff. = -8.5%; 95% CI, -4.2 to -12.9) and follow-up (adj. diff. = -7.7%; 95% CI, -3.3 to -12.1). There were no sex differences in revascularization after accounting for obstructive CAD or adverse cardiovascular outcomes during median follow-up of 33 months. Conclusion: In this contemporary cohort of patients with suspected IHD, women were less likely to receive lipid testing and aspirin therapy, but not statin therapy. Women did not experience worse outcomes. Sex differences in statin therapy reported by others may be due to inadequate accounting for baseline risk.

Burden of Readmissions Among Patients With Critical Limb Ischemia.

BACKGROUND: Readmissions constitute a major health care burden among critical limb ischemia (CLI) patients. OBJECTIVES: This study aimed to determine the incidence of readmission and factors affecting readmission in CLI patients. METHODS: All adult hospitalizations with a diagnosis code for CLI were included from State Inpatient Databases from Florida (2009 to 2013), New York (2010 to 2013), and California (2009 to 2011). Data were merged with the directory available from the American Hospital Association to obtain detailed information on hospital-related characteristics. Geographic and routing analysis was performed to evaluate the effect of travel time to the hospital on readmission rate. RESULTS: Overall, 695,782 admissions from 212,241 patients were analyzed. Of these, 284,189 were admissions with a principal diagnosis of CLI (primary CLI admissions). All-cause readmission rates at 30 days and 6 months were 27.1% and 56.6%, respectively. The majority of these were unplanned readmissions. Unplanned readmission rates at 30 days and 6 months were 23.6% and 47.7%, respectively. The major predictors of 6-month unplanned readmissions included age, female sex, black/Hispanic race, prior amputation, Charlson comorbidity index, and need for home health care or rehabilitation facility upon discharge. Patients covered by private insurance were least likely to have a readmission compared with Medicaid/no insurance and Medicare populations. Travel time to the hospital was inversely associated with 6-month unplanned readmission rates. There was a significant interaction between travel time and major amputation as well as travel time and revascularization strategy; however, the inverse association between travel time and unplanned readmission rate was evident in all subgroups. Furthermore, length of stay during index hospitalization was directly associated with the likelihood of 6-month unplanned readmission (odds ratio for log-transformed length of stay: 2.39 [99% confidence interval: 2.31 to 2.47]). CONCLUSIONS: Readmission among patients with CLI is high, the majority of them being unplanned readmissions. Several demographic, clinical, and socioeconomic factors play important roles in predicting readmissions.

Measuring Adherence and Outcomes in the Treatment of Patients With Multiple Sclerosis.

CONTEXT: Both adherence and outcomes are more difficult to measure in patients with multiple sclerosis (MS) than in patients with diseases such as hypertension, for which most medications are taken orally and surrogate outcomes (eg, blood pressure) are routinely collected. OBJECTIVES: To characterize the adherence and outcomes of patients with MS within a large integrated health system and to assess the relationship between adherence and outcomes. STUDY DESIGN: Retrospective review of adherence and health care utilization outcomes via electronic health records and claims (2004-2013) combined with a prospective survey regarding adherence and functional outcomes (2012-2013). METHODS: Retrospectively, medication possession ratios were calculated, and adherence groups were compared regarding health care utilization and costs. Prospectively, patients were recruited to complete questionnaires to measure self-reported adherence (SRA) and MS-specific outcomes, including the Multiple Sclerosis Impact Scale (MSIS), the Kurtzke Expanded Disability Status Scale (EDSS), and the Treatment Satisfaction Questionnaire for Medication (TSQM). Regression was used to statistically test for differences in these outcomes among adherence groups. RESULTS: A total of 681 patients were studied. Most patients (307 of 375 [82%] in the retrospective cohort and 244 of 306 [89%] in the prospective cohort) had greater that 80% adherence to their MS medications. Mean inpatient days per patient for MS-related admissions was highest for high-adherence than for intermediate and low-adherence patients (0.52 vs 0.23 and 0.34, respectively; P<.001), but no other associations between adherence and health care utilization were found. Mean outpatient costs and total costs were lowest for the low-adherence group, suggesting that higher adherence may not guarantee cost savings overall. Patients with intermediate and high self-reported adherence showed significantly better mean scores than patients with low adherence on several MS outcomes, including EDSS (4.1 and 4.2 vs 4.8, P<.05), MSIS physical function (33 and 35 vs 41, P<.05), and TSQM Global Satisfaction (75 and 78 vs 70, P<.05). CONCLUSIONS: The findings of this study indicate that patients with MS are mostly adherent to their existing treatments. Patients with greater medication adherence may have increased cost, but their physical outcomes are better. This finding may shed light on other chronic disease entities and how we view the success of treatments.

The value of value-based insurance design: savings from eliminating drug co-payments.

OBJECTIVES: To estimate the cost impact of a $0 co-pay prescription drug program implemented by a large healthcare employer as a part of its employee wellness program. STUDY DESIGN: A $0 co-pay program that included approximately 200 antihypertensive, antidiabetic, and antilipid medications was offered to Geisinger Health System (GHS) employees covered by Geisinger Health Plan (GHP) in 2007. Claims data from GHP for the years 2005 to 2011 were obtained. The sample was restricted to continuously enrolled members with Geisinger primary care providers throughout the study period. METHODS: The intervention group, defined as 2251 GHS employees receiving any of the drugs eligible for $0 co-pay, was propensity score matched based on 2 years of pre-intervention claims data to a comparison group, which was defined as 3857 non-GHS employees receiving the same eligible drugs at the same time. Generalized linear models were used to estimate differences in terms of per-member-per-month (PMPM) claims amounts related to prescription drugs and medical care. RESULTS: Total healthcare spending (medical plus prescription drug spending) among the GHS employees was lower by $144 PMPM (13%; 95% CI, $38-$250) during the months when they were taking any of the eligible drugs. Considering the drug acquisition cost and the forgone co-pay, the estimated return on investment over a 5-year period was 1.8. CONCLUSIONS: This finding suggests that VBID implementation within the context of a wider employee wellness program targeting the appropriate population can potentially lead to positive cost savings.

Factors associated with opioid overdose: a 10-year retrospective study of patients in a large integrated health care system.

OBJECTIVE: Opioid overdoses (ODs) have been increasing, and harm reduction efforts are a priority. The success of these efforts will be dependent on the identification of at-risk patients and improved access to the antidote naloxone. Therefore, to identify access to naloxone and factors associated with negative health outcomes, we conducted a retrospective study of patients with OD to identify those at highest risk of adverse outcomes and to assess the use of naloxone. METHODS: We conducted a study of electronic health records for patients admitted to the largest multihospital system in the region - the Geisinger Health System (GHS) for ODs - from April 2005 through March 2015. ODs were defined by International Classification of Diseases-9 codes (age range: 10-95 years). Bivariate analyses and multiple logistic regressions were conducted to identify pre-OD factors associated with adverse health outcomes post-OD. RESULTS: We identified 2,039 patients with one or more ODs, of whom 9.4% were deceased within 12 months. Patient demographics suggest that patients with OD had a mean age of 52 years, were not married (64%), and were unemployed (78%). Common comorbidities among patients with OD include cardiovascular disease (22%), diabetes (14%), cancer (13%), and the presence of one or more mental health disorders (35%). Few patients had a prescription order for naloxone (9%) after their OD. The majority of patients with OD were in proximity to GHS health care facilities, with 87% having a GHS primary care provider. In multiple logistic regressions, common predictors of adverse outcomes, including death, repeated ODs, frequent service use, and high service cost, were higher prescription opioid use, comorbid medical conditions, comorbid mental disorders, and concurrent use of other psychotropic medications. CONCLUSION: This study suggests opportunities for improving OD outcomes. Those who receive higher quantities of prescription opioids concurrent with other psychotropic medicines may need closer monitoring to avoid death, repeated OD events, higher service use, and higher service costs. Other opportunities for improving OD outcomes include the use of electronic health records to notify physicians of high-risk patients and updating of guidelines/operation manuals focused on the distribution of naloxone to those in highest need.

Mental Health Disorders and Treatment Seeking Among Veterans in Non-VA Facilities: Results and Implications from the Veterans' Health Study.

We surveyed 700 veterans who were outpatients in a non-Veterans Affairs (VA) multihospital system. Our objective was to assess the prevalence of mental disorders and service use among these veterans. The majority were Vietnam veterans (72.0%), and male (95.9%), and 40.4% reported recently using the VA for care. The prevalence of lifetime post-traumatic stress disorder (PTSD) was 9.6%, lifetime depression 18.4%, and lifetime mental health service use 50.1%. In multivariate analyses, significant factors associated with PTSD, depression, and mental health service use were low self-esteem, use of alcohol/drugs to cope, history of childhood adversity, high combat exposure, and low psychological resilience. VA service use was associated with greater mental health service use and combat exposure. With the exception of alcohol misuse, the mental health status of veterans seen in non-VA facilities appeared to be better than reported in past studies. Because most veterans have access to both VA and non-VA services, these findings have implications for veterans and outcomes research.

Chronic care model strategies in the United States and Germany deliver patient-centered, high-quality diabetes care.

Improving the quality of care for chronic diseases is an important issue for most health care systems in industrialized nations. One widely adopted approach is the Chronic Care Model (CCM), which was first developed in the late 1990s. In this article we present the results from two large surveys in the United States and Germany that report patients' experiences in different models of patient-centered diabetes care, compared to the experiences of patients who received routine diabetes care in the same systems. The study populations were enrolled in either Geisinger Health System in Pennsylvania or Barmer, a German sickness fund that provides medical insurance nationwide. Our findings suggest that patients with type 2 diabetes who were enrolled in the care models that exhibited key features of the CCM were more likely to receive care that was patient-centered, high quality, and collaborative, compared to patients who received routine care. This study demonstrates that quality improvement can be realized through the application of the Chronic Care Model, regardless of the setting or distinct characteristics of the program.

Cost-effectiveness of IL28Β genotype-guided protease inhibitor triple therapy versus standard of care treatment in patients with hepatitis C genotypes 2 or 3 infection.

BACKGROUND/AIMS: Triple therapy [adding protease inhibitors to standard of care (SOC)] dramatically increases treatment response in selected patients with hepatitis C virus (HCV). Interleukin 28B (IL28Β) genotyping helps predict responsiveness in these patients; however, the economic implications of IL28Β genotyping in HCV genotype 2 or 3 infected patients are unknown. Short- and long-term costs and outcomes of SOC therapy were calculated and used to determine the cost-effectiveness thresholds for using triple therapy in HCV genotype 2 or 3 infected patients. METHODS: Costs and outcomes were calculated by conducting cohort simulations on decision trees modeling SOC and triple therapy. Quality-adjusted life expectancies and long-term costs were predicted through Markov modeling. RESULTS: For triple therapy to be cost-effective, sustained virologic response (SVR) rates must improve (depending on age) by 7.91-11.11 and 9.06-12.8% for HCV genotype 2 and 3 cohorts, respectively. When triple therapy is guided by 2 IL28Β variants, a 2.63-3.72% improvement in SVR is needed for cost-effectiveness, and when guided by only one variant, a 1.4-8.91% improvement is needed. CONCLUSIONS: Markov modeling revealed that modest increases in SVR rates from IL28Β-guided triple therapy can lead to both lower costs and better health outcomes than SOC therapy in the long run.

Primary care diabetes bundle management: 3-year outcomes for microvascular and macrovascular events.

OBJECTIVES: To determine whether a system of care with an all-or-none bundled measure for primary-care management of diabetes mellitus reduced the risk of microvascular and macrovascular complications compared with usual care. STUDY DESIGN: A parallel pre-post observational design was used. In 2006, a system of care for diabetes was implemented for some members of the Geisinger Health Plan. A total of 4095 primary-care patients were in the Diabetes System of Care group (DS) and compared with a propensity score-matched cohort of 4095 primary care patients not in the system of care (non-Diabetes System of Care [NDS]). METHODS: Cumulative hazard rate was measured over a 3-year period for retinopathy, amputation, stroke, and myocardial infarction (MI). RESULTS: The adjusted hazard ratios (HRs) for MI (HR, 0.77; 95% CI, 0.65- 0.90), stroke (HR, 0.79; CI, 0.65-0.97), and retinopathy (HR, 0.81; CI, 0.68-0.97) were all significantly lower among DS patients. The adjusted HR for major amputations (HR, 1.32; CI, 0.45-3.85) did not differ between groups, but only 17 major amputations occurred during the follow-up period. The necessary number of patients to treat in order to prevent 1 event over 3 years was 82 for MI, 178 for stroke, and 151 for retinopathy. CONCLUSIONS: A system of care with an all-or-none bundled measure used in primary care for patients with diabetes may reduce the risk of MI, stroke, and retinopathy over a 3-year period.

Can health insurance improve employee health outcome and reduce cost? An evaluation of Geisinger's employee health and wellness program.

OBJECTIVE: To evaluate the impact of a health plan-driven employee health and wellness program (known as MyHealth Rewards) on health outcomes (stroke and myocardial infarction) and cost of care. METHODS: A cohort of Geisinger Health Plan members who were Geisinger Health System (GHS) employees throughout the study period (2007 to 2011) was compared with a comparison group consisting of Geisinger Health Plan members who were non-GHS employees. RESULT: The GHS employee cohort experienced a stroke or myocardial infarction later than the non-GHS comparison group (hazard ratios of 0.73 and 0.56; P < 0.01). There was also a 10% to 13% cost reduction (P < 0.05) during the second and third years of the program. The cumulative return on investment was approximately 1.6. CONCLUSION: Health plan-driven employee health and wellness programs similarly designed as MyHealth Rewards can potentially have a desirable impact on employee health and cost.