Pamela N. Peterson

Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease

BACKGROUND Little is known about the effect of nonadherence among patients with coronary artery disease (CAD) on a broad spectrum of outcomes including cardiovascular mortality, cardiovascular hospitalizations, and revascularization procedures. METHODS This was a retrospective cohort study of 15,767 patients with CAD. Medication adherence was calculated as proportion of days covered for filled prescriptions of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statin medications. Multivariable Cox regression assessed the association between medication nonadherence as a time-varying covariate and a broad range of outcomes, adjusting for demographics and clinical characteristics. Median follow-up was 4.1 years. RESULTS Rates of medication nonadherence were 28.8% for beta-blockers, 21.6% for ACE inhibitors, and 26.0% for statins. In unadjusted analysis, nonadherence to each class of medication was associated with higher all-cause and cardiovascular mortality. In multivariable analysis, nonadherence remained significantly associated with increased all-cause mortality risk for beta-blockers (hazard ratio [HR] 1.50, 95% CI 1.33-1.71), ACE inhibitors (HR 1.74, 95% CI 1.52-1.98), and statins (HR 1.85, 95% CI 1.63-2.09). In addition, nonadherence remained significantly associated with higher risk of cardiovascular mortality for beta-blockers (HR 1.53, 95% CI 1.16-2.01), ACE inhibitors (HR 1.66, 95% CI 1.26-2.20), and statins (HR 1.62, 95% CI 1.124-2.13). The findings of increased risk associated with nonadherence were consistent for cardiovascular hospitalization and revascularization procedures. CONCLUSIONS Nonadherence to cardioprotective medications is common in clinical practice and associated with a broad range of adverse outcomes. These findings suggest that medication nonadherence should be a target for quality improvement interventions to maximize the outcomes of patients with CAD.

2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America

Glenn N. Levine, MD, FACC, FAHA, Chair Patrick T. O’Gara, MD, FACC, FAHA, Chair-Elect Jonathan L. Halperin, MD, FACC, FAHA, Immediate Past Chair [‡‡][1] Sana M. Al-Khatib, MD, MHS, FACC, FAHA Kim K. Birtcher, PharmD, MS, AACC Biykem Bozkurt, MD, PhD, FACC, FAHA Ralph G. Brindis, MD,

Health Literacy and Outcomes Among Patients With Heart Failure

CONTEXT Little is known about the effects of low health literacy among patients with heart failure, a condition that requires self-management and frequent interactions with the health care system. OBJECTIVE To evaluate the association between low health literacy and all-cause mortality and hospitalization among outpatients with heart failure. DESIGN, SETTING, AND PATIENTS Retrospective cohort study conducted at Kaiser Permanente Colorado, an integrated managed care organization. Outpatients with heart failure were identified between January 2001 and May 2008, were surveyed by mail, and underwent follow-up for a median of 1.2 years. Health literacy was assessed using 3 established screening questions and categorized as adequate or low. Responders were excluded if they did not complete at least 1 health literacy question or if they did not have at least 1 year of enrollment prior to the survey date. MAIN OUTCOME MEASURES All-cause mortality and all-cause hospitalization. RESULTS Of the 2156 patients surveyed, 1547 responded (72% response rate). Of 1494 included responders, 262 (17.5%) had low health literacy. Patients with low health literacy were older, of lower socioeconomic status, less likely to have at least a high school education, and had higher rates of coexisting illnesses. In multivariable Cox regression, low health literacy was independently associated with higher mortality (unadjusted rate, 17.6% vs 6.3%; adjusted hazard ratio, 1.97 [95% confidence interval, 1.3-2.97]; P = .001) but not hospitalization (unadjusted rate, 30.5% vs 23.2%; adjusted hazard ratio, 1.05 [95% confidence interval, 0.8-1.37]; P = .73). CONCLUSION Among patients with heart failure in an integrated managed care organization, low health literacy was significantly associated with higher all-cause mortality.

Evaluating the Evidence Is There a Rigid Hierarchy

Health outcomes research applies a wide range of methods to identify optimal approaches to determine optimal approaches to determine the effects of healthcare interventions and policies. Critical evaluation skills are necessary to navigate the evidence and identify studies that should influence clinical decision making and policy. A hierarchical “pyramid of evidence” that emphasizes randomized controlled clinical trials (RCTs) has been promulgated as the approach to judging study design and quality. Whereas this hierarchy may be suitable for the evaluation of efficacy, it may be inappropriate for many health outcomes research questions. This article examines the relevance of this construct to questions beyond those of therapeutic efficacy and discusses the essential role of study designs beyond RCTs. The strengths and weaknesses of study designs commonly encountered in the medical literature are reviewed. The article concludes with 2 case studies that apply the concepts reviewed and illustrate the need to match the study design with the research question. Of note, the concepts of internal validity, external validity, confounding, and bias are central to the discussion of the strengths and weaknesses of study designs in the medical literature. Readers not familiar with these concepts should refer to the Appendix in the online-only Data Supplement for clarification. ### The Pyramid of Evidence: A Useful Construct? Traditionally, the design of a study has been considered a principal barometer of the validity of its findings. In this construct, different study designs are considered in the context of a pyramid of evidence, in which studies most susceptible to threats to internal validity reside at the bottom and those least prone reside at the top (Figure). This hierarchy is widely used in discussions about the quality of medical studies and is integrated into the grading of evidence in practice guidelines.1 However, although the pyramid of evidence is undoubtedly well suited for questions of therapeutic efficacy, …

A Validated Risk Score for In-Hospital Mortality in Patients With Heart Failure From the American Heart Association Get With the Guidelines Program

Background—Effective risk stratification can inform clinical decision-making. Our objective was to derive and validate a risk score for in-hospital mortality in patients hospitalized with heart failure using American Heart Association Get With the Guidelines–Heart Failure (GWTG-HF) program data. Methods and Results—A cohort of 39 783 patients admitted January 1, 2005, to June 26, 2007, to 198 hospitals participating in GWTG-HF was divided into derivation (70%, n=27 850) and validation (30%, n=11 933) samples. Multivariable logistic regression identified predictors of in-hospital mortality in the derivation sample from candidate demographic, medical history, and laboratory variables collected at admission. In-hospital mortality rate was 2.86% (n=1139). Age, systolic blood pressure, blood urea nitrogen, heart rate, sodium, chronic obstructive pulmonary disease, and nonblack race were predictive of in-hospital mortality. The model had good discrimination in the derivation and validation datasets (c-index, 0.75 in each). Effect estimates from the entire sample were used to generate a mortality risk score. The predicted probability of in-hospital mortality varied more than 24-fold across deciles (range, 0.4% to 9.7%) and corresponded with observed mortality rates. The model had the same operating characteristics among those with preserved and impaired left ventricular systolic function. The morality risk score can be calculated on the Web-based calculator available with the GWTG-HF data entry tool. Conclusions—The GWTG-HF risk score uses commonly available clinical variables to predict in-hospital mortality and provides clinicians with a validated tool for risk stratification that is applicable to a broad spectrum of patients with heart failure, including those with preserved left ventricular systolic function.

2013 ACCF/AHA Guideline for the Management of Heart Failure

Jeffrey L. Anderson, MD, FACC, FAHA, Chair; Alice K. Jacobs, MD, FACC, FAHA, Immediate Past Chair[‡‡][1]; Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect; Nancy M. Albert, PhD, CCNS, CCRN, FAHA; Biykem Bozkurt, MD, PhD, FACC, FAHA; Ralph G. Brindis, MD, MPH, MACC; Mark A. Creager, MD, FACC,

Gender Differences in Procedure-Related Adverse Events in Patients Receiving Implantable Cardioverter-Defibrillator Therapy

Background— Women are at higher risk than men for adverse events with certain invasive cardiac procedures. Our objective was to compare rates of in-hospital adverse events in men and women receiving implantable cardioverter- defibrillator (ICD) therapy in community practice. Methods and Results— Using the National Cardiovascular Data Registry ICD Registry, we identified patients undergoing first-time ICD implantation between January 2006 and December 2007. Outcomes included in-hospital adverse events after ICD implantation. Multivariable analysis assessed the association between gender and in-hospital adverse events, with adjustment for demographic, clinical, procedural, physician, and hospital characteristics. Of 161 470 patients, 73% were male, and 27% were female. Women were more likely to have a history of heart failure (81% versus 77%, P<0.01), worse New York Heart Association functional status (57% versus 50% in class III and IV, P<0.01), and nonischemic cardiomyopathy (44% versus 27%, P<0.01) and were more likely to receive biventricular ICDs (39% versus 34%, P<0.01). In unadjusted analyses, women were more likely to experience any adverse event (4.4% versus 3.3%, P<0.001) and major adverse events (2.0% versus 1.1%, P<0.001). In multivariable models, women had a significantly higher risk of any adverse event (OR 1.32, 95% CI 1.24 to 1.39) and major adverse events (OR 1.71, 95% CI 1.57 to 1.86). Conclusions— Women are more likely than men to have in-hospital adverse events related to ICD implantation. Efforts are needed to understand the reasons for higher ICD implantation–related adverse event rates in women and to develop strategies to reduce the risk of these events.

Importance of Therapy Intensification and Medication Nonadherence for Blood Pressure Control in Patients With Coronary Disease

BACKGROUND Despite the importance of blood pressure (BP) control in secondary prevention, a significant proportion of patients with coronary disease have uncontrolled BP. METHODS This retrospective cohort study of patients with coronary disease (N = 10 447) evaluated the impact of medication nonadherence and therapy intensification on reaching target BP goals. Medication adherence was calculated as the proportion of days covered for filled prescriptions of antihypertensive medications. Therapy intensification included dosage increase or increase in number of antihypertensive medications. The primary outcome was uncontrolled systolic BP (SBP) over time, using a latent class model that incorporated longitudinal SBP data and assigned patients to SBP trajectory groups. Multivariable regression evaluated the association between medication nonadherence (ie, proportion of days covered, <0.80) and therapy intensification with SBP control over time, with adjustment for demographics and clinical characteristics. RESULTS Three SBP trajectory groups were identified: (1) patients with BP that remained controlled (ie, SBP, <or=140 mm Hg) over time (n = 9114 [87.2%]); (2) patients with high BP that became controlled (n = 779 [7.5%]); and (3) patients with BP that remained high over time (n = 554 [5.3%]). In multivariable analyses, therapy intensification (odds ratio, 1.31; 95% confidence interval, 1.01-1.70) and medication nonadherence (odds ratio, 1.73; 95% confidence interval, 1.34-2.24) were associated with uncontrolled BP compared with high SBP that became controlled over time. CONCLUSIONS These findings suggest that medication nonadherence can help explain why BP levels remained elevated despite intensification of antihypertensive medications. Successful BP control is seen with a combination of intensification and adherence, suggesting that therapy intensification must be coupled with interventions to enhance medication adherence.

Impact of Medication Nonadherence on Hospitalizations and Mortality in Heart Failure

BACKGROUND Limited literature exists on the association between medication adherence and outcomes among patients with heart failure. METHODS AND RESULTS We conducted a retrospective longitudinal cohort study of 557 patients with heart failure with reduced ejection fraction (HFrEF) (defined by EF <50%) in a large health maintenance organization. We used multivariable Cox proportional hazards models to assess the relationship between adherence (with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, and aldosterone antagonists) and the primary outcome of all-cause mortality plus cardiovascular hospitalizations. Mean follow-up time was 1.1 years. Nonadherence (defined as <80% adherence) was associated with a statistically significant increase in the primary outcome in the cohort overall (hazard ratio 2.07, 95% confidence interval 1.62-2.64; P < .0001). This association remained significant when all 3 classes of heart failure medications and the components of the composite end point were considered separately and when the adherence threshold was varied to 70% or 90%. CONCLUSIONS Medication nonadherence was associated with an increased risk of all-cause mortality and cardiovascular hospitalizations in a community heart failure population. Further research is needed to define systems of care that optimize adherence among patients with heart failure.

ACCF/AHA 2010 Position Statement on Composite Measures for Healthcare Performance Assessment A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures (Writing Committee to Develop a Position Statement on Composite Measures)

There is an increasing national focus on measuring, reporting, and rewarding the provider’s quality of care based on objective measures of performance.1 The conceptual and methodological issues underlying the development of individual performance measures have previously been described,2 yet little has been written about the methods used to combine multiple individual metrics into summary or “composite” performance measures. The goals of this document are to 1) explore the uses of, and challenges associated with, composite performance measures in assessing healthcare quality; 2) discuss methods used in their creation; and 3) set forth some general principles for appropriate development, validation, application, and interpretation of composite measures. A composite performance measure …