Background

Hypertension is a significant problem in the United States, affecting 1 in 3 adults aged above 18 years and is associated with a higher risk for cardiovascular disease and stroke. The prevalence of hypertension has increased in medically underserved areas (MUAs). Mobile health technologies, such as digital self-monitoring devices, have been shown to improve the management of chronic health conditions. However, patients from MUAs have reduced access to these devices because of limited resources and low health literacy. Health coaches and peer training programs are a potentially cost-effective solution for the shortage of physicians available to manage hypertension in MUAs. Activating young people as student health coaches (SHCs) is a promising strategy to improve community health.

Objective

This pilot study aims to assess (1) the feasibility of training high school students as health technology coaches in MUAs and (2) whether the addition of SHCs to digital home monitoring improves the frequency of self-monitoring and overall blood pressure (BP) control.

Methods

In total, 15 high school students completed 3-day health coach training. Patients who had a documented diagnosis of hypertension were randomly assigned to 1 of the 3 intervention arms. The QardioArm alone (Q) group was provided a QardioArm cuff only for convenience. The SHC alone (S) group was instructed to meet with a health coach for 30 min once a week for 5 weeks to create action plans for reducing BP. The student+QardioArm (S+Q) group received both interventions.

Results

Participants (n=27) were randomly assigned to 3 groups in a ratio of 9:9:9. All 15 students completed training, of which 40% (6/15) of students completed all the 5 meetings with their assigned patient. Barriers to feasibility included transportation and patient response drop-off at the end of the study. Overall, 92% (11/12) of the students rated their experience as very good or higher and 69% (9/13) reported that this experience made them more likely to go into the medical field. There was a statistically significant difference in the frequency of cuff use (S+Q vs Q groups: 37 vs 17; P<.001). Participants in the S+Q group reported better BP control after the intervention compared with the other groups. The average BP at the end of the intervention was 145/84 (SD 9/18) mm Hg, 150/85 (SD 18/12) mm Hg, and 128/69 (SD 20/14) mm Hg in the Q, S, and S+Q groups, respectively.

Conclusions

This pilot study demonstrates the feasibility of pairing technology with young student coaches, although challenges existed. The S+Q group used their cuff more than the Q group. Patients were more engaged in the S+Q group, reporting higher satisfaction with their SHC and better control of their BP.

Background

Hemoglobin A1C (HbA1C) is associated with increased risk of cardiovascular events, but its use for prediction of cardiovascular disease (CVD) events in combination with conventional risk factors has not been well defined.

Methods and results

To understand the effect of HbA1C on CVD risk in the context of other CVD risk factors, we analyzed HbA1C and other CVD risk factor measurements in 2000 individuals aged 40 to 79 years without pre-existing diabetes mellitus or CVD from the 2011 to 2012 National Health and Nutrition Examination Surveys survey. The resulting regression model was used to predict the HbA1C distribution based on individual patient characteristics. We then calculated post-test 10-year atherosclerotic CVD risk incorporating the actual versus predicted HbA1C, according to established methods, for a set of example scenarios. Age, sex, race/ethnicity, and traditional cardiovascular risk factors were significant predictors of HbA1C in our model, with the expected HbA1C distribution being significantly higher in non-Hispanic black, non-Hispanic Asian, and Hispanic individuals than that in non-Hispanic white/other individuals. Incorporating the expected HbA1C distribution into pretest atherosclerotic CVD risk has a modest effect on post-test atherosclerotic CVD risk. In the patient examples, we assessed that having an HbA1C of <5.7% reduced post-test risk by 0.4% to 2.0% points, whereas having an HbA1C of ≥6.5% increased post-test risk by 1.0% to 2.5% points, depending on the scenario. The post-test risk increase from having an HbA1C of ≥6.5% tends to approximate the risk increase from being 5 years older.

Conclusions

HbA1C has modest effects on predicted atherosclerotic CVD risk when considered in the context of conventional risk factors.

Objectives

To estimate and compare the risk of emergent bradycardia associated with starting immediate-release (IR) and slow-release (SR) formulations of metoprolol.

Design

Retrospective analysis of administrative claims data.

Data source

State of California Medicaid program (Medi-Cal) claims database.

Patients

A total of 31,574 adults beginning metoprolol between May 1, 2004, and November 1, 2009, without a pharmacy claim for a β blocker within the previous 6 months of metoprolol initiation; patients with a primary or secondary diagnosis of symptomatic bradycardia, pacemaker, or implantable cardioverter-defibrillator placement before metoprolol initiation were excluded.

Measurements and main results

The study outcome was the time to first occurrence of emergent bradycardia, measured at an emergency department visit or hospitalization due to diagnosis of symptomatic bradycardia, after metoprolol initiation. We calculated the incidence and compared the risk of emergent bradycardia by using a proportional hazards model that included the metoprolol formulation with adjustment for total daily metoprolol dose and the use of other drugs as time-varying covariates, as well as demographics and comorbidities. Among 31,574 patients starting metoprolol, 18,516 (58.6%) used the IR formulation. The incidence of emergent bradycardia was 19.1/1000 person-years overall but was nearly twice as common in patients using the IR versus the SR formulation (24.1/1000 person-yrs in the IR group versus 12.9/1000 person-yrs in the SR group, unadjusted hazard ratio [HR] 1.81, 95% confidence interval [CI] 1.28-2.56). Adjustment for other drugs also associated with symptomatic bradycardia (cytochrome P450 2D6 inhibitors, class I or III antiarrhythmics, and atrioventricular node-blocking agents), metoprolol dose, and other participant characteristics somewhat attenuated the association (adjusted HR 1.48, 95% CI 1.03-2.13).

Conclusion

The risk of emergent bradycardia associated with metoprolol initiation was higher with the IR formulation than the SR formulation, although the absolute risk was low.

The Patient-Centered Outcomes Research Institute (PCORI) launched a multi-institutional "network of networks" in 2013 - Patient-Centered Clinical Research Network (PCORnet) - that is designed to conduct clinical research that is faster, less expensive, and more responsive to the information needs of patients and clinicians. To enhance cross-network and cross-institutional collaboration and catalyze the use of PCORnet, PCORI has supported formation of 11 Collaborative Research Groups focusing on specific disease types (e.g., cardiovascular health and cancer) or particular patient populations (e.g., pediatrics and health disparities). PCORnet's Collaborative Research Groups are establishing research priorities within these focus areas, establishing relationships with potential funders, and supporting development of specific research projects that will use PCORnet resources. PCORnet remains a complex, multilevel, and heterogeneous network that is still maturing and building a diverse portfolio of observational and interventional people-centered research; engaging with PCORnet can be daunting, particularly for outside investigators. We believe the Collaborative Research Groups are stimulating interest and helping investigators navigate the complexity, but only time will tell if these efforts will bear fruit in terms of funded multicenter PCORnet projects.

Background

Recent data suggest that aspirin may be effective for reducing cancer mortality.

Objective

To examine whether including a cancer mortality-reducing effect influences which men would benefit from aspirin for primary prevention.

Design

We modified our existing Markov model that examines the effects of aspirin among middle-aged men with no previous history of cardiovascular disease or diabetes. For our base case scenario of 45-year-old men, we examined costs and life-years for men taking aspirin for 10 years compared with men who were not taking aspirin over those 10 years; after 10 years, we equalized treatment and followed the cohort until death. We compared our results depending on whether or not we included a 22 % relative reduction in cancer mortality, based on a recent meta-analysis. We discounted costs and benefits at 3 % and employed a third party payer perspective.

Main measure

Cost per quality-adjusted life year (QALY) gained.

Key results

When no effect on cancer mortality was included, aspirin had a cost per QALY gained of $22,492 at 5 % 10-year coronary heart disease (CHD) risk; at 2.5 % risk or below, no treatment was favored. When we included a reduction in cancer mortality, aspirin became cost-effective for men at 2.5 % risk as well (cost per QALY, $43,342). Results were somewhat sensitive to utility of taking aspirin daily; risk of death after myocardial infarction; and effects of aspirin on stroke, myocardial infarction, and sudden death. However, aspirin remained cost-saving or cost-effective (< $50,000 per QALY) in probabilistic analyses (59 % with no cancer effect included; 96 % with cancer effect) for men at 5 % risk.

Conclusions

Including an effect of aspirin on cancer mortality influences the threshold for prescribing aspirin for primary prevention in men. If such an effect is real, many middle-aged men at low cardiovascular risk would become candidates for regular aspirin use.

Background

The coronary artery calcium (CAC) score is an independent predictor of coronary heart disease. We sought to combine information from the CAC score with information from conventional cardiac risk factors to produce post-test risk estimates, and to determine whether the score may add clinically useful information.

Methods

We measured the independent cross-sectional associations between conventional cardiac risk factors and the CAC score among asymptomatic persons referred for non-contrast electron beam computed tomography. Using the resulting multivariable models and published CAC score-specific relative risk estimates, we estimated post-test coronary heart disease risk in a number of different scenarios.

Results

Among 9341 asymptomatic study participants (age 35-88 years, 40% female), we found that conventional coronary heart disease risk factors including age, male sex, self-reported hypertension, diabetes and high cholesterol were independent predictors of the CAC score, and we used the resulting multivariable models for predicting post-test risk in a variety of scenarios. Our models predicted, for example, that a 60-year-old non-smoking non-diabetic women with hypertension and high cholesterol would have a 47% chance of having a CAC score of zero, reducing her 10-year risk estimate from 15% (per Framingham) to 6-9%; if her score were over 100, however (a 17% chance), her risk estimate would be markedly higher (25-51% in 10 years). In low risk scenarios, the CAC score is very likely to be zero or low, and unlikely to change management.

Conclusion

Combining information from the CAC score with information from conventional risk factors can change assessment of coronary heart disease risk to an extent that may be clinically important, especially when the pre-test 10-year risk estimate is intermediate. The attached spreadsheet makes these calculations easy.

Background

It is unclear whether coronary heart disease (CHD) risk factor exposure during early adulthood contributes to CHD risk later in life. Our objective was to analyze whether extent of early adult exposures to systolic and diastolic blood pressure (SBP, DBP) and low-and high-density lipoprotein cholesterol (LDL, HDL) are independent predictors of CHD events later in life.

Methods and findings

We used all available measurements of SBP, DBP, LDL, and HDL collected over 40 years in the Framingham Offspring Study to estimate risk factor trajectories, starting at age 20 years, for all participants. Average early adult (age 20-39) exposure to each risk factor was then estimated, and used to predict CHD events (myocardial infarction or CHD death) after age 40, with adjustment for risk factor exposures later in life (age 40+). 4860 participants contributed an average of 6.3 risk factor measurements from in-person examinations and 24.5 years of follow-up after age 40, and 510 had a first CHD event. Early adult exposures to high SBP, DBP, LDL or low HDL were associated with 8- to 30-fold increases in later life CHD event rates, but were also strongly correlated with risk factor levels later in life. After adjustment for later life levels and other risk factors, early adult DBP and LDL remained strongly associated with later life risk. Compared with DBP≤70 mmHg, adjusted hazard ratios (HRs) were 2.1 (95% confidence interval: 0.8-5.7) for DBP = 71-80, 2.6 (0.9-7.2) for DBP = 81-90, and 3.6 (1.2-11) for DBP>90 (p-trend = 0.019). Compared with LDL≤100 mg/dl, adjusted HRs were 1.5 (0.9-2.6) for LDL = 101-130, 2.2 (1.2-4.0) for LDL = 131-160, and 2.4 (1.2-4.7) for LDL>160 (p-trend = 0.009). While current levels of SBP and HDL were also associated with CHD events, we did not detect an independent association with early adult exposure to either of these risk factors.

Conclusions

Using a mixed modeling approach to estimation of young adult exposures with trajectory analysis, we detected independent associations between estimated early adult exposures to non-optimal DBP and LDL and CHD events later in life.

Background

Family history has been shown to be associated with increased risk of atrial fibrillation (AF). However, the specific AF characteristics that travel with a family history have not yet been elucidated. The purpose of this study was to determine whether a family history of AF is associated with specific patient characteristics in a worldwide, remote cohort.

Methods

From the Health eHeart Study, an internet-based prospective cohort, we performed a cross-sectional analysis of AF participants who reported their family history and completed questionnaires regarding their medical conditions and AF symptoms. We assessed demographics, cardiovascular comorbidities, and AF symptom characteristics in AF participants with and without a family history of AF.

Results

In multivariable analysis of 5,884 participants with AF (mean age 59.9 ± 14.5, 59% male, 92% white), female sex (odds ratio [OR]=1.35, 95% CI, 1.17-1.54, p<0.0001) and birth in the U.S. (OR=2.54, 95% CI, 2.12-3.05, p<0.0001) were independently associated with having a family history of AF. Having a family history of AF was also more commonly associated with symptoms of shortness of breath (OR=1.40, 95% CI, 1.07-1.82, p=0.014), chest pain, pressure, or discomfort (OR=1.95, 95% CI, 1.22-3.13, p=0.0052), and feeling generally "off" about oneself (OR=1.84, 95% CI, 1.27-2.67, p=0.0013).

Conclusions

Patients with a family history of AF are more likely to be female, be US-born, and experience symptoms of AF, suggesting underlying mechanistic differences between those with and without family history of AF.

Background and aims

In some states, liver transplantation (LT) for alcohol-associated liver disease (ALD) is covered by Medicaid only with documentation of abstinence and/or alcohol rehabilitation. Different Medicaid policies may affect the distribution of LT for ALD, particularly post-2011, as centers have adopted early (i.e., specific abstinence period not required) LT practices.

Approach and results

We surveyed Medicaid policies in all states actively performing LT and linked state policies to prospectively collected national registry data on LT recipients from 2002 to 2017 with ALD as the primary listing diagnosis. We categorized Medicaid policies for states as "restrictive" (requiring documentation of a specific abstinence period and/or rehabilitation) versus "unrestrictive" (deferring to center eligibility policies). Difference-of-differences analysis, comparing 2002-2011 versus 2012-2017, evaluated whether restrictive policies were associated with decreased proportion of LTs paid by Medicaid among patients with ALD post-2011. We performed sensitivity analyses to account for any differences by diagnosis of hepatocellular carcinoma, hepatitis C virus, nonalcoholic steatohepatitis, or Medicare insurance. We also performed a sensitivity analysis to account for any difference by prevalence of ALD among restrictive versus unrestrictive states. Of 10,836 LT recipients in 2002-2017, 7,091 were from 24 states in the restrictive group and 3,745 from 14 states in the unrestrictive group. The adjusted proportion (95% confidence interval) of LTs paid by Medicaid among restrictive versus unrestrictive states between 2002 and 2011 was 17.6% (15.4%-19.8%) versus 18.9% (15.4%-22.3%) (P = 0.54) and between 2012 and 2017, 17.2% (14.7%-19.7%) versus 23.2% (19.8%-26.6%) (P = 0.005). In difference-of-differences analysis, restrictive (versus unrestrictive) policies were associated with a 4.7% (0.8%-8.6%) (P = 0.02) absolute lower adjusted proportion of LTs for ALD paid by Medicaid post-2011.

Conclusions

Restrictive Medicaid policies are present in most states with active LT centers and are associated with lower proportions of LTs for ALD paid by Medicaid post-2011 compared to states with unrestrictive Medicaid policies. Reevaluation of Medicaid alcohol use policies may be warranted, to align more closely with contemporary center-level practices.