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Clinical practice guidelines have traditionally recommended blood pressure treatment based primarily on blood pressure thresholds. In contrast, using predicted cardiovascular risk has been advocated as a more effective strategy to guide treatment decisions for cardiovascular disease (CVD) prevention. We aimed to compare outcomes from a blood pressure-lowering treatment strategy based on predicted cardiovascular risk with one based on systolic blood pressure (SBP) level. We used individual participant data from the Blood Pressure Lowering Treatment Trialists' Collaboration (BPLTTC) from 1995 to 2013. Trials randomly assigned participants to either blood pressure-lowering drugs versus placebo or more intensive versus less intensive blood pressure-lowering regimens. We estimated 5-y risk of CVD events using a multivariable Weibull model previously developed in this dataset. We compared the two strategies at specific SBP thresholds and across the spectrum of risk and blood pressure levels studied in BPLTTC trials. The primary outcome was number of CVD events avoided per persons treated. We included data from 11 trials (47,872 participants). During a median of 4.0 y of follow-up, 3,566 participants (7.5%) experienced a major cardiovascular event. Areas under the curve comparing the two treatment strategies throughout the range of possible thresholds for CVD risk and SBP demonstrated that, on average, a greater number of CVD events would be avoided for a given number of persons treated with the CVD risk strategy compared with the SBP strategy (area under the curve 0.71 [95% confidence interval (CI) 0.70-0.72] for the CVD risk strategy versus 0.54 [95% CI 0.53-0.55] for the SBP strategy). Compared with treating everyone with SBP ≥ 150 mmHg, a CVD risk strategy would require treatment of 29% (95% CI 26%-31%) fewer persons to prevent the same number of events or would prevent 16% (95% CI 14%-18%) more events for the same number of persons treated. Compared with treating everyone with SBP ≥ 140 mmHg, a CVD risk strategy would require treatment of 3.8% (95% CI 12.5% fewer to 7.2% more) fewer persons to prevent the same number of events or would prevent 3.1% (95% CI 1.5%-5.0%) more events for the same number of persons treated, although the former estimate was not statistically significant. In subgroup analyses, the CVD risk strategy did not appear to be more beneficial than the SBP strategy in patients with diabetes mellitus or established CVD. A blood pressure-lowering treatment strategy based on predicted cardiovascular risk is more effective than one based on blood pressure levels alone across a range of thresholds. These results support using cardiovascular risk assessment to guide blood pressure treatment decision-making in moderate- to high-risk individuals, particularly for primary prevention.

Examine associations between health literacy and several medication self-management constructs among a population of adults with uncontrolled hypertension. Cross-sectional study of health center patients from the Chicago area with uncontrolled hypertension enrolled between April 2012 and February 2015. Medication self-management constructs-applied to hypertension medications, chronic condition medications and all medications-included: 1) medication reconciliation, 2) knowledge of drug indications, 3) understanding instructions and dosing, and 4) self-reported adherence over 4 days (no missed doses). We determined associations between health literacy and self-management outcomes using multivariable generalized linear regression. There were 1460 patients who completed screening interviews; 62.9% enrolled and had complete baseline data collected, and were included in the analysis. Of 919 participants, 47.4% had likely limited (low), 33.2% possibly limited, and 19.4% likely adequate health literacy. Compared to participants with likely adequate health literacy, participants with low health literacy were less likely to have chronic medications reconciled (18.0% versus 29.6%, p=0.007), know indications for chronic medications (64.1% versus 83.1%, p<0.001), and demonstrate understanding of instructions and dosing (68.1% versus 82.9%, p=0.001). Self-reported adherence to hypertension medications was higher among the low health literacy group (65.6% versus 56.0%, p=0.010). In multivariable models, health literacy was strongly associated with knowledge of drug indications, and understanding of instructions and dosing. Low health literacy was associated with worse medication self-management in several domains. However, non-adherence was greatest in the most health literate in unadjusted analysis. Among a population of patients with uncontrolled hypertension, the drivers of poor control may vary by health literacy.

Current algorithms for cardiovascular-risk prediction focus on identifying individuals who are at high short-term risk of experiencing a cardiovascular event. Drs Karmali and Lloyd-Jones advocate that lifetime-risk estimation should be used as an adjunct to 10 year risk prediction, to motivate individuals who have a low short-term, but substantial lifetime, risk (such as many women and young men) to adopt healthy, preventive behaviour. Current practice in the primary prevention of cardiovascular disease (CVD) involves estimation of the short-term (typically 5–10-year) risk of developing CVD. This risk estimation can serve as the prelude to a conversation between physicians and patients about CVD risk and risk-reducing therapies. However, focusing solely on short-term risk directs these conversations towards individuals who, in all likelihood, have already accrued substantial atherosclerosis during their lifetime. We suggest that estimation of lifetime risk and other novel methods of risk communication, such as risk-adjusted age, should be used as an adjunct to 10-year risk estimation. We believe that these strategies will improve patient understanding of CVD risk, identify new sections of the population who might benefit from preventive therapy, and motivate lifestyle changes and adherence to therapy early in the course of disease progression.

Previous studies have demonstrated gaps in achievement of low-density lipoprotein-cholesterol (LDL-C) goals among U.S. individuals at high cardiovascular disease risk; however, recent studies in selected populations indicate improvements. We sought to define the longitudinal trends in achieving LDL-C goals among high-risk United States adults from 1999-2008. We analyzed five sequential population-based cross-sectional National Health and Nutrition Examination Surveys 1999-2008, which included 18,656 participants aged 20-79 years. We calculated rates of LDL-C goal achievement and treatment in the high-risk population. The prevalence of high-risk individuals increased from 13% to 15.5% (p = 0.046). Achievement of LDL-C <100 mg/dL increased from 24% to 50.4% (p<0.0001) in the high-risk population with similar findings in subgroups with (27% to 64.8% p<0.0001) and without (21.8% to 43.7%, p<0.0001) coronary heart disease (CHD). Achievement of LDL-C <70 mg/dL improved from 2.4% to 17% (p<0.0001) in high-risk individuals and subgroups with (3.4% to 21.4%, p<0.0001) and without (1.7% to 14.9%, p<0.0001) CHD. The proportion with LDL-C ≥130 mg/dL and not on lipid medications decreased from 29.4% to 18% (p = 0.0002), with similar findings among CHD (25% to 11.9% p = 0.0013) and non-CHD (35.8% to 20.8% p<0.0001) subgroups. The proportions of the U.S. high-risk population achieving LDL-C <100 mg/dL and <70 mg/dL increased over the last decade. With 65% of the CHD subpopulation achieving an LDL-C <100 mg/dL in the most recent survey, U.S. LDL-C goal achievement exceeds previous reports and approximates rates achieved in highly selected patient cohorts.

Background The ACS QUIK trial showed that a multicomponent quality improvement toolkit intervention resulted in improvements in processes of care for patients with acute myocardial infarction in Kerala but did not improve clinical outcomes in the context of background improvements in care. We describe the development of the ACS QUIK intervention and evaluate its implementation, acceptability, and sustainability. Methods We performed a mixed methods process evaluation alongside a cluster randomized, stepped-wedge trial in Kerala, India. The ACS QUIK intervention aimed to reduce the rate of major adverse cardiovascular events at 30 days compared with usual care across 63 hospitals ( n  = 21,374 patients). The ACS QUIK toolkit intervention, consisting of audit and feedback report, admission and discharge checklists, patient education materials, and guidelines for the development of code and rapid response teams, was developed based on formative qualitative research in Kerala and from systematic reviews. After four or more months of the center’s participation in the toolkit intervention phase of the trial, an online survey and physician interviews were administered. Physician interviews focused on evaluating the implementation and acceptability of the toolkit intervention. A framework analysis of transcripts incorporated context and intervening mechanisms. Results Among 63 participating hospitals, 22 physicians (35%) completed online surveys. Of these, 17 (77%) respondents reported that their hospital had a cardiovascular quality improvement team, 18 (82%) respondents reported having read an audit report, admission checklist, or discharge checklist, and 19 (86%) respondents reported using patient education materials. Among the 28 interviewees (44%), facilitators of toolkit intervention implementation were physicians’ support and leadership, hospital administrators’ support, ease-of-use of checklists and patient education materials, and availability of training opportunities for staff. Barriers that influenced the implementation or acceptability of the toolkit intervention for physicians included time and staff constraints, Internet access, patient volume, and inadequate understanding of the quality improvement toolkit intervention. Conclusions Implementation and acceptability of the ACS QUIK toolkit intervention were enhanced by hospital-level management support, physician and team support, and usefulness of checklists and patient education materials. Wider and longer-term use of the toolkit intervention and its expansion to potentially other cardiovascular conditions or other locations where the quality of care is not as high as in the ACS QUIK trial may be useful for improving acute cardiovascular care in Kerala and beyond. Trial registration NCT02256657

Mobile applications (apps) may help improve hypertension self-management. To investigate the effect of an artificial intelligence smartphone coaching app to promote home monitoring and hypertension-related behaviors on systolic blood pressure level compared with a blood pressure tracking app. This was a 2-group, open, randomized clinical trial. Participants with uncontrolled hypertension were recruited in 2016 and 2017 and were followed up for 6 months. Data analysis was performed from April 2019 to December 2019. Intervention group participants received a smartphone coaching app to promote home monitoring and behavioral changes associated with hypertension self-management plus a home blood pressure monitor. Control participants received a blood pressure tracking app plus a home blood pressure monitor. The primary study outcome was systolic blood pressure at 6 months. Secondary outcomes included self-reported antihypertensive medication adherence, home monitoring and self-management practices, measures of self-efficacy associated with blood pressure, weight, and self-reported health behaviors. There were 333 participants randomized, and 297 completed the follow-up assessment. Among the participants who completed the study, the mean (SD) age was 58.9 (12.8) years, 182 (61.3%) were women, and 103 (34.7%) were black. Baseline mean (SD) systolic blood pressure was 140.6 (12.2) mm Hg among intervention participants and 141.8 (13.4) mm Hg among control participants. After 6 months, the corresponding mean (SD) systolic blood pressures were 132.3 (15.0) mm Hg and 135.0 (13.9) mm Hg, with a between-group adjusted difference of -2.0 mm Hg (95% CI, -4.9 mm Hg to 0.8 mm Hg; P = .16). At 6 months, self-confidence in controlling blood pressure was greater in the intervention group (0.36 point on a 5-point scale; 95% CI, 0.18 point to 0.54 point; P < .001). There were no significant differences between the 2 groups in other secondary outcomes. The adjusted difference in self-reported physical activity was 26.7 minutes per week (95% CI, -5.4 minutes per week to 58.8 minutes per week; P = .10). Subgroup analysis raised the possibility that intervention effects differed by age. Among individuals with uncontrolled hypertension, those randomized to a smartphone coaching app plus home monitor had similar systolic blood pressure compared with those who received a blood pressure tracking app plus home monitor. Given the direction of the difference in systolic blood pressure between groups and the possibility for differences in treatment effects across subgroups, future studies are warranted. ClinicalTrials.gov Identifier: NCT03288142.

The Reynolds Risk Score (RRS) is one alternative to the Framingham Risk Score (FRS) for cardiovascular risk assessment. The Adult Treatment Panel III (ATP III) integrated the FRS a decade ago, but with the anticipated release of ATP IV, it remains uncertain how and which risk models will be integrated into the recommendations. We sought to define the effects in the United States population of a transition from the FRS to the RRS for cardiovascular risk assessment. Using the National Health and Nutrition Examination Surveys, we assessed FRS and RRS in 2,502 subjects representing approximately 53.6 Million (M) men (ages 50-79) and women (ages 45-79), without cardiovascular disease or diabetes. We calculated the proportion reclassified by RRS and the subset whose LDL-C goal achievement changed. Compared to FRS, the RRS assigns a higher risk category to 13.9% of women and 9.1% of men while assigning a lower risk to 35.7% of men and 2% of women. Overall, 4.7% of women and 1.1% of men fail to meet newly intensified LDL-C goals using the RRS. Conversely, 10.5% of men and 0.6% of women now meet LDL-C goal using RRS when they had not by FRS. In the U.S. population the RRS assigns a new risk category for one in six women and four of nine men. In general, women increase while men decrease risk. In conclusion, adopting the RRS for the 53.6 million eligible U.S. adults would result in intensification of clinical management in 1.6 M additional women and 2.10 M fewer men.

We aimed to investigate whether the benefits of blood pressure-lowering drugs are proportional to baseline cardiovascular risk, to establish whether absolute risk could be used to inform treatment decisions for blood pressure-lowering therapy, as is recommended for lipid-lowering therapy. This meta-analysis included individual participant data from trials that randomly assigned patients to either blood pressure-lowering drugs or placebo, or to more intensive or less intensive blood pressure-lowering regimens. The primary outcome was total major cardiovascular events, consisting of stroke, heart attack, heart failure, or cardiovascular death. Participants were separated into four categories of baseline 5-year major cardiovascular risk using a risk prediction equation developed from the placebo groups of the included trials (<11%, 11–15%, 15–21%, >21%). 11 trials and 26 randomised groups met the inclusion criteria, and included 67 475 individuals, of whom 51 917 had available data for the calculation of the risk equations. 4167 (8%) had a cardiovascular event during a median of 4·0 years (IQR 3·4–4·4) of follow-up. The mean estimated baseline levels of 5-year cardiovascular risk for each of the four risk groups were 6·0% (SD 2·0), 12·1% (1·5), 17·7% (1·7), and 26·8% (5·4). In each consecutive higher risk group, blood pressure-lowering treatment reduced the risk of cardiovascular events relatively by 18% (95% CI 7–27), 15% (4–25), 13% (2–22), and 15% (5–24), respectively (p=0·30 for trend). However, in absolute terms, treating 1000 patients in each group with blood pressure-lowering treatment for 5 years would prevent 14 (95% CI 8–21), 20 (8–31), 24 (8–40), and 38 (16–61) cardiovascular events, respectively (p=0·04 for trend). Lowering blood pressure provides similar relative protection at all levels of baseline cardiovascular risk, but progressively greater absolute risk reductions as baseline risk increases. These results support the use of predicted baseline cardiovascular disease risk equations to inform blood pressure-lowering treatment decisions. None.