Healthiness of food products promoted through placement strategies in Australian online supermarkets: a cross-sectional study.

BACKGROUND: Prominent product placement is a core promotional tactic in retail food environments. How this practice has been adapted for online supermarkets, and the extent to which it is applied to healthier and less healthy food products in this setting, is largely unknown. We aimed to investigate placement-type promotions of food products in Australian online supermarkets. METHODS: We developed a new method to assess placement promotions and applied it to the online stores of the two largest supermarket retailers in Australia. Each online store was audited across six 'locations' (input prior to data collection), including a randomly selected high socio-economic position area and low socio-economic position area from each of the three largest Australian cities. The names, page locations and type of placement strategy of promoted food products were captured, with product healthiness assessed using the Health Star Rating (HSR) nutrient profiling system. Descriptive statistics summarised the page locations of promoted products and the placement strategies used to promote them, and chi-squared tests applied to compare product healthiness by retailer and socio-economic position. RESULTS: We recorded 12,152 food products promoted through placement strategies, 99% of which were eligible for a HSR. Overall, 44% of products promoted through placement strategies were unhealthy. Cross-promotions and recommendations was the most common strategy recorded overall (55.9% of all strategies), and advertisements and site content was the strategy most likely to promote unhealthy products (53.7% of products unhealthy). One retailer was more likely to promote unhealthy products (46% v 43%, p = 0.004) and unhealthy products were more likely to be promoted in more disadvantaged than less disadvantaged locations (45% vs 43%, p = 0.05), though the magnitudes of difference were small. CONCLUSIONS: A considerable number of unhealthy products are likely presented to online grocery shoppers in Australia. Public health policies targeting unhealthy food promotions may need to be updated, including with consideration of the different ways that products can be prominently displayed online, to avoid exacerbating risks of diet-related disease and health inequalities. Our novel methodology could be used for ongoing monitoring of online supermarkets in Australia and elsewhere to inform such policies.

deliVERy of optimal blood pressure coNtrol in afrICA (VERONICA)-Nigeria study: Rationale and design of a randomized clinical trial.

BACKGROUND: Blood pressure (BP) control among treated patients in Africa is very suboptimal, with low levels of combination therapy use and therapeutic inertia being among the major barriers to effective control of hypertension. The VERONICA-Nigeria study aims to evaluate, among Black African adults with hypertension, the effectiveness and safety of a triple pill-based treatment protocol compared to Nigeria hypertension treatment protocol (standard care protocol) for the treatment of hypertension. METHODS: This study involves a randomized, parallel-group and open-label trial. Adults with uncontrolled hypertension (n = 300), untreated or receiving monotherapy, with no contraindication to study treatments will be randomly assigned 1:1 to treatment with a triple pill based-treatment protocol or standard care protocol. Follow-up is for 6 months, with interim follow up visits at month 1, 2, and 3. In a noncomparative extension treatment period, participants completing the 6 months randomized period and on ≤3 BP-lowering drugs will receive treatment with the triple pill-based treatment protocol for 12 months. The primary outcome is change in home mean SBP from baseline to month 6, and key secondary efficacy outcome is percentage of participants with clinic BP <140/90 mmHg at month 6. The primary safety outcome is discontinuation of trial treatment due to adverse events from randomization to month 6. Economic evaluation will be conducted to assess the cost-effectiveness of the triple pill-based treatment protocol, and process evaluation will be conducted to understand the context in which the trial was conducted, implementation of the trial and interventions and mechanisms of effect, and potential barriers and facilitators to implementing the intervention in clinical practice. CONCLUSION: The VERONICA-Nigeria trial will provide evidence of effectiveness and safety of the triple-based treatment protocol for the pharmacological management of hypertension, in Black African adults. TRIAL REGISTRATION: PACTR202107579572114.

Rationale, Design and Baseline Characteristics of a Randomized Controlled Trial of a Cardiovascular Quality Improvement Strategy in India: The C-QIP Trial.

BACKGROUND: Quality of chronic care for cardiovascular disease (CVD) remains suboptimal worldwide. The Collaborative Quality ImProvement (C-QIP) trial aims to develop and test the feasibility and clinical effect of a multicomponent strategy among patients with prevalent CVD in India. METHODS: The C-QIP is a clinic-based, open randomized trial of a multicomponent intervention vs usual care that was locally developed and adapted for use in Indian settings through rigorous formative research guided by Consolidated Framework for Implementation Research (CFIR). The C-QIP intervention consisted of 5 components: 1) electronic health records and decision support system for clinicians, 2) trained nonphysician health workers (NPHW), 3) text-message based lifestyle reminders, 4) patient education materials, 5) quarterly audit and feedback reports. Patients with CVD (ischemic heart disease, ischemic stroke, or heart failure) attending outpatient CVD clinics were recruited from September 2022 to September 2023 and were randomized to the intervention or usual care arm for at least 12 months follow-up. The co-primary outcomes are implementation feasibility, fidelity (ie, dose delivered and dose received), acceptability, adoption and appropriateness, measured at multiple levels: patient, provider and clinic site-level, The secondary outcomes include prescription of guideline directed medical therapy (GDMT) (provider-level), and adherence to prescribed therapy, change in mean blood pressure (BP) and LDL-cholesterol between the intervention and control groups (patient-level). In addition, a trial-based process and economic evaluations will be performed using standard guidelines. RESULTS: We recruited 410 socio-demographically diverse patients with CVD from 4 hospitals in India. Mean (SD) age was 57.5 (11.7) years, and 73.0% were males. Self-reported history of hypertension (48.5%) and diabetes (41.5%) was common. At baseline, mean (SD) BP was 127.9 (18.2) /76.2 (11.6) mm Hg, mean (SD) LDLc: 80.3 (37.3) mg/dl and mean (SD) HbA1c: 6.8% (1.6%). At baseline, the GDMT varied from 62.4% for patients with ischemic heart disease, 48.6% for ischemic stroke and 36.1% for heart failure. CONCLUSION: This study will establish the feasibility of delivering contextually relevant, and evidence-based C-QIP strategy and assess whether it is acceptable to the target populations. The study results will inform a larger scale confirmatory trial of a comprehensive CVD care model in low-resource settings. TRIAL REGISTRATION: Clinical Trials Registry India: CTRI/2022/04/041847; Clinicaltrials.gov number: NCT05196659.

Interventions and contextual factors to improve retention in care for patients with hypertension in primary care: Hermeneutic systematic review.

BACKGROUND: Regular engagement over time in hypertension care, or retention, is a crucial but understudied step in optimizing patient outcomes. This systematic review leverages a hermeneutic methodology to identify, evaluate, and quantify the effects of interventions and contextual factors for improving retention for patients with hypertension. METHODS: We searched for articles that were published between 2000 and 2022 from multiple electronic databases, including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, clinicaltrials.gov, and WHO International Trials Registry. We followed the latest version of the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guideline to report the findings for this review. We also synthesized the findings using a hermeneutic methodology for systematic reviews, which used an iterative process to review, integrate, analyze, and interpret evidence. RESULTS: From 4686 screened titles and abstracts, 18 unique studies from 9 countries were identified, including 10 (56%) randomized controlled trials (RCTs), 3 (17%) cluster RCTs, and 5 (28%) non-RCT studies. The number of participants ranged from 76 to 1562. The overall mean age range was 41-67 years, and the proportion of female participants ranged from 0% to 100%. Most (n = 17, 94%) studies used non-physician personnel to implement the proposed interventions. Fourteen studies (78%) implemented multilevel combinations of interventions. Education and training, team-based care, consultation, and Short Message Service reminders were the most common interventions tested. CONCLUSIONS: This review presents the most comprehensive findings on retention in hypertension care to date and fills the gaps in the literature, including the effectiveness of interventions, their components, and contextual factors. Adaptation of and implementing HIV care models, such differentiated service delivery, may be more effective and merit further study. REGISTRATION: CRD42021291368. PROTOCOL REGISTRATION: PROSPERO 2021 CRD42021291368. Available at: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=291368.

Low-Dose Triple-Pill vs Standard-Care Protocols for Hypertension Treatment in Nigeria: A Randomized Clinical Trial.

Importance: With the high burden of hypertension in sub-Saharan Africa, there is a need for effective, safe and scalable treatment strategies. Objective: To compare, among Black African adults, the effectiveness and safety of a novel low-dose triple-pill protocol compared with a standard-care protocol for blood pressure lowering. Design and Setting: Randomized, parallel-group, open-label, multicenter trial conducted in public hospital-based family medicine clinics in Nigeria. Participants: Black African adults with uncontrolled hypertension (≥140/90 mm Hg) who were untreated or receiving a single blood pressure-lowering drug. Interventions: Participants were randomly allocated to low-dose triple-pill or standard-care protocols. The triple-pill protocol involved a novel combination of telmisartan, amlodipine, and indapamide in triple one-quarter, one-half, and standard doses (ie, 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg), with accelerated up-titration. The standard-care protocol was the Nigeria hypertension treatment protocol starting with amlodipine (5 mg). Main Outcomes and Measures: The primary effectiveness outcome was the reduction in home mean systolic blood pressure, and the primary safety outcome was discontinuation of trial treatment due to adverse events, both from randomization to month 6. Results: The first participant was randomized on July 19, 2022, and the last follow-up visit was on July 18, 2024. Among 300 randomized participants (54% female; mean age, 52 years; baseline mean home blood pressure, 151/97 mm Hg; and clinic blood pressure, 156/97 mm Hg), 273 (91%) completed the trial. At month 6, mean home systolic blood pressure was on average 31 mm Hg (95% CI, 28 to 33 mm Hg) lower in the triple-pill protocol group and 26 mm Hg (95% CI, 22 to 28 mm Hg) lower in the standard-care protocol group (adjusted difference, -5.8 mm Hg [95% CI, -8.0 to -3.6]; P < .001]). At month 6, clinic blood pressure control (<140/90 mm Hg) was 82% vs 72% (risk difference, 10% [95% CI, -2% to 20%]) and home blood pressure control (<130/80 mm Hg) was 62% vs 28% (risk difference, 33% [95% CI, 22% to 44%]) in the triple-pill compared with the standard-care protocol group; these were 2 of 21 prespecified secondary effectiveness end points. No participants discontinued trial treatment due to adverse events. Conclusions and Relevance: Among Black African adults with uncontrolled hypertension, a low-dose triple-pill protocol achieved better blood pressure lowering and control with good tolerability compared with the standard-care protocol. Trial Registration: Pan African Clinical Trials Registry Identifier: PACTR202107579572114.

Current food labelling practices in online supermarkets in Australia.

BACKGROUND: Food product labelling can support consumer decision-making. Several food product labels (nutrition information panels (NIPs), ingredients lists, allergen declarations and country-of-origin) are mandated for physical product packaging in Australia, with a voluntary front-of-pack nutrition labelling system, Health Star Ratings (HSRs), also available. However, labelling requirements are not explicitly extended to online settings and the extent to which this information is available in these increasingly important food environments has not been assessed. METHODS: Data from all individual food product pages was collected from the online stores of the two dominant supermarket retailers in Australia using automated web scraping in April-May 2022 (n = 22,077 products collected). We assessed the proportion of pages displaying NIPs, ingredients, allergens, country-of-origin and HSRs after excluding products ineligible to display the respective label. We also assessed whether HSRs were differentially available for higher- (healthier) and lower-scoring (less healthy) products, with HSR scores drawn from a comprehensive Australian food composition database, FoodSwitch. A manual inspection of randomly selected product pages (n = 100 for each label type per supermarket), drawn from products displaying the relevant label, was conducted to assess whether the labels were immediately visible to users (i.e. without scrolling or clicking). Differences in labelling prevalence and visibility were compared using chi-squared tests. RESULTS: Across both supermarkets, country-of-origin labelling was almost complete (displayed on 93% of food product pages), but NIPs (49%), ingredients (34%) and allergens (53%) were less frequently displayed. HSRs were infrequently displayed (14% across both supermarkets) and more likely to be applied to higher-scoring products (22% on products with ≥ 3.5HSR v 0.4% on products with < 3.5HSR, p < 0.001). One supermarket was far more likely to make NIPs (100% v 2%, p < 0.001), ingredients (100% v 19%, p < 0.001) and allergens (97% v 0%, p < 0.001) information immediately visible, though the other made HSRs more apparent (22% v 75%, p < 0.001). Both supermarkets displayed country-of-origin labels prominently (100% v 86%, p < 0.001). CONCLUSIONS: Food product labelling varies in online supermarkets in Australia overall and between supermarkets, while the design of online stores resulted in differences in labelling visibility. The near-complete display of country-of-origin labels and differential application of HSRs to higher-scoring products may reflect their use as marketing tools. Our findings highlight an urgent need for food labelling regulations to be updated to better account for online retail food environments.

Seeing Through the Blind: Belief about Treatment Randomization and Smoking Cessation Outcome among People with Current or Past Major Depressive Disorder who Smoke in a Placebo-Controlled Trial of Varenicline.

INTRODUCTION: Blinding participants to randomization is a cornerstone of science. However, participant beliefs about their allocation can influence outcomes. We examined blind integrity, the association between trial arm belief and cessation, and potential mechanisms linking treatment arm and treatment arm belief among people with major depressive disorder (MDD) who smoke receiving varenicline in a placebo-controlled trial. METHODS: 175 participants were asked at the end of treatment (EOT) if they thought they received placebo, varenicline, or were not sure. We assessed the relationship between treatment arm belief and actual treatment allocation, examined the association between treatment arm belief and EOT cessation, and evaluated changes in craving, withdrawal, side effects, depression symptoms, and smoking reward as mediators through which treatment arm was believed. RESULTS: Treatment arm belief was significantly associated with actual arm assignment (χ2(2)=13.0, p=0.002). Participants in the varenicline arm were >3 times as likely to believe they were taking varenicline, vs. "not sure" (RR=3.05 [1.41-6.60], p=0.005). Participants in the placebo arm were just as likely to believe they were taking placebo vs. "not sure" (χ2[2]=0.75, p=0.69). Controlling for treatment arm, belief that one received varenicline was significantly associated with an increase in cessation rate (OR=5.91 [2.06-16.92], p=0.001). Change in the rewarding experience of smoking may mediate participant ability to discern getting varenicline B=0.077 [0.002-0.192], p <0.05). CONCLUSIONS: Participants receiving varenicline can discern that they received varenicline and this belief is associated with higher cessation rates. Research is needed to continue to examine how participants correctly identify their allocation to varenicline.

Clinical characteristics and treatment patterns of pregnant women with hypertension in primary care in the Federal Capital Territory of Nigeria: cross-sectional results from the hypertension treatment in Nigeria Program.

BACKGROUND: Hypertensive disorders of pregnancy, including hypertension, are a leading cause of maternal mortality in Nigeria. However, there is a paucity of data on pregnant women with hypertension who receive care in primary health care facilities. This study presents the results from a cross-sectional analysis of pregnant women enrolled in the Hypertension Treatment in Nigeria Program which is aimed at integrating and strengthening hypertension care in primary health care centres. METHODS: A descriptive analysis of the baseline results from the Hypertension Treatment in Nigeria Program was performed. Baseline blood pressures, treatment and control rates of pregnant women were analysed and compared to other adult women of reproductive age. A complete case analysis was performed, and a two-sided p value < 0.05 was considered statistically significant. RESULTS: Between January 2020 to October 2022, 5972 women of reproductive age were enrolled in the 60 primary healthcare centres participating in the Hypertension Treatment in Nigeria Program and 112 (2%) were pregnant. Overall mean age (SD) was 39.6 years (6.3). Co-morbidities were rare in both groups, and blood pressures were similar amongst pregnant and non-pregnant women (overall mean (SD) first systolic and diastolic blood pressures were 157.4 (20.6)/100.7 (13.6) mm Hg and overall mean (SD) second systolic and diastolic blood pressures were 151.7 (20.1)/98.4 (13.5) mm Hg). However, compared to non-pregnant women, pregnant women had a higher rate of newly diagnosed hypertension (65.2% versus 54.4% p = 0.02) and lower baseline walk-in treatment (32.1% versus 42.1%, p = 0.03). The control rate was numerically lower among pregnant patients (6.3% versus 10.2%, p = 0.17), but was not statistically significant. Some pregnant patients (8.3%) were on medications contraindicated in pregnancy, and none of the pregnant women were on aspirin for primary prevention of preeclampsia. CONCLUSIONS: These findings indicate significant gaps in care and important areas for future studies to improve the quality of care and outcomes for pregnant women with hypertension in Nigeria, a country with the highest burden of maternal mortality globally.

Facilitators and barriers to optimal home blood pressure management in patients with hypertensive disorders of pregnancy in a tertiary care facility in Abuja, Nigeria: a qualitative research study.

BACKGROUND: Nigeria has one of the highest burdens of maternal deaths globally, and hypertensive disorders of pregnancy (HDP) are the leading cause of maternal morbidity and mortality in the country. There is a significant implementation gap in utilizing evidence-based practices for the management of HDP in Nigeria. This study evaluated facilitators and barriers to implementing a home blood pressure monitoring program to improve management of HDP. METHODS: From August 2022 to September 2022, we conducted 15 semi-structured, key informant interviews and 4 focus group discussions among patients, health care workers, and administrators at University of Abuja Teaching Hospital (UATH), a tertiary care centre in Nigeria. The study used the Consolidated Framework for Implementation Research to assess five domains: individual characteristics, inner and outer settings, intervention characteristics, and process of implementation. Audio files were transcribed, and data were analysed using a combination of inductive and deductive approaches. We also conducted 32 brief surveys on the participants to assess acceptability, appropriateness, and feasibility of a blood pressure monitoring program. RESULTS: The study sample consisted of healthcare workers (n=22) including specialists in cardiology, obstetrics and gynaecology, maternal-foetal medicine, nurses/midwives and resident doctors as well as patients (n=10). Mean (SD) age was 39.5 (10.9), and 78% were female. Participants identified facilitators including the perceived simplicity of home blood pressure monitoring program, high burden of HDP, and availability of a multi-disciplinary team of healthcare professionals with expertise in HDP management. Barriers identified were cost, limited knowledge of HDP amongst patients, limited transportation networks, inconsistent management protocols, and inadequate manpower and facilities. Survey results indicated that between 81% and 88% of participants reported that a blood pressure monitoring program would be acceptable, 56%-72% reported that it would be appropriate, and 47%-69% reported that it would be feasible. CONCLUSION: This study identified facilitators and barriers while highlighting key implementation strategies to leverage and effectively address these respectively to enable successful implementation of a home blood pressure monitoring program. It also demonstrated that a home blood pressure monitoring program was considered acceptable, appropriate and feasible among respondents interviewed at UATH.

Aspirin for Secondary Prevention of Cardiovascular Disease in 51 Low-, Middle-, and High-Income Countries.

Importance: Aspirin is an effective and low-cost option for reducing atherosclerotic cardiovascular disease (CVD) events and improving mortality rates among individuals with established CVD. To guide efforts to mitigate the global CVD burden, there is a need to understand current levels of aspirin use for secondary prevention of CVD. Objective: To report and evaluate aspirin use for secondary prevention of CVD across low-, middle-, and high-income countries. Design, Setting, and Participants: Cross-sectional analysis using pooled, individual participant data from nationally representative health surveys conducted between 2013 and 2020 in 51 low-, middle-, and high-income countries. Included surveys contained data on self-reported history of CVD and aspirin use. The sample of participants included nonpregnant adults aged 40 to 69 years. Exposures: Countries' per capita income levels and world region; individuals' socioeconomic demographics. Main Outcomes and Measures: Self-reported use of aspirin for secondary prevention of CVD. Results: The overall pooled sample included 124 505 individuals. The median age was 52 (IQR, 45-59) years, and 50.5% (95% CI, 49.9%-51.1%) were women. A total of 10 589 individuals had a self-reported history of CVD (8.1% [95% CI, 7.6%-8.6%]). Among individuals with a history of CVD, aspirin use for secondary prevention in the overall pooled sample was 40.3% (95% CI, 37.6%-43.0%). By income group, estimates were 16.6% (95% CI, 12.4%-21.9%) in low-income countries, 24.5% (95% CI, 20.8%-28.6%) in lower-middle-income countries, 51.1% (95% CI, 48.2%-54.0%) in upper-middle-income countries, and 65.0% (95% CI, 59.1%-70.4%) in high-income countries. Conclusion and Relevance: Worldwide, aspirin is underused in secondary prevention, particularly in low-income countries. National health policies and health systems must develop, implement, and evaluate strategies to promote aspirin therapy.

Eligibility and Prevalence of the American Heart Association Heart Check Certification Program in the US Packaged Food and Beverage Supply: A Cross-Sectional Study.

Objective: Consumers in the US make choices within a food supply dominated by processed packaged foods and beverage products. Front-of-package nutrition labels (FOPL) equip consumers to make healthier choices, but further evaluation and regulation regarding FOPL format, scope, and display have been recommended by the World Health Organization. As a leader in consumer FOPL guidance, the American Heart Association's (AHA) Heart Check programme certifies food companies seeking to add an AHA Heart Check logo as a FOPL for qualifying heart healthy products. A cross-sectional assessment of the AHA Heart Check Standard Certification was conducted within the US packaged food and beverage supply to assess the eligibility and prevalence of the programme as a FOPL. Methods: Data were derived from Label Insight's Open Data initiative, which is the largest publicly-available US branded food composition database. The proportions of products that were certified and eligible to be certified for the Standard Certification were reported by nutrient attributes, grocery aisles and food brands. Results: Among 153,453 products examined, fewer than 1% exhibited the Heart Check certification on their label. Among products that were not Heart Check certified,13.8% were eligible for Standard Certification. The most common reason for ineligibility was the saturated fat content (52%), followed by total fat content (47%) and sodium content (47%). Heart Check certification and eligibility differed substantially across grocery aisle categories. Conclusions: The abundance of unhealthy products in the US packaged food and beverage supply and absence of harmonized FOPL policies suggest the need for FOPL like the Heart Check label to promote adherence to healthy diets. There are opportunities for food manufacturers and the AHA to certify more heart healthy foods and beverages. However, more consistent criteria and transparent labelling could enhance Heart Check certification to facilitate consumers' ability to make more informed and healthful purchases.

Fixed-dose combination therapies with and without aspirin for primary prevention of cardiovascular disease: an individual participant data meta-analysis.

BACKGROUND: In randomised controlled trials, fixed-dose combination treatments (or polypills) have been shown to reduce a composite of cardiovascular disease outcomes in primary prevention. However, whether or not aspirin should be included, effects on specific outcomes, and effects in key subgroups are unknown. METHODS: We did an individual participant data meta-analysis of large randomised controlled trials (each with ≥1000 participants and ≥2 years of follow-up) of a fixed-dose combination treatment strategy versus control in a primary cardiovascular disease prevention population. We included trials that evaluated a fixed-dose combination strategy of at least two blood pressure lowering agents plus a statin (with or without aspirin), compared with a control strategy (either placebo or usual care). The primary outcome was time to first occurrence of a composite of cardiovascular death, myocardial infarction, stroke, or arterial revascularisation. Additional outcomes included individual cardiovascular outcomes and death from any cause. Outcomes were also evaluated in groups stratified by the inclusion of aspirin in the fixed-dose treatment strategy, and effect sizes were estimated in prespecified subgroups based on risk factors. Kaplan-Meier survival curves and Cox proportional hazard regression models were used to compare strategies. FINDINGS: Three large randomised trials were included in the analysis (TIPS-3, HOPE-3, and PolyIran), with a total of 18 162 participants. Mean age was 63·0 years (SD 7·1), and 9038 (49·8%) participants were female. Estimated 10-year cardiovascular disease risk for the population was 17·7% (8·7). During a median follow-up of 5 years, the primary outcome occurred in 276 (3·0%) participants in the fixed-dose combination strategy group compared with 445 (4·9%) in the control group (hazard ratio 0·62, 95% CI 0·53-0·73, p<0·0001). Reductions were also observed for the separate components of the primary outcome: myocardial infarction (0·52, 0·38-0·70), revascularisation (0·54, 0·36-0·80), stroke (0·59, 0·45-0·78), and cardiovascular death (0·65, 0·52-0·81). Significant reductions in the primary outcome and its components were observed in the analyses of fixed-dose combination strategies with and without aspirin, with greater reductions for strategies including aspirin. Treatment effects were similar at different lipid and blood pressure levels, and in the presence or absence of diabetes, smoking, or obesity. Gastrointestinal bleeding was uncommon but slightly more frequent in the fixed-dose combination strategy with aspirin group versus control (19 [0·4%] vs 11 [0·2%], p=0·15). The frequencies of haemorrhagic stroke (10 [0·2%] vs 15 [0·3%]), fatal bleeding (two [<0·1%] vs four [0·1%]), and peptic ulcer disease (32 [0·7%] vs 34 [0·8%]) were low and did not differ significantly between groups. Dizziness was more common with fixed-dose combination treatment (1060 [11·7%] vs 834 [9·2%], p<0·0001). INTERPRETATION: Fixed-dose combination treatment strategies substantially reduce cardiovascular disease, myocardial infarction, stroke, revascularisation, and cardiovascular death in primary cardiovascular disease prevention. These benefits are consistent irrespective of cardiometabolic risk factors. FUNDING: Population Health Research Institute.

Protocol for a novel sodium and blood pressure reduction intervention targeting online grocery shoppers with hypertension - the SaltSwitch Online Grocery Shopping randomized trial.

BACKGROUND: High dietary sodium intake is a leading cause of hypertension. A major source of dietary sodium is salt added to processed food products available in retail food environments. The fast-growing online grocery shopping setting provides new opportunities for salt reduction interventions that support consumers in choosing healthier options. METHODS: The SaltSwitch Online Grocery Shopping randomized controlled trial is investigating the feasibility, acceptability, and effectiveness of a novel intervention for lowering salt consumption and blood pressure amongst people with hypertension who shop for groceries online. The intervention is based on a bespoke web browser extension that interfaces with a major retailer's online store to highlight and interpret product sodium content and suggest similar but lower-sodium alternatives. The primary outcome of interest is change in mean systolic blood pressure between individuals randomized (1:1) to the intervention and control (usual online shopping) arms at 12 weeks. Secondary outcomes are diastolic blood pressure, spot urinary sodium and sodium:potassium ratio, sodium purchases, and dietary intake. Intervention implementation and lessons for future uptake will be assessed using a mixed methods process evaluation. Participants with hypertension who shop online for groceries and exhibit high sodium purchasing behavior are being recruited across Australia. A target sample size of 1,966 provides 80% power (2-sided alpha = 0.05) to detect a 2 mm Hg difference in systolic blood pressure between groups, assuming a 15 mm Hg standard deviation, after allowing for a 10% dropout rate. DISCUSSION: This trial will provide evidence on an innovative intervention to potentially reduce salt intake and blood pressure in people with hypertension. The intervention caters to individual preferences by encouraging sustainable switches to similar but lower-salt products. If effective, the intervention will be readily scalable at low cost by interfacing with existing online retail environments.

Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial.

BACKGROUND: Over half of patients with elevated blood pressure require multi-drug treatment to achieve blood pressure control. However, multi-drug treatment may lead to lower adherence and more adverse drug effects compared with monotherapy. OBJECTIVE: The Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET) USA trial was designed to evaluate whether initiating treatment with ultra-low-dose quadruple-combination therapy will lower office blood pressure more effectively, and with fewer side effects, compared with initiating standard dose monotherapy in treatment naive patients with SBP < 180 and DBP < 110 mm Hg and patients on monotherapy with SBP < 160 and DBP < 100 mm Hg. METHODS/DESIGN: QUARTET USA was a prospective, randomized, double-blind trial (ClinicalTrials.gov NCT03640312) conducted in federally qualified health centers in a large city in the US. Patients were randomly assigned (1:1) to either ultra-low-dose quadruple combination therapy or standard dose monotherapy. The primary outcome was mean change from baseline in office systolic blood pressure at 12-weeks, adjusted for baseline values. Secondary outcomes included measures of blood pressure change and variability, medication adherence, and health related quality of life. Safety outcomes included occurrence of serious adverse events, relevant adverse drug effects, and electrolyte abnormalities. A process evaluation aimed to understand provider experiences of implementation and participant experiences around side effects, adherence, and trust with clinical care. DISCUSSION: QUARTET USA was designed to evaluate whether a novel approach to blood pressure control would lower office blood pressure more effectively, and with fewer side effects, compared with standard dose monotherapy. QUARTET USA was conducted within a network of federally qualified healthcare centers with the aim of generating information on the safety and efficacy of ultra-low-dose quadruple-combination therapy in diverse groups that experience a high burden of hypertension.

Disparities in Secondary Prevention between Stroke and Coronary Heart Disease in China: Cross-Sectional Community-Based Study, 2014-2016.

BACKGROUND: Health care quality and insurance coverage have improved with economic development in China, but the burden of cardiovascular diseases (CVDs) continues to increase with ongoing gaps in prevention. We aimed to compare the uptake of secondary CVD prevention between stroke and coronary heart disease (CHD) patients in China. METHODS: In a cross-sectional community-based survey of 47,841 adults (age ≥45 years) in 7 regions of China between 2014 and 2016, we identified those with a history of stroke or CHD to quantify disparities in conventional secondary CVD prevention strategies in multivariable logistic regression models. RESULTS: There were 4,105 and 1,022 participants with a history of stroke and CHD, respectively. Compared to participants with CHD, those with a history of stroke were significantly less likely to be taking blood-pressure-lowering (39.7% vs. 53%), lipid-lowering (13.7% vs. 36.8%), and antiplatelet (20.8% vs. 50.6%) agents, at least one (48.9% vs. 70.8%) or all 3 recommended medicines (6.1% vs. 24.0%), and were less likely to achieve a lipid-cholesterol target (30.3% vs. 44.0%). Participants with a history of stroke achieved less optimal secondary prevention goals for medication use, either from any (adjusted odds ratio [aOR] 0.54, 95% confidence interval [CI] 0.44-0.66) or all 3 medications (aOR 0.27, 95% CI 0.20-0.36), as well as better blood pressure (aOR 0.81, 95% CI 0.66-0.98) and low-density lipoprotein cholesterol (aOR 0.34, 95% CI 0.27-0.43) levels of control. There were no significant differences in weight, smoking, or physical activity between the groups. CONCLUSION: Stroke patients had lower use of secondary CVD-preventive medication and achieved lower levels of risk factor control than those of CHD patients in China. Nationwide disease-specific strategies, and better education of participants and health care providers, may narrow these gaps.

Essential medicines for cardiovascular diseases in India: Rapid appraisal of policies and processes at the subnational level.

Background The burden of cardiovascular diseases (CVDs) and response to health systems vary widely at the subnational level in India. Our study aimed to assess the variation in state-level access to medicines for CVDs by comparing the essential medicines lists (EMLs) at the national and subnational levels in India and by rapid appraisal of the existing policies and processes of drug procurement. Methods We assessed the inclusion of six classes of medicines for CVDs in the recent and publicly available national and subnational EMLs from July to September 2018 in the states of Telangana and Madhya Pradesh. We examined the drug procurement and distribution policies and processes using documentary review and five key informant interviews between March and June 2018. Results The WHO's EML, India's national EML, and 21 of 28 publicly available (75%) Indian state and Union Territory EMLs included all six classes of essential medicines for CVDs. However, some medicines were not included in the policy packages of essential medicines meant for primary health centres. Both the states used centralized tendering and decentralized distribution as part of the public sector drug procurement process. The requirement was based on the previous year's consumption. The approximate time between procurement planning and distribution was 7-8 months in both the states. Conclusion Substantial variation exists in the selection of drugs for CVDs in EMLs at the subnational level in India. Improving forecasting techniques for requirement of medicines and reducing time lags between forecasting and distribution to health facilities may allow for better access to essential medicines.

Availability, healthiness, and price of packaged and unpackaged foods in India: A cross-sectional study.

Background: Vulnerable populations are the most prone to diet-related disease. The availability, healthiness, and price of foods have established associations with diet-related disease in communities. However, data describing this in India are sparse, particularly in urban slums and rural areas. Aim: To quantify and compare availability, healthiness, and price of packaged and unpackaged foods and beverages in India, and to identify opportunities to improve diets and health of vulnerable populations. Methods: Nutrition data and price were collected on foods and beverages available at 44 stores in urban, urban slum, and rural areas in four states in India between May and August 2018. Healthiness was assessed using the Australasian Health Star Rating system and product retail prices were examined. Comparisons in the findings were made across state, community area type, and adherence to current and draft Indian food labeling regulations. Results: Packaged foods and beverages (n = 1443, 89%) were more prevalent than unpackaged (n = 172, 11%). Unpackaged products were healthier than packaged (mean Health Star Rating = 3.5 vs 2.0; p < 0.001) and lower in price (median price per 100 g/ml: 13.42 Indian rupees vs 25.70 Indian rupees; p < 0.001), a pattern observed across most community area types and states. 96% of packaged products were compliant with current Indian labeling regulations but only 23% were compliant with proposed labeling regulations. Conclusions: Unpackaged products were on average much healthier and lower in price than packaged foods and beverages. Food policies that support greater availability, accessibility and consumption of unpackaged foods, while limiting consumption of packaged foods, have enormous potential for sustaining the health of the Indian population.

Sex Differences in Primary and Secondary Prevention of Cardiovascular Disease in China.

BACKGROUND: Despite improvements in diagnostic and therapeutic interventions to combat cardiovascular disease (CVD) in recent decades, there are significant ongoing access gaps and sex disparities in prevention that have not been adequately quantified in China. METHODS: A representative, cross-sectional, community-based survey of adults (aged ≥45 years) was conducted in 7 geographic regions of China between 2014 and 2016. Logistic regression models were used to determine sex differences in primary and secondary CVD prevention, and any interaction by age, education level, and area of residence. Data are presented as adjusted odds ratios (ORs) and 95% CIs. RESULTS: Of 47 841 participants (61.3% women), 5454 (57.2% women) had established CVD and 9532 (70.5% women) had a high estimated 10-year CVD risk (≥10%). Only 48.5% and 48.6% of women and 39.3% and 59.8% of men were on any kind of blood pressure (BP)-lowering medication, lipid-lowering medication, or antiplatelet therapy for primary and secondary prevention, respectively. Women with established CVD were significantly less likely than men to receive BP-lowering medications (OR, 0.79 [95% CI, 0.65-0.95]), lipid-lowering medications (OR, 0.69 [95% CI, 0.56-0.84]), antiplatelets (OR, 0.53 [95% CI, 0.45-0.62]), or any CVD prevention medication (OR, 0.62 [95% CI, 0.52-0.73]). Women with established CVD, however, had better BP control (OR, 1.31 [95% CI, 1.14-1.50]) but less well-controlled low-density lipoprotein cholesterol (OR, 0.66 [95% CI, 0.57-0.76]), and were less likely to smoke (OR, 13.89 [95% CI, 11.24-17.15]) and achieve physical activity targets (OR, 1.92 [95% CI, 1.61-2.29]). Conversely, women with high CVD risk were less likely than men to have their BP, low-density lipoprotein cholesterol, and bodyweight controlled (OR, 0.46 [95% CI, 0.38-0.55]; OR, 0.60 [95% CI, 0.52-0.69]; OR, 0.55 [95% CI, 0.48-0.63], respectively), despite a higher use of BP-lowering medications (OR, 1.21 [95% CI, 1.01-1.45]). Younger patients (<65 years) with established CVD were less likely to be taking CVD preventive medications, but there were no sex differences by area of residence or education level. CONCLUSIONS: Large and variable gaps in primary and secondary CVD prevention exist in China, particularly for women. Effective CVD prevention requires an improved overall nationwide strategy and a special emphasis on women with established CVD, who have the greatest disparity and the most to benefit.

The American Heart Association 2030 Impact Goal: A Presidential Advisory From the American Heart Association.

Each decade, the American Heart Association (AHA) develops an Impact Goal to guide its overall strategic direction and investments in its research, quality improvement, advocacy, and public health programs. Guided by the AHA's new Mission Statement, to be a relentless force for a world of longer, healthier lives, the 2030 Impact Goal is anchored in an understanding that to achieve cardiovascular health for all, the AHA must include a broader vision of health and well-being and emphasize health equity. In the next decade, by 2030, the AHA will strive to equitably increase healthy life expectancy beyond current projections, with global and local collaborators, from 66 years of age to at least 68 years of age across the United States and from 64 years of age to at least 67 years of age worldwide. The AHA commits to developing additional targets for equity and well-being to accompany this overarching Impact Goal. To attain the 2030 Impact Goal, we recommend a thoughtful evaluation of interventions available to the public, patients, providers, healthcare delivery systems, communities, policy makers, and legislators. This presidential advisory summarizes the task force's main considerations in determining the 2030 Impact Goal and the metrics to monitor progress. It describes the aspiration that these goals will be achieved by working with a diverse community of volunteers, patients, scientists, healthcare professionals, and partner organizations needed to ensure success.

Distribution and Correlates of Incident Heart Failure Risk in South Asian Americans: The MASALA Study.

BACKGROUND: South Asian Americans experience disproportionately high burden of cardiovascular diseases. Estimating predicted heart failure (HF) risk distribution may facilitate targeted prevention. We estimated the distribution of 10-year predicted risk of incident HF in South Asian Americans and evaluated the associations with social determinants of health and clinical risk factors. METHODS AND RESULTS: In the Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study, we calculated 10-year predicted HF risk using the Pooled Cohort Equations to Prevent Heart Failure multivariable model. Distributions of low (<1%), intermediate (1%-5%), and high (≥5%) HF risk, identified overall and by demographic and clinical characteristics, were compared. We evaluated age- and sex-adjusted associations of demographic characteristics and coronary artery calcium with predicted HF risk category using ordinal logistic regression. In 1159 participants (48% women), with a mean age of 57 ± 9 years, 40% had a low, 37% had an intermediate, and 24% had a high HF risk. Significant differences in HF risk distribution existed across demographic (income, education, birthplace) and clinical (diabetes, hypertension, body mass index, coronary artery calcium) groups (P < .01). Significant associations with high predicted HF risk were observed for a family of income 75,000/year or more (adjusted odds ratio 0.5 [95% confidence interval (CI) 0.4-0.7]), college education (0.6 [95% CI 0.4-0.9]), birthplace in another South Asian country (1.9 [95% CI 1.2-3.2], vs. born in India), and prevalent coronary artery calcium (2.6 [95% CI 1.9-3.6]). CONCLUSIONS: Almost two-thirds of South Asian Americans in the MASALA cohort are at intermediate or high predicted 10-year HF risk, with varying risk across demographic and clinical characteristics.