The Management of Elevated Blood Pressure in the Acute Care Setting: A Scientific Statement From the American Heart Association.

Over the past 3 decades, a substantial body of high-quality evidence has guided the diagnosis and management of elevated blood pressure (BP) in the outpatient setting. In contrast, there is a lack of comparable evidence for guiding the management of elevated BP in the acute care setting, resulting in significant practice variation. Throughout this scientific statement, we use the terms acute care and inpatient to refer to care received in the emergency department and after admission to the hospital. Elevated inpatient BP is common and can manifest either as asymptomatic or with signs of new or worsening target-organ damage, a condition referred to as hypertensive emergency. Hypertensive emergency involves acute target-organ damage and should be treated swiftly, usually with intravenous antihypertensive medications, in a closely monitored setting. However, the risk-benefit ratio of initiating or intensifying antihypertensive medications for asymptomatic elevated inpatient BP is less clear. Despite this ambiguity, clinicians prescribe oral or intravenous antihypertensive medications in approximately one-third of cases of asymptomatic elevated inpatient BP. Recent observational studies have suggested potential harms associated with treating asymptomatic elevated inpatient BP, which brings current practice into question. Despite the ubiquity of elevated inpatient BPs, few position papers, guidelines, or consensus statements have focused on improving BP management in the acute care setting. Therefore, this scientific statement aims to synthesize the available evidence, provide suggestions for best practice based on the available evidence, identify evidence-based gaps in managing elevated inpatient BP (asymptomatic and hypertensive emergency), and highlight areas requiring further research.

Neuromarkers associated with two levels of physical activity in persons with chronic conditions.

Although research has largely focused on the effects of physical activity (PA) on the brain, less is known about the influence of the brain on engagement in healthy-living behaviors, such as regular PA. In this secondary analysis of a study of brain activity and participation in healthy-living behaviors, we examined relationships between the activation of selected brain networks and PA in persons self-managing chronic conditions. Fifty-eight individuals with chronic conditions underwent functional magnetic resonance imaging while exposed to a protocol consisting of listening to emotion-focused and analytic-focused information and measures of activation of three neuromarkers were obtained: default mode network (DMN), task-positive network (TPN), and ventromedial prefrontal cortex (vmPFC). In an exploratory analysis, we assessed differences in neuromarker activation between two PA levels (representing higher and lower accelerometry-measured PA levels) of 1) moderate-to-vigorous physical activity (MVPA) minutes, 2) metabolic equivalents expended (METs), and 3) daily steps. Results showed positive associations between MVPA and DMN (r = 0.31, P = 0.018), steps and DMN (r = 0.28, P = 0.035), and MVPA and vmPFC (r = 0.29, P = 0.026). No associations were found between the TPN and any of the PA measures. Individuals with high MVPA and METs had higher DMN values compared with those with low MVPA (t = -2.17, P = 0.035) and METs (t = -2.02, P = 0.048). No differences in TPN and vmPFC were found among PA levels. These results suggest that providing health information that activates the emotion-focused brain network may be more useful than analytic-focused information (centered on logic and reasoning) to assist people with chronic conditions to engage in more PA.NEW & NOTEWORTHY The influence of the brain on engagement in regular physical activity (PA) has not been well studied. We examined relationships between the activation of three neuromarkers and two PA levels in 58 persons self-managing chronic conditions. Findings suggest that individuals who optimally process health-information when the emotional tone is high (Empathic Network; DMN) may engage in more PA compared with individuals who respond to health information when the emotional tone is low (Analytic Network; TPN).

Differences among physical activity actigraphy algorithms in three chronic illness populations.

OBJECTIVES: In three chronic illness populations and in a combined sample, we assessed differences in two algorithms to determine wear time (WT%) and four algorithms to determine: Kilocalories, light physical activity (PA), moderate-to-vigorous PA (MVPA), and metabolic equivalents (METs). METHODS: Data were collected from 29 people living with HIV (PLHIV), 27 participants recovering from a cardiac event, and 15 participants with hypertension (HTN). Participants wore the ActiGraphTM wGT3X-BT for > 3 days on their hip. Analysis of variance (ANOVA) was used to assess differences among the algorithms. RESULTS: No differences were found between the two algorithms to assess WT% or among the four algorithms to assess kilocalories in each of the chronic illness populations or in the combined sample. Significant differences were found among the four algorithms for light PA (p < .001) and METs (p < .001) in each chronic illness population and in the combined sample. MVPA was significantly different among the four algorithms in the PLHIV (p = .007) and in the combined sample (p < .001), but not in the cardiac (p = .064) or HTN samples (p = .200). DISCUSSION: Our findings indicate that the choice of algorithm does make a difference in PA determination. Differences in algorithms should be considered when comparing PA across different chronic illness populations.

An Overview of Telehealth in the Management of Cardiovascular Disease: A Scientific Statement From the American Heart Association.

Telehealth enables the remote delivery of health care through telecommunication technologies and has substantially affected the evolving medical landscape. The COVID-19 pandemic accelerated the utilization of telehealth as health care professionals were forced to limit face-to-face in-person visits. It has been shown that information delivery, diagnosis, disease monitoring, and follow-up care can be conducted remotely, resulting in considerable changes specific to cardiovascular disease management. Despite increasing telehealth utilization, several factors such as technological infrastructure, reimbursement, and limited patient digital literacy can hinder the adoption of remote care. This scientific statement reviews definitions pertinent to telehealth discussions, summarizes the effect of telehealth utilization on cardiovascular and peripheral vascular disease care, and identifies obstacles to the adoption of telehealth that need to be addressed to improve health care accessibility and equity.

Association of Intensive vs Standard Blood Pressure Control With Cerebral Blood Flow: Secondary Analysis of the SPRINT MIND Randomized Clinical Trial.

IMPORTANCE: Antihypertensive treatments benefit cerebrovascular health and cognitive function in patients with hypertension, but it is uncertain whether an intensive blood pressure target leads to potentially harmful cerebral hypoperfusion. OBJECTIVE: To investigate the association of intensive systolic blood pressure (SBP) control vs standard control with whole-brain cerebral blood flow (CBF). DESIGN, SETTING, AND PARTICIPANTS: This substudy of the Systolic Blood Pressure Intervention Trial (SPRINT) randomized clinical trial compared the efficacy of 2 different blood pressure-lowering strategies with longitudinal brain magnetic resonance imaging (MRI) including arterial spin labeled perfusion imaging to quantify CBF. A total of 1267 adults 50 years or older with hypertension and increased cardiovascular risk but free of diabetes or dementia were screened for the SPRINT substudy from 6 sites in the US. Randomization began in November 2010 with final follow-up MRI in July 2016. Analyses were performed from September 2020 through December 2021. INTERVENTIONS: Study participants with baseline CBF measures were randomized to an intensive SBP target less than 120 mm Hg or standard SBP target less than 140 mm Hg. MAIN OUTCOMES AND MEASURES: The primary outcome was change in whole-brain CBF from baseline. Secondary outcomes were change in gray matter, white matter, and periventricular white matter CBF. RESULTS: Among 547 participants with CBF measured at baseline, the mean (SD) age was 67.5 (8.1) years and 219 (40.0%) were women; 315 completed follow-up MRI at a median (IQR) of 4.0 (3.7-4.1) years after randomization. Mean whole-brain CBF increased from 38.90 to 40.36 (difference, 1.46 [95% CI, 0.08-2.83]) mL/100 g/min in the intensive treatment group, with no mean increase in the standard treatment group (37.96 to 37.12; difference, -0.84 [95% CI, -2.30 to 0.61] mL/100 g/min; between-group difference, 2.30 [95% CI, 0.30-4.30; P = .02]). Gray, white, and periventricular white matter CBF showed similar changes. The association of intensive vs standard treatment with CBF was generally similar across subgroups defined by age, sex, race, chronic kidney disease, SBP, orthostatic hypotension, and frailty, with the exception of an indication of larger mean increases in CBF associated with intensive treatment among participants with a history of cardiovascular disease (interaction P = .05). CONCLUSIONS AND RELEVANCE: Intensive vs standard antihypertensive treatment was associated with increased, rather than decreased, cerebral perfusion, most notably in participants with a history of cardiovascular disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01206062.

Neural Processing of Health Information and Hypertension Self-Management in African Americans.

BACKGROUND: Uncontrolled blood pressure (BP) rates are persistently high among African Americans with hypertension. Although self-management is critical to controlling BP, little is known about the brain-behavior connections underlying the processing of health information and the performance of self-management activities. OBJECTIVES: In this pilot study, we explored the associations among neural processing of two types of health information and a set of self-management cognitive processes (self-efficacy, activation, decision-making, and hypertension knowledge) and behaviors (physical activity, dietary intake, and medication taking) and health status indicators (BP, health-related quality of life, anxiety, and depression). METHODS: Using a descriptive cross-sectional design, 16 African Americans with uncontrolled hypertension (mean age = 57.5 years, 68.8% women) underwent functional magnetic resonance imaging to assess activation of two neural networks, the task-positive network and the default mode network, and a region in the ventromedial prefrontal cortex associated with emotion-focused and analytic-focused health information. Participants completed self-reports and clinical assessments of self-management processes, behaviors, and health status indicators. RESULTS: Our hypothesis that neural processing associated with different types of health information would correlate with self-management cognitive processes and behaviors and health status indicators was only partially supported. Home diastolic BP was positively associated with ventromedial prefrontal cortex activation ( r = .536, p = .09); no other associations were found among the neural markers and self-management or health status variables. Expected relationships were found among the self-management processes and behaviors and health status indicators. DISCUSSION: To advance our understanding of the neural processes underlying health information processing and chronic illness self-management, future studies are needed that use larger samples with more heterogeneous populations and additional neuroimaging techniques.

Robust demographically-adjusted normative data for the Montreal Cognitive Assessment (MoCA): Results from the systolic blood pressure intervention trial.

To generate robust, demographically-adjusted regression-based norms for the Montreal Cognitive Assessment (MoCA) using a large sample of diverse older US adults.Baseline MoCA scores were examined for participants in the Systolic Blood Pressure Intervention Trial (SPRINT). A robust, cognitively-normal sample was drawn from individuals not subsequently adjudicated with cognitive impairment through 4 years of follow-up. Multivariable Beta-Binomial regression was used to model the association of demographic variables with MoCA performance and to create demographically-stratified normative tables.Participants' (N = 5,338) mean age was 66.9 ± 8.8 years, with 35.7% female, 63.1% White, 27.4% Black, 9.5% Hispanic, and 44.5% with a college or graduate education. A large proportion scored below published MoCA cutoffs: 61.4% scored below 26 and 29.2% scored below 23. A disproportionate number falling below these cutoffs were Black, Hispanic, did not graduate from college, or were ≥75 years of age. Multivariable modeling identified education, race/ethnicity, age, and sex as significant predictors of MoCA scores (p<.001), with the best fitting model explaining 24.4% of the variance. Model-based predictions of median MoCA scores were generally 1 to 2 points lower for Black and Hispanic participants across combinations of age, sex, and education. Demographically-stratified norm-tables based on regression modeling are provided to facilitate clinical use, along with our raw data.By using regression-based strategies that more fully account for demographic variables, we provide robust, demographically-adjusted metrics to improve cognitive screening with the MoCA in diverse older adults.

Barriers to and Facilitators of Using mHealth Technology Among African-Americans Living with Hypertension.

MHealth provides a new way of promoting hypertension self-management behaviors. However, the acceptance, feasibility, and effectiveness of interventions incorporating mHealth technology have been understudied in African-Americans with hypertension. This study aimed to explore participants' (n = 30) experiences using a community and technology-based intervention to self-manage their hypertension (COACHMAN). Focus groups were conducted with African-Americans living with hypertension. Focus groups were audio-recorded, and the data were transcribed verbatim and analyzed qualitatively using thematic analysis. Regarding the use of mHealth-enabled self-management hypertension interventions to support hypertension control among African-Americans, the thematic analysis produced the following five barrier themes: (a) lack of knowledge regarding how to use technology, (b) resistance to learning new technology, (c) lack of access to technology, (d) privacy and security concerns, and (e) issues with the medication management support features. Facilitator themes that emerged from the thematic analysis were all related to the intervention components, which were: (a) reminders, (b) rewards, and (c) education modules. This study focused on mHealth barriers and facilitators as described by African-Americans living with hypertension. Results provide a starting point for developing a mHealth intervention for African-Americans that incorporates a self-management program.

A Pilot Study Evaluating the Effects of a Technology-Based and Positive Psychological Training Intervention on Blood Pressure in African Americans With Hypertension.

Behavioral interventions consolidating technology are underutilized and do not reach diverse populations such as African Americans with hypertension. This pilot study aimed to evaluate the effects of a theoretically derived, technology-based intervention in African Americans with hypertension. African Americans with hypertension (N = 18; age range 25-85; 72.22% females) were randomized to the technology-based plus positive psychological training (PPT) experimental group (n = 10) or the comparison group (n = 8) for 12 weeks. The technology-based intervention included analytic components (web-based education, self-monitoring of blood pressure [BP], and medication management using a commercially free app-Medisafe) and an emotional component (comprised of skills and behaviors directed at engaging 1 in positive activities to help build increasing healthy behaviors). The comparison group received the technology-based intervention alone. Demographic information, self-management cognitive processes, self-management behaviors, and health status outcomes were assessed. After completing the 12-week intervention, the groups did not significantly differ in health outcomes, health behavior outcomes, and technology utilization outcomes. Mean systolic BP decrease 6.02 mmHg (standard deviation [SD] = 22.75) in the comparison group and 1.1 mmHg (SD = 20.64; P = .439) in the experimental group. Diastolic BP decreased 0.1 mmHg (SD = 11.78) in the comparison group and 1.5 mmHg (SD = 12.7; P = .757) in the experimental group. Our findings suggest that behavioral interventions using technology have the potential to improve self-management outcomes among African American populations. Further research is warranted in a larger sample size and a longer time frame to identify the intervention's effectiveness.

SPRINT Revisited: Updated Results and Implications.

The SPRINT (Systolic Blood Pressure Intervention Trial) results have influenced clinical practice but have also generated discussion regarding the validity, generalizability, and importance of the findings. Following the SPRINT primary results manuscript in 2015, additional results and analyses of the data have addressed these concerns. The primary objective of this article is to respond to key questions that have been raised.

Harnessing Mobile Health Technology for Secondary Cardiovascular Disease Prevention in Older Adults: A Scientific Statement From the American Heart Association.

Secondary prevention of cardiovascular disease (CVD), the leading cause of morbidity and mortality, is critical to improving health outcomes and quality of life in our aging population. As mobile health (mHealth) technology gains universal leverage and popularity, it is becoming more user-friendly for older adults and an adjunct to manage CVD risk and improve overall cardiovascular health. With the rapid advances in mHealth technology and increasing technological engagement of older adults, a comprehensive understanding of the current literature and knowledge of gaps and barriers surrounding the impact of mHealth on secondary CVD prevention is essential. After a systematic review of the literature, 26 studies that used mHealth for secondary CVD prevention focusing on lifestyle behavior change and medication adherence in cohorts with a mean age of ≥60 years were identified. Improvements in health behaviors and medication adherence were observed, particularly when there was a short message service (ie, texting) component involved. Although mobile technologies are becoming more mainstream and are starting to blend more seamlessly with standard health care, there are still distinct barriers that limit implementation particularly in older adults, including affordability, usability, privacy, and security issues. Furthermore, studies on the type of mHealth that is the most effective for older adults with longer study duration are essential as the field continues to grow. As our population ages, identifying and implementing effective, widely accepted, cost-effective, and time-efficient mHealth interventions to improve CVD health in a vulnerable demographic group should be a top health priority.

The Targeted Management (TEAM) Intervention for Reducing Stroke Risk in African American Men: Rationale and Study Design of a Prospective Randomized Controlled Trial.

BACKGROUND: African American (AA) male survivors of strokes or transient ischemic attacks (TIA) have the highest risk of recurrent stroke when compared to other racial-ethnic men. However, there is a paucity of evidence-based strategies, including organizational, educational, or behavioral interventions, that targets secondary stroke risk reduction in AA men. METHODS: Targeted Management for Reducing Stroke Risk (TEAM) is an ongoing, 6-month prospective, randomized controlled trial that will determine whether a curriculum-guided self-management approach, using peer dyads (men who had a stroke or TIA and their care partners) will improve post-stroke care in AA men. RESULTS: The study sample will consist of 160 AA men who have experienced a stroke or TIA within 5 years, randomized to TEAM or Wait-list control group. The primary outcome changes in systolic blood pressure (BP) and high-density lipoprotein (HDL), while secondary outcomes include diastolic BP, total cholesterol, low-density lipoprotein, triglycerides, and glycemic control for diabetics. We hypothesize that AA men in TEAM will have significantly lower systolic BP and higher HDL when compared to AA men in the Wait-list control group at 6-month. CONCLUSION: Persistent disparities for stroke burden in AA men highlight the need for novel interventions to promote secondary stroke-risk reduction. Building on promising pilot data, TEAM uses a group format, with a nurse and patient co-led intervention focused on AA men and family needs, practice in problem-solving, and attention to emotional and role management. In addition, the TEAM approach may help reduce stroke risk factors and health disparities in AA men. CLINICALTRIALSGOV IDENTIFIER: NCT04402125.

Successful and Cost-Effective Facebook Recruitment: Is It Possible? Results From a Longitudinal Randomized Clinical Trial in Grandmother Caregivers.

Facebook is often cited in health-related research as a practical option to recruit participants into research studies, but issues with recruiting verifiable and qualified participants and unpredictable costs exist. The purpose of this paper is to describe a social network theory-guided, no-cost, Facebook recruitment strategy in comparison to a traditional recruitment campaign for a national online intervention study for grandmother caregivers (n = 348); 211 participants were recruited via Facebook, and 137 through traditional techniques. Participation rates did not vary by recruitment method. Facebook participants were slightly older, higher income, and more likely to be white and married, but did not differ in education levels. Our strategy quickly obtained an engaged and committed participant base. The application of social network theory to traditional recruitment strategies represents a novel way for researchers to recruit through Facebook and yield viable and engaged participants without investing in Facebook ads.

A Community and Technology-Based Approach for Hypertension Self-Management (COACHMAN) to Improve Blood Pressure Control in African Americans: Results from a Pilot Study.

PURPOSE: Adoption of technology has increased to support self-managing chronic diseases. However, behavioral interventions evaluating such technology have been understudied in African Americans with hypertension. The aim of this study was to explore a community and technology-based intervention for hypertension self-management (COACHMAN) intervention on blood pressure (BP) control and health-related quality of life (HRQoL) in African Americans with hypertension. METHODS: Sixty African Americans (mean age 60; 75% females) who were prescribed antihypertensive medications and owning a smartphone were randomized to the COACHMAN (n = 30) or enhanced usual care (n = 30) group for 12 weeks. COACHMAN is comprised of four components: web-based education, home BP monitoring, medication management application, and nurse counseling. Hypertension knowledge, self-efficacy, technology adoption/use, medication adherence, BP, and HRQoL scores were assessed. RESULTS: Mean systolic and diastolic BP at baseline was 150.49 (SD = 13.89) and 86.80 (SD = 13.39), respectively. After completing the 3-month intervention to improve hypertension self-management, the groups did not significantly differ in BP control and HRQoL. Clinically relevant BP reduction was observed in the intervention group. Paired t-test showed that mean medication-taking adherence scores significantly improved in the intervention group (P = 0.023) compared to the control group (P = 0.075). CONCLUSION: Using technology may have a positive impact on supporting hypertension self-management, particularly in medication-taking adherence. Further research is warranted in a larger sample and should include standardization of medication management to isolate the effects of behavioral interventions on changes in BP. CLINICALTRIALSGOV IDENTIFIER: NCT03722667.

The Design and Rationale of a Pilot Study: A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN).

African-Americans with hypertension continue to demonstrate poor blood pressure (BP) control and have markedly lower rates of hypertension self-management compared to non-African-Americans. Innovative and practical solutions such as mHealth technology are promising and can be leveraged to promote self-management of hypertension. Substantial evidence has demonstrated the importance of community support in improving patients' management of chronic illnesses. Unfortunately, such programs do not offer technology-based interventions (TBI) as a delivery method. Thus, this paper describes the design and rationale of an ongoing pilot study that incorporates TBI using a community-based participatory approach.

Association of Psychosocial Symptoms, Blood Pressure, and Menopausal Status in African-American Women.

African-American women have disproportionate rates of hypertension that can be further complicated as they transition through menopause. Stress, coupled with depression and hypertension in perimenopausal African-American women has not been fully explored. This study examines the associations of stress, depression, and social support on systolic blood pressure (SBP) among a sample of 184 perimenopausal African-American women. We used descriptive statistics, Pearson's correlation, and logistic regression to analyze data stratified by menopausal status (perimenopausal or menopausal) and SBP status (<130 mmHg vs. >130 mmHg). Women classified as menopausal reported higher levels of stress and depressive symptoms, and lower levels of social support. Age, body mass index (BMI), health insurance, and perceived health status were significant predictors of SBP in menopausal women. Stress, depression, and social support did not play a role in SBP. It is necessary that future research focus on reducing cardiovascular risk include addressing menopausal health.

Diagnosis of ischemic stroke using circulating levels of brain-specific proteins measured via high-sensitivity digital ELISA.

Limited lower detection ranges associated with traditional immunoassay techniques have prevented the use of brain-specific proteins as blood biomarkers of stroke in the acute phase of care, as these proteins are often only present in circulation at low concentrations. Digital ELISA is a newly developed technique with allows for quantification of proteins in biofluids with up to 1000 times greater sensitivity than conventional ELISA techniques. The purpose of this study was to determine whether the extended lower limits of detection associated with digital ELISA could enable the use of brain-specific proteins as blood biomarkers of ischemic stroke during triage. Blood was sampled from ischemic stroke patients (n = 14) at emergency department admission, as well as from neurologically normal controls matched in terms of risk factors for cardiovascular disease (n = 33). Plasma levels of two brain-specific axonal proteins, neurofilament light chain (NfL) and tau, were measured via digital ELISA, and receiver-operating characteristic analysis was used to determine their ability to discriminate between groups. Plasma levels of NfL and tau were both significantly elevated in stroke patients versus controls, and could respectively discriminate between groups with 92.9% sensitivity / 84.9% specificity, and 85.7% sensitivity / 54.6% specificity. Furthermore, adjustment of measured NfL and Tau levels according to the lower-limits of detection associated with commercially-available conventional ELISA assays resulted in a dramatic and statistically significant decrease in diagnostic performance. Collectively, our results suggest that the increased analytical sensitivity of digital ELISA could enable the use of brain-specific proteins as blood biomarkers of ischemic stroke during triage.

Use of high-sensitivity digital ELISA improves the diagnostic performance of circulating brain-specific proteins for detection of traumatic brain injury during triage.

Background: Historically, limited sensitivity associated with traditional immunoassay methods has prevented the use of brain-specific proteins as blood biomarkers of traumatic brain injury (TBI) during triage, as these proteins exhibit low circulating concentrations. Digital ELISA is a newly-developed technique that is up to 1000 times more sensitive than conventional ELISA methods. The purpose of this study was to determine whether the use of digital ELISA over conventional ELISA improves the performance of brain-specific proteins as blood biomarkers of TBI during triage.Methods: Blood was sampled from TBI patients (n = 13) at emergency department admission, as well as from neurologically normal controls (n = 72). Serum levels of two brain-specific proteins, neurofilament light chain (NfL) and Tau, were measured via digital ELISA. Estimated conventional ELISA measures were generated by adjusting values according to the lower limits of detection achievable with commercially available conventional ELISA assays, and receiver operating characteristic (ROC) analysis was used to compare the diagnostic performance of digital ELISA measures to estimated conventional ELISA measures in terms of their ability to discriminate between TBI patients and controls.Results: Used in combination, digital ELISA measures of NfL and Tau could discriminate between groups with 100% sensitivity and 91.7% specificity. Estimated conventional ELISA measures could only discriminate between groups with 7.7% sensitivity and 94.4% specificity. This difference in diagnostic performance was statistically significant when comparing areas under ROC curves.Conclusions: The use of digital ELISA over conventional ELISA methods improves the diagnostic performance of circulating brain-specific proteins for detection of TBI during triage.

Association of Intensive vs Standard Blood Pressure Control With Cerebral White Matter Lesions.

Importance: The effect of intensive blood pressure lowering on brain health remains uncertain. Objective: To evaluate the association of intensive blood pressure treatment with cerebral white matter lesion and brain volumes. Design, Setting, and Participants: A substudy of a multicenter randomized clinical trial of hypertensive adults 50 years or older without a history of diabetes or stroke at 27 sites in the United States. Randomization began on November 8, 2010. The overall trial was stopped early because of benefit for its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. Brain magnetic resonance imaging (MRI) was performed on a subset of participants at baseline (n = 670) and at 4 years of follow-up (n = 449); final follow-up date was July 1, 2016. Interventions: Participants were randomized to a systolic blood pressure (SBP) goal of either less than 120 mm Hg (intensive treatment, n = 355) or less than 140 mm Hg (standard treatment, n = 315). Main Outcomes and Measures: The primary outcome was change in total white matter lesion volume from baseline. Change in total brain volume was a secondary outcome. Results: Among 670 recruited patients who had baseline MRI (mean age, 67.3 [SD, 8.2] years; 40.4% women), 449 (67.0%) completed the follow-up MRI at a median of 3.97 years after randomization, after a median intervention period of 3.40 years. In the intensive treatment group, based on a robust linear mixed model, mean white matter lesion volume increased from 4.57 to 5.49 cm3 (difference, 0.92 cm3 [95% CI, 0.69 to 1.14]) vs an increase from 4.40 to 5.85 cm3 (difference, 1.45 cm3 [95% CI, 1.21 to 1.70]) in the standard treatment group (between-group difference in change, -0.54 cm3 [95% CI, -0.87 to -0.20]). Mean total brain volume decreased from 1134.5 to 1104.0 cm3 (difference, -30.6 cm3 [95% CI, -32.3 to -28.8]) in the intensive treatment group vs a decrease from 1134.0 to 1107.1 cm3 (difference, -26.9 cm3 [95% CI, 24.8 to 28.8]) in the standard treatment group (between-group difference in change, -3.7 cm3 [95% CI, -6.3 to -1.1]). Conclusions and Relevance: Among hypertensive adults, targeting an SBP of less than 120 mm Hg, compared with less than 140 mm Hg, was significantly associated with a smaller increase in cerebral white matter lesion volume and a greater decrease in total brain volume, although the differences were small. Trial Registration: ClinicalTrials.gov Identifier: NCT01206062.

The impact of central IRB's on informed consent readability and trial adherence in SPRINT.

BACKGROUND: Federal agencies have encouraged the use of central institutional review boards (CIRBs) for multi-site clinical trials. There is limited evidence supporting the use of CIRBs. Our aim is to evaluate how SPRINT sites regulated by CIRBs performed regarding informed consent readability and participant trial adherence compared to those regulated by local IRBs. METHODS: We conducted a cohort study using the SPRINT clinical trial. We collected the IRB of record from the stamped and approved 2012 informed consents from each of the sites. We defined CIRB as an IRB for more than one SPRINT site. Our outcomes were informed consent readability measured using the Flesch-Kincaid readability scale and trial adherence defined as a loss to follow-up, consent withdrawal, and missed last 3-month visit. RESULTS: Sixty-one percent of all SPRINT sites used a CIRB as their IRB of record. The adjusted mean grade reading level for CIRB consents was 13.4 (95% CI 12.6-13.8) compared to 12.3 (95% CI 12.1-13.1) for non CIRB consents (p = 0.07). CIRB sites had similar rates of withdrawal of consent and loss to follow-up as non-CIRB sites; subjects missing the last appointment of the study were more likely to come from sites regulated by a CIRB. The Veterans Affairs CIRB had the lowest rate of withdrawal of consent (1.9%) and the lowest rate of missed appointments (1.9%) among CIRBs. CONCLUSIONS: Niether CIRB-regulated sites nor IRB regulated sites enforce the recommended readability level of the informed consent documents. Sites regulated by both IRBs had similar participant trial adherence.