Relationship of Blood Pressure, Health Behaviors, and New Diagnosis and Control of Hypertension in the BP-CHECK Study.

BACKGROUND: Undiagnosed hypertension and uncontrolled blood pressure (BP) are common and contribute to excess cardiovascular morbidity and mortality. We examined whether BP control, changes in BP, and patient behaviors and attitudes were associated with a new hypertension diagnosis. METHODS: We performed a post hoc analysis of 323 participants from BP-CHECK (Blood Pressure Checks for Diagnosing Hypertension), a randomized diagnostic study of BP measuring methods in adults without diagnosed hypertension with elevated BP recruited from 12 primary care clinics of an integrated health care system in Washington State during 2017 to 2019. All 323 participants returned a positive diagnostic test for hypertension based on 24-hour ambulatory BP monitoring and were followed for 6 months. We used linear regression to examine the relationships between a new hypertension diagnosis (primary independent variable) and differences in the change in study outcomes from baseline to 6-month. RESULTS: Mean age of study participants was 58.3 years (SD, 13.1), 147 (45%) were women, and 253 (80%) were of non-Hispanic White race. At 6 months, 154 of 323 (48%) participants had a new hypertension diagnosis of whom 88 achieved target BP control. Participants with a new hypertension diagnosis experienced significantly larger declines from baseline in BP (adjusted mean difference: systolic BP, -7.6 mm Hg [95% CI, -10.3 to -4.8]; diastolic BP, -3.8 mm Hg [95% CI, -5.6 to -2.0]) compared with undiagnosed peers. They were also significantly more likely to achieve BP control by 6 months compared with undiagnosed participants (adjusted relative risk, 1.5 [95% CI, 1.1 to 2.0]). At 6 months, 101 of 323 participants (31%) with a positive ambulatory BP monitoring diagnostic test remained with undiagnosed hypertension, uncontrolled BP, and no antihypertensive medications. CONCLUSIONS: Approximately one-third of participants with high BP on screening and ambulatory BP monitoring diagnostic testing remained with undiagnosed hypertension, uncontrolled BP, and no antihypertensive medications after 6 months. New strategies are needed to enhance integration of BP diagnostic testing into clinical practice. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03130257.

Describing Racial Disparity in Hypertension Control in a Large Minnesota Outpatient Practice.

Introduction: This analysis is a part of ongoing quality improvement efforts aiming at improving hypertension control among various racial minority groups seen in a large outpatient practice with a special focus on two war refugee populations, the Hmong and the Somali populations. Method: Deidentified medical records were reviewed for adult hypertensive patients who had an outpatient encounter with a hypertension diagnosis during the years 2015 through 2019. The study outcome was the rate of uncontrolled hypertension, defined as systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg, and stratified by race, age, and gender. Results: There were 752,504 patient records representing 259,824 unique patients (mean age 61 ± 13 years) with 49.1% women, 82.1% white 8.3% African American, 4% Asian, 1.6% Hispanic, Somali 0.6%, and 0.2% Hmong. Hmong men had the highest rate of uncontrolled HTN (33.6%) followed by African American (31.3%) then Somali (29.2%). Among women, African Americans had the highest rate (28.6%) followed by Hmong (28.5%) then Somali (25.7%). In all races except Somali, the rate of uncontrolled hypertension was highest in the 18-29 age group, decreased progressively over the next several decades, then increased again in the ≥70 age group. Conclusion: Hmong, African American, and Somali groups have the highest rates of uncontrolled hypertension. Efforts to address hypertension management need to be tailored to the specific characteristics of each racial group and to target young adults.

Association Between CKD and Major Hemorrhage in Older Persons: Data From the Aspirin in Reducing Events in the Elderly Randomized Trial.

Introduction: Data on the association between chronic kidney disease (CKD) and major hemorrhage in older adults are lacking. Methods: We used data from a double-blind randomized controlled trial of aspirin in persons aged ≥ 70 years with prospective capture of bleeding events, including hemorrhagic stroke and clinically significant bleeding. CKD was defined as an estimated glomerular filtration rate (eGFR) < 60 ml/min per 1.73 m2 and/or urinary albumin-to-creatinine ratio (UACR) ≥ 3 mg/mmol (26.6 mg/g). We compared bleeding rates in those with and without CKD, undertook multivariable analyses, and explored effect modification with aspirin. Results: Of 19,114 participants, 17,976 (94.0%) had CKD status recorded, of whom 4952 (27.5%) had CKD. Participants with CKD had an increased rate of major bleeding events compared with those without CKD (10.4/1000 vs. 6.3/1000 person-years [py], respectively) and increased bleeding risk (risk ratio [RR] 1.60; 95% confidence interval [CI]: 1.40, 1.90 for eGFR < 60 ml/min per 1.73 m2) and RR (2.10; 95% CI: 1.70, 2.50) for albuminuria. In adjusted analyses, CKD was associated with a 35% increased risk of bleeding (hazard ratio [HR] 1.37; 95% CI: 1.15, 1.62; P < 0.001). Other risk factors were older age, hypertension, smoking, and aspirin use. There was no differential effect of aspirin on bleeding by CKD status (test of interaction P = 0.65). Conclusion: CKD is independently associated with an increased risk of major hemorrhage in older adults. Increased awareness of modifiable risk factors such as discontinuation of unnecessary aspirin, blood pressure control, and smoking cessation in this group is warranted.

Acceptability and Adherence to Home, Kiosk, and Clinic Blood Pressure Measurement Compared to 24-H Ambulatory Monitoring.

BACKGROUND: The US Preventive Services Task Force recommends measuring blood pressure (BP) outside of clinic/office settings. While various options are available, including home devices, BP kiosks, and 24-h ambulatory BP monitoring (ABPM), understanding patient acceptability and adherence is a critical factor for implementation. OBJECTIVE: To compare the acceptability and adherence of clinic, home, kiosk, and ABPM measurement. DESIGN: Comparative diagnostic accuracy study which randomized adults to one of three BP measurement arms: clinic, home, and kiosk. ABPM was conducted on all participants. PARTICIPANTS: Adults (18-85 years) receiving care at 12 Kaiser Permanente Washington primary care clinics (Washington State, USA) with a high BP (≥ 138 mmHg systolic or ≥ 88 mmHg diastolic) in the electronic health record with no hypertension diagnosis and on no hypertensive medications and with high BP at a research screening visit. MEASURES: Patient acceptability was measured using a validated survey which was used to calculate an overall acceptability score (range 1-7) at baseline, after completing their assigned BP measurement intervention, and after completing ABPM. Adherence was defined based on the pre-specified number of BP measurements completed. KEY RESULTS: Five hundred ten participants were randomized (mean age 59 years), with mean BP of 150/88. Overall acceptability score was highest (i.e. most acceptable) for Home BP (mean 6.2, SD 0.7) and lowest (least acceptable) for ABPM (mean 5.0, SD 1.0); scores were intermediate for Clinic (5.5, SD 1.1) and Kiosk (5.4, SD 1.0). Adherence was higher for Home (154/170, 90.6%) and Clinic (150/172, 87.2%) than for Kiosk (114/168, 67.9%)). The majority of participants (467/510, 91.6%) were adherent to ABPM. CONCLUSIONS: Participants found home BP measurement most acceptable followed by clinic, BP kiosks, and ABPM. Our findings, coupled with recent evidence regarding the accuracy of home BP measurement, further support the routine use of home-based BP measurement in primary care practice in the US. TRIAL REGISTRATION: ClinicalTrials.gov NCT03130257 https://clinicaltrials.gov/ct2/show/NCT03130257.

Primary care physician beliefs and practices regarding blood pressure measurement: results from BP-CHECK qualitative interviews.

BACKGROUND: Early identification and control of hypertension is critical to reducing cardiovascular disease events and death. U.S. Preventive Services Task Force guidelines recommend health care professionals screen all adults for hypertension, yet 1 in 4 adults with hypertension are unaware of their condition. This gap between guidelines and clinical practices highlights an important opportunity to improve blood pressure (BP) screening and hypertension diagnosis, including measurement outside of clinic settings. To identify targets for future diagnostic interventions, we sought to understand primary care physicians' (PCPs) beliefs and practices regarding use of common forms of BP measurement. METHODS: Study participants were PCPs (N = 27) who had patients enrolled in the BP-CHECK trial. The trial compared the accuracy of 24-h ambulatory BP monitoring (ABPM) to: 1) clinic-based monitoring, 2) home BP monitoring (HBPM), or 3) use of a BP kiosk in clinics or pharmacies. Physicians were interviewed by phone and compensated for their participation. Interviews were recorded, transcribed, and analyzed using a template analysis approach. RESULTS: Overall, PCPs preferred and trusted clinic BP measurement for diagnosing hypertension, particularly when measured with a manual sphygmomanometer. Concerns with HBPM included the belief that patients did not follow protocols for rest and body positioning at home, that home machines were not accurate, that home BPs could not be entered into the medical record, and that HBPM would make some patients anxious. Issues regarding kiosk measurement included beliefs that the public setting created stress for patients, that patients did not follow resting protocols when using kiosks, and concerns about the maintenance of these machines. ABPM was recognized as highly accurate but was not perceived as accessible. Additionally, some PCPs found it challenging to interpret the multiple readings generated by ABPM and HBPM, especially when these readings differed from clinic BPs. CONCLUSIONS: Our findings suggest that both additional physician education and training and investments in equipment and system-level processes are needed to increase the acceptance and utilization of out of office BP measurement for identification and treatment of hypertension. These changes are needed to improve ensure everyone in the U.S receive optimal care for hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT03130257 . Initial registration date: 4/21/2017.

Bolstering the Business Case for Adoption of Shared Decision-Making Systems in Primary Care: Randomized Controlled Trial.

BACKGROUND: Limited budgets may often constrain the ability of health care delivery systems to adopt shared decision-making (SDM) systems designed to improve clinical encounters with patients and quality of care. OBJECTIVE: This study aimed to assess the impact of an SDM system shown to improve diabetes and cardiovascular patient outcomes on factors affecting revenue generation in primary care clinics. METHODS: As part of a large multisite clinic randomized controlled trial (RCT), we explored the differences in 1 care system between clinics randomized to use an SDM intervention (n=8) versus control clinics (n=9) regarding the (1) likelihood of diagnostic coding for cardiometabolic conditions using the 10th Revision of the International Classification of Diseases (ICD-10) and (2) current procedural terminology (CPT) billing codes. RESULTS: At all 24,138 encounters with care gaps targeted by the SDM system, the proportion assigned high-complexity CPT codes for level of service 5 was significantly higher at the intervention clinics (6.1%) compared to that in the control clinics (2.9%), with P<.001 and adjusted odds ratio (OR) 1.64 (95% CI 1.02-2.61). This was consistently observed across the following specific care gaps: diabetes with glycated hemoglobin A1c (HbA1c)>8% (n=8463), 7.2% vs 3.4%, P<.001, and adjusted OR 1.93 (95% CI 1.01-3.67); blood pressure above goal (n=8515), 6.5% vs 3.7%, P<.001, and adjusted OR 1.42 (95% CI 0.72-2.79); suboptimal statin management (n=17,765), 5.8% vs 3%, P<.001, and adjusted OR 1.41 (95% CI 0.76-2.61); tobacco dependency (n=7449), 7.5% vs. 3.4%, P<.001, and adjusted OR 2.14 (95% CI 1.31-3.51); BMI >30 kg/m2 (n=19,838), 6.2% vs 2.9%, P<.001, and adjusted OR 1.45 (95% CI 0.75-2.8). Compared to control clinics, intervention clinics assigned ICD-10 diagnosis codes more often for observed cardiometabolic conditions with care gaps, although the difference did not reach statistical significance. CONCLUSIONS: In this randomized study, use of a clinically effective SDM system at encounters with care gaps significantly increased the proportion of encounters assigned high-complexity (level 5) CPT codes, and it was associated with a nonsignificant increase in assigning ICD-10 codes for observed cardiometabolic conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02451670; https://clinicaltrials.gov/ct2/show/NCT02451670.

Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial.

BACKGROUND: A team approach is one of the most effective ways to lower blood pressure (BP) in uncontrolled hypertension, but different models for organizing team-based care have not been compared directly. METHODS: A pragmatic, cluster-randomized trial compared 2 interventions in adult patients with moderately severe hypertension (BP≥150/95 mm Hg): (1) clinic-based care using best practices and face-to-face visits with physicians and medical assistants; and (2) telehealth care using best practices and adding home BP telemonitoring with home-based care coordinated by a clinical pharmacist or nurse practitioner. The primary outcome was change in systolic BP over 12 months. Secondary outcomes were change in patient-reported outcomes over 6 months. RESULTS: Participants (N=3071 in 21 primary care clinics) were on average 60 years old, 47% male, and 19% Black. Protocol-specified follow-up within 6 weeks was 32% in clinic-based care and 27% in telehealth care. BP decreased significantly during 12 months of follow-up in both groups, from 157/92 to 139/82 mm Hg in clinic-based care patients (adjusted mean difference -18/-10 mm Hg) and 157/91 to 139/81 mm Hg in telehealth care patients (adjusted mean difference -19/-10 mm Hg), with no significant difference in systolic BP change between groups (-0.8 mm Hg [95% CI, -2.84 to 1.32]). Telehealth care patients were significantly more likely than clinic-based care patients to report frequent home BP measurement, rate their BP care highly, and report that BP care visits were convenient. CONCLUSIONS: Telehealth care that includes extended team care is an effective and safe alternative to clinic-based care for improving patient-centered care for hypertension. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02996565.

Association of an Automated Blood Pressure Measurement Quality Improvement Program With Terminal Digit Preference and Recorded Mean Blood Pressure in 11 Clinics.

Importance: Terminal digit preference has been shown to be associated with inaccurate blood pressure (BP) recording. Objective: To evaluate whether converting from manual BP measurement with aneroid sphygmomanometers to automated BP measurement was associated with terminal digit preference, mean levels of recorded BP, and the rate at which hypertension was diagnosed. Design, Setting, and Participants: This quality improvement study was conducted from May 9, 2021, to March 24, 2022, using interrupted time series analysis of medical record data from 11 primary care clinics in a single health care system from April 2008 to April 2015. The study population was patients aged 18 to 75 years who had their BP measured and recorded at least once during the study period. Exposures: Manual BP measurement before April 2012 vs automated BP measurement with the Omron HEM-907XL monitor from May 2012 to April 2015. Main Outcomes and Measures: The main outcome was the distribution of terminal digits and mean systolic BP (SBP) values obtained during 4 years of manual measurement vs 3 years of automated measurement, assessed using a generalized linear mixed regression model with a random intercept for clinic and adjusted for seasonal fluctuations and patient demographic and clinical characteristics. Results: The study included 1 541 227 BP measurements from 225 504 unique patients during the entire study period, with 849 978 BP measurements from 165 137 patients (mean [SD] age, 47.1 [15.2] years; 58.2% female) during the manual measurement period and 691 249 measurements from 149 080 patients (mean [SD] age, 48.4 [15.3] years; 56.3% female) during the automated measurement period. With manual measurement, 32.8% of SBP terminal digits were 0 (20% was the expected value because nursing staff was instructed to record BP to the nearest even digit). This proportion decreased to 12.4% during the automated measurement period (expected value, 10%) when both even and odd digits were to be recorded. After automated measurement was implemented, the mean SBP estimated with statistical modeling increased by 5.09 mm Hg (95% CI, 4.98-5.19 mm Hg). Fewer BP values recorded during the automated than the manual measurement period were below 140/90 mm Hg (69.9% vs 84.3%; difference, -14.5%; 95% CI, -14.6% to -14.3%) and below 130/80 mm Hg (42.1% vs 60.0%; difference, -17.9%; 95% CI, -18.0% to -17.7%). The proportion of patients with a diagnosis of hypertension was 4.3 percentage points higher (23.4% vs 19.1%) during the automated measurement period. Conclusions and Relevance: In this quality improvement study, automated BP measurement was associated with decreased terminal digit preference and significantly higher mean BP levels. The method of BP measurement was also associated with the rate at which hypertension was diagnosed. These findings may have implications for pay-for-performance programs, which may create an incentive to record BP levels that meet a particular goal and a disincentive to adopt automated measurement of BP.

Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence.

BACKGROUND: Explanatory trials are designed to assess intervention efficacy under ideal conditions, while pragmatic trials are designed to assess whether research-proven interventions are effective in "real-world" settings without substantial research support. METHODS: We compared two trials (Hyperlink 1 and 3) that tested a pharmacist-led telehealth intervention in adults with uncontrolled hypertension. We applied PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) scores to describe differences in the way these studies were designed and enrolled study-eligible participants, and the effect of these differences on participant characteristics and adherence to study interventions. RESULTS: PRECIS-2 scores demonstrated that Hyperlink 1 was more explanatory and Hyperlink 3 more pragmatic. Recruitment for Hyperlink 1 was conducted by study staff, and 2.9% of potentially eligible patients enrolled. Enrollees were older, and more likely to be male and White than non-enrollees. Study staff scheduled the initial pharmacist visit and adherence to attending this visit was 98%. Conversely for Hyperlink 3, recruitment was conducted by clinic staff at routine encounters and 81% of eligible patients enrolled. Enrollees were younger, and less likely to be male and White than non-enrollees. Study staff did not assist with scheduling the initial pharmacist visit and adherence to attending this visit was only 27%. Compared to Hyperlink 1, patients in Hyperlink 3 were more likely to be female, and Asian or Black, had lower socioeconomic indicators, and were more likely to have comorbidities. Owing to a lower BP for eligibility in Hyperlink 1 (>140/90 mm Hg) than in Hyperlink 3 (>150/95 mm Hg), mean baseline BP was 148/85 mm Hg in Hyperlink 1 and 158/92 mm Hg in Hyperlink 3. CONCLUSION: The pragmatic design features of Hyperlink 3 substantially increased enrollment of study-eligible patients and of those traditionally under-represented in clinical trials (women, minorities, and patients with less education and lower income), and demonstrated that identification and enrollment of a high proportion of study-eligible subjects could be done by usual primary care clinic staff. However, the trade-off was much lower adherence to the telehealth intervention than in Hyperlink 1, which is likely to reflect uptake under real-word conditions and substantially dilute intervention effect on BP. TRIAL REGISTRATION: The Hyperlink 1 study (NCT00781365) and the Hyperlink 3 study (NCT02996565) are registered at ClinicalTrials.gov.

Variation in Mean Arterial Pressure Increases Falls Risk in Elderly Physically Frail and Prefrail Individuals Treated With Antihypertensive Medication.

BACKGROUND: Impaired cerebral blood flow has been associated with an increased risk of falls. Mean arterial pressure (MAP) and variability in MAP have been reported to affect cerebral blood flow but their relationships to the risk of falls have not previously been reported. METHODS: Utilising data from the Aspirin in Reducing Events in the Elderly trial participants, we estimated MAP and variability in MAP, defined as within-individual SD of MAP from baseline and first 2 annual visits. The relationship with MAP was studied in 16 703 participants amongst whom 1539 falls were recorded over 7.3 years. Variability in MAP was studied in 14 818 of these participants who experienced 974 falls over 4.1 years. Falls were confined to those involving hospital presentation. Cox regression was used to calculate hazard ratio and 95% CI for associations with falls. RESULTS: Long-term variability in MAP was not associated with falls except amongst frail or prefrail participants using antihypertensive medications. Within this group each 5 mm Hg increase in long-term variability in MAP increased the risk of falls by 16% (hazard ratio, 1.16 [95% CI, 1.02-1.33]). Amongst the antihypertensive drugs studied, beta-blocker monotherapy (hazard ratio, 1.93 [95% CI, 1.17-3.18]) was associated with an increased risk of falls compared with calcium channel blockers. CONCLUSIONS: Higher levels of long-term variability in MAP increase the risk of serious falls in older frail and prefrail individuals taking antihypertensive medications. The observation that the relationship was limited to frail and prefrail individuals might explain some of the variability of previous studies linking blood pressure indices and falls.

COVID-19 Vaccination Of People Experiencing Homelessness And Incarceration In Minnesota.

We used data from a statewide public health-health system collaboration to describe trends in COVID-19 vaccination rates by racial and ethnic groups among people experiencing homelessness or incarceration in Minnesota. Vaccination completion rates among the general population and people incarcerated in state prisons were substantially higher than those among people experiencing homelessness or jail incarceration.

Blood Pressure Checks for Diagnosing Hypertension: Health Professionals' Knowledge, Beliefs, and Practices.

INTRODUCTION: The US Preventive Services Task Force recommends out-of-office blood pressure (BP) measurement before making a new hypertension diagnosis and initiating treatment, using 24-hour ambulatory (ABPM) or home BP monitoring. However, this approach is not common. METHODS: e-mail-linked surveys were sent to primary care team members (n = 421) from 10 clinics. The sample included medical assistants, licensed practical nurses, registered nurses, and advanced practice registered nurses (LPN/RN/APRNs), physician assistants (PAs), and physicians. Those licensed to diagnosis hypertension (physician/PA/APRNs) received additional questions. Data were collected from November 2017 to July 2019. RESULTS: 2-thirds of invitees responded (163 MA/LPN/RNs, 86 physicians, and 33 PA/APRNs). When making a new hypertension diagnosis, most respondents believed that BP measured manually with a stethoscope (78.6%) or ABPM (84.2%) were very or highly accurate. In contrast, most did not believe that automated clinic BPs, home BP, or kiosk BP measurements were very or highly accurate. Almost all reported always or almost always relying on clinic BP measurements in making a diagnosis (95.7%), but most physician/PA/APRNs (60.5%) would prefer ABPM if it was readily available. Very few physician/PA/APRNs used the guideline-concordant diagnostic threshold (135/85 mmHg) with home monitoring (14.0%) or ABPM (8.4%), with 140/90 mmHg the most commonly reported threshold for home (59.4%) and ABPM (49.6%). DISCUSSION: Our study found health care professional knowledge, beliefs, and practices gaps in diagnosing hypertension. These gaps could lead to clinical care that is not aligned with guidelines. CONCLUSION: System changes and interventions to increase use of evidence-based practices could improve hypertension diagnosis and outcomes.

Automated Office Blood Pressure and the Impact of Attendance and Rest on Diagnostic Accuracy.

BACKGROUND: Automated office blood pressure (AOBP) using 3-5 measurements taken with an oscillometric device with or without an attendant in the room may decrease "white coat" effect. We evaluated the impact of the presence or absence of the attendant and rest on BP and diagnosis of hypertension. METHODS: We randomly assigned 133 adults aged 18-85 with high BP at baseline (≥140/90 mm Hg), no hypertensive diagnosis and no antihypertensive medications to either attended AOBP first, unattended second, or unattended AOBP first, attended second. Outcomes included within-person BP difference for attended vs. unattended measurements; 5 vs. 15 minutes of rest; and the diagnostic performance of AOBP compared with daytime automated blood pressure measurement (ABPM). RESULTS: We found no significant differences between attended and unattended AOBP (mean difference attended - unattended [95% confidence interval, CI], systolic 0.14 mm Hg [-0.78, 1.06]; diastolic 0.16 mm Hg [-0.45, 0.78]) or by rest time (mean difference 15 - 5 minutes [95% CI], systolic -0.45 mm Hg [-1.36, 0.47]; diastolic 0.61 mm Hg [-1.23, 0.003]). AOBP was lower than mean daytime ABPM, regardless of attendance or rest (after 5 minutes rest systolic -3.6 and diastolic -2.55 mm Hg, P = 0.001 for both comparisons). Using daytime ABPM of ≥135/85 mm Hg as the diagnostic threshold, AOBP sensitivity and specificity after 5 minutes of rest were 71.0% and 54.1%, respectively. CONCLUSIONS: The presence or absence of a clinic attendant during AOBP measurement and the amount of rest time before AOBP measurements had no effects on BP. AOBP measurements have low sensitivity and specificity for making a new diagnosis of hypertension.

Clinic, Home, and Kiosk Blood Pressure Measurements for Diagnosing Hypertension: a Randomized Diagnostic Study.

BACKGROUND: The US Preventive Services Task Force recommends blood pressure (BP) measurements using 24-h ambulatory monitoring (ABPM) or home BP monitoring before making a new hypertension diagnosis. OBJECTIVE: Compare clinic-, home-, and kiosk-based BP measurement to ABPM for diagnosing hypertension. DESIGN, SETTING, AND PARTICIPANTS: Diagnostic study in 12 Washington State primary care centers, with participants aged 18-85 years without diagnosed hypertension or prescribed antihypertensive medications, with elevated BP in clinic. INTERVENTIONS: Randomization into one of three diagnostic regimens: (1) clinic (usual care follow-up BPs); (2) home (duplicate BPs twice daily for 5 days); or (3) kiosk (triplicate BPs on 3 days). All participants completed ABPM at 3 weeks. MAIN MEASURES: Primary outcome was difference between ABPM daytime and clinic, home, and kiosk mean systolic BP. Differences in diastolic BP, sensitivity, and specificity were secondary outcomes. KEY RESULTS: Five hundred ten participants (mean age 58.7 years, 80.2% white) with 434 (85.1%) included in primary analyses. Compared to daytime ABPM, adjusted mean differences in systolic BP were clinic (-4.7mmHg [95% confidence interval -7.3, -2.2]; P<.001); home (-0.1mmHg [-1.6, 1.5];P=.92); and kiosk (9.5mmHg [7.5, 11.6];P<.001). Differences for diastolic BP were clinic (-7.2mmHg [-8.8, -5.5]; P<.001); home (-0.4mmHg [-1.4, 0.7];P=.52); and kiosk (5.0mmHg [3.8, 6.2]; P<.001). Sensitivities for clinic, home, and kiosk compared to ABPM were 31.1% (95% confidence interval, 22.9, 40.6), 82.2% (73.8, 88.4), and 96.0% (90.0, 98.5), and specificities 79.5% (64.0, 89.4), 53.3% (38.9, 67.2), and 28.2% (16.4, 44.1), respectively. LIMITATIONS: Single health care organization and limited race/ethnicity representation. CONCLUSIONS: Compared to ABPM, mean BP was significantly lower for clinic, significantly higher for kiosk, and without significant differences for home. Clinic BP measurements had low sensitivity for detecting hypertension. Findings support utility of home BP monitoring for making a new diagnosis of hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT03130257 https://clinicaltrials.gov/ct2/show/NCT03130257.

Safety and tolerability of high-dose daily vitamin D3 supplementation in the vitamin D and type 2 diabetes (D2d) study-a randomized trial in persons with prediabetes.

BACKGROUND/OBJECTIVES: Routine use of vitamin D supplements has increased substantially in the United States. However, the safety and tolerability of long-term use of high-dose vitamin D are not known. We assessed the safety and tolerability of high-dose, daily vitamin D3 in the vitamin D and type 2 diabetes (D2d) study. SUBJECTS/METHODS: In total, 2423 overweight/obese persons with prediabetes were randomized in a double-blind manner to either 4000 IU of vitamin D3 (the tolerable upper intake level for adults by the National Academy of Medicine) taken daily or matching placebo. All participants were included in this analysis. Incident adverse events (AE) were ascertained 4 times a year at in-person visits (twice a year) and interim remote encounters (twice a year) and were defined as untoward or unfavorable medical occurrences. Serious adverse events (SAE) included death, life-threatening events, and hospitalizations. RESULTS: A total of 8304 AEs occurred during 3 years of follow-up and were less frequent in the vitamin D group compared to placebo (Incidence Rate Ratio [IRR] = 0.94; 95% Confidence Interval (CI) 0.90, 0.98). The overall frequency of protocol-specified AEs of interest, which included nephrolithiasis, hypercalcemia, hypercalciuria, or low estimated glomerular filtration rate, was low and did not differ by group. There were no significant between-group differences in total SAEs (IRR = 0.96 (0.81, 1.14)). CONCLUSION: Vitamin D3 supplementation at 4000 IU per day was safe and well tolerated among overweight/obese participants at high risk for diabetes who were appropriately monitored for safety. In this population, this dose of vitamin D3 did not increase risk of AEs or SAEs, including those previously associated with vitamin D such as hypercalcemia, hypercalciuria, or nephrolithiasis. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01942694, prospectively registered September 16, 2013.

Effectiveness of BNT162b2 and mRNA-1273 Second Doses and Boosters for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection and SARS-CoV-2-Related Hospitalizations: A Statewide Report From the Minnesota Electronic Health Record Consortium.

Using vaccine data combined with electronic health records, we report that mRNA boosters provide greater protection than a 2-dose regimen against SARS-CoV-2 infection and related hospitalizations. The benefit of a booster was more evident in the elderly and those with comorbidities.

Minnesota Electronic Health Record Consortium COVID-19 Project: Informing Pandemic Response Through Statewide Collaboration Using Observational Data.

OBJECTIVE: Robust disease and syndromic surveillance tools are underdeveloped in the United States, as evidenced by limitations and heterogeneity in sociodemographic data collection throughout the COVID-19 pandemic. To monitor the COVID-19 pandemic in Minnesota, we developed a federated data network in March 2020 using electronic health record (EHR) data from 8 multispecialty health systems. MATERIALS AND METHODS: In this serial cross-sectional study, we examined patients of all ages who received a COVID-19 polymerase chain reaction test, had symptoms of a viral illness, or received an influenza test from January 3, 2016, through November 7, 2020. We evaluated COVID-19 testing rates among patients with symptoms of viral illness and percentage positivity among all patients tested, in aggregate and by zip code. We stratified results by patient and area-level characteristics. RESULTS: Cumulative COVID-19 positivity rates were similar for people aged 12-64 years (range, 15.1%-17.6%) but lower for adults aged ≥65 years (range, 9.3%-10.7%). We found notable racial and ethnic disparities in positivity rates early in the pandemic, whereas COVID-19 positivity was similarly elevated across most racial and ethnic groups by the end of 2020. Positivity rates remained substantially higher among Hispanic patients compared with other racial and ethnic groups throughout the study period. We found similar trends across area-level income and rurality, with disparities early in the pandemic converging over time. PRACTICE IMPLICATIONS: We rapidly developed a distributed data network across Minnesota to monitor the COVID-19 pandemic. Our findings highlight the utility of using EHR data to monitor the current pandemic as well as future public health priorities. Building partnerships with public health agencies can help ensure data streams are flexible and tailored to meet the changing needs of decision makers.