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.

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.

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.

Accelerometer-Measured Daily Steps, Physical Function, and Subsequent Fall Risk in Older Women: The Objective Physical Activity and Cardiovascular Disease in Older Women Study.

Steps per day were measured by accelerometer for 7 days among 5,545 women aged 63-97 years between 2012 and 2014. Incident falls were ascertained from daily fall calendars for 13 months. Median steps per day were 3,216. There were 5,473 falls recorded over 61,564 fall calendar-months. The adjusted incidence rate ratio comparing women in the highest versus lowest step quartiles was 0.71 (95% confidence interval [0.54, 0.95]; ptrend across quartiles = .01). After further adjustment for physical function using the Short Physical Performance Battery, the incidence rate ratio was 0.86 ([0.64, 1.16]; ptrend = .27). Mediation analysis estimated that 63.7% of the association may be mediated by physical function (p = .03). In conclusion, higher steps per day were related to lower incident falls primarily through their beneficial association with physical functioning. Interventions that improve physical function, including those that involve stepping, could reduce falls in older adults.

Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial.

OBJECTIVE: There is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial. DESIGN: Data were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010-2017 ('ASPirin in Reducing Events in the Elderly (ASPREE)', n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm. RESULTS: Over a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors. CONCLUSION: Aspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin. TRIAL REGISTRATION NUMBER: ASPREE. NCT01038583.

Self-Measured Blood Pressure Monitoring at Home: A Joint Policy Statement From the American Heart Association and American Medical Association.

The diagnosis and management of hypertension, a common cardiovascular risk factor among the general population, have been based primarily on the measurement of blood pressure (BP) in the office. BP may differ considerably when measured in the office and when measured outside of the office setting, and higher out-of-office BP is associated with increased cardiovascular risk independent of office BP. Self-measured BP monitoring, the measurement of BP by an individual outside of the office at home, is a validated approach for out-of-office BP measurement. Several national and international hypertension guidelines endorse self-measured BP monitoring. Indications include the diagnosis of white-coat hypertension and masked hypertension and the identification of white-coat effect and masked uncontrolled hypertension. Other indications include confirming the diagnosis of resistant hypertension and detecting morning hypertension. Validated self-measured BP monitoring devices that use the oscillometric method are preferred, and a standardized BP measurement and monitoring protocol should be followed. Evidence from meta-analyses of randomized trials indicates that self-measured BP monitoring is associated with a reduction in BP and improved BP control, and the benefits of self-measured BP monitoring are greatest when done along with cointerventions. The addition of self-measured BP monitoring to office BP monitoring is cost-effective compared with office BP monitoring alone or usual care among individuals with high office BP. The use of self-measured BP monitoring is commonly reported by both individuals and providers. Therefore, self-measured BP monitoring has high potential for improving the diagnosis and management of hypertension in the United States. Randomized controlled trials examining the impact of self-measured BP monitoring on cardiovascular outcomes are needed. To adequately address barriers to the implementation of self-measured BP monitoring, financial investment is needed in the following areas: improving education and training of individuals and providers, building health information technology capacity, incorporating self-measured BP readings into clinical performance measures, supporting cointerventions, and enhancing reimbursement.

Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly.

BACKGROUND: Aspirin is a well-established therapy for the secondary prevention of cardiovascular events. However, its role in the primary prevention of cardiovascular disease is unclear, especially in older persons, who have an increased risk. METHODS: From 2010 through 2014, we enrolled community-dwelling men and women in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. The primary end point was a composite of death, dementia, or persistent physical disability; results for this end point are reported in another article in the Journal. Secondary end points included major hemorrhage and cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure). RESULTS: Of the 19,114 persons who were enrolled in the trial, 9525 were assigned to receive aspirin and 9589 to receive placebo. After a median of 4.7 years of follow-up, the rate of cardiovascular disease was 10.7 events per 1000 person-years in the aspirin group and 11.3 events per 1000 person-years in the placebo group (hazard ratio, 0.95; 95% confidence interval [CI], 0.83 to 1.08). The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001). CONCLUSIONS: The use of low-dose aspirin as a primary prevention strategy in older adults resulted in a significantly higher risk of major hemorrhage and did not result in a significantly lower risk of cardiovascular disease than placebo. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).

Effect of Aspirin on All-Cause Mortality in the Healthy Elderly.

BACKGROUND: In the primary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, now published in the Journal, we report that the daily use of aspirin did not provide a benefit with regard to the primary end point of disability-free survival among older adults. A numerically higher rate of the secondary end point of death from any cause was observed with aspirin than with placebo. METHODS: From 2010 through 2014, we enrolled community-dwelling persons in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. Deaths were classified according to the underlying cause by adjudicators who were unaware of trial-group assignments. Hazard ratios were calculated to compare mortality between the aspirin group and the placebo group, and post hoc exploratory analyses of specific causes of death were performed. RESULTS: Of the 19,114 persons who were enrolled, 9525 were assigned to receive aspirin and 9589 to receive placebo. A total of 1052 deaths occurred during a median of 4.7 years of follow-up. The risk of death from any cause was 12.7 events per 1000 person-years in the aspirin group and 11.1 events per 1000 person-years in the placebo group (hazard ratio, 1.14; 95% confidence interval [CI], 1.01 to 1.29). Cancer was the major contributor to the higher mortality in the aspirin group, accounting for 1.6 excess deaths per 1000 person-years. Cancer-related death occurred in 3.1% of the participants in the aspirin group and in 2.3% of those in the placebo group (hazard ratio, 1.31; 95% CI, 1.10 to 1.56). CONCLUSIONS: Higher all-cause mortality was observed among apparently healthy older adults who received daily aspirin than among those who received placebo and was attributed primarily to cancer-related death. In the context of previous studies, this result was unexpected and should be interpreted with caution. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).

Effect of Aspirin on Disability-free Survival in the Healthy Elderly.

BACKGROUND: Information on the use of aspirin to increase healthy independent life span in older persons is limited. Whether 5 years of daily low-dose aspirin therapy would extend disability-free life in healthy seniors is unclear. METHODS: From 2010 through 2014, we enrolled community-dwelling persons in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or physical disability. Participants were randomly assigned to receive 100 mg per day of enteric-coated aspirin or placebo orally. The primary end point was a composite of death, dementia, or persistent physical disability. Secondary end points reported in this article included the individual components of the primary end point and major hemorrhage. RESULTS: A total of 19,114 persons with a median age of 74 years were enrolled, of whom 9525 were randomly assigned to receive aspirin and 9589 to receive placebo. A total of 56.4% of the participants were women, 8.7% were nonwhite, and 11.0% reported previous regular aspirin use. The trial was terminated at a median of 4.7 years of follow-up after a determination was made that there would be no benefit with continued aspirin use with regard to the primary end point. The rate of the composite of death, dementia, or persistent physical disability was 21.5 events per 1000 person-years in the aspirin group and 21.2 per 1000 person-years in the placebo group (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11; P=0.79). The rate of adherence to the assigned intervention was 62.1% in the aspirin group and 64.1% in the placebo group in the final year of trial participation. Differences between the aspirin group and the placebo group were not substantial with regard to the secondary individual end points of death from any cause (12.7 events per 1000 person-years in the aspirin group and 11.1 events per 1000 person-years in the placebo group), dementia, or persistent physical disability. The rate of major hemorrhage was higher in the aspirin group than in the placebo group (3.8% vs. 2.8%; hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001). CONCLUSIONS: Aspirin use in healthy elderly persons did not prolong disability-free survival over a period of 5 years but led to a higher rate of major hemorrhage than placebo. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).

Recent trends in cardiovascular disease deaths: a state specific perspective.

BACKGROUND: The rate of decline in cardiovascular disease (CVD) mortality has lessened nationally. How these findings apply to specific states or causes of CVD deaths is not known. Examining these trends at the state level is important to plan local interventions. METHODS: We analyzed CVD mortality trends in Minnesota (MN) using the U.S. Centers for Disease Control and Prevention (CDC) Wide-ranging ONline Data for Epidemiologic Research (WONDER). Trends were analyzed by age, sex, type of CVD and location of death. RESULTS: CVD mortality rates in MN declined in 2000-2009 and then leveled off in 2010-2018, paralleling national rates. Age- and sex-adjusted CVD mortality decreased by 3.7% per year in 2000-2009 (average annual percent changes [AAPC]: -3.7; 95% CI: - 4.8, - 2.6) with no change observed in 2010-2018. Those aged 65-84 years had the most rapid early decline in CVD mortality (AAPC: -5.9, 95% CI: - 6.2, - 5.7) and had less improvement in 2010-2018 (AAPC: -1.8, 95% CI: - 2.2, - 1.5), and the younger age group (25-64 years) now experiences the most adverse trends (AAPC: 1.2, 95% CI: 0.7-1.8). Coronary heart disease (CHD) and cerebrovascular disease had the largest relative decreases in mortality in 2000-2009 (CHD AAPC: -5.2; 95% CI: - 6.5,-3.9; cerebrovascular disease AAPC: -4.4, 95% CI: - 5.2, - 3.6) with no change 2010-2018. Heart failure (HF)/cardiomyopathy followed similar trends with a 2.5% decrease (AAPC 95% CI: - 3.5, - 1.5) per year in 2000-2009 and no change in 2010-2018. Deaths from other CVD also decreased in the early time period (AAPC: -1.6, 95% CI: - 2.7, - 0.5) but increased in 2010-2018 (AAPC: 1.9, 95% CI: 0.5, 3.3). In- and out-of-hospital death rates improved in 2000-2009 with a slowing in improvement for in-hospital death and no further improvement for out-of-hospital death in 2010-2018. CONCLUSION: Concerning CVD mortality trends occurred in MN. In the most recent decade (2010-2018) mortality from all CVD subtypes plateaued or even increased. CVD mortality among the younger age groups increased as well. These data are congruent with adverse national trends supporting their generalizability. These adverse trends underscore the urgent need for CVD prevention and treatment, as well as continued surveillance to assess progress at the state and national level.

Early Patient-Centered Outcomes Research Experience With the Use of Telehealth to Address Disparities: Scoping Review.

BACKGROUND: Health systems and providers across America are increasingly employing telehealth technologies to better serve medically underserved low-income, minority, and rural populations at the highest risk for health disparities. The Patient-Centered Outcomes Research Institute (PCORI) has invested US $386 million in comparative effectiveness research in telehealth, yet little is known about the key early lessons garnered from this research regarding the best practices in using telehealth to address disparities. OBJECTIVE: This paper describes preliminary lessons from the body of research using study findings and case studies drawn from PCORI seminal patient-centered outcomes research (PCOR) initiatives. The primary purpose was to identify common barriers and facilitators to implementing telehealth technologies in populations at risk for disparities. METHODS: A systematic scoping review of telehealth studies addressing disparities was performed. It was guided by the Arksey and O'Malley Scoping Review Framework and focused on PCORI's active portfolio of telehealth studies and key PCOR identified by study investigators. We drew on this broad literature using illustrative examples from early PCOR experience and published literature to assess barriers and facilitators to implementing telehealth in populations at risk for disparities, using the active implementation framework to extract data. Major themes regarding how telehealth interventions can overcome barriers to telehealth adoption and implementation were identified through this review using an iterative Delphi process to achieve consensus among the PCORI investigators participating in the study. RESULTS: PCORI has funded 89 comparative effectiveness studies in telehealth, of which 41 assessed the use of telehealth to improve outcomes for populations at risk for health disparities. These 41 studies employed various overlapping modalities including mobile devices (29/41, 71%), web-based interventions (30/41, 73%), real-time videoconferencing (15/41, 37%), remote patient monitoring (8/41, 20%), and store-and-forward (ie, asynchronous electronic transmission) interventions (4/41, 10%). The studies targeted one or more of PCORI's priority populations, including racial and ethnic minorities (31/41, 41%), people living in rural areas, and those with low income/low socioeconomic status, low health literacy, or disabilities. Major themes identified across these studies included the importance of patient-centered design, cultural tailoring of telehealth solutions, delivering telehealth through trusted intermediaries, partnering with payers to expand telehealth reimbursement, and ensuring confidential sharing of private information. CONCLUSIONS: Early PCOR evidence suggests that the most effective health system- and provider-level telehealth implementation solutions to address disparities employ patient-centered and culturally tailored telehealth solutions whose development is actively guided by the patients themselves to meet the needs of specific communities and populations. Further, this evidence shows that the best practices in telehealth implementation include delivery of telehealth through trusted intermediaries, close partnership with payers to facilitate reimbursement and sustainability, and safeguards to ensure patient-guided confidential sharing of personal health information.

Primary care physician perspectives on using team care in clinical practice.

BACKGROUND: Primary care physicians were prompted to refer eligible patients with uncontrolled hypertension (HTN) to a program that offered home blood pressure telemonitoring and pharmacist care management. Understanding attitudes, barriers and facilitators, and use of team care in this program provides insight into how physicians incorporate team care into their practice. OBJECTIVE: To understand physician attitudes and use of team care in the context of a study intervention that included telehealth care with pharmacist care management. METHODS: Clinicians who were part of the telehealth intervention arm of the Hyperlink 3 study and had at least 20 opportunities to refer an eligible patient with HTN to a clinical pharmacist were invited to be interviewed. Nine physician interviews were conducted, recorded, and transcribed. Each interview lasted approximately 30 minutes and followed an interview guide, allowing for some variation and deeper dives into content on the basis of the clinician response. Three research staff coded each interview and sorted coded text to identify patterns at the physician level and then identified themes across interviews using a comparative process. RESULTS: Physicians had an overall positive attitude about team care. Communication, access, trust, and perceived role competency of team members influenced physician engagement in team care. Individualized practice styles influenced how physicians used team care and which care team members they involved most often. All physicians felt that their individual style best achieved high-quality care. CONCLUSION: For health care teams to be most effective, an understanding of how a physician's practice style influences their use of team care is likely to be more successful than a one-size-fits-all approach. Incorporating practice style into the key factors necessary for high-functioning teams, such as communication, access, and trust, is necessary for health care teams to thrive.

Association between post-stroke disability and 5-year hip-fracture risk: The Women's Health Initiative.

BACKGROUND: Hip fractures are a significant post-stroke complication. We examined predictors of hip fracture risk after stroke using data from the Women's Health Initiative (WHI). In particular, we examined the association between post-stroke disability levels and hip fracture risk. METHODS: The WHI is a prospective study of 161,808 postmenopausal women aged 50-79 years. Trained physicians adjudicated stroke events and hip fractures. Our study included stroke survivors from the observational and clinical trial arms who had a Glasgow Outcome Scale of good recovery, moderately disabled, or severely disabled and survived more than 7 days post-stroke. Hip fracture-free status was compared across disability levels. Secondary analysis examined hip fracture risk while accounting for competing risk of death. RESULTS: Average age at time of stroke was 74.6±7.2 years; 84.3% were white. There were 124 hip fractures among 4,640 stroke survivors over a mean follow-up time of 3.1±1.8 years. Mortality rate was 23.3%. Severe disability at discharge (Hazard Ratio (HR): 2.1 (95% Confidence Interval (CI): 1.4-3.2), but not moderate disability (HR: 1.1 (95%CI: 0.7-1.7), was significantly associated with an increased risk of hip fracture compared to good recovery status. This association was attenuated after accounting for mortality. White race, increasing age and higher Fracture Risk Assessment Tool (FRAX)-predicted hip fracture risk (without bone density information) were associated with an increased hip fracture risk. After accounting for mortality, higher FRAX risk and white race remained significant. CONCLUSION: Severe disability after stroke and a higher FRAX risk score were associated with risk of subsequent hip fracture. After accounting for mortality, only the FRAX risk score remained significant. The FRAX risk score appears to identify stroke survivors at high risk of fractures. Our results suggest that stroke units can consider the incorporation of osteoporosis screening into care pathways.

Smoking cessation, weight gain, and risk of stroke among postmenopausal women.

The relationship between smoking cessation, concurrent weight gain, and stroke events is not yet understood. Thus, we examined the association between smoking cessation and subsequent stroke risk and whether the association was modified by concurrent weight gain. In 2017, we analyzed data from 109,498 postmenopausal US women enrolled in the Women's Health Initiative from 1993 to 1998. Women with a history of cancer or cardiovascular disease events were excluded. The median length of follow-up time was 14.01 years. Variables of primary focus were smoking cessation, weight change, and clinically confirmed incident cases of hemorrhagic and ischemic stroke. Hazard ratios were estimated for stroke incidences (all, ischemic, and hemorrhagic) associated with smoking cessation using Cox regression. The exposure-outcome relationship of smoking cessation and risk of stroke was evaluated for effect modification by weight change. Recent quitters between baseline and year 3 had a significantly lower risk for all stroke and ischemic stroke, but not hemorrhagic stroke, when compared to the reference group of continuing smokers. In the multivariable-adjusted model for ischemic stroke, the hazard ratio for recent quitters was 0.66 (95% CI: 0.46, 0.95). In the model for hemorrhagic stroke, the hazard ratio for recent quitters was 0.76 (95% CI: 0.36, 1.61). The association between recent quitting and stroke risk was not significantly modified by weight change. Smoking cessation was associated with a significant reduction in stroke risk. The benefit of smoking cessation on the risk of stroke was not attenuated by concurrent weight gain.

Accuracy of self-reported weight in the Women's Health Initiative.

OBJECTIVE: To assess the extent of error present in self-reported weight data in the Women's Health Initiative, variables that may be associated with error, and to develop methods to reduce any identified error. DESIGN: Prospective cohort study. SETTING: Forty clinical centres in the USA.ParticipantsWomen (n 75 336) participating in the Women's Health Initiative Observational Study (WHI-OS) and women (n 6236) participating in the WHI Long Life Study (LLS) with self-reported and measured weight collected about 20 years later (2013-2014). RESULTS: The correlation between self-reported and measured weights was 0·97. On average, women under-reported their weight by about 2 lb (0·91 kg). The discrepancies varied by age, race/ethnicity, education and BMI. Compared with normal-weight women, underweight women over-reported their weight by 3·86 lb (1·75 kg) and obese women under-reported their weight by 4·18 lb (1·90 kg) on average. The higher the degree of excess weight, the greater the under-reporting of weight. Adjusting self-reported weight for an individual's age, race/ethnicity and education yielded an identical average weight to that measured. CONCLUSIONS: Correlations between self-reported and measured weights in the WHI are high. Discrepancies varied by different sociodemographic characteristics, especially an individual's BMI. Correction of self-reported weight for individual characteristics could improve the accuracy of assessment of obesity status in postmenopausal women.

Impact of hormone therapy on Medicare spending in the Women's Health Initiative randomized clinical trials.

BACKGROUND: Randomized trials can compare economic as well as clinical outcomes, but economic data are difficult to collect. Linking clinical trial data with Medicare claims could provide novel information on health care utilization and cost. METHODS: We linked data from Medicare claims of women ≥65 years old who had Medicare fee-for-service coverage with their clinical data from the Women's Health Initiative trials of conjugated equine estrogens plus medroxyprogesterone acetate (CEE+MPA) versus placebo and of CEE-alone versus placebo. The primary outcome was total Medicare spending during the intervention phase of the trial, and the secondary outcomes were spending on diseases hypothesized a priori to be sensitive to the effects of hormone therapy. RESULTS: In the CEE+MPA trial, 4,557 participants ≥65 years old were included. Women randomly assigned to CEE+MPA had 4% higher mean Medicare spending overall ($45,690 vs $43,920, P = .08) but 0.5% lower spending for hormone-sensitive diseases ($3,526 vs $3,547, P = .07), with 73% higher spending for coronary heart disease (P = .045) and 122% higher spending for pulmonary embolism (P = .026). In the CEE-alone trial, 3,107 participants were included. Total spending among women randomly assigned to CEE was 3.3% higher ($75,411 vs $72,997, P = .16), and 1.7% higher spending for hormone-sensitive diseases ($5,213 vs $5,127, P = .57), but with 39% lower spending for hip fracture (p<0.03). CONCLUSIONS: Menopausal hormone therapy increased spending for some diseases, but decreased spending for others. These offsetting effects led to modest (3%-4%), nonsignificant increases in overall spending among women aged 65 years and older.

Key components of success in a randomized trial of blood pressure telemonitoring with medication therapy management pharmacists.

OBJECTIVES: The Hyperlink trial tested a 12-month intervention of home blood pressure (BP) telemonitoring with pharmacist case management in adults with uncontrolled hypertension. The intervention resulted in improved BP control compared with usual care at both 6 (72% vs. 45%; P < 0.001) and 12 months (71% vs. 53%; P = 0.005). We sought to investigate factors contributing to intervention success. DESIGN: Mixed-methods analysis of process of care data, patient focus groups, and pharmacist interviews. PARTICIPANTS: Data from 228 intervention patients were examined from the original 450 patients randomly assigned from 16 primary care clinics. Five patient focus groups and 4 pharmacist interviews were conducted to ascertain the patient and pharmacist perspective. Focus group and interview data were coded, and themes relevant to pharmacists were identified. OUTCOME MEASURES: Home BP readings of less than 135/85 mm Hg and patient focus group and pharmacist interview themes. RESULTS: Mean BP at the intake visit was 148/85 mm Hg. Antihypertensive medications were adjusted in 10% of patients at the initial in-person visit, 33% at phone visit 1, 36% at phone visit 2, and 19% at phone visit 3. Thereafter, medication changes declined. The mean home BP for patients at the first phone visit was 136/80 mm Hg, 126/74 mm Hg at 3 months, and 123/73 mm Hg at 5 months, with little change thereafter. Key components of success from patient and pharmacist interviews included a strong patient-pharmacist relationship, individualized treatment plans, and frequent phone contact with the pharmacist. CONCLUSION: Frequent adjustments to the antihypertensive treatment regimen based on home BP telemonitoring resulted in rapid lowering of BP. Our results suggest that an intensive telephone-based intervention with the key components of medication adjustments, a strong patient and pharmacist relationship, and individualized treatment plans can achieve BP control in only 3 months in many patients with uncontrolled hypertension.

Self-monitoring of blood pressure in hypertension: A systematic review and individual patient data meta-analysis.

BACKGROUND: Self-monitoring of blood pressure (BP) appears to reduce BP in hypertension but important questions remain regarding effective implementation and which groups may benefit most. This individual patient data (IPD) meta-analysis was performed to better understand the effectiveness of BP self-monitoring to lower BP and control hypertension. METHODS AND FINDINGS: Medline, Embase, and the Cochrane Library were searched for randomised trials comparing self-monitoring to no self-monitoring in hypertensive patients (June 2016). Two reviewers independently assessed articles for eligibility and the authors of eligible trials were approached requesting IPD. Of 2,846 articles in the initial search, 36 were eligible. IPD were provided from 25 trials, including 1 unpublished study. Data for the primary outcomes-change in mean clinic or ambulatory BP and proportion controlled below target at 12 months-were available from 15/19 possible studies (7,138/8,292 [86%] of randomised participants). Overall, self-monitoring was associated with reduced clinic systolic blood pressure (sBP) compared to usual care at 12 months (-3.2 mmHg, [95% CI -4.9, -1.6 mmHg]). However, this effect was strongly influenced by the intensity of co-intervention ranging from no effect with self-monitoring alone (-1.0 mmHg [-3.3, 1.2]), to a 6.1 mmHg (-9.0, -3.2) reduction when monitoring was combined with intensive support. Self-monitoring was most effective in those with fewer antihypertensive medications and higher baseline sBP up to 170 mmHg. No differences in efficacy were seen by sex or by most comorbidities. Ambulatory BP data at 12 months were available from 4 trials (1,478 patients), which assessed self-monitoring with little or no co-intervention. There was no association between self-monitoring and either lower clinic or ambulatory sBP in this group (clinic -0.2 mmHg [-2.2, 1.8]; ambulatory 1.1 mmHg [-0.3, 2.5]). Results for diastolic blood pressure (dBP) were similar. The main limitation of this work was that significant heterogeneity remained. This was at least in part due to different inclusion criteria, self-monitoring regimes, and target BPs in included studies. CONCLUSIONS: Self-monitoring alone is not associated with lower BP or better control, but in conjunction with co-interventions (including systematic medication titration by doctors, pharmacists, or patients; education; or lifestyle counselling) leads to clinically significant BP reduction which persists for at least 12 months. The implementation of self-monitoring in hypertension should be accompanied by such co-interventions.

Risk of Diabetes After Hysterectomy With or Without Oophorectomy in Postmenopausal Women.

The aim of this study was to determine the associations between hysterectomy, bilateral salpingo-oophorectomy (BSO), and incidence of diabetes in postmenopausal women participating in the Women's Health Initiative (WHI), a series of trials conducted in the United States, during the period 1993-1998. A total of 67,130 postmenopausal women aged 50-79 years were followed for a mean of 13.4 years. Among them, 7,430 cases of diabetes were diagnosed. Multivariable Cox proportional hazards models were used to assess the association between hysterectomy/oophorectomy status and diabetes incidence. Compared with women without hysterectomy, women with hysterectomy had a significantly higher risk of diabetes (hazard ratio = 1.13, 95% confidence interval: 1.06, 1.21). The increased risk of diabetes was similar for women with hysterectomy only and for women with hysterectomy with concomitant BSO. Compared with hysterectomy alone, hysterectomy with BSO was not associated with additional risk of diabetes after stratification by age at hysterectomy and hormone therapy status. In our large, prospective study, we observed that hysterectomy, regardless of oophorectomy status, was associated with increased risk of diabetes among postmenopausal women. However, our data did not support the hypothesis that early loss of ovarian estrogens is a risk factor for type 2 diabetes. The modest increased risk of diabetes associated with hysterectomy may be due to residual confounding, such as the reasons for hysterectomy.

Effect of depression before breast cancer diagnosis on mortality among postmenopausal women.

BACKGROUND: Few previous studies investigating depression before the diagnosis of breast cancer and breast cancer-specific mortality have examined depression measured at more than 1 time point. This study investigated the effect of depression (combining depressive symptoms alone with antidepressant use) measured at 2 time points before the diagnosis of breast cancer on all-cause mortality and breast cancer-specific mortality among older postmenopausal women. METHODS: A large prospective cohort, the Women's Health Initiative, was used. The study included 3095 women with incident breast cancer who had measures of depressive symptoms and antidepressant use before their diagnosis at the baseline and at year 3. Multivariate Cox proportional hazards regression was used to estimate adjusted hazard ratios (HRs) between depression at the baseline, depression at year 3, and combinations of depression at these time points and all-cause mortality and breast cancer-specific mortality. RESULTS: Depression at year 3 before a breast cancer diagnosis was associated with higher all-cause mortality after adjustments for multiple covariates (HR, 1.35; 95% confidence interval [CI], 1.02-1.78). There was no statistically significant association of baseline depression and all-cause mortality or breast cancer-specific mortality whether or not depression was also present at year 3. In women with late-stage (regional- or distant-stage) breast cancer, newly developed depression at year 3 was significantly associated with both all-cause mortality (HR, 2.00; 95% CI, 1.13-3.56) and breast cancer-specific mortality (HR, 2.42; 95% CI, 1.24-4.70). CONCLUSIONS: Women with newly developed depression before the diagnosis of breast cancer had a modestly but significantly increased risk for death from any cause and for death from breast cancer at a late stage. Cancer 2017;123:3107-15. © 2017 American Cancer Society.