Use of Different Blood Pressure Thresholds to Reduce the Number of Home Blood Pressure Monitoring Days Needed for Detecting Hypertension.

BACKGROUND: Home blood pressure (BP) monitoring over a 7-day period is recommended to confirm the diagnosis of hypertension. METHODS: We determined upper and lower home BP thresholds with >90% positive predictive value and >90% negative predictive value using 1 to 6 days of monitoring to identify high home BP (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg) based on 7 days of home BP monitoring. The sample included 361 adults from the Improving the Detection of Hypertension Study who were not taking antihypertensive medication. We used two 7-day periods, at least 3 days apart, the first being a sampling period and the second a reference period. For each number of days in the sampling period, we determined the percentage of participants who had a high likelihood of having (>90% positive predictive value) or not having (>90% negative predictive value) high BP and would not need to continue home BP monitoring. Only the participants in an uncertain category (ie, positive predictive value ≤90% and negative predictive value ≤90%) after each day were carried forward to the next day of home BP monitoring. RESULTS: Of the 361 participants (mean [SD] age of 41.3 [13.2] years; 60.4% women), 38.0% had high home BP during the reference period. There were 63.7%, 17.1%, 10.5%, 3.3%, 3.6%, and 1.4% participants who would not need to continue after 1, 2, 3, 4, 5, and 6 days of monitoring. CONCLUSIONS: In most people, high home BP can be identified or excluded with a high degree of confidence with 3 days or less of monitoring.

Uptake of non-statin lipid-lowering therapies for secondary prevention in community practice.

Nearly two-thirds of individuals with atherosclerotic cardiovascular disease (ASCVD) do not reach target low-density lipoprotein cholesterol despite statin therapy. Three novel lipid-lowering therapies have proven to further reduce ASCVD beyond statins, including: ezetimibe, proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), and icosapent ethyl. This study evaluated the use of these three agents in 728,423 individuals with ASCVD from 89 US health systems from 01/2018 through 03/2021 using the electronic health record. As of 2021, only 6.0% of ASCVD patients were on ezetimibe, 1.6% were on a PCSK9i, and 1.3% on icosapent ethyl, with utilization only marginally increasing over the study period. Addressing the underutilization of non-statin lipid-lowering therapy for secondary prevention is a critical step in improving the treatment gap of patients with residual risk of ASCVD.

SAMSON and the Nocebo Effect: Management of Statin Intolerance.

PURPOSE OF REVIEW: Statins are essential medications in the treatment of atherosclerotic cardiovascular disease; however, remain widely underutilized in large part due to concerns regarding adverse side effects. We describe the role of the nocebo effect in the perception of statin intolerance and provide management recommendations utilizing both statin and non-statin lipid-lowering therapies. RECENT FINDINGS: The recent Self-Assessment Method for Statin side-effects Or Nocebo (SAMSON) trial demonstrated that 90% of adverse symptoms related to statins were also elicited by placebo, a powerful demonstration of the nocebo effect. Importantly, 50% of the study patients were able to successfully reinitiate statin therapy. Statin intolerance is common and can often be managed with expectation setting and adjustment of doses and/or dosing regimens. In those who remain unable to tolerate statins, numerous alternative lipid-lowering therapies exist with strong safety and efficacy profiles.

Cuffless Blood Pressure Devices.

Hypertension is associated with more end-organ damage, cardiovascular events, and disability-adjusted life years lost in the United States compared with all other modifiable risk factors. Several guidelines and scientific statements now endorse the use of out-of-office blood pressure (BP) monitoring with ambulatory BP monitoring or home BP monitoring to confirm or exclude hypertension status based on office BP measurement. Current ambulatory or home BP monitoring devices have been reliant on the placement of a BP cuff, typically on the upper arm, to measure BP. There are numerous limitations to this approach. Cuff-based BP may not be well-tolerated for repeated measurements as is utilized with ambulatory BP monitoring. Furthermore, improper technique, including incorrect cuff placement or use of the wrong cuff size, may lead to erroneous readings, affecting diagnosis and management of hypertension. Compared with devices that utilize a cuff, cuffless BP devices may overcome challenges related to technique, tolerability, and overall utility in the outpatient setting. However, cuffless devices have several potential limitations that limit its routine use for the diagnosis and management of hypertension. The review discusses the different approaches for determining BP using various cuffless devices including engineering aspects of cuffless device technologies, validation protocols to test accuracy of cuffless devices, potential barriers to widespread implementation, and future areas of research. This review is intended for the clinicians who utilize out-of-office BP monitoring for the diagnosis and management of hypertension.

Gaps and Disparities in Primary Prevention Statin Prescription During Outpatient Care.

The 2018 American College of Cardiology/American Heart Association Guideline on the Management of Blood Cholesterol recommends statin therapy for eligible patients to reduce the risk of atherosclerotic cardiovascular disease (ASCVD). We extracted electronic health record data for patients with at least one primary care or cardiology visit between October 2018 and January 2020 at an urban, academic medical center in New York City. Clinical and demographic data were used to identify patients eligible for primary prevention statin therapy. Statin prescription status was extracted from the electronic health record, and multivariate logistic regression was used to assess the association between statin prescription and age, gender, race, ethnicity, and other clinical and demographic covariables. In 7,550 patients eligible for primary prevention statin therapy, 3,994 (52.9%) were prescribed statins on at least 1 visit. Statin prescription was highest in patients with diabetes mellitus (73.6%) and with a 10-year ASCVD risk ≥20% (60.6%) and was lowest for those with a 10-year ASCVD risk between 5% and 7.5% (18.7%). Compared with those never prescribed statins, patients prescribed statins were less likely to be women, mainly driven by lower statin prescription rates for women with diabetes. In a fully adjusted model, women remained less likely to be prescribed statin therapy (adjusted odds ratios 0.79, 95% confidence interval 0.71 to 0.88). In conclusion, primary prevention statin therapy remains underutilized.

The patient journey with proprotein convertase subtilisin/kexin type 9 inhibitors in community practice.

BACKGROUND: Trials have demonstrated that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are effective as an adjunct to statin therapy, but access and cost issues have limited their use in community practice. OBJECTIVE: The aim of the study was to better understand patients' experiences when trying to obtain, fill, and use PCSK9 inhibitor therapy in community practice. METHODS: We conducted a patient survey to evaluate patient experiences with PCSK9 inhibitors including medication initiation, indication for treatment, insurance approval status, medication persistence, and reason for discontinuation. The survey was emailed to 4740 adults who used a patient access support program. RESULTS: Overall, 1327 of 4740 adults completed the survey (28.0% response rate). Of those, 75.0% were aged >60 years, 52.8% were male, and 92.4% were White. At the time of PCSK9 inhibitor prescription, 70.2% were not on a statin (with 84.4% of those not on a statin reporting statin intolerance). Overall, 74.6% of patients found the drug approval process to be "somewhat" or "very" burdensome. Among n = 1216 patients who initiated treatment, 33.7% discontinued by the time of the survey, with 50.0% taking the drug for 1 to 6 months. Patient out-of-pocket costs were the leading reported reason for discontinuation. CONCLUSIONS: Most PCSK9 inhibitor users in community practice were not on a statin, presumably because of statin intolerance. The drug approval process and costs continue to be strong reasons for lower initiation of PCSK9 agents, as well as higher discontinuation rates.

Patient-Reported Reasons for Declining or Discontinuing Statin Therapy: Insights From the PALM Registry.

Background Many adults eligible for statin therapy for cardiovascular disease prevention are untreated. Our objective was to investigate patient-reported reasons for statin underutilization, including noninitiation, refusal, and discontinuation. Methods and Results This study included the 5693 adults recommended for statin therapy in the PALM (Patient and Provider Assessment of Lipid Management) registry. Patient surveys evaluated statin experience, reasons for declining or discontinuing statins, and beliefs about statins and cardiovascular disease risk. Overall, 1511 of 5693 adults (26.5%) were not on treatment. Of those not on a statin, 894 (59.2%) reported never being offered a statin, 153 (10.1%) declined a statin, and 464 (30.7%) had discontinued therapy. Women (relative risk: 1.22), black adults (relative risk: 1.48), and those without insurance (relative risk: 1.38) were most likely to report never being offered a statin. Fear of side effects and perceived side effects were the most common reasons cited for declining or discontinuing a statin. Compared with statin users, those who declined or discontinued statins were less likely to believe statins are safe (70.4% of current users vs. 36.9% of those who declined and 37.4% of those who discontinued) or effective (86.3%, 67.4%, and 69.1%, respectively). Willingness to take a statin was high; 67.7% of those never offered and 59.7% of patients who discontinued a statin would consider initiating or retrying a statin. Conclusions More than half of patients eligible for statin therapy but not on treatment reported never being offered one by their doctor. Concern about side effects was the leading reason for statin refusal or discontinuation. Many patients were willing to reconsider statin therapy if offered.

Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010-2016: A Systematic Literature Review.

BACKGROUND: The use of mobile devices in clinical research has advanced substantially in recent years due to the rapid pace of technology development. With an overall aim of informing the future use of mobile devices in interventional clinical research to measure primary outcomes, we conducted a systematic review of the use of and clinical outcomes measured by mobile devices (mobile outcomes) in observational and interventional clinical research. METHOD: We conducted a PubMed search using a range of search terms to retrieve peer-reviewed articles on clinical research published between January 2010 and May 2016 in which mobile devices were used to measure study outcomes. We screened each publication for specific inclusion and exclusion criteria. We then identified and qualitatively summarized the use of mobile outcome assessments in clinical research, including the type and design of the study, therapeutic focus, type of mobile device(s) used, and specific mobile outcomes reported. RESULTS: The search retrieved 2,530 potential articles of interest. After screening, 88 publications remained. Twenty-five percent of the publications (n = 22) described mobile outcomes used in interventional research, and the rest (n = 66) described observational clinical research. Thirteen therapeutic areas were represented. Five categories of mobile devices were identified: (1) inertial sensors, (2) biosensors, (3) pressure sensors and walkways, (4) medication adherence monitors, and (5) location monitors; inertial sensors/accelerometers were most common (reported in 86% of the publications). Among the variety of mobile outcomes, various assessments of physical activity were most common (reported in 74% of the publications). Other mobile outcomes included assessments of sleep, mobility, and pill adherence, as well as biomarkers assessed using a mobile device, including cardiac measures, glucose, gastric reflux, respiratory measures, and intensity of head-related injury. CONCLUSION: Mobile devices are being widely used in clinical research to assess outcomes, although their use in interventional research to assess therapeutic effectiveness is limited. For mobile devices to be used more frequently in pivotal interventional research - such as trials informing regulatory decision-making - more focus should be placed on: (1) consolidating the evidence supporting the clinical meaningfulness of specific mobile outcomes, and (2) standardizing the use of mobile devices in clinical research to measure specific mobile outcomes (e.g., data capture frequencies, placement of device). To that aim, this manuscript offers a broad overview of the various mobile outcome assessments currently used in observational and interventional research, and categorizes and consolidates this information for researchers interested in using mobile devices to assess outcomes in interventional research.

Trends in medical error education: are we failing our residents?

BACKGROUND: The Institute of Medicine has called for physician education as a key step in medical error prevention. In our 2002 national survey, pediatric resident education about medical error prevention was sporadic. We sought to describe the amount and type of pediatric resident training about medical errors and to assess the change in training since 2002. METHODS: We surveyed a national sample of 50 pediatric chief residents randomly selected from the 198 Accreditation Council for Graduate Medical Education-accredited residency programs from August to November 2010. The 31-item telephone survey was developed from the 2002 survey, with the addition of 10 items about electronic learning and resident quality improvement projects. The survey included 4 domains: current patient safety curriculum, chief resident knowledge, learning from medical errors, and demographics. RESULTS: We phoned 55 chief residents and contacted 51. Fifty participated (90% participation rate). Ninety-four percent of chief residents stated that their program had a formalized curriculum to discuss medical errors, compared to only 50% (P < .001) in 2002. Ninety-six percent understood that the response to a medical error should be systemic change. The primary method for educating residents about medical error reported was informal teaching. Ninety-two percent reported never or rarely discussing medical error in an outpatient setting. Seventy-four percent of chief residents reported that they never or rarely learn from an error made by an attending physician, and 50% never or rarely learned from an error made by a fellow resident. CONCLUSIONS: Although resident education about medical errors has improved since 2002, opportunities to model learning from mistakes are frequently missed.