Dan R. Berlowitz

Inadequate management of blood pressure in a hypertensive population.

BACKGROUND Many patients with hypertension have inadequate control of their blood pressure. Improving the treatment of hypertension requires an understanding of the ways in which physicians manage this condition and a means of assessing the efficacy of this care. METHODS We examined the care of 800 hypertensive men at five Department of Veterans Affairs sites in New England over a two-year period. Their mean (+/-SD) age was 65.5+/-9.1 years, and the average duration of hypertension was 12.6+/-5.3 years. We used recursive partitioning to assess the probability that antihypertensive therapy would be increased at a given clinic visit using several variables. We then used these predictions to define the intensity of treatment for each patient during the study period, and we examined the associations between the intensity of treatment and the degree of control of blood pressure. RESULTS Approximately 40 percent of the patients had a blood pressure of > or =160/90 mm Hg despite an average of more than six hypertension-related visits per year. Increases in therapy occurred during 6.7 percent of visits. Characteristics associated with an increase in antihypertensive therapy included increased levels of both systolic and diastolic blood pressure at that visit (but not previous visits), a previous change in therapy, the presence of coronary artery disease, and a scheduled visit. Patients who had more intensive therapy had significantly (P<0.01) better control of blood pressure. During the two-year period, systolic blood pressure declined by 6.3 mm Hg among patients with the most intensive treatment, but increased by 4.8 mm Hg among the patients with the least intensive treatment. CONCLUSIONS In a selected population of older men, blood pressure was poorly controlled in many. Those who received more intensive medical therapy had better control. Many physicians are not aggressive enough in their approach to hypertension.

Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial

IMPORTANCE The appropriate treatment target for systolic blood pressure (SBP) in older patients with hypertension remains uncertain. OBJECTIVE To evaluate the effects of intensive (<120 mm Hg) compared with standard (<140 mm Hg) SBP targets in persons aged 75 years or older with hypertension but without diabetes. DESIGN, SETTING, AND PARTICIPANTS A multicenter, randomized clinical trial of patients aged 75 years or older who participated in the Systolic Blood Pressure Intervention Trial (SPRINT). Recruitment began on October 20, 2010, and follow-up ended on August 20, 2015. INTERVENTIONS Participants were randomized to an SBP target of less than 120 mm Hg (intensive treatment group, n = 1317) or an SBP target of less than 140 mm Hg (standard treatment group, n = 1319). MAIN OUTCOMES AND MEASURES The primary cardiovascular disease outcome was a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in a myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes. All-cause mortality was a secondary outcome. RESULTS Among 2636 participants (mean age, 79.9 years; 37.9% women), 2510 (95.2%) provided complete follow-up data. At a median follow-up of 3.14 years, there was a significantly lower rate of the primary composite outcome (102 events in the intensive treatment group vs 148 events in the standard treatment group; hazard ratio [HR], 0.66 [95% CI, 0.51-0.85]) and all-cause mortality (73 deaths vs 107 deaths, respectively; HR, 0.67 [95% CI, 0.49-0.91]). The overall rate of serious adverse events was not different between treatment groups (48.4% in the intensive treatment group vs 48.3% in the standard treatment group; HR, 0.99 [95% CI, 0.89-1.11]). Absolute rates of hypotension were 2.4% in the intensive treatment group vs 1.4% in the standard treatment group (HR, 1.71 [95% CI, 0.97-3.09]), 3.0% vs 2.4%, respectively, for syncope (HR, 1.23 [95% CI, 0.76-2.00]), 4.0% vs 2.7% for electrolyte abnormalities (HR, 1.51 [95% CI, 0.99-2.33]), 5.5% vs 4.0% for acute kidney injury (HR, 1.41 [95% CI, 0.98-2.04]), and 4.9% vs 5.5% for injurious falls (HR, 0.91 [95% CI, 0.65-1.29]). CONCLUSIONS AND RELEVANCE Among ambulatory adults aged 75 years or older, treating to an SBP target of less than 120 mm Hg compared with an SBP target of less than 140 mm Hg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01206062.

Risk factors for pressure sores. A comparison of cross-sectional and cohort-derived data.

The purpose of this study was to identify prospectively risk factors for pressure sores and to compare these results with a cross‐sectional analysis in the same population. Medical records on all admissions to a chronic care hospital over a 13‐month period were reviewed. Data on potential risk factors were abstracted from the initial history, physical examination, nursing assessment, and laboratory studies. Pressure sore status on admission and at three weeks was determined from a standardized form completed on all patients with a sore. The cross‐sectional analysis was performed by comparing patients with and without a pressure sore at the time of admission. The cohort analysis used patients initially without a pressure sore and monitored for a new sore at three weeks. Factors associated with pressure sores on univariate testing were entered into a stepwise logistic regression model. One hundred of the 301 admissions presented with a pressure sore. Factors significantly associated with the presence of a sore were altered level of consciousness (OR = 4.1), bed‐ or chair‐bound (OR = 2.4), impaired nutritional intake (OR = 1.9), and hypoalbuminemia (OR = 1.8 for 10 mg/mL decrease). Of the 185 patients without a pressure sore, 20 (10.8%) developed a sore. Factors significantly associated with the development of a new pressure sore were a history of cerebrovascular accident (OR = 5.0), bed‐ or chair‐bound (OR = 3.8), and impaired nutritional intake (OR = 2.8). Neither urinary nor fecal incontinence, nor the presence of hypoalbuminemia, was associated with sore development. We have prospectively identified risk factors for pressure sores. Although cross‐sectional studies may identify several of these risk factors, important differences exist. Cohort studies should be used in future research.

The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: The Systolic Blood Pressure Intervention Trial (SPRINT)

Background: High blood pressure is an important public health concern because it is highly prevalent and a risk factor for adverse health outcomes, including coronary heart disease, stroke, decompensated heart failure, chronic kidney disease, and decline in cognitive function. Observational studies show a progressive increase in risk associated with blood pressure above 115/75 mm Hg. Prior research has shown that reducing elevated systolic blood pressure lowers the risk of subsequent clinical complications from cardiovascular disease. However, the optimal systolic blood pressure to reduce blood pressure–related adverse outcomes is unclear, and the benefit of treating to a level of systolic blood pressure well below 140 mm Hg has not been proven in a large, definitive clinical trial. Purpose: To describe the design considerations of the Systolic Blood Pressure Intervention Trial (SPRINT) and the baseline characteristics of trial participants. Methods: The Systolic Blood Pressure Intervention Trial is a multicenter, randomized, controlled trial that compares two strategies for treating systolic blood pressure: one targets the standard target of <140 mm Hg, and the other targets a more intensive target of <120 mm Hg. Enrollment focused on volunteers of age ≥50 years (no upper limit) with an average baseline systolic blood pressure ≥130 mm Hg and evidence of cardiovascular disease, chronic kidney disease, 10-year Framingham cardiovascular disease risk score ≥15%, or age ≥75 years. The Systolic Blood Pressure Intervention Trial recruitment also targeted three pre-specified subgroups: participants with chronic kidney disease (estimated glomerular filtration rate <60 mL/min/1.73 m2), participants with a history of cardiovascular disease, and participants 75 years of age or older. The primary outcome is first the occurrence of a myocardial infarction (MI), acute coronary syndrome, stroke, heart failure, or cardiovascular disease death. Secondary outcomes include all-cause mortality, decline in kidney function or development of end-stage renal disease, incident dementia, decline in cognitive function, and small-vessel cerebral ischemic disease. Results: Between 8 November 2010 and 15 March 2013, Systolic Blood Pressure Intervention Trial recruited and randomized 9361 people at 102 clinics, including 3331 women, 2648 with chronic kidney disease, 1877 with a history of cardiovascular disease, 3962 minorities, and 2636 ≥75 years of age. Limitations: Although the overall recruitment target was met, the numbers recruited in the high-risk subgroups were lower than planned. Conclusions: The Systolic Blood Pressure Intervention Trial will provide important information on the risks and benefits of intensive blood pressure treatment targets in a diverse sample of high-risk participants, including those with prior cardiovascular disease, chronic kidney disease, and those aged ≥75 years.

Patient characteristics associated with oral anticoagulation control: results of the Veterans AffaiRs Study to Improve Anticoagulation (VARIA)

Summary.  Background: In patients receiving oral anticoagulation, improved control can reduce adverse outcomes such as stroke and major hemorrhage. However, little is known about patient‐level predictors of anticoagulation control. Objectives: To identify patient‐level predictors of oral anticoagulation control in the outpatient setting. Patients/Methods: We studied 124 619 patients who received oral anticoagulation from the Veterans Health Administration from October 2006 to September 2008. The outcome was anticoagulation control, summarized using percentage of time in therapeutic International Normalized Ratio range (TTR). Data were divided into inception (first 6 months of therapy; 39 447 patients) and experienced (any time thereafter; 104 505 patients). Patient‐level predictors of TTR were examined by multivariable regression. Results: Mean TTRs were 48% for inception management and 61% for experienced management. During inception, important predictors of TTR included hospitalizations (the expected TTR was 7.3% lower for those with two or more hospitalizations than for the non‐hospitalized), receipt of more medications (16 or more medications predicted a 4.3% lower than for patients with 0–7 medications), alcohol abuse (− 4.6%), cancer (− 3.1%), and bipolar disorder (− 2.9%). During the experienced period, important predictors of TTR included hospitalizations (four or more hospitalizations predicted 9.4% lower TTR), more medications (16 or more medications predicted 5.1% lower TTR), alcohol abuse (− 5.4%), female sex (− 2.9%), cancer (− 2.7%), dementia (− 2.6%), non‐alcohol substance abuse (− 2.4%), and chronic liver disease (− 2.3%). Conclusions: Some patients receiving oral anticoagulation therapy are more challenging to maintain within the therapeutic range than others. Our findings can be used to identify patients who require closer attention or innovative management strategies to maximize benefit and minimize harm from oral anticoagulation therapy.

Angioedema Incidence in US Veterans Initiating Angiotensin-Converting Enzyme Inhibitors

Angioedema is a rare but potentially serious complication of angiotensin-converting enzyme inhibitor (ACE) use. We conducted a study to estimate incidence of ACE-related angioedema and explore its determinants in a large racially diverse patient population. We used linked medical and pharmacy records to identify all patients in the US Veterans Affairs Health Care System from April 1999 through December 2000 who received first prescriptions for antihypertensive medications. We studied 195 192 ACE initiators and 399 889 patients initiating other antihypertensive medications (OAH). New angioedema was identified by diagnosis codes using methods validated in a national sample of 869 angioedema cases with confirmation for over 95% of cases. Overall, 0.20% of ACE initiators developed angioedema while on the medication and the incidence rate was 1.97 (1.77 to 2.18) cases per 1000 person years. This compares with a rate of 0.51 (0.43 to 0.59) in OAH initiators and the adjusted relative risk estimate was 3.56 (2.82 to 4.44). Fifty five percent of cases occurred within 90 days of first ACE use but risk remained elevated with prolonged use, even beyond 1 year. We estimate that 58.3% of angioedema in patients starting antihypertensives was related to ACE. We also found that angioedema rates were nearly 4-fold higher in blacks, 50% higher in women, and 12% lower in those with diabetes. This study provides a reliable estimate of angioedema incidence associated with ACE use in a diverse nontrial patient population, confirming that the incidence is low, but finding substantial variation by race, sex, and diabetes status.

Pressure-related deep tissue injury under intact skin and the current pressure ulcer staging systems.

OBJECTIVETo identify how current pressure ulcer staging systems and experts describe pressure-related deep tissue injury under intact skin in the published research literature. DESIGNA systematic review of published English-language literature as of November 2002 with the words decubitus or pressure ulcer(s) in the title. Additional relevant articles were identified by National Pressure Ulcer Advisory Panel members and were included in the analysis. An expert commentary was developed by iterative review by the National Pressure Ulcer Advisory Panel members. MAIN OUTCOME MEASURESManuscripts were reviewed for staging systems cited or described, definitions of Stage I pressure ulcers, and descriptions or definitions of pressure-related deep tissue injury under intact skin. MAIN RESULTSNinety-four relevant articles were identified. Seventy-three articles (78%) described a staging system, and 55 of 73 (75%) cited the staging definitions from Shea, the National Pressure Ulcer Advisory Panel, or the Agency for Health Care Policy and Research. The National Pressure Ulcer Advisory Panels staging definitions were the most frequently cited overall. Twenty-three articles (25%) included some discussion that could be interpreted as relevant to the topic of pressure-related deep tissue injury under intact skin; however, no consistency in definitions of Stage I pressure ulcers or terminology for pressure-related deep tissue injury under intact skin was found. CONCLUSIONSSeveral pressure ulcer staging systems are frequently cited, but none define pressure-related deep tissue injury under intact skin. The National Pressure Ulcer Advisory Panel recommends using the terms “pressure-related deep tissue injury under intact skin” or “deep tissue injury under intact skin” for describing these lesions and encourages investigators to establish the epidemiology and natural history of these lesions.

Self-Reported vs Administrative Race/Ethnicity Data and Study Results

Concerns about administrative data on race/ethnicity have led some researchers to consider self-reported race/ethnicity as superior.1–5 However, few studies have examined the differential impact of the source of race/ethnicity data, that is, observed or selfreported, on study outcomes. We investigated whether differences in reporting of race/ethnicity led to different results with regard to the use of one therapeutic dental procedure, root canal therapy.

Risk-Adjusted Percent Time in Therapeutic Range as a Quality Indicator for Outpatient Oral Anticoagulation Results of the Veterans Affairs Study To Improve Anticoagulation (VARIA)

Background— Oral anticoagulation is safer and more effective when patients receive high-quality care. However, there have been no prior efforts to measure quality of oral anticoagulation care or to risk adjust it to ensure credible comparisons. Our objective was to profile site performance in the Veterans Health Administration (VA) using risk-adjusted percent time in therapeutic range (TTR). Methods and Results— We included 124 551 patients who received outpatient oral anticoagulation from 100 VA sites of care for indications other than valvular heart disease from October 1, 2006, to September 30, 2008. We calculated TTR for each patient and mean TTR for each site of care. Expected TTR was calculated for each patient and each site based on the variables in the risk adjustment model, which included demographics, comorbid conditions, medications, and hospitalizations. Mean TTR for the entire sample was 58%. Site-observed TTR varied from 38% to 69% or from poor to excellent. Site-expected TTR varied from 54% to 62%. Site risk-adjusted performance ranged from 18% below expected to 12% above expected. Risk adjustment did not alter performance rankings for many sites, but for other sites, it made an important difference. For example, the site ranked 27th of 100 before risk adjustment was one of the best (risk-adjusted rank, 7). Risk-adjusted site rankings were consistent from year to year (correlation between years, 0.89). Conclusions— Risk-adjusted TTR can be used to profile the quality of outpatient oral anticoagulation in a large, integrated health system. This measure can serve as the basis for quality measurement and quality improvement efforts.

Quality improvement implementation in the nursing home

OBJECTIVE To examine quality improvement (QI) implementation in nursing homes, its association with organizational culture, and its effects on pressure ulcer care. DATA SOURCES/STUDY SETTING Primary data were collected from staff at 35 nursing homes maintained by the Department of Veterans Affairs (VA) on measures related to QI implementation and organizational culture. These data were combined with information obtained from abstractions of medical records and analyses of an existing database. STUDY DESIGN A cross-sectional analysis of the association among the different measures was performed. DATA COLLECTION/EXTRACTION METHODS Completed surveys containing information on QI implementation, organizational culture, employee satisfaction, and perceived adoption of guidelines were obtained from 1,065 nursing home staff. Adherence to best practices related to pressure ulcer prevention was abstracted from medical records. Risk-adjusted rates of pressure ulcer development were calculated from an administrative database. PRINCIPAL FINDINGS Nursing homes differed significantly (p<.001) in their extent of QI implementation with scores on this 1 to 5 scale ranging from 2.98 to 4.08. Quality improvement implementation was greater in those nursing homes with an organizational culture that emphasizes innovation and teamwork. Employees of nursing homes with a greater degree of QI implementation were more satisfied with their jobs (a 1-point increase in QI score was associated with a 0.83 increase on the 5-point satisfaction scale, p<.001) and were more likely to report adoption of pressure ulcer clinical guidelines (a 1-point increase in QI score was associated with a 28 percent increase in number of staff reporting adoption, p<.001). No significant association was found, though, between QI implementation and either adherence to guideline recommendations as abstracted from records or the rate of pressure ulcer development. CONCLUSIONS Quality improvement implementation is most likely to be successful in those VA nursing homes with an underlying culture that promotes innovation. While QI implementation may result in staff who are more satisfied with their jobs and who believe they are providing better care, associations with improved care are uncertain.