Gbenga Ogedegbe

Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium.

Treatment fidelity refers to the methodological strategies used to monitor and enhance the reliability and validity of behavioral interventions. This article describes a multisite effort by the Treatment Fidelity Workgroup of the National Institutes of Health Behavior Change Consortium (BCC) to identify treatment fidelity concepts and strategies in health behavior intervention research. The work group reviewed treatment fidelity practices in the research literature, identified techniques used within the BCC, and developed recommendations for incorporating these practices more consistently. The recommendations cover study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. Funding agencies, reviewers, and journal editors are encouraged to make treatment fidelity a standard part of the conduct and evaluation of health behavior intervention research.

European Society of Hypertension Position Paper on Ambulatory Blood Pressure Monitoring

Ambulatory blood pressure monitoring (ABPM) is being used increasingly in both clinical practice and hypertension research. Although there are many guidelines that emphasize the indications for ABPM, there is no comprehensive guideline dealing with all aspects of the technique. It was agreed at a consensus meeting on ABPM in Milan in 2011 that the 34 attendees should prepare a comprehensive position paper on the scientific evidence for ABPM.This position paper considers the historical background, the advantages and limitations of ABPM, the threshold levels for practice, and the cost-effectiveness of the technique. It examines the need for selecting an appropriate device, the accuracy of devices, the additional information and indices that ABPM devices may provide, and the software requirements.At a practical level, the paper details the requirements for using ABPM in clinical practice, editing considerations, the number of measurements required, and the circumstances, such as obesity and arrhythmias, when particular care needs to be taken when using ABPM.The clinical indications for ABPM, among which white-coat phenomena, masked hypertension, and nocturnal hypertension appear to be prominent, are outlined in detail along with special considerations that apply in certain clinical circumstances, such as childhood, the elderly and pregnancy, and in cardiovascular illness, examples being stroke and chronic renal disease, and the place of home measurement of blood pressure in relation to ABPM is appraised.The role of ABPM in research circumstances, such as pharmacological trials and in the prediction of outcome in epidemiological studies is examined and finally the implementation of ABPM in practice is considered in relation to the issue of reimbursement in different countries, the provision of the technique by primary care practices, hospital clinics and pharmacies, and the growing role of registries of ABPM in many countries.

Call to action on use and reimbursement for home blood pressure monitoring: a joint scientific statement from the American Heart Association, American Society Of Hypertension, and Preventive Cardiovascular Nurses Association.

Home blood pressure monitoring (HBPM) overcomes many of the limitations of traditional office blood pressure (BP) measurement and is both cheaper and easier to perform than ambulatory BP monitoring. Monitors that use the oscillometric method are currently available that are accurate, reliable, easy to use, and relatively inexpensive. An increasing number of patients are using them regularly to check their BP at home, but although this has been endorsed by national and international guidelines, detailed recommendations for their use have been lacking. There is a rapidly growing literature showing that measurements taken by patients at home are often lower than readings taken in the office and closer to the average BP recorded by 24-hour ambulatory monitors, which is the BP that best predicts cardiovascular risk. Because of the larger numbers of readings that can be taken by HBPM than in the office and the elimination of the white-coat effect (the increase of BP during an office visit), home readings are more reproducible than office readings and show better correlations with measures of target organ damage. In addition, prospective studies that have used multiple home readings to express the true BP have found that home BP predicts risk better than office BP (Class IIa; Level of Evidence A). This call-to-action article makes the following recommendations: (1) It is recommended that HBPM should become a routine component of BP measurement in the majority of patients with known or suspected hypertension; (2) Patients should be advised to purchase oscillometric monitors that measure BP on the upper arm with an appropriate cuff size and that have been shown to be accurate according to standard international protocols. They should be shown how to use them by their healthcare providers; (3) Two to 3 readings should be taken while the subject is resting in the seated position, both in the morning and at night, over a period of 1 week. A total of >or=12 readings are recommended for making clinical decisions; (4) HBPM is indicated in patients with newly diagnosed or suspected hypertension, in whom it may distinguish between white-coat and sustained hypertension. If the results are equivocal, ambulatory BP monitoring may help to establish the diagnosis; (5) In patients with prehypertension, HBPM may be useful for detecting masked hypertension; (6) HBPM is recommended for evaluating the response to any type of antihypertensive treatment and may improve adherence; (7) The target HBPM goal for treatment is <135/85 mm Hg or <130/80 mm Hg in high-risk patients; (8) HBPM is useful in the elderly, in whom both BP variability and the white-coat effect are increased; (9) HBPM is of value in patients with diabetes, in whom tight BP control is of paramount importance; (10) Other populations in whom HBPM may be beneficial include pregnant women, children, and patients with kidney disease; and (11) HBPM has the potential to improve the quality of care while reducing costs and should be reimbursed.

A New Tool to Assess Treatment Fidelity and Evaluation of Treatment Fidelity across 10 Years of Health Behavior Research.

A. Bellg, B. Borrelli, et al. (2004) previously developed a framework that consisted of strategies to enhance treatment fidelity of health behavior interventions. The present study used this framework to (a) develop a measure of treatment fidelity and (b) use the measure to evaluate treatment fidelity in articles published in 5 journals over 10 years. Three hundred forty-two articles met inclusion criteria; 22% reported strategies to maintain provider skills, 27% reported checking adherence to protocol, 35% reported using a treatment manual, 54% reported using none of these strategies, and 12% reported using all 3 strategies. The mean proportion adherence to treatment fidelity strategies was .55; 15.5% of articles achieved greater than or equal to .80. This tool may be useful for researchers, grant reviewers, and editors planning and evaluating trials.

Evidence Supporting a Systolic Blood Pressure Goal of Less Than 150 mm Hg in Patients Aged 60 Years or Older: The Minority View

The 2014 Evidence-Based Guideline for the Management of High Blood Pressure In Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) recommends several major changes from the JNC 7 report (1, 2). The 2014 guideline is based on a systematic review of randomized, controlled trials (RCTs) by a multidisciplinary panel using a process informed by Institute of Medicine recommendations for guideline development (3). Although there was almost unanimous agreement on nearly all recommendations, a minority of the panel (the authors of this commentary) disagreed with the recommendation to increase the target systolic blood pressure (SBP) from 140 to 150 mm Hg in persons aged 60 years or older without diabetes mellitus (DM) or chronic kidney disease (CKD). This target guides both the initiation of therapy and treatment goals. Although this issue has major clinical and public health implications, the guideline only briefly summarized the concerns underlying the minority opinion to maintain the target of less than 140 mm Hg. The Institute of Medicine recommendation for guideline development encourages guidelines to provide a description and explanation of any differences of opinion regarding the recommendation (3). This summarizes the evidence and rationale underlying the minority opinion to maintain the SBP target of 140 mm Hg or lower in persons aged 60 years or older until there is greater certainty of the risks and benefits of a higher target. First, increasing the target will probably reduce the intensity of antihypertensive treatment in a large population at high risk for cardiovascular disease (CVD) (Table 1). The higher SBP goal would apply to some of the groups at highest cardiovascular risk, such as African Americans, hypertensive patients with multiple CVD risk factors other than DM or CKD, and those with clinical CVD. Second, the evidence supporting increasing the SBP target from 140 to 150 mm Hg in persons aged 60 years or older was insufficient and inconsistent with the evidence supporting the panels recommendations for an SBP target of less than 140 mm Hg in persons younger than 60 years and those aged 60 years or older with DM or CKD. Third, the higher SBP goal in individuals aged 60 years or older may reverse the decades-long decline in CVD, especially stroke mortality (4). In the absence of definitive evidence defining the optimum SBP target, observational studies and RCT data that the panel did not systematically review more strongly support the SBP goal of less than 140 mm Hg, especially in high-risk individuals. Other recent guideline groups reviewing similar evidence have recommended a goal of less than 140 mm Hg, particularly in persons aged 80 years or younger (59). Table 1. U.S. Cardiovascular Disease Death Rates for Persons Younger and Older Than 65 y Persons Aged 60 Years or Older With Hypertension and SBP Controlled to 140 mm Hg or Lower More than half of the 72 million persons with hypertension in the United States are aged 60 years or older (10, 11). Among these individuals, the 2014 guideline recommends the SBP goal of 140 mm Hg or lower only for those with DM and those younger than 70 years with CKD (2). Although the prevalence of hypertension in this age group (65% to 67%) did not change between 1999 and 2010, the percentage with adequate blood pressure control increased from 27.4% (19992000) to 50.5% (20112012), with 82.2% now receiving antihypertensive medications (10, 12). Data from NHANES (National Health and Nutrition Examination Survey) from 2001 to 2008 show that among treated and untreated hypertensive adults aged 60 years or older, median SBPs were 136 mm Hg and 152 mm Hg, respectively (13), and SBPs have been decreasing in this age group over the past 5 decades (Figure) (4). Thus, a target of less than 150 mm Hg would likely increase blood pressures in the treated hypertensive population and would suggest that nearly half of the untreated hypertensive patients in this age range should remain untreated. The large population at high risk for CVD, with most currently at an SBP of 140 mm Hg or lower, creates concern that a higher SBP target will adversely affect public health. Figure. Smoothed weighted frequency distribution, median, and 90th percentile of systolic blood pressure for persons aged 60 to 74 y: United States, 19592010. Reproduced from Lackland and colleagues (4). NHANES = National Health and Nutrition Examination Survey; NHES = National Health Examination Survey. High Risk in Persons With the Higher Goal Age substantially increases risk for cardiovascular events (Table 1), so differences in cardiovascular risk do not justify different targets for patients older and younger than 60 years. The risk range for white and African American men aged 60 years is 9% to 30%, depending on risk factor profile. For men of both ethnicities who are aged 70 years or older and have SBP controlled to 140 mm Hg, even without clinical CVD or DM, the 10-year risk exceeds 20% (14). Thus, on the basis of absolute risk, using an age threshold of 60 years to define eligibility for less aggressive treatment lacks consistency. Persons aged 60 to 79 years are at higher risk than those who are younger, even if the younger persons have DM. Insufficient Evidence for Differential Hypertension Treatment Benefit for Patients Older and Younger Than 60 Years The 2014 guideline panel failed to identify evidence of differential benefits or harms of treatment using an SBP goal of 140 mm Hg with an age threshold of 60 years. There is little RCT evidence of risk or benefit in treating persons younger than 60 years to this target, except in those with diastolic hypertension. The guideline indicates that no qualifying evidence was found comparing an SBP less than 140 mm Hg to any other SBP goal for persons younger than 60 years (2). However, in persons aged 60 years or older, the SHEP (Systolic Hypertension in the Elderly Program) trial showed benefit of treating hypertension to an SBP goal between 140 and 145 mm Hg (Table 2) (15). HYVET (Hypertension in the Very Elderly Trial) found a benefit of an SBP target of less than 150 mm Hg on health outcomes, including mortality in persons aged 80 years or older (16). Patients in the HYVET treatment group achieved an SBP of 144 mm Hg at 2 years compared with 159 mm Hg in the control group, and blood pressures continued to decrease in both groups until the end of the trial. Therefore, HYVET and the SHEP trial provide evidence that reducing SBP to around 140 mm Hg has substantial benefit without major harm in older persons. Thus, the best evidence available for an SBP target around 140 mm Hg, which meets the guideline RCT criteria, is in persons older than 60 years. The lack of benefit seen in 2 Japanese trials in older individuals (JATOS [Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients] [17] and the VALISH [Valsartan in Elderly Isolated Systolic Hypertension] trial [18]) was cited by some to rationalize the higher SBP target, but these trials were underpowered (Table 2). The SHEP trial and HYVET together reported 365 strokes and more than 285 coronary heart disease events, whereas JATOS and the VALISH trial only had a combined total of 125 strokes and 67 coronary heart disease events. In addition, the much larger FEVER (Felodipine Event Reduction) trial (19) did not meet criteria for inclusion in the panels deliberation (Table 2). This trial, which was conducted in a Chinese population (age range, 50 to 79 years; mean age, 62 years), reported a significant 27% reduction in its primary outcome, as well as significant reductions in all CVD, total mortality, coronary heart disease, and heart failure in patients treated to an SBP of 137 mm Hg with a thiazide diureticcalcium-channel blocker combination versus 143 mm Hg with a thiazide diuretic plus placebo (19). Table 2. Trials Comparing Different Systolic Blood Pressure Thresholds In addition, generalizability of the Japanese trials to other populations of patients older than 60 years, such as African Americans, is uncertain. African Americans are at highest risk for all complications of hypertension and are historically undertreated. Thus, we believe that recommending less aggressive targets in this or other high-risk populations requires stronger justification than the guideline cites. Three recent guidelines from other countries have concluded that the appropriate cut point for an age-related differential SBP goal is 80 years or older (57). We agree that this higher treatment target in frail hypertensive patients aged 80 years or older better reflects existing evidence. Safety and Adverse Event Risk in Hypertensive Patients Aged 60 Years or Older Despite the limited number of end points in JATOS and the VALISH trial, their size and duration provide evidence of safety of the SBP target of less than 140 mm Hg. The VALISH investigators concluded that this target was safe in relatively healthy patients aged 70 years or older with isolated systolic hypertension (18). In JATOS, adverse events requiring treatment discontinuation were reported in only 36 patients, with no differences in discontinuation rate between groups (17). This evidence and the favorable results at slightly higher blood pressures in the SHEP trial and HYVET provide reassurance of the safety of an SBP goal of less than 140 mm Hg in older, nonfrail persons. Other Trial Evidence of Benefit of Treatment at an SBP of 140 mm Hg or Lower Results of the SPS3 (Secondary Prevention of Small Subcortical Strokes) trial indicated that an SBP target of less than 130 mm Hg versus 144 mm Hg in 3020 patients (mean age, 63 years) reduced subsequent strokes by 19% (P= 0.08) and hemorrhagic strokes by nearly 50% (P< 0.01) (20). Of note, the FEVER trial reported a 44% (P< 0.001) reduction in all strokes in a subgroup analysis of patients older than 65 years (17). Finally, 2 meta-analyses supported

European Society of Hypertension practice guidelines for ambulatory blood pressure monitoring

Given the increasing use of ambulatory blood pressure monitoring (ABPM) in both clinical practice and hypertension research, a group of scientists, participating in the European Society of Hypertension Working Group on blood pressure monitoring and cardiovascular variability, in year 2013 published a comprehensive position paper dealing with all aspects of the technique, based on the available scientific evidence for ABPM. The present work represents an updated schematic summary of the most important aspects related to the use of ABPM in daily practice, and is aimed at providing recommendations for proper use of this technique in a clinical setting by both specialists and practicing physicians. The present article details the requirements and the methodological issues to be addressed for using ABPM in clinical practice, The clinical indications for ABPM suggested by the available studies, among which white-coat phenomena, masked hypertension, and nocturnal hypertension, are outlined in detail, and the place of home measurement of blood pressure in relation to ABPM is discussed. The role of ABPM in pharmacological, epidemiological, and clinical research is also briefly mentioned. Finally, the implementation of ABPM in practice is considered in relation to the situation of different countries with regard to the reimbursement and the availability of ABPM in primary care practices, hospital clinics, and pharmacies.

Beyond Medications and Diet: Alternative Approaches to Lowering Blood Pressure: A Scientific Statement From the American Heart Association

Many antihypertensive medications and lifestyle changes are proven to reduce blood pressure. Over the past few decades, numerous additional modalities have been evaluated in regard to their potential blood pressure–lowering abilities. However, these nondietary, nondrug treatments, collectively called alternative approaches, have generally undergone fewer and less rigorous trials. This American Heart Association scientific statement aims to summarize the blood pressure–lowering efficacy of several alternative approaches and to provide a class of recommendation for their implementation in clinical practice based on the available level of evidence from the published literature. Among behavioral therapies, Transcendental Meditation (Class IIB, Level of Evidence B), other meditation techniques (Class III, Level of Evidence C), yoga (Class III, Level of Evidence C), other relaxation therapies (Class III, Level of Evidence B), and biofeedback approaches (Class IIB, Level of Evidence B) generally had modest, mixed, or no consistent evidence demonstrating their efficacy. Between the noninvasive procedures and devices evaluated, device-guided breathing (Class IIA, Level of Evidence B) had greater support than acupuncture (Class III, Level of Evidence B). Exercise-based regimens, including aerobic (Class I, Level of Evidence A), dynamic resistance (Class IIA, Level of Evidence B), and isometric handgrip (Class IIB, Level of Evidence C) modalities, had relatively stronger supporting evidence. It is the consensus of the writing group that it is reasonable for all individuals with blood pressure levels >120/80 mm Hg to consider trials of alternative approaches as adjuvant methods to help lower blood pressure when clinically appropriate. A suggested management algorithm is provided, along with recommendations for prioritizing the use of the individual approaches in clinical practice based on their level of evidence for blood pressure lowering, risk-to-benefit ratio, potential ancillary health benefits, and practicality in a real-world setting. Finally, recommendations for future research priorities are outlined.

Call to Action on Use and Reimbursement for Home Blood Pressure Monitoring: Executive Summary

Home blood pressure monitoring (HBPM) overcomes many of the limitations of traditional office blood pressure (BP) measurement and is both cheaper and easier to perform than ambulatory BP monitoring. Monitors that use the oscillometric method are currently available that are accurate, reliable, easy to use, and relatively inexpensive. An increasing number of patients are using them regularly to check their BP at home, but although this has been endorsed by national and international guidelines, detailed recommendations for their use have been lacking. There is a rapidly growing literature showing that measurements taken by patients at home are often lower than readings taken in the office and closer to the average BP recorded by 24-hour ambulatory monitors, which is the BP that best predicts cardiovascular risk. Because of the larger numbers of readings that can be taken by HBPM than in the office and the elimination of the white-coat effect (the increase of BP during an office visit), home readings are more reproducible than office readings and show better correlations with measures of target organ damage. In addition, prospective studies that have used multiple home readings to express the true BP have found that home BP predicts risk better than office BP (class IIa; level of evidence A). This call-to-action article makes the following recommendations: (1) It is recommended that HBPM should become a routine component of BP measurement in the majority of patients with known or suspected hypertension; (2) Patients should be advised to purchase oscillometric monitors that measure BP on the upper arm with an appropriate cuff size and that have been shown to be accurate according to standard international protocols. They should be shown how to use them by their healthcare providers; (3) Two to 3 readings should be taken while the subject is resting in the seated position, both in the morning and at night, over a period of 1 week. A total of >or=12 readings are recommended for making clinical decisions; (4) HBPM is indicated in patients with newly diagnosed or suspected hypertension, in whom it may distinguish between white-coat and sustained hypertension. If the results are equivocal, ambulatory BP monitoring may help to establish the diagnosis; (5) In patients with prehypertension, HBPM may be useful for detecting masked hypertension; (6) HBPM is recommended for evaluating the response to any type of antihypertensive treatment and may improve adherence; (7) The target HBPM goal for treatment is <135/85 mm Hg or <130/80 mm Hg in high-risk patients; (8) HBPM is useful in the elderly, in whom both BP variability and the white-coat effect are increased; (9) HBPM is of value in patients with diabetes, in whom tight BP control is of paramount importance; (10) Other populations in whom HBPM may be beneficial include pregnant women, children, and patients with kidney disease; and (11) HBPM has the potential to improve the quality of care while reducing costs and should be reimbursed.

Principles and techniques of blood pressure measurement

Although the mercury sphygmomanometer is widely regarded as the gold standard for office blood pressure measurement, the ban on use of mercury devices continues to diminish their role in office and hospital settings. To date, mercury devices have largely been phased out in United States hospitals. This situation has led to the proliferation of nonmercury devices and has changed (probably forever) the preferable modality of blood pressure measurement in clinic and hospital settings. In this article, the basic techniques of blood pressure measurement and the technical issues associated with measurements in clinical practice are discussed. The devices currently available for hospital and clinic measurements and their important sources of error are presented. Practical advice is given on how the different devices and measurement techniques should be used. Blood pressure measurements in different circumstances and in special populations such as infants, children, pregnant women, elderly persons, and obese subjects are discussed.

A Practice-Based Trial of Motivational Interviewing and Adherence in Hypertensive African Americans

BACKGROUND Poor medication adherence is a significant problem in hypertensive African Americans. Although motivational interviewing (MINT) is effective for adoption and maintenance of health behaviors in patients with chronic diseases, its effect on medication adherence remains untested in this population. METHODS This randomized controlled trial tested the effect of a practice-based MINT counseling vs. usual care (UC) on medication adherence and blood pressure (BP) in 190 hypertensive African Americans (88% women; mean age 54 years). Patients were recruited from two community-based primary care practices in New York City. The primary outcome was adherence measured by electronic pill monitors; the secondary outcome was within-patient change in office BP from baseline to 12 months. RESULTS Baseline adherence was similar in both groups (56.2 and 56.6% for MINT and UC, respectively, P = 0.94). Based on intent-to-treat analysis using mixed-effects regression, a significant time x group interaction with model-predicted posttreatment adherence rates of 43 and 57% were found in the UC and MINT groups, respectively (P = 0.027), with a between-group difference of 14% (95% confidence interval, -0.2 to -27%). The between-group difference in systolic and diastolic BP was -6.1 mm Hg (P = 0.065) and -1.4 mm Hg (P = 0.465), respectively, in favor of the MINT group. CONCLUSIONS A practice-based MINT counseling led to steady maintenance of medication adherence over time, compared to significant decline in adherence for UC patients. This effect was associated with a modest, nonsignificant trend toward a net reduction in systolic BP in favor of the MINT group.