VA/DoD CLINICAL PRACTICE GUIDELINE FOR THE DIAGNOSIS AND MANAGEMENT OF HYPERTENSION IN THE PRIMARY CARE SETTING Department of Veterans Affairs Department of Defense QUALIFYING STATEMENTS The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision making. They are not intended to define a standard of care and should not be construed as one. Neither should they be interpreted as prescribing an exclusive course of management. This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological evidence. Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical relationships between various care options and health outcomes while rating both the quality of the evidence and the strength of the recommendation. Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation. These guidelines are not intended to represent Department of Veterans Affairs or TRICARE policy. Further, inclusion of recommendations for specific testing and/or therapeutic interventions within these guidelines does not guarantee coverage of civilian sector care. Additional information on current TRICARE benefits may be found at www.tricare.mil or by contacting your regional TRICARE Managed Care Support Contractor. Prepared by: The Diagnosis and Management of Hypertension in the Primary Care Setting Work Group With support from: The Office of Quality, Safety and Value, VA, Washington, DC & Office of Evidence Based Practice, U.S. Army Medical Command Based on evidence reviewed through March 2019 Table of Contents A. Epidemiology and Impact in the General Population 8 B. Hypertension in the Department of Defense and the Department of Veterans Affairs III. About this Clinical Practice Guideline 9 a. Grading Recommendations 10 b. Reconciling 2014 Clinical Practice Guideline Recommendations 12 c. Peer Review Process 12 B. Summary of Patient Focus Group Methods and Findings 13 C. Conflicts of Interest 14 D. Scope of this Clinical Practice Guideline 14 E. Highlighted Features of this Clinical Practice Guideline 15 F. Patient-centered Care 15 G. Shared Decision Making 15 H. Co-occurring Conditions 15 IV. Guideline Work Group 17 V. Algorithm 18 A. Module A: Screening and Diagnosis 19 B. Module B: Treatment 20 VII. Recommendations 23 A. Screening, Diagnosis, and Monitoring 26 b. Measurement Techniques 27 B. Treatment Goals and General Approaches to Hypertension Management 33 a. Blood Pressure Goals 33 b. General Approaches to Hypertension Management 39 C. Non-pharmacological Management 45 a. Weight Reduction 45 b. Exercise/Physical Activity 48 c. Dietary Modifications 50 D. Pharmacological Treatment 54 a. For Hypertension 54 b. For Resistant Hypertension 59 VIII. Research Priorities 62 A. Automated Office Blood Pressure and Out-of-office Blood Pressure 62 B. Self-monitoring of Blood Pressure 62 C. New Technology 62 D. Interdisciplinary Approaches 62 E. Diet and Exercise 62 F. Obesity and Hypertension 63 H. Screening for Asymptomatic Hypertension-mediated Target Organ Damage 63 Appendix A: Evidence Review Methodology 64 A. Developing the Scope and Key Questions 64 B. Conducting the Systematic Review 70 a. General Criteria for Inclusion in Systematic Review 74 b. Key Question Specific Criteria 74 c. Literature Search Strategy 75 C. Convening the Face-to-face Meeting 75 D. Grading Recommendations 76 E. Recommendation Categorization 79 a. Recommendation Categories and Definitions 79 b. Categorizing Recommendations with an Updated Review of the Evidence 80 c. Categorizing Recommendations without an Updated Review of the Evidence 81 F. Drafting and Submitting the Final Clinical Practice Guideline 81 Appendix B: Patient Focus Group Methods and Findings 83 B. Findings 83 a. Provide comprehensive information and education to patients regarding their condition, management strategies, and self-management, including expanding available information on complementary and alternative therapies 83 b. Improve the method of measuring blood pressure in the office 84 c. Education around home monitoring devices and strategies for measurement and management, including frequency of measurement, is important 84 d. Improve communication between providers and patients, considering patient preferences regarding frequency of communication and mode of communication 84 e. All patients understood the importance of lifestyle modifications to lower their blood Appendix C: Evidence Table 86 Appendix D: 2014 Recommendation Categorization Table 90 Appendix E: Dietary Information 97 Appendix F: Drug Dosage Table 98 Appendix G: Guidance for Conducting Office Blood Pressure Measurement 102 Appendix H: Guidance for Conducting Home Blood Pressure Measurement 105 Appendix I: Participant List 107 Appendix J: Literature Review Search Terms and Strategy 108 A. EMBASE and Medline Embase.com Syntax 108 B. PsycINFO with Ovid Syntax 117 Appendix K: Alternative Text Descriptions of Algorithms 121 A. Module A: Screening and Diagnosis 121 B. Module B: Treatment 122 Appendix L: Abbreviations 124 References 127 I. Introduction The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the Health Executive Committee (HEC) on the use of clinical and epidemiological evidence to improve the health of the population across the Veterans Health Administration (VHA) and Military Health System (MHS), by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations.[1] This CPG is intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the individual needs and preferences of patients with hypertension (HTN), thereby leading to improved clinical outcomes. In 2014, the VA and DoD published a CPG for the Diagnosis and Management of Hypertension in the Primary Care Setting (2014 VA/DoD HTN CPG), which was based on evidence reviewed through April 2014. Since the release of that guideline, a growing body of research has expanded the general knowledge and understanding of HTN. Consequently, a recommendation to update the 2020 VA/DoD HTN CPG was initiated in 2018. The updated 2020 VA/DoD HTN CPG includes objective, evidence-based information on the diagnosis and management of HTN. It is intended to assist healthcare providers in all aspects of patient care, including, but not limited to, screening, diagnosis, and management. The system-wide goal of evidence-based guidelines is to improve the patient s health and well-being by guiding health providers who are caring for patients with HTN along management pathways that are supported by the evidence. The expected outcome of successful implementation of this guideline is to: Assess the individual s condition and determine the best treatment method, in collaboration with the patient Optimize health outcomes and improve quality of life Minimize preventable complications and morbidity Emphasize the use of patient-centered care (PCC) II. Background This guideline, developed under the auspices of the VHA and the DoD pursuant to directives from the VA, is an update to the 2014 VA/DoD Clinical Practice Guideline for Diagnosis and Management of Hypertension in the Primary Care Setting. The definition of HTN continues to evolve and an international consensus does not exist. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7), published in 2003, defined HTN as a systolic blood pressure (SBP) 140 mm Hg or a diastolic blood pressure (DBP) 90 mm Hg. This definition was not changed in the 2014 Evidence Based Guideline for the Management of High Blood Pressure in Adults.[2] Prehypertension was classified as SBP 120-139 or DBP 80-89.[3] The 2017 American College of Cardiology/American Heart Association (ACC/AHA) defines HTN as an SBP 130 mm Hg, a DBP 80 mm Hg, or both.[4] Prehypertension was removed as a clinical term; however, elevated blood pressure was added and defined as an SBP of 120-129 with a DBP <80 mm Hg. For the purposes of this CPG, the Work Group, based on our review of the literature, defines HTN as an SBP 130 mm Hg, a DBP 90 mm Hg, or both, assuming proper measurement technique. The reason for the evolution over time in the definition of HTN is because the evidence base supporting the benefits of treatment continue to change. While the relationship between systemic arterial pressure and cardiovascular morbidity or mortality appears to be linear above 115/75 mm Hg based on epidemiologic data, the evidence supporting benefit from treatment of elevated blood pressure starts at a higher threshold.[5] Kaplan and Victor suggests the definition of HTN should be the point at which the benefit of treatment of elevated blood pressure outweighs the risks and cost.[6] Treatment of HTN has long been associated with benefit, but this treatment benefit has not been proven for lowering slightly elevated blood pressures to a normal blood pressure of 115/75 mm Hg. In this CPG, the Work Group specifically investigated the point of proven benefit for HTN treatment (see Recommendation 9); based on this evidence, the Work Group defines HTN as SBP and/or DBP at or above 130/90 mm Hg, assuming proper measurement technique. For those with a blood pressure above normal but not in the hypertensive range, there is no evidence to date that there is a benefit from treatment; however, their cardiovascular risk remains elevated. HTN is described as either primary or secondary HTN. Primary, or essential, HTN accounts for about 95% of cases and is a heterogeneous disorder in which different causal factors, including genetic predisposition, central adiposity, sedentary lifestyle, and dietary choices, can lead to high blood pressure.[7] Secondary HTN is high blood pressure that results from an underlying and identifiable cause.[8] Main causes of secondary HTN include adverse effects (AEs) of medications (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], corticosteroids, decongestants, hormonal contraception, erythropoietin, amphetamines prescription or illicit) or illegal drugs, renovascular disease, chronic kidney disease (CKD), obstructive sleep apnea (OSA), hyperaldosteronism, pheochromocytoma, aortic coarctation, and others. Complications of HTN include damage to the large arteries (macrovascular complications) that can lead to stroke, myocardial infarction (MI), or peripheral arterial disease, as well as damage to the smaller arteries (microvascular complications) that can lead to CKD, lacunar infarcts, multi-infarct dementia, or retinopathy. In addition to these arterial complications, HTN itself can lead to cardiac complications including diastolic dysfunction, left ventricular hypertrophy (LVH) and chronic heart failure (CHF) with preserved or reduced ejection fraction. Treatment of HTN reduces the risk of these complications. A. Epidemiology and Impact in the General Population Blood pressure is a continuous variable that increases with advancing age similar to the increase in associated comorbid conditions like coronary artery disease, heart failure, stroke, peripheral vascular disease, and CKD.[5] This hypertensive risk is elevated in persons with diabetes and/or CKD. Over 66% of both men and women 65 years of age and over have HTN compared to <15% of men and women between 20 and 44 years of age.[9] HTN is more common in older adults; in 2016, a higher percentage of men 20-44 versus >64 years old (33% versus 16%) were unaware they had HTN. The asymptomatic nature of HTN can lead to challenges with detection; therefore, routine screening is important in order to diagnose the condition. Also, the asymptomatic nature of HTN can lead to challenges with adherence to treatment. In African Americans, HTN develops at a younger age and may present with a higher prevalence of complications at the time of diagnosis, including stroke and end-stage kidney disease, when compared with other ethnic groups.[10] The definition of HTN has evolved over the past five decades as clinical trials have progressively lowered the level of blood pressure at which the benefits of treatment outweigh the risks. Based on National Health and Nutrition Examination Survey (NHANES) data from 9,623 participants studied between 2011 and 2014, it is estimated that 72 million (or about one in three adult Americans) have HTN using the definition of SBP 140 and DBP 90 mm Hg published in the JNC 7 guidelines in 2003.[3,11] By the eighth decade of life, over 75% meet the aforementioned criteria, most commonly based on systolic elevation. In 2017, the AHA/ACC high blood pressure guideline recommended that the definition of HTN be lowered to 130/80 mm Hg or higher based on new clinical trial evidence of cardiovascular benefit from treatment to lower targets.[11] The implication of this recommendation is that an additional 14% of the adult United States (U.S.) population (or 31 million Americans) now meet the blood pressure criteria for HTN.[4] B. Hypertension in the Department of Defense and the Department of Veterans Affairs Populations Estimates of HTN prevalence among active duty military are limited and undoubtedly skewed by policies that exclude recruitment of individuals who already have cardiovascular risk factors such as HTN, obesity, and diabetes. However, it was reported in 2008 that 13% of active duty military had HTN,[12] similar to the percentage in the general population 20-44 years of age.[9] As in the civilian population, increased age, increased body mass index (BMI), male sex, and African American race were all independently associated with HTN. Compared to active duty military not deployed, exposure to multiple stressful deployments was also associated with a new diagnosis of HTN.[13] In the first study to directly compare cardiovascular health metrics of active duty Army men and women with those of NHANES participants evaluated between 2011 and 2012, NHANES participants had a higher prevalence of ideal blood pressure defined as <120/80 mm Hg (46% versus 27% for men, 63% versus 52% for women) compared to active duty Army personnel, even though NHANES participants were considerably older than the Army personnel (only 50% of NHANES participants <40 years old versus 86% of Army personnel <40 years old).[14] The prevalence of HTN among Veterans was 37% in 2011.[15] Although more recently published data on prevalence of HTN among Veterans is lacking, this prevalence is lower than the 46% reported for the U.S. general population, which was based on data accumulated between 2013 and 2016.[16] The reported blood pressure control rate, based on a treatment goal of <140/90 mm Hg, was 76.3% in 2010, which shows that blood pressure control among Veterans is better than that reported in the general This CPG on the management of HTN in the primary care setting is intended to promote evidence-based management of HTN and thereby improve patients clinical outcomes. It can assist primary care providers in the screening and diagnosis of HTN, determination of appropriate treatment, and delivery of individualized interventions. Although it was developed for a broad range of clinical settings, it should be applied with enough flexibility to accommodate local practice and individual situations. III. About this Clinical Practice Guideline This updated guideline represents a significant effort toward improving the screening, diagnosis, and management of HTN among patients who are eligible to receive care in the VA and/or DoD healthcare systems. As with other CPGs, however, challenges remain. These include evidence gaps, as well as ongoing needs to develop effective strategies for guideline implementation and to evaluate the effect of guideline adherence on clinical outcomes. This guideline is intended for VA and DoD healthcare primary care practitioners including physicians, nurse practitioners, physician assistants, nurses, dietitians, pharmacists, social workers, and others involved in the team caring for patients with HTN. Additionally, this guideline is intended for those in community practice involved in the care of Service Members or Veterans with HTN. As elaborated in the qualifying statement on page one, this CPG is not intended to serve as a standard of care. Standards of care are determined based on all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on information available through March 25, 2019 and is intended to provide a general guide to best practices. The guideline can assist care providers, but the use of a CPG must always be considered as a recommendation within the context of a variety of factors such as providers clinical judgment, patient values and preferences, state and federal legal statutes, ethical guidelines, professional standards, and healthcare system policies. A. Methods The current document is an update to the 2014 VA/DoD HTN CPG. The methodology used in developing the 2020 VA/DoD HTN CPG follows the Guideline for Guidelines, an internal document of the VA and DoD EBPWG that was updated in January 2019.[17] The Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (Champions) and other subject matter experts (SMEs) from within the VA and DoD (known as the Work Group) and the development and submission of an updated HTN CPG. The Champions and Work Group for this CPG were charged with developing evidence-based clinical practice recommendations and writing and publishing a guideline document to be used by primary care providers within the VA/DoD healthcare systems as well as those within the community who treat individuals within the VA and DoD. Specifically, the Champions and Work Group members for this guideline were responsible for identifying the key questions (KQs) of the most clinical relevance, importance, and interest for the diagnosis and management of patients with HTN. The Champions and the Work Group also provided direction on inclusion and exclusion criteria for the evidence review and assessed the level and quality of the evidence. The amount of new scientific evidence that had accumulated since the previous version of the CPG was also taken into consideration in the identification of the KQs. In addition, the Champions assisted in: Identifying appropriate disciplines of individuals to be included as part of the Work Group Directing and coordinating the Work Group Participating throughout the guideline development and review processes The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified four clinical leaders, William Cushman, MD and Dan Berlowitz, MD, MPH from the VA and CDR Travis E. Harrell, MD, FACC, FACP and CDR Mark P. Tschanz, DO, MACM, FACP from the DoD, as Champions for the 2020 VA/DoD HTN CPG. The Lewin Team, including The Lewin Group, Duty First Consulting, ECRI Institute, Sigma Health Consulting, and Anjali Jain Research & Consulting, was contracted by the VA and DoD to support the development of this CPG and conduct the evidence review. The first conference call was held in October 2018, with participation from the contracting officer s representative (COR), leaders from the VA Office of Quality, Safety and Value and the DoD Office of Evidence Based Practice, and the Champions. During this call, participants discussed the scope of the guideline initiative, the roles and responsibilities of the Champions, the project timeline, and the approach for developing and prioritizing specific research questions on which to base a systematic review (SR) about the diagnosis and management of HTN. The group also identified a list of clinical specialties and areas of expertise that are important and relevant to the management of HTN, from which Work Group members were recruited. The specialties and clinical areas of interest included: internal medicine, family medicine, nephrology, cardiology, nutrition, nursing, and pharmacy. The guideline development process for the 2020 VA/DoD HTN CPG update consisted of the following steps: 1. Formulating and prioritizing KQs and defining critical outcomes 2. Convening a patient focus group 3. Conducting the systematic evidence review 4. Convening a face-to-face meeting with the CPG Champions and Work Group members to develop recommendations 5. Drafting and submitting a final CPG on the management of HTN to the VA/DoD EBPWG Appendix A provides a detailed description of each of these tasks. a. Grading Recommendations The Champions and Work Group used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to assess the quality of the evidence base and assign a strength for each recommendation. The GRADE system uses the following four domains to assess the strength of each Balance of desirable and undesirable outcomes Confidence in the quality of the evidence Patient or provider values and preferences Other implications, as appropriate, e.g.: Resource use Equity Acceptability Feasibility Subgroup considerations Additional information regarding these domains can be found in Appendix A. Using these four domains, the Work Group determined the relative strength of each recommendation ( Strong or Weak ). Generally, a Strong recommendation indicates a high confidence in the quality of the available scientific evidence, a clear difference in magnitude between the benefits and harms of an intervention, similar patient or provider values and preferences, and understood influence of other implications (e.g., resource use, feasibility). Generally, if the Work Group has less confidence after the assessment across these domains and believes that additional evidence may change the recommendation, it assigns a Weak recommendation. It is important to note that the GRADE terminology used to indicate the assessment across the four domains (i.e., Strong versus Weak ) should not be confused with the clinical importance of the recommendation. A Weak recommendation may still be important to the clinical care of a patient with HTN. Occasionally, instances may occur when the Work Group feels there is insufficient evidence to make a recommendation for or against a particular therapy or preventive measure. This can occur when there is an absence of studies on a particular topic that met the evidence review inclusion criteria, studies included in the evidence review report conflicting results, or studies included in the evidence review report inconclusive results regarding the desirable and undesirable outcomes. Using these elements, the grade of each recommendation is presented as part of a continuum: Strong for (or We recommend offering this option ) Weak for (or We suggest offering this option ) No recommendation for or against (or There is insufficient evidence ) Weak against (or We suggest not offering this option ) Strong against (or We recommend against offering this option ) The grade of each recommendation made in the 2020 VA/DoD HTN CPG can be found in the section on Recommendations. Additional information regarding the use of the GRADE system can be found in Appendix A. b. Reconciling 2014 Clinical Practice Guideline Recommendations Evidence-based CPGs should be current, which typically requires revisions of previous guidelines based on new evidence or as scheduled and subject to time-based expirations.[19] For example, the U.S. Preventive Services Task Force (USPSTF) has a process for refining or otherwise updating its recommendations pertaining to preventive services.[20] The HTN CPG Work Group largely focused on developing new and updated recommendations based on the evidence review conducted for the priority areas addressed by the KQs. In addition to those new and updated recommendations, the Work Group considered, without complete review of the relevant evidence, the current applicability of other recommendations that were included in the 2014 VA/DoD HTN CPG, subject to evolving practice in today s environment. A set of recommendation categories was adapted from those used by the National Institute for Health and Care Excellence (NICE).[21,22] These categories, along with their corresponding definitions, were used to account for the various ways in which older recommendations could have been updated. In brief, the categories considered whether or not the evidence that related to a recommendation was systematically reviewed, the degree to which the recommendation was modified, and the degree to which a recommendation is relevant in the current care environment and within the scope of the CPG. Additional information regarding these categories and their definitions can be found in Recommendation Categorization. The categories for the recommendations included in the 2020 version of the guideline can be found in the section on Recommendations. The categories for the recommendations carried forward from the 2014 VA/DoD HTN CPG are noted in Appendix D. c. Peer Review Process The CPG was developed through an iterative process in which the Work Group produced multiple drafts of the CPG. The process for developing the initial draft is described in more detail in Drafting and Submitting the Final Clinical Practice Guideline. Once a near-final draft of the guideline was agreed upon by the Champions and Work Group members, the draft was sent out for peer review and comment. The draft was posted on a wiki website for a period of 14 business days. The peer reviewers comprised individuals working within the VA and DoD healthcare systems as well as experts from relevant outside organizations designated by the Work Group members. Organizations that were designated by the Work Group to participate in the peer review and provided feedback included the following: American Association of Nurse Practitioners Mayo Clinic Scripps Clinic Tulane University of Medicine The VA and DoD Leadership reached out to both the internal and external peer reviewers to solicit their feedback on the CPG. Reviewers were provided a hyperlink to the wiki website where the draft CPG was posted. All feedback from the peer reviewers was discussed and considered by the Work Group. Modifications made throughout the CPG development process were made in accordance with the evidence. B. Summary of Patient Focus Group Methods and Findings When forming guideline recommendations, consideration should be given to the values of those most affected by the recommendations: patients. Patients bring perspectives, values, and preferences into their healthcare experience that can vary from those of clinicians. These differences can affect decision making in various situations and should be highlighted and made explicit due to their potential to influence a recommendation s implementation.[23,24] Focus groups can be used as an efficient method to explore ideas and perspectives of a group of individuals and collect qualitative data on a thoughtfully predetermined set of questions. Therefore, as part of the effort to update this CPG, VA and DoD Leadership, along with the HTN CPG Work Group, held a patient focus group. The patient focus group was held on January 23,2019 at the Naval Medical Center in San Diego, CA. The aim of the focus group was to further understand and incorporate the perspective of patients with HTN and who are covered and/or receiving their care through the VA and/or DoD healthcare systems, as these patients are most affected by the recommendations put forth in the CPG. The focus group lasted for approximately three hours and delved into the patients perspectives on a set of topics related to their HTN management, including their priorities, the challenges they have experienced, the information they received regarding their care, and the impacts of their care on their lives. The focus group comprised a convenience sample, and the Work Group recognizes the lack of generalizability and other limitations inherent in the small sample size. A total of three patients and one caregiver were included in the focus group to be consistent with the requirements of the Federal Paperwork Reduction Act, 1980. The Work Group acknowledges that the sample included in this focus group is not representative of all patients within the VA and DoD healthcare systems. Further, time limitations for the focus group prevented exhaustive exploration of all topics related to HTN management in the VA and DoD and the patients broader experiences with their care. Thus, the Work Group made decisions regarding the priority of topics to discuss at the focus groups. These limitations, as well as others, were considered during guideline development as the information collected from the discussion was being used. Recruitment for participation in the focus groups was managed by the Champions and VA and DoD Leadership, with assistance from coordinators at the facilities at which the focus groups took place. The following ideas and suggestions about aspects of care that are important to patients with HTN emerged as recurring themes during the discussions (Table 1). These concepts were important parts of the participants care and added to the Work Group s understanding of patient values and perspectives. Additional details regarding the patient focus group methods and findings can be found in Appendix B. Table 1. Hypertension CPG Focus Group Concepts Patient Focus Group Themes A. Provide comprehensive information and education to patients regarding their condition, management strategies, and self-management, including expanding available information on complementary and alternative therapies. B. Improve the method of measuring blood pressure in the office. C. Education around home monitoring devices and strategies for measurement and management, including frequency of measurement, is important. D. Improve communication between providers and patients, considering patient preferences regarding frequency of communication and mode of communication. E. All patients understood the importance of lifestyle modifications to lower their blood pressure. C. Conflicts of Interest At the start of this guideline development process and at other key points throughout, the project team was required to submit disclosure statements to reveal any areas of potential conflict of interest (COI) in the past 24 months. The project team followed the guidance on COI management from the VA/DoD EBPWG. Verbal affirmations of no COI were used as necessary during meetings throughout the guideline development process. The project team was also subject to random web-based surveillance (e.g., Centers for Medicare and Medicaid Services [CMS] open payments or ProPublica). If a project team member reported a COI (actual or potential), then it was reported to the VA and DoD program offices. It was also discussed with the HTN CPG Champions in tandem with their review of the evidence and development of recommendations. The VA and DoD program offices and the HTN CPG Champions determined whether or not action, such as restricting participation or voting on sections related to the conflict or removal from the Work Group, was necessary. If it was deemed necessary, action to mitigate the COI was taken by the Champions and VA and DoD program offices, based on the level and extent of involvement. No COIs were identified for the HTN CPG Work Group members or Champions. Disclosure forms are on file with the VA Office of Quality, Safety and Value and available upon request. D. Scope of this Clinical Practice Guideline Regardless of setting, any patient in the VA and DoD healthcare systems should ideally have access to the interventions that are recommended in this guideline after taking into consideration the patient s specific circumstances. Guideline recommendations are intended to be patient centered. Thus, treatment and care should consider a patient s needs and preferences. Effective, open communication between healthcare professionals and the patient is essential and should be supported by evidence-based information tailored to the patient s needs. Use of an empathetic and non-judgmental approach facilitates discussions sensitive to gender, culture, ethnic, and other considerations. The information that patients are given about treatment and care should be culturally appropriate and available to people with limited literacy skills. Treatment information should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family and caregiver involvement should be considered, if appropriate. This CPG is designed to assist in managing or co-managing patients with HTN. Moreover, the patient population of interest for this CPG is patients with HTN who are eligible for care in the VA and DoD healthcare delivery systems and those who are in the community receiving care from community-based clinicians. It includes Veterans as well as deployed and non-deployed active duty Service, Guard, and Reserve Members and their dependents. E. Highlighted Features of this Clinical Practice Guideline The 2020 edition of the VA/DoD HTN CPG is the third update to the original CPG. It provides practice recommendations for the care of individuals with HTN as well as guidance for treatment. A particular strength of this CPG is the multidisciplinary stakeholder involvement from its inception, ensuring representation from the broad spectrum of clinicians engaged in the diagnosis and management of HTN. The framework for recommendations in this CPG considered factors beyond the strength of the evidence, including balancing desired outcomes with potential harms of the intervention, the potential for variation in patient values and preferences, and other considerations (e.g., resource use, subgroup considerations) as appropriate. Applicability of the evidence to VA/DoD populations was also taken into consideration. An algorithm accompanies the guideline to provide an overview of the recommendations in the context of the flow of patient care and to assist with training providers (see Algorithm section). The algorithm may be used to help facilitate translation of guideline recommendations into practice. F. Patient-centered Care VA/DoD CPGs encourage providers to use a PCC approach that is individualized based on patient needs, characteristics, and preferences. Regardless of setting, all patients in the healthcare system should be able to access evidence-based care appropriate to their specific needs or condition. When properly executed, PCC may decrease patient anxiety, increase trust in clinicians, and improve treatment adherence.[25,26] Improved patient-clinician communication and a PCC approach conveys openness and supports disclosure of current and future concerns. As part of the PCC approach, providers should ask each patient about any concerns he or she has or barriers to high quality care he or she has experienced. G. Shared Decision Making Throughout this VA/DoD CPG, the authors encourage clinicians to focus on shared decision making (SDM). The SDM model was introduced in Crossing the Quality Chasm, an Institute of Medicine (IOM) (now called the National Academy of Medicine [NAM]) report, in 2001.[27] It is readily apparent that patients, together with their clinicians, make decisions regarding their plan of care and management options. Patients with HTN require sufficient information and time to be able to make informed decisions. Clinicians must be adept at presenting information to their patients regarding treatments, expected outcomes, and levels and/or locations of care. Clinicians are encouraged to use SDM to individualize treatment goals and plans based on patient capabilities, needs, goals, and preferences. H. Co-occurring Conditions Co-occurring health conditions are important to recognize because they can modify the degree of risk and trajectory of an individual s lifestyle, impact the diagnosis and management of HTN, influence patient or provider treatment priorities and clinical decisions, and affect the overall provider approach to the management of HTN. Providers should expect that many Veterans, Service Members, and their families will have one or more co-occurring health conditions. Because of the nature of HTN management, which sometimes takes place in parallel with ongoing care for co-occurring conditions, it is often best to manage HTN collaboratively with other care providers. Some co-occurring conditions may require early specialist consultation in order to discuss any necessary changes in treatment or to establish a common understanding of how care will be coordinated and delivered. VA/DoD CPGs exist for CKD,1 obesity and overweight,3 I. Implementation This CPG and algorithm are designed to be adapted by individual healthcare providers with consideration of local needs and resources. The algorithms serve as tools to prompt providers to consider key decision points during an episode of care. Although this CPG represents the recommended practices on the date of its publication, medical practice is evolving and requires ongoing awareness by providers of newly published information. New technology and additional research will improve patient care in the future. The CPG can assist in identifying priority areas for research and informing optimal allocation of resources. Future studies examining the results of CPG implementation may lead to the development of new evidence particularly relevant to clinical practice. 1 See the VA/DoD Clinical Practice Guideline for the Management of Chronic Kidney Disease. Available at: https://www.healthquality.va.gov/guidelines/CD/CKD/ 2 See the VA/DoD Clinical Practice Guideline for the Management of Type 2 Diabetes Mellitus in Primary Care. Available at: https://www.healthquality.va.gov/guidelines/CD/diabetes/ 3 See the VA/DoD Clinical Practice Guideline for Screening and Management of Obesity and Overweight. Available at: https://www.healthquality.va.gov/guidelines/CD/obesity/ 4 See the VA/DoD Clinical Practice Guideline for the Management of Pregnancy. Available at: https://www.healthquality.va.gov/guidelines/WH/up/ IV. Guideline Work Group Organization Namesa Department of Veterans Affairs William Cushman, MD (Champion) Dan Berlowitz, MD, MPH (Champion) Jennifer Ballard-Hernandez, DNP, NP, CCRN Elaine Furmaga, PharmD Peter Glassman, MBBS, MSc, FACP Elvira O. Gosmanova, MD, FASN Lillian Pinault, MS, RD, CSG, CDE Pedro Roldan, MD, FAAFP Addison Taylor, MD, PhD Department of Defense CDR Travis E. Harrell, MD, FACC, FACP (Champion) CDR Mark P. Tschanz, DO, MACM, FACP (Champion) Angela A. Allerman, PharmD, BCPS Asha Jain, MA, RD, CDE Lt Col Joseph Sky, MD, FACP, FACC LTC Tommy L. Thompson, DNP, FNP-C Lt Col Jesse Wickham, DO, FACP Office of Quality, Safety and Value Veterans Health Administration M. Eric Rodgers, PhD, FNP-BC James Sall, PhD, FNP-BC Rene Sutton, BS, HCA, FAC-COR II Office of Evidence Based Practice U.S. Army Medical Command Corinne K. B. Devlin, MSN, RN, FNP-BC Lisa D. Jones, BSN, RN, MHA, CPHQ The Lewin Group Clifford Goodman, PhD Christine Jones, MS, MPH, PMP Helen Dawson, MPH Nicolas Stettler-Davis, MD, MSCE Erika Beam, MS ECRI Institute Kristen D Anci, PhD Kelley Tipton, MPH Linnea Hermanson, MA Joann Fontanarosa, PhD Benjamin Rouse, MHS Allison Hedden-Gross, MS, MLS Sigma Health Consulting Frances Murphy, MD, MPH Duty First Consulting Rachel Piccolino, BA Megan McGovern, BA Anjali Jain Research & Consulting Anjali Jain, MD a Additional contributor contact information is available in Appendix I. V. Algorithm This CPG includes an algorithm that is designed to facilitate understanding of the clinical pathways and decision-making processes used in managing patients with HTN. The use of the algorithm format as a way to represent patient management was chosen based on the understanding that such a format may promote more efficient diagnostic and therapeutic decision making; it also has potential to change patterns of resource use. Although the Work Group recognizes that not all clinical practices are linear, the simplified linear approach depicted through the algorithm and its format allows the provider to assess the critical information needed at the major decision points in the clinical process. It includes: An ordered sequence of steps of care Recommended observations and examinations Decisions to be considered Actions to be taken For each VA/DoD CPG, there is a corresponding clinical algorithm that is depicted by a step-by-step decision tree. Standardized symbols are used to display each step in the algorithm, and arrows connect the numbered boxes indicating the order in which the steps should be followed.[28] Shape Description Rounded rectangles represent a clinical state or condition Hexagons represent a decision point in the guideline, formulated as a question that can be answered Yes or No Rectangles represent an action in the process of care Ovals represent a link to another section within the guideline Appendix K contains alternative text descriptions of Module A and Module B. A. Module A: Screening and Diagnosis Abbreviations: ABPM: ambulatory blood pressure monitoring; CV: cardiovascular; DBP: diastolic blood pressure; EKG: electrocardiogram; HBPM: home blood pressure monitoring; HTN: hypertension; SBP: systolic blood pressure B. Module B: Treatment Abbreviations: HBPM: home blood pressure monitoring; HTN: hypertension; SDM: shared decision making Sidebar 1: Office Blood Pressure Measurement See Appendix G of the full HTN CPG for appropriate blood pressure cuff selection, patient preparation, and proper technique AOBP (preferred) Fully automated machine programmed to wait five minutes and record the average of three measurements separated by at least 30 seconds Standard Technique (alternative) Use a properly calibrated and validated sphygmomanometer Use an average of >2 readings Abbreviations: AOBP: automated office blood pressure; CPG: clinical practice guideline; HTN: hypertension Sidebar 2: Confirm Diagnosis If the follow-up clinic blood pressure value is >130 mm Hg SBP or >90 mm Hg DBP, make diagnosis of HTN without further testing Consider HBPM or ABPM to inform the diagnosis in select patients (see Recommendation 4) If blood pressure is <130 mm Hg SBP and <90 mm Hg DBP, yet there is evidence of target organ damage, which may suggest the presence of masked HTN, consider HBPM or ABPM to inform the diagnosis (see Abbreviations: ABPM: ambulatory blood pressure monitoring; DBP: diastolic blood pressure; HBPM: home blood pressure monitoring; HTN: hypertension; SBP: systolic blood pressure Sidebar 3: Examples of Target Organ Damage and Comorbid Conditions* Target organ damage: stroke, MI, peripheral arterial diseases, LVH, CHF, CKD, and retinopathy Comorbid conditions: CKD, dyslipidemia, diabetes, obesity/overweight, OSA, and tobacco dependence *If patient has comorbid conditions, engage relevant VA/DoD CPGs, when available (e.g., CKD5 , ) Abbreviations: CHF: chronic heart failure; CKD: chronic kidney disease; CPGs: clinical practice guidelines; LVH: left ventricular hypertrophy; MI: myocardial infarction; OSA: obstructive sleep apnea Sidebar 4: Goals for Blood Pressure Systolic Goal (see Recommendations 6 8) <130 mm Hg If less stringent goal is desired per clinical judgment and/or patient preferences, aim for at least: <150 mm Hg for patients age 60 and over <140 mm Hg for patients age 60 and over with type 2 diabetes Diastolic Goal (see Recommendation 9) <90 mm Hg for patients age 30 and over 5 See the VA/DoD Clinical Practice Guideline for the Management of Chronic Kidney Disease. Available at: https://www.healthquality.va.gov/guidelines/CD/CKD/ 6 See the VA/DoD Clinical Practice Guideline for the Management of Dyslipidemia for Cardiovascular Risk Reduction. Available at: https://www.healthquality.va.gov/guidelines/CD/lipids/ 7 See the VA/DoD Clinical Practice Guideline for the Management of Type 2 Diabetes Mellitus in Primary Care. Available at: https://www.healthquality.va.gov/guidelines/CD/diabetes/ 8 See the VA/DoD Clinical Practice Guideline for Screening and Management of Obesity and Overweight. Available at: https://www.healthquality.va.gov/guidelines/CD/obesity/ Sidebar 5: Initiate Drug Therapy General Population: Recommend one or more of the following: Thiazide-type diuretics ACEIs or ARBs* Long-acting CCBs For patients unlikely to achieve goal with monotherapy (e.g., patients with SBP/DBP of >20/10 mm Hg above goal), consider initiating treatment with combination therapy or monotherapy with close follow-up for titration and/or addition of medications based on blood pressure response Specific Populations: For patients age 65 and over, we suggest a thiazide-type diuretic for reduction in composite cardiovascular outcomes For African American patients, we recommend against using ACEIs or ARBs as monotherapy For patients with CKD, see the VA/DoD CKD CPG9 *We recommend against more than one of the following three drug classes together in the same patient: ACEIs, ARBs, or direct renin inhibitors Abbreviations: ACEI: angiotensin-converting enzyme inhibitor; ARB: angiotensin II receptor blocker; CCB: calcium channel blocker; CKD: chronic kidney disease; CPG: clinical practice guideline Sidebar 6: Optimize Treatment Assess adherence Consider evaluating for interfering substances (some prescription medications, NSAIDs, alcohol, recreational drugs) Consider evaluating and addressing contributing lifestyle factors Optimize treatment (refer to Appendix F, Table F-1) Titrate initial drug Add another agent from a different class Reevaluate diagnosis (resistant HTN, secondary causes of HTN) Consider specialty consultation for patients with resistant HTN Consider co-interventions to enhance management of HTN and improve blood pressure: Pharmacist-led Nurse-led Dietitian-led Abbreviations: HTN: hypertension; NSAIDs: nonsteroidal anti-inflammatory drugs 9 See the VA/DoD Clinical Practice Guideline for the Management of Chronic Kidney Disease. Available at: https://www.healthquality.va.gov/guidelines/CD/CKD/ VII. Recommendations Topic Sub- topic # Recommendation Strengtha Categoryb Screening, Diagnosis, and Monitoring a. Screening 1. We recommend screening adults for elevated blood pressure periodically. Strong for Not Reviewed, Amended b. Measurement Techniques 2. We suggest using attended or unattended, fully automated office blood pressure measurement (programmed to wait five minutes and record the average of three measurements separated by at least 30 seconds). Weak for Reviewed, New-added 3. When fully automated blood pressure measurement is not available, we suggest measurement of blood pressure using standard technique and a properly calibrated and validated sphygmomanometer. Weak for Reviewed, New-replaced 4. We suggest using out-of-office blood pressure monitoring methods (ambulatory 24-hour monitoring or home blood pressure measurements) to inform the diagnosis and management of hypertension. Weak for Reviewed, New-replaced c. Monitoring 5. Among patients treated for hypertension, we suggest offering home blood pressure self-monitoring with co-interventions for lowering systolic and diastolic blood pressure. Weak for Reviewed, New-added Treatment Goals and General Approaches to Hypertension Management a. Blood Pressure Goals 6. For all patients, including those with type 2 diabetes, we suggest treating to a systolic blood pressure goal of <130 mm Hg. Weak for Reviewed, New-added 7. For patients 60 years and over, we recommend treating to a systolic blood pressure goal of <150 mm Hg with added benefit to lowering systolic blood pressure further for those between 130 mm Hg and 150 mm Hg. Strong for Reviewed, Amended 8. For patients 60 years and over with type 2 diabetes, we recommend treating to a systolic blood pressure goal of <140 mm Hg with added benefit to lowering systolic blood pressure further for those between 130 mm Hg and 140 mm Hg. Strong for Reviewed, Amended 9. For patients 30 years and over, we recommend treating to a diastolic blood pressure goal of <90 mm Hg. Strong for Reviewed, Amended Topic Sub- topic # Recommendation Strengtha Categoryb Treatment Goals and General Approaches to Hypertension Management (cont.) b. General Approaches to HTN Management 10. We recommend offering pharmacist-led medication management as an option for patients with hypertension. Strong for Reviewed, New-replaced 11. We suggest offering nurse-led interventions as an option for patients treated for hypertension. Weak for Reviewed, New-replaced 12. We suggest offering registered dietitian-led nutrition interventions as an option for patients with hypertension who are or are not on medication. Weak for Reviewed, New-replaced 13. We suggest technology-based interventions (e.g., e-counseling, electronic transmission of data, telemonitoring, mobile applications) for improving control of hypertension. Weak for Reviewed, New-replaced Non-Pharmacological Treatment a. Weight Reduction 14. We suggest advising patients with hypertension and overweight/obesity to lose weight to improve blood pressure. Weak for Reviewed, Amended 15. For patients with hypertension and overweight/obesity, we suggest offering a diet directed at weight loss for the treatment of hypertension. Weak for Reviewed, New-added 16. For the treatment of hypertension, there is insufficient evidence for or against offering weight loss medications for patients with obesity and hypertension. Neither for nor against Reviewed, New-added 17. For the treatment of hypertension, there is insufficient evidence to suggest for or against bariatric surgery for patients with obesity and hypertension. Neither for nor against Reviewed, New-added b. Exercise/ Physical Activity 18. We suggest offering individual or group-based exercise for the treatment of hypertension to reduce blood pressure. Weak for Reviewed, Amended 19. We recommend a target for aerobic exercise of at least 120 minutes per week for reduction in blood pressure. Strong for Not Reviewed, Amended c. Dietary Modifications 20. We recommend a dietitian-led Dietary Approaches to Stop Hypertension Diet for the treatment or prevention of hypertension for patients with hypertension or interested patients with other cardiovascular risk factors. Strong for Not Reviewed, Amended 21. In patients with hypertension, we recommend that sodium intake be limited to no more than 2,300 mg/day (100 mmol/day), with referral to a dietitian or other support as appropriate. Strong for Not Reviewed, Not Changed 22. In patients with additional cardiovascular risk factors, such as dyslipidemia, we suggest considering a dietitian-led Mediterranean Diet as an alternative to the Dietary Approaches to Stop Hypertension Diet. Weak for Not Reviewed, Not Changed Topic Sub- topic # Recommendation Strengtha Categoryb Pharmacological Treatment a. For Hypertension 23. We recommend offering a thiazide-type diuretic, calcium channel blocker, or either an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker as primary pharmacologic therapy for hypertension for reduction in composite cardiovascular outcomes. Strong for Reviewed, New-replaced 24. In African American patients with hypertension, we recommend against using an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker as monotherapy. Strong against Not Reviewed, Not Changed 25. In hypertensive patients 65 years and over, we suggest a thiazide- type diuretic for reduction in composite cardiovascular outcomes. Weak for Reviewed, New-added 26. We recommend against more than one of the following three drug classes together in the same patient: angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, or direct renin inhibitors. Strong against Not Reviewed, Not Changed 27. For the treatment of hypertension, there is insufficient evidence to recommend for or against initiating combination therapy over initiating monotherapy with the sequential addition of another medication. Neither for nor against Reviewed, New-replaced b. For Resistant Hypertension 28. For patients with resistant hypertension (defined as those who are not adequately controlled with maximally tolerated dose of triple therapy [i.e., a thiazide-type diuretic, calcium channel blockers, and angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker]), we suggest adding spironolactone in those patients without contraindications. Weak for Reviewed, New-replaced a For additional information, please refer to Grading Recommendations. b For additional information, please refer to Recommendation Categorization and Appendix D. A. Screening, Diagnosis, and Monitoring a. Screening Recommendation 1. We recommend screening adults for elevated blood pressure periodically. (Strong for | Not Reviewed, Amended) Discussion A 2007 review of the evidence for the USPSTF describes the rationale for blood pressure screening.[29] Based on their review, the USPSTF concluded that the benefits of blood pressure screening far outweigh any risks. The risk for cardiovascular events and the potential benefit from screening and subsequent treatment of HTN depend on both the degree and duration of blood pressure elevation and the presence of other cardiovascular risk factors, such as age, gender, lipid disorders, smoking, and diabetes. Because the degree and duration of blood pressure elevation are unknown before screening, selective screening to identify individuals who would benefit most from detection and treatment of HTN would need to target individuals with other cardiovascular risk factors. The 2015 update from the USPSTF concluded that, given the strong evidence base for the previous recommendations, the indirect evidence path for HTN screening did not need updating.[30] For patients who are screened, estimates of the potential benefit of treatment can be improved both by carefully measuring the degree of blood pressure elevation and by assessing the contribution of other risk factors to global cardiovascular risk.[31-33] Since increasing age is related to greater incidence of HTN, and because lifetime risk of developing HTN is so high (reaching approximately 90% for octogenarians), it is sensible to screen periodically.[34] Multiple separate guidelines make recommendations for rescreening intervals, but none are evidence based. Although not included in the systematic evidence review conducted as part of this guideline update, and thus not considered in determining the strength of recommendation, a 2015 SR by the USPSTF identified 40 studies addressing rescreening interval and hypertensive incidence in screened normotensive persons (defined as blood pressure <140/90 mm Hg using office blood pressure measurements).[35] There were highly variable estimates of incident HTN ranging from 2.2-4.4% at one- year interval and 2.1-28.4% at five-year intervals. This confirms the recommendation that there is value to screening normotensive adults, but the evidence remains unclear as to what the optimal interval should be. As this is a Not Reviewed, Amended recommendation, the Work Group did not systematically review evidence related to this recommendation. Based on the assessment of the quality of the evidence put forth in the 2014 VA/DoD HTN CPG,[29,31-34] the Work Group s confidence in the quality of the evidence is moderate. The body of evidence had some limitations including different treatment goals/targets and confounders in the analysis. Other considerations regarding this recommendation included the benefits, including improved outcomes in cardiovascular events and mortality, outweighing the potential harm of adverse events (e.g., false positive screening, missed diagnosis), which was small. Patient values and preferences were similar, as blood pressure screening is a routine part of almost all outpatient medical care. Thus, the Work Group decided that a Strong for recommendation was warranted. More research is needed on the best screening method for HTN as well as the best interval between screenings in both the general population and those at-risk for HTN. b. Measurement Techniques Recommendation 2. We suggest using attended or unattended, fully automated office blood pressure measurement (programmed to wait five minutes and record the average of three measurements separated by at least 30 seconds). (Weak for | Reviewed, New-added) 3. When fully automated blood pressure measurement is not available, we suggest measurement of blood pressure using standard technique and a properly calibrated and validated sphygmomanometer. (Weak for | Reviewed, New-replaced) Discussion The diagnosis and management of HTN has been based primarily on measurement of blood pressure in a medical clinic or office. Office measurements were used by most observational studies and all randomized controlled trials (RCTs) defining both the risk of various blood pressure levels and the goal blood pressures that have reduced cardiovascular outcomes or mortality. To obtain the values most representative of the patient s office blood pressure, evidence supports that at least two readings be taken on each of two occasions, at least one day apart. Blood pressure was measured by standard technique in all critical studies that have been used to develop recommendations for both the blood pressure levels at which to begin drug treatment as well as the blood pressure goals of treatment. Therefore, in order to make appropriate decisions in clinical practice, blood pressure should be measured with a properly calibrated and validated sphygmomanometer and with a standard technique similar to what has been used in studies.[36] Older studies used manual blood pressure determinations, such as with a mercury sphygmomanometer, while more recent studies have used fully automated oscillometric sphygmomanometers. A fully automated oscillometric manometer can be set to wait a specified rest time and take an average of several blood pressure readings with one activation. A semi-automated oscillometric device takes a single reading without a rest period after activation. SRs and meta-analyses have reported that blood pressure readings were similar when comparing fully automated oscillometric sphygmomanometer with daytime average ambulatory blood pressure readings, but routine office readings without standard technique averaged 7.0 to 14.5 mm Hg higher than fully automated readings.[37,38] In one SR, SBP readings using research quality manual or oscillometric technique averaged 7 mm Hg higher than fully automated oscillometric technique; however, in the one study included in the SR in which the order was randomized, there was very little difference between these two techniques, suggesting the others may have been biased by regression to the mean.[38] In addition, another SR/meta-analysis concluded that, when fully automated oscillometric readings were obtained, there was not a significant difference in blood pressure levels when an observer was in the room (attended) or the patient was alone in the room (unattended).[39] As a good summary of standard measurement technique used in research studies, the 2019 AHA recommendations for blood pressure measurement include the following key steps about proper seated blood pressure measurement in the office (adapted).[36] Table 2. Key Steps for Proper Blood Pressure Measurements Key Steps Specific Instructions Step 1: Properly prepare the patient 1. Have the patient relax, sitting in a chair with feet flat on floor and back supported. The patient should be seated for 3-5 min without talking or moving around before recording the first blood pressure reading. 2. The patient should avoid caffeine, exercise, and smoking for at least 30 min before measurement. 3. Ensure that the patient has emptied his/her bladder. 4. Neither the patient nor the observer should talk during the rest period or during the measurement. 5. Remove clothing covering the location of cuff placement. 6. Measurements made while the patient is sitting on an examining table do not fulfill these criteria. Step 2: Use proper technique for blood pressure measurements 1. Use an upper-arm cuff blood pressure measurement device that has been validated and ensure that the device is calibrated periodically. 2. Support the patient s arm (e.g., resting on a desk) at heart level; the patient should not be holding his/her arm because isometric exercise will affect the blood pressure levels. 3. Position the middle of the cuff on the patient s upper arm at the level of the right atrium (midpoint of the sternum). 4. Use the correct cuff size such that the bladder encircles 75%-100% of the arm. 5. Use either the stethoscope diaphragm or bell for auscultatory readings. Step 3: Take the proper measurements needed for diagnosis and treatment of elevated blood pressure/HTN 1. At the first visit, record blood pressure in both arms. Use the arm that gives the higher reading for subsequent readings (if consistently 10-15 mm Hg higher). 2. Separate repeated measurements by at least 30 seconds. 3. For auscultatory determinations, use a palpated estimate of radial pulse obliteration pressure to estimate SBP. Inflate the cuff 20-30 mm Hg above this level for an auscultatory determination of the blood pressure level. Step 4: Properly document accurate blood pressure readings 1. Record SBP and DBP; if using the auscultatory technique, record SBP and DBP as the onset of the first of at least 2 consecutive beats and the last audible sound, respectively. 2. If using the auscultatory technique, record SBP and DBP to the nearest even number; if oscillometric, record reading displayed (or average displayed). 3. Note the time that the most recent blood pressure medication was taken before measurements. Step 5: Average the readings Use an average of 2 readings obtained on 2 occasions to estimate the patient s blood pressure. If fully automated oscillometric technique, manometer should display average of 2-3 readings. Step 6: Provide blood pressure readings to patient Provide the patient with his or her SBP/DBP readings both verbally and in writing. Assist the patient interpret the results. Abbreviations: DBP: diastolic blood pressure; HTN: hypertension; SBP: systolic blood pressure The 2019 AHA guidelines on measurement of blood pressure also provide a table of proper blood pressure cuff sizes.[36] Miscuffing can provide erroneous values. Table 3. Proper Blood Pressure Cuff Sizes Cuff Size Arm Circumference (cm) Bladder Dimension (width x length, cm) Abbreviation: cm: centimeter Although SRs and meta-analyses have reported the mean differences (MD) in intra-arterial compared with cuff blood pressure measurements and arm compared with leg blood pressure measurements, whenever possible, decisions concerning diagnosis and management of HTN should be made with brachial cuff determinations.[40,41] Previous evidence suggested that automated blood pressure monitors are accurate for SBP but not DBP measurement in the presence of atrial fibrillation. A recent SR and meta-analysis provided additional support by concluding that, although some monitors have been shown to be accurate with atrial fibrillation, there is considerable heterogeneity between devices, particularly for DBP measurement; accuracy for devices untested in atrial fibrillation cannot be assumed.[42] Although standard blood pressure measurement technique in the office is critical to making correct decisions about the diagnosis and management of HTN, there is widespread failure to use proper technique in clinical practice settings.[43] The reasons for this include lack of knowledge of proper technique, lack of appreciation of the importance of many aspects of proper technique, and resistance to change, especially taking the extra time needed for quiet during the rest and measurement periods. There also may be resistance to incorporating fully automated blood pressure technique in practice, since it requires time not speaking with the patient and allowing for rest and several measurements (approximately seven to eight minutes on average when accounting for five minutes of rest and time to take measurements). The main concern is the time required for busy clinic staff to incorporate this technique. However, using automated office blood pressure (AOBP) allows staff to attend to other patients or tasks during this time. In the patient focus group carried out as part of this guideline update, patients described the following (see Appendix B): 1. Patients noted that when their blood pressure was measured by machine in the office setting, they experienced pain and uncomfortable pressure. 2. Some of the patients noted that their blood pressure had to be taken twice when in the office setting, as the first reading was rarely accurate. 3. Patients felt the office blood pressure readings were inaccurate; they trusted the devices they use at home more. 4. There were noticeable differences between blood pressure readings when it was taken manually versus with a machine. The Work Group believed these perspectives from patients generally support use of fully automated oscillometric manometers in clinical practice. Although there is some expense to fully automated oscillometric manometers and concern over pain of measurements, the Work Group believed these issues were minor compared with the benefits of reducing observer error and providing more accurate blood pressure data. As Recommendations 2 and 3 are Reviewed, New-added and Reviewed, New-replaced recommendations, respectively, the Work Group systematically reviewed evidence related to these recommendations in the evidence review conducted as part of this guideline update.