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Blood Pressure Assessment in Adults in Clinical Practice and Clinic-Based Research: JACC Scientific Expert Panel

January 2019
Journal of the American College of Cardiology 73(3):317-335

DOI:10.1016/j.jacc.2018.10.069

Authors:

Paula Einhorn

National Institutes of Health

William C Cushman

University of Tennessee

Paul Whelton

Tulane University

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The accurate measurement of blood pressure (BP) is essential for the diagnosis and management of hypertension. Restricted use of mercury devices, increased use of oscillometric devices, discrepancies between clinic and out-of-clinic BP, and concerns about measurement error with manual BP measurement techniques have resulted in uncertainty for clinicians and researchers. The National Heart, Lung, and Blood Institute of the U.S. National Institutes of Health convened a working group of clinicians and researchers in October 2017 to review data on BP assessment among adults in clinical practice and clinic-based research. In this report, the authors review the topics discussed during a 2-day meeting including the current state of knowledge on BP assessment in clinical practice and clinic-based research, knowledge gaps pertaining to current BP assessment methods, research and clinical needs to improve BP assessment, and the strengths and limitations of using BP obtained in clinical practice for research and quality improvement activities.

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THE PRESENT AND FUTURE

JACC SCIENTIFIC EXPERT PANEL

Blood Pressure Assessment in

Adults in Clinical Practice and

Clinic-Based Research

JACC Scientiﬁc Expert Panel

Paul Muntner, PHD,

Paula T. Einhorn, MD, MS,

William C. Cushman, MD,

Paul K. Whelton, MB, MD, MSC,

Natalie A. Bello, MD, MPH,

Paul E. Drawz, MD, MHS, MS,

Beverly B. Green, MD, MPH,

Daniel W. Jones, MD,

Stephen P. Juraschek, MD, PHD,

Karen L. Margolis, MD, MPH,

Edgar R. Miller 3RD, MD, PHD,

Ann Marie Navar, MD, PHD,

Yechiam Ostchega, PHD, RN,

Michael K. Rakotz, MD,

Bernard Rosner, PHD,

Joseph E. Schwartz, PHD,

Daichi Shimbo, MD,

George S. Stergiou, MD, PHD,

Raymond R. Townsend, MD,

Jeff D. Williamson, MD,

Jackson T. Wright, JR, MD, PHD,

Lawrence J. Appel, MD, MPH,

from a 2017 National Heart, Lung, and Blood Institute Working Group

JACC JOURNAL CME/MOC/ECME

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Successful completion of this CME activity, which includes participa-

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ticipants will earn MOC points equivalent to the amount of CME credits

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to submit participant completion information to ACCME for the pur-

pose of grant ing ABIM MOC credit.

Blood Pressure Assessment in Adults in Clinical Practice and Clinic-Based

Research: JACC Scientiﬁc Expert Panel will be accredited by the

European Board for Accreditation in Cardiology (EBAC) for 1 hour of

External CME credits. Each participant should claim only those hours

of credit that have actually been spent in the ed ucational activity. The

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the European Board for Accreditation in Cardiology (EBAC) have

recognized each other’saccreditationsystemsassubstantially

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While offering the credits noted above, this program is not intended

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To obtain credit for JACC CME/MOC/ECME, you must:

1. Be an ACC member or JACC subscriber.

2. Carefully read the CME/MOC/ECME-designated article available on-

line and in this issue of the Journal.

3. Answer the post-test questions. A passing score of at least70% must be

achieved to obtain credit.

4. Complete a brief evaluation.

5. Claim your CME/MOC/ECME credit and receive your certiﬁcate electron-

ically by following the instructions given at the conclusion of the activity.

CME/MOC/ECME Objective for This Article: Upon completion of

this activity, the learner should be able to: 1) describe the challenges in

obtaining valid blood pressure measurements in the clinic setting; 2)

discuss the reasons for measuring blood pressure outside of the clinic

setting; 3) describe the regulatory issues surrounding blood pressure mea-

surement; 4) discussthe challenges of measuring blood pressure in special

populations including older and obese adults, pregnant women, and those

with arrhythmias; and 5) identify highpriority research questions thatneed

to be addressed in future studies.

CME/MOC/ECME Editor Disclosure: JACC CME/MOC/ECME Editor

Ragavendra R. Baliga, MD, FACC, has reported that he has no ﬁnancial

relationships or interests to disclose.

Author Disclosures: This work was supported by the Division of Cardio-

vascular Sciences (DCVS) of the National Heart, Lung, and Blood Insti-

tute (NHLBI). Dr. Muntner has received grant support from the

American Heart Association (15SFRN2390002) and from Amgen Inc. Dr.

Whelton has received grant support from the National Institute of

General Medical Sciences of the National Institutes of Health (NIH)

(P20GM109036). Dr. Bello has received grant support from the National

Center for Advancing Translation Sciences (5KL2TR001874-02) and the

ISSN 0735-1097/$36.00 https://doi.org/10.1016/j.jacc.2018.10.069

Listen to this manuscript’s

audio summary by

Editor-in-Chief

Dr. Valentin Fuster on

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. 73, NO. 3, 2019

ª2019 THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION.

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National Heart, Lung, and Blood Institute (NHLBI) (K23HL136853-01A1).

Dr. Green has received grant support from the Patient-Centered

Outcomes Research Institute (CER-1511-32979 and IHS-1507-31146), and

NHLBI (1R01HL136575). Dr. Jones has received grant support from the

National Institute of General Medical Sciences (1U54GM115428). Dr.

Juraschek has received grant support from NHLBI (7K23HL135273-02).

Dr. Margolis has received grant support from the Patient-Centered

Outcomes Research Institute (IHS-1507-31146) and NHLBI

(R01HL090965). Dr. Navar has received grant support from NHLBI (K01

HL133416). Dr. Schwartz has received grant support from NHLBI (P01

HL47540). Dr. Shimbo has received grant support from NHLBI (K24-

HL125704, R01HL117323, and P01 HL47540). Dr. Cushman has received

institutional grant support from Eli Lilly; and has been a consultant to

Sanoﬁand an uncompensated consultant to Novartis and Takeda. Dr.

Navar has received institutional research support from Amgen, Amarin,

Janssen, Regeneron, and Sanoﬁ; and has been a consultant/served on

advisory boards for Amarin, NovoNordisk, Amgen, and Sanoﬁ.

Dr. Rakotz is an employee of the American Medical Association.

Dr. Stergiou has received institutional research support from iHealth,

InBody, Maisense, and Microlife; and consulting fees from Maisense,

Microlife, and Omron. The views expressed in this report are those of

the authors and do not necessarily represent the views of the National

Heart, Lung, and Blood Institute; the National Institutes of Health; or

the Department of Health and Human Services. The ﬁndings and

conclusions in this report are those of the authors and do not necessarily

represent the views of the American Medical Association. All other

authors have reported that they have no relationships relevant to the

contents of this paper to disclose.

Medium of Participation: Print (article only); online (article and quiz).

CME/MOC/ECME Term of Approval

Issue Date: January 29, 2019

Expiration Date: January 28, 2020

From the

Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama;

Division of Cardiovascular

Sciences, National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda, Maryland;

Preventive Medicine

Section, Medical Service, Veterans Affairs Medical Center, Memphis, Tennessee;

Department of Epidemiology, Tulane University

School of Public Health and Tropical Medicine, New Orleans, Louisiana;

Department of Medicine, Division of Cardiology,

Columbia University Medical Center, New York, New York;

Division of Renal Diseases & Hypertension, University of Minnesota,

Minneapolis, Minnesota;

Kaiser Permanente Washington Health Research Institute, Seattle, Washington;

Department of Med-

icine, University of Mississippi Medical Center, Jackson, Mississippi;

Department of Medicine, Beth Israel Deaconess Medical

Center, Harvard Medical School, Boston, Massachusetts;

HealthPartners Institute, Minneapolis, Minnesota;

Department of

Medicine, Johns Hopkins University, Baltimore, Maryland;

Duke Clinical Research Institute, Durham, North Carolina;

National

Center for Health Statistics of the Centers for Disease Control and Prevention, Hyattsville, Maryland;

American Medical Associ-

ation, Chicago, Illinois;

Department of Medicine, Brigham’s and Women’s Hospital, Harvard University, Boston, Massachusetts;

Department of Psychiatry and Behavioral Sciences, Stony Brook University, Stony Brook, New York;

The Hypertension Center,

Columbia University Medical Center, New York, New York;

Hypertension Center STRIDE-7, National and Kapodistrian University

of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece;

Department of Medicine, Uni-

versity of Pennsylvania, Philadelphia, Pennsylvania;

Department of Medicine, Wake Forest University, Winston-Salem, North

Carolina; and the

Department of Medicine, Case Western Reserve University, Cleveland, Ohio. This work was supported by the

Division of Cardiovascular Sciences (DCVS) of the National Heart, Lung, and Blood Institute (NHLBI). Dr. Muntner has received

grant support from the American Heart Association (15SFRN2390002) and from Amgen Inc. Dr. Whelton has received grant support

from the National Institute of General Medical Sciences of the National Institutes of Health (NIH) (P20GM109036). Dr. Bello has

received grant support from the National Center for Advancing Translation Sciences (5KL2TR001874-02) and the National Heart,

Lung, and Blood Institute (NHLBI) (K23HL136853-01A1). Dr. Green has received grant support from the Patient-Centered Outcomes

Research Institute (CER-1511-32979 and IHS-1507-31146), and NHLBI (1R01HL136575). Dr. Jones has received grant support from the

National Institute of General Medical Sciences (1U54GM115428). Dr. Juraschek has received grant support from NHLBI

(7K23HL135273-02). Dr. Margolis has received grant support from the Patient-Centered Outcomes Research Institute (IHS-1507-

31146) and NHLBI (R01HL090965). Dr. Navar has received grant support from NHLBI (K01 HL133416). Dr. Schwartz has received

grant support from NHLBI (P01 HL47540). Dr. Shimbo has received grant support from NHLBI (K24-HL125704, R01HL117323, and

P01 HL47540). Dr. Cushman has received institutional grant support from Eli Lilly; and has been a consultant to Sanoﬁand an

uncompensated consultant to Novartis and Takeda. Dr. Navar has received institutional research support from Amgen, Amarin,

Janssen, Regeneron, and Sanoﬁ; and has been a consultant/served on advisory boards for Amarin, NovoNordisk, Amgen, and

Sanoﬁ. Dr. Rakotz is an employee of the American Medical Association. Dr. Stergiou has received institutional research support

from iHealth, InBody, Maisense, and Microlife; and consulting fees from Maisense, Microlife, and Omron. The views expressed in

this report are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the

National Institutes of Health; or the Department of Health and Human Services. The ﬁndings and conclusions in this report are

those of the authors and do not necessarily represent the views of the American Medical Association. All other authors have re-

ported that they have no relationships relevant to the contents of this paper to disclose.

Manuscript received July 1, 2018; revised manuscript received October 14, 2018, accepted October 15, 2018.

Muntner et al.JACC VOL. 73, NO. 3, 2019

Blood Pressure Assessment in Adults JANUARY 29, 2019:317–35

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Blood Pressure Assessment in Adults in

Clinical Practice and Clinic-Based Research

JACC Scientiﬁc Expert Panel

Paul Muntner, PHD,

Paula T. Einhorn, MD, MS,

William C. Cushman, MD,

Paul K. Whelton, MB, MD, MSC,

Natalie A. Bello, MD, MPH,

Paul E. Drawz, MD, MHS, MS,

Beverly B. Green, MD, MPH,

Daniel W. Jones, MD,

Stephen P. Juraschek, MD, PHD,

Karen L. Margolis, MD, MPH,

Edgar R. Miller 3RD, MD, PHD,

Ann Marie Navar, MD, PHD,

Yechiam Ostchega, PHD, RN,

Michael K. Rakotz, MD,

Bernard Rosner, PHD,

Joseph E. Schwartz, PHD,

Daichi Shimbo, MD,

George S. Stergiou, MD, PHD,

Raymond R. Townsend, MD,

Jeff D. Williamson, MD,

Jackson T. Wright, JR, MD, PHD,

Lawrence J. Appel, MD, MPH,

from a 2017 National Heart, Lung, and Blood Institute Working Group

ABSTRACT

The accurate measurement of blood pressure (BP) is essential for the diagnosis and management of hypertension.

Restricted use of mercury devices, increased use of oscillometric devices, discrepancies between clinic and out-of-clinic

BP, and concerns about measurement error with manual BP measurement techniques have resulted in uncertainty for

clinicians and researchers. The National Heart, Lung, and Blood Institute of the U.S. National Institutes of Health

convened a working group of clinicians and researchers in October 2017 to review data on BP assessment among adults in

clinical practice and clinic-based research. In this report, the authors review the topics discussed during a 2-day meeting

including the current state of knowledge on BP assessment in clinical practice and clinic-based research, knowledge

gaps pertaining to current BP assessment methods, research and clinical needs to improve BP assessment, and the

strengths and limitations of using BP obtained in clinical practice for research and quality improvement activities.

Hypertension affects about 103 million

adults in the United States and over a

billion people worldwide (1–3). The accu-

rate assessment of arterial blood pressure (BP) levels

is needed for the diagnosis and treatment of hyper-

tension. Researchers ﬁrst measured BP in the 1700s,

and by the late 1800s, BP assessment was introduced

into clinical practice (4).However,itwasnotuntilthe

20th century that observational data showed that

higher BP levels were associated with increased car-

diovascular disease (CVD) risk. Subsequently, ran-

domized trials demonstrated that lowering BP from

levels that were previously considered “essential”

(systolic/diastolic BP up to 210/100 mm Hg) reduced

the risk of CVD and death.

The direct measurement of BP requires an intra-

arterial assessment. In clinical practice and most

clinic-based research studies, BP is estimated using

noninvasive methods. In the current document, we

use the term BP measurement for estimates obtained

through noninvasive means. For much of the 20th

century, BP was assessed through au scultation and the

recognition of Korotkoff sounds, with mercury-based

sphygmomanometer measurements serving as the

reference standard. This noninvasive auscultatory

approach remained the reference standard until the

early 21st century.

More recently, restrictions on the use of mercury

devices, increased availability of oscillometric de-

vices, discrepancies between clinic BP and out-of-

clinic BP, and an increasing recognition of the sus-

ceptibility of BP assessed using the auscultatory

method to measurement error have resulted in

uncertainty for clinicians and researchers. To date,

hypertension treatment guidelines and quality con-

trol metrics have largely relied on BP measured in

the clinic setting. Performance measures, which are

often reported using data captured by electronic

medical records (EMR), have expanded the role of

clinic-based BP. However, different values are often

obtained when BP is measured in the clinic versus

outside of the clinic setting, and it is recommended

that out-of-clinic measurements be obtained to

conﬁrm the presence of hypertension based on

clinic measurements and for the management of

high BP (1,5).

TheNationalHeart,Lung,andBloodInstituteof

theU.S.NationalInstitutesofHealthconveneda

JACC VOL. 73, NO. 3, 2019 Muntner et al.

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working group of clinicians and researchers

in October 2017 to review data on BP assess-

ment in adults in clinical practice and clinic-

based research. BP assessment in children

and adolescents is a complex topic that

merits separate attention. The working group

held a conference that was designed to

complement ongoing American Heart Asso-

ciation (AHA) activities including the 2017

Task Force’s Guideline for Prevention,

Detection, Evaluation and Management of

High Blood Pressure in Adults and an update

of the 2005 AHA ScientiﬁcStatementonBP

measurement in humans (1,6). This state-

ment presents the discussion and recom-

mendations from the Blood Pressure

Measurement Working Group convened by

the National Heart, Lung, and Blood Insti-

tute, whose aims were to: 1) evaluate the

current state of knowledge on BP assessment

in clinical practice and clinic-based research

for diagnosing hypertension and evaluating response

to antihypertensive treatment; 2) identify knowledge

gaps pertaining to current BP assessment methods; 3)

evaluate research and clinical needs to improve BP

assessment for the aforementioned purposes; and 4)

evaluate the use of BP obtained in clinical practice for

research and quality improvement activities. In

addressing these objectives, the working group

focused on 2 primary topics: 1) how different mea-

surement methods can be integrated into clinic-based

research and routine clinical practice to perform ac-

curate BP assessment; and 2) how the quality of BP

measurements obtained in routine clinical practice

can be improved to provide better patient care and to

be suitable for clinic-based research (Central

Illustration). It is outside the scope of this document

to provide practice guidelines on BP measurement.

BP ASSESSMENT IN AMBULATORY CLINICAL

PRACTICE AND CLINIC-BASED RESEARCH:

CURRENT PRACTICE AND CHALLENGES

CURRENT APPROACHES TO BP MEASUREMENT. In

the clinic setting, BP can be estimated by an observer

listening to Korotkoff sounds with a stethoscope

using the auscultatory approach and a manual

manometer or with an electronic device using the

oscillometric approach. Over the past 40 years,

devices have been developed and validated to

estimate BP outside of the clinic setting through

ambulatory blood pressure monitoring (ABPM) or

self-monitoring. Self-monitored BP has been stud-

ied frequently using measurements taken in the

home (referred to as home blood pressure moni-

toring [HBPM]), but also includes measurements

takeninpublicsettings(e.g.,apharmacyorgrocery

store) using a semiautomated or automated oscil-

lometric device. Automated devices can take mul-

tiple BP readings at set intervals (e.g., 1 min apart)

with a single activation, whereas semiautomated

devices require manual initiation for each individ-

ual BP measurement. Most out-of-clinic BP mea-

surements are obtained using the oscillometric

approach.

BP MEASUREMENT IN THE CLINIC SETTING. BP is

typically assessed in routine clinical practice during

outpatient visits. An initial BP measurement is most

often performed by a medical assistant or nurse who

frequently is also collecting information on other

physical measurements (e.g., height, weight), rele-

vant medical history, and current medications being

taken before the patient is seen by a clinician. A

follow-up BP measurement may be performed by a

clinician to conﬁrm the initial reading. The primary

purposes of measuring BP in routine clinical practice

are to screen for hypertension and hypotension, and

to monitor the response to antihypertensive treat-

ment. There are often time constraints affecting the

accuracy of completed BP measurements in clinical

practice settings. Although contemporary data are

sparse, training in BP measurement, equipment used,

and measurement methods vary widely across clinics,

and nearly always deviate from methods recom-

mended by guidelines.

In clinical trials, the protocol used to measure BP is

often standardized across sites to minimize system-

atic errors and variability. However, protocols often

differ across trials and are not always reported in

detail in publications. Differences in measurement

techniques across clinical trials include the device

employed, the use and duration of a rest period, the

arm used, participant position during measurement,

the presence of ambient noise, conversation with the

participant, whether the measurement is observed

or unobserved, time of day when BP is measured,

trial activities that precede BP assessment, the num-

ber of measurements taken, and the number of mea-

surement occasions (7). BP variability is increased

when measurements do not follow a speciﬁcstudy

protocol. As a result, BP readings measured in

different research settings and between research and

routine clinical practice can differ substantially from

what they would be if a standardized protocol had

been used (8).

The auscultatory approach requires good hearing,

extensive training and retraining, and periodic certi-

ﬁcation to record the onset and disappearance of the

ABBREVIATIONS

AND ACRONYMS

ABPM =ambulatory blood

pressure monitoring

ACC =American College of

Cardiology

AF =atrial ﬁbrillation

AHA =American Heart

Association

AOBP =automated ofﬁce

blood pressure

BP =blood pressure

CVD =cardiovascular disease

DBP =diastolic blood pressure

EMR =electronic medical

record

FDA =Food and Drug

Administration

HBPM =home blood pressure

monitoring

SBP =systolic blood pressure

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Korotkoff sounds (9,10).Althoughrarelyused

anymore in clinical and research settings, the mer-

cury sphygmomanometer is still considered the

reference standard device. It remains useful for vali-

dating oscillometric devices (11).Calibratedaneroid

manometers can be considered a substitute for mer-

cury devices (12).However,aneroidmanometersare

easily damaged and require frequent recalibration to

ensure their measurement accuracy (13).

Oscillometric BP devices estimate systolic BP (SBP)

and diastolic BP (DBP) from the mean arterial pres-

sure using a device-speciﬁc algorithm and the oscil-

lometric pulse waves detected in the BP cuff,

typically during deﬂation although some devices

assess BP during inﬂation. Each manufacturer of

oscillometric devices incorporates its own undis-

closed proprietary algorithm(s) for estimating SBP

and DBP. Aging and other conditions that affect

CENTRAL ILLUSTRATION Clinic, Home, and Ambulatory Blood Pressure Measurements

Muntner, P. et al. J Am Coll Cardiol. 2019;73(3):317–35.

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arterial compliance, such as pregnancy, diabetes,

kidney disease, and arrhythmias, may affect the ac-

curacy of these algorithms (14).AnyoscillometricBP

measurement device used in clinical or research set-

tings should have peer-reviewed published docu-

mentation of its rigorous validation with a mercury

device or non-mercury device that meets the ISO

81060-1 requirements for accuracy of a noninvasive

sphygmomanometer (15).The“black box”nature of

proprietary algorithms used in oscillometric devices

is a limitation (16). Some updated oscillometric de-

vices may be using modiﬁed algorithms to estimate

BP, and validation studies are not always performed

to conﬁrm their accuracy. Even after devices have

been validated, they still need to be used in a stan-

dardized manner. This includes correctly positioning

the patient, having the BP cuff at heart level on a bare

upper arm, using an appropriate size and correctly

ﬁtting BP cuff, and having the patient rest before the

ﬁrst measurement and between repeat measurements

(Table 1).

In the clinic setting, several oscillometric devices

that take multiple BP measurements automatically,

at set intervals, are available. These automated ofﬁce

blood pressure (AOBP) devices can measure BP

with or without an observer present (17).Some

studies have suggested that BP measured with staff

present (attended BP assessment) result in higher

readings than those obtained with staff absent dur-

ing measurement (unattended AOBP). In a pooled

analysis of 8,558 adults, the mean clinic BP was

10/7 mm Hg higher when recorded by a provider

in clinical practice using the auscultatory method

with a mercury sphygmomanometer versus with

unattended AOBP (18–24). In 2017, the Hypertension

Canada guideline recommended unattended AOBP as

TABLE 1 Key Steps and Instructions for the Proper Measurement of Clinic BP

Key Steps for Proper BP Measurements Speciﬁc Instructions

Step 1: Properly prepare the patient 1. T he pati ent sh ould av oid caffein e, exer cise , and smo king f or at lea st 30 min befor e the measure ment p roced ure

begins.

2. Ensure the patient has emptied his/her bladder.

3. Neither the patient nor the observer should talk during the rest period or during the measurement.

4. Remove clothing covering the location of cuff placement. Be sure to avoid rolling up sleeves; this may cause a

(partial) tourniquet effect.

5. Measurements made while the patient is sitting or lying on an examining table do not fulﬁll these criteria.

Step 2: Use proper technique for

BP measurements

1. Use a BP measurement device that has been validated, and ensure that the device is calibrated at recommended

intervals.

2. Obtain the patient’s mid-arm circumference. For more details on how to accurately obtain mid-arm circumference,

see the Anthropometry Procedures Manual on the NHANES website.

3. Record the mid-arm circumference for future use.

4. Support the patient’s arm (e.g., resting on a desk).

5. Position the middle of the cuff on the patient’s upper arm at the level of the right atrium (the midpoint of the

sternum).

6. Use the correct cuff size, such that the bladder encircles 75% to 100% of the arm and a width that is 37% to 50% of

the arm circumference.

7. Once the patient is prepared, have him/her relax, sitting in a chair with their fee t ﬂat on the ﬂoor and back supported.

The patient should be seated for 5 min without talking or moving around before recording the ﬁrst BP reading.

A shorter wait period is used for some AOBP devices.

8. Either the stethoscope diaphragm or bell may be used for auscultatory readings.

Step 3: Take the proper measurements

needed for diagnosis and treatment of

elevated BP/hypertension

1. At the ﬁrst visit, record BP in both arms. Use the arm that gives the higher reading for subsequent readings if there is

a consistently higher level (e.g., $10 mm Hg) in one arm versus the other.

2. Separate repeated measurements by 1 to 2 min.

3. For auscultatory determinations, use a palpated estimate of radial pulse obliteration pressure to estimate SBP.

Inﬂate the cuff 20 to 30 mm Hg above this level for an auscultatory determination of the BP level.

4. For auscultatory determinations, place the head of the stethoscope over the brachial artery.

5. For oscillometric devices, position the center of the blood pressure cuff over the upper arm brachial ar tery at least

1inch above the crease of the elbow.

6. For auscultatory readings, deﬂate the cuff pressure 2 mm Hg/s, and listen for Korotkoff sounds.

7. Staff retraining required at 6-month intervals.

Step 4: Properly document accurate BP readings 1. R ecord SBP and D BP. If us ing the a uscul tato ry tech niqu e, reco rd SBP as o nset of the ﬁrstofatleast2consecutive

beats and the last audible sound as DBP, Korotkoff phases 1 and 5, respectively. In case that the sounds are audible at

full deﬂation or until very low DBP levels (<40 mm Hg), then Korotkof f phase 4 (mufﬂing of sounds) should be

recorded and reported for DBP.

2. If using the auscultatory approach, record SBP and DBP to the nearest even number.

3. Note the time of most recent BP medication taken before measurements.

Step 5: Average the readings Use an average of $2 readings obtained on $2 occasions to estimate the individual’s level of BP.

Step 6: Provide BP readings to patient Provide patients their SBP/DBP readings both verbally and in writing. Information to help patients interpret their BP values

should also be provided.

Adapted with permission from Mancia et al. (45), Pickering et al. (6), Weir et al. (131), and Whelton et al. (1).

AOBP ¼automated ofﬁce blood pressure; BP ¼blood pressure; DBP ¼diastolic blood pressure; NHANES ¼National Health and Nutrition Examination Survey; SBP ¼systolic blood pressure.

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the preferred method of clinic BP measurement (25).

Unattended and attended BP measurements should

ideally be compared using the same device. In ran-

domized studies comparing unobserved and

observed AOBP using the same device, the difference

in BP using these 2 approaches has been small

(26,27). Also, a secondary analysis of the Systolic

Blood Pressure Intervention Trial found no differ-

ence in BP levels measured in clinical sites that had

staff present versus absent during BP measurement

(28). These data suggest that no differences in BP

may be present when assessed using attended versus

unattended AOBP as long as a BP measurement

protocol is rigorously followed and an oscillometric

device is used. However, as these protocols are rarely

followed in routine clinical practice, unattended

AOBP may be useful to minimize the occurrence of

protocol violations (e.g., talking during the BP mea-

surement, insufﬁcient amount of rest before and

between BP measurements).

BP MEASUREMENT OUTSIDE OF THE CLINIC

SETTING. ABPM and HBPM are used to obtain BP

measurements outside of medical settings, without a

health care provider, researcher, or observer present.

Typically, more BP readings are obtained with ABPM

and HBPM than with clinic measurements (29).Both

ABPM and HBPM are typically used to assess average

BP outside of the clinic, which enables the identiﬁ-

cation of mismatches between clinic hypertension

and out-of-clinic hypertension including white coat

hypertension and masked hypertension (deﬁned later

in the text) (30). An important difference between

ABPM and HBPM is that ABPM assesses daytime and

nighttime BP typically over one 24-h period while a

person goes about their routine daily activities. By

contrast, HBPM typically assesses BP during the day,

usually in the morning and early evening, over a

period of days to weeks while the person is seated

and resting, but typically not during sleep (30).

ABPMandHBPMshouldnotbeconsideredinter-

changeable, because there is only moderate agree-

ment between daytime values on ABPM and home BP

on HBPM (31,32). Until recently, HBPM could not

obtain BP readings during sleep, preventing the

determination of diurnal BP patterns. However,

HBPM devices that can assess BP during sleep, typi-

cally 3 measurements at 1-h intervals, have recently

become available (33). There is currently insufﬁcient

evidence to decisively determine whether BP

measured using ABPM or HBPM has a stronger asso-

ciation with risk for CVD events, although there are

more data linking out-of-clinic BP on ABPM to CVD

events (34). The selection of ABPM or HBPM may

depend on the application. In clinical practice, ABPM

may be most useful in identifying white coat, masked

hypertension, or nocturnal hypertension because

multiple readings are taken throughout the day.

HBPM may be more useful to monitor BP for patients

taking antihypertensive medication because it can be

used over prolonged periods of time. More data are

needed on the use of HBPM devices to identify white

coat and masked hypertension, phenotypes that are

described later in the text.

Oscillometric devices, often located in a booth or

kiosk in pharmacies, grocery stores, ﬁtness facilities,

or other locations, offer a convenient way to check

BP. These devices may be conﬁgured to allow BP data

to be directly transmitted to health care providers or

to an EMR, which can then be used to help manage BP

control. Although scarce evidence exists, there are

some data suggesting that BP obtained in public set-

tings may be similar to daytime ABPM (35).However,

caution is needed. Many devices in public settings

utilize a single-size cuff that is considered too small

(<33 cm) for the arm circumferences of many adults.

Most of these devices have not undergone a valida-

tion study, or manufacturers have declined to share

validation data when queried (36).Thedevicesare

frequently located in noisy, high-trafﬁcareas,which

FIGURE 1 BP Phenotypes Deﬁned by Combinations of Clinic and Out-of-Clinic BP

Sustained

Hypertension

Normotension

Hypertension† based on:

Out-of-clinic Blood Pressure

Hypertension* based on:

Clinic Blood Pressure

No Yes

Yes

Masked Hypertension

White Coat

Hypertension

*$130/80 mm Hg is the threshold for clinic blood pressure (BP) recommended in

the 2017 American College of Cardiology/American Heart Association guideline

($140/90 mm Hg was the threshold for clinic blood pressure used in Seventh Report of

the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of

High Blood Pressure [JNC 7]). †$130/80 mm Hg is the threshold for awake and home

blood pressure recommended in the 2017 American College of Cardiology/American

Heart Association guideline ($135/85 mm Hg was the threshold for awake blood pressure

used in JNC 7). Some guidelines also recommend considering 24-h and asleep blood

pressure. The terms listed in the ﬁgure refer to untreated individuals. Among

individuals taking antihypertensive medication, the corresponding terms are:

white coat hypertension—white coat effect; masked hypertension—masked uncontrolled

hypertension; sustained hypertension—uncontrolled hypertension; and

normotension—controlled hypertension.

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are not conducive to obtaining an accurate resting BP

measurement. In addition, there are no data showing

the association of BP measured in a booth or kiosk

andCVDrisk.Furthermore,thresholdsforwhat

should be considered a normal BP level have not been

determined for this setting. When BP values from

measurements in a kiosk are available, it is important

that the device has undergone validation and is

located in a quiet setting. An alternative approach is

having pharmacists measure BP. There are some data

suggesting pharmacist-measured BP aligns with

awake BP on ABPM (37).

Despite recommendations from the United States

Preventive Services Task Force and American College

of Cardiology (ACC)/AHA to assess out-of-clinic BP to

identify white coat and masked hypertension, out-of-

clinic BP is rarely obtained before a hypertension

diagnosis is made in the United States (1,5).Ina

qualitativeresearchstudyconductedwithprimary

care providers in Alabama and New York, cost, time

requirements, lack of infrastructure including access

to BP monitoring devices, and low reimbursement

were reported as major barriers to performing ABPM

(38). In contrast to ABPM, barriers preventing the

more widespread use of HBPM relate to providers’

concerns that patients will not measure their BP

correctly and that patients will become preoccupied

with their BP (39,40). Device affordability may be a

barrier for conducting HBPM in some populations.

Also, health care providers may lack conﬁdence

in their own skills and knowledge to interpret out-

of-clinic BP assessments from ABPM and HBPM (38).

The successful incorporation of ABPM and HBPM

into clinical practice may require additional equip-

ment, staff training, and time in conducting and un-

derstanding what constitutes satisfactory recordings.

Additionally, knowledge about which devices are

validated and how to interpret out-of-clinic BP read-

ings and incorporate out-of-clinic BP into clinical

decision making is needed (30). Currently, there

are no core clinical competencies for conducting

out-of-clinic BP assessment (30). Before undergoing

ABPM, patients should be instructed on proper posi-

tioning and anticipating potential mild discomfort

and disturbance of sleep associated with cuff inﬂation

and deﬂation while BP is being measured, to prevent

removal of the ABPM device and cuff (30,41).For

HBPM, patients should be instructed on proper posi-

tioning, where and when to measure their BP, and

how to interpret the results.

Software for downloading BP readings from ABPM

is included with each device and typically generates

reports that include mean daytime, nighttime, and

24-h values as well as daytime-to-nighttime BP ratio.

In addition to PC-based software, some HBPM device

manufacturers have developed mobile app and

Internet-based software that automatically stores BP

readings, making it possible for patients to share

HBPM data with their health care providers and to

prevent misreporting of self-measurements. Ideally,

individual ABPM and HBPM readings can be entered

into structured ﬁelds of EMRs, using automated data

transfer processes; such data could be useful for

quality measures and to generate summary statis-

tics, including average BP over time. Currently, few

providers and patients have access to these

resources.

WHITE COAT HYPERTENSION AND MASKED

HYPERTENSION. The difference between clinic and

out-of-clinic BP measurements is often substantial

(42–44). Thus, there are individuals who meet the

criteria for hypertension based on their clinic BP, but

not based on their out-of-clinic BP, and vice versa.

This results in 4 BP phenotypes deﬁned by

the possible combinations of hypertensive/non-

hypertensive clinic BP and hypertensive/non-

hypertensive out-of-clinic BP: 1) normotension; 2)

white coat hypertension; 3) masked hypertension;

and 4) sustained hypertension (Figure 1). European

guidelines have suggested deﬁning white coat and

masked hypertension using mean out-of-clinic

awake, sleep, or 24-h BP (45).Speciﬁcally, it is sug-

gested to deﬁne white coat hypertension as BP in the

hypertension range when measured in the clinic, but

mean awake, asleep, and 24-h BP not in the hyper-

tension range. Analogously, masked hypertension is

deﬁned by BP not in the hypertension range when

measured in the clinic but mean awake, asleep, or

24-h BP in the hypertension range.

In a New York metropolitan area community sam-

ple (N ¼888) not taking antihypertensive medication,

the prevalence of white coat hypertension among

those with clinic SBP $140 mm Hg or DBP $90 mm Hg

was 19.1%, whereas the prevalence of masked hy-

pertension among those with clinic SBP <140 mm Hg

and DBP <90 mm Hg was 15.7% (42).IntheJackson

Heart Study, a cohort comprised exclusively of Afri-

can Americans, the prevalence of white coat hyper-

tension and masked hypertension among those not

taking antihypertensive medication was 30.2% and

25.4%, respectively (46).

When compared with normotension, masked

hypertension has been associated with a 2 times

higher risk for CVD (47,48).Insomestudies,therisk

for CVD has been reported to be similar for

individuals with masked hypertension and sustained

hypertension (48,49). It is unclear whether white

coat hypertension is associated with a substantially

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increased risk for CVD compared with normotension

(50,51).However,itshouldberecognizedthata

high proportion of participants with white coat

hypertension in prior studies may have initiated

antihypertensive medication during follow-up, which

would have resulted in a lower CVD risk compared

with what might have been identiﬁed had they

remained untreated. Also, the incidence of sustained

hypertension is substantially higher for adults with

white coat hypertension versus normotension

(52,53).

Theprevalenceofwhitecoathypertensionis

higher in those who are older, female, and have lower

BMI, and the prevalence of masked hypertension is

higher in those who are older, male, have a higher

BMI, have reduced kidney function, and are smokers

(54–56). The strongest predictors of white coat

hypertensionandmaskedhypertensionareclinicSBP

and DBP, with the probability being highest when

clinic BP is close to the threshold used for deﬁning

hypertension. Similar to BP measured in the clinic,

the accuracy and reproducibility of out-of-clinic BP

improves as the number of readings being averaged

increases (57). However, the marginal beneﬁtofeach

additional reading decreases as the total number

of readings increases. The concern with diagnostic

accuracy and reproducibility is compounded when

using out-of-clinic BP in conjunction with clinic BP.

Several studies have shown that diagnoses of white

coat hypertension or masked hypertension are only

moderately reproducible (58,59).

EMERGING ALTERNATIVE APPROACHES TO BP

ASSESSMENT IN AMBULATORY CLINICAL SETT INGS.

The explosion in iPhone and Android apps has made

its way into the BP measurement arena. A number of

apps measure BP directly, whereas others allow for

readings to be manually entered for storage (60,61).

Many apps use a combination of ﬁnger plethysmog-

raphy and pulse transit time calculations to estimate

BP (62). Few rigorous studies assessing the validity of

theseappshavebeenconducted.Onestudyshowed

poor performance for one of these apps (63).TheU.S.

Food and Drug Administration (FDA) only oversees

some forms of mobile health technology, and there

are insufﬁcient validation data and no outcome data

supporting their use. The U.S. FDA oversees mobile

health technology that is used to diagnose and treat

disease. Noninvasive BP monitors are considered

moderate-risk medical devices that must be cleared

by the FDA. However, these devices, including mobile

apps that measure BP, are only required to show

“substantial equivalence”to another device that has

been cleared by the FDA. There have been calls for

laws requiring studies that demonstrate sufﬁcient

accuracy for new BP monitors.

Other “wearable”devices use a calibrated radial

pulsewaveformtoestimateBPandcandosoover

extended periods of time. Some devices appear to

maintain calibration and be accurate for at least 24 h

and, thus, have been suggested as a surrogate for

ABPM in some populations (64). An additional chal-

lenge is to ensure that measurements are obtained

with the device at heart level; otherwise measured BP

values will tend to under- or overestimate actual BP

depending on whether the wrist is above or below

heart level, respectively.

STATISTICAL CONSIDERATIONS. The diagnosis of

hypertension and evaluation of response to treatment

require accurate assessment of BP to prevent under-

or overtreatment. BP varies both within and between

visits. Although both sources of variability are

important to recognize, variability is greater between

versus within visits, and the precision of observed

mean BP depends on the number of visits and the

number of measurements per visit (65). For example,

in one study with 1 research-grade measurement

obtained at a single visit, the standard errors of SBP

and DBP were approximately 7.0 and 6.0 mm Hg,

respectively, whereas 3 measurements at 2 visits

resulted in standard errors of 3.7 and 3.2 mm Hg,

respectively (Online Table 1). BP measurements

in routine clinic practice probably have larger

standard errors. Hypertension screening algorithms

can be determined on the basis of a function of

between-person and within-person variability, and

2 or more BP measurements on 2 or more occasions is

required to accurately screen adults for high BP in the

clinic (65,66). Similar approaches can be used to

assess the response to treatment and require 2 or

more pre- and post-treatment visits and a change of

5to7mmHginDBPtobe80%conﬁdent that true

change has occurred (67).

SPECIAL POPULATIONS AND CLINICAL ISSUES.

Older adults. Because of its high prevalence in older

adults, hypertension is a leading cause of preventable

morbidity, mortality, and premature disability and

institutionalization in this population (68–71).

Although mean SBP increases at older ages, the

standard deviation of SBP and DBP is not substan-

tially different when compared with younger persons

with similar levels of BP (72). Additionally, in a recent

meta-analysis, older age was not associated with the

difference in BP when measured intra-arterially and

noninvasively with a BP cuff (73). However, as in all

ages, there is a subset of older adults in whom the

accurate measurement of BP is challenging due to the

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presence of comorbidity, aging-related cardiovascu-

lar changes, arrhythmia, and polypharmacy (74).For

example, some older adults have noncompressible

arteries, which may make BP readings inaccurate (75).

Additionally, an auscultatory gap might be present

among older adults (76). The 2018 AAMI-ESH-ISO

universal standard for the validation of BP monitors

does not consider older adults a special population

warranting a distinct validation of oscillometric BP

monitors (15).

Orthostatic hypotension. Orthostatic hypotension

is a risk factor for falls, syncope, CVD, stroke, and

death (77–82). The prevalence of orthostatic hypo-

tension increases with age, and is more common

among patients with uncontrolled hypertension

(79,83). Although it is recommended that orthostatic

hypotensionbeassessedinpatientswithahistoryof

falls or postural dizziness, it has unclear utility in

guiding BP management (84,85). Recent clinical trials

have shown that lower versus higher BP goals may

not increase the risk for having orthostatic hypoten-

sion, and that there is only modest overlap between

measured orthostatic hypotension and symptoms of

dizziness or lightheadedness on standing (86–88).

However, methodologic limitations may be respon-

sible for these null ﬁndings.First,multipleprotocols

exist for performing orthostatic hypotension assess-

ments (e.g., seated vs. supine vs. tilt-table) (89).

Second, there is substantial heterogeneity in guide-

lines as to when orthostatic hypotension should be

assessed, ranging from within 1 min to after 3 min of

standing (25,45,90), and BP measurements performed

sooner after rising appear to be stronger predictors of

long-term risk for adverse outcomes, including falls

(80,91–94). Third, current cutpoints used to deﬁne

orthostatic hypotension on the basis of change in SBP

or DBP (i.e., a drop of 20 mm Hg in SBP or a drop of

10 mm Hg in DBP) do not reﬂect natural thresholds of

risk, are insensitive for orthostatic symptoms, and

may perform poorly among adults with hypertension

(81,85).Otherdeﬁnitions of orthostatic hypotension

have been proposed for patients with hypertension

(e.g., a change in SBP of >30 mm Hg or a standing

SBP <90 mm Hg) (95). However, it is possible that

orthostatic symptoms are more important for long-

term outcomes than protocol-based changes in BP

upon standing.

Obesity. TheprevalenceofobesityinU.S.adultshas

increased substantially in recent years (96).The

measurement of BP in obese adults, including those

who are morbidly obese, is an increasingly common

challenge (97). Obesity with its associated increase in

arm circumference requires use of larger BP cuffs

(98). Selecting an appropriately sized cuff is a key

component for obtaining valid BP measurements. An

extra-large cuff or “thigh cuff”has been shown to

provide accurate BP measurements in obese adults.

However, there are few studies comparing BP mea-

surement approaches using extra-large cuffs with

direct intra-arterial measurements, and the 2018

AAMI/ESH/ISO device validation review recommends

a separate validation be performed on individuals

with an arm circumference >42 cm (15). A challenge

encountered with using larger cuffs is that large arm

shapes are often conic. Some extra-large cuffs are

available with a conic shape for these situations.

When a sufﬁciently large cuff is not available to

obtain BP measurements in the brachial artery, a

properly used validated wrist device held at the level

of the heart may be more accurate than measure-

ments taken at the brachial artery (99).

Atrial ﬁbrillation. Atrial ﬁbrillation (AF) is a com-

mon arrhythmia that complicates the measurement

of BP (100). There are no accepted noninvasive

approaches for determining BP in AF, and the accu-

racy of the auscultatory method, which, as

mentioned earlier in the text, is the reference for

validating BP monitors, is unknown within this

population. Interobserver and intraobserver varia-

tion for measuring BP is higher in AF than in sinus

rhythm (101). However, BP may be reasonably accu-

rate in patients with AF if 3 or more readings are

obtained (102). A meta-analysis of validation studies

of automated (mostly oscillometric) BP monitors in

AF showed no difference in SBP compared with

TABLE 2 Key Components of BP Measurement That Should Be Documented in the EMR

Component Rationale/Notes/Necessary for:

Date/time Allows for assessment of trends and diurnal

variation

Location (emergency department,

clinic, hospital ward, and so on)

Clinical interpretation

Staff member Quality control including the monitoring

of digit preference

Position (supine, seated, standing) Clinical interpretation

Site of cuff placement

(right/left side, arm/leg)

Clinical interpretation

Duration of quiet rest before the ﬁrst

measurement and between readings

Quality control/monitoring protocol adherence

Mid-arm circumference and cuff

size used

Quality control

Device utilized Quality control

Individual BP levels As opposed to just entering average of 2 or 3 BP

measurements. Allows for assessment of

variability and quality control/monitoring

protocol adherence (>1 BP measured).

BP levels in both arms Determine which arm is appropriate for future

measurements (arm with the higher BP should

be used)

Pain level Clinical interpretation

BP ¼blood pressure; EMR ¼electronic medical record.

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manual auscultatory measurements but a small, yet

consistent, overestimation of DBP (103). This over-

estimation of DBP may be less important because

most people with AF are older, a population wherein

SBP has more prognostic importance (100).ABPMis

feasible in AF, with similar reliability as in sinus

rhythm (104). Preliminary evidence suggests that for

patients with AF both auscultatory and oscillometric

BP measurements are clinically relevant, because

they show similar associations with intra-arterial

measurements and preclinical organ damage indices

(102,105,106). Other arrhythmias, such as frequent

premature atrial and ventricular contractions, may

also affect the accuracy of oscillometric BP mea-

surements, but evidence is sparse.

Pregnancy. Due to hemodynamic changes and

edema that often accompany pregnancy and compli-

cations including preeclampsia, oscillometric devices

that are accurate in the general adult population may

not be accurate in pregnant women, and it is recom-

mended that these devices be separately tested for

accuracy in this population (107). A systematic review

of validation studies of clinic, ABPM, and HBPM de-

vices in pregnant women found 61% of devices spe-

ciﬁcally evaluated for use in pregnancy, including

preeclampsia, met the validation criteria (108).How-

ever, only 34% of the studies wherein the device met

the validation criteria were performed without any

protocol violations (108). Current recommendations

for the use of HBPM in pregnancy include at least

weekly home measurements in women with gesta-

tional hypertension, and its use is also suggested for

women with chronic hypertension and poorly

controlled BP. The only recommendation for the use

of ABPM in pregnancy is to rule out a diagnosis of

suspected white coat hypertension before initiating

antihypertensive medication (109).Althoughdataare

limited, approximately 30% of high-risk pregnant

women have been reported to have masked hyper-

tensiononABPM(110,111).

PROS AND CONS OF USING BP

MEASUREMENTS OBTAINED IN ROUTINE

CLINICAL PRACTICE FOR RESEARCH

The advantage of using BP measurements obtained in

clinical practice for research is that over time, pa-

tients tend to have a large number of visits with BP

readings, improving precision, and potentially

reducing or even eliminating the need for research

visits. Additionally, measurements obtained in clin-

ical practice represent those used for management

and decision making, and are the basis for perfor-

mance measures. Because BP is routinely measured at

many encounters, especially in people with elevated

BP or hypertension, the number and frequency

of measurements may exceed those in research

protocols. However, major concerns with using BP

measurements obtained in clinical practice for

research are the lack of standardization and the

questionable accuracy of clinic BP measurements,

with the potential for both systematic and random

errors. Furthermore, unless BP measurements,

TABLE 3 Sources of Inaccuracy in the Measurement of BP in the Clinic Setting

Potential Source of Inaccuracy Effect on SBP Effect on DBP

Before measurement

Acute meal ingestion, mm Hg 65to1.9

Acute alcohol consumption, mm Hg 23.6 to þ24 14 to þ16

Acute caffeine consumption, mm Hg þ3toþ14 þ2.1 to þ13

Acute nicotine use or exposure, mm Hg þ2.8 to þ25 þ2toþ18

Bladder distension, mm Hg þ4.2 to þ33 þ2.8 to þ18.5

Cold exposure, mm Hg þ5toþ32 þ4toþ23

Insufﬁcient rest period, mm Hg þ4.2 to þ11.6 þ1.8 to þ4.3

Device

Device not calibrated 0% to 70%

>3mmHg*

0% to 70%

>3mmHg*

Patient positioning

Standing versus sitting, mm Hg 2.9 to þ5.0 þ7

Supine versus sitting, mm Hg 10.7 to þ9.5 13.4 to þ6.4

Legs crossed at the knee, mm Hg þ2.5 to þ14.9 þ1.4 to þ10.8

Unsupported back, mm Hg Not signiﬁcant effects þ6.5

Unsupported arm, mm Hg þ4.9 þ2.7 to þ4.8

Arm lower than heart level, mm Hg þ3.7 to þ23 þ2.8 to þ12

Attaching the device to the person

Paretic arm, mm Hg þ2þ5

Too small cuff size, mm Hg þ2.1 to þ11.2 þ1.6 to þ6.6

Too large cuff size, mm Hg 3.7 to 1.5 4.7 to 1.0

Cuff placed over clothing, mm Hg Not signiﬁcant effects Not signiﬁcant effects

Stethoscope placed under cuff, mm Hg þ1.0 to þ3.1 10.6 to 3.5

Taking the measurement

White coat effect, mm Hg 12.7 to þ26.7 8.2 to þ21

Talking during the measurement, mm Hg þ4toþ19 þ5toþ14.3

Use of stethoscope bell vs.

diaphragm, mm Hg

3.8 to 1.5 1.6

Excessive pressure on stethoscope

head, mm Hg

Not signiﬁcant effects 15 to 9

Fast cuff deﬂation, mm Hg 9to2.6 þ2.1 to þ6.3

Observer hearing deﬁcit, mm Hg 1.6 to 0.1 þ1.1 to þ4.3

Recording Korotkoff phase IV versus V

for DBP, mm Hg

Not applicable þ12.5

Short interval between

measurements, mm Hg

Not signiﬁcant effects Not signiﬁcant effects

Interpreting the measurement

Reliance on a single measurement, mm Hg þ3.3 to þ10.4 2.4 to þ0.6

Inter-arm differences, mm Hg 3.3 to 6.3†2.7 to 5.1†

Terminal digit preference 1% to 79% over-

representation of

terminal of 0

3% to 79% over-

representation of

terminal of 0

*Depending on type of device used (mercury, aneroid or automated). †Values could be too low or too high

depending on the arm used. Adapted from Kallioinen N, Hill A, Horswill M, Ward SE, Watson MO. Sources of

inaccuracy in the measurement of adult patients’resting blood pressure in clinical settings: a systematic review. J

Hypertens 2017;35:421–41. Full results from the systematic review can be found in this paper.

Abbreviations as in Table 1.

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including out-of-clinic readings, are recorded in an

EMR, it may be impractical to extract them.

It is commonly believed that research-quality BP

measurements are lower than the same individuals’

BP measurements in the routine practice setting.

However,thepressuretoscorewellonqualitymea-

sures may increase the likelihood of bias in the

opposite direction (112,113). In MESA (Multi-Ethnic

Study of Atherosclerosis), a large prospective obser-

vational study, research-grade SBP measurements

were on average 6.3 mm Hg lower than the most

proximal clinic measurement, before or after the

study visit, recorded in the EMR (114). This study

highlights the high likelihood for misclassiﬁcation of

hypertension status of patients in settings without

the use of standardized BP measurement protocols

and validated devices. However, the association

between routine clinic and research BP may not be

consistent across sites and may be modiﬁed by

patient characteristics such as age, sex, race, and

comorbidities. A standardized BP measurement pro-

tocol including the use of an oscillometric device,

training of medical assistants, and monitoring

compliance with BP protocols has shown promise in

reducing systematic measurement errors (115).Also,

when BP measurement in clinical practice is per-

formed using established protocols and validated

automated equipment, it may be acceptable for

research purposes and yield similar conclusions as

measurements obtained in research settings.

In clinical trials aimed at reducing BP, the statisti-

cal power to detect a between-group difference in BP

change depends on 2 factors: the number of partici-

pants in each group and the standard deviation of the

change in BP (SD

). The SD

can be reduced by

averaging multiple readings taken over multiple

visits for both the pre-intervention and post-

intervention BP assessments. Using BP measure-

ments from routine clinic visits, where BP from more

visits are available, would result in a smaller SD

and, therefore, a smaller sample size required for a

clinical trial. However, increasing the number of

measurements obtained will not overcome intra-

person variability introduced by an inconsistent

technique in how BP is measured and by concurrent

clinical factors (e.g., acute medical conditions) that

may be present when BP is measured in routine

clinical practice. ABPM and HBPM are alternative

approaches that provide many BP measurements.

EMERGING APPROACHES TO OBTAINING BP

MEASUREMENTS FOR CLINICAL PRACTICE

ANDCLINIC-BASEDRESEARCH

The availability of accurate and relatively inexpen-

sive oscillometric devices that measure BP and

transmit data wirelessly represents an emerging

approach to BP assessment. Data may be transmitted

from a device located in a clinic or out-of-clinic

setting to a wireless hub or smartphone, and from

there to a secure server. BP data may also be trans-

mitted to an EMR, provided appropriate security

procedures are in place, where it can then be used for

clinical care and research purposes. The development

of common data models has made it possible to pool

BP and other clinical data from different research

organizations. Databases that include BP measure-

ments, diagnosis codes, and pharmacy data may be

used to characterize the hypertension status of large

populations and to create virtual registries. EMRs are

likely to be used increasingly in observational studies

and in trials for recruitment, delivery of in-

terventions, and outcome ascertainment. These data

willbegreatlyenhancedbystandardizationoftheBP

measurement method and the use of validated

devices.

TABLE 4 Recommendations That Constitute a Minimum Standard for Clinical and

Epidemiological Research

Observer training and testing

Indicate number of observers trained and their background (e.g., physician, nurse, and

so on).

All staff who directly assess BP or train others in BP measurement should be trained

and tested as part of quality control for research. They should also have experience

conducting BP measurement on a routine basis.

If auscultatory BP assessment used, training and testing for technique and accuracy

using double-head stethoscope is recommended.

Observer measurement competency testing should occur at least every 6 months

throughout duratio n of a study, including assessment for measurement bias.

Retraining should be performed whenever deﬁciencies are found.

The BP measurement protocol should be provided in sufﬁcientdetailsothatitcanbe

duplicated by others.

Measurement conditions should be clearly deﬁned (e.g., location, position, resting

period, and so on) (119).

BP measurement devices

BP devices should be assessed for calibration at the start, every 6 months, and end of

a study (at a minimum). Date of calibration, and when next calibration is due should be

clearly marked on the device. More frequent calibration is warranted for aneroid

devices.

Data should be assessed and reported for terminal digit prefere nce.

When using the oscillometric approach, only devices that have passed accepted na-

tional or international validation protocols should be used (with references provided).

For each cuff size used, specify the bladder dimensions and range of acceptable arm

circumferences.

Only upper-arm cuffs are recommended.

BP assessment

Multiple readings should be taken and averaged at each assessment.

Multiple visits with BP assessments are preferred at baseline and during an inter-

vention follow-up.

The addition of out-of-clinic BP (ABPM or HBPM) to those measured only in research/

clinical settings is preferred.

For out-of-clinic assessments, ABPM is preferred over HBPM unless both methods can

be used.

ABPM ¼ambulatory blood pressure monitoring; BP ¼blood pressure; HBPM ¼home blood pressure monitoring.

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OPTIMIZATION OF MEASUREMENTS IN

CLINICAL PRACTICE AND IN

CLINIC-BASED RESEARCH STUDIES

KEY PRINCIPLES. Key aspects of the measurement

process include time of day, the staff member who

prepared the participant and measured BP, location

(emergency room, clinic, hospital, and so on), posi-

tion (lying, seated, standing), site of cuff placement

(right/left side, arm/leg), cuff size, and the speciﬁcBP

device used. All BPs should be recorded in the EMR in

structured data ﬁelds as individual measurements

rather than the average in order to facilitate moni-

toring of adherence to protocols that call for 2 or more

BP measurements at each visit and for the purpose of

using the data for ongoing clinical care and research.

To avoid recording errors, BP values from the clinic,

HBPM, or ABPM should be directly transferred from

the device to the EMR, whenever possible. If the

average BP is recorded without notation, it is difﬁcult

to determine whether the appropriate number of BP

measurements was obtained. Documentation of BPs

in the EMR should include key components of the

measurement process, listed in the preceding text,

along with the actual BP values (Table 2).

TRAINING AND QUALITY CONTROL. Clinical

practice. Recommendations for standardization of

BP assessment have not changed substantially from

JNC7 in 2003 (116) and the 2005 AHA Scientiﬁc

Statement on BP measurement (6) to the 2017 ACC/

AHA BP guideline (1). However, a standardized

approach is rarely followed in clinical practice (6,117).

Increasingly, guidelines recommend use of validated

upper-arm oscillometric devices in place of auscul-

tation (25,45), which can reduce human error and

bias, but does not eliminate many of the factors that

contribute to inaccurate measurements and the need

for trained observers (Table 3)(118).

The technician or health care provider remains the

most important component of accurate and reliable

BP measurement, and standardization of training,

retraining, and certiﬁcation at regular intervals are

recommended for everyone who measures BP (6,117).

Although training may occur in ambulatory settings

for clinical staff, physicians are not typically trained

or tested in BP measurement accuracy after medical

school. Although they may not be the primary person

conducting BP measurements, physicians routinely

conﬁrm abnormal BP readings obtained in examina-

tion rooms, often using auscultation, the most tech-

nically demanding method of BP measurement.

These manual backup BP readings are likely to be

inaccurate in the absence of using a calibrated device,

selection of an appropriately sized cuff, and regular

retraining (117). After initial training, auscultatory

skills decline rapidly without regular retraining and

accuracy testing (117). Also, although guidelines

recommend averaging BP within and across visits,

informal polling of clinicians has found this is rarely

done (1). Using AOBP devices may facilitate obtaining

the average of multiple measurements during a visit.

However, devices that provide individual readings, in

addition to an average, should be used.

Research studies. In research studies, rigorous

standardized protocols for measurement are needed

to ensure the comparability and accuracy of BP as-

sessments because of measurement error and physi-

ological BP variability (119,120). TRUE (inTernational

consoRtium for qUality resEarch) was formed in 2015

to make recommendations to improve the quality of

research BP assessment (121).Table 4 summarizes

recommendations that constitute a minimum stan-

dard for clinical and epidemiological research.

REGULATORY APPROACHES AND PARTNERSHIPS.

To date, efforts to improve the quality of BP mea-

surements have focused on educating health care

providers at an early stage of their career and on

minimizing manual aspects of measurements (e.g., by

using automated devices). Although contemporary

evidence is sparse, prior studies have repeatedly

documented poor quality of measurements as

evidenced by digit preference and excess BP vari-

ability (122,123). Promulgation of recent guidelines is

unlikely to be effective in improving BP measurement

techniques, given prior lack of beneﬁtwhenprevious

guidance has been published. In this context, a case

can be made for regulatory and accreditation bodies,

such as The Joint Commission: Accreditation, Health

Care, CertiﬁcationandNationalCommitteefor

Quality Assurance, to develop and monitor basic

standards for BP measurement, similar to those

implemented in clinical research (124).Suchstan-

dards could include requiring the use of validated

devices, establishing criteria to assure continued

device calibration, using appropriately sized cuffs,

and training and retraining technicians and providers

on key features of BP measurement. These re-

quirements would reinforce the importance of accu-

racy in the measurement of BP.

An approach to ensure BP measurement proced-

ures are followed will likely require collaboration

between policymakers, insurers, health care systems,

EMR vendors, device manufacturers, and profes-

sional organizations (American Academy of Family

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Physicians, ACC, American College of Physicians,

AHA, American Medical Association, and others).

Agencies such as the Centers for Medicare and

Medicaid Services provide incentives to health care

plans/organizations for meeting quality metrics,

including the percentage of the population with hy-

pertension who have controlled BP. Currently, how-

ever, BP control is determined using only a single BP

measurement or the lowest SBP or DBP of 2 or more

measurements taken on the same day, rather than

averaging at least 2 BP measurements on 2 or more

occasions, as is recommended in clinical practice

guidelines. Also, the United States Preventive Ser-

vices Task Force and ACC/AHA guidelines recom-

mend out-of-clinic BP measurement to conﬁrm the

diagnosis of hypertension (1,5). No quality assurance

metrics guide the appropriate measurement of BP,

and little reimbursement supports the clinical pro-

cedure of BP assessment, whether in-clinic or out-of-

clinic, despite the potential high cost of under- and

overtreatment of a condition, hypertension, that af-

fects about one-half of the U.S. adult population (2).

Additionally, health insurers could provide increased

time and adequate reimbursement to correctly mea-

sure BP.

Use of resources to improve the quality of BP

measurements and care of patients with high BP

may produce better hypertension control rates, and

more importantly, lower cardiovascular morbidity

and mortality. In the United States, improved

management of high BP, including encouragement

of standardized BP measurement, is a central

component of the Centers for Medicare and

Medicaid Services Million Hearts (125) and the AHA/

American Medical Association TARGET BP (126)

initiatives. Globally, the World Health Organiza-

tion’sGlobalHearts(127) and the Vital Strategies

Resolve (128) projects have similar goals. Although

as yet unproven, these initiatives hold promise for

improving the health of adults in the United States

and other countries.

SUMMARY AND CONCLUSIONS

Over the past 2 decades, there have been several de-

velopments in the approach to BP measurement that

have provided opportunities, yet presented new

challenges, for clinical practice and research.

BP measurements obtained in routine clinical

practice are increasingly being used for research and

quality improvement activities. Despite repeated

guideline recommendations and educational efforts,

it appears that the quality of BP measured routinely

in clinical practice remains poor. Current limitations

with clinic BP measurement include lack of stan-

dardization, infrequent technician/clinician training

and retraining, use of devices that have not been

validated and/or regularly calibrated, not using an

appropriately sized cuff, improper conditions and

technique, and inadequate documentation of the

procedure. Also, despite guideline recommendations,

theaveragingofBPwithinandacrossvisitsisrarely

done.

There is substantial evidence demonstrating that

out-of-clinic BP measurements, using ABPM and

HBPM, have stronger associations with risk for CVD

events than clinic BP measurements (129).Although

guidelines recommend the use of ABPM and HBPM to

guide the initiation and intensiﬁcation of antihyper-

tensive treatment, they are often not integrated into

EMRs. Documenting out-of-clinic BP in the medical

record could become more common with Healthcare

Effectiveness Data and Information Set and National

Committee for Quality Assurance recommendations

to conduct ABPM or HBPM. It is important to recog-

nize that despite strong observational data, ABPM

and HBPM have not been used to determine eligibility

for or to guide antihypertensive treatment in large

randomized controlled trials. Additionally, there has

been rapid innovation with a burgeoning array of

novel BP measurement devices being developed for

out-of-clinic BP measurement, including some that

measure BP without cuffs. However, few formal

validation studies of the accuracy of these devices

have been performed, and at present, these devices

cannot be recommended.

EMRs provide an opportunity to document BP

assessment and facilitate use of routine clinical BP

measurements in research, but most of the concerns

about obtaining high-quality measurements persist.

Efforts to standardize BP measurement procedures

and improve their quality in routine clinical practice

are needed. This may include documentation of BP

training, selection of validated devices, and periodic

device calibration by accreditation bodies. An

exampleofthiseffortisthechecklistusedbyRakotz

et al. (130) to observe medical students measuring BP.

Also, there is a need to develop and improve EMR

functionality, including documentation of key fea-

tures of BP measurement, seamless transmission of

data from measurement devices, including out-of-

clinic devices, to the EMR, tools to manipulate and

average BP data at individual visits and over time,

and improved data presentation to facilitate patient

care, health system improvements, and research

applications.

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RESEARCH RECOMMENDATIONS

A robust research portfolio is needed to provide an

evidence base for future clinical practice guidelines

and clinical research, particularly research on the use

of routinely collected clinic BP for research purposes.

The working group has identiﬁed several objectives

for future research with potentially high impact

(Central Illustration).

a. Determine the variation in BP measurement ap-

proaches being used in routine clinical practice

across the United States and in clinical research

protocols.

b. Identify the aspects of the BP measurement pro-

tocol (e.g., presence of an observer, duration of

wait time) that have the most substantial impact

on the accuracy and precision of clinic BP. This

research can guide the development of simpliﬁed

BP measurement protocols for implementation in

routine clinical practice.

c. Evaluate the effect of interventions to improve

BP measurements in routine clinical practice

(e.g., use of automated devices that obtain and

averagemultiplereadings)ontheaccuracyand

precision of clinic BP measurements and BP

control rates.

d. Evaluate head-to-head comparative data on the

association of standardized clinic versus out-of-

clinic BP with CVD outcomes and mortality.

e. Evaluate the impact of systematic and random

errors on the diagnosis and management of hy-

pertension, and identify approaches to delineate

real changes in BP from random error following

treatment initiation.

f. Assess the associations between routine clinic and

research BP measurements, and determine in

what circumstances measurements obtained in

routine clinical practice are acceptable to be used

in research.

g. Determine the optimal quality metric for BP con-

trol (e.g., using the average BP at an individual

visit or across several visits, using only the last

available BP reading) from the EMR.

h. Evaluate the role of ABPM and HBPM in the

diagnosis and treatment of hypertension;

including:

i. Whether BP from ABPM versus HBPM pro-

vides a more accurate estimate of CVD risk,

including the contribution of sleep

measurements;

ii. The utility of using unattended AOBP and

HBPM as screening tools before conducting

ABPM among adults not taking and taking

antihypertensive medication;

iii. The CVD and all-cause mortality risk reduc-

tion beneﬁt of initiating antihypertensive

medication among adults with white coat

hypertension and masked hypertension, and

intensifying antihypertensive medication

among adults with white coat effect and

masked uncontrolled hypertension;

iv. The utility of nighttime BP in the diagnosis of

hypertension and the beneﬁts of antihyper-

tensive interventions among adults with

asleep hypertension (e.g., chronotherapy);

v.Effectivewaystoreducebarriersto

conducting ABPM and HBPM in clinical

practice;

vi. TheoptimalprotocolforusingHBPMreadings

to diagnose and assess control of hyperten-

sion (what time of day, how many BP mea-

surements, minimum acceptable number of

measurements, duration of measurement

period); and

vii. Quantifying the burden associated with con-

ducting 24-h ABPM, including sleep distur-

bances and restriction on daily activities.

i. Evaluate the role of BP measured in public loca-

tions for hypertension screening and conducting

follow-up BP measurements that can be used to

guide antihypertensive medication titration.

j. Determine the validity of novel approaches (e.g.,

cufﬂess devices) for BP measurement and the as-

sociation of BP measured with these devices and

CVD risk.

k. Assess the value of using orthostatic hypotension

as part of the protocol to guide antihypertensive

therapy.

l. Evaluate the prognostic impact of different

orthostatic hypotension deﬁnitions with an

emphasis on position (supine vs. seated), timing

of BP measurements after standing, and thresh-

olds of change in BP versus self-reported ortho-

static symptoms.

m. Evaluate apps for simplifying and organizing the

incoming data from out-of-clinic BP measurements.

n. Evaluate approaches to measuring BP in morbidly

obese adults including where (e.g., forearm,

ﬁnger, or wrist) BP should be measured.

ACKNOWLEDGMENTS The authors thank Dr. David

Goff, Director, DCVS, and the Division leadership for

their support. The authors also acknowledge the

DCVS Planning Committee (Dr. Jeffrey Cutler, Dr.

Lawrence Fine, Dr. Michael Mussolino, Ms. Joni

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Snyder,Mr.MichaelWolz,andDr.JacquelineWright)

for their input into development of the working group

objectives and the conference agenda. They also

thank Dr. Michael Lauer, Deputy Director for Extra-

mural Research, NIH, for making a presentation on

real-world clinical practice data in clinical research at

the conference.

ADDRESS FOR CORRESPONDENCE: Dr. Paul Muntner,

Department of Epidemiology, School of Public Health,

University of Alabama at Birmingham, 1665 University

Boulevard, Suite 140J, Birmingham, Alabama 35294.

E-mail: pmuntner@uab.edu. Twitter: @Muntnerpaul,

@UABNews.

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Blood Pressure Assessment in Adults in Clinical Practice and Clinic-Based Research: JACC Scientific Expert Panel

Abstract