An Evidence-Based Review of Patient-Centered Behavioral ... · An Evidence-Based Review of Patient-Centered Behavioral Interventions for Hypertension L ... Pooled results revealed

Review and Special Articles

An Evidence-Based Review of Patient-CenteredBehavioral Interventions for HypertensionL. Ebony Boulware, MD, MPH, Gail L. Daumit, MD, MHS, Kevin D. Frick, PhD, Cynthia S. Minkovitz, MD, MPP,Robert S. Lawrence, MD, Neil R. Powe, MD, MPH, MBA

Introduction: While behavioral interventions may be viewed as important strategies to improve bloodpressure (BP), an evidence-based review of studies evaluating these interventions may helpto guide clinical practice.

Methods: We employed systematic review and meta-analysis of the literature (1970–1999) to assessthe independent and additive effects of three behavioral interventions on BP control(counseling, self-monitoring of BP, and structured training courses).

Results: Of 232 articles assessing behavioral interventions, 15 (4072 subjects) evaluated theeffectiveness of patient-centered counseling, patient self-monitoring of BP, and structuredtraining courses. Pooled results revealed that counseling was favored over usual care (3.2mmHg [95% CI, 1.2–5.3] improvement in diastolic blood pressure [DBP] and 11.1 mmHg[95% CI, 4.1–18.1] improvement in systolic blood pressure [SBP]) and training courses (10mmHg improvement in DBP [95% CI, 4.8–15.6]). Counseling plus training was favoredover counseling (4.7 mmHg improvement in SBP [95% CI, 1.2–8.2]) and afforded moresubjects hypertension control (95% [95% CI, 87–99]) than those receiving counseling(51% [95% CI, 34–66]) or training alone (64% [95% CI, 48–77]).

Conclusions: Evidence suggests that counseling offers BP improvement over usual care, and that addingstructured training courses to counseling may further improve BP. However, there is notenough evidence to conclude whether self-monitoring of BP or training courses alone offerconsistent improvement in BP over counseling or usual care. The magnitude of BPreduction offered by counseling indicates this may be an important adjunct to pharmaco-logic therapy.

Medical Subject Headings (MeSH): hypertension, meta-analysis, patient-centered care(Am J Prev Med 2001;21(3):221–232) © 2001 American Journal of Preventive Medicine

Introduction

Over 43 million individuals in the United Stateshave hypertension, and less than one thirdreach adequate levels of blood pressure (BP)

control.1,2 Heightened awareness of inadequate levelsof BP control for a majority of patients has helped bringto light the need to refocus strategies to improve

hypertension control.3 While medications are arguablythe most important therapy for hypertension, behav-ioral strategies have long been recommended as first-line initial and adjunctive therapy.1,4,5 Specifically, ed-ucational approaches designed to help patientsincorporate commonly accepted lifestyle changes (e.g.,nutrition, weight loss, exercise, and social behaviors,including altering tobacco and ethanol use) into theirdaily living have been advocated.6–13 It has also beenproposed that increasing patient participation in hyper-tension care through techniques such as self-BP moni-toring may increase patients’ vigilance about theircondition and potentially improve adherence to medi-cations, ultimately leading to improvement in BPcontrol.14

Improving BP through adjunctive, patient-centered,education-based behavioral interventions might haveother potential salutary effects such as decreased costsof pharmaceuticals to patients and insurers, improvedpatient compliance with appointments, and decreasedrisk of complications from polypharmacy. However,

From the Department of Medicine (Boulware, Daumit, Lawrence,Powe) and Department of Pediatrics (Minkovitz), Johns HopkinsSchool of Medicine, Baltimore, Maryland; Department of HealthPolicy and Management (Daumit, Lawrence, Powe), Department ofPopulation and Family Health Sciences (Minkovitz), and Departmentof Epidemiology (Powe), Johns Hopkins Bloomberg School of PublicHealth, Baltimore, Maryland; and the Welch Center for Prevention,Epidemiology and Clinical Research, Johns Hopkins Medical Institu-tions (Boulware, Daumit, Powe), Baltimore, Maryland

Address correspondence and reprint requests to: Neil R. Powe,MD, MPH, MBA, Welch Center for Prevention, Epidemiology, andClinical Research, Johns Hopkins Medical Institutions, 2024 EastMonument Street, Suite 2-600, Baltimore, MD 21205. E-mail:[email protected].

The full text of this review article is available via AJPM Online atwww.elsevier.com/locate/ajpmonline.

221Am J Prev Med 2001;21(3) 0749-3797/01/$–see front matter© 2001 American Journal of Preventive Medicine • Published by Elsevier Science Inc. PII S0749-3797(01)00356-7

some physicians may have difficulty employing suchtechniques because of increasing time pressures, lim-ited resources and reimbursement for interventionssuch as counseling, and uncertainty regarding whichapproaches to patient education are most effective. Atthe same time, other physicians may employ thesetechniques without substantive evidence to support thetime, energy, and resources required to appropriatelycarry out these interventions.

To address these issues, we performed a systematicreview to assess the independent and incremental ef-fects of three commonly performed patient education–based behavioral interventions on BP control: counsel-ing techniques, structured training courses, and patientself-monitoring of BP.

MethodsStudy Design and Eligibility Criteria

We conducted a systematic review of the literature describingbehavioral interventions for hypertension. We sought toaddress two hypotheses in this review: (1) that the structure ofmultidimensional patient education may be important inrelaying commonly accepted lifestyle advice, and (2) thatpatient self-BP monitoring (alone or in combination withpatient education), by more directly involving patients intheir care, may offer independent and/or incremental advan-tages over education approaches alone. To address thesehypotheses, we investigated the effectiveness of counseling,structured training courses, and patient self-BP monitoringinterventions when used singly or in combination to improveBP control.

We included only peer-reviewed English-language articles,published from January 1970 through July 1999, which fo-cused on counseling, structured training courses, and patientself-BP monitoring. Self-monitoring of BP was defined ashome BP monitoring performed by the patient for thepurposes of recording or monitoring BP. Counseling wasdefined as individual or group discussion and teaching with apersonalized approach, set in a nonclassroom format inwhich individuals or group members might often share theirpersonal experiences. Training courses, which were curricu-lum-based courses aimed at teaching several people at once,were less personal than group counseling and usually oc-curred in a classroom setting with one or more curriculumleaders. Both counseling and training interventions weremultidimensional in nature, primarily advocating general,commonly accepted lifestyle practice changes: encouraginghealthy diet, weight loss, exercise, and tobacco cessation. Wesought to assess common clinical practice in terms of coun-seling structure and general content of patient education,and we hypothesized that many primarily diet-focused inter-ventions might, through attempts to drastically decreaseweight and serum sodium, have additional effects on bloodpressure reduction. Thus, although we included studies in-corporating general dietary counseling as a part of a multidi-mensional education program, we eliminated several studiesthat were centered primarily on diet and weight loss—focusing on efficacy of treatment rather than effective-ness—or that focused on a specific diet prescription. For

example, studies with interventions featuring meals that wereprepared for participants were excluded, as were studies withinterventions featuring diets with a prescribed amount ofsodium, potassium, magnesium, or calorie intake. Finally, weincluded studies that were primarily “patient-centered.” Thatis, we sought to evaluate studies that were designed to detectthe effects of changes in patient behavior on BP as a result ofthe intervention, not interventions in which the healthcareprovider was the unit of analysis.

We excluded efficacy studies for drug therapy for hyper-tension and any articles that did not measure a clinicaloutcome (e.g., blood pressure, hypertension control, or pa-tient compliance with medical regimen). In addition, weexcluded articles with a total sample size of ,50 people or,25 people in each study arm.

Identification of Articles

To find eligible articles, we searched medical and psychologyelectronic databases (Medline, PsychInfo, CINAHL, HealthStar, Sociologic Abstracts, Social Science Abstracts, EI Com-pendex, and Current Contents) using keywords and medicalsubject headings (MeSH) including: blood pressure, commu-nity based, coping behavior, counseling (group, individual),disease detection, health behavior, health education, hyper-tension, locus of control, managed care, meta-analysis, occu-pational health, patient compliance, physician behavior, pre-ventive health services, research synthesis, screening, andtreatment compliance. For each relevant article, we reviewedthe references for additional candidate studies, and we ob-tained references from experts in hypertension.

Data Extraction

Using a structured abstraction instrument, data were ab-stracted on content, quality, and outcomes of studies.15 Sixreviewers participated in literature abstraction, with two re-viewers independently abstracting data on each article. Gen-eral information (e.g., study subject characteristics, setting, anddesign) was abstracted, as well as more specific characteristicsof the intervention (e.g., leader of intervention, length ofeach session of the intervention, frequency of sessions, dura-tion of the entire study, and the criteria used for BP control).

Follow-up BP measurements for study groups receiving theintervention of interest were abstracted. Up to seven discreteoutcomes were reported: difference in either (1) diastolicblood pressure (DBP) or (2) systolic blood pressure (SBP)between treatment and control groups at follow-up, differ-ence in change in (3) DBP or (4) SBP between treatment andcontrol groups, change in either (5) DBP or (6) SBP atfollow-up, and (7) percentage of subjects with hypertensioncontrol at follow-up. Difference in change in DBP and SBPbetween follow-up represents the difference between thechange in BP for one group from start to end of the studyminus the change in the other group from start to end of thestudy. After initial independent data abstraction by eachreviewer, the two reviewers adjudicated differences in qualityratings and data abstraction until they came to an agreement.

Assessment of Article Quality

We developed a 100-point scale to describe the internal andexternal validity of the studies, as well as the reporting of

222 American Journal of Preventive Medicine, Volume 21, Number 3

important study characteristics. This scale included threedimensions: (1) study population description, (2) interven-tion design/outcomes description, and (3) methods of anal-ysis and results reporting. Study population description fo-cused on the articles’ descriptions of sociodemographiccharacteristics of those who enrolled versus those who did notenroll and reasons for eligible subjects not enrolling. Studyintervention design/outcomes description focused on howthe intervention was described, quality of randomization andblinding (if applicable), handling of withdrawals or cross-overs, comparability of treatment groups (if applicable),length and frequency of the intervention, percentage ofsubjects completing the intervention, and assessment of out-comes. Study analysis focused on appropriateness of statisticaltests chosen and presentation of statistical significance. Di-mensions were weighted similar to Chalmers et al.16 (Studypopulation/design570% of the total possible score; studyanalysis530% of the total possible score.)

Data Synthesis and Statistical Analysis

We evaluated initial agreement between raters for the assess-ment of article quality by calculating the observed percentageagreement and the k coefficient for interrater reliability.17

To include all evidence available to evaluate these interven-tions, we assigned a “study type” to each article for thepurpose of statistical analysis: (1) single-intervention group,and (2) between-intervention groups. An intervention groupwas defined as a group of study participants receiving aparticular intervention.

Single-Intervention Group Analysis

If an article described a study comparing more than oneintervention but not all the interventions met the eligibilitycriteria for this review, we abstracted information on only theintervention groups receiving the interventions of interest.We then analyzed these abstracted results as if the study weredesigned to evaluate only that intervention (with no compan-ion or control groups available for comparison). For exam-ple, if a study compared two groups of patients—one receiv-ing biofeedback and one receiving counseling—we abstractedonly information on the group of participants receivingcounseling. In what we call the “single-group” statisticalanalysis, we then pooled abstracted information from thisstudy along with information similarly abstracted from otherstudies with intervention groups who received counseling. Assuch, individual intervention groups were treated as smallseparate prospective studies, and results were pooled toobtain the magnitude of BP improvements among singlegroups from beginning to end of each intervention.

Between-Intervention Groups Analysis

Studies with suitable comparison intervention groups con-taining either usual care or one of the three interventions ofinterest were incorporated into a separate analysis, evaluatingdifferences between treatment (interventions of interest) andcontrol (usual care or alternative intervention) groups. If astudy group contained any other interventions besides thethree interventions of interest, it was excluded from bothtypes of analyses.

For each analysis, results were pooled across studies, using

both fixed- and random-effects models to estimate summaryeffects for all combined studies.17,18 In the fixed-effectsanalyses, homogeneity was assessed both overall and withinsubgroups (chi-square test). Variances for individual studyresults were calculated from standard errors when provided,from p values or reported t-test results for studies for whichraw data were not available, using the largest p value consis-tent with the published data for studies not reporting exactp values (e.g., p,0.05 was considered to be p50.05). Fordifferences between treatment and control groups, if raw datawere not provided, pooled variance estimates were calculatedas described by Greenland.18 Calculations were performedusing Microsoft Excel 2000 (Microsoft Corp, Redmond, WA)and STATA Statistical Software: Release 6.0 (Statacorp, Col-lege Station, TX).

Subgroup analysis for articles focusing on counseling wasperformed by categorizing articles by year of publication,leader of intervention, duration of intervention, age of par-ticipants, percentage of white participants, and quality scoresof articles.

ResultsYield of Relevant Articles

The initial search identified 232 articles focusing onhypertension detection and management. Of these, 15articles (studying a total of 4072 people) containedinterventions focusing exclusively on counseling, self-monitoring of BP, and training courses.19–33

Characteristics of Articles

Table 1 describes primary characteristics of the articlesincluded in the analysis. The majority of articles werepublished between 1980 and 1999, with most focusingon counseling. Study settings varied, with the majorityoccurring at hospital- or community-based clinics. Themean total number of subjects per study was 310 (range53 to 1880, median 130), and among those articlesreporting gender, the mean percentage of male sub-jects was 53% (range 21 to 100, median 49). Amongarticles reporting on age and race, the mean age ofsubjects was 57 years (range 50 to 65, median 55), andthe mean percentage of white subjects was 34% (range0 to 97, median 11). The mean intervention group sizewas 63 (range 23 to 115, median 54). Seven studiescontained intervention and design characteristics com-patible for the between-intervention group analysis,while nine studies contained interventions that couldbe used only for the single-intervention group analysis.Subjects in 13 of the studies were taking concomitantantihypertensive medications.

Table 2 includes selected characteristics of eachindividual intervention. Nurses, physicians, and phar-macists led the majority of interventions. The length ofeach episode of the intervention of interest varied from5 to 90 minutes; 12 studies did not report on the lengthof each intervention interval.19–24,26,28–31,33 The fre-quency with which episodes of each intervention oc-

Am J Prev Med 2001;21(3) 223

Tab

le1.

Ch

arac

teri

stic

sof

arti

cles

exam

inin

gbl

ood

pres

sure

inte

rven

tion

s

Stud

yIn

terv

enti

onSe

ttin

g

Subj

ects

Stud

yty

pe

Out

com

es

Tot

alN

% Mal

e

Mea

nag

e(y

ears

)% W

hite

Gro

upN

On

med

sD

dbp

Dsb

pH

CD

dbp

Dsb

pD

Ddb

pD

Dsb

p

Cou

nsel

ing

inte

rven

tion

sB

illau

ltet

al.1

9C

HB

C20

063

53—

a85

Yes

Sx

xB

ond

etal

.20

CH

BC

214

——

—58

Yes

Sx

Eri

ckso

net

al.2

2C

HB

C80

3165

1140

Yes

B/S

xx

xx

Hei

rich

etal

.23

CW

S18

80—

——

88—

Sx

Log

anet

al.2

6C

WS

194

7250

8491

Yes

B/S

xx

xM

oris

kyet

al.2

7C

HB

C40

030

5414

44Ye

sS

xPa

rket

al.2

9C

P53

4960

9723

Yes

B/S

xx

xx

xPh

eley

etal

.30

CC

BC

200

44.5

55—

108

Yes

Sx

xx

Stam

ler

etal

.31

CN

S11

510

0—

—11

5N

oS

xx

Web

bet

al.3

2C

CB

C12

321

620

31Ye

sB

x

Mon

itor

ing

inte

rven

tion

sJo

hn

son

etal

.25

MH

136

6053

—34

Yes

Sx

xx

Tra

inin

gin

terv

enti

ons

Web

bet

al.3

2T

CB

C12

321

620

37Ye

sB

xx

Com

bina

tion

inte

rven

tion

sC

arn

ahan

etal

.21

CM

HB

C10

098

55—

50Ye

sB

xIs

oet

al.2

4C

1T

CH

S11

156

59—

48Ye

sB

xx

Muh

lhau

ser

etal

.28

C1

M1

TC

BC

200

4551

—86

Yes

Sx

xW

yka-

Fitz

gera

ldet

al.3

3C

1T

HB

C66

——

—66

Yes

Sx

aN

otre

port

ed.

Inte

rven

tion

:C

,co

unse

ling;

T,

trai

nin

g;M

,m

onit

orin

g.Se

ttin

g:C

BC

,co

mm

unit

y-ba

sed

clin

ic;

HB

C,

hos

pita

l-bas

edcl

inic

;C

HS,

com

mun

ity

hea

lth

cen

ter;

H,

hom

e;P,

phar

mac

y;W

S,w

ork

site

.A

nal

ysis

:S,

sin

gle

arm

;B

,be

twee

nar

m.

Qua

lity

scor

e:12

-poi

nt

scal

ew

eigh

ted

wit

hpo

pula

tion

desc

ript

ion

30%

,st

udy

inte

rven

tion

desc

ript

ion

40%

,an

dan

alys

is30

%.

Out

com

es:D

BP,

dias

tolic

bloo

dpr

essu

re;S

BP,

syst

olic

bloo

dpr

essu

re;D

dbp,

chan

gein

DB

Pat

follo

w-u

p;D

sbp,

chan

gein

SBP

atfo

llow

-up;

HC

,per

cen

tage

ofsu

bjec

tsw

ith

hyp

erte

nsi

onco

ntr

olat

follo

w-u

p;D

dbp,

diff

eren

cein

DB

Pbe

twee

ntr

eatm

ent

grou

psat

follo

w-u

p;D

sbp,

diff

eren

cein

SBP

betw

een

trea

tmen

tgr

oups

atfo

llow

-up;

DD

dbp,

diff

eren

cein

chan

gein

DB

Pbe

twee

ntr

eatm

ent

grou

psat

follo

w-u

p;D

Dsb

p,di

ffer

ence

inch

ange

inSB

Pbe

twee

ntr

eatm

ent

grou

psat

follo

w-u

p.


Tab

le2.

Ch

arac

teri

stic

sof

inte

rven

tion

s

Stud

yIn

terv

enti

onL

eade

rL

engt

hof

each

inte

rval

Freq

uenc

yof

inte

rval

sD

urat

ion

ofst

udy

Cou

nsel

ing

inte

rven

tion

sB

illau

ltet

al.1

9C

Phys

icia

n—

a—

8m

onth

sB

ond

etal

.20

CPh

arm

acis

t—

—9

mon

ths

Eri

ckso

net

al.2

2C

Phar

mac

ist

——

5m

onth

sH

eiri

chet

al.2

3C

Cou

nse

lor

——

72m

onth

sL

ogan

etal

.26

CN

urse

—E

very

1–3

mon

ths

12m

onth

sM

oris

kyet

al.2

7C

Phys

icia

n,

Soci

alw

orke

r5–

10m

inut

es—

24m

onth

sPa

rket

al.2

9C

Phar

mac

ist

—E

very

1m

onth

4m

onth

sPh

eley

etal

.30

CN

urse

—E

very

2–4

wee

ks12

mon

ths

Stam

ler

etal

.31

C—

—E

very

1–3

mon

ths

60m

onth

sW

ebb

etal

.32

CSo

cial

wor

ker

60m

inut

esE

very

3w

eeks

6m

onth

s

Mon

itor

ing

inte

rven

tion

sJo

hn

son

etal

.25

MT

rain

edpe

rson

nel

NA

Dai

ly6

mon

ths

Tra

inin

gin

terv

enti

ons

Web

bet

al.3

2T

Nur

se60

min

utes

Eve

rym

onth

6m

onth

s

Com

bina

tion

inte

rven

tion

sC

arn

ahan

etal

.21

C1

MC

Nur

se—

2to

8se

ssio

ns

per

6m

onth

s6

mon

ths

MN

urse

/Sel

fN

AT

wic

eda

ily6

mon

ths

Iso

etal

.24

C1

TC

—7

sess

ion

spe

r18

mon

ths

18m

onth

sT

Phys

icia

n30

min

utes

7se

ssio

ns

per

18m

onth

s18

mon

ths

Muh

lhau

ser

etal

.28

C1

M1

TC

Phys

icia

nan

dA

ssis

tan

ts—

—19

mon

ths

MPh

ysic

ian

and

Ass

ista

nt/

Self

NA

Tw

ice

daily

19m

onth

sT

Phys

icia

ns

and

Ass

ista

nts

60–9

0m

inut

esFo

urco

nse

cuti

vew

eeks

19m

onth

sW

yka-

Fitz

gera

ldet

al.3

3C

1T

CN

urse

Prac

titi

oner

——

1.25

mon

ths

TN

urse

Prac

titi

oner

90m

inut

esFi

veco

nse

cuti

vew

eeks

1.25

mon

ths

aN

otre

port

ed.

C,

coun

selin

g;M

,m

onit

orin

g;T

,tr

ain

ing.

Am J Prev Med 2001;21(3) 225

curred during the study varied as well, ranging fromevery 2 weeks to every 3 months for counseling inter-ventions, daily to twice daily for monitoring interven-tions, and weekly to several months for combinedinterventions. Finally, the mean study duration was 17.2months (range 1.25 to 72, median 12 months).

Assessment of Article Quality

Prior to adjudication of differences, initial interrateragreement for assessment of article description of studypopulation ranged from 73% to 85% (k5.56), agree-ment for assessment of intervention design itemsranged from 78% to 97%(k5.69), and agreement forarticle reporting and appropriateness of analysis and86% to 98% (k5.80). Table 3 demonstrates qualityscores for all studies, divided into three areas. Summaryquality scores ranged from 20.1 to 84.8 points out of apossible 100 points (mean quality score 65.9). Notably,14 articles had quality score deductions in the areas ofdescription of population, intervention, and outcomemeasurements.

An assessment of how investigators obtained BPmeasurements was included in the quality score fordescription of study, intervention, and outcome mea-surements. Table 4 illustrates the reporting character-istics of articles regarding the ascertainment of BPoutcome measurements. Investigators in only eightstudies directly obtained BP measurements. In addi-tion, few of the studies reported the type of sphygmo-manometer used to measure BP, and the protocolsreported for measurement varied.

Outcomes

Table 1 shows the BP outcomes measured in eachstudy. (Actual data from individual studies are includedin the Appendix.) Figures 1 and 2 demonstrate thepooled evidence supporting the interventions singlyand in combination; Figure 1 demonstrates the resultsof the “between-group analysis” (results of comparisonstudies), while Figure 2 demonstrates the results of the“single-group analysis” (magnitude of effect of an inter-vention on single groups).

Table 3. Quality attributes of articles

Study Intervention

Population descriptiona

(maximum possible 524)

Study and interventiondescriptionb (maximumpossible 5 46)

Analysisdescriptionandappropriatenessc

(maximumpossible5 30)

Summaryscored

Counseling interventionsBillault et al.19 C 11.6 23.8 17.5 52.9Bond et al.20 C 7.0 34.4 16.8 58.2Erickson et al.22 C 14.0 40.8 30.0 84.8Heirich et al.23 C 10.5 32.1 20.6 63.2Logan et al.26 C 18.8 34.9 27.5 81.2Morisky et al.27 C 16.6 37.4 19.4 73.4Park et al.29 C 15.8 34.0 15.0 64.8Pheley et al.30 C 10.5 32.4 16.8 59.7Stamler et al.31 C 0 7.0 13.1 20.1Webb et al.32 C 15.5 36.5 27.5 79.5

Monitoring interventionsJohnson et al.25 M 13.3 33.2 22.5 69.0

Training interventionsWebb et al.32 T 15.5 36.5 27.5 79.5

Combination interventionsCarnahan et al.21 M 15.8 33.7 20.1 69.6Iso et al.24 C 1 T 21.3 31.5 16.9 69.7Muhlhauser et al.28 C 1 M 1 T 20.8 36.5 24.4 81.7Wyka-Fitzgerald et al.33 C 1 T 7.2 25.3 14.8 47.3a Four to seven questions focused on characteristics of study population, randomization (if applicable), sociodemographics of those who enrolledand those who did not enroll, and reasons for eligible subjects not enrolling.b Six questions focused on how well intervention was described, blinding (if applicable), comparability of treatment groups (if applicable),handling of withdrawals or crossovers, comparability of retained subjects to withdrawals, length and frequency of intervention, percentage ofsubjects completing intervention, and standardized/valid assessment of outcomes.c Four questions focusing on the appropriateness of statistical tests chosen, presentation of statistical significance, mention of power calculations,and adjustments for potential confounders or differences between groups.dSum of population description, study and intervention description, and analysis description and appropriateness scores.C, counseling; M, monitoring; T, training.


Tab

le4.

Rep

orti

ng

char

acte

rist

ics

ofar

ticl

esre

gard

ing

asce

rtai

nm

ent

ofbl

ood

pres

sure

(BP)

outc

omes

Stud

yIn

terv

enti

on

BP

mea

sure

ddi

rect

lyby

inve

stig

ator

s?

Met

hod

ofas

cert

ainm

ent

ofB

Pby

inve

stig

ator

Typ

eof

sphy

gmom

anom

eter

Pro

toco

lre

port

ed

Cou

nsel

ing

inte

rven

tion

sB

illau

ltet

al.1

9C

No

Ch

art

revi

ew—

a—

Bon

det

al.2

0C

No

Ch

art

revi

ew—

—E

rick

son

etal

.22

CYe

sSp

hyg

mom

anom

eter

—1

read

ing,

seat

ed15

min

utes

Hei

rich

etal

.23

CYe

sSp

hyg

mom

anom

eter

——

Log

anet

al.2

6C

Yes

Sph

ygm

oman

omet

er—

3re

adin

gsM

oris

kyet

al.2

7C

No

Ch

art

revi

ew—

—Pa

rket

al.2

9C

Yes

Sph

ygm

oman

omet

erM

ercu

ry2

con

secu

tive

read

ings

Phel

eyet

al.3

0C

No

Ch

art

revi

ew—

—St

amle

ret

al.3

1C

Yes

Sph

ygm

oman

omet

er—

—W

ebb

etal

.32

CN

oC

har

tre

view

——

Mon

itor

ing

inte

rven

tion

sJo

hn

son

etal

.25

MYe

sSp

hyg

mom

anom

eter

—Pa

tien

tre

port

Tra

inin

gin

terv

enti

ons

Web

bet

al.3

2T

No

Ch

art

revi

ew—

—

Com

bina

tion

inte

rven

tion

sC

arn

ahan

etal

.21

C1

MYe

sSp

hyg

mom

anom

eter

—Pa

tien

tre

port

Iso

etal

.24

C1

TYe

sSp

hyg

mom

anom

eter

Ran

dom

zero

mer

cury

3re

adin

gs,

30se

con

dsap

art,

seat

ed5

min

utes

Muh

lhau

ser

etal

.28

C1

M1

TN

oC

har

tre

view

——

Wyk

a-Fi

tzge

rald

etal

.33

C1

TN

o—

——

aN

otm

enti

oned

orn

otre

port

ed.

C,

coun

selin

g;M

,m

onit

orin

g;T

,tr

ain

ing.

Am J Prev Med 2001;21(3) 227

CounselingCounseling offered significant BP improvement overusual care in four comparison studies (Figure1).22,26,29,32 Counseling groups had a 3.2mmHg im-provement in follow-up DBP (95% confidence interval[CI], 1.2–5.3) over groups receiving usual care (twostudies, total 264 subjects) and a 3.5 mmHg improve-ment in DBP (95% CI, 1.0–6.2) over usual care groupsat follow-up (three studies, total 307 subjects). Coun-seling groups also had an 11.1 mmHg improvement in

SBP (95%CI, 4.1–18.1) over usual care groups at fol-low-up (two studies, total 109 subjects; not shownin figure).22,29

Ten studies assessed the magnitude of BP cont-rol afforded groups receiving counseling (Figure2).19,20,22,23,26,27,29–32 Groups receiving counseling had5.0 mmHg (95% CI, 2.7–7.2) and 6.2 mmHg (95% CI,2.4–10.0) changes in DBP and SBP, respectively. TheseBP changes were not statistically significantly differentfrom changes observed in subjects receiving monitor-

Figure 1. Blood pressure outcomes by intervention, between-intervention group analysis. Results reported in figures areestimates obtained using fixed-effects models and were supported by results obtained with random-effects models (results intext). Findings to the right of 0 favor the intervention group.

Figure 2. Blood pressure outcomes by intervention, analysis of single-intervention group. Results reported in figures areestimates obtained using fixed-effects models and were supported by results obtained with random-effects models (results intext). Findings to the right of 0 favor the intervention group.


ing or subjects receiving all three interventions incombination. Similarly, 51% (95% CI, 34–66) of sub-jects had BP control at follow-up after receiving coun-seling. While the magnitude of hypertension controlwas statistically significantly less than that experiencedby groups receiving counseling plus monitoring, it wasnot statistically significantly different from groups re-ceiving training.

Because of heterogeneity among some studies thatassessed the effect of counseling on difference in DBPbetween treatment and control groups at follow-up(p50.038), the absolute magnitude of change in DBP(p,0.01) and SBP (p,0.01), and hypertension control(p,0.01), we also used a random-effects model, whichassumed BP changes varied not only within each of thestudies (as reflected by the study standard error) butalso between studies. Using this approach, estimatesfrom comparison studies of counseling versus usualcare were not appreciably different, but confidenceintervals were wider: Counseling offered a 5.4 mmHg(95% CI, 23.1–13.9) improvement over usual care infollow-up DBP. For the two remaining estimates fromcomparison studies (difference in change in SBP andDBP), there was no significant heterogeneity and thefixed-effects estimates were maintained, supportingcounseling over usual care. Using the random-effectsapproach, the estimates of magnitude of BP reductionwere similar as well, although confidence intervals werewider: The magnitude of DBP and SBP reductions were5.0 mmHg (95% CI, 21.8–11.6) and 7.8 mmHg (95%CI, 21.0–16.6), respectively. Random-effects modelingdid not appreciably change the estimate of percentageof subjects afforded hypertension control with counsel-ing: 51% (95% CI, 31–73).

Subgroup analyses of studies featuring counselingdemonstrated interesting trends when articles werecategorized according to the leader of the intervention,the year of publication, and their qualityscores.19,22,26,29,30 In studies where pharmacists andnurses led the counseling interventions, statisticallysignificant improvements in DBP and SBP were ob-served (Figure 3). This contrasts with a single study inwhich physicians led the counseling intervention andno improvement in DBP or SBP was seen. Pharmacist-led counseling interventions had a 4.3 mmHg changein DBP (95% CI, 0.7–7.9) and a 12.2 mmHg change inSBP (95% CI, 6.8–17.6), while nurse-led counselinginterventions had a 6.4 mmHg improvement in DBP(95% CI, 4.6–8.2) and a 6.2 mmHg improvement inSBP (95% CI, 2.9–9.5). Increased BP reductions wereobserved in studies with earlier publication dates and instudies with higher quality scores, but these differenceswere not statistically significant.

Patient Self-BP Monitoring

In the one study evaluating patient self-BP monitoring,comparison of self-monitoring of BP versus usual caredemonstrated statistically insignificant differences be-tween the group receiving monitoring and the groupreceiving usual care (Figure 1).25 In this study, themagnitude of BP reduction for the single group receiv-ing self-monitoring of BP was an 8.9 mmHg change inDBP from baseline (95% CI, 5.2–12.6) (Figure 2).When compared to single groups evaluating counsel-ing, training, and combined interventions, this effectwas not statistically significantly different from the

Figure 3. Subgroup analysis of counseling intervention, categorized by leader of the counseling intervention. Results reportedin figures are estimates obtained using fixed-effects models and were supported by results obtained with random-effects models(results in text). Findings to the right of 0 favor the intervention group.

Am J Prev Med 2001;21(3) 229

change in DBP seen in individuals receiving counselingalone or all three interventions combined.

Training Courses

One comparison study evaluated training courses, com-paring training to both usual care and counselingseparately.32 Counseling was favored over trainingcourses (decrease in DBP at follow-up of 10 mmHg[95% CI, 4.8–15.6]; Figure 1). Sixty-four percent ofsubjects (95% CI, 48–77) in this study had hyperten-sion control at follow-up. This effect was not signifi-cantly larger than the magnitude of hypertension con-trol afforded by counseling, but the effect wassignificantly less than the percentage of subjects withhypertension control who received counseling andtraining combined (95% [95% CI, 87–99]) (Figure 2).

Combination Interventions

Four studies featured combined interventions, includ-ing two comparison studies of combined interventionsversus counseling: (1) counseling plus monitoring ver-sus counseling, and (2) counseling plus training versuscounseling.21,24,28,33 SBP changes were different for thetwo interventions. No statistically significant SBP reduc-tion was seen for counseling plus monitoring overcounseling; in contrast, counseling plus training of-fered a 4.7 mmHg (95% CI, 1.2–8.2) SBP reductionover counseling. Neither combination offered improve-ments in DBP over counseling (Figure 1).

Two studies assessed the magnitude of BP reductionafforded to groups receiving combined interven-tions.28,33 Subjects receiving counseling, monitoring,and training combined as a single intervention experi-enced reductions in both DBP and SBP: change in DBP6.0 mmHg (95% CI, 3.6–8.4), change in SBP 8.0mmHg (95% CI, 4.4–11.6). These BP reductions werenot statistically significantly different from those ob-served in groups receiving counseling alone or moni-toring alone. In contrast, among subjects receivingcounseling plus training in a separate study, 95%achieved hypertension control (95% CI, 87–99). Thisrepresented a statistically significant improvement overthe magnitude of hypertension control afforded sub-jects receiving training alone and for subjects receivingcounseling alone (Figure 2).

Discussion

While patient-centered, education-based behavioral in-terventions may be viewed as important strategies toeducate patients and improve BP control, definition ofthe clinical benefits through careful and systematicreview of these approaches in hypertension care isnecessary to guide evidence-based practice. As such,this systematic review assessed in incremental and com-

bined fashion the BP benefit provided by these threepatient-centered behavioral interventions.

Pooled results favor counseling over usual care withan absolute decrease in DBP of 3.2 mmHg and im-provements in changes in DBP and SBP of 3.5 mmHgand 11.1 mmHg, respectively. Counseling is also fa-vored over training courses, offering a 10.2 mmHgreduction in DBP over training at follow-up. The mag-nitudes of DBP and SBP reductions for single groupsreceiving counseling alone are 5.0 mmHg and 6.2mmHg, respectively. In contrast, neither self-monitoringof BP nor training courses offer any statistically significantimprovement in DBP at follow-up over usual care, and thecombined interventions do not demonstrate substantialimprovement over counseling except when looking athypertension control in one study, in which 95% ofsubjects achieved hypertension control, which is statisti-cally significantly more than with counseling and training.

Nearly all articles we reviewed used these interven-tions as adjunctive therapy to pharmacologic ap-proaches for hypertension management. A previoussystematic review of first-line pharmacologic agentsused to treat hypertension (beta blockers, calciumchannel blockers, and thiazide diuretics) reported thatSBP and DBP benefits gained from these agents rangedfrom 10.0 mmHg to 15.6 mmHg and from 5.0 mmHgto 7.3 mmHg, respectively.34 Our results indicate thatadditional BP benefit gained from adding counselingcould be as high as 5 to 6 mmHg reductions in bothDBP and SBP. This improvement may be mediated byenhanced patient compliance with medication regi-mens and physician visits, improved patient behaviors,as well as potentially heightened patient awarenessregarding ongoing needs for continued aggressive hy-pertension management.

Notwithstanding the strength of this systematic re-view, there are limitations. First, despite an extensivesearch, 15 articles met our criteria, focusing specificallyon these three commonly practiced interventions. Be-cause we sought to address only the effects of thesethree behavioral interventions singly or in combinationwith each other, it was necessary to eliminate manystudies that included these interventions combinedwith other important interventions. This resulted in avery small number of studies evaluating patient self-BPmonitoring or training courses, limiting our statisticalpower to estimate accurately the effect of these twointerventions. Second, there was moderate heterogene-ity of interventions in terms of content, leader, andduration. This reflects variation in how these interven-tions have been implemented and evaluated. Althoughour subgroup analyses were limited in statistical power,there is a strong suggestion that effectiveness of theseinterventions may differ based on these more detailedaspects of intervention implementation. However, thesmall number of studies available inhibited our abilityto draw conclusions regarding any possible dose-re-


sponse effects in terms of length and frequency ofinterventions. Third, there were few randomized exper-imental trials, which are considered the best studydesign to derive inferences about the efficacy of inter-ventions. Many of our studies employed noncompara-tive designs and reported varying outcomes, prohibit-ing less complex approaches to evaluating interventioneffectiveness. Lack of control groups may also prohibitassessment of potential placebo and Hawthorne ef-fects.35 Finally, our review of article quality revealedthat, in many cases, less than optimal attention was paidtoward reporting important aspects of study populationand intervention description. Nevertheless, this body ofevidence is what is available to guide clinical practice.

In summary, this study provides substantive evidencethat behavioral interventions can play an importantrole in improving BP management. Counseling is sup-ported by the evidence as an effective technique tofurther lower BP beyond the benefit afforded by med-ications alone. Substantial evidence is lacking on train-ing or self-monitoring of BP interventions. Theoreti-cally, combining interventions should provide even aneven greater degree of BP control, although consistentevidence is lacking to support this theory.

There is a clear need for more focused research thataddresses individual interventions separately. Improve-ments in descriptions of interventions (e.g., the leaderof the intervention, the precise content of counseling,the length and duration of the interventions) as well asprovision of more standardized reporting mechanismsfor outcomes will further strengthen the existing evi-dence regarding patient-centered interventions for hy-pertension and will help guide development of recom-mendations for clinical practice.30–33

We are grateful to Lynda Anderson, PhD, and Gail Janes,PhD, at the Centers for Disease Control and Prevention(Atlanta, GA) for their valuable support and contributions.This study was supported in part by a National ResearchService Award #2T32PE10025, Health Resource and ServicesAdministration (LEB); grant #K08MH0178701, National In-stitute of Mental Health (GLD); grant #5T32HL07024, Na-tional Heart, Lung and Blood Institute (GLD); and grant#K240502643, National Institute of Diabetes and Digestiveand Kidney Diseases (NRP).

References1. The sixth report of the Joint National Committee on prevention, detection,

evaluation, and treatment of high blood pressure. Arch Intern Med1997;157:2413–46 (erratum appears in 1998;158:573).

2. Burt VL, Whelton P, Roccella EJ, et al. Prevalence of hypertension in theU.S. adult population: results from the Third National Health andNutrition Examination Survey, 1988 –1991. Hypertension 1995;25:305–13.

3. U.S. Department of Health and Human Services. U.S. Department ofHealth and Human Services. Healthy People 2010: understanding andimproving health and objectives for improving health, 2nd ed. 2 vols.Washington, DC: U.S. Government Printing Office, 2000.

4. Psaty BM, Smith NL, Siscovick DS, et al. Health outcomes associated withantihypertensive therapies used as first-line agents. A systematic review andmeta-analysis. JAMA 1997;277:739–45.

5. Moser M, Hebert PR. Prevention of disease progression, left ventricularhypertrophy and congestive heart failure in hypertension treatment trials.J Am Coll Cardiol 1996;27:1214–8.

6. Puddey IB, Parker M, Beilin LJ, Vandongen R, Masarei JR. Effects ofalcohol and caloric restrictions on blood pressure and serum lipids inoverweight men. Hypertension 1992;20:533–41.

7. Appel LJ, Moore TJ, Obarzanek E, et al. A clinical trial of the effects ofdietary patterns on blood pressure: DASH Collaborative Research Group.N Engl J Med 1997;336:1117–24.

8. Hypertension Prevention Collaborative Research Group. Effects ofweight loss and sodium reduction intervention on blood pressure andhypertension incidence in overweight people with high-normal bloodpressure: the trials of hypertension prevention. Arch Intern Med1997;157:657– 67.

9. U.S. Department of Health and Human Services. Physical activity andhealth. A report of the Surgeon General. Washington, DC: U.S. Depart-ment of Health and Human Services, 1996.

10. Stamler J, Caggiula AW, Grandits GA. Relation of body mass and alcohol,nutrient, fiber, and caffeine intakes to blood pressure in the specialintervention and usual care groups in the Multiple Risk Factor InterventionTrial. Am J Clin Nutr 1997;65(suppl 1):338–65.

11. Greenberg G, Thompson SG, Brennan, PJ. The relationship betweensmoking and the response to anti-hypertensive treatment in mild hyper-tensives in the Medical Research Council’s trial of treatment. Int JEpidemiol 1987;16:25–30.

12. U.S. Department of Health and Human Services. The health benefits ofsmoking cessation. A report of the Surgeon General. Washington, DC: U.S.Department of Health and Human Services, 1990.

13. Fodor JG, Whitmore B, Leenen F, Larochelle P. Lifestyle modifications toprevent and control hypertension. 5. Recommendations on dietary salt.Canadian Hypertension Society, Canadian Coalition for High Blood Pres-sure Prevention and Control, Laboratory Centre for Disease Control atHealth Canada, Heart and Stroke Foundation of Canada. Can Med AssocJ 1999;160(suppl 9):S29–34.

14. Pickering T. Recommendations for the use of home (self) and ambulatoryblood pressure monitoring: American Society of Hypertension Ad HocPanel. Am J Hypertens 1996;9:1–11.

15. Daumit GL, Boulware LE, Powe NR, et al. A system for evaluating theeffectiveness of preventive interventions. Public Health Rep, 2001. Inpress.

16. Chalmers TC, Smith H, Blackburn B, et al. A method for assessing thequality of a randomized control trial. Control Clin Trials 1981;2:31–49.

17. Orwin RL. Evaluating coding decisions. In: Cooper H, Hedges LV, eds. Thehandbook of research synthesis. New York: Russell Sage Foundation, 1994:139–62.

18. Greenland S. Quantitative methods in the review of epidemiologic litera-ture. Epidemiol Rev 1987;9:1–30.

19. Billault B, Degoulet P, Devries C, Plouin PF, Chatellier G, Menard J. Useof a standardized personal medical record by patients with hyperten-sion: a randomized controlled prospective trial. MD Computing 1995;12:31–5.

20. Bond CA, Monson R. Sustained improvement in drug documentation,compliance, and disease control: a four-year analysis of an ambulatory caremodel. Arch Intern Med 1984;144:1159–62.

21. Carnahan JE, Nugent CA. The effects of self-monitoring by patients on thecontrol of hypertension. Am J Med Sci 1975;269:69–73.

22. Erickson SR, Slaughter R, Halapy H. Pharmacists’ ability to influenceoutcomes of hypertension therapy. Pharmacotherapy 1997;17:140–7.

23. Heirich MA, Foote A, Erfurt JC, Konopka B. Work-site physical fitnessprograms: comparing the impact of different program designs on cardio-vascular risks. J Occup Med 1993;35:510–17.

24. Iso H, Shimamoto T, Yokota K, Sankai T, Jacobs DR, Komachi Y. Commu-nity-based education classes for hypertension control: a 1.5-year random-ized controlled trial. Hypertension 1996;27:968–74.

25. Johnson AL, Taylor DW, Sackett DL, Dunnett CW, Shimizu AG. Self-recording of blood pressure in the management of hypertension. Can MedAssoc J 1978;119:1034–9.

26. Logan AG. Clinical effectiveness and cost-effectiveness of monitoringblood pressure of hypertensive employees at work. Hypertension 1983;5:828 –36.

27. Morisky DE, Levine DM, Green LW. Five-year blood pressure control and

Am J Prev Med 2001;21(3) 231

mortality following health education for hypertensive patients. Am J PublicHealth 1983;73:153–62.

28. Muhlhauser I, Sawicki PT, and Didjurgeit U. Evaluation of a structuredtreatment and teaching programme on hypertension in general practice.Clin Exp Hypertens 1993;15:125–42.

29. Park JJ, Kelly P, Carter BL, Burgess PP. Comprehensive pharmaceuticalcare in the chain setting. J Am Pharmaceutical Assoc 1996;NS36:443–51.

30. Pheley AM, Terry P, Pietz L, Fowles J, McCoy CE, Smith H. Evaluation of anurse-based hypertension management program: screening, management,and outcomes. J Cardiovasc Nurs 1995;9:54–61.

31. Stamler J, Farinaro E, Mojonnier LM, Hall Y, Moss D, Stamler R. Preventionand control of hypertension by nutritional hygienic means: long-term

experience of the Chicago Coronary Prevention Evaluation Program.JAMA 1980;243:1819–23.

32. Webb PA. Effectiveness of patient education and psychosocial counselingin promoting compliance and control among hypertensive patients. J FamPract 1980;10:1047–55.

33. Wyka-Fitzgerald CA. Long-term evaluation of group education for highblood pressure control. Cardiovasc Nurs 1984;20:13–17.

34. Wright JM, Lee CH, Chambers GK. Systematic review of antihypertensivetherapies: does the evidence assist in choosing a first-line drug? Can MedAssoc J 1999;161:25–32.

35. Fletcher RH, Fletcher SW, Wagner EH. Clinical epidemiology: the essen-tials. Baltimore: Williams & Wilkins, 1996.

Appendix. Outcome data obtained from studies

Study Intervention

Outcomes

DDBPa DSBPa HCa DDBPb DSBPb DDDBPb DDSBPb

Counseling interventionsBillault et al.19 C 0.1 (1.6) 1.6 (1.4) —c — — — —Bond et al.20 C — — 69% (6) — — — —Erickson et al.22 C 4.7 (1.7) 12 (3.4) — — — 9.3 (12.5) 2.1 (5.0)Heirich et al.23 C — — 43% (5) — — — —Logan et al.26,d C 10.5 (1.1) — — 2.8 (0.6) — 2.8 (1.2) —Morisky et al.27,d C — — 53% (9) — — — —Park et al.29 C 3.7 (2.0) 12 (2.4) 52% (10) — — 5 (1.8) 13 (13.1)Pheley et al.30 C 4.4 (0.8) 6.2 (1.7) 44% (5) — — — —Stamler J et al.31 C 8 (2.4) 11 (3.2) — — — —Webb P et al.32 C — — 53% (9) — — — —

Monitoring interventionsJohnson et al.25,d M 8.9 (1.9) — — 1.6 (2.4) — 1.3 (3.4) —

Training interventionsWebb et al.32 T — — 64% (8) 1.1 (9.8) — — —

Combination interventionsCarnahan et al.21,d C 1 M — — — — 11.4 (561) — —Iso et al.24,d C 1 T — — — 0.4 (0.9) 4.7 (3.2) — —Muhlhauser et al.28 C1 M 1 T 6.0 (1.2) 8.0 (1.8) — — — — —Wyka-Fitzgerald et al.33 C 1 T — — 95% (2) — — — —a Estimate (Standard error).b Estimate (Variance).c Not reported.d In these studies, outcomes assessors were blinded to treatment assignment.Intervention: C, counseling; M, monitoring; T, training.Outcomes: DDBP 5 change in diastolic blood pressure (DBP) at follow-up; DSBP5 change in systolic blood pressure (SBP) at follow-up; HC5percent of subjects with hypertension control at follow-up; DDBP 5 difference in DBP between treatment groups at follow-up; DSBP 5 differencein SBP between treatment groups at follow-up; DDDBP 5 difference in change in DBP between treatment groups at follow-up; DDSBP 5difference in change in SBP between treatment groups at follow-up.Note: All outcomes except HC expressed as mmHG.


Documents

An Evidence-Based Review of Patient-Centered Behavioral ... · An Evidence-Based Review of Patient-Centered Behavioral Interventions for Hypertension L ... Pooled results revealed