the NHLBI Working Group

Management of patient compliance in the treatment of hypertension. Report of

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Management of Patient Compliance in the
Treatment of Hypertension
Report of the NHLBI Working Group
R. BRIAN HAYNES, M.D., PH.D., Working Group Chairman
McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
MARGARET E. MATTSON, PH.D., Executive Secretary;
National Heart, Lung, and Blood Institute, Bethesda,
Maryland.
ARAM V. CHOBANIAN, M.D., Boston University Medical
School, Boston, Massachusetts
JACQUELINE M. DUNBAR, R.N., PH.D., Stanford Univer-
sity School of Medicine, Stanford, California
TILMER O. ENGEBRETSON JR., National Heart, Lung
and Blood Institute, Bethesda, Maryland
THOMAS F. GARRITY, PH.D., University of Kentucky Col-
lege of Medicine, Lexington, Kentucky
HOWARD LEVENTHAL, PH.D., University of Wisconsin,
Department of Psychology, Madison, Wisconsin
ROBERT J. LEVINE, M.D., Yale University School of
Medicine, New Haven, Connecticut
RONA L. LEVY, M.S.W., PH.D., M.P.H., University of
Washington School of Social Work, Seattle, Washington
SUMMARY Low patient cooperation erodes many of the proven benefits of antihypertensive therapy. Over
the last few years, there have been important advances in our understanding of the nature and management of
patient compliance in hypertension and other chronic illnesses. In this article we review the theoretical founda-
tion of compliance behavior; methods of measuring compliance; established and promising approaches to
managing compliance; ethical considerations in measuring, improving, and researching compliance; the cur-
rent state of implementation of compliance techniques in practice settings; and the efforts to disseminate infor-
mation on compliance through undergraduate and continuing health professional education programs.
(Hypertension 4: 415-423, 1982)
K E Y WORD S patient compliance compliance measurement public health education ethics
T
HE benefits of antihypertensive therapy have
been well documented in both selected popu-
lations
1
'
2
and the general community.
8
However, demonstrations of the efficacy of blood
pressure lowering required circumventing patient
compliance as a problem by disqualifying non-
compliers from entering the study
4
or utilizing extra-
ordinary measures to improve compliance that would
be difficult to apply en block in the usual delivery of
medical care.
8
This review was prepared by an ad hoc committee appointed and
supported by the National Heart, Lung, and Blood Institute, United
States Department of Health and Human Services. The views ex-
pressed herein are those of the authors and do not necessarily reflect
those of the Institute or the Department.
Address for reprints: M.E. Mattson, Ph.D ., Clinical Trials
Branch, National Heart, Lung, and Blood Institute, Federal Build-
ing Room 216,7550 Wisconsin Avenue, Bethesda, Maryland 20205.
Received August 7, 1981; revision accepted October 22, 1981.
Under common conditions of medical practice, the
extent to which low patient compliance undermines
the effectiveness of antihypertensive therapy is truly
staggering.
6
At each step from detection through long-
term follow-up, large numbers of patients fall out of
care: up to 50% fail to follow through with referral ad-
vice;
8
'
7
over 50% of those who begin treatment drop
out of care within 1 year;
7
"
9
and only about two-thirds
of those who stay under care consume enough of their
prescribed medication to achieve adequate blood pres-
sure reduction.
10
'
n
It is no wonder that studies have
repeatedly shown that only 20% to 30% of individuals
who know themselves to be hypertensive are under
good control.
12
'
1S
Achieving and maintaining high
compliance with antihypertensive therapy thus present
challenges that must be met if we are to realize the
benefits of modern medical therapy for high blood
pressure.
415
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416 HYPERTENSION VOL 4, No 3, MAY-JUNE 1982
OUTLINE
Definition of Compliance
Theories of Compliance Behavior
Historical Background
Educational Model
Health Belief Model
Emotional Drive Model
Behavioral Learning Model
Self-Regulation Model
Measuring Compliance
Monitoring Attendance
Clinical Judgment
Patient Self-Reports
Pill Counts
Drug Level Measurement
Biological Effects Assessment
Patient Reactivity
Improving Compliance
Screening Programs
Referral from Screening
Medication and Follow-Up
New Directions in Improving Compliance
Clinician-Patient Relationship
Social Support
Ethical Concerns in Applying Compliance Strategies
Utilization of Strategies to Increase Compliance
cides with medical advice.
14
Although this definition of
compliance is nonjudgmental, for many the term im-
plies patient sin and serfdom. Terms that can be used
synonymously include "adherence" and "default-
ing," with the former term having perhaps fewer
negative connotations.
Theories of Compliance Behavior
Historical Background
The study of compliance behavior holds fascina-
tion for those who wish to understand it (without
necessarily attempting to modify it) as well as those
who wish to modify it (without necessarily under-
standing it). Theory provides an organizational frame-
work through which research can be conducted in an
orderly fashion to satisfy both these perspectives.
Theories of compliance behavior have developed in
an expected fashion from simplistic to relatively
sophisticated. Early theories held that compliance was
related to easily tested characteristics of patients or
their social environments such as age, sex, marital
status, education, intelligence, religion, and socio-
economic status. Empirical testing of these "struc-
tural models" failed to reveal consistent relationships
between these variables and compliance, however.
16
Studies on "situational barriers," such as incon-
venient clinics and complex regimens, were somewhat
more fruitful but still failed to explain more than a
fraction of the compliance problems,
16
and it followed
that compliance was not much affected by simply
making treatments easier to follow and treatment
visits more convenient.
19
"
18
Because it has been only a decade since the first con-
vincing demonstration of the efficacy of antihyper-
tensive treatment,
1
-
2
it is hardly surprising that in-
novative approaches to improving patient acceptance
of this therapy are of recent vintage. Our understand-
ing of compliance and of ways to improve low compli-
ance has grown considerably during the last few
years.
14
This article is a concise summary of the
theory, research, ethics, and application of compliance
management methods in the treatment of hyper-
tension as viewed by an interdisciplinary group of
clinicians and researchers convened by the National
Heart, Lung, and Blood Institute for the purpose of
reviewing current developments in compliance
research.
Definition of Compliance
Compliance is the extent to which a person's be-
havior (in terms of keeping appointments, taking
medications, and executing life-style changes) coin-
Educational Model
A major theory of compliance behavior holds that
patients generally lack sufficient knowledge of their
illness and treatment to comply properly and that
thorough instruction will therefore result in better
compliance. This appears to have merit for short-term
treatments (less than 2 weeks in duration)
19
"
22
but has
very limited value for chronic disease regimens.
11
-
23
~
28
Health Belief Model
The health belief model
2
'
12S
is perhaps the com-
monest "motivational model" of compliance. Simply
stated, it holds that an individual's cooperation with
health advice depends upon the extent to which that
person perceives that he or she is susceptible to the dis-
ease, that the disease is serious, that the treatment is
efficacious, and that the barriers to compliance are
possible to overcome. A cue to action has also been
built into the model to account for the influence of ex-
ternal factors. Tests of the model show that it does
have predictive value for at least some preventive and
short-term therapeutic health actions
27
-
28
but that the
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COMPLIANCE IN HYPERTENSION/AWLS/ Working Group 417
magnitude of its predictive value is modest at best.
29
"
81
Furthermore, communications that influence health
attitudes may have no observable effect on compli-
ance,
32
"
34
making the model of less interest from a
clinical perspective.
Emotional Drive Model
The emotional drive model is related to the health
belief and educational models in that it attempts to
achieve compliance through information about the ill-
ness to which is added some form of motivational
appeal. Generally, the motivating part of the message
seeks to arouse fear in the patient about dire conse-
quences of failing to comply. A graded effect on
behavior has sometimes been demonstrated, with
stronger threat messages effecting greater compli-
ance,
32
-
36
but other studies have shown no such grad-
ient.
33
'
3<i 3e
Most of the studies of this model have
been of once-only or short-term compliance; threats
and fear arousal appear to have little long-term in-
fluence.
37
'
38
Behavioral Learning Model
The behavioral learning model provides a more
powerful explanation of why people comply and how
compliance can be improved. Operant learning
theory, as originally developed by Skinner,
89
'
40
sug-
gests that behavior is solely the result of environ-
mental cues and rewards. More recently, cognitive
learning theory or social learning theory
41
'
42
has been
developed to account for the interaction of en-
vironmental events with a person's perception of
them. This model departs from operant learning
theory in two important ways. First, it holds that the
individual's interpretation of the environment deter-
mines what is reinforcing and what is not. Second, it
postulates that it is possible to teach someone when
and how to respond, without rewarding him or her for
performing the response, especially through "model-
ing" the behavior, that is, by having the person
observe someone execute the desired behavior. Thus,
both the person and his or her environment have an
important effect on a given behavior, with the person
perhaps holding the balance of power. Rather than
competing with the models described earlier, social
learning theory can be seen as a broad frame of
reference that encompasses them.
Self-Regulation Model
The final theoretical construct of relevance is that of
self-regulation. This model attempts to describe,
within the framework of social learning theory, the
role and method of acting of an individual when
presented with health advice. It comprises the follow-
ing components: 1) extracting information from the
environment; 2) generating a representation of the ill-
ness danger to oneself; 3) planning and acting, which
involves imagining response alternatives to deal with
the problem and taking selected actions to achieve
specific effects; and 4) monitoring how ones coping
reactions affect the problem and oneself.
43
"
45
At pres-
ent this model holds promise for both understanding
and modifying a person's compliance, but it has had
only preliminary empirical testing in the health
sphere.
Measuring Compliance
The efficient management of patient compliance
requires accurate and available methods of measure-
ment.
Monitoring Attendance
Because up to 50% of hypertensive patients simply
drop out of care within 1 year of its beginning,
7
'
9
monitoring attendance at appointments is critical.
This is not as obvious a technique as it sounds, as
many primary care practitioners do not make definite
follow-up appointments for their patients or fail to
note when patients miss appointments. Furthermore,
attendance at appointments is not a substitute for
medication compliance, as about one-third of pa-
tients who remain in care fail to follow the prescribed
treatment.
10
'
n
Clinical Judgment
The commonest method of assessing medication
compliance is probably clinical judgment. This is in-
tuitively attractive to clinicians and easily applied, but
it has been shown repeatedly that clinicians cannot
reliably predict the compliance of their patients
4650
even when they feel confident of their predictions.
46
-
60
Thus, clinicians should avoid depending upon their
subjective impressions in monitoring compliance.
Patient Self-Reports
When patients are asked directly about their
compliance they tend to overestimate the amount of
medication they are taking.
8168
However, about half
of noncompliant patients will admit to missing at least
some medication and the ease with which this infor-
mation can be obtained makes it very valuable. The
value of self-reports can be augmented by self-
monitoring through regular recording by the patient
or by special medication dispensers that perform this
task automatically.
64
' " Self-monitoring is one of the
few ways that one can determine the pattern of
medication consumption as distinguished from the
quantity consumed.
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418 HYPERTENSION
VOL 4, No 3, MAY-JUNE 1982
Pill Counts
Pill counts provide a quantitative estimate of
compliance over a period of time. This method is
relatively reliable if performed at the patient's home
and with scrupulous attention to bookkeeping,
53
- "
ST
but these requirements make it largely impractical for
clinical settings. Although it has not been dem-
onstrated empirically, it is generally felt that pill
counts are unreliable when they are performed on pills
that patients bring with them to clinic visits non-
compliant patients may bring only some of their un-
used pills, or forget to bring their pills with them, or
fail to attend the appointment entirely. In general, the
pill count gives higher estimates of compliance than
biological assays"-" and lower compliance than
patient self-reports.
81
-
s3
'
M
Drug Level Measurement
Drug level determinations can be useful, partic-
ularly for drugs that have a sufficiently long half-life to
have minimal fluctuation in plasma concentration dur-
ing usual clinical dosing intervals. For example, digox-
in
s
and phenytoin
60
'
61
plasma levels can provide infor-
mation on compliance which can be used to guide
compliance interventions. However, their interpreta-
tion is subject to the foibles of individual variation in
drug absorption, metabolism, and excretion.
68
Further, drug level assessments are not routinely
available for antihypertensive drugs.
Biological Effects Assessment
In contrast to the direct measurement of drug
levels, the biologic effects of drugs have not been
found to correlate well with compliance. For example,
thiazide diuretics lower blood pressure and serum
potassium and raise serum uric acid; but none of these
effects provides as good an indication of compliance as
simply asking the patient.
83
Nevertheless, in clinical
practice it would improve efficiency to focus concern
about compliance on only those patients who fail to
achieve the therapeutic goal despite prescription of
usually adequate doses of treatment.
63
Patient Reactivity
All methods of assessing patient compliance are
susceptible to "reactivity." That is, if patients become
aware of the purpose of the assessment, they may alter
their compliance. Generally, one would expect any
change in compliance to be in a favorable direction,
and thus this is a potentially useful phenomenon
clinically. For research, it is clearly a hazard if the
purpose of the measurement is solely to document
rather than alter compliance.
While no single method of assessing compliance is
wholly satisfactory, many of the measures provide
more information than guessing and sequential com-
binations of the measures can minimize the amount of
effort required. For example, in routine patient care,
compliance need not be considered a problem unless
the patient fails to respond to usually adequate treat-
ment. When the treatment response is judged inade-
quate, the patient can be asked about compliance. If
the patient reports less than complete compliance, the
clinician can proceed with compliance interventions.
If the patient reports full compliance, problems with
the treatment itself can be considered along with
application of more sophisticated methods of measur-
ing compliance.
63
Improving Compliance
From the perspective of compliance, optimum
control of hypertension in the community will only be
achieved if four aims are met. First, screening
programs must gain the full cooperation of citizens;
second, referral from screening must be successful;
third, appointments for those in care must be attended
regularly; and finally, medication must be taken as
prescribed. These four steps require somewhat
different tactics, but research into compliance has
generated successful methods of dealing with each of
them. All of the following methods have been subjects
of controlled clinical trials unless otherwise stated.
Screening Programs
The yield of screening programs can be increased by
home visits, especially if executed outside usual work-
ing hours.
64
However, most screening programs reach
no more than 25% of the population,
7
-
M
and then only
for the duration of the program. Inasmuch as 70% of
the people visit a physician within a given year,
66
it
would seem logical to shift the site of hypertension
screening to the physician's office. Whether physi-
cians will take up this task, however, remains to be
seen.
Referral from Screening
The success of referral from screening can be aug-
mented by counseling
86
and by assisting patients to
make and keep appointments.
67
Although not
evaluated in controlled trials of compliance strategies
which would perhaps be unnecessary with the results
obtained, virtually complete referral success has been
achieved in two studies in which patients were
followed until at least one appointment had been
kept.
17
-
88
Medication and Follow-Up
Once the patient is under care for hypertension,
additional efforts are usually required to prevent the
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COMPLIANCE IN HYPERTENSION//V7/Ifl/ Working Group
419
patient from dropping out of treatment and to pro-
mote full compliance with prescribed therapy. Unfor-
tunately, there does not appear to be as yet a single-
dose or single-modality cure for noncompliance.
Indeed, none of the following methods has improved
compliance when tested as the only intervention:
special learning packages
17
and pamphlets;
28
counsel-
ing about medication and compliance by a health
educator;
24
home visits;
88
increased convenience of
care at the worksite;
17
'
70
self-monitoring of blood
pressure;
6
"-
71
tangible rewards;
71
group discussions;
71
and counseling by nurses.
71
In contrast to the lack of effect of unimodal inter-
ventions, several controlled trials have shown
statistically and clinically significant increases in com-
pliance from combinations of interventions, including
some that have not worked in isolation. All of these
approaches are characterized by interactions between
providers and patients, leading to the general conclu-
sion that the level of supervision of and attention to
ongoing care is a key factor.
72
Within this framework,
there appears to be a variety of effective options for in-
teraction. These include feedback of the blood
pressure response to the patient, through blood
pressures taken by either the provider
10
-
78
or the pa-
tient;
74
- " rewarding the patient for improved com-
pliance and/or lowered blood pressure;
28
- "
74
tailor-
ing of medications to daily schedules to decrease
forgetting and inconvenience;
68
'
74
encouraging family
support;
24
engendering self-help through group sup-
port and discussion;
24
-" negotiating a brief written
contract with the patient for improvements in health
behavior;
23
and calling back patients who miss ap-
pointments.
78
Although a provider is present in all of the success-
ful interactions, the type of provider does not appear
to be important. Physicians,
7
' nurses,
8
-
J8> 68
pharma-
cists,
10
health educators,
24
psychologists," and even in-
dividuals with no formal health training
74
have played
the key role in successful interventions. In a similar
vein, although a place for provider and patient to meet
is required, the specific site does not appear to be im-
portant. Compliance with antihypertensive treatment
has been increased in community clinics,
73
general
medical clinics,
76
hypertension clinics,
28
-
24
-
7B
phar-
macies,
10
worksites,
70
-
74
and patients' homes.
8
While most interventions were applied directly to
the patient or the patient's family, one study reported
a beneficial effect of tutorials for house staff and at-
tending staff in a general medical clinic.
76
This study
has important implications for the education of health
professionals.
New Directions in Improving Compliance
The comments in the section above are based on
controlled clinical trials of compliance improvement
strategies which provide us with the most reliable in-
formation available on how to improve compliance;
they indicate that several methods are worthwhile.
Nevertheless, our understanding of compliance
remains incomplete and the ways of improving com-
pliance tested to date are both personnel intensive and
less than fully effective. Thus, we must continue to
seek better understanding of compliance and better
ways to manage it. Two promising avenues of ap-
proach to these goals are studies of the clinician-pa-
tient relationship and the role of social support in
compliance.
Clinician-Patient Relationship
Research into the interactions between clinicians
and patients can be broadly classified into four cate-
gories. Studies in the first category deal with the peda-
gogical techniques employed by practitioners to in-
form patients about their prescribed treatment. These
studies are both correlational
77
"
80
and experimen-
tal
23
-
81
in their design and suggest that greater pro-
vider explicitness regarding needed patient behaviors
is associated with better patient follow-through.
The second category of studies addresses the extent
to which clinicians and patients share the same expec-
tations about their interactions and the effect of this
on subsequent patient compliance ("mutuality of ex-
pectations"). Studies on this topic are difficult to per-
form and remain descriptive at present. They indicate
that when patients' expectations are not fulfilled (for
tests they feel should be ordered, and for treatments
and advice they feel should be rendered), compliance
is likely to be low.
82
"
84
The third category includes investigations into
patients' acceptance of responsibility for following
their prescribed therapy, a procedure suggested by the
self-regulation theories described above. Shulman
85
has found that compliance is better among patients
who feel that they are actively involved in their own
care. While no study has yet isolated patient responsi-
bility from other elements of the therapeutic process,
several studies show that negotiating care with the pa-
tient, rather than simply dictating or prescribing it,
results in better compliance.
11
'
8e
'
M
Roter
90
also found
that attendance at appointments improved when
patients were encouraged to take greater responsi-
bility by asking more questions of their physicians.
Finally, Nessman et al.
7B
found that blood pressures
were better controlled and compliance was higher
among patients randomly allocated to monitor their
own blood pressures at home and choose their own
medications in group sessions, according to a stan-
dard step-wise regimen.
The last category concerns the affective tone of the
patient-clinician encounter. The social learning theory
described above suggests that liked and powerful
others would be more influential. This, again, has
proven a difficult matter to study, and no inter-
ventional studies have been reported. Studies in which
the clinician-patient interaction has been observed
directly support the concept that approachability and
friendliness of the clinician to the patient are positively
correlated with compliance.
80
-
B1
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420 HYPERTENSION VOL 4, No 3, MAY-JUNE 1982
Social Support
The second promising new direction for under-
standing and managing patient compliance is that of
social support, that is, the help that patients receive
from their family and friends to carry on with their
treatments. It has been well documented that patients
from disrupted or isolated social circumstances are
less likely to be good compliers than those with stable
families and/or helpful friends.
92
"
99
Only recently,
however, have there been systematic studies of
attempts to engender or direct social support in order
to improve compliance with antihypertensive.
therapy.
24
'
10
These studies have not shown an inde-
pendent effect on compliance of attempting to pro-
mote social support, but their results must be regarded
as preliminary. Both social learning and self-regula-
tion theories point to a number of complex ways that
social support could enhance compliance.
Ethical Concerns in Applying Compliance Strategies
When attempts are made to improve compliance in
medical practice, rather than in research, the ethical
practitioner should consider the following guide-
lines.
101
'
102
First, the diagnosis must be correct. Sec-
ond, the therapy must be of established efficacy.
Third, neither the illness nor the proposed treatment
can be trivial. Fourth, the patient must be an informed
and willing partner in any attempts to alter his compli-
ance behavior. Finally, the strategy to be employed to
improve compliance must also be of established merit.
Of course, the practitioner must tailor these guide-
lines to fit the circumstances of the individual patient:
therapies and compliance interventions that benefit
most patients are not suitable for all.
In research, the focus of intent shifts from benefit to
the individual patient to the testing of a hypothesis in
order to develop new knowledge. The compliance con-
siderations are somewhat different in this context and
depend on whether the object of the research is testing
a new treatment or a new method of improving com-
pliance. If the former, the compliance maneuver used
should, itself, be of established merit, and we should
be able to say that its application will result in more
adequate testing of the new treatment than could be
achieved without the compliance maneuver. Arrange-
ments should be specified in such studies for detecting
harm to patients to permit their prompt removal from
the study, as an effective compliance maneuver would
increase the rate at which harm occurs and poten-
tially the severity of any harm.
When the object of research is to test the safety
and/or efficacy of a compliance intervention itself, say
in increasing compliance to a standard antihyper-
tensive regimen, there must be good cause to believe
that the compliance intervention is worth testing. This
would include an adequate theoretical base as well as a
protocol for testing that details an adequate research
design. In both this and the previous research situa-
tion, the anticipated harms and benefits must be dis-
closed to the prospective research subject who will be
the final arbitor of the favorability of the balance of
harms and benefits, and thus reach a decision concern-
ing participation in the project.
103
"
105
Monitoring patient compliance also poses ethical
problems because some of the most powerful methods
of measuring compliance require deception in order to
maintain validity. While this matter merits more dis-
cussion than can be provided in this article, the basic
ethical principles that must be observed are that pa-
tients and research subjects must be aware of the fact,
if not the details, of measurement and must agree to
its execution. Practitioners and investigators should
avoid circumstances that create the necessity for
"deceptive debriefing" or "inflicted insight" which are
harms incurred by informing patients about com-
pliance monitoring after the fact.
108
Ethical issues may seem to be insurmountable bar-
riers to the execution of at least some compliance
research: in particular cases there may be serious ten-
sions between the demands of scientific design and
obligations to be respectful of the rights and welfare of
human subjects. However, the guidelines above are
not absolute but rather enter into a more general con-
sideration of benefit versus harm in the decision to
execute a research project. Furthermore, it is usually
possible to negotiate resolutions of such tensions that
all concerned will find satisfactory.
Utilization of Strategies to Increase Compliance
Just as the availability of antihypertensive drugs
does not ensure that they will be prescribed optimally,
the demonstration that various methods of promoting
compliance are effective does not mean that prac-
titioners will or do apply them to advantage or that
students of the health sciences will be taught them. We
attempted to ascertain the extent of utilization of com-
pliance promotion in the public and private health
care delivery sectors and teaching of compliance
management in schools of medicine, nursing and phar-
macy. Sources of information included published
literature and direct contact with medical associa-
tions, schools, clearing houses, and organizations con-
cerned with blood pressure control and education ac-
tivities. This informal survey, the details of which are
related elsewhere,
107
leads us to a few general con-
clusions.
First, there is a vigorous effort being made, partic-
ularly through the National High Blood Pressure Edu-
cation Program, under the National Heart, Lung, and
Blood Institute, to disseminate information about
management of compliance and long-term follow-up
of hypertensive patients, and to organize at the state
level various intervention programs. Through this
process and others, several practical strategies are in
common use including streamlined services, patient
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COMPLIANCE IN HYPERTENSION/A7/fl/ Working Group
421
tracking, instruction, and counseling. However, it is
noteworthy that the most frequently used techniques,
such as public and patient instruction, are not those
shown to be the most effective in well-designed con-
trolled trials. Second, research in this area continues
to grow rapidly.
14
Third, compliance management is
beginning to be taught as a subject in some medical
and other health professional schools. Finally, and un-
fortunately, the private practice sector, in which the
majority of hypertensives are treated, appears as yet
little affected by new information about the manage-
ment of patient compliance.
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