a psychosocial perspective in the explanation of patients' drug-taking behavior

9
sot. sci. hied. v01. 27, NO. 3, pp. 277-285, 1988 Printed in Great Britain 0277-9536/aa 53.00 + 0.00 Pergamon Press pk A PSYCHOSOCIAL PERSPECTIVE IN THE EXPLANATION OF PATIENTS’ DRUG-TAKING BEHAVIOR L. DOUGLAS RIED’ and DALE B. CHRISTENSEN’ ‘Assistant Professor of Pharmacy Practice and 2Associate Professor of Pharmacy Practice, School of Pharmacy X-69, University of Washington, Seattle, WA 98195, U.S.A. Abstract-The goal of this study was to examine the applicability of the Health Belief (HBM) and Theory of Reasoned Action (TRA) models in predicting drug-taking compliance behavior among female patients with uncomplicated urinary tract infections. Thirty-eight percent of the respondents were compliant, 25% finished all of their medication, but missed one or more doses during the course of therapy, and 37% did not finish all of their medication as directed. Two HBM and three TRA variables had a statistically significant relationship with compliance: barriers and benefits (HBM) and belief strength, outcome evaluation, and behavioral intention (TRA). HBM variables explained 10% of the variance in the compliance variable. Adding the TRA variables to the model explained an additional 19% of the variance. Social influence variables (normative expectations, motivation to comply, and subjective norms) had a significant influence in the prediction of behavioral intention, but not in the prediction of compliance behavior. Suggestions for improving compliance based on these findings include: simplification of drug therapy by customizing and simplifying the regimen, continued patient reminders of the therapy’s value, and benchmarks for patients to evaluate the success or failure of therapy. A frank and open discussion from the start of therapy about its complexity, the medication’s side effects, time and fiscal constraints, and other factors which may modify patients’ perception of the likelihood of compliance is an important key to improving patients’ compliance behavior. Key words-Health Belief Model, Theory of Reasoned Action, compliance, health beliefs, drug-taking behavior INTRODUCTION For the past decade or more, attention has focused on the drug-taking compliance ‘problem’. Consid- erable effort has been directed to identify the reasons for noncompliance and to employ them in developing intervention strategies. Initial inquiries focused on patient sociodemographic and disease-related factors associated with and, presumably, predictive of non- compliance. While useful, these factors were un- satisfactory because they tended to differ across settings and patient groups. Further, they were not particularly instructive in understanding the compli- ance decision-making process, which would be useful in developing intervention strategies. It became in- creasingly clear that a theory or model of compliance behavior was needed to incorporate these disparate factors. The earliest and the most thoroughly examined health behavior model is the Health Belief Model (HBM) (11. The HBM originally postulated that an individual’s health-related behaviors were dependent upon: (1) one’s readiness to take action, which is determined by perceptions of the seriousness of the disease and susceptibility (or re-susceptibility) to a particular disease or its sequelae; (2) one’s assessment of the benefits versus costs of alternative health behaviors, and; (3) a cue or stimulus to trigger the response. In the first case, the model suggests that persons who are more likely to be compliant perceive themselves to be susceptible to a health problem or perceive the health problem to be serious. In the second case, benefits are evaluated in terms of the likelihood of disease prevention, cure, control, or symptom relief. Costs of alternative treatment plans (including no treatment) are defined broadly to in- clude economic costs, inconvenience, discomfort, and time costs. The assessment of costs and benefits is considered relative to the perceived threat to health. Finally, cues to action can be internal (e.g. symp- toms) or external (e.g. social pressure). The HBM was originally proposed to explain preventive health behavior. However, it has since been expanded to explain sick role behavior and compliance with prescribed medication regimes. Becker and Maiman modified the model by adding elements of general health motivations (e.g. concerns about health, orientation toward preventive health behavior) and modifying and enabling factors (e.g. general faith in physicians and medical care, and treatment regimen complexity) [2]. Accumulated evi- dence has partially validated the model in a variety of disease circumstances [3-lo]. Individual elements of the model (e.g. perceptions of susceptibility and severity) have been shown to LXsalient predictors of physician contact by persons perceiving themselves to be sick, behavior by persons diagnosed as sick, compliance behavior with short term drug therapies, and drug-taking compliance behavior for long term drug therapies by patients with chronic conditions. While certain elements of the HBM have been supported empirically, the model in its entirety has not. The model has been criticized as incomplete and the relationships among its predictive elements have 277

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Page 1: A psychosocial perspective in the explanation of patients' drug-taking behavior

sot. sci. hied. v01. 27, NO. 3, pp. 277-285, 1988 Printed in Great Britain

0277-9536/aa 53.00 + 0.00 Pergamon Press pk

A PSYCHOSOCIAL PERSPECTIVE IN THE EXPLANATION OF PATIENTS’ DRUG-TAKING

BEHAVIOR

L. DOUGLAS RIED’ and DALE B. CHRISTENSEN’ ‘Assistant Professor of Pharmacy Practice and 2Associate Professor of Pharmacy Practice, School of

Pharmacy X-69, University of Washington, Seattle, WA 98195, U.S.A.

Abstract-The goal of this study was to examine the applicability of the Health Belief (HBM) and Theory of Reasoned Action (TRA) models in predicting drug-taking compliance behavior among female patients with uncomplicated urinary tract infections.

Thirty-eight percent of the respondents were compliant, 25% finished all of their medication, but missed one or more doses during the course of therapy, and 37% did not finish all of their medication as directed. Two HBM and three TRA variables had a statistically significant relationship with compliance: barriers and benefits (HBM) and belief strength, outcome evaluation, and behavioral intention (TRA). HBM variables explained 10% of the variance in the compliance variable. Adding the TRA variables to the model explained an additional 19% of the variance. Social influence variables (normative expectations, motivation to comply, and subjective norms) had a significant influence in the prediction of behavioral intention, but not in the prediction of compliance behavior.

Suggestions for improving compliance based on these findings include: simplification of drug therapy by customizing and simplifying the regimen, continued patient reminders of the therapy’s value, and benchmarks for patients to evaluate the success or failure of therapy. A frank and open discussion from the start of therapy about its complexity, the medication’s side effects, time and fiscal constraints, and other factors which may modify patients’ perception of the likelihood of compliance is an important key to improving patients’ compliance behavior.

Key words-Health Belief Model, Theory of Reasoned Action, compliance, health beliefs, drug-taking behavior

INTRODUCTION

For the past decade or more, attention has focused on the drug-taking compliance ‘problem’. Consid- erable effort has been directed to identify the reasons for noncompliance and to employ them in developing intervention strategies. Initial inquiries focused on patient sociodemographic and disease-related factors associated with and, presumably, predictive of non- compliance. While useful, these factors were un- satisfactory because they tended to differ across settings and patient groups. Further, they were not particularly instructive in understanding the compli- ance decision-making process, which would be useful in developing intervention strategies. It became in- creasingly clear that a theory or model of compliance behavior was needed to incorporate these disparate factors.

The earliest and the most thoroughly examined health behavior model is the Health Belief Model (HBM) (11. The HBM originally postulated that an individual’s health-related behaviors were dependent upon: (1) one’s readiness to take action, which is determined by perceptions of the seriousness of the disease and susceptibility (or re-susceptibility) to a particular disease or its sequelae; (2) one’s assessment of the benefits versus costs of alternative health behaviors, and; (3) a cue or stimulus to trigger the response. In the first case, the model suggests that persons who are more likely to be compliant perceive themselves to be susceptible to a health problem or perceive the health problem to be serious. In the

second case, benefits are evaluated in terms of the likelihood of disease prevention, cure, control, or symptom relief. Costs of alternative treatment plans (including no treatment) are defined broadly to in- clude economic costs, inconvenience, discomfort, and time costs. The assessment of costs and benefits is considered relative to the perceived threat to health. Finally, cues to action can be internal (e.g. symp- toms) or external (e.g. social pressure).

The HBM was originally proposed to explain preventive health behavior. However, it has since been expanded to explain sick role behavior and compliance with prescribed medication regimes. Becker and Maiman modified the model by adding elements of general health motivations (e.g. concerns about health, orientation toward preventive health behavior) and modifying and enabling factors (e.g. general faith in physicians and medical care, and treatment regimen complexity) [2]. Accumulated evi- dence has partially validated the model in a variety of disease circumstances [3-lo]. Individual elements of the model (e.g. perceptions of susceptibility and severity) have been shown to LX salient predictors of physician contact by persons perceiving themselves to be sick, behavior by persons diagnosed as sick, compliance behavior with short term drug therapies, and drug-taking compliance behavior for long term drug therapies by patients with chronic conditions.

While certain elements of the HBM have been supported empirically, the model in its entirety has not. The model has been criticized as incomplete and the relationships among its predictive elements have

277

Page 2: A psychosocial perspective in the explanation of patients' drug-taking behavior

278 L. DOLJGLA~ RED and DALE B. CHRISTENSEN

Salient

be1iefs \ Attitude

0utc0ms A evaluation

\ Behavloro~ ,ntention - Behavior

Normative

/ be’iefr \ Subjective

Motivotion~norms to comply

Fig. 1. Theory of reasoned action.

not been sufficiently articulated or empirically estab- lished. Second, other important determinants (e.g. intention to comply) have not routinely been tested in the HBM framework. While the original HBM has been modified to include intent to comply as a health motivation variable [2], it has been examined in only one other previous study [ll]. Third, the HBM is recognized as an adaptation of a value-expectancy model, yet the concepts of expected value of a particular outcome and the likelihood of its occur- rence have not been theoretically developed or tested. Fourth, while the role of social influences on an individual’s behavior is acknowledged in some adap- tations, investigations of social influences are not generally included in empirical tests. Langlie, who has made one of the few formal attempts to incorpo- rate the social network variables in the health belief framework, found them to have considerable joint and independent influence on preventive health be- haviors [12]. Finally, lack of standardization among measurements of psychosocial variables is among the reasons for the inconsistency found in the HBM study’s findings [2, 131.

The Theory of Reasoned Action (TRA) is a general model of behavior which is based upon the same precepts as other value-expectancy models [14, 151. The TRA (Fig. 1) addresses some of the afore- mentioned shortcomings of the HBM. First, it estab- lishes a link between behavioral intention and behav- ior, and specifies the inter-relationships and causal processes among the variables. Second, it addresses the value-expectancy concepts through the salient belief strength and outcome evaluation variables. According to the TRA, patients evaluate the benefits and barriers to compliance in terms of their like- lihood of occurrence. Third, it recognizes the im- portance of social influences on the individual, namely perceptions of referent others’ normative expectations, subjective norms, and the individual’s degree of motivation to comply with referent others. Finally, measurement of the concepts are specified in detail [14] and can be adapted to TRA’s specific behaviors, including health-related behaviors [ 161. This would result in more consistent measurement of the TRA’s concepts, facilitating comparisons across studies.

Ried et al. examined the applicability of this model in explaining compliance intentions among 300 male veterans taking antihypertensive medications [ 171. These patients were given questionnaires inquiring about their beliefs concerning susceptibility to hyper-

tension and its sequelae, the benefits of drug-taking, the seriousness of the disease, perceptions of their physicians’ expectations about their behavior, subjec- tive norms, motivation to comply, attitudes, and drug-taking compliance intention. As predicted by the model, all independent variables were positively correlated with intention to take medicines. Overall, the variables predicted 35% of the variance Patients who expressed an intention to take their high blood pressure medicines perceived themselves to be more susceptible to the disease or its sequelae, expected to gain positive benefits, and had more favorable attitudes about taking their medication. Further, salient health beliefs and physicians’ expectations significantly affected development of favorable atti- tudes towards taking prescribed high blood pressure medicines. Results of path analysis showed that attitudes and subjective norms had the greatest direct impact upon the development of intention to take the medication as prescribed. Two other factors, sus- ceptibility and physicians’ normative expectations, also had significant direct effects on drug-taking intentions.

While the study of VA patients was instructive, it also raised several other questions. Only male hyper- tensives were studied. Is the model equally effective in explaining drug-taking behavioral intentions and compliance behavior among other populations? Among patients with other types of diseases (e.g. acute conditions)? Finally, is patient’s subsequent drug-taking behavior consistent with their intentions and can compliance be predicted as well as behavioral intentions?

Study objectives

The goal of this study was to examine these questions by exploring the applicability of the HBM and TRA models in predicting compliance behavior among female patients with uncomplicated urinary tract infections (UTI). The specific study objectives were to:

1. E,xamine the inter-relationships among attitudes, health beliefs, social influences, and behavioral in- tentions;

2. Examine the relationship between attitudes, health beliefs, social influences, and behavioral in- tentions and patients’ drug-taking compliance behav- ior, and;

3. Evaluate and compare the ability of the HBM and the TRA to predict drug-taking compliance.

Page 3: A psychosocial perspective in the explanation of patients' drug-taking behavior

Patients’ drug-taking behavior 279

METHODOLOGY Independent variables

Subjects

Two groups of subjects were identified for this study. One was female students seeking medical care at the Oregon State University Student Health Cen- ter. The other group consisted of female enrollees at Kaiser Permanente, a large prepaid group practice HMO in the Portland, Oregon area. Eligible subjects were those presenting to the student health center and HMO pharmacies a prescription to treat an uncom- plicated UTI. UT1 was chosen as the study disease because symptoms of UTIs are easily recognized and associated with the disease, it is usually of short duration and nonrecurrent, and consistent drug- taking for short periods is an established and effective treatment 118201.

The independent variables included in this study are drawn from the HBM and TBA (Appendix). Measures of patients’ beliefs about the benefits and barriers to compliance, seriousness of non- compliance, and susceptibility to the disease’s adverse consequences are included from the HBM. Measures of the patient’s outcome evaluation, salient belief strength, normative expectations, motivation to com- ply, attitude, subjective norms, and behavioral in- tention are included from the TR4. The outcome evaluation and salient belief strength variables repre- sent patients’ expected value of a particular outcome and likelihood of its occurrence. Social influences are represented by the normative expectations, subjective norms, and motivation to comply variables.

Procedures

During a 30-day period in March, 1984 at the student health center, and a 90-day period from April to June 1985 at the HMO, all patients presenting a prescription for 20 tablets of trimethoprim 160 mg/sulfamethoxazole 800 mg for treatment of an uncomplicated UT1 were asked to participate in the study. If they consented, they were asked to complete a self-administered questionnaire while waiting to have their prescription filled. When completed, pa- tients placed their questionnaire in a locked box located at the pharmacy or mailed it directly to the primary author if they could not wait. Questionnaires were distributed in this fashion to 40 patients seen at the student health center and 148 patients seen at the HMO.

Ten of the 11 independent variables were initially measured with multiple items. Only subjective norms was operationalized by a single item, patterned after the wording suggested by Ajzen and Fishbein [14]. Patients’ responses to the individual items were summed as a composite index. The internal consis- tency of nine of the indices was calculated with item analysis*. The alpha coefficients are shown in Table 1.

Dependent variable

All patients selected were prescribed the same drug regimen in order to control for length and complexity of drug therapy. Upon receipt of the filled pre- scription, each patient received specific verbal and written instructions from the pharmacist to take 1 tablet every 12 hr for 10 days.

The compliance variable was operationalized by asking the patient, “Have you finished all of your medicine? If not, how many tablets do you have remaining?’ The number of tablets which should have been remaining (20 tablets - [no. of days x 2 tablets/day]) was subtracted from the number of tablets actually remaining, as determined from the pill count. If the result was within + 1 tablet, the patient was considered to be compliant. If patients were directed to discontinue taking the medication by their physician because of an adverse drug reaction, allergy, or some other reason, they were considered to be compliant.

Patients were interviewed by telephone approx. 10 days later and asked about their actual drug-taking behavior and current health-related beliefs and atti- tudes. A questionnaire was mailed to patients if they could not be contacted by telephone within 4 days. Telephone interviews or mailed questionnaires were completed and returned by 35 student health center patients (87.5% response rate) and 78 HMO patients (52.7% response rate). The combined response rate was 60%.

Inaccurate reporting of compliance rates is a recog- nized problem. In this study, we attempted to en- hance response validity by first assuring the subjects of the confidentiality of their responses. Further, questions were phrased in the manner suggested by Sackett and others to maximize accurate recording. These approaches appeared moderately successful. The reported level of noncompliance in this study was found to be similar to others’ estimates of non- compliance [21, 221, and patients interviewed by tele- phone could be heard counting the tablets.

Patients were also asked if they had “ever forgotten a dose” and if they had taken their medication “exactly as directed for all 10 days?” Patients were considered noncompliant if they answered ‘yes’ to the first question and ‘no’ to the second. Whether or not patients had completed the prescribed medication was of paramount importance in assigning comph- ante scores to patients. Not taking the medication exactly as directed in all instances (e.g. forgetting a dose, but taking it later) was considered to be of lesser importance. Compliance scores were assigned to patients based on the hierarchy shown in Table 2.

The SPSS and SPSS/PC+ computer packages were used to perform the statistical analyses [23-251. Statistical significance is reported at P Q 0.05.

*One index, perceptions of barriers, consisted of only two items, therefore calculation of the alpha coefficient was not possible.

Student health center patients averaged 23 years (range 18-35 years) and HMO patients averaged 30 years (range 16-79). A majority of the HMO patients had at least some college education. The distribution of compliance scores showed that 38% of the re- spondents were compliant (Table 2). An additional 25% of the respondents finished all of their medica-

RESULTS

Page 4: A psychosocial perspective in the explanation of patients' drug-taking behavior

Tab

le

I.

Inte

rcor

rela

tion,

m

ean,

st

anda

rd

devi

atio

n an

d re

liabi

lity

estim

ates

of

va

riab

les’

(X,)

(X

,)

(X,)

(X

,)

(X,)

(X

,)

(X,)

(X

s)

(X,)

(X

I,)

(X,1

) (X

,2)

Bar

rier

s (X

,)

Seri

ous

(X,)

Su

scep

tibili

ty

(X,)

B

enef

its

(X,)

B

elie

f st

reng

th

(X,)

O

utco

me

eval

uatio

n (X

,)

Nor

mat

ive

expe

ctat

ions

(X

,)

Mot

ivat

ion

(Xs)

A

ttitu

de

(X,)

Su

bjec

tive

norm

(X

,,)

Inte

ntio

n (X

, ,)

Com

plia

nce

(X,,)

M

ean

sn

1.00

0.

16*

0.16

’ I .

oo

0.16

. Po

.lo

0.38

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23**

0.

08

-0.1

0 0.

01

0.28

.’

0.13

0.

17’

0.11

0.

18.

0.20

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08

0.16

’ 0.

20.

0.20

’ 0.

14

0.31

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09

9.09

2.

85

2.68

0.

73

0.17

. -0

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0.

04

0.07

-0

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- 0.

03

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2 0.

01

0.00

0.

10

0.03

2.

85

0.49

0.43

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0.26

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- 0.

05

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0.

18.

0.09

0.

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0.09

0.

55..

0.16

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08

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51

0.65

0.09

-0

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0.08

0.

22.

I .oo

0.

08

0.04

0.

02

0.07

0.

10

0.12

0.

32.’

3.

68

0.44

0.01

0.

15

0.13

0.

22.

0.16

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31.’

0.

20’

0.21

. 0.

09

0.21

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04

0.04

0.

03

0.01

0.

00

0.1

I 0.

22

0.12

0.

69.’

0.

18**

0.

09

0.05

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03

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01

1.00

0.

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0.32

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03

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1.

00

0.50

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0.32

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I SK

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0.

29**

-0

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20’

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6 0.

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5.18

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83

3.16

5.

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0.

62

n V

i n

75

n 43

n

54

-.--

--

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ronb

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pha

0.93

0.

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0.26

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3.86

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42

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‘Cor

rela

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mat

rix

belo

w

the

diag

onal

re

pres

ents

in

terc

orre

latio

n of

var

iabl

es

usin

g th

e si

ngle

ite

m

inte

ntio

n va

riab

le,

corr

elat

ion

mat

rix

abov

e th

e di

agon

al

repr

esen

ts

inte

rcor

rela

tion

of

vari

able

s co

rrec

ted

for

atte

nuat

ion.

~~

al

pha

coef

fici

ent

for

the

beha

vior

al

inte

ntio

n in

dex

was

lo

w

and

elim

inat

ion

of

any

one

item

re

duce

d th

e in

dex’

s re

liabi

lity

even

fu

rthe

r.

Tw

o al

tern

ativ

es

to

this

pr

oble

m

wer

e

eval

uate

d.

Firs

t, a

sing

le

item

, “H

ow

likel

y is

it

that

yo

u w

ill

take

th

e m

edic

ine

for

your

in

fect

ion

exac

tly

as d

irec

ted

for

the

next

IO

day

s ”

was

sel

ecte

d to

be

use

d as

the

m

easu

re

of

beha

vior

al

inte

ntio

n.

Thi

s pa

rtic

ular

ite

m

was

ch

osen

fr

om

the

thre

e al

tern

ativ

es

beca

use

it ha

d th

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ghes

t ze

ro

orde

r co

rrel

atio

n w

ith

the

com

plia

nce

depe

nden

t va

riab

le

and

this

w

ordi

ng

is r

ecom

men

ded

by

Ajz

en

and

Fish

bein

[l

4)

and

was

us

ed

by

Bec

ker

e! a

l. [I

I).

Sec

ond,

th

e co

rrel

atio

ns

wer

e “c

orre

cted

fo

r at

tenu

atio

n”.

In

this

ca

se,

sam

ple

corr

elat

ions

ob

tain

ed

from

th

e da

ta

are

adju

sted

to

co

mpe

nsat

e fo

r th

e er

ror

or

unre

liabi

lity

of

the

mea

sure

men

t of

th

e va

riab

les.

T

his

was

do

ne

usin

g th

e fo

rmul

a:

Whe

re

I is

the

cor

rect

ed

corr

elat

ion;

ri

y is

the

ob

tain

ed

corr

elat

ion;

r_

an

d r,

, ar

e th

e re

liabi

lity

estim

ates

of

th

e tw

o va

riab

les

(26.

271.

M

anip

ulat

ions

of

the

co

rrec

ted

corr

elat

ions

sh

ould

iiv

e a

clos

er

appr

oxim

atio

n to

the

the

oret

ical

ly

unde

rlyi

ng

rela

tions

hips

th

an

wou

ld

man

ipul

atio

ns

of t

he

unco

rrec

ted

data

[Z

S].

Reg

ress

ions

w

ere

run

usin

g bo

th

corr

elat

ion

mat

rice

s an

d co

mpa

red.

T

here

w

ere

no

subs

tant

ive

diff

eren

ces

in

the

resu

lts

whe

re

the

com

plia

nce

vari

able

w

as

the

depe

nden

t va

riab

le.

How

ever

, us

e of

th

e co

rrec

ted

corr

elat

ion

mat

rix

impr

oved

th

e pr

edic

tion

of

beha

vior

al

inte

ntio

n si

gnif

ican

tly

(R’

= 0.

55

vers

us

0.18

).

The

re

sults

re

port

ed

here

in

are

base

d on

th

is

seco

nd

alte

rnat

ive.

_”

- .-

_

- -

-..-

-

-._

. .^

-.

.~

- ._

.

-.

_ --

_ _

_ -

- -

- -

- -.

-

Page 5: A psychosocial perspective in the explanation of patients' drug-taking behavior

Patients’ drug-taking behavior

Table 2. Patient corn&awe

281

Number %

Finished AND took exactly 43 38. I Finished BUT not taken exactly 28 24.8

NOT finished, took exactly 28 24.8

NOT finished, not taken exactly 14 12.3

Total 113 100

Table 3. Comparison of HBM and TRA in predicting compliance

HBM alone’ HBM plus TRA*

Susceptibility .O.Ol -0.04

Serious 0.03 -0.01

Benefits 0.06 0.04

Barriers 0.28t 0.24t

Intention - 0.20t

Normative expectations - -0.17t

Belief strength - 0.26f

Outcome evaluation - 0.227

Attitude - 0.03

Motivation to comply - -0.03

Subjective norms - 0.11

Total R’ 0.10 0.29

F ,4,,,2, = 2.80; P < 0.03 F ,,,, p51 = 3.48; P < 0.001

Sig. of RZ change = FC7,9Jl = 3.59; P -z 0.002.

*Standardized partial regression co&icient.

tP <0.05. tP < 0.01.

tion, but missed one or more doses during the course of therapy. The remaining 37% did not complete the course of therapy as directed.

The possibility of nonresponse bias was explored because of the observed differences in the response rate between the two patient groups. Respondents unable to be followed up, either by mail or telephone, may have been different in their pre-drug regimen beliefs, attitudes and perceptions of norms. Re- sponder’s and nonresponder’s mean scores for each of the independent variables were compared using Student’s t-test. The two group’s mean scores did not differ on any of the 11 independent variables.

Next, the possibility of differences between the student and HMO patient’s pre-drug regimen beliefs, attitudes and perceptions of norms influencing the results was investigated. Respondent’s mean scores did not differ on any of the variables, including the compliance variable. This suggets that the beliefs, attitudes and perceptions of social expectations of these two groups of female patients were similar. In the absence of any significant differences, the two patient groups were pooled together for the remain- ing analyses.

The inter-relationships among the variables under study were next explored. Means, standard devi- ations, and zero order correlations are presented in Table 1. As expected, most independent variables

were positively correlated with each other and with behavioral intention and compliance. Perceptions of barriers, benefits, seriousness, belief strength, nor- mative expectations, attitude and subjective norms were associated with behavioral intention. Compli- ance was significantly associated with two of the HBM variables, barriers and benefits, and three of the TRA variables, belief strength, outcome evalu- ation and behavioral intention. Belief strength has the highest correlation with compliance, followed by behavioral intention, perceptions of barriers, out- come evaluation, and perceptions of benefits of the drug therapy.

Stepwise multiple regression analysis was used to examine the utility of HBM variables alone in pre- dicting compliance (Table 3). Combined, the HBM variables accounted for 10% of the variance. The one statistically significant predictor was perceptions of barriers to compliance. Despite a statistically significant zero order correlation with compliance, perceived benefits did not enter into the equation once barriers had entered. This was due in part to its moderately high correlation with barriers (r = 0.38).

It was hypothesized that addition of the TRA value-expectancy, social influence and intention vari- ables would significantly improve prediction of com- pliance when compared to the HBM variables alone. This hypothesis was investigated using hierarchical

Table 4. Summary of stepwise multiple regression analysis of TRA predictor variables alone on compliance intention

and compliance behavior* (N = 107)

Compliance intention Compliance behavior

Step Variable &tat Cum R’ Variable &tat Cum R’

I Subjective norms 0.36 0.07 Belief strength 0.27 0.12

2 Normative expectations -0.61 0.23 Compliance intention 0.27 0.19

3 Belief strength 0.24 0.30 Outcome evaluation 0.19 0.23

4 Attitude 0.22 0.34

‘Stepwise inclusion and removal procedure terminated when the probability of F to enter is greater than 0.05 and

probability of F to remove is greater than 0.10

tstandardized regression coefficients.

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282 L. DOUGLAS RED and DALE B. CHRISTENSEN

Table 5. Summary of hierarchical regression analysis of social influences on compliance intention and compliance behavior* (N = 107)

Variable

Compliance intention Compliance behavior

Belief/value Social Belief/value Social expectancy influences expectancy mfluences

alone added alone added

Benefits Barriers Susceptibihty Seriousness Attitude Outcome evaluation Belief strength Compliance intention Motivation to comply Normative expectations Subjective norms Total R2

- 0.30

-0.15 0.3% 0.10 0.324 0.26t

-0.05 0.285

-0.03 -0.X+

0.3% 0.55

0.04

0.20 -0.04 -0.04 -0.01

0.2 I 0.26: 0.20t

-

- 0.26

0.03 0.25t

-0.02 0.00 0.03 0.247 0.30t 0.06:

-0.04 -0.22

0.14 0.29

Sig. of R2 change F ,,,PJ) = 17.33; P c 0.001 F (3.94, = 1.15; P bO.05

*Standardized partial regression coefficient. tP < 0.05. $P <O.Ol. §P < 0.001.

regression procedures. The HBM variables were first entered into the equation as a group, followed by the grouped TFL4 variables (Table 3). The TFL4 variables made a significant contribution to the prediction of compliance [29]. The value-expectancy, social influence and intention variables explained an addi- tional 19% of the variance in the compliance vari- able, raising the total explained variance to 29%. The following four variables were found to be approxi- mately equal in importance as statistically significant predictors of compliance behavior in this combined model: barriers, intention, belief strength, and out- come evaluation.

The utility of TRA variables alone in predicting behavioral intention and compliance was next exam- ined using stepwise regression analysis (Table 4). Four variables were significant predictors of behav- ioral intention. First to enter was subjective norms, which explained 7% of the variance. The remaining three variables, in order, were: normative ex- pectations, salient belief strength, and attitude. Com- bined, these four variables explained 34% of the variance in behavioral intention.

A similar stepwise multiple regression procedure was used to examine the ability of the TRA variables, including behavioral intention, to predict compliance behavior (Table 4). Three variables were statistically significant, explaining 23% of the variance. However, these were not the same variables as those most strongly predicting behavioral intention. First to enter was belief strength, followed by behavioral intention and outcome evaluation. Behavioral in- tention and belief strength were nearly equal in importance as predictors of compliance.

Table 7. Parsimonious stepwise regression model of most significant predictor variables on compliance behavior* (N = 107)

Step Variable Betat Cum R’

I Belief strength 0.3 I 0.12 2 Barriers 0.28 0.20 3 Outcome evaluation 0.18 0.23 4 Compliance intention 0.19 0.26

*Stepwise inclusion and removal procedure terminated when the probability of F to enter is greater than 0.05 and probability of F to remove is greater than 0.10.

tstandardized regression coefficient.

The role of social influences on behavioral in- tention and compliance was further investigated us- ing hierarchical regression procedures (Table 5). First examined was the role of social influence variables versus belief/value-expectancy variables alone in predicting behavioral intention. The belief/value- expectancy variables were entered into the equation first as a group. Combined, they explained 30% of the variance in behavioral intention, with three statis- tically significant predictors. Next, the following social influence variables were entered into the equa- tion as a group: normative expectations, subjective norms, and motivation to comply. Together these variables explained an additional 25% of the variance.

It was interesting to note that the addition of the social influence variables to the equation predicting behavioral intention had almost no effect on the standardized regression coefficients of the three statis- tically significant belief/value-expectancy variables. They were, however, correlated with two other vari- ables: perception of benefits and outcome evaluation,

Table 6. Impact of including social influence variables on compliance intentions in predicting compliance*

Variable I

Compliance intention 0.20 Normative expectations - Subiective norms -

step

2 3 4

0.13 0.06 0.06 -0.15 -0.23 -0.22

- 0.13 0.14 Moiivation to comply - - - -0.04

*All of the belief/value-expectancy variables are also included in each equation.

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Patients’ drug-taking behavior 283

thereby weakening their contribution to the predic- tive model.

A similar hierarchical regression procedure was used to examine the role of social influence versus belief/value-expectancy variables alone in predicting compliance (Table 5). Different results were observed than for predicting behavioral intention. Belief strength, outcome evaluation, and compliance in- tention emerged as stastistically significant belief/value-expectancy predictor variables. These variables accounted for 26% of the variance. Seriousness and attitude were statistically significant predictors of behavioral intention, but did not emerge as important predictors of behavior, possibly because of the intercorrelation with the compliance intention variable.

The social influence variables were added to the equation in the second step. These variables ex- plained only an additional 3% of the variance. As was the case with compliance intention, there were no significant changes in the magnitude of the belief/value-expectancy standardized regression coefficients when the social influence variables were added, indicating again that these were independent (e.g. uncorrelated) predictors of compliance. Of the three social influence variables added, only normative expectations approached statistical significance.

Of particular interest was the finding that a significant reduction occurred in the standardized partial regression coefficient for compliance intention after the social influence variables were added to the equation (before beta = 0.20; after beta = 0.06). This again suggests substantial intercorrelation among the variables. However, the correlations with compliance intention were not large (highest r = 0.27). To further elucidate this finding, we investigated the impact of adding the social influence variables in a step- wise manner on compliance intention in this model (Table 6). The greatest reduction in the magnitude of the compliance intention standardized regression coefficient occurred when normative expectations was added to the equation and was reduced even further when subjective norms was included.

Finally, all of the variables from each model were combined in a stepwise regression procedure in order to obtain and evaluate a more parsimonious model (Table 7). The first variable to enter into the equation was salient belief strength, which accounted for 10% of the variance. This was followed by perceptions of barriers, outcome evaluation and behavioral in- tention, respectively. Together, these four variables explained 26% of the variance in compliance. Addi- tion of the seven remaining variables to the equation explained only an additional 3% of the variance. The following variables did not significantly improve the prediction of drug-taking compliance: motivation to comply, subjective norms, normative expectations, attitude, benefits of the treatment regimen, patients’ beliefs about their susceptibility or the seriousness of the disease.

DI!XUSSION

The results of this study are consistent with those of several other studies regarding the prevalence of the drug-taking noncompliance problem. Only 38%

of the patients being treated for an uncomplicated UT1 were completely compliant with their medica- tion regimen. An additional 25% completed their drug therapy, but missed one dose or more during the 10 day period. The remaining patients (37%) did not complete their medication regimen as directed.

Anecdotally, a number of patients who completed their therapy, but forgot a dose or two, stated during the telephone interview that they took their medica- tion faithfully until the symptoms subsided. Only then did they forget to take their medication. At least among these noncompliant patients, this would argue for the dynamic decision-making model similar to the one suggested by Christensen [30,31]. He suggests that patients’ perceptions of the importance of com- pliance change over time and that they consciously or unconsciously reassess their decision to comply be- cause of their exposure to new information (e.g. the pain went away). After reassessment, if prospects for recovery from a disorder appear good, further drug- taking may be considered less necessary, unnecessary, expensive, or inconvenient.

Overall, the “readiness to take action” belief di- mensions from the HBM explained only a small portion of the variance in compliance, and only perceptions of barriers had a significant impact on patient behavior. These results can be interpreted to say that patients who find taking medication to be easy and convenient are more likely to be compliant. However, this study did not investigate why the same regimen is ‘easy’ and ‘convenient’ for some patients and not for others.

The findings from this study lend support to critics of the HBM who state that the model is insufficiently articulated, and that important determinants are not included. Becker and Maiman [2] included “intent to comply” in their modification of the HBM, however, this variable is seldom added to empirical in- vestigations. We found that “intention to comply” significantly improved the prediction of compliance behavior, however it was not the sole predictor of compliance behavior as the TRA model specifies. In fact, it was not even the strongest predictor. This is consistent with the conceptual concerns and findings of others. For example, Becker et al. [I l] found that a mother’s estimate of the likelihood that she would be able to keep her child on the prescribed diet was the most influential “general motivation” item, how- ever, it was not a significant predictor of long-run clinic appointment keeping behavior. Others have reported similar findings which indicate that behav- ioral intention is probably not the best predictor of actual behavior [32,33]. Prior behavior has been shown to be among the best predictors of future behavior along with the situational variables which modify patients’ intentions towards further drug- taking over time.

Addition of the TRA variables improved the model’s prediction of compliance. In each regression analysis, ‘belief strength”, or belief in the likelihood of symptomatic relief, was a stronger predictor of compliance than any of the “readiness to take action” variables, including perceptions of the importance, worth, safety or other benefits of compliance. It is interesting to note that none of the social variables entered into the final equation predicting compliance

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284 L. DOUGLAS RIED and DALE B. CHRISTENSEN

behavior, even though they were the strongest predic- tors of compliance intention. One interpretation of our findings is that expectations of significant others, namely spouse, family and physician, play a significant role in the development of intentions, however, they do not seem to carry over to actual behavior (at least not for this acute disease). While intentions are shaped by significant persons in their environment, a patient’s own beliefs/value- expectancy and situational circumstances had a greater influence on whether they actually completed their course of medication. On the other hand, for asymptomatic, chronic diseases where discomforting symptoms do not act as internal cues to compliance, social influences may be more important and re- minders from significant others or public health announcements may serve as external cues to compliance.

In development of a more parsimonious model, two of the statistically significant predictors were value-expectancy variables, belief strength and out- come evaluation. Compliant patients believe more strongly that compliance with their medication regi- men is likely to relieve their symptoms and to evalu- ate the symptoms associated with UTI’s more nega- tively. Compliant patients are also more likely to intend to take the medication exactly as directed from the start and are less likely to feel that taking their medication as directed is too difficult or too incon- venient.

The results of this study should be generalized only with caution to other populations or other disease states. Nevertheless, our findings suggest directions for developing strategies that health care profession- als may use to improve compliance with drug ther- apies for acute conditions. Not only is it necessary for patients to feel there are benefits associated with taking the medication exactly as directed, but they must also believe that these benefits are likely to accrue. Health care practitioners need to continually remind patients of the therapy’s value and to point out benchmarks for patients to evaluate the success or failure of the therapy. This requires close super- vision and on-going communication. Maintaining patients’ perceptions of the likelihood of success and the value of the treatment over time is an important key to improving patient’s compliance behavior.

Perceptions of barriers was the second strongest predictor of compliance. Health care professionals must reduce the perception that medication taking is difficult or inconvenient. This may be done by select- ing more acceptable dosage forms, including long acting drugs, and by customizing and simplifying the regimen, particularly by reducing the number of dosage intervals. A change in condition from symp- tomatic to asymptomatic or an increase in time constraints due to resuming regular family or work responsibilities as recovery takes place could also signal the beginning of noncompliance. Barriers to compliance can be significant enough in certain situ- ations to overcome patients’ intentions, however strong their intentions were in the beginning.

Finally, the patient’s evaluation of their likelihood of taking the medication as directed is a significant benchmark in judging whether a patient will be compliant or not in the future. Modifying situations

influence even the best of intentions, but patients who do not intend to take the medication from the beginning are less likely to be compliant. A frank and open discussion about the complexity of the therapy, the medication’s side effects. time and fiscal con- straints, and other factors which may modify pa- tients’ perception of the likelihood of compliance should be discussed from the start.

Acknowledgemenr-This work was supported in part by NIH Biomedical Research Grant RR07079.

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APPENDIX

Index Measures of TRA and HBM Variables

Barriers

taking the medicine. ”

easy-hard convenient-inconvenient

(2) Perceptions of seriousness of noncompliance (serious)

If you were NOT to take the medicine for your infection exactly as directed for the next 10 days, how serious would the consequences be for you?

PAIN when urinating. DIFFICULTY when uri- nating

BLOOD in the urine.. CHILLS . FEVER. BURNING when urinating

(3) Susceptibility

“My body seems to resist illness well . ” “1 seem to get sick easier than other people do. . ” “When there is something going around I usually catch it . ” “Most people get sick easier than 1 ”

(4) Benefits

Below are pairs of opposite words,

important-unimportant safe-dangerous worthwhile-worthless healthy-unhealthy

(5) Belief strength

If you take the medicine for your infection exactly as directed for the next 10 days, how likely is it that you will have:

PAIN when urinating . DIFFICULTY when uri- nating

BLOOD in the urine.. CHILLS FEVER.. BURNING when urinating

(6) Ourcome evaluation

Think about how ‘good’ or ‘bad’ you feel each of the following things is.

PAIN when urinating. DIFFICULTY when uri- nating

. . BLOOD in the urine. CHILLS . FEVER. BURNING when urinating

(7) Normative beliefs

Generally speaking, which of the following are true about you? cc. . . My - think I should take my medicine for the next 10 days.”

doctors. family. . .

. spouse.

. . . good friends.

(8) Motivation to comply

Generally speaking, which of the following are true about you? “ . . I want to do what my - think I should do. . ”

doctors. . . . family. . . . spouse. . . . good friends. .

(9) Artirude

Below are pairs of opposite words which have been found to describe people’s attitudes about taking their medicine.

good-bad harmful-helpful foolish-wise smart-dumb

(IO) Subjective norms

“Most of the people who are important to me think I should take the medicine for my infection exactly as directed for the next 10 days...”

( I I ) Compliance inlenrion

How likely is it that you will take the medicine for your infection exactly as directed for the next 10 days? “I intend to take the medicine exactly as directed for the next 10 days” “I will probably not be able to take the medicine exactly as directed”

(12) Compliance

“Have you finished all of your medicine?” “Did you ever forget a dose?’ “Did you take your medicine exactly as directed for all IO days?’