Journal of Clinical Pharmacy and Therapeutics (1992)17,283-295

REVIEW ARTICLE

Patient compliance-an overview

L. Stockwell Morris, and R. M. Schulz
Division of Health Care Policy and Evaluation, United Healthcare Corporation and College of Pharmacy, University of
South Carolina, U.S.A.

SUMMARY INTRODUCTION

The Office of the Inspector General reported that the

This article reviews the major topic areas of com-
consequences of non-compliance among the elderly can
pliance research. Much of the research in the area
include increased morbidity and mortality, in addition
has focused on measurement, extent, and determi-
to increased cost of treatment (I). Non-compliance has
nants of non-compliance. Research on the effective-
beenlinked to23%ofnursing homeadmissions(2)andup
ness of educational and behavioural strategies to
to 10% of all hospital admissions (3).Non-compliance
improve compliance suggests the need to combine
with treatment for cardiovascular disease contributes to
them. While some authors have attempted to model
approximately 125,000 deaths and several thousand
compliance or medication-taking behaviours, these
hospitalizations per year (4). The annual cost of treat-
models cannot be applied widely.
ment for moderate to severe hypertension was esti-
After decades of compliance research, very little
mated to be $4,850 if patients purchased all of the
consistent information is available, except that
medications and were 100% compliant. This annual cost
people do not take their medications as prescribed.
rose to $10,500 when patients purchased the medi-
The methodological rigour of compliance studies
cations but took them irregularly (5). For these reasons,
may partially contribute to this situation. Method-
non-compliance has been considered a major public
ological flaws have included design features and
health problem (6).
study execution. In addition, researchers have pro-
Compliance research has focused on the extent and
ceeded with studies without regard to a theoretical
determinants of non-compliance, and strategies to
framework.
improve compliance. The purpose of this article is to
Many have argued that much of the existing
summarize and review research on compliance with
compliance literature also lacks conceptual rigour.
medications in these areas. In addition, the method-
Although we know that people do not take their
ological rigour and conceptual basis of traditional
medications consistently, we do not know specifi-
compliance studies will be discussed.
cally why they have done so. One reason for this
lack of understanding is that compliance research
has been dominated by the perspective of the health DEFINITION
professional. To better understand medication-
taking behaviour, researchers need to examine Compliance has been defined (7) as 'the extent to which
the patient's perspective. Consequently, future a person's behavior (in terms of taking medications,
research needs to investigate a patient's decision- following diets, or executing lifestyle changes) coincides
making process and the reasons for those with medical or health advice'. Thus, compliance is
decisions. viewed as a process. Some researchers have put this
definition into operation by dividing their sample popu-
*Correspondence:Dr Lisa Stockwell Morris, Pharmacy Research
lations into compliers and non-compliers based on stat-
Scientist, Healthcare Evaluation Services, Division of Health Care
Policy and Evaluation, United Healthcare Corporation, 9900 Bren istical measures such as the median or mean levels of
Road East, P.O. Box 1459,Minneapolis, MIN 55440,U.S.A. medicine taken (8).Those who fall below the mean or
Series editor: Dr D. Worthen. median are labelled as non-compliant, while those above
284 L. Stockwell Morris and R. M. Schulz

the criteria are compliant. Other researchers have used cations and different individuals. In addition, direct
previously reported levels of medication-taking to dis- measurements can be quite difficult to perform and
tinguish between compliance and non-compliance or costly.
relied on their personal belief that a certain level is Indirect measurements of compliance are more
significant (8). frequently reported in the literature, possibly due to
Compliance can also be viewed in terms of the the relative ease by which these measures are
results of taking medication. Compliance as an out- obtained. Examples of indirect measurements of com-
come is defined as ’the number of doses not taken or pliance include therapeutic or preventive outcome,
taken incorrectly that jeopardize the therapeutic out- impression of the physician or predictability, patient
come (6)’, or ’the point below which the desired interview, prescription filling dates, and pill counts
preventive or desired therapeutic result is unlikely to (13). As with direct measurements, each indirect
be achieved (9)’.Both of these definitions recognize means of measuring compliance has inherent advan-
the possibility that taking less than 100% of the tages and disadvantages.
medication can result in a desired health outcome. The therapeutic outcome may seem a viable means to
Outcome-oriented definitions differ from the pro- assess compliance, however, patients do improve for
cess-oriented definition in their emphasis on the end- reasons other than following the prescribed regimen.
result or outcome of the actions taken. For example, Epstein and Cluss (14) reported that compliance with
Luscher and co-workers (10)reported that 80% com- either the active product or placebo was associated with
pliance to a medication regimen for hypertension an appropriate clinical outcome. In addition, a person’s
lowered blood pressures to a normal level. However, condition can deteriorate or remain stable even when
compliance of 50% or less was ineffective in adequa- the medications are taken as prescribed.
tely lowering blood pressures. Olson and co-workers The physician’s estimate of patient compliance has
(11) reported that a compliance rate of 80% was been very inadequate. Caron and Roth (15)determined
necessary for therapeutic results in children with that physicians do not estimate compliance any better
streptococcal pharyngitis, but 33% compliance than if they simply rely on chance as a predictor.
reduced the rate of contracting streptococcus infec- Mushlin and Appel(16)reported that less than one-half
tions in children taking oral penicillin as a prophylac- of a physician’s predictions correctly discriminated
tic for rheumatic fever. The absence of a singular between compliers and non-compliers, while three-
conceptual basis of compliance is problematic. Strat- quarters of their predictions of non-compliance were
egies to improve compliance can be evaluated only inaccurate.
within the context of a given definition. Further- Compliance can also be assessed using a patient
more, comparative assessment of the compliance interview or self-report. Park and Lipman (17) used
literature cannot be done across studies using differ- both pill counts and patient interviews to assess com-
ent definitions of compliance. pliance of psychiatric patients with imipramine. Using
interviews, they categorized 100 patients as com-
pliers, but using pill counts only 58 would be com-
MEASUREMENT pliers. In addition, in only 68 of the patients did both
methods lead to the same classification. Gordis et al.
Compliance is measured directly and indirectly. Direct (18),interviewing mothers and their children and cor-
measurements of compliance generally involve the relating these with the findings of urine tests, found
detection of a chemical in a body fluid. Examples of that both the mother and child overstated compliance
direct measurements include blood levels or urinary and understated non-compliance. Morisky et al. (19)
excretion of the medication, a metabolite, or a marker. developed a four-item scale for self-report of compliance
The primary reason for using direct measurements is that demonstrated both concurrent and predictivevalidity
they are less subject to bias than are indirect measure- of blood pressure control and supported the use of patient
ments (12). They can be misleading, however, if the interviews.
patient takes the medication prior to testing. Little infor- Using centralized pharmacy records to check refill
mation can be derived regarding the use of medication dates or the number of pills obtained is another indirect
over time. Direct measurements do not account for the means to measure compliance (20-24). Steiner and co-
variability of pharmacokinetic factors of different medi- workers (25)reported that refill records of the managed
 Patient compliance 285

care setting under study were valid correlates of medi- At this point in time, there is not a consistent measure
cation effects and compliance. The authors believe that used to determine compliance. Researchers will often
this method is useful in detecting non-compliant patients choose a particular method due to ease and convenience.
who remain in the health care system but only fill some of Likewise, it is not known what is the most appropriate
the medications prescribed. The validity of this method, means to measure compliance. The use of various
however, rests on the completeness of the pharmacy measurement techniques makes it very difficult to
database, usually most complete in institutional seitings. compare compliance research findings.
Pill counts have also been used to assess compliance.
Roth and co-workers (26) suggested that pill counts
often over estimate compliance. Bergman and Werner EXTENT OF NON-COMPLIANCE
(27) found that, based on urinalysis, 8% of their study
population was compliant, while pill counts showed Fedder (31)stated that, ’it seems that a third of patients
18% of the population to be compliant. Rudd and co- always comply, a third never comply and a third some-
workers (28) found that weekly pill counts indicated times comply’. Regardless of the patient population,
variability within subjects, between subjects, and disease state, or compliance measurement used, the
among the different regimens. compliance rate is usually well below 100%.
A recent advance in compliance measurement is elec- The duration of therapy is a factor which can influence
tronic monitoring. The prescription vial contains a the extent of compliance. Compliance with short-term
microprocessor in the lid. This recording device will medications is generally considered to be somewhat
identify the date and time the prescription vial is higher than for long-term medication regimens. How-
opened. Although the device does not verify that the ever, rapid declines in compliance occur during even the
medicine was consumed, it does provide an accurate first 10 days of short-term therapy (32). This suggests
record of when the vial was opened, supposedly for the that compliance behaviour may be unstable even in
purpose of taking the medicine. In this regard, electronic short-term therapy.
monitoring should be able to identify individuals who Generally, the rates of compliance in long-term ther-
falsely claim they are taking medicine as prescribed. apy tend to converge to SO%, regardless of the illness or
Engstrom (29) reported that five of 19 patients who setting (32). The compliance rate for long-term medi-
provided prescription medicine in vials with micro- cations used for prevention, treatment, or cure can range
processors embedded in the caps were non-compliant. from 33 to 94% (32). Published compliance rates for
None of those five patients claimed to be non- long-term medication use are shown in Table 1(32-34).
compliant. Four of the five patients did not improve The extent of compliance in a specific disease popu-
clinically. Cramer et al. (30)used the electronic monitor- lation has also been evaluated. Hogarty and co-workers
ing system with 24 epileptic patients who consumed (35) found that only 42% of the 374 schizophrenic
7,413 doses over 3,428 days. A comparison of elec- patients studied were taking their medications
tronic monitored data and pill counts showed that correctly. Young et al. (36) reviewed the literature on
pill counts overestimated compliance as compliance non-compliance of schizophrenic out-patients and
declined. Furthermore, a dear relationship was estab- reported a median compliance rate of 41%, with a
lished between adherence to the prescribed regimen, as range of 10-76%. These findings approach the 50%
determined by electronic monitoring, and clinical out- compliance reported for long-term therapy.
come. Five patients reported seizures during monitoring; Compliance rates for those with affective disorders
five of these patients’ seizures could be attributed to are very similar. Johnson and Freeman (37) found that
missed doses documented by electronic monitoring. 16% of the 73 patients prescribed medications for
Cramer ef al. (30) view electronic monitoring as an depression stopped taking their medication within 1
additional and needed dimension in measuring patient week of beginning the treatment. Within 30 days of the
compliance. Electronic monitoring helps to explain how initiation of the treatment, 68% had stopped taking the
the total number of doses were taken, if the dosing prescribed medicine. In three studies that examined
regimen was followed, and if clinical outcomes can be compliance with lithium therapy, researchers reported
related to non-compliance. Although not a panacea, elec- that between 25 and 50% of patients failed to take their
tronic monitoring improves clinicians’ and researchers’ medications as prescribed (38),only 47% of the patients
understanding of how patients take prescribed medicine. were thought to be complying perfectly over the first 2
286 L. Stockwell Morris and R. M. Schulz

Table 1 Compliance with long-term medication'

~~

Treatment Measure Definition Compliance rate%

Penicillin prophylaxis for rheumatic fever Urine assay Medication in urine 33

(94)
Anxiolytics in neurotics (95) Pill counts Counts within 25% of 54
prescribed amounts
Antipsychotics in schizophrenics (35) Interview Taking medications 42
correctly
Tuberculosis medications (96) Interview and urine Taking medications 55
testing throughout follow-up
Tuberculosis medications (97) Record review Continuing therapy 63
Various medications used by the elderly (98) Interview Taking medications 41
correctly
Various medications for diabetes or Interview Taking medications 42
congestive heart failure (99, 100) correctly
Various medications used by patients in Interview Taking medications 69
homes for the aged (101) correctly
Antihypertensives (102) Record reviews (same Remaining in care and on 1year 94
subjects) therapy 2years 65
3 years 34
Antihypertensives (103, 104) Pill counts (same Taking > 80%of 6month 53
subjects) medication 12month 53

'This table represents articles that provided demographic descriptions of the subjects and employed statistically rigorous sampling tech-
niques. Examples include the use of random population samples, three or more hospitals/clinicsin a geographicalarea, or a regional programme/
referral system.

years of treatment (39, and 24% withdrew from treat- fell into the categories between definitely compliant and
ment during the h s t 2 years (40). These studies definitely non-compliant. Eisler and Mattson (45)
further support the lack of stability of compliance as a reported that 40% of patients taking anticonvulsants
behaviour. missed enough doses to affect blood levels. In addition,
Compliance rates for hypertensive patients are quite non-therapeutic serum anticonvulsant levels have been
similar to rates reported with other conditions. For measured in as many as 97% of 34 patients (46) and as
example, more than 50% of these patients dropped out low as 26% in 153 cases (47). As with other diseases
of therapy within the first year, while of those remaining presented, theextent of compliancewith anticonvulsants
about 33% did not take enough of their prescribed medi- is quite variable, but still within the range expected for
cations to reduce their blood pressure adequately (41, long-term therapy.
42). This finding implies that compliance behaviour is The average rate of compliance tends to converge to
relatively unstable over time. Widmer and associates 50% for long-term therapy, regardless of disease and
(43) reported a mean compliance rate of 87% for 291 compliance behaviour tends to decline with time.
hypertensive patients in a rural mid-west study. The The increasing prevalence of chronic conditions for
high rate of compliance may have been partially attri- which long-term therapy is prescribed suggests that
buted to the method of measurement and the definition compliance will remain an area of concern.
of compliance. Such a conclusion supports the conten-
tion that comparability of studies should be done with DETERMINANTS
great caution.
Dodrill and co-workers (44) identified 80 of the 282 Meichenbaum and Turk (12) identified over 200 vari-
adults with epilepsy studied as definitely compliant, ables that have been examined in studying compliance.
while 42 were non-compliant. The remaining subjects The majority of these variables are characterized as
 Patient compliance 287

demographic variables, such as age, sex, education, and Features of the treatment regimen have also been
socio-economic factors, or disease-experience variables. evaluated as possible determinants of compliance.
In this section, the influence that demographic variables, Haynes (51)reported that the duration of treatment, the
disease features, and treatment regimen features have number of medications,and their cost negatively affected
on compliance will be presented. compliance, while parenteral medication administration
Demographics have been shown to be poor predictors improved compliance. Sbarbaro (52) suggested that
of compliance.Hulka (48)reported that the demographic shortening the duration of therapy and reducing the
factors of age, sex, marital status, education, number of number of times that a medication is taken each day will
people in the household, and social class are not statisti- help to improve patient compliance.Note that while the
cally associated with compliance. In a study of hyperten- presence of side effects intuitively seems to decrease
sive patients, Widmer et al. (43) found no significant compliance, Haynes (51) reported that when patients
differencesbetween mean compliance rates for males and were asked to give reasons for non-compliance, side-
females. Similarly, Dodrill and co-workers (44) found that effects were mentioned by only 5-10%. According to
the sex and age of the epileptic patients studied did not Haynes, however, future research in the area Qf disease
adequately predict compliance. However, under certain features, and to some extent treatment features, should
specific conditions, such as a particular disease, demo- receive low priority because of the inability to increase
graphic variables can predict compliance behaviour (49). detection or improve compliance (51).
Unfortunately,the findingsfor these specificconditionsdo More than 20 years of research in the area of com-
not extend to other situations. Such inconsistent results pliance has produced very little consistent information
havemade it impossible todevelopaprototypeof thenon- on the factors which can be correlated with non-
compliant individual. Porter (50)summed up the situation compliant behaviour. Most of the variables examined
well by stating 'it must be emphasized that it has not are inconsistently correlated with compliance and
proved possible to identify an uncooperative type. Every thus cannot be used to predict compliant behaviour
patient is a potential defaulter. Compliance can never be adequately.
assumed.'
Features of the disease have also been investigated.
In a review of the literature published before 1978, INTERVENTIONS T O IMPROVE
Haynes (51) suggested that disease factors were poor COMPLIANCE
indicators of compliance. Less than half of the studies
found any significant correlations between compliance Educationd strategies
and disease features. In addition, even where signifi-
cant correlations were noted, the direction of these Educational strategies, such as verbal communication or
associations was inconsistent between studies. Only counselling, have been shown to improve compliance
three disease features were found to be determinants (53). Hecht (54) found that counselling provided by
of compliance (51). First, psychiatric patients, es- registered nurses to patients receiving out-patient
pecially those with schizophrenia, paranoia, or person- chemotherapy decreased drug errors. Nessman ef al.
ality disorders, are generally low compliers. Second, (55)developed a programme that combined audiovisual
when more symptoms are reported by patients, their teaching with counselling by a registered nurse which
compliance rate is lower. This finding does not sup- decreased medication errors and diastolic blood press-
port the assumption that increasing severity of symp- ures. Zismer and associates (56) reported that counsell-
toms should encourage compliance, suggesting that as ing of hypertensive adults at clinic visits by graduate
people notice more symptoms they begin to give up research assistants produced a substantial decrease in
on the treatment. In addition, patients with sympto- blood pressure. Similarly, counselling by a pharmacist
matic illness, such as rheumatoid arthritis, become less resulted in a significant clinical decrease in the diastolic
compliant. Third, the degree of disability produced blood pressures of adults attending a neighbourhood
by the disease positively influences compliance. The clinic. Based on these studies, one-to-one counsell-
increased compliance could be the result of the sever- ing appears to be an effective means of improving
ity of the disease or increased supervision due to the compliance.
disability. The authors felt that increased supervision Not all research supports the association between
was the more likely explanation. educational strategies and compliance. In a review
288 1.Stockwell Morris and R. M. Schulz

including only those articles published before 1979, which received both verbal and written information
only one of the four studies involving medication were collapsed into one group, compliance at 3 weeks
instruction found a significant change in compliance due was significantly higher for this new group than for the
to the intervention (57). In this study of patients being group which received no written information and
discharged from the hospital, 90% of the patients who limited verbal information. These results were not sus-
received counselling from the pharmacist before dis- tained over 6 weeks. Myers and Calvert (63)suggested
charge were compliant with the prescription orders, but that verbal and written information improves com-
only 24% of those who did not receive counselling were pliance by an attention-placebo effect rather than a
compliant (58). Note that Compliance did appear to be cognitive effect. Consequently, it would seem that com-
positively affected by pharmacy counselling over the pliance poses a larger problem in long-term therapy or
short-term of the study. In the other three studies once the information intervention is removed. Brown
reviewed by Haynes (57), two of which involved phar- et al. (64) found that individuals who receive verbal
macy counselling and one of which involved nursing and written information gain more medical knowledge
counselling, these interventions did not produce than those who receive only verbal information, but
statistically significant changes in patient compliance. instruction does not significantly affect compliance.
In their review of the literature on written cornmuni- The use of educational strategies to improve com-
cation, Morris and Halperin (59) concluded that written pliance is based on the information model of compliance
information may be effective for short-term medication management (65). The model suggests that patients fail
therapy. Written information alone is not sufficient to to comply because they do not have s&cient infor-
increase patient compliance in medication used in long- mation regarding the risks of the disease, the benefits of
term therapy. In a meta-analysis of artides written treatment, and the details of the treatment. From the
between 1961 and 1984 on intervention strategies, studies presented, educational strategies alone may not
written interventions, except for patient package significantly improve patient compliance. Information
inserts, were shown to produce increased knowledge and may provide its greatest benefit for short-term therapy.
decreased medication utilization errors (60).The studies Similarly,information is valuable during the early stages
on patient package inserts resulted in an average effect of long-term medication regimens. However, in the
size value near zero for both knowledge and medication long-term, once the intervention is removed, information
utilization errors (60).This indicates that these inserts may affect compliance less.
have limited ability in improving knowledge or decreas-
ing medication utilization errors. Gibbs et al. (61)found
that compliance was not significantly different for Behavioural strategies
those patients who received patient information leaflets,
however, their knowledge of the medication was better. Behavioural strategies, such as reminders and special
In a meta-analysis of combinations of intervention medication containers, have been shown to improve
strategies, one-to-one counselling, group education, and compliance (53, 66). Patients with hypertension who
written and/or audiovisual interventions, except patient used a medication reminder chart showed improved
package inserts, increased knowledge and decreased knowledge of medication use, dose, and frequency of
medication utilization errors (60). Robinson and co- administration after using the chart (67).They presented
workers (62) found that when written information was with fewer incidences of forgetting to take the medi-
combined with verbal reinforcement, compliance was cation and a lower number of deviations from the pre-
significantly higher than when written information was scribed regimen. Another type of reminder is a refill
used alone. In addition, compliance was higher for the reminder which is generated at the pharmacy level.
intervention groups than for the control. Myers and S i n s and Wenzloff (68)investigated the use of post-
Calvert (63) found no significant differences in com- card refill reminders and telephone-call refill reminders.
pliance between a group which was told the purpose of These researchers found that both types of reminders
the medication but was given no written information, a increased refill compliance, but there were no significant
group which received verbal and written information differences in compliance between the two types.
about the side-effects of the medication, and a group Specialmedication containers are another behavioural
receiving verbal and written information about the ben- intervention. They help the patient to organize medi-
eficial effects of the medication. When the two groups cations and monitor self-administration of products on
 Patient compliance 289

Table 2 Successful compliance

interventions Effect on
compliance Effect on
Condition Strategy (%) outcome

Hypertension (104) Self-monitoring +cueing + +21 Improved

rewards
Hypertension(105) Nurse management at + 19 Improved
work + cueing + self-
monitoring +rewards
Hypertension(55) +
Self-monitoring group + 19 Improved
discussion + self-
management
Hypertension (106) Written instruction+ + 15 Improved
treatment cards +recall
of nonattenders

daily to weekly intervals (53).Special medication pack- superior in improving compliance than the other inter-
aging has shown to increase compliance (69,70).Wong ventions. Swain & Steckel(74) investigated the effects
and Norman (71) investigated the use of a calendar of patient education and contingency contracts on com-
blister-pak to improve compliance. The average non- pliance. Patients received routine care only, routine care
compliance index significantly decreased when patients plus education, or routine care plus education and a
used the blister-pak, indicating that this type of special contingency contract between the patient and the nurse.
packaging may be advantageous in improving com- This latter group exhibited a decrease in diastolic blood
pliance. Some manufacturers are now selling their pressures.
products in special packaging. Oral contraceptive packs Haynes (65) has reported methodologically rigorous
and the Medrol DosepakB are two examples of special studies of compliance interventions. All of the successful
unit-of-use packaging. interventions, or those which had significantly positive
effects on compliance and treatment outcome, involve
Educational and behavioural combinations a combination of interventions. A sample of these
interventions can be found in Table 2.
Many researchers have evaluated the use of both It appears, from the materials presented in this section,
educational and behavioural strategies in a combined that compliance can best be improved by interventions
intervention. Combining behavioural and educational combining educational and behavioural components.
strategies is supported by the compliance activity The effectiveness of interventions combining edu-
model (65). This model recognizes the relationships cational and behavioural techniques was supported by
between behavioural, cognitive, and social factors in the findings of a meta-analysis prepared by Mullen et al.
determining compliant behaviour. In a study of patients (60). Compliance packaging, which incorporates both
with epilepsy, the intervention group received patient educational and behavioural components, has been intro-
counselling, a special medication container, mailed duced recently by the pharmaceutical industry in an
reminders to have prescriptions refilled, and they were effort to improve compliance. This packaging ideally
asked to self-record medication intake and seizure fre- serves as a patient education tool and makes it easier for
quency (72). Patient compliance significantly improved the patient to remember to take the medication (75). An
in patients receiving this combined intervention. example of this is the M A C P A P manufactured by
Ascione and Shimp (73)evaluated the effectiveness of Norwich Eaton Pharmaceuticals, Inc.
oral instructions alone, oral instructions plus a medi-
cation reminder calender, oral instructions plus a
medication reminder package, and oral inshuctions plus MODELS OF CQMPLIANCE
written medication information. Interventions including One of the first models used to explain compliance was
either the medication reminder calendar or package were the Health Belief Model (76). This model was initially
290 L. Stockwell Morris and R. M. Schulz

applied to preventive health behaviour. Becker and support of others were used in conjunction with the
Maiman (77) incorporated general health motivations demographic variables and health locus of control scales
and modifying and enabling factors into the model to to develop an equation to predict compliance. Patient
provide a focus on sick role behaviour and compliance satisfaction was the only significant predictor of medi-
with medications. While many of the studies that evalu- cation compliance.The results of this study indicate that
ate the Health Belief Model support the components of either this model or the measurement of the variables is
the model, some studies do not (78).Under certain dis- inappropriate. The authors suggest that the limitations
ease conditions, some of the components of the Health of cognitive variables in predicting compliance in
Belief Model do help in the understanding of compliance. patients with chronic diseases can partially explain the
However, the entire model has not been supported results. In addition, subjects in this study had received
empirically (79). In response, researchers attempted to treatment for an average of 17 years. Because of these
improve the model by adding more components. characteristics, their health beliefs and health locus of
Ried and Christensen (79) incorporated the Theory of control may differ from patients in other circumstances.
Reasoned Action into the Health Belief Model. In this In response to inadequate findings when using the
study, the Health Belief Model explained 10% of the Health Belief Model, Schlenk and Hart (82) investigated
variance in the compliance variable. The inclusion of the the use of Rotter's Social Learning Theory. These
Theory of Reasoned Action explained an additional 19% authors incorporated health locus of control, health
of the variance. The Health Belief Model variables of value, and social support in their model. A significant
barriers and benefits and the Theory of Reasoned Action relationship was found between compliance and social
variables of belief strength, outcome evaluation, and support, powerful others health locus of control, and
behavioural intention were found to be significantly internal health locus of control. In a multiple regression
related to compliance.The social influence variables, part analysis, social support and powerful others health locus
of the Theory of Reasoned Action, were able to predict of control accounted for 50% of the variance in com-
behavioural intention, but not compliance behaviour. pliance. Because a non-experimental design with a small
The research supported the contention that some of the number of subjects was used in this study, the results
paths of the models are significant but the models as a may be different under a more controlled experiment
whole cannot predict compliance. Even with the com- with more subjects.
bined models, only 29%of the variance was explained. Stanton (83) proposed a model which included
This suggests the possibility of missing paths in the patient-provider communication, knowledge of medi-
model or the improper measurement of the variables. cation regimen, satisfaction with the provider, internal
The Health Decision Model (80),developed by Eraker locus of control, perceived social support, and treatment
et al. incorporates the Health Belief Model and patient disruption to lifestyle as variables that directly and
preference, including decision analysis and behavioural indirectly lead to adherence to a medical regimen. The
decision theory. The model is based on the strengths of link between adherence to medical regimens and the
the Health Belief Model and patient preference models. outcome of blood pressure change were also evaluated.
The model includes bidirectional arrows and feedback Greater expectancy for internal control over health and
loops which suggest that compliance behaviour can also hypertension, greater knowledge of the treatment regi-
change beliefs. The validity and predictability of this men, and stronger social supports were significantly
model was not statistically tested by these authors. predictive of adherence to medication regimens. In
Nagy and Wolfe (81)evaluated a model using vari- addition, higher levels of adherence were related to
ables derived from the health locus of control and the blood pressure reduction. Again, several components of
Health Belief Model. The demographic variables of age the proposed model were statistically significant but the
and socio-economic status were also included in the entire model could not predict compliance better than
model. Scales to assess Internal Health Locus of Control, the individual paths in the model.
chance Health Locus of Control, and powerful others As with the other areas of compliance research,
Health Locus of Control were administered. The latter modelling has produced inconsistent findings. It was
scale evaluated the person's belief that health pro- intended that these models should serve as data
fessionals or family can affect health. The perceived reducers and organizers. However, a strong model of
severity of illness, outlook on illness, experienced symp- compliance still does not exist. Possibly the problem
toms, satisfaction with treatment, family support and is that the researchers are examining inappropriate
 Patient compliance 291

paths or relationships. Another problem may be the family life’. Stimson (89)points out that people are not
inconsistency of techniques employed when evaluating taking medicines in a thoughtless vacuum but that they
the variables in the models and the context may influence have ideas and attitudes about medicine. These ideas and
the fit of the model, thus limiting wider applications of attitudes are based on their relationships with others and
any model. past experiences. Because of the social context of taking
medications, researchers should focus on compliance
from the patient’s perspective rather than from the view-
INADEQUACIES OF COMPLIANCE
point of health professionals (87,89-92).This approach
RESEARCH
should focus on the reasons or motivations for the medi-
The methodological rigour of compliance studies has cation-taking behaviour adopted. This type of research
been questioned. Haynes (65) indicated that the scien- has received the lowest priority in much of the previous
tific merit of these studies ranged from primitive to research (89).
exceptionally high. One explanation for this situation Other problematic assumptions that have prevailed
may be that health care researchers empirically test in previous research on compliance have been noted by
potential factors that might overcome low compliance, Gabe and Thorogood (93). First, researchers have
regardless of any theoretical framework (84).In addition, assumed that the individual is the methodological unit
researchers differ in their ability to recognize and control of analysis. Individualswere treated as though they were
for design features and execution of the study (85).These members of a single population, rather than as members
flaws in design and execution affect the certainty of the of many sub-cultures. Second, researchers have
conclusions of the projects. attempted to identify causal relationships between vari-
Haynes and co-workers (65,85)developed criteria to ables, assuming that the variables can be treated as
judge the methodology of 537 original articles on independent. However, the phenomenon of medication-
compliance. Bruer (86)combined the results of Haynes taking behaviour involves variables that are inter-related
bibliography with citation data from the Science Citation with the possibility of feedback loops. Third, researchers
Index to determine whether methodologically rigorous have explained medication use through establishing
studies were cited more frequently by compliance strong relationships between certain variables and medi-
researchers than less rigorous articles. The results indi- cation use. This approach has neglected to determine
cated a statistically significant, but low, correlation how these associations were formed. They have ignored
between methodological rigour and citation frequency. the social contexts which are involved in behaviour. The
Another area of concern is the conceptual rigour of fourth assumption noted involves the manner in which
compliance studies. According to Trostle (87), the subjective meanings are gathered. In cases where sub-
notion of compliance is dominated by ideological beliefs jective meanings are introduced as a causal variable,
of the appropriate roles for patients and physicians. The they are obtained through standardized questionnaires.
concept of compliance is based on the doctor’s perspec- By using these methods, researchers have failed to
tive and implies that the physician is the benevolent obtain the social and historical context of medication
authority and the patients should willingly accept the use in peoples‘ own words.
doctor’s word (88). Stimson (89) suggested that The years of research on compliance provide little
researchers have not questioned the assumption that consistent information other than the fact that people
patient’s should comply with doctor’s orders. Conse- do not always follow the doctor’s orders. Unfortu-
quently, seeing patients as defaulters or deviants has nately, we do not know specificallywhat the patient has
resulted in an unproductive approach to the problem of done. For example, research has not indicated if indi-
medication use. viduals consistently take fewer doses or a lower dose.
This medically oriented approach to compliance has Future research needs to investigate how patients admin-
portrayed the doctor-patient relationship as the key to ister their medications and the decision-making process
medication taking behaviour. However, Conrad (90) used by the patients. For example, as Trostle (87)
suggests that this may not adequately reflect the true suggests, we need to evaluate how patients respond in
situation. This view is supported by Trostle (87),who daily life to the advice and treatment regimens pre-
indicates that ’noncompliance is an unavoidable by- sented by the medical profession. Above all, there
product of collisions between the clinical world and appears to be a need to focus on compliance from the
other competing worlds of work, play, friendship, and patient’s perspective.
292 L. Stockwell Morris and R. M. Schulz

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