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1 ,a,
School of Pharmacy, University of Wisconsin-Madison, 425 No. Charter St., Madison, WI 53706, USA
b
Assistant Professor, College of Pharmacy, University of North Carolina at Chapel Hill, NC, USA
c
Swedish National Board of Health and Welfare, Stockholm, Sweden
Received 3 March 1998; received in revised form 30 April 1998; accepted 16 July 1998
Abstract
Self-report tools for monitoring adherence can be useful in identifying patients who need assistance with their
medications, assessing patient concerns, and evaluating new programs. The aim of this study is to test the validity of the
Brief Medication Questionnaire (BMQ), a new self-report tool for screening adherence and barriers to adherence. The tool
includes a 5-item Regimen Screen that asks patients how they took each medication in the past week, a 2-item Belief Screen
that asks about drug effects and bothersome features, and a 2-item Recall Screen about potential difficulties remembering.
Validity was assessed in 20 patients using the Medication Events Monitoring System (MEMS). Results varied by type of
non-adherence, with the Regimen and Belief Screens having 80100% sensitivity for repeat non-adherence and the Recall
Screen having 90% sensitivity for sporadic non-adherence. The BMQ appears more sensitive than existing tools and may
be useful in identifying and diagnosing adherence problems. 1999 Elsevier Science Ireland Ltd. All rights reserved.
Keywords: Patient compliance; Drug utilization; Measurement; Questionnaire
1. Introduction
and health settings [1]. Studies
show that approxi- mately 25% of all prescribed
doses are omitted by
Patient non-compliance or lack of adherence with patients [2] and that this non-adherence is a signifidrug regimens continues to be a major problem in cant factor in cardiovascular morbidity and mortality,
virtually all medical specialties, patient populations,
rejection of transplanted kidneys, leukemia relapse,
vision loss in glaucoma, and other indicators of
treatment failure [37]. Poor adherence also has
*Corresponding author. Tel.: 1 1 608 2652128; fax: 1 1 608
been implicated in unnecessary and costly proce2623397.
dures and hospitalization in asthma and other conE-mail address: blsvarstad@pharmacy.wisc.edu (B.L. Svarstad)
1
William S. Apple Professor
2
Assistant Professor
ditions [8]. Researchers have identified many determinants of non-adherence [2,9], specific ways in
which communication between professionals and
11
4
B.L. Svarstad et al. / Patient Education and Counseling 37 (1999) 113 124
patients contributes to non-adherence [911], and This is a serious drawback, because patients often
effective interventions [9,12]. Unfortunately, no sinincrease drug intake a few days before coming to the
gle intervention is totally effective for all patients clinic, giving an erroneous impression of adherence
and it is not yet possible to predict which individual
[19].
or subgroup actually needs a given intervention.
The most innovative and sophisticated method of
Patients also are reluctant to admit non-adherence
measuring adherence is the Medication Events Moniunless clinicians make specific efforts to monitor the
toring System ([MEMS ], Aprex Corporation, Fredegree of adherence on a regular basis [10,11].
mont, CA). The MEMS involves dispensing each
Practitioners therefore need accurate, practical, and
patients medication in a bottle that contains a
clinically relevant tools for screening or detecting
microprocessor in the cap. The microprocessor readherence problems [1316]. Accurate information
cords the date and time of each bottle opening, with
about adherence also is useful in targeting intereach opening counted as a presumptive dose. There
ventions more effectively and efficiently [17], studyis no assurance that patients actually consume their
ing professionalpatient relationships [18], interpretmedication, but they would have to open and close
ing drug effects [4,19], and measuring the outcomes
the bottle at prescribed intervals on a daily basis to
of patient education and disease management procreate a false pattern of adherence. Studies have
grams [20].
demonstrated that MEMS is more accurate than other
Researchers have tested the accuracy of several
available methods and is therefore considered the
methods of detecting non-adherence. Unfortunately,
gold standard of adherence measurement [16,19].
no single method is adequate [16]. One of the
Despite these advantages, this tool has not yet been
earliest methods of measuring non-adherence inapplied widely due to its cost and other practical
volved physician estimates. Findings revealed that
issues that limit its use in large studies and routine
this method was no more accurate than chance alone,
clinical practice [20].
leading researchers to abandon it [13,21]. Later
Self-report measures (face-to-face or telephone
studies showed that pill counts provide useful ininterviews, questionnaires, diaries) provide a practiformation if done in patients homes and the purpose
cal and flexible method of assessing adherence and a
of this assessment is not emphasized beforehand
unique opportunity to identify patient concerns.
[14]. However, home visits are not always feasible
While self-reported adherence has been linked to
and patients often combine medication from several
clinical outcomes [22], there are serious concerns
bottles into a single container, making it difficult to
about the accuracy of these measures due to poor
interpret pill counts [22]. Researchers also have
sensitivity or ability to detect true non-adherence
criticized clinic-based pill counts, because many
[18,32]. In fact seven of eight published studies
patients do not bring containers back to the clinic
examining the validity of self-report adherence mea[23] and those that are returned seriously overestisures show a sensitivity level below 60% (Table 1).
mate adherence when compared to more objective
This means that existing tools incorrectly classify at
methods [19,24].
least 40% of patients with true non-adherence.
Pharmacy refill records and drug claims provide
Stewart [18] attempted to improve this situation by
relatively objective, unobtrusive, and inexpensive
developing a more specific and comprehensive set of
estimates of adherence in large populations over
questions. While her approach yielded excellent
extended periods of time [2528]. However, these
results in patients with new prescriptions (85.5%
methods only provide a gross measure of adherence
sensitivity), it failed to detect most cases of nonand cannot be used for short-term regimens [20].
adherence in patients with refills (40% sensitivity).
Researchers also have used laboratory tests, blood
There are several explanations for the low senpressure readings, and other physiological measures
sitivity of existing self-report measures. First, it is
for detecting non-adherence [13,29,30]; however,
possible that no single tool can detect all types of
these methods are not always available or feasible.
non-adherence and that multiple tools are needed.
Another concern is that these techniques only reflect
For example, Park and Lipman [33] found that their
drug-taking in the day or two before the test [31].
instrument was more sensitive in detecting major
Table 1
a
Studies examining the validity of self-report measures of adherence
Study
Stewart [18]
Morisky et al. [22]
Craig [30]
Inui et al. [15]
Gilbert et al. [13]
Haynes et al. [14]
Gordis et al [29]
Park and Lipman [33]
a
Criterion
b
measure
PPV
%
70.8
50.0
5
102.
0.0
8
58.
90.
100.
0.0
8
8.
Specificity
%
d
d
81.0
100.0
87.9
92.0
95.8
100.0
100.0
Accur
acy
%
75.5
66.7
69.0
85.0
67.6
70.4
75.4
68.9
59.8
days did you take it? How many times per day did given medication. For each medication, the patient is
you take it? How many pills did you take each asked: How well does (did) this medication work
time? and How many times did you miss taking a for you? (very well, ok, not well). After reporting
pill? We focused on the past week, because a how well each medication works, the patient is
shorter recall period may reduce reporting error, as asked: Do any of your medications bother you in
suggested earlier. Patients receive a score of 1 if any way?. Patients receive a score of 1 if they
their initial or spontaneous report indicates potential respond not well or dont know when asked nonadherence with the current regimen for the target how well the target medication works for them and a
medication and a score of 0 if this report indicates
score of 1 if the medication was identified as
no non-adherence. Indicators of potential non-adher- bothersome. Item scores are summed to obtain a total
ence including: failing to mention the target medica- belief score, with positive scores indicating one or
tion (without prompting or interviewer assistance),
more belief barriers (range 5 02).
stating that one cannot answer or remember, reportThe third screen is called the Recall Screen and
ing any interruption or discontinuation due to a late
includes two items that measure potential problems
refill or other reason, reporting any missed doses, or
remembering all doses. These barriers are identified
reporting any extra doses. Patient responses to the
by reviewing the dosage regimen and by asking the
five items also are used to calculate the rate of dose
patient How hard is it for you to remember to take
omission (proportion of prescribed doses omitted
all the pills? (very, somewhat, not at all). Patients
according to initial report). (See Appendix A for a
receive a score of 0 they have a single dose
copy of the questions and procedures used to score
regimen (once daily) and report that it is not at all
them).
hard to remember all the pills, a score of 1 if they
After patients finish reporting how each mentioned
have a multiple dose regimen (two or more times per
drug was taken, the interviewer asks one or more
day), or report that it is very or somewhat hard
neutral probes to identify additional medications that
to remember all the pills, and a score of 2 if both
the patient did not mention for some reason (e.g.
indicators are present. The BMQ also asks about
Do you have any other medications that you may
difficulties opening the container, reading labels,
have stopped for some reason?). If the patient
obtaining refills, and other practical issues. However,
identifies additional medications, the interviewer
we have excluded them from the present analysis due
should list them and repeat the above mentioned
to limited variability in this study
population. questions. However, it is important to mark medications listed in the patients initial (spontaneous)
report versus additional medications identified after
any interviewer probes, reminders, or prompts about
3. Data analysis
a specific drug that was omitted from the patients
listing of drugs used in the past week. Patients
To assess the effects of MEMS assignment, we
obviously can forget to mention certain drugs taken
compare rates of dose omission for patients in the
in the past week, but previous work [10] suggests
MEMS and non-MEMS groups using pill count data
that patients who forget to mention a prescribed
and the t-test. We then test the BMQs sensitivity or
drug often have stopped or reduced their use of that
ability to detect true non-adherence, as measured by
drug according to more objective measures. We
MEMS. Standard epidemiologic methods [18,35] are
therefore rely on the patients initial (spontaneous)
used to define and calculate sensitivity, spereport when scoring the Regimen Screen.
cificity, positive predictive value, and overall
The Belief Screen measures two beliefs that have
accuracy of the Regimen, Belief, and Recall
been linked to non-adherence in past studies [9,11].
Screens (Table 2). The Fishers exact test is used to
These particular items address patient concerns or
analyze the relationship between categorical meadoubts about the efficacy of a given medication and
sures of adherence, and Pearson correlation techconcerns about unwanted side effects, short-term or
niques are used to analyze relationships between
long-term risks, or other bothersome features of a
continuous measures of adherence.
Table 2
Calculation of BMQ sensitivity, specificity, positive predictive
value, and overall accuracy
20
medihad
BMQ
(self-report)
Positive screen
Negative screen
Dosage error
present
Dosage error
absent
a
b
c
Sensitivity 5 a /(a 1 c) 3
100.
Specificity 5 d /(b 1 d ) 3 100.
the Positive predictive value (PPV) 5 a /(a 1 b) 3 100.
Overall accuracy 5 (a 1 d )/(a 1 b 1 c 1 d ) 3 100.
How
19%
Non-MEMS
MEMS
Number of cases
43
21
Patient background
Age, mean years
Sex, % male
Education, mean years
Race, % white
Scheduled drugs, mean no.
Drug type, % captopril
Drug length, mean months
Drug regimen, % multiple doses
52.6
60.5
13.8
95.3
4.5
48.8
25.4
46.5
51.1
42.9
14.0
95.2
4.6
47.6
29.6
47.6
54.0
a
77.3
13.6
95.5
4.5
50.0
21.4
45.4
18.6
18.6
34.9
25.6
4.1
10.7
4.8
23.8
28.6
23.8
2.6
10.8
31.8
13.6
40.9
27.3
5.5
19.2
10.5
13.0
22
Chi-square test for non-MEMS versus MEMS group was significant at 0.05 level. No significant differences were found for other
background, BMQ, or adherence measures.
Table 4
Validity of BMQ by type of screen and type of non-adherence according to MEMS, n 5 20
Type of screen and a
type of non-adherence
Regimen Screen
Repeat non-adherence
Sporadic non-adherence
Belief Screen
Repeat non-adherence
Sporadic non-adherence
Recall Screen
Repeat non-adherence
Sporadic non-adherence
a
PPV
(%)
Specificity
(%)
Accuracy
(%)
100.0
100.0
95.0
37.5
70.0
62.5
12.5
80.0
42.9
85.0
25.0
40.0
c
90.0
18.2
81.8
40.0
80.0
40.0
85.0
80.0
0.0
100.0
10.0
Type of non-adherence in past week according to MEMS : repeat 5 took at least 20% over or under the prescribed
amount; sporadic 5 took 119% over or under the prescribed amount.
b
See Table 2 for definition of sensitivity, positive predictive value (PPV), specificity, and accuracy.
c
Fishers exact test, P , 0.01 (1-tailed).
B.L. Svarstad et al. / Patient Education and Counseling 37 (1999) 113 124
121
P 5 0.001) and past month (r 5 0.89; P 5 0.001) more difficult to report due to its unintentional,
according to MEMS. Findings also showed signifi- infrequent, or erratic nature. Patients seem aware of
cant correlations between the total Belief Screen their remembering difficulties, but unable to pinpoint
score and true rate of dose omission in the past week when or how often they occur. In contrast, repeat
(r 5 0.71; P 5 0.001) and past month (r 5 0.61;
non-adherence probably reflects deliberate
changes
, 0.01). In contrast, there was a slightly negative in the regimen by patients who have unresolved
but non-significant relationship between the patients concerns or doubts about the drug and how it is
score on the Recall Screen and actual rate of dose affecting them. While these patients may be reluctant
omission in the past week (20.13; ns) and past to disclose the full extent of their non-adherence,
month (20.08, ns). These findings are consistent many admit at least some non-adherence and concern
with earlier results and reinforce the importance of about a particular drug regimen when asked carefully
using several tools and assessing different types of worded questions designed to reduce the different nonadherence.
types of reporting errors that can occur in this
context.
Our results are encouraging, because they are
5. Discussion
based on a test population with
multiple drugs and refill prescriptions, factors
known to reduce the
Our results are consistent with previous studies sensitivity of self-report adherence measures [18].
which show that patients generally under report their Larger studies in other settings clearly are needed to
non-adherence. However, it is clear that the sensitiviassess BMQ performance in patients with other
ty and overall accuracy of self-report measures can
characteristics. Further research also is needed to test
be improved by employing established principles of the BMQs ability to predict future behavior and to
survey methodology. By applying these principles determine how BMQ results are affected by variamore rigorously, we obtained a Regimen Screen with
tions in interviewer training and background, how
a sensitivity level of 80%, a positive predictive value and where the instrument is administered, number of
and specificity level of 100%, and an overall accuraadministrations, modifications in question wording
cy of 95%. These results compare favorably to and order, interviewer reactions or attempts to
published self-report adherence tools, which show an change patient behavior and beliefs, and alternative
average sensitivity level of approximately 46% and
methods of scoring. Any of these could influence
an average accuracy level of 71% (Table 1). We also
interview or questionnaire results.
found strong correlations between the reported rate
of omission in the past week and true rates of
omission in the past week and past month (r 5 0.67
6. Practice implications
and r 5 0.89, respectively). These findings also
compare favorably with past studies which show
Clinical studies are needed to evaluate the BMQs
correlations between subjective and objective adherutility in various medical and pharmacy practice
ence measures ranging from 0.43 to 0.74 [14,22,30].
settings. However, we believe it can add important
Our study is among the first to demonstrate that
dimensions to adherence monitoring and enhance
sensitivity levels vary by type of non-adherence and
communication between patients and their care givtype of screening tool. We found that the Regimen
ers. First, it provides a clinically relevant and flexible
and Belief Screens had good sensitivity when exmethod of screening non-adherence in patients with
amining repeat non-adherence and poor sensitivity
diverse drugs and drug regimens. When and how
with regard to sporadic non-adherence, whereas, the
often it is administered depends on the patient
Recall Screen had good sensitivity with regard to
population and how the information will be used.
sporadic non-adherence and poor sensitivity with
Second, it has excellent potential for self-administraregard to repeat non-adherence. We suspect that
tion by patients, thus providing an inexpensive and
sporadic non-adherence is under reported in the
easy-to-use tool for screening adherence on a regular
Regimen Screen, largely because this behavior is
basis. Additional time, training, and reallocation of
B.L. Svarstad et al. / Patient Education and Counseling 37 (1999) 113 124
123
References
[1] Cramer, JA, Spilker B, editors. Patient compliance in
medical practice and clinical trials. New York: Raven Press,
1991.
[2] Cramer JA. Compliance with contraceptives and other
treatments. Obstetr Gynecol 1996;88:S4S12.
[3] Rudd P. Clinicians and patients with hypertension: Unsettled
issues about compliance. Am Heart J 1995;130:5729.
[4] Urquhart J. Patient compliance as an explanatory variable in
four selected cardiovascular studies. In: Cramer JA, Spilker
B, editors. Patient compliance in medical practice and
clinical trials. New York: Raven Press, 1991:30122.
[5] Didlake RH, Dreyfus K, Kermman RH, et al. Patient noncompliance: a major cause of late graft failure in cyclosporine-treated renal transplants. Transplant Proc 1988;20:63
9.
[6] Snodgrass W, Smith S, Trueworthy R, et al. Pediatric clinical
pharmacology of 6-mercaptopurine:lack of compliance as a
factor in leukemia relapse. Proc Am Soc Clin Oncol
1984;3:204.
[7] Priddy JT, Kass MA, Gordon MO, et al. Factors related to
compliance with topical pilocarpine treatment. Invest Ophthalmol Visual Sci 1987;28:37.
[8] Rand CS, Wise RA. Measuring adherence in asthma medication regimens. Am J Resp Crit Care Med 1994;149:S6976.
[9] Meichenbaum D, Turk E. Facilitating treatment adherence: a
practitioners guide. New York: Plenum Press, 1987.
[10] Svarstad BL. Physicianpatient communication and patient
conformity with Medical Advice. In: Mechanic, D editor.
The growth of bureaucratic medicine. New York: Wiley,
1976:220238.
[11] Svarstad B. Patientpractitioner relationships and compliance with prescribed medical regimens. In: Aiken L,
Mechanic D, editors. Applications of social science to
[12]
[13]
[14]
[15]
[16]
[17]