A Comparative Study among Different Treatment Adherence

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Internacional Journal of Cardiovascular Sciences. 2015;28(2):122-129
ORIGINAL MANUSCRIPT
A Comparative Study among Different Treatment Adherence Methods in
Hypertensive Patients
Tania Pavão Oliveira Rocha1, José Albuquerque de Figueredo Neto2, Darci Ramos Fernandes1,
Ewaldo Eder Carvalho Santana3, Jerusa Emídia Roxo Abreu4, Raimundo Luís Silva Cardoso4, Jorgiléia Braga de Melo5
Universidade Federal do Maranhão - Programa de Pós-graduação em Ciências da Saúde - São Luís, MA - Brazil
Universidade Federal do Maranhão - Departamento de Medicina I - São Luís, MA - Brazil
3
Universidade Federal do Maranhão - Departamento de Engenharia Elétrica - São Luís, MA - Brazil
4
Universidade Federal do Maranhão - Programa de Pós-graduação em Saúde e Ambiente - São Luís, MA - Brazil
5
Universidade Federal do Maranhão - Programa de Pós-graduação em Saúde Materno-infantil - São Luís, MA - Brazil
1
2
Abstract
Background: Cardiovascular diseases are the leading cause of death in Brazil, and systemic hypertension is one
of the main risk factors. In this sense, adherence to treatment is critical for controlling hypertension and prevention
of its complications.
Objectives: To determine and compare non-adherence rates to hypertension treatment by using different methods
and blood pressure control, and determine the factors associated with non-adherence of hypertensive patients in
Estratégia Saúde da Família (Family Health Strategy), in the city of São Luís, state of Maranhão.
Methods: The cross-sectional study, conducted in São Luís, State of Maranhão, with 502 users of Estratégia Saúde
da Família (Family Health Strategy - FHS). In order for adherence to be assessed, we used the Morisky and Green
Test (MGT), Qualiaids team’s Medication Adherence Questionnaire (QAM-Q) and Haynes’ Questionnaire. To
check the relation between adherence to treatment and sociodemographic and clinical variables, either Fisher’s
exact test or Chi-Square Test was used.
Results: Non-adherence prevalence rate measured by MGT, MAQ-Q and Haynes was, respectively, 29.28%,
60.16% and 13.15%. Concordance between Haynes─MAQ-Q tests (kappa=80.68%) was substantial, while those
between MAQ-Q─Morisky (kappa=48.61%) and Morisky─Haynes (kappa=55.58%) were moderate. Variables
such as patient’s smoking habit and return to physician for a follow-up visit have been shown, in all three tests,
to be associated with non-adherence to treatment.
Conclusions: Tests under evaluation have been shown to have good concordance. Non-adherence rate was high
when measured by MAQ-Q, but low when measured by MGT and Haynes. Considering the control of blood
pressure, MAQ-Q and Haynes presented statistical significance; MAQ-Q identified the greatest number of
individuals with non-controlled blood pressure among those who do not adhere. The variables smoking and
showing up to return visits were associated with non-adhesion in the three questionnaires.
Keywords: Hypertension; Medication adherence; Questionnaires
Introduction
Systemic hypertension (SH) is a multifactorial clinical
condition characterized by high and sustained levels of
blood pressure (BP). It is often associated with functional
and/or structural changes to target organs (heart, brain,
kidneys and blood vessels) and metabolic changes, with
consequent increased risk of fatal and non-fatal
cardiovascular events1.
In Brazil, a review study on SH prevalence, carried out
in various cities, found SH prevalence rates ranging
from 19% to 44% (depending on the criteria adopted
and the assessment process), with higher rates among
Corresponding author: Tania Pavão Oliveira Rocha
Estrada da Pimenta, 100 CND - Costa do Sauípe casa 04 - Alto do Calhau - 65071-760 - São Luís, MA - Brazil
E-mail: tpavaorocha@gmail.com
DOI: 10.5935/2359-4802.20150015
Manuscript received on September 8, 2014; approved on January 28, 2015; revised on February 13, 2015.
Int J Cardiovasc Sci. 2015;28(2):122-129
Original Manuscript
individuals aged over 60 and with lower educational
level2.
Non-adherence to treatment, both in relation to
patient’s lifestyle changes and whether physician’s
prescription is followed, directly affects the control of
blood pressure levels 3. Moreover, the absence of
symptoms and the chronic nature of hypertension are
two aspects that strongly contribute to poor adherence
to treatment4.
Adherence to hypertension treatment may be considered
the coincidence degree observed between the patient’s
behavior and healthcare professionals’ therapeutic
recommendations5. Blood pressure control, reduced
incidence or delayed occurrence of complications and
improved quality of life are expected as a result6.
Although there are several strategies available to evaluate
adherence to hypertension treatment, there is no
consensus on which to consider the “golden standard”
among them7. Methods can be either direct such as the
dosage of the drug active ingredient/metabolite, or
indirect such as the pill count and user’s self-report8.
Some authors have developed generic questionnaires to
assess adherence to treatment in chronic diseases, which
have also been applied to hypertensive individuals9. The
use of validated instruments to measure the construct of
adherence allows subjective data on the routine care
provided to hypertensive individuals to be accurately
measured9.
Non-adherence to hypertension treatment is a challenge
for those who work and investigate this area. According
to Mascarenhas et al.10, in order for adherence to occur,
a patient should be knowledgeable about their condition,
conscious of the importance of blood pressure control
and have access to health care services, which must be
maintained for the patient’s entire lifetime.
Rocha et al.
Methods of Adherence to Hypertension Treatment
Data was collected from August 2011 to
September 2012, with 502 hypertensive
ABBREVIATIONS AND
ACRONYMS
individuals randomly drawn from
different public health districts of the
•MAQ-Q – Medication
municipality11. The following inclusion
Adherence Questionnaire criteria were used: male/female patients
Qualiaids
with systemic hypertension, who are
•MGT – Morisky-Green Test
users of the Estratégia Saúde da Família
• SH – Systemic Hypertension
(Family Health Strategy) health care
model, in the capital city of São Luís,
state of Maranhão, over 18 years old, being monitored
for at least six months.
A structured questionnaire was used to record the
sociodemographic data (gender, age, marital status,
educational level, occupation and family income);
lifestyle habits (smoking, alcohol consumption and
physical activity); diagnosis and treatment (elapsed
time between diagnosis and treatment; if under
hypertension treatment; type of treatment and return
to physician for a follow-up visit) and clinical data
(blood pressure measure, waist circumference, body
mass index (BMI)).
For treatment adherence to be assessed, the following
questionnaires were used: Qualiaids team’s Medication
Adherence Questionnaire (MAQ-Q), Morisky-Green
test (MGT) and Haynes’ questionnaire.
MAQ-Q7 consists of three questions. It addresses the
action (if the individual takes the medication and how
much), process (how the medication is taken within a
seven-day period; if doses are skipped or irregularly
spaced; if doses are suspended for determined
periods), and adherence results (in this case, if blood
pressure was under control). Respondents are deemed
non-adherent if they fail to take the correct dosage
(80%-120% of the prescribed doses), or take it in a
manner that was not recommended (with “suspended
periods”, “irregularly spaced doses”, treatment
abandonment or “partial adherence”), or report any
alteration in blood pressure.
Methods
The Morisky-Green test12 is based on the misuse of drugs
that, according to the authors, occurs due to one or all of
the following events: forgetfulness, carelessness, drug
interruption due to improvement or worsening of the
patient’s health condition. It consists of four questions,
and a positive answer to any of these questions classifies
the individual as non-adherent. This test has been chosen
because of its availability in Portuguese language, small
number of questions, ease of measurement and
understanding, and as it offers the possibility to check
patient’s behavior towards drug intake.
This is a descriptive, cross-sectional analytical study
conducted in São Luís, MA, Brazil.
Haynes’ questionnaire13 consists of a single question whose
positive answer classifies the individual as non-adherent.
Considering the relevance of this subject matter, this
research aimed to make a comparison between three tools
used for assessment of adherence to hypertension
treatment, taking the rates found and blood pressure
control into consideration. To check the relation between
adherence to treatment and sociodemographic and
clinical characteristics of patients studied.
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Int J Cardiovasc Sci. 2015;28(2):122-129
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Categorical variables were expressed by frequency rates
and percentages. Association between adherence to
treatment and sociodemographic and clinical variables
was determined by either Fisher’s exact test or Chi-Square
Test. Concordance between the methods was assessed
using the Cohen’s kappa statistics, with the following
criteria: <0 - poor; 0-20% - low; 21-40% - considerable;
41-60% - moderate; 61-80% - substantial and 81-100% - almost
perfect14. The statistical STATA program, version 12.0,
was used, considering a significance level of 5%
(p <0.05).
This study protocol was approved by the Ethics
Committee of Hospital Universitário Clementino Fraga
Filho of Universidade Federal do Rio de Janeiro, under
no. 38/11. All participants signed an Informed Consent
Form, in compliance with the Helsinki Declaration.
Results
Table 1 shows patients’ answers to the three questionnaires
used. Regarding the manner in which the medication is
taken, obtained by the MAQ-Q, 106 patients (21.12%)
reported not having taken the medication or taken at
least one extra tablet, and 261 patients (51.99%) reported
alterations in their blood pressure in the most recent
blood pressure reading. As for MGT, of the four evaluated
questions, the highest percentages of positive attitudes
towards medication intake were for “When you feel
better, do you sometimes stop taking medications?” “No” (91.24%), and for “Sometimes, when you feel worse,
do you stop taking your medicine?” - “No” (91.83%).
In Haynes’ questionnaire, most patients (86.85%)
reported that they had no difficulty taking their
medications in the last 30 days.
Table 1
Frequency rate of answers to the questionnaires used in the assessment of adherence to antihypertensive treatment
MAQ-Q - Qualiaids team’s Medication Adherence Questionnaire
1. In the past seven days, didn’t/did you take at least one extra tablet of this
medication?
2. In this period, how many tablets did you miss or how many extra tablets did
you take?
3. What was your most recent blood pressure reading?
n
%
Yes
106
21.12
No
396
78.88
None
30
28.30
One
36
33.96
Two
33
31.13
Three
7
6.60
More than
three
-
-
Normal
241
48.01
Altered
261
51.99
Yes
126
25.10
No
376
74.90
Yes
106
21.12
No
396
78.88
Yes
44
8.76
No
458
91.24
Yes
41
8.17
No
461
91.83
Yes
66
13.15
No
436
86.85
MGT - Morisky Questionnaire
1.
Have you ever forgotten to take your medicine?
2. Are you careless at times about taking medications?
3. When you feel better, do you sometimes stop taking medications?
4. Sometimes, when you feel worse, do you stop taking your medicine?
Haynes’ Questionnaire
1. Many people have some kind of difficulty taking their medication. Over the last
30 days, have you had any difficulty taking your blood pressure medication?
Int J Cardiovasc Sci. 2015;28(2):122-129
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Rocha et al.
Methods of Adherence to Hypertension Treatment
Table 2 shows the prevalence rates of adherent/nonadherent patients, according to the tests used and blood
pressure control. The MAQ-Q had 60.16% non-adherence,
followed by MGT, with 29.28%, and Haynes, with 13.15%.
From among the questionnaires used, only the MAQ-Q
and Haynes were significantly associated (p<0.05) with
the control of blood pressure. The QAM-Q questionnaire
was the only instrument to identify, among non-adherent
patients, the largest number of individuals with
uncontrolled pressure (74.12%).
Regarding concordance level between the
questionnaires used, Haynes─MAQ-Q (kappa=80.68%)
concordance level was substantial, while those
between MAQ-Q─Morisky (kappa=48.61%) and
Morisky─Haynes (kappa=55.58%) were moderate.
Concordance assessed whether patients who were
considered non-adherent by a method were also
considered so by the other.
Table 3 shows the association between sociodemographic
and clinical variables with non-adherence, considering
each of the tests used. Concerning income, nonadherence was higher among those who received less
than the minimum wage, with association only for
Haynes (20.0%). “Smoking” and “return to physician
for a follow-up visit” variables were significant in all
three questionnaires; non-adherence was proportional
among smokers and those who rarely attended
follow-up visits. Among variables with statistical
significance for both Haynes and Morisky, nonadherence rate was higher for retired individuals with
paid work, non-alcoholic individuals and for those who
used monotherapy as a form of treatment.
Table 2
Antihypertensive treatment adherence prevalence, according the methodology used and blood pressure control
Controlled hypertension
Overall
Variables
Yes
No
p-value
n
%
n
%
n
%
200
39.84
134
54.25
66
25.88
MAQ-Q
Adherent patients
<0.001
Non-adherent patients*
302
60.16
113
45.75
189
74.12
355
70.72
184
74.49
171
67.06
Morisky
Adherent patients
0.067
Non-adherent patients*
147
29.28
63
25.51
84
32.94
436
86.85
223
90.28
213
83.53
Haynes
Adherent patients
0.025
Non-adherent patients*
66
13.15
MAQ-Q – Qualiaids team’s Medication Adherence Questionnaire
*Kappa
MAQ-Q ─Morisky: 48.61% concordance (p <0.001)
Morisk ─ Haynes: 55.58% concordance (p <0.001)
Haynes ─ MAQ-Q: 80.68% concordance (p <0.001)
24
9.72
42
16.47
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Table 3
Frequency rate of patients who do not adhere to antihypertensive treatment, according to the methodology used and
sociodemographic and clinical characteristics
Variables
Non-adherent
patients
(Haynes)
p-valor
Non-adherent
patients
(QAM-Q)b
p-valor
Non-adherent
patients
(Morisky)
n
%
n
%
n
%
< 1#
8
20.00
27
67.50
13
32.50
1─3
50
13.09
233
60.99
114
29.84
4─5
8
18.18
24
54.55
16
36.36
>5
-
-
18
50.00
4
11.11
Active
16
13.01
75
60.98
38
30.89
Retiree w/ paid activ.
19
22.89
52
62.65
36
43.37
Unemployed
4
11.76
23
67.65
9
26.47
Pens. benef.
11
6.15
104
58.10
38
21.23
Homeworker
66
19.28
48
57.83
26
31.33
Never smoked
34
10.76
181
57.28
84
26.58
Former smoker
27
16.07
103
61.31
52
30.95
Smoker
5
27.78
18
100.00
11
61.11
Absent
21
24.71
53
62.53
36
42.35
Present
45
10.79
249
59.71
111
26.62
Yes
64
12.90
297
59.88
142
28.63
No
2
33.33
5
83.33
5
83.33
Monotherapy
31
17.32
116
64.80
63
35.20
Combined therapy
35
10.90
185
57.63
84
26.17
Yes
40
10.47
215
56.28
97
25.39
Sometimes
20
20.20
70
70.71
40
40.40
No
-
-
6
66.61
2
22.22
Seldom
6
50.00
11
91.67
8
66.67
p-valor
Income (MW)
0,017*
0,371a
0,070a
Occupation
0,001a
0,828a
0.007a
Smoking
0,045
a
<0,001*
0.006a
Alcoholism
0,001a
0,650a
0.004a
Treatment
0,141a
0,410*
0.003a
Form of treatment
0,042a
0,116a
0.034a
Attendance to follow-up visits
<0,001*
0,005*
0.001*
MAQ-Q – Qualiaids team’s Medication Adherence Questionnaire; MW – Minimum Wage; Retiree w/ paid activ. – Retiree with paid
activity; Pens. benef. – pension beneficiary
a
chi-square test; *Fisher’s exact test; #1 minimum wage: BRL 622.00
Int J Cardiovasc Sci. 2015;28(2):122-129
Original Manuscript
Discussion
The term adherence is used to refer to the compliance with
therapy recommendations. Antihypertensive treatment
adherence rates vary widely in the literature 7, 15-20.
Worldwide statistics show that treatment adherence rates
range from 7-65%, with Japan being the country with the
highest adherence rate and Slovakia21 with the lowest.
Studies are not often comparable as they address different
individual profiles and use different adherence
identification methods.
In recent years, therapeutic adherence has become one
of the biggest problems in medical practice due to its
complexity. About 40-60% of patients do not use
prescribed medication22. This percentage increases when
lifestyle is evaluated21.
The use of questionnaires validated to assess adherence
has increased in recent years. An integrative review
study9 showed this increase, especially in the years 2008
and 2009; a likely explanation for this growth is the
interest of professionals in understanding the adherence/
non-adherence phenomenon.
The data obtained by this study has revealed that patients
identified as hypertensive by MGT reported having had
positive attitudes towards medication intake when
answering the questions “When you feel better, do you
sometimes stop taking medications? - “No” (91.24%) and
“Sometimes, when you feel worse, do you stop taking
your medicine?” - “No” (91.83%). These results were
similar to those from other studies17, 18. The highest
number of negative answers (25.1%) was given for the
question “Have you ever forgotten to take your
medicine?” - “Yes”, and 21.12% of the patients reported
being careless about the time to take their medications.
A study conducted by Plaster19 assessed adherence by
means of the Morisky-Green test. That study found, as
in this study, the highest rate of “yes” answers for
questions 1 and 2. Adherence questions based on
forgetfulness, carelessness and medications taken when
patients feel better or worse enable our perception of
patients from areas in which non-adherence is higher
and lower.
Another tool used to assess adherence was the Haynes’
test. In this case, the question about therapeutic adherence
or non-adherence is made in a friendly manner, trying to
express the lowest possible pressure. According to this
test, 87.85% of the individuals reported no difficulty taking
their antihypertensive medications. These results were
Rocha et al.
Methods of Adherence to Hypertension Treatment
similar to those from the study conducted by Melchiors23,
Hamilton18 and Santa-Helena et al.7, which obtained 70.2%,
84.0%, 88.0%, respectively. This may reflect that these tools
have low sensitivity to detect non-adherence, which was
also pointed out in a previous study3.
A research on adherence to antihypertensive drug
treatment, conducted in the city of São Luís, State of
Maranhão, found a non-adherence rate of 32.7%24 and
used as a measure the sum of the number of tablets taken
in the last five days.
Non-adherence prevalence rate measured, in this study,
by MGT, MAQ-Q and Haynes was, respectively, 29.28%,
60.16% and 13.15%. Non-adherence levels measured by
MGT and Haynes, reported in this study, were lower
than those found in other researches 7,16-18,20,25. After
establishing a correlation between hypertension control
with indirect adherence tests, MAQ-Q and Haynes were
found to have statistical significance, whereas among
non-adherent patients, MAQ-Q was the test that
identified the highest rate for uncontrolled hypertension.
In another study, this relation was not revealed23. Tests
had a good concordance level, in contrast to what was
obtained in the study by Bastos-Barbosa et al.15
When used, the MAQ-Q found a non-adherence
prevalence rate of 60.16%. This result was higher than
that found in southern Brazil7 where MAQ-Q resulted in
a non-adherence rate of 47.8%. When compared to other
methods, this tool obtained lower adherence rates,
because when it is used, its cutoff point for non-adherence
is increased as a manner to improve sensitivity, as it
considers adherent those who took the correct dosage of
their medicines, in the prescribed manner and reporting
a favorable effect.
Findings in this research have shown a statistically
significant relationship between variables: income,
occupation, smoking, alcoholism, form of treatment and
return to physician for a follow-up visit, with nonadherence in at least one of the tests. Income was
described as a factor negatively associated with
adherence to treatment of chronic diseases26, coinciding
with results from this study, in which the non-adherent
patients earned less than the minimum wage as monthly
income. However, this association was not observed in
other studies17,20,27.
Regarding occupation variable, it has been shown to have
statistical significance with non-adherence in both
Haynes and Morisky tests, in which retirees with paid
work were those who had the highest non-adherence
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rates. Other studies20,27, however, show that retirement
has a positive impact, as it provides patients with more
time to dedicate themselves to the treatment.
Ungari and Dal Fabro17 found no significant association
between non-adherence level and the socioeconomic
variables. Most authors unanimously report that
association between therapeutic adherence level and
sociodemographic factors is not consistent.
With regard to lifestyle habits such as smoking,
significant differences were found in relation to nonadherence in the three methods used, with smokers being
identified as those who least adhered to the treatment.
These results were similar to those obtained in other
studies 28,29. It is worth of stressing that changing
hypertensive patients’ habits and lifestyle should be
emphasized as part of therapeutic care, as it significantly
contributes to the reduction of blood pressure.
Regarding treatment method, individuals with lower
adherence rates were those using monotherapy, with
statistical significance in Haynes and MGT, contrary to the
results of other studies reporting that a higher adherence
rate is associated with lower amounts of prescribed drugs
and adoption of simple therapeutic treatments30,31.
Return to physician for a follow-up visit was associated
with non-adherence in the three questionnaires, with
patients who had the lowest adherence rate being those
who rarely attended the follow-up physician visits.
According to a study by Santos et al. 32, patients’
attendance at scheduled physician appointments has
positive correlation with treatment adherence, i.e., the
more regularly patients attend to appointments, the
greater will be their adherence to treatment, which is
consistent with the results obtained in this research.
As limitations to this study, the lack of consensus on the
optimal method for assessing treatment adherence can
be mentioned, as well as the varied methods used in the
literature, which rendered comparison difficult. Despite
such limitations, it was possible to estimate adherence/
Int J Cardiovasc Sci. 2015;28(2):122-129
Original Manuscript
non-adherence to treatment in a sample of hypertensive
patients from northeastern Brazil, contributing to a body
of evidence that supports interventions aimed at this
group of patients.
It is also inferred that the limitations of this study lie in
the impossibility of listing the causes of non-adherence,
suggesting that future research can foster an
understanding of related factors, thus contributing by
means of actions to increase the effectiveness of
hypertension control programs.
It is also worth pointing out that this study was developed
within the public service specific reality, suggesting the
need for studies involving different contexts.
Conclusions
This study showed that in general the three study
adhesion tests had a good concordance level. When
establishing the relationship between questionnaires and
blood pressure control, both MAQ-Q and Haynes has
shown to be statistically significant, while MAQ-Q
identified the largest number of individuals with
uncontrolled pressure among those who did not adhere
to treatment. MAQ-Q had the highest non-adherence
rate. Variables such as smoking and patients’ return to
physician for a follow-up visit had an association with
non-adherence to treatment in all three tests.
Potential Conflicts of Interest
No relevant conflicts of interest.
Sources of funding
This study was funded by Fundo de Amparo à Pesquisa do
Maranhão -FAPEMA, under No. 12/2009.
Academic association
This manuscript is part of the Master’s dissertation of Tânia
Pavão Oliveira Rocha, submitted to the Health Science Graduate
Program, from Universidade Federal do Maranhão.
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