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How Does Patient Education and Self-management
among Asthmatics and Patients with Chronic
Obstructive Pulmonary Disease Affect Medication?
FRODE GALLEFOSS and PER SIGVALD BAKKE
Section of Pulmonary Medicine, Medical Department, Vest-Agder Central Hospital, Kristiansand, Norway; and Department of
Thoracic Medicine, University Hospital of Bergen, Bergen, Norway
The effect of patient education on steroid inhaler compliance and rescue medication utilization in patients with asthma or chronic obstructive pulmonary disease (COPD) has not been previously investigated in a single study. We randomized 78 asthmatics and 62 patients with COPD after ordinary outpatient management. Intervention consisted of two 2-h group sessions and 1 to 2 individual sessions
by a trained nurse and physiotherapist. A self-management plan was developed. We registered for 12
mo medication dispensed from pharmacies according to the Anatomical Therapeutic Chemical (ATC)
classification index. Steroid inhaler compliance (SIC) was defined as (dispensed/prescribed) 3 100
and being compliant as SIC . 75%. Among asthmatics 32% and 57% were compliant (p 5 0.04) with
a median (25th/75th percentiles) SIC of 55% (27/96) and 82% (44/127) (p 5 0.08) in the control and
intervention groups, respectively. Patient education did not seem to change SIC in the COPD group.
Uneducated patients with COPD were dispensed double the amount of short-acting inhaled b2-agonists compared with the educated group (p 5 0.03). We conclude that patient education can change
medication habits by reducing the amount of short-acting inhaled b2-agonists being dispensed
among patients with COPD. Educated asthmatics showed improved steroid inhaler compliance compared with the uneducated patients, whereas this seemed unaffected by education in the COPD
group. Gallefoss F, Bakke PS. How does patient education and self-management among asthmatics and patients with chronic obstructive pulmonary disease affect medication?
AM J RESPIR CRIT CARE MED 1999;160:2000–2005.
Medication regimens for patients with asthma or chronic obstructive pulmonary disease (COPD) are particularly vulnerable to adherence problems because of the chronic nature of
the diseases, the use of multiple medications, and the periods
of symptom remission. Rates of noncompliance in the treatment of asthma may vary from 20 to 80% (1). Factors leading
to poor compliance are not fully understood, but lack of education may be one cause (1).
Previous surveys in asthmatics examining the effect of education programs on compliance have shown conflicting results.
Windsor and coworkers (2) reported from a study in 267 adult
asthmatics that patient education consisting of one individual
and one group session gave significantly improved medication
adherence compared with the control group after a 1-yr follow-up. In a controlled intervention study of 116 asthmatics
Allen and coworkers (3) observed an increased compliance 12
mo after a 2.5 3 4 h group session. The Grampian Asthma
Study of Integrated Care (GRASSIC) did not show any change
in the use of bronchodilators or inhaled steroids after an enhanced education program (4). In two of the studies cited (2,
3) the compliance was self-reported, whereas the third study
(4) based the compliance data on medication prescribed by
the patients’ doctors. Only one of the studies presented data
on inhaled steroid compliance (4). No data are available regarding the effect of patient education on medication adherence in the Nordic countries. To our knowledge data are lacking on the effect of patient education on compliance in
patients with COPD as well as comparable studies on asthma
and COPD.
We performed a randomized, controlled intervention study
in patients with mild to moderate asthma or COPD using a
standardized education program and a self-management plan.
The objectives of the present report are to assess the effect of
patient education on antiobstructive medication dispensed from
pharmacies.
METHODS
(Received in original form January 11, 1999 and in revised form June 23, 1999)
Supported by the Norwegian Medical Association’s Fund for Quality Improvement.
Correspondence and requests for reprints should be addressed to Frode Gallefoss, Lungeseksjonen, med avd, Vest-Agder Sentralsykehus, 4604 Kristiansand,
Norway.
Am J Respir Crit Care Med Vol 160. pp 2000–2005, 1999
Internet address: www.atsjournals.org
Study Design
Between May 1, 1994 and December 1, 1995, 140 consecutive patients
were included in the study after having received ordinary consultation
care at our outpatient chest clinic at Central Hospital of Vest-Agder,
Kristiansand, Norway. At inclusion they signed a written consent and
were then randomized to an intervention group or a control group.
The control group were followed by their general practitioners, and
the intervention group received an education program and were then
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Gallefoss and Bakke: Asthma School, Compliance, and Drug Therapy
also transferred to a 1-yr follow-up by their general practitioners (Figure 1).
Eligible subjects were patients with bronchial asthma or COPD
between 18 and 70 yr of age, not suffering from any serious disease,
such as unstable coronary heart disease, heart failure, serious hypertension, diabetes mellitus, kidney or liver failure.
Subjects with stable asthma were to have a prebronchodilator
FEV1 equal to or higher than 80% of predicted value (5). Furthermore we required either a positive reversibility test (5), a documented
20% spontaneous variability (peak expiratory flow [PEF] or FEV1),
or a positive methacholine test (provocative dose causing a 20% decrease in FEV1 [PD20]) (6). A positive reversibility test required at
least a 20% increase (FEV1 or PEF) after inhalation of 400 mg salbutamol. Because we wanted to include those with mild COPD, subjects with COPD were to have a prebronchodilator FEV1 equal to or
higher than 40% and lower than 80% of predicted (7). Among patients with COPD 32% were reversible to ipratropium bromide 80 mg
and/or salbutamol (8, 9). These measures were obtained from the participants’ charts.
Of the eligible patients, the inclusion rate was 92% (78 of 85) and
91% (62 of 68) for the asthma and COPD group, respectively.
Educational Intervention
The educational intervention has been thoroughly described (10).
Briefly, it consisted of a specially constructed patient brochure, two 2-h
group sessions (separate groups for asthmatics and patients with
COPD) concentrating on pathophysiology, antiobstructive medication, symptom awareness, treatment plans, and physiotherapy. One or
two 40-min individual sessions were supplied by both a nurse and a
physiotherapist (Figure 1). With regard to antiobstructive medication
the following was emphasized: The components of obstruction were
explained together with the site of action of the actual medication.
The patient’s pulmonary symptoms were registered and discussed
with emphasis on the early symptoms experienced at exacerbations.
The individual factors causing attacks/exacerbations and concerns regarding adverse effects of medication were discussed and inhalation
Figure 1. Study design and withdrawals.
technique was checked. At the final teaching the patients received an
individual treatment plan on the basis of the acquired personal information and 2 wk of peak flow monitoring (10). The personal understanding of the treatment plan with regard to changes in PEF and
symptoms was discussed and tested (Table 1).
All patients received treatment plans aimed at making early
changes in medication at exacerbations. Among the educated asthmatics, 94% received standard treatment plans incorporating peak
flow monitoring (Table 1). In the COPD group 12 of 26 (46%) received standard treatment plans. Nonstandard treatment plans incorporated the use of oral steroids as the first line of action in the yellow
zone if, for example, the patient already used high dosages of inhalation steroids as maintenance therapy or could tell that a double or triple increase in inhalation steroids previously had marginal effect on
the course of attacks/exacerbations. Among those 14 patients with
COPD receiving nonstandard treatment plans, eight patients did not
want to or were not able to use peak flow monitoring as a basis for
change in medication. For those patients, only symptom-based treatment plans were issued (Table 1).
Outcome Variables
All medication was coded to Defined Daily Dosages (DDD) according to the Anatomical Therapeutic Chemical (ATC) classification
index (11, 12) for comparison of medication within the same chemical–therapeutic groups, thus allowing us to compare those using, for
instance, beclomethasone and budesonide. Prescribed Defined Daily
Dosage (PDDD) of regular medication (11, 12) is expressed as the
regular dosage recommended by the lung clinic at baseline. Short-acting b2-agonist inhalations were in this study categorized as rescue
medication because it was not recommended as regular medication.
Dispensed medication was reported from all local pharmacies through
monthly print-outs from the pharmacy data registers. At the 1-yr follow-up all patients were asked whether they had received medication
elsewhere. Only one individual reported this and the data were included.
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TABLE 1
MODEL FOR THE STEPWISE TREATMENT PLAN
Color Code
PEF*
Symptoms
Treatment
Green
. 80%
Yellow
80–60%
Orange
60–40% or
. 150 L/min
The effect of inhaled b2-agonists lasts
, 2 h; shortness of breath on exertion
Red
, 40% or
, 150 L/min
Inhaled b2-agonists of little help or
effect lasts , 30 min; shortness of
breath when talking
No symptoms; occasional use of inhaled
b2-agonist
Start of a cold; night symptoms; cough;
or increased use of inhaled b2-agonists
Maintenance treatment
Double or triple dosage of inhalation steroids until
back in green zone, then continue double or triple
dosage for as long a time as outside green zone
Prednisolone 30–40 mg/d until back in green
zone, then 10–20 mg/d for as long a time as
outside green zone
Take prednisolone 40 mg and high-dose inhaled
b2-agonist and contact doctor immediately
* In relation to personal best.
Compliance of regular medication was calculated as a percentage:
(dispensed DDD/PDDD) 3 100 during the 1-yr follow-up. Standard
definition of compliance differs in the literature and is variably defined to values from 70% (13, 14) to 90% (3). We defined a priori the
patient as compliant when dispensed regular medication was greater
than 75% of prescribed regular medication during the study period (15).
Number of prednisolone courses was retrospectively self-reported
at 12 mo follow-up. Prebronchodilator spirometry was performed before randomization and at 12 mo follow-up by standard methods (5)
using a Jaeger MasterLab Body Box (Würzburg, Germany). The technical staff did not know whether the patients belonged to the control
or intervention groups.
Statistics
A number of the outcome variables showed skewed distribution as
judged by normality plots, and Lilliefors’ test for normality with p ,
0.05 and then median (the value that separates the highest 50% of the
scores from the lowest 50%) values are shown as a measure of central
tendency with the 25th and 75 percentiles (the interquartile range) as
a measure of dispersion. For normally distributed data the measures
of central tendency and dispersion are mean and standard deviation
(SD), respectively. The nonparametric Mann-Whitney U test was applied when comparing continuous, skewed variables between groups.
Chi-square test was applied for categorized dependent variables also
giving the odds ratio. All tests were done two-sided. An alpha , 0.05
was considered statistically significant.
When testing the correlation between the change in FEV1 over the
study period and steroid inhaler compliance (SIC) and between dispensed b2-agonist inhalation DDD and SIC, bivariate nonparametric
correlation analysis (Spearman’s correlation coefficient rho [r]) was
applied.
All analyses were performed on Compaq computers applying
SPSS version 7.5 (SPSS Inc., Chicago, IL). Permission to establish a
person register was given from the National Data Supervision Center.
The methodological procedures were in accordance with the ethical
standards of the Helsinki Declaration as approved by the regional ethical committee.
RESULTS
The study population consisted of 140 patients, with 39 patients randomized to each asthma treatment group and 31 to
each COPD treatment group. The baseline parameters are
shown in Table 2.
Table 3 shows the mean PDDD per year at randomization
in the control and intervention groups. In the asthma group
96% used inhalation steroids at randomization amounting to a
mean (6 SD) steroid inhaler PDDD of 313 6 164. The corresponding numbers in the COPD group were 92% and 439 6
216, respectively. Eighty-one percent and 14% of the asthmatics used one and two regular medications, respectively compared with 60% and 23% in the COPD group.
Among the asthmatics the proportion of patients with SIC
above 75% in a 1-yr follow-up (Figure 2) was almost twice (57/
32 5 1.8) as large in the educated group as in the control
group (p 5 0.04). The odds ratio for having a SIC . 75% were
2.8 (95% confidence interval: 1.1 to 7.7) in the educated group
TABLE 2
BASELINE CHARACTERISTICS OF PATIENTS INCLUDED IN THE STUDY
Asthma
Sex, women, n (%)
Age, yr, mean 6 SD
Smoking habits
Current smokers, n (%)
Pack-years, median*
Ex-smokers, n (%)
Never-smokers, n (%)
Current use of peak flow meter, n (%)
FVC% pred, mean 6 SD
FEV1% pred, mean 6 SD
PEF% pred, mean 6 SD
COPD
Control Group
Intervention Group
Control Group
Intervention Group
(n 5 39)
(n 5 39)
(n 5 31)
(n 5 31)
31 (79)
44 6 12
24 (62)
41 6 12
15 (48)
58 6 10
16 (52)
57 6 9
13 (33)
11
11 (28)
15 (39)
12 (31)
105 6 15
95 6 17
107 6 25
9 (23)
6
14 (36)
16 (41)
16 (41)
104 6 12
93 6 13
106 6 19
12 (39)
17
19 (61)
0
4 (13)
90 6 12
56 6 11
70 6 19
12 (39)
17
15 (48)
4 (13)
9 (29)
88 6 14
59 6 9
69 6 20
* Median (the value that separates the highest 50% of the scores from the lowest 50%) values are shown as a measure of central tendency for non-normally distributed data.
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Gallefoss and Bakke: Asthma School, Compliance, and Drug Therapy
TABLE 3
BASELINE MEDICATION CHARACTERISTICS AT RANDOMIZATION
Asthma
Control
(n 5 39)
Inhalation steroids
Long-acting b2-agonist inhalations
Ipratropium bromide inhalations
Xanthine derivative tablets
b2-Agonist tablets
Steroid tablets
COPD
Intervention
(n 5 39)
Control
(n 5 31)
Intervention
(n 5 31)
n (%)
PDDD*
n (%)
PDDD*
n (%)
PDDD*
n (%)
PDDD*
38 (97)
3 (8)
2 (5)
1 (3)
0
2 (5)
335 6 161
425 6 105
364 6 171
638
37 (95)
10 (26)
2 (5)
0
1 (3)
1 (3)
294 6 164
383 6 134
486 6 0
27 (87)
8 (26)
12 (39)
3 (10)
0
2 (7)
476 6 216
387 6 152
455 6 75
577 6 105
30 (97)
11 (36)
12 (39)
3 (10)
1 (3)
3 (10)
406 6 200
373 6 193
455 6 105
638
486
151 6 52
182 6 128
365
97
227 6 64
* PDDD/patient/year is shown as mean 6 SD. Mean and SD values are calculated only for those using the medications. Short-acting
b2-agonist inhalations are not included because we only recommended their use as rescue medication.
compared with the control group. No significant difference
was observed between the COPD treatment groups. Table 4
shows the median compliances for the regular medication. In
the asthmatics the median SIC was higher in the intervention
than in the control group, the difference being of borderline
statistical significance (p 5 0.08). For the compliances of the
other regular medications no overt differences were observed
between the intervention and control groups, but the small
numbers did not allow sound statistical analyses and should be
interpreted with caution.
Among the asthmatics 26 of 71 (37%) did not collect shortacting b2-agonist inhalations (rescue medication) at the pharmacies; in the COPD group the corresponding ratio was six
of 53 (11%) (p 5 0.001, chi-square test). Figure 3 shows the
amount of short-acting b2-agonist inhalations being dispensed
during a 1-yr follow-up. The educated patients with COPD received less than half the amount of rescue medication compared with the control group. In the asthmatics a similar tendency was observed, but the difference was not statistically
significant. Nine subjects in both asthma treatment groups (p 5
0.63, chi-square test) reported a median (25th/75th percentiles) number of two (1/2) steroid courses (p 5 0.86, MannWhitney U test) during the 1-yr follow-up. Eighteen of 26
(69%) educated COPD patients reported steroid courses compared with 12 of 27 (44%) in the control group (p 5 0.07, chisquare test) among which a median (25th/75th percentiles) of
three (1/4) and four (1/7) steroid courses were recorded, respectively (p 5 0.42, Mann-Whitney U test). The COPD control patients who needed steroid tablets were dispensed a me-
dian (25th/75th percentiles) of 100 (58/181) DDD compared
with 200 (100/288) DDD in the educated group (p 5 0.02), but
then steroid tablets as a rescue medication (being dispensed in
advance as a “just in case” medication) was included for the
educated group. If rescue medication was subtracted, the median (25th/75th percentiles) number of reported steroid courses
for the COPD intervention group was 125 (100/425) DDD,
and the difference was no longer statistically significant (p 5
0.21).
Bivariate nonparametric correlation analysis between SIC
and dispensed b2-agonist inhalation DDD showed a weak association for the asthma group (Spearman’s r 5 0.36, p 5
0.03), the higher the DDD of steroid inhalers received, the
higher the received DDD of short-acting b2-agonist inhalations (rescue medication). This correlation tended to be stronger in the educated asthma group (Spearman’s r 5 0.49, p 5
0.006) than in the control group (Spearman’s r 5 0.27, p 5
0.11). No such correlation was found for the COPD group
(Spearman’s r 5 0.16, p 5 0.29).
Bivariate nonparametric correlation analysis between change
in FEV1 as dependent variable and SIC showed no correlation
(Spearman’s r 5 0.04 and 0.22, p 5 0.75 and 0.13) for the
asthma group and patients with COPD, respectively.
Withdrawals
Of the 140 included patients, nine withdrew in the educational
period for reasons listed in Figure 1; during the 12-mo follow-up, four and three patients withdrew in the control and intervention groups, respectively. Details about withdrawals have
been described previously (10).
DISCUSSION
Figure 2. Proportion of patients with steroid inhaler compliance
. 75% during a 1-yr follow-up.
Our study showed that patient education emphasizing selfmanagement and control of exacerbations in asthmatics gave
a better SIC when compared with traditional treatment at our
outpatient clinic with general practitioner (GP) follow-up. SIC
seemed unaffected by patient education in the COPD group,
while the need for short-acting b2-agonist inhalations as rescue
medication was doubled in the uneducated group. Use of oral
steroids did not differ significantly between the intervention
and control group, neither among the asthmatics nor in the patients with COPD.
Evaluation of compliance in the present study was based
on the dispensed DDD from pharmacies. The method is regarded as useful for measuring compliance with long-term
medication regimens (16). It is unobtrusive, not reminding the
patients of the registration going on, thereby reducing the bias
of the study itself. However, the method provides no informa-
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TABLE 4
MEDIAN COMPLIANCES FOR REGULAR MEDICATIONS IN CONTROL
AND INTERVENTION GROUPS DURING A 1-yr FOLLOW-UP*
Asthma
Control Group
(n 5 39)
Steroid inhaler
Long-acting b2 inhaler
Ipratropium bromide inhaler
COPD
Intervention Group
(n 5 32)
n
Median
25th/75th
Percentiles
n
Median
38
3
2
55
90
134
27/96
44/90
103/165
30
9
1
82
74
134
Control Group
(n 5 27)
Intervention Group
(n 5 26)
25th/75th
Percentiles
p
Value
n
Median
25th/75th
Percentiles
n
Median
25th/75th
Percentiles
p
Value
44/127
37/97
0.08
0.93
1.00
24
6
10
82
82
62
31/134
47/115
50/100
24
7
12
85
99
81
51/110
74/99
57/109
0.94
0.94
0.37
* Median (the value that separates the highest 50% of the scores from the lowest 50%) values are shown as a measure of central tendency with the 25th and 75th percentiles (the
interquartile range) as a measure of dispersion. Compliance data for xanthine derivative, b2-agonist, and steroid tablets are not shown owing to small numbers.
tion about daily patterns of medication use (medication adherence) and gives a coarse and probably overestimated measure
of compliance, since return of issued medication was not measured.
There are several alternative methods available for measuring compliance. First, self-reported medication/asthma diaries could have been used giving more exact knowledge, especially about change in medication, but this method has highly
variable validity (16). Patient adherence to asthma diaries over
time is frequently poor. Asthma diary data are also vulnerable to patient deceit (16). Second, medication monitors (electronic monitors recording date and time of medication use)
could be an applicable alternative, but this is an expensive
method. In addition, we would have had to adjust this type of
equipment to many different devices. Patients could also react
on the presence of a monitoring device, altering natural patterns of medication use (16). In our setting the retrospective
interpretation of such data for 12 mo would be difficult and
would necessitate more frequent controls for safe interpretation of data, which again would increase the bias on compliance in the study.
Regarding inhaled steroids, we found a higher degree of complying (compliance . 75%) subjects among educated compared
with uneducated asthmatics. The educated asthmatics were almost two times as likely to be steroid inhaler compliant compared with the uneducated. This finding is in alignment with
previous self-management studies (2, 3). However, the present
study is the first to show such a finding when compliance is not
self-reported. There might be several reasons for this observation. It could reflect a basically better adherence to recommended regular medication, but could also have been influenced by compliance to the self-management plan which
recommended higher doses during exacerbations, as found by
others after patient education (17, 18). It is likely that both
factors influenced our result. The degree of noncompliance in
the educated asthma group was, however, still unsatisfactory.
As many as 90% of the patients with COPD used inhaled
steroids. These high figures reflect the liberal use of such medication for the patients with COPD in Norway when the study
was conducted (19). Patient education did not alter SIC in the
COPD group. However, the results should be interpreted with
caution owing to limited ability to detect these differences in
the COPD groups. There may be several reasons for the pre-
Figure 3. Dispensed short-acting b2-agonist inhalations as DDD during a 12-mo follow-up stratified by
treatment group.
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Gallefoss and Bakke: Asthma School, Compliance, and Drug Therapy
sumed lack of difference in SIC between groups: The educational method, the rationale for regular use of medication, and
a stepwise self-management plan may all be more easily adjusted, incorporated, and justified for asthmatics than for patients with COPD. SIC was equivalent in both the COPD control and intervention group to the compliance attained in the
educated asthma group; this finding could be explained by the
fact that patients with COPD might have experienced more
daily symptoms than asthmatics, which may have reinforced
the use of regular medication. To our knowledge, the effect of
an education program on SIC in patients with COPD has not
been previously investigated. Prescription charges are not
likely to have influenced our results because the maximum
amount a Norwegian citizen must pay from his or her own
pocket per year for medication and total medical treatment
(hospital included) is approximately $US 150.
The short-acting b2-agonist inhalations dispensed to the
uneducated groups were approximately twice as high as in the
educated groups, but the difference was only statistically significant for the COPD group. These figures imply that the uneducated COPD patient took approximately two extra inhalations of either salbutamol 0.2 mg/d or terbutaline 0.5 mg
compared with the educated. There could be several reasons
for this finding: Educated patients with COPD might have had
less daily symptoms than uneducated patients or might have
treated their exacerbations more effectively. A greater tolerance to symptoms without the use of rescue medication could
also partly explain the figures for the educated COPD group.
The short-acting b2-agonist results dispensed to the asthma
group should be interpreted with caution because seven more
persons in the educated group were on long-acting b2-agonists
at randomization compared with the uneducated group. The
reduced use of b2-agonists in the educated asthma group could
theoretically be explained by the higher SIC, but an opposite
correlation was found. Among asthmatics increased SIC was
correlated to increased use of b2-agonists. Interpretation of
this finding should be cautious, but could support a theory that
those who needed more inhalation steroids presumably were
sicker and so might also have used more b2-agonists. Patient
education seemed to strengthen this correlation.
We cannot explain what part of the education influenced
compliance, but we emphasized the regular use of steroid inhalations to avoid the daily use of b2-agonists. An overall impression was that the educated group had been more aware of
their symptoms and the effect of their change in medication
according to their self-management plan.
We conclude that patient education can change medication
habits toward more desirable goals by reducing the collection
of short-acting inhaled b2-agonists among patients with COPD.
Educated asthmatics showed improved SIC while this seemed
unaffected by education in the COPD group.
Acknowledgment : The authors thank the following pharmacies for their
smooth cooperation in this study regarding the registration of dispensed
medication: Sykehusapoteket i Kristiansand, Elefantapoteket, Lveapoteket,
Randesund apotek, Vågsbygd apotek, and Vennesla apotek. They also acknowledge Ole Høie, M.D., for his neat and robust adaptation of DataEase
for registration of the study parameters, the consistent and precise registration work done by Signe Valebrokk (project nurse), the educational support
from Aud Salveson (pharmacist), and support with the study PC from Astri
Thorsen on behalf of our Hospital Pharmacy.
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