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Systematic review of rheumatoid arthritis patient education.

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Arthritis & Rheumatism (Arthritis Care & Research)
Vol. 51, No. 6, December 15, 2004, pp. 1045–1059
DOI 10.1002/art.20823
© 2004, American College of Rheumatology
REVIEW
Systematic Review of Rheumatoid Arthritis
Patient Education
ROBERT P. RIEMSMA,1 ERIK TAAL,2 JOHN R. KIRWAN,3 AND JOHANNES J. RASKER4
Introduction
Rheumatoid arthritis (RA) is a common chronic condition
characterized by uncertain disease progression and an unpredictable course of exacerbations and remissions. Approximately 1–3% of the population in Western countries
is affected by RA (1). Various interventions may alleviate
its course, and patients come into contact with a large
number and variety of health professionals. For many patients, pain, disability, deformity, and reduced quality of
life persist in spite of treatment. There is room for new
approaches to enhance current treatment effectiveness. Patient education is one such approach that is thought to be
beneficial in helping patients cope with their disease and
cooperate with its complex management (2,3).
As with other chronic diseases, there is no cure for most
types of arthritis, including RA. Furthermore, the disease
This article is a summary of a Cochrane systematic review: Riemsma R, Kirwan J, Taal E, Rasker J. Patient education for adults with rheumatoid arthritis. Cochrane Database Syst Rev 2002;(3):CD003688.
An editorial discussing the main results of the review has
been published: Riemsma RP, Taal E, Kirwan JR, Rasker JJ.
Patient education programmes for adults with rheumatoid
arthritis [editorial]. BMJ 2002;325:558 –9.
The results of a Cochrane review can be interpreted differently, depending on people’s perspectives and circumstances. Please consider the conclusions presented carefully. They are the opinions of review authors, and are not
necessarily shared by the Cochrane Collaboration. The
views expressed in this report are those of the authors and
not necessarily those of the Dutch Arthritis Association. Any
errors are the responsibility of the authors.
Supported by a grant from the Dutch Arthritis Association.
1
Robert P. Riemsma, PhD: Centre for Reviews and Dissemination, University of York, York, United Kingdom; 2Erik
Taal, PhD: University of Twente, Enschede, The Netherlands; 3John R. Kirwan, BSc, MD: Bristol Royal Infirmary,
Bristol, United Kingdom; 4Johannes J. Rasker, MD, PhD:
University of Twente and Medisch Spectrum Twente, Enschede, The Netherlands.
Address correspondence to Robert P. Riemsma, PhD, Centre for Reviews and Dissemination, University of York,
York, YO10 5DD, UK. E-mail: rpr1@york.ac.uk.
Submitted for publication July 4, 2003; accepted in revised form November 30, 2003.
course is often unpredictable and the symptoms that patients experience can vary from day to day or even from
hour to hour. Because of the nature of pain and disability,
the partial and inconsistent effects of treatment, and the
unpredictability people with arthritis face on a daily basis,
patient education programs have become a complement to
traditional medical treatment (4). Thus, patient education
programs have given people with arthritis the strategies
and the tools necessary to make daily decisions to cope
with the disease (5,6).
Patient education has been defined as “any set of
planned educational activities designed to improve patients health behaviors and/or health status” (7). Lorig has
further stated “the purpose of patient education is to maintain or improve health, or, in some cases, to slow deterioration” (7). The focus of arthritis patient education programs is to teach patients to adjust their daily activities as
dictated by disease symptoms. In other words, in addition
to teaching patients what they should do, patients are also
instructed on how to approach situations and to make
adjustments that are appropriate for each individual and
his or her own needs.
There has been increasing research in the field of patient
education, and major reviews of published studies have
been conducted on the value of education in general (8)
and, more recently, on education in arthritis (5,6,9,10).
Two reviews on arthritis patient education reported combined effect estimates on main outcome measures, such as
pain, functional disability, and psychological outcomes
(9,10). Hawley reviewed 34 rheumatic disease patient education clinical trials performed between 1985 and 1995
(9). She reported average effect sizes for treatment groups
compared with nonintervention controls for RA patient
pain, functional ability, and depression at postintervention of 0.13, – 0.16, and 0.01, respectivley; effect sizes for
osteoarthritis (OA) patient pain, functional ability, and
depression at postintervention were 0.44, 0.28, and 0.56,
respectively (confidence intervals were not reported).
These data show a trend to greater improvement for OA
compared with RA patients (9). Superio-Cabuslay et al
compared the effects of 19 patient education trials and 28
nonsteroidal antiinflammatory drug trials between 1966
and 1993 among patients with OA and RA (10). They
found an average effect size for treatment compared with
nonintervention controls for RA patient pain and func1045
1046
tional disability at postintervention of 0.16 (95% confidence interval [95% CI] – 0.18, 0.50) and 0.18 (95% CI
– 0.27, 0.63); the comparable effect sizes for OA patients
were 0.16 (95% CI – 0.69, 1.02) and 0.0 (95% CI – 0.61,
0.61), suggesting that RA patients show greater improvements compared with OA patients after completion of an
educational intervention (10). Although the data are ambiguous, available data suggest that there may be a difference in efficacy by diagnosis.
From the available literature, it is not clear what type
of educational interventions are most effective in improving health status for patients with chronic diseases
(11). Education strategies can vary from the provision
of information only to the use of cognitive-behavioral strategies.
Our objective was to determine the effectiveness of patient education in patients with RA based on a systematic
review of the evidence from randomized controlled trials
(RCTs). We focused on the effects of patient education on
pain, functional disability, joint counts, patient and physician global assessment, affect scores, and measures of
acute phase reactants. These outcome measures are based
on the core set of outcome measures to be used in clinical
trials in RA as identified and agreed upon by Outcome
Measures in Rheumatology Clinical Trials (OMERACT)
(12). This set of outcome measures has been acknowledged
as the gold standard for outcome measures in RA by the
World Health Organization (WHO) and the International
League of Associations for Rheumatology (ILAR) (13). To
examine the differential effects of various types of patient
education, we have made a distinction between 3 types of
patient education in our analyses: information only, counseling, and behavioral treatment. Information only includes all interventions aimed primarily at the exchange of
information by means of persuasive communication or
informational brochures; these interventions do not include a behavioral component and are not aimed at generating support. Counseling includes interventions mainly
aimed at social support and giving patients the opportunity to discuss their problems. Behavioral treatment refers
to interventions that include techniques aimed at behavioral change, such as behavioral instruction, skills training, and biofeedback.
Literature search
A systematic search using the recommendations of the
Cochrane Collaboration was conducted using 3 databases (Medline, EMBASE, and PsycInfo) using entries
from 1966 forward to September 2002. A similar search
was performed in the Cochrane database, and a selection
of review articles were examined to identify additional
relevant publications (5,6,9,10,14 –23). Search terms included arthritis, health promotion, patient education, behavior therapy, occupational therapy, self care, psychological adaptation, counseling, and exercise therapy. No
restrictions were made concerning the language of publication (24,25).
RCTs in which patients with a confirmed diagnosis of
RA were included. Studies with mixed populations were
included, but only data regarding RA patients were used in
Riemsma et al
the analyses. Furthermore, RCTs had to include a nonintervention control group and pretest and posttest results
had to be available separately for RA, either in the publication or from the studies’ authors. Studies that did not
include data on the predefined set of outcome measures
were reported, but excluded from the meta-analysis. If data
necessary for the calculation of weighted mean differences
(WMDs) or standardized mean differences (SMDs) were
unavailable, either in the publication or from the studies’
authors, the study was also excluded from the analysis.
Studies that did include data on the predefined set of
outcome measures, but only for specific parts of the body,
e.g., pain in the hand, were also excluded. Outcomes included in the review are scores on pain, functional disability, joint counts, patient and physician global assessment, psychological status (anxiety and depression), and
disease activity (acute phase reactants).
All patient education interventions were eligible for inclusion in this review. We defined a patient education
intervention as one that includes formal structured instruction on arthritis and ways to manage arthritis symptoms. Studies that used modern psychobehavioral methods to promote changes in health behaviors were also
included. As a complement to an instructional component, interventions could include exercise, biofeedback, or
psychosocial support.
The title and abstract of each citation were examined by
2 reviewers (RPR and ET) and the trials were retrieved
that, according to at least 1 of the reviewers, cited RCTs. If
it was unclear from the title and abstract whether allocation of the intervention had been conducted in a randomized manner or whether the intervention included an educational component or whether RA patients were
involved, the full report was retrieved. Both reviewers
then examined the full reports. Disagreements regarding
inclusion status were resolved by discussion.
Types of outcome measures
A core set of outcome measures to be used in clinical trials
in RA have been identified and agreed upon by OMERACT
(12). This set of outcome measures has been acknowledged
as the gold standard for outcome measures in RA by the
WHO and ILAR (13). For RA, the preliminary core set of
outcomes identified by OMERACT including validated
measures of pain, functional disability, joint pain/tenderness, joint swelling, patient and physician global assessment, and acute phase reactants (erythrocyte sedimentation rate and C-reactive protein) were selected as outcome
measures to be included in this review. Because psychological status is an important aspect of health status, we
also included affect scores (psychological status, anxiety,
and depression).
Assessment of study quality
Methodologic quality of the included trials was assessed
independently by 2 assessors (RPR and JRK) using an
adapted version of the instrument developed by Jadad et al
(26). This was done by evaluating the methods and results
of the reports without knowledge of the authors. Disagreement among the reviewers regarding the quality of the
RA Patient Education: Review
1047
Table 1. Criteria for the assessment of methodologic
quality of randomized controlled trials*
Description of criteria
Selection bias
Randomization reported but not specified
On-site computer, random number tables
Centralized or in prenumbered/coded/
identical boxes or containers
Attrition (losses to followup)
Followup ⬍80% overall or not reported
Followup ⱖ80%
Intention-to-treat, explicit and clear
Detection bias (blinding of outcome
assessment)
Not reported
Reported but not fully blinded
Outcome assessment fully blinded
Performance bias (cointerventions)
Cointerventions allowed but not reported
Cointerventions allowed, reported
Cointerventions allowed, reported,
analyzed, or not allowed
Scoring
0
1
2
0
1
2
0
1
2
0
1
2
* Each criterion was scored from 0 to 2; therefore, a maximum score
of 8 and a minimum score of 0 could be achieved for each trial.
articles was readily resolved by discussion and consensus.
Our quality scale comprises the 3 criteria proposed by
Jadad et al (26), which cover 3 of 4 criteria outlined in the
Cochrane Collaboration handbook (27): selection bias, attrition bias, and detection bias. We added 1 item concerning cointerventions to cover the fourth criterion: performance bias (see Table 1). Performance bias refers to
systematic differences in care provided to comparison
groups other than the intervention of interest.
Data extraction and presentation
The details of the included reports were scrutinized by 1
reviewer (RPR) and a standardized form was used for data
abstraction.
For continuous variables, WMDs, SMDs, and their 95%
CIs were calculated using RevMan 4.2.2 software (28).
Effect sizes were calculated for each outcome as the value
of the mean change from baseline to postintervention (or
final followup) in the experimental group minus the mean
change from baseline to postintervention (or final followup) in the control group, divided by the pooled standard deviation of the change scores in both groups. In
RevMan, the weight given to each study is the inverse of
its variance, i.e., more precise estimates (from larger
studies with more events) are given more weight (29). The
calculation of effect sizes (WMDs and SMDs) was such
that negative values favor the patient education intervention. If absolute values were reported, we calculated
mean differences in scores from baseline to postintervention. The results for each trial were tested for heterogeneity
using the chi-square statistic. Effect estimates were analyzed using fixed effects models unless heterogeneity,
due to differences in the outcome measures, was signifi-
cant (at P ⬍ 0.05); in which case a random effects model
was used.
Results are reported at first followup and at final followup. First followup refers to the assessment immediately after the intervention. Depending on the duration of
the intervention, this ranged from 3 weeks to 9 months
after baseline assessment. Final followup refers to the last
assessment in the study, this ranged from 3 to 14 months
after the intervention. For studies with a waiting-list control group, assessments that were performed after the
crossover are not included in this review. Results are reported separately for 3 types of interventions: information
only, counseling, and behavioral treatment.
Potential bias in meta-analytic research is publication
bias, which occurs when trials showing no effect are selectively not published (30). One method used to detect
publication bias is to draw a funnel plot. Funnel plots
show the distribution of effect sizes according to sample
size: it is to be expected that the points will fill a funnel
shape, with there being more variability in reported effect
sizes for smaller studies. Large gaps in the funnel indicate
a group of possibly “missing” publications. These omissions are usually small studies with point estimates suggesting a different effect from those available and are
unlikely to be missing at random (31). We investigated
whether publication bias existed among these studies
by plotting sample sizes versus effect sizes for the outcomes that were most often reported: pain and functional
disability.
Sensitivity analyses
Other sources of bias in the meta-analysis were dealt with
by several sensitivity analyses. The results are shown with
and without use of quality scores to examine the effect of
quality scores and we have run the analysis with only the
larger studies to help determine the extent to which publication bias affected the conclusions. The main analyses
focused on outcomes reported at first followup, i.e., immediately after the intervention irrespective of the duration of
the intervention. However, as some studies assessed first
followup after 3 weeks and others after 9 months, depending on the duration of the intervention, we did a separate
analysis for studies that reported outcomes 2– 4 months
after baseline assessment. A way to reduce heterogeneity is
using only one, the most commonly used, instrument to
measure each outcome; therefore a separate sensitivity
analysis was performed using the most commonly used
instrument to measure each outcome. Some studies included 2 or 3 experimental conditions. Because we included comparisons of each experimental condition versus the control condition, the control conditions for these
studies were included 2 or 3 times, thus overestimating the
results of the control condition. To see whether this overestimation seriously influenced results, we have done separate analysis including only 1 (the most extreme, see
Table 2) educational intervention.
Studies selected
The search strategies identified 1,423 references, which
were first examined on the basis of titles and abstracts (see
0
NR
30
15
15
23
6
3
3
15
37
12
35
13
4
3
7
46
9
1
6
0
n
18
108
602
150
65
60
35
105
79
68
100
105
34
63
100
60
219
98
33
84
141
59
Author, year (ref.)*
Appelbaum, 1988 (67)
Barlow, 1997 (40,41,pers com)
Barlow, 2000 (48)
Bell, 1998 (49)
Brus, 1998 (50,92,pers com)
Geissner, 1994 (51,pers com)
Multimodal pain management**
Visualization techniques
Relaxation training
Hammond, 1999 (52)
Helewa, 1991 (68,pers com)
Helliwell, 1999 (53)
Hewlett, 1998 (pers com)
Hill, 2001 (54)
Huiskes, 1991 (44,45,pers com)
Combination therapy**
Cognitive behavioral therapy
Occupational therapy
Kaplan, 1981 (69)
Leibing, 1999 (55)
Lindroth, 1997 (56,pers com)
Maisiak 1996 (70,pers com)
Maisiak 1996 (58, pers com)
Treatment counseling**
Symptom monitoring
Neuberger, 1993 (57)
Nurse patient contracts**
Practice time and demonstrations
Self instruction
O’Leary, 1988 (71)
Parker, 1988 (59,pers com)
Cognitive behavioral group**
Attention placebo
Parker, 1995 (60,pers com)
Stress management course**
Patient education course
Radojevic, 1992 (61)
Behavioral therapy with family support**
Behavioral therapy without family support
Education family support
Dropout
%†
54
60
49
61
53
49
53
55
54
60
55
54
53
57
63
57
62
59
58
56
59
48
Age, mean,
years
76
43
100
4
66
100
75
83
100
92
83
87
66
69
73
68
11
81
84
80
80
78
Female
%
4
4
4
10 ⫹ 5
10 ⫹ 5
4
4
4
10 ⫹ 65
10 ⫹ 65
1 ⫹ 52
1 ⫹ 52
13 ⫹ 26
13 ⫹ 26
5⫹6
5⫹6
1 wk clinic ⫹ 6
1 wk clinic ⫹ 6
10
10
10
12
12
8
26
10
10
10
12
12
8
5–8
16
16
16
5
4–6
4–6
4–6
6
6
4
5
24
6
6
6
4(⫹1)
6
4
5
7
4
4
4
5
6
3
6
6
39
10
Mailed leaflets
6
4
6
No. of sessions‡
Program
duration,
weeks
BT
BT
Inf
BT
Inf
BT
Inf
BT
BT
Inf
BT
C
Inf
BT
BT
BT
C
BT
BT
C
BT
BT
BT
BT
BT
Inf
BT
Inf
BT
Inf
BT
BT
BT
Intervention
type§
Table 2. Arthritis patient education trials included in the meta-analysis
G, Pa, A
G, A
G, V, Pa
F, CP
F, CP
F ⫹ G, W
F ⫹ G, W, V
F, W
F
F, W
G, W
T
T
G, W
G, W
G, W
G
G
G, W
T
G
G
G
G, W, V, Pa
F
G, W, Pa
G
F, W
F
W
G, W
F, W,
G, W, Pa
Education
mode¶
Ps
Ps
Ps
Ps, CP
Ps, CP
In
In
N
N
N
FE
TC
US
(continued)
R, Ps, OT
R, Ps, BT
R, OT
PC, Ps
Ps
R, N, Ps, OT, SW, Di
PC
Ps
Ps
Ps
OT
OT
HP
N, OT, PT, Ps
RN
SP
NA
LL
PT
R
Program facilitator#
1048
Riemsma et al
21
19
NR
8
0
15
23
5
24
48
238
50
183
68
53
105
42
75
n
55
50
48
55
56
52
52
45
56
Age, mean,
years
70
74
79
70
75
80
75
97
62
Female
%
20
5 ⫹ 39
5 ⫹ 39
13
13
13
2
8
10
10
12
5
20
5⫹3
5⫹3
ⱖ1
10
10
9
8
10
10
36
5
No. of sessions‡
Program
duration,
weeks
BT
C
BT
BT
BT
C
BT
BT
BT
BT
Inf
BT
Intervention
type§
G
G
HE, W, A
G, Pa, W, A
G, W
G, W
G, Pa, W
F, W
G, Pa, W, A
G, W, A
F
G, A
Education
mode¶
Ps
Ps
NA
HP
BT, N/SW
PC
R, O, PT, Ps, SW
Ps
HP
HP
R
PC, Ps
Program facilitator#
* pers com ⫽ personal communication.
† NR ⫽ not reported.
‡ Number of sessions: 4(⫹1) ⫽ 4 consecutive sessions plus 1 additional session if required; 5 ⫹ 6 ⫽ 5 sessions during the first period and 6 during the second period; 1 wk clinic⫹6 ⫽ 1 week clinic
stay and 6 sessions during the following 12 months; 10 ⫹ 5 ⫽ 10 sessions during the first period and 5 during the second period; 5 ⫹ 3 ⫽ 5 sessions during the first period and 3 during the second
period (see program duration for length of each period).
§ Intervention type: BT ⫽ behavioral treatment; Inf ⫽ information only; C ⫽ counselling.
¶ Education mode: A ⫽ audiocassettes; CP ⫽ computer program; F ⫽ individual face-to-face contact; G ⫽ group sessions; HE ⫽ home exercises; Pa ⫽ partner participation; T ⫽ telephone contact; V ⫽
video; W ⫽ written materials.
# Programme facilitator: BT ⫽ behavioral therapist; CP ⫽ computer program; Di ⫽ dietician; FE ⫽ female experimenters; HP ⫽ health professional; In ⫽ instructors; LL ⫽ lay leader; N ⫽ nurse; O ⫽
orthopedist; OT ⫽ occupational therapist; PC ⫽ patient counselor; Ps ⫽ psychologist/psychiatrist; PT ⫽ physiotherapist; R ⫽ rheumatologist; RN ⫽ rheumatology nurse; SP ⫽ student in psychology;
SW ⫽ social worker; TC ⫽ trained and experienced arthritis patient counselor; US ⫽ untrained student; NA ⫽ not applicable.
** Interventions included in the analysis using only one intervention for each trial.
Rhodes, 1988 (72)
Riemsma, 1999 (pers com)
Group education with partner**
Group education without partner
Rodriguez-Lozano, 1996 (62)
Savelkoul, 2000 (47, pers com)
Coping intervention group**
Mutual support
Scholten, 1999 (63)
Sharpe, 2001 (94)
Shearn, 1985 (73)
Self management**
Mutual support
Stenstrom, 1994 (65,pers com)
Taal, 1993 (66,93,pers com)
Author, year (ref.)*
Dropout
%†
Table 2. Arthritis patient education trials included in the meta-analysis (Continued)
RA Patient Education: Review
1049
1050
Riemsma et al
(Hewlett S: personal communication; Riemsma R: personal communication; Savelkoul M: personal communication). Subsequently, 2 of these have been published
(46,47). In total, 50 studies are suitable for inclusion in this
review.
For these 50 studies, we found complete data on 24
studies (refs. 40, 44, 47– 66, and Hewlett S: personal
communication; Riemsma R: personal communication)
and 7 other studies gave incomplete data (67–73), the
authors of these studies did not reply to our requests
for more information. Therefore, 31 studies were included in this review and these trials are summarized in
Table 2.
Of the remaining 19 studies that were suitable for
inclusion, we have no data yet for 2 studies (74,75), but
the authors replied that the information requested will
be sent as soon as possible. On 8 studies, we found no data
relating to the outcomes under investigation in the report
(76 – 83), and the authors have not replied to our requests
for more information. Finally, the relevant data are not
available for 9 studies according to the authors (43,
84 –91). We received additional data through personal
communication for 18 of the 31 included studies (refs. 92
and 93, and Barlow J: personal communication; Bradley L:
personal communication; Brus H: personal communication; McEvoy-DeVellis B: personal communication; Fries J:
personal communication; Stenstrom C: personal communication; Geissner E: personal communication; Goeppinger J: personal communication; Helewa A: personal
communication; Kraaimaat F: personal communication;
Lindroth Y: personal communication; Lorig K: personal
communication; Maisiak R: personal communication; Oermann M: personal communication; Smarr K: personal
communication; Hewett J: personal communication; Taal
E: personal communication).
Figure 1. Flow diagram of search strategy. RCT ⫽ randomized
controlled trial; RA ⫽ rheumatoid arthritis.
Figure 1). For 229 references, the full report was retrieved.
Eighty-six publications were not RCTs; in 32 publications,
the subjects involved were not RA patients; in 29 publications, the intervention did not include an educational
component; 11 publications involved secondary analysis;
8 publications did not include a nonintervention control
group; 2 publications presented only preliminary results;
in 1, the intervention was education for health professionals; 2 turned out to be conference abstracts (we have not
been able to find more information about these 2 studies);
and 1 publication could not be retrieved (32). One publication is awaiting assessment because we need more information from the authors (33). In 6 studies, the outcome
variables did not include any of the selected outcome
measures (34 –39).
The remaining 50 publications are suitable for inclusion
in this review. Among the 50 references, we found 3 studies with double publications (40 – 45); therefore, 47 trials
were suitable for inclusion in the review. We also searched
for unpublished studies, and were able to retrieve data
from 3 additional trials that have recently been completed
Publication bias
We have drawn funnel plots showing sample sizes versus
effect sizes for the 2 outcomes that were assessed most
often: pain and functional disability (see Figures 2 and 3).
The distribution appears symmetric and small studies
with comparatively negative outcomes are as frequently
reported as those with comparatively more positive outcomes.
Methodologic quality of the studies
The quality of the 31 included studies was assessed (Table
3). For the studies on which we had 2 publications or
more, we used all available information from all publications to assess the quality of each study. If it was possible
to retrieve additional information from the authors concerning the quality of the study, this was incorporated in
the score as well. If it was not possible to retrieve additional information, the quality score reported reflects the
quality of the study as it is reported in the article. This may
not reflect the true quality of the study.
The quality of studies on average was not very high. The
mean score from all 31 studies was 3.26 (of a possible 8).
Of all 31 randomized controlled trials, only 8 received the
full 2 points for description of the randomization proce-
RA Patient Education: Review
1051
Figure 2. Funnel plot showing sample sizes versus effect sizes for scores on pain. SMD ⫽ standardized mean difference.
Figure 3. Funnel plot showing sample sizes versus effect sizes for scores on functional disability. SMD ⫽ standardized mean difference.
1052
Riemsma et al
Table 3. Methodologic quality of included studies
Study*
Selection
Performance
Attrition
Blinding
Total
score
Appelbaum, 1988 (67)
Barlow, 1998 (46, 41, pers com)
Barlow, 2000 (48)
Bell, 1998 (49)
Brus, 1998 (50, 92, pers com)
Geissner, 1994 (51, pers com)
Hammond, 1999 (52)
Helewa, 1991 (68, pers com)
Helliwell, 1999 (53)
Hewlett, 1998 (pers com)
Hill, 2001 (54)
Huiskes, 1991 (44, 45, pers com)
Kaplan, 1981 (69)
Leibing, 1999 (55)
Lindroth, 1997 (56, pers com)
Maisiak, 1996 (70, pers com)
Maisiak, 1996 (58, pers com)
Neuberger, 1993 (57)
O’Leary, 1988 (71)
Parker, 1988 (59, pers com)
Parker, 1995 (60, pers com)
Radejovic, 1992 (61)
Rhodes, 1988 (72)
Riemsma, 1999 (pers com)
Rodriguez-Lozano, 1996 (62)
Savelkoul, 2000 (47, pers com)
Scholten, 1999 (63)
Sharpe, 2001 (94)
Shearn, 1985 (73)
Stenstrom, 1994 (65, pers com)
Taal, 1993 (66, 93, pers com)
Total of all 31 studies
0
0
2
2
0
0
2
1
2
2
2
0
0
0
0
1
0
0
0
1
0
0
0
0
0
2
1
2
0
0
1
21
0
0
0
2
1
2
1
0
2
1
2
0
0
2
1
0
1
0
0
0
1
1
0
0
1
1
1
0
0
0
0
20
0
0
2
2
1
0
1
2
2
2
0
1
1
1
2
2
1
0
1
1
1
1
0
2
1
2
1
2
0
1
0
33
0
0
1
1
2
0
1
1
1
1
2
1
1
1
0
1
2
0
1
0
1
0
1
1
0
2
2
1
0
1
1
27
0
0
5
7
4
2
5
4
7
6
6
2
2
4
3
4
4
0
2
2
3
2
1
3
2
7
5
5
0
2
2
101
* pers com ⫽ personal communication.
dure, these were all published in the last 5 years. Only
5 other studies received 1 point for randomization,
making randomization together with cointerventions the 2
least well-reported elements of the 4 quality items, with a
mean of 0.68 and 0.65 (of a possible score of 2) for randomization and cointerventions, respectively. Most studies scored higher on attrition; with a mean of 1.06 (of 2),
this item showed the highest scores of the quality items.
A separate analysis was undertaken including only
the 17 studies with a quality score of 3 or higher and
on which we have data (refs. 47–50, 52–56, 58, 60, 63,
68, 70, and 94, and Hewlett S: personal communication; Riemsma R: personal communication) to check
whether the quality of studies seriously influences the
results.
Effectiveness of patient education
We found significant effects of patient education at first
followup, i.e., immediately after the intervention (depending on the duration of the intervention, this ranged
from 3 weeks to 9 months after baseline assessment),
for scores on functional disability (SMD ⫽ – 0.17; 95% CI
⫺0.25, ⫺0.09; Z ⫽ 3.97; P ⫽ 0.00007; N ⫽ 2,275) involving
25 trials and 37 comparisons; joint counts (SMD ⫽ ⫺0.13;
95% CI ⫺0.24, ⫺0.01; Z ⫽ 2.14; P ⫽ 0.03; N ⫽ 1,158)
involving 15 trials and 23 comparisons; patient global
assessment (SMD ⫽ ⫺0.28; 95% CI ⫺0.49, ⫺0.07; Z ⫽
2.65; P ⫽ 0.008; N ⫽ 358) involving 4 trials and 6 comparisons; psychological status (SMD ⫽ ⫺0.16; 95% CI ⫺0.28,
⫺0.04; Z ⫽ 2.66; P ⫽ 0.008; N ⫽ 1,138) involving 8
trials and 18 comparisons; and depression (SMD ⫽ – 0.14;
95% CI ⫺0.23, ⫺0.05; Z ⫽ 2.90; P ⫽ 0.004; N ⫽ 1,770)
involving 18 trials and 29 comparisons. The number of
comparisons is more than the number of trials for each
outcome because a number of trials included ⬎1 intervention arm.
Physician global assessment was not assessed in any
of the included studies. Of anxiety, pain, and disease
activity, none showed significant effects. A trend was
found in favor of patient education for pain; however
(SMD ⫽ – 0.08; 95% CI – 0.16, 0.00; Z ⫽ 1.86; P ⫽ 0.06;
N ⫽ 2,219), this involved 24 trials and 37 comparisons
(see Figure 4). Heterogeneity was not significant for all
measures; therefore, in all cases the fixed effect model was
used.
RA Patient Education: Review
1053
Figure 4. Forest plots of main results (pain, functional disability, joint count, patient global assessment, psychological status,
anxiety, depression, and disease activity) at first followup. Pooled effect sizes (center points) and 95% confidence intervals
(horizontal bars) for A, all patient education interventions, B, information-only interventions, C, counseling interventions, and D,
behavioral treatment interventions. Exp ⫽ experimental; SMD ⫽ standardized mean difference; 95% CI ⫽ 95% confidence interval.
*The random effects model was used because heterogeneity was significant (P ⬍ 0.05).
1054
At final followup, no significant effects of patient education were found (see Figure 5). A trend was seen in favor
of patient education, however, for scores on functional
disability (SMD ⫽ – 0.09; 95% CI – 0.20, 0.02; Z ⫽ 1.66;
P ⫽ 0.10; N ⫽ 1,308) involving 15 trials and 23 comparisons.
Analyses by type of intervention
We found 9 studies that included 9 comparisons (and 687
patients) of an intervention aimed at information only
versus control. The pooled analyses showed no significant
effects at first followup for scores on pain, functional disability, joint counts, patient global assessment, anxiety,
depression, and disease activity. However, scores on pain
and psychological status showed a trend in favor of the
information-only group: pain scores involved 8 trials and 8
comparisons (SMD ⫽ – 0.15; 95% CI – 0.32, 0.02; Z ⫽ 1.71;
P ⫽ 0.09; N ⫽ 524) and psychological status scores involved 3 trials and 3 comparisons (SMD ⫽ – 0.24; 95% CI
– 0.48, 0.01; Z ⫽ 1.88; P ⫽ 0.06; N ⫽ 257) (Figure 4). At
final followup, no significant effects of information only
were found (see Figure 5).
We found 5 studies that included 5 comparisons (and
430 patients) of an intervention aimed at counseling versus control. The pooled analyses showed no significant
effects for scores on pain, functional disability, joint
counts, patient global assessment, anxiety, depression, or
disease activity (Figure 4). However, a trend was found in
favor of the intervention for scores on psychological status
(SMD ⫽ – 0.25; 95% CI – 0.52, 0.03; Z ⫽ 1.74; P ⫽ 0.08; N ⫽
203) involving only 2 trials and 2 comparisons. At final
followup, no significant effects of counseling were found
(see Figure 5).
We found 24 studies that included 31 comparisons (and
2,493 patients) of an intervention aimed at behavioral
treatment versus control. The pooled analyses showed significant effects for scores on functional disability (SMD ⫽
– 0.23; 95% CI – 0.36, – 0.10; Z ⫽ 3.52; P ⫽ 0.0004; N ⫽
1,532) involving 21 trials and 27 comparisons; patient
global assessment (SMD ⫽ – 0.30; 95% CI – 0.55, – 0.04;
Z ⫽ 2.25; P ⫽ 0.02; N ⫽ 236) involving 4 trials and 4
comparisons; and depression (SMD ⫽ – 0.14; 95% CI
– 0.25, – 0.04; Z ⫽ 2.63; P ⫽ 0.009; N ⫽ 1,350) involving 16
trials and 21 comparisons (Figure 4). Heterogeneity was
found to be significant for scores on functional disability,
therefore the random effects model was used. A trend in
favor of the intervention was found for scores on pain
(SMD ⫽ – 0.09; 95% CI – 0.19, 0.02; Z ⫽ 1.67; P ⫽ 0.10; N ⫽
1,453) involving 19 trials and 26 comparisons. At final
followup, no significant effects of behavioral treatment
were found (see Figure 5). However, trends in favor of
behavioral treatment were found for scores on functional
disability (SMD ⫽ ⫺0.10; 95% CI – 0.23, 0.02; Z ⫽ 1.64;
P ⫽ 0.10; N ⫽ 1,003) involving 14 trials and 18 comparisons and depression (SMD ⫽ – 0.12; 95% CI – 0.25, 0.01;
Z ⫽ 1.80; P ⫽ 0.07; N ⫽ 911) involving 12 trials and 16
comparisons.
Sensitivity analyses results
Looking only at higher-quality studies and large studies,
we found significant effects favoring patient education for
Riemsma et al
scores on functional disability, patient global assessment,
psychological status, and depression. These results confirm the results from the main analyses and show that the
effects found are quite robust.
Three other sensitivity analyses were performed: 1) using only 1 instrument to measure each outcome to reduce
heterogeneity in outcome measures; 2) including only 1
educational intervention, thus not overestimating the results of the control condition in studies with ⬎1 experimental condition; and 3) comparing trials at a fixed time
point (after 2– 4 months) to reduce heterogeneity in outcome assessment. The results of these 3 sensitivity analyses showed similar effects for scores on functional disability, patient global assessment, and depression, which
again show that the results are quite robust. However,
standardized effect sizes ranged from – 0.11 to – 0.32, indicating that the effect is very small. The results of the
sensitivity analyses are presented in Table 4.
Discussion
In this review we examined the effectiveness of patient
education interventions on health status (disease activity,
patient global assessment, joint counts, pain, functional
disability, and psychological wellbeing) in patients with
RA. We found a small beneficial effect of patient education
at first followup for functional disability (SMD ⫽ – 0.17;
95% CI – 0.25, – 0.09), joint counts (SMD ⫽ – 0.13; 95% CI
– 0.24, – 0.01), patient global assessment (SMD ⫽ – 0.28;
95% CI – 0.49, – 0.07), psychological status (SMD ⫽ – 0.16;
95% CI – 0.28, – 0.04), and depression (SMD ⫽ – 0.14; 95%
CI – 0.23, – 0.05). At final followup (3–14 months), there
were no significant benefits.
These results suggest significant effects of patient education for scores on functional disability, and moreover
these effects were quite robust, as most sensitivity analyses
showed significant effects. However, standardized effect
sizes ranged from – 0.11 to – 0.21, indicating that the effect
is very small. An SMD of 0.17 in favor of patient education
can be translated into an improvement on the Stanford
Health Assessment Questionnaire (HAQ; range 0 –3) of
0.10, assuming the mean score in the control group remains the same and a standard deviation of 0.60 in both
groups. Assuming a start level of 1.00 on the HAQ, an SMD
of – 0.17 translates to a 10% (95% CI 5, 16) improvement
on the HAQ.
Similarly, compared with no intervention, patient education produced a 4% (95% CI 0, 9) decrease in pain visual
analog scale; 9% (95% CI 1, 16) improvement on the
Ritchie Articular Index; 12% (95% CI 3, 22) improvement
on the Arthritis Impact Measurement Scales (AIMS) arthritis impact subscale; 5% (95% CI 1, 9) improvement on the
AIMS2 affect subscale; and 12% (95% CI 4, 19) improvement on depression scores.
In summary, the statistically significant benefits of patient education at first followup are modest (5–12%). The
most important benefit was for functional disability, with
an effect size of – 0.17. This compares with the following
effect sizes for disease-modifying drug treatments: – 0.09
(95% CI – 0.45, 0.27) for antimalarials (95); – 0.19 (95% CI
– 0.39, 0.02) for auranofin (96); – 0.29 (95% CI – 0.77, 0.19)
RA Patient Education: Review
1055
Figure 5. Forest plots of main results (pain, functional disability, joint count, patient global assessment, psychological status,
anxiety, depression, and disease activity) at final followup. Pooled effect sizes (center points) and 95% confidence intervals
(horizontal bars) for A, all patient education interventions, B, information-only interventions, C, counseling interventions, and D,
behavioral treatment interventions. For definitions of abbreviations, see Figure 4.
1056
Riemsma et al
Table 4. Summary of statistically significant results (P < 0.05) or trends (P < 0.10) for SMD and WMD for main study and
various sensitivity analyses*
Functional Joint Patient global Psychological
Disease
disability counts assessment
status
Anxiety Depression activity
Measure
Pain
SMD
WMD
⫺0.08†
⫺0.38‡
⫺0.17‡
⫺0.19†
⫺0.13‡
⫺1.79‡
Sensitivity analysis: one
experimental condition
Sensitivity analysis: high quality
studies
Sensitivity analysis: large studies
Sensitivity analysis: 2–4 months
Sensitivity analysis: comparable
interventions: information
Sensitivity analysis: comparable
interventions: counseling
Sensitivity analysis: comparable
interventions: behavioral
Final followup
Main analysis
Sensitivity analysis: one
instrument
SMD
VAS
⫺0.10†
HAQ
⫺0.23‡
RAI
⫺0.15‡
Sensitivity analysis: one
experimental condition
Sensitivity analysis: high quality
studies
Sensitivity analysis: large studies
Sensitivity analysis: 2–4 months
Sensitivity analysis: comparable
interventions: information
Sensitivity analysis: comparable
interventions: counseling
Sensitivity analysis: comparable
interventions: behavioral
SMD
First followup
Main analysis
Sensitivity analysis: one
instrument
⫺0.20‡
SMD
SMD
SMD
SMD
⫺0.10†
⫺0.15†
⫺0.15‡
⫺0.14‡
⫺0.17†
⫺0.28‡
⫺0.16‡
⫺0.45†
⫺0.14‡
⫺0.62‡
⫺0.30‡
AIMS
⫺0.16†
HAD
⫺0.18‡
⫺0.32‡
⫺0.18‡
⫺0.21‡
⫺0.31‡
⫺0.22†
⫺0.13†
⫺0.13‡
⫺0.11‡
⫺0.25†
SMD
SMD
⫺0.24†
⫺0.09†
⫺0.23
⫺0.09†
⫺0.11‡
SMD
WMD
⫺0.13†
HAQ
⫺0.12†
⫺0.30‡
⫺0.14‡
⫺1.55‡
RAI
⫺0.14†
SMD
SMD
SMD
SMD
SMD
SMD
⫺0.12†
⫺0.12†
* SMD ⫽ standardized mean difference; WMD ⫽ weighted mean difference; VAS ⫽ visual analog scale; HAQ ⫽ Health Assessment Questionnaire;
RAI ⫽ Ritchie Articular Index; AIMS ⫽ Arthritis Impact Measurement Scales; HAD ⫽ Hospital Anxiety and Depression Scale.
† P ⬍ 0.10.
‡ P ⬍ 0.05
for penicillamine (97); – 0.31 (95% CI –1.06, 0.44) for azathioprine (98); – 0.78 (95% CI –1.10, – 0.47) for cyclosporine (99); and –1.48 (95% CI –1.82, –1.14) for methotrexate
(100). Glucocorticoids, when given in addition to diseasemodifying drugs, have an additional effect size of – 0.57
(95% CI – 0.92, – 0.22) (101).
Our results suggest significant effects of patient education for scores on functional disability. It is important to
keep in mind that this outcome refers to the functional
ability to perform certain tasks. Patient education interventions can enable patients to perform these tasks more
easily and with less pain through education and training.
Unfortunately, the effects are short lived. Therefore, strategies to preserve the effects over time need to be explored.
In evaluating clinical effects of patient education, it
must be taken into account that patient education was
provided in addition to standard medical care so the effects of patient education are always supplementary to the
benefits of standard medical care. Also, it needs to be taken
into account that in all these studies, patients were invited
to take part in an experimental procedure and randomly
allocated to intervention or control groups. This contrasts
with routine clinical practice in which patients may be
more likely to select themselves for education sessions.
As reported, the quality of studies was not very high.
Most studies (18 of 31) failed to score any points for the
way randomization and concealment of allocation were
reported. Therefore, the findings are subject to selection
bias. Sixteen of 31 studies did not score any points for
performance bias. Studies have shown that contamination
(provision of the intervention to the control group) and
cointervention (provision of unintended additional care to
either comparison group) can affect study results
(102,103). Although the quality scores reported in this
review reflect the quality of the study as it is reported in
the article and may not reflect the true quality of the
studies, these limitations have to be taken into account
when interpreting the findings of this review.
RA Patient Education: Review
Patient education has been advocated in arthritis for
information provision itself, and for its therapeutic potential (4). In practice, many patient education programs have
not been disease specific and there has been the assumption that all benefits would be generic. This analysis raises
doubts over the achievement of meaningful benefits in
patients with RA specifically, who are recruited via invitation to participate usually through a hospital outpatient
department. Future research should be disease specific
and should seek to identify which patient characteristics
are relevant to beneficial outcomes from educational intervention, and which components of patient education programs are effective (104). In this review, we performed
separate analyses for 3 types of interventions, with behavioral programs showing the best results compared with no
intervention. However, behavioral programs themselves
show great variation in content (e.g., physical exercise,
relaxation, pain coping, biofeedback), methods (e.g., group
versus individual programs or brochures, homework assignments, contracting), and organization (professional or
lay leaders, numbers and lengths of sessions, etc.). Further
investigation to assess what components are most effective
is warranted. A review of educational benefits in other
specific forms of arthritis, particularly OA, would be
worthwhile as well.
In this review, we assessed the effects of patient education on core outcomes as defined by the OMERACT group
for clinical trials of medical therapies. It should be considered whether these outcomes are appropriate for patient education interventions and other health care interventions, such as occupational or physical therapy. Other
measures that might be more appropriate include fatigue
and social participation in life situations as defined in the
new international classification of functioning, functional
disability and health of the WHO (105). Many patient
education programs are aimed at teaching patients how to
cope with stress and pain or how to manage consequences
of their disease in daily life. Measuring change in social
participation, e.g., fulfillment of social or work roles, is
often omitted from education studies. Trials of education
should include as outcome measures the WHO-ILAR core
set as defined by the OMERACT group (12), together with
measures of psychological status, such as the Hospital
Anxiety and Depression Scale, AIMS2 affect subscale, or
Center for Epidemiologic Studies Depression Scale, and
measures of social participation.
ACKNOWLEDGMENTS
The authors would like to thank the Cochrane Musculoskeletal Group editorial team and the Dutch Cochrane
Centre for their support in the preparation of this systematic review.
1057
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
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