Effect of psycho-educational interventions on quality of life in patients with implantable cardioverter defibrillators: a meta-analysis of randomized controlled trials
Kao et al. Health and Quality of Life Outcomes
Effect of psycho-educational interventions on quality of life in patients with implantable cardioverter defibrillators: a meta-analysis of randomized controlled trials
Chi-Wen Kao 0 1
Ting-Yu Chen 0
Pai-Hui Lin 1
0 National Defense Medical Center, School of Nursing , No.161, Minchuan E. RD., Sec. 6, Taipei 114 , Taiwan
1 Department of Nursing, Tri-Service General Hospital , No.325, Sec.2, Chenggong Rd., Taipei 114 , Taiwan
Background: Implantable cardioverter defibrillators (ICD) were developed for primary and secondary prevention of sudden cardiac death. However, ICD recipients' mortality is significantly predicted by their quality of life (QOL). The aim of this meta-analysis was to evaluate the effects of psycho-educational interventions on QOL in patients with ICDs. Methods: We systematically searched PubMed, Medline, Cochrane Library, and CINAHL through April 2015 and references of relevant articles. Studies were reviewed if they met following criteria: (1) randomized controlled trial, (2) participants were adults with an ICD, and (3) data were sufficient to evaluate the effect of psychological or educational interventions on QOL measured by the SF-36 or SF-12. Studies were independently selected and their data were extracted by two reviewers. Study quality was evaluated using a modified Jadad scale. The meta-analysis was conducted using the Cochrane Collaboration's Review Manager Software Package (RevMan 5). Study heterogeneity was assessed by Q statistics and I2 statistic. Depending on heterogeneity, data were pooled across trials using fixed-effect or random-effect modeling. Results: Seven randomized controlled trials fulfilled the inclusion and exclusion criteria, and included 1017 participants. The psycho-educational interventions improved physical component summary (PCS) scores in the intervention groups more than in control groups (mean difference 2.08, 95 % CI 0.86 to 3.29, p < 0.001), but did not significantly affect mental component summary (MCS) scores (mean difference 0.84, 95 % CI -1.68 to 3.35, p = 0.52). Conclusion: Our meta-analysis demonstrates that psycho-educational interventions improved the physical component, but not the mental component of QOL in patients with ICDs.
Implantable cardioverter defibrillator (ICD) has been
established as an efficient treatment for primary and
secondary prevention of sudden cardiac death [1–4]. Thus,
the number of ICD implantations worldwide is growing
exponentially every year. In the United States, the ICD
implantation rate increased from 6.1 % in 1993 to 46.2 %
in 2006, with the average rate significantly increasing
17.9 % per year (95 % confidence interval [CI]:
17.618.3 %, p < 0.001) . In Australia, the number of ICD
implantations nationwide increased from 708 in 2000 to
3198 in 2009, with the implantation rate significantly
increasing 19.2 % per year (p < 0.001) .
Once the device is implanted, patients face various
ICD-related changes that affect their quality of life
(QOL). For example, patients with ICDs in a systematic
review of qualitative studies were found to experience
changes that were both physical (e.g., discomfort, sleep
disturbance, fatigue) and psychological (e.g., fear of
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shocks from the ICD, uncertainty about the future,
worry about ICD function), which negatively affected
their daily activities and QOL . Several other factors
related to worse QOL have been identified in patients
with ICDs, such as worry about the duration and number
of shocks [7–11], uncertainty in daily life , anxiety [9,
13, 14], feeling loss of control in life [7, 9], ICD-related
concerns , lower level of device-related acceptance
, depression [14, 15], high comorbidity burden ,
Type D personality , and negative attitudes toward
technology dependency . A significant proportion of
ICD recipients experience psychological distress. Indeed,
11–28 % of ICD patients were diagnosed as depressed
[19–21], and furthermore a systematic review of 45
studies indicated that 5–41 % of ICD patients had elevated
depressive symptoms when assessed by self-report
instruments . In the same systematic review with more
than 5000 ICD recipients, 11–26 % of patients were
diagnosed with anxiety disorders . Thus, healthcare
providers should be concerned not only with how long
patients live (their quantity of life) with an ICD, but also
Drawing overall conclusions about the effect of an ICD
on QOL is difficult because of inconsistent results
reported . For example, ICD recipients in a systematic
review of studies from 1994 to 2006 had better QOL than
patients treated with antiarrhythmic medication, but
worse than that of the general public or patients with
pacemakers . On the other hand, a more recent study
found varying results in 80 ICD recipients: 44.7, 20.7, and
34.2 % had no change in QOL, worse QOL, and better
QOL, respectively, after implantation . Furthermore, a
study conducted in Hong Kong showed that the 85 ICD
recipients in this study had a lower level of QOL
compared with the general population . In contrast, QOL
(SF-36 scores) of 300 patients with ICDs was improved in
all domains during the 1-year follow-up, except for the
emotional role functioning domain .
Quality of life is an important outcome for patients with
ICDs since it predicts survival in the first year after
implantation . Moreover, the psychological aspects of
QOL were cited by the American Heart Association as
desirable outcomes of psychological and educational
interventions for ICD patients . The return to normal QOL
in ICD patients has been shown to be facilitated by
structured follow-up and the development of
psychoeducational intervention programs [7, 10, 27–29].
During the past decade, various psychological and
educational interventions have been designed and
provided to ICD patients. Moreover, the effectiveness of
these interventions in improving ICD patients’ QOL has
been examined in several randomized controlled trials.
However, the current evidence for the effectiveness of
these trials has not been comprehensively reviewed.
Therefore, the aim of this systematic review and
metaanalysis was to evaluate the overall effectiveness of
psycho-educational interventions on QOL in patients
This systematic review and meta-analysis was guided by
the Preferred Reporting Items for Systematic Reviews
and Meta-Analysis (PRISMA) guideline .
We systematically searched the literature in following
databases: Medline, PubMed, Cochrane Library, and
CINAHL. The databases were searched from inception
to April 2015. Search key words used were “implantable
cardioverter defibrillator,” “psychosocial intervention,”
“psychological intervention,” “psycho-education
intervention,” and “quality of life.” We also used Medical
Subject Headings (MeSH) to identify the terminology of
key words. To find additional studies and data, we hand
searched the references of relevant publications and
contacted the authors.
Study selection criteria
Studies were eligible for review if they met following
criteria: (1) a randomized controlled trial, (2) subjects were
adult patients with ICDs, (3) a psycho-educational
intervention was administered, (4) QOL was measured using
the SF-36 or SF-12, and (5) written in English or
We selected SF-36 or SF-12 scores as the outcome
indicator for QOL to preserve sufficient homogeneity for
meta-analysis because these instruments have good
properties and are the most widely used to measure
QOL in studies on the ICD population internationally
. SF-36 or SF-12 scores are calculated and aggregated
into two summary scores, a mental component summary
score (MCS), and a physical component summary score
(PCS) [31, 32].
The methodological quality of each trial was
independently evaluated by two reviewers (CWK and TYC) using
a quality-assessment scale. . This Jadad scale
includes 11 items: (1) Was the study designed as
randomized? (2) Was the study designed as double blind? (3)
Was there a description of withdrawals and drop outs?
(4) Were the objects of the study defined? (5) Were the
outcome measures defined clearly? (6) Was there a clear
description of the inclusion and exclusion criteria? (7)
Was the sample size justified? (8) Was there a clear
description of the interventions? (9) Was there at least one
control group? (10) Was the method used to assess
adverse effects described? (11) Were the methods of
statistical analysis described? The maximum possible
score was 13, and more than nine points was identified
as good. Any disagreements in the quality evaluation
between two reviewers were resolved by discussion.
Each selected article was examined to abstract the
following data: title of study, authors, publication year,
sample size (number of participants in the
experimental and control groups), participants’ age and sex,
intervention details (type, course, duration, and
follow-up), type of control, and the SF-36 or SF-12
score at less than 6 months post-intervention. To
assure the accuracy of data extraction, two reviewers
abstracted data independently, and discussed any
inconsistencies to reach consensus.
Data analysis and synthesis
The meta-analysis was conducted using RevMan 5.3
(Cochrane Collaboration) software. SF-36 or SF-12
scores are continuous data, which were analyzed as
mean differences and 95 % CIs. The statistical
heterogeneity among trials was measured by Q statistics and
I2. Higher values of I2 indicate greater heterogeneity,
with I2 values of 25, 50, and 75 % signifying mild,
moderate, and high heterogeneity, respectively [34, 35].
Depending on the heterogeneity findings, data were pooled
to estimate the overall effect of all interventions by
random-effect or fixed-effect modeling. Publication bias
was assessed using the funnel plot method, whose
asymmetrical shape shows bias .
Characteristics of trials
The flow diagram for the study selection process is
presented in Fig. 1. Of the 151 articles retrieved from our
initial search, we reviewed abstracts and removed 35
duplicate articles and 88 articles that were inconsistent
with the aim of the meta-analysis. Among the remaining
28 full-length articles, we excluded 17 studies that did
not meet the inclusion criteria. Among the remaining 11
studies, four were not included. One study did not
provide the mean and standard deviation of SF-36 scores
even after we contacted the authors , one study had
high dropout rates in each group , and two studies
[39, 40] analyzed the long-term follow-up outcome of
one randomized controlled trial, but we already included
the post-intervention outcomes of this trial in our
analysis. Therefore, the final data analysis included seven
studies [41–47] (Table 1).
These seven studies included 1017 ICD recipients as
participants, with 516 randomly assigned to the
experimental group, and 501 to the control group. The
majority of participants were male (80.4 %, n = 818), with
mean age across the studies ranging from 55.9 to
64.4 years, and mean ejection fraction lower than 35 %
in five studies [41–43, 45, 47] and not reported in two
studies [44, 46]. QOL outcomes were measured in four
studies with the SF-12 [42, 45–47], and in three studies
using the SF-36 [41, 43, 44].
Table 2 presents the quality assessment of the
reviewed studies according to the 11-item Jadad Scale.
Five studies had Jadad scores ≥ 9 points, indicating good
quality . Two studies had Jadad scores of eight
points because they did not meet four of the 11 criteria:
double blind, description of dropouts, sample size
justified, and report of adverse effects.
Effect of psycho-educational intervention on QOL
The effect of psycho-educational interventions on QOL
was examined by separately considering the effects on
PCS and MCS, respectively. For the intervention effect
on PCS, we used fixed-effect modeling since no
heterogeneity was detected among trials (χ2 = 2.51, p = 0.87; I2
= 0 %). The mean difference in PCS scores between
experimental and control groups in all seven studies was
estimated as 2.08 (95 % CI 0.86 to 3.29, p < 0.001). This
result indicates that the psycho-educational
interventions significantly improved the physical component of
QOL in patients with ICDs (Fig. 2).
Search terms in Medline, Cochrane Library, CINAHL, and
PubMed: “implantable cardioverter defibrillators,” “psychosocial
intervention,” “psychological intervention,” “psycho-education
intervention,” and “quality of life”
Abstracts reviewed for inclusion and
exclusion criteria (N=151)
RCTs meeting inclusion and
exclusion criteria (n=11)
Fig. 1 Flow diagram for study selection process
Exercise training; twice a week
Psycho-education; once/month for 6 months, and every
2 months for the next 6 months
Online problem-solving course based on CBT principles
CBT in eight telephone sessions, psycho-educational
book, CD with meditation exercises, muscle relaxation
Psychological treatment by phone call
PACER-CD-ROM-based on psycho-educational CBT
Relaxation/stress management training
Group discussion and social support
Nursing telephone support
ICD recovery management
Reduce emotional distress
Structure information provided
Table 1 Characteristics of included RCTs
Comprehensive cardiac rehabilitation
I intervention, C control, EF ejection fraction, QoL quality of life, w weeks, m months, CBT cognitive-behavioral therapy
Table 2 Quality assessment of the included RCTs
size of the
Fig. 2 Forest plot of mean differences in physical component summary scores (PCS)
For the intervention effect on MCS, we used
randomeffect modeling since heterogeneity was identified
among trials (χ 2 = 21.33, p = 0.002; I2 = 72 %). The mean
difference in MCS scores between the experimental and
control groups was estimated as 0.84 (95 % CI -1.68 to
3.35, p = 0.52), indicating that the psycho-educational
interventions were not effective in improving the mental
component of QOL in patients with ICDs (Fig. 3). Since
ICD patients’ anxiety and depressive symptoms have
been suggested to respond to cognitive behavioral
therapy (CBT), we conducted a subgroup analysis of three
randomized control trials that used CBT approaches in
their interventions [43, 45, 46] to determine if these
interventions were effective for the mental component of
QOL. The effectiveness of these studies in improving
MCS was assessed using random-effect modeling since
heterogeneity was identified among trials (χ2 = 10.64,
p = 0.005; I2 = 81 %). The mean difference in MCS scores
between the experimental and control groups was 3.29
(95 % CI -3.16 to 9.73, p = 0.32). The result revealed that
using the CBT approach in the psycho-educational
interventions for ICD patients was still not significantly
effective in improving their mental component of QOL.
As two studies had Jadad scores of 8 points, we
eliminated these two studies and conducted a meta-analysis
of five randomized controlled trials [41–44, 47]. The
psycho-educational interventions still significantly
improved the physical component of QOL (95 % CI 0.65 to
3.19, p = 0.003), but not the mental component of QOL
(95 % CI -3.46 to 1.47, p = 0.43) in patients with ICDs.
Our funnel plot assessment of PCS and MCS showed no
evidence of asymmetry, indicating the absence of
Our systematic review and meta-analysis of seven
randomized controlled trials on 1017 ICD patients provides
evidence that psycho-educational interventions effectively
improve the physical component but not the mental
component of patients’ QOL. Although the majority of
recipients regard the ICD as a life-saving medical device that
offers them a new chance in life [24, 48], they are affected
physically and emotionally by adjustments to the ICD .
The psycho-education interventions in the seven reviewed
studies were designed to improve recipients’ physical
capacity, self-management of ICD-specific care, and
selfperceived health [41–47]. The psycho-education
interventions included exercise training, psycho-education,
problem-solving, ICD-specific education and recovery
management, as well as relaxation training. ICD recipients
Fig. 3 Forest plot of mean differences in mental component summary scores (MCS)
in the experimental groups received more information
and strategies to deal with life changes related to ICD
implantation, which may have improved their perceived
health. Finally, the findings of this meta-analysis indicate
that the psycho-educational interventions effectively and
significantly improved the physical component of ICD
recipients’ QOL (PCS).
Most of the psycho-educational interventions in the
seven randomized controlled trials we analyzed aimed
to deal with ICD patients’ documented psychological
distress and improve their QOL [41–47]. However,
our meta-analysis did not detect any effectiveness of
these psycho-educational interventions in improving
the mental component of QOL. This lack of effect
may have been due to the psycho-educational
interventions not adequately addressing psychological
distress. We also conducted the subgroup analysis of
three randomized control trials which used CBT in
their interventions [43, 45, 46] to determine whether
CBT was effective for the mental component of QOL
since ICD patients’ anxiety and depressive symptoms
have been suggested to respond to CBT [44, 49]. One
study provided CBT in eight telephone consultations
with supporting literature , another study
provided CBT with a patient-assisted computerized
intervention program , and the third study provided
CBT in the context of a 6-week or 1-day ICD
shockand-stress management program . However, the
finding cannot support a statistically significant
This lack of effect may have been due to low
statistical power of the studies. Among these three studies,
two had relatively small samples, with only 15
participants in each group [45, 46]. Another contributing
factor may have been limitations of the SF-36, which
is a generic measurement to assess health status and
QOL. Even though the SF-36 is commonly used in
ICD population studies, it may not detect
ICDspecific QOL outcomes, especially mental health
wellbeing . Indeed, the mental health subscale of the
SF-36 was reported to be less sensitive to changes in
mental health than the WHO-Five Well-Being Scale
. In addition, MCS scoring assigns positive
weights to four domains (vitality, social functioning,
role-emotional, and emotional well-being) and
negative weights to four other domains (physical
functioning, role-physical, bodily pain, and general health).
. The ICD patients recruited in these seven
studies had poor health due to their heart condition.
Most of them had a heart failure history in NYHA
class III or IV, and left ventricular ejection fraction <
35 % [41–47]. Therefore, their responses to questions
on the negatively weighted last four domains may
have driven down their MCS scores.
Among participants in these seven studies, those in
five studies experienced ICD shocks [41, 43, 44, 46, 47],
those in one study were reported not to experience any
ICD shock during the study , and the ICD shock
experiences of those in another study were not reported
. Most people living with an ICD have to cope with
stressful or even traumatic events, including having ICD
shocks . ICD shocks can be appropriate or
inappropriate (not related to therapeutic outcomes), and all ICD
shocks adversely affect patients’ mental health . In
one qualitative study, ICD patients described their
reactions to receiving a shock as losing consciousness,
feeling anxious, fearing death and pain, despairing, and
worrying about the device not working effectively .
Even worse, patients’ psychological distress was greater
due to fear of shocks than to actual shocks . In our
meta-analysis, we did not detect any effectiveness of
psycho-educational interventions on improving the
mental component of ICD patients’ QOL (MCS).
The strengths of our study are that it is, to the best of
our knowledge, the first meta-analysis of randomized
control trials on the effects of psycho-educational
interventions on QOL in ICD recipients, the meta-analysis
followed the PRISMA guidelines, and we avoided
publication bias by hand searching retrieved articles for other
studies and tried to contact researchers to ask for
However, this meta-analysis had some limitations. The
studies included in the meta-analysis were diverse, with
different psycho-educational interventions. To address
this issue, we analyzed studies for heterogeneity and,
based on these findings, used fixed- or random-effect
modeling to pool the data to determine an overall
intervention effect. We only included studies published in
English or Chinese, which may have introduced
publication bias. Finally, only seven studies qualified for
inclusion in our meta-analysis, six of which had relatively
small samples (<100 participants). Therefore, even
though psycho-educational interventions in the original
studies [41, 43, 45–47] reported improvements in
psychological distress, e.g., depression and anxiety, we did
not find that the pooled data from the
psychoeducational interventions improved the mental
component of QOL (MCS) in ICD recipients.
The findings of this meta-analysis provide evidence that
psycho-educational interventions improved the physical
component of QOL (PCS), but not the mental component
of QOL (MCS) in patients with ICDs. Nonetheless, we
recommend that healthcare providers should still consider
the psycho-social adaptation issues of ICD recipients.
Identifying effective psycho-educational interventions for
improving QOL in ICD recipients will require conducting
large-scale randomized clinical trials. Further long-term
evaluation follow-up may be needed to examine the
durable effectiveness of psycho-educational interventions in
patients with ICDs.
CBT: Cognitive behavioral therapy; CI: Confidence interval; ICD: Implantable
cardioverter defibrillator; MCS: Mental component summary score;
MeSH: Medical Subject Heading; NYHA: New York heart association;
PCS: Physical component summary score; PRISMA: Preferred Reporting Items
for Systematic Reviews and Meta-Analysis; QOL: Quality of life; SF-36: 36-Item
Short Form Health Survey; WHO: World Health Organization
We are grateful to the authors who responded to our emails and provided
additional information about their studies.
Availability of data and material
The data will not be shared because we do not have the raw data. This
manuscript reported results of a meta-analysis, which we extracted the data
for meta-analysis from published papers.
CWK, MYC, and PHL conducted the systematical search, and data extraction.
CWK, MYC, and TYC analyzed the data. CWK and TYC evaluated the quality
of each study. CWK wrote the manuscript. All authors read and approved the
The authors declare that they have no competing interests.
Consent for publication
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