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Original Article
Case management does not decrease mortality ofpatients with myocardial infarction or unstableangina: Evidence from a systematic review
Li-Juan Yi a,1, Xu Tian a,1, Ting Shuai a,1, Zi Zeng a, Li Ma a, Yan Wang b,Guo-Min Song c,*
a Graduate College, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, Chinab School of Nursing, Tianjin University traditional Chinese Medicine, Tianjin 300193, Chinac Nursing Department of Tianjin Hospital, Tianjin 400020, China
a r t i c l e i n f o
Article history:
Received 24 July 2015
Accepted 29 April 2016
Available online 29 June 2016
Keywords:
Case management
Meta-analysis
Myocardial infarction
Systematic review
Unstable angina
* Corresponding author.E-mail address: [email protected]
Peer review under responsibility of Chine1 These authors have contributed equally
http://dx.doi.org/10.1016/j.ijnss.2016.04.0112352-0132/Copyright © 2016, Chinese Nursinthe CC BY-NC-ND license (http://creativecom
a b s t r a c t
Objective: To objectively assess the impact of case management on patients with myocar-
dial infarction or unstable angina.
Methods: PubMed, EMBASE, Web of Science, Cochrane Library, China National Knowledge
Infrastructure (CNKI), and Chinese Biomedical Literature Database were searched for
relevant randomized controlled trials (RCTs) published through February 2015. The quality
of eligible studies was independently assessed by two investigators. The primary outcome
assessed from included studies was all-cause mortality, with total cholesterol, systolic and
diastolic blood pressures, smoking cessation rates and cost-effectiveness as secondary
outcomes. The pooled effect sizes were expressed as relative risk, odds risk, and standard
mean difference with 95% confidence intervals. Heterogeneity among studies was assessed
using Cochrane Q and determined with an I2 statistic.
Results: After the initial search, a total of four studies divided into six RCTs that included
1293 participants met the inclusion criteria and were analyzed. The results of meta- and
descriptive analyses failed to identify any significant differences in all-cause mortality
during the follow-up period of up to 36 months. Furthermore, a definitive conclusion for
remaining indicators could not be drawn due to limited evidence.
Conclusion: Case management is not beneficial to all-cause mortality after myocardial
infarction or unstable angina compared to routine care. Additional, prospective RCTs of
high quality and large scale are warranted to verify these results.
Copyright © 2016, Chinese Nursing Association. Production and hosting by Elsevier B.V.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.
org/licenses/by-nc-nd/4.0/).
(G.-M. Song).
se Nursing Association.to this article.
g Association. Productionmons.org/licenses/by-nc
and hosting by Elsevier B.V. This is an open access article under-nd/4.0/).
i n t e r n a t i o n a l j o u r n a l o f nu r s i n g s c i e n c e s 3 ( 2 0 1 6 ) 1 9 0e1 9 7 191
1. Introduction
Myocardial infarction (MI) is one of the leading contributors to
cardiovascular-related deaths worldwide. An estimated
36,6698 new MI cases are diagnosed annually in America,
which are responsible for 5,5005 deaths [1]. MI is often pre-
ceded by unstable angina (UA), which may be an indicator of
severe coronary artery disease [2]. With the modification of
major risk factors and advancement in treatments, mortality
from acute MI and UA has declined in recent years [3,4].
Nevertheless, survivors remain at risk for fatal or nonfatal
heart events [5]. Moreover, MI and UA patients frequently
have multiple pre-existing comorbidities such as diabetes
mellitus, hypertension and hyperlipidemia [8e10] that also
affect the quality of life and prognosis.
Case management (CM) is a collaborative and a multidis-
ciplinary practice designed to promote quality of care and
meet the health needs of the individual and their family, while
ultimately achieving cost-effectiveness of medical nursing.
CM comprises three basic elements, namely systematic
monitoring of patients, support for continuation of treatment,
and interventional measures in cases of low compliance or
with no obvious improvement [11]. Different from disease
management, CM not only focus on the disease entity, but
also pay attention to disease-related risk factors (abnormal
level of blood pressure and blood glucose) and patient-related
factors (deficiency of knowledge about cardiovascular dis-
eases) that prevent the rehabilitation processes [12e15].
Hence, it may be a better choice for patients with multiple
comorbidities.
Several studies have investigated the effects of CM on pa-
tients with acute cardiovascular diseases, such as MI and UA,
but have not provided conclusive results. To address this, a
systematic review and meta-analysis of all available, relevant
randomized controlled trials (RCTs) was performed to objec-
tively assess the impact of CM on these conditions.
2. Methods
The Preferred Reporting Items for Systematic Reviews and
Meta-analysis (PRISMA) Statement [16] and Cochrane Hand-
book for Systematic Reviews of Interventions [17] were
adopted to guide this systematic review and meta-analysis.
All pooled analyses were based on previously published
studies, and thus no ethical approval or patient informed
consent was required.
2.1. Search strategies
PubMed, EMBASE, Web of Science, Cochrane Library, China
National Knowledge Infrastructure and Chinese Biomedical
Literature Database were searched to identify potentially
relevant RCTs published through February 2015. The search
strategies utilized are shown in Appendix A. The reference
lists of included articles were also manually searched to
identify any additional eligible studies.
2.2. Study selection
RCTs that involved patients diagnosed with MI or UA were
selected for analysis. Inclusion criteria were studies where CM
alone or combination with other forms of treatment was used
in the study group and routine or other viable interventions
were used for the control group. The primary outcome from
included studies was all-cause mortality, with total choles-
terol, systolic and diastolic blood pressures, smoking cessa-
tion rates and cost-effectiveness as secondary outcomes. Only
studies published in English or Chinesewere included. Studies
that specifically assessed the comprehensive effect of CM plus
other interventions were excluded. Studies with data that was
incomplete or not reported in sufficient detail were excluded
from analyses.
2.3. Data abstraction
Two investigators (L.-J. Yi and T. Shuai) independently
extracted the following basic information and continuous and
binary data from each included study: first author and publi-
cation year, country of origin, target diseases, sample size,
randomization method, age of participants, interventions,
reported outcome of interest and intervention time. Corre-
sponding authors of the studies would be contacted to acquire
the complete data if necessary. Any discrepancies between
investigators concerning the eligibility of a study were
resolved by consensus or consulting a third investigator (X.
Tian).
2.4. Quality appraisal
The quality of articles included in the study was assessed
independently by two investigators (Z. Zeng and L. Ma) using
the Cochrane Risk of Bias tool [17]. This tool addresses six
specific domains: sequence generation, allocation conceal-
ment, blinding, incomplete outcome data, selective outcome
reporting, and other issues. The bias risk of each incorporated
study was rated as “high”, “unclear” or “low” according to the
adequacy level of information extracted. Any discrepancies
between investigators concerning the quality of the studies
was resolved by consulting a third investigator (G.-M. Song).
2.5. Statistical analyses
Primary and secondary outcomes from all included studies
were calculated. Heterogeneitywas evaluated using the c2 test
with corresponding p value, and the level of heterogeneitywas
quantified using the I2 statistic. An I2 � 50% indicated het-
erogeneity, in which case a random-effects model was used,
otherwise a fixed-effects model was used. The pooled effect
size was expressed as relative risk (RR), odds ratio or standard
mean difference (SMD) with 95% confidence intervals (CI). A
two-sided p < 0.05 indicated statistical significance. A
descriptive analysis was utilized to objectively present the
results from eligible studies in terms of outcomes of interest
that were not suitable for quantitative analysis. All pooled
analyses were performed using Review Manager v5.3.0
(Cochrane Collaboration, Copenhagen, Denmark). A sensi-
tivity analysis was conducted to determine the possible
i n t e r n a t i o n a l j o u rn a l o f n u r s i n g s c i e n c e s 3 ( 2 0 1 6 ) 1 9 0e1 9 7192
causes of heterogeneity and further identify their influence on
the overall risk estimate. Furthermore, the influence of a
single trial on overall heterogeneity was assessed using leave-
one-out cross-validation to test the robustness of the primary
outcomes [18].
3. Results
3.1. Selection of included trials
The initial search yielded 612 records, of which only four tri-
als, which were divided into six RCTs [19e24] met the criteria
for inclusion after screening the title, abstract and full-text
(Fig. 1). Three of these studies [22e24] were from the same
medical centre. Complete data was available from all included
articles, which were published in English and involved a total
of 1253 participants. The characteristics of the six publications
are shown in Table 1.
3.2. Assessment of risk of bias
Assessment of study quality revealed that all studies had low
risks of biases (Fig. 2). Specifically, all included studies pro-
vided sufficient information for random sequence generation
and adequately reported allocation concealment. Based on the
Fig. 1 e PRISMA flow diagram depicting the selection of include
controlled trial.
nature of the disease treatments, and the fact that partici-
pants were required to sign informed consent forms, blinding
of the participants and medical personnel was not possible.
However, the outcomes assessed were objective measures,
and thus not subject to operation bias; thus this domain was
regarded as “low risk” for all articles. All articles were at low
risk for attrition bias as they detailed dropout, withdrawal and
loss to follow-up. Although five studies [19,20,22e24] were
based on intention-to-treat analyses, missing outcome data
was balanced in numbers across intervention groups in the
remaining study [21]. Three studies [19e21] adequately re-
ported all outcomes of interest, and the remaining three ar-
ticles [22e24] share the same protocol that provided all related
information about endpoints. Finally, all studies were funded
by non-commercial organizations. There was insufficient
statistical power to appropriately assess publication bias, thus
a funnel plot was not constructed.
3.3. Intervention effects
3.3.1. All-cause mortalityFour articles [19e21,24] reported the all-cause mortality rate,
which was calculated from the follow-up data, and two arti-
cles [20,24] reported values at different time points. Subgroup
analyses for the different time points (9e12 mo, 18 mo, and 36
mo) were therefore conducted (Fig. 3). No heterogeneity was
d studies. CM, case management; RCT, randomized
Table 1 e Characteristics of six trials included in the study.
Study Country Targetdiseases
N (E/C) Randomization Age (yr) Interventions Outcomes Duration
E C
Debusk et al.
(1994) [16]
United States AMI 293/292 Computer program that achieved
a balanced allocation to the two
management conditions within
each hospital
E: 57 ± 8
C: 57 ± 8
Smoking Intervention;
Nutritional counseling;
Lipid-lowering drug therapy;
Instruct patient's self-reports;
Scheduled interactions
Smoking intervention;
Nutritional counseling;
Lipid-lowering drug therapy
I, II, III 1 yr or until
death
Nordmann et al.
(2001) [17]
Switzerland AMI and UA 99/102 Primary care physicians
were used as the unit of
randomization
E: 61 ± 10
C: 62 ± 9
Regular house staff;
Structured counseling program;
Information about cardiovascular
risk factors;
Interactions between the study
physician and patients as well
as with treating hospital-based
or primary care physicians
Regular house staff;
Treating physicians solely
provide information
concerning cardiovascular
risk factors
I, II, III, IV, V 18 mo
Lapointe et al.
(2006) [18]
Canada AMI 64/63 Informed consent form to be
signed would depend on the
group allocation
E: 57.8 ± 9.6
C: 56.9 ± 8.8
Systematic follow-up of patients;
Systematic lipid testing;
Supervision of primary care
physicians in their interventions;
Close re-evaluation of the patient
until treatment results in a lipid
profile consistent with
consensus targets
Follow-up of patients
by their regular physician
I 18 mo
Seidl et al.
(2014) [19]
Germany AMI 168/172 Randomization list E: 75.2 ± 6
C: 75.6 ± 6
Initial session before discharge:
provide information and
individual education;
Home visits and telephone calls
Routine care VI 1 yr or until
death
Hunger et al.
(2015) [20]
IV, V
Kirchberger et al.
(2015) [21]
I, IV, V
AMI: acute myocardial infarction; C: control group; E: experimental study group; MI: myocardial infarction; UA: unstable angina; I: all-cause mortality; II: total cholesterol; III: smoking cessation rates;
IV: systolic blood pressure; V: diastolic blood pressure; VI: cost-effectiveness.
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Fig. 2 e Risk of bias. All six studies demonstrated low risk
of bias in all categories.
i n t e r n a t i o n a l j o u rn a l o f n u r s i n g s c i e n c e s 3 ( 2 0 1 6 ) 1 9 0e1 9 7194
observed (I2 values < 50%), thus a fixed-effectmodel was used.
The results showed that there was no significance difference
between experimental and control groups in all-cause mor-
tality at any of the follow-up time points.
3.3.2. Total cholesterolTwo studies [19,20] reported total cholesterol as an outcome.
Due to the significant heterogeneity for these studies
(I2 ¼ 93.2% p < 0.01), a descriptive analysis was performed.
Fig. 3 e Meta-analysis fo
Debusk et al. [19] compared supplemental CM with routine
care alone in a study involving 585 participants, of which 487
were included in the final analysis, which showed a significant
effect (SMD ¼ �0.73, 95% CI: �0.91 to 0.54; p < 0.01). However,
Nordmann et al. [20] did not find a significant effect on total
cholesterol (SMD ¼ �0.08, 95% CI: �0.35 to 0.20, p ¼ 0.58).
However, the authors noted there analyzed sample (170/201
participants) was below the sample size of 186 determined
necessary to achieve sufficient power. (Note: For other studies
involved, we adopt the same minimum sample size to mea-
sure their power; the value is based on a clinically significant
difference in total cholesterol of 0.5 mmol/L between the two
groups with a power of 80% at a two-sided p value of 0.05).
3.3.3. Smoking cessation ratesTwo articles [19,20] reported the smoking cessation rates. Due
to significant heterogeneity between the studies (I2 ¼ 86.0%;
p < 0.01), a descriptive analysis was used. Debusk et al. [19]
found that CM increased the smoking cessation rates
(RR ¼ 1.32, 95% CI: 1.16e1.50; p < 0.01). However, a significant
effect was not observed in the study by Nordmann et al. [20]
(RR ¼ 0.99, 95% CI: 0.84e1.17; p ¼ 0.09). A possible contrib-
utor to the discrepancy between these studies is the age of the
participants, as the study by Nordmann et al. [20] included an
older patient population than in the report by Debusk et al.
[19]. It is possible that the older individuals had a longer his-
tory of smoking or a more severe nicotine dependence that
made it more difficult to quit [19,20,25].
3.3.4. Blood pressureThree studies [20,23,24] reported blood pressure values as an
outcome. Subgroup analyses were conducted for the different
follow-up periods (9e12 mo and 36 mo). No significant het-
erogeneity was found between the two studies reporting at a
9e12 mo follow-up [20,23], and thus the fixed-effect model
was used. CM did not improve systolic blood pressures,
although pooled results indicated a marginally better mean
systolic blood pressure at 9e12 mo (p ¼ 0.05) (Fig. 4A).
r all-cause mortality.
A
B
Fig. 4 e Meta-analysis for blood pressure. Subgroup analyses for systolic blood pressure (A) and diastolic blood pressure (B).
i n t e r n a t i o n a l j o u r n a l o f nu r s i n g s c i e n c e s 3 ( 2 0 1 6 ) 1 9 0e1 9 7 195
Similarly, no significant effect was observed between groups
with regard to diastolic blood pressure (Fig. 4B).
3.3.5. Cost-effectivenessOnly one included study conducted a within-trial cost-utility
ratio evaluation [22]. The cost-effectiveness analysis was
based on a multiple imputation approach. The mean quality-
adjusted life-year difference was �0.0163 (CI: �0.0681 to
0.0354), and the overall cost reductionwas estimated atV17.61
(CI: V�2601 to 2615). Among survivors, the EQ-5D-3L health
outcomemeasure showed substantial improvements within 6
Fig. 5 e Sensitivity analysis of all-cause mortality. Met
mo (þ0.0509) in the intervention group, but returned towards
baseline levels by month 12.
3.3.6. Sensitivity analysisThe study by Nordmann et al. [20] included patients with UA
in their analyses. Inconsistencies in the severity of illness can
lead to clinical heterogeneity and potentially affect pooled
results. To determine the effect on all-cause mortality, a
sensitivity analysis was performed after excluding the study
by Nordmann et al. [20]. The same overall result was observed,
with no significant effect of CM on all-cause mortality (Fig. 5).
a-analysis results after removal of a single study.
i n t e r n a t i o n a l j o u rn a l o f n u r s i n g s c i e n c e s 3 ( 2 0 1 6 ) 1 9 0e1 9 7196
4. Discussion
Cardiovascular conditions are prevalent, with population sur-
veillance surveys reporting that 4.0% of respondents have suf-
fered from MI [26], and an overall standardized UA incidence
rate of 77 per 100,000 persons [27]. Nevertheless, only six RCTs
have been published evaluating the effectiveness of the well-
known CM strategy in these patients. These studies were con-
ducted in different hospital settings (e.g. teaching or general
hospitals) and geographic locations (Europe and North Amer-
ica), and utilized varying interventionmodels. Ameta-analysis
of these studies failed to show substantial improvements in
mortality rate with CMafter patientswere discharged from the
hospital. Furthermore, the lack of statistical power demon-
strates that there is insufficient evidence to draw reliable con-
clusions ofwhether CMcan improve total cholesterol, smoking
cessation rates and bloodpressure levels. In addition, onehigh-
quality study failed to find significant cost-effectiveness with
CM. However, other well-conducted and controlled trials
describe benefits of CM in dementia, diabetes and other illness
[28,29], thus demonstrating CM as a desirable intervention that
should be more widely advocated.
4.1. Lack of survival benefit
There are several possible reasons that these trials did not
reveal a significant survival benefit even after a three-year
follow-up. First, the study population included older adults
with a variety of multiple chronic conditions [30], many of
which can exert a negative impact on mortality [31,32].
Indeed, the risk of mortality increases with patient age and
the number of comorbid chronic conditions [33,34]. Thus, a
longer follow-up period may be needed to observe a signifi-
cant effect of CM. Second, the primary post-discharge form of
interaction between patients and case managers in the
included studies was via telephone calls. Although this
Search Query Items found
#1 Search “Myocardial Infarction” [Mesh] 148,585
#2 Search (Cardiovascular Stroke*[Title/Abstract]) OR Myocardial Infarct*
[Title/Abstract]) OR “Myocardial Infarction” [Mesh]
204,023
#3 Search “Angina, Unstable” [Mesh] 10,019
#4 Search Unstable Angina*[Title/Abstract] OR Angina at Rest [Title/Abstract]
OR Myocardial Preinfarction Syndrome*[Title/Abstract] OR Preinfarction
Angina*[Title/Abstract] OR “Angina, Unstable” [Mesh]
16,606
#5 Search#2 OR#4 210,138
#6 Search “Case management” [Mesh] OR Case management*[Title/Abstract] 13,341
#7 Search#5 OR#6 80
#8 Search#5 OR#6 Filters: Chinese, English 72
method is very well accepted by patients, it lacks visual cues
and the ability for healthcare providers to closely supervise
their patients [35]. In addition, this method could introduce
sampling bias, as patients who were available at home (e.g.
not employed) may have been overrepresented. Third, due to
advancements in medical treatment, routine healthcare pro-
vides substantial positive effects on health outcomes, thus
minimizing the ability to detect small benefits that can be
gained from additional strategies. Further high-quality RCTs
with larger sample sizes and longer follow-upsmay be needed
to elucidate these effects.
4.2. Study limitations
Several limitations of the present study should be acknowl-
edged. First, although a computerized search of six databases
was performed, it is possible that a greater number of studies
could be identified in a wider search. Furthermore, the search
was restricted to studies published in English or Chinese, thus
limiting the pool of potential trials. Finally, all trials in this
review were conducted and published in developed countries
that applied various means of intervention. Indeed, the effect
of CM may be greater in developing countries with limited
access to advanced medical procedures and treatments.
5. Conclusion
The results of this systematic review and meta-analysis show
that there is no benefit of CM to patients with MI or UA in
terms of mortality rate or other secondary measures. How-
ever, additional large-scale and well-designed prospective
studies are warranted to verify this conclusion.
Conflicts of interest statement
The authors declare no conflicts of interest.
Appendix. Search strategy via PubMed.
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