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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: songguomin134@163.com

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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