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Do Surgical Care Bundles Reduce
Do Surgical Care Bundles Reduce
Background. Care bundles are a strategy that can be used to reduce the risk of surgical site infection
(SSI), but individual studies of care bundles report conflicting outcomes. This study assesses the
effectiveness of care bundles to reduce SSI among patients undergoing colorectal surgery.
Methods. We performed a systematic review and meta-analysis of randomized controlled trials, quasi-
experimental studies, and cohort studies of care bundles to reduce SSI. The search strategy included
database and clinical trials register searches from 2012 until June 2014, searching reference lists of
retrieved studies and contacting study authors to obtain missing data. The Downs and Black checklist
was used to assess the quality of all studies. Raw data were used to calculate pooled relative risk (RR)
estimates using Cochrane Review Manager. The I2 statistic and funnel plots were performed to identify
publication bias. Sensitivity analysis was carried out to examine the influence of individual data sets on
pooled RRs.
Results. Sixteen studies were included in the analysis, with 13 providing sufficient data for a meta-
analysis. Most study bundles included core interventions such as antibiotic administration, appropriate
hair removal, glycemic control, and normothermia. The SSI rate in the bundle group was 7.0% (328/
4,649) compared with 15.1% (585/3,866) in a standard care group. The pooled effect of 13 studies
with a total sample of 8,515 patients shows that surgical care bundles have a clinically important
impact on reducing the risk of SSI compared to standard care with a CI of 0.55 (0.39–0.77; P = .0005).
Conclusion. The systematic review and meta-analysis documents that use of an evidence-based, surgical
care bundle in patients undergoing colorectal surgery significantly reduced the risk of SSI. (Surgery
2015;158:66-77.)
From the School of Health Sciences,a University of Nottingham, Nottingham; Faculty of Health and Life
Sciences,b De Montfort University, Leicester; Institute of Skin Integrity and Infection Prevention,c University of
Huddersfield, Huddersfield; Richard Wells Research Centre,d University of West London, London, UK; and
Department of Surgery,e Medical College of Wisconsin, Milwaukee, WI
SURGICAL SITE INFECTIONS (SSIs) are associated with operative procedures are performed in the United
increased morbidity, increased duration of hospi- States to treat colon-related diseases; as a surgical
talization, re-admission, and excess utilization of specialty, colorectal surgery has one of the highest
health care resources. Each year >600,000 rates of SSI. This rate as measured by several inde-
pendent investigators is highly variable, ranging
Accepted for publication March 3, 2015.
from 15 to 30%.1-4 A recent collaborative study
Reprint requests: Judith Tanner, PhD, School of Health Sci-
by the Joint Commission Center for Transforming
ences, University of Nottingham, A Floor, Queen’s Medical Healthcare and the American College of Surgeons
Centre, Nottingham NG7 2HA, UK. E-mail: judith.tanner@ (ACS) found a baseline rate of 15.8% among 7 US
nottingham.ac.uk. institutions participating in a multidisciplinary
0039-6060/$ - see front matter effort to reduce the risk of infections after colo-
Ó 2015 Elsevier Inc. All rights reserved. rectal surgery.5 The financial cost of treating SSIs
http://dx.doi.org/10.1016/j.surg.2015.03.009 can be substantial. The Joint Commission/ACS
66 SURGERY
Surgery Tanner et al 67
Volume 158, Number 1
collaborative study estimated that the use of cohort studies are more likely to be subject to
evidence-based practices can prevent >30,000 in- selection bias where not all patients receive the
fections, with an estimated collective saving of intervention.15 We decided to extend the inclusion
$834 million.5 After discharge, patients who criterion beyond randomized trials, because care
develop an SSI often experience an impairment bundles comprise existing best practice interven-
of both physical and mental well-being.6 This pro- tions such as appropriate antibiotic management
cess is exacerbated in patients undergoing colo- and implementing a non-intervention group may
rectal resection of cancer, further impacting their be unethical. The inclusion of cohort studies also
health-related quality of life. added to the breadth of clinical data.
Numerous clinical interventions with varying The IHI defines care bundles as $3 evidence-
levels of supporting evidence have been imple- based interventions with the potential to prevent
mented to reduce SSIs among colorectal patients. SSI that are implemented in a consistent manner
A recent approach to improving patient outcomes for all patients. Importance is placed on the
is the use of care bundles. Care bundles were first consistent and systematic application of all ele-
introduced by the Institute for Healthcare ments within a bundle rather than on individual
Improvement (IHI) in 2001 to improve clinical selective elements. For this reason, all bundles
outcomes in the critical care population.7 The designed to reduce SSI were included in this
concept of a care bundle was developed from evi- review, despite variations among individual inter-
dence documenting that a structured approach ventions. Only patients undergoing colorectal
to performing 3–5 evidence-based collective inter- surgery were included. No constraints were placed
ventions could lead to an improved patient on language of the publication.
outcome. While specific interventions may vary be- Outcomes of interest. SSI among patients hav-
tween bundles, it is the bundle approach that en- ing colorectal surgery was the primary outcome.
sures consistent implementation of all measures Search strategy. A member of the research team
that is claimed to be successful. Surgical care bun- (W.P.) performed a comprehensive literature
dles have been developed to reduce SSI after the search using terms identified and agreed by the
success of care bundles in reducing catheter- authors. PubMed, Embase, CINAHL, Scopus, the
related bacteremia and ventilator-associated Cochrane Database of Systematic Reviews, the
pneumonia.8,9 Central Register of Controlled Trials, Academic
To date, there has been no systematic review of Search Premier, and clinicaltrials.gov were
the effect of care bundles to reduce SSIs, and searched from 2002 to June 2014 using the key-
individual studies report conflicting findings of words: ‘‘surgical site infection,’’ ‘‘compliance’’ or
successes and failures.10-13 Our analysis represents ‘‘adherence,’’ ‘‘care bundle,’’ ‘‘care package,’’
the first systematic review of the effectiveness of ‘‘care checklist,’’ ‘‘care pathway,’’ ‘‘care interven-
surgical care bundles to reduce SSIs among pa- tion,’’ ‘‘prevention bundle,’’ ‘‘surgical care
tients undergoing colorectal surgery. improvement,’’ ‘‘5 million lives,’’ ‘‘SCIP,’’ ‘‘100000
lives,’’ and ‘‘colorectal.’’ We also reviewed the refer-
METHODS ence lists of retrieved studies to identify studies
This systematic review was conducted and is that had not been identified by the search strategy.
reported in accordance with the PRISMA If studies were identified as potentially able to
statement.14 answer the study question but contained missing
Research question. The aim of this study was to data, authors were contacted in an attempt to fill
determine if implementation of an SSI care in the missing variables.
bundle reduced the rate of SSIs among patients Data extraction and risk of bias assessment. Two
having colorectal surgery. review authors independently assessed the titles
Inclusion and exclusion criteria. We included all and abstracts of 518 potentially relevant studies. If
studies that compared a care bundle designed to it was unclear from the title or abstract whether a
reduce SSI against a control group, baseline study met the criteria or there was a disagreement
group, or early implementation group, and re- over eligibility, the study was retrieved in full and
ported SSIs among colorectal patients as an assessed further by all 6 review authors indepen-
outcome for both groups. While randomized trials dently. Two review authors independently ex-
are usually the focus of a meta-analysis, meta- tracted details from eligible studies onto data
analysis can also be applied to cohort studies. extraction forms which were cross-checked and
This is a common practice, although the Cochrane used to create Tables I and II. The Downs and
Collaboration cautions that meta-analyses of Black quality checklist was used to assess all
Table I. Study description
68 Tanner et al
First author Data collection Compliance with SSI data and
and year Study design period Sample group Sample size (patients) interventions surveillance SSI outcome
Anthony 2011 RCT 2 y, 8 months Colorectal Baseline 97 Compliance data CDC definition. Control 24.7%
Single center Cohort 100 for composite Surveillance at Intervention 45%
bundle in both 30 days.
groups
Berenguer 2010 Cohort (before Baseline 1 y Colorectal Baseline 113 Compliance data Superficial SSIs Superficial SSI data
and after Cohort 1 y Single center Cohort 84 for composite only. NSQIP only
implementation) bundle in definition, Baseline 13.3%
baseline and collected by Cohort 8.3%
cohort dedicated nurse
Bull 2011* Cohort (before Baseline 1 y Colorectal Baseline 180 Compliance data Australian NHSN Baseline 15%
and after Cohort 1 y Single center Cohort 275 for composite definition. No Cohort 7%
implementation) bundle and additional
quarterly for information.
individual
interventions for
cohort
Cima 2013 Cohort (before Baseline 1 y Colorectal Baseline 531 Compliance data NSQIP defined Baseline 9.8%
and after Cohort 2 y Single center Cohort 198 for individual outcomes Cohort 4.0%
implementation) interventions for
baseline and
cohort
Crolla 2012y Cohort (before Baseline 1.5 y Colorectal Baseline 394 Compliance data CDC definition. Baseline 21.5%
and after Cohort 2.5 y Single center Cohort 377 for composite Surveillance by Cohort 16.1%
implementation) bundle and dedicated
individual infection control
interventions for staff until 30 days
baseline and
cohort
Hawn 2011z,x Cohort Baseline 1 y Colorectal, CABG, Baseline not known Compliance data CDC definition. No baseline data
Cohort 3 y cardiac, Cohort 15,444 for composite Surveillance at Cohort 14.2%
orthopedic. bundle and 30 days.
Multicenter individual
interventions for
cohort only
(continued)
July 2015
Surgery
Table I. (continued)
Tanner et al 69
early and late
(continued)
Table I. (continued)
70 Tanner et al
First author Data collection Compliance with SSI data and
and year Study design period Sample group Sample size (patients) interventions surveillance SSI outcome
Tillman 2013z Cohort (before Baseline 1 y Cardiac, colorectal, Baseline 79 Compliance data SSI definition Baseline 24.0%
and after Cohort 1 y general, Cohort 104 for individual unclear but Cohort 11.5%
implementation) gynecologic, interventions for presumably
orthopedic, baseline and based on NSQIP.
thoracic, vascular cohort
Single center
Waits 2014 Cohort Cohort 3 y Colorectal 1 intervention, 99; Compliance data International 1 17.1%
(comparison of Multicenter 2 interventions, for individual Classification of 2 14.1%
increasing 552; interventions Diseases. 3 8.3%
number of 3 interventions, and composite Surveillance at 4 6.1%
interventions 1,179; bundle 30 days 5 2.6%
within bundle) 4 interventions, 6 2.1%
1,438;
5 interventions,
730; 6
interventions, 87
Wick 2008x Cohort Cohort Colorectal Cohort 298 Compliance data CDC definition. No baseline data
11 months Single center for individual Surveillance at Cohort 20%
interventions for 30 days by
baseline and attending
cohort surgeon
Wick 2012 Cohort (before Baseline 1 y Colorectal Baseline 278 Compliance data NSQIP defined Baseline 27.3%
and after Cohort 1 y Single center Cohort 324 for individual outcomes Cohort 18.2%
implementation) interventions for Surveillance
baseline and unknown
cohort
*Study authors provided additional information.
yData from 2009 and 2010 was excluded as bundle implementation was incomplete during this time.
zColorectal data extracted.
xInsufficient data to be included in the meta-analysis.
CABG, Coronary artery bypass grafting; CDC, Centers for Disease Control and Prevention; NHSN, National Healthcare Safety Network; NSQIP, National Surgical Quality Improvement Program; RCT, randomized,
controlled trial; SSI, surgical site infection.
July 2015
Surgery
Table II. Bundle interventions
Tanner et al 71
plus oral antibiotics
Oral antibiotics given with U
mechanical bowel prep if used
(continued)
72 Tanner et al Surgery
July 2015
U
U
numeric score out of 30 points based on 5 themed
sections. The 5 sections comprise study quality
(overall quality), external validity (ability to gener-
2013
strong.17
Statistical analysis. Raw data only were used to
calculate pooled relative risk (RR) estimates from
random effects models using Cochrane Review
Manager version 5.2.
2011
*Omission of mechanical bowel preparation was revised during study to mechanical bowel preparation plus oral antibiotics.
BMI, Body mass index; CHG, chlorhexidine gluconate; SSI, surgical site infection.
RESULTS
2010
with CHG
meta-analysis.20,24 One author was unable to pro- baseline with a CI of 0.55 (0.39 to 0.77; P = .0005);
vide the requested data, and attempts to contact the I2 test for homogeneity was 84%.
the remaining 2 study authors were unsuccess- The 3 studies that did not provide sufficient data
ful.12,23,29 Thirteen studies provided sufficient raw to be included in the meta-analysis had varying
data to be grouped together in a meta-analysis (Fig findings.12,23,29 One study, which focused on
2).1,10,11,19-22,24,28-30 Baseline data were taken from improving compliance, reported a sample size that
the control groups, pre-implementation groups, was too small to draw any definite conclusions.29
early implementation groups, and single interven- The second study found no increase in compliance
tion only groups.1,10,11,19-22,24,28-30 Intervention with any bundle interventions and found no change
data were taken from the care bundle intervention in SSI rates.23 The third study found that, although
groups, post-implementation groups, late imple- reported adherence to core interventions
mentation groups, and complete bundle implemen- increased, SSI rates remained unchanged.12
tation groups.1,10,11,19-22,24,28,30 The meta-analysis
included 8,515 patients and found an SSI rate in DISCUSSION
the surgical care bundle group of 7.0% (328/ To date, no systematic review has been published
4,649) compared with 15.1% (585/3,866) in the in the peer literature examining the effect of care
74 Tanner et al Surgery
July 2015
Fig 2. Forest plot. Surgical care bundles to reduce the risk of surgical site infections.
bundles on SSI rates among any surgical patient care bundle; these interventions included the elim-
groups. Our study represents the first systematic ination of mechanical bowel preparation, removal
review of selective surgical care bundles used to of oral antibiotic preparation, restriction of intrao-
reduce SSIs in patients undergoing colorectal perative fluid administration, and use of wound
surgery. The current collective meta-analysis com- protectors, which have limited, or conflicting, sup-
prises >8,500 patients, documenting that use of a portive documentation.31,32
surgical care bundle, comprising selective evidence- The majority of the reviewed studies included a
based interventions, results in a significant reduc- group of ‘‘core,’’ evidence-based interventions,
tion in the rate of SSI in the colorectal patient comprising appropriate antibiotic management,
population. One randomized, highly ranked, well- appropriate hair removal, maintenance of normo-
designed study evaluating the use of surgical care thermia, and glycemic control. The justification
bundles found that selected care bundle elements for inclusion of these 4 core measures, especially in
were not effective in decreasing the risk of SSI.19 A US-based publications, is associated with the Cen-
possible reason for the contrary results of this ran- ters for Medicare and Medicaid Services
domized trial may have been associated with the mandating the use of these 4 measures for all
specific interventions chosen for this particular patients undergoing colorectal surgery.33 These 4
Surgery Tanner et al 75
Volume 158, Number 1
interventions were also a core requirement for the $13,253. Variable direct costs were defined as the
statewide, surgical care bundle implemented by costs incurred during hospitalization, including
the Michigan Surgical Quality Collaborative.34 operating room time, equipment, drugs, and
The evidence to support these selective interven- nursing and laboratory services, but excluding phy-
tions is relatively strong, based on randomized tri- sician’s time. Keenen et al1 suggest that the in-
als and systematic reviews; however, level 1 crease in variable direct costs may have been
evidence is lacking for several of the ‘‘non-core’’ in- influenced by inflationary health care costs or
terventions included in many of the care bundles charges associated directly with post-operative
analyzed in this review. care management unrelated to the care bundle
Assessing the reported compliance rate associ- process. Berenguer et al10 calculated the average,
ated within each bundle intervention was problem- in-patient cost of a superficial SSI at $8,900 and
atic throughout this review. Compliance was assumed that the implementation of the bundle
particularly important as many bundle interven- would result in a cost savings. Liau et al24 estimated
tions were implemented already before the intro- that the average cost of treating each SSI in
duction of the full surgical care bundle. It was Thailand was $1,532 and reported an overall saving
necessary, therefore, to know baseline and post- of $147,967 during the 2-year study. Alfonso et al35
implementation compliance rates to determine suggested that the average cost of an SSI, including
whether uptake of the selective bundle elements direct, indirect, and societal costs, has been under-
had increased. Although almost all of the studies estimated grossly and more accurately approaches
reported compliance data, 4 studies did not provide $100,000, of which the health care cost is approxi-
a compliance rate for both baseline and cohort mately 10%. In the effort to calculate the cost of an
groups.1,12,24,25 Seven studies did report the per- SSI, few authors factor into the equation the socie-
centage of patients who received the entire surgical tal cost or the economic impact that an SSI may
care bundle10,12,19,20,22,26,28; compliance with the have on quality of life or economic productivity af-
complete bundle was variable with reported rates ter infection. While it is difficult to arrive at a
ranging from 2.1 to 92%.10,28 This observation sug- consensus of the economic benefit of embracing
gests that, while there is recognition of the benefit a strategy of surgical care bundles, enhanced
of a surgical care bundle as an effective strategy to compliance, especially of the core processes, will
improving patient outcomes, full implementation likely be cost effective for the majority of patients
is limited. Furthermore, in the case of the study by undergoing colorectal surgery.
Waits et al,28 there was a direct correlation between The present study has 2 limitations. The first is a
implementation (full versus partial) of a surgical failure of some of the studies to report a bundle
care bundle and colorectal SSI rate. compliance rate, and the second, a failure in the
Implementing an effective SSI surgical care consistency of SSI data collection, with studies
bundle requires a fiscal and logistical commitment reporting a range of methods used within active
on the part of the health care institution to cover and passive programs of surveillance. These 2
staff time, effort, and consumables. At present, limitations could have led to an underestimation
there are insufficient data to conduct economic of the overall clinical benefit of embracing a
modelling to determine the cost-effectiveness of a strategy of surgical care bundles. That said, a
surgical care bundle for reducing the risk of SSI thoughtful and thorough review of the current
among colorectal patients. Four of the studies peer literature suggests that implementation of an
included in this review do, however, discuss the approach using surgical care bundles has a signif-
probable cost benefits or expenses associated with icant impact on reducing the risk of SSI in elective
executing a surgical care bundle.1,10,22,24 One colorectal surgery.
Dutch study identified an annual implementation A final comment worthy of consideration is:
cost of approximately $50,000, although these what comprised the optimal surgical care bundle
funds were used for dedicated staff members who for decreasing the risk of colorectal SSIs? Selective
were involved in the project.22 This bundle was core elements such as normothermia, glycemic
deemed by the authors to be cost effective because control, timely and appropriate antimicrobial pro-
there was an estimated annual savings of $234,261 phylaxis, and appropriate hair removal should be
through a reduction in duration of hospitalization. viewed as representing baseline consideration.
In another study, Keenan et al1 found that the These selective elements by themselves, however,
reduction in superficial SSIs as a result of bundle are not sufficient to provide the comprehensive
implementation was associated with a 36% in- risk reduction benefit required to reduce the
crease in variable direct costs, from $9,779 to overall risk of infection.12,26,36 Additional
76 Tanner et al Surgery
July 2015
26. Pastor C, Artinyan A, Varma MG, et al. An increase in 31. Guenaga KF, Matos D, Wille-Jorgensen P. Mechanical bowel
compliance with the surgical care improvement project preparation for elective colorectal surgery. Cochrane Data-
measures does not prevent surgical site infection in colo- base Syst Rev 2011;9:CD001544.
rectal surgery. Dis Colon Rectum 2010;53:24-30. 32. Morris MS, Graham LA, Chu DI, et al. Oral antibiotic bowel
27. Tillman M, Wehbe-Janek H, Hodges B, et al. Surgical care preparation significantly reduces surgical site infection
improvement project and surgical site infections: can rates and readmission rates in elective colorectal surgery.
integration in the surgical safety checklist improve quality Ann Surg 2015 Jan 20 [Epub ahead of print].
performance and clinical outcomes? J Surg Res 2013;184: 33. Fry DE. Surgical site infections and the surgical care
150-6. improvement project (SCIP): evolution of national quality
28. Waits SA, Fritze D, Banerjee M, et al. Developing and measures. Surg Infect (Larchmt) 2008;9:579-84.
argument for bundled interventions to reduce surgical 34. Henke PK, Kubus J, Englesbe MJ, et al. A statewide con-
site infections in colorectal surgery. Surgery 2014;155: sortium of surgical care: a longitudinal investigation of
602-6. vascular operative procedures at 16 hospitals. Surgery
29. Wick EC, Gibbs L, Indorf LA, et al. Implementation of qual- 2010;148:883-9.
ity measures to reduce surgical site infection in colorectal 35. Alfonso JL, Pereperez SB, Canoves JM, et al. Are we really
patients. Dis Colon Rectum 2008;51:1004-9. seeing the total costs of surgical site infections? Wound
30. Wick EC, Hobson DB, Bennett JL, et al. Implementation of Repair Regen 2007;15:474-81.
a surgical comprehensive unit-based safety program to 36. Edmiston CE, Spencer M, Lewis BD, et al. Reducing the risk
reduce surgical site infections. J Am Coll Surg 2012;215: of surgical site infections: did we really think that SCIP would
193-200. lead us to the promise land? Surg Infect 2011;12:169-77.