Running head: SYNTHESIS SUMMATIVE 1

Synthesis Paper Summative

Deanne Buchholtz
University of South Florida














SYNTHESIS SUMMATIVE 2

Abstract
Numerous venous thromboembolism cases occur in the hospital setting each year. Nearly
15% of high-risk patients, defined as individuals with a risk of mortality either greater than 5%
or twice the risk of the population (Boyd & Jackson, 2005), that are not receiving prophylactic
measures are diagnosed with deep vein thrombosis (DVT). This has been shown to greatly
increase the risk for life-threatening VE and pulmonary embolism. Is the use of Sequential
Compression Devices (SCD) an effective form of DVT prevention in all types of patients? In
what instances are SCDs deemed less effective, in favor of other prevention measures? This
paper will evaluate the efficacy of the use of SCDs for the prevention of DVT development in
hospitalized, immobile patients. Information was synthesized from a combination of randomized
controlled trials and supplemented with systematic reviews. The search engines utilized were
Google Scholar, the US National Library of Medicine, The American Heart Association, and
Science Direct. Key words used for the search include interdisciplinary care of an acute
ischemic stroke patient, prevention of DVT, reducing risk of death in immobile post-surgical
patients, CLOTS trial, and portable calf compression. The first study reveals a risk
reduction of DVT in post-surgical patients that used intermittent pneumatic compression (IPC).
The second study shows correlations among various comorbidities with in-hospital deaths from
VTE, DVT, and PE. Results show that treating these conditions may reduce mortality rates.
Results of the third study show the use of the Venowave portable calf compression devices was
correlated with a decreased risk of DVT. Upon evaluation of these studies, we conclude the use
of SCDs presents an effective method for DVT prophylaxis for post-surgical and medical
patients.
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Synthesis Paper Summative
According to an expert panel study done by The Centers for Disease Control and
Prevention, up to 900,000 new cases and 300,000 deaths occur each year in the US and may be
attributed to pulmonary embolism secondary to deep vein thrombosis (DVT) and venous
thromboembolism (VTE) (Grant, Boyle, & Atrash, 2011). The specific causes of DVT and VTE
can be either hereditary or hospital-acquired. The fact that thrombosis risk factors are identified
in nearly 80% of hospitalized, immobile patients, however, presents a serious issue for health
care providers, because numerous prophylactic and treatment measures exist to tackle this
overwhelmingly common problem. In a statement made by the American Heart Association and
American Stroke Association, ischemic stroke represents 87% of all strokes (Summers et al,
2009). What prevention measures are best when caring for these at-risk patients? What should be
done to reduce these risks? This paper aims to synthesize information regarding one particular
DVT/VTE prevention measure: the use of Sequential Compression Devices (SCD) in both
surgical and medical patients. In doing so, we may evaluate the efficacy of SCD use in the
hospital setting. Our PICOT question asks, In moderate to high-risk patients, is the use of
SCDs, compared with the neglecting of SCDs in favor of another prevention measure, an
effective form of DVT prophylaxis in hospitalized, immobile patients?. Let us examine certain
recent studies that were performed in efforts to answer this question.
Literature Search
The search engines used to gather information regarding this topic include Google
Scholar, the US National Library of Medicine, The American Heart Association and American
Stroke Association, and Science Direct. Various phrases and key words were utilized to narrow
SYNTHESIS SUMMATIVE 4
the search to pertinent articles and studies. These include interdisciplinary care of an acute
ischemic stroke patient, prevention of DVT, reducing risk of death in immobile post-surgical
patients, CLOTS trial, prevention of hospital-acquired venous thromboembolism, and
portable calf compression.
Literature Review
The first study reviewed was a randomized controlled trial performed in the UK, whose
results were reported earlier this year, called The Effectiveness of Intermittent Pneumatic
Compression (IPC) In Reduction of Risk of Deep Vein Thrombosis in Patients Who Have Had a
Stroke, also referred to as the CLOTS 3 trial (Stevens & Woller, 2013). The purpose of the trial
was to evaluate the use of IPC (another name for SCD) in immobile, post-stroke patients and
provide evidence that these devices truly reduce the risk for DVT in a hospital setting. The trial
took place from December 8, 2008 to September 6, 2012, and documented nearly 3,000
randomly enrolled patients across 94 centers. On days 0 to 3 of admission, the enrollees were
allocated to receive either IPC or no IPC. After 7 to 10 days, an ultrasound test was performed on
each patient, and all individuals were followed up with after 6 months to determine DVT/VTE
presence and post-stroke survival. The primary outcome, where DVT was noted in the
ultrasound test, occurred in 122 (8.5%) out of the 1438 total patients given IPC treatment. Within
the group not allocated IPC, 174 (12.1%) of these patients did show signs of DVT development.
The absolute reduction in risk was 3.6%, with a 95% confidence interval. Deaths within the trial
period occurred in 11% of patients with IPC and in 13% of patients without IPC, who passed
within 30 days of treatment (p= 0.057) (Stevens & Woller, 2013). Strengths of this trial include
its great number of participants over four years and its evaluation of various facets of health
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related to the immobile patient such as falls and skin breakdown. One weakness that may be
noted is the manufacturers modification of the sleeves. This was done to increase comfort and
adherence in the 42% of patients in the remainder of the trial. Could this change skew results
when comparing pre- to post- modification adherence? Despite this discrepancy, CLOTS 3
provides solid evidence supporting the value of SCDs in immobile patients. Please refer to the
table for a summation of information.
The study Predictive Accuracy of 29-Comorbidity Index for In-Hospital Deaths in US
Adult Hospitalizations with a Diagnosis of Venous Thromboembolism (Tsai et al., 2013) provides
crucial information regarding the relationship between patients with DVT, VTE, and PE in
addition to other comorbidities with in-hospital death rates. The performers of the trial state that,
in patients at-risk for developing thromboses, complications such as congestive heart failure,
pulmonary disease, and fluid and electrolyte imbalance may be responsible for up to 180,000
deaths in the US each year. The trial assessed case-fatality and prevalence of comorbidities in a
sample of 153, 518 patients. They then used the comorbidity study to develop an interval model
called the AHRQ-29 comorbidity index to reveal predictors and statuses of in-hospital deaths.
The results showed 41, 944 in-hospital deaths among their sample of patients, with a 95%
confidence interval. Comorbidities were associated with 10 to 125% increased likelihood of in-
hospital death. C-statistical values ranged from 0.776 to 0.802, with 37.8% of patients with DVT
dying when at least five comorbidities were present (Tsai et al., 2013). Determining
comorbidities in individual patients will help characterize the complexity of each patients
burden and resistance to treatment, and will therefore aid healthcare staff in tailoring plans to suit
specific needs. The PICOT question relevant to this project asks In moderate to high-risk
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patients, is the use of SCDs, compared with the neglecting of SCDs in favor of another
prevention measure, an effective form of DVT prophylaxis in hospitalized, immobile patients?
Data from this study reveals the staggering figures of in-hospital deaths related to DVT
complications (combined with other comorbidities) and the crucial nature of determining tailored
prevention measures for these patients based on individual needs. It offers insight into the
various types of patients health care staff will treat, using the proposed clinical practice
guidelines to be discussed in a subsequent section. Its primary strength lies in its provision of
comprehensive data in the form of tables, graphs, statistics, and cross-references, as well as the
comorbidity index itself. The study does not present any drastic weakness other than the volume
of esoteric data that may prove difficult to interpret. See the table below for succinct information
on this trial.
A third trial offered further valuable data to round out our evaluation. The Randomized
Controlled Trial of a New Portable Calf Compression Device (Venowave) for Prevention of
Venous Thrombosis in High-Risk Neurosurgical Patients purported that patients undergoing
neurosurgical procedures are at an elevated risk for developing DVT and VTE (Sobiera-Teague,
et al., 2012). In 29-60% of cases, DVT occurred in patients not receiving some sort of
prophylaxis. Taking into account post-surgical patients risk for bleeding, another prevention
measure must be introduced beyond anticoagulant therapy. The study consisted of 150 patients
and tested the effectiveness of Venowave portable compression devices not only in DVT
prevention, but also in comfort and compliance compared to the more cumbersome in-hospital
SCDs and graduated compression stockings. Once allocated to the trial or control group, patients
and caregivers were informed of their status. The study group had the devices applied to both
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calves within 4 hours of having surgery or within 24 hours of admission for the non-surgical
patients. Their use was continued until a DVT developed, the patient refused to wear them, or the
study concluded and an exam was performed. Compliance and nurse assessment data was
recorded. A bilateral venogram was performed on days 9 through 11. Results showed that for the
Venowave group the rate of VTE was 4.0% compared to 18.7% in the control group, with a
relative risk of VTE with no device use at 0.21% (95% confidence interval and P= 0.008).
Proximal DVT results were 2.7% versus 8.0% for the control group (Sobiera-Teague et al., 2012)
. Strengths of this study include the well-balanced demographics and valid results based upon
statistical analysis. The only weaknesses appear to be the relatively small sample size and the
fact that the study was performed in a single facility. Despite these points, this study proves
beneficial in further solidifying the belief that compression devices decrease a patients risk for
DVT development.
These studies indeed proffer conclusive evidence toward the benefits of DVT prophylaxis
in immobilized patients, and consistent SCD use as a primary component of that treatment. The
synthesis of this data and propulsion into the project-planning phase, however, requires
supplemental support in the form of documented national guidelines in favor SCD use. One such
guideline, the Guide to the Care of the Hospitalized Patient with Ischemic Stroke, delineates six
categories, Counseling, Diagnosis, Evaluation, Management, Prevention, and Treatment, related
to the care of post-stroke status patients (American Association of Neuroscience Nurses, 2008).
Within the discussion on stroke management and prevention, the guide concludes that there is no
significant difference between the use of low molecular weight heparin and SCDs as viable
treatments. In patients where anticoagulant therapy is contraindicated, however, prophylactic
SYNTHESIS SUMMATIVE 8
prevention should include the use of bilateral-sequential compression devices (American
Association of Neuroscience Nurses, 2008). This national guideline clearly names SCD use as a
beneficial option for lowering an immobilized patients risk of DVT.
Three of the U.S.s leading health agencies (The Department of Health and Human
Services, Centers for Disease Control and Prevention, and The American Heart Association)
have named the risk for DVT a high client safety indicator. Knowing this, the efficacy of SCDs
as a viable DVT prophylaxis measure for various types of patients must be evaluated.
Specifically the question at-hand is: In moderate to high-risk patients, is the use of SCDs,
compared with the neglecting of SCDs in favor of some other prevention measure, an effective
form of DVT prophylaxis in hospitalized, immobile patients? After perusing the data presented
in these three mentioned trials, as well as other information gleaned from articles and systematic
reviews, there is enough available evidence to state that SCD use does lower the risk for
thromboses. The first study discussed earlier, the CLOTS 3 Trial, which took place across four
years and documented nearly 3,000 patients in 94 health centers, noted significant figures. Out of
1438 total patients allotted the compression devices, only 8.5% were diagnosed with DVT, as
opposed to the 12.1% of the control group not allocated IPC that were diagnosed with DVT. The
best evidence to note is the absolute reduction on risk of 3.6% (Stevens & Woller, 2013). This
therapy was not used in conjunction with any other. Consider the possibilities for DVT
prevention when other treatments are utilized as well. The Venowave trial is similar to CLOTS 3
in that it also studied the relationship between portable compression device use and lower rates
of DVT in users. The results of this study revealed that, among 150 total participants, only 2.7%
of Venowave users, versus 8.0% of non-users, showed signs and symptoms of DVT development
SYNTHESIS SUMMATIVE 9
(Sobiera-Teague et al., 2012). Comparing these two trials, one must note the first trials greater
scope, both in time spent and participants included. However, the findings of Venowave
shouldnt be diminished; both trials propose significant evidence toward the efficacy of SCD use.
Although the AHRQ-29 Comorbidity Index study (Tsai et al., 2013) does not specifically
evaluate SCD use among randomized patients, its results hone in on the relationship between in-
hospital death rates and rates of those patients suffering from various comorbidities and DVT.
Results of 153, 518 patients assessed over one year showed up to a 125% increased likelihood of
death when DVT and additional health issues were present. 37.8% of patients with DVT died
(Tsai et al., 2013). The nugget of wisdom to be gleaned from this study is the imperative nature
of tailored DVT prophylaxis for at-risk patients. The goal of this PICOT proposal has been to
determine if SCD use will lower rates of DVT, and thus reduce risk of stroke death in immobile
patients; its focus and goals were spearheaded by this study.
Currently, the primary gap in knowledge and practice is the lack of criteria to determine
for whom these devices are most beneficial, even though evidence supports their general efficacy
as a positive treatment option. The call to action is two-fold, then: firstly, using the acquired data,
further plans should be enacted to devise a comprehensive criteria assessment for St. Josephs
Hospital. Secondly, if compression devices are deemed the most appropriate form of
prophylaxis, then SCDs should be utilized in those patients while hospitalized, and perhaps made
available in portable form for the patients at discharge. Future practice must be centered around
providing not only prime care to patients, but also around tailored interventions to suit individual
needs. These specific actions will certainly guide healthcare staff toward best practices and
optimal patient care.
SYNTHESIS SUMMATIVE 10
References

American Association of Neuroscience Nurses (2008). Guide to the care of the hospitalized
patient with ischemic stroke. American Association of Neuroscience Nurses, 2(38).
Retrieved from:
http://www.guideline.gov/content.aspx?id=13575&search=scd+and+dvt+prophylaxis

Boyd, O. & Jackson, N. (2005). How is risk defined in high-risk surgical patient management?.
Critical Care, 9(390-396). doi: 10.1186/cc3057.

Grant, A., Boyle, C., & Atrash, H. (2011). Prevention of hospital-acquired venous
thromboembolism (ha-vte) expert panel meeting. The Centers of Disease Control and
Prevention. Retrieved from: cdc.gov/ncbddd/dvt/documents/12_232434-A_sayers-HA-
VTE_Workshop_Report_508.pdf

Sobiera-Teague, M., Hirsh, J., Yip, G., Gastaldo, F., Stokes, T., Sloane, D., Eikelboom, J.W.
(2012). Randomized controlled trial of a new portable calf compression device
(venowave) for prevention of venous thrombosis in high-risk neurosurgical patients.
Journal of Thrombosis and Haemostasis, 10(229-235). doi: 10.1111/j.1538-
7836.2011.04598.x.

SYNTHESIS SUMMATIVE 11
Stevens, S. M. & Woller, S. C. (2013). Effectiveness of intermittent pneumatic compression in
reduction of risk of deep vein thrombosis in patients who have had a stroke (CLOTS 3):
A multicentre randomised controlled trial. The Lancet, 382(9891), 516-524. doi:
http://www.sciencedirect.com/science/article/pii/S01406736136105086

Summers, D., Leonard, A., Wentworth, D., Saver, J., Simpson, J., Spiker, J.,Mitchell, P.
(2009). Comprehensive overview of nursing and interdisciplinary care of the acute
ischemic stroke patient: A scientific statement from the American heart association. AHA
Journal, 40(2911-2944). doi:10.1161/STROKEAHA.109.192362.

Tsai, A., Abe, K., Boulet, S., Beckman, M., Hooper, W., Grant, A. (2013). Predictive accuracy
of 29-comorbidity index for in-hospital deaths in us adult hospitalizations with a
diagnosis of venous thromboembolism. PLoS ONE, 8(7): e70061.
doi:10.1371/journal.pone.0070061.





SYNTHESIS SUMMATIVE 12
Table 1
Literature Review

Reference Aims
Design/Measures
Sample Outcome/Stat
Sobiera-Teague, To test the
M., et al (2012). hypothesis
Randomized con- that Venowave
trolled trial of a compression
new portable calf devices prov-
compression dev- ide a viable
ice (venowave) option for
for prevention of DVT prevent-
venous thrombo- ion as well as
sis in high-risk improve comp-
neurosurgical rates.
patients. Journal
of Thrombosis
and Haemostasi,
10(229-235). doi:
10.1111/j.1538-
7836.2011.04598.x

Stevens, S.M., & Evaluate use of
Woller, S.C. (2013). IPC in immo-
Effectiveness of int- bile stroke
ermittent pneumatic patients and
compression in provide evi-
reduction of deep dense that
vein thrombosis in these devices
patients who have reduce risk
hada stroke (clots 3): for DVT
a multicentre rand-
omised trial.The
Lancet, 382
(9891), 516-524. doi:
S01406736136105086





RCT


Measures:
-Rates of DVT after
use
vs. non-use
-Compliance among
users









RCT


Measures:
-Rates of
DVT after use
vs, non-use












150 patients admitted -Rate of
DVT/VTE
for either cranial or was 4.0% for the
spinal neurosurgery trial group,
compared
or intracranial hemorr- to 18.7% in
control
hage at Hamilton Gen- group.
eral Hospital
-Relative risk for
DVT/VTE w/o
device at 0.21%,
95% CI, P= 0.008

-Proximal DVT
results were 2.7%
vs. 8.0% for
control



3,000 randomly -8.5% out of 1438
enrolled patients patients given IPC
across 94 centers developed DVT.
in the UK 12% of control
group developed
DVT.

-Absolute risk was
3.6%, with 95%
CI

-Death occurred in
11% with IPC, 13%
w/o IPC, p= 0.057


Tsai, A., et al To assess case-fatality
(2013). Predict- and prevalence
Ive accuracy of of comorbidities
29-comorbidity in patients who
index for in- have DVT/VTE
hospital deaths
in us adult
hospitalizations
with a diagnosis
of venous
thromboembolism.
PLoS ONE, 8(7);
E70061.doi: 10.
1371/journal.
Pone.0070061.
RCT

Measures:
-Death rate in
patients with or
w/o DVT/VTE

-Number of
comorbidities
in relation to
increased risk

153, 518 randomly -Results show 41,944
selected patients in-hospital deaths
across many health related to multiple
care facilties comorbidities among
sample. 95% CI

-Comorbidities
associated with 10-
125% increased
likelihood of in-
hospital death.

-C-stat values ranged
from 0.776-0.802
with 37.8% patients
with DVT dying
when 5+ comorbid-
ities present