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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_2721_Библиотеки_им_академика_М_И_Перельмана
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ing, diagnostics, and treatments to evaluate if a
patient will require in patient admission. In th e
absence of an available OU, emergency department (ED) patients who n eed this additional
time are typically managed in inpatient beds
even though most will not end up qualifying
for an inpati ent billing status; otherwise, providers in the ED would quickly lose the capacity
to care for new patients. However, when an OU
is available, it can serve as the setting of care for
these patients who would have otherwise been
sent to an inpatient bed. Observation services
are considered outpatient services, yet are recognized as distinct and separate from either the ED
visit or an inpatient admission – as recognized
by both Current Procedural Terminology (CPT)
and the Ce nters for Medicare and Medicaid Services (CMS).
The research confirming the value and success
of such OUs is extensive. Over the past several
decades, an increasingly robust evidence basis
demonstrating the advantages of delivering care
in an OU setting has developed across a wide
variety of specific conditions. This chapter, using
an evidence-based approach to the literature,
delineates the specific research dealing with
observation medicine in adults. The following
chapter addresses the same critical questions for
patients based on age, for example, the use of such
protocol-driven, dedicated units for children and
infants and the elderly.
Methodology
We created this summary of the currently available
peer-reviewed literature on observation care
after careful review and critical analysis of the
medical literature. Ad ditional studies were found
by searching th e reference lists of included
papers. All articles listed in this cha pter were
graded by two authors for quality and strength
of evidence. If th ere was a difference between
two authors, a third author provided a tiebreaking grade to settle on a final grade. We
classified the articles into three classes of evidence on the basis of the design of the study.
Design 1 represents the strongest evidence for
therapeutic, diagnostic, and prognostic studies,
respectively and Design 3 represents the weakest
evidence (Appendix A). Authors of this chapter
did not grade papers they authored themselves.
Articles were then graded on dimensions related
to the study’s m ethodological features: blinded
versus nonblinded outcome assessment, blinded
or randomized allocation, dir ect or indirect outcome measures (reliability and validity), biases
(e.g., selection, detecti on, transfer), external validity (e.g., generalizability), and sufficient sample
size. Articles received a final grade (Class I, II,
III) on the basis of a predetermined formula,
taking into accoun t the design and study quality;
articles irrelevant to the question or with a fatal
flaw were given an “X” and were not utiliz ed in
creating the final recommendation (Appendix
B). Finally, patient management recommendations were made according to the criteria in
Appendix C (Level A, B, o r C).
The literature reviewed included articles
worldwide and not just in the United States.
Therefore, the scope of application could be international, in addition to the myriad of articles
from the United States. The inclusion criteria
are adult patients presenting to the ED. We
excluded pediatric patients, who are addressed in
another chapter.
We adjusted reported cost data to 2013 U.S.
dollars usin g the medical portion of the Consumer Price Index and prevailing international
currency exchange rates as of February 2013.
Articles are organized by condition and
listed by level of evidence first and chronologically second; for papers published in the same
year, they are further liste d by strength of
evidence and then grouped by use of a
dedicated OU (Table 80.1) and use of OU
tools/methodology, such as protocol-driven
care (Table 80.2).
Results
Of the 102 articles reviewed, there were 83 articles
that dealt directly with adult patients managed in
an OU. The number of evidence-based articles
was greatest for cardiac diagnoses with 43 articles
(chest pain 29, congestive heart failure 7, atrial
fibrillation 6, deep vein thrombosis 1). The
remaining 40 articles included trauma 7 (general/abdominal trauma 4, head injury 3), asthma
6, ED efficiency 6, toxicology 3, pyelonephritis 3,
abdominal pain 3, transient ischemic attack 3,
syncope 2, and the following with 1 article each:
pneumonia, COPD exacerbation, cellulitis, and
decompression illness, plus 3 systematic reviews
(Table 80.1A).
Christopher W. Baugh, Sharon E. Mace, Margarita E. Pena, and J. Stephen Bohan
085
21:45:54
Table 80.1 Evidentiary Table for Critical Questions #1 and #2
Author/
Year
Design Outcomes Limitations/
Comments
Class
Length of Stay
(LOS)
Cost Patient Satisfaction Other Metrics
Chest pain
de Leon
et al.
2
1989
Prospective cohort
study of CP patients
placed in a CPOU
utilizing a cardiac
profile enzyme screen
(N=495) compared to a
historical inpatient
group
LOS 11.1h
CPOU, 3 days for
historical
inpatient group
Average cost for
discharged nonMI patients $589
CPOU vs. $3,103
historical inpatient
group 2013 USD
$1,635 CPOU vs.
$8,614 inpatient
Rate of discharge
from CPOU after
serial cardiac profile
enzyme screen and
non-diagnostic ECG
66%; rate of
hospitalization 48h
after discharge from
CPOU 0%; serial
cardiac profile
enzyme screen false
negative rate 0.6%
and false positive
rate 2%
Limited 48h f/u
on 31% of
patients
I
Gibler et al.
3
1992
Prospective
multicenter cohort
study utilizing a Heart
ER protocol in lowintermediate risk CP
patients (N=1010)
Discharge to home
rate 82.1%, AMA
2.8%, admission rate
15.1% with ACS
confirmed in 33.9%
of these; rate of AMI
patients with initial
nondiagnostic ECG
63.9%; sensitivity
79.7% and NPV
96.2% of serial CKMB in AMI patients
with nondiagnostic
ECG; sensitivity of
combined ECG and
serial CK-MB at 3h
88.4%
Patient
population not
consecutive;
possible false
positive results
of elevated
CK-MB due to
other
noncardiac
causes
I
085
21:45:54
Gaspoz
et al.
4
1994
Prospective study of
clinical outcomes and
cost of patients placed
in a CPOU (N=592) vs.
comparison group of
inpatients and
discharged ED patients
(N=924)
Mean, median
LOS 2.3 days,
1 day CPOU
vs. 6.3 days,
4 days inpatient
Median total cost/
patient index visit
$1,318 CPOU vs.
$3,589 inpatient
Median total cost
at 6-month f/u
$1,927 CPOU vs.
$4,712 inpatient
2013 USD Index
visit $3,941 CPOU
vs. $10,731
inpatient 6- month
f/u $5,762 CPOU vs.
$14,089 inpatient
72h post-CPOU
discharge AMI rate
0.8%; 6-month postCPOU discharge
AMI rate 1.7%,
mortality rate 2.2%,
cardiac mortality
rate 1.7%, and
overall survival rate
97.8%
Nonrandomized,
variation in unit
setting and
staffing
I
Gomez
et al.
5
1996
Prospective cohort of
100 low-risk CP
patients assigned to
rapid rule-out protocol
in CPOU compared to
low-risk CP historical
inpatient care control
group
LOS 12.1h ED
OU vs. 22.3h
inpatient
Index visit hospital
charges $893 ED
OU vs. $1,349
inpatient; hospital
charges through
30-day f/u $898 ED
OU vs. $1,522
inpatient 2013 USD
Index visit $1,623
ED OU vs. $2,452
inpatient; 30-day
f/u $1,632 ED OU
vs. $2,766 inpatient
No diff in ACS
between groups
during index visit;
no death or missed
ACS diagnosis after
discharge through
30-days f/u in either
group
Low rate of ACS
in either group;
charges vs. cost
data used;
possible bias
due to nonblinded study
I
Roberts
et al.
6
1997
Prospective,
randomized controlled
trial to compare ED CP
patients treated using
an accelerated
diagnosis protocol
(ADP) in an ED OU
(N=82) vs. inpatient
controls (N=83)
LOS 33.1h ADP
vs. 44.8h
inpatient; 15.7h
in ADP
subgroup sent
home
Mean total cost
per patient $1,528
ADP vs. $2,098
inpatient; $803 for
ADP subgroup
sent home
2013 USD $3,148
ADP vs. $4,322
inpatient; $1,654
for ADP subgroup
sent home
Discharge to home
rate 55% in ADP
group vs. 0% in
control group. No
diff in readmission
rates (6.1% vs. 4.8%)
Unable to
measure
differences in
mortality or
morbidity due
to small sample
size of patients
with poor
outcomes
I
433
085
21:45:54
Table 80.1 (cont.)
Author/
Year
Design Outcomes Limitations/
Comments
Class
Length of Stay
(LOS)
Cost Patient Satisfaction Other Metrics
Chest pain
Rydman
et al.
7
1997
Prospective study of
low-risk CP patients
randomized to a CPOU
(N=52) or an inpatient
unit (N=52)
Mean score for overall
satisfaction 3.57 CPOU vs. 3.06
inpatient on 4-point Likert
scale (1 is lowest, 4 is highest)
Mean scores for
quality of service
3.67 CPOU vs. 2.98
inpatient,
recommendation of
service 3.38 CPOU
vs. 3.08 inpatient,
effective handling
of problem 3.63
CPOU vs. 3.20
inpatient unit
Non-blinded
study
I
Zalenski
et al.
8
1997
Prospective, cohort of
low-risk CP patients
undergoing a 12-h rule
out AMI protocol and
immediate exercise
stress testing in a CPOU
(N=317)
CP diagnostic
protocol patients
with ACS 9.5% and
AMI 3%; protocol
sensitivity 90%,
specificity 50.5%,
PPV 16%, NPV 98%;
CK-MB, serial ECGs,
and stress testing
improved protocol
sensitivity and
accuracy
No standard
criteria for
diagnosis of ACS
I
Farkouh
et al.
9
1998
Prospective, controlled
trial of intermediaterisk CP patients with
unstable angina
randomized to either
CPOU or to inpatient
care (N=424)
LOS 9.2h in
CPOU group (no
data for
inpatient group)
Inpatient group
~61%; more costs
related to cardiac
care during index
visit and 6-month
follow-up period
No diff in MACE
(8.5% vs. 7.1%)
Majority of
patients white
(~95%) and
middle class
I
085
21:45:54
Goodacre
et al.
10
2004
Prospective
randomized controlled
trial comparing
protocol-directed CPU
care (N=479) vs. nonprotocol-directed
routine care (N=493)
Mean cost per
patient for CPrelated care over
6-month f/u £478
CPU vs. £556
routine care
2013 USD $1,050
CPU vs. $1,221
routine care
Discharge to home
rate 63% for CPU
care vs. 46% for
routine care 0.0137
QALYs gained for
CPU care group
compared to
routine care; no diff
in MACE (3.8%
vs. 3.4%)
Possible
selection bias
I
Goodacre
et al.
11
2004
Prospective
randomized controlled
trial comparing effect
of assessment with
protocol-directed CPU
care (N=479) vs. nonprotocol-directed
routine care (N=493)
upon psychological
symptoms and healthrelated quality of life
HADS depression
scores at 2 days and
1 month follow-up
4.3, 4.42 CPU care
vs. 5.23, 5.43 routine
care, CPU care was
associated with
significant
improvements
(p<0.05) in all
dimensions of health
related QOL
measures at 1 month
except the
emotional role
dimension,
incidence and
severity (visual
analog scale) of
subsequent chest
pain at 1 month 45%,
36.5mm CPU care
vs. 53.5%, 43mm
routine care; no diff
in time taken off
work at 1 month
15.6% CPU care
vs. 18.4% routine
care
Patients not
blinded to
intervention;
possible
selection bias
I
435
085
21:45:54
Table 80.1 (cont.)
Author/
Year
Design Outcomes Limitations/
Comments
Class
Length of Stay
(LOS)
Cost Patient Satisfaction Other Metrics
Chest pain
Miller et al.
12
2010
Prospective study of
intermediate- and
high-risk CP patients
randomized to OU/
stress cardiac MRI
(N=53) vs. inpatient
(N=57)
Median LOS
25.7h OU with
cardiac MRI
vs. 29.9h
inpatient
Median direct cost
$2,062 OU with
cardiac MRI vs.
$2,680 inpatient;
Median total
revenue $1,854
OU with cardiac
MRI vs. $897
inpatient
2013 USD $2,350
OU with cardiac
MRI vs. $3,055
inpatient; Median
total revenue
$2,113 OU with
cardiac MRI vs.
$1,022 inpatient
No diff in rate of
ACS after 30-day f/u
(0%)
Selection bias –
select times of
MRI availability;
limited external
validity – single
institution
I
Sayre et al.
14
1994
Retrospective cost
analysis of CP patients
evaluated in an ED OU
(N=751) vs. inpatient
(N=132)
Mean cost all
patients $1,299 ED
OU vs. $2,748
inpatient; mean
cost discharged
patients $995 ED
OU vs. $2,026
inpatient 2013 USD
All patients $2,554
ED OU vs. $5,402
inpatient;
discharged patients
$1,956 ED OU vs.
$3,983 inpatient
Discharge to home
rate 82.4% ED OU
II
085
21:45:54
Graff et al.
15
1997
Multiple site registry
study of 8 CPOUs to
assess for effectiveness
and cost (N=23,407)
Saved cost from
avoided hospital
admissions
$4,093,466 and
estimated overall
true cost savings
$2,873,966 for the
8 OU study
hospitals
2013 USD
$7,237,202 saved
from avoided
admissions,
$5,081,140 in true
cost savings
Discharge to home
rate after initial ED
evaluation 59% OU
study population
vs. 43% comparable
population;
proportion of CP
patients with ruleout MI evaluation
after initial ED
evaluation 67% OU
study population
vs. 57% comparable
population;
proportion of
missed AMI 0.4%
OU study
population vs. 4.5%
comparable
population
Very large N;
variable OU
criteria among
CPOU sites;
missed AMI and
cost data
estimated
II
Mikhail
et al..
16
1997
Prospective
observational study of
low- to moderate-risk
CP patients with
immediate stress
testing after AMI ruled
out in a CPOU (N=502)
CPOU LOS
12.75h
Average total costper-case $894
CPOU vs. $2,364
inpatient. Cost of
mandatory stress
testing to identify
one patient with
IHD after AMI
ruled out $3,125
2013 USD $1,757
CPOU vs. $4,647
inpatient. cost to
identify IHD
patient: $6,143
99.5% moderate or very
satisfied with CPOU care
CPOU discharge
home rate 86%;
discharged patients
with negative CPOU
work-up 0%
mortality/AMI at
5-month f/u
No prospective
control group;
possible inability
to extrapolate
cost analysis to
other
institutions
II
Zalenski
et al.
17
1997
Observational study of
a low-risk CPOU
protocol with stress
test (N=63)
ED patients
admitted for chest
pain with low
probability for AMI
Use of historical
reports for
diagnosis of AMI
II
437
085
21:45:54
Table 80.1 (cont.)
Author/
Year
Design Outcomes Limitations/
Comments
Class
Length of Stay
(LOS)
Cost Patient Satisfaction Other Metrics
Chest pain
53.3% (Goldman’s
algorithm);
proportion
appropriate for
CPOU 14%; eligible
patients excluded
due to CAD history
(46%) and inability
to perform a valid
exercise stress test
(42%)
or angina;
population bias
Stomel
et al.
18
1999
Retrospective study to
assess effects of
implementing a CPOU
and a patient
management
algorithm for
evaluation of CP
patients (N=140 lowrisk CP; N=333
intermediate-risk CP)
LOS 12.7h lowrisk CP vs. 18.2h
intermediate-risk
CP; mean LOS
16.6h
Total charges
(cost) for
intermediate-risk
patients $3,113
($1,071) CPOU vs.
$5,840 ($2,568)
inpatient
2013 USD $5,153
($1,773) CPOU vs.
$9,667 ($4,251)
inpatient
Admission rate 27%
before vs. 21% after
management
algorithm
implemented; CP
risk discharged
from CPOU 70.4%
intermediate-risk CP
vs. 29.6% low-risk
CP; MACE at 1-year
f/u 2.4%
Inability to
intervention
wholly
responsible for
changes
II
Lai et al.
19
2003
Retrospective chart
review of managed
care CP patients
discharged from OU
without stress testing
(N=344)
Rate of 60-day f/u
MACE 6%, mortality
2%; rate of ED
return for CP after
discharge within
60days 7%; rate of
primary care f/u
55.2%; rate of stress
Retrospective
small study size;
selection bias –
study
population
limited to
patients with
II
085
21:45:54
test performed
within 60 days after
OU discharge 43.3%
PCP and a high
likelihood of f/u
Jagminas
et al.
20
2005
Retrospective,
observational study of
CP patients placed in
an ED OU (N=440) vs.
an inpatient OU
(N=973) during
separate time periods
Mean charge $890
ED OU vs. $1,040
inpatient OU
2013 USD $1,524
ED OU vs. $1,781
inpatient OU
Discharge to home
rate 92.1% for ED
OU, 80.8% for
inpatient OU
Patient selection
uncontrolled in
both groups
II
Diercks
et al.
21
2007
Retrospective study of
CPOU patients
(N=4568) presenting
with associated
cocaine and
amphetamine use
(N=224)
5% CPOU patients
Utox positive for
cocaine or
amphetamines
(N=224); CAD
diagnosis 9% Utox
negative vs. 12%
Utox positive
Possible
selection bias of
Utox patients
place in CPOU;
not all CPOU
patients had
Utox and/or
diagnostic
testing; No f/u
period
II
Chang
et al.
22
2008
Retrospective
convenience study
comparing evaluation
of ED CP patients with
immediate CTA
without serial
biomarkers (N=98); OU
with serial biomarkers
and CTA (N=102); OU
with serial biomarkers
and stress testing
(N=154); usual care
(admission with serial
biomarkers and
hospitalist-directed
evaluation) (N=289)
LOS 8.1h
immediate CTA
vs. 20.9h OU
with serial
biomarker and
CTA vs. 26.2h
OU with serial
biomarker and
stress test
vs. 30.2h usual
care
Median facility
cost $1,240
immediate CTA vs.
$2,318 OU with
serial biomarkers
and CTA vs. $4,024
OU with serial
biomarkers and
stress test vs.
$2,913 usual care
2013 USD $1,413
immediate CTA vs.
$2,642 OU with
serial biomarkers
and CTA vs. $4,586
OU with serial
No diff in CAD
diagnosis, death or
MI rates; 30-day
readmission rate 0%
immediate CTA
vs. 3.2% OU with
serial biomarkers
and CTA vs. 2.3%
OU with serial
biomarkers and
stress test vs. 12.2%
usual care
Selection bias –
decision of
which group
patient is placed
by physician
II
439
085
21:45:54
Table 80.1 (cont.)
Author/
Year
Design Outcomes Limitations/
Comments
Class
Length of Stay
(LOS)
Cost Patient Satisfaction Other Metrics
Chest pain
biomarkers and
stress test vs.
$3,320 usual care
Limkakeng
et al.
23
2010
Retrospective study to
assess prevalence of
renal dysfunction in CP
OU patients and effect
on cardiac evaluation
outcomes (N=529)
Rate of patients
with GFR 90
43.3%, GFR <90 and
60 43.7%, GFR
<60 13%; rate of
patients with
abnormal
evaluation for ACS
12.1%; majority of
patients 43/64
(67%) with
abnormal
evaluation for ACS
had at least mild
renal impairment
(GFR <90); rate of
positive or
indeterminate ST
9.1% GFR 90,
13.4% GFR<90 and
60, 17.4% <60
Small sample
size, selection
bias
II
Maag et al.
24
1997
Observational
descriptive study of a
process improvement
initiative to implement
LOS 12h in bestpractice CPOU
Use of a five phase
process and best
practice modeling
allowed 5 of 9
III
085
21:45:54
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