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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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Deep vein thrombosis
Levine
et al.
47
1996
Prospective,
randomized study of
patients with proximal
DVT either to UF
heparin in the hospital
vs. LMWH at home
(N=500)
LOS 1.1 days for
LMWH group, 6.5
days for UF
heparin group
No significant diff in
recurrent DVT or major
bleeding at 90 days
I
O’Brien
et al.
48
1999
Randomized trial
comparing cost of
standard hospital- based
treatment for DVT with
LMWH (N=300)
Saving of $2,617
Canadian per patient for
outpatient Rx 2013 USD
Savings of $4,524 per
patient for outpatient Rx
disposition choices
were home vs. admit
I
Vinson
et al.
49
2001
Observational study of
patients before and after
the implementation of a
DVT protocol using
LMWH at two EDs
(N=274)
Total hospital
days for group
before pathway
was 383d, total for
after pathway was
6 days
No significant diff in
outcomes between
groups
No mention of ED OU,
though concept is
apparent
II
Rodger
et al.
50
1998
Observational,
retrospective evaluation
of effectiveness and
safety of protocol for
management of DVT
with output LMWH
(N=105)
Total case costs for
hospitalization for UF
heparin was $3,048 vs.
output cost of $1,641 for
LMWH 2013 USD UF
heparin $5,734 vs.
$3,087 for LMWH
No diff in bleeding risk,
lower risk of recurrence
and death in LMWH
group
Patients who had
difficulty with initial
injections received a
12h visit
III
Gould
et al.
51
1999
Modeling costeffectiveness of LMWH
vs. UF heparin
If half of patients were
eligible for full or partial
outpatient Rx: $790
savings per patient
2013 USD $1,486
savings per patient
Small mention of
“outpatient” Rx, and
“partial” outpatient Rx
III
Atrial fibrillation
Kim et al.
54
2002
Prospective randomized
trial of patients for a
Mean costs were $879
and $1,706 for pathway
Small numbers, but
some statistically
II
461
085
21:45:54
Table 80.2 (cont.)
Author/
Year
Design Outcomes Limitations/
Comments
Class
Length of Stay
(LOS)
Cost Patient
Satisfaction
Other Metrics
Other
rapid pathway for
cardioversion of atrial
fibrillation vs. traditional
admission (N=18)
LOS in pathway
4.8h and 29.8h in
admitted group
and admission; savings of
$827 per visit and 40% of
costs of pathway were for
LMWH 2013 USD Costs of
$1,276 and $2,477 for
pathway and admission;
savings of $1,201 per visit
significant findings
Downgrade for small
number of patients
Vinson
et al.
59
2012
Case series of patients in
3 community EDs in
same system to test EDbased cardioversion
protocol (N=206)
89% of patients
discharged home after
protocol; 2 patients with
embolic event at 30-day
follow-up
Patients selected as
convenience sample
III
Abdominal pain
Lopez
et al.
60
2007
Prospective randomized
trial of female patients
to either observation or
CT scan if appendicitis
was suspected; used
Alvarado appendicitis
score (N=90)
No significant diff
in LOS
No significant diff in
hospital charges
The two groups were
similar in diagnostic
accuracy, sensitivity, and
specificity
Observation was
performed in an
inpatient setting
I
White
et al.
61
1975
Retrospective cohort
study of pediatric
patients with
intermediate suspicion
of acute appendicitis
before and after the
routine use of an
observation period prior
to surgery (N=136)
Negative laparotomy
rate fell from 15% to
1.9% Rate of death and
ruptured appendicitis
unchanged
Historical controls;
antedates widespread
use of CT
II
Atrial fibrillation
085
21:45:54
Thomson
et al.
64
1986
Prospective
observational study.
One clinician did serial
examinations over 12h
on all patients (adult
and children) at two
hospitals; (N=252)
Negative laparotomy
rate was 5% vs.
historical 20%
Single examiner;
historical controls;
antedates wide spread
use of CT
III
Head injury
Geijerstam
et al.
67
2006
Randomized patients
between CT during ED
visit and home if
negative vs. no CT and
observation according
to local custom
(N=2,602)
Satisfaction
equal in
both groups
No significant diff in
outcomes at 3 months
I
Norlund
et al.
68
2006
Randomized patients
between CT during ED
visit and home if
negative vs. no CT and
observation according
to local custom
(N=2,602)
CostperpatientforCT
group was €461; for
observation group €677,
32% less 2013 USD Cost
perpatientforCTgroup
was $756; for observation
group $1,110
No diff in death or
disability at 90 days
Does not account for
indirect costs associated
with CT scan, such as
exposure to ionizing
radiation
I
Geijerstam
et al.
71
2004
Modeling cost
difference between
observation of patients
with minor head injury
vs. immediate CT
Cost saving of immediate
CT and home could be
£170 per case, 36% lower
than observation,
2013 USD Savings of $343
per case
Superseded by Norland
et al.
68
2006
III
Toxicology/drug overdose
Foulke
et al.
87
1995
Case series of patients
with antidepressant
overdose, classified as
high or low risk (N=67)
28 (42%) of patients were
low risk; no subsequent
complications identified
in this group
Potential to apply
screening criteria and
divert low-risk
antidepressant
overdose patients away
from inpatient care
III
463
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464
Table 80.2 (cont.)
Author/
Year
Design Outcomes Limitations/
Comments
465
Class
21:45:54 085
Sickle cell crisis
Other
Benjamin
98
et al.
2000
Case series of visits at a
specialty outpatient
clinic delivering a care
protocol for
uncomplicated sickle
cell pain crisis as an
alternative to standard
ED care (N=2,554)
Tables 80.1 and 80.2
ACS: Acute coronary syndrome
ADP: Accelerated diagnostic protocol
AMA: Against medical advice
AMI: Acute myocardial infarction
AOU: Asthma observation unit
Appts: Appointments
CAD: Coronary artery disease
CK-MB: Creatine kinase MB isoenzyme
COPD: Chronic obstructive pulmonary disease
CP: Chest pain
CPU: Chest pain unit
CPOU: Chest pain observation unit
CT: Computed tomography
CTA: Computed tomography angiogram
d/c: Discharged
Diff: Difference
DPL: Diagnostic peritoneal lavage
DVT: Deep venous thrombosis
ED OU: Emergency department observation unit
EDTU: Emergency department treatment unit
F/u: Follow-up
GFR: Glomerular filtration rate
GI: Gastrointestinal
h: Hours
HADS: Hospital anxiety depression scale
Hosp: Hospital
HOSTT: Holding, observation, short-term therapy
IHD: Ischemic heart disease
Info: Information
LMWH: Low molecular weight heparin
LOS: Length of stay
LWBS: Left without being seen
MACE: Major adverse cardiac events
NPV: Negative predictive value
NSR: Normal sinus rhythm
Obs: Observation
OR: Odds ratio
OU: Observation unit
PED: Pediatric emergency department
Peds: Pediatric
PG: Press Ganey
PPV: Positive predictive value
pro: Professional
QALY: Quality-adjusted life year
QOL: Quality of life
Rehosp: Rehospitalization
Rx: Treatment
SBP: Systolic blood pressure
TIMI: Thrombolysis in myocardial infarction
TnI: Troponin I
UF: Unfractionated
USD: United States Dollar
Utox: Urine toxicology
VT: Ventricular tachycardia
WBC: White blood cell count
Length of Stay
(LOS)
Mean clinic visit
LOS was 4.5h,
vs. 13h for ED
visits
Cost Patient
Satisfaction
Total single-hospital
savings estimated at
$1.7M over 5 years 2013
USD Savings of $2.7M
over 5 years
Other Metrics
81% of patients
discharged home after
clinic visit Inpatient
admissions # by 40%
after clinic opened
Setting was specialty
clinic, not ED OU, but
suggests a standard
protocol can be
successfully used in
these patients
III
Table 80.3 Summary of Evidence-Based Articles for Critical Question #1 and #3
# Articles # Articles # Articles # Articles
Level of evidence Class I Class II Class III Total
Cardiovascular: Chest pain 11 10 8 29
Cardiovascular: CHF 1247
Cardiovascular: Atrial fibrillation 2136
Cardiovascular: DVT 1 - - 1
Respiratory: Asthma 3 - 3 7
Respiratory: COPD exacerbation - - 1 1
Respiratory/infection: Pneumonia - 1 - 1
Infections: Pyelonephritis - 1 2 3
Infections: Cellulitis - - 1 1
Neurologic: TIA 1113
Neurologic: Syncope 1 - 1 2
Abdominal Pain - 2 1 3
Trauma – Head injury 1113
Trauma – General/abdominal - - 4 4
Toxicology - - 3 3
Decompression illness - - 1* 1
ED efficiency 1236
Systematic review articles - - 3* 3
Total number of articles 22 21 40 83
Decompression Illness is also a systematic review so there
were 4 systematic reviews but is counted under
decompression illness
Summary of Evidence-Based Articles for Critical Question #2
# Articles # Articles # Articles # Articles
Level of Evidence Class I Class II Class III Total
Cardiovascular: Chest Pain - 1 - 1
Cardiovascular: DVT 2 1 2 5
Cardiovascular: Atrial Fibrillation - 1 1 2
Neurologic: TIA - 2 1 3
Abdominal Pain 1 1 1 3
Trauma – Head Injury 2 - 1 3
Sickle Cell - - 1 1
Toxicology - - 1 1
Total Number of Articles 5 6 8 19
Evidence Basis for Observation Medicine in Adults
085
21:45:54
In addition, there were 19 articles that dem-
onstrated the utility of standardized diagnostic
protocols and/or an accelerated “upfront” loading
of patient diagnostic and/or therapeutic interventions that are an integral part of current OU
management of patients. These clinical conditions/disorders (and the number of articles) that
were dealt with were as follows: deep vein thrombosis (5), transient ischemic attack (3), abdominal
pain (3), head injury (3), atrial fibrillation (2),
chest pain (1), sickle cell disease (1), and toxicology
1
. These are all conditions/disorders that have
been successfully managed in OUs (Table 80.2).
Moreover, if we add the 37 articles in the
following chapter on the evidence-based literature
for pediatrics (33 articles) and geria trics (4 articles), there are 139 articles encompassing many
different diseases and conditions and all ages of
patients. A summary of the literature by diagnosis
and condition is listed in Table 80.3 (excludes the
articles from the next chapter).
Overall Summary
Of all the 102 adult articles (and 37 pediatric/
geriatric studies for 139 studies, see Chapter 81),
which include the 19 articles employing OU-type
protocols and/or methodology, the advantages of
OU management were noted in every one of these
studies. Even when separating out the studies
based on a specific disorder (i.e., cardiac disease
or respiratory disorders, trauma, infections, etc.
or by diagnostic category, such as cardiac vs.
noncardiac) there is overwhelming Level
A evidence supporting the use of OUs. The many
Summary of Evidence-Based Articles for Critical Questions #1, #2, #3
# Articles # Articles # Articles # Articles
Level of evidence Class I Class II Class III Total
Cardiovascular: Chest pain 11 10 8 29
Cardiovascular: CHF 1247
Cardiovascular: Atrial fibrillation 2136
Cardiovascular: DVT 1 - - 1
Respiratory: Asthma 3 - 3 6
Respiratory: COPD exacerbation - - 1 1
Respiratory/Infection: Pneumonia - 1 - 1
Infections: Pyelonephritis - 1 2 3
Infections: Cellulitis - - 1 1
Neurologic: TIA 1113
Neurologic: Syncope 1 - 1 2
Abdominal Pain - 2 1 3
Trauma – Head injury 1113
Trauma – General/abdominal - - 4 4
Toxicology - - 3 3
Decompression illness - - 1* 1
ED efficiency 1236
Systematic review articles - - 3* 3
Total number of articles 22 21 40 83
*Decompression illness is also a systematic review so there
were 4 systematic reviews but is counted under
decompression illness
Christopher W. Baugh, Sharon E. Mace, Margarita E. Pena, and J. Stephen Bohan
085
21:45:54
advantages include, but are not limited to,
better patient outcomes, decreased LOS, lower
costs, fewer readmissions, and increased patient
satisfaction. A summary of level of recommendation for selected clinical conditions is listed in
Appendix D.
Critical Questions
1. In adult patients, when compared with
inpatient treatment does the provision of
observation services, specifically in a
dedicated, protocol-driven OU, improve
patient outcomes, decrease LOS, reduce
costs, increase patient satisfaction and have
other benefits, including (but not limited to)
decreased readmissions?
Recommendations
Level A recommendations. In adult ED
patients, when compared with standard
inpatient therapy, the use of a dedicated,
protocol-driven OU decreases LOS, reduces
costs, and increases patient satisfaction.
Level B recommendations. In adult ED patients,
when compared with standard inpatient
therapy, the use of a dedicated, protocol-driven
OU improves patient outcomes.
Level C recommendations. In adult ED
patients, when compared with standard
inpatient therapy the use of a dedicated,
protocol driven OU decreases hospital
readmissions.
2. In adult patients, does the use of OU clinical
and administrative methodology (by
aggressive early diagnostic and therapeutic
management using tools such as protocoldriven therapy) produce equivalent or better
results (e.g., in patient outcomes, LOS,
costs, and adverse events) compared with
routine inpatient care?
Recommendations
Level A recommendations. In adult ED
patients, when compared with standard
inpatient therapy, the use of OU methodology
with aggressive early diagnostic and therapeutic
management, such as using protocol-driven
patient management, decreases LOS and
reduces costs when compared with standard
inpatient therapy.
Level B recommendations. In adult ED patients,
when compared with standard inpatient
therapy, the use of OU methodology with
aggressive early diagnostic and therapeutic
management, such as using protocol-driven
patient management, improves outcomes when
compared with standard inpatient therapy.
Level C recommendations. None specified.
3. In the adult ED, does use of an OU
improve key measures of department
efficiency, such as decreases in the ED LOS,
door-to-doctor time, ambulance diversion,
and the left-without-being-seen rate?
Recommendations
Level A recommendations. None specified.
Level B recommendations. In the adult ED, use
of an OU improves key measures of department
efficiency, such as door-to-doctor time and a
decrease in the left-without-being-seen rate.
Level C recommendations. In the adult ED, use
of an OU improves key measures of department
efficiency, including professional billing rates,
ED LOS for both inpatient boarders and treat
and release patients, and ambulance diversion
time.
Future Research
The use of dedicated OU and employing aggressive, early management and protocol-driven care
is still a relatively new but promising care delivery
model. It has the potential to have a major positive
impact, not only on patient outcomes and cost
savings, but also on the entire health care system.
However, only about one-third of the hospitals in
the United States have an OU. For a given hospital, the implementation of such an OU could
result in about $4.6 million dollars in annual
savings, and for the U.S. health care system, $3.1
billion dollars in overall savings in one year alone
if eligible hospitals opened these units.
1
Evidence Basis for Observation Medicine in Adults
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21:45:54
Appendix A: Literature Classification Schema
Design/
Class
Therapy Diagnosis Prognosis
1 Randomized, controlled trial
or meta-analysis of
randomized trials
Prospective cohort using a criterion
standard or meta-analysis of
prospective studies
Population prospective
cohort or meta-analysis of
prospective studies
2 Nonrandomized trial Retrospective observational Retrospective cohort; Case
control
3 Case series; Case report;
Other (e.g., consensus,
review)
Case series; Case report; Other (e.g.,
consensus, review)
Case series; Case report;
Other (e.g., consensus,
review)
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Appendix B: Approach to Downgrading
Strength of Evidence
Design/Class
Downgrading 1 2 3
None I II III
1 Level II III X
2 Levels III X X
Fatal flaw X X X
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Appendix C: Criteria Used for Clinical Findings
and Strength of Recommendations
Level A recommendation Generally accepted
principles for patient management that indicate a
high degree of clinical certainty (i.e., based on
strength of evidence Class I or overwhelming
evidence from strength of evidence Class II studies
that directly address all of the issues).
Level B recommendation Generally accepted
principles for patient management that indicate a
moderate degree of clinical certainty (i.e., based on
strength of evidence Class II studies that directly
address all of the issues, decision analysis that
directly addresses the issue, or strong consensus of
strength of evidence Class III studies).
Level C recommendation Patient management
strategies that are based on strength of evidence
Class III studies.
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