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Appendix D: Critical Questions Based on
Specific Diagnosis or Condition
Critical Questions
1. In adult patients, when compared with inpatient treatment does the provision of observation
services, specifically in a dedicated, protocoldriven OU, improve patient outcomes,
decrease LOS, reduce costs, increase patient
satisfaction, and have other benefits, including
(but not limited to) decreased readmissions?
Recommendations Based on Specific
Diagnosis or Condition
Level A Recommendations
In adult ED patients with chest pain, asthma,
transient ischemic attack, syncope, or congestive
heart failure, when compared with standard inpatient therapy, the use of a dedicated, protocoldriven OU decreases LOS and reduces costs.
In adult ED patients with chest pain and
asthma, when compared with standard inpatient
therapy, the use of a dedicated, protocol-driven
OU increases patient satisfaction.
In adult ED patients with atrial fibrillation,
when compared with standard inpatient therapy,
the use of a dedicated, protocol-driven observation decreases LOS.
In adult ED patients with traumatic head
injury, when compared with standard inpatient
therapy, the use of a dedicated, protocol-driven
OU decreases LOS.
Level B Recommendations
In adult ED patients with chest pain, when compared
with standard inpatient therapy, the use of a dedicated, protocol-driven OU improves patient
outcomes.
In adult ED patients with abdominal pain, when
compared with standard inpatient therapy the use
of a dedicated, protocol-driven OU decreases LOS.
In adult ED patients with pyelonephritis, when
compared with standard inpatient therapy the use
of a dedicated, protocol-driven OU decreases LOS.
Level C Recommendations
In adult ED patients with abdominal trauma,
when compared with standard inpatient therapy
the use of a dedicated, protocol-driven OU
decreases LOS and reduces cost.
In adult ED patients with toxic exposures,
when compared with standard inpatient therapy
the use of a dedicated, protocol-driven OU
decreases LOS and reduces cost.
In adult ED patients with COPD and pneumonia, when compared with standard inpatient
therapy the use of a dedicated, protocol-driven
OU decreases LOS.
In adult ED patients with congestive heart
failure, when compared with standard inpatient
therapy the use of a dedicated, protocol-driven
OU decreases hospital readmissions.
Critical Question 2:
In patients, does the use of OU clinical and
administrative methodology (by aggressive
early diagnostic and therapeutic management
using tools such as protocol-driven therapy)
produce equivalent or better results (e.g.,
patient outcomes, LOS, costs, and adverse
events) compared with routine inpatient care?
Recommendations
Level A Recommendations
In adult ED patients with deep venous thrombosis, 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 with chest pain, when compared with standard inpatient therapy the use of
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21:45:54
and therapeutic management, such as using
protocol-driven patient management, decreases
LOS and reduces costs when compared with
standard inpatient therapy.
In adult ED patients with transient ischemic
attack, when compared with standard inpatient
therapy the use of OU methodology with aggressive early diagnostic and therapeutic management, such as using protocol-driven patien t
management, improves outcomes when compared with standard inpatient therapy.
In adult ED patients with atrial fibrillation,
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.
In adult ED patients with sickle cell disease,
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 C Recommendations
None specified.
Critical Question 3: In the adult ED, does use of
an OU improve key measures of department
efficiency, such as decreases in ED LOS, doorto-doctor time, ambulance diversion, and the
left-without-being-seen rate?
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 leftwithout-being-seen rate.
Level C Recommendations
In the adult ED, use of an OU improves key
measures of department efficiency, such
professional billing rates, ED LOS for both
inpatient boarders and treat and release
patients, and ambulance diversion time.
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Christopher W. Baugh, Sharon E. Mace, Margarita E. Pena, and J. Stephen Bohan
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Part VII
Chapter
81
Evidence Basis for Observation Medicine
The Evidence Basis for Age-Related
Observation Care
Sharon E. Mace, MD, FACEP, FAAP
Christopher W. Baugh, MD, MBA, FACEP
Madeline Joseph, MD, FACEP, FAAP
Abstract
In this chapter, we examine and summarize the evidence for observation care based on age, for
example, the pediatric and geriatric population, as the previous chapter did for adults with a
given condition or diagnosis, such as chest pain or asthma. The critical questions addressed in
this chapter are:
1. Can infants and children (e.g., pediatric patients) be successfully and safely treated in an
observation unit setting?
2. Can geriatric patients be successfully and safely treated in an observation unit setting?
Introduction
The key components in any discussion of health
care and health care reform include patient outcomes, patient safety, quality, and cost.
1
When a
safe and efficient alternative exists, avoiding inpatient hospital admissions can have benefits for the
individual patient, as well as more efficient use of
the health care system. Avoiding hospital admissions and/or decreasing length of stay (LOS)
improves patient safety and outcomes by decreasing the opportunities for patient error and other
risks to the patient, including medication errors,
nosocomial infections, adverse drug events, use of
restraints, delirium, pressure sores, falls, and a
deterioration in functional status.
2–5
Nearly onethird of the health care cost in the United States is
attributable to inpatient hospital care
6
and over
50% (55% excluding maternal/neonatal admissions according to the Healthcare Cost and Utilization Project) of hospitalizations in the United
States begin in the emergency department (ED).
7
Obviously, avoiding hospital admissions, improving patient flow through hospitals, and decreasing
hospital readmissions should decrease the cost of
health care.
8
Thus, there is a critical need for any
process or system of care that prevents “avoidable
admissions” and/or decreases LOS, while maintaining high-quality, cost-effective patient care,
increased patient satisfaction and providing a
critical link to accountable care organizations
(ACOs)
6,7
(See ACO Chapter 20). Observation
units (OUs) can meet this need.
5, 9–11
Observation medicine is designed to improve
the patient throughput process, increase patient
safety and quality, and improve outcomes by the
efficient use of systems of care and key clinical
and administrative methods or techniques. Such
techniques include clinical protocols and pathways, order sets, observation unit guidelines,
monitoring of performance metrics, appropriate
staffing, and the coordination or streamlining of
hospital systems (see Clinical Protocols Chapters
82–87, Administrative Policies Chapter 88, Order
Sets Chapter 89–96). The Institute of Medicine in
its 2006 report endorsed the use of emergency
department observation units (ED OUs) as a
method for decreasing ambulance diversion, ED
boarding, and avoidable hospital admissions.
9
A recent policy by the American College of Emergency Physicians on ED OUs identifies the provision of care “in a dedicated ED observation area,
instead of a general inpatient bed or acute care ED
bed” as a “best practice.”
10
Properly designed and managed OUs have
been proposed as a solution to the health care
crisis including escalating costs and concerns for
patient safety and quality, since they can provide
high-quality patient care at a lower cost with
increased patient satisfaction.
5, 8–11
It is estimated
that hospital systems in the United States alone
could save an additional $3.1 billion per year
086
21:50:33
through the avoidance of 3.6 million annual inpatient hospital admissions just by opening more
observation units.
11
Protocol-driven, dedicated OUs for specific
diagnoses and/or complaints in adults have been
studied. There is robust evidence that such units,
by efficiently utilizing clinical and administrative
resources and methodology, attain a LOS that is a
small fraction of the time required elsewhere for
the same patient population (see The Evidence
Basis for Observation Medicine Chapter 80). This
leads us to examine the question of whether there
are the same advantages, such as decreased LOS,
for patients in the extremes of age: children and
elderly patients.
Methodology
We systematically evaluated the literature to
develop evidence-based recommendations to
answer the following critical questions: 1. “Can
infants and children (e.g., pediatric patients) be
successfully and safely treated in an observation
unit setting?” A related secondary question is “In
pediatric patients, does the provision of observation services, using observation unit methodology
characterized by aggressive early diagnostic and
therapeutic management, usually in the setting of
a dedicated, protocol-driven observation unit,
decrease LOS, decrease costs, decrease inpatient
admissions, and have other benefits when compared with inpatient hospital care?” 2. “Can geriatric patients be successfully and safely treated in
an observation unit setting?” A related secondary
question is “In the elderly does the provision of
observation services, using observation unit
methodology characterized by early aggressive
diagnostic and therapeutic management, usually
in the setting of a dedicated, protocol- driven
observation unit, decrease LOS, decrease costs,
decrease inpatient admissions and have other
benefits when compared with inpatient
hospital care?”
We performed a literature search, graded the
evidence, and provided recommendations based
on the strength of the available data in the medical
literature.
We created this document regarding the
currently available peer-reviewed literature on
observation care after careful review and critical
analysis of the medical literature. Additional
studies were found by searching the reference
lists of included papers. All articles listed in this
chapter were graded b y two authors for quality
and strength of evidence. If there was a difference between two authors, a third author provided a tie-breaking 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. Design 3 represents the weakest evidence
for therapeutic, diagnostic, and prognostic studies, respectively (Appendix A). Authors of this
chapter did not grade papers they authored
themselves. Articles were then graded on dimensions related to the study’s methodological features: blinded versus non-blinded, outcome
assessment, blinded or r andomized allocation,
direct or indirect outcome measures (reliability
and validity), biases (e.g., selection, detection,
transfer), external validity (i.e., generalizability),
and sufficient sample size. Articles received a
final grade (Class I, II, III) on the basis of a
predetermined formula, taking into account the
design and study quality (Appendix A). Articles
irrelevant to the question or with a fatal flaw were
given an “X” and were not utilized in creating
the final recommendation (Appendix B). Clinical
results and strength of the recommendation were
made according to the criteria in Appendix C.
The literature we reviewed included article s
worldwide and not just from the United States.
Therefore, the scope of application is international, not just within the United States. The
inclusion criteria are for pediatric patients (age
≤ 21 years old) and geriatric patients (age
65 years old) presenting to the ED. The exclusion
criteria are for adult non-geriatric patients, who
are addressed in the previous chapter.
We adjusted reported cost data to United States
dollars using the medical portion of the Consumer
Price Index and prevailing international currency
exchange rates as of February 2013.
We divided the articles into pediatric and
geriatric sections and listed them by level of evidence first and then chronologically by year of
publication.
Results: Pediatric
There were six class I studies, 20 Class II studies
and 7 Class III studies.
12–44
Sharon E. Mace, Christopher W. Baugh, and Madeline Joseph
086
21:50:33
In the various clinical studies, pediatric
patients in all age groups from infants to adolescents, even neonates, were successfully managed
in an OU setting.
12–40
Direct comparison of similar patient populations in an OU versus inpati ent
setting revealed significantly shorter LOS in OUs
in all five studies (one Class I, four Class II) for
various common pediatric illnesses. In the Class
I study of infants 3–24 months old with dehydration from gastroenteritis who were treated with
IV fluids, the LOS was 9.9 hours for the ED
holding unit versus 103.2 hours for inpatients
(p < 0.00001).
12
In the Class II study of infants
with hyperbilirubinemia, the observation unit
median LOS of 17.8 hours was significantly different (p < 0.0001) from the inpatient comparison of 41.8 hours.
13
For pediatric patients status
post an uncomplicated barium enema for the
reduction of intussusception (Class II study), the
mean observation unit LOS was 7.1 hours vs. 22.7
hours inpatient (p < 0.001).
14
A Class II study of
pediatric patients with croup comparing the preversus post-observation LOS reported a 27.2 hour
pre-observation LOS and 21.3 hour postobservation LOS (p < 0.03).
15
Another Class II
study reported a me an LOS for pediatric asthmatic patients in a short-stay unit (SSU) of 35.3
hours, which was significantly different at p <
0.0001 from the 47.2 hours LOS for non-shortstay unit patients.
16
This was not an ED OU but
an inpatient SSU adjacent to the pediatric ward,
which may explain the relatively longer LOS than
in other reports. Some SSU allow up to 48 hours
for patient management, whereas most OUs have
a 24-hour set criteria for maximum LOS.
In all seven studies (three Class I, four Class
II) that evaluated cost, the observation unit
charges and/or costs were significantly less than
the inpatient costs
12, 15–20
For the Class I study of
infants with dehydration from acute gastroenteritis who were treated with intravenous fluids, the
costs for observation was $1,481, while the costs
for the an inpatient stay was $8,920 (p <
0.00001).
12
The Class I study of pediatric asthmatics found significantly (p < 0.001) higher costs for
inpatients: $9,939 compared to $5,667 for the ED
holding room.
17
In the Class I report from Australia, the cost was $302 per bed day and the
hospital cost savings was $509,690 for one year
for the general hospital, and $408 per bed day and
hospital cost savings of $4,213,363 for two years
for the Children’s hospital.
18
Four Class II studies
also found significantly lower costs for children
and infants treated in an OU setting versus inpatient hospitalization. One Class II study of asthmatics at a children’s hospital using the median
per diem hospital costs of $2,496 and direct costs
of $1,012 for the non-ICU asthmatic patients
estimated the annual decrease in hospital charges
to be $628,739 and in direct costs of $254,914 if
the short-stay unit managed half of the 1,016
asthma patients admitted in one year.
16
In
another Class II study of asthmatic infants and
children, the costs per patient were $885 for ED
holding unit vs. $5,716 for admitted patients.
19
The results for pediatric patients with croup were
$2,110 if an observation unit patient and $2,679
if an admitted patient (p = 0.03).
15
This study
appears not to have differentiated the OU patients
from the inpatients in their post-OU data when
comparing with the pre-OU charges. Thus, it is
possible, even likely, that the actual savings may
be even greater than reported if they separated out
the OU patients from the inpatients in their postOU charges. In another study of pediatric patients
with all types of conditions/illnesses in a SSU,
the cost per patient was no greater than $390
(and may have been < $390 for some patients)
for the SSU and $1,378 if an inpatient.
20
This
yielded decreased charges of $3,320,720 for one
year.
20
All costs were adjusted to 2013 USD.
In all of the studies (two Class I, four Class II)
that reported admission rates to the inpatient
hospital following the introduction of an OU or
SSU, the admission rates all showed decreases.
There was a reduction in hospital admissions for
the Class I Australian study by 10.3% (from 5,315
in 1993 to 4,766 in 1994) at the teaching hospital
and 14.7% (from 8,065 in 1997 to 6,873 in 1998)
at the children’s hospital after the introduction of
a SSU.
18
A Class I multi-center French study
found that the introduction of a SSU “reduced
inpatient hospitalizations.”
21
In the Class II study
of patients with croup, the admission rate after
the introduction of a pediatric OU dropped by
more than half from 9.5% to 4.2% (p < 0.0001).
15
In another Class II study from Canada, after the
introduction of a pediatric OU, the admi ssion rate
for asthmatics declined significantly from 31% to
24% (p ≤ 0.01) and 1-day admissions decreased
from 17% to 10% (p ≤ 0.01).
22
According to a
Class II French study, referrals to the pediatric ED
had been increasing by 8.25% per year and hospitalizations on pediatric wards were increasing by
The Evidence Basis for Age-Related Observation Care
086
21:50:33
5% annually.23But after the opening of a SSU,
although the number of referrals to the pediatric
ED continued to increase, the “increase in hospitalizations was stopped and even decreased
slightly.”
23
In another Class II study of pediatric
asthmatics, inpatient admissions fell from 9.5% to
7.7% (SSU opened in August of that year) and
7.0% the following year SSU was open for the
entire year).
16
For other metrics, there were thirteen studies:
three Class I and ten Class II.
12–14, 16–18, 20,22, 24–26,
38,44
Time to initiate treatment (and LOS) was
markedly reduced with admission to an OU compared to inpatient admission. In the Class II study
of hyperbilirubinemia in neonates, the median
time to beginning treatment (e.g., phototherapy)
was more than four times greater for the inpatients (N=105) at 6.7 hours compared to 1.6 hours
for the OU (N=62) patients (p < 0.001).
13
In another class I study, there was no increase
in morbidity and a decreased percentage of
returns to the hospital within 28 days was noted
with the treatment of asthmatics of comparable
severity (by 39 pretreatment and treatment variables including asthma scores) in an ED holding
unit versus those admitted to the hospital.
17
Returns within 28 days occurred in 11.4% (4/35)
of holding unit patients and in 17.6% (12/68) of
inpatients.
17
For dehydrated infants with acute
gastroenteritis treated with IV fluids (N=14) in
the ED holding unit or as a hospital inpatient,
both groups were successfully rehydrated clinically, and by laboratory and clinical parameters
there were no significant differences either at
baseline or at 24 hours between the ED holding
unit patients versus the inpatients except for the
significantly decreased costs and LOS for the ED
holding unit patients (Class I study).
12
In the
Class I study from Australia with two hospitals
(one “teaching” hospital and one “children’s” hospital), there were “no adverse events or critical
incidents” for 6,248 patients and observation was
“considered safe.”
18
Unscheduled visits within
72 hours of discharge at the teaching hospital
were 0.4% (4/1300) and at the children’s hospital
0.9% (44/4948).
18
The authors noted that all the
return visits within 72 hours of discharge were
“all with minor problems, which were mostly due
to parental anxiety”.
18
Readmission rates within 72 hours of discharge for pediatric asthmatics admitted to a
SSU on a pediatric ward was 0.6% (2/298) versus
2.0% (2/102) for those not admitted to the SSU
(Class II study).
16
In a Class II study of SSU
patients in the United States, there were no
fatalities and only 1% of 437 patients needed
readmission to the hospital.
20
A similar rate of
returns to the ED within 72 hours that were
admitted was found in a Class II study of pediatric
gastroenteritis patients (1.6%, 7 out of 430 OU
admissions).
34
In general, studies in pediatric
patients from neonates to adolescents all reported
a decrease or no difference in returns to the ED or
hospital when observation/short-stay patients
were compared with inpatients. One outlier was
a Class II Canadian study in asthmatics that
found repeat ED visits after treatment for asthma
was 3% before the OU and 5 % (p- 0.01) after
opening of the OU.
22
This study had an extremely
short OU LOS of 5.3 hours if discharged home
and 6.5 hours if admitted, which may help explain
this exception to the findings in other studies of a
decreased or equivalent rate of return to the ED or
hospital for OU patients when compared
to inpatients.
In the Class II study of pediatric patients who
had a barium enema for intussusception, there
were no adverse events in either group (observation N=51 or inpatient N=27) and the reoccurrence rates were less for the observation patients
(7.8%, 4/51) than for the inpatients (14.8%, 4/
27).
14
A second Class II study of infants status
post barium enema reduction of intussusception
confirmed these findings with no complications
(such as perforation, sepsis or shock) in any of
their 149 OU patients.
28
A Class II study that
included pediatric patients (N=363) as well as
adults in an OU reported no mortalities, 0.8% of
pediatric patients went to the operating room, and
no pediatric patients signed out against medical
advice.
24
An Australian Class II study of infants and
children with croup compared OU and mandatory steroid use with pre-observation and nonmandatory steroid use (i.e., optional steroid use
per individual physician discretion): average
number of ICU transfers 2.6% versus 11.6%, average number of intubated patients 4 versus 8, and
average ICU days 24 versus 129.
25
The drawback
to this study is that it is difficult to separate out
the effect of mandatory steroids from the initiation of OU. It does point out that the institution
of “best practices” may be easier in a dedicated,
protocol-driven observation unit than for
Sharon E. Mace, Christopher W. Baugh, and Madeline Joseph
086
21:50:33
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