Beruflich Dokumente
Kultur Dokumente
Original Investigation
he ideal timing of performing a tracheostomy in critically ill patients requiring mechanical ventilation has
been the subject of much contention. Numerous trials
have taken place to investigate the differential outcomes associated with early and late tracheostomies1-11; however, the
results have been inconsistent. Meta-analyses have been
performed to synthesize the existing data.12-14 Outcomes have
suggested that early tracheostomy is associated with a decreased intensive care unit (ICU) length of stay,12 decreased
short-term mortality,13 and decreased rates of pneumonia.14
However, adopting an early tracheostomy strategy increases
the risk of performing unnecessary surgery in patients who,
when given more time, would have been successfully weaned
and extubated.
A late tracheostomy strategy would theoretically result in
fewer inappropriate tracheostomies being performed; however, it may result in prolonged ICU stays and worse clinical
outcomes. Given the lack of current validated instruments to
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Methods
Key Points
Patient Population
The population of critically ill patients requiring prolonged mechanical ventilation is heterogeneous. Similarly, randomized
clinical trials investigating early vs late tracheostomy have
involved varied patient populations, including those who require mechanical ventilation secondary to trauma, burn injuries, neurological insult, and medical illnesses such as pneumonia. Subgroup analysis from a recent meta-analysis did not
find a statistically significant difference in outcomes based on
the illness population12; therefore, our model was based on an
unselected group of critically ill patients.
effectiveness value of 1 (eNoTrach). The performance of a tracheostomy was assigned an effectiveness value of 0 (eTrach)
(Table). The probabilities and clinical outcomes used for our
model were extracted from meta-analyses of randomized and
quasi-randomized clinical trials of early vs late tracheostomies (Table).12-14 The probabilities of decannulation in the early
and late tracheostomy groups were taken from a randomized
clinical trial by Koch et al.8 The probability of short-term complication occurrence associated with a tracheostomy was taken
from a multi-institutional retrospective study by Halum et al.23
Long-term complication rates (eg, the rates of tracheal stenosis) were not included in our model because studies have not
found a significant difference in this parameter between tracheostomized patients and those who receive prolonged
endotracheal intubation.5,32
Costs
The analysis was performed from the perspective of the US
health care third-party payer. All costs are expressed in US
dollars as of August 2015. The mean cost per ICU day of $2119
(SE, $773) was obtained from a prospective microcosting study
by Lefrant et al.26 This daily ICU cost included staff time for
patient care, medications, consumables (eg, dressing material), interventions (eg, hemodialysis machines), laboratory
tests, and administrative expenses. The length of ICU stays in
the early and late tracheostomy groups are 13.5 and 22.6 days,
respectively.12 There is a paucity of data for the exact timeline of short-term mortality in the ICU; however, it has been
found that most deaths occur within the first 7 days.25 Therefore, in our model, the length of stay in those patients who die
in the ICU is 7 days.
The tracheostomy cost was estimated from a metaanalysis of percutaneous vs open tracheotomy outcomes performed by Oliver et al24 combined with data from a retrospective analysis by Halum et al,23 which demonstrated that 82.2%
of tracheostomies were performed in an open fashion and 17.8%
were performed percutaneously. Using the open:percutaneous
ratio of 4:1 and the cost data from the study by Oliver et al,24
we calculated the weighted mean cost of 1 tracheostomy to be
$3178.01 (SE, $215.73) (Table).
A recent meta-analysis27 showed that the most common
short-term complications following either percutaneous or open
tracheostomy were major postoperative bleeding and infection of the stoma. Major postoperative bleeding was defined
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Figure 1. Decision Tree Model of Early Tracheostomy Strategy vs Late Tracheostomy Strategy
Short-term mortality
pEarlyMortality
Decannulation
Pneumonia
Short-term complication
(bleeding, stomal
infection)
Early trach
pEarlyTrach
pEarlyPneumonia
#
Survive
pEarlyTrachDecan
Pneumonia
pEarlyPneumonia
No trach
complication
#
Short-term mortality
pEarlyTrachDecan
[cTrach + (cICU*DaysICUEarly) +
cPneumonia]\eTrach
No pneumonia
[cTrach + (cICU*DaysICUEarly) +
cTrachComp]\eTrach
#
Early
tracheostomy
strategy
[cTrach + (cICU*DaysICUEarly) +
cTrachComp + cPneumonia]\eTrach
pTrachComp
No pneumonia
pEarlyTrachDecan
[cTrach + (cICU*DaysICUEarly)]
\eTrach
[cDeath + (cICU*DaysICUMortality)]\eNoTrach
pEarlyMortality
No trach
Pneumonia
[(cICU*DaysICUEarly) + cPneumonia]\eNoTrach
pEarlyPneumonia
Survive
#
No pneumonia
ICU admission
cDeath = dist_cDeath
cHomeCare = dist_
cHomeCare
cICU = dist_cICU
cPneumonia =
dist_cPneumonia
cTrach = dist_cTrach
cTrachComp =
dist_cTrachComp
DaysICUEarly =
dist_daysICUEarly
DaysICULate =
dist_daysICULate
DaysICUMortality =
dist_DaysICUMortality
eNoTrach = 1
eTrach = 0
pEarlyMortality = dist_
pEarlyMortality
pEarlyPneumonia =
dist_pEarlyPneumonia
pEarlyTrach =
dist_pEarlyTrach
pEarlyTrachDecan =
dist_pEarlyTrachDecan
pLateMortality =
dist_pLateMortality
pLatePneumonia =
dist_pLatePneumonia
pLateTrach =
dist_pLateTrach
pLateTrachDecan =
dist_pLateTrachDecan
pTrachComp =
dist_pTrachComp
pEarlyTrachDecan
[(cICU*DaysICUEarly)]\eNoTrach
Short-term mortality
pLateMortality
Decannulation
Pneumonia
Short-term complication
(bleeding, stomal
infection)
Late trach
pLateTrach
pLatePneumonia
#
Survive
Pneumonia
pLatePneumonia
No trach
complication
#
Short-term mortality
[cTrach + (cICU*DaysICULate) +
cTrachComp]\eTrach
[cTrach + (cICU*DaysICULate) +
cPneumonia]\eTrach
No pneumonia
pLateTrachDecan
Decannulation
#
Late
tracheostomy
strategy
[cTrach + (cICU*DaysICULate) +
cTrachComp + cPneumonia]\eTrach
pTrachComp
No pneumonia
No trach
pLateTrachDecan
pLateTrachDecan
[cTrach + (cICU*DaysICULate)]
\eTrach
[cDeath + (cICU*DaysICUMortality)]\eNoTrach
pLateMortality
Pneumonia
[(cICU*DaysICULate) + cPneumonia]\eNoTrach
pLatePneumonia
Survive
#
No pneumonia
[(cICU*DaysICULate)]\eNoTrach
A decision tree model with a 90-day time horizon. c Indicates cost; comp, complication; decan, decannulation; dist, distribution; e, effect; ICU, intensive care unit;
p, probability; trach, tracheotomy; #, 1 (the probability of the event of the complement branch) (eg, the probability of receiving an early tracheostomy
(pEarlyTrach) = 0.81. In this case, # represents the probability of not receiving a tracheostomy. Therefore, # for no trach is 0.19 (ie, 1 0.81).
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Description
Early
mortality
Early
pneumonia
Early
tracheostomy
Early
decannulation
Late
mortality
Late
pneumonia
Late
tracheostomy
Tracheostomy
complication
Late
decannulation
Length of
ICU stay, d
Early
Late
Mortality
Value (SE)
Source
0.20 (0.093)
Liu et al13
0.42 (0.300)
Siempos et al14
0.81 (0.145)
Liu et al12
0.72 (0.35)
Koch et al8
0.25 (0.137)
Liu et al13
0.51 (0.239)
Siempos et al14
0.64 (0.233)
Liu et al12
0.057 (0.01)
Halum et al23
Putensen et al27
Koch et al8
0.40 (0.20)
13.46 (6.44)
Liu et al12
22.59 (10.65)
Liu et al12
7 (3)
Potgieter et al25
Costs, $
ICU
2119.15 (773.13)
Lefrant et al26
Pneumonia
9386.33 (212.05)
Tracheostomy
Cost of tracheostomy
3178.01 (215.73)
Oliver et al25
Tracheostomy
complication
Home care
7642.47 (262.39)
Death
14 842.26 (7400)
1826.43 (600.00)
Nemetz et al31
Effects
Tracheostomy
0 (NA)
Present study
No
tracheostomy
1 (NA)
Present study
Sensitivity Analysis
To account for the inherent uncertainty surrounding mean values inputted into the model, we performed a multivariate
probabilistic sensitivity analysis (PSA) using a Monte Carlo
simulation with 15 000 scenarios. Following guideline recommendations, SEs were used as the measure of variance for
model inputs. 38 The SEs were obtained from the metaanalyses or calculated using the data extracted from the
individual trials. Results are presented in both a costeffectiveness acceptability curve (CEAC) and ICER scatterplot.
The CEAC provides a quantitative value of certainty that the
intervention is cost-effective at different willingness-to-pay
(WTP) thresholds.39 It provides the probability that the intervenE4
Results
Reference Case
The reference case demonstrated that the cost of the late tracheostomy strategy was $45 943.81 for 0.36 of effectiveness.
The cost of the early tracheostomy strategy was $31 979.12 for
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0.19 of effectiveness. The ICER of the late tracheostomy strategy compared with the early tracheostomy strategy is
$82 145.24 per tracheostomy avoided.
tracheostomy strategy becomes cost-effective with 51% certainty. The ICER scatterplot is shown in Figure 3 and demonstrates that 56% of the ICERs of early vs late tracheostomy lie
below the $50 000 WTP line in quadrants I and III.
Sensitivity Analysis
The multivariate probabilistic sensitivity analysis demonstrated that the probability that the early tracheostomy strategy is cost-effective at a maximum WTP threshold of $50 000
per quality-adjusted life-year (QALY) is 56% (Figure 2). When
the WTP threshold is increased to $80 000, the 2 strategies
have approximately equal probabilities of being the more costeffective intervention. At a WTP threshold of $85 000, the late
Iterations Cost-effective, %
100
Strategy
Early tracheostomy
Late tracheostomy
80
60
40
20
0
0
20 000
40 000
60 000
80 000
100 000
Willingness-to-Pay, $
Discussion
Tracheostomies are among the most commonly performed procedures in the critically ill population.41,42 Currently, the indications and timing for tracheostomy in this population are
poorly defined, and the decision to perform surgery can be
challenging. With the goal to assist in clinical-decision making, the objective of this economic evaluation was to examine the cost-effectiveness of an early tracheostomy strategy vs
a late tracheostomy strategy in the critically ill population requiring prolonged mechanical ventilation. Outcomes from this
model suggested that an early tracheostomy strategy might be
more cost-effective; however, the decision to adopt a strategy depends on the hospital and payers threshold to pay for
the avoidance of a tracheostomy.
Based on the literature, the possible benefits of an early
tracheostomy are decreased rates of pneumonia, decreased
short-term mortality, and decreased ICU length of stay.12-14
However, more tracheostomies are performed with an early
tracheostomy strategy, thus increasing the risk that some patients are receiving a tracheostomy unnecessarily. Adopting a
late tracheostomy strategy would circumvent the issue of
unnecessary tracheostomy because patients receive more
time to be weaned from mechanical ventilation; however, a late
strategy may increase rates of pneumonia, short-term
mortality, and ICU stay.
The outcome from this economic models reference case
demonstrated that adopting a more conservative late
Figure 3. Incremental Cost-effectiveness Ratio (ICER) Scatterplot of the Early vs Late Tracheostomy Strategies
160 000
140 000
120 000
100 000
80 000
Incremental Cost, $
60 000
40 000
20 000
0
20 000
40 000
60 000
80 000
95% Confidence
ellipse
100 000
120 000
140 000
160 000
1.0
0.80
0.60
0.20
0.20
0.40
0.60
0.80
1.0
Incremental Effectiveness
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tracheostomy strategy is more effective at avoiding a tracheostomy but it was also more expensive. The incremental cost
of avoiding a single tracheostomy was $82 145.24. When a payer
is willing to pay $50 000 per tracheostomy avoided (ie, WTP
threshold), the early tracheostomy strategy is the costeffective strategy with 56% certainty. If the WTP increases to
$85 000, then the late tracheostomy strategy becomes costeffective with 51% certainty (Figure 2). The adaptation of either
the early or late tracheostomy strategy depends on the ultimate goal of the decision-makers. If the goal is to minimize
costs, then an early tracheostomy strategy would be an appropriate decision. On the contrary, if the priority were to minimize the risk of performing unnecessary tracheostomies,
regardless of the cost, then a late tracheostomy strategy would
be preferable.
The strengths of this economic evaluation include the use
of high-quality data derived from multiple meta-analyses, use
of true health care costs as opposed to hospital charges, and
the inclusion of a robust multivariate sensitivity analysis to account for inherent uncertainty surrounding mean values used
in the reference case. Despite these strengths, there are limitations that should be considered when interpreting the results from this study. The primary outcome of cost per tracheostomy avoided is not generalizable compared with using
the cost per QALY. However, there is a lack of data evaluating the long-term utilities for various health states in critically ill patients with tracheostomies, making the QALY an unreliable outcome at present time. We hope that future research
will shed light on tracheostomy-associated quality of life, which
can be used to refine the economic evaluation of this important clinical topic.
A second limitation of our study relates to the absence of
data regarding certain model parameters, thereby necessitat-
Conclusions
Tracheostomy is a commonly performed procedure in critically ill patients requiring mechanical ventilation. The results
from this decision tree economic evaluation suggests that up
to a WTP threshold of $80 000, an early tracheostomy strategy would have a higher probability of being the cost-effective
decision compared with a late tracheostomy strategy. Whether
the early tracheostomy strategy becomes adopted by a health
care system depends on the value that is placed on avoiding tracheostomies. To improve the accuracy of this model, future research is needed to elucidate tracheostomy-associated quality
of life as well as long-term sequelae associated with tracheostomy and prolonged endotracheal intubation.
ARTICLE INFORMATION
Accepted for Publication: May 22, 2016.
Published Online: July 28, 2016.
doi:10.1001/jamaoto.2016.1829.
Author Contributions: Both authors had full access
to all of the data in the study and takes
responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Both authors.
Acquisition, analysis, or interpretation of data: Both
authors.
Drafting of the manuscript: Both authors.
Critical revision of the manuscript for important
intellectual content: Both authors.
Statistical analysis: Both authors.
Study supervision: Rudmik.
Conflict of Interest Disclosures: All authors have
completed and submitted the ICMJE Form for
Disclosure of Potential Conflicts of Interest, and
none were reported.
REFERENCES
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ing the making of assumptions. Specifically, our model assumed that all patients discharged with tracheostomies will
require homecare for 1 year. This parameter was important to
include in order to capture potential postdischarge costs of the
early tracheostomy strategy because it is associated with an
increase in tracheostomies performed and a larger number of
patients are likely to be discharged with tracheostomies under this strategy. However, there are no studies, to the best of
our knowledge, that report the timeline for successful decannulation as an outpatient. While our assumption of 12 months
of home care is likely an overestimation, we believe that it was
important to adopt a more conservative assumption in order
to minimize the potential for bias of the analysis toward the
early tracheostomy strategy. Again, we hope that future research yielding data regarding the outpatient management of
tracheostomies will help refine cost-effectiveness analyses on
this topic.
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