In this episode, Dr. Dante Yeh is joined by Tejen Shah, MD, from The Ohio State University Wexner Medical Center. They discuss his study, which shows that contrary to published enhanced recovery program (ERP) literature, most study hospitals had difficulty improving process compliance, with 80% not achieving substantial improvement. ERP bundles should be implemented in a more deliberate manner with better-planned, pragmatic, and informed strategies.
Disclosure Information: Dr Shah has nothing to disclose. Dr Yeh receives author royalties from UpToDate, advisory panel/training honoraria from Takeda Pharmaceuticals, and advisory panel honoraria from Baxter, Eli Lilly, and Fresenius Kabi.
To earn 0.25 AMA PRA Category 1 Credits™ for this episode of the JACS Operative Word Podcast, click here to register for the course and complete the evaluation. Listeners can earn CME credit for this podcast for up to 2 years after the original air date.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:01):
Welcome to the Operative Word,
a podcast brought to you by the
Journal of the American College of
Surgeons.
I'm Dr. Jamie Coleman.
And throughout this series, Dr.
Dante Yeh and I will speak with
recently published authors about the
motivation behind their latest
research and the clinical
implications it has for the
practicing surgeon.
(00:22):
The opinions expressed in this
podcast are those of the
participants and not necessarily
that of the American College of
Surgeons.
Welcome to the Operative Word, a
podcast from the Journal of the
American College of Surgeons.
I'm Dr. Dante Yeh, one of
your co-hosts for this series.
In this episode, we'll be taking an
in-depth look into the current
(00:43):
article, Truth of Colorectal
Enhanced Recovery Programs (00:45):
Process
Measure Compliance in 151
Hospitals.
I'm honored today to be joined by
the author, Tejen Shah, M.D.
from the Ohio State
University Wexner Medical Center.
Dr. Shah, thank you for joining me
today.
Before we begin, do you have any
potential conflicts of interest to
disclose?
(01:06):
No, I don't have any.
Can you give us a brief summary of
your study design?
And describe to us your main
findings.
Sure.
So enhanced recovery programs
have largely become the norm
in perioperative care for
patients undergoing elective
colorectal surgery.
And there is a large amount
(01:26):
of evidence from large institutions
that have reported that
when you implement colorectal
enhanced recovery programs, you get
significant improvement in process
measure compliance, which is
about more than 20% improvement from
where you started. And your outcomes
significantly improve.
And so what we did in our study
was to evaluate improvement
(01:48):
uniformity among 151
hospitals that were exposed
to an eighteen month implementation
protocol for six
colorectal enhanced recovery
process measures which
were oral antibiotic prophylaxis,
mechanical bowel prep,
multimodal pain control, early
mobilization, early liquids
(02:09):
and early solids.
And this essentially was
part of a program
from the
ISCR, which
is the improvement
of surgical care and recovery
program.
And the idea
was to implement these and have
recovery programs across
(02:30):
hospitals in the in the United
States.
And so the 151 hospitals that we
looked at in our study, what we
found is that 85%
of hospitals in our sample
did not achieve substantial
improvement in their process measure
compliance.
And when you look at
the 151 hospitals times
the six process measures we looked
(02:52):
at, which comes out to
663 total
available opportunities for
improvement, 80% of
these opportunities did not achieve
substantial improvement.
The simple process measures
like multimodal pain control and
oral antibiotics improved
by 23 to 16%.
(03:12):
But more resource intensive process
measures like early mobilization,
early solids, early liquids
improved the least by 2 to
7%.
All of this highlights
the fact that implementation
of ERAS protocols is difficult.
ERAS protocols are not one size
fits all and that
(03:32):
they are very dependent on the local
context.
Great. Thank you.
That was a it was a great high
level introduction
to your study.
There's a lot to pick apart here.
We can drill down to a
lot of details, and I
have some questions.
But first, why don't we start broad?
Tell me some more about this
improving surgical care
(03:53):
and recovery, The ISCR
project.
How did it begin?
Who is sponsoring this project?
Where's the money coming from?
And on the at the local
level, at the site, who is uploading
the data?
So the Improving Surgical Care and
Recovery program is funded
by the Agency for Healthcare
Research and Quality, the AHRQ.
And this program is a collaboration
(04:15):
between the American College of
Surgeons, Johns Hopkins
Armstrong Institute for Patient
Safety and Quality.
And and and the AHRQ.
And the primary
aim, essentially, like I said, is to
accelerate the adoption of enhanced
recovery practices in the United
States across multiple
subspecialties.
Colorectal, OBGYN,
(04:36):
orthopedics, emergency general
surgery. By providing hospitals
with evidence based toolkits,
documentation, resources and
coaching webinars
in these hospitals
that participate in the program,
volunteer to participate.
And each hospital has their
individual surgical clinical
reviewers that extracted data
(04:58):
from their
from their individual
electronic health records using
standard data definitions and
uploaded them often to the ISCR
data registry, which is built
on the NSQIP platform.
Awesome. Thank you.
What do, what other previous
findings or publications
(05:18):
have resulted from this
collaborative project?
So Dr. Clifford Ko and Dr.
Elizabeth Wick are the principal
investigators in the ISCR program,
and Chelsea Fisher, who
was a clinical scholar at the
American College of Surgeons, have
published a couple of studies from
the ISCR project,
one that highlighted the
feasibility of implementing
(05:39):
enhanced recovery programs for
emergent colorectal surgeries.
So not just elective surgeries.
They've also looked at
how ERAS implementation is
dependent on the local environment,
the leadership commitment and the
culture, as well as
the association between
compliance to process measures
and outcomes for ERAS.
(06:02):
I see. I see.
So it sounds like a massive project
with a long history behind it and
presumably and hopefully a long
future ahead of it.
You know, ERAS has been
hot. It's so hot for
at least ten years that I can think
of probably longer.
And it's it's still
generating a lot of interest.
(06:22):
I see it as sort of taking
the logical next progression
in its evolution.
You know, these bundles
that that we're seeing, they start
out locally, they get some
external validity, and then we try
to scale up.
And from what I'm understanding from
your study, we're having some
(06:44):
difficulty with scaling up
with with getting the compliance
part of it.
You focused only specifically
on six process
measures. Can you remind me again
what those six were?
Yes. So the six pauses measures
we looked at were oral
antibiotic prophylaxis, mechanical
bowel prep, early mobilization,
(07:06):
early solids, early
liquids and multimodal
pain control.
All right. So these six
have...The problem with the bundle,
as you know, is that if
you show that the bundle works,
that's great. But what is the
relative weight
or contribution of each
of those individual bundle
(07:27):
components?
You know, that's that's been as a
trauma critical care surgeon, I'm
most familiar with the catheter care
bundles from the Peter
Pronovost studies.
I'm also
intimately familiar
with the sepsis care bundles.
We can talk about that a little bit
later. But have each of these
(07:48):
six measures
that you've examined, have they
been individually validated
as as having a positive
impact on patient outcomes?
Yeah. So the
ACRS and SAGES release their
colorectal ERAS guidelines in 2023
where they reviewed the evidence
behind 26 different
(08:10):
ERAS process measures.
And within these
26 there were six that
we looked at as part of our study
and they graded those six as
a 1b recommendation, which was a
strong recommendation with moderate
quality evidence.
And moderate quality evidence was
defined as randomized
clinical trials with some
limitations.
(08:31):
There are some nuances.
So randomized clinical trials
that looked at mechanical bowel prep
alone did not find
it to reduce surgical site
infections. But randomized clinical
trials that looked at mechanical
bowel prep combined with oral
antibiotics did shownto reduce
SSI.
And then when you look at
(08:51):
different RCTs,
different definitions of early
liquids and early solids, but early
feeding in general has been shown to
reduce length of stay in randomized
clinical trials.
And then when the prior
study I mentioned
as part of the ISCR project looked
at the ERP bundle
of these six process measures
(09:12):
and they showed that the full
adherence to the ERP bundle
compared to partial adherence was
associated with better surgical
outcomes, particularly decreased
SSI, readmission rates,
and the length of stay.
And yeah, so it sounds like
a really complex relationship
that perhaps it's synergistic,
(09:32):
right? So the bowel prep is only
useful if it's combined with the
oral antibiotics,
the early liquid intake
and early solid intake.
It's hard for me to wrap my head
around how I would code
it because does one sip of
of ginger ale count as
early liquid intake.
How much of your meal do you
(09:53):
have to eat in order to
qualify as a check mark for
early solid intake?
Yeah. And I think I think that's
that that's a challenge.
So there, there are a lot of
different definitions of it.
And for the purposes
of our study, it was more of a
binary definition
of a yes or no if you took it or
(10:13):
whether that was documented.
But like I said, there's a lot
of variability in,
in kind of the literature about
what qualifies as early solids
and early liquids and where you draw
the line.
And a lot more studies are needed
to prove that.
And I assume the same holds true for
early post-operative mobilization.
(10:36):
There was no universal definition
of, okay, well you have to walk 50
feet or ten, ten meters or something
in order to qualify.
Yeah. So in our study, our
definition for mobilization
was ambulate at a distance
of ten feet or more, or
ambulate in a duration of two,
2 minutes or more, with or without
assistance of a walking aid.
(10:57):
That was the standard definition we
used in there.
But there in the literature, this
is not a standard definition.
I think everybody uses their own.
I see. Got it.
All right. Well, it sounds like
you you included a
smaller cohort.
So first of all, hospitals
who wanted to participate
(11:19):
in this, they're they're already
self-selecting anyway because it's
not mandatory and it's volunteer,
right? They're not getting
paid any support for this.
So they have to have some sort of
interest to begin with to even
participate. But with but if
I'm reading your study correctly,
out of the original 262
study hospitals that reported
mandatory process outcomes,
(11:41):
you only selected 151.
So it was even more selective a
cohort or subset.
And so we're we're
really looking at the most motivated
and interested and possibly the best
of the best. And yet they struggled
to to improve process
measure compliance.
Am I interpreting it correctly?
(12:02):
Exactly. Yes.
These are the hospitals that
were the most motivated that
you could assume, and
they wanted to make ERAS a success,
but found it more difficult than
anticipated.
And the reason we included 151
hospitals is that the initial
sample of 262 hospitals
volunteered, but a lot of them,
(12:23):
for a variety of reasons,
didn't continue to report their
process measure compliance.
So the 151 hospitals we included
reported cases in the
first or second month of their
cohort and through to their
11th and 12th month of the cohort.
So that's why we could see
improvement over time.
And the other hospitals for some
(12:44):
reason or the other,
decided not to continue to
participate.
I see. I understand.
But yes,
when you if we were to include
everybody, I think our study
essentially underestimates likely
how difficult it is
to implement ERAS.
And can you
maybe conjecture?
(13:06):
Can you can you sort of tell me what
what you think explains
why they had difficulty improving
their compliance?
I think one of the biggest
things we're finding is that
ERAS implementation
is similar to quality
improvement in
the surgical world, and
(13:27):
quality improvement and ERAS
implementation are very dependent
on your local context,
local context meaning your local
environment, the resources that you
have available, the time constraints
that you have, and
those things really affect how
you're able to do it.
So when when we look at
why certain processes measure
(13:48):
compliance, like
multimodal pain control
did better as compared to
early mobilization, I think
our assumption there
is that things like multimodal pain
control are simple interventions.
They require just
the one provider to
write a prescription that is well
(14:09):
documented versus early mobilization
is a more resource intensive
process measure.
It requires a multidisciplinary
effort. You need you need physical
therapists, occupational therapists,
nurses to
help mobilize a patient.
To document that mobilization
effort. You need advanced practice
providers, surgeons, residents
(14:31):
to encourage patients to ambulate
on a daily basis, and the patients
themselves have to be motivated.
All of this cuts across the entire
hospital and, like I said, bumps up
against resource constraints, time
constraints.
That makes it difficult to
improve.
So I think it's that local context
and resource availability that's
difficult.
(14:52):
Yeah, I completely understand
that.
So I, I also understand
how with these constraints in
place, it would be
reasonable to expect that compliance
remained unchanged.
But it looks like
compliance actually worsened in
in almost 30% of
of your included process
(15:12):
measures, which is cause for
concern.
If you believe that compliance
it will translate into into improved
patient outcomes.
Now, reading your methods, it
seems like you also at
the outset you excluded
opportunities
that had a baseline compliance
rate greater than 80%
(15:33):
in order to avoid a ceiling effect.
However, given that almost 30%
of your included process measures
had a worsening in compliance, is it
possible that some of your excluded
by compliance process measures
also had a similar decrease in
compliance over the study period?
Yeah.
So we did take a look at the
ones that we excluded to see how
(15:55):
they turned out.
And compliance did worsen for
in 30 to 35% of those
excluded instances.
But I think the important thing to
characterize there is that the
absolute change was pretty minimal.
So a hospital most likely
went from 92% to
90% or 92
to 91%, which is,
(16:15):
which, a 1% change is likely
not clinically significant, even
though it would be defined as
worsening compliance.
Got it. Got it.
All right.
So can I ask you I'd like
you to explain
or clarify something to me
about the statistical methods
that you used.
You used a logistic random effects
(16:37):
model using hospital as
random intercept and the subject
for a random effect of time.
Can you explain to me in layman's
terms the difference between a
random effects versus a fixed effect
model and why you chose to
treat the hospital and subject as
random?
A fixed effect model
assumes that an independent
(16:58):
variable has a constant
relationship with the dependent
variable across all observations.
While a random effect model
recognizes that data points may
have systematic groupings
that may cause the effect to vary
from one observation to another.
The reason we chose the random
effects model is that we believe
(17:19):
different hospitals have different
resources that are likely
to make their ability to improve or
change also be different at the
hospital level.
And since our aim was to look at
change over time, we
needed time to be random.
We needed hospital to be the subject
or grouping of that random effect,
and each hospital is likely to
(17:39):
have its own baseline.
So we included a random intercept
for that hospital.
Okay, I'm
going to try and wrap my head around
this, but if I'm understanding you
correctly, there's
something unique about every
hospital that
that is sort of specific
to that local environment which
(17:59):
makes it special.
And so it's kind of like a
clustering effect.
So the patients who
are treated within that hospital
are more alike to each other than
patients treated at another
hospital. Is that sort
of?
I would say it's it's not more so
the, the patients who are treated
are more alike.
It's that the hospital environment
(18:20):
is more alike.
And the resources the hospital
has is more alike.
So I think
I'm not a statistician
and this is simplifying it a lot.
But when you when you think about
fixed effects, think about, let's
say if you were to compare two
different race cars and
you're comparing a Lamborghini to
(18:40):
a Ferrari
and you're comparing acceleration
for those things, now that would be
looking at a fixed effect.
If you were to look at
a random effect, you'd be looking at
a lot of different types of
you would be looking at a sports
car, you'd be looking at a car that
we regularly drive on the road like
a Honda and Toyota, and
there would be those.
(19:02):
Essentially, those car models have a
systematic grouping that affects
their acceleration. So
that's know if that if
that makes sense.
Yep, thank you. Yeah that that's
that helps to clarify it in my mind.
I appreciate the analogy.
Thank you.
All right.
I know the the purpose or let's say
the the focus of this study
(19:24):
was on the compliance and process
measures. But did you have any data
about patient outcomes?
No. So there
are other parts of the
study with the actual project there
navigating the patient outcomes.
We specifically
decided to focus on compliance
because the literature around
compliance wasn't as
(19:46):
well developed as the one around
outcomes.
And so we really wanted to highlight
the implementation challenges
with ERAS, and that's why we decided
to specifically focus on compliance.
Mm hmm.
Yeah. There's this bridge
from knowledge to action, right?
There's a whole field of science,
implementation science that has
sprung up to try and help us
(20:07):
translate from the bench
to the bedside.
And if I'm not mistaken, the
Institute of Medicine said that it
takes about 17 years.
So
I think we're we've got a long road
ahead of us.
Well, let me ask you, what's what's
next? What are the next steps for
you as a researcher?
How are you going to build upon
(20:28):
your findings from this current
study?
So I think as I've talked about,
everyone involved with this
ISCR project was really passionate
about ERAS and they put in a lot
of effort.
And essentially what
the study highlighted was that the
implementation is a challenge in
that it's not a one size
fits all.
(20:48):
So we're really thinking
about looking at implementation of
each process measure as a
QI project in itself.
And our next steps are
to really figure out how to address
those implementation barriers and
provide resources to
healthcare providers to not
only better implement ERAS, but
also better conduct all different
(21:10):
types of surgical improvement
efforts.
And in in our work with
the American College of Surgeons, we
have already published
the first version of the surgical
quality Improvement framework
as well as launch the QI Basics
course that's going to support
providers in conducting better
improvement efforts, and we are
working on further developing these
(21:30):
projects.
So it's a lot of work towards the
implementation side of things.
Sounds like a lot of work.
And I am grateful that
you have the passion and the
expertise to to continue
this this important work.
Well, I really appreciate your time,
Dr. Shah.
Thank you for listening to the
Operative Word.
Please send us any feedback at
(21:51):
postmaster@FACS.org.
Thank you for listening to the
Journal of the American College of
Surgeons Operative Word Podcast.
If you've enjoyed today's episode,
spread the word on social media by
using the hashtag
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Subscribe to the operative word
wherever podcasts are available
(22:12):
or listen on the American College of
Surgeons website at
FACS.org/podcast.
Welcome to the Operative Word,
a podcast brought to you by the
Journal of the American College of
Surgeons.
I'm Dr. Jamie Coleman.
And throughout this series, Dr.
Dante Yeh and I will speak with
recently published authors about the
motivation behind their latest
research and the clinical
implications it has for the
practicing surgeon.
(00:22):
The opinions expressed in this
podcast are those of the
participants and not necessarily
that of the American College of
Surgeons.
Welcome to the Operative Word, a
podcast from the Journal of the
American College of Surgeons.
I'm Dr. Dante Yeh, one of
your co-hosts for this series.
In this episode, we'll be taking an
in-depth look into the current
(00:43):
article, Truth of Colorectal
Enhanced Recovery Programs (00:45):
Process
Measure Compliance in 151
Hospitals.
I'm honored today to be joined by
the author, Tejen Shah, M.D.
from the Ohio State
University Wexner Medical Center.
Dr. Shah, thank you for joining me
today.
Before we begin, do you have any
potential conflicts of interest to
disclose?
(01:06):
No, I don't have any.
Can you give us a brief summary of
your study design?
And describe to us your main
findings.
Sure.
So enhanced recovery programs
have largely become the norm
in perioperative care for
patients undergoing elective
colorectal surgery.
And there is a large amount
(01:26):
of evidence from large institutions
that have reported that
when you implement colorectal
enhanced recovery programs, you get
significant improvement in process
measure compliance, which is
about more than 20% improvement from
where you started. And your outcomes
significantly improve.
And so what we did in our study
was to evaluate improvement
(01:48):
uniformity among 151
hospitals that were exposed
to an eighteen month implementation
protocol for six
colorectal enhanced recovery
process measures which
were oral antibiotic prophylaxis,
mechanical bowel prep,
multimodal pain control, early
mobilization, early liquids
(02:09):
and early solids.
And this essentially was
part of a program
from the
ISCR, which
is the improvement
of surgical care and recovery
program.
And the idea
was to implement these and have
recovery programs across
(02:30):
hospitals in the in the United
States.
And so the 151 hospitals that we
looked at in our study, what we
found is that 85%
of hospitals in our sample
did not achieve substantial
improvement in their process measure
compliance.
And when you look at
the 151 hospitals times
the six process measures we looked
(02:52):
at, which comes out to
663 total
available opportunities for
improvement, 80% of
these opportunities did not achieve
substantial improvement.
The simple process measures
like multimodal pain control and
oral antibiotics improved
by 23 to 16%.
(03:12):
But more resource intensive process
measures like early mobilization,
early solids, early liquids
improved the least by 2 to
7%.
All of this highlights
the fact that implementation
of ERAS protocols is difficult.
ERAS protocols are not one size
fits all and that
(03:32):
they are very dependent on the local
context.
Great. Thank you.
That was a it was a great high
level introduction
to your study.
There's a lot to pick apart here.
We can drill down to a
lot of details, and I
have some questions.
But first, why don't we start broad?
Tell me some more about this
improving surgical care
(03:53):
and recovery, The ISCR
project.
How did it begin?
Who is sponsoring this project?
Where's the money coming from?
And on the at the local
level, at the site, who is uploading
the data?
So the Improving Surgical Care and
Recovery program is funded
by the Agency for Healthcare
Research and Quality, the AHRQ.
And this program is a collaboration
(04:15):
between the American College of
Surgeons, Johns Hopkins
Armstrong Institute for Patient
Safety and Quality.
And and and the AHRQ.
And the primary
aim, essentially, like I said, is to
accelerate the adoption of enhanced
recovery practices in the United
States across multiple
subspecialties.
Colorectal, OBGYN,
(04:36):
orthopedics, emergency general
surgery. By providing hospitals
with evidence based toolkits,
documentation, resources and
coaching webinars
in these hospitals
that participate in the program,
volunteer to participate.
And each hospital has their
individual surgical clinical
reviewers that extracted data
(04:58):
from their
from their individual
electronic health records using
standard data definitions and
uploaded them often to the ISCR
data registry, which is built
on the NSQIP platform.
Awesome. Thank you.
What do, what other previous
findings or publications
(05:18):
have resulted from this
collaborative project?
So Dr. Clifford Ko and Dr.
Elizabeth Wick are the principal
investigators in the ISCR program,
and Chelsea Fisher, who
was a clinical scholar at the
American College of Surgeons, have
published a couple of studies from
the ISCR project,
one that highlighted the
feasibility of implementing
(05:39):
enhanced recovery programs for
emergent colorectal surgeries.
So not just elective surgeries.
They've also looked at
how ERAS implementation is
dependent on the local environment,
the leadership commitment and the
culture, as well as
the association between
compliance to process measures
and outcomes for ERAS.
(06:02):
I see. I see.
So it sounds like a massive project
with a long history behind it and
presumably and hopefully a long
future ahead of it.
You know, ERAS has been
hot. It's so hot for
at least ten years that I can think
of probably longer.
And it's it's still
generating a lot of interest.
(06:22):
I see it as sort of taking
the logical next progression
in its evolution.
You know, these bundles
that that we're seeing, they start
out locally, they get some
external validity, and then we try
to scale up.
And from what I'm understanding from
your study, we're having some
(06:44):
difficulty with scaling up
with with getting the compliance
part of it.
You focused only specifically
on six process
measures. Can you remind me again
what those six were?
Yes. So the six pauses measures
we looked at were oral
antibiotic prophylaxis, mechanical
bowel prep, early mobilization,
(07:06):
early solids, early
liquids and multimodal
pain control.
All right. So these six
have...The problem with the bundle,
as you know, is that if
you show that the bundle works,
that's great. But what is the
relative weight
or contribution of each
of those individual bundle
(07:27):
components?
You know, that's that's been as a
trauma critical care surgeon, I'm
most familiar with the catheter care
bundles from the Peter
Pronovost studies.
I'm also
intimately familiar
with the sepsis care bundles.
We can talk about that a little bit
later. But have each of these
(07:48):
six measures
that you've examined, have they
been individually validated
as as having a positive
impact on patient outcomes?
Yeah. So the
ACRS and SAGES release their
colorectal ERAS guidelines in 2023
where they reviewed the evidence
behind 26 different
(08:10):
ERAS process measures.
And within these
26 there were six that
we looked at as part of our study
and they graded those six as
a 1b recommendation, which was a
strong recommendation with moderate
quality evidence.
And moderate quality evidence was
defined as randomized
clinical trials with some
limitations.
(08:31):
There are some nuances.
So randomized clinical trials
that looked at mechanical bowel prep
alone did not find
it to reduce surgical site
infections. But randomized clinical
trials that looked at mechanical
bowel prep combined with oral
antibiotics did shownto reduce
SSI.
And then when you look at
(08:51):
different RCTs,
different definitions of early
liquids and early solids, but early
feeding in general has been shown to
reduce length of stay in randomized
clinical trials.
And then when the prior
study I mentioned
as part of the ISCR project looked
at the ERP bundle
of these six process measures
(09:12):
and they showed that the full
adherence to the ERP bundle
compared to partial adherence was
associated with better surgical
outcomes, particularly decreased
SSI, readmission rates,
and the length of stay.
And yeah, so it sounds like
a really complex relationship
that perhaps it's synergistic,
(09:32):
right? So the bowel prep is only
useful if it's combined with the
oral antibiotics,
the early liquid intake
and early solid intake.
It's hard for me to wrap my head
around how I would code
it because does one sip of
of ginger ale count as
early liquid intake.
How much of your meal do you
(09:53):
have to eat in order to
qualify as a check mark for
early solid intake?
Yeah. And I think I think that's
that that's a challenge.
So there, there are a lot of
different definitions of it.
And for the purposes
of our study, it was more of a
binary definition
of a yes or no if you took it or
(10:13):
whether that was documented.
But like I said, there's a lot
of variability in,
in kind of the literature about
what qualifies as early solids
and early liquids and where you draw
the line.
And a lot more studies are needed
to prove that.
And I assume the same holds true for
early post-operative mobilization.
(10:36):
There was no universal definition
of, okay, well you have to walk 50
feet or ten, ten meters or something
in order to qualify.
Yeah. So in our study, our
definition for mobilization
was ambulate at a distance
of ten feet or more, or
ambulate in a duration of two,
2 minutes or more, with or without
assistance of a walking aid.
(10:57):
That was the standard definition we
used in there.
But there in the literature, this
is not a standard definition.
I think everybody uses their own.
I see. Got it.
All right. Well, it sounds like
you you included a
smaller cohort.
So first of all, hospitals
who wanted to participate
(11:19):
in this, they're they're already
self-selecting anyway because it's
not mandatory and it's volunteer,
right? They're not getting
paid any support for this.
So they have to have some sort of
interest to begin with to even
participate. But with but if
I'm reading your study correctly,
out of the original 262
study hospitals that reported
mandatory process outcomes,
(11:41):
you only selected 151.
So it was even more selective a
cohort or subset.
And so we're we're
really looking at the most motivated
and interested and possibly the best
of the best. And yet they struggled
to to improve process
measure compliance.
Am I interpreting it correctly?
(12:02):
Exactly. Yes.
These are the hospitals that
were the most motivated that
you could assume, and
they wanted to make ERAS a success,
but found it more difficult than
anticipated.
And the reason we included 151
hospitals is that the initial
sample of 262 hospitals
volunteered, but a lot of them,
(12:23):
for a variety of reasons,
didn't continue to report their
process measure compliance.
So the 151 hospitals we included
reported cases in the
first or second month of their
cohort and through to their
11th and 12th month of the cohort.
So that's why we could see
improvement over time.
And the other hospitals for some
(12:44):
reason or the other,
decided not to continue to
participate.
I see. I understand.
But yes,
when you if we were to include
everybody, I think our study
essentially underestimates likely
how difficult it is
to implement ERAS.
And can you
maybe conjecture?
(13:06):
Can you can you sort of tell me what
what you think explains
why they had difficulty improving
their compliance?
I think one of the biggest
things we're finding is that
ERAS implementation
is similar to quality
improvement in
the surgical world, and
(13:27):
quality improvement and ERAS
implementation are very dependent
on your local context,
local context meaning your local
environment, the resources that you
have available, the time constraints
that you have, and
those things really affect how
you're able to do it.
So when when we look at
why certain processes measure
(13:48):
compliance, like
multimodal pain control
did better as compared to
early mobilization, I think
our assumption there
is that things like multimodal pain
control are simple interventions.
They require just
the one provider to
write a prescription that is well
(14:09):
documented versus early mobilization
is a more resource intensive
process measure.
It requires a multidisciplinary
effort. You need you need physical
therapists, occupational therapists,
nurses to
help mobilize a patient.
To document that mobilization
effort. You need advanced practice
providers, surgeons, residents
(14:31):
to encourage patients to ambulate
on a daily basis, and the patients
themselves have to be motivated.
All of this cuts across the entire
hospital and, like I said, bumps up
against resource constraints, time
constraints.
That makes it difficult to
improve.
So I think it's that local context
and resource availability that's
difficult.
(14:52):
Yeah, I completely understand
that.
So I, I also understand
how with these constraints in
place, it would be
reasonable to expect that compliance
remained unchanged.
But it looks like
compliance actually worsened in
in almost 30% of
of your included process
(15:12):
measures, which is cause for
concern.
If you believe that compliance
it will translate into into improved
patient outcomes.
Now, reading your methods, it
seems like you also at
the outset you excluded
opportunities
that had a baseline compliance
rate greater than 80%
(15:33):
in order to avoid a ceiling effect.
However, given that almost 30%
of your included process measures
had a worsening in compliance, is it
possible that some of your excluded
by compliance process measures
also had a similar decrease in
compliance over the study period?
Yeah.
So we did take a look at the
ones that we excluded to see how
(15:55):
they turned out.
And compliance did worsen for
in 30 to 35% of those
excluded instances.
But I think the important thing to
characterize there is that the
absolute change was pretty minimal.
So a hospital most likely
went from 92% to
90% or 92
to 91%, which is,
(16:15):
which, a 1% change is likely
not clinically significant, even
though it would be defined as
worsening compliance.
Got it. Got it.
All right.
So can I ask you I'd like
you to explain
or clarify something to me
about the statistical methods
that you used.
You used a logistic random effects
(16:37):
model using hospital as
random intercept and the subject
for a random effect of time.
Can you explain to me in layman's
terms the difference between a
random effects versus a fixed effect
model and why you chose to
treat the hospital and subject as
random?
A fixed effect model
assumes that an independent
(16:58):
variable has a constant
relationship with the dependent
variable across all observations.
While a random effect model
recognizes that data points may
have systematic groupings
that may cause the effect to vary
from one observation to another.
The reason we chose the random
effects model is that we believe
(17:19):
different hospitals have different
resources that are likely
to make their ability to improve or
change also be different at the
hospital level.
And since our aim was to look at
change over time, we
needed time to be random.
We needed hospital to be the subject
or grouping of that random effect,
and each hospital is likely to
(17:39):
have its own baseline.
So we included a random intercept
for that hospital.
Okay, I'm
going to try and wrap my head around
this, but if I'm understanding you
correctly, there's
something unique about every
hospital that
that is sort of specific
to that local environment which
(17:59):
makes it special.
And so it's kind of like a
clustering effect.
So the patients who
are treated within that hospital
are more alike to each other than
patients treated at another
hospital. Is that sort
of?
I would say it's it's not more so
the, the patients who are treated
are more alike.
It's that the hospital environment
(18:20):
is more alike.
And the resources the hospital
has is more alike.
So I think
I'm not a statistician
and this is simplifying it a lot.
But when you when you think about
fixed effects, think about, let's
say if you were to compare two
different race cars and
you're comparing a Lamborghini to
(18:40):
a Ferrari
and you're comparing acceleration
for those things, now that would be
looking at a fixed effect.
If you were to look at
a random effect, you'd be looking at
a lot of different types of
you would be looking at a sports
car, you'd be looking at a car that
we regularly drive on the road like
a Honda and Toyota, and
there would be those.
(19:02):
Essentially, those car models have a
systematic grouping that affects
their acceleration. So
that's know if that if
that makes sense.
Yep, thank you. Yeah that that's
that helps to clarify it in my mind.
I appreciate the analogy.
Thank you.
All right.
I know the the purpose or let's say
the the focus of this study
(19:24):
was on the compliance and process
measures. But did you have any data
about patient outcomes?
No. So there
are other parts of the
study with the actual project there
navigating the patient outcomes.
We specifically
decided to focus on compliance
because the literature around
compliance wasn't as
(19:46):
well developed as the one around
outcomes.
And so we really wanted to highlight
the implementation challenges
with ERAS, and that's why we decided
to specifically focus on compliance.
Mm hmm.
Yeah. There's this bridge
from knowledge to action, right?
There's a whole field of science,
implementation science that has
sprung up to try and help us
(20:07):
translate from the bench
to the bedside.
And if I'm not mistaken, the
Institute of Medicine said that it
takes about 17 years.
So
I think we're we've got a long road
ahead of us.
Well, let me ask you, what's what's
next? What are the next steps for
you as a researcher?
How are you going to build upon
(20:28):
your findings from this current
study?
So I think as I've talked about,
everyone involved with this
ISCR project was really passionate
about ERAS and they put in a lot
of effort.
And essentially what
the study highlighted was that the
implementation is a challenge in
that it's not a one size
fits all.
(20:48):
So we're really thinking
about looking at implementation of
each process measure as a
QI project in itself.
And our next steps are
to really figure out how to address
those implementation barriers and
provide resources to
healthcare providers to not
only better implement ERAS, but
also better conduct all different
(21:10):
types of surgical improvement
efforts.
And in in our work with
the American College of Surgeons, we
have already published
the first version of the surgical
quality Improvement framework
as well as launch the QI Basics
course that's going to support
providers in conducting better
improvement efforts, and we are
working on further developing these
(21:30):
projects.
So it's a lot of work towards the
implementation side of things.
Sounds like a lot of work.
And I am grateful that
you have the passion and the
expertise to to continue
this this important work.
Well, I really appreciate your time,
Dr. Shah.
Thank you for listening to the
Operative Word.
Please send us any feedback at
(21:51):
postmaster@FACS.org.
Thank you for listening to the
Journal of the American College of
Surgeons Operative Word Podcast.
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(22:12):
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