- Hi everyone and good afternoon.
Thank you for joining us
today for our webinar title,
implementing the 2019
ASCCP risk-based management
guidelines for abnormal
cervical cancer screening tests
in your practice.
We hope you're all doing
well and staying safe.
My name is Nicole Nguyen, health educator
at the California
Prevention Training Center.
The CAPTC under contract with
the California Department
of Healthcare Services
Office of Family Planning
is sponsoring today's event.
So before we get started,
let's just go over some
quick housekeeping slides
so that you can join us.
So first,
make sure that you check
your audio and select
your desired settings to join
through your computer audio,
or to call in through your phone.
If your internet is shaky,
we recommend that you
call in through your phone
for the best possible sound.
And so please check to make
sure that you're able to see
the viewer screen with
the slides on the left
and the go-to webinar
control panel on your right.
And then under the audio tab right here.
When you click on this white
arrow to expand is how you can
choose at any time to change
your audio preference.
Again, if your internet is shaky,
please call in through your phone.
And then under here is the questions box,
where you can submit all
your comments and questions.
Also, the thing is you
can see this orange button
with a white arrow.
This is how you can collapse
or expand your dashboard
if it's taking up some real estate space.
You can close it and
then bring it back up.
Or if you accidentally click it,
this is how you can make it appear again.
So today's webinar will
take about 90 minutes
and will include time at
the end for our presenters
to answer your questions.
So please send in your questions
throughout the webinar and
our speakers will address
as many of them as possible
at the very end.
This webinar is recorded,
so any responses to
questions not answered today
by our presenters will be sent
out to participants later,
along with the recording
and the slide deck.
There is an evaluation at the end,
so please fill it out because
your feedback is extremely
important to us and it'll help
us to guide us in developing
our future content.
So now I would like to
introduce our presenters.
For our first presenter,
we are really excited to
have Dr. Michael Policar.
Dr. Policar serves as clinical
professor of obstetrics,
gynecology, and reproductive sciences
at the University of
California, San Francisco
School of Medicine.
From 2005 to 2014,
he was the medical
director of program support
and evaluation for the
family pact program,
administered by the
California department of
Healthcare Services
Office of Family Planning.
He currently serves as professor
emeritus of obstetrics,
gynecology, and reproductive
sciences at UCSF.
And then for our second speaker,
we are really thrilled and
excited to have Patty Cason
join us today.
Patty is a family nurse
practitioner, trainer,
and educator with a specialty
in sexual and reproductive health.
She has practiced for 38 years
in a wide variety of clinical
and academic settings and
is a contracted consultant
to training agencies, nonprofits,
and state departments of
health across the U.S.
Patty serves on the
ASCCP board of directors
and is a member of the
communications work group
that developed the 2019 risk-based
and management consensus guidelines.
Petty also developed the path
framework for person-centered
reproductive goals and
contraception counseling.
She's also an editor of the
21st edition of contraceptive
technology for which she
wrote a seminal chapter
on reproductive goals and
contraception counseling.
Other publications include
research and opinion pieces
and peer-reviewed journals,
nationally utilized,
online learning courses,
instructional videos,
textbook chapters, clinical protocols,
job aids, and manuals.
And with that, Patty and
Mike the floor is yours.
- Okay, great.
- Yes, so let skip.
- And thank you all for joining us.
I'm just waiting a second
for our slides to come up.
- So go ahead, Patty.
You can share your screen now.
- Okay, here we go.
Next.
Okay, we don't have, well,
our disclosures you've heard about.
Patty is a member of
the board of directors
of ASCPP and I have no disclosures.
These are our objectives for today.
Next slide.
But I do wanna start
with a little bit of a,
an outline to tell you
how we're gonna do this.
So we've just finished the
welcome and introductions.
I want to say a word about
sort of the evolution of these
policies as they relate to
the family pact program.
And then I will give you a
very quick roadmap through
the quite comprehensive,
2019 ASCCP guidelines.
Then I will hand the
microphone over to Patty
who will tell you about
how to obtain an use
that ASCCP app, about the
guidelines themselves,
and then I'll close with a few words about
implementation of the
2019 ASCCP guidelines
in your practice.
And then you'll have lots of time,
hopefully for questions
and answers afterwards.
I've been associated with the
family pact program all the
way back then 1996.
There are a few of you in
the audience that might
remember when this was called
State Only Family Planning,
even before we were the
family pact program.
But if we go back almost
25 years or so, cervical.
I should say screening for
cervical cancer has really gone
through so many really
significant changes during
that time period.
When family pact first started in 1996,
remember that cervical
psychology with screening,
screening was done once a year.
Women basically had annual pap smears.
And of course now the much
more standard benchmark
is every three years or every five years.
Second is the fact that we
did cervical cancer screening
for sexually active women of all ages,
including young teenagers
who hadn't even started
their sexual activity yet,
or soon after a sexual debut.
And of course,
now we don't start until 21 years of age
for the large majority of them.
Most of you remember the
days when cervical cancer
screening was a matter of
taking a sample from the cervix,
smearing it on a glass slide,
and that was read by a cytotechnologist.
And nowadays we use much higher
tech approaches to screening
both with liquid-based cytology
and with high-risk HPV testing.
Well, lastly, you might remember that
back in the late 90s, early 2000s,
that all grades of
cervical dysplasia or CIN,
including CIN one were
treated with cryotherapy,
and of course now we
don't do that any longer.
So since then family pact,
of course added liquid-based cytology,
high-risk HPV-alone screening
and co-testing years ago.
Nowadays the large majority
of cervical cytology samples
are read in a computer-assisted
format and then re-reviewed
by a cyto-technician
sometimes cytopathologist.
But I do wanna mention that
from the very beginning,
family pact has followed ASCCP guidelines
for the management of
abnormal cervical cytology
and abnormal histology
obtained through colposcopy.
And of course, with this version,
we continue to do what
we did with the 2000,
with the earlier guidelines
that were just mentioned.
Now, one of the things I
wanna say upfront is the fact
that we will not be talking
about cervical cancer screening intervals,
or the technologies used to
screen for cervical cancer.
This is gonna be focused much
more on managing abnormals.
But I do wanna remind you
that we published a clinical
practice alert in February of this year
on cervical cancer screening
that talks about the age
ranges of when to start
and when to stop screening intervals.
Specific regular, I should say policies
that have to do with screening
people who are HIV positive
or immune compromised.
And in a fairly comprehensive
listing of the family pact
cervical cancer screening benefits.
So if you were to click
on that link below,
you would be able to find the,
the clinical practice alert that has to do
with screening policies of family pact.
Now I just wanna take you
on a very quick roadmap,
of the content of the guidelines.
They are published in
two separate articles
that we've referenced for you,
and it contains about
seven or eight sections.
And the reason that I wanna do this
is because of the fact
that I was so impressed
about how comprehensive
these guidelines are.
They're not only an update
of the 2012 management guidelines,
but in addition to that
draw from other guidelines
and bringing them into this one.
Probably the best example
of that is how to manage
the results of HPV-alone screening.
So it starts with an executive
summary and introduction.
Next.
Then it goes through their
recommendations for a variety
of circumstances when people
should go through surveillance
or have colposcopy or when
they should be treated.
Next.
The next section has to do
with pathology reporting
and laboratory tests.
And here there's a section
that has to do with the fact
that, of course, we've used
the terms low SIL and high SIL
for well over a decade as
they relate to cytology.
Now they're very diff, very
definite about the fact
that they want that to
pertain to histology.
That is to say biopsies as well.
The next part of that
section has to do with
some of the policies
and guidelines regarding
primary HPV screening,
also referred to as HPV-alone screening.
And it replaces the earlier
guideline from 2015,
that was referenced in the PTBI.
Next.
- I did wanna add that
while the last terminology
has suggested that we
prefer LSIL and high SIL
for histologic results.
You're still gonna be receiving results
that are or CIN one, CIN two, CIN three,
or CIN two slash three.
So these results will
still be coming to you
and in many cases,
the pathologist will also say
whether it's LSIL or HSIL.
- Great. Thanks Patty.
Next slide. Oh, okay.
Next is management of
rare cytology results.
So the ones that we see
really infrequently.
AGC unsatisfactory cytology,
absent transformation zone on psychology.
Benign endometrial cells in
both premenopausal patients
and post menopausal patients
are all covered as well.
Next is a section on the
ASCCP colposcopy standards,
which were finalized a couple
of years ago by ASCCCP,
and are really excellent
guidelines that basically set
a floor and a ceiling on
how to provide high quality
colposcopy services
and really worth a read
if you haven't seen that part already.
Next.
- Yeah, I just wanna
underline that three times.
There are so many changes
that are represented
in these standards.
And if you haven't been
to a meeting recently
or been to a training recently,
you'll be surprised by how
many things have changed
over the years based on the data.
- Yeah.
Thanks.
Next section is management
based on biopsy results.
And you can see the whole
listing of the kinds of results
that might come back after a colposcopy.
And, letting you know,
mostly through algorithms,
but not entirely about how
they should be managed.
The next section has to
do with surveillance after
abnormalities, both short term
and long term surveillance.
And this area has changed
quite significantly
as Patty will explain.
And then the last dimension
is advice about management
and special populations.
Those younger than 25,
management during pregnancy,
management of females
with immunosuppression,
which is important.
ASCCP did a statement
on that a few years ago.
Now it's integrated into
this guideline and then
on management for females
that are older than 65
with prior abnormalities,
also a very significant change
that Patty will explain.
- I wanna add that in terms
of special populations,
maybe we don't think of it
as a special population.
But a lot of attention was
paid in the consensus meetings
to people that want to be
doing everything they can
to preserve their fertility.
So this comes to a question
of what type of treatment
or if there will be treatments.
So that is a special
exception in many cases.
- Yeah, great.
That's always such a
tough clinical dilemma.
I'm glad they clarified that.
- They spend a lot of time with it.
- Okay.
So from here, I'm going
to hand this over to Patty
to tell us about how you'll be able to use
these new guidelines and
also a look under the hood
about why they're written
the way they are, Patty.
- Thank you.
That was great to tee all of this up.
So there is an app it's brand new.
It really has virtually nothing
to do with the prior app.
So don't expect it to look
like or act like the prior app,
if you have that one.
You'll also have to pay for
it again, and I'm sorry,
that's been the thing that
people complain about most.
It's got to put a lot of
information into one app
and make it easy for you.
So we tried to do it as best we could.
So let's get into it.
If you'd like to follow
along, it's always best.
If you're wanting to use this,
use this app in your practice,
it would be best if you
could download it now.
And then as I'm talking through this,
you can go follow along with me.
So if you go to your search
field in either your Google Play
or your app store it on an iPad device,
and these are only available right now
through mobile devices.
So they are not yet on the website.
This exact same app essentially
will be on the website
and it will be free, but
it's not available just yet.
It should be pretty soon.
So hopefully before the end of August,
hopefully even the end of July,
if we're really lucky.
So you just go to the
search field in whichever
mobile device you're using
and type in ASCCP guidelines,
this will come up and
you're just gonna open that.
And then when you start to use it,
the first page you're gonna see is for you
to enter their demographics.
So it's the age, and then after that,
you're gonna look at what
the clinical situation is.
So first you put in the age,
then you look at clinical situation
and this is confusing for some people.
But if you look at each of the things
under the clinical situation.
I'm not gonna talk about
the ones at the bottom
'cause they're fairly obvious.
But I'm gonna show you what
each of these line items means.
So management of routine
screening results,
as you can imagine,
is telling the app what the results
of your primary HPV
screening or your co-testing,
or much less recommended your
cytology result goes in here.
So first you say management
of routine screening results,
then you click next.
It won't allow you to click next,
unless you've filled in
whatever information is required
before you go to the next screen.
So that's going to help you.
It defaults to no prior screening if.
So if there is no prior tests,
that's gonna be put into the
app when you're using it,
then you don't have to
check no, it defaults to no.
But if the person has any prior results,
this is quite important.
It's important to put them in
because it changes the recommendation.
And that's one of the major
changes with these guidelines
is that the prior testing
plays into figuring out
what the percent risk is for things.
So if they don't have a prior test result,
you just click next.
And if they do have prior testing,
you go ahead and put it in here.
And then you will say at
that point is the book
default to no again, and
then you'll just click next.
I wanna point out that when
you get to the very end
and it gives you the recommendations
and the references and the percent risk,
and sometimes it also
gives you an algorithm.
When you get to that page,
you can always start over.
But if prior to the last page,
you'd like to go back to the
beginning and start over.
You only have to click on
management and it will ask you,
do you really wanna start
over, and you say yes,
and then it brings you to the beginning.
So after that, you're gonna
come to a confirmation page.
There's nothing that you will
be inputting into this page.
This is really just to double check
that you put everything in properly,
and then you're gonna have next.
Sorry.
My, my next is not working on
my computer all of a sudden.
So then it'll give you this
lovely recommendation page.
Now this,
I wanna say that one of the
things that's not great about
this is that if you have a
patient who has been managed
incorrectly, according to the guidelines,
sometimes they will punt
and not give you an answer.
So sometimes what they'll say is
this was not handled properly,
or this person was supposed
to have had X or Y.
So that's one thing you're
gonna run into, in some cases.
Hopefully the person has been
managed properly up until now.
Then it'll give you the recommendation.
It'll also give you this
percent risk down at the bottom,
which is, I'm gonna be
explaining in a moment.
Okay, so it's gonna give
you the recommendation,
the percent risk,
and then you're going to
go ahead and start over
if you want to.
But if you, but if what you
want to do at that point is
to see why they're giving
you these recommendations.
It'll provide you a
hyperlink to get you to
one of the two articles,
about the new guidelines that basically
explain all of the data that
went into the new guidelines.
And so it'll give you that
as well if you want it.
So if the person is being
followed after an abnormal test
or an HPV result, but they
haven't yet had a colposcopy,
that's what this particular
line item is for.
So you've got somebody
they've had screening,
they had abnormal testing.
You've gone ahead and done
whatever that followup
recommendation was, and now
you've got those results.
So I wanna be really clear about this,
this isn't right after the
person has had the abnormal test,
that information you will have gotten
from the prior line item.
This is for people who have
already had an abnormal,
and you followed them
with the repeat in a year
or repeat in three
years or whatever it was
that was the recommendation.
And then at that point, you
need to know what to do next.
And so that's what this is for.
And it will give you a
percent recommend risk
and recommendation as you'll see here.
This is actually gonna now
be whether the person gets a,
because of the results.
I left the one on the left blank,
because there are many different results
that could bring you to colposcopy.
But the point here is
that once they give you
a recommendation of colposcopy,
and they give you this percent risk.
This shows you where on
the spectrum of risk,
your patient lies in terms of,
would it be beneficial to
not only do a colposcopy,
but to go ahead and do
expedited treatment.
Big change in this set of guidelines,
than in the 2012 is
the expedited treatment
is actually recommended in some cases.
So once you know the pathology results,
you've done a colposcopy,
you've had several biopsies,
hopefully not just one.
Do we have a?
- Yeah I have to make
a quick clarification.
So expedited treatment,
is that the same as see and treat leep?
- That is the same as see and treat leep.
Yes.
- Okay.
- Thank you, I should have clarified that.
So it's, so what you're
gonna be doing at this point
is you're gonna wanna
know what to do next.
So do I go ahead and continue
to follow this patient,
or do I treat this patient?
And if so, do I use ex,
must I use excision,
or can I either use excision,
or a treatment that doesn't
actually give me a specimen
to look at afterwards?
And so you will have put in one of these
before it gives it to you.
So this is how it lays it out,
and these are your options.
And you'll see that they use
the last technology of each SIL
and then they give you
the old terminology,
CIN three, for example.
And then they'll give you
one of these three pages.
And either they'll recommend
that you follow conservatively,
which is the algorithm on the left,
or they're going to recommend treatment,
or sometimes they'll give you
an option depending on what
the patient preferences.
There is a lot of attention
paid to share decision making
in these consensus guidelines.
So how, that's all on the app,
this just popped forward all by itself.
But how were these guidelines updated?
So this is really something
we're proud of is that we had
a very large number of organizations,
both medical professional societies,
but also patient advocacy groups.
So we had these patient advocacy groups
and they were quite involved
with the guidelines.
They really were instrumental in bringing
to the conversation with
issues that patients
are concerned about as primary.
So that's a really,
that's a pretty big shift
from the way things have
been traditionally handled.
We also had the CDC and the NCI.
The NCI was actually very involved,
with these guidelines.
Both in terms of the
data that they brought,
but also the way that they
helped to process the data
that we've, the data we
have from the databases.
They were able to help us
with those risk assessments.
And you can see there
that that's a very large
group of organizations.
So let's talk, let's back
up for just a second.
And I wanna say that there's
a lot of confusion frequently
about why we do screening.
I think we wanna be very clear.
Why do we do this?
Why do we want our entire
population to be screened
for cervical cancer?
It's not screening for cervical cancer.
So I just wanna say that first up.
What it's for is actually
to find precancer,
so you can treat precancer.
So the person doesn't get cancer.
So we're not really,
we don't want to know about
an incident HPV infection.
We don't want to know
about things that are going
to just cause anxiety,
but never lead to any
kind of disease process.
So what we really,
the goal of all of this
is to find precancer.
So precancer is generally
considered to be high SIL.
So it will be CIN two or
three and not low grade
and not CIN one.
Those are considered to
be pretty synonymous if.
I'm not gonna go a hundred
percent with synonymous,
because there's some amount
of disagreement about this.
But it's fairly true to say
that there's when there is
a CIN one or low SIL result.
We generally consider that to
be representing an incident,
HPV infection, an HPV
infection that was destined
to go away by itself.
So fundamental concepts,
HPV is the cause of cervical cancer.
So now that we know that
it's very reasonable to focus
on HPV as the thing that
we need to prevent or treat
in order not to have the
person develop cancer.
And it's not just
cervical cancer, honestly,
there's HPV obviously
causes head neck cancers,
and anal cancers and bulbar
cancers and vaginal cancers.
But we're for today
talking about the cervix
and HPV by itself as
an incident infection,
is almost always dealt with
by the person's immune system.
So it is almost never actually
gonna become a problem
for that person.
When it doesn't go away by itself,
and I say go away by itself meaning
your immune system is handling
it and getting rid of it,
and you don't, you know, you
can't do anything about it.
Did I hear another?
Okay.
So not only do you need
to have HPV to get cancer,
you need to have HPV that has persisted.
Because HPV that's presented
to the body's immune system
and the immune system handles it,
actually won't ever have caused a problem.
HPV that the person becomes
infected with and doesn't
get taken care of by the
immune system will over time,
and sometimes the short
period of time be incorporated
into the genome of the
cells, and it will actually
start to become
carcinogenic at that point.
And that takes a long time
to progress to cancer,
but it doesn't necessarily
take a long time for it to go
from an infection into
something that is a precancer.
So in addition to time mattering.
So in other words, an infection
that somebody got last month
or six months ago, you really
don't wanna know about.
An infection, somebody got five years ago,
you very much want to know about.
So time matters, but type matters also.
Type 16 is by far the most virulent,
most dangerous and
associated with most cancers.
18 is also one of the
really more concerning ones
because of its association
with cancer and adenocarcinoma,
not as much because it's the
big player that HPV-16 is.
And then if you know the person's current
and past HPV status.
Then you really actually know the majority
of the information that you need
in order to know what next
steps are gonna have to be.
Because that person's risk
is very, very much informed
by what their HPV status is today and
what it was the last time you checked it.
And then if you wanna just
sort of think top level broadly
and wanna give yourself a
cheat sheet, essentially.
If the person has had
two consecutive HPV tests
that were positive,
regardless of genotype,
just two that are positive,
even if they're not HPV-16.
The person will go to
colposcopy in every instance
that we're gonna see.
So that's just a cheat sheet.
If you know, your patients
has just had two HPV tests
in a row that were positive,
you don't necessarily have to use the app.
You can go ahead and do a colposcopy.
So we talk about persistence.
We talk about incident infections.
So many of us get HPV,
the vast majority of us.
If we're having sex of
any kind with anybody,
we're probably going to get HPV
and our bodies are gonna get rid of it.
So that's that really wonderful
swath down along the bottom,
and you can see that by two, three years,
the vast majority of people
have cleared their HPV.
Then we come to this yellow portion.
Obviously in the beginning,
we can't say that it's persisted because
it's zero time point.
But as time progresses and the
person's HPV, doesn't clear,
you'll see that right
above that big yellow swath
is a little pink swath, that's
getting bigger and bigger.
So that's when somebody's persistent HPV
has caused whatever is going
on cellularity on the cervix
to be high grade, to be pre-cancer.
And if you don't at that
point, treat that high grade,
that precancer, then
over some period of time,
it will go to invasion.
So the new guidelines really
clearly prefer HPV testing.
And this is a departure, this
is one of the big departures.
If the person doesn't have
access to HPV testing,
for some reason, then
cytology alone is acceptable.
But if that's gonna happen,
you have to do cytology much
more frequently than you have
to do HPV testing because of
the sensitivity of the test.
So if for example,
cytology is recommended,
excuse me, HPV is recommended annually.
When we say HPV testing,
it means the following
either just an HPV test
with the ability to then
reflex to a cytology,
if you have a positive,
and to reflex to genotyping typing,
to tell you whether you've
got a 16, 18 or not.
So that's what we mean when
we say HPV-based testing
either just the HPV test alone
with the reflex to the other
tests says if it's positive
or HPV test plus cytology
at the same, in other words a co-test.
So if that is being recommended annually,
because the person has
had a prior abnormal,
and they're going to this
much more intensive followup
of annual HPV-based screening.
Then if they didn't have
HPV-based screening,
they only had cytology.
We're gonna be asking that to
happen at six month intervals
for example, or if the
HPV co-test is recommended
at three year intervals,
then cytology will be
recommended annually.
And the reason for this is that it's just
not as good of a test.
It's gonna pick up less disease initially.
And I'm gonna show you
some numbers about that
in just a minute.
So another really fundamental concept,
not just with cervical
disease process in general,
but specifically around these guidelines,
is that everything that is
put into the recommendation,
is gonna, everything that goes
into the recommendation is
going to significantly change
what that recommendation is
depending on what the result is.
So it's not just the current results,
it's the past results as well.
So if you have an unknown
history, that's also significant.
So that's information unknown or something
that was abnormal or normal.
That's what you put into the
app, if you're using the app
and that's what was put
into the decision tree
to figure out what was
gonna be the next step.
So if we look at this are our
pretty little rainbow here.
The box at the top it says
expedited treatment preferred
is essentially representing
the highest risk,
either combination of biopsy
and pap or the highest risk
person based on their past results
and their current results.
And then we go all the way
down to the very bottom
and we've got in blue,
a return in five years.
So that's somebody who is
essentially at the risk
of a general population that has,
that's not in a management paradigm.
General population that
does not have a history of abnormals.
And then everything in between.
And it gives you,
you can see here that
it gives you sort of,
how to think about this percentage wise.
So the percent risk is the
thing that you'll see right
at the beginning.
So up at the very, very top.
If the person has a 60%
risk of having CIN three
of having high grade disease,
that's why expedited
treatment is preferred.
And if the person has a less
than 15% risk of having CIN
three right now, that's
what we expect is going on,
when we offer screening recommendations.
In other words,
you screen an asymptomatic
population with no disease,
and we expect a less than 0.15 risk of
the person having current CIN three.
How did we, how did they come
up with these guidelines?
It was based on the data.
The data was based on databases
and the major portion of the
information that was used,
the database that was used
was from Kaiser Permanente.
It was over a hundred,
1,500,000 participants.
They were just people who
were having their testing
at Kaiser Permanente.
And there was a very large
number of these that also
had HPV genotyping.
And this was over quite a
long time span, over 14 years.
And, it gave us enough
in terms of data points.
So the database was large
enough so that we could really
start to parse out minor
differences in percent risk,
and make sure that what
we're doing with management
is appropriate in terms of
the risk that we were able to
then calculate based on this.
And if the person has a past,
that was all negative screening
and they have been well screened.
That's also important
information because you can have
a longer length of followup in that case.
So you might ask Kaiser
Permanente patients
are well a screened population.
Kaiser Permanente is a enclosed system,
and people generally are that, you know,
they're generally getting
very standardized follow up.
So it is by definition, a
well screened population.
So we didn't know,
is this population really representative
of the United States?
Can we really make national guidelines
based on this population?
So two other databases,
one with 450,000 and one with
200,000 and then another,
with 150,000, which was really
part of the same database.
So CDCs national breast
and cervical cancer,
early detection program had
one part of the database
of people that were
rarely or never screened
or inadequately screened.
And then the other
portion of the population
were well screened.
So the nice thing about
this is that these databases
came up with really very
similar risk cutoffs,
and so there really wasn't discrepancy.
What that tells us is that
regardless of the population
being screened within the United States,
we think that these guidelines
should be appropriate.
I think that's a really
important part of this.
A lot of providers that I
talked to have a sense that
they're going to protect
their patient better
if they do something
other than the guidelines,
because their patient is special,
because their patient has
had a lot of sexual partners,
or something else of that
lifestyle, they've had STDs.
Not that they've had a past
history of a positive HPV test,
but that they have some risk
that you're concerned about
or a new sexual partner,
which definitely is not a
reason to do a new screening.
It's actually the opposite.
Because remember I said,
an incident HPV infection
is destined in the vast majority of cases
to go away on its own.
So we don't want to find
something that was never
going to be a problem for the person.
So all of these people in
all of these populations
that were represented here,
have a wide range of sexual,
number of sexual partners,
number of sexually transmitted infections,
whether they smoke or not,
what they have as risk factors
for all kinds of other diseases.
This was a very varied population.
So I would urge you to
think not to specialize
your treatment with
patients that you perceive
to be high risk.
Because remember in
all of these databases,
the thing that was really
showing up as what was going
to predict the person's risk
was their HPV status currently
and their prior HPV status,
not sexual behaviors.
So are there other risk factors
that influence pre-cancer development?
We know that smoking does right.
We know that if you've been
vaccinated from it against HPV,
that's gonna have a huge impact.
But, interestingly, all of the
things that we think may have
some contribution to increasing
risk have not been shown
to actually alter it enough
to do anything special
about them in the guidelines
other than HPV status.
Now, one would say we have
HPV vaccination available
in the United States.
We're trying to have our entire
population immunized against
HPV as they move past
childhood into adulthood.
So unfortunately we don't have that.
We want to have really good
HPV vaccination coverage
in the United States,
but we don't have it.
So the decision was made
because there just isn't enough.
There aren't enough
people in the population
who have been vaccinated.
We don't have enough to justify
actually putting that in
as an exception within the guidelines.
Because if 50% of eligible
just female first doses
was achieved in 2015,
that's really not enough
of the population yet.
But we're expecting as things
get better in terms of having
our population vaccinated,
then we're gonna be able
to change the guidelines.
So that should happen fairly soon.
The colposcopy threshold is 4%.
So if when you put in the
patient's results and demographics
and you come up with a percent
risk of anything over 4%,
that person should go to colposcopy.
So that's just something
to think, to bear in mind.
That was the level of risk
that was determined to be
most likely to pick up current pre-cancer.
So that would be down here
if it's just colposcopy.
In other words,
if it's between 4% risk of
having current high grade disease
and 24% risk of having high grade disease,
then the person's going to be recommended
to go to colposcopy.
And colposcopy according to
the colposcopic standards
that ASCCP put out.
For example, one of the main differences
with the way colposcopy should be done
from the way it used to
be recommended to do it
is to do multiple biopsies,
at least two, three biopsies.
And that's a really big
departure for some people
in the way they practice.
So if you are above 4%, if
your patient is above 4% risk,
it's recommended that
they go to colposcopy
and you can see here, this
is how the numbers work.
Two examples,
one would be ASC-US with the
HPV positive, over 4% risk.
A low SIL with HPV
positives, also over 4%,
that's why they're highlighted in red.
And importantly, we think
of, ASC-US low SIL results.
Even if they have positive
HPV associated with them
as low grade results.
They're most likely in
most cases associated
with incident HPV infection
or with lower risk,
less virulent strains of HPV.
Sometimes you see changes, and
this is a little confusing.
But sometimes you see
changes on the person cervix
that are based on a low grade, excuse me,
a low risk strain of HPV that.
So the person's HPV test
might show negative,
but they've got this sort of
simmering CIN one for a year
or so two years until the body has cleared
that low risk strain.
So it's a little confusing.
So that's why we just go with the results.
We don't try to figure it out.
Well, wait, how could that be?
If they have a negative HPV
and they have a positive,
low SIL, and then they ended up
after having that many times
they went to colposcopy.
Don't try to figure it out
because there are so many strands of HPV.
The important thing to know
is that no low-risk strains
caused cervical cancer.
So they can't cause precancer
that will go on to cause cancer.
Anytime we test for HPV we're
testing for high-risk strains.
But what happens to the same person,
who's got the positive
LSIL or a positive ASC-US.
In other words, positive HPV with ASC-US
or positive HPV with LSIL,
low grade changes that we, as I described.
If they had a prior
negative HPV-based screen.
So if they had a negative
HPV private prior,
their risk goes from over 4% to under 4%.
So this is a very large
cohort of people that now
do not need colposcopy
that needed it before.
Well that the guideline is
for them to have colposcopy.
Whereas the guideline would have been not.
Now the guideline says that
they should not have colposcopy,
previously it would
have said that they did.
So this is great.
We don't wanna do more
colposcopy than we have to.
What we, our real goal is
to get as close as possible
to doing colposcopy in
people that have pre-cancer
and not having to put
somebody through colposcopy
if they don't have it.
So if the person does have
one of these low grade changes
and they've had a history of
a negative HPV in the past,
you can go ahead and extend
their time period before they
get a colposcopy.
And if that subsequent result is positive,
at that point, they
would go to colposcopy.
Now the immediate risk of having HPV-16
with a low grade change is very different.
And you can see that in, the 5.3, 6.7,
these are higher than the
low like fours percentages
in the fours that you saw when
it was just HPV in general,
that was positive, not
specifically HPV-16.
And for this reason,
HPV-16 is, it stands out and
it's alone in the guidelines.
18 for other reasons,
but 16 is in the
guidelines as an exception.
And this is why,
because it is associated
with much more precancer
and much more cancer.
So we really want to be
able to not to treat people,
not to test people with a
colposcopy and biopsies who are
not destined to have precancer
and to absolutely focus
our resources on those people who,
and whom we have found precancer,
or we know that we need
to look to find out
if there is pre-cancer.
So the concepts are similar
to the 2012 guidelines,
when we really were making that
effort to get fewer people,
having to have colposcopy
that was to come to nothing.
But to be able to really
focus more intensive followup
in the people that had
high risk changes found
on their colposcopy.
And this is one thing I find
very helpful when talking
to patients about it.
Because it seems to people
sometimes that we're doing less.
And that can seem to them
like we're trying to do this
on the cheap, we're trying to ration care,
so we don't give them
what the best care is.
And this really is not what
this is, what we really
have been trying to do ever
since 2012, and even before,
when we were developing the
2012 guidelines, is to prevent
somebody from having
to go through something
that's potentially traumatic,
that they don't need,
that they don't have to have.
And the justification I use
with patients that's really
helpful is to explain that
were something to be detected
on this screen that you're
having, that was significant.
We're gonna do a lot
more followup on you now,
because now we understand the risk more.
So we're gonna be, assuming
that you don't have
a big problem,
and we're not going to be
subjecting you to tests
that you probably don't need.
And on the other end, if
you do show a problem,
we're gonna be all over it.
And this is why we wanna focus
the resource of treatment
in particular, on people that
have the highest risk, right.
So when we talk about treatment,
what's the most aggressive
treatment see and treat, right.
So that was what we were talking
about expedited treatment.
So the reason why we have
this expedited treatment
is that as you can see,
if the person has any high-grade pap
with a positive HPV of any kind.
So if the person has CIN
three on their pap, I'm sorry,
high grade on their pap, and
they have a positive HPV test,
any positive HPV test,
any high-risk HPV test
that's positive.
They have a very high over 50%,
60% risk of actually having
a precancer that day.
And if you have done a
genotype and you know,
that that HPV test is positive for 16,
they have a greater than 75% risk,
which is why expedited
treatment is now recommended
first line for these folks.
And this just breaks down
the clinical action
thresholds essentially.
So this is the immediate risk
of a pre-cancer for somebody.
If it's below 25, then colposcopy
and biopsy is preferred,
and then if it's,
in other words, preferred
over expedited treatment.
And if it's in that intermediate range,
over 25% risk, but under 60%
risk 'cause 60% is the cutoff.
Then, you could do
immediate see and treat
expedited treatment.
But it's, so it's acceptable,
but that's not the
recommendation as the first line.
Obviously they would want to
have a colposcopy and biopsies,
but they don't,
it's not preferred for them
to have expedited treatment.
And then you flip it when the
person has a less than 60,
excuse me, an over 60% risk.
You flip it, and now expedited
treatment is preferred.
When we say treatment in
this case, it's excision.
So it's not ablation.
You're not just treating
with cryo or something
or a laser where you're treating,
but won't have a specimen.
You're doing something where
you're going to have a specimen
to send to the lab, if you're
gonna do see and treat.
So that would be leep, cone,
a laser that actually
gives you a specimen.
So we're talking about
people having see and treat
means that you're doing this before
you have a confirmatory biopsy.
So this requires shared decision making.
You need to explain this to the patient.
We will have a biopsy to test,
but we won't know for a fact
that you had something going on
that we need you to treat
until we get that back.
But you will have already been treated.
Other changes, HPV testing at
six months after a high grade.
So a treatment of high grade.
This is a change and then
annually for three years.
So this whole intensive
followup after being treated
for high grade is more
intensive than it used to be.
And then here's a really big one.
This is gonna be probably
for people who see patients
who are post-menopausal and
older, the hugest change.
Which is for anyone who has had
disease treated in the past,
and that's a lot of people.
They will continue to have screening,
surveillance screening,
not every five years, every three years.
Every three years for at least 25 years.
And we don't expect that
it's going to ever be less
than 25 years again.
Because the data as they're
accruing are showing that
the risk at 20 years and the
risk at 25 years are the same.
So we expect that the
risk, there's some degree
of increased risk for the
lifetime of the patient,
if they've been treated in the
past for high grade disease.
So what about your patient
who has another condition
that doesn't give them
a long life expectancy?
Please stop screening those people.
Please stop doing any kind of intervals
of any interval of treatment,
excuse me, screening
for people who have a
shortened life expectancy,
because of whatever
comorbidity is going on.
So also we said,
if the person's going
to have a see and treat,
an expedited treatment.
Then you wanna have excisional,
you don't wanna do ablative.
But in general now the guideline
is preferring excisional
treatment over ablative treatment.
If the person has a concern for
or has AIS, excision always.
So in other words, if there's
no personal insight to,
or there's some concern about that,
then excision is always
going to be recommended.
And then very also importantly, CIN one.
There was a lot of
conversation in the meetings
about would we go out
and clearly say CIN one
is most likely representing
a transient HPV infection,
please don't treat.
Which is how the members of
the consensus guidelines group
felt about it, if it were
they that were to have it.
Because in terms of medical
risk, that the person is really,
probably not at a very high risk.
If they are only having
persistent CIN one,
nothing showing anything high grade.
But then we come to the patient.
The patient is having CIN
results over and over again.
They're going through,
they're having coming in
and having repeated procedures
and having a repeated testing,
and this can be very wearing.
So at some point, a patient
may want to be treated.
We'd like to ask you not to do that
any sooner than two years.
And I mentioned that HPV-18 is special.
So is atypical glandular cells,
even if it has an HPV
negative associated with it.
And then clearly ASC-H,
so this is something where,
there were not enough high grade cells for
the cytopathologist to say
that this is a high grade lesion,
or high-grade screen high grade cells,
not lesion I'm sorry,
high-grade cells then.
But they see enough so
that they're not willing
to call it, ASC-US.
This is a significant results.
So we treat ASC-H and AGC differently
than the other categories.
Because of the percent risk involved,
not just of high grade disease,
but of cancer and true also of HPV 18.
We said originally that the thing
you're looking for is precancer.
So you can treat it and
the person doesn't go on
to get cancer,
and that's the bottom line to all of this.
But in some cases,
when we looked at the
special situation of ASC-H
or the special situation
of atypical glandular cells
with a negative HPV or
anybody with a positive 18.
What we saw was that the
percent risk for precancer
wasn't exceeding the 4% threshold,
but the risk for cancer was
higher than in other categories.
So that's why it's treated differently.
So in addition to the pretty
little rainbow telling you
that you have the option
of expedited treatment,
if it's over 60% risk and only coloscopy,
if it's four to 24% risk.
You also have the same percent
risks applied to the spectrum
of ways that you can follow
somebody after having
an abnormal screening test
that didn't cause them
to have a coloscopy.
So the goal of all of this is
to make this simple for us.
And I say that,
and it sounds so silly
because this is such
a lot of new information.
And the go on the app,
when you start to play with it
really does feel like there's
a lot of information
inherent in it, and there is.
There was a lot of
information that went into
changing these guidelines.
So we really need to simplify that.
And the way to simplify
that is first of all,
not to try to look at other
timeframes besides the ones
we already had from the 2012 guidelines.
People are used to having
the patients follow up
in either one, three or five years.
So that's something they're
accustomed to already.
So they didn't look at
changing that at all,
because that would just make
things more complicated.
Also, there are systems in
place to make those followups
a reality for your
patient based on the laws,
based on the, what
triggers, what management
in your EHR, for example,
or in the log that you're using,
to follow up somebody with management.
So we wanted to make that simpler,
and that's why the intervals
remained exactly the same
at one, three and five.
But you may notice that we
did say if your recommendation
is to have one year intervals
with HPV-based screening,
this becomes six month intervals,
if you're just doing cytology alone.
Just remember that.
And all of this is based on when you see
an asymptomatic population
without a history of disease,
and you do a co-test,
or you do an HPV alone,
you're gonna get a less
than 1.4, less than one,
0.14% for a co-test and
less than 0.12 the opposite.
Less than 0.14, if the
person has a positive,
has a negative HPV.
It will predict that
in the next five years,
they have less than a 0.14%
of having high grade disease.
If somebody has a co-test after they had.
Remember they had no history beforehand,
they're coming into the
screening with no history
of abnormal tests previously.
So that person with a co-test
that's negative negative
is gonna be able to feel pretty confident
that less than 0.12% of the time,
are they going to be having
CIN three high grade disease
within the next five years.
So that's predicting in the
future that they're gonna be
okay up until their next screening test,
which is in five years.
This is a very low number.
So anything that you do
in terms of coming up with
how frequently somebody is
going to need to come back
when they're under surveillance.
The number has to be close to this.
That's what we're going for.
That's why they say one
year versus three year
versus five years,
because we're trying to get
to the same amount of ability
to predict that in the
subsequent five years,
the person's not going to
develop high grade disease.
So the five-year clinical
action threshold,
which is essentially thinking about that.
The five year is the normal population.
Do I hear a?
I thought somebody was gonna ask, okay.
So this is what I'm talking about.
When it's predicted that they
are gonna have a less than
0.15 risk of having CIN
three in the next five years.
That's when you can
get a five year return.
Now, if it's a,
if you're going to be
recommending a three year return,
that's based on a higher percentage.
So if the person's being screened for CIN,
for pre-cancer, then in five years,
their risk of progression
would be too high.
So you want,
because remember you want
to bring that risk down
to being similar to that 0.12 or 0.14
that you would get with a co-test.
So you need to go to three years
because it's at 0.33 and
0.45, which is too high.
So we're looking to get
below 0.55, for three years.
If you go above 0.55,
then you're gonna be going
for a one year return.
So for the, between 0.15,
which would give you a
five year return and 0.55
you're going to do a three year return.
If it's above 0.55, but under 4%.
'Cause remember that 4% is for colposcopy.
So if it's above 0.55, but under 4%,
you're gonna go ahead and do a one year.
Here's just some examples of
how three year returns look.
And same thing with the one year return,
it's essentially 4% or above.
You're gonna have obviously
going to colposcopy.
And as I said earlier, if
it's greater than 0.55%,
that and less than 4%,
you're gonna do three years,
and then one year for above, 0.55.
Here's another example, HPV
positive with a normal pap,
2.1% immediate risk.
HPV negative with low
SIL 1% immediate risk.
In both cases, this is above 0.55,
so the person's gonna come back in a year.
And then these are things that
you'll see after colposcopy
that again will give you
above 0.55 risk, but below 4%,
and that would be.
A low grade pap brings
you to your colposcopy.
The result of the colposcopy
is less than CIN two,
in other words, a lower grade result.
Then that gives you an
immediate risk of 2%,
and the other, an immediate risk of 3.1%.
So key changes that I mentioned earlier,
I did talk about this earlier.
But I do wanna say that any,
so we are very strongly
recommending HPV-based testing.
So the entire management strategy is based
on these recommendations
as are the screening recommendations.
And once you've gotten a positive,
then you should have
the capacity at the lab
and the way it's testing,
the way that you're doing the testing,
to be able to then reflex to cytology
and also be able to reflex to genotyping,
or even get genotyping initially
when you get the positive
of the HPV.
So it's better if you can do it
to have that in the same
laboratory specimen.
If it's not possible, then
you could have them come back.
But if the person has a
positive HPV, that is 16,
then they're gonna go
to colposcopy anyway.
So you don't need to do the cytology.
If you didn't have enough of the specimen
to be able to do cytology,
and the person had a 16,
you can just do the cytology
at the time of the colposcopy.
But otherwise you would
want to bring them back
and do the cytology.
If HPV-16 and 18 is positive,
then these people have the
highest risk of having,
as I said, with CIN, excuse me, with 16,
the highest risk of high grade disease.
And with 18, well, it
doesn't have the highest risk
of high grade disease.
It has a higher than
acceptable risk of cancer.
And the hope with these
guidelines is that they're gonna
take us into the future for
an indefinite period of time,
because they're done in
such a way that they are
able to be modified.
So the thing that we expect to
continue is the percent risk
thresholds, the 4% for
colposcopy, et cetera.
All the things I've been talking about.
And as people are becoming
vaccinated and CIN three
is going, you know, hopefully
in the country way way
down and hopefully getting
diminishing-ly small.
We're gonna change the recommendations
for management screening,
because of the present risk
that we're going to be seeing.
So as the present risks change,
we're gonna change the
management accordingly.
We're not changing the thresholds
at which we're gonna do
one thing versus the other.
But we're gonna change the,
what kinds of results
constitute those thresholds,
will bring us to those thresholds.
Oh, the other thing is we,
when we have a population who
are being properly screened
with HPV-based screening.
With each subsequent test,
it predicts better and better
that the person's going to not
have high grade disease in the future.
So that test becomes,
because remember HPV
persistence is the thing
that's associated with high grade disease.
So if they have multiple
tests over multiple five-year
intervals, that's giving
you a lot of reassurance.
There's a lot of technology
right now in development,
and it's going to potentially
the way that we do manage it.
But the way the guidelines are set up,
it's designed to be able to include these
in the management strategies.
Because again, we're
gonna use the percent risk
as the thing that's the decider.
So the test characteristics
will be essentially
compared to the thresholds
we already have.
And in some cases that's gonna be based on
the industry sponsored trial.
In some cases, it's going
to be conglomeration
of several different clinical trials,
and they come up with enough of a database
to be able to give us a percent of risk.
So at that point,
when we have enough information
that we're gonna get
enough of a population,
enough of a database
to get a percent risk,
that's the point at which those tests
will be put into the guidelines.
So there was a lot,
there were a lot of
people that went into this
in addition to ASCCP,
the voting participants and
the Kaiser Permanente team.
As I said,
the National Cancer
Institute did all of the,
running the percent risks.
So they're the ones who
gave us those numbers.
And then all of the steering committee
and working with participants.
So now I'm gonna turn this over
and Dr Policar if you
wanna take over here.
- Great. Okay yeah.
I do have two questions for you first,
before I close things out.
Just because, I mean, there
were many, many things
that you brought up that were,
really significant changes
about how we've been doing things.
But I wanna ask you two
questions specifically,
based on your decades of experience
as an expert colposcopic.
So one of the things that you
mentioned is a recommendation
that we should be doing,
between two and four biopsies routinely.
So what if a patient is referred in,
because she's got a high SIL on cytology,
you do her colposcopy, it's
adequate, same as satisfactory.
She has a small one quadrant,
I see the white lesion,
kind of plus minus connotation.
Okay, and it's only big enough
for you to do one biopsy.
So in that case,
do you really need to do
three or four biopsies
or two or three biopsies?
And if that's the case, do you
obviously biopsy the lesion
and then do you also biopsy
an area that looks normal?
So how do you put that two or
three biopsy recommendation
into clinical practice?
- Endocervical curettage for one thing.
It's a matter of contention,
people are discussing it.
Whether, the concept
that you're asking about
is do we do blind bio,
do we do biopsies in tissue
that looks completely normal.
So you're gonna have opinions both ways.
I think the most important
thing about the case you told me
about just now would be to
look in the vagina, actually.
If you're not finding the
disease that was represented
on that cytology.
So another option is
depending on whether they had
a positive 16 or not,
you could do the see and treat
at that point, obviously.
But I would say my personal,
what I would do personally is I would do,
I would do the biopsy of
the area. I would do an ECC.
I would look in the vagina.
It's really nice to use
Lugol's, to look in the vagina.
It's, I call it an idiot test for myself.
It's just to see where the spot,
where you need to biopsy.
And then, yeah, I would
do a random quadrant,
the other three quadrant
biopsy, that's what I would do.
Other people wouldn't necessarily so.
- Right. Okay.
All right. Well good
thanks for your opinion.
So here's the other one,
and this one relates to a lot
of family planning clinics.
So near the end,
you said that excisional
treatment is preferred
over ablative therapy.
And so now the question is,
do you think there's still,
you or the whole committee
think there's still
any role for cryotherapy?
- Oh definitely. Oh definitely.
- Bio is ablative, it's not excisional.
But it seems like the
recommendation is that it's better
to do a loop excision
than it is to do a cryo.
So what about that?
- It is, but the other
thing that the committee
was really cognizant of
is that the data looking
at adverse potential
effect on birth outcomes,
and, you know, this is important,
are not seen with cryo.
So that's actually a really
important option for us.
And if you, you have to
follow the rules of cryo.
You can't have a disease
that extends into the canal.
You have to have something
that's, you know,
really limited to just the small area,
that's able to be put
underneath the cryoprobe.
And, you know, if you
fulfill all the criteria
for being safe to do cryo,
then it's a perfectly valid option.
But in the studies, it's
just not quite as good,
and you don't have something
to actually look at
in the lab afterwards.
But if, certainly if the
person has concerns about
future fertility, it's a
perfectly reasonable option
if they are a candidate for it.
And it was actually, there's
a lot of other things that,
I mean, this is beyond these guidelines.
But there are a lot of other
ways that you can use cryo.
They're beyond the scope of this talk.
But it's definitely not
something that anyone on that
consensus work group wanted to throw out
as a treatment option.
- Okay, great.
I mean, I think it's really
important to hear that.
Because when people read the guideline,
and they see that excision is preferred.
You know some folks who
are gonna interpret that
like NEC category four, you know,
in terms of cryo and just stop doing it.
And I agree with your
answer that it still clearly
has a role, as long as
you follow the rules
about the fact that it's a
completely visible lesion,
that is to say a
satisfactory colposcopy make.
Either unnecessary ECC or a
negative ECC and a small leak,
just one or two quadrants
because with larger regions,
that's when you'd rather
do an excisional procedure
than you would in a ablative
procedure, like a cryo.
Okay, let me go ahead and wrap up,
and then we'd love to have your questions.
So Patty did a fabulous job
of explaining both the app and
how the guidelines are
different than they were before
and why they're different from before.
So that's kind of your homework once you,
once this is over in
terms of how to implement
these guidelines in your practice.
Well, first off,
I think that it's important
that any of the clinicians
in your clinic, particularly colposcopist,
but other clinicians as well,
or other staff that you have
that are doing client followup,
really should get the app.
Either that or should become
quite familiar with and facile
at using the online version that's free
at the ASCCP website.
As Patty was saying, it's
not up and running yet,
but it will be soon.
And those are the two different ways.
But you should try to make
that transition to using
these new guidelines
as quickly as you can.
Number two, most clinics
do have clinic protocols,
and it's gonna be time to
update your clinic protocols,
both for cervical cancer
screening intervals ages,
if you haven't done that so far.
You've already heard about the preference
for using HPV-alone screening.
Although you can continue
the co-test as well
as your protocols for colposcopy.
Next is at some point you
might think about doing
an inservice of your entire staff
regarding the 2019 guidelines.
'Cause it certainly in
any family planning clinic
and virtually all primary care clinics,
of course they know the GYN practices.
It's gonna be important
that all the staff,
the front desk, the back
office nurses, that you know,
your health educators, everyone,
in addition to clinicians
is up to date on how these
guidelines are different
than how we used to do things before.
Next is that there might be
a few cases where you have
to inform individual clients
that are under surveillance now
that their management
might be a little different
based on the updated guidelines.
Particularly in terms of the
frequency that they come back
or when they do come back,
having HPV-alone screening.
And then lastly,
watch for updated coding
and billing policies
from your payers.
They haven't happened yet.
I mean, these guidelines
are so new that family pact
has not issued any
changes nor has Medi-Cal,
nor has the Every Woman
Counts program in California.
But we would certainly forecast
that by later this year,
probably in the fall.
You will be seeing a new
coding and payment policies
that come from not only your
state payers like family pact,
EWC, Medi-Cal, but
you'll probably see that
from your commercial payers as well.
So not yet, but on the way.
So with that, I will stop as well.
And, I firm back to Nicole.
And if we have any questions
she is going to direct them
either to Patty or to me.
I think you're muted.
- Yes. Hi, sorry about
that can you hear me now?
- Yes.
- Yeah. Okay sorry about that.
So let's start with the questions.
So this one's, first one
is for Patty from Joanna.
I love to be able to
interpret without the app
or internet-based app.
Are there PDF, the algorithms,
like those last guidelines
or another way to do so?
- Great question.
No.
But the two papers that went
into the guidelines that were
published that explained all
of the data and the databases
and how things were arrived at.
Those have algorithms
in them, their figures.
So you could print those
out and just make them large
for yourself to see if
that's how you wanna do it.
And there are, I mean,
these figures do exist and
they are part of the algorithm,
part of the app.
So it's not that we don't have
algorithms anymore, we do.
And actually, when there's not a change
of like the ones I described,
it's gonna be the same as
the old algorithm actually,
in some cases.
- Let me add my two cents
worth though and that is
I did read both of the papers.
They're really good,
they're really, evidence-based,
they're very, very dense.
So they're not going to be,
I think the kind of resource
that you'll be able to jump to
immediately in clinic and use
the papers as a way of making
decisions about the,
about the management
of individual clients.
You will find that's gonna
be so much, not only better,
it's going to be way more
personalized if you're able to do
it either with the app or on the website.
And you know, that, to me that was one of
the really impressive
things about this guideline
is the fact that they
emphasize over and over
about the fact that this has
now become a more personalized
management approach for
each individual client,
especially because it takes
into account cryo results.
But no more is it like
going through the algorithm,
you know, from the top to the bottom
and sort of one size fits all basically.
Now this is much, much more adjusted
to the individual client,
particularly based on her past history,
as well as her current history.
And I think you really
need the app and you,
or you really need the
website in order to take
full advantage of that.
- Or if you're somebody that's
super academic and you really
wanna through it with a fine
tooth comb like you did.
Because the figures are there.
If I were going to do it
that way, which I wouldn't,
I would do it with the app, absolutely.
But if I weren't going to do
it with the app, as I said,
I would print out just the algorithm.
So in other words,
you're asking to use the
algorithms and those are figures
and I would just make them larger.
It's a lot of sort of
making something yourself.
Maybe in the future,
somebody will do that
and put it out for people
that like it.
You know, there's always
those sort of aftermarket
things that happen.
So stay tuned because it might be on,
there may be some indication
that there's gonna be
something like that available.
It won't be anytime soon though.
- Okay. All right.
And the second question is also for Patty.
Will the existing app be updated,
or will we have to purchase
the new updated app?
- Yeah, that's a really good question.
So the old app is not being updated.
This is a brand new app and
you have to buy it again.
But once, the idea is that
once you've bought this one,
all of the potential changes
that are gonna come about
because of testing,
that's gonna be available,
that we didn't have,
you know, technologies
that we don't have available
now that we will have.
Information that we get,
that we don't have now,
and the impact of immunization,
which is a huge, huge thing
that's gonna change.
And not, that is not in
the very distant future
that's coming up fairly soon.
So as those changes happen,
the guidelines will be
changed within the app.
The app will be updated and
you won't have to pay for it.
That's the goal.
That's the, I'm gonna say,
that's not just the goal,
but that's going to happen.
The intention is just to buy it once.
- Okay.
- During, that's what the whole ideas is,
that was one of the main ideas on it.
Is that we don't have to keep
having consensus conferences,
and then coming up with these
big guideline packages for you
every seven years, instead as
things happen in real time,
we can update.
- Okay and this one's from Sharon.
I'm confused about cytology
and HPV testing annually
versus quarterly six months.
- So if you are using HPV testing.
HPV-based testing means
either you're only testing
for high-risk HPV.
And if it's positive
you're going to then reflex
to a cytology from the same specimen,
and you're going to want to
get the genotype as well.
If it's positive, if the
HPV test is positive.
So that's an HPV test.
HPV-based screening is
either that test plus a pap
or that high-risk HPV test alone.
If you don't have HPV tests available,
if that's just not something
that's available within
your system or for the particular
patient, for some reason.
That's when you go to six months.
So that's when, if the
recommendation is a surveillance
of every one year,
because it's above 0.55%.
That's the point at which you're gonna
instead of doing one year return,
you're gonna do a six
months surveillance return.
- Okay.
So we have a lot so we'll
try to go through this quick.
So the next one is also for you both.
Can the speakers address--
- Wait I'm sorry cytology.
I want to underline cytology
because it's not as accurate
as HPV testing.
It's really taken a pretty big back seat.
We're all used to pap and I
understand that and you know,
we've all been working on it for years.
It just isn't as good at
predicting what we want to predict,
which is pre-cancer.
So it's just not as good.
And so that's why it takes a backseat.
That's why we have to do it more often.
But people often get confused
and think that cytology
is a way that you can predict the disease.
It's essentially often
mistakenly scooted into
a diagnostic category
when it's supposed to be
in a screening category.
So if a pap is showing
low grade versus ASC-US,
like one time it's low
grade, one time it's ASC-US,
one time it's ASC-H.
That doesn't give you a diagnosis.
It gives you a red flag that
then you will do surveillance
on to decide at what point,
if ever you need to actually
do the diagnostic test,
which is the colposcopy.
So don't be confused by trying
to parse out serial pap tests
and think that, oh, they
went from low SIL to ASC-US
they're getting better.
That's not the way we use it at all.
It's not diagnostic.
Sorry.
- No problem.
Okay, the next one is for you both.
Can the speakers address HPV
vaccination after age 26?
- Do you wanna go first?
- No, you go ahead, it's good.
(Patty & Michael laughs)
- Okay, so the vaccine has
the indication to go up to 45.
I personally feel like
this is a really good time
to do some shared decision making.
Your typical person that
would be the perfect candidate
to have HPV vaccination
after the age of 26
would be the person who
hasn't ever been exposed
to HPV in the past,
because they haven't ever
had anybody touch them below
their belly button ever in their life.
No skin to skin contact below the waist.
And now they are going to be
having skin to skin contact
and potentially with, you know, other
unnamed numbers of partners.
That would be obviously
the slam dunk person
that would want to get
it for their own benefit.
We think that in general,
if somebody is over 26 and
they've been having sex since
their late teens, early 20s,
and they have had some number partners.
They've probably been exposed to at least
some of the strains
that are in the vaccine.
And so therefore there hasn't
been a lot of ability to say
that doing that prevents
disease on a population level,
that it really actually
impacts it in the way that
using immunization prior to
exposure to HPV would do.
But that doesn't mean that
in a given individual,
it couldn't have value.
So it becomes really a
conversation about, you know,
coverage and what they anticipate to be
the way they wanna conduct
themselves in their sexual life.
And it's a conversation at that point.
But I will say that we haven't
had an abundance of data
saying that, if you immunize
people from 26 to 45,
that you're gonna have a huge impact
on high grade disease
nationally in terms of numbers.
That just hasn't been
shown to have that kind of
really big impact that you see with people
who were vaccinated
prior to exposure to HPV.
Another thing I think
that we're gonna see,
and we're getting more data about this.
But HPV vaccine is not
a therapeutic vaccine.
If you're, if you have disease,
it's not recommended
that you get HPV vaccine
to treat the disease.
However, if you have HPV-based disease,
which is cervical cancer
or precancer stage,
it's because of HPV,
and you were to get immunized
where you haven't been before.
You will be immunized
against the other strains.
There is a factor in who gets precancer
and who has persistent
HPV and who gets cancer,
that's essentially the host,
these are host factors.
We don't know what all
those host factors are.
Some people seem to be much
more susceptible to persistence.
Some people seem to clear HPV better.
Some people tend to have precancer more.
We don't know what those host factors or
why some people are.
So if somebody should already had disease,
then we know that they
at least probably have
some host factors that might
make them more vulnerable.
You could argue that that would
be a population that would
be potentially benefiting
from vaccination at that age,
not as a therapeutic vaccine.
But definitely for preventing
disease in the future,
which is also quite important.
Now you're gonna go ahead and
you have to disagree with
everything I just said.
Take your time.
- I think that was great actually.
- This next one is for Dr. Policar.
So does F pact cover
all HPV-based screening
and surveillance strategy as recommended
in these guidelines, including
genotyping two subtypes?
Any particular recommendations
of one type of LBC,
such as SurePath versus
ThinPrep for these purposes?
- So the answer is that
yeah, family pact does cover
all of these strategies as
long they are consistent
with the recommendations of the U.S.
Preventative Services Task Force.
And you remember how they are
broken down into different
age categorizations,
primarily for our purposes,
for women between 21 and
29, and then 30 up until 65.
But particularly for the
group of females that are 30
and older, either surgical cytology alone,
or HPV alone, or co-testing.
Any one of those three are
considered to be benefits
for the purpose of a family pact.
Now then the next question is,
is does family pact cover
genotyping into subtypes?
And the answer to that is yes.
But there is sort of the caveat to that,
and that is to say that if you're doing,
let's say HPV-only screening, okay.
That test looks for 14
different types of HPV,
including 16 and 18.
And so if that initial
test is positive, okay,
then subtyping it into 16 or 18 or both
is considered to be acceptable.
But you have to have a
positive high-risk HPV panel
for all 14 types first, and
then if that's positive,
then that will reflex to
the subtypes of 16 and 18.
You couldn't order 16 to 18 by itself.
You have to go through having
the high-risk HPV panel
as a 14 first and then later as a reflex.
But family pact has covered
that since, since last fall.
The other part of the question is,
does family pack have any
particular recommendation
for liquid based cytology?
There are a variety
of products out there, ThinPrep, SurePath.
Even some other like homegrown varieties,
and also family planning and Medi-Cal
have no recommendation about that.
That's really up to the decision
of the individual clinic
or clinician and the
labs that you work with.
- And so these two are ask--
- With the cytology question.
There's sort of common
misunderstanding across the country,
that liquid-based cytology
is better than what we used
to have with the with the slides,
you know, traditional pap.
And it isn't better, but
we all have adopted it.
But when I say we all have
adopted liquid-based cytology,
not every single site has
liquid-based cytology.
Some still have conventional slides.
If you do, that's not a problem
from a cytology perspective.
It is though a problem because
you don't have a medium
with which to do an
HPV test at that point.
So liquid-based cytology isn't.
If what you're going to do
is only cytology screening.
You do that with
conventional slides as well.
But we would really urge
you to get the ability
to do HPV screening and testing.
- In reality the main
reason for the proliferation
of liquid-based cytology
is it makes things easier for the labs.
They have much greater
throughput when they use it
as liquid-based.
Because it cleans up the
background so much that
a cytotechnician can look
at many more slides per day.
So it's primarily for
the benefit of the lab,
rather than us.
'Cause I agree with
Patty that the accuracy
is probably about the same.
Another question that I
see that Nicole's probably
gonna ask me next, but it's important.
And that is, is leep
covered by family pact?
And the answer is yes,
it had been all along.
But remember there are a couple
of different varieties of leep.
So one is the excision,
and here when I'm talking about varieties,
I'm talking about not
only how they're done,
but the CPT codes that have used.
So one is an excisional leep,
and that has been covered
for at least a decade,
by family pact.
Although interestingly
not the see and treat,
the expedited treatment
you've been hearing about.
The old expectation is that
the leep would be based
on biopsy results.
So a CIN two or a CIN three lesions.
There is another CPT code for leep,
which is basically a leep cone.
And that one is not
covered by family pact.
I'm 99% sure, I'll have to look this up,
that it would be covered
as part of the EWC program
or the BCCTP, the treatment program.
But that's something that
hypothetically could change
in the future.
But definitely the only
benefit at this point,
for family pact is the excisional.
- Okay.
So the next question is.
Sorry let me pull that up.
Oh, what do you recommend,
what tests do you recommend
for HPV testing alone?
- Did you say what test?
- Yeah. What test do you
recommend for HPV testing alone?
- That's a really good question.
There are a very large variety
of HPV tests that are done
in laboratories that are,
they use their own controls
within their own lab.
And they, we fondly call them homegrown,
and they have not been FDA
approved for that purpose.
That doesn't, it's not like it's,
it's not the same kind of FDA
approval that you would get
with a drug.
It's just that FDA says
that this test is approved
for this purpose, and
it really doesn't mean
it's the only test you can use.
In general, it doesn't really mean that.
Now, I'm gonna back off from that and say,
from an ASCCP and consensus
guidelines perspective,
absolutely prefer tests
that had been FDA approved
for that purpose.
So there's really only two right now,
and there should be more in the future.
But look for a test that you know,
is FDA approved for primary HPV screening.
There are other test that
are approved for co-testing
that aren't yet approved
for primary screening.
We expect they will be, but
they don't have the data yet.
So it's, with the HPV as a approved test.
- Is that the same as being FDA cleared?
- It's the, the right term is cleared.
Thank you.
It's not approved tests for drugs, FDA.
I'm not even sure that
cleared is the word.
- Laboratory tests they clear them,
as opposed to drugs, which they approved.
- Right.
- Yeah.
- They give their stamp.
- Exactly.
- Okay, so we are the 1:30 mark.
We have three tough potential questions.
I don't know how you feel about maybe just
going through a few more,
and we will record this.
If you have to leave early, feel free,
we will send out the recording.
But I wanna to be respectful
of both your time.
- So Nicole we can take
a couple more questions.
But I also wanna remind everyone
that what we don't get to
we typically, Patty and I
will go through the questions
afterwards and then we will,
we'll post on the familypact.org website.
A written Q&A like a week or two from now
for the questions that
we haven't gotten to.
- Okay. So I'll try to go through
some of the short questions.
So this is for Patty.
Will the app provide
pictures of abnormal cervix?
- No, I'm sorry.
That would be so nice, wouldn't it?
- So.
And then this for Dr. Pelicar.
Does F pact pay for co-testing
in women under 24-years-old?
- Well certainly not as a screening test.
And Patty can help me on this,
but under 24 it probably
would not be a co-test.
It would only be an HPV alone
test as a followup, correct?
- 'Cause I figure they screen,
they don't clarify HPV.
They pretty much don't
clarify when they say
HPV-based screening between
HPV-alone and co-testing.
But I just wanna put
out there that, don't.
If you possibly can,
unless the person is on
a management algorithm
where they must be followed
up with an HPV-based test.
If you screen people under the age of 30
and certainly under the age of 25 for HPV,
you're going to find
HPV and it's going to be
the vast majority of
those are gonna be just
incident HPV infection.
So what you will have done to this person,
who's just coming into their
sexuality and they have,
they're just starting
to sort all that out.
You're gonna hit them with,
you've got a cancer causing
virus that you got from somebody
that you had sex with.
And generally when you
have sex with somebody,
you love them and you trust them.
And you've just been given something
that could kill you from this.
And, when, it's gonna go away
by itself, almost always.
So we really try not to test
people under the age of 25
for HPV, with the assumption
that by and large,
most of them will have it.
It's kind of a developmental stage.
- Well, it's really clear that
we would never do an HPV test
as a screening test in a
person that's under 30.
The question is, is it part of
the now management algorithms
or the surveillance algorithms?
Let's say for a person who
is 23, who maybe was treated
for a high SIL with a cryo for example.
And in subsequent followup,
would HBV be a part of that?
And my recollection is
that HPV alone would,
but not doing it as a co-test.
- I'm just looking, I didn't
know that that was the case.
So I'll get back to you.
Think of another question,
I will get it up by then.
- Yeah so for Dr. Policar.
Are there any coding or billing
changes that you anticipate?
- Well for now the answer to
that is no, nothing's changed.
Going forward, yes.
I think that in the fall,
there will be at least a few changes
in two different parts of the PTBI.
One is in the section called
family planning related
benefits or Fam-Ben related.
So it's the, the non-contraceptive
benefits in family pact.
It has a section that has
to do with cervical cancer
screening and colposcopy benefits.
So later in the fall that will be updated.
And then the other section of the PTBI
is in the lab section,
and that will be updated as well.
I definitely can't give you
a date and it hasn't been
determined yet exactly
what those changes will be.
But nothing for now, keep your eyes open.
I'm sure there'll be a blast,
e-blast, a news blast sometime in the fall
to let you know what those changes are.
- So I didn't see anything
in the app for people,
for that younger cohort of just doing HPV.
It always says HPV-based testing.
So I'll keep looking,
but I haven't found it in
any of the possible options yet.
I don't know where you saw that, but.
- Oh, okay so this is for Patty.
Will the ASCCP text us the updated?
Should the current edition
continue to be the recommend
use for cohort providers.
- Yeah. I mean, I think
that the textbook is
it's old now, obviously.
And it's so, so many of the
concepts that are in there
are gonna remain.
So you can use the textbook,
it's got pictures, it's got technique,
lots and lots of fine tuned
things about technical ways
to do things with colposcopy.
And it does a great job of explaining
some of the science behind it.
Now that said, if you, you
have to remove anything
in you mind.
Remove anything in the
textbook about guidelines
or what to do next or any of that,
because the guidelines
completely supersede all of that.
And the other thing that's even more,
probably relevant is that
the colposcopy standards that
I mentioned will have, in
some cases, some differences.
Although now I edited the
textbook and I read every word
over and over.
So I should remember,
but I don't remember completely
whether it already was.
I think we were already
recommending multiple biopsies
at that point, I'm 90% sure.
But if I'm wrong and there's
some part of that textbook
that doesn't say that if it
says, oh find the nice lesion
that you are most worried
about and take that,
that's don't do that if you see that.
Now it will also say that
we are not at this point
talking about doing a new
text, an updated textbook
at this point.
It's sort of like the guidelines
have been occupying everything.
- This is a question
actually very relevant
to this time right now.
How do I advise patients
who are due for their pap,
but leery of unnecessary
exposure to COVID-19?
How much leeway do we have?
- All right, I will take one. (laughs)
Then Patty can add to
whatever I leave out of it.
So maybe about four
months or so ago ASCCP,
actually issued guidelines about,
about the followup that
should be done relative
to the public health emergency.
The kinds of things that
could potentially wait
until the public health emergency is over,
as opposed to those circumstances
where we really really
needed to try to get people
in for an in-person visit.
And what we'll do for
you is we will, number,
two things to tell you.
Number one, those are actually
on the familypact.org,
COVID-19 section of the website,
where we've, we have a link
to that ASCCP guideline.
I think they're also listed.
We covered those in a webinar
that we did a couple of months
ago that had to do with
COVID-19 about specifically
what those ASCCP recommendations
are about either delaying
or trying to do in-person
visits right now.
And we'll also include
them for you in the written
questions and answers.
But like I said, they're
very easy to get to,
if you go to asccp.org to their website.
There's a COVID-19 section
of the menu, and from there,
you can see exactly what
their recommendations are
about who needs to come in now,
which are mostly people
with high-grade lesions,
awaiting treatment,
or very scary cytology results.
While people with low-grade lesions
can definitely wait it out.
- Okay, and this one's for you Patty.
Is HPV self-testing possible
and acceptable in the U.S. yet?
- That's a great questions.
I consider HPV self-testing
to be of extreme benefit
for the future.
We are getting data daily
about how this is an acceptable
way to do it.
So I think we're gonna
find that it is close
in terms of sensitivity.
It seems like that's what
all the data is showing
and what a wonderful option,
because our patients can
do it from any remote area
that they're in.
If they have a history of
trauma and they don't like to go
to the provider, if they have.
If they have any technical, excuse me,
logistical reason with their family,
why they can't get in.
You name it,
there's a million reasons why people
are under screened or unscreened.
And many of those reasons can be addressed
by self-sampling.
So yes, it will be,
it's definitely a very hot topic,
and it's going to be top line
in the near future I think
as an option.
It's not yet integrated into any of this,
but it will be soon probably
based on all the data
that we're seeing.
And also the sort of
chatter is pretty excited
about it 'cause it's.
Especially now we're
in a pandemic amazing,
if somebody could just
screen themselves at home
and mail it in and nobody has
to be hands on with anybody.
- Yeah.
I'm gonna go back to one
topic very, very quickly
while Nicole was reading questions.
And that is,
let's say the patient does need
to come in for a colposcopy.
She's part of that ASCCP
updated recommendation,
which says, yeah,
we really would like to see
her in the next month or two,
and now it's time to do that.
You know, that's a whole talk in itself,
but just to bring it down to, you know,
the most essential things is
number one to make absolutely
sure that everybody in
the room has a mask.
Make sure that the person
doing the colposcopy
has eye protection.
And if there's someone up
at the head of the table
that is kind of talking
to patients through it,
they should be wearing
that protection as well.
And also make a point of doing colposcopy
in your largest exam room
with the best ventilation.
The one thing you want to
avoid is a real small room,
that doesn't have any ventilation.
So try to use the biggest
room that you have,
hopefully with negative ventilation.
If not, if that room has
a window, open the window
to try to get air circulating
as much as possible.
But the most important things
are masks, eye protection,
big room, lots of air circulars.
- And then this one is from Elliot asking.
Why the aggressive approach with biopsy,
won't this compromise woman's fertility?
And isn't there evidence,
given the case of CIN three
those lesions can regress on their own?
- Wow, that's a lot of good
questions packed into one.
Okay, so first.
Biopsies have not been
shown to be associated
with any impact on fertility.
The tissue that's removed
is such a small amount.
The body grows it back quite quickly.
So that's not a concern.
Biopsies are and can be painful.
But some of the ways that you
can make them less painful is
to make sure your instruments
are super, super sharp.
Meaning that you don't
go through, you know,
multiple clinic days of
colposcopy without sending them in
to get sharpened.
And you don't throw them into the bucket,
you just placed them down.
There's a lot of things you can do
that can make your instruments more dull.
And we've actually got some
data showing that using
some topical lidocaine on
the cervix, a little bit of,
not a block, but a little
bit of topical lidocaine.
Not topical, I'm sorry we do
inject it, but it's local.
Will help with the pain
and for those of you,
this is not for everyone.
But some people find it
very successful to put
the biopsy instrument,
right against the cervix,
press into the tissue and
then have the person cough
as you take the specimen.
That's not for novices, and
only if you have been doing it,
practice it a little bit, get used to it.
It's not something that you
wanna do right away when
you're first learning.
The other part of the
question so was about
do multiple biopsies affect fertility.
And what was the other
part of the question?
- Oh, it was about, sorry.
I lost it. I'm sorry I was
reading these questions.
Oh.
Oh and is there evidence
in the case of CIN three
those lesions can regress on their own?
- Okay, that's a critical point.
Yes, absolutely it can
regress on their own.
But do you remember the chart that showed
the percent progression to cancer?
'Cause yes they can, but they, but CIN two
is more likely to regress.
We don't even think of the
concept of progress regress
when it comes to CIN, one
we think it's its own thing
and it's just a transient HPV infection.
So will something progress
from CIN two to three
and three to cancer.
The cutoffs sort of becomes
three because once it's three,
absolutely anybody can
regress at any time,
but it's just much less likely.
And the downside risk is too
big because if you don't treat
it, it can progress to cancer.
And we don't know how
long that's going to be,
because we don't know how long
that person's had CIN three necessarily.
We may not even know when they,
how long they've had the HPV persisting.
We don't have that information.
We don't have technology
yet to tell us that.
So in answer, yes it regresses.
But we don't consider that
to be a safe enough option
to offer it to our patients.
So we don't, we consider
the cut off for pretty much
treating anybody who's
not pregnant is CIN three.
Because of the--
- Okay, yeah.
All right, so there's
this one last question
about the one 145 mark.
So this is about to ask.
How far back do you consider paps history
for the average of the results?
Like do you go back farther than,
is there a way to input
results older than five years,
for you to consider that as well?
- Yeah, the only results we
can put in from way along ago.
They'll let you put in two paps results,
but they won't let you put
in every single result.
And the only time when that's an exception
is when it's a histology.
They can let you do a history
of what was the original
offending disease process
that brought the person
into the management paradigm.
- Okay so that.
We have a lot more, so we will
collect all these questions
and give it to our speakers
so they can answer,
and we'll send the questions
out with the responses.
And that concludes our webinar today.
Thank you Mike and Patty for
this wonderful presentation,
it was really helpful and yeah.
And we have the evaluation at the end,
so we hope that you please fill it out
so we can get feedback on
this and any future content.
So with that, we will
conclude our webinar.
Thank you all for attending today.
Have a great rest of your week.
- Thank you.
- Bye.
- Bye.
