Surveillance of Emerging Threats to Pregnant Women

Surveillance of Emerging Threats to Pregnant Women


>>Good afternoon, good
evening, or good morning, depending on from when and
where you’re joining us. I’m Dr. Phoebe Thorpe. It’s my pleasure to welcome you to CDC Public Health Grand
Rounds for September 2018: Surveillance for Emerging
Threats to Pregnant Women and Infants, Data for Action. We have an exciting session,
so let’s get started. But first a few housekeeping
slides. Public Health Grand Rounds has
continuing education available for physicians, nurses,
pharmacists, veterinarians, health educators, and others. The course code is PHGR10. Please see our website or the
TCO website for more details. Grand Rounds is available
on all your favorite web and social media sites. Please send questions
to [email protected] cdc.gov. And if we can get them in
time, we’ll include them in our Q&A session today. Want to know more
about this topic? We have a featured
video segment on YouTube and our website called
Beyond the Data, which is posted shortly
after the session. This month’s segment
features my interview with Dr. Michael Fraser, chief
executive officer of ASTHO. We have also partnered with
the CDC Public Health Library to feature scientific
articles about this topic. The full listing is available
at cdc.gov/scienceclips. Here’s a preview of
upcoming Public Health Grand Round topics. Please join us live or on
the web at your convenience. In addition to our
outstanding speakers, I’d also like to take a moment to acknowledge the
important contribution of individuals listed here. Thank you. And now for a few words from
CDC’s director, Dr. Redfield.>>Thank you very
much and welcome. Today’s topic, Surveillance
and Emerging Threats to Pregnant Women and
Infants, Data for Action. As a science-based, data-driven
service organization, CDC uses data in every
aspect of our work. And surveillance
systems are the backbone of helping us put
science into action. The health risks of
pregnant women for them, Zika serves as a stark
reminder about the importance of surveillance, the
vulnerability of pregnant women and infants to infectious
diseases. Pregnant women face some special
challenges, unique physiology, changes in the immune system,
various pregnancy complications. But as we all know
too well these days, it’s not just infectious
diseases. But pregnant women are
challenged by the opioid crisis. Today about 100 babies are
born a day in the United States with neonatal abstinence
syndrome, one baby is born
every 15 minutes. I recently just got back from
West Virginia, where I went to some of the neonatal
centers that take care of neonatal abstinence syndrome,
and I was sort of shocked to find out that 5% of
all the pregnancies now in West Virginia
give birth to a baby with neonatal abstinence
syndrom. Babies are born preterm,
low birth weight, and they have significant
risk for poor health outcomes. Longitudinal surveillance data and their systems can help us
better understand the possible outcomes for these
children and begin to recognize the importance of various social
determinants of health. In today’s Grand
Rounds of Surveillance of Emergency Threats to Pregnant
Women and their Infants, Data for Action, we’re
going to focus on some of these challenges to women’s
health, obviously the opioids. An old friend that’s
back again, syphilis. Zika, an emerging new threat. So I think today you’re going to
get to see how surveillance data and real-time information
in public health is able to be put into action. So I welcome the speakers
today and look forward to hearing what they
have to say. [ Applause ]>>Thank you, Dr. Redfield. And now for our first
speaker, Dr. Bowen.>>Thank you. Good afternoon. During 2017, 918 infants
were reported to CDC as cases of congenital syphilis. This represents a 44%
increase over 2016, when 639 infants were reported,
and a 176% increase over 2012, when a relative low of
334 cases were reported. Changes in congenital syphilis
typically mirror changes seen in primary and secondary
syphilis, or incident infection
among women. Cases among women are
represented here by a red line. Why is the reemergence of
congenital syphilis a concern? Syphilis is treatable. And every case of congenital
syphilis is preventable. But syphilis is a
complicated disease. Syphilis is caused by the
bacteria Treponema pallidum, which is typically
spread by sexual contact. Signs and symptoms of early
syphilis can be difficult to detect. During the primary stage of
syphilis, genital lesions or chancres appear at the site where the bacteria
entered the body. These chancres are painless
and often go unnoticed. Even without treatment,
these shakers will resolve on their own within a few weeks. Syphilis then enters
the secondary stage, which is characterized by
rashes, wart-like growths in the genital area,
and hair loss. Few patients in the
secondary stage experience all of these symptoms. Without treatment, these
two will quietly fade away. Untreated syphilis then enters
a latent phase characterized by the absence of
signs and symptoms. Patients can persist in
this latent phase for years, making syphilis difficult
to detect. Although less common today
in the antibiotic era, syphilis can move into
a late stage of disease, known as tertiary syphilis. This affects the brain
and heart and may lead to dementia or heart disease. Diagnosing syphilis is
challenging given the many stages of disease and
clinical presentations. At every stage of
infection, diagnosis is made by medical history, clinical
exam, and two blood tests. Screening by blood
tests is the only way to detect a latent infection. An infected woman
can transmit syphilis to her fetus during pregnancy. This transmission can occur
at any stage of syphilis, even during the asymptomatic
latent phase, and at any trimester
of pregnancy. Infant infection is known
as congenital syphilis. Congenital infection
can result in stillbirth and early infant death. Surviving infants may experience
neurologic impairments, including deafness,
and deformities of the long bones and teeth. The infant on the right suffers
from congenital rash as well as an enlarged liver and spleen,
marked in ink on his abdomen. Adequately treating syphilis
during pregnancy can prevent congenital syphilis. 37 states reported at least
one case of congenital syphilis in 2017, but 70% of the nation’s
congenital syphilis morbidity resides in five states alone. These states: California,
Arizona, Texas, Louisiana, and Florida, are shown in red. Syphilis is curable
using long-acting injectable penicillin. The timely detection and
treatment of syphilis in a pregnant woman is essential for preventing congenital
syphilis and its complications. Because of this, CDC recommends
screening all pregnant women for syphilis at the
first prenatal visit, regardless of their
perceived risk. And also recommends
screening women again early in the third trimester if they
are at high individual risk for syphilis or if they
are living in an area of high syphilis morbidity. Prenatal syphilis
screening is the cornerstone of congenital syphilis
prevention. This was upheld several
weeks ago when the US Preventive Services
Task Force issued a statement reaffirming its prior
grade A recommendation for syphilis screening
in all pregnant women. Understanding risk factors for syphilis among women may
help clinicians determine whether a woman’s
individual risk is heightened and more frequent
screening may be warranted. Knowing risk factors may
also guide the development of interventions
within a community. Known risk factors for syphilis
among women include having multiple sex partners, a
history of incarceration, substance use disorders,
and exchanging sex for drugs, money, or housing. In addition, some women will
present with no risk factors of their own, but they’ll
report a partner who has one of these risk factors. Once a woman is both pregnant
and infected with syphilis, receiving late or no prenatal
care is significantly associated with delivering an infant
with congenital syphilis. There are four key opportunities to prevent congenital
syphilis during pregnancy. First, a woman needs to enter
the prenatal care system. Nationally, 34% of the mothers of congenital syphilis
cases received late or no prenatal care and
were not screened in time to prevent congenital syphilis. Within prenatal care,
all women need to be screened for syphilis. An additional 8% of case mothers
missed this opportunity despite being in prenatal care. A woman who screens
positive for syphilis needs to be adequately treated
with a regimen that is timely and appropriate for
her stage of disease. 18% of case mothers were
either treated too late or with an inadequate regimen. Lastly, many women, including
high-risk women and women living in a high morbidity area, are
candidates for rescreening in the early third trimester. An additional 16% of women
tested negative for syphilis at their first screening but were later infected
during pregnancy. Many of these infections
were preventable by early third trimester
screening. Having information on these four
key opportunities is imperative for tailoring an
appropriate response. Some 16% of all congenital
syphilis cases cannot be classified based on incomplete
information provided to CDC. Which presents a challenge for identifying missed
opportunities in these cases. CDC has been working to turn around the congenital
syphilis trend for some time. In April 2017, CDC published
a Syphilis Call to Action, which outlines activities
needed to control adult syphilis and prevent congenital syphilis. This prevention will require
coordination among healthcare providers, public
health departments, and pregnant women,
among others. Several concrete
actions that were called for in the document include
improving the way health departments collect pregnancy
status among women with syphilis and overall improvements in the risk factor information
that’s reported to CDC. The report also identified
key surveillance gaps and opportunities
for collaboration. Following the call to
action, CDC awarded $4 million to nine high morbidity
areas to pilot some of the prevention
activities outlined. The goals of the supplemental
funding include making sustainable improvements to congenital syphilis-related
activities, strengthening prevention
through prospective information gathering, and continuing to
strengthen our understanding of missed opportunities,
by asking for a thorough, retrospective review
of all cases. This pilot project
highlighted several gaps in our current methods
of surveillance. The current system lacks
timely ascertainment of pregnancy status for
women with syphilis. Not only does this
impact our understanding, it may impact the action
taken toward pregnant women at the local level. The current system
does not provide CDC or our local health
department partners with negative test results,
which may limit our ability to monitor rates of screening and rescreening within
prenatal care. The current system does
not create a linkage at the national level
between female and congenital syphilis
case reports. This limits the way we can
describe the maternal risk factors among cases of
congenital syphilis. Additionally, CDC does
not receive information about syphilis exposed infants,
unless the infant is classified as a case of congenital
syphilis. Not receiving information
on the healthy babies who were syphilis exposed
hinders our ability to compare congenital
syphilis cases to non-cases and identify compelling risk
factors during pregnancy. Lastly, the current system
lacks significant detail on fetal syphilis and
long-term outcomes for syphilis exposed infants. Longitudinal surveillance
center around pregnant women with syphilis may provide a
helpful step toward closing the gaps in surveillance
that I outlined. As a result, CDC is now
beginning to work in this area. Longitudinal surveillance
that enrolls pregnant women at the time of their syphilis
diagnosis may ensure more complete congenital syphilis
case ascertainment, may allow us to examine additional maternal and fetal risk factors during
pregnancy, and may allow us to follow infants postpartum
and document early outcomes. The timely entry
of pregnant women into longitudinal
surveillance may also allow for more real-time health
department intervention. Perhaps most importantly, longitudinal surveillance
during pregnancy and immediately following may
be integrated across diseases, including with those that you
will hear about today, like Zika and neonatal abstinence
syndrome. I’d now like to introduce
Dr. Masha Yazdy, director of the Massachusetts
Center for Birth Defects Research
and Prevention, who will speak about using birth
defects surveillance to monitor Zika during
pregnancy. [ Applause ]>>Thanks, Dr. Bowen, and
thank you for the opportunity to share our experience
in Massachusetts. Zika is a mosquito borne A.
Aegypti virus that’s related to dengue, yellow
fever, and West Nile. 80% of people who contract
Zika have no symptoms, but infection does
induce lifelong immunity. Zika spread to the Americas and
the Caribbean in 2014 and 2015, and it was the largest Zika
outbreak ever recorded. We know that Zika virus
infection during pregnancy can cause congenital Zika syndrome,
which is a distinct pattern of birth defects among
fetuses and newborns, which include microcephaly and other severe brain
and birth defects. Two national efforts
were established by CDC for Zika surveillance. One is the US Zika
Pregnancy and Infant Registry, which includes pregnant
women and infant with laboratory evidence of
possible Zika virus infection. This surveillance is based on
exposure, and women and infant with possible infections
were followed to understand potential outcomes
of Zika infection in pregnancy. And in Massachusetts, this
effort was led by our state lab. The other effort is the Zika
Birth Defect Surveillance, which monitors all infants
with any birth defect that has been associated
with Zika exposure regardless of whether there was
exposure to Zika. This surveillance is
based on the outcome. And in Massachusetts,
this was led by us in the birth defects program. Both of these surveillance
efforts — one based on exposure and
the other on outcome — are very complementary
of each other. In Massachusetts,
the Zika Pregnancy and Infant Registry
put a priority on testing pregnant women and
communicating with providers. For women and infants
in the registry, information is collected
on maternal health history, pregnancy exposures,
neonatal outcomes, and infant outcomes
through age two. In Massachusetts, all the women
and infants in the Pregnancy and Infant Registry
contracted Zika through travel, as we had no local
transmission in Massachusetts. And there are 169
infants in the registry. As part of this effort, we in the birth defects program
collaborated with the state lab by completing the maternal
and neonatal assessment forms. We have highly trained
abstractors who are experienced in going through medical records
for infants with birth defects. So we contributed this
expertise to the effort. The state lab would also notify
us if there were any women who tested positive for
Zika so we would be prepared to abstract the records as
soon as there was a delivery. In addition, the state
lab would notify us if there was a birth
defect identified when they do their infant
follow-up through age two. In Massachusetts, the Zika Birth
Defects Surveillance effort is led by us in the birth
defects monitoring program, and we were charged with
doing rapid surveillance of those infants with birth
defects that had been associated with Zika, regardless of whether
there was any exposure to Zika. We also provided
families with materials of maternal child
health services available to them in Massachusetts. In Massachusetts, we’ve
identified 690 infants and fetuses with a birth
defect that has been associated with Zika, the vast majority of
which had no exposure to Zika. As part of our collaboration
with the state lab, our abstractors in the birth
defect program will notify the state lab if there’s any
mention of Zika exposure in the medical records. We also crosscheck all of the
infants and fetuses identified as part of the Zika
Birth Defect Surveillance against the Pregnancy and Infant
Registry of the state lab. We also check to see if
any had a negative test. So this collaboration with
the state lab allowed us in Massachusetts to submit
data to CDC with test results, both positive and negative, for Zika birth defects
surveillance cases. Before talking about how
we did rapid surveillance, I’ll give you a quick overview of our birth defects
monitoring program. We’re an active population-based
statewide surveillance system. We first receive reports of
cases from multiple sources. Once we receive these reports,
we have six abstractors across the state who will review and abstract the
information on cases. Cases are then reviewed
by clinicians to ensure they meet
our case definition, confirm cases are
included in our registry, and then are available
for surveillance and research purposes. When it came time to
do rapid surveillance, there were two ways
that we achieved this. One was by prioritizing
those birth defects had been associated with Zika
exposure, and the other was to get remote access to
electronic medical records. Getting remote access decreased
the amount of time needed to review the records, but also
allowed for quick follow-up if we needed additional
information on a case. To prioritize the Zika birth
defects surveillance cases, we pushed them to the top
of our extraction list to make sure they
were done first. For the remote access, we currently have
access at 18 facilities. When we first started this work, we focused on our
tertiary care hospitals, recognizing they have
the largest impact. And in fact, four of our tertiary hospitals
alone accounted for 35% of our abstractions. And in this figure,
we see the impact of these efforts on our data. When we first started this
effort, it took us over 80 days to abstract a case from when
we first ascertained it. In about a year later,
we’ve halved the amount of time it takes
to abstract a case. Less than a year after
establishing the Zika Pregnancy and Infant Registry,
the first study came out assessing birth
defects in relation to Zika infection in pregnancy. And it found that among
completed pregnancies in the US with lab evidence of
possible Zika infection, 6% of the fetuses or infants had
Zika-associated birth defects. When looking at symptom status, a similar proportion was
found among symptomatic and asymptomatic women,
suggesting the severity of illness was not indicative of having an infant
with a birth defect. And among women with infection
in the first trimester, birth defects were
associated with 11%. So this study raised
the question of: What is the baseline prevalence
of these birth defects? Is what we’re seeing with
Zika higher than the baseline, or is it what we would expect? In order to answer this
question, data was collected from existing birth
defects surveillance systems for the years prior
to the Zika epidemic. We were one of three states that
was able to provide the data in the time needed to assess
the baseline prevalence. What we found was the
prevalence in 2013 to 2014 was 3 per
1000 live births. And when we look at the
prevalence in the Zika Pregnancy and Infant Registry — so for pregnancies
with Zika exposure — we see a prevalence of
60 per 1000 live births. So this is a 20 fold increase
in Zika-related birth defects. When we consider brain
abnormalities and microcephaly, we observed a 33 fold increase. This study highlights
the importance of having surveillance
data, because without data from these birth defects
surveillance systems, we wouldn’t have been able
to understand the magnitude of increase caused by Zika. Currently our surveillance
efforts in Massachusetts are evolving
based on recent developments. Hurricane Maria hit Puerto
Rico almost a year ago, and as a result many families
have chosen to relocate from hurricane-impacted areas. We have the fifth-largest
Puerto Rican population in the, US and it’s estimated over
7000 individuals have relocated to Massachusetts. Given the large impact
of Zika in Puerto Rico, we want to ensure that
families with infants affected by Zika were receiving the care
that is needed, and there aware of the maternal child health
services available in the state. We’re currently in the process
of assessing what the needs and gaps are in relation to the
families that have relocated, with the goal of
connecting families to available maternal
child health services, identifying families with
an infant affected by Zika, and notifying the state
lab of potential infants that are eligible for the Zika
Pregnancy and Infant Registry. One of the challenges
early on was to establish a standard
case definition. This was done primarily at CDC
where clinicians reviewed cases in both the pregnancy
and infant registry and the Zika birth
defects surveillance data to identify common
patterns of birth defects. In Massachusetts, we updated
our definition to ensure that we are collecting data
consistent with other states. Some of the conditions
monitored as part of Zika birth defects
surveillance were not previously collected in our surveillance
system, therefore we needed to change our process to ensure
these cases were abstracted and reviewed. We also had to work with our
newborn hearing screening program to identify infants
with congenital deafness, as this was also a condition
we did not ascertain as part of our surveillance system. In addition, a challenge
we had in Massachusetts and heard other states
had as well was ensuring that information around Zika
exposure was transferred from the obstetrician to
the infant’s pediatrician. Another challenge for us was
there was lost to follow-up with the infants in the
Pregnancy and Infant Registry. And the longer-term outcomes for these infants are
still not well understood. In Massachusetts, our Zika
surveillance efforts were quite successful because
of our collaboration with the state lab. When Zika first came on our
radar, the two programs reached out to each other and this
early collaboration resulted in a more robust
response to Zika. When it came time to report
data, we were the first state to transfer data for the Zika
Pregnancy and Infant Registry, and among the first group to provide birth defects
surveillance data. The collaboration led to
improved data quality. In addition to the
surveillance efforts, the birth defects program and the state lab jointly
organized other activities and assisted each other in
connecting to other programs across the health department. In conclusion, our experience with Zika birth defects
surveillance has been a success and provides a model for future
responses to emerging threats. It facilitated improvements
in our surveillance system and collaborations between
bureaus that will be of use well beyond
the Zika epidemic. And ultimately we were
able to provide data to evaluate the potential impact of Zika infection
during pregnancy. And now it’s my pleasure to
introduce Dr. Sharon Watkins, the state epidemiologist at the Pennsylvania
Department of Health. [ Applause ]>>Thank you for
this opportunity to present on Pennsylvania. What I’d like to talk today
is about how we as a state with no birth defects
surveillance prior to 2016 used Zika birth
defects surveillance resources and lessons learned to rapidly
respond to an emerging threat, neonatal abstinence
syndrome, described below. Based on 2015 data, there were
nearly 4 million live births in the US, and 44 out of
50 states had some sort of birth defects
surveillance program, covering nearly 33.7
million live births. But over 250,000
births were not covered with the birth defects
surveillance program. Pennsylvania represented
55% of the uncovered births, indicating that we
were the largest state with no program at that time. There are reasons for this. There are many challenges
in Pennsylvania . One being that we had no legal
authority to collect this data. It was not on a reportable
disease list. Making it difficult for us
to request this information from providers or facilities. We have historically had
this information located as a checkbox on the
birth certificate for a select group
of birth defects. However, we know that this
method is not accurate or the best way to
do surveillance. Pennsylvania has statewide data
for inpatient hospitalization, but it is collected and
managed by another entity. And the department is only able to receive the deidentified
data. This is really problematic
for repeat hospitalizations, for following transferred
infants, and does not allow us to easily validate case
codes or perform linkage. Pennsylvania had considered
self-reporting by facilities, or trying to build networks
of facilities to report. But the legal challenges
still remained. However, with the advent of Zika
epidemic and the funding streams for the Zika Pregnancy Registry and the Zika birth defects
surveillance process, our legal team reviewed this
and determined that outcomes such as possible birth defects from a reportable
infectious disease such as Zika could now
be considered reportable. So the department began
surveillance for birth defects. And we used both a passive
and an active method for case ascertainment. Passive in that we contacted
the birthing facilities with the listing of the
relevant ICD10 codes, and then facilities
provided back to us a facility-based case
list, which we reviewed. We then sent a list with
cases we would like to review and potentially abstract. So then we actively
reviewed medical records for case verification,
abstracted relevant data, and recorded that data
in redcap cloud database. As you can see, funding
began on August 2016. We rapidly hired staff. And by October 2017, we had uploaded our
first abstracted cases to the CDC portal. That was a great
success for Pennsylvania. But three months later, after Pennsylvania had uploaded
their first birth defects cases to CDC, Governor Wolf issued
the very first 90 day state of emergency for a public health
problem, the opioid epidemic. One of the tasks that the
governor had requested was rapid collection of cases and data on
neonatal abstinence syndrome. We didn’t know a lot about neonatal abstinence
syndrome in Pennsylvania. However, a group using
Pennsylvania hospital discharge data has recently put
out a report indicating that the number of NAS-related
newborn stays per 1000 newborn stays, had increased by over
1000% from 2001 to 2017. And the estimated
associated hospital costs of over $14 million by 2017. But the actual number
and the rate of NAS births was
not well known, as this graphic represents
hospital stays, not infants. So we had to rapidly think
about how to do surveillance. And for reportable
disease surveillance, we use PA-NEDSS, but
we knew that could not be easily or rapidly amended
to address NAS. We considered distributing
a paper-based form, but we realized that we
already had a web-based system, redcap cloud, and this
could be streamlined. We decided to leverage the
knowledge we had gained from Zika birth defect
surveillance efforts. We began by producing a list of
Pennsylvania birthing facilities and the corresponding
annual live birth counts, to prioritize outreach. We realized we knew
what data fields and information we could find in the birth records
and where to find it. And we already had experience with the web-based
database redcap cloud, in which we’d already completed
extensive functional testing. So in a very short
period of time, the department worked toward
creating a case report form. We performed literature reviews. We determined what
other states were doing. We created a list of
facilities to reach out to. We reviewed what data elements
would be known at the time that the case report form would
be filled out, which was likely to be before infant discharge. And we created defined
response sets. We knew a key would be to
create a one-page form, so a short form, so that we
could visually shorten the form with skip patterns
and drop downs. We had to balance the desire
for robust clinical data with a one-page template. You can see from this graphic
that we went from a declaration on January 10 to a green
light to proceed on the 24th, a survey completed on the
26th, and a live survey link and guidance distributed to
93 facilities by February 8th. Within two days, 18 cases were
reported from six facilities. We were very excited. And as of September 13, we
have 1419 cases of NAS reported that meet the case definition. As you can see, we have
continued case collection because the declaration has
been extended multiple times. Within one week of
beginning data collection, we had 24 facilities reporting. As of September 13, we
have 80, which is 84% of the total facilities. When we include facilities
that report cases that did not meet
case definition but they’re still reporting,
that means we have a total of 89% of our facilities
reporting and engaged. So let’s talk about the data. This table reflects analysis
of data as of August 2, 2018. Mothers of infants
reported to us with NAS who meet the case definition
are more often identified as: of white race, having
less prenatal care, more often have Medicaid
identified as the payer source, the infants are of
lower birth weight and more often have
a gestational age that is less than 37 weeks. In addition, nearly half
receive care in the NICU, and almost all display three
or more symptoms of NAS. The following table indicates
that most babies reported as exhibiting NAS are tested for
laboratory evidence of opioids. Excluding missing data, 90%
of infants in fact are tested. And of all cases that were
tested, 67% were positive for opioids, 12% tested
negative, 11% were pending at the time of reporting,
and then the 10% not tested. So among those testing positive,
85 were positive for some form of opioid, 67% had
a positive result for drugs typically related to
medically-assisted treatment, and 23% were positive for
things like oxycodone, fentanyl, or other opioids. Of the total infants reported
to us, nearly 1/3 were recorded as having no treatment
at the time of reporting, 44% were receiving morphine, and 26% of infants
were being treated with a nonpharmacological
therapy. So the department did not just
send a link to facilities. We also developed and
distributed guidance that described our authority
to report, a case definition, and what criteria to
exclude from reporting. We collaborated with our
hospital advocacy group, and we created a long list of
frequently-asked questions. We also included a
comment and question box within the survey
instrument itself to aid in data collection. We count this effort
as a success, however, we acknowledge there
are challenges. There is no nationally
standardized case definition for public health surveillance. Although CSTE is
working on this. We also had no time to launch a
well launch provider education. And this immediately
produced some challenges. We did see differences
in diagnosis criteria and case definitions
across facilities. And as with any new
surveillance effort, there really should
be continuous feedback between the department
and the facilities. And we simply did not have
the capacity for this. However, for Pennsylvania, this
has been a significant success. The department was able to
leverage the infrastructure and the experience gained from one time Zika birth
defect surveillance to cede efforts in
an emerging event. We were able to respond to
an emergency declaration, collect large amounts of
data in a short time period. And we were able to demonstrate
data collection tools and methods. In other words, we realized
we were data prepared. Next steps, and there are always
next steps, include working with CDC through an
Epi-Aid to survey facilities and to understand the barriers, as well as to understand
differing case definitions and diagnosis criteria. We hope to eventually abstract
a select group of records in a few facilities
to validate the data and the use of data elements. Things we are doing next
steps are that we are working to make NAS a reportable
condition through our reportable
disease laws. And we are considering adding
it to our newborn screening tool to facilitate ongoing reporting. We’ve had to have robust
discussions with partners on policies and procedures and coordinated public health
actions with our children youth and family stakeholders and
others in our department. All of these steps and outcomes
would not have been possible without the receipt of funding for Zika birth defects
surveillance and our leveraging of these tools and lessons for critical emerging
crisis such as opioids. And now it is my pleasure to
introduce Dr. Meaney-Delman, acting branch chief,
Prevention Research and Translation Branch
at the CDC. [ Applause ]>>Thank you very much, Dr.
Watkins, and welcome everyone. As you heard today, there
are multiple threats that impact mothers and infants. And today I will discuss how
surveillance data can inform our response to emerging threats and
ultimately clinical practice. As a practicing obstetrician
and gynecologist, my everyday clinical
decision-making relies heavily on evidence-based clinical
recommendations and guidelines. Guidelines published by the
CDC and the American College of Obstetricians and
Gynecologists are based on different types of data. Caring for pregnant women and infants still relies very
heavily on the interpretation of observational data. While randomized controlled
trials are the gold standard, pregnant women are often
excluded from these trials due to concerns about unknown
risks to the fetus. Observational data from surveillance systems
provides another source of evidence to inform
clinical recommendations. When I came to CDC six years
ago, I expected to have access to a national longitudinal
data system that linked pregnancy
outcomes — excuse me, pregnancy
exposures to future outcomes. And while many different
surveillance systems already exist to look at a specific
disease or a specific outcome, a national comprehensive
surveillance system that links pregnancy exposure
data to longitudinal outcomes for infants and children
has yet to be realized. Real-time surveillance for
pregnant women, infants, and children is complex. First, as you see listed here, there are multiple
outcomes to consider. Second, there is a time
delay, up to nine months between exposure
and birth outcome. And an even longer delay when
we consider an exposure during pregnancy and childhood
outcomes. Third, outcomes differ by the
type, level, and the timing of exposure during pregnancy. Despite these challenges, we
have used surveillance data to explore associations
between pregnancy exposures and maternal outcomes. For example, we have
systems already in place to better understand the risk
factors for maternal mortality, which has undoubtedly led to
improvements in clinical care. We have defined new associations between pregnancy
exposures and birth defects. CDC conducts birth defect
surveillance and research and through one-time
supplemental funding, expanded our Zika birth
defects surveillance. And this ultimately helped to define what congenital
Zika syndrome looks like. We have begun to link childhood
outcomes to pregnancy exposures. And while we recognize
major confounders exist, electronic systems can now
link maternal and birth records with early intervention
and educational data. And this model, which is in its
infancy, allows us to explore if pregnancy exposures are
associated with cognitive, motor, and developmental
effects. Recent public health emergencies
have demonstrated the importance of surveillance data
to define outcomes for pregnant women and infants. During emergencies, healthcare
providers request guidance on infection control,
prevention, and treatment of
emerging diseases. And rapid data collection
has informed our response and our national guidelines. Here are some specific
lessons we learned from each of the recent responses about how our data
influenced clinical care. The 2009 H1N1 flu pandemic
highlighted the vulnerability of pregnant women to
infectious diseases. In this outbreak, pregnant women
experienced an increase risk of dying. 5% of all reported H1N1 deaths
were among pregnant women, who represent approximately
1% of the general population. Early antiviral use was vital. Of the 56 deaths due to
H1N1 among pregnant women, 55 did not receive timely
antiviral medications. And this highlighted the
need to communicate clearly that early antiviral
use was critical, despite the limited safety
data available at the time. We also faced challenges
with maternal acceptance. We still face these challenges. And partially due to concerns about the possible
risks to the fetus. It became very clear during
the outbreak that we needed to articulate the risks of
H1N1 infection to the mother and the fetus as well as
the protective benefits of maternal vaccination to both. And lastly, providers needed to know what was happening
during the outbreak. And CDC set up a pregnancy
flu line to answer questions and disseminate information. And through this resource, CDC collected data demonstrating
how severe influenza was among pregnant women and
postpartum women. During Ebola, we observed
high rates of pregnancy loss and maternal and
neonatal deaths. However, our surveillance
systems did not routinely capture pregnancy status,
and no systematic collection of pregnancy or infant
outcome data occurred. Thus, we do not know
whether pregnant women are disproportionately affected or
face a higher risk of death. We do know that obstetrical
wards served as points of disease transmission. High levels of Ebola virus
were present in the placenta and in the amniotic fluid. And concerns about potential
Ebola transmission during childbirth had obstetricians
and gynecologists around the world
worried about the risk of healthcare associated
infections. This demonstrated the need for infection control
recommendations specific to labor and delivery settings. But among the most recent
public health emergencies, Zika undoubtedly served as the
greatest and most stark reminder of the need to understand
the impact of emerging infectious diseases
on pregnant women and infants. Not since rubella have we
seen an infection cause such serious abnormalities
and never from the bite of a mosquito. Zika demonstrated what a
surveillance system can do. It can inform the pattern
of defects associated with an infectious disease. It can provide estimates
of the risks associated with congenital infection. And it can define the timeframes of greatest risk
during pregnancy. Despite these clear benefits
and the reemergence as you heard of Zika — excuse me, of
syphilis and opioids, we do not yet have a sustainable model for a longitudinal
surveillance system to assess exposures during
pregnancy and outcomes. The multipronged approach to
use during Zika is an example that could be adapted
for other exposures. And as you heard from
Dr. Yazdy, CDC collaborated with state health departments to build the US Zika
Pregnancy and Infant Registry. And this registry has collected
information about pregnant women and infants in the US
states and territories. The registry now
includes 7300 pregnancies, the largest cohort
being monitored. And it has unparalleled
potential to answer key questions
about the full impact of Zika by following the children through their later
years of life. CDC also leveraged birth
defect surveillance to rapidly identify
fetuses and infants with Zika-related birth defects. And by capturing infants
with the outcome of interest, birth defect surveillance
explored exposures from a retrospective lens and established the baseline
prevalence of particular defects as well as trends over time. Now, birth defect surveillance
was especially important with Zika, because many Zika
infections are asymptomatic, and therefore the diagnosis of maternal Zika may
have been missed. I think this displays
how identifying infants with birth defects through the
Zika birth defect surveillance system complements the case
finding of an exposure registry. To ensure data could be
captured in real-time, CDC provided surge capacity
staff for health departments. These professionals provided
additional public-health support during the crisis. And lastly, similar to flu, CDC
quickly established a hotline to answer questions and to ensure the most
up-to-date information could be accessed by every healthcare
provider in the country. The benefits of surveillance
data were realized at the national, state,
community, and individual level. Data was used to inform
clinical guidance, provide targeted outreach,
identify families in need, and to facilitate
appropriate testing. The lessons learned can
be applied to other known or emerging threats,
such as the opioid crisis that we heard is
affecting pregnant women and infants across the country. A similar surveillance system to Zika could help us better
understand maternal outcomes associated with opioids
and other substances. Infant outcomes could
also be better understood through surveillance. You heard from Dr. Watkins
that infants are being born with neonatal abstinence
syndrome. And because a standard case
definition does not yet exist, it is difficult to track
this condition nationwide. CDC is working with
the Council of State and Territorial Epidemiologists to define the public
health case definition. And once established, we
can use surveillance systems to track NAS nationally. In fact, several states have
already begun surveillance based on state-specific
case definitions. Other infant outcomes
associated with opioid use, like low birth weight,
infant deaths, are also important to track. And we need to understand if polysubstance use poses
a risk of birth defects. Pregnancy exposures to opioids and other substances may
have long-term challenges for children. Emerging data suggests some
infants may have special educational and developmental
needs. And through longitudinal
surveillance data and linkages, we can explore long-term
outcomes for infants with prenatal substance
exposure. So CDC is interested in
developing SETNET, a multipronged pregnancy and infant surveillance
system for emerging threats. And in addition to
Zika and opioids, this platform could
be used to look at other exposures during
pregnancy and could be leveraged for the next public
health emergency. These presentations you’ve
heard today have several common themes. There is a common need for
longitudinal surveillance of the mother-infant dyad. The need for routine
capturing of pregnancy status. The need for collection
of real-world timely data. And the need for
standard case definitions. In addition, access to multiple
data sources can facilitate rapid data collection
and data linkage, and can help us identify
screening and intervention opportunities. And of course, all of this
requires ongoing outreach and education to disseminate
what we learn when we learn it. Common challenges you’ve heard, these occur across
pregnancy exposures, inconsistent case definitions
do not allow us to compare data across different systems. It can be difficult to identify
pregnant women who are exposed. For example, as we
heard from Dr. Bowen, women who do not participate
in routine prenatal care, it’s difficult to assess
and to treat those mothers. Lost to follow-up is an issue,
specifically as children age, families move, or they change
providers or healthcare systems. And then long-term
outcomes may not be known, so we don’t know what
we’re looking for. To circle back to my
own personal story, the past six years at CDC
has shown me the value of public health data and how
it can inform clinical guidance and help us provide better care
for pregnant women and infants. In summary, a multipronged
sustained approach to pregnancy and infant surveillance can
identify risks associated with exposures during pregnancy,
can inform prevention strategies and clinical management, and ultimately can help us link
families to the care they need. I want to thank you
for your attention. And now I’d like to introduce
and welcome Dr. Fan Tait to the stage, the
chief medical officer from the American
Academy of Pediatrics, who will moderate our Q&A. Welcome. [ Applause ]>>Wow. Please join me in thanking again the
whole panel, please. [ Applause ] Thank you, thank you
all for excellent, excellent presentations and
such important presentations. Dr. Redfield said that surveillance is
the backbone of the CDC. I had written bread
and butter of the CDC. You can see I’m from the South. This is so important as
a pediatric neurologist and listening to what
you all have presented. I was thinking about
lost to follow-up, what happens to the children. Where we lose them and where
they have these exposures in utero or otherwise. And the other thing I thought
about is early intervention. So how do we make sure that they
get the help that they need? And then how do we circle
back, as has been said, to primary care providers to make a difference
in the outcome ? So this is wonderful
and we thank you. Now we have a few minutes,
and it’s my privilege to facilitate the questions
that we have for our panelists. We will be having
questions from online as well as you all here in the audience. I would ask please that
you keep your questions — that you make your questions
concise, because we want to have a lot of them. So if you have questions, please
either use your microphones if you’re down here
in the front, or make your way
to the microphone. And we’re also watching for
questions from online too. There’s one online, we’ll
start with that one.>>Yes. First, I’d like to say that this entire session
recorded version as well as the beyond the data interview and the slides themselves
will be posted to our website at cdc.gov/grand-rounds. Any questions can be sent
to [email protected] And we will post questions
related to this session here. One general question we
have from Kristin is: Why is the mortality rate
in the US so much higher than in other countries,
even Third World countries? And I realize that’s not
specific to this session but it’s something that
we could possibly address.>>So why don’t I punt that
one to Dr. Dana please.>>So there are different
parts of CDC that work on different parts
of surveillance. So this is definitely
not in my wheelhouse. I think there are a lot of
reasons why we see higher rates of maternal mortality. Specific things that we
are concerned about — and again, this is not
my area of expertise — are things like high blood
pressure during pregnancy, bleeding issues. And then we know that there is
an aging maternal population, and many of those women have
additional chronic conditions as we see more older
women giving birth. So I think there’s a
lot of causes for it. What’s exciting is that there
are state-based maternal mortality systems that are
looking within their state at what are the causes of
maternal mortality and looking at ways to adjust that. Again, this is work being
led out of the division of Reproductive Health at CDC. And it’s really been
exciting to see over the years how we can really
establish locally what the challenges are and why women
are dying in particular states.>>Thank you Dr. Meaney-Delman. A question in the back and
then we’ll come to the front.>>Yes. What I would like
to know is, have HIE’s or health information
exchanges been used as a surveillance data source to
get more of a regional picture for either NAS or Zika?>>I think that’s an
excellent question. From a state perspective,
would — Dr. Watkins, would you
like to address that?>>Sure. That’s something
we certainly have been thinking about. But how many states — and I think Pennsylvania’s
not alone — are not that far along
in our ability to accept and really be able to consume and use health exchange
information. So although that’s
down the road, that isn’t quite what we have
available to us right now.>>Thank you.>>Thank you. Here in front.>>Denise Jamison,
representing American College of Obstetricians
and Gynecologists. I think we’re fully
supportive of surveillance for emerging threats
to pregnant women. And it’s really important to
ensure ongoing sustainable and well-supported surveillance
systems for emerging threats. But I wanted just to point out that the threat
is not opioid use. The threat is opioid
use in pregnancy, not medically-assisted therapy,
which is a recommended therapy. And similarly, neonatal
abstinence syndrome is an expected and treatable
outcome of prenatal opioid use. So I think we have
to be really careful about our communication
messages. Flu and Zika are
threats to women. So in this setting, how
do we avoid stigmatizing medically-assisted
therapy and women who are using opioids
in pregnancy? And secondly, how do we maintain
the focus on the overall threats of opioids to maternal
and child’s health?>>Thank you. We’ll go back to NAS in the
state, but I’ll ask for others to chime in too please.>>You make an excellent point. And I think in Pennsylvania
we have used this opportunity to not just be collecting
the data but to engage in conversations
with our partners. And that’s where it’s
really important, because NAS includes
symptomatic infants, but we’re really worried about
all infants who may be exposed. And then where we can do
interventions down the road in that family, in the
life of that infant. So we’re starting
with data collection, but I think it’s a conversation
with partners and keeping in mind that stigmatization and
making sure that we do our best to avoid that, including
the way we do surveillance and how we use it.>>Thank you, Dr. Watkins. So Dr. Meaney-Delman.>>So Denise, thank you,
and I completely agree. And I think the most important
thing we need to do is make sure that people understand that substance use
disorder is a disorder, it’s a medical condition. And I think there’s still
a lot of stigma associated with individuals who experience
substance use disorder. I agree, I think that — I’ve
used medication-assisted therapy in my practice for years, and
I think we’ve seen the benefits of medication-assisted therapy. I think it still is unclear which one is the
best one to use. And I think there’s a lot more
emphasis and data that’s needed to really inform which
one is the best one for moms and for babies.>>Thank you. Question in the back?>>Thank you very much
for this presentation. My name is Margaret Lampe. I work in our division of
HIV/AIDS prevention at CDC. And while, you know, we’ve nearly eliminated
perinatal HIV transmission in the United States, and
that’s a really exciting accomplishment, but as
some of you may know, recently a potential signal of
neural tube defects was observed in Botswana with periconceptional
dolutegravir use. And so we are now
here domestically and around the globe
trying to understand if the signal is real, is
there a drug class affect. And really if indeed
this is real, we likely would not
have observed this here in the United States. So you know, this is very
applicable to what we are trying to understand now
with dolutegravir use in the short-term
outcomes of birth defects. But, you know, there
are other key questions. You know, Dana —
thinking through sort of long-term outcomes. We wrap our minds around what
are potential other adverse long-term outcomes for
infants exposed, you know, periconceptionally
and during pregnancy. The French have identified
mitochondrial toxicity as a potential problem. And we’re really
not quite sure how to have an understanding
of that. So I’m really excited by
this start of a conversation. And I can assure you there are
many potential questions we could look into.>>Thank you. I think it speaks to the need
here and globally and otherwise. I was just thinking in
terms of the syphilis piece. And Dr. Bowen, I wonder
if you want to comment on, if we had not been
following that, if you were not following
that, where would we be? And how would be treating? So maybe just the importance
of the ongoing piece of what we’re talking about.>>Sure. Thank you. I think, you know,
it speaks to — currently we rely heavily in the congenital
syphilis surveillance era, we rely heavily on
case reporting. And I think what we’re trying to envision here is actually
a system that would move us into the 21st century,
where we are more certain that we have actually
ascertained all of the cases of congenital syphilis
that are out there. That does remain
a concern for us. And especially as our numbers
go up, we kind of expect — as we do better case
ascertainment, they will go up before they come down. So I think it’s worth pointing out that the numbers
are increasing now and may even continue
to increase next year. And that’s not necessarily
inherently a bad thing. It could mean that
we’re doing a better job with case ascertainment. And I think a longitudinal
surveillance system could perhaps be a step in
the right direction to continue that progress.>>Thank you. One more, online.>>From our Grand
Rounds email box. Pregnancy outcomes vary
greatly by race, ethnicity, and country of birth of mothers. How are race, ethnicity, and country of birth
disparities being monitored in the surveillance
systems discussed today?>>Dr. — I’m looking at who
I should call on for that. It’s an excellent question. Dr. Meaney-Delman, do
you want to address that?>>So I can say that
the surveillance systems that we’re working with
do include those factors and those variables. And we do look at that
across our various outcomes . So I think it’s included in the
national surveillance systems, and my understanding
is it’s also included in most state surveillance
systems. But I want to turn
it to you guys.>>So talking about state
surveillance systems, much of our reportable
disease conditions are based on electronic laboratory
reporting. And for those of you in states,
you know that race and ethnicity and nativity are not
often filled out. So for most of those kind of
conditions, including things like childhood lead,
where we really do want to have more understanding
about disparities, for example, those factors are
not filled out. And they require either calling
and much resource on the part of the state to get
that information, or perhaps the next
generation where we’re looking at electronic health records, to be able to get
that information in. But I will point out. In most of the surveillance where we’re using administrative
data sets, we’re able to link across systems, we would be
able to gather that information. But for other things, it’s
something we have to rely on laboratory records. And then if it’s
not there, get it.>>Dr. Yazdy.>>In Massachusetts, in our birth defects
surveillance system, we do have race, ethnicity, and
country of origin as it comes from the birth certificate. So if it is there, we have it. And we do routine
monitoring by race ethnicity. We’ve also participated
in multistate studies, where we’ve pulled
data across states, which gives us a wider variety
of race ethnicity to look at, and to look at trends
of birth defects over time by these factors.>>Thank you. And I think I’m getting
the hook, so. [applause].>>Thank you, yes,
for the speakers and thank you for moderating.>>Thank you.>>And yes, that is
all we have time for. And please join us next month
for Public Health Grand Rounds. [ Applause ]

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