Att K_NBDPS Q&A Pamphlet

Questions You May Have...
How did you get my name?
Part of our ongoing work to find causes of birth
defects includes studying them when they occur.
State law allows us to monitor cases of birth defects.
This is how we identified most women in the study.
Women whose babies do not have birth defects
were selected randomly from women who gave
birth in the same year.

What does the study involve?
The study has two parts:1) a telephone interview at
a time convenient for you,and 2) a collection of
cheek cells from immediate family members.

How will the study benefit my family?

Questions You May Have (continued)...
Can you not get this information
from my doctor or my hospital
records?
No. Most doctors do not routinely ask about
the topics we are studying. You are the
only one who can supply the information
we need.

What if I do not want to answer?
You may skip any questions you wish.

What if I can not remember?
It is OK to say so. We want you to answer as
accurately and honestly as possible.

Study results will not directly benefit you or your
family. However,many women feel good about
helping to find causes of birth defects.

How did you decide what topics to
study? Are these things known to
cause birth defects?

What do I get for participating?

We do not know what causes or does not
cause most birth defects. The purpose of the
study is to find this out. Many topics were
chosen because parents frequently have
questions about them.

We have enclosed $20 with the introductory
letter to thank you for your time and
inconvenience. We will send another $20
with the cheek cell kit.

Do I have to participate?
No. There will be no harmful effects if you refuse.
Your decision will not affect health care services or
other benefits you or your family may receive.

What will I be asked in the interview?
The interview covers a wide range of topics
about you and the father. These include your:
recent pregnancy and the 3 months
before you became pregnant
past pregnancies
health and diet
prescription and non-prescription drugs
taken
family background
work and hobbies
lifestyle

·
·
·
·
·
·
·

The interviewers ask everyone the same
questions in the same way. Sometimes we ask
you to answer in your own words; other times,
we will give you several possible responses to
choose from.

National
Birth
Defects
Prevention
Study

Contact Information
We hope you will participate in our study.
The information you can give us is crucial.
We believe this type of study holds the
best promise for solving the mystery of
birth defects.
For more information, please contact:
Sarah Ruuska, MPH
National Center on Birth Defects and
Developmental Disabilities
Centers for Disease Control and Prevention
1600 Clifton Road, MS E86
Atlanta, GA 30341-3721
Phone: 404-498-4315
E-mail: nbdps@cdc.gov

Q&A

Questions & Answers

Department of Health and Human Services
Centers for Disease Control and Prevention

About the Study...
Why are you studying birth defects?
People are often surprised to learn that birth
defects are common, found in 1 in 33
newborns. Most of the time, doctors and
scientists do not know what caused them.
This study will move us closer to
understanding the causes of birth defects
and ways to prevent them.

What is the National Birth Defects
Prevention Study?
A nationwide effort to find causes of
birth defects.
Interviews are conducted by 10 birth
defects programs called "Centers for Birth
Defects Research and Prevention.” They
are located in Arkansas, California, Georgia,
Iowa, Massachusetts, New Jersey, New York,
North Carolina, Texas, and Utah.

Why are you interviewing women?
There is no way to recreate the many events
and exposures that happen during pregnancy
in a lab - only women can give us this
information.

Why do you need information about
genes?
The cheek cell samples provide critical genetic
information. The interview provides critical
information about factors in the environment
that may affect birth defects. This study will
help us find out how the two interact.

·

About the Findings...
How do you interpret the results?

·
·
·
·
·

·
·
·
·
·

About 2,500 women are interviewed each
year.
Many different types of birth defects are
being studied. About 1,800 women
interviewed yearly will have had children
or pregnancies affected by birth defects.
About 700 of those interviewed yearly are
mothers of infants with no birth defects.
Women interviewed will be sent a cheek
cell collection kit to help us compare
genetic factors with information given
during the interview.
The study is funded by the Centers for
Disease Control and Prevention.

We ask the same questions to all women,
whether or not their pregnancies were
affected by birth defects.
We then compare responses between
groups.
We do not look at individual answers; we
only consider groups. We calculate
averages and other statistics for our
analyses.
We combine data from all Centers to
perform statistical tests.
We study genetic material from cheek
cells to see if certain forms of genes are
more likely to be seen when birth
defects occur.

Can you give an example of a
risk factor?
Cigarette smoking is a risk factor for
developing lung cancer. This means that
those with lung cancer are more likely to be
smokers. While not all smokers develop lung
cancer and not all persons with lung cancer
are smokers, we know that not smoking helps
prevent lung cancer.
Likewise, the same is true for findings from
this birth defects study. Having one or more
risk factors does not prove what caused birth
defects in a particular case. But avoiding
those risk factors, if possible, may help prevent
future birth defects.

What will you do with the study
findings?
We publish findings in medical journals.
Because birth defects are of great interest,
findings are often covered in the news as well.
They may also be used in health education
materials. We will also publish findings in a
yearly newsletter that we send to women
who took part in the study. Remember, all our
findings pertain to groups of women; no one
will be able to identify you from our reports
or publications.

·
·
·

An interviewer will call you in about 2 weeks
to set up a convenient time for the phone
interview. She will make sure that you
understand the most important points about
the study, its disadvantages and benefits.
These are:
This is a national study to discover clues
about what causes birth defects. It is
being conducted in 10 states. It has 2
parts: a telephone interview and a cheek
cell collection.
The interview takes an hour or so. It can
be split into several segments to best suit
your schedule. It covers a broad range
of topics.
Some women interviewed find it
emotionally difficult to discuss their
pregnancies. There is no other likely
disadvantage.
Taking part in the study will not benefit
you or your family directly. However, the
findings may help others prevent birth
defects in the future.
You can choose not to participate. This
decision will not affect the care or
services that you or your family receives.
You can choose not to answer any
specific questions. You are free to stop
the interview at any time.
You can choose not to provide cheek
cell samples.
All your answers and results of genetic
tests are confidential. Your identity will
remain private.

·
·
·
·
·
·
·
·

What will the results show?
The study looks at a large group of women.
This means findings will apply to "the average
woman" rather than any specific individual.
There are many possible results. We may
uncover:
Risk factors, things that contribute to
birth defects.
Protective factors, things that lower the
chances of having a baby with birth defects.
Neutral factors, things that neither raise
nor lower risk.

To Participate...

About the Findings (continued)..

About the Study (continued)...

Your privacy will be protected in the following ways:

·
·
·
·

Your answers and any results of genetic tests will not be seen by anyone outside the study.
Your identity is secret. We will never use your name, the father's name, or your child's name
in any report or publication.
Information about you will not be given to anyone outside the study, including insurance
companies or other government agencies, even if requested by a court of law.
Records are kept under lock and key. Identifying information is removed from computer
files, which are password protected.