Att L - Q/A Brochure

Questions & Answers

u.s. Department of Health and Human Services
Centers for Disease Control and Prevention
Centers for Birth Defects Research & 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 9 birth defects programs
called “Centers for Birth Defects Research and Prevention.”
They are located in Arkansas, California, Georgia, Iowa,
Massachusetts, New York, North Carolina,Texas, and Utah.
· 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.

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?
· 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.

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.

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.

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.

To Participate...
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 risks and benefits. These are:
· This is a national study to discover clues about what causes
birth defects. It is being conducted in 9 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.
· Cheek cell collection consists of rubbing a soft brush inside
the cheek. This procedure causes little to no discomfort. The
kit will be sent to you in the mail.
· 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.

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

What do I get for participating?
We have enclosed $20 with the introductory letter to thank
you for your time and inconvenience. The money is yours to
keep whether or not you participate in the study. We will send
another $20 with the cheek cell kit. And if you complete both
parts of the study, you will get a third $20 when we receive your
cheek cell samples.

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 and lifestyle
· work and hobbies
CS209001-A

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.

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.

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

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:
Tineka Yowe-Conley
National Center on Birth Defects and
Developmental Disabilities
Centers for Disease Control and Prevention
1600 Clifton Road, MS E86
Atlanta, GA 30333
Phone: 404-498-4315
E-mail: [email protected]
Website: www.nbdps.org