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Nigel Paneth MD MPH

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A ONCE IN A LIFETIME OPPORTUNITY TO STUDY CHILD HEALTH IN DEPTH Nigel Paneth MD MPH Michigan State University ARNOLD EINHORN LECTURE DC CHILDRENS – PowerPoint PPT presentation

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Title: Nigel Paneth MD MPH


1
THE NATIONAL CHILDRENS STUDYA ONCE IN A
LIFETIME OPPORTUNITY TO STUDY CHILD HEALTH IN
DEPTH
  • Nigel Paneth MD MPH
  • Michigan State University
  • ARNOLD EINHORN LECTURE
  • DC CHILDRENS
  • MARCH 23, 2011

2
THIS TALK CAN BE FOUND ON MY WEBSITE
  • http//www.epi.msu.edu/faculty/paneth.htm

3
ONE OF THE MOST IMPORTANT PRINCIPLES THAT ARNOLD
TAUGHT ME
  • KEEP IT SIMPLE!

4
Paneth N Apgar score and risk of cerebral palsy.
BMJ 2010, Oct 7341c5175.7
  • MY ORIGINAL
  • BMJ EDITED VERSION
  • A wise clinician once pointed out to me that the
    most important academic surgeons were not those
    with the best manual dexterity. Fabulous
    procedures requiring intricate skills will not
    carry very far. Simple procedures that can be
    performed widely by ordinary mortals will always
    have more impact on the health of the public.
  • Experience suggests that simple procedures that
    can be performed widely have a greater impact on
    health than more complex and demanding procedures
    that are less widely applied. The Apgar scoring
    system works because it comprises just a few
    components that can easily be memorised, and
    requires no equipment and modest training

5
THE CHARGE FROM CONGRESS PL 106-310. Childrens
Health Act of 2000
  • The Director of NICHD shall establish a
    consortium from appropriate Federal agencies
    (including the CDC and EPA) to
  • (1) plan, develop, and implement a prospective
    longitudinal study, from birth to adulthood, to
    evaluate the effects of both chronic and
    intermittent exposures on child health and human
    development and
  • (2) investigate basic mechanisms of developmental
    disorders and environmental factors, both risk
    and protective, that influence health and
    developmental processes.

6
THE RESPONSEThe National Childrens Study
  • The NCS is a longitudinal study of a nationally
    representative sample of 100,000 children, their
    families, and their environment from before birth
    through age 21.
  • It is the largest longitudinal study of
    childrens health and development ever conducted
    in the U.S.
  • It may be the largest study combining all forms
    of measurement in depth (self-report, clinical
    examinations, biological samples) ever conducted
    on any human population.

7
FUNDING FOR THE NCS
  • Separate line item in congressional budget not a
    part of NICHDs overall budget.
  • Assigned to the NIH directors office
  • Administered by NICHD, with involvement of CDC,
    EPA and NIEHS
  • 2007 and 2008 Approx 60 million via
    congressional continuing resolution, because not
    supported by White House
  • 2009 2011 White House supporting study with
    approximately 190 M annual allocations

8
WHY IS SUCH A STUDY NEEDED?
  • It will be expensive likely to cost anywhere
    from three to five billion dollars over its 25
    year lifetime
  • It will require a great deal of scientific
    research effort that otherwise go into other
    research projects
  • It will require a considerable commitment from
    the participating families
  • So we must have some very good reasons to
    undertake this massive study

9
1. BECAUSE MOST CHRONIC CHILDHOOD CONDITIONS ARE
STABLE OR INCREASING IN PREVALENCE
  • Chronic conditions that are decreasing
  • Neural Tube Defects (folic acid)
  • Chronic conditions that are not decreasing
  • Most birth defects
  • Learning Disabilities
  • Severe Mental Retardation
  • Chronic conditions that may be on the rise
  • Cerebral Palsy
  • Autism
  • Chronic conditions that are definitely increasing
  • Asthma
  • Premature Birth
  • Juvenile Diabetes

10
2. BECAUSE CHRONIC AND DISABLING CONDITIONS OF
CHILDHOOD ARE VERY COSTLY
  • ESTIMATED ANNUAL COSTS IN US
  • Severe Mental Retardation 51 billion
  • Autism 30 billion1
  • Premature birth 26 billion
  • Juvenile Diabetes 14 billion
  • Cerebral Palsy 12 billion
  • Birth defects 8 billion2
  • Vision and Hearing Loss 4 billion
  • 1. No formal estimate available
  • 2. Estimate from 1992

11
IN OTHER WORDS.
  • BECAUSE THERE IS NO DECLINE IN CHRONIC AND
    DISABLING CHILDHOOD CONDITIONS, YEAR IN AND YEAR
    OUT THESE CONDITIONS PRESENT US WITH AN ECONOMIC
    BILL OF AT LEAST 100 BILLION.
  • WHAT CAN WE DO?

12
WE HAVE TO FIND OUT HOW TO PREVENT DISEASE
  • Improvement in child health over the past 50
    years has mainly been because of improved
    treatment (e.g. cancer chemotherapy, newborn
    intensive care). There has been very little
    prevention.
  • The only way to reduce our massive health care
    expenditures is via disease prevention
  • The only way to prevent disease is to learn what
    the causes are and figure out ways to address
    them.
  • This means undertaking research on what happens
    before disease arises, the antecedents of
    disease.

13
WEIGHING THE COSTS
  • The NCS budget is currently about 200 M per
    year. At that pace, over 25 years, it would cost
    5B. (actually pace of spending is likely to
    decline once enrollment is complete).
  • This is less than 0.2 of the costs of the
    diseases we study.
  • This 5B will be returned to our economy in
    three years, if the only result is
  • Preventing 20 of preterm birth, or
  • Preventing 5 of autism, or
  • Preventing 3 of mental retardation

14
RESEARCH IS EXPENSIVE
  • BUT NOT DOING RESEARCH IS MUCH MORE EXPENSIVE

15
WHAT IS THE STRATEGY FOR A STUDY THAT COULD LEAD
TO PREVENTION?
  • Start with healthy people
  • Follow them until disease occurs
  • See what was different about people, who later
    got disease or didnt get disease, when they were
    healthy.
  • This is called the longitudinal cohort study
    approach in epidemiology

16
LARGE PROSPECTIVE LONGITUDINAL STUDIES WORK!
  • The best example of success using the
    longitudinal study model is the reduction in
    heart disease.
  • The Framingham Heart Study followed healthy
    adults for many years, and taught us that factors
    such as high blood pressure, diabetes, smoking
    and high cholesterol predispose to heart disease.
  • Risk factor control has been the largest
    contributor to the 60 reduction in the heart
    disease death rate, the 42 reduction in the
    overall death rate, and an extra 9 years of life
    expectancy over the past 50 years in the US.
  • Framingham had 5,000 participants because heart
    disease is common. To study the several rarer
    childhood chronic conditions, a much larger
    sample size is needed.
  • We needs a Framingham study for children!

17
Consequence of Framingham Incidence of Coronary
Heart Disease, USA, 1950-2000 (age-adjusted)
18
THE NATIONAL CHILDRENS STUDY
  • WHAT, WHERE, WHO?

19
WHAT IS BEING STUDIED?
20
SOME STUDY QUESTIONS
  • How is asthma incidence and severity influenced
    by the interaction of early life infection and
    air quality?
  • Do assisted reproductive technologies (ART)
    increase the risk of fetal growth restriction,
    birth defects, and developmental disabilities?
  • Does impaired maternal glucose metabolism during
    pregnancy cause obesity in children?
  • How does high level exposure to media content in
    infancy affect development and behavior in
    children?
  • Does pre-and post-natal exposure to
    endocrine-active environmental agents alter age
    at onset, duration, and completion of puberty?

21
DATA TO BE COLLECTED PRIOR TO BIRTH
  • Study begins with a home visit prior to
    conception (in women trying to get pregnant) or
    in the first trimester of pregnancy
  • Two additional clinic visits and three phone
    contacts during pregnancy.
  • In one of the clinic visits, a third trimester
    study ultrasound is obtained.
  • A major emphasis on collecting biological and
    environmental samples in pregnancy and at birth
    to use to study future hypotheses.

22
PRE-CONCEPTIONAL OR FIRST TRIMESTER HOME VISIT
  • Questionnaires Household Composition and
    Demographics Perceived Stress Social Support
    Family Processes Health Behaviors Diet and
    Toxicant Exposure through Food Environmental
    exposures
  • Biospecimens from both partners if available
    blood, hair, urine, nail, saliva. Vaginal fluid
    from woman.
  • Environmental samples dust, air, water, soil
  • Physical measurements height, weight, skinfolds,
    other anthropmetry, blood pressure

23
DATA TO BE COLLECTED AT BIRTH
24
DATA TO BE COLLECTED AFTER BIRTH
  • Home visits at six and twelve months and frequent
    phone contacts.
  • Further collection of biological and
    environmental specimens at home visits (breast
    milk, formula, baby urine)
  • Health surveys obtained at all visits
  • Abstraction of medical records
  • Continued follow-up to age 21, though full
    protocol beyond age 2.5 not yet developed

25
BIOLOGICAL STORAGE AND INFORMATICS
  • All material collected in the study
    (environmental and biological specimens) will be
    stored in duplicate in two locations
  • After aliquotting, an estimated 32 million
    specimens will be stored in the first seven years
    of the study, most in vapor phase liquid nitrogen
    at -150 or less.
  • All survey and health data collected will be
    protected by the highest levels of security

26
WHERE DOES THE NCS TAKE PLACE?
All Births in the Nation
4 million births in 3,141 counties
105 primary sampling units (mostly counties)
Sample of Study Locations
Selection of Neighborhoods or segments
Sample of Study Segments
Study Households
All households within segments
All eligible women in the household
Study Women
27
  • 7 VANGUARD SITES FROM 2009
  • 30 NEW VANGUARD SITES FROM 2011
  • ANOTHER 68 SITES TO BE ACTIVATED IN THE FUTURE
  • TOTAL 105 SITES

28
TIME FRAME FOR ENROLLMENT
  • Primary sampling units (PSU) are usually
    counties, but in some cases are a group of very
    small counties (e.g. in Minnesota-South Dakota)
    or sub-divisions of counties (e.g. Los Angeles
    county is 4 PSUs).
  • The segments are chosen so that about 350-400
    births per year are expected to take place.
  • This should allow each PSU to recruit 250 births
    a year for 4 years, or 1,000 total per PSU, thus
    producing the sample of 100,000

29
DIFFERENCES ACROSS COUNTIES IN THE US
  • Study centers (universities or consortia who
    submitted proposals for the NCS contracts) manage
    variable numbers and types of counties across the
    US, ranging from one (many) to eight counties
    (NY-NJ consortium).
  • The Michigan Alliance for the National Childrens
    Study has contracts for five counties.
  • In our largest county, Wayne, we must enroll 250
    births from 25,000 annual births taking place in
    26 hospitals and cared for in 150 prenatal care
    settings
  • In our smallest county, Grand Traverse, we have a
    total of 1,000 births, all cared for in 5
    prenatal care settings and delivering in one
    hospital

30
INITIAL ENROLLMENT STRATEGYDOOR-TO-DOOR
ENROLLMENT
  • In sampled segments of counties (specific
    neighborhoods selected to be representative of
    the counties), all women of child-bearing age are
    contacted first by mail, then phone, then in
    person at their residences.
  • We attempt to enroll the woman is she is
    planning a pregnancy or is pregnant and in the
    first trimester.
  • This system was used in the 7 vanguard counties,
    and had difficulty identifying pregnancies,
    although consent rates once pregnancies were
    identified were good, nearly 70.

31
NEW ENROLLMENT STRATEGIES
  • Recognizing that enrollment was not as efficient
    as hoped in the Vanguard Counties, and risked
    creating a non-representative sample, a decision
    was made in 2010 to have an experimental phase in
    which enrollment would proceed in one of three
    ways
  • 10 counties would continue household enrollment
  • 10 counties would enroll in prenatal care
    settings
  • 10 counties would emulate the census and mail
    surveys to a large number of women, and then
    select within that sample for more in depth
    study.
  • All three approaches retain the fundamental
    sampling frame (i.e. households in segments)

32
The Michigan Alliance for the National
Childrens Study (MANCS)
33
THE FIVE STUDY COUNTIES IN MICHIGAN
34
THE FIVE MANCS PARTICIPATING INSTITUTIONS
  • Henry Ford Health System (HFHS)
  • Michigan Department of Community Health (MDCH)
  • Michigan State University (MSU)
  • University of Michigan (UM)
  • Wayne State University (WSU) Childrens Hospital
    of Michigan (CHM)
  • Plus the health departments of each of the
  • five counties

35
WORK BEFORE ENROLLMENT
  • Selection of segments
  • Engaging the community, including formation of a
    community advisory board
  • Making arrangement with hospitals and
    providers
  • Dealing with IRBs
  • Hiring and training staff

36
A COMMON IRB
  • We have managed to get agreement from our four
    partners to have the MSU IRB serve as the IRB of
    record for all MANCS protocols
  • Our partners send representatives to the MSU IRB
    when it discusses MANCS protocols
  • Some, but not all, hospitals in Wayne County
    accept this arrangement, and defer to the MSU
    IRB, if they think they are engaged in research

37
PREGNANCY ASCERTAINMENT VIA PRENATAL CARE
PROVIDERS
  • We do surveillance in prenatal care to identify
    women from the study segments
  • We obtain lists from clinics of upcoming prenatal
    patient appointments and then use
    address-matching software identify women eligible
    for the NCS
  • We then ask providers or their staff to let women
    know about the study and ask permission for us to
    approach the women.
  • We currently do this for 34 practice sites, soon
    to expand to 41, which cover some 70 of all
    prenatal care in Wayne County.

38
LABOR ASCERTAINMENT BY HOSPITALS
  • We cannot rely on study women to let us know they
    are in labor, so we work with hospitals to notify
    us if an eligible woman is admitted in labor.
  • We make arrangements with each hospital to
    collect the required specimens
  • We spend a great deal of time working to bring
    hospitals on board.

39
HELPING WOMEN WITH THE PROTOCOL THE PARTICIPANT
ADVOCATE COORDINATOR (PAC)
  • We budgeted an additional staff member, the PAC.
    This is a woman from the community with
    experience of pregnancy and labor issues whose
    role is to assist the participant to complete the
    protocol. She does not collect data (though she
    may help with birth collections)
  • She is usually the first person to tell a woman
    about the study
  • She keeps in touch with the participant reminding
    her of the protocol requirements
  • The PAC will go with subjects to study visits,
    and to LD with mother, if required
  • In Wayne County, we have one PAC per 30 women per
    7 months (from first trimester visit to delivery)

40
ENROLLMENT RESULTS IN THE FIRST MONTH
  • We began working in our clinics in mid-February,
    and in the first five weeks we have
  • Address-matched 5,621 women listed on prenatal
    care appointment lists
  • Identified 112 women who are likely to be
    pregnant
  • Obtained permission to contact from 47 of 51
    mothers who were approached by providers.
  • Approached 26 of them, finding 19 eligible (the
    7 ineligible were not pregnant or trying)
  • All 19 eligibles have consented to participate.
  • Another 5 women ready to consent, awaiting
    Spanish or Arabic language consent forms, or
    address verification.

41
THANKS VERY MUCH FOR LISTENING
  • IM HAPPY TO ANSWER QUESTIONS
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