[Federal Register Volume 75, Number 56 (Wednesday, March 24, 2010)]
[Notices]
[Pages 14165-14168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6434]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and Human Development;
Revision to Proposed Collection; Comment Request; the National
Children's Study, Vanguard (Pilot) Study
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
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the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of Child
Health and Human Development (NICHD), the National Institutes of Health
(NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
Proposed Collection:
Title: The National Children's Study, Vanguard (Pilot) Study
Type of Information Collection Request: Revision
Need and Use of Information Collection: The purpose of the proposed
methodological study is to evaluate the feasibility, acceptability, and
cost of three separate recruitment strategies for enrollment of
pregnant women into a prospective, national longitudinal study of child
health and development. This study is one component of a larger group
of studies being conducted during the Vanguard Phase of the National
Children's Study (NCS). In combination, these studies will be used to
inform the design of the Main Study of the National Children's Study.
Background: The National Children's Study is a prospective,
national longitudinal study of the interaction between environment,
genetics on child health and development. The Study defines
``environment'' broadly, taking a number of natural and man-made
environmental, biological, genetic, and psychosocial factors into
account. By studying children through their different phases of growth
and development, researchers will be better able to understand the role
these factors have on health and disease. Findings from the Study will
be made available as the research progresses, making potential benefits
known to the public as soon as possible. The National Children's Study
is led by a consortium of federal partners: the U.S. Department of
Health and Human Services (including the Eunice Kennedy Shriver
National Institute of Child Health and Human Development and the
National Institute of Environmental Health Sciences of the National
Institutes of Health and the Centers for Disease Control and
Prevention), and the U.S. Environmental Protection Agency.
To conduct the detailed preparation needed for a study of this size
and complexity, the NCS was designed to include a preliminary pilot
study known as the Vanguard Study. The purpose of the Vanguard Study is
to assess the feasibility, acceptability, and cost of the recruitment
strategy, study procedures, and outcome assessments that are to be used
in the NCS Main Study. The Vanguard Study begins prior to the NCS Main
Study and will run in parallel with the Main Study. At every phase of
the NCS, the multiple methodological studies conducted during the
Vanguard phase will inform the implementation and analysis plan for the
Main Study.
The Vanguard Study was designed to enroll approximately 1,750
pregnant women through seven study locations after 12 months of data
collection. Two of the locations began recruitment in January 2009 and
the remaining 5 in April 2009. As of March 2010, however, approximately
700 pregnant women have been enrolled, leading to questions about the
assumptions underlying the Vanguard Study recruitment model.
Under this proposed plan, additional sites will be added to the
Vanguard Study, both to increase enrollment in the Vanguard Study and
to evaluate the feasibility, acceptability and cost of three separate
recruitment strategies for enrollment of pregnant women into the NCS.
The seven currently enrolled sites use a household enumeration and
screening strategy to identify eligible women for recruitment into the
study. Although household enumeration is often considered the gold
standard for reducing sampling bias, in that all dwelling units are
canvassed for eligibility, for the NCS Vanguard Study this method has
not yielded the target number of births projected from initial models.
Although current enumeration rates (~85%) and current consent rates
(~60%) are comparable to other birth cohort studies, they yielded fewer
pregnant women and births than originally estimated. Study planners are
thus investigating alternate methods to increase enrollment rates and
ultimately the number of women and children enrolled in the study.
Research Goal: The guiding research goal for this methodological
study is identification of recruitment strategies and components of
recruitment strategies that are most effective to identify, recruit and
enroll sufficient numbers of eligible participants into a population
based cohort study.
Methods: We propose to add as many as 30 additional sites to the
Vanguard Cohort in order to ensure an adequate cohort size. The
additional sites will be chosen from among those already identified for
the Main Study of the NCS. These selected Study Centers represent a
range of demographic and other characteristics that will be important
for the NCS' evaluation of recruitment strategies, including racial and
ethnic backgrounds, languages spoken, socioeconomic status, education
level, population density and urbanicity, and geographic region of the
United States, but they do not constitute a statistically
representative sample. Across these additional sites, we will compare
three alternate recruitment strategies. Each of the alternative
strategies is designed to identify and recruit age- and geographically-
eligible women to participate in the study, while retaining the
probability basis of the sample. Women targeted for enrollment include
both pregnant women and women who are not pregnant but who might become
pregnant in the future. Women must be part of the probability sample;
that is, they must reside in a preselected study segment. The provider-
based recruitment method relies on health care providers for assistance
in participant identification and recruitment. The enhanced household
recruitment method builds on the lessons learned in the existing
Vanguard Study by enhancing enumeration techniques and a more
streamlined recruitment process. The two-tiered recruitment method
relies on larger secondary sampling units to increase the number of
geographically-eligible women in a given area. We describe anticipated
features of each strategy below.
We will evaluate the feasibility (technical performance),
acceptability (respondent tolerance and impact on study
infrastructure), and cost (operations, time, and effort) of each
strategy using pre-determined measures. We will compare these findings
and use them as a basis to inform the strategies, or combinations of
strategies, that might be used in the Main Study of the NCS.
Provider-Based Recruitment Strategy: The goal of this strategy is
to introduce the NCS through the existing health care system, by
providing pregnant and other age-eligible women with information about
the NCS via health care providers in a familiar and trusted
environment. A group of Vanguard Study sites will develop lists of
health care providers who serve women in the geographically-eligible
segments. These providers will receive information about the NCS and
would be invited to participate collaboratively in efforts to identify
potentially eligible women and to inform them about the study. It is
expected that a variety of strategies to inform and engage potential
participants will be used once women express interest, depending on the
specific setting. For example in more rural communities, where one
provider sees most of the patients, NCS staff may decide to co-locate
in the providers office to provide information and recruit participants
into the study. In more
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urban areas, where there are multiple providers, the provider may
decide to simply provide information about the study to their patients
and a phone number or additional contact information for patients to
contact the study center. Study staff (not providers) will be available
to eligible women to answer questions about the study. The Study staff
will check the geographic eligibility of potential study participants;
segment boundaries will not be communicated to non-Study staff. To
maintain the household-based probability sampling frame, NCS staff will
only actually recruit women identified in the heath care provider
settings that live in the identified sample segments. Using estimates
from the original Vanguard Study proposal, less enumeration efforts and
efficiencies gained from field experience, we estimate this recruitment
strategy will require 27,800 respondent burden hours over the first two
years of data collection. (For reference, the original Vanguard Study
proposed expending 37,042 respondent burden hours for the same data
collection period.)
The provider-based recruitment strategy draws on the advantages of
utilizing a trusted source for initial introduction to the study, an
approach used effectively in many other studies. Additionally, as
compared to other recruitment strategies, this approach enhances
identification of pregnant women by centering recruitment activities at
places of prenatal care and other locations that pregnant women visit
for health care. As such, this approach is likely to be more cost
effective than other less targeted efforts. Like the other recruitment
strategies considered, it retains a household-based probability
sampling design. However, one disadvantage of this approach is that it
focuses on identification of women receiving prenatal care. In 2005, it
was estimated that 3.5% of pregnant women in the U.S. had no prenatal
care or began prenatal care in the third trimester. One way to address
the potential under representation of women who do not seek early
prenatal care is to develop lists of providers encompassing a wide
range of health care facilities, including emergency care and public
health clinics, and then to systematically evaluate coverage (or under-
coverage) as children are born into the Study. The NCS also allows
recruitment through the end of the hospital stay associated with labor,
delivery and birth, thus it would be possible to invite women who do
not receive prenatal care to join the study during the perinatal
period. Another potential limitation is that characteristics of the
provider, provider staff, or setting may result in selection bias
regarding the presentation of information about the NCS to potentially
eligible women. This potential bias will be assessed as the strategy is
implemented. Furthermore, with the geographic sampling approach we will
have the ability to compare actual recruitment to the targeted
population through analyses of birth certificate data.
Enhanced Household Enumeration Strategy: The enhanced household
enumeration recruitment model would improve our ability to identify
pregnant women by using enumerators trained in best practices to assist
in the most labor-intensive and among the most important aspects of the
study. The enhanced household enumeration recruitment model would
primarily utilize these staff directly as enumerators, but could also
use the best of the enumerators to train new enumerators at study
centers, or a combination of the two. Techniques for contacting
participants will need to continue to be refined over time to ensure
the study reaches hard-to-reach individuals. Using estimates from the
original Vanguard Study proposal, less efficiencies in enumeration
efforts and other aspects of field work based on field experience, we
estimate this recruitment strategy will require 32,230 respondent
burden hours over the first two years of data collection. (For
reference, the original Vanguard Study proposed expending 37,042
respondent burden hours for the same data collection period.)
The enhanced household recruitment model is considered by many to
make use of the gold standard for recruiting an unbiased sample,
thereby increasing the generalizability of the resulting data. It
relies on established enrollment methods used in other large-scale
observation studies, and is most compatible with the existing
probability-based sample, since it is not susceptible to external lists
that may have coverage issues. However, household enumeration, even
when maximally efficient, is time, labor, and cost intensive. Some
households are difficult to contact. Additionally, given the fairly
high observed enumeration and consent rates in the original Vanguard
Center effort, this method may not yield a sufficient increase in
enrollment rates over the current method. The method also is dependent
upon recruiting and retaining an adequate number of expert enumerators
to scale up for the target population of the Main Study.
Two-Tiered Recruitment Strategy: The two-tiered recruitment
strategy has several goals. Like the provider-based recruitment
strategy and the enhanced household recruitment strategy, the two-
tiered recruitment strategy aims to increase enrollment in the Study.
The two-tier strategy would do this using two means. First, the two-
tiered strategy would increase the number of identified pregnant women
by increasing the area determining geographic eligibility into the
Vanguard study. Second, the two-tiered strategy would facilitate
participation in the Study by administering a lower intensity data
collection effort initially; after a period of time during which
rapport may be developed, we would then invite a subsample of
participants to join a higher intensity data collection (that is, the
current full protocol). In this way, we would attempt to increase the
enrollment of women who might be initially reluctant join the full
study protocol.
The major goals of the two-tier strategy also include generating
data to gauge the desired size of the secondary sampling units
necessary to yield enrollment targets, and developing information
needed to better estimate bias between women who chose to participate
in the low intensity data collection and the high intensity data
collection. These analyses will significantly benefit Study recruitment
planning, regardless of which of the alternate recruitment strategies
are found to be most efficient.
In the two-tier approach, the primary sampling units (that is,
counties or groups of counties) would remain the same as in the
original sampling frame, but the geographic areas selected for the
secondary sampling units would be larger (for example, larger clusters
of census blocks) than those used for the original Vanguard Study
locations. From these comparatively larger secondary sampling units,
tertiary sampling units would be selected. These tertiary sampling
units would comprise smaller clusters of census blocks and would be
similar in size to the secondary sampling units employed in the
original Vanguard Study and in the provider-based and enhanced
household based recruitment strategies.
In the two-tiered recruitment strategy, age-eligible women residing
in the secondary sampling units and in the tertiary sampling units
would be asked to participate in a low intensity data collection
effort. This effort would be collected by mail or other self-
administered means. After a period of time during which rapport may be
established between the participant and
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the data collector, age-eligible women residing in the tertiary
sampling units would also be invited to participate in the high
intensity data collection, which is the current Vanguard Study
protocol. If a woman eligible to participate in the high intensity
collection effort declines, she may continue participating in the low
intensity effort.
Based on data collected to date, and assuming no household
enumeration or provider-referrals, we anticipate that the secondary
sampling units would need to be three times larger than the original
Vanguard Study secondary sampling units to identify the required number
of pregnant women within the Study's timeframe. Accordingly, assuming
age-sex eligible targets three times larger than those in the original
Vanguard Study proposal, an approximate 80% participation rate to the
initial screener, an approximate 65% consent rate to minimal, self-
administered data collection at approximately 30 minutes each 6 month
period, less enumeration effort and efficiencies in other aspects of
field work based on field experience, we estimate the low intensity
tier recruitment strategy will require 78,222 respondent burden hours
over the first two years of data collection. For the high intensity
tier strategy, assuming respondent burden estimates from the original
Vanguard Study proposal, less enumeration efforts and efficiencies
gained from field experience, we estimate this recruitment strategy
will require 27,800 respondent burden hours over the first two years of
data collection. Combined, this recruitment strategy would require
approximately 106,022 respondent burden hours over a two year period.
(For reference, the original Vanguard Study proposed expending 37,042
respondent burden hours for the same data collection period.)
There are several goals of this recruitment strategy that recommend
it despite comparatively higher estimated respondent burden. The two-
tier strategy allows the opportunity to engage women participating in
the low intensity data collection effort and build trust before
participants are asked to consider joining the high intensity effort.
This aspect may increase the likelihood of participation in the high
intensity data collection (that is, the full protocol) as compared to
the other alternate recruitment strategies. This strategy also fits
within the existing probability-based sampling frame for the Main
Study. Women that decide to leave the high intensity data collection
may remain within the study in a structured context in the low
intensity setting. Additionally, the two-tier strategy offers a means
to gauge the size of geographic areas that might be necessary for
reaching alternative enrollment targets and to systematically compare
bias in enrollment between high and low intensity groups--analyses that
will benefit the design of the Main NCS study regardless of which
recruitment strategies are ultimately chosen.
Frequency of Response: See above descriptions.
Affected Public: Pregnant women and their children
The annualized cost to respondents over the two year data
collection period for all three recruitment strategies combined is
estimated at $1,660,520 (based on $10 per hour). There are no Capital
Costs to report. There are no Operating or Maintenance Costs to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to minimize the burden of the collection
of information on those who are to respond, including the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Dr. Sarah L. Glavin, Deputy Director, Office of
Science Policy, Analysis and Communication, National Institute of Child
Health and Human Development, 31 Center Drive Room 2A18, Bethesda,
Maryland 20892, or call non-toll free number (301) 496-1877 or e-mail
your request, including your address, to [email protected].
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: March 18, 2010.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications,
National Institute of Child Health and Human Development, National
Institutes of Health.
[FR Doc. 2010-6434 Filed 3-23-10; 8:45 am]
BILLING CODE 4140-01-P