[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