Dataset Information

The National Children's Study: Early Recruitment Outcomes Using the Direct Outreach Approach.

ABSTRACT: OBJECTIVE:In 2009, the National Children's Study (NCS) Vanguard Study tested the feasibility of household-based recruitment and participant enrollment by using a birth rate probability sample. In 2010, the NCS Program Office launched 3 alternative recruitment methods. We tested whether direct outreach (DO) recruitment could be a more efficient strategy to recruit women of child-bearing age. METHODS:The NCS DO recruitment approach recruited women, 18 to 49 years, who were pregnant or trying to conceive using passive recruitment methods emphasizing broad community outreach and engagement to create study awareness. Study mailings to listed households included a pregnancy screening questionnaire to identify potentially eligible women from selected neighborhoods to contact the study center. Unique features of this recruitment approach included the following: (1) expansion of selected neighborhoods to maximize potential participant recruitment and enrollment while minimizing in-person participant contact and (2) offering 2 levels of study participation distinguished by data collection intensity. RESULTS:Ten study centers listed 255?475 geographically eligible households for contact representing, on average, 3.3% of households per Primary Sampling Unit. A total of 19?354 women were identified for screening, and 17?421 completed a pregnancy screener representing 6.8% of eligible households. Study-eligible pregnant women were older, more educated, and less likely to be Hispanic than the general population. Only 16% (2786) of 17?421 screened women were study-eligible, and 81.1% of these 2786 women consented to participate. CONCLUSIONS:Although feasible, the DO approach recruited a sample of study-eligible pregnant women significantly different from the population. This recruitment approach was labor intensive for the yield of enrolled women.

SUBMITTER: McGovern PM

PROVIDER: S-EPMC4878107 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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The National Children's Study: Early Recruitment Outcomes Using the Direct Outreach Approach.

McGovern Patricia M PM Nachreiner Nancy M NM Holl Jane L JL Halfon Neal N Dabelea Dana D Caulfield Laura L Cauley Jane A JA Innocenti Mark S MS Amsden Laura L Markovic Nina N Riddles Minsun M Adams Sara S

Pediatrics 20160601

<h4>Objective</h4>In 2009, the National Children's Study (NCS) Vanguard Study tested the feasibility of household-based recruitment and participant enrollment by using a birth rate probability sample. In 2010, the NCS Program Office launched 3 alternative recruitment methods. We tested whether direct outreach (DO) recruitment could be a more efficient strategy to recruit women of child-bearing age.<h4>Methods</h4>The NCS DO recruitment approach recruited women, 18 to 49 years, who were pregnant ...[more]

PMID: 27251869

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Project description:Meeting recruitment targets for clinical trials and health research studies is a notable challenge. Unsuccessful efforts to recruit participants from traditionally underserved populations can limit who benefits from scientific discovery, thus perpetuating inequities in health outcomes and access to care. In this study, we evaluated direct mail and email outreach campaigns designed to recruit women who gave birth in North Carolina for a statewide research study offering expanded newborn screening for a panel of rare health conditions. Of the 54,887 women who gave birth in North Carolina from September 28, 2018, through March 19, 2019, and were eligible to be included on the study's contact lists, we had access to a mailing address for 97.9% and an email address for 6.3%. Rural women were less likely to have sufficient contact information available, but this amounted to less than a one percentage point difference by urbanicity. Native American women were less likely to have an email address on record; however, we did not find a similar disparity when recruitment using direct-mail letters and postcards was concerned. Although we sent letters and emails in roughly equal proportion by urbanicity and race/ethnicity, we found significant differences in enrollment across demographic subgroups. Controlling for race/ethnicity and urbanicity, we found that direct-mail letters and emails were effective recruitment methods. The enrollment rate among women who were sent a recruitment letter was 4.1%, and this rate increased to 5.0% among women who were also sent an email invitation. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Under-representation by traditionally underserved populations in clinical trials and health research is a challenge that may in part reflect inequitable opportunities to participate. WHAT QUESTION DID THIS STUDY ADDRESS? Are direct-mail and email outreach strategies effective for reaching and recruiting women from traditionally underserved and rural populations to participate in large-scale, population-based research? WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? Despite sending recruitment letters and email invitations in roughly equal proportion by urbanicity and race/ethnicity, women living in rural areas were less likely to enroll (2.8%) than women from urban areas (4.2%). Additionally, enrollment rates decreased as the probability that women were members of a racial or ethnic minority group increased. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? Results from this study might encourage researchers to take a holistic and participant-centered view of barriers to study enrollment that may disproportionately affect underserved communities, including differences in willingness to participate, trust, and access to resources needed for uptake.

Project description:BackgroundPrenatal exposure to metals may play an important role in fetal growth. However, the epidemiologic evidence for certain metals is sparse, and most of the existing research has focused on evaluating single metals in highly exposed target populations.ObjectivesWe evaluated associations of cadmium, lead, manganese, selenium, and total mercury exposures during pregnancy with fetal growth using data from mother-infant pairs participating in the National Children's Study.MethodsPrenatal metal exposures were measured using maternal blood collected from 6 to 32 weeks of gestation. Birth outcomes, including gestational age, birthweight, birth length, head circumference, and ponderal index, were ascertained through physical measurement at birth or abstraction from medical records. Regression coefficients and their 95% confidence intervals were estimated from multivariable linear regression models in the overall study population as well as among male and female infants. We further evaluated pairwise metal-metal interactions.ResultsSex-specific associations were observed for lead, with inverse associations for birthweight, birth length, head circumference, and gestational age observed only among female infants. Sex-specific associations were also observed for selenium, with a positive association for birthweight observed among male infants; selenium was also positively associated with ponderal index and inversely associated with birth length among female infants. Overall, total mercury was inversely associated with birthweight and ponderal index, and the association with birthweight was stronger among female infants. No significant associations were observed with cadmium and manganese. In the metal-metal interaction analyses, we found evidence of a synergistic interaction between lead and total mercury and antagonistic interaction between selenium and total mercury with selected birth outcomes.ConclusionsOur findings suggest that prenatal exposure to metals may be related to birth outcomes, and infant sex may modify these associations.

Project description:BackgroundChronic arsenic exposure has been associated with pregnancy complications and reduced fetal growth in populations where total arsenic exposure exceeds 50 μg/L. However, the potential effect on pregnancy outcomes remains unclear at lower levels of arsenic exposure, such as those most commonly observed in the United States.ObjectivesWe evaluated the associations between arsenic exposure during pregnancy with fetal growth and risk of pregnancy complications using data from mother-infant pairs participating in the National Children's Study.MethodsPrenatal arsenic exposure was measured using maternal urine collected during the third trimester. Information about pregnancy complications was abstracted from medical records. Fetal growth, including gestational age, birth weight, birth length, head circumference, and ponderal index, was ascertained through physical measurement at birth and extracted from medical records.ResultsMedians [interquartile range (IQR)] of maternal urinary total arsenic and dimethylarsinic acid (DMA) were 7.77 μg/L (7.98) and 3.44 μg/L (3.13), respectively. Each increase in IQR of prenatal total arsenic level was associated with greater birth length (+0.28 cm; 95% CI: 0.14, 0.42), greater head circumference (+0.12 cm; 95% CI: 0.04, 0.21), and lower ponderal index (-0.37 kg/m3; 95% CI: -0.58, -0.17). Similar results were obtained for levels of prenatal DMA. Tests for multiplicative interaction indicate that prenatal urinary DMA was negatively associated with gestational age among female infants (-0.44 week decrease in gestational age estimated for each IQR increase in DMA; 95% CI: -0.84, -0.05), while no association was observed among male infants (pinteraction = 0.02). No significant associations were detected between arsenic and birth weight or pregnancy complications.ConclusionsHigher prenatal arsenic exposure was associated with longer birth length, greater head circumference, and lower ponderal index. Associations between arsenic and gestational age may be modified by infant sex.

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The National Children's Study: Early Recruitment Outcomes Using the Direct Outreach Approach.

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The National Children's Study: Early Recruitment Outcomes Using the Direct Outreach Approach.

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