Inadequacy and underreporting of study subjects' race and ethnicity in federally funded pelvic floor research.

BACKGROUND: The inclusion of participants who are Black, Indigenous people of color, and participants of various ethnicities is a priority of federally sponsored research. OBJECTIVE: This study aimed to describe the reporting of race and ethnicity in federally funded research published by the Eunice Kennedy Shriver National Institute of Child Health and Human Development-funded Pelvic Floor Disorders Network. STUDY DESIGN: Pelvic Floor Disorders Network publications were reviewed to determine whether race or ethnicity was reported. The number of participants included in each manuscript who were identified as White, Black, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and "other," and the number of participants who identified as having Hispanic ethnicity were recorded. Data were analyzed by publication and by the pelvic floor disorder investigated, including urinary incontinence, pelvic organ prolapse, fecal incontinence, pregnancy-related pelvic floor disorders, and multiple pelvic floor disorders. Many publications reported on overlapping patient populations, which included primary trials and secondary analyses and studies. Data were analyzed both by counting participants every time they were reported in all papers and by counting the unique number of participants in only the original trials (primary paper published). RESULTS: A total of 132 Pelvic Floor Disorders Network publications were published between 2003 and 2020. Of these, 21 were excluded because they were methods papers or described research without participants. Of the 111 remaining articles, 90 (81%) included descriptions of race and 55 (50%) included descriptions of ethnicity. All 13 primary trials described race and 10 of 13 (76.9%) described ethnicity. Of those publications that described race, 50 of 90 (56%) included only the categories of "White," "Black," and "Other," and 14 of 90 (16%) only described the percentage of White patients. Of the 49,218 subjects, there were 43,058 (87%) with reported race and 27,468 (56%) with reported ethnicity. Among subjects with race and ethnicity reported, 79% were reported as White, 9.9% as Black, 0.4% as Asian, 0.1% as American Indian or Alaska Native, and 4% as "other," whereas 13% were reported to be of Hispanic ethnicity. The racial and ethnic diversity varied based on the pelvic floor disorder studied (P<.01), which was driven by pregnancy-related and fecal incontinence studies because these had lower proportions of White patients than studies of other pelvic floor disorders. CONCLUSION: Federally funded Pelvic Floor Disorders Network research does not consistently report the race and ethnicity of participants. Even in the publications that report these characteristics, Black, Indigenous people of color, and people of Hispanic ethnicity are underrepresented. Consistent reporting and recruitment of a diverse population of women is necessary to address this systemic inequity.

Maternal mortality in the United States: research gaps, opportunities, and priorities.

Maternal mortality and severe maternal morbidity are urgent issues in the United States. It is important to establish priority areas to address these public health crises. On April 8, 2019, and May 2 to 3, 2019, the Eunice Kennedy Shriver National Institute of Child Health and Human Development organized and invited experts with varied perspectives to 2 meetings, a community engagement forum and a scientific workshop, to discuss underlying themes involved in the rising incidence of maternal mortality in the United States. Experts from diverse disciplines reviewed current data, ongoing activities, and identified research gaps focused on data measurement and reporting, obstetrical and health system factors, social determinants and disparities, and the community perspective and engagement. Key scientific opportunities to reduce maternal mortality and severe maternal morbidity include improved data quality and measurement, understanding the populations affected as well as the numerous etiologies, clinical research to confirm preventive and interventional strategies, and engagement of community participation in research that will lead to the reduction of maternal mortality in the United States. This article provides a summary of the workshop presentations and discussions.

Length of Fellowship Training in Population Health Research and Long-term Bibliometric Outcomes.

BACKGROUND: The length of research fellowships, the number of doctorates pursuing them, and the academic job market have changed dramatically in recent years. However, there is limited investigation on attributes of fellowships most relevant to future scientific achievement. We analyzed the association of a modifiable aspect of research training, fellowship length, with future achievement and differences across research discipline in the Division of Intramural Population Health Research (DIPHR), Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health. METHODS: Demographics of 88 DIPHR trainees from 1998 to 2016 were collected from publicly available annual reports. Research performance metrics, including total publication count and H index through 2016, were collected via Scopus. We used linear regression models for associations between fellowship length, including both total exposure to research training and duration of postdoctoral training alone, and research performance adjusted for start year, publications at entry, branch (e.g., Biostatistics and Bioinformatics, Epidemiology, and Health Behavior), and mentor seniority. RESULTS: Each additional year of research training in DIPHR was associated with a 15% increase in H index (95% confidence interval [CI] = 3.0, 28.4) and 21% more lifetime publications (95% CI = 3.0, 41.9). Results were similar, although attenuated, when evaluating postdoctoral training alone. Differences by discipline were observed, with the strongest positive associations in the Biostatistics and Bioinformatics and Epidemiology Branches. CONCLUSIONS: Longer training at DIPHR was associated with improved measures of research performance, though this relationship varied by discipline. Additional research is needed to tailor training programs to optimize success of trainees.

Association of National Institute of Child Health and Human Development Career Development Awards With Subsequent Research Project Grant Funding.

IMPORTANCE: Investing in the next generation of researchers is essential, as recently highlighted in the 21st Century Cures Act. From its inception, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has supported training and career development to ensure a robust pipeline of investigators who are prepared to lead their respective fields of inquiry. In recent years, the NICHD has emphasized institutional over individual training awards to a greater degree than many other National Institutes of Health institutes of similar size. OBJECTIVE: To evaluate the success of individuals supported by NICHD career development and training awards, as measured by subsequent application and receipt of independent National Institutes of Health research project grant funding. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study identified 417 physician-scholars who were supported by NICHD career development awards between October 1, 1999, and September 30, 2001. This period was selected to allow adequate follow-up of research project grant applications and funding. Among these physician-scholars, 355 met inclusion criteria. MAIN OUTCOMES AND MEASURES: The primary outcomes were the numbers of research project grant applications submitted and, of these, the numbers that were successfully funded. RESULTS: Among 355 physician-scientists, scholars who had an MD degree only and received a K award or both an individual K award and institutional K12 support were more likely than those who received only K12 support (individual K only vs institutional K12 only: odds ratio [OR], 4.86; 95% CI, 1.83-13.62; both K and K12 vs K12 only: OR, 3.19; 95% CI, 1.46-7.10) to apply for subsequent project grant funding (88.0% vs 82.8% vs 60.1%, respectively; P < .001) and to receive it (60.0% vs 60.9% vs 32.9%, respectively; P < .001). For physicians with both MD and PhD degrees, neither application nor funding rates were statistically significantly different whether their career development was supported by individual or institutional awards. CONCLUSIONS AND RELEVANCE: Physician-scholars are more likely to apply for and receive a National Institutes of Health research grant if they are trained on an individual career development award, with or without an institutional training award. Based on the data, the NICHD intends to provide a greater proportion of its career development fund allocation to individual awards. The NICHD recognizes the importance of institutional awards and will continue to support them. The NICHD remains committed to training and intends to maintain its investment in training and career development awards going forward.

Fetal growth standards: the NICHD fetal growth study approach in context with INTERGROWTH-21st and the World Health Organization Multicentre Growth Reference Study.

Three recently completed longitudinal cohort studies have developed intrauterine fetal growth charts, one in the United States and two international. This expert review compares and contrasts the Eunice Kennedy Shriver National Institute of Child Health and Human Development Fetal Growth Studies, INTERGROWTH-21st and World Health Organization Multicentre Growth Reference Study conclusions in light of differences in aims, sampling frames, and analytical approaches. An area of controversy is whether a single growth reference is representative of growth, regardless of ethnic or country origin. The INTERGROWTH and World Health Organization Fetal studies used a similar approach as the World Health Organization Multicentre Growth Reference Study for infants and children, the aim of which was to create a single international reference for the best physiological growth for children aged 0-5 years. INTERGROWTH made the same assumption (ie, that there would be no differences internationally among countries or racial/ethnic groups in fetal growth when conditions were optimal). INTERGROWTH found differences in crown-rump length and head circumference among countries but interpreted the differences as not meaningful and presented a pooled standard. The World Health Organization Multicentre Growth Reference Study was designed to create a pooled reference, although they evaluated for and presented country differences, along with discussion of the implications. The Eunice Kennedy Shriver National Institute of Child Health and Human Development Study was designed to assess whether racial/ethnic-specific fetal growth standards were needed, in recognition of the fact that fetal size is commonly estimated from dimensions (head circumference, abdominal circumference, and femur length) in which there are known differences in children and adults of differing racial/ethnic groups. A pooled standard would be derived if no racial/ethnic differences were found. Highly statistically significant racial/ethnic differences in fetal growth were found resulting in the publication of racial/ethnic-specific derived standards. Despite all 3 studies including low-risk status women, the percentiles for fetal dimensions and estimated fetal weight varied among the studies. Specifically, at 39 weeks, the 50th percentile for estimated fetal weight was 3502 g for whites, 3330 g for Hispanics, 3263 g for Asians, and 3256 for blacks in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Study, compared with 3186 g for INTERGROWTH and 3403 g for World Health Organization Multicentre Growth Reference Study. When applying these standards to a clinical population, it is important to be aware that different percentages of small- and large-for-gestational-age fetuses will be identified. Also, it may be necessary to use more restrictive cut points, such as the 2.5th or 97.5th, for small-for-gestational-age or large-for-gestational-age fetuses, respectively. Ideally, a comparison of diagnostic accuracy, or misclassification rates, of small-for-gestational-age and large-for-gestational-age fetuses in relation to morbidity and mortality using different criteria is necessary to make recommendations and remains an important data gap. Identification of the appropriate percentile cutoffs in relation to neonatal morbidity and mortality is needed in local populations, depending on which fetal growth chart is used. On a final point, assessment of fetal growth with a one-time measurement remains standard clinical practice, despite recognition that a single measurement can indicate only size. Ultimately, it is knowledge about fetal growth in addition to other factors and clinical judgment that should trigger intervention.

Comparison of Recruitment Strategy Outcomes in the National Children's Study.

BACKGROUND AND OBJECTIVES: In 2000, the US Congress authorized the National Institutes of Health to conduct a prospective national longitudinal study of environmental influences on children's health and development from birth through 21 years. Several recruitment methodologies were piloted to determine the optimal strategy for a main National Children's Study. METHODS: After an initial pilot recruitment that used a household enumeration strategy performed poorly, the National Children's Study Vanguard Study developed and evaluated the feasibility, acceptability, and cost of 4 alternate strategies to recruit a large prospective national probability sample of pregnant women and their newborn children. We compare household-based recruitment, provider-based recruitment, direct outreach, and provider-based sampling (PBS) strategies with respect to overall recruitment success, efficiency, cost, and fulfillment of scientific requirements. RESULTS: Although all 5 strategies achieved similar enrollment rates (63%-81%) among eligible women, PBS achieved the highest recruitment success as measured by the ratio of observed-to-expected newborn enrollees per year of 0.99, exceeding those of the other strategies (range: 0.35-0.48). Because PBS could reach the enrollment target through sampling of high volume obstetric provider offices and birth hospitals, it achieved the lowest ratio of women screened to women enrolled and was also the least costly strategy. With the exception of direct outreach, all strategies enrolled a cohort of women whose demographics were similar to county natality data. CONCLUSIONS: PBS demonstrated the optimal combination of recruitment success, efficiency, cost, and population representativeness and serves as a model for the assembly of future prospective probability-based birth cohorts.

Parenting in infancy and self-regulation in preschool: an investigation of the role of attachment history.

Parenting and attachment are critical in the emergence of self-regulation (SR) in preschool. However, most studies use general indexes of parenting quality, failing to explore the unique contributions of sensitivity and home quality to SR. Further, the nature of the interplay between parenting and attachment history is not well understood. Using a sample of 938 children from The National Institute of Child Health and Human Development Study of Early Child Care and Youth Development, a series of structural equation models were fit to determine whether sensitivity and home quality concurrently predicted SR at 54 months, and whether attachment mediated or moderated these pathways. Results suggest that both sensitivity and home quality uniquely predict SR. Further, these early parenting variables were each indirectly associated with SR through children's attachment history. That is, higher levels of sensitivity and home quality predicted secure attachment history, which, along with parenting, predicted more advanced SR skills at 54 months. No moderated pathways emerged, suggesting that attachment history may be best conceptualized as a mediating mechanism.

The National Children's Study: Recruitment Outcomes Using the Provider-Based Recruitment Approach.

OBJECTIVE: In 2009, the National Children's Study (NCS) Vanguard Study tested the feasibility of household-based recruitment and participant enrollment using a birth-rate probability sample. In 2010, the NCS Program Office launched 3 additional recruitment approaches. We tested whether provider-based recruitment could improve recruitment outcomes compared with household-based recruitment. METHODS: The NCS aimed to recruit 18- to 49-year-old women who were pregnant or at risk for becoming pregnant who lived in designated geographic segments within primary sampling units, generally counties. Using provider-based recruitment, 10 study centers engaged providers to enroll eligible participants at their practice. Recruitment models used different levels of provider engagement (full, intermediate, information-only). RESULTS: The percentage of eligible women per county ranged from 1.5% to 57.3%. Across the centers, 3371 potential participants were approached for screening, 3459 (92%) were screened and 1479 were eligible (43%). Of those 1181 (80.0%) gave consent and 1008 (94%) were retained until delivery. Recruited participants were generally representative of the county population. CONCLUSIONS: Provider-based recruitment was successful in recruiting NCS participants. Challenges included time-intensity of engaging the clinical practices, differential willingness of providers to participate, and necessary reliance on providers for participant identification. The vast majority of practices cooperated to some degree. Recruitment from obstetric practices is an effective means of obtaining a representative sample.

Executive summary: evaluation of the evidence to support practice guidelines for nutritional care of preterm infants-the Pre-B Project.

Preterm birth (infants born at <37 wk of gestational age) is a significant clinical and public health challenge in the United States and globally. No universally accepted practice guidelines exist for the nutritional care of preterm infants. To address the current state of knowledge and to support systematic reviews that will be used to develop evidence-informed guidance, a consortium consisting of the American Academy of Pediatrics, the ASN, the American Society for Parenteral and Enteral Nutrition, the Academy of Nutrition and Dietetics, the Food and Drug Administration, the CDC, the USDA/Agricultural Research Service (USDA/ARS), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development/NIH initiated the Pre-B Project. The project included the constitution of 4 thematic working groups charged with the following tasks: 1) develop a series of topics/questions for which there is sufficient evidence to support a systematic review process to be conducted by the Academy of Nutrition and Dietetics' Evidence Analysis Library (EAL), leading to the development of new guidelines for nutritional care of preterm infants, and 2) develop a targeted research agenda to address priority gaps in our understanding of the role of nutrition in the health and development of preterm/neonatal intensive care unit infants. This review consists of a project overview including a summary of a workshop hosted by the USDA/ARS Children's Nutrition Research Center and summary reports of the 4 working groups established to address the following themes: 1) nutrient specifications, 2) clinical/practical issues in enteral feeding, 3) gastrointestinal and surgical issues, and 4) current standards for assessing infant feeding outcomes. These reports will serve as the basis for the ultimate guideline development process to be conducted by the Academy of Nutrition and Dietetics' EAL.

Racial/ethnic standards for fetal growth: the NICHD Fetal Growth Studies.

OBJECTIVE: Fetal growth is associated with long-term health yet no appropriate standards exist for the early identification of undergrown or overgrown fetuses. We sought to develop contemporary fetal growth standards for 4 self-identified US racial/ethnic groups. STUDY DESIGN: We recruited for prospective follow-up 2334 healthy women with low-risk, singleton pregnancies from 12 community and perinatal centers from July 2009 through January 2013. The cohort comprised: 614 (26%) non-Hispanic whites, 611 (26%) non-Hispanic blacks, 649 (28%) Hispanics, and 460 (20%) Asians. Women were screened at 8w0d to 13w6d for maternal health status associated with presumably normal fetal growth (aged 18-40 years; body mass index 19.0-29.9 kg/m(2); healthy lifestyles and living conditions; low-risk medical and obstetrical history); 92% of recruited women completed the protocol. Women were randomized among 4 ultrasonography schedules for longitudinal fetal measurement using the Voluson E8 (GE Healthcare, Milwaukee, WI). In-person interviews and anthropometric assessments were conducted at each visit; medical records were abstracted. The fetuses of 1737 (74%) women continued to be low risk (uncomplicated pregnancy, absent anomalies) at birth, and their measurements were included in the standards. Racial/ethnic-specific fetal growth curves were estimated using linear mixed models with cubic splines. Estimated fetal weight (EFW) and biometric parameter percentiles (5th, 50th, 95th) were determined for each gestational week and comparisons made by race/ethnicity, with and without adjustment for maternal and sociodemographic factors. RESULTS: EFW differed significantly by race/ethnicity >20 weeks. Specifically at 39 weeks, the 5th, 50th, and 95th percentiles were 2790, 3505, and 4402 g for white; 2633, 3336, and 4226 g for Hispanic; 2621, 3270, and 4078 g for Asian; and 2622, 3260, and 4053 g for black women (adjusted global P < .001). For individual parameters, racial/ethnic differences by order of detection were: humerus and femur lengths (10 weeks), abdominal circumference (16 weeks), head circumference (21 weeks), and biparietal diameter (27 weeks). The study-derived standard based solely on the white group erroneously classifies as much as 15% of non-white fetuses as growth restricted (EFW <5th percentile). CONCLUSION: Significant differences in fetal growth were found among the 4 groups. Racial/ethnic-specific standards improve the precision in evaluating fetal growth.