Methodologic and Logistic Issues in Conducting Longitudinal Birth Cohort Studies: Lessons Learned from the Centers for Children's Environmental Health and Disease Prevention Research
Eskenazi, Brenda, Gladstone, Eleanor A., Berkowitz, Gertrud S., Drew, Christina H., Faustman, Elaine M., Holland, Nina T., Lanphear, Bruce, Meisel, Stefanie J., Perera, Frederica P., Rauh, Virginia A., Sweeney, Anne, Whyatt, Robin M., Yolton, Kimberly, Environmental Health Perspectives
In anticipation of the National Children's Study, lessons can be learned from the smaller birth cohort studies conducted by five Centers for Children's Environmental Health and Disease Prevention Research funded by the National Institute of Environmental Health Sciences and the U.S. Environmental Protection Agency. The populations studied are diverse in ethnicity and social class and reside in urban and rural environments. Although almost all of the centers chose to enroll participants through medical care facilities, they had to develop independent staffs and structures because of the overburdened medical care system. Some of the lessons learned by the centers include the importance of continuous funding, building community partnerships to conduct culturally appropriate research, hiring bilingual and bicultural staff from the community, prioritizing research goals, developing biorepositories to ensure future utility of samples, instituting quality control procedures for all aspects of specimen and data collection, maintaining frequent contact with study participants, ensuring ethical conduct of the research in a changing medical-legal climate, and communicating results in a timely and appropriate manner to participants and the wider community. All centers underestimated the necessary start-up time, staff, and costs in conducting these birth cohort studies. Despite the logistical complexity and added expenses, all centers emphasize the importance of studying the impact of environmental exposures on those children most at risk, those living in minority and low-income communities. These centers present barriers encountered, solutions found, and considerations for future research, with the hope that the lessons learned can help inform the planning and conduct of the National Children's Study. Key words: biologic samples, biorepository, birth cohort, children, environmental health, ethics, growth, National Children's Study, neurodevelopment, pregnancy. Environ Health Perspect 113:1419-1429 (2005). doi: 10.1289/ehp.7670 available via http://dx.doi.org/[Online 24 June 2005]
Longitudinal birth cohort studies provide a rich source of information about antecedents of disease that originate in pregnancy or childhood. There have been two previous major longitudinal birth cohort studies in the United States: the Child Health and Development Studies (van den Berg et al. 1988) and the National Collaborative Perinatal Project (Niswander and Gordon 1972). Since these studies were conducted, > 40 years ago, science and research infrastructures have changed dramatically in the United States. These changes include but are not limited to advances in biomarkers and molecular and cellular biology, the use of computers in tracking and statistics, the increased difficulty of integrating research into routine clinical practice, the diversity and health disparity of the population, and growing complexities of medical-legal-ethical issues. The standards for quality research have risen considerably and with them the logistical complexities in conducting such research.
The purpose of this article is to outline the methods used by the five Centers for Children's Environmental Health and Disease Prevention Research (Children's Centers) that are conducting birth cohort studies. Three centers (University of California, Berkeley, Columbia University, and Mount Sinai School of Medicine) began their studies in 1998, and two centers (University of Cincinnati and University of Illinois) in 2000. All but two centers (Columbia and Mount Sinai), which had prior funding, started enrollment approximately 1 year after funding. Table 1 provides an overview of the five centers (also see Kimmel et al. 2005), each of which recruited racially/ethnically diverse and often low-income populations (Appalachian, Dominican, Hmong, Laotian, Mexican, African American, and Puerto Rican). Our centers worked closely with our respective communities to develop partnerships, strengthen community infrastructure, build trust, and conduct culturally appropriate research (Israel et al. …