Promoting collaborations to improve birth defects surveillance, research, and prevention: A joint editorial from the National Birth Defects Prevention Network and the Organization of Teratology Information Specialists.

Abstract

In the past few years, and with COVID-19 most recently, we have been reminded of the importance of robust public health monitoring programs as they relate to birth defects surveillance, research, and prevention. With the never-ending appearance of new exposures—such as novel medications, infections, vaccines, chemicals, herbal products, and substances of abuse— it is vital that public health agencies are sufficiently prepared to evaluate the impact of these exposures on the occurrence of birth defects and to evaluate the presence of new birth defect syndromes. A multidisciplinary approach is needed to not only conduct birth defects surveillance but also to mitigate the impact of birth defects. As an example, in this editorial we propose a framework for a stronger collaboration between National Birth Defect Prevention Network (NBDPN) and the Organization of Teratology Information Specialists (OTIS) with the goal of addressing the impact of novel and existing exposures on the occurrence of birth defects. COVID-19 is not the first, nor the last, illness that will be monitored for its effects on pregnancy and birth outcomes. When Zika Virus (ZV) emerged in the Americas, the NBDPN and OTIS, including its local MotherToBaby affiliates, responded alongside other international partners such as the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). During the early stages of the pandemic, given the news reports and early scientific publications, birth defects and teratology experts suspected the teratogenic effects of ZV. Pregnancies and newborn health outcomes were subsequently monitored. Early on, and without clear scientific evidence, public health messaging urged pregnant women to avoid contracting ZV. Reports of microcephaly and other brain anomalies in Zika-exposed infants appeared in the clinical literature and in the media. Suspicions grew that ZV could cause birth defects. In a relatively short period of time, sufficient peer-reviewed evidence was gathered for experts to clearly state “that a causal relationship exists between prenatal Zika virus infection and microcephaly and other serious brain anomalies” and to urge movement “toward the prevention of adverse outcomes caused by congenital Zika virus infection” (Rasmussen, Jamieson, Honein, & Petersen, 2016). Following this statement, organizations such as OTIS and NBDPN worked together to craft more specific public health messages and engage in prevention efforts. Although ZV was not widespread in the United States (US), the lessons learned from ZV (Harris-Sagaribay et al., 2020) apply to our current threat of COVID-19. Strategic and proactive collaboration among government agencies, professional societies, and healthcare organizations builds the intangible infrastructure needed to protect mothers and babies from ongoing threats and helps promote healthy birth outcomes. When faced with a pandemic or other public health crisis, timely collaboration among scientific organizations contributes to successful disease response. NBDPN and OTIS are two organizations working to establish such a collaboration. These organizations fulfill different but complementary roles in identifying, educating about, and preventing adverse birth outcomes within and outside the context of pandemics. The NBDPN works with programs in all states, Puerto Rico, and the District of Columbia to conduct surveillance of birth defects, associated risk factors, and outcomes. It is comprised of individuals involved in birth defects surveillance, research, and prevention. Created to establish and maintain a national network of state and population-based programs for birth defects surveillance and research, NBDPN assesses the impact of birth defects upon children, families, and health care; identifies factors that can be used to develop primary prevention strategies; and assists families and their providers in secondary disabilities prevention. NBDPN analyses of surveillance data identify birth defects outcomes and associated demographic, genetic, and environmental risk factors through multi-site surveillance and research. NBDPN members and their colleagues have developed expertise in identifying and reporting on birth defects and developmental delays. While specifics vary, some local programs collect information from medical records of births, interviews with parents, and/or DNA tests; many have clinical geneticists review cases to ensure correct classification; and records are linked to vital statistics for population-based analysis. Pooling data in annual reports and collaborative studies help to ensure surveillance truly is population-based and nationally representative. More information about NBDPN can be found at www.nbdpn.org. OTIS works with the fourteen teratogen information services (MotherToBaby affiliates) across the US and covers all states and territories to influence research and provide health education to the public and clinicians. OTIS's members, teratogen information specialists, span the globe beyond those affiliates within the US. Some of the services in the US have operated for over 35 years, joining forces to establish OTIS as their professional organization (Leen-Mitchell, Martinez, Gallegos, Robertson, & Carey, 2000). OTIS's defining role has been providing teratogen information to the public, through its service arm MotherToBaby which serves women potentially exposed to teratogens during pregnancy as well as providers who care for those pregnant women and require information about potential risk of specific exposures, prescriptions or recommended medications (Clementi & Ornoy, 2004). OTIS/MotherToBaby answers thousands of questions each year about a wide range of exposures including cleaning products, cosmetics, occupational exposures, vaccines, diseases, substances of abuse, and medications (Campbell, Kast, Kamyar, Robertson, & Sherwin, 2016). MotherToBaby specialists counter the inaccurate information about teratogens often found online by patients and clinicians. Furthermore, providers and the public often lack the time and training to interpret large amounts of research and have inaccurate perceptions of risks from exposures (Conover & Polifka, 2011). Teratogen information specialists are experienced in reviewing studies, comparing outcomes, and translating health information for consumers. More information about OTIS/MotherToBaby can be found at www.mothertobaby.org. NBDPN and OTIS primarily intersect in five areas which impact disease response: Research, networking, health education, policy development, and workforce development. Given the gaps in knowledge about exposures, OTIS conducts and supports research (Clementi & Ornoy, 2004), and sometimes identifies research needs through routine operations. As local teratogen information services respond to questions from women and their providers, their staff develop a sense of where research and health education is needed. For example, daily concerns brought to OTIS about antidepressants and about supplements such as melatonin highlighted the need for research and education on some new and existing medications. These emerging trends in questions are used to inform future research studies. For most OTIS-led studies, a three-group prospective cohort design follows women with a condition and medication, women with the condition without a medication, and control groups of women who do not have the disease to help determine if the untreated condition increases risks rather than the medication, such as the risks associated with an asthma medication compared with risks of poorly controlled asthma (Chambers et al., 2001). The studies also collect data from maternal interviews and physical examinations of infants by trained dysmorphologists to supplement the data collection. The different research designs, large database studies, prospective cohorts, and surveillance studies, contribute different strengths to piecing together the puzzle of what may increase risks for birth defects, functional problems, or developmental delays. In contrast to the signals OTIS may receive through interaction with individuals, NBDPN members identify research opportunities through population-based birth defects surveillance. In the United States, NBDPN coordinates the collection of birth defects surveillance data and provides guidance to state programs to improve consistency in surveillance. Local birth defects surveillance programs sometimes employ clinicians such as geneticists and dysmorphologists to classify and review cases based on medical records. As clinicians review cases of birth defects in children, they are poised to notice trends in birth defects and exposures. Although each organization currently conducts its own research program, many researchers are involved in both organizations (Rasmussen, Erickson, Reef, & Ross, 2009). NBDPN and OTIS are working to identify more timely feedback mechanisms for sharing signals and events of interest to both organizations. Data, health education messaging, and research collaborations are strategically shared between both organizations. Both organizations engage teratogen experts and share mutually beneficial contacts. Both organizations aspire to provide coordinated, timely, and concurrent messaging on birth defects prevention and findings. OTIS utilizes research from NBDPN and other groups to inform its messages. OTIS/MotherToBaby provides individualized information through client contacts by phone, text, email, and chat in addition to providing traditional and social media (Facebook, Twitter, Instagram, blogs, podcasts, videos, etc.) messaging. NBDPN uses social media and research platforms to disseminate surveillance data and health education. Although the two organizations do not currently collaborate to influence policy, there is ample opportunity to do so. The two organizations can provide a unified voice as experts in the areas of birth defects surveillance and prevention to create white papers, policy proposals, and legislative briefs. Second, the organizations can work together under the larger umbrella of organizations interested in birth defects and developmental delays to further accelerate the creation and advocate for useful policies. Professional development opportunities among both organizations refine the skills of those committed to birth defects prevention. OTIS/MotherToBaby provides professional development seminars to improve the skills of teratogen information specialists and to update risk statements. The seminars typically review a research article about an exposure in pregnancy or breastfeeding. Local OTIS affiliates, pharmacists, teratogen database administrators, NBDPN members, clinicians, public health professionals, and others from multiple countries around the world add expertise and clinical experience to the discussion. Other professionals can join OTIS or the seminars by contacting OTIS. Annual meetings and webinars provide topics of interest and continuing education to both groups. OTIS/MotherToBaby collaborates with the Society for Birth Defects Research and Prevention (SBDRP) (formerly the Teratology Society) and the Developmental Neurotoxicology Society (DNTS) to hold joint, annual educational meetings. The three societies recognize the advantages of combining efforts to provide professional development and networking opportunities for members. While NBDPN as an organization has not collaborated often in these meetings, multiple NBDPN members attend joint meetings as members of the other three organizations, contributing to conference planning in various ways. In March 2020, shortly before the nationwide shutdown for the COVID-19 pandemic, OTIS/MotherToBaby held its Mid-Year Research Meeting co-located with NBDPN's Annual Meeting. This allowed for joint sessions as both organizations sought to foster a stronger partnership and working relationship. Joint, co-located and virtual meetings will continue providing opportunities to support professional development. Cross-training of professionals in these areas of birth defect surveillance and providing teratogen information is essential. Training is time-consuming and expensive, taking months to prepare individuals to begin to work in these fields, and years to become proficient. Understanding the complexities of birth defects and explaining teratogenic exposures to the public are specialized skills. As pandemics rise and fall, there may be more critical, hopefully relatively temporary, need for professionals on the tracking side than on the educating side. After a pandemic subsides, there may be a greater need for interpreting studies, providing public messages, and educating individuals and providers. Complementary and collaborative efforts between health agencies and OTIS have been ongoing: The ZV pandemic demonstrated the flexible but unique and collaborative roles of major players in disease response. CDC, NBDPN, OTIS/MotherToBaby, state birth defects programs, and local MotherToBaby affiliates collaborated to provide consistent messaging nationally and locally to help women avoid exposure to the virus (Harris-Sagaribay et al., 2020). Women who contracted the virus during travel were referred for testing, follow-up, and to the national pregnancy registry. Consistent messages were provided on websites and social media, and in press interviews and printed materials. CDC studied the virus and related outcomes, and provided public health messages. NBDPN and local birth defects registries identified and followed cases. OTIS and local MotherToBaby affiliates answered individual questions from families and their providers and referred women to the registries. With their different roles, the organizations were able to focus their expertise during the pandemic when resources were stretched thin. No single organization performs all of these roles. Having local programs work with national organizations allowed for rapid communication in both directions when challenges arose, and when the government needed data and input on adapting messaging and strategies. At the present time, evidence concerning COVID-19 does not suggest increased risks for structural malformations but other possible adverse outcomes are being monitored. However, the current pandemic provides an opportunity to collaborate and prepare for developments in knowledge about possibly teratogenic viruses (Ludorf, Salemi, Kirby, Tanner, & Agopian, 2020). The population-based surveillance data provided by CDC and programs in NBDPN remains crucial during the pandemic and its aftermath. Population-based surveillance enables tracking structural malformations and developmental disabilities in an organized manner. Now and in the future, clinicians associated with NBDPN programs can be tapped to identify emerging trends from case review. They can also propose research, suggest surveillance ideas, and encourage further research on potentially teratogenic exposures. Even if public health data and messaging are available on teratogens and birth defects, public health professionals rarely interact with individuals in the public. Private medical visits are not a quick source of information. OTIS is uniquely positioned to serve as a bridge between government agencies providing health messaging to individuals and complements the role of medical providers (Kaye et al., 2001). Many providers may be unfamiliar with the nuances of responding to questions about teratogenic exposures or addressing inaccurate information in outdated references or on the internet. The differentiation of roles allows clinical providers to be experts in treating conditions while allowing teratogen information specialists to be experts in explaining the potential teratogenicity of any exposure, including new medications and diseases. In this sense, the work of OTIS can greatly benefit both the public health and private healthcare communities in efficiently communicating health messages. Given the need for the specialized services provided by birth defects surveillance programs and teratogen information services, states and municipalities should consider investing in both programs. Additional funding, potentially from multiple sources including national and state funds, healthcare organizations, pharmaceutical industries, and other organizations, is needed to keep these national organizations and local programs operating. Research has demonstrated that these programs save millions of dollars a year in addition to improving public health by dispelling myths about medications and preventing untreated maternal conditions due to inaccurate information (Luca et al., 2020). Although budgets have been strained and cut across government agencies, OTIS and NBDPN continue to function, often behind-the scenes, ensuring that birth defects data are reviewed and education disseminated. The strategic partnership between NBDPN and OTIS provides an example of how public health infrastructure can be strengthened despite shifting priorities and uncertain funding. Participation from other professional societies and non-governmental organizations (for example, the March of Dimes Foundation, the Society for Birth Defects Research and Prevention, the American College of Obstetricians and Gyneologists, and the American Academy of Pediatrics) can enhance and amplify these collaborative efforts. The current and future work of these organizations will continue to protect maternal and infant health in the United States. In this time of (a) increasing data and information, (b) novel exposures and pathogens, and (c) uncertainty surrounding these issues—it is vital that public health professionals from various backgrounds unite to interpret these data and develop evidence-based recommendations and interventions. Through these efforts, we hope to reduce the impact of new and existing exposures on adverse outcomes—including birth defects. We propose that a first and important step is strengthening the collaboration between the NBDPN—an organization focused on birth defects surveillance, research, and prevention—and OTIS—a society of professionals dedicated to evaluating risks to pregnancy from medications and other exposures. Through this expanded collaboration, we anticipate that effective responses to emerging threats can be implemented in real time, thereby reducing the prevalence and impact of birth defects. Data sharing is not applicable to this article as no new data were created or analyzed in this study.