SPECIFIC AIMS
The overall goal of the proposed study is to examine the availability, accuracy, and utility of prenatal
substance exposure data in the existing electronic medical records (EMR).
Research on the impact of substance use during pregnancy on child outcomes has relied on large prospective,
longitudinal studies to provide accurate data on exposures and outcomes. This has resulted in knowledge
lagging significantly, especially problematic with the rapidly evolving opioid epidemic and recent legalization of
commercial-grade marijuana. Population-based datasets have produced prevalence and more general
information, but do not contain exposure information that is granular enough to reliably answer specific
research questions. Individual patient EMRs contain a wealth of clinical information that can potentially be used
for research purposes, however this potential related to prenatal exposures is largely unstudied. Our work, and
the work of others, has demonstrated the possibilities for using EMR data to answer questions about the
impact of prenatal substance exposures on child outcomes, while also highlighting the limitations and
unknowns. EMRs provide the opportunity of linking pediatric outpatient records with up to three other types of
EMRs (newborn inpatient record, maternal inpatient delivery record, and maternal outpatient prenatal care
record), expanding available information about exposures for many patients.
Our study will involve the following Specific Aims:
1. To determine exactly what exposure data is available in each of the four EMR types, with what
frequency, and the congruence between exposure data sources.
2. To construct composite exposure variables from different data sources and examine the degree
to which each: a) correlates with cord test results, and b) correlates with child outcomes.
3. To determine factors that predict availability, accuracy, and utility of exposure data.
4. To develop enduring study methodology materials including exposure variable coding
algorithms.
The study will utilize the EMRs from both a large but fairly rural community based pediatric outpatient practice,
and from a large urban academic pediatric ambulatory service, which will produce substantial racial and
socioeconomic diversity and will involve the two most common EMR systems in the U.S (Epic and Cerner). A
minimum of 2,500 pediatric outpatients age 6 and under will be identified across the two sites for study
inclusion, with at least 40% expected to have had some type of prenatal substance exposure (tobacco, alcohol,
prescription drugs of abuse, and/or illicit drugs). The four EMR types examined for each participant will be the
linked pediatric outpatient record, newborn inpatient record, maternal inpatient delivery record, and maternal
outpatient prenatal care record. In addition to background, comorbidity, and outcomes information, any
information about prenatal substance exposure will be abstracted to include: ICD-10 diagnosis and procedure
codes, urine drug screens, cord blood/tissue/meconium analysis, additional biochemical testing, self-
report/screening questions for drug use/exposure, lists of prescribed medications, newborn withdrawal
assessment/treatment, and additional information from notes fields. Specific Aims will be evaluated with
descriptive and bivariate statistics, sensitivity/specificity analyses, and predictive modeling, with the end
product the development of enduring study methodology materials including exposure variable coding
algorithms.
If we are able to identify ways EMR data could be reliably used to not only identify pediatric patients with
prenatal substance exposure, but also to develop valid exposure variables to use for research purposes,
participants in studies examining the links between prenatal exposures and later outcomes could be recruited
at the point of outcome assessment. This would significantly shorten the time needed to do valid studies in this
field by leveraging existing data via validated methods. Study findings will also provide valuable methodological
insights to inform the ultimate gold-standard prospective longitudinal studies examining the impacts of prenatal
substance exposure.
