Agreement between maternal report and medical records on use of medications during early pregnancy in New York

Abstract

Background Studies evaluating associations between medication use in pregnancy and birth outcomes rely on various sources of exposure information. We sought to assess agreement between self‐reported use of medications during early pregnancy and medication information in prenatal medical records to understand the reliability of each of these information sources. Methods We compared self‐reported prescription medication use in early pregnancy to medical records from 184 New York women with deliveries in 2018 who participated in the Birth Defects Study To Evaluate Pregnancy exposureS. We assessed medications used chronically and episodically, and medications within 12 therapeutic groups. We calculated agreement using kappa (κ) coefficients, sensitivity, and specificity. We assessed differences by case/control status, maternal age, education, time to interview, and interview language. Results Medications used chronically showed substantial agreement between self‐report and medical records (κ = 0.75, 0.61–0.88), with agreement for therapeutic groups used chronically ranging from κ = 0.61 for antidiabetics to κ = 1.00 for antihypertensives. Prescription medications used episodically showed worse agreement (κ = 0.40, 0.25–0.54), with the lowest agreement for opioid analgesics (κ = 0.20) and anti‐infectives (κ = 0.33). Agreement did not differ by the characteristics examined, although we observed potential differences by interview language. Conclusions Among our sample, we observed good agreement between self‐report and medical records for medications used chronically and substantially less agreement for medications used episodically. Differences by source may be due to poor recall in self‐reports, non‐adherence with prescribed medications and lack of complete prescription information within medical records. Limitations should be considered when assessing prescription medication exposures during early pregnancy in epidemiologic studies.

Maternal exposure to zolpidem and risk of specific birth defects

“…We do not believe that we have underestimated early‐pregnancy zolpidem use because our prevalence estimates (0.2% of both NBDPS and BDS controls) are similar to other estimates of the prevalence of zolpidem use in pregnancy based on prescription claims data (Askaa et al, 2014; Wikner & Källén, 2011). We explored the impact of potential exposure misclassification through a quantitative bias analysis, relying on the literature for parameter estimates (Evandt et al, 2019; Howley et al, 2023; Sarangarm et al, 2012). A recent validation study among birth defect cases and controls in New York found that there was no difference in agreement by case/control status for medications used chronically or those used episodically.…”

“…Thus, we conducted a non‐differential misclassification bias analysis. Using estimates from the BD‐STEPS validation and two other studies comparing medication use in early pregnancy from self‐report and medical records/pharmacy claims, we assumed that the sensitivities of self‐reported zolpidem use were lower than specificities (Evandt et al, 2019; Howley et al, 2023; Sarangarm et al, 2012). We used the methods and SAS macro developed by Fox et al to obtain bias‐adjusted, confounder‐aOR estimates (adjusting for the same confounders for each defect from the main analysis), assigning a trapezoidal distribution (minimum, mode 1, mode 2 and maximum) to the sensitivity (0.55, 0.65, 0.75, 0.90) and specificity (0.998, 0.999, 0.9995, 1.0) for use of zolpidem use (Fox et al, 2005).…”

“…Instead, we used estimates from the literature for sensitivity and specificity of maternal recall of sleep aid medications in early pregnancy, and assigned bias parameters based on these values. Our bias analysis was largely informed by a medication validation conducted among a sample of participants in the Birth Defects Study To Evaluate Pregnancy exposureS (BD‐STEPS; Howley et al, 2023). BD‐STEPS is a subsequent study to NBDPS with similar methods and conducted at a subset of NBDPS sites (Tinker et al, 2015).…”

Antifungal medication use during pregnancy and the risk of selected major birth defects in the National Birth Defects Prevention Study, 1997–2011

“…33 Results from a medication validation study suggest that misclassification for medications taken episodically, such as antifungal use, did not vary by birth defect diagnosis. 34 We assumed the sensitivity of self-reported antifungal use was lower than the specificity. We assigned a trapezoidal distribution to our sensitivity (0.25, 0.35, 0.45, 0.50) and specificity (0.998, 0.999, 0.9995, 1.0) parameters, chosen based on published medication validation reports.…”

“…We assigned a trapezoidal distribution to our sensitivity (0.25, 0.35, 0.45, 0.50) and specificity (0.998, 0.999, 0.9995, 1.0) parameters, chosen based on published medication validation reports. [34][35][36] Each bias parameter was sampled 10 000 times, and estimates were summarized as the median AOR and 95% simulation interval, which included both random and systematic error. Estimates were adjusted for the same confounders included in the main analysis.…”