Last data update: May 13, 2024. (Total: 46773 publications since 2009)
Records 1-11 (of 11 Records) |
Query Trace: Parker SE[original query] |
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Bias analyses to investigate the impact of differential participation: Application to a birth defects case-control study
Petersen JM , Kahrs JC , Adrien N , Wood ME , Olshan AF , Smith LH , Howley MM , Ailes EC , Romitti PA , Herring AH , Parker SE , Shaw GM , Politis MD . Paediatr Perinat Epidemiol 2023 BACKGROUND: Certain associations observed in the National Birth Defects Prevention Study (NBDPS) contrasted with other research or were from areas with mixed findings, including no decrease in odds of spina bifida with periconceptional folic acid supplementation, moderately increased cleft palate odds with ondansetron use and reduced hypospadias odds with maternal smoking. OBJECTIVES: To investigate the plausibility and extent of differential participation to produce effect estimates observed in NBDPS. METHODS: We searched the literature for factors related to these exposures and participation and conducted deterministic quantitative bias analyses. We estimated case-control participation and expected exposure prevalence based on internal and external reports, respectively. For the folic acid-spina bifida and ondansetron-cleft palate analyses, we hypothesized the true odds ratio (OR) based on prior studies and quantified the degree of exposure over- (or under-) representation to produce the crude OR (cOR) in NBDPS. For the smoking-hypospadias analysis, we estimated the extent of selection bias needed to nullify the association as well as the maximum potential harmful OR. RESULTS: Under our assumptions (participation, exposure prevalence, true OR), there was overrepresentation of folic acid use and underrepresentation of ondansetron use and smoking among participants. Folic acid-exposed spina bifida cases would need to have been ≥1.2× more likely to participate than exposed controls to yield the observed null cOR. Ondansetron-exposed cleft palate cases would need to have been 1.6× more likely to participate than exposed controls if the true OR is null. Smoking-exposed hypospadias cases would need to have been ≥1.2 times less likely to participate than exposed controls for the association to falsely appear protective (upper bound of selection bias adjusted smoking-hypospadias OR = 2.02). CONCLUSIONS: Differential participation could partly explain certain associations observed in NBDPS, but questions remain about why. Potential impacts of other systematic errors (e.g. exposure misclassification) could be informed by additional research. |
Periconceptional nonsteroidal anti-inflammatory drug use, folic acid intake, and the risk of spina bifida
Esposito DB , Parker SE , Mitchell AA , Tinker SC , Werler MM . Birth Defects Res 2021 113 (17) 1257-1266 BACKGROUND: Use of nonsteroidal anti-inflammatory drugs (NSAIDs) during pregnancy may increase risk for neural tube defects (NTDs), including spina bifida. Folic acid intake can prevent NTDs, but it is not known whether it modifies any risks associated with NSAID use. OBJECTIVES: To assess the impact of periconceptional NSAID use on the risk of spina bifida overall and stratified by folic acid intake. STUDY DESIGN: We analyzed 1998-2015 data from the Slone Epidemiology Center Birth Defects Study, a multi-site, case-control study. Mothers were interviewed to identify sociodemographic factors, behaviors, and exposures during pregnancy. Periconceptional NSAID use was defined as use of aspirin, ibuprofen, naproxen, or COX2 inhibitors within the month before or after the last menstrual period. Logistic regression models were used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for NSAID use, adjusted for study center and race/ethnicity stratified by average daily folic acid intake above ("high FA") or below ("low FA") 400 mcg/day. RESULTS: We compared mothers of 267 infants with spina bifida to mothers of 6,233 nonmalformed controls. Among control mothers, 20% used NSAIDS periconceptionally (16% ibuprofen, 4% aspirin, 3% naproxen, and <1% COX-2 inhibitors). For any NSAID use, the aORs among low FA and high FA women were 1.70 (95% CI [1.13, 2.57]) and 1.09 (95% CI [0.69, 1.71]), respectively. CONCLUSIONS: We observed a small increase in the risk for spina bifida among infants born to women who used NSAIDs periconceptionally, but this risk was limited to those who had inadequate folic acid intake. |
Folic acid antagonist use before and during pregnancy and risk for selected birth defects
Kerr SM , Parker SE , Mitchell AA , Tinker SC , Werler MM . Birth Defects Res 2020 112 (18) 1526-1540 BACKGROUND: Maternal folic acid (FA) intake before and during early pregnancy reduces the risk for neural tube defects (NTDs); evidence suggests it may also reduce the risk for oral clefts, urinary defects, and cardiac defects. We sought to re-examine the use of drugs, which affect folate metabolism, dihydrofolate reductase inhibiting (DHFRI) medications, and anti-epileptic drugs (AEDs), in data collected in the post-FA fortification era (1998+) in the Slone Birth Defects Study. METHODS: We assessed maternal DHFRI and AED use and risk for NTDs, oral clefts, and urinary and cardiac defects. We estimated odds ratios (ORs) and 95% confidence intervals (CIs) using logistic regression. We assessed daily average FA intake of ≥400 mcg as a potential effect modifier. RESULTS: We analyzed data from 10,209 control and 9,625 case mothers. Among controls, the prevalence of exposure to DHFRI medications was 0.3% and to AEDs was 0.5%. Maternal use of AEDs was associated with increased risks for NTDs (OR: 3.4; 95% CI: 1.5, 7.5), oral clefts (OR: 2.3; 95% CI: 1.3, 4.0), urinary defects (OR: 1.6; 95% CI: 1.0, 2.7), and cardiac defects (OR: 1.6; 95% CI: 1.1, 2.3); similar or further increased risks were found among those with FA intake ≥400 mcg per day. DHFRI use was rare and relative risk estimates were imprecise and consistent with the null. CONCLUSIONS: Similar to our previous analyses, we observed associations between AED use and these defects. For DHFRI exposure, we found no evidence for increased risk of these defects. Though statistical power to examine FA effect modification was low, we found no evidence of further protection among those with FA intake ≥400 mcg, with some associations somewhat stronger in this group. |
Periconceptional folic acid and risk for neural tube defects among higher risk pregnancies
Petersen JM , Parker SE , Benedum CM , Mitchell AA , Tinker SC , Werler MM . Birth Defects Res 2019 111 (19) 1501-1512 BACKGROUND: Women with a previous neural tube defect (NTD)-affected pregnancy are recommended to consume 4,000 mug daily folic acid (FA) for prevention (10 times the general-population recommendation). Protection from doses between 400 and 4,000 mug for this and other higher risk groups is unclear. METHODS: In the case-control Slone Birth Defects Study (1988-2015), we examined the associations between periconceptional FA doses and NTDs among four higher risk groups: NTD family history, periconceptional antiepileptic drug exposure (AED), pregestational diabetes, and prepregnancy obesity. Mothers completed standardized interviews about pregnancy events and exposures. FA categorizations were based on (a) supplements only and (b) supplements and diet ("total folate"). We estimated odds ratios (ORs) and 95% confidence intervals (CIs) (adjusted for age and study center) using logistic regression. RESULTS: Cases and controls included: 45 and 119 with family history, 25 and 108 with AED exposure, 12 and 63 with pregestational diabetes, 111 and 1,243 with obesity. Daily FA supplementation was associated with lower NTD risk compared to no supplementation (adjusted ORs were 0.33 [95% CI 0.13, 0.76] for family history, 0.31 [0.09, 0.95] for AED exposure, 0.25 [0.04, 1.05] for pregestational diabetes, 0.65 [0.40, 1.04] for obesity). Though estimates were imprecise, as total folate increased stronger point estimates were observed, notably among family history. No mothers with a prior NTD-affected pregnancy supplemented with 4,000 mug. CONCLUSIONS: Our findings reinforce that all women of childbearing potential should consume at least 400 mug FA/day to protect against NTDs. Higher risk groups may benefit from higher doses. |
One-carbon cofactor intake and risk of neural tube defects among women who meet folic acid recommendations: A multicenter case-control study
Petersen JM , Parker SE , Crider KS , Tinker SC , Mitchell AA , Werler MM . Am J Epidemiol 2019 188 (6) 1136-1143 We aimed to investigate associations between individual and concurrent (>/=2) intakes of one-carbon cofactors vitamins B6 and B12, choline, betaine, and methionine and neural tube defect (NTD) outcomes among mothers meeting the folic acid recommendations. In the Slone Birth Defects Study (case-control design; North America, 1998-2015), mothers of 164 NTD cases and 2,831 nonmalformed controls completed food frequency questionnaires and structured interviews. Estimated intakes of one-carbon cofactors were dichotomized (high vs. low) for all except betaine (low or middle vs. high). We used logistic regression models to estimate odds ratios and 95% confidence intervals adjusted for center, age, and race. The analysis was restricted to mothers with estimated daily total folate intake of >/=400 mug during periconception. Fewer cases, compared with controls, had high intakes for each one-carbon cofactor except betaine, where the starkest contrast occurred in the middle group. Women with concurrent high intakes of B6, B12, choline, and methionine and moderate intake of betaine had approximately half the risk of an NTD-affected pregnancy (odds ratio = 0.49, 95% confidence interval: 0.23, 1.08). These findings suggest that, in the presence of folic acid, one-carbon cofactors-notably when consumed together-might reduce NTD risk. Additional research should inform any changes to clinical recommendations. |
Periconceptional maternal fever, folic acid intake, and the risk for neural tube defects
Kerr SM , Parker SE , Mitchell AA , Tinker SC , Werler MM . Ann Epidemiol 2017 27 (12) 777-782 e1 PURPOSE: Previous studies have shown an association between maternal fever in early pregnancy and neural tube defects (NTDs) such as spina bifida. Periconceptional folic acid intake has been shown to reduce the risk of these outcomes. METHODS: Using data from the Slone Epidemiology Center Birth Defects Study (1998-2015), we examined the impact of folic acid on the relationship between maternal fever in the periconceptional period (28 days before and after the last menstrual period) and NTDs. Logistic regression models were used to calculate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Mothers of 375 cases and 8247 nonmalformed controls were included. We observed an elevated risk for NTDs for fever in the periconceptional period (OR: 2.4; 95% CI: 1.5-4.0). This association was weaker for mothers who reported consuming the recommended amount of folic acid (≥400 mug per day; OR: 1.8; 95% CI: 0.8-4.0) than mothers with low folic acid intake (<400 mug per day; OR: 4.2; 95% CI: 2.2-8.2). CONCLUSIONS: Our data support an association between maternal periconceptional fever and an increased risk for NTDs and also provide evidence that this association was attenuated for mothers who reported consuming folic acid at recommended levels in the periconceptional period. |
Population-based microcephaly surveillance in the United States, 2009 to 2013: An analysis of potential sources of variation
Cragan JD , Isenburg JL , Parker SE , Alverson CJ , Meyer RE , Stallings EB , Kirby RS , Lupo PJ , Liu JS , Seagroves A , Ethen MK , Cho SJ , Evans M , Liberman RF , Fornoff J , Browne ML , Rutkowski RE , Nance AE , Anderka M , Fox DJ , Steele A , Copeland G , Romitti PA , Mai CT . Birth Defects Res A Clin Mol Teratol 2016 106 (11) 972-982 BACKGROUND: Congenital microcephaly has been linked to maternal Zika virus infection. However, ascertaining infants diagnosed with microcephaly can be challenging. METHODS: Thirty birth defects surveillance programs provided data on infants diagnosed with microcephaly born 2009 to 2013. The pooled prevalence of microcephaly per 10,000 live births was estimated overall and by maternal/infant characteristics. Variation in prevalence was examined across case finding methods. Nine programs provided data on head circumference and conditions potentially contributing to microcephaly. RESULTS: The pooled prevalence of microcephaly was 8.7 per 10,000 live births. Median prevalence (per 10,000 live births) was similar among programs using active (6.7) and passive (6.6) methods; the interdecile range of prevalence estimates was wider among programs using passive methods for all race/ethnicity categories except Hispanic. Prevalence (per 10,000 live births) was lowest among non-Hispanic Whites (6.5) and highest among non-Hispanic Blacks and Hispanics (11.2 and 11.9, respectively); estimates followed a U-shaped distribution by maternal age with the highest prevalence among mothers <20 years (11.5) and ≥40 years (13.2). For gestational age and birth weight, the highest prevalence was among infants <32 weeks gestation and infants <1500 gm. Case definitions varied; 41.8% of cases had an HC ≥ the 10th percentile for sex and gestational age. CONCLUSION: Differences in methods, population distribution of maternal/infant characteristics, and case definitions for microcephaly can contribute to the wide range of observed prevalence estimates across individual birth defects surveillance programs. Addressing these factors in the setting of Zika virus infection can improve the quality of prevalence estimates. |
Maternal exposures in the National Birth Defects Prevention Study: time trends of selected exposures
Dawson AL , Razzaghi H , Arth A , Canfield MA , Parker SE , Reefhuis J . Birth Defects Res A Clin Mol Teratol 2015 103 (8) 703-12 BACKGROUND: Our objective was to describe time trends in selected pregnancy exposures in the National Birth Defects Prevention Study (NBDPS). METHODS: We analyzed data from the NBDPS, a multi-site case-control study of major birth defects, for mothers of live-born infants without birth defects (controls), with an expected date of delivery (EDD) from 1998 to 2011. Mothers from the 10 participating centers across the United States were interviewed by phone between 6 weeks and 2 years after the EDD. We focused on maternal race/ethnicity and five maternal risk factors: obesity, use of folic acid-containing multivitamins, opioid analgesics, selective serotonin reuptake inhibitors, and loratadine because of their prevalence of use and some reports of associations with major birth defects. Prevalence time trends were examined using the Kendall's taubeta test statistic. RESULTS: The exposure trend analysis included 11,724 control mothers with EDDs from 1998 to 2011. We observed a significant increase in obesity prevalence among control mothers, as well as use of selective serotonin reuptake inhibitors and loratadine. We also observed an increase in periconceptional use of folic acid-containing multivitamins. Some of the time trends varied by race/ethnicity. No remarkable trend in the overall use of opioid analgesics was observed. The racial/ethnic distribution of mothers changed slightly during the study period. CONCLUSION: Long-term, population-based case-control studies continue to be an effective way to assess exposure-birth defects associations and provide guidance to health care providers. However, investigators examining rare outcomes covering many years of data collection need to be cognizant of time trends in exposures. |
Maternal medication and herbal use and risk for hypospadias: data from the National Birth Defects Prevention Study, 1997-2007
Lind JN , Tinker SC , Broussard CS , Reefhuis J , Carmichael SL , Honein MA , Olney RS , Parker SE , Werler MM . Pharmacoepidemiol Drug Saf 2013 22 (7) 783-93 PURPOSE: To investigate associations between maternal use of common medications and herbals during early pregnancy and risk for hypospadias in male infants. METHODS: We used data from the National Birth Defects Prevention Study, a multi-site, population-based, case-control study. We analyzed data from 1537 infants with second-degree or third-degree isolated hypospadias and 4314 live-born male control infants without major birth defects, with estimated dates of delivery from 1997 to 2007. Exposure was reported use of prescription or over-the-counter medications or herbal products, from 1 month before to 4 months after conception. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were estimated using multivariable logistic regression, adjusting for maternal age, race/ethnicity, education, pre-pregnancy body mass index, previous live births, maternal subfertility, study site, and year. RESULTS: We assessed 64 medication and 24 herbal components. Maternal uses of most components were not associated with an increased risk of hypospadias. Two new associations were observed for venlafaxine (aOR 2.4; 95%CI 1.0, 6.0) and progestin-only oral contraceptives (aOR 1.9; 95%CI 1.1, 3.2). The previously reported association for clomiphene citrate was confirmed (aOR 1.9; 95%CI 1.2, 3.0). Numbers were relatively small for exposure to other specific patterns of fertility agents, but elevated aORs were observed for the most common of them. CONCLUSIONS: Overall, findings were reassuring that hypospadias is not associated with most medication components examined in this analysis. New associations will need to be confirmed in other studies. Increased risks for hypospadias associated with various fertility agents raise the possibility of confounding by underlying subfertility. (Copyright (c) 2013 John Wiley & Sons, Ltd.) |
Updated national birth prevalence estimates for selected birth defects in the United States, 2004-2006
Parker SE , Mai CT , Canfield MA , Rickard R , Wang Y , Meyer RE , Anderson P , Mason CA , Collins JS , Kirby RS , Correa A . Birth Defects Res A Clin Mol Teratol 2010 88 (12) 1008-16 BACKGROUND: The National Birth Defects Prevention Network collects state-specific birth defects surveillance data for annual publication of prevalence estimates and collaborative research projects. In 2006, data for 21 birth defects from 1999 through 2001 were presented as national birth prevalence estimates. The purpose of this report was to update these estimates using data from 2004 through 2006. METHODS: Population-based data from 11 active case-finding programs, 6 passive case-finding programs with case confirmation, and 7 passive programs without case confirmation were used in this analysis. Pooled birth prevalence estimates for 21 birth defects, stratified by case ascertainment approach, were calculated. National prevalence estimates, adjusted for maternal race/ethnicity and maternal age (trisomy 13, trisomy 18, and Down syndrome only) were determined using data from 14 programs. The impact of pregnancy outcomes on prevalence estimates was also assessed for five specific defects. RESULTS: National birth defects prevalence estimates ranged from 0.72 per 10,000 live births for common truncus to 14.47 per 10,000 live births for Down syndrome. Stratification by type of surveillance system showed that active programs had a higher prevalence of anencephaly, anophthalmia/microphthalmia, cleft lip with or without cleft palate, reduction defect of upper limbs, and trisomy 18. The birth prevalence of anencephaly, trisomy 13, and trisomy 18 also varied substantially with inclusion of elective terminations. CONCLUSION: Accurate and timely national estimates of the prevalence of birth defects are needed for monitoring trends, assessing prevention efforts, determining service planning, and understanding the burden of disease due to birth defects in the United States. Birth Defects Research (Part A), 2010. (c) 2010 Wiley-Liss, Inc. |
Multistate study of the epidemiology of clubfoot
Parker SE , Mai CT , Strickland MJ , Olney RS , Rickard R , Marengo L , Wang Y , Hashmi SS , Meyer RE , National Birth Defects Prevention Network . Birth Defects Res A Clin Mol Teratol 2009 85 (11) 897-904 BACKGROUND: Although clubfoot is a common birth defect, with a prevalence of approximately 1 per 1000 livebirths, the etiology of clubfoot remains largely unknown. Studies of the prevalence and risk factors for clubfoot in the United States have previously been limited to specific states. The purpose of this study was to pool data from several birth defects surveillance programs to better estimate the prevalence of clubfoot and investigate its risk factors. METHODS: The 10 population-based birth defects surveillance programs that participated in this study ascertained 6139 cases of clubfoot from 2001 through 2005. A random sample of 10 controls per case, matched on year and state of birth, was selected from birth certificates. Data on infant and maternal risk factors were collected from birth certificates. Prevalence was calculated by pooling the state-specific data. Conditional logistic regression was used to investigate the association between risk factors and clubfoot. RESULTS: The overall prevalence of clubfoot was 1.29 per 1000 livebirths; 1.38 among non-Hispanic whites, 1.30 among Hispanics, and 1.14 among non-Hispanic blacks or African Americans. Maternal age, parity, education, and marital status were significantly associated with clubfoot. Maternal smoking and diabetes also showed significant associations. Several of these observed associations were consistent between surveillance programs. CONCLUSIONS: We estimated the prevalence of clubfoot using data from several birth defects programs, representing one-quarter of all births in the United States. Our findings underline the importanceof birth defects surveillance programs and their utility in monitoring population-based prevalence and investigating risk factors. Birth Defects Research (Part A), 2009. (c) 2009 Wiley-Liss, Inc. |
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