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There is a dearth of safety data on maternal outcomes after perinatal medication exposure. Data-mining for unexpected adverse event occurrence in existing datasets is a potentially useful approach. One method, the Poisson tree-based scan statistic (TBSS), assumes that the expected outcome counts, based on incidence of outcomes in the control group, are estimated without error. This assumption may be difficult to satisfy with a small control group. Our simulation study evaluated the effect of imprecise incidence proportions from the control group on TBSS' ability to identify maternal outcomes in pregnancy research. We simulated base case analyses with "true" expected incidence proportions and compared these with imprecise incidence proportions derived from sparse control samples. We varied parameters that have an impact on type I error and statistical power (exposure group size, outcome's incidence proportion, and effect size). We found that imprecise incidence proportions generated by a small control group resulted in inaccurate alerting, inflation of type I error, and removal of very rare outcomes for TBSS analysis due to "zero" background counts. Ideally, the control size should be at least several times larger than the exposure size to limit the number of false positive alerts and retain statistical power for true alerts. This article is part of a Special Collection on Pharmacoepidemiology. [ABSTRACT FROM AUTHOR]

Key Points: Question: Does prenatal exposure to the combination of buprenorphine and naloxone compared with buprenorphine alone increase the risk of adverse neonatal and maternal outcomes? Findings: This observational study noted similar and, in some instances, more favorable neonatal and maternal outcomes for pregnancies exposed to buprenorphine combined with naloxone compared with buprenorphine alone. Meaning: The findings demonstrate comparative safety for the combination of buprenorphine with naloxone for the outcomes considered, supporting both formulations as reasonable options for treating opioid use disorder during pregnancy. Importance: Buprenorphine combined with naloxone is commonly used to treat opioid use disorders outside of pregnancy. In pregnancy, buprenorphine alone is generally recommended because of limited perinatal safety data on the combination product. Objective: To compare perinatal outcomes following prenatal exposure to buprenorphine with naloxone vs buprenorphine alone. Design, Settings, and Participants: Population-based cohort study using health care utilization data from Medicaid-insured beneficiaries in the US from 2000 to 2018. The cohort was restricted to pregnant individuals linked to their liveborn infants, with maternal Medicaid enrollment from 3 months before pregnancy to 1 month after delivery and infant enrollment for the first 3 months after birth, unless they died sooner. Exposure: Use of buprenorphine with naloxone vs buprenorphine alone during the first trimester based on outpatient dispensings. Main Outcomes and Measures: Outcomes included major congenital malformations, low birth weight, neonatal abstinence syndrome, neonatal intensive care unit admission, preterm birth, respiratory symptoms, small for gestational age, cesarean delivery, and maternal morbidity. Confounder-adjusted risk ratios were calculated using propensity score overlap weights. Results: This study identified 3369 pregnant individuals exposed to buprenorphine with naloxone during the first trimester (mean [SD] age, 28.8 [4.6] years) and 5326 exposed to buprenorphine alone or who switched from the combination to buprenorphine alone by the end of the first trimester (mean [SD] age, 28.3 [4.5] years). When comparing buprenorphine combined with naloxone with buprenorphine alone, a lower risk for neonatal abstinence syndrome (absolute risk, 37.4% vs 55.8%; weighted relative risk, 0.77 [95% CI, 0.70-0.84]) and a modestly lower risk for neonatal intensive care unit admission (absolute risk, 30.6% vs 34.9%; weighted relative risk, 0.91 [95% CI, 0.85-0.98]) and small for gestational age (absolute risk, 10.0% vs 12.4%; weighted relative risk, 0.86 [95% CI, 0.75-0.98]) was observed. For maternal morbidity, the comparative rates were 2.6% vs 2.9%, respectively, and the weighted relative risk was 0.90 (95% CI, 0.68-1.19). No differences were observed with respect to major congenital malformations overall, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery. Results were consistent across sensitivity analyses. Conclusions and Relevance: There were similar and, in some instances, more favorable neonatal and maternal outcomes for pregnancies exposed to buprenorphine combined with naloxone compared with buprenorphine alone. For the outcomes assessed, compared with buprenorphine alone, buprenorphine with naloxone during pregnancy appears to be a safe treatment option. This supports the view that both formulations are reasonable options for the treatment of opioid use disorder in pregnancy, affirming flexibility in collaborative treatment decision-making. This population-based cohort study uses health care utilization data for pregnant individuals with opioid use disorder to compare neonatal and maternal outcomes following prenatal exposure to buprenorphine combined with naloxone vs buprenorphine alone. [ABSTRACT FROM AUTHOR]

Epidemiologists spend a great deal of time on confounding in our teaching, in our methods development, and in our assessment of study results. This may give the impression that uncontrolled confounding is the biggest problem observational epidemiology faces, when in fact, other sources of bias such as selection bias, measurement error, missing data, and misalignment of zero time may often (especially if they are all present in a single study) lead to a stronger deviation from the truth. Compared with the amount of time we spend teaching how to address confounding in data analysis, we spend relatively little time teaching methods for simulating confounding (and other sources of bias) to learn their impact and develop plans to mitigate or quantify the bias. Here we review the accompanying paper by Desai et al (Am J Epidemiol. 2024;193(11):1600-1608), which uses simulation methods to quantify the impact of an unmeasured confounder when it is completely missing or when a proxy of the confounder is measured. We discuss how we can use simulations of sources of bias to ensure that we generate better and more valid study estimates, and we discuss the importance of simulating realistic datasets with plausible bias structures to guide data collection. This article is part of a Special Collection on Pharmacoepidemiology. [ABSTRACT FROM AUTHOR]

Key Points: Question: Is prescription stimulant treatment for attention-deficit/hyperactivity disorder during pregnancy associated with neurodevelopmental disorders in children? Findings: In this cohort study including 7065 pregnancies exposed to amphetamine/dextroamphetamine and 1123 pregnancies exposed to methylphenidate in the second half of pregnancy, neither medication was associated with autism spectrum disorder, attention-deficit/hyperactivity disorder, or a composite of any neurodevelopmental disorder in children after careful adjustment for confounding by indication through various design and analytic approaches. Meaning: These findings suggest that amphetamine/dextroamphetamine and methylphenidate exposure during pregnancy are not likely to meaningfully increase the risk of childhood neurodevelopmental disorders. This cohort study evaluates the association between prescription stimulant use during pregnancy and neurodevelopmental disorders in childhood. Importance: Use of medications for attention-deficit/hyperactivity disorder (ADHD) during pregnancy is increasing in the US. Whether exposure to these medications in utero impacts the risk of neurodevelopmental disorders in children is uncertain. Objective: To evaluate the association of childhood neurodevelopmental disorders with in utero exposure to stimulant medications for ADHD. Design, Setting, and Participants: This cohort study included health care utilization data from publicly insured (Medicaid data from 2000 to 2018) and commercially insured (MarketScan Commercial Claims Database data from 2003 to 2020) pregnant individuals aged 12 to 55 years in the US with enrollment from 3 months prior to pregnancy through 1 month after delivery, linked to children. Children were monitored from birth until outcome diagnosis, disenrollment, death, or end of the study (December 2018 for Medicaid and December 2020 for MarketScan). Exposures: Dispensing of amphetamine/dextroamphetamine or methylphenidate in the second half of pregnancy. Main Outcomes and Measures: Autism spectrum disorder, ADHD, and a composite of any neurodevelopmental disorder were defined using validated algorithms. Hazard ratios were estimated comparing amphetamine/dextroamphetamine and methylphenidate to no exposure. Results: The publicly insured cohort included 2 496 771 stimulant-unexposed, 4693 amphetamine/dextroamphetamine-exposed, and 786 methylphenidate-exposed pregnancies with a mean (SD) age of 25.2 (6.0) years. The commercially insured cohort included 1 773 501 stimulant-unexposed, 2372 amphetamine/dextroamphetamine-exposed, and 337 methylphenidate-exposed pregnancies with a mean (SD) age of 31.6 (4.6) years. In unadjusted analyses, amphetamine/dextroamphetamine and methylphenidate exposure were associated with a 2- to 3-fold increased risk of the neurodevelopmental outcomes considered. After adjustment for measured confounders, amphetamine/dextroamphetamine exposure was not associated with any outcome (autism spectrum disorder: hazard ratio [HR], 0.80; 95% CI, 0.56-1.14]; ADHD: HR, 1.07; 95% CI, 0.89-1.28; any neurodevelopmental disorder: HR, 0.91; 95% CI, 0.81-1.28). Methylphenidate exposure was associated with an increased risk of ADHD (HR, 1.43; 95% CI, 1.12-1.82]) but not other outcomes after adjustment (autism spectrum disorder: HR, 1.06; 95% CI, 0.62-1.81; any neurodevelopmental disorder: HR, 1.15; 95% CI, 0.97-1.36). The association between methylphenidate and ADHD did not persist in sensitivity analyses with stricter control for confounding by maternal ADHD. Conclusions and Relevance: The findings in this study suggest that amphetamine/dextroamphetamine and methylphenidate exposure in utero are not likely to meaningfully increase the risk of childhood neurodevelopmental disorders. [ABSTRACT FROM AUTHOR]

Background: Most studies assessing the safety of parental drug exposures during pregnancy and around the time of conception describe the effects of maternal exposure. Recent publications have raised awareness of the need for additional research regarding the safety of paternal drug exposures on pregnancy outcomes. Objectives: To identify and describe studies that use secondary databases in paternal drug safety studies and to describe the secondary databases that were used. Methods: A systematic review of studies assessing paternal medication exposure and pregnancy and infant outcomes using secondary databases was performed. In addition, the secondary databases used for these studies was described. Literature search was conducted using Embase, Web of Science, and PubMed, over the period January 1, 2012 to April 30, 2023. For each eligible study, paternal drug exposure, outcome, and data source characteristics were extracted in a data extraction form. Results: After reviewing the literature, 17 studies met inclusion criteria. The medications assessed for paternal safety were anti‐rheumatic drugs (n = 10), anti‐depressants (n = 3), anticonvulsants (n = 2), and anti‐diabetes medications (n = 2). Pregnancy safety outcomes included congenital malformations, birth weight, and developmental disorders. The studies used five different databases across Europe and North America. The included studies used databases from Denmark (n = 12), Norway (n = 2), Sweden (n = 1), Canada (n = 1), and the United States (n = 1). The European studies utilized national patient registers that linked fathers to births and prescription histories. The North American databases used included insurance claims and electronic health records. Conclusions: Our review shows that few studies have been completed on paternal medication exposures and pregnancy outcomes, despite the availability of secondary databases that contain data necessary to link fathers to infants. More research on the potential adverse impacts of paternal medication exposures is needed. [ABSTRACT FROM AUTHOR]

Pregnant individuals with opioid use disorder have a high incidence of postpartum death due to opioid overdose, other substance-related injuries, accidents, and suicide. OBJECTIVE: To assess the incidence and risk factors for postpartum opioid overdose death and describe other causes of postpartum death in individuals with opioid use disorder (OUD). METHODS: We conducted a cohort study that used health care utilization data from the Medicaid Analytic eXtract linked to the National Death Index in the United States from 2006 to 2013. All pregnant individuals with live births or stillbirths and continuous enrollment for 3 months before delivery were eligible, including 4,972,061 deliveries. A subcohort of individuals with a documented history of OUD in the 3 months before delivery was identified. We estimated the cumulative incidence of death as occurring between delivery and 1 year postpartum among all individuals and individuals with OUD. Risk factors for opioid overdose death were assessed using odds ratios (ORs) and descriptive statistics, including demographics, health care utilization, obstetric conditions, comorbidities, and medications. RESULTS: The incidence of postpartum opioid overdose death per 100,000 deliveries was 5.4 (95% CI 4.5–6.4) among all individuals and 118 (95% CI 84–163) among individuals with OUD. Individuals with OUD had a sixfold higher incidence of all-cause postpartum death than all individuals. Common causes of death in individuals with OUD were other drug- and alcohol-related deaths (47/100,000), suicide (26/100,000), and other injuries, including accidents and falls (33/100,000). Risk factors strongly associated with postpartum opioid overdose death included mental health and other substance use disorders. Among patients with OUD, postpartum use of medication to treat OUD was associated with 60% lower odds of opioid overdose death (OR 0.4, 95% CI 0.1–0.9). CONCLUSION: Postpartum individuals with OUD have a high incidence of postpartum opioid overdose death and other preventable deaths, including nonopioid substance-related injuries, accidents, and suicide. Use of medications for OUD is strongly associated with lower opioid-related mortality. [ABSTRACT FROM AUTHOR]

This cohort study evaluates the risk of first-trimester antipsychotic exposure with respect to congenital malformations, focusing on individual drugs and specific malformation subtypes. Key Points: Question: Is prenatal antipsychotic exposure associated with increased risk of major congenital malformations? Findings: In this cohort study of more than 26 000 antipsychotic-exposed pregnancies from 6 countries, prenatal exposure to individual antipsychotics was generally not associated with an increase in risk of major congenital malformations. Meaning: Considering the evidence from both primary and sensitivity analyses, there was no indication that antipsychotics are major teratogens; the potential signals observed for oral clefts, gastroschisis, and certain brain anomalies will require confirmation as evidence continues to accumulate. Importance: Psychiatric disorders are common among female individuals of reproductive age. While antipsychotic medication use is increasing, the safety of such medications in pregnancy is an area with large evidence gaps. Objective: To evaluate the risk of first-trimester antipsychotic exposure with respect to congenital malformations, focusing on individual drugs and specific malformation subtypes. Design, Setting, and Participants: This cohort study used data from nationwide health registers from the 5 Nordic countries and the US and spanned 1996 to 2018. The Nordic cohort included all pregnancies resulting in singleton live-born infants, and the US cohort consisted of publicly insured mothers linked to their live-born infants nested in the nationwide Medicaid Analytic eXtract. Data were analyzed from November 2020 to April 2022. Exposures: One or more first-trimester dispensing of any atypical, any typical, and individual antipsychotic drugs. Main Outcomes and Measures: Any major congenital malformation and specific malformation subtypes previously suggested to be associated with antipsychotic exposure in utero: cardiovascular malformations, oral clefts, neural tube defects, hip dysplasia, limb reduction defects, anorectal atresia/stenosis, gastroschisis, hydrocephalus, other specific brain anomalies, and esophageal disorders. Propensity score stratification was used to control for potential confounders. Pooled adjusted estimates were calculated using indirect standardization. Results: A total of 6 455 324 unexposed mothers (mean maternal age range across countries: 24-31 years), 21 751 mothers exposed to atypical antipsychotic drugs (mean age range, 26-31 years), and 6371 mothers exposed to typical antipsychotic drugs (mean age range, 27-32 years) were included in the study cohort. Prevalence of any major malformation was 2.7% (95% CI, 2.7%-2.8%) in unexposed infants, 4.3% (95% CI, 4.1%-4.6%) in infants with atypical antipsychotic drug exposure, and 3.1% (95% CI, 2.7%-3.5%) in infants with typical antipsychotic drug exposure in utero. Among the most prevalent exposure-outcome combinations, adjusted relative risks (aRR) were generally close to the null. One exception was olanzapine exposure and oral cleft (aRR, 2.1 [95% CI, 1.1-4.3]); however, estimates varied across sensitivity analyses. Among moderately prevalent combinations, increased risks were observed for gastroschisis and other specific brain anomalies after atypical antipsychotic exposure (aRR, 1.5 [95% CI, 0.8-2.6] and 1.9 [95% CI, 1.1-3.0]) and for cardiac malformations after chlorprothixene exposure (aRR, 1.6 [95% CI, 1.0-2.7]). While the association direction was consistent across sensitivity analyses, confidence intervals were wide, prohibiting firm conclusions. Conclusions and Relevance: In this study, considering the evidence from primary and sensitivity analyses and inevitable statistical noise for very rare exposure-outcome combinations, in utero antipsychotic exposure generally was not meaningfully associated with an increased risk of malformations. The observed increased risks of oral clefts associated with olanzapine, gastroschisis, and other specific brain anomalies with atypical antipsychotics and cardiac malformations with chlorprothixene requires confirmation as evidence continues to accumulate. [ABSTRACT FROM AUTHOR]

Purpose: The US Food and Drug Administration established the Sentinel System to monitor the safety of medical products. A component of this system includes parameterizable analytic tools to identify mother‐infant pairs and evaluate infant outcomes to enable the routine monitoring of the utilization and safety of drugs used in pregnancy. We assessed the feasibility of using the data and tools in the Sentinel System by assessing a known association between topiramate use during pregnancy and oral clefts in the infant. Methods: We identified mother‐infant pairs using the mother‐infant linkage table from six data partners contributing to the Sentinel Distributed Database from January 1, 2000, to September 30, 2015. We compared mother‐infant pairs with first‐trimester exposure to topiramate to mother‐infant pairs that were topiramate‐unexposed or lamotrigine‐exposed and used a validated algorithm to identify oral clefts in the infant. We estimated adjusted risk ratios through propensity score stratification. Results: There were 2007 topiramate‐exposed and 1 066 086 unexposed mother‐infant pairs in the main comparison. In the active‐comparator analysis, there were 1996 topiramate‐exposed and 2859 lamotrigine‐exposed mother‐infant pairs. After propensity score stratification, the odds ratio for oral clefts was 2.92 (95% CI: 1.43, 5.93) comparing the topiramate‐exposed to unexposed groups and 2.72 (95% CI: 0.75, 9.93) comparing the topiramate‐exposed to lamotrigine‐exposed groups. Conclusions: We found an increased risk of oral clefts after topiramate exposure in the first trimester in the Sentinel database. These results are similar to prior published observational study results and demonstrate the ability of Sentinel's data and analytic tools to assess medical product safety in cohorts of mother‐infant pairs in a timely manner. [ABSTRACT FROM AUTHOR]

Purpose: It is a priority of the US Food and Drug Administration (FDA) to monitor the safety of medications used during pregnancy. Pregnancy exposure registries and cohort studies utilizing electronic health record data are primary sources of information but are limited by small sample sizes and limited outcome assessment. TreeScan™, a statistical data mining tool, can be applied within the FDA Sentinel System to simultaneously identify multiple potential adverse neonatal and infant outcomes after maternal medication exposure. Methods: We implemented TreeScan using the Sentinel analytic tools in a cohort of linked live birth deliveries and infants nested in the IBM MarketScan® Research Database. As a case study, we compared first trimester fluoroquinolone use and cephalosporin use. We used the Bernoulli and Poisson TreeScan statistics with compatible propensity score‐based study designs for confounding control (matching and stratification) and used multiple propensity score models with various strategies for confounding control to inform best practices. We developed a hierarchical outcome tree including major congenital malformations and outcomes of gestational length and birth weight. Results: A total of 1791 fluoroquinolone‐exposed and 8739 cephalosporin‐exposed mother‐infant pairs were eligible for analysis. Both TreeScan analysis methods resulted in single alerts that were deemed to be due to uncontrolled confounding or otherwise not warranting follow‐up. Conclusions: In this implementation of TreeScan using Sentinel analytic tools, we did not observe any new safety signals for fluoroquinolone use in the first trimester. TreeScan, with tailored or high‐dimensional propensity scores for confounding control, is a valuable tool in addition to current safety surveillance methods for medications used during pregnancy. [ABSTRACT FROM AUTHOR]

Yucatan is a region with a high impact of water contamination since it has a karst type soil favoring contaminants entry into the phreatic level, the only source of freshwater in the area. However, no studies report pesticides in water for human consumption or the risk it represents. The objective of this study was to detect and measure pesticide concentrations in domestic tap water to estimate the risk (carcinogenic and non-carcinogenic) to health. A non-probabilistic sampling was applied of 48 tap water sources, and then pesticide detection with solid-phase extraction gas chromatography coupled to the electron capture and flame photometric detectors allowed the estimation of risk through hazard ratios. The present results suggest that aldrin, heptachlor, and β-BHC residues in domestic tap water from Ticul, Yucatan, pose a risk to children's health, particularly for potential carcinogenic risks. [ABSTRACT FROM AUTHOR]

Objectives. We analyzed outcomes from a study that examined social-contextual factors in cancer prevention interventions for working class, multiethnic populations. Methods. Ten community health centers were randomized to intervention or to control. Patients who resided in low-income, multiethnic neighborhoods were eligible; the intervention targeted fruit and vegetable consumption, red meat consumption, multivitamin intake, and physical activity. Outcomes were measured at 8 months. Results. The intervention led to significant increases in fruit and vegetable consumption and multivitamin intake and reductions in red meat consumption; no change was found in physical activity levels. The intervention effect was not changed when contextual variables that may function as confounders or effect modifiers (e.g., gender, education, race/ethnicity, respondent and parents' country of birth, and poverty status) were included in the analyses. Conclusions. The intervention led to significant improvements in health behaviors among a working class, multiethnic population, regardless of race/ethnicity and socioeconomic status. Interventions that respond to the social context of working class individuals across racial/ethnic categories hold promise for improving cancer-related risk behaviors. doi:10.2105/AJPH.2004.038695)

Importance: Neurodevelopmental disorders are associated with poor health and social outcomes. Population-based data on incidence, age at diagnosis, and demographic variations are essential to identify modifiable risk factors and inform the planning of services and interventions.Objectives: To assess the incidence and timing of diagnosis of neurodevelopmental disorders during childhood in the US and to evaluate differences by population characteristics.Design, Setting, and Participants: This population-based cohort study used nationwide data on birth cohorts nested in the 2000-2014 Medicaid Analytic eXtract and the 2003-2015 IBM MarketScan Research Database on 2 070 541 publicly and 1 309 900 privately insured children enrolled at birth. Data were analyzed between May 1, 2020, and June 30, 2021.Main Outcomes and Measures: Neurodevelopmental disorders, autism spectrum disorders, attention-deficit/hyperactivity disorder, learning disabilities, speech or language disorders, developmental coordination disorders, intellectual disabilities, and behavioral disorders were identified based on validated algorithms. Kaplan-Meier analyses were used to estimate the incidence and timing of diagnosis, stratified by child's sex, birth year, maternal age at delivery, and race and ethnicity.Results: The cohorts comprised 2 070 541 publicly insured children (1 045 426 boys [50.5%]) and 1 309 900 privately insured children (667 607 boys [51.0%]) enrolled at birth. By 8 years of age, 23.9% of publicly insured children and 11.0% of privately insured children received a diagnosis of 1 or more neurodevelopmental disorders (autism spectrum disorder, 1.6% and 1.3%; attention-deficit/hyperactivity disorder, 14.5% and 5.8%; learning disability, 1.2% and 0.6%; speech or language disorder, 8.4% and 4.5%; developmental coordination disorder, 0.9% and 0.7%; intellectual disability, 0.7% and 0.1%; and behavioral disorder, 8.4% and 1.5%). Risks were substantially higher among boys (incidence of ≥1 neurodevelopmental disorder by age 8 years for boys vs girls: 30.7% vs 16.7% among publicly insured children and 15.0% vs 6.7% among privately insured children) and White children (30.2% vs 9.1% among Asian children, 23.0% among Black children, 15.4% among Hispanic children, and 22.7% among children of unknown race or ethnicity; information on race and ethnicity was available only for publicly insured children). The association of maternal age and birth year with incidence of neurodevelopmental disorders varied by outcome. Except for attention-deficit/hyperactivity disorder, the diagnosis tended to be established somewhat earlier for privately insured children. The association of race and ethnicity with age at diagnosis varied by outcome. Co-occurring neurodevelopmental disorders were common, especially among children with autism spectrum disorder and intellectual disability (>70% had ≥1 other disorder).Conclusions and Relevance: In this population-based cohort study, a relatively high incidence of and co-occurrence of neurodevelopmental disorders as well as the disparity in incidence and timing of diagnosis by insurance type and race and ethnicity were found. These findings represent important public health concerns and underscore the need for timely and accessible developmental assessments and educational services to help reduce the burden of these disorders. [ABSTRACT FROM AUTHOR]

Purpose: To validate healthcare claim‐based algorithms for neurodevelopmental disorders (NDD) in children using medical records as the reference. Methods: Using a clinical data warehouse of patients receiving outpatient or inpatient care at two hospitals in Boston, we identified children (≤14 years between 2010 and 2014) with at least one of the following NDDs according to claims‐based algorithms: autism spectrum disorder/pervasive developmental disorder (ASD), attention deficit disorder/other hyperkinetic syndromes of childhood (ADHD), learning disability, speech/language disorder, developmental coordination disorder (DCD), intellectual disability, and behavioral disorder. Fifty cases per outcome were randomly sampled and their medical records were independently reviewed by two physicians to adjudicate the outcome presence. Positive predictive values (PPVs) and 95% confidence intervals (CIs) were calculated. Results: PPVs were 94% (95% CI, 83%–99%) for ASD, 88% (76%–95%) for ADHD, 98% (89%–100%) for learning disability, 98% (89%–100%) for speech/language disorder, 82% (69%–91%) for intellectual disability, and 92% (81%–98%) for behavioral disorder. A total of 19 of the 50 algorithm‐based cases of DCD were confirmed as severe coordination disorders with functional impairment, with a PPV of 38% (25%–53%). Among the 31 false‐positive cases of DCD were 7 children with coordination deficits that did not persist throughout childhood, 7 with visual‐motor integration deficits, 12 with coordination issues due to an underlying medical condition and 5 with ADHD and at least one other severe NDD. Conclusions: PPVs were generally high (range: 82%–98%), suggesting that claims‐based algorithms can be used to study NDDs. For DCD, additional criteria are needed to improve the classification of true cases. [ABSTRACT FROM AUTHOR]

Abstract Background This paper presents the study design, intervention components, and baseline data from Open Doors to Health, a study designed to address social contextual factors in colorectal cancer (CRC) prevention for low-income, racial/ethnic minority populations. Methods A cluster randomized design with 12 housing sites as the primary sampling units was used: 6 sites were assigned to a "Peer-led plus Screening Access" (PL) condition, and 6 were assigned to "Screening Access only" (SCR) condition. Study-related outcomes were CRC screening, physical activity (measured as mean steps/day), and multivitamin use. Results At baseline (unweighted sample size = 1554), two-thirds self-reported that they were current with screening recommendations for CRC (corrected for medical records validation, prevalence was 52%), with half having received a colonoscopy (54%); 96% had health insurance. Mean steps per day was 5648 (se mean = 224), and on average 28% of the sample reported regular multivitamin use. Residents reported high levels of social support [mean = 4.40 (se = .03)] and moderately extensive social networks [mean = 2.66 (se = .02)]. Conclusion Few studies have conducted community-based studies in public housing communities; these data suggest areas for improvement and future opportunities for intervention development and dissemination. Findings from the randomized trial will determine the effectiveness of the intervention on our health-related outcomes as well as inform future avenues of research.