Scanxiety and Fear of Recurrence in Young Adult Female Breast and Gynaecological Cancer Survivors: Investigating Shared Mechanisms.

Background: Adolescent and young adult (AYA) females are vulnerable to psychological sequelae following cancer diagnosis and treatment. Fear of cancer recurrence (FCR) is well-documented in cancer survivors, however AYA survivors of breast and gynaecological cancers are less well-studied. Moreover, little is known about scan-related fears and anxiety ('scanxiety') in survivors of any age group.

Considerations for practical use of tree-based scan statistics for signal detection using electronic healthcare data: a case study with insulin glargine.

Background: Hypothesis-free signal detection (HFSD) methods such as tree-based scan statistics (TBSS) applied to longitudinal electronic healthcare data (EHD) are increasingly used in safety monitoring. However, challenges may arise in interpreting HFSD results alongside results from disproportionality analysis of spontaneous reporting.

Research Design And Methods: Using the anti-diabetes drug insulin glargine (Lantus®) we apply two different tree-based scan designs using TreeScan™ software on retrospective EHD and compare the results to one another as well as to results from a disproportionality analysis using SRD.

Utility of fertility procedures and prenatal tests to estimate gestational age for live-births and stillbirths in electronic health plan databases.

Purpose: Current algorithms to evaluate gestational age (GA) during pregnancy rely on hospital coding at delivery and are not applicable to non-live births. We developed an algorithm using fertility procedures and fertility tests, without relying on delivery coding, to develop a novel GA algorithm in live-births and stillbirths.

Methods: Three pregnancy cohorts were identified from 16 health-plans in the Sentinel System: 1) hospital admissions for live-birth, 2) hospital admissions for stillbirth, and 3) medical chart-confirmed stillbirths.

The emerging role of real-world data in advanced breast cancer therapy: Recommendations for collaborative decision-making.

Among stakeholders and decision-makers in advanced breast cancer, the demand for insights from real-world data (RWD) is increasing. Although RWD can be used to support decisions throughout different stages of a breast cancer drug's life cycle, barriers exist to its use and acceptance. We propose a collaborative approach to generating and using RWD that is meaningful to multiple stakeholders, and encourage frameworks toward international guidelines to help standardize RWD methodologies to achieve more efficient use of RWD insights.

Prevalence of prescription opioid use during pregnancy in eight US health plans during 2001-2014.

Purpose: To estimate prevalence of prescription opioid use during pregnancy in eight US health plans during 2001-2014.

Methods: We conducted a cohort study of singleton live birth deliveries. Maternal characteristics were ascertained from health plan and/or birth certificate data and opioids dispensed during pregnancy from health plan pharmacy records.

Validation of an ICD-10-based algorithm to identify stillbirth in the Sentinel System.

Purpose: To develop and validate an International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM)-based algorithm to identify cases of stillbirth using electronic healthcare data.

Methods: We conducted a retrospective study using claims data from three Data Partners (healthcare systems and insurers) in the Sentinel Distributed Database. Algorithms were developed using ICD-10-CM diagnosis codes to identify potential stillbirths among females aged 12-55 years between July 2016 and June 2018.

Validity of diagnosis and procedure codes for identifying neural tube defects in infants.

Purpose: The use of validated criteria to identify birth defects in electronic healthcare databases can avoid the cost and time-intensive efforts required to conduct chart reviews to confirm outcomes. This study evaluated the validity of various case-finding methodologies to identify neural tube defects (NTDs) in infants using an electronic healthcare database.

Methods: This analysis used data generated from a study whose primary aim was to evaluate the association between first-trimester maternal prescription opioid use and NTDs.

A quantitative bias analysis of the confounding effects due to smoking on the association between fluoroquinolones and risk of aortic aneurysm.

Purpose: Epidemiologic studies consistently report an increased risk of aortic aneurysm (AA) among users of fluoroquinolones (FQ), but confounding by smoking could explain all or some of the observed risk. Therefore, to better elucidate the potential causal impact of FQ on AA, we quantitatively evaluated the potential confounding effect of smoking on this observed association.

Methods: We conducted a series of quantitative bias analyses using three previously published approaches: the E-value approach, the rule-out approach, and the array approach.

Antipsychotic Use and Stroke: A Retrospective Comparative Study in a Non-Elderly Population.

Objective: To evaluate stroke risk among users of typical antipsychotics compared to users of atypical antipsychotics in a non-elderly and non-demented US population.

Methods: New users of antipsychotics aged 18-64 years without dementia were identified via electronic health care data from 13 health plans participating in the Sentinel System from January 2001 to September 2015. The risk of hospitalized stroke events, identified via ICD-9-CM diagnostic criteria, was compared between typical and atypical antipsychotic users using 1:1 matching on propensity score.

Overall and cause-specific mortality in the Sentinel system: A power analysis.

Purpose: Mortality data within the Sentinel Death Tables remain generally uncharacterized. Assessment of mortality data within Sentinel will help inform its utility for medical product safety studies.

Methods: To determine if Sentinel contains sufficient all-cause and cause-specific mortality events to power postmarketing safety studies.

Misclassification in Assessment of First Trimester In-utero Exposure to Drugs Used Proximally to Conception: the Example of Letrozole Utilization for Infertility Treatment.

Letrozole is an aromatase inhibitor that has an unapproved use for ovulation induction with infertility. Because of the proximity of this use to conception, we selected letrozole to study the effect of 3 different methods for identifying the pregnancy start date and their impact on exposure misclassification. Using electronic health data from the US Sentinel database (2001-2015), we identified live-birth pregnancies conceived through in-vitro fertilization or intrauterine insemination.

Psychiatric Medications and Reproductive Safety: Scientific and Clinical Perspectives Pertaining to the US FDA Pregnancy and Lactation Labeling Rule.

Pregnancy labeling of prescription medications in the US is in the midst of a major transformation. The FDA's previous system, which used letter ratings to convey drug safety, was simple but led to misunderstandings-both faulty assurances and undue concerns. The new system, established under the Pregnancy and Lactation Labeling Rule, aims for more descriptive and up-to-date explanations of risk as well as context needed for informed decision-making based on available data.

Incidence of Heart Failure and Cardiomyopathy Following Initiation of Medications for Attention-Deficit/Hyperactivity Disorder: A Descriptive Study.

Purpose/background: Stimulant abuse is associated with cardiomyopathy, but cardiomyopathy rates with therapeutic use of stimulants for attention-deficit/hyperactivity disorder (ADHD) are poorly characterized. Labels for methylphenidate, amphetamine, and atomoxetine caution against use in patients with cardiovascular disease. We sought to assess the incidence of new-onset heart failure or cardiomyopathy among initiators of these medications.

Utilization of drugs with pregnancy exposure registries during pregnancy.

Purpose: To describe the utilization of drugs with pregnancy exposure registries by trimester during pregnancy, in comparison with matched nonpregnant episodes and a pre-pregnancy period.

Methods: We identified live-born deliveries from women aged 10 to 54 years and matched the pregnancies 1:1 with nonpregnant episodes from a comparator cohort not delivering live-born infants, using data from 2001 to 2013 in the Sentinel Distributed Database. We evaluated the utilization of 34 drugs with pregnancy exposure registries, comparing utilization during pregnancy to the matched nonpregnant episodes, and to the 90 days before pregnancy.

Risk comparison for prenatal use of analgesics and selected birth defects, National Birth Defects Prevention Study 1997-2011.

Purpose: To compare the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or opioids to the use of acetaminophen without NSAIDs or opioids with respect to associations with birth defects.

Methods: We used data from the National Birth Defects Prevention Study (1997-2011). Exposure was self-reported maternal analgesic use from the month before through the third month of pregnancy (periconceptional).

Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer's Capture of Spontaneous Reports for Exposed Pregnancies.

Introduction: Pregnancy registries and spontaneous reports are essential pharmacovigilance tools to evaluate drug safety during pregnancy.

Objectives: The aim of this study was to evaluate postmarket capture of exposed pregnancies.

Methods: Pregnancy registries for drugs and biologics were identified in a systematic review.

Antiemetic use among pregnant women in the United States: the escalating use of ondansetron.

Purpose: To examine ondansetron use in pregnancy in the context of other antiemetic use among a large insured United States population of women delivering live births.

Methods: We assessed ondansetron and other antiemetic use among pregnant women delivering live births between 2001 and 2015 in 15 data partners contributing data to the Mini-Sentinel Distributed Database. We identified live birth pregnancies using a validated algorithm, and all forms of ondansetron and other available antiemetics were identified using National Drug Codes or procedure codes.

A systematic review of pregnancy exposure registries: examination of protocol-specified pregnancy outcomes, target sample size, and comparator selection.

Purpose: Our study sought to systematically evaluate protocol-specified study methodology in prospective pregnancy exposure registries including pre-specified pregnancy outcomes, power calculations for sample size, and comparator group selection.

Methods: U.S.

Development of a mother-child database for drug exposure and adverse event detection in the Military Health System.

Purpose: The aim of this study was to develop a mother-child linked database consisting of all eligible active duty military personnel, retirees, and their dependents in order to conduct medication-related analyses to improve the safety and quality of care in the Military Health System (MHS).

Methods: Eligible women of reproductive age with at least one pregnancy-related encounter between January 2005 and December 2013 receiving care in the MHS were included in the study population. Building on previously published algorithms, we used pregnancy-related diagnostic and procedure codes, parameterized temporal constraints, and data elements unique to the MHS to identify pregnancies ending in live births, stillbirth, spontaneous abortion, or ectopic pregnancy.

Neuropsychiatric events in varenicline and nicotine replacement patch users in the Military Health System.

Aim: To determine the rate ratio of neuropsychiatric hospitalizations in new users of varenicline compared to new users of nicotine replacement therapy (NRT) patch in the Military Health System (MHS).

Design, Setting And Participants: Varenicline (n = 19,933) and NRT patch (n = 15,867) users who initiated therapy from 1 August 2006 to 31 August 2007 within the MHS were included in this retrospective cohort study. After matching according to propensity scores, 10,814 users remained in each cohort.