Identifying Pediatric Hypertension in Observational Data: Comparing Clinical and Claims Cohorts in Real World Data.

We conducted retrospective public health surveillance using data from 2006 to 2016 in seven integrated delivery systems from FDA's Sentinel System. We identified pediatric hypertensive patients by clinical and claims-based definitions and compared demographics, baseline profiles and follow-up time profiles. Among 3,757,803 pediatric patients aged 3 to 17 years, we identified 781,722 children and 551,246 teens with at least three blood pressure measures over 36-months.

Association between SARS-CoV-2 infection and select symptoms and conditions 31 to 150 days after testing among children and adults.

Background: An increasing number of studies have described new and persistent symptoms and conditions as potential post-acute sequelae of SARS-CoV-2 infection (PASC). However, it remains unclear whether certain symptoms or conditions occur more frequently among persons with SARS-CoV-2 infection compared with those never infected with SARS-CoV-2. We compared the occurrence of specific COVID-associated symptoms and conditions as potential PASC 31- to 150-day following a SARS-CoV-2 test among adults and children with positive and negative test results.

Real-world Evidence Comparing Tofacitinib and Vedolizumab in Anti-TNF-experienced Patients With Ulcerative Colitis.

Background: Antitumor necrosis factor (anti-TNF) inhibitors are first-line treatment among patients with ulcerative colitis (UC). With time, patients tend to lose response or become intolerant, necessitating switching to small cell biologics such as tofacitinib or vedolizumab. In this real-world study of a large, geographically diverse US population of TNF-experienced patients with UC, we evaluated the effectiveness and safety of newly initiating treatment with tofacitinib vs vedolizumab.

Association between SARS-CoV-2 Infection and Select Symptoms and Conditions 31 to 150 Days After Testing among Children and Adults.

Background: An increasing number of studies have described new and persistent symptoms and conditions as potential post-acute sequelae of SARS-CoV-2 infection (PASC). However, it remains unclear whether certain symptoms or conditions occur more frequently among persons with SARS-CoV-2 infection compared with those never infected with SARS-CoV-2. We compared the occurrence of specific COVID-associated symptoms and conditions as potential PASC 31 to 150 days following a SARS-CoV-2 test among adults (≥20 years) and children (<20 years) with positive and negative test results documented in the electronic health records (EHRs) of institutions participating in PCORnet, the National Patient-Centered Clinical Research Network.

Real-World Evidence Comparing Vedolizumab and Ustekinumab in Antitumor Necrosis Factor-Experienced Patients With Crohn's Disease.

Introduction: Many patients with Crohn's disease (CD) lose response or become intolerant to antitumor necrosis factor (TNF) therapy and subsequently switch out of class. We compared the effectiveness and safety of ustekinumab to vedolizumab in a large, geographically diverse US population of TNF-experienced patients with CD.

Methods: We conducted a retrospective cohort study using longitudinal claims data from a large US insurer (Anthem, Inc.

Prevalence of depression and anxiety in women newly diagnosed with vulvovaginal atrophy and dyspareunia.

Objective: To quantify the association between vulvovaginal atrophy and depression, major depressive disorder, and anxiety.

Methods: Women with vulvovaginal atrophy from the Truven Health MarketScan Commercial and Medicare Supplemental Databases (01/2010-09/2016) with ≥365 days of continuous insurance coverage before and after the first vulvovaginal atrophy/dyspareunia diagnosis (index date) were selected. Women with vulvovaginal atrophy were matched 1:3 to women without (controls) according to age, calendar year, health plan, and region.

Privacy-protecting multivariable-adjusted distributed regression analysis for multi-center pediatric study.

Background: Privacy-protecting analytic approaches without centralized pooling of individual-level data, such as distributed regression, are particularly important for vulnerable populations, such as children, but these methods have not yet been tested in multi-center pediatric studies.

Methods: Using the electronic health data from 34 healthcare institutions in the National Patient-Centered Clinical Research Network (PCORnet), we fit 12 multivariable-adjusted linear regression models to assess the associations of antibiotic use <24 months of age with body mass index z-score at 48 to <72 months of age. We ran these models using pooled individual-level data and conventional multivariable-adjusted regression (reference method), as well as using the more privacy-protecting pooled summary-level intermediate statistics and distributed regression technique.

Combining distributed regression and propensity scores: a doubly privacy-protecting analytic method for multicenter research.

Purpose: Sharing of detailed individual-level data continues to pose challenges in multi-center studies. This issue can be addressed in part by using analytic methods that require only summary-level information to perform the desired multivariable-adjusted analysis. We examined the feasibility and empirical validity of 1) conducting multivariable-adjusted distributed linear regression and 2) combining distributed linear regression with propensity scores, in a large distributed data network.

Validity of Privacy-Protecting Analytical Methods That Use Only Aggregate-Level Information to Conduct Multivariable-Adjusted Analysis in Distributed Data Networks.

Distributed data networks enable large-scale epidemiologic studies, but protecting privacy while adequately adjusting for a large number of covariates continues to pose methodological challenges. Using 2 empirical examples within a 3-site distributed data network, we tested combinations of 3 aggregate-level data-sharing approaches (risk-set, summary-table, and effect-estimate), 4 confounding adjustment methods (matching, stratification, inverse probability weighting, and matching weighting), and 2 summary scores (propensity score and disease risk score) for binary and time-to-event outcomes. We assessed the performance of combinations of these data-sharing and adjustment methods by comparing their results with results from the corresponding pooled individual-level data analysis (reference analysis).

Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause.

Objective: The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM).

Methods: In a prospective, randomized, double-blind, and placebo-controlled phase III clinical trial, the effect of daily intravaginal 0.50% DHEA (6.

Serum steroid concentrations remain within normal postmenopausal values in women receiving daily 6.5mg intravaginal prasterone for 12 weeks.

This study integrates all data obtained in women aged 40-80years enrolled with moderate to severe symptoms of vulvovaginal atrophy (VVA) who received daily intravaginal administration of 0.50% (6.5mg) dehydroepiandrosterone (DHEA; prasterone) for 12weeks (n=723; ITT-S population) as compared with placebo (n=266; ITT-S population).

Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause.

Objective: The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM).

Methods: In a prospective, randomized, double-blind, and placebo-controlled phase III clinical trial, the effect of daily intravaginal 0.50% DHEA (6.

Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study.

Objective: Intravaginal DHEA (dehydroepiandrosterone, prasterone), the exclusive precursor of androgens and estrogens in postmenopausal women, has previously been shown to improve all the domains of sexual function by a strictly local action in the vagina. The well recognized female sexual function index (FSFI) questionnaire was used in the present study.

Design: The long-term effect of 52-week treatment with daily intravaginal 0.

Evaluation of the acceptability of intravaginal prasterone ovule administration using an applicator.

The objective of the study is to evaluate the acceptability of the intravaginal administration of ovules/suppositories of DHEA (dehydroepiandrosterone, prasterone) for the treatment of vulvovaginal atrophy (VVA) in women with moderate to severe dyspareunia who were administered daily for 12 weeks intravaginal 0.50% (6.5 mg) DHEA or placebo.

Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy.

Introduction: Previous data have shown that intravaginal dehydroepiandrosterone (DHEA, prasterone) improved all the domains of sexual function, an effect most likely related to the local formation of androgens from DHEA.

Aims: To confirm in a placebo-controlled, prospective, double-blind and randomized study the benefits of daily intravaginal DHEA for 12 weeks on sexual function using the Female Sexual Function Index (FSFI) questionnaire.

Methods: Placebo was administered daily to 157 women while 325 women received 0.

Serum levels of sex steroids and metabolites following 12 weeks of intravaginal 0.50% DHEA administration.

The objective of the present phase III, placebo-controlled, double-blind, prospective and randomized study was to confirm the efficacy of daily intravaginal administration of 0.50% dehydroepiandrosterone (DHEA; prasterone) ovules for 12 weeks on moderate to severe dyspareunia (or pain at sexual activity) as most bothersome symptom of vulvovaginal atrophy (VVA) while having serum steroid concentrations within normal postmenopausal values. To this end, serum levels of DHEA, DHEA-sulfate (DHEA-S), Androst-5-ene-diol-3β, 17β-diol (5-diol), testosterone, dihydrotestosterone (DHT), androstenedione (4-dione), estrone (E1), estradiol (E2), estrone sulfate (E1-S), androsterone glucuronide (ADT-G), and androstane-3α, 17β-diol 17-glucuronide (3α-diol-17G) were measured by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Prasterone has parallel beneficial effects on the main symptoms of vulvovaginal atrophy: 52-week open-label study.

Objective: An objective was to analyze the time course of efficacy of daily intravaginal administration of 0.5% (6.5mg) DHEA (prasterone) for 52 weeks on the moderate to severe (MS) symptoms and signs of vulvovaginal atrophy (VVA).

Multivariable confounding adjustment in distributed data networks without sharing of patient-level data.

Purpose: It is increasingly necessary to analyze data from multiple sources when conducting public health safety surveillance or comparative effectiveness research. However, security, privacy, proprietary, and legal concerns often reduce data holders' willingness to share highly granular information. We describe and compare two approaches that do not require sharing of patient-level information to adjust for confounding in multi-site studies.

Costs associated with cardiovascular events in patients with hypertension in US managed care settings.

Study quantified incremental cost of cardiovascular (CV) events in 6 high-risk and compelling indication subgroups: post-myocardial infarction (MI), diabetes, diabetic nephropathy, elderly, chronic kidney disease, and prior stroke. Based on claims data from privately insured individuals with 2+ hypertension (HTN) diagnoses in 2004-2006, we estimated regression-adjusted per-member-per-month healthcare costs after CVE. Costs were compared between patients with and without a CV events, and before and after CV events in each subgroup.

The economic impact of pre-dialysis epoetin alpha on health care and work loss costs in chronic kidney disease: an employer's perspective.

The objective of the study was to quantify the direct and indirect incremental costs of epoetin alpha (EPO) therapy for anemia in pre-dialysis chronic kidney disease (CKD). Using employer claims data from January 1998 to January 2005, direct (medical and pharmacy) and indirect (sick leave and disability) costs were compared between CKD-anemic patients treated with EPO before dialysis (n = 199) and those not treated with an erythropoiesis-stimulating therapy (EST) (n = 196). Among the results, incremental direct and indirect cost savings for EPO-treated patients were $1443 and $328 per member per month (PMPM) (p < 0.

Actual versus predicted first-year utilization patterns of teriparatide in patients with employer-sponsored health insurance.

Objective: To characterize first-year utilization patterns of teriparatide derived from a claims database analysis versus predictions from an economic model.

Research Design And Methods: Claims data for actual teriparatide utilization were obtained from an integrated administrative database of approximately 3.4 million beneficiaries.

Risk of cancer treatment-associated bone loss and fractures among women with breast cancer receiving aromatase inhibitors.

Background: Aromatase inhibitors (AIs) are a novel hormonal therapy for patients with breast cancer. However, AIs can cause bone loss by blocking estrogen production. This study aims to assess the association between AIs and treatment-related bone loss in a large managed-care population of women with breast cancer.

Risk of clinical fractures after gonadotropin-releasing hormone agonist therapy for prostate cancer.

Purpose: We assessed the relationship between GnRH agonists and the risk of clinical fractures in men with prostate cancer.

Materials And Methods: Using a database of medical claims from 16 large American companies we identified a study group of 3,779 men with prostate cancer who received treatment with a GnRH agonist and a control group of 8,341 with prostate cancer who were not treated with a GnRH agonist. Men with 1 or more medical claims for bone metastases were excluded.

The relationship between technology availability and health care spending.

We analyze the relationship between the supply of new technologies and health care utilization and spending, focusing on diagnostic imaging, cardiac, cancer, and newborn care technologies. As anticipated by previous research, increases in the supply of technology tend to be related to higher utilization and spending on the service in question. In some cases, notably diagnostic imaging, increases in availability appear associated with incremental utilization rather than substitution for other services.