The Effect of Denosumab on Risk for Emergently Treated Hypocalcemia by Stage of Chronic Kidney Disease : A Target Trial Emulation.

Background: There is a paucity of data on treatment of osteoporosis in patients with advanced chronic kidney disease (CKD).

Objective: To assess the risk for emergently treated hypocalcemia with denosumab by stage of CKD and presence of CKD-mineral and bone disorder (CKD-MBD).

Design: Target trial emulation.

Efficacy of a Multimodal Digital Behavior Change Intervention on Lifestyle Behavior, Cardiometabolic Biomarkers, and Medical Expenditure: Protocol for a Randomized Controlled Trial.

Background: The US Preventive Services Task Force recommends providers offer individualized healthy behavior interventions for all adults, independent of their risk of cardiovascular disease. While strong evidence exists to support disease-specific programs designed to improve multiple lifestyle behaviors, approaches to adapting these interventions for a broader population are not well established. Digital behavior change interventions (DBCIs) hold promise as a more generalizable and scalable approach to overcome the resource and time limitations that traditional behavioral intervention programs face, especially within an occupational setting.

Development and Validation of an Algorithm to Predict Stillbirth Gestational Age in Medicaid Billing Records.

Introduction: With Medicaid covering half of US pregnancies, Medicaid Analytic eXtract (MAX) provides a valuable data source to enrich understanding about stillbirth etiologies.

Objective: We developed and validated a claims-based algorithm to predict GA at stillbirth.

Method: We linked the stillbirths identified in MAX 1999-2013 to Florida Fetal Death Records (FDRs) to obtain clinical estimates of GA (N=825).

Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients.

Background: Pembrolizumab has a manageable safety profile as described in its label, which was primarily based on 2799 patients who participated in clinical trials for melanoma or non-small cell lung cancer. Here, we evaluated the safety of pembrolizumab in a broader population of patients from 31 advanced cancer clinical trials across 19 cancer types.

Methods: Safety was analyzed in patients who received at least one dose of pembrolizumab (200 mg every 3 weeks [Q3W], 10 mg/kg Q2W or Q3W, or 2 mg/kg Q3W).

Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients.

Importance: Dialysis-dependent patients experience high rates of morbidity from fractures, yet little evidence is available on optimal treatment strategies. Chronic kidney disease-mineral and bone disorder is nearly universal in dialysis-dependent patients, complicating diagnosis and treatment of skeletal fragility.

Objective: To examine the incidence and comparative risk of severe hypocalcemia with denosumab compared with oral bisphosphonates among dialysis-dependent patients treated for osteoporosis.

Well-Being Parameters and Intention to Leave Current Institution Among Academic Physicians.

Importance: Physician turnover interrupts care delivery and creates health care system financial burden.

Objective: To describe the prevalence of burnout, professional fulfillment, and intention to leave (ITL) among physicians at academic-affiliated health care systems and identify institutional and individual factors associated with ITL.

Design, Setting, And Participants: This cross-sectional study administered a survey to 37 511 attending-level medical specialists at 15 academic medical institutions participating in the Healthcare Professional Well-Being Academic Consortium.

Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775.

JCO We report the final prespecified analysis for overall survival (OS), along with updated progression-free survival (PFS) and objective response rate (ORR), and safety from the open-label, randomized, phase III Study 309/KEYNOTE-775. In total, 827 patients with advanced, recurrent, or metastatic endometrial cancer (EC) were randomly assigned to receive lenvatinib 20 mg orally once daily plus pembrolizumab 200 mg intravenously once every 3 weeks (n = 411) or chemotherapy of the treating physician's choice (doxorubicin 60 mg/m intravenously once every 3 weeks or paclitaxel 80 mg/m intravenously once weekly [3 weeks on; 1 week off] [n = 416]). Efficacy was reported for patients with mismatch repair proficient (pMMR) tumors and all-comers, and by subgroups (histology, prior therapy, MMR status).

Validation of an ICD-9-Based Algorithm to Identify Stillbirth Episodes from Medicaid Claims Data.

Introduction: In administrative data, accurate timing of exposure relative to gestation is critical for determining the effect of potential teratogen exposure on pregnancy outcomes.

Objective: To develop an algorithm for identifying stillbirth episodes in the ICD-9-CM era using national Medicaid claims data (1999-2014).

Methods: Unique stillbirth episodes were identified from clusters of medical claims using a hierarchy that identified the encounter with the highest potential of including the actual stillbirth delivery and that delineated subsequent pregnancy episodes.

Factors driving burnout and professional fulfillment among emergency medicine residents: A national wellness survey by the Society for Academic Emergency Medicine.

Objectives: This study aimed to identify rates of and contributors to burnout and professional fulfillment among emergency medicine (EM) resident physicians.

Methods: This was a cross-sectional, national survey of resident members of the Society for Academic Emergency Medicine (SAEM). Primary outcomes were burnout and professional fulfillment measured using a previously validated instrument with additional domains pertaining to the academic environment.

Drivers of professional fulfillment and burnout among emergency medicine faculty: A national wellness survey by the Society for Academic Emergency Medicine.

Background: Professional fulfillment and the mitigation of burnout can enhance clinician well-being and the resiliency of the health care organization. This study examined the extent to which specific individual and workplace factors are associated with professional fulfillment and burnout among a national sample of academic emergency physicians.

Methods: This was a cross-sectional survey of faculty members of the Society for Academic Emergency Medicine.

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.

Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer.

Background: Standard therapy for advanced endometrial cancer after failure of platinum-based chemotherapy remains unclear.

Methods: In this phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with advanced endometrial cancer who had previously received at least one platinum-based chemotherapy regimen to receive either lenvatinib (20 mg, administered orally once daily) plus pembrolizumab (200 mg, administered intravenously every 3 weeks) or chemotherapy of the treating physician's choice (doxorubicin at 60 mg per square meter of body-surface area, administered intravenously every 3 weeks, or paclitaxel at 80 mg per square meter, administered intravenously weekly [with a cycle of 3 weeks on and 1 week off]). The two primary end points were progression-free survival as assessed on blinded independent central review according to the Response Evaluation Criteria in Solid Tumors, version 1.

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.

The AAMC Standardized Video Interview: Lessons Learned From the Residency Selection Process.

Calls to change the residency selection process have increased in recent years, with many focusing on the need for holistic review and alternatives to academic metrics. One aspect of applicant performance to consider in holistic review is proficiency in behavioral competencies. The Association of American Medical Colleges (AAMC) developed the AAMC Standardized Video Interview (SVI), an online, asynchronous video interview that assesses applicants' knowledge of professionalism and their interpersonal and communication skills.

Changes to the ACGME Common Program Requirements and Their Potential Impact on Emergency Medicine Core Faculty Protected Time.

The Accreditation Council for Graduate Medical Education (ACGME), which regulates residency and fellowship training in the United States, recently revised the minimum standards for all training programs. These standards are codified and published as the Common Program Requirements. Recent specific revisions, particularly removing the requirement ensuring protected time for core faculty, are poised to have a substantial impact on emergency medicine training programs.

Interventions to Improve Mental Health, Well-Being, Physical Health, and Lifestyle Behaviors in Physicians and Nurses: A Systematic Review.

Objective: This systematic review focused on randomized controlled trials (RCTs) with physicians and nurses that tested interventions designed to improve their mental health, well-being, physical health, and lifestyle behaviors.

Data Source: A systematic search of electronic databases from 2008 to May 2018 included PubMed, CINAHL, PsycINFO, SPORTDiscus, and the Cochrane Library.

Study Inclusion And Exclusion Criteria: Inclusion criteria included an RCT design, samples of physicians and/or nurses, and publication year 2008 or later with outcomes targeting mental health, well-being/resiliency, healthy lifestyle behaviors, and/or physical health.

Idelalisib for Treatment of Relapsed Follicular Lymphoma and Chronic Lymphocytic Leukemia: A Comparison of Treatment Outcomes in Clinical Trial Participants vs Medicare Beneficiaries.

Importance: Idelalisib (IDEL) is approved as monotherapy in relapsed follicular lymphoma (FL) and with rituximab (IDEL+R) for relapsed chronic lymphocytic leukemia (CLL). Toxic effects can be severe and treatment-limiting. Outcomes in a real-world population are not yet characterized.

First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies.

BackgroundThe safety of gadolinium-based contrast agent (GBCA) exposure during pregnancy has not been established, and the use of GBCAs during pregnancy is not recommended unless it is essential to the health of the woman or fetus.PurposeTo examine the prevalence of GBCA exposure in a large sample of pregnancies resulting in a live birth.Materials and MethodsThe Sentinel Distributed Database was used to retrospectively identify U.

Applicant Reactions to the AAMC Standardized Video Interview During the 2018 Application Cycle.

Purpose: This study examined applicant reactions to the Association of American Medical Colleges Standardized Video Interview (SVI) during its first year of operational use in emergency medicine (EM) residency program selection to identify strategies to improve applicants' SVI experience and attitudes.

Method: Individuals who self-classified as EM applicants applying in the Electronic Residency Application Service 2018 cycle and who completed the SVI in summer 2017 were invited to participate in 2 surveys. Survey 1, which focused on procedural issues, was administered immediately after SVI completion.

Healthy User Bias in Comparative Safety Studies for Brand-Name vs. Generic Products: The Example of Warfarin.

Warfarin was selected as a case study to examine confounding when comparing a product across different manufacturers because it is a narrow therapeutic index drug with prevalent beliefs for brand-name superiority. Medicare beneficiaries aged ≥65 years with atrial fibrillation and an incident outpatient warfarin prescription from July 2006 through July 2015 were included in the study population (N = 746,098). Substantial imbalances were observed between brand-name warfarin and generics for (i) clinical comorbidity, (ii) socioeconomic status, (iii) prescriber specialty, (iv) recent ambulatory and emergent care, (v) drug adherence, (vi) pharmacy setting (e.