A new analytic tool for assessing the impact of the US Food and Drug Administration regulatory actions.

Purpose: Develop and test a flexible, scalable tool using interrupted time series (ITS) analysis to assess the impact of Food and Drug Administration (FDA) regulatory actions on drug use.

Methods: We applied the tool in the Sentinel Distributed Database to assess the impact of FDA's 2010 drug safety communications (DSC) concerning the safety of long-acting beta2-agonists (LABA) in adult asthma patients. We evaluated changes in LABA use by measuring the initiation of LABA alone and concomitant use of LABA and asthma controller medications (ACM) after the DSCs.

Precision Public Health for Non-communicable Diseases: An Emerging Strategic Roadmap and Multinational Use Cases.

Non-communicable diseases (NCDs) remain the largest global public health threat. The emerging field of precision public health (PPH) offers a transformative opportunity to capitalize on digital health data to create an agile, responsive and data-driven public health system to actively prevent NCDs. Using learnings from digital health, our aim is to propose a vision toward PPH for NCDs across three horizons of digital health transformation: Horizon 1-digital public health workflows; Horizon 2-population health data and analytics; Horizon 3-precision public health.

Gender differences in dermatologist practice locations in the United States: A cross-sectional analysis of current gender gaps.

Background: The percentage of female dermatologists has increased from 6.9% in 1970 to 48.9% in 2017.

In New England, Partisan Differences In ACA Marketplace Participation And Potential Financial Harm.

Political orientation can be a powerful motivator of certain health care decisions. This study examines how political orientation was associated with decisions to use the Affordable Care Act Marketplaces to enroll in nongroup health insurance plans and whether it was also associated with adverse financial consequences. We used administrative records and surveys of nongroup Marketplace enrollees from a large insurer in New England.

Ambulatory Care Access And Emergency Department Use For Medicare Beneficiaries With And Without Disabilities.

Establishing care with primary care and specialist clinicians is critical for Medicare beneficiaries with complex care needs. However, beneficiaries with disabilities may struggle to access ambulatory care. This study uses the 2015-17 national Medicare Current Beneficiary Survey linked to claims and administrative data to explore these questions.

Substance use, substance use disorders, and treatment in adolescent and young adult cancer survivors-Results from a national survey.

Background: Substance use can exacerbate cancer-related morbidity and mortality in adolescent/young adult (AYA) cancer survivors and place them at increased risk for adverse health outcomes. The objective of this study was to assess substance use, misuse, and substance use disorders [SUDs], as well as receipt of treatment for SUDs, among AYA cancer survivors.

Methods: The authors used data from the National Survey of Drug Use and Health (2015-2018) to identify a nationally representative sample of AYAs aged 12 to 34 years.

African American Nurses' Perspectives on Genomic Medicine Research.

Background: There is a lack of African American (AA) community engagement in genomic medicine research. Recent popular interest in the experience of AAs, such as that of Henrietta Lacks, has perhaps prompted interest in research on how AA nurses can provide strategies to better engage AA communities in genomic medicine research.

Methods: The authors conducted one-on-one semi-structured interviews with 11 National Black Nurses Association (NBNA) chapter leaders from 8 different US states, representing 782 NBNA members.

Institutions For Mental Diseases Medicaid Waivers: Impact On Payments For Substance Use Treatment Facilities.

The Institutions for Mental Diseases (IMD) exclusion prohibits use of federal Medicaid funds to treat enrollees ages 21-64 in psychiatric residential treatment facilities that have more than sixteen beds. In 2015 the federal government created a streamlined application pathway for state waivers of this rule to allow Medicaid coverage for substance use disorder (SUD) treatment in residential facilities. Nine states received IMD waivers during the period 2015-18.

The Complex Cancer Care Coverage Environment - What is the Role of Legislation? A Case Study from Massachusetts.

Over the past decades, anti-cancer treatments have evolved rapidly from cytotoxic chemotherapies to targeted therapies including oral targeted medications and injectable immuno-oncology and cell therapies. New anti-cancer medications come to markets at increasingly high prices, and health insurance coverage is crucial for patient access to these therapies. State laws are intended to facilitate insurance coverage of anti-cancer therapies.

Costs Are Higher For Marketplace Members Who Enroll During Special Enrollment Periods Compared With Open Enrollment.

More than 20 percent of Affordable Care Act (ACA) exchange market (Marketplace) members insured by a large national insurer in 2015 and 2016 enrolled during a special enrollment period (SEP), defined as any enrollment outside the annual open enrollment period. These members were younger and had approximately 34 percent higher average monthly total costs than members who enrolled during open enrollment. SEP members had 69-114 percent higher inpatient costs and 11-19 percent higher emergency department costs than open enrollment members.

Fewer Than Half Of US Mental Health Treatment Facilities Provide Services For Children With Autism Spectrum Disorder.

Despite estimates of rising prevalence of children with autism spectrum disorder (ASD) in the US, there is little research on the availability of behavioral health care services for this vulnerable population. To fill the gap, we surveyed 8,184 mental health treatment facilities in the contiguous US. As of August 2019, 43.

Self-Help Groups And Medication Use In Opioid Addiction Treatment: A National Analysis.

Self-help groups and medications (buprenorphine, methadone, and naltrexone) both play important roles in opioid addiction treatment. The relative use of these two treatment modalities has not been characterized in a national study. Using national treatment data, we found that self-help groups were rarely provided in conjunction with medication treatment: Among all adult discharges from opioid addiction treatment in the period 2015-17, 10.

Using Implementation Science to Optimize the Uptake of Evidence-Based Medicine into Dermatology Practice.

An estimated 17-year lag exists between evidence generation and its integration into routine clinical care. The field of implementation science has emerged to close this gap by applying rigorous methods to systematically study the obstacles and facilitators of the uptake of evidence-based practices. However, implementation science has not gained wide traction in dermatology.

Lack Of Access To Specialists Associated With Mortality And Preventable Hospitalizations Of Rural Medicare Beneficiaries.

People living in rural areas have worse health outcomes than their urban counterparts do. Understanding what factors account for this could inform policy interventions for reducing rural-urban disparities in health. We examined a nationally representative survey of Medicare beneficiaries with one or more complex chronic conditions, which represented 61 percent of rural and 57 percent of urban Medicare beneficiaries.

Medicaid Expansion Associated With Reductions In Preventable Hospitalizations.

Hospitalizations for ambulatory care-sensitive conditions indicate barriers to care outside of inpatient settings. We found that Medicaid expansions under the Affordable Care Act were associated with meaningful reductions in these hospitalizations, which suggests the potential of Medicaid expansions to reduce the need for preventable hospitalizations in vulnerable populations and produce cost savings for the US health care system.

The impact of the Orphan Drug Act on Food and Drug Administration-approved therapies for rare skin diseases and skin-related cancers.

The Orphan Drug Act of 1983 (ODA) put in place a set of financial and marketing incentives to stimulate the development of drugs to treat rare diseases, and since its passage, more than 600 orphan drug and biologic products have been brought to market in the United States. Rapid growth in orphan drug approvals in conjunction with high orphan drug prices have triggered concern that drug makers are exploiting certain aspects of the ODA for financial gain and that some pharmaceutical drugs are receiving orphan status where it is not warranted. The landscape of approved therapies for rare skin diseases has not been well described.

Vulnerable And Less Vulnerable Women In High-Deductible Health Plans Experienced Delayed Breast Cancer Care.

The effects of high-deductible health plans (HDHPs) on breast cancer diagnosis and treatment among vulnerable populations are unknown. We examined time to first breast cancer diagnostic testing, diagnosis, and chemotherapy among a group of women whose employers switched their insurance coverage from health plans with low deductibles ($500 or less) to plans with high deductibles ($1,000 or more) between 2004 and 2014. Primary subgroups of interest comprised 54,403 low-income and 76,776 high-income women continuously enrolled in low-deductible plans for a year and then up to four years in HDHPs.

A new analytic tool developed to assess safe use recommendations.

Purpose: Develop a flexible analytic tool for the Food and Drug Administration's (FDA's) Sentinel System to assess adherence to safe use recommendations with two capabilities: characterize adherence to patient monitoring recommendations for a drug, and characterize concomitant medication use before, during, and/or after drug therapy.

Methods: We applied the tool in the Sentinel Distributed Database to assess adherence to the labeled recommendation that patients treated with dronedarone undergo electrocardiogram (ECG) testing no less often than every 3 months. Measures of length of treatment, time to first ECG, number of ECGs, and time between ECGs were assessed.

Four States With Robust Prescription Drug Monitoring Programs Reduced Opioid Dosages.

State prescription drug monitoring programs (PDMPs) aim to reduce risky controlled-substance prescribing, but early programs had limited impact. Several states implemented robust features in 2012-13, such as mandates that prescribers register with the program and regularly check its registry database. Some states allow prescribers to fulfill the latter requirement by designating delegates to check the registry.

Actigraphy-based sleep estimation in adolescents and adults: a comparison with polysomnography using two scoring algorithms.

Objectives: Actigraphy is widely used to estimate sleep-wake time, despite limited information regarding the comparability of different devices and algorithms. We compared estimates of sleep-wake times determined by two wrist actigraphs (GT3X+ versus Actiwatch Spectrum [AWS]) to in-home polysomnography (PSG), using two algorithms (Sadeh and Cole-Kripke) for the GT3X+ recordings.

Subjects And Methods: Participants included a sample of 35 healthy volunteers (13 school children and 22 adults, 46% male) from Boston, MA, USA.

Risk of anaphylaxis after vaccination in children and adults.

Background: Anaphylaxis is a potentially life-threatening allergic reaction. The risk of anaphylaxis after vaccination has not been well described in adults or with newer vaccines in children.

Objective: We sought to estimate the incidence of anaphylaxis after vaccines and describe the demographic and clinical characteristics of confirmed cases of anaphylaxis.

The association of early childhood cognitive development and behavioural difficulties with pre-adolescent problematic eating attitudes.

Objectives: Few studies have prospectively investigated associations of child cognitive ability and behavioural difficulties with later eating attitudes. We investigated associations of intelligence quotient (IQ), academic performance and behavioural difficulties at 6.5 years with eating attitudes five years later.

Four health data networks illustrate the potential for a shared national multipurpose big-data network.

Information in electronic health data that are drawn from large populations of patients is transforming health care, public health practice, and clinical research. This article describes our experience in developing data networks that repurpose electronic health records and administrative data. The four programs we feature are the Food and Drug Administration's Mini-Sentinel program (which focuses on medical product safety), the National Patient-Centered Clinical Research Network (PCORnet, comparative effectiveness research), the National Institutes of Health's Health Care Systems Research Collaboratory Distributed Research Network (biomedical research), and ESPnet (public health surveillance).