On 13 December 2016, President Obama signed the 21st Century Cures Act ("the Act") into law. Many of its provisions support the creation of an "Information Commons," an ecosystem of separate but interconnected initiatives that facilitate open and responsible sharing of genomic and other data for research and clinical purposes. For example, the Act supports the National Institutes of Health in mandating data sharing, provides funding and guidance for the large national cohort program now known as All of Us, expresses congressional support for a global pediatric study network, and strengthens patient access to health information. The Act also addresses potential barriers to data sharing. For example, it makes the issuance of certificates of confidentiality automatic for federally funded research involving "identifiable, sensitive" information and strengthens the associated protections. At the same time, the Act exacerbates or neglects several challenges, for example, increasing complexity by adding a new definition of "identifiable" and failing to address the financial sustainability of data sharing and the scope of commercialization. In sum, the Act is a positive step, yet there is still much work to be done before the goals of broad data sharing and utilization can be achieved.
Background: Caribbean populations face complex health issues related to diet and food security as they undergo a rapid nutrition transition, resulting in some of the world's highest number of premature deaths from noncommunicable diseases (NCDs). Despite policy efforts to promote local and regional food consumption, reliance on food imports remains high with many Caribbean countries importing more than 80% of their food from larger economies. Previous regional research revealed the importance of food sharing practices in the Caribbean, with implications for the consumption of local foods, food security, and community resilience against climate change.
Background: Elinzanetant is a dual neurokinin-1,3 receptor antagonist in development for the treatment of menopausal vasomotor symptoms. The objectives of these studies were to characterize the mass balance and biotransformation of elinzanetant.
Methods: In the clinical evaluation, whole blood, plasma, urine, and feces were collected from healthy fasted male volunteers (n = 6) following a single dose of 120 mg [C]-elinzanetant oral suspension for analysis of total radioactivity and metabolite profiling.
Arterial and venous thromboembolism are leading causes of morbidity and death worldwide. Despite significant advances in the diagnosis, prognostication, and treatment of thrombotic diseases over the past 3 decades, the adoption of findings stemming from translational biomarker research in clinical practice remains limited. Biomarkers provide an opportunity to enhance our understanding of pathophysiological processes and optimize treatment strategies.
Introduction: Healthcare organisations should create and disseminate readable information to citizens and patients to reduce the level of health literacy required for individuals. Several systematic reviews have reported overviews of the readability of written health information for each subject area. This systematic review of systematic reviews will synthesise evidence from existing systematic reviews to provide an overview of studies that assessed readability in diverse areas and identify gaps to be filled in future research and practice to improve the readability of health information.
Objective: To assess consent rates and reasons for refusing consent after the introduction of peer navigators into the Outcomes of Babies With Opioid Exposure (OBOE) Study.
Design: Secondary analysis of data from the OBOE Study, a multisite observational study.
Setting: Medical centers in Alabama, Ohio, and Pennsylvania (N = 4).
