Short-Term Immunogenicity of Licensed Subunit RSV Vaccines in Residents of Long-Term Care Facilities (LTCF) Compared to Community-Dwelling Older Adults.

Objectives: Phase 3 licensing trials for the recently approved respiratory syncytial virus (RSV) vaccines did not include many residents of long-term care facilities (LTCF). Our primary objective was to assess humoral immune responses in LTCF residents, aged 60 and older, to the RSV vaccines, and demonstrate noninferiority to antibody responses in community-dwelling (CD) adults who were representative of the phase 3 trial participants in whom the vaccines were highly efficacious.

Design: Prospective non-randomized intervention trial of RSV vaccines in LTCF residents.

Experience with the use of a digital sleep diary in symptom management by individuals with insomnia -a pilot mixed method study.

Background: Insomnia is the most common sleep disorder. The recommended treatment is cognitive behavioural therapy for insomnia (CBTi). A sleep diary is a core tool in CBTi.

Zwitterionic peptides: Tunable next-generation stealth nanoparticle modifications.

Adsorption of proteins to nanoparticles (NPs), a complex process that results in a protein corona, is controlled by NP surface properties that define NP interactions . Efforts to control adsorbed protein quantity through surface modification have led to improvements in circulation time or biodistribution. Still, current approaches have yet to be identified to control adsorbed protein identities within the corona.

Impact of Nanoparticle Physicochemical Properties on Protein Corona and Macrophage Polarization.

Macrophages, the major component of the mononuclear phagocyte system, uptake and clear systemically administered nanoparticles (NPs). Therefore, leveraging macrophages as a druggable target may be advantageous to enhance NP-mediated drug delivery. Despite many studies focused on NP-cell interactions, NP-mediated macrophage polarization mechanisms are still poorly understood.

Shared decision making: A novel approach to personalized treatment in obstructive sleep apnea.

Study Objectives: i) To describe a novel approach of phenotyping by shared decision making (SDM) in obstructive sleep apnea (OSA) discharge consultations ii) to describe correlation between patient and observer based evaluations of SDM and iii) to describe treatment adherence.

Methods: Consecutive patients referred to the otorhinolaryngology department at Akershus University Hospital with suspected OSA between 2015 and 2016 participated. Patients with body mass index >30 were oversampled.

Novel oxygen desaturation parameters are associated with cardiac troponin I: Data from the Akershus Sleep Apnea Project.

Novel diagnostic markers for obstructive sleep apnea beyond the apnea-hypopnea index (AHI) have been introduced. There are no studies on their association with markers of subclinical myocardial injury. We assessed the association between novel desaturation parameters and elevated cardiac troponin I and T.

Biomaterials for Orthopaedic Diagnostics and Theranostics.

Despite widespread use of conventional diagnostic methods in orthopaedic applications, limitations still exist in detection and diagnosing many pathologies especially at early stages when intervention is most critical. The use of biomaterials to develop diagnostics and theranostics, including nanoparticles and scaffolds for systemic or local applications, has significant promise to address these shortcomings and enable successful clinical translation. These developments in both modular and holistic design of diagnostic and theranostic biomaterials may improve patient treatments for myriad orthopaedic applications ranging from cancer to fractures to infection.

Delivery of RNAi-Based Therapeutics for Bone Regeneration.

Purpose Of Review: The clinical significance, target pathways, recent successes, and challenges that preclude translation of RNAi bone regenerative approaches are overviewed.

Recent Findings: RNA interference (RNAi) is a promising new therapeutic approach for bone regeneration by stimulating or inhibiting critical signaling pathways. However, RNAi suffers from significant delivery challenges.

Rigor and reproducibility in polymer nanoparticle synthesis and characterization.

Standardized process improvement methods and tools were used to enhance the rigor and reproducibility of diblock copolymer nanoparticle (NP) synthesis and characterization. Models linking design parameters with NP characteristics boosted process control for NP synthesis, which may improve translation and commercialization of NP research.

An in vitro platform for elucidating the molecular genetics of S. aureus invasion of the osteocyte lacuno-canalicular network during chronic osteomyelitis.

Staphylococcus aureus osteomyelitis is a devasting disease that often leads to amputation. Recent findings have shown that S. aureus is capable of invading the osteocyte lacuno-canalicular network (OLCN) of cortical bone during chronic osteomyelitis.

The investigation of four technologies to assist in detecting mild to moderate traumatic brain injury of U.S. Military service members.

Background: A standard, reliable, objective measure is needed for identifying individuals with mild to moderate traumatic brain injury (TBI).

Objective: The purpose of this study was to examine balance using an AMTI OR6-7 force platform (FP), neurocognition and mood using the Automated Neuropsychological Assessment Metric4 (ANAM4), blood flow comparisons using a Brain Acoustic Monitor (BAM), and voice using Voice Analysis software (VA) for screening service members for a mild to moderate TBI.

Methods: Active duty and retired service member volunteers (n = 88, 35 with a diagnosis of mild to moderate TBI and 53 who never had a TBI) completed an informed consent document, and evaluations using the four technologies.

Value of Genetics-informed Drug Dosing Guidance in Pregnant Women: A Needs Assessment with Obstetric Healthcare Providers at Johns Hopkins.

In order to better understand the potential value of genetics-informed drug dose guidance to obstetric healthcare providers at Johns Hopkins we administered a web-based needs assessment survey. The survey included questions about: 1) experience with adjusting drug doses during pregnancy; 2) comfort prescribing medications to pregnant women with chronic conditions; 3) awareness and use of genetics-informed dosing guidance; and 4) perceived value of access to services to provide genetics-informed dosing guidance. Among thirty-one respondents, 81% indicated an interest in access to genetics-informed drug dose guidance, particularly a mobile or electronic health record (EHR) application.

User-centered design of multi-gene sequencing panel reports for clinicians.

The objective of this study was to develop a high-fidelity prototype for delivering multi-gene sequencing panel (GS) reports to clinicians that simulates the user experience of a final application. The delivery and use of GS reports can occur within complex and high-paced healthcare environments. We employ a user-centered software design approach in a focus group setting in order to facilitate gathering rich contextual information from a diverse group of stakeholders potentially impacted by the delivery of GS reports relevant to two precision medicine programs at the University of Maryland Medical Center.

Practical considerations for implementing genomic information resources. Experiences from eMERGE and CSER.

Objectives: To understand opinions and perceptions on the state of information resources specifically targeted to genomics, and approaches to delivery in clinical practice.

Methods: We conducted a survey of genomic content use and its clinical delivery from representatives across eight institutions in the electronic Medical Records and Genomics (eMERGE) network and two institutions in the Clinical Sequencing Exploratory Research (CSER) consortium in 2014.

Results: Eleven responses representing distinct projects across ten sites showed heterogeneity in how content is being delivered, with provider-facing content primarily delivered via the electronic health record (EHR) (n=10), and paper/pamphlets as the leading mode for patient-facing content (n=9).

Integrating Genomic Resources with Electronic Health Records using the HL7 Infobutton Standard.

Background: The Clinical Genome Resource (ClinGen) Electronic Health Record (EHR) Workgroup aims to integrate ClinGen resources with EHRs. A promising option to enable this integration is through the Health Level Seven (HL7) Infobutton Standard. EHR systems that are certified according to the US Meaningful Use program provide HL7-compliant infobutton capabilities, which can be leveraged to support clinical decision-making in genomics.

Harnessing next-generation informatics for personalizing medicine: a report from AMIA's 2014 Health Policy Invitational Meeting.

The American Medical Informatics Association convened the 2014 Health Policy Invitational Meeting to develop recommendations for updates to current policies and to establish an informatics research agenda for personalizing medicine. In particular, the meeting focused on discussing informatics challenges related to personalizing care through the integration of genomic or other high-volume biomolecular data with data from clinical systems to make health care more efficient and effective. This report summarizes the findings (n = 6) and recommendations (n = 15) from the policy meeting, which were clustered into 3 broad areas: (1) policies governing data access for research and personalization of care; (2) policy and research needs for evolving data interpretation and knowledge representation; and (3) policy and research needs to ensure data integrity and preservation.

The genomic CDS sandbox: An assessment among domain experts.

Genomics is a promising tool that is becoming more widely available to improve the care and treatment of individuals. While there is much assertion, genomics will most certainly require the use of clinical decision support (CDS) to be fully realized in the routine clinical setting. The National Human Genome Research Institute (NHGRI) of the National Institutes of Health recently convened an in-person, multi-day meeting on this topic.

Practical considerations in genomic decision support: The eMERGE experience.

Background: Genomic medicine has the potential to improve care by tailoring treatments to the individual. There is consensus in the literature that pharmacogenomics (PGx) may be an ideal starting point for real-world implementation, due to the presence of well-characterized drug-gene interactions. Clinical Decision Support (CDS) is an ideal avenue by which to implement PGx at the bedside.

Providing Access to Genomic Variant Knowledge in a Healthcare Setting: A Vision for the ClinGen Electronic Health Records Workgroup.

The Clinical Genome Resource (ClinGen) is a National Institutes of Health (NIH)-funded collaborative program that brings together a variety of projects designed to provide high-quality, curated information on clinically relevant genes and variants. ClinGen's EHR (Electronic Health Record) Workgroup aims to ensure that ClinGen is accessible to providers and patients through EHR and related systems. This article describes the current scope of these efforts and progress to date.

Prioritizing Approaches to Engage Community Members and Build Trust in Biobanks: A Survey of Attitudes and Opinions of Adults within Outpatient Practices at the University of Maryland.

Background: Achieving high participation of communities representative of all sub-populations is needed in order to ensure broad applicability of biobank study findings. This study aimed to understand potentially mutable attitudes and opinions commonly correlated with biobank participation in order to inform approaches to promote participation in biobanks.

Methods: Adults from two University of Maryland (UMD) Faculty Physicians, Inc.

CSER and eMERGE: current and potential state of the display of genetic information in the electronic health record.

Objective: Clinicians' ability to use and interpret genetic information depends upon how those data are displayed in electronic health records (EHRs). There is a critical need to develop systems to effectively display genetic information in EHRs and augment clinical decision support (CDS).

Materials And Methods: The National Institutes of Health (NIH)-sponsored Clinical Sequencing Exploratory Research and Electronic Medical Records & Genomics EHR Working Groups conducted a multiphase, iterative process involving working group discussions and 2 surveys in order to determine how genetic and genomic information are currently displayed in EHRs, envision optimal uses for different types of genetic or genomic information, and prioritize areas for EHR improvement.

Making pharmacogenomic-based prescribing alerts more effective: A scenario-based pilot study with physicians.

To facilitate personalized drug dosing (PDD), this pilot study explored the communication effectiveness and clinical impact of using a prototype clinical decision support (CDS) system embedded in an electronic health record (EHR) to deliver pharmacogenomic (PGx) information to physicians. We employed a conceptual framework and measurement model to access the impact of physician characteristics (previous experience, awareness, relative advantage, perceived usefulness), technology characteristics (methods of implementation-semi-active/active, actionability-low/high) and a task characteristic (drug prescribed) on communication effectiveness (usefulness, confidence in prescribing decision), and clinical impact (uptake, prescribing intent, change in drug dosing). Physicians performed prescribing tasks using five simulated clinical case scenarios, presented in random order within the prototype PGx-CDS system.

Developments in intervertebral disc disease research: pathophysiology, mechanobiology, and therapeutics.

Low back pain is a leading cause of disability worldwide and the second most common cause of physician visits. There are many causes of back pain, and among them, disc herniation and intervertebral disc degeneration are the most common diagnoses and targets for intervention. Currently, clinical treatment outcomes are not strongly correlated with diagnoses, emphasizing the importance for characterizing more completely the mechanisms of degeneration and their relationships with symptoms.

Physician Attitudes toward Adopting Genome-Guided Prescribing through Clinical Decision Support.

This study assessed physician attitudes toward adopting genome-guided prescribing through clinical decision support (CDS), prior to enlisting in the Clinical Implementation of Personalized Medicine through Electronic Health Records and Genomics pilot pharmacogenomics project (CLIPMERGE PGx). We developed a survey instrument that includes the Evidence Based Practice Attitude Scale, adapted to measure attitudes toward adopting genome-informed interventions (EBPAS-GII). The survey also includes items to measure physicians' characteristics (awareness, experience, and perceived usefulness), attitudes about personal genome testing (PGT) services, and comfort using technology.

Using Workflow Modeling to Identify Areas to Improve Genetic Test Processes in the University of Maryland Translational Pharmacogenomics Project.

Delivering genetic test results to clinicians is a complex process. It involves many actors and multiple steps, requiring all of these to work together in order to create an optimal course of treatment for the patient. We used information gained from focus groups in order to illustrate the current process of delivering genetic test results to clinicians.