NIH begins early human clinical trial of Ebola vaccine

The testing of a second investigational Ebola vaccine candidate, VSV-ZEBOV (developed by researchers at the Public Health Agency of Canada’s National Microbiology Laboratory), was begun in October at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. The early phase trial will evaluate the vaccine for safety and effectiveness in healthy adults who receive two intramuscular doses. Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) are conducting this phase.

This vaccine was also being tested as a single dose simultaneously at the Walter Reed Army Institute of Research at its Clinical Trials Center in Silver Spring, Maryland.

In September, human testing of another investigational Ebola vaccine (co-developed by NIAID and GlaxoSmithKline) was begun. Results are expected to be available by the end of the year.

More information about the NIAID clinical trial of the investigational VSV-ZEBOV Ebola vaccine is available at ClinicalTrials.gov.

Grant to help raise awareness of firefighter suicides

The Federal Emergency Management Agency (FEMA), part of the Department of Homeland Security (DHS), has awarded a $23,750 Assistance to Firefighters Grant to the nonprofit Firefighter Behavioral Health Alliance (FBHA) in Palatine, Illinois. The Alliance will use the funds to provide suicide awareness and prevention workshops for fire departments and firefighters in Illinois and around the country.

U.S. Sen. Dick Durbin (D-IL), who supported the Alliance in obtaining the grant, noted: “Firefighters and first responders help members of our communities when crises occur, and oftentimes they encounter both tragic and traumatic events in the line of duty. This funding will help support them after the emergency is over and as they work to address the behavioral health impacts of their job.”

FBHA Founder Jeff Dill, a captain at Palatine Rural Fire Protection District in Inverness, Illinois, and a licensed professional counselor, said the grant will enable the FBHA to educate hundreds of firefighters and EMS personnel about suicide awareness and prevention.

New NIMH RDoC unit “reframes” mental health research

The National Institutes of Health (NIH) has established the Research Domain Criteria (RDoC) http://1.usa.gov/W1FQsa framework to help guide the classification of patients in clinical studies and facilitate communication among scientists, clinicians, and the public, which, the NIH says, will “reframe mental health research from diagnosis to treatment.” Implemented by the NIH’s National Institute of Mental Health (NIMH), the objective of the RDoC initiative “is to accelerate the pace of research that translates basic science into clinical settings by understanding the multilayered systems that contribute to mental function,” explains NIMH. The new approach, which emphasizes neurodevelopment and environmental effects, is in keeping with modern views concerning mental disorders.

RDoC Unit Director Bruce N. Cuthbert, Ph.D, coordinator of the RDoC working group, says the new unit is the result of more than five years of effort by the institute and members of the research community. Four full-time staff members will coordinate the program and increase communication with scientists and the public.

“RDoC represents a significant paradigm shift in the way we think about and study mental disorders,” says Thomas R. Insel, M.D., director of NIMH. “The RDoC approach cuts across traditional diagnostic categories to identify relationships among observable behavior, neurobiological measures, and patient self-report of mental status.” The unit is expecting to launch a new online discussion forum within the next few months that will enable investigators and clinicians to continue to converse and collaborate with each other around the RDoC framework in a virtual environment.

Cuthbert explains that the basic framework of RDoC will continually grow and evolve as research progresses. “Through the RDoC discussion forum, we are inviting the research community to help us refine the RDoC matrix by weighing in on the current framework and suggesting new domains, constructs, and units of analysis,” he adds. The RDoC database will use the same data-sharing platform that NIMH created for the National Database for Autism Research (NDAR) < http://ndar.nih.gov/>. NIMH anticipates that the increase in the number of data sets in the database will enable researchers to better use data mining practices to identify subgroups of patients within current diagnostic categories and ultimately develop better-tailored treatments.

Insel sees the establishment of the RDoC unit as the mechanism for bringing “precision medicine one step closer to the diagnosis and treatment of mental disorders.” The newly updated RDoC section of the NIMH Web site is at http://1.usa.gov/W1FQsa. The NIH news release is available at: http://1.usa.gov/116cESA.

NASEMSO establishes performance measures for local patient care

The National Association of State Emergency Medical Services Officials (NASEMSO), in a cooperative agreement with the National Highway Traffic Safety Administration (NHTSA), has developed a comprehensive set of emergency medical services performance measures. NHTSA funded the two-year project.

“We see this as a huge opportunity to transform how we do EMS in this country,” says NASEMSO Executive Director Dia Gainor. “It will give EMS agencies across the country the ability to ensure they are providing high-quality, patient-centered care.”

According to NASEMSO, performance measures relevant to EMS agencies, regulators, and patients will be developed by a diverse group of EMS stakeholders; they will be based on the latest National EMS Information System version data; and they will allow local and state EMS agencies to use their own data meaningfully. Dozens of EMS and healthcare experts and organizations are expected to participate in the process, which will provide “multiple opportunities for input and public comment.”

“This project,” envisions NHTSA’s Drew Dawson, director of the NHTSA Office of EMS, “is the next step in helping EMS-from ambulance services and other emergency medical services; to government agencies; and, ultimately, to the communities and patients they serve.”

Performance measurements in EMS and this initiative are to be discussed in great detail at a National EMS Performance Measurement Stakeholder Summit on December 2 (after press time) in Washington, DC. The performance measures, derived from the latest published literature and identified best practices, will be tested with actual data in real-world situations to determine feasibility, accuracy, and validity. They will address clinical care and areas including call volume, human resources, fleet management, finance, reimbursement, and patient experience. The measures are to comply with the format used by the Centers for Medicare and Medicaid Services (CMS) and the Joint Commission and ultimately are to be endorsed by the National Quality Forum.

An important goal of the initiative is to “reach out to real-world EMS practitioners,” notes Nick Nudell, the project manager, a noted data expert and a paramedic. “They are the ones who initially collect data on their patients, and getting an electronic patient care report that is accurate and comprehensive is fundamental to the process.”

“Performance measures have become an integral part of not only the quality improvement process but also the reimbursement models throughout the healthcare system,” Gainor points out. “It is essential that the EMS community come together to develop these measures, which may soon be required by CMS and other payers.”

FEMA announces training classes for trainers

FEMA’s Emergency Management Institute (EMI), in Emmitsburg, Maryland, has announced its schedules for classes for the Basic Academy and Master Trainer programs in emergency management. The schedule and other information for the Basic Academy are at http://1.usa.gov/1qIoEAv. The schedule and information for the Master Trainer Program is at http://1.usa.gov/1yF8AUf.

HHS reports on hospital preparedness during Superstorm Sandy

Eighty-nine percent of 174 Medicare-certified hospitals studied in Connecticut, New Jersey, and New York experienced “substantial challenges” responding during Superstorm Sandy in October 2012, according to a report from the Department of Health and Human Services’ Office of the Inspector General. Among the problems areas they cited were interrelated infrastructure and resource-sharing in the storm’s aftermath. The document is at http://go.usa.gov/7pGA.

911 Health Watch comments on 9/11 victim compensation

“Over the past year, the September 11th Victim Compensation Fund (VCF) has made clear and substantial progress in both processing claims and making determinations for compensation for injured and ill 9/11 responders, survivors, and their families,” notes 911 Health Watch in its assessment of the third annual report of the September 11th VCF. 911 Health Watch cited “many changes made in procedures over the past year and the additional resources that they have brought to bear.”

The following information is according to the VCF report:

• As of September 30, 2014, of the 16,833 who have submitted eligibility forms to VCF, 8,517 have been determined eligible for compensation; 7,438 claims cannot be decided because they are missing either signed permission to obtain claimants’ records, inadequate medical documentation, or sufficient proof that claimants were at the site.
• Of the 8,517 claimants who were determined eligible, 4,958 have submitted compensation forms, and compensation decisions were made for 2,042.
• As of September 30, 2014, the VCF has made determinations for compensation of $551,269,835, an increase of $57,503,162 since the beginning of September.
• Of the 2,042 claims that have had determinations made, 1,755 have been for responders, 260 for nonresponders, and 27 for injured residents.

The new updated annual report is at http://bit.ly/1zUT3DS. You can download a pdf of the report at http://bitly/1yFa2WO.