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February 2016 - Issue 6
Welcome to the Battelle Health & Analytics, a quarterly publication from Battelle. We put this together as a service to our public health clients, to keep you informed of the latest public health news from our researchers and the industry.
The Battelle Health & Analytics team works with agencies and healthcare institutions to advance public health research, practice and policy with the latest science and technology. Battelle Health and Analytics will keep you up-to-date on cutting edge research and public health innovations.
What factors define a successful inter-agency partnership? Battelle recently conducted an evaluation study for the National Institutes of Health, Office of Science Policy in the Office of the Director to find out.
The focus of this study was on the role that collaborations between NIH and other agencies within the Department of Health and Human Services (HHS) play in promoting the uptake and utilization of NIH-supported research results into the policies, programs and services used to fulfill the mission of HHS. The evaluation fostered an understanding of the full scope and nature of the many collaborative efforts, and examined in more detail how results from NIH-sponsored research flow into and inform the work of other HHS agencies. It also identified the key factors that facilitate or hinder those efforts.
In addition, the evaluation was used to:
The evaluation consisted of several tasks and components, including a literature review, analysis of data in the NIH Inter-agency Collaboration Reporting System (CRS) and a mixed methods approach to collecting and analyzing relevant data. Data were collected from federal employees affiliated with six operating divisions within the HHS through web surveys and in-depth, one-on-one interviews. Battelle analyzed the collected data (quantitative and qualitative) and delivered written reports, plus in-person briefings, on the results of all of the evaluation components.
Viral hepatitis is the most common blood-borne pathogen in the United States. It is estimated that over 5 million people in the U.S. are living with hepatitis B or hepatitis C infection, and 65%-75% of infected individuals are unaware of their infection status.
Because of the high disease burden, low rate of testing and high proportion of people who do not know they are infected, viral hepatitis infection has been described as a “silent epidemic.” Lack of awareness of viral hepatitis in the U.S. contributes to continuing transmission, missed opportunities for prevention, missed possibilities for effective treatment and poor health outcomes in infected persons.
In 2011, the U.S. Department of Health and Human Services (HHS) released its first Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis to provide a strategic framework for combating the epidemic. The Action Plan, which was the first cross-cutting federal initiative to address the viral hepatitis epidemic, detailed more than 150 actions to be undertaken between 2011 and 2013. Achieving the goals of the Action Plan required effort from a range of stakeholders including federal and local government, community-based organizations and the private sector.
Under a contract with HHS, Battelle was tasked with assessing and evaluating the response to the Action Plan. Researchers captured input from a range of stakeholders including federal, state and local government agencies, healthcare settings, community-based organizations, non-profits and the private sector. A community assessment was also conducted in Alabama, Massachusetts, New York and Washington to identify activities from the Action Plan that were being implemented locally as well as challenges facing local stakeholders in executing this work.
To collect information, the Battelle team utilized key informant interviews, site visits, and observations of viral hepatitis planning meetings. A summary of findings was presented to HHS during an in-person briefing. The results helped to inform the second iteration of the Action Plan, which was released in February 2014 to guide 2014-2016 viral hepatitis activities.
The public health community often relies on Public Service Announcements (PSAs) and other media outreach to educate target populations about critical health risks. But how do you know if a campaign has been effective? Battelle recently completed an evaluation of the Centers for Disease Control and Prevention’s (CDC) Inside Knowledge campaign, which is aimed at increasing awareness of gynecological cancers.
Gynecological cancers—including cervical, ovarian, uterine, vaginal and vulvar cancers—are responsible for nearly 100,000 new diagnoses and more than 30,000 deaths in the United States annually. However, the signs and symptoms are often vague and easy to ignore. In 2009, the CDC launched a new public service campaign in order to increase awareness of gynecological cancers and encourage women to see their doctors. The initiative was in response to Johanna’s Law, named for Johanna Silver Gordon, who died of ovarian cancer in 2000.
CDC contracted with a national advertising agency to develop an integrated campaign that included television, radio and web advertising directed at women ages 40-60 as well as posters, print materials and training for healthcare providers. The PSAs began to air nationally in the fall of 2010.
In 2012, CDC contracted with Battelle to conduct a formal evaluation of the program as required by Johanna’s Law. Battelle researchers designed and executed the study to evaluate the process, reach and ultimate outcomes of the CDC campaign. Key research questions for each phase included:
In order to evaluate the outcomes of the campaign, Battelle set up a field experiment aimed at women in four cities. San Antonio and Milwaukee were used as treatment groups; special paid advertising campaigns were implemented in the cities using CDC’s radio and television PSAs and web ads during the summer of 2015. Las Vegas and Cincinnati were used as comparison cities. Surveys of women in the target population (ages 40-60) were conducted in all four cities both before and after the treatment period to determine whether the media campaign had a measureable impact on women’s knowledge or intended behaviors in the treatment cities. Cities were selected based on their demographics, cancer incidence, overall population size and the presence of a large enough population of women in the target group.
The Battelle study demonstrated that CDC’s advertising was effective in raising awareness of the signs and symptoms of gynecological cancer. While overall awareness of which cancers are gynecological cancers was high among all groups, women in the treatment cities demonstrated higher knowledge of the warning signs and symptoms of these cancers. They also showed higher aided awareness of the ads. Intentions to seek care if experiencing symptoms were already high among all groups, and did not show an increase after the intervention.
The study showed a significant increase in traffic to CDC’s Inside Knowledge website from the treatment cities during the campaign, which dropped off again once the intervention was complete. The CDC also documented several phone calls from the treatment cities during the intervention period.
During the course of the evaluation, Battelle surveyed 2,495 women between the ages of 40 and 60. While 37% had a relative with breast cancer, very few had relatives with gynecological cancers. In the post-treatment surveys in the intervention cities, 25% remembered seeing one or more of the Inside Knowledge ads. Of the women who remembered the ads, most reported that the campaign was informative, meaningful and convincing; very few women reported that they were irritated or scared by the ads.
The results are encouraging not only for CDC’s Inside Knowledge campaign but for other public health organizations seeking to improve awareness and positive intentions around health risks. The study showed that well-designed media campaigns, including radio and television PSAs and web advertising, have the power to make a difference. Battelle’s evaluation services are helping program planners measure the success of their campaigns and determine when changes are needed to improve campaign efficacy.
This past October, Battelle was pleased to attend the annual Pioneers of Global Health Awards Dinner and Auction for the Washington Global Health Alliance (WGHA). The fundraising event was one chapter in a long history of collaboration and support between Battelle and WGHA.
WGHA is a Seattle-based organization connecting public and private organizations operating in the health and life sciences sector in Washington State and beyond. Their mission is to “strategically connect, expand and strengthen the global health community to advance health equity.” They act as a networking and information clearinghouse for the strong and vibrant health community in the Northwest region, providing a safe space for collaboration among researchers, providers, non-profits, government entities, and private industry to solve local, national and global health challenges.
Washington is rapidly becoming a global hub for public health and healthcare research and innovation, driven in part by the activities of WGHA. The area is home to a growing number of global leaders in life sciences, public health, healthcare, health education, biotechnology and medical device development, in addition to influential non-profits such as PATH (formerly known as the Program for Appropriate Technology in Health), the University of Washington, the Washington State Public Health Association, and the Gates Foundation (all members of WGHA).
Battelle was one of the founding members of the Alliance in 2007 and has maintained an active presence in the organization ever since through our Seattle office. Battelle has operated in Seattle since 1967 and is an active part of the research and business community in the state. Through our participation with WGHA, Battelle has been able to develop and sustain valuable relationships with other health research entities and public and private organizations operating in the region. In return, we have been able to leverage our large national and global network of Battelle researchers to connect organizations in WGHA with needed expertise.
Battelle also participates and hosts educational events with the Alliance, and donates to the science, technology, engineering and math (STEM) student scholarship funds of organizations in Washington. This winter, Battelle researchers will attend an information sharing event focused on online and mobile application development for healthcare services. The Battelle Seattle office will host its own roundtable event later this year.
Participating in organizations like WGHA is a natural fit for Battelle. As the largest non-profit research organization in the world, we strive to serve and invest in the communities in which we operate. We are pleased to continue to collaborate with WGHA in 2016 and beyond.
Is your medical device putting patient safety or hospital data at risk? Cybersecurity is an issue that medical device manufacturers can no longer afford to ignore. In fact, cybersecurity may soon be considered as critical as safety and human factors testing in the device development process.
Hospitals are finding themselves at increasing risk from malware and malicious hackers. While harming patients through medical devices is rarely the end goal, devices are often seen as the “weak links” that provide easy entry into a hospital network. If the code for a critical medical device is compromised in the process, patient safety can be put at risk. Even if no patients are directly harmed, data breaches and data ransom attacks can disrupt hospital operations and make patients and employees vulnerable to identity theft.
For these reasons, hospital purchasers and the FDA are putting increased emphasis on medical device cybersecurity. Many hospital systems have added cybersecurity requirements to their purchasing guidelines. The FDA released draft guidance for premarket submissions in October 2014; post-market guidance was released January 22, 2016. As the industry evolves, we can expect that cybersecurity will be part of a new FDA regulatory framework for medical apps and connected devices.
Preparing for new market and regulatory realities requires a coordinated approach to cybersecurity, from initial design to post-market monitoring. Here are five steps medical device manufacturers can implement now to prepare:
Pre-design: Before design begins, manufacturers should start by gathering requirements and expectations around cybersecurity from stakeholders such as hospital procurement and IT departments. Many hospitals will no longer consider purchase of devices that cannot produce adequate security documentation. Manufacturers must be prepared to provide documentation on their security plan and the specific security precautions taken for the individual device.
Design process: During the design process, manufacturers should conduct a device-specific threat assessment of their design, which includes characterizing, modeling and measuring potential threats specific to the device. Cybersecurity experts look at the ways the devices are connecting, the kind of data they are sending and receiving, and the potential for threat actors to introduce changes in the code. This threat modeling process helps developers determine what risks and vulnerabilities exist in the devices and how these risks can be mitigated. It’s significantly cheaper to make these adjustments during the design phase than during prototyping or final testing.
Prototyping: At the prototype phase, developers should put their cybersecurity measures to the test. Cybersecurity researchers conduct penetration testing to observe how the device behaves under various attack scenarios. They may also perform “fuzz testing,” a software testing technique used to discover coding errors and security loopholes in software or operating systems.
Post-Market Updates: Manufacturers must also have a strategy for updating the device as new security threats emerge and operating systems change. There are two important considerations to keep in mind. First, the device must have a secure method for pushing security updates. Second, companies must have processes in place to keep track of new vulnerabilities and respond to them as they emerge. Companies must have dedicated internal resources to track emerging threats and make mitigation recommendations.
Responsible Disclosure Policy: Risks uncovered by outside agents, accidentally or through deliberate probing, can expose manufacturers if they do not have a publically accessible reporting mechanism and clear internal procedures for investigating and mitigating reported risks. A public, responsible disclosure policy tells potential reporters how to tell you about a vulnerability and what your company will do with the information once it is submitted. Developing a clear internal policy for responding to disclosures, and making both the policy and the reporting mechanism easily visible for the public, can help companies reduce their exposure.
Battelle has put together a suite of services for medical device manufacturers called Battelle DeviceSecure® Services. The Battelle cybersecurity team works with clients to develop a comprehensive security risk management plan that includes:
By putting these protocols into place, developers can minimize risks for patients and hospitals and prepare for emerging market and regulatory expectations.
Please join us in welcoming our latest additions to the Battelle Health and Analytics team. Their research and experience will help us to continue to expand our public health research programs and services.
Kerry Cobb joined our Behavioral Health team on January 1. Kerry comes to Battelle Health and Analytics from a different division within Battelle where she has been successfully leading Quality Operations across 4 different laboratory facilities. Kerry will be working with the Behavioral Health team as both a staff manager and project manager and brings to the team her demonstrated leadership experience and an extensive background in regulatory science. She currently holds a Master’s degree in Regulatory and Quality Compliance and plans to pursue a PhD in Regulatory Science to enhance her training in this strategic area.
Dr. Gillian Schauer joined the Behavioral Health team on December 14. Dr. Schauer comes to Battelle Health and Analytics from the CDC where she has been a pivotal advocate for epidemiology and policy surrounding both tobacco and marijuana use and regulation. She is a member of numerous professional organizations and will bring her expertise and national reputation to Battelle’s Public Health Center for Tobacco Research and our growing marijuana research program.
Jeffrey Geppert believes in the power of analytics to make a difference in the world. “Patient safety is still a huge problem in this country,” he explains, “but if we can measure it—if we put hard numbers on adverse events—we can start to get a handle on it and ultimately change it.”