Archive for category HealthCore

Closing Gaps in Real-World Evidence through Data Linkage

Interview with Dr. Kevin Haynes, Principal Scientist, HealthCore-NERI.

Dr. Patti Peeples, CEO of HealthEconomics.Com, sat down with Dr. Kevin Haynes, Principal Scientist at HealthCore-NERI, to discuss closing gaps in real-world evidence through data linkage. The mission of HealthCore-NERI is to provide clarity that empowers decision makers to act with precision to improve quality, safety, and affordability in health care. HealthCore-NERI works with life science companies, payers and providers, and government and academic organizations to provide real-world evidence in support of a wide variety of health care decisions.

Dr. Peeples: Why is fragmentation in health care so important to health care researchers, and specifically real-world evidence?

Dr. Haynes: The fact that patients can seek care across health care systems, may move across geographies over time, and may change health plans fragments the patient journey within the health system. This fragmentation within the US health care system creates fragmentation of health care data and this data fragmentation inhibits our ability to generate high-quality evidence. In my opinion, the biggest gap to close is a gap in data. When we close the data gap, then we can begin to close the gaps in evidence. The same gaps in data that prevent us from generating high-quality evidence also create gaps in care. These gaps are closing as Health Information Exchanges, all-payer claims databases, and data integration with prescription dispensing records feed back into electronic medical record systems. As these data gaps close, our ability to generate high-quality evidence will improve. One area of data fragmentation is in the patient journey across health care systems creating a long-term fragmentation. As people traverse a lifetime of follow up periods, we traverse periods of our lives moving from childhood to college and early careers. This creates a fluid space of data moving across health plans as jobs, spouse, and life circumstances change our insurance coverage and access to health care systems. Today we need to be developing the infrastructure to be able to address these research issues moving forward. This is a long-term game as fragmentation of health care delivery currently has an impact on our ability to conduct observational comparative effectiveness research over a lifetime. Another area of fragmentation is cross-sectional data fragmentation which occurs as we seek care across health systems. For example in cancer we invariably fragment care as we instruct patients to seek a second opinion. As such tests and work up may be contained within one health system’s electronic records and treatment and longitudinal follow-up may be contained in a second health system’s electronic record.

Dr. Peeples: What are some of the biggest issues among stakeholders (providers, payers, patients, researchers, policy makers)?

Dr. Haynes: The biggest issue for stakeholders is data privacy and the governance required to manage the use of data for various purposes. There is clear governance with regards to HIPPA and other privacy considerations that govern the research aspects of data. Often the use of observational data at the institutional level notes loss of confidentiality as the only risk to the patient, and ensures that all data will be stored on secure servers with limited access. However, we are in an era now where we need to link to other data sources to close gaps in data fragmentation. This creates a need to utilize protected health information or personal identifiable information which may increase the risk to study participants in observational research. Therefore, we need to implement the technology to improve data privacy.

Dr. Peeples: With the fragmentation of health care across health systems, what do you see as the opportunities to overcome these data fragmentation challenges to enhance real-world evidence?

Dr. Haynes: There is tremendous opportunity as there is a lot going on in the data linkage space as people develop relationships with patients. For example, researchers involved in PCORnet’s Patient or People Powered Research Networks (PPRNs), the NIH’s All of Us, and other commercial ventures – are developing relationships with patients. They are able to get and seek, not only the consent, but also the authorization to link data across resources to develop the evidence that is needed. When researchers have access to patients, it is important to obtain sufficient patient authorization to conduct these linkage activities. Other opportunities exist in the space of protecting patient privacy in observational research, such as creating privacy protection record linkage.

Dr. Peeples: How do we do the data linkage? Are there specific use cases that have been successful?   

Dr. Haynes: One must either obtain patient consent through a relationship with the patient or utilize privacy-preserving record linkage strategies. For example, patients participating in PCORnet’s ADAPTABLE study, which seeks to identify the most appropriate dose of aspirin for secondary prevention of cardiovascular morbidity – have consented to participate. The study is therefore able to outreach and obtain authorization from participants to allow their health plan to share limited longitudinal information to help address one of the data gaps with regards to this study. Among PCORnet’s demonstration studies is a large obesity observational study looking at the effect of pediatric antibiotic exposure on the microbiome and the effect of weight gain at 5 and 10 years. This study is involving hundreds of thousands of patients. Considering the impossibility of obtaining the consent of or relationship with all patients, researchers are employing privacy-preserving record linkage to facilitate linkage of health plan pharmacy claims with clinical data.

Dr. Peeples: Patient privacy is of vital importance in the conduct of data linkage. How do you conduct the research and ensure patients their privacy is not being breached? What changes have occurred over time? What do you do that is a higher bar than is necessary, if anything?

Dr. Haynes: We as researchers need to develop the trust with our patients, especially patients who are recruited and enrolled in clinical trials where we have a relationship with the patient, to seek the necessary authorizations to do these linkages. We must also ensure that these linkages are used only for that intended purpose. As such, there is a need for governance around data use. When we have a relationship with the patient, we have an obligation to educate and inform patients in things like the ADAPTABLE study, the All of Us study, potential patient registries, and others, to inform patients of the importance of the linkage and that the linkage activities will be governed in such a way as to protect patient privacy. We also have a societal obligation to ensure that any linkage activities utilizing privacy-preserving record linkage modalities protect patients and their privacy.

Dr. Peeples: Expanding on the concept of data linkage, are there disease or therapeutic areas that are particularly challenging? Or areas where this data linkage has shown success?  

Dr. Haynes: There are tremendous opportunities and areas that are particularly challenging in this space of linkage. These challenges focus on both linking longitudinally and on linking over defined time periods to get deep clinical data. One example is in the opioids space where many states have prescription drug monitoring programs (PDMP). These programs are designed to capture all of the opioid prescriptions such that providers can access this resource and ensure that they have a complete picture of exposure to opioids across health systems. Pharmacists have an opportunity to assess this system to evaluate opioid utilizations beyond their pharmacy. These systems are designed to close a gap in care. However, one challenge is that these systems are not able to be utilized by health plans to potentially close gaps in evidence. The high-quality exposure information from state PDMP and the high quality outcome data from health plans would provide an opportunity to address evidence in the opioid epidemic.

Dr. Peeples: What are the ultimate rewards of linked data resources for RWE?  

Dr. Haynes: The most important thing from an epidemiologic standpoint to linked data is to reduce what we call information bias. There are several forms of information bias, including misclassification. Therefore, capturing outcomes or exposures of interest and knowing that you have complete capture is vital to the conduct of real-world data analysis.


Dr. Kevin Haynes, PharmD, MSCE, is a Principal Scientist at HealthCore-NERI. He is the Principal Investigator on two Patient Centered Outcomes Research Institute (PCORI) awards and the site Principal Investigator for HealthCore within the FDA Sentinel Initiative as well as a Data Core Co-Lead on Sentinel. At HealthCore-NERI, Dr. Haynes is currently responsible for developing responses to proposals and providing clinical pharmacoepidemiology expertise to various projects. Dr. Haynes has more than 14 years of experience in clinical pharmacy, clinical research, epidemiology, pharmacoepidemiology, surveillance, medical informatics, and project management. In addition, he has extensive experience collaborating with the Food and Drug Administration as well as multiple investigators on pharmacoepidemiology projects.

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Integrating Big Data: How HealthCore is using Research to Improve Care, Safety, and Outcomes.

BIGDATA-USCompanies are striving to advance beyond the buzzword of Big Data to delivering real, actionable results that change the way our healthcare system works.  The power to access and analyze these enormous data sets, and then develop insights that can be acted upon at the patient, provider and policy level, can greatly improve our ability to both anticipate and treat illness.  Consistent with a global effort to improve healthcare value, Big Data can also help key stakeholders better understand the effectiveness and safety of interventions.  Treatment decisions, including the inputs into those decisions as well as the outputs (or the outcomes) can be more quickly and accurately assessed – in nearly real-time.  Who, in the healthcare industry, is poised to do this?  And what have we learned so far, using and interpreting healthcare big data, that can help us in the future?

HealthCore, a health services research organization, has been a leader in translating large data sets into real-world insight for two decades.  As a wholly-owned outcomes research subsidiary of Anthem, Inc., one of the nation’s leading health benefits companies, HealthCore will showcase their Big Data innovations with case studies and actual research examples, in an upcoming Virtual Conference on Wednesday, February 18, 2015, Actionable Insights into Health Policy, Practice and Outcomes Through Research and Big Data – with a Spotlight on Oncology, from 9:30am-11:30am ET with an encore presentation from 11:30am-1:30pm ET.

How are large integrated healthcare datasets being used to make a difference in patient outcomes, medical practice, and health policy?  Attend this two-hour event to find out.  Just click on the Register link below.

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This event will take place in the interactive virtual environment of HE-Xpo®, and attendees will be able to view real-time presentations by seven senior executives of HealthCore, ask questions, visit a virtual Exhibit Booth, download educational materials from the Learning Center, and interact with presenters and other attendees in the virtual Lounge.  The meeting is free to attend; you may view the Agenda here and register here.  You will need a working internet connection to take part in this virtual conference.  Below is a preview of what will be presented.
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“There’s lots of Big Data out there with not a lot of robust insight,” says Marcus Wilson, PharmD, President, HealthCore. “There is a limit to what you can get from it without it being effectively integrated.”

Dr. Wilson will share his views on the industry’s future in terms of research collaborations and the promise of a unique integrated research environment and health care data analytics.

“We’re looking at practical approaches to accelerate the speed at which we can develop evidence in the general population, as well as specific populations, so that we can get this information in the hands of clinicians and benefit patients earlier,” said Mark Cziraky, PharmD, Vice President of Research at HealthCore.

There is increasing interest among the pharmaceutical industry and the payer community in developing unique partnerships that reflect collaboration, connectivity, and shared decision-making among major stakeholders. HealthCore has been an active participant in multiple collaborations with various pharmaceutical companies and payers focusing on the use of real-world evidence, with an aim to cut down on the typical 17-year time frame for research evidence to reach clinical practice. Mark Cziraky will speak at this virtual event on “Evolving Research Connectivity, Better Decisions for the Health Care Industry.” Dr. Cziraky will provide examples of the processes and desired goals of various real-world evidence research collaborations, and dive into some of the implications of the research that can be conducted when stakeholders connect towards the goal of improving health outcomes for patients. If you are part of an organization interested in forming alliances with stakeholders on real-world evidence collaboratives, you will not want to miss this presentation.

Vince Willey, PharmD. Staff VP, Industry Sponsored Research.

“HealthCore’s environment, with its data environment and experienced researchers, provides a unique opportunity for conducting research” said Vince Willey, PharmD, Staff Vice President of HealthCore’s Industry Sponsored Research Unit.  “It has the ability to pull in data from medical and pharmacy claims, clinical information from the physician, medical charts, and other information from patients that allow us to answer complex clinical, economic and health policy questions.”

Oncology therapeutics is one of the fastest growing arenas in healthcare, with cancer treatments estimated to exceed the $100 billion mark worldwide within the next few years. The promise of targeted cancer treatments, as well as the recent US and European focus on the cost-effectiveness of cancer treatments, have piqued interest in how data analytics can be used to maximize outcomes. Dr. Willey will present “A Focus on Oncology within HealthCore’s Research Environment.” He will describe the types of oncology data that are available, showcase insights derived from oncology data, and address the realized value to the healthcare industry. If you would like to better understand how data assets can be used to answer complex clinical and economic health outcomes questions in oncology, this session will be of utmost interest.

Crystal Holick, ScD. Sr. Dirctor, Safety and Epidemiology Research.

The promise of using healthcare big data to monitor safety is never far from the thoughts of many who believe that fundamental improvements in our healthcare system are on the next horizon. Crystal Holick, ScD is well-suited to delve into this topic, bringing experienced perspectives from her role as Senior Director, Safety and Epidemiology Research at HealthCore. Dr. Holick will provide an overview of how HealthCore’s research environment is used for greater insights into safety, and explore how these results were used by the pharmaceutical industry, payer audiences, and other stakeholders to improve care delivery, identify research opportunities, and advance patient outcomes. This presentation is also an important opportunity to learn more about how using databases for medical product safety assessment requires careful research consideration to ensure that the interpretation is both valid and based on rigorous analytic methods.

Nandini Selvam, PhD. Sr. Director, Government and Academic Research.In the past several years, HealthCore’s collaborative approaches have extended into new health care industry arenas, including government and academic groups, thereby marshaling expertise and sharing insights to improve health policy and practice.  If you work closely with academic institutions or government agencies, be sure to listen to this enlightening presentation by Nandini Selvam, PhD, Senior Director of HealthCore’s Government and Academic Research.

John Barron, PharmD. Staff VP, Payer and Provider Research.

Andrea DeVries, PhD. Sr. Director, Payer and Provider Research.

Rounding out this information-packed two-hour virtual event is a joint presentation by John Barron, PharmD and Andrea DeVries, PhD of HealthCore’s Payer and Provider Research division. Drs. Barron and DeVries have extensive experience managing hundreds of projects.  They will provide a practical and instructive presentation on “How Research Can Provide Actionable Information to Health Plans”.  Expect to hear case studies on how health plans can directly benefit from health services research to inform strategies, identify new opportunities, and gain insights into changing consumer and provider behavior.

Do you have some areas that you would like to see addressed? Some questions you would like to raise? Click on the Comment link below and share your views with HealthCore in advance.

Please do not miss this opportunity to attend the event on Wednesday, February 18, 2015, Actionable Insights into Health Policy, Practice and Outcomes Through Research and Big Data – with a Spotlight on Oncology, from 9:30am-11:30am ET with an encore presentation from 11:30am-1:30pm ET. Speakers will be available to answer your questions in real-time at the end of the 2-hour session.

If you have a conflict with this event on February 18th, you have the option to view the full presentation “on-demand” at any time. Register on the link below to receive instructions for “on-demand” access.





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