By David Thompson and Daniel Levy
Advances in health information technology and new federal financial incentives are fueling rapid growth in the use of electronic medical record (EMR) systems. The growth of EMRs presents a host of opportunities and challenges for the conduct of practice-based registry studies, reducing the burden of data entry but at the same time leading to newfound complexities in system compatibility. The key question for biopharma planners is finding the best way to leverage the capabilities of EMRs in tandem with patient registries, particularly understanding the benefits and limitations of this data to support optimal clinical research and decision-making.
EMRs Versus Registries
If it is not already, the word “interoperability” — that is, the ability of EMR systems and traditional registries to work cohesively together — will soon become part of every clinical operations manager’s vocabulary. Why? Because the potential time and cost savings of tapping into EMRs for research purposes are too great to go unrealized. That said, linking EMRs to registries is not easy; just because medical records data and registry data are both captured electronically, it does not mean they are automatically compatible.
Let’s clarify some key differences between registries and EMRs. While a registry is an apparatus for collection of observational data on a particular population, data collected in EMRs are for individual health tracking. Registries capture information on patients that are specifically selected based on a study protocol, whereas EMRs record data for all patients in a physician’s practice. Key differences also exist around data format, which is extremely structured and controlled in a registry, but may be variable in an EMR, as well as reliance on data quality, timing of information captured and data standards.
There are essentially three areas where EMRs can facilitate the patient registry process:
• Planning – EMR databases can be used to assess protocol feasibility. Using an EMR database, we can identify patients, and then gauge how stringent the criteria are on the basis of protocol. EMRs can tell us if some exclusions are too stringent, leaving us literally without a population to study. We can use EMRs to pre-screen patients for eligibility as well.
• Recruitment – EMR networks can be tapped to identify potential investigators based on current patients. We can use aggregated EMR data to conduct preliminary searches of eligible patients and identify specific practices and providers.
• Execution – Registry CRFs can be programmed into EMRs to facilitate data capture, and likewise, EMRs can auto-feed data into registry CRFs.
In fact, EMRs are transforming the way we approach all three of these components of the patient registry process. It’s analogous to the way in which global positioning systems (GPS) transformed our approach to navigation. When it was first introduced, many users questioned its usefulness; after all, if we know the way to our local grocery store, why do we need a GPS system to show us? Then, we began to realize the benefits of traffic maps, alternate routes, and turn-by-turn directions with an estimated time of arrival. GPS-based navigation changed everything, and the investment required to adopt the new technology quickly paid off.
EMRs are similarly poised. Whereas GPS systems locate a user’s destination, EMRs locate investigators and patients. Further, EMRs allow us to do so with greater ease and efficiency than ever before, with results in the form of “heat maps” showing high-yield geographic clusters. We also have the capacity to drill down further to identify eligible patients and specific providers based on national provider identification, all in a HIPPA-compliant manner in which no protected patient information is viewed.
The EMR Challenge: Achieving Interoperability
EMR data can support evidence generation for understanding real-world treatment patterns, evaluating safety and benefit risk, comparative effectiveness, and more. However, without interoperability with patient registries, the secondary use of EMR data requires data re-entry for activities such as quality reporting, safety surveillance and public health reporting. The goal is to apply methods to re-use that data and automate the data transfer for these secondary purposes.
Fortunately, significant advances have been made in the development of industry standards for interoperability and recent technologies to allow us to accomplish this. For example, registries traditionally require a provider to fill out an “encounter form” to capture information about the patient, in which variables like gender, date of birth, and diagnosis are re-entered from that patient’s chart. Now, when interoperability mechanisms are in place, we can use an EMR in the normal course of patient care, and re-use that data — variables such as gender and date of birth — for secondary uses such as registry participation. Once a diagnosis is made, a trigger fires that reveals a link reminding us of our participation in a registry collecting information on this diagnosis. If we click that link, the registry form is pre-populated with key patient information, requiring significantly less data re-entry.
In the coming years, as interoperability standards evolve and are adopted broadly by all EMR vendors, greater efficiencies will be achieved – at that point, the same registry form may be surfaced inside every EMR, allowing this option to be offered to any provider using an EMR and participating in a registry. The international standard currently in development to link the world of EMRs with clinical research is known as Retrieve Form for Data Capture (RFD). RFD was developed by the Clinical Data Interchange Standards Consortium (CDISC) in collaboration with Integrating the Healthcare Enterprise (IHE) an initiative of healthcare professionals working together to improve how computer systems in healthcare share information.
In addition, the options for a trigger mechanism within the EMR go far beyond patient diagnosis. A procedure code could also trigger a disease or health services registry; a treatment or medication could link with a product or exposure registry; a medication discontinuation could trigger an alert to an evaluation of an adverse event of that medication; and a device replacement could trigger a link to a potential device safety report. The possibilities are far reaching. There are also non-trigger mechanisms in which an EMR can surface a list of forms from other registries, to which that provider has already subscribed, and relevant data for a patient can be shared with those programs without the burden of re-entering that data.
EMRs and Registries in the Era of Healthcare Reform
A number of recent policy issues have impacted trends in EMRs. It is becoming increasingly clear that in the era of healthcare reform, EMRs will become indispensible to post-approval research – and post-approval research will become indispensible to EMRs.
As part of the Affordable Care Act, incentives are given to providers who adopt EMR technology. Providers must now demonstrate meaningful use of EMRs to the Centers for Medicare and Medicaid Services (CMS) in order to receive reimbursement. The goal is to not just employ EMRs, but also demonstrate improvements in health outcomes.
In addition, the Comparative Effectiveness Research Movement is now under way to build evidence that compares the benefits and risks of methods to prevent, diagnose and treat a clinical condition, and PCORI (Patient Centered Outcomes Research Institute) is calling for data requirements with a greater focus on the clinical characteristics of patients. Both of these movements speak to the co-dependency of EMRs and post-approval research; the new healthcare era is calling for not only more population-based research, but also more registries to demonstrate their importance.
To support this growing demand, the Registry of Patient Registries (RoPR) has now launched to provide a searchable central listing of patient registries. Similar to (and associated with) www.clinicaltrials.gov, RoPR’s primary objective is to promote collaboration, reduce redundancy and improve transparency in the use of registries.
In conclusion, adoption of EMR systems is on the rise in the wake of healthcare reform, and advances in standards and technology are paving the way to leverage interoperability with patient registries to facilitate their use. Many stakeholders, including biopharmaceutical services organizations, EMR providers, life sciences companies, and government agencies are highly invested in meeting this interoperability challenge, so there is no doubt that the future will yield increased compatibility with registries and an overall greater focus on patient-centered, post-approval research.
Four Bold Statements that Surprise on EMRs in Patient Registries
• If it is not already, the word “interoperability” will soon become part of every clinical operations manager’s vocabulary.
• People think it is easy to link EMRs to registries, but that is not always the case.
• EMRs are poised to become to patient registries what GPS has become to navigation.
• In the era of healthcare reform, EMRs will become indispensible to post-approval research – and post-approval research will become indispensible to EMRs.
David Thompson, PhD is Senior Vice President & Global Head of Emerging Businesses at Quintiles. He can be reached at email@example.com Daniel Levy, M.S., is the Chief Technology Officer at Quintiles Outcome. He can be reached at firstname.lastname@example.org