Vision Document
EHR Clinical Research Value Case Workgroup
The purpose of this vision document is to provide an overview of the current and desired states for the use of information from electronic health records to support clinical research. By describing the general framework of information flow through the perspectives of clinical research, this document may support the harmonization of health information technology standards for this application with those of existing use cases and interoperability specifications for other domains. This document is developed as background information to support the Health Information Technology Standards Panel.
Charge to the Work Group:
Recommend specific Value Cases to the Health Information Technology Standards Panel facilitating the use of interoperable, standards-based electronic health records that support clinical research in the multi-institutional, global settings where it is currently performed. Provide context demonstrating the benefits to a broad range of health information stakeholders achieved by facilitating health information exchange between settings of health care delivery, clinical research and regulatory organizations.
Vision Summary
In response to the American Health Information Community (AHIC) recommendations, and with the support of the AHIC Successor, Inc. (ASI), a workgroup has been established by the American National Standards Institute (ANSI) to define priorities in the area of electronic health records (EHR), including personal health records (PHR), to support clinical research. This workgroup will advance these priorities to the Healthcare Information Technology Standards Panel (HITSP) for standards harmonization and drafting of interoperability specifications. This workgroup, known as the EHR Clinical Research workgroup, will develop information resources to facilitate the work of HITSP with the ultimate goal of value case development and recommendations to advance the ability of EHR to support clinical research.
The concepts and statements in this document are directed to HITSP and subject to further deliberation by the workgroup, ANSI, and ASI. The Workgroup’s vision is predicated on the idea that health, health care, and research activities are intertwined in a system in which patients, consumers, physicians and other health care providers, researchers and others that support research activities have common interests in supporting the exchange of health information.
What follows is the vision for the future and the current state of health information transfer as perceived by the diverse stakeholders involved in the clinical research endeavor.
The Vision for the Desired Future
Clinical research[1] provides the conduit for new knowledge about health and illness to be incorporated into health care practices. The impact of discovery and improvement in the quality and outcomes of health care span the interests of all parties in the medical and health care enterprise including consumers, patients, and their advocates. Realization of this vision requires streamlining processes that lead to the development of new knowledge, its translation into subsequent health care practices and its dissemination via clinical decision support.
This workgroup recognizes that the common point of interaction between health care and clinical research is the patient. Therefore, this vision for the future of health information support of clinical/translational research primarily considers the consumer’s and patient’s perspectives on actions required for information exchange. Information about clinical trials, outcomes research, population-based studies, and the knowledge gained by clinical research will be progressively more important to patients, they will increasingly access it using electronic communication tools, and their care will be impacted by this information as it becomes accessible to their health care providers.
In the future, consumers will have access to better communication tools such as electronic newsletters, personalized weekly health updates, personal health records (PHR), as well as interactive systems allowing them to electronically identify opportunities to participate in research. It is foreseeable that based on information in their EHR, automated notification systems will alert patients to clinical trials, outcomes research activities, or other research activities. With these resources, consumers will become more health literate and informed about clinical research. Consumers who are better informed about clinical research in a meaningful way and their opportunities to engage in it will be more likely to participate.
Electronic information sources will also support oversight processes that protect research participants. Electronic information systems will provide secured messaging between research participants and clinical research officials to protect against unauthorized disclosures. Confidentiality of patient information will be highly safeguarded using authentication methods, electronic patient notification, role-based access controls, and other protections, including Federal protection under the law. Information about research activities, interaction with patients for informed consent and follow-up of research activities will all involve electronic information handling. Overall, a secondary benefit of a patient’s participation in clinical research will likely be their own increased awareness of health and disease and may contribute, through their own efforts, to healthier behavior.
Sponsors and investigators involved in clinical research are also key stakeholders in the use of electronic information obtained from health care delivery. Key standardized information from EHR can support identification of potential research participants. Improved accuracy and efficiency in transfer of information from a research participant’s health records will serve to improve the quality of data in clinical research and enhance the protection of participants from potential untoward outcomes of research. Electronic auditing and authorizations for data validation will become supported electronically as an extension of electronic submission filings for federal and institutional regulatory authorities, improving the monitoring ability of both sponsor and regulatory organizations.
Electronic data collection systems and health information exchange will be the most common technology support methods for outcomes research data collection, surveys, post-marking surveillance programs, and patient registries. The interface between research organizations and health delivery organizations will be strengthened by common data use policies and methods for privacy, security, and confidentiality provisions. This means that information exchange from all sources will need to adhere to the rigorous data use policies detailed in clinical research protocols.
Research organizations that sponsor, support, and conduct clinical research will be highly integrated with standards-based electronic information systems for patient information. Data sources will include, but not be limited to, computerized data entry of research subject interventions, point-of-care devices with electronic data transmission, imaging data systems, and electronic forms for workflow processing. Patients participating in research activities will likely use multiple forms of electronic communication for reporting data such as personal data assistants, remote telemetry, web-based diaries, and biophysiologic sensing systems that will transmit data directly to reporting sites, data repositories, and other data registration sites. Many health care delivery systems will have data warehouses for detailed, integrated health information that collect longitudinal data to support epidemiologic research, biosurveillance, medical product and other health intervention effects in order to monitor safety and report adverse events. Patient portals or PHR will be integrated with health institutions’ data collection capabilities and be supported through national health information network exchanges. Information transmission from research sites will be coordinated through highly secured information networks to support global data transmission and usage, which will facilitate international research programs. Standards harmonization for regulatory practices will be integrated into electronic systems that will include verification software providing assurances for authentic patient information.
Research and public health will benefit from improved access to the vast amounts of information readily accessible at clinics and hospital bedsides collected in a standardized, searchable format utilizing discrete data points. Overall, the linear translation of information from ‘bench to bedside’ will become a reinforcing loop through the return of information from ‘bedside to bench.’ Medical research activities will be improved by higher quality information about individual differences in health status and there will be greater ability to obtain and interpret research results allowing their implementation in clinical care through publication and electronic clinical decision support on a more efficient and timely basis.
Current Status
Today, consumers, providers, and other stakeholders are presented with a fragmented health care sector, where the emphasis of primary care is on treatment and acute care rather than on prevention. Information for clinical research from patients and their health care systems remains predominantly paper-based with little connectivity among institutions. Increasingly, patients seek information about health interventions and clinical research activities, particularly clinical trials, when faced with serious illnesses or health concerns. Despite this interest, many challenges exist when consumers and patients attempt to identify clinical research options. Meanwhile, clinical researchers struggle to identify participants, slowing their progress. Currently, to identify clinical research activities, patients find information by connecting with health advocacy organizations, through their health care provider, or by some electronic resources, such as clinicaltrials.gov or PatientsLikeMe.com.
Current information indicates that 57% of consumers would participate in clinical research[2], but have questions about their roles and the risks involved, and have difficulty finding satisfactory answers. Furthermore, finding a clinical trial for which they are eligible and their doctor approves, compounded by their questions about the confidentiality, privacy, and security of their personal health information, can be a deterrent to participation in clinical research.
For investigators and sponsors of clinical research, the economic barriers related to information collection are significant. Frequently cited as one of the most costly aspects of this task is the multitude of data sources used in various health care settings with non-standards-based patient information. Another problem is the lack of use of common terms to describe phenotypic (clinical characteristics of health and disease) parameters that are important to compare results among research participants and clinical research studies. To overcome the barrier of various research sites using different data systems, additional software and personnel are used to collect and reconcile data prior to analysis. This creates substantial delays, adds overhead, and presents opportunities for errors in data transmission. Often, in clinical research projects conducted today, the format for data collection does not permit re-use, future longitudinal studies, or comparison of results across related studies (i.e. meta-analyses). Presently, targeted goals for national adoption of EHR have not been reached. Many large research institutions have electronic systems and data warehouses, but interoperability to support the sharing of information in multi-site clinical research is non-existent. Sharing of information from the health care delivery system is complicated by locality differences in data sharing policies and perspectives on providing information to non-institutional data users.
Agencies overseeing clinical research activities at federal and local levels have limited electronic information exchange to facilitate tracking of informed consent, institutional review and privacy review practices. New electronic technology[3] to enhance research participant understanding is being developed and used in some settings but is not widely deployed. Many of the authorizations involving the patient and research sponsor remain paper-based transactions.
Electronic reporting of research information and transmission to regulatory authorities has made progress. Federal oversight organizations are becoming largely standards based in their approach to electronic submission and transactions for review and oversight. Public access to research data is being enhanced with new policies requiring publication of clinical research results and provisions for public domain access of such information in a timely fashion.
Defining Characteristics of the Health Care System in the Context of Supporting Clinical Research
Various characteristics of the current status and the future vision of the use of EHR to support clinical research are articulated below. This describes the impact of the transition from the current to the future state on key stakeholders’ experiences and expectations.
Consumer’s Perspective
Many patients and consumers today find information about their health confusing and difficult to apply. Consumers are often challenged to maintain current information of importance to their health care. They desire greater empowerment and tools that go beyond displaying data but turn data into usable information for informed decision-making. With regard to clinical research, the vast majority of patients and consumers do not participate in clinical research activities. Informed consumers in search of medical options often seek help from patient advocacy organizations who represent an interface with research programs. Most patients approached about clinical research are interested in sharing information about their health conditions to benefit others. Among the primary concerns about participation are impact on their health care provisions (i.e., will it add costs to their health care), potential risks in participating in research that includes experimental interventions, the intended use of the information gathered, and potential benefits they may receive through participation. The loss of public confidence, especially among patients whose participation in clinical studies is essential, is an important problem in clinical research. Capabilities offered by HIT and EHR to provide feedback to research participants and otherwise increase transparency can help build this trust. Patients are concerned that without Federal protection for discrimination on employment and insurance coverage, promises of confidentiality carry no real enforceable protections. One field where the majority of patients are participants in clinical research, pediatric clinical cancer research, may provide useful lessons about involved patient populations in clinical research.
Increasingly, patients seek information about health and potential research projects through the use of the internet. Some consumers, primarily those of younger age groups, are increasingly sharing information about their health via electronic social networking resources. This informal method of information exchange takes place outside of protections of personal health information security and privacy. In addition, many patients seek information about research from health care practitioners who have widely variable levels of knowledge about research. Overall, consumers are interested in clinical research, but the electronic information systems to inform them often require active engagement and expert assistance that may not be readily available.
Health Care Provider’s Perspective
Health care providers serve as an important interface between patients and clinical research. Patient information maintained in clinical records is critical to the conduct of clinical research. Information in providers’ records is often the starting point for determining patient eligibility for clinical research. Vital health information, diagnoses, medical history, clinical descriptive information, laboratory and medical imaging data, and many other components of the medical record support clinical research. Providers in many cases may identify clinical research opportunities for patients and serve as an important information source for consumers considering participation. Health care practitioners today may have concerns about research participation by their patients. These may include added costs to conventional medical management, interactions or interference with current medical management, potential loss of patients to other providers, and patient safety concerns. As medical information for clinical research often originates from health care providers’ or institutional records, concerns about the additional time and labor of administrative procedures, incompatibility with normal workflow, authorization for use, and research oversight may overwhelm the perceived benefits of participating in research.