Dipak Kalra

Electronic health records: new opportunities for clinical research

Clinical research is on the threshold of a new era in which electronic health records (EHRs) are gaining an important novel supporting role. Whilst EHRs used for routine clinical care have some limitations at present, as discussed in this review, new improved systems and emerging research infrastructures are being developed to ensure that EHRs can be used for secondary purposes such as clinical research, including the design and execution of clinical trials for new medicines. EHR systems should be able to exchange information through the use of recently published international standards for their interoperability and clinically validated information structures (such as archetypes and international health terminologies), to ensure consistent and more complete recording and sharing of data for various patient groups. Such systems will counteract the obstacles of differing clinical languages and styles of documentation as well as the recognized incompleteness of routine records. Here, we discuss some of the legal and ethical concerns of clinical research data reuse and technical security measures that can enable such research while protecting privacy. In the emerging research landscape, cooperation infrastructures are being built where research projects can utilize the availability of patient data from federated EHR systems from many different sites, as well as in international multilingual settings. Amongst several initiatives described, the EHR4CR project offers a promising method for clinical research. One of the first achievements of this project was the development of a protocol feasibility prototype which is used for finding patients eligible for clinical trials from multiple sources.

A CORBA-based integration of distributed electronic healthcare records using the Synapses approach

The ability to exchange in a meaningful, secure, and simple fashion relevant healthcare data about patients is seen as vital in the context of efficient and cost-effective shared or team-based care. The electronic healthcare record (EHCR) lies at the heart of this information exchange, and it follows that there is an urgent need to address the ability to share EHCRs or parts of records between carers and across distributed health information systems. This paper presents the Synapses approach to sharing based on a standardized shared record, the Federated Healthcare Record, which is implemented in an open and flexible manner using the Common Object Request Broker Architecture (CORBA). The architecture of the Federated Healthcare Record is based on the architecture proposed by the Technical Committee 251 of the European Committee for Standardization.

Inter-organizational future proof EHR systems A review of the security and privacy related issues

OBJECTIVES Identification and analysis of privacy and security related issues that occur when health information is exchanged between health care organizations. METHODS Based on a generic scenario questions were formulated to reveal the occurring issues. Possible answers were verified in literature. RESULTS Ensuring secure health information exchange across organizations requires a standardization of security measures that goes beyond organizational boundaries, such as global definitions of professional roles, global standards for patient consent and semantic interoperable audit logs. CONCLUSION As to be able to fully address the privacy and security issues in interoperable EHRs and the long-life virtual EHR it is necessary to realize a paradigm shift from storing all incoming information in a local system to retrieving information from external systems whenever that information is deemed necessary for the care of the patient.

Using electronic health records for clinical research

OBJECTIVES To describe the IMI EHR4CR project which is designing and developing, and aims to demonstrate, a scalable, widely acceptable and efficient approach to interoperability between EHR systems and clinical research systems. METHODS The IMI EHR4CR project is combining and extending several previously isolated state-of-the-art technical components through a new approach to develop a platform for reusing EHR data to support medical research. This will be achieved through multiple but unified initiatives across different major disease areas (e.g. cardiovascular, cancer) and clinical research use cases (protocol feasibility, patient identification and recruitment, clinical trial execution and serious adverse event reporting), with various local and national stakeholders across several countries and therefore under various legal frameworks. RESULTS An initial instance of the platform has been built, providing communication, security and terminology services to the eleven participating hospitals and ten pharmaceutical companies located in seven European countries. Proof-of-concept demonstrators have been built and evaluated for the protocol feasibility and patient recruitment scenarios. The specifications of the clinical trial execution and the adverse event reporting scenarios have been documented and reviewed. CONCLUSIONS Through a combination of a consortium that brings collectively many years of experience from previous relevant EU projects and of the global conduct of clinical trials, of an approach to ethics that engages many important stakeholders across Europe to ensure acceptability, of a robust iterative design methodology for the platform services that is anchored on requirements of an underlying Service Oriented Architecture that has been designed to be scalable and adaptable, EHR4CR could be well placed to deliver a sound, useful and well accepted pan-European solution for the reuse of hospital EHR data to support clinical research studies.

Confidentiality of personal health information used for research

Researchers must balance the quest for better health for all against the need to respect the privacy of research participants. What needs to be done to ensure best practice?

Benefits and risks of structuring and/or coding the presenting patient history in the electronic health record: systematic review

Background Patient histories in electronic health records currently exist mainly in free text format thereby limiting the possibility that decision support technology may contribute to the accuracy and timeliness of clinical diagnoses. Structuring and/or coding make patient histories potentially computable. Methods A systematic review was undertaken of the benefits and risks of structuring and/or coding patient history by searching nine international databases for published and unpublished studies over the period 1990–2010. The focus was on the current patient history, defined as information reported by a patient or the patients caregiver about the patients present health situation and health status. Findings were synthesised through a theoretically based textural analysis. Findings Of the 9207 potentially eligible papers identified, 10 studies satisfied the eligibility criteria. There was evidence of a modest number of benefits associated with structuring the current patient history, including obtaining more complete clinical histories, improved accuracy of patient self-documented histories, and better associated decision-making by professionals. However, no studies demonstrated any resulting improvements in patient care or outcomes. When more detailed records were obtained through the use of a structured format no attempt was made to confirm if this additional information was clinically useful. No studies investigated possible risks associated with structuring the patient history. No studies examined coding of the patient history. Conclusions There is an insufficient evidence base for sound policy making on the benefits and risks of structuring and/or coding patient history. The authors suggest this field of enquiry warrants further investigation given the interest in use of decision support technology to aid diagnoses.

Clinical information modeling processes for semantic interoperability of electronic health records: systematic review and inductive analysis

OBJECTIVE This systematic review aims to identify and compare the existing processes and methodologies that have been published in the literature for defining clinical information models (CIMs) that support the semantic interoperability of electronic health record (EHR) systems. MATERIAL AND METHODS Following the preferred reporting items for systematic reviews and meta-analyses systematic review methodology, the authors reviewed published papers between 2000 and 2013 that covered that semantic interoperability of EHRs, found by searching the PubMed, IEEE Xplore, and ScienceDirect databases. Additionally, after selection of a final group of articles, an inductive content analysis was done to summarize the steps and methodologies followed in order to build CIMs described in those articles. RESULTS Three hundred and seventy-eight articles were screened and thirty six were selected for full review. The articles selected for full review were analyzed to extract relevant information for the analysis and characterized according to the steps the authors had followed for clinical information modeling. DISCUSSION Most of the reviewed papers lack a detailed description of the modeling methodologies used to create CIMs. A representative example is the lack of description related to the definition of terminology bindings and the publication of the generated models. However, this systematic review confirms that most clinical information modeling activities follow very similar steps for the definition of CIMs. Having a robust and shared methodology could improve their correctness, reliability, and quality. CONCLUSION Independently of implementation technologies and standards, it is possible to find common patterns in methods for developing CIMs, suggesting the viability of defining a unified good practice methodology to be used by any clinical information modeler.

National evaluation of the benefits and risks of greater structuring and coding of the electronic health record: exploratory qualitative investigation

Objective We aimed to explore stakeholder views, attitudes, needs, and expectations regarding likely benefits and risks resulting from increased structuring and coding of clinical information within electronic health records (EHRs). Materials and methods Qualitative investigation in primary and secondary care and research settings throughout the UK. Data were derived from interviews, expert discussion groups, observations, and relevant documents. Participants (n=70) included patients, healthcare professionals, health service commissioners, policy makers, managers, administrators, systems developers, researchers, and academics. Results Four main themes arose from our data: variations in documentation practice; patient care benefits; secondary uses of information; and informing and involving patients. We observed a lack of guidelines, co-ordination, and dissemination of best practice relating to the design and use of information structures. While we identified immediate benefits for direct care and secondary analysis, many healthcare professionals did not see the relevance of structured and/or coded data to clinical practice. The potential for structured information to increase patient understanding of their diagnosis and treatment contrasted with concerns regarding the appropriateness of coded information for patients. Conclusions The design and development of EHRs requires the capture of narrative information to reflect patient/clinician communication and computable data for administration and research purposes. Increased structuring and/or coding of EHRs therefore offers both benefits and risks. Documentation standards within clinical guidelines are likely to encourage comprehensive, accurate processing of data. As data structures may impact upon clinician/patient interactions, new models of documentation may be necessary if EHRs are to be read and authored by patients.

Electronic health records in complementary and alternative medicine.

OBJECTIVES This paper investigates the potential for a standardised electronic health record (EHR) designed for conventional medicine also to be used by complementary and alternative medicine. METHOD The research was undertaken using anonymised samples of patient records from homoeopathy practices, to investigate if the patient data could be modelled using the forthcoming joint European and International Standard for EHR Communications (ISO/EN 13606). The research deliberately did not consider the effectiveness of complementary and alternative medicine or the clinical evidence for any particular CAM practice or treatment. The focus was purely on the patient data captured routinely by CAM therapists, to determine whether current approaches to the representation and communication of EHRs could incorporate such records. RESULTS Five homoeopathic patient records, authored by different practitioners in different practice settings, were re-represented in a structured form in conformance with the ISO/EN 13606 reference Model. A sixth practitioner confirmed that the transposition had been as faithful to the original records as was possible given some limitations in the clarity of the originals. CONCLUSION The authors conclude that the ISO/EN 13606 model can be used to represent patient records from homoeopathy, including the evidence and reasoning used to arrive at a formulation and to determine the appropriate remedy. It is therefore feasible that future EHR systems adopting this standard could enable patient records to be shared between complementary and conventional medical practice, in support of integrated healthcare.

Assuring the confidentiality of shared electronic health records

Sharing data between multiple institutions offers better regulation and public protection