Leveraging electronic health records for clinical research

Electronic health records (EHRs) can be a major tool in the quest to decrease costs and timelines of clinical trial research, generate better evidence for clinical decision making, and advance health care. Over the past decade, EHRs have increasingly offered opportunities to speed up, streamline, and enhance clinical research. EHRs offer a wide range of possible uses in clinical trials, including assisting with prestudy feasibility assessment, patient recruitment, and data capture in care delivery. To fully appreciate these opportunities, health care stakeholders must come together to face critical challenges in leveraging EHR data, including data quality/completeness, information security, stakeholder engagement, and increasing the scale of research infrastructure and related governance. Leaders from academia, government, industry, and professional societies representing patient, provider, researcher, industry, and regulator perspectives convened the Leveraging EHR for Clinical Research Now! Think Tank in Washington, DC (February 18-19, 2016), to identify barriers to using EHRs in clinical research and to generate potential solutions. Think tank members identified a broad range of issues surrounding the use of EHRs in research and proposed a variety of solutions. Recognizing the challenges, the participants identified the urgent need to look more deeply at previous efforts to use these data, share lessons learned, and develop a multidisciplinary agenda for best practices for using EHRs in clinical research. We report the proceedings from this think tank meeting in the following paper

Patient Awareness and Approval for an Opt-Out Genomic Biorepository

Aim: In this study, we sought to assess patient awareness and perceptions of an opt-out biorepository. Materials & methods: We conducted exit interviews with adult patients and parents of pediatric patients having their blood drawn as part of their clinical care at Vanderbilt University Medical Center (TN, USA). Results: 32.9% of all patients and parents of pediatric patients report having heard of the opt-out biorepository, while 92.4% approve of this research effort based on a brief description. Awareness that leftover blood could be used for research increased among adult patients during the study period, from 34.3 to 50.0%. Conclusion: These findings will inform ongoing assessments of the suitability of opt-out and opt-in methods as alternatives to written informed consent for inclusion in a biorepository

Incorporating Biobank Consent into a Healthcare Setting: Challenges for Patient Understanding

Biobank participants often do not understand much of the information they are provided as part of the informed consent process, despite numerous attempts at simplifying consent forms and improving their readability. We report the first assessment of biobank enrollees’ comprehension under an "integrated consent” process, where patients were asked to enroll in a research biobank as part of their normal healthcare experience. A number of healthcare systems have implemented similar integrated consent processes for biobanking, but it is unknown how much patients understand after enrolling under these conditions. Methods: We recruited patients who enrolled in a biobank while in a healthcare setting when receiving ordinary care. We assessed knowledge of consent materials using 11 true/false questions drawn from a well-known biobank knowledge test. After reviewing the results from 114 participants, we revised the consent form and repeated the knowledge assessment with 144 different participants. Results: Participants scored poorly on the knowledge test in both rounds, with no significant differences in overall scores or individual items between the rounds. In Phase 1, participants answered 53% of the questions correctly, 25% incorrectly, and 22% “I don’t know.” In Phase 2, participants answered 53% of questions correctly, 24% incorrectly, and 23% “I don’t know.” Participants scored particularly poorly on questions about data sharing and accessing medical records. Conclusions: Enrollees under an integrated consent model had significant misunderstandings that persisted despite an attempt to improve information specifically about those topics in a consent form. These results raise challenges for current approaches that attribute misunderstanding to overly complex consent forms. They also suggest that the pressures of the clinic may compound other problems with patient understanding of biobank consent. As health systems increasingly blend research and care, they may need to rethink their approach to educating patients about participation in a biobank

The collection, linking and use of data in biomedical research and health care: ethical issues

This report takes as its starting point the massive accumulation of data in biomedical research and health care, and the increasing power of data science to extract value by linking and re-using that data, for example in further health or population research. It examines the scientific, policy and economic drivers to exploit these opportunities, and the concerns and potential risks associated with doing so. The faltering ability of conventional information governance measures to keep pace with these developments is identified as a significant problem. The report therefore poses and addresses the following question: "how can we define a set of morally reasonable expectations about the use of data in any given data initiative and what conditions are required to give sufficient confidence that those expectations will be satisfied?" The report sets out a number of general recommendations, including four guiding principles for ethical design and governance of data initiatives. These help to identify specific examples of existing good practice and to make recommendations for improved practice in the use of data in the fields of health care (re-use of NHS records, clinical research, etc.) and population research (biobanks, epidemiological studies, etc.)

The Ethics of Medical Data Donation

This open access book presents an ethical approach to utilizing personal medical data. It features essays that combine academic argument with practical application of ethical principles. The contributors are experts in ethics and law. They address the challenges in the re-use of medical data of the deceased on a voluntary basis. This pioneering study looks at the many factors involved when individuals and organizations wish to share information for research, policy-making, and humanitarian purposes. Today, it is easy to donate blood or even organs, but it is virtually impossible to donate one’s own medical data. This is seen as ethically unacceptable. Yet, data donation can greatly benefit the welfare of our societies. This collection provides timely interdisciplinary research on biomedical big data. Topics include the ethics of data donation, the legal and regulatory challenges, and the current and future collaborations. Readers will learn about the ethical and regulatory challenges associated with medical data donations. They will also better understand the special nature of using deceased data for research purposes with regard to ethical principles of autonomy, beneficence, and justice. In addition, the contributors identify the key governance issues of such a scheme. The essays also look at what we can learn in terms of best practice from existing medical data schemes

The Ethics of Medical Data Donation

This open access book presents an ethical approach to utilizing personal medical data. It features essays that combine academic argument with practical application of ethical principles. The contributors are experts in ethics and law. They address the challenges in the re-use of medical data of the deceased on a voluntary basis. This pioneering study looks at the many factors involved when individuals and organizations wish to share information for research, policy-making, and humanitarian purposes. Today, it is easy to donate blood or even organs, but it is virtually impossible to donate one’s own medical data. This is seen as ethically unacceptable. Yet, data donation can greatly benefit the welfare of our societies. This collection provides timely interdisciplinary research on biomedical big data. Topics include the ethics of data donation, the legal and regulatory challenges, and the current and future collaborations. Readers will learn about the ethical and regulatory challenges associated with medical data donations. They will also better understand the special nature of using deceased data for research purposes with regard to ethical principles of autonomy, beneficence, and justice. In addition, the contributors identify the key governance issues of such a scheme. The essays also look at what we can learn in terms of best practice from existing medical data schemes

Front-Line Physicians' Satisfaction with Information Systems in Hospitals

Day-to-day operations management in hospital units is difficult due to continuously varying situations, several actors involved and a vast number of information systems in use. The aim of this study was to describe front-line physicians' satisfaction with existing information systems needed to support the day-to-day operations management in hospitals. A cross-sectional survey was used and data chosen with stratified random sampling were collected in nine hospitals. Data were analyzed with descriptive and inferential statistical methods. The response rate was 65 % (n = 111). The physicians reported that information systems support their decision making to some extent, but they do not improve access to information nor are they tailored for physicians. The respondents also reported that they need to use several information systems to support decision making and that they would prefer one information system to access important information. Improved information access would better support physicians' decision making and has the potential to improve the quality of decisions and speed up the decision making process.Peer reviewe

The evaluation and harmonisation of disparate information metamodels in support of epidemiological and public health research

BACKGROUND: Descriptions of data, metadata, provide researchers with the contextual information they need to achieve research goals. Metadata enable data discovery, sharing and reuse, and are fundamental to managing data across the research data lifecycle. However, challenges associated with data discoverability negatively impact on the extent to which these data are known by the wider research community. This, when combined with a lack of quality assessment frameworks and limited awareness of the implications associated with poor quality metadata, are hampering the way in which epidemiological and public health research data are documented and repurposed. Furthermore, the absence of enduring metadata management models to capture consent for record linkage metadata in longitudinal studies can hinder researchers from establishing standardised descriptions of consent. AIM: To examine how metadata management models can be applied to ameliorate the use of research data within the context of epidemiological and public health research. METHODS: A combination of systematic literature reviews, online surveys and qualitative data analyses were used to investigate the current state of the art, identify current perceived challenges and inform creation and evaluation of the models. RESULTS: There are three components to this thesis: a) enhancing data discoverability; b) improving metadata quality assessment; and c) improving the capture of consent for record linkage metadata. First, three models were examined to enhance research data discoverability: data publications, linked data on the World Wide Web and development of an online public health portal. Second, a novel framework to assess epidemiological and public health metadata quality framework was created and evaluated. Third, a novel metadata management model to improve capture of consent for record linkage metadata was created and evaluated. CONCLUSIONS: Findings from these studies have contributed to a set of recommendations for change in research data management policy and practice to enhance stakeholders’ research environment

Informatics for Health 2017 : advancing both science and practice

Conference report, The Informatics for Health congress, 24-26 April 2017, in Manchester, UK.Introduction : The Informatics for Health congress, 24-26 April 2017, in Manchester, UK, brought together the Medical Informatics Europe (MIE) conference and the Farr Institute International Conference. This special issue of the Journal of Innovation in Health Informatics contains 113 presentation abstracts and 149 poster abstracts from the congress. Discussion : The twin programmes of “Big Data” and “Digital Health” are not always joined up by coherent policy and investment priorities. Substantial global investment in health IT and data science has led to sound progress but highly variable outcomes. Society needs an approach that brings together the science and the practice of health informatics. The goal is multi-level Learning Health Systems that consume and intelligently act upon both patient data and organizational intervention outcomes. Conclusions : Informatics for Health demonstrated the art of the possible, seen in the breadth and depth of our contributions. We call upon policy makers, research funders and programme leaders to learn from this joined-up approach.Publisher PDFPeer reviewe