Electronic health records to facilitate clinical research

Cowie, Martin R.; Blomster, Juuso; Curtis, Lesley H.; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, Jörg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P.; Southworth, Mary Ross; Stough, Wendy Gattis; Thoenes, Martin; Zannad, Faı̈ez; Zalewski, Andrew

doi:10.1007/s00392-016-1025-6

Cited by 461 publications

(340 citation statements)

References 49 publications

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“…In terms of the number of publications, the increasing temporal trend shown in Figure This noticeable change could have happened because of the growing availability and universality of electronic health records for health research [7], which might have provided researchers with the opportunities to base their study methodology on the utilization of electronic health records.…”

Section: Discussionmentioning

confidence: 99%

Trends and Visibility of “Digital Health” as a Keyword in Articles by JMIR Publications in the New Millennium: Bibliographic-Bibliometric Analysis (Preprint)

Kavanagh¹,

Clark²,

Drennan³

et al. 2018

Preprint

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Take home messages The reflection of different digital health technologies -mobile health, health information technology, wearable devices, telehealth, and personalized medicine -in epidemiology journals increased dramatically over the past decade. Pharmacoepidemiol Drug Saf was the leading major epidemiology journal in this endeavor, publishing around one-third of all articles over the past decade which utilized digital health technologies in their methodologies. Overall interest in referring to the articles which have used digital health technologies increased over time. For improving the share of epidemiology journals in publishing literature around digital health technologies, more regular bibliographic and bibliometric analyses would be needed. Word Count 1,503 2 AbstractBackground: Digital health -mobile health, health information technology, wearable devices, telehealth, and personalized medicine -is an advancing phenomenon in the healthcare systems of modern societies. Epidemiology has provided frameworks to support studies which utilize, evaluate, focus on, or benefit from digital health technologies in their methodology.

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Section: Discussionmentioning

confidence: 99%

Trends and Visibility of “Digital Health” as a Keyword in Articles by JMIR Publications in the New Millennium: Bibliographic-Bibliometric Analysis (Preprint)

Kavanagh¹,

Clark²,

Drennan³

et al. 2018

Preprint

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“…In contrast, electronic health records and often large registry data are collected and entered by the personnel involved in the routine clinical care of the patient, although the personnel and organisational resources vary across regions of the world. In some cases, the data may be coded by non-clinical personnel based on medical record documentation, and data that are coded for the purpose of billing may introduce certain biases 42. Thus, data quality concerns may arise with regard to data accuracy or completeness.…”

Section: Challenges To Implementing Streamlined Clinical Trialsmentioning

confidence: 99%

“…‘Noisy’ data will, in general, create a ‘bias toward the null’, making it more difficult to detect treatment differences. Timeliness of data may also be an issue if data are not entered at the point of care but require subsequent coding 42. Creating linkages between distinct electronic systems with different data structures and data definitions, or mapping electronic health record fields to electronic case report form fields, can be technically problematic, especially in multicentre, international trials.…”

Section: Challenges To Implementing Streamlined Clinical Trialsmentioning

confidence: 99%

“…The analytic and technical issues previously discussed are major determinants of whether these trial designs will be acceptable to provide the level of unbiased evidence required for approval 42. A particular problem would be the conduct of non-inferiority studies using such approaches, as the ability of the control agent to have its expected effect in novel circumstances could be open to doubt,49 and, as noted, ‘noisy’ data introduce a ‘bias toward the null’, that is, a finding of non-inferiority.…”

Section: Challenges To Implementing Streamlined Clinical Trialsmentioning

confidence: 99%

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Streamlining cardiovascular clinical trials to improve efficiency and generalisability

Zannad

Pfeffer

Bhatt

et al. 2017

Heart

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Controlled trials provide the most valid determination of the efficacy and safety of an intervention, but large cardiovascular clinical trials have become extremely costly and complex, making it difficult to study many important clinical questions. A critical question, and the main objective of this review, is how trials might be simplified while maintaining randomisation to preserve scientific integrity and unbiased efficacy assessments. Experience with alternative approaches is accumulating, specifically with registry-based randomised controlled trials that make use of data already collected. This approach addresses bias concerns while still capitalising on the benefits and efficiencies of a registry. Several completed or ongoing trials illustrate the feasibility of using registry-based controlled trials to answer important questions relevant to daily clinical practice. Randomised trials within healthcare organisation databases may also represent streamlined solutions for some types of investigations, although data quality (endpoint assessment) is likely to be a greater concern in those settings. These approaches are not without challenges, and issues pertaining to informed consent, blinding, data quality and regulatory standards remain to be fully explored. Collaboration among stakeholders is necessary to achieve standards for data management and analysis, to validate large data sources for use in randomised trials, and to re-evaluate ethical standards to encourage research while also ensuring that patients are protected. The rapidly evolving efforts to streamline cardiovascular clinical trials have the potential to lead to major advances in promoting better care and outcomes for patients with cardiovascular disease.

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“…Concerns on data quality and validity, completeness of data capture and lack of interoperability have been identified as important barriers to the use of EHRs for clinical research [4]. Experiences from European and American efforts in the use or reuse of health data from EHRs have identified several important challenges [5,6].…”

Section: Introductionmentioning

confidence: 99%

Health Data for Research Through a Nationwide Privacy-Proof System in Belgium: Design and Implementation (Preprint)

Delvaux¹,

Aertgeerts²,

Bussel³

et al. 2018

Preprint

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BACKGROUND Health data collected during routine care have important potential for reuse for other purposes, especially as part of a learning health system to advance the quality of care. Many sources of bias have been identified through the lifecycle of health data that could compromise the scientific integrity of these data. New data protection legislation requires research facilities to improve safety measures and, thus, ensure privacy. OBJECTIVE This study aims to address the question on how health data can be transferred from various sources and using multiple systems to a centralized platform, called Healthdata.be, while ensuring the accuracy, validity, safety, and privacy. In addition, the study demonstrates how these processes can be used in various research designs relevant for learning health systems. METHODS The Healthdata.be platform urges uniformity of the data registration at the primary source through the use of detailed clinical models. Data retrieval and transfer are organized through end-to-end encrypted electronic health channels, and data are encoded using token keys. In addition, patient identifiers are pseudonymized so that health data from the same patient collected across various sources can still be linked without compromising the deidentification. RESULTS The Healthdata.be platform currently collects data for >150 clinical registries in Belgium. We demonstrated how the data collection for the Belgian primary care morbidity register INTEGO is organized and how the Healthdata.be platform can be used for a cluster randomized trial. CONCLUSIONS Collecting health data in various sources and linking these data to a single patient is a promising feature that can potentially address important concerns on the validity and quality of health data. Safe methods of data transfer without compromising privacy are capable of transporting these data from the primary data provider or clinician to a research facility. More research is required to demonstrate that these methods improve the quality of data collection, allowing researchers to rely on electronic health records as a valid source for scientific data.

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Electronic health records to facilitate clinical research

Cited by 461 publications

References 49 publications

Trends and Visibility of “Digital Health” as a Keyword in Articles by JMIR Publications in the New Millennium: Bibliographic-Bibliometric Analysis (Preprint)

Trends and Visibility of “Digital Health” as a Keyword in Articles by JMIR Publications in the New Millennium: Bibliographic-Bibliometric Analysis (Preprint)

Streamlining cardiovascular clinical trials to improve efficiency and generalisability

Health Data for Research Through a Nationwide Privacy-Proof System in Belgium: Design and Implementation (Preprint)

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