Wilson, MG;
Palmer, E;
Asselbergs, FW;
Harris, SK;
(2023)
Integrated rapid-cycle comparative effectiveness trials using flexible point of care randomisation in electronic health record systems.
Journal of Biomedical Informatics
, 137
, Article 104273. 10.1016/j.jbi.2022.104273.
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Abstract
Whilst the Randomised Controlled Trial remains the gold standard for deriving robust causal estimates of treatment efficacy, too often a traditional design proves prohibitively expensive or cumbersome when it comes to assessing questions regarding the comparative effectiveness of routinely used treatments. As a result, patients experience variation in practice as clinicians lack the evidence needed to personalise treatments effectively. This variation may be classified as unwarranted, where existing evidence is ignored, or legitimate where in the absence of evidence, clinicians rely on experience, expert opinion, and inferred principles from basic science to make decisions. We argue that within the right ethical and technological framework, legitimate variation can be transformed into a mechanism for evidence generation and learning. Learning Health Systems which harness existing variation in practice, represent a novel approach for generating evidence from everyday clinical practice. The development of these systems has gained traction due to the increased availability of modern Electronic Health Record Systems. However, despite their promise, overcoming hurdles to successfully integrating clinical trials within Learning Health Systems has proven challenging. This article describes the origins of integrated clinical trials and explores two main barriers to their further implementation - how best to obtain informed consent from patients to participate in routine comparative effectiveness research, and how to automate and integrate randomisation into a clinical workflow. Having described these barriers, we present a potential solution in the form of a research pipeline using a novel form of flexible point-of-care randomisation to allow clinicians and patients to participate in studies where there is clinical equipoise.
| Type: | Article |
|---|---|
| Title: | Integrated rapid-cycle comparative effectiveness trials using flexible point of care randomisation in electronic health record systems |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1016/j.jbi.2022.104273 |
| Publisher version: | https://doi.org/10.1016/j.jbi.2022.104273 |
| Language: | English |
| Additional information: | This version is the version of record. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | Science & Technology, Technology, Life Sciences & Biomedicine, Computer Science, Interdisciplinary Applications, Medical Informatics, Computer Science, Keywords, Electronic health record trials, Point of care randomisation, Comparative effectiveness research, Learning health systems, Clinically integrated trials, CLINICAL-TRIALS, INTENSIVE-CARE, INFORMED-CONSENT, ETHICS, IMPLEMENTATION, MULTICENTER, EQUIPOISE, DESIGN |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Health Informatics UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Health Informatics > Clinical Epidemiology |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10165524 |
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