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Designing and Delivering a DTx Clinical Research Program: No Need to Re-invent the Wheel
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Colin A. Espie, Alasdair L. Henry
Agencies such as the FDA and the MHRA issue guidance on clinical trials, which must adhere to Good Clinical Practice (GCP) and ensure the safety and well-being of research participants are protected. Therefore, clinical evidence generation and research standards are of paramount importance for regulatory authorities. Regulators expect to see trials that generate clinically meaningful outcomes directly associated with the use of the SaMD in the target healthcare situation or condition. They also expect the product's clinical research program to extend to real-world surveillance data to ensure that any problems or risks associated with the device are identified once it is freely marketed. Sometimes this is known as the medical devices vigilance system. Therefore, regulators are interested in the clinical research program as a pipeline, not just as a study or a research event.
Engaging Patients with Personal Health IT for Quality
Published in Jan Oldenburg, Dave Chase, Kate T. Christensen, Brad Tritle, Engage!, 2020
A strong reason for patient vigilance—looking at clinical test results, medication list, allergy list, and problem list, for example—is that no single provider can attend to all the information and needs of each of his or her patients. Chances are high that some errors will be identified and corrections requested, although typically only a few of those errors would significantly improve the care received by the patient.
Transplacental Cocaine Exposure: Behavioral Consequences
Published in Richard J. Konkol, George D. Olsen, Prenatal Cocaine Exposure, 2020
Aaron S. Wilkins, Barry E. Kosofsky, Anthony G. Romano, John A. Harvey
There are several different forms of attention, including selective attention, divided attention, and sustained attention, which includes vigilance.39 Deficits in mechanisms underlying these forms of attention may result in specific impairments in performance in humans and rodents. In normal humans, treatment with IV clonidine, a noradrenergic alpha2 agonist, impairs attentional performance.40–43 In rats, Robbins and colleagues found that performance in tasks requiring attention can be disrupted by lesioning the dorsal noradrenergic bundle (DNAB).44,45 In a visual discrimination task (5-choice serial reaction time task), rats were required to detect brief visual stimuli presented unpredictably at one of five locations and then push a panel paired with the stimulus. Animals with the DNAB lesions displayed deficits in attention in this task when a) loud bursts of white noise were interpolated immediately prior to each visual stimulus,44 b) the stimuli were presented unpredictably in time,46 and c) the rats were treated with amphetamine, which caused impulsive and premature responding.47 Thus the noradrenergic system is believed to be involved in attentional processing.39,46,48,49 Yet researchers have found that lesions of the dopaminergic,48 serotonergic,50 or cholinergic51 systems also disrupt attention. According to Robbins and Everitt,49 these systems probably interact in modulating attention.
Use of neuroimaging to measure neurocognitive engagement in health professions education: a scoping review
Published in Medical Education Online, 2022
Serkan Toy, Dana D Huh, Joshua Materi, Julie Nanavati, Deborah A. Schwengel
Our review did not identify a strong literature base within the health professions education for real-time monitoring of tasks that require vigilance and sustained attention. One group examined the effect of fatigue on clinical reasoning skills across two separate pilot studies as internal medicine physicians answered and reflected on multiple-choice questions from the US medical licensing and/or maintenance of certification exams [29,32]. The results were consistent with those of other studies outside medical education, which have shown that fatigue and sleep quantity are associated with significant changes in brain activation patterns, especially in the medial and/or lateral PFC and other working memory-related areas. Although the exact nature of this relationship was not clear, these preliminary findings emphasize the importance of examining how fatigue and sleep deprivation might regulate neurocognitive engagement. The interplay among various factors such as expertise level, task, cognitive load, attention, and medical errors presents critical research opportunities for functional neuroimaging studies. Numerous studies in other fields could offer guidance for such efforts in health professions education. This type of research can have significant implications for real-time monitoring, and potentially intervention, during critical clinical tasks.
Venous thromboembolism in plastic surgery: the current state of evidence in risk assessment and chemoprophylactic options
Published in Journal of Plastic Surgery and Hand Surgery, 2019
Kenneth L. Fan, Cara K. Black, Olivia Abbate, Karen Lu, Rachel C. Camden, Karen K. Evans
The inpatient plastic surgery population has an overall VTE incidence of 1.69% as determined by the Venous Thromboembolism Prevention Study (VTEPS) [1]. Among the outpatient population, the overall incidence of VTE remains low (0.09%). High-risk procedures include abdominoplasties (0.34%), combined procedures (0.67%), thigh lifts (0.25%) and lower body lifts (0.23%) (Table 1) [2–6]. Survey indicates that among plastic surgeons, 80% have had postoperative VTE and 53% have had PE in their patients [7]. However, 40% of surveyed surgeons continue to forgo prophylaxis, either due to the concern of bleeding, lack of solid evidence, or unawareness [8,9]. The lack of solid evidence mandates a higher level of vigilance in the practitioner. This review is split into two portions. The first section intends to outline the available evidence and the gaps in understanding in VTE risk stratification and chemoprophylaxis with enoxaparin among plastic surgery patients. The second will examine the emerging use of oral chemoprophylaxis options in plastic surgery.
AI, Machine Learning, and Ethics in Health Care
Published in Journal of Legal Medicine, 2019
We need to remain vigilant and understand the technology as it is rolled out across health care. These technologies must be appropriately developed, evaluated, and tailored to different clinical situations before they are applied to daily medical practice.12 In July 2018, Nick Bostrom, philosopher at Oxford University, in a statement to UK Parliament on AI and Future Generations, stated, “Intelligence relies not on math, but on computation. Computation is the transformation of information. Computation is a physical process, taking time, energy, & space. Mistaking it for math may be why we naively expect AI to be pure, ethical, omniscient, and eternal. It isn’t.”13 This statement reminds us to remain alert to errors that can occur in data systems particularly when ML is applied to large volumes of data because the errors could be amplified.