Background: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals.
Objective: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC).
Mitapivat is an investigational, oral, small-molecule allosteric activator of pyruvate kinase (PK). PK is a regulatory glycolytic enzyme that is key in providing the red blood cell (RBC) with sufficient amounts of adenosine triphosphate (ATP). In sickle cell disease (SCD), decreased 2,3-DPG levels increase the oxygen affinity of hemoglobin, thereby preventing deoxygenation and polymerization of sickle hemoglobin.
View Article and Find Full Text PDFBackground: Clinical decision support systems (CDSSs) based on routine care data, using artificial intelligence (AI), are increasingly being developed. Previous studies focused largely on the technical aspects of using AI, but the acceptability of these technologies by patients remains unclear.
Objective: We aimed to investigate whether patient-physician trust is affected when medical decision-making is supported by a CDSS.
The most common forms of sickle cell disease (SCD) are sickle cell anemia (SCA; HbSS) and HbSC disease. In both, especially the more dense, dehydrated and adherent red blood cells (RBCs) with reduced deformability are prone to hemolysis and sickling, and thereby vaso-occlusion. Based on plasma amino acid profiling in SCD, a composition of 10 amino acids and derivatives (RCitNacQCarLKHVS; Axcella Therapeutics, USA), referred to as endogenous metabolic modulators (EMMs), was designed to target RBC metabolism.
View Article and Find Full Text PDFTargeting the primary pathogenic event of sickle cell disease (SCD), the polymerization of sickle hemoglobin (HbS), may prevent downstream clinical events. Mitapivat, an oral pyruvate kinase (PK) activator, has therapeutic potential by increasing adenosine triphosphate (ATP) and decreasing 2,3-diphosphoglycerate (2,3-DPG), a glycolytic red blood cell (RBC) intermediate. In the previously reported 8-week dose-finding period of this phase 2, investigator-initiated, open-label study, mitapivat was well tolerated and showed efficacy in SCD.
View Article and Find Full Text PDFBiological processes underlying decreased cerebral blood flow (CBF) in patients with cardiovascular disease (CVD) are largely unknown. We hypothesized that identification of protein clusters associated with lower CBF in patients with CVD may explain underlying processes. In 428 participants (74% cardiovascular diseases; 26% reference participants) from the Heart-Brain Connection Study, we assessed the relationship between 92 plasma proteins from the Olink® cardiovascular III panel and normal-appearing grey matter CBF, using affinity propagation and hierarchical clustering algorithms, and generated a Biomarker Compound Score (BCS).
View Article and Find Full Text PDFBackground: Acute kidney injury (AKI) is defined as a sudden episode of kidney failure but is known to be under-recognized by healthcare professionals. The Kidney Disease Improving Global Outcome (KDIGO) guidelines have formulated criteria to facilitate AKI diagnosis by comparing changes in plasma creatinine measurements (PCr). To improve AKI awareness, we implemented these criteria as an electronic alert (e-alert), in our electronic health record (EHR) system.
View Article and Find Full Text PDFBackground And Aims: Patients who underwent carotid endarterectomy (CEA) still have a residual risk of 13% of developing a major adverse cardiovascular event (MACE) within 3 years. Inflammatory processes leading up to MACE are not fully understood. Therefore, we examined blood cell characteristics (BCCs), possibly reflecting inflammatory processes, in relation to MACE to identify BCCs that may contribute to an increased risk.
View Article and Find Full Text PDFRed blood cell distribution width (RDW) is a biomarker associated with a variety of clinical outcomes. While anemia and subclinical inflammation have been posed as underlying pathophysiology, it is unclear what mechanisms underlie these assocations. Hence, we aimed to unravel the mechanisms in silico using a large clinical dataset and validate our findings in vitro.
View Article and Find Full Text PDFBackground: The Utrecht Cardiovascular Cohort - CardioVascular Risk Management (UCC-CVRM) was set up as a learning healthcare system (LHS), aiming at guideline based cardiovascular risk factor measurement in all patients in routine clinical care. However, not all patients provided informed consent, which may lead to participation bias. We aimed to study participation bias in a LHS by assessing differences in and completeness of cardiovascular risk management (CVRM) indicators in electronic health records (EHRs) of consenting, non-consenting, and non-responding patients, using the UCC-CVRM as an example.
View Article and Find Full Text PDFThis commentary discusses the prevalence and causes of anemia in primary care in the Netherlands and the role of laboratory diagnostics in determining the cause of anemia. There are indications that guidelines in primary care regarding anemia are insufficiently followed; there are also indications that the correct laboratory measurements are requested too limited (under-diagnosis). A possible solution lies in the introduction of reflective testing, in which the laboratory specialist has additional diagnostic laboratory tests performed on the basis of the laboratory results and specific characteristics of the patient.
View Article and Find Full Text PDFBackground: Immune checkpoint inhibitors (ICI) show remarkable results in cancer treatment, but at the cost of immune-related adverse events (irAE). irAE can be difficult to differentiate from infections or tumor progression, thereby challenging treatment, especially in the emergency department (ED) where time and clinical information are limited. As infections are traceable in blood, we were interested in the added diagnostic value of routinely measured hematological blood cell characteristics in addition to standard diagnostic practice in the ED to aid irAE assessment.
View Article and Find Full Text PDFIt is of paramount importance that healthcare professionals can participate in the academic and societal debate surrounding medical AI. To realise this critical-constructive guidance of AI, it is necessary to be able to distinguish between different types of AI, different applications of AI and to paint the different shades of grey in the current black-and-white debate. This article describes and nuances eight misconceptions that currently dominate the public debate surrounding AI in healthcare.
View Article and Find Full Text PDFAccurate sepsis diagnosis is paramount for treatment decisions, especially at the emergency department (ED). To improve diagnosis, clinical decision support (CDS) tools are being developed with machine learning (ML) algorithms, using a wide range of variable groups. ML models can find patterns in Electronic Health Record (EHR) data that are unseen by the human eye.
View Article and Find Full Text PDFBackground: A longer emergency department length of stay (EDLOS) is associated with poor outcomes. Shortening EDLOS is difficult, due to its multifactorial nature. A potential way to improve EDLOS is through shorter turnaround times for diagnostic testing.
View Article and Find Full Text PDFElectronic health records (EHRs) contain valuable data for reuse in science, quality evaluations, and clinical decision support. Because routinely obtained laboratory data are abundantly present, often numeric, generated by certified laboratories, and stored in a structured way, one may assume that they are immediately fit for (re)use in research. However, behind each test result lies an extensive context of choices and considerations, made by both humans and machines, that introduces hidden patterns in the data.
View Article and Find Full Text PDFThe increased use of electronic health records (EHRs) has improved the availability of routine care data for medical research. Combined with machine learning techniques this has spurred the development of early warning scores (EWSs) in hospitals worldwide. EWSs are commonly used in the hospital where they have been developed, yet few have been transported to external settings and/or internationally.
View Article and Find Full Text PDFThe University Medical Center (UMC) Utrecht piloted a hospital-wide innovation data analytics program over the past 4 years. The goal was, based on available data and innovative data analytics methodologies, to answer clinical questions to improve patient care. In this viewpoint, we aimed to support and inspire others pursuing similar efforts by sharing the three principles of the program: the data analytics value chain (data, insight, action, value), the innovation funnel (structured innovation approach with phases and gates), and the multidisciplinary team (patients, clinicians, and data scientists).
View Article and Find Full Text PDFPurpose: Although standard-of-care has been defined for the treatment of glioblastoma patients, substantial practice variation exists in the day-to-day clinical management. This study aims to compare the use of laboratory tests in the perioperative care of glioblastoma patients between two tertiary academic centers-Brigham and Women's Hospital (BWH), Boston, USA, and University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.
Methods: All glioblastoma patients treated according to standard-of-care between 2005 and 2013 were included.
Aims: With the ageing European population, the incidence of coronary artery disease (CAD) is expected to rise. This will likely result in an increased imaging use. Symptom recognition can be complicated, as symptoms caused by CAD can be atypical, particularly in women.
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