Enabling machine learning models in alarm fatigue research: Creation of a large relevance-annotated oxygen saturation alarm data set.

Background: Too many unnecessary alarms in the intensive care unit are one of the main reasons for alarm fatigue: Medical staff is overburdened and fails to respond appropriately. This endangers both patients and staff. Currently, there are no algorithms that can determine which alarms are clinically relevant and which are not.

Developing a Change Readiness Survey for Health Technology Implementation.

Addressing the challenges of health technology implementation, this study aims to develop a survey that assesses staff readiness for change in clinical settings. The survey items were refined from 67 to 38 through a narrative literature review, expert focus groups, and cognitive interviews. The survey suggests an approach that prioritizes the user's needs in identifying barriers and facilitators to the adoption of health technology in order to ensure successful implementation by proactively addressing potential obstacles.

User Experience Design for Intensive Care Alarm Management.

Alarm fatigue is a pressing issue in intensive care units. Based on user experience design, including clinical shadowings and feedback loops, we developed a prototype for a redesigned patient monitor: The prototype moves away from today's threshold-based alarm systems. It combines a sleek design with machine learning driven clinical insights to mitigate alarm fatigue.

Alarm Management in Intensive Care: Qualitative Triangulation Study.

Background: The high number of unnecessary alarms in intensive care settings leads to alarm fatigue among staff and threatens patient safety. To develop and implement effective and sustainable solutions for alarm management in intensive care units (ICUs), an understanding of staff interactions with the patient monitoring system and alarm management practices is essential.

Objective: This study investigated the interaction of nurses and physicians with the patient monitoring system, their perceptions of alarm management, and smart alarm management solutions.

ARTEMIS: An alarm threshold and policy mining system for the intensive care unit.

Background: Alarm fatigue is a major technology-induced hazard for patients and staff in intensive care units. Too many - mostly unnecessary - alarms cause desensitisation and lack of response in medical staff. Unsuitable alarm policies are one reason for alarm fatigue.

A Standardized Clinical Data Harmonization Pipeline for Scalable AI Application Deployment (FHIR-DHP): Validation and Usability Study.

Background: Increasing digitalization in the medical domain gives rise to large amounts of health care data, which has the potential to expand clinical knowledge and transform patient care if leveraged through artificial intelligence (AI). Yet, big data and AI oftentimes cannot unlock their full potential at scale, owing to nonstandardized data formats, lack of technical and semantic data interoperability, and limited cooperation between stakeholders in the health care system. Despite the existence of standardized data formats for the medical domain, such as Fast Healthcare Interoperability Resources (FHIR), their prevalence and usability for AI remain limited.

The influence of patient characteristics on the alarm rate in intensive care units: a retrospective cohort study.

Intensive care units (ICU) are often overflooded with alarms from monitoring devices which constitutes a hazard to both staff and patients. To date, the suggested solutions to excessive monitoring alarms have remained on a research level. We aimed to identify patient characteristics that affect the ICU alarm rate with the goal of proposing a straightforward solution that can easily be implemented in ICUs.

MIMIC-IV as a Clinical Data Schema.

Routinely collected electronic health records (EHR) in clinical information systems (CIS) are often heterogeneous, have inconsistent data formats and lack of documentation. We use the well-known open-source database schema of MIMIC-IV to address this issue aiming to support collaborative secondary analysis. Over 154 million data records from a German ICU have already been mapped and inserted into the schema successfully.

Utilizing Intensive Care Alarms for Machine Learning.

Alarms help to detect medical conditions in intensive care units and improve patient safety. However, up to 99% of alarms are non-actionable, i.e.

Randomised clinical trial: semaglutide versus placebo reduced liver steatosis but not liver stiffness in subjects with non-alcoholic fatty liver disease assessed by magnetic resonance imaging.

Background: Glucagon-like peptide-1 receptor agonists may be a treatment option in patients with non-alcoholic fatty liver disease (NAFLD).

Aims: To investigate the effects of semaglutide on liver stiffness and liver fat in subjects with NAFLD using non-invasive magnetic resonance imaging (MRI) methods.

Methods: This randomised, double-blind, placebo-controlled trial enrolled subjects with liver stiffness 2.

Clinical Characteristics of a Non-Alcoholic Fatty Liver Disease Population Across the Fibrosis Spectrum Measured by Magnetic Resonance Elastography: Analysis of Screening Data.

Introduction: Non-alcoholic fatty liver disease (NAFLD), one of the most common liver diseases, is associated with liver-related complications and metabolic comorbidities. The phenotype is wide, ranging from simple steatosis to non-alcoholic steatohepatitis with advanced fibrosis. In this analysis of a phase 1 trial, clinical characteristics of screened subjects with NAFLD were studied according to the extent of fibrosis assessed using magnetic resonance elastography (MRE).

Population Pharmacokinetics of Semaglutide for Type 2 Diabetes.

Introduction: The aim of the present analysis was to characterise the absorption, distribution and elimination of semaglutide by means of population pharmacokinetic (PK) models using data from nine clinical pharmacology trials conducted in both healthy subjects and those with type 2 diabetes.

Methods: Data were obtained from trials with subcutaneous and intravenous administration of semaglutide that utilised frequent PK sampling and included a total of 353 subjects with 10,573 concentration values.

Results: Semaglutide PK properties across trials, drug product strengths and populations were well characterised by a two-compartment model with first-order absorption and elimination.

Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis.

Introduction: Semaglutide, a new treatment option approved for the treatment of patients with type 2 diabetes mellitus, is a glucagon-like peptide-1 receptor agonist to be injected subcutaneously once weekly. This analysis used a population pharmacokinetic model of semaglutide to identify clinically relevant covariates for exposure.

Methods: A total of 1612 patients with up to seven pharmacokinetic observations each were included in the analysis.

No QTc Prolongation with Semaglutide: A Thorough QT Study in Healthy Subjects.

Introduction: Semaglutide is a glucagon-like peptide-1 (GLP-1) analog approved for the once-weekly treatment of type 2 diabetes. The objective of this 16-week, double-blind, single-center thorough QT study was to confirm that semaglutide treatment does not prolong cardiac repolarization versus placebo. Prolongation of the QT interval is a biomarker for ventricular tachyarrhythmia.

Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes.

Aims: To evaluate dose levels for semaglutide, a glucagon-like peptide-1 analogue approved for the treatment of type 2 diabetes, by examining the effects of demographic factors on efficacy and safety in an exposure-response analysis.

Methods: We analysed data from 1552 adults from four randomized phase III trials of 30 to 56 weeks' duration, investigating once-weekly semaglutide doses 0.5 and 1.

A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects.

Introduction: Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects.

Methods: In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.

Semaglutide improves postprandial glucose and lipid metabolism, and delays first-hour gastric emptying in subjects with obesity.

Aim: To investigate the effects of semaglutide on fasting and postprandial glucose and lipid responses, and on gastric emptying.

Materials And Methods: This was a randomized, double-blind, placebo-controlled, 2-period, crossover trial. Subjects with obesity (N = 30) received once-weekly subcutaneous semaglutide, dose-escalated to 1.

Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial.

Aims/hypothesis: Semaglutide is a glucagon-like peptide-1 analogue in development for the treatment of type 2 diabetes. Its effects on first- and second-phase insulin secretion and other measures of beta cell function and glycaemic control were assessed.

Methods: In this single-centre, double-blind, placebo-controlled, parallel-group trial, conducted at the Profil Institut für Stoffwechselforschung, Germany, 75 adult (aged 18-64 years) participants with type 2 diabetes (eligibility: HbA of 6.

Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment.

Background: The pharmacokinetics and tolerability of semaglutide, a once-weekly human glucagon-like peptide-1 analog in development for the treatment of type 2 diabetes mellitus, were investigated in subjects with/without renal impairment (RI).

Methods: Fifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg.

Effects of once-weekly semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity.

Aim: The aim of this trial was to investigate the mechanism of action for body weight loss with semaglutide.

Materials And Methods: This randomised, double-blind, placebo-controlled, two-period crossover trial investigated the effects of 12 weeks of treatment with once-weekly subcutaneous semaglutide, dose-escalated to 1.0 mg, in 30 subjects with obesity.

Liraglutide in Type 2 Diabetes Mellitus: Clinical Pharmacokinetics and Pharmacodynamics.

Liraglutide is an acylated glucagon-like peptide-1 analogue with 97 % amino acid homology with native glucagon-like peptide-1 and greatly protracted action. It is widely used for the treatment of type 2 diabetes mellitus, and administered by subcutaneous injection once daily. The pharmacokinetic properties of liraglutide enable 24-h exposure coverage, a requirement for 24-h glycaemic control with once-daily dosing.

Semaglutide, a once-weekly human GLP-1 analog, does not reduce the bioavailability of the combined oral contraceptive, ethinylestradiol/levonorgestrel.

The effect of semaglutide, a once-weekly human glucagon-like peptide-1 (GLP-1) analog in development for type 2 diabetes (T2D), on the bioavailability of a combined oral contraceptive was investigated. Postmenopausal women with T2D (n = 43) on diet/exercise ± metformin received ethinylestradiol (0.03 mg)/levonorgestrel (0.

Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes.

Aims: Liraglutide reduces bodyweight in patients with type 2 diabetes mellitus (T2DM). This study aimed to investigate the mechanisms underlying this effect.

Methods: The comparative effects of liraglutide, glimepiride and placebo on energy intake, appetite, nausea, gastric emptying, antral distension, bodyweight, gastrointestinal hormones, fasting plasma glucose and resting energy expenditure (REE), were assessed in subjects with T2DM randomised to treatment A (liraglutide-placebo), B (placebo-glimepiride) or C (glimepiride-liraglutide).

Determinants of appetite ratings: the role of age, gender, BMI, physical activity, smoking habits, and diet/weight concern.

Background: Appetite measures are often recorded by visual analogue scales (VAS), and are assumed to reflect central nervous system (CNS) perceptions and sensations. However, little is known about how physiological, psychological, social, and cultural factors influence VAS.

Objective: To investigate whether age, gender, body mass index (BMI), smoking habits, physical activity, diet behaviour, and menstruation cycle are determinants of appetite ratings.