Late gadolinium enhancement and the risk of ventricular arrhythmias and sudden death in NYHA I patients with non-ischemic cardiomyopathy.
Sign Up to like & getrecommendations! Published in 2023 at "European journal of heart failure"
DOI: 10.1002/ejhf.2793
Abstract: AIMS To compare the risk of ventricular arrhythmias (VA) and sudden death (SD) between NYHA I and NYHA II-III patients with non-ischemic cardiomyopathy (NICM). METHODS AND RESULTS Observational retrospective cohort study including patients with NICM… read more here.
Keywords: nyha iii; endpoint; nyha patients; death ... See more keywords
Sample size formula for a win ratio endpoint
Sign Up to like & getrecommendations! Published in 2022 at "Statistics in Medicine"
DOI: 10.1002/sim.9297
Abstract: The win ratio composite endpoint, which organizes the components of the composite hierarchically, is becoming popular in late‐stage clinical trials. The method involves comparing data in a pair‐wise manner starting with the endpoint highest in… read more here.
Keywords: sample size; endpoint; win ratio; size ... See more keywords
What endpoints should be used for clinical studies in acute kidney injury?
Sign Up to like & getrecommendations! Published in 2017 at "Intensive Care Medicine"
DOI: 10.1007/s00134-017-4732-1
Abstract: Introduction Probably the easiest way to ruin a clinical trial is to choose the wrong endpoint. Our assessment as to whether something works in medicine, whether treatment or diagnostic, is based on “hitting” the primary… read more here.
Keywords: medicine; kidney injury; endpoint; endpoints used ... See more keywords
Solution to titration endpoint challenge
Sign Up to like & getrecommendations! Published in 2019 at "Analytical and Bioanalytical Chemistry"
DOI: 10.1007/s00216-019-01800-7
Abstract: This challenge invites us to think about the endpoint estimates in acid-base titration [1]. The purpose of titration is to establish the amount of a substance present in solution by chemically reacting that substance with… read more here.
Keywords: endpoint; titration endpoint; titration; challenge ... See more keywords
Improving categorical endpoint longitudinal exposure-response modeling through the joint modeling with a related endpoint.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of pharmacokinetics and pharmacodynamics"
DOI: 10.1007/s10928-021-09796-3
Abstract: Exposure-response modeling is important to optimize dose and dosing regimens in clinical drug development. While primary clinical trial endpoints often have few categories and thus provide only limited information, sometimes there may be additional, more… read more here.
Keywords: response modeling; exposure response; endpoint; response ... See more keywords
Interim monitoring in a treatment strategy trial with a composite primary endpoint.
Sign Up to like & getrecommendations! Published in 2019 at "Contemporary clinical trials"
DOI: 10.1016/j.cct.2019.105846
Abstract: When a clinical trial has a composite endpoint and a comparison of treatment strategies with multiple intervention components, interim data reviews by a data safety and monitoring board (DSMB) can be challenging as the data… read more here.
Keywords: trial; endpoint; treatment; study ... See more keywords
A systematic review of in-hospital worsening heart failure as an endpoint in clinical investigations of therapy for acute heart failure.
Sign Up to like & getrecommendations! Published in 2018 at "International journal of cardiology"
DOI: 10.1016/j.ijcard.2017.10.023
Abstract: BACKGROUND In-hospital worsening heart failure (WHF) occurs frequently in patients hospitalized for acute heart failure (AHF) and has strongly negative prognostic associations. It may be a useful endpoint in studies of AHF management but important… read more here.
Keywords: hospital whf; failure; endpoint; heart failure ... See more keywords
COPDCompEx: A novel composite endpoint for COPD exacerbations to enable faster clinical development.
Sign Up to like & getrecommendations! Published in 2020 at "Respiratory medicine"
DOI: 10.1016/j.rmed.2020.106175
Abstract: BACKGROUND Frequency of moderate and severe chronic obstructive pulmonary disease exacerbations is an important endpoint in clinical trials, but makes them large and lengthy when powered to evaluate it. We aimed to develop a composite… read more here.
Keywords: endpoint; copdcompex; treatment; event ... See more keywords
Quantitative decision-making in randomized Phase II studies with a time-to-event endpoint
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2018.1489400
Abstract: ABSTRACT One of the most critical decision points in clinical development is Go/No-Go decision-making after a proof-of-concept study. Traditional decision-making relies on a formal hypothesis testing with control of type I and type II error… read more here.
Keywords: decision; phase; endpoint; time event ... See more keywords
The endpoint theorem * * This paper is dedicated to the memory of Christopher J S Clarke.
Sign Up to like & getrecommendations! Published in 2021 at "Classical and Quantum Gravity"
DOI: 10.1088/1361-6382/abe1fe
Abstract: The endpoint theorem links the existence of a sequence (curve), without accumulation points, in a manifold to the existence of an open embedding of that manifold so that the image of the given sequence (curve)… read more here.
Keywords: endpoint; paper dedicated; theorem paper; sequence curve ... See more keywords
Adaptive clinical trial designs with blinded selection of binary composite endpoints and sample size reassessment.
Sign Up to like & getrecommendations! Published in 2022 at "Biostatistics"
DOI: 10.1093/biostatistics/kxac040
Abstract: For randomized clinical trials where a single, primary, binary endpoint would require unfeasibly large sample sizes, composite endpoints (CEs) are widely chosen as the primary endpoint. Despite being commonly used, CEs entail challenges in designing… read more here.
Keywords: sample size; primary endpoint; endpoint; trial ... See more keywords