The impact of high versus standard enteral protein provision on functional recovery following intensive care admission: Protocol for a pre-planned secondary Bayesian analysis of the PRECISe trial.
Heuts, Samuel; de Heer, Pieter; Gabrio, Andreaet al.
2024 • In Clinical Nutrition ESPEN, 59, p. 162 - 170
2024 Clin Nutrition ESPEN - The impact of high versus standard enteral protein provision on functional recovery following intensive care admission- Protocol for a pre-planned secondary Bayesian analysis of the PRECISe trial.pdf
Bayesian; Critical illness; Functional outcomes; Nutrition; Protein; Adult; Humans; Bayes Theorem; Hand Strength; Cross-Sectional Studies; Critical Care/methods; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; Quality of Life; Critical Illness/therapy; Critical Care; Endocrinology, Diabetes and Metabolism; Nutrition and Dietetics
Abstract :
[en] [en] BACKGROUND: The PRECISe trial is a pragmatic, multicenter randomized controlled trial that evaluates the effect of high versus standard enteral protein provision on functional recovery in adult, mechanically ventilated critically ill patients. The current protocol presents the rationale and analysis plan for an evaluation of the primary and secondary outcomes under the Bayesian framework, with an emphasis on clinically important effect sizes.
METHODS: This protocol was drafted in agreement with the ROBUST-statement, and is submitted for publication before database lock and primary data analysis. The primary outcome is health-related quality of life as measured by the EQ-5D-5L health utility score and is longitudinally assessed. Secondary outcomes comprise the 6-min walking test and handgrip strength over the entire follow-up period (longitudinal analyses), and 60-day mortality, duration of mechanical ventilation, and EQ-5D-5L health utility scores at 30, 90 and 180 days (cross-sectional). All analyses will primarily be performed under weakly informative priors. When available, informative priors elicited from contemporary literature will also be incorporated under alternative scenarios. In all other cases, objectively formulated skeptical and enthusiastic priors will be defined to assess the robustness of our results. Relevant identified subgroups were: patients with acute kidney injury, severe multi-organ failure and patients with or without sepsis. Results will be presented as absolute risk differences, mean differences, and odds ratios, with accompanying 95% credible intervals. Posterior probabilities will be estimated for clinically important benefit and harm.
DISCUSSION: The proposed secondary, pre-planned Bayesian analysis of the PRECISe trial will provide additional information on the effects of high protein on functional and clinical outcomes in critically ill patients, such as probabilistic interpretation, probabilities of clinically important effect sizes, and the integration of prior evidence. As such, it will complement the interpretation of the primary outcome as well as several secondary and subgroup analyses.
Disciplines :
Anesthesia & intensive care
Author, co-author :
Heuts, Samuel ; Department of Cardiothoracic Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands
de Heer, Pieter; Department of Intensive Care Medicine, Maastricht University Medical Center+, Maastricht, the Netherlands
Gabrio, Andrea; Department of Methodology and Statistics, Maastricht University, Maastricht, the Netherlands
Bels, Julia L M ; Department of Intensive Care Medicine, Maastricht University Medical Center+, Maastricht, the Netherlands, School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands
Lee, Zheng-Yii ; Department of Anaesthesiology, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia, Department of Cardiac Anesthesiology & Intensive Care Medicine, Charité Berlin, Germany
Stoppe, Christian ; Department of Cardiac Anesthesiology & Intensive Care Medicine, Charité Berlin, Germany, University Hospital Würzburg, Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, Würzburg, Germany
van Kuijk, Sander; Department of Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht University Medical Center+, Maastricht, the Netherlands
Beishuizen, Albertus ; Intensive Care Center, Medisch Spectrum Twente, Enschede, the Netherlands
de Bie-Dekker, Ashley; Department of Intensive Care Medicine, Catharina Ziekenhuis Eindhoven, Eindhoven, the Netherlands
Fraipont, Vincent ; Intensive Care Unit, Citadelle Hospital, Liège, Belgium
Lamote, Stoffel; Department of Intensive Care Medicine, Academisch Ziekenhuis Groeninge, Kortijk, Belgium
Ledoux, Didier ; Université de Liège - ULiège > Département des sciences cliniques
Scheeren, Clarissa; Department of Intensive Care Medicine, Zuyderland Medisch Centrum, Heerlen, the Netherlands
De Waele, Elisabeth ; Department of Nutrition, Universitair Ziekenhuis Brussel, Jette, Belgium
van Zanten, Arthur ; Department of Intensive Care Medicine, Gelderse Vallei Ziekenhuis, Ede, the Netherlands, Division of Human Nutrition & Health, Wageningen University & Research, Wageningen, the Netherlands
Mesotten, Dieter; Department of Intensive Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium, Faculty of Medicine and Life Sciences, UHasselt, Diepenbeek, Belgium
van de Poll, Marcel C G ; Department of Intensive Care Medicine, Maastricht University Medical Center+, Maastricht, the Netherlands, School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands, Department of Surgery, Maastricht University Medical Center+, Maastricht, the Netherlands. Electronic address: marcel.vande.poll@mumc.nl
The impact of high versus standard enteral protein provision on functional recovery following intensive care admission: Protocol for a pre-planned secondary Bayesian analysis of the PRECISe trial.
ZonMw - Nederlandse Organisatie voor Gezondheidsonderzoek en Zorginnovatie KCE - Federaal Kenniscentrum voor de Gezondheidszorg
Funding text :
This research is funded by the Dutch Organisation for Health Research and Development (ZonMW) and the Belgian Healthcare Knowledge Centre (KCE) under the joint BeNeFIT call (BeNeFIT18574). Blinded study feeds are provided in-kind by Nutricia Research, Utrecht, the Netherlands.This research is funded by the Dutch Organisation for Health Research and Development (ZonMW) and the Belgian Healthcare Knowledge Centre (KCE) under the joint BeNeFIT call (BeNeFIT18574). Blinded study feeds are provided in-kind by Nutricia Research, Utrecht, the Netherlands.MvdP received travel and speaker fees from Nutricia and research funding from Nestle Health Science and Fresenius-Kabi, not related to this research. EDW received research grants, travel and speakers fees from the Belgian Government Health, KCE (Belgian Health Care), Baxter Healthcare, Fresenius, Nestlé and Art Medical.
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