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
Document Type
Article
Publication Date
1-1-2024
Abstract
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. © 2023 The Author(s)
Keywords
Adult, Bayes Theorem, Critical Care, Critical Illness, Cross-Sectional Studies, Hand Strength, Humans, Multicenter Studies as Topic, Quality of Life, Randomized Controlled Trials as Topic, high protein enteral nutrition, miscellaneous drugs and agents, nutrition supplement, standard protein enteral nutrition, unclassified drug, acute kidney failure, adult, Article, artificial ventilation, Bayes theorem, clinical outcome, clinical protocol, controlled study, European Quality of Life 5 Dimensions 5 Level questionnaire, follow up, grip strength, health care cost, health care quality, hepatic encephalopathy, hospital admission, hospitalization, human, intensive care, length of stay, male, multicenter study, multiple organ failure, muscle strength, outcome assessment, physical activity, quality of life, questionnaire, randomized controlled trial, sepsis, Sequential Organ Failure Assessment Score, six minute walk test, Bayes theorem, critical illness, cross-sectional study, hand strength, intensive care, multicenter study (topic), procedures, quality of life, randomized controlled trial (topic)
Divisions
anaesthesiology
Funders
Netherlands Organization for Health Research and Development,Belgian Healthcare Knowledge Centre (KCE) (BeNeFIT18574),Danone Nutricia
Publication Title
Clinical Nutrition ESPEN
Volume
59
Publisher
Elsevier
Additional Information
Cited by: 0; All Open Access, Hybrid Gold Open Access