title: Nutritional papers in ICU patients: what lies between the lines?
abstract: The abundance of literature related to nutritional support reflects its recently recognised role in preventing metabolic complications and gut dysfunction during critical illness. However, some published studies lack relevance to critically ill patients, as a result of the selection of subjects and outcome variables, or flaws in the study design, as well as in the type, composition, timing, route of administration and amount of nutritional support given. This review will highlight these confounding factors by describing two imaginary (but typical) clinical trials and by analysing some studies published. The point at issue is that basic quality requirements, such as the formulation of a prospective hypothesis and the delineation of the effects of the reference treatment, are often lacking in many studies published. Data analysis was often found to be biased by the absence of statistical power calculation and intention-to-treat analysis. Globally, studies designed to assess the effects of nutritional support on the outcome of critically ill patients, rarely fulfil basic quality requirements and should therefore be interpreted cautiously. We suggest simple strategies or study design that will allow important questions to be answered by future clinical trials.
authors.affiliation: Department of Intensive Care, RHMS, 80 chaussée de Saint-Amand, 7500 Tournai, Belgium. preiserj@ulb.ac.be
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Preiser
authors.forename: René
authors.initials: R
authors.lastname: Chioléro
authors.forename: Jan
authors.initials: J
authors.lastname: Wernerman
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D003362:Cost-Benefit Analysis; D003422:Critical Care / Q000191:economics / Q000379:methods* / Q000592:standards; D016638:Critical Illness / Q000401:mortality / Q000628:therapy*; D003627:Data Interpretation, Statistical; D004734:Energy Metabolism; D017408:Guidelines as Topic; D017052:Hospital Mortality; D006801:Humans; D016247:Information Storage and Retrieval; D007902:Length of Stay; D016239:MEDLINE; D009751:Nutritional Requirements; D018529:Nutritional Support / Q000191:economics / Q000379:methods* / Q000592:standards; D011643:Publishing; D012107:Research Design / Q000592:standards*; D012449:Safety; D015983:Selection Bias; D013997:Time Factors; D016896:Treatment Outcome