Consent is a confounding factor in a prospective observational study of critically ill elderly patients
Flaatten, Hans (Haukeland University Hospital (Bergen, Noruega))
Guidet, Bertrand (Sorbonne Université)
Jung, Christian (University Hospital of Düsseldorf (Alemanya))
Boumendil, Ariane (Hôpital Saint-Antoine)
Leaver, Susannah (Research Lead Critical Care Directorate St George's Hospital)
Szczeklik, Wojciech (Jagiellonian University Medical College)
Artigas Raventós, Antoni (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Andersen, Finn H (Ålesund Hospital)
Moreno, Rui (Centro Hospitalar Universitário de Lisboa Central)
Walther, Sten (Linkoping University Hospital)
Oeyen, Sandra (Universitair Ziekenhuis Gent)
Schefold, Joerg C. (University of Bern)
Marsh, Brian (Mater Misericordiae University Hospital(Dublín, Irlanda))
Joannidis, Michael (Medical University Innsbruck)
Elhadi, Muhammed (University of Tripili)
Nalapko, Yuriy (European Wellness International)
Fjølner, Jesper (Viborg Regional Hospital)
De Lange, Dylan W (University Utrecht)
Universitat Autònoma de Barcelona

Date:	2022
Abstract:	During analysis of a prospective multinational observation study of critically ill patients ≥80 years of age, the VIP2 study, we also studied the effects of differences in country consent for study inclusion. This is a post hoc analysis where the ICUs were analyzed according to requirement for study consent. Group A: ICUs in countries with no requirement for consent at admission but with deferred consent in survivors. Group B: ICUs where some form of active consent at admission was necessary either from the patient or surrogates. Patients' characteristics, the severity of disease and outcome variables were compared. Totally 3098 patients were included from 21 countries. The median age was 84 years (IQR 81-87). England was not included because of changing criteria for consent during the study period. Group A (7 countries, 1200 patients), and group B (15 countries, 1898 patients) were comparable with age and gender distribution. Cognition was better preserved prior to admission in group B. Group A suffered from more organ dysfunction at admission compared to group B with Sequential Organ Failure Assessment score median 8 and 6 respectively. ICU survival was lower in group A, 66. 2% compared to 78. 4% in group B (p<0. 001). We hence found profound effects on outcomes according to differences in obtaining consent for this study. It seems that the most severely ill elderly patients were less often recruited to the study in group B. Hence the outcome measured as survival was higher in this group. We therefore conclude that consent likely is an important confounding factor for outcome evaluation in international studies focusing on old patients.
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Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	PloS one, Vol. 17 (october 2022) , ISSN 1932-6203

DOI: 10.1371/journal.pone.0276386
PMID: 36301954

9 p, 437.1 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Parc Taulí Research and Innovation Institute (I3PT
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