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Consent is a confou...
Consent is a confounding factor in a prospective observational study of critically ill elderly patients
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- Flaatten, Hans (author)
- Haukeland Hosp, Norway
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- Guidet, Bertrand (author)
- Sorbonne Univ, France
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- Jung, Christian (author)
- Heinrich Heine Univ, Germany
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- Boumendil, Ariane (author)
- Hop St Antoine, France
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- Leaver, Susannah (author)
- St George Hosp, England
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- Szczeklik, Wojciech (author)
- Jagiellonian Univ Med Coll, Poland
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- Artigas, Antonio (author)
- Autonomous Univ Barcelona, Spain
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- Andersen, Finn (author)
- Alesund Hosp, Norway
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- Moreno, Rui (author)
- Ctr Hosp Univ Lisboa Cent, Portugal
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- Walther, Sten (author)
- Linköpings universitet,Institutionen för hälsa, medicin och vård,Medicinska fakulteten,Region Östergötland, Thorax-kärlkliniken i Östergötland
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- Oeyen, Sandra (author)
- Ghent Univ Hosp, Belgium
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- Schefold, Joerg C. (author)
- Univ Bern, Switzerland
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- Marsh, Brian (author)
- Mater Misericordiae Univ Hosp, Ireland
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- Joannidis, Michael (author)
- Med Univ Innsbruck, Austria
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- Elhadi, Muhammed (author)
- Univ Tripili, Libya
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- Nalapko, Yuriy (author)
- European Wellness Int, Ukraine
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- Fjolner, Jesper (author)
- Viborg Reg Hosp, Denmark
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- de Lange, Dylan W. (author)
- Univ Utrecht, Netherlands
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(creator_code:org_t)
- 2022-10-27
- 2022
- English.
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In: PLOS ONE. - : PUBLIC LIBRARY SCIENCE. - 1932-6203. ; 17:10
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Anestesi och intensivvård (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Anesthesiology and Intensive Care (hsv//eng)
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- art (subject category)
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- By the author/editor
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Flaatten, Hans
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Guidet, Bertrand
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Jung, Christian
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Boumendil, Arian ...
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Leaver, Susannah
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Szczeklik, Wojci ...
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show more...
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Artigas, Antonio
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Andersen, Finn
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Moreno, Rui
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Walther, Sten
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Oeyen, Sandra
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Schefold, Joerg ...
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Marsh, Brian
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Joannidis, Micha ...
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Elhadi, Muhammed
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Nalapko, Yuriy
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Fjolner, Jesper
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de Lange, Dylan ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Anesthesiology a ...
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PLOS ONE
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Linköping University