
Consent is a confounding factor in a prospective observational study of critically ill elderly patients
- Author
- Hans Flaatten, Bertrand Guidet, Christian Jung, Ariane Boumendil, Susannah Leaver, Wojciech Szczeklik, Antonio Artigas, Finn Andersen, Rui Moreno, Sten Walther, Sandra Oeyen (UGent) , Joerg C. Schefold, Brian Marsh, Michael Joannidis, Muhammed Elhadi, Yuriy Nalapko, Jesper Fjølner and Dylan W. de Lange
- Organization
- 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.
- Keywords
- Multidisciplinary
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Citation
Please use this url to cite or link to this publication: http://hdl.handle.net/1854/LU-01GS84HNH38Z9QATC5EM27M5V8
- MLA
- Flaatten, Hans, et al. “Consent Is a Confounding Factor in a Prospective Observational Study of Critically Ill Elderly Patients.” PLOS ONE, edited by Giuseppe Vittorio De Socio, vol. 17, no. 10, Public Library of Science (PLoS), 2022, doi:10.1371/journal.pone.0276386.
- APA
- Flaatten, H., Guidet, B., Jung, C., Boumendil, A., Leaver, S., Szczeklik, W., … de Lange, D. W. (2022). Consent is a confounding factor in a prospective observational study of critically ill elderly patients. PLOS ONE, 17(10). https://doi.org/10.1371/journal.pone.0276386
- Chicago author-date
- Flaatten, Hans, Bertrand Guidet, Christian Jung, Ariane Boumendil, Susannah Leaver, Wojciech Szczeklik, Antonio Artigas, et al. 2022. “Consent Is a Confounding Factor in a Prospective Observational Study of Critically Ill Elderly Patients.” Edited by Giuseppe Vittorio De Socio. PLOS ONE 17 (10). https://doi.org/10.1371/journal.pone.0276386.
- Chicago author-date (all authors)
- Flaatten, Hans, Bertrand Guidet, Christian Jung, Ariane Boumendil, Susannah Leaver, Wojciech Szczeklik, Antonio Artigas, Finn Andersen, Rui Moreno, Sten Walther, Sandra Oeyen, Joerg C. Schefold, Brian Marsh, Michael Joannidis, Muhammed Elhadi, Yuriy Nalapko, Jesper Fjølner, and Dylan W. de Lange. 2022. “Consent Is a Confounding Factor in a Prospective Observational Study of Critically Ill Elderly Patients.” Ed by. Giuseppe Vittorio De Socio. PLOS ONE 17 (10). doi:10.1371/journal.pone.0276386.
- Vancouver
- 1.Flaatten H, Guidet B, Jung C, Boumendil A, Leaver S, Szczeklik W, et al. Consent is a confounding factor in a prospective observational study of critically ill elderly patients. De Socio GV, editor. PLOS ONE. 2022;17(10).
- IEEE
- [1]H. Flaatten et al., “Consent is a confounding factor in a prospective observational study of critically ill elderly patients,” PLOS ONE, vol. 17, no. 10, 2022.
@article{01GS84HNH38Z9QATC5EM27M5V8, 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.}}, articleno = {{e0276386}}, author = {{Flaatten, Hans and Guidet, Bertrand and Jung, Christian and Boumendil, Ariane and Leaver, Susannah and Szczeklik, Wojciech and Artigas, Antonio and Andersen, Finn and Moreno, Rui and Walther, Sten and Oeyen, Sandra and Schefold, Joerg C. and Marsh, Brian and Joannidis, Michael and Elhadi, Muhammed and Nalapko, Yuriy and Fjølner, Jesper and de Lange, Dylan W.}}, editor = {{De Socio, Giuseppe Vittorio}}, issn = {{1932-6203}}, journal = {{PLOS ONE}}, keywords = {{Multidisciplinary}}, language = {{eng}}, number = {{10}}, pages = {{9}}, publisher = {{Public Library of Science (PLoS)}}, title = {{Consent is a confounding factor in a prospective observational study of critically ill elderly patients}}, url = {{http://doi.org/10.1371/journal.pone.0276386}}, volume = {{17}}, year = {{2022}}, }
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