دورية أكاديمية
Perspectives of ICU Patients on Deferred Consent in the Context of Post-ICU Quality of Life: A Substudy of a Randomized Clinical Trial.
| العنوان: | Perspectives of ICU Patients on Deferred Consent in the Context of Post-ICU Quality of Life: A Substudy of a Randomized Clinical Trial. |
|---|---|
| المؤلفون: | van der Wal LI; Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands.; Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands., Grim CCA; Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands.; Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands., Del Prado MR; Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands., van Westerloo DJ; Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands., Schultz MJ; Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands.; Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands.; Department of Intensive Care, Amsterdam University Medical Centre, Location AMC, Amsterdam, The Netherlands.; Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand.; Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.; Department of Medical Ethics and Health Law, Leiden University Medical Centre, Leiden, The Netherlands., Helmerhorst HJF; Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands.; Department of Anaesthesiology, Leiden University Medical Centre, Leiden, The Netherlands., de Vries MC; Department of Medical Ethics and Health Law, Leiden University Medical Centre, Leiden, The Netherlands., de Jonge E; Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands. |
| مؤلفون مشاركون: | ICONIC Investigators |
| المصدر: | Critical care medicine [Crit Care Med] 2024 May 01; Vol. 52 (5), pp. 694-703. Date of Electronic Publication: 2024 Jan 05. |
| نوع المنشور: | Randomized Controlled Trial; Multicenter Study; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0355501 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1530-0293 (Electronic) Linking ISSN: 00903493 NLM ISO Abbreviation: Crit Care Med Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Philadelphia, PA : Lippincott Williams & Wilkins Original Publication: New York, Kolen. |
| مواضيع طبية MeSH: | Quality of Life* , Intensive Care Units*, Humans ; Netherlands |
| مستخلص: | Objectives: Deferred consent enables research to be conducted in the ICU when patients are unable to provide consent themselves, and there is insufficient time to obtain consent from surrogates before commencing (trial) treatment. The aim of this study was to evaluate how former ICU patients reflect on their participation in a study with deferred consent and examine whether their opinions are influenced by the quality of life (QoL) following hospital discharge. Design: Survey study by questionnaire. Setting: Eight ICUs in The Netherlands. Patients: Former ICU patients who participated in the ICONIC trial, a multicenter randomized clinical trial that evaluated oxygenation targets in mechanically ventilated ICU patients. Interventions: Participants enrolled in the ICONIC trial in one of the eight participating centers in The Netherlands received a questionnaire 6 months after randomization. The questionnaire included 12 close-ended questions on their opinion about the deferred consent procedure. QoL was measured using the EQ-5D-5L questionnaire. By calculating the EQ-5D index, patients were divided into four QoL quartiles, where Q1 reflects the lowest and Q4 is the highest. Measurements and Main Results: Of 362 participants who were contacted, 197 responded (54%). More than half of the respondents (59%) were unaware of their participation in the ICONIC study. In total 61% were content with the deferred consent procedure, 1% were not content, 25% neutral, 9% did not know, and 9% answered "other." Those with a higher QoL were more likely to be content ( p = 0.02). In all QoL groups, the legal representative was the most often preferred individual to provide consent. Conclusions: Former ICU patients who participated in the ICONIC study often did not remember their participation but were predominantly positive regarding the use of deferred consent. Those with a higher QoL were most likely to be content. Competing Interests: Dr. van der Wal’s institution received funding from the Dutch Research Council (NWO). Dr. Hemerhorst received support for article research from the NWO. Dr. Schultz is team leader of Medical Research at Hamilton Medical AG, Switzerland, since January 2022 and received grants from ZonMw, The Netherlands, for studies of ventilation. The Dutch Research Council funded the original trial, but was not involved in the study design, the collection of the data, the analysis or interpretation of the data, the writing of the report, or the decision to submit the article for publication. The remaining authors have disclosed that they do not have any potential conflicts of interest. (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and Wolters Kluwer Health, Inc.) |
| التعليقات: | Comment in: Crit Care Med. 2024 May 1;52(5):839-842. (PMID: 38619341) |
| References: | Eur Stroke J. 2021 Dec;6(4):395-402. (PMID: 35342818) Stroke. 2019 Apr;50(4):1017-1020. (PMID: 30869570) Trials. 2022 May 16;23(1):411. (PMID: 35578362) Ann Emerg Med. 2020 Sep;76(3):343-349. (PMID: 32446674) Intensive Care Med. 2002 Jul;28(7):898-907. (PMID: 12122528) Acta Neurochir (Wien). 2005 Jun;147(6):633-9; discussion 639-40. (PMID: 15806325) BMJ Open. 2022 May 4;12(5):e054787. (PMID: 35508349) BMC Emerg Med. 2020 Oct 1;20(1):76. (PMID: 33004018) Qual Life Res. 2021 Mar;30(3):647-673. (PMID: 33284428) Intensive Care Med. 2009 Oct;35(10):1655-8. (PMID: 19582396) Crit Care. 2010;14(1):R6. (PMID: 20089197) Resuscitation. 2012 Jan;83(1):81-5. (PMID: 21801702) Clin Trials. 2017 Apr;14(2):180-186. (PMID: 28359192) Emerg Med Australas. 2020 Aug;32(4):570-572. (PMID: 32043294) Intensive Care Med. 2013 Mar;39(3):472-80. (PMID: 23096429) Crit Care Med. 2015 Mar;43(3):603-12. (PMID: 25574795) Trials. 2022 Feb 13;23(1):136. (PMID: 35152909) Intensive Crit Care Nurs. 2022 Oct;72:103252. (PMID: 35396103) JAMA. 2013 Nov 27;310(20):2191-4. (PMID: 24141714) Am J Respir Crit Care Med. 2023 Oct 1;208(7):770-779. (PMID: 37552556) |
| تواريخ الأحداث: | Date Created: 20240105 Date Completed: 20240416 Latest Revision: 20240522 |
| رمز التحديث: | 20240523 |
| مُعرف محوري في PubMed: | PMC11008447 |
| DOI: | 10.1097/CCM.0000000000006184 |
| PMID: | 38180043 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1530-0293 |
|---|---|
| DOI: | 10.1097/CCM.0000000000006184 |