Intensive care unit patients' opinion on enrollment in clinical research: A multicenter survey
| Autor: | Adriano José Pereira, Carolina Aguiar Sant Anna Siqueri, Ricardo Luiz Cordioli, Fernanda Guimarães Aguiar, Ary Serpa Neto, Thiago Domingos Corrêa, Renato Carneiro de Freitas Chaves, Niklas Söderberg Campos, Flavia Julie do Amaral Pfeilsticker, Murillo Santucci Cesar de Assunção, Maria Laura Romagnoli, Carolina Scoqui Guimarães |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
Biomedical Research Economics Epidemiology Social Sciences Cultural Anthropology law.invention 0302 clinical medicine Sociology Informed consent law Surveys and Questionnaires Medicine and Health Sciences Salaries Prospective Studies 030212 general & internal medicine Aged 80 and over Informed Consent Multidisciplinary Middle Aged Intensive care unit Emergency situations Hospitals Icu admission Religion Intensive Care Units Research Design Medicine Female Brazil Research Article Adult medicine.medical_specialty Drug Research and Development Critical Care Research Subjects Science Research and Analysis Methods 03 medical and health sciences medicine Humans Clinical Trials Aged Pharmacology Survey Research business.industry 030208 emergency & critical care medicine Health Care Clinical trial Clinical research Attitude Health Care Facilities Labor Economics Anthropology Medical Risk Factors Family medicine Multicenter survey Minimum Wage Law and Legal Sciences Clinical Medicine business Scientific study |
| Zdroj: | PLoS ONE, Vol 15, Iss 8, p e0236675 (2020) PLoS ONE |
| ISSN: | 1932-6203 |
| Popis: | BACKGROUND: In most emergency situations or severe illness, patients are unable to consent for clinical trial enrollment. In such circumstances, the decision about whether to participate in a scientific study or not is made by a legally designated representative. OBJECTIVE: To address the willingness of patients admitted to the intensive care unit (ICU) to be enrolled in a scientific study as volunteers, and to assess the agreement between patients' and their legal representatives' opinion concerning enrollment in a scientific study. METHODS: This survey was conducted in two hospitals in São Paulo, Brazil. Patients (≥18 years) with preserved cognitive functions accompanied by a surrogate admitted to the ICU were eligible for this study. A survey containing 28 questions for patients and 8 questions for surrogates was applied within the first 48h from ICU admission. The survey for patients comprised three sections: demographic characteristics, opinion about participation in clinical research and knowledge about the importance of research. The survey for legal representatives contained two sections: demographic characteristics and assessment of legal representatives' opinion in authorizing patients to be enrolled in research. RESULTS: Between January 2017 and May 2018, 208 pairs of ICU patients and their respective legal representatives answered the survey. Out of 208 ICU patients answering the survey, 73.6% (153/208) were willing to be enrolled in the study as volunteers. Of those patients, 65.1% (97/149) would continue participating in a research even if their legal representative did not support their enrollment. Agreement between patients' and surrogates' opinion concerning participation was poor [Kappa = 0.11 (IC95% -0.02 to 0.25)]. If a consent for study participation had been obtained, 69.1% (103/149) of patients would continue participating in the study until its conclusion, and 23.5% (35/149) would allow researchers to use data collected to date, but would withdraw from the study on that occasion. CONCLUSION: The majority of patients admitted to the ICU were willing to be enrolled in a scientific study as volunteers, also after a deferred informed consent procedure has been used. Nevertheless, contradictory opinions between patients and their and their legal representatives' concerning enrollment in a scientific study were often observed. |
| Databáze: | OpenAIRE |
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