Resuscitation plus · 2026
Attitudes of patients and family members towards deferred and waived consent in ECPR research, an ancillary study of the INCEPTION trial.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
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Eussen Stijn E D M, van de Koolwijk Anina F, Delnoij Thijs S R, Suverein Martje M, Essers Brigitte A B, Hermanides Renicus C, Otterspoor Luuk C, Elzo Kraemer Carlos V, Vlaar Alexander P J, van der Heijden Joris J, Scholten Erik, den Uil Corstiaan A, Reis Mirada Dinis Dos, Akin Sakir, de Metz Jesse, van der Horst Iwan, Winkens Bjorn, Maessen Jos G, Lorusso Roberto, van de Poll Marcel C G, INCEPTION-investigators
Аннотация
BACKGROUND: In emergency settings, obtaining timely informed consent is not always feasible, making deferred and waived consent a potential solution. Despite its frequent use in high-risk research, the experiences and opinions of patients and (bereaved) relatives have been scarcely investigated. This study examined their attitudes towards enrolment in the INCEPTION-trial (NCT03101787) on extracorporeal cardiopulmonary resuscitation (ECPR).
METHODS: Questionnaires were sent to survivors and (bereaved) relatives who had signed consent forms for follow-up research in the initial INCEPTION-trial. Additionally, relatives where consent was waived were contacted through their general practitioner with a request to participate. Responses included Likert-scale and free-text data, were analysed using descriptive statistics and non-parametric tests.
RESULTS: A total of 32 of 38 (overall response rate 84.2%) sent questionnaires were returned, from 9 survivors, 9 corresponding relatives of these survivors, 6 relatives of non-survivors who provided proxy consent and 8 relatives of non-survivors whose consent was waived. 81.3% of the respondents (strongly) supported alternative consent procedures. No statistically significant differences were found between survivors and non-survivors or ECPR versus conventional cardiopulmonary resuscitation (CCPR). The need for, and challenges of research in an emergency setting were acknowledged. Aftercare contact improved understanding of the trial and helped in bereavement processing.
CONCLUSIONS: Overall, patients and (bereaved) relatives had a positive attitude towards waived and deferred consent procedures in high-risk, high-mortality research in the emergency setting. Information provision at a later stage, once the emotional burden has eased, is appreciated.
METHODS: Questionnaires were sent to survivors and (bereaved) relatives who had signed consent forms for follow-up research in the initial INCEPTION-trial. Additionally, relatives where consent was waived were contacted through their general practitioner with a request to participate. Responses included Likert-scale and free-text data, were analysed using descriptive statistics and non-parametric tests.
RESULTS: A total of 32 of 38 (overall response rate 84.2%) sent questionnaires were returned, from 9 survivors, 9 corresponding relatives of these survivors, 6 relatives of non-survivors who provided proxy consent and 8 relatives of non-survivors whose consent was waived. 81.3% of the respondents (strongly) supported alternative consent procedures. No statistically significant differences were found between survivors and non-survivors or ECPR versus conventional cardiopulmonary resuscitation (CCPR). The need for, and challenges of research in an emergency setting were acknowledged. Aftercare contact improved understanding of the trial and helped in bereavement processing.
CONCLUSIONS: Overall, patients and (bereaved) relatives had a positive attitude towards waived and deferred consent procedures in high-risk, high-mortality research in the emergency setting. Information provision at a later stage, once the emotional burden has eased, is appreciated.