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- W3093436280 abstract "Background: The Swiss Federal Act on Research involving Human Beings was revised in2014. To our knowledge, the impact of these new rules regarding research in emergencysituations with persons unable to consent has not been demonstrated yet. The objective of thiswork is to assess flow, quality, and effectiveness of informed consent in a clinical trial involvingadults with acute consciousness disorders, the CERTA study (Continuous EEG RandomizedTrial in Adults), aiming at assessing the impact on clinical outcome of continuouselectroencephalography. This analysis could reveal whether the recent laws can be translatedinto practice and how they might affect study results.Methods: We analysed the consent procedure from patients with impaired consciousnessenrolled in the CERTA study. All information was prospectively collected. Patients included inthe CERTA study were adults (18 years) with acute consciousness disorders of any etiology,treated in an intensive or intermediate care unit of 4 Swiss tertiary hospitals (Centre HospitalierUniversitaire Vaudois, Hopital du Valais, Inselspital Bern, Universitatsspital Basel), requiringan EEG for clinical purposes. The last inclusion criterion was the obtainment of informedconsent for research in emergency situations according to the Human Research Act. Waiversof informed consent were granted from the Ethics Committee in some specific conditions(patients dying early, care withdrawal, or relative’s unavailability despite repeated attempts).Results: 402 patients were randomized. Among those, 7 (1.7%) were excluded (6 doubleinclusions, 1 death prior to intervention) and data from 27 (6.7%) could not be used becauseof a lack of consent, leaving 368 (91.5%) analysable patients. For each, we found that all stepsof the consent procedure were completed. However, only in 14.1% (52/368 analysablepatients) could a statement of wishes reporting no objection to research before the currentcondition be identified in medical charts or with the family, despite at least 3 attempts. In 134subjects (36.4% of analysable patients), consent was waived according to a per protocolprocedure allowing analysis of patients dying early, while 234 (63.6% of analysable) patientshad an informed consent. Among the latter, 77 (20.9%) were post-hoc, 102 (27.7%) were byproxy, and 55 (14.9%) patients had both a post-hoc and a proxy consent.Conclusion: While the consent process in this particular setting seems applicable, certainpoints appear difficult to translate into clinical practice. A statement of wishes reporting noobjection to research could be retrieved in only 14.1% of recruited patients, after severalattempts. Informed consent was obtained in only approximately 2/3 of patients, more frequentlyby proxy, and was waived in approximately 1/3 according to an exception stipulated in theprotocol, which shows the importance of these waivers for recruitment and the study validity insuch conditions. Also, nearly 7% of enrolments did not comply with the consent process andhad to be completely discarded, not only potentially biasing outcome assessment (only insurviving patients could consent be refused) but also preventing analysis of reasons for this.Further trials in this setting should aim at allowing analysis of at least some non-sensitive dataof patients with consent refusals, and specifically foresee inclusion of patients reaching earlyan endpoint for the study." @default.
- W3093436280 created "2020-10-22" @default.
- W3093436280 creator A5035318671 @default.
- W3093436280 date "2019-01-01" @default.
- W3093436280 modified "2023-09-26" @default.
- W3093436280 title "Evaluation of informed consent to clinical investigation in patients with acute impairment of consciousness" @default.
- W3093436280 hasPublicationYear "2019" @default.
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