"There is nothing better than participating in this study": Living the PAPAartis cardiovascular randomised controlled trial.

Autor:	Romo-Avilés N; Department of Social Anthropology, University of Granada, Spain., Zapata JF; Medical Anthropologist, Medical Anthropology Research Center, Berlin, Germany., Keuneke A; Department of Social Anthropology, University of Granada, Spain., Petroff D; Clinical Trial Centre, University of Leipzig, Germany., Etz CD; University Department for Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany., Epstein D; Department of Applied Economics, University of Granada, Spain.
Jazyk:	angličtina
Zdroj:	Contemporary clinical trials communications [Contemp Clin Trials Commun] 2022 Sep 03; Vol. 29, pp. 100987. Date of Electronic Publication: 2022 Sep 03 (Print Publication: 2022).
DOI:	10.1016/j.conctc.2022.100987
Abstrakt:	Qualitative research can bring new dimensions of understanding decision-making process in clinical trials. Participating in a randomized clinical trial requires patients to accept complex information and make decisions in a context of uncertainty. It becomes especially complicated in the case of serious diseases in which the treatment itself implies unknown risks. This study examines these issues in the context of the PAPAartis randomized clinical trial, which aims to prevent spinal cord injuries that can occur as an adverse event following complex surgical repair of thoracoabdominal aneurysm. In this study, we accessed a group of 16 patients participating in the trial and, through in-depth interviews, sought to understand the decision-making process when taking part in the trial and their experience of it. Our results showed that patients participated for different reasons: due to trust in doctors, the hope of having a better treatment or for altruistic and collaborative reasons with science. Many patients felt they did not fully understand the extraneous information provided about the study and the complex nature of the procedure. Avoidance of paraplegia played a fundamental role in the decision to participate in this trial. Family support and the socioeconomic conditions of the patients influenced the recovery process after surgery. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2022 The Authors.)
Databáze:	MEDLINE
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