Romo-Avilés Nuria, Zapata Johanna Fröhlich, Keuneke Alena, Petroff David, Etz Christian D, Epstein David
Department of Social Anthropology, University of Granada, Spain.
Medical Anthropologist, Medical Anthropology Research Center, Berlin, Germany.
Contemp Clin Trials Commun. 2022 Sep 3;29:100987. doi: 10.1016/j.conctc.2022.100987. eCollection 2022 Oct.
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.
定性研究可以为理解临床试验中的决策过程带来新的维度。参与随机临床试验要求患者接受复杂的信息,并在不确定性的背景下做出决策。在严重疾病的情况下,这变得尤为复杂,因为治疗本身就意味着未知的风险。本研究在PAPAartis随机临床试验的背景下审视了这些问题,该试验旨在预防在胸腹主动脉瘤复杂手术修复后可能作为不良事件发生的脊髓损伤。在本研究中,我们接触了一组参与该试验的16名患者,并通过深入访谈,试图了解他们参与试验时的决策过程及其体验。我们的结果表明,患者参与的原因各不相同:出于对医生的信任、希望获得更好的治疗,或出于利他主义以及与科学合作的原因。许多患者觉得他们没有完全理解所提供的关于该研究的无关信息以及该程序的复杂性。避免截瘫在参与该试验的决策中起了根本性作用。患者的家庭支持和社会经济状况影响了术后的康复过程。