Albert Malin, Thonander Marie, Forsberg Sune, Lindgren Frida, Thuccani Meena, Odell Annika, Skoglund Kristofer, Bergh Niklas, Hollenberg Jacob, Ringh Mattias, Jonsson Martin, Nordberg Per, Lundgren Peter
Department of Clinical Science and Education, Södersjukhuset, Centre for Resuscitation Science, Karolinska Institutet, Sweden.
Department of Molecular and Clinical Medicine, Institute of Medicine, University of Gothenburg, Sweden.
Resusc Plus. 2024 Apr 26;18:100645. doi: 10.1016/j.resplu.2024.100645. eCollection 2024 Jun.
No previous study has evaluated patients attitudes towards inclusion in an ongoing cardiac arrest clinical trial. The aim of this study was to assess patientś willingness and motives to participate in the ongoing randomized controlled drug trial "Vasopressin and Steroids in addition to Adrenaline in cardiac arrest" (VAST-A trial) in case of an in-hospital cardiac arrest (IHCA).
Hospitalized patients, men ≥ 18 and women ≥ 50 years, were asked for informed consent for inclusion in the VAST-A trial in case of an IHCA, the reason for approving or declining inclusion in the trial and baseline characteristics.
Patients admitted to hospital were asked to give informed consent of inclusion in VAST-A in case of an IHCA during their hospital stay. Patients were also asked why they approved or declined inclusion as well as baseline characteristics questions.
1,064 patients were asked about willingness to participate in the VAST-A trial, of these 902 (84.8%) patients approved inclusion. A subgroup of 411 patients were, except willingness, also asked about motives to participate or not and basic characteristics. The main reason for approving inclusion was to contribute to research ( = 328, 83.9%). The main reason for declining inclusion was concerns regarding testing the drug treatment ( = 6, 30%).
Among hospitalized patients the vast majority gave informed consent to inclusion in an ongoing randomized cardiac arrest drug trial. The main reason for approving inclusion was to contribute to research.
此前尚无研究评估患者对于纳入正在进行的心脏骤停临床试验的态度。本研究的目的是评估患者在发生院内心脏骤停(IHCA)时参与正在进行的随机对照药物试验“心脏骤停时除肾上腺素外使用血管加压素和类固醇”(VAST-A试验)的意愿和动机。
询问年龄≥18岁的男性和≥50岁的女性住院患者,在发生IHCA时是否愿意知情同意纳入VAST-A试验,批准或拒绝纳入试验的原因以及基线特征。
要求住院患者在住院期间就发生IHCA时纳入VAST-A试验给予知情同意。还询问患者批准或拒绝纳入的原因以及基线特征问题。
询问了1064名患者参与VAST-A试验的意愿,其中902名(84.8%)患者批准纳入。411名患者的亚组除了被询问意愿外,还被询问参与或不参与的动机以及基本特征。批准纳入的主要原因是为研究做出贡献(n = 328,83.9%)。拒绝纳入的主要原因是对药物治疗试验的担忧(n = 6,30%)。
在住院患者中,绝大多数人给予了知情同意,纳入正在进行的随机心脏骤停药物试验。批准纳入的主要原因是为研究做出贡献。