• Injury · Nov 2024

    Deferred consent in emergency trauma research: A qualitative study assessing the healthcare professional's opinions.

    • Zynab Noori, Niek J Vianen, Van LieshoutEsther M MEMMTrauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. Electronic address: e.vanlieshout@erasmusmc.nl., KompanjeErwin J OEJODepartment of Intensive Care, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. Electronic address: e.j.o.kompanje@erasmusmc.nl., Iscander M Maissan, VerhofstadMichiel H JMHJTrauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. Electronic address: m.verhofstad@erasmusmc.nl., and Mark G Van Vledder.
    • Trauma Research Unit Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. Electronic address: zynab03@gmail.com.
    • Injury. 2024 Nov 1; 55 (11): 111759111759.

    IntroductionSeverely injured patients are often incapacitated to provide informed consent for clinical studies. Deferred consent could facilitate unbiased enrollment in studies involving these patients. Little is known about how healthcare professionals (HCPs) perceive deferred consent and how this impacts patient enrollment. The aim of this study was to identify factors that could influence HCPs decision-making during recruitment of patients for interventional studies in (pre)hospital emergency trauma research.MethodsThis was a qualitative study in which physicians and nurses working in prehospital or in-hospital care were interviewed using a semi-structured interview guide. Interviews were audio-recorded, transcribed, and analyzed according to thematic analysis as described by Braun and Clarke.ResultsTen semi-structured interviews were conducted with six physicians and four nurses. Eight themes were identified as being relevant consent related factors influencing HCPs' decision-making during patient recruitment in studies using deferred consent: (1) HCPs' lack of knowledge; (2) Patients' and proxies' inability to be informed; (3) Practical (im)possibilities for informed consent; (4) Nature of intervention; (5) HCPs' personal beliefs; (6) Importance of emergency care research; (7) HCPs' trust in legal base; and (8) Communication and collaboration.ConclusionsEight consent-related factors influencing HCPs' decision making were identified. Insufficient knowledge about consent procedures among HCPs leads to significant negative attitudes towards deferred consent.Copyright © 2024. Published by Elsevier Ltd.

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