Division of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Department of Medical Humanities and Education, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
BMC Med Ethics. 2019 Jan 23;20(1):8. doi: 10.1186/s12910-019-0347-0.
Obtaining adequate informed consent from trauma patients is challenging and time-consuming. Healthcare providers must communicate complicated medical information to enable patients to make informed decisions. This study aimed to explore the challenges of obtaining valid consent and methods of improving the quality of the informed consent process for surgical procedures in trauma patients.
We conducted a systematic review of relevant English-language full-text original articles retrieved from PubMed (1961-August 2018) that had experimental or observational study design and involved adult trauma patients. Studies involving informed consent in clinical or research trials were excluded. Titles and abstracts of searched articles were reviewed and relevant data were extracted with a structured form. Results were synthesized with a narrative approach.
A total of 2044 articles were identified in the initial search. Only eight studies were included in the review for narrative synthesis. Six studies involved orthopedic surgeries, one involved nasal bone surgeries, and one involved trauma-related limb debridement. Only one study was conducted in an emergency department. Information recall was poor for trauma patients. Risk recall and comprehension were greater when written or video information was provided than when information was provided only verbally. Patient satisfaction was also greater when both written and verbal information were provided than when verbal information alone was provided; patients who received video information were more satisfied than patients who received written or verbal information.
Many articles have been published on the subject of informed consent, but very few of these have focused on trauma patients. More empirical evidence is needed to support the success of informed consent for trauma patients in the emergency department, especially within the necessarily very limited time frame. To improve the informed consent process for trauma patients, developing a structured and standardized informed consent process may be necessary and achievable; its effectiveness would require evaluation. Adequately educating and training healthcare providers to deliver structured, comprehensive information to trauma patients is crucial. Institutions should give top priority to ensuring patient-centered health care and improved quality of care for trauma patients.
从创伤患者处获得充分的知情同意是具有挑战性且耗时的。医疗保健提供者必须传达复杂的医疗信息，以使患者能够做出明智的决策。本研究旨在探讨获取有效同意书的挑战以及提高创伤患者手术知情同意过程质量的方法。
我们对从 PubMed（1961 年 8 月）检索到的具有实验或观察性研究设计且涉及成年创伤患者的相关英文全文原始文章进行了系统评价。排除了涉及临床或研究试验中知情同意的研究。对搜索文章的标题和摘要进行了审查，并使用结构化表格提取了相关数据。结果采用叙述性方法进行综合。
最初的搜索共确定了 2044 篇文章。只有 8 项研究被纳入综述进行叙述性综合。6 项研究涉及骨科手术，1 项涉及鼻骨手术，1 项涉及与创伤相关的肢体清创术。仅有 1 项研究在急诊科进行。创伤患者的信息回忆较差。与仅口头提供信息相比，提供书面或视频信息时，风险回忆和理解更好。当提供书面和口头信息时，患者满意度更高，而仅提供口头信息时患者满意度较低；与提供书面或口头信息的患者相比，提供视频信息的患者更满意。
许多文章都涉及知情同意书主题，但其中很少有专门针对创伤患者的。需要更多的实证证据来支持急诊科创伤患者知情同意书的成功，尤其是在必要的非常有限的时间范围内。为了改善创伤患者的知情同意过程，可能需要制定结构化和标准化的知情同意过程；其有效性需要进行评估。充分教育和培训医疗保健提供者，向创伤患者提供结构化、全面的信息至关重要。各机构应优先确保以患者为中心的医疗保健，并提高创伤患者的护理质量。
