Department of Experimental Medicine, Campania University L. Vanvitelli, Section of Hygiene Via L. Armanni 5, 80138, Naples, Italy.
BMC Med Ethics. 2019 Jan 7;20(1):1. doi: 10.1186/s12910-018-0340-z.
Informed consent (IC) is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions.
Adult postsurgical patients in nine general hospitals of Italy's Campania Region were interviewed via a structured questionnaire between the second and seventh day after the surgery at the end of the first surgical follow up visit. Physicians who were independent from the surgical team administered the questionnaire.
The written IC form was given to 84.5% of those interviewed. All recipients of the form signed it, either personally or through a delegate; however, 13.9% did not know/remember having done so; 51.8% said that they read it thoroughly. Of those who reported to have read it, 90.9% judged it to be clear. Of those receiving the written consent form, 52.0% had gotten it the day before the surgery at the earliest 41.1% received it some hours or immediately before the procedure. The written IC form was explained to 65.6% of the patients, and 93.9% of them received further oral information that deemed understandable. Most attention was given to the diagnosis and the type of surgical procedure, which was communicated respectively to 92.8 and 88.2% of the patients. Almost one in two patients believed that the information provided some emotional relief, while 23.2% experienced increased anxiety. Younger patients (age ≤ 60) and patients with higher levels of education were more likely to read the written IC form.
The written IC form is not sufficient in assuring patients and making them fully aware of choices they made for their health; pre-operative information that was delivered orally better served the patients' needs. To improve the quality of communication we suggest enhancing physicians' communication skills and for them to use structured conversation to ensure that individuals are completely informed before undergoing their procedures.
知情同意（IC）是帮助患者了解其治疗决策后果的重要步骤。对于手术而言，患者了解手术的风险和益处并据此做出决定至关重要。我们探讨了是否向患者提供了书面 IC 表格；他们是否阅读并签署了表格；他们是否与医生进行了口头沟通；这些沟通是否影响了患者的决策。
意大利坎帕尼亚地区 9 家综合医院的成年术后患者在术后第 2 天至第 7 天，在第一次手术随访结束时，通过结构化问卷接受采访。独立于手术团队的医生进行了问卷调查。
接受采访的患者中，84.5%的人收到了书面 IC 表格。所有收到表格的人都亲自或通过代表签署了表格；然而，13.9%的人表示不知道/不记得已经签署；51.8%的人表示他们已仔细阅读。在表示已阅读的人当中，90.9%的人认为表格内容清晰易懂。在收到书面同意书的人中，52.0%的人是在手术前一天最早收到的，41.1%的人是在手术前几小时或立即收到的。65.6%的患者收到了书面 IC 表格的解释，其中 93.9%的患者收到了他们认为可以理解的进一步口头信息。大多数患者关注的是诊断和手术类型，分别有 92.8%和 88.2%的患者获得了相关信息。近一半的患者认为提供的信息在某种程度上缓解了他们的情绪压力，而 23.2%的患者感到更加焦虑。年轻患者（年龄≤60 岁）和受教育程度较高的患者更有可能阅读书面 IC 表格。
书面 IC 表格并不能确保患者充分了解他们为自己的健康所做的选择；而口头提供的术前信息则更好地满足了患者的需求。为了提高沟通质量，我们建议增强医生的沟通技巧，并使用结构化对话确保在患者接受手术前完全知情。
