VA Center for Health Equity Research and Promotion, VA Pittsburgh, Healthcare System, Pittsburgh, Pennsylvania 15206, USA.
J Surg Res. 2012 Jun 15;175(2):227-33. doi: 10.1016/j.jss.2011.04.056. Epub 2011 May 23.
The Veterans Affairs Healthcare System implemented a computer-based tool (iMedConsent) to improve the quality of informed consent in 2004. The impact of this tool on the process of informed consent remains unknown. Our aim was to determine the impact of iMedConsent on patient information preference, anxiety, trust in the surgeon, ambivalence about the surgical decision, and comprehension of procedure-specific risk, benefits, and alternatives.
We prospectively enrolled a consecutive cohort of patients presenting to a general surgery clinic for possible cholecystectomy or inguinal herniorrhaphy from October 2009 to August 2010. We administered questionnaires before and after the clinic visit.
Seventy-five patients completed pre-visit questionnaires. After evaluation by the surgeon, 42 patients were offered surgery and documented their informed consent using iMedConsent, of whom 38 (90%) also completed a post-visit questionnaire. Among the participants who completed both pre- and post-visit questionnaires, participant comprehension of procedure-specific risks benefits and alternatives improved from 50% at baseline to 60% after the clinic visit (P < 0.001). No differences were noted in ambivalence, trust, or anxiety. After the clinic visit, significantly more patients expressed a preference for participating in decision making with their surgeon (98% versus 71%, P = 0.008). However, significantly fewer expressed a preference for knowing all possible details about their illness (25% to 83%, P ≤ 0.001).
The informed consent process using iMedConsent improves patient comprehension of procedure-specific risks, benefits, and alternatives. It also increases patient preferences for participating more actively in the decision-making process. However, the process may provide more detail than patients want regarding their illness.
退伍军人医疗保健系统于 2004 年实施了一种基于计算机的工具（iMedConsent），以提高知情同意的质量。该工具对知情同意过程的影响尚不清楚。我们的目的是确定 iMedConsent 对患者信息偏好、焦虑、对外科医生的信任、对手术决策的矛盾心理、以及对特定程序风险、收益和替代方案的理解的影响。
我们前瞻性地招募了 2009 年 10 月至 2010 年 8 月期间因胆囊切除术或腹股沟疝修补术就诊普外科诊所的连续队列患者。我们在就诊前和就诊后进行问卷调查。
75 例患者完成了就诊前的问卷。经外科医生评估后，42 例患者接受了手术，并使用 iMedConsent 记录了他们的知情同意书，其中 38 例（90%）也完成了就诊后的问卷。在完成就诊前和就诊后问卷的参与者中，参与者对特定程序风险收益和替代方案的理解从基线时的 50%提高到就诊后的 60%（P<0.001）。在矛盾心理、信任或焦虑方面没有差异。就诊后，更多的患者表示更喜欢与外科医生共同参与决策（98%比 71%，P=0.008）。然而，更喜欢了解他们疾病的所有可能细节的患者明显减少（25%到 83%，P≤0.001）。
使用 iMedConsent 的知情同意过程提高了患者对特定程序风险、收益和替代方案的理解。它还增加了患者更积极参与决策过程的偏好。然而，该过程可能会提供比患者希望了解更多关于他们疾病的信息。
