Department of Internal Medicine III, University of Cologne, Cologne, Germany.
PLoS One. 2010 Dec 20;5(12):e15164. doi: 10.1371/journal.pone.0015164.
Patients' informed consent is legally essential before elective invasive cardiac angiography (CA) and successive intervention can be done. It is unknown to what extent patients can remember previous detailed information given by a specially trained doctor in an optimal scenario as compared to standard care.
METHODOLOGY/PRINCIPAL FINDINGS: In this prospective cohort study 150 consecutive in-patients and 50 out-patients were included before elective CA was initiated. The informed consent was provided and documented in in-patients by trained and instructed physicians the day before CA. In contrast, out-patients received standard information by different not trained physicians, who did not know about this investigation. All patients had to sign a form stating that enough information had been given and all questions had been answered sufficiently. One hour before CA an assessment of the patients' knowledge about CA was performed using a standard point-by-point questionnaire by another independent physician. The supplied information was composed of 12 potential complications, 3 general, 4 periprocedural and 4 procedural aspects. 95% of the patients felt that they had been well and sufficiently informed. Less than half of the potential complications could be remembered by the patients and more patients could remember less serious than life-threatening complications (27.9±8.8% vs. 47.1±11.0%; p<0.001). Even obvious complications like local bleeding could not be remembered by 35% of in-patients and 36% of out-patients (p = 0.87). Surprisingly, there were only a few knowledge differences between in- and out-patients.
The knowledge about CA of patients is vague when they give their informed consent. Even structured information given by a specially trained physician did not increase this knowledge.
在选择性侵入性心脏血管造影（CA）和随后的干预之前，患者的知情同意在法律上是必不可少的。目前尚不清楚在最佳情况下，与标准护理相比，患者能在多大程度上记住专门培训的医生之前提供的详细信息。
方法/主要发现：在这项前瞻性队列研究中，在开始选择性 CA 之前，共纳入了 150 名住院患者和 50 名门诊患者。在住院患者中，由经过培训和指导的医生在 CA 前一天提供并记录知情同意书。相比之下，门诊患者由未经培训的不同医生接受标准信息，这些医生并不知道这项检查。所有患者都必须签署一份表格，表明已提供足够的信息，并已充分回答了所有问题。在 CA 前 1 小时，由另一位独立医生使用标准的逐项问卷评估患者对 CA 的了解程度。提供的信息包括 12 种潜在的并发症、3 种一般、4 种围手术期和 4 种手术方面的问题。95%的患者认为他们得到了很好且充分的告知。患者只能记住不到一半的潜在并发症，而且更多的患者只能记住不太严重的危及生命的并发症（27.9±8.8%比 47.1±11.0%；p<0.001）。即使是局部出血等明显的并发症，也有 35%的住院患者和 36%的门诊患者无法记住（p=0.87）。令人惊讶的是，住院患者和门诊患者之间的知识差异很小。
当患者给予知情同意时，他们对 CA 的了解是模糊的。即使是由专门培训的医生提供的结构化信息也没有增加这种知识。
