CEO, Patient Safety America, Houston, Texas, USA
University of Kansas, Lawrence, Kansas, USA.
BMJ Open. 2019 Jul 30;9(7):e028957. doi: 10.1136/bmjopen-2019-028957.
In approximately half the states in the USA, and more recently in the UK, informed consent is legally defined as what a reasonable patient would wish to know. Our objective was to discern the information needs of a hospitalised, 'reasonable patient' during the informed-consent process.
We performed a cross-sectional study to develop a survey instrument and better define 'reasonable person' in relation to informed consent in a hypothetical scenario where an invasive procedure may be an option.
A 10-question survey was administered from April 19 through 22 October 2018 to three groups: student nurses (n=76), health professions educators (n=63) and a US national population (n=1067).
The primary outcome measure was the average intensity, on a 5-point scale, by which survey groups wished to have each of 10 questions answered. The secondary outcome was to discern relationships between survey demographics and the intensity by which participants wanted an answer.
Despite substantial demographic differences in the nursing-student group and health-professions-educator group, the average intensity scores were within 0.2 units on nine of 10 questions. The national survey revealed a strong desire to have an answer to each question (range 3.98-4.60 units). It showed that women desired answers more than men and older adults desired answers more than younger adults.
Based on responses to 10 survey questions regarding wishes of people in a situation where an invasive procedure may be necessary, the vast majority want an answer to each question. They wanted to know about all treatment options, risky drugs, decision aids, who will perform the procedure, and the cost. They wanted their advocate present, periodic review of their medical record, a full day to review documents and expected outcomes and restrictions after the procedure.
在美国约一半的州,以及最近在英国,知情同意在法律上被定义为一个合理的患者希望知道的内容。我们的目的是在知情同意过程中,确定住院“合理患者”的信息需求。
我们进行了一项横断面研究,以开发一种调查工具,并在一个可能选择侵入性程序的假设情况下,更好地定义与知情同意相关的“合理人”。
2018 年 4 月 19 日至 10 月 22 日,我们向三组人群发放了一份包含 10 个问题的调查问卷:学生护士(n=76)、医疗保健专业教育者(n=63)和美国全国人口(n=1067)。
主要结果测量指标是各调查小组希望回答 10 个问题中的每个问题的 5 分制平均强度。次要结果是要发现调查人群统计学与参与者希望回答问题的强度之间的关系。
尽管护理学生组和医疗保健专业教育者组在人口统计学上存在很大差异,但在 10 个问题中的 9 个问题上,平均强度得分相差在 0.2 个单位以内。全国性调查显示,人们强烈希望对每个问题都有答案(范围为 3.98-4.60 个单位)。结果表明,女性比男性更希望得到答案,而老年人比年轻人更希望得到答案。
根据对 10 个关于在可能需要进行侵入性程序的情况下人们意愿的调查问题的回答,绝大多数人希望对每个问题都有答案。他们想了解所有治疗方案、风险药物、决策辅助工具、谁将进行手术以及手术费用。他们希望有自己的代言人在场、定期审查他们的医疗记录、一整天时间审查文件和预期结果以及手术后的限制。