Chatzopoulou Despoina, Jalal Arif Hanafi Bin, Stoyanov Danail, Marcus Hani J, Pandit Anand S
Department of General Surgery, Southampton General Hospital, Southampton, United Kingdom.
UCL Medical School, University College London, London, United Kingdom.
Front Surg. 2024 Feb 21;11:1361040. doi: 10.3389/fsurg.2024.1361040. eCollection 2024.
Informed consent is a fundamental component in the work-up for surgical procedures. Statistical risk information pertaining to a procedure is by nature probabilistic and challenging to communicate, especially to those with poor numerical literacy. Visual aids and audio/video tools have previously been shown to improve patients' understanding of statistical information. In this study, we aimed to explore the impact of different methods of risk communication in healthy participants randomized to either undergo the consent process with visual aids or the standard consent process for lumbar puncture.
Healthy individuals above 18 years old were eligible. The exclusion criteria were prior experience of the procedure or relevant medical knowledge, lack of capacity to consent, underlying cognitive impairment and hospitalised individuals. After randomisation, both groups received identical medical information about the procedure of a lumbar puncture in a hypothetical clinical scenario via different means of consent. The control group underwent the standard consent process in current clinical practice (Consent Form 1 without any illustrative examples), whereas the intervention group received additional anatomy diagrams, the Paling Palette and the Paling perspective scale. Anonymised questionnaires were received to evaluate their perception of the procedure and its associated risks.
Fifty-two individuals were eligible without statistically significant differences in age, sex, professional status and the familiarity of the procedure. Visual aids were noted to improve the confidence of participants to describe the risks by themselves ( = 0.009) and participants in the intervention group felt significantly less overwhelmed with medical information ( = 0.028). The enhanced consent process was found to be significantly more acceptable by participants ( = 0.03). There was a trend towards greater appropriateness ( = 0.06) and it appeared to have "good" usability (median SUS = 76.4), although this also did not reach statistical significance ( = 0.06).
Visual aids could be an appropriate alternative method for medical consent without being inferior regarding the understanding of the procedure, its risks and its benefits. Future studies could possibly compare or incorporate multiple interventions to determine the most effective tools in a larger scale of population including patients as well as healthy individuals.
知情同意是外科手术检查工作的一个基本组成部分。与手术相关的统计风险信息本质上是概率性的，且难以传达，尤其是对于那些数字素养较差的人。此前已有研究表明，视觉辅助工具和音频/视频工具可提高患者对统计信息的理解。在本研究中，我们旨在探讨不同风险沟通方法对随机分配接受腰椎穿刺可视化辅助同意过程或标准同意过程的健康参与者的影响。
18岁以上的健康个体符合条件。排除标准包括既往有该手术经验或相关医学知识、无同意能力、存在潜在认知障碍以及住院患者。随机分组后，两组通过不同的同意方式，在假设的临床场景中接受关于腰椎穿刺手术的相同医学信息。对照组采用当前临床实践中的标准同意过程（无任何示例的同意书1），而干预组则额外获得了解剖图、帕林调色板和帕林视角量表。通过匿名问卷评估他们对手术及其相关风险的认知。
52名个体符合条件，在年龄、性别、职业状况和对手术的熟悉程度方面无统计学显著差异。视觉辅助工具被认为可提高参与者自行描述风险的信心（P = 0.009），干预组的参与者对医学信息的不知所措感明显减轻（P = 0.028）。参与者认为强化后的同意过程明显更可接受（P = 0.03）。在适当性方面有增加的趋势（P = 0.06），并且似乎具有“良好”的可用性（SUS中位数 = 76.4），尽管这也未达到统计学显著性（P = 0.06）。
视觉辅助工具可能是医学同意的一种合适替代方法，在对手术过程、其风险和益处的理解方面并不逊色。未来的研究可能会比较或纳入多种干预措施，以在包括患者和健康个体在内的更大规模人群中确定最有效的工具。
