Department of Radiology, Division of Interventional Radiology, University of California San Diego, La Jolla, CA.
Department of Radiology, Division of Interventional Radiology, Stanford University, 300 Pasteur Dr, H3630, Stanford, CA 94305.
AJR Am J Roentgenol. 2023 Feb;220(2):272-281. doi: 10.2214/AJR.22.28165. Epub 2022 Sep 21.
Patient decision aids (PDAs) improve informed consent practices. Available PDAs for image-guided procedures are of limited quality. The purpose of this article was to evaluate the impact of PDAs on understanding and satisfaction among patients undergoing informed consent conversations before outpatient image-guided procedures. This prospective study included patients awaiting an interventional radiology clinic visit to discuss and obtain informed consent for an image-guided procedure. The study was conducted at two academic medical centers (site A, visits from August 2020 to July 2021; site B, visits from January 2021 to October 2021). Patients were assigned systematically at site A and randomly at site B to electronically receive or not receive a two-page PDA before the visit. PDAs described procedures and their benefits, risks, and alternatives at a sixth- to eighth-grade health literacy level and were vetted by diverse patient focus groups. Patients completed a postvisit survey (site A, by telephone; site B, online) assessing understanding of the procedure and satisfaction with the consent conversation using 5-point scales. Data were pooled between sites. The study included 105 patients (59 men, 46 women; median age, 67 years; 51 from site A, 54 from site B; 53 who received PDA, 52 who did not). Survey response rate was 100% (51/51) at site A and 67% (62/92) at site B. Patients who received, versus did not receive, a PDA reported greater understanding of benefits (4.5 vs 4.0, < .001), risks (4.4 vs 3.6, < .001), and alternatives (4.0 vs 3.3, < .001), and of what procedures involved (4.4 vs 4.1, = .02) and were more likely to feel that they were provided with enough time with the clinician (4.7 vs 4.5, = .03), listened to carefully (4.8 vs 4.4, < .001), free to choose any option including not to have the procedure (4.7 vs 4.3, < .001), given enough time to make a decision (4.8 vs 4.3, < .001), encouraged to ask questions (4.8 vs 4.5, < .001), and had questions answered (4.8 vs 4.4, = .001). Well-vetted plain-language PDAs provided before image-guided procedure consent conversations improve patients' self-perceived understanding of the procedure and satisfaction with the conversation. PDAs can be implemented effectively without requiring additional clinician time or effort.
患者决策辅助工具（PDAs）可改善知情同意实践。现有的用于图像引导程序的 PDAs 质量有限。本文旨在评估 PDAs 对接受门诊图像引导程序前知情同意谈话的患者理解和满意度的影响。这项前瞻性研究纳入了等待介入放射学诊所就诊以讨论和获得图像引导程序知情同意的患者。该研究在两家学术医疗中心进行（站点 A：2020 年 8 月至 2021 年 7 月就诊；站点 B：2021 年 1 月至 2021 年 10 月就诊）。在站点 A，患者系统地被分配，在站点 B 随机分配，在就诊前通过电子方式接收或不接收两页 PDA。PDAs 以六年级至八年级的健康素养水平描述了程序及其益处、风险和替代方案，并由不同的患者焦点小组进行了审查。患者在就诊后通过电话（站点 A）或在线（站点 B）完成调查，使用 5 分制评估对程序的理解和对同意谈话的满意度。数据在站点之间汇总。该研究纳入了 105 名患者（59 名男性，46 名女性；中位年龄 67 岁；51 名来自站点 A，54 名来自站点 B；53 名接受 PDA，52 名未接受 PDA）。站点 A 的调查回复率为 100%（51/51），站点 B 为 67%（62/92）。与未接受 PDA 的患者相比，接受 PDA 的患者报告对益处（4.5 比 4.0，<0.001）、风险（4.4 比 3.6，<0.001）和替代方案（4.0 比 3.3，<0.001）的理解程度更高，对所涉及的程序（4.4 比 4.1，=0.02）和与医生有足够的时间（4.7 比 4.5，=0.03）的理解程度更高，且更有可能感到他们得到了足够的时间与临床医生交谈（4.8 比 4.4，<0.001），仔细倾听（4.8 比 4.4，<0.001），可以自由选择任何选项，包括不进行该程序（4.7 比 4.3，<0.001），有足够的时间做出决定（4.8 比 4.3，<0.001），鼓励提问（4.8 比 4.5，<0.001），并得到问题的解答（4.8 比 4.4，=0.001）。经过充分审查的通俗易懂的 PDAs 在图像引导程序同意谈话之前提供，可提高患者对程序的自我感知理解和对谈话的满意度。PDAs 可以在不增加临床医生时间或精力的情况下有效实施。
