关键词: Clinical trial Incidental findings Radiographic imaging Research engagement

来  源:   DOI:10.1016/j.conctc.2024.101305   PDF(Pubmed)

Abstract:
UNASSIGNED: Incidental findings (IFs) in radiographic imaging are unexpected discoveries unrelated to the purpose of the scan. While the protocol for communicating IFs is better defined for clinical providers, little formal guidance on communicating IFs identified on research scans to participants is available. This study explored participants\' experience with communication and management of IFs found on imaging identified in a clinical research trial.
UNASSIGNED: Participants who completed the parent clinical trial, which included imaging, were invited to participate. A survey, developed by the study team, was administered telephonically, and consisted of multiple choice and open-ended questions.
UNASSIGNED: Thirty participants enrolled in the survey study. Ninety-three percent of all participants (with and without IFs) reported they would participate in another research study to learn information that was important to their health. Seventeen participants reported being notified about an IF on their study scan(s). Ninety-four percent of those participants with an IF were satisfied with how the IF was communicated, and 71 % were grateful to find out about a health problem before it became an issue. Forty-one percent reported that learning about the IF led to improved health. Content analysis of the data from the open-ended questions revealed categories and themes which enriched the quantitative data.
UNASSIGNED: Participants generally wanted to know when an IF was discovered unexpectedly on their imaging scan, as they learned important information about their health. Findings underscore the importance of having a clear protocol for communicating IFs to research study participants that undergo evaluation with radiographic imaging.
摘要:
射线照相成像中的偶然发现(IF)是与扫描目的无关的意外发现。虽然为临床提供者更好地定义了通信IF的协议,关于将研究扫描中确定的IF传达给参与者的正式指导很少。这项研究探索了参与者在一项临床研究试验中确定的影像学上发现的IF的沟通和管理经验。
完成父母临床试验的参与者,其中包括成像,被邀请参加。一项调查,由研究小组开发,是通过电话管理的,由多项选择题和开放式问题组成。
30名参与者参加了调查研究。所有参与者(有和没有IFs)的93%报告说,他们将参加另一项研究,以了解对他们的健康重要的信息。17名参与者报告在他们的研究扫描中被告知IF。有IF的参与者中有94%对IF的传达方式感到满意,71%的人很感激在健康问题成为问题之前发现了它。41%的人报告说,了解IF可以改善健康状况。对开放式问题的数据进行内容分析,揭示了丰富定量数据的类别和主题。
参与者通常想知道何时在成像扫描中意外发现了IF,当他们了解到有关健康的重要信息时。研究结果强调了具有明确协议的重要性,该协议将IF传达给接受射线照相成像评估的研究参与者。
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