Noohi Forough, Sundaresan Manu S, Naylor Rochelle N, Ross Lainie Friedman
Department of Medicine, University of Chicago, Chicago, IL, USA.
Department of Pediatrics, University of Chicago, Chicago, IL, USA.
J Clin Transl Sci. 2023 Nov 22;7(1):e260. doi: 10.1017/cts.2023.684. eCollection 2023.
OBJECTIVES/GOALS: The Rare and Atypical DIAbetes NeTwork (RADIANT) aims to discover the underlying pathoetiology of atypical diabetes by conducting both genotyping and non-genetic deep phenotyping. While the return of genetic test results in research settings has been investigated, the return of non-genetic results (RoR-NG) has received less attention. We explore the RoR-NG with RADIANT investigators and participants.
METHODS/STUDY POPULATION: We conducted one-on-one interviews with 10 adult RADIANT participants and 10 RADIANT investigators. Participants also completed two health literacy screening tools and a survey on perspectives regarding return of results (RoR). Investigators completed one survey on experience and confidence in explaining clinical tests utilized in the RADIANT study and another survey on perspectives regarding RoR.
Most participants were non-Hispanic White. All participants had high scores on health literacy screens. Both RADIANT participants and investigators expressed strong support for RoR-NG. RADIANT participants and investigators acknowledged the different roles and responsibilities between research and clinical care for interpreting and acting on non-genetic results. However, the lines between clinical care and research in returning and acting on results were often blurred by both participants and investigators.
DISCUSSION/SIGNIFICANCE: Our study provides important insight into how both investigators and participants simultaneously distinguish and blur clinical and research roles and responsibilities when discussing non-genetic research results and the return of these results. Further study should engage individuals from diverse racial and ethnic backgrounds and with varying levels of health literacy to understand how best to support all participants when returning research results.
罕见与非典型糖尿病网络（RADIANT）旨在通过基因分型和非基因深度表型分析来发现非典型糖尿病的潜在病因。虽然研究环境中基因检测结果的反馈已得到研究，但非基因结果的反馈（RoR-NG）受到的关注较少。我们与RADIANT的研究人员和参与者探讨了RoR-NG。
方法/研究人群：我们对10名成年RADIANT参与者和10名RADIANT研究人员进行了一对一访谈。参与者还完成了两种健康素养筛查工具以及一项关于结果反馈（RoR）观点的调查。研究人员完成了一项关于解释RADIANT研究中使用的临床检测的经验和信心的调查，以及另一项关于RoR观点的调查。
大多数参与者为非西班牙裔白人。所有参与者在健康素养筛查中得分都很高。RADIANT的参与者和研究人员都对RoR-NG表示强烈支持。RADIANT的参与者和研究人员承认在解释和处理非基因结果方面，研究和临床护理之间存在不同的角色和责任。然而，参与者和研究人员在结果反馈和处理方面，临床护理与研究之间的界限往往模糊不清。
讨论/意义：我们的研究为研究人员和参与者在讨论非基因研究结果及其反馈时如何同时区分和模糊临床与研究的角色和责任提供了重要见解。进一步的研究应纳入来自不同种族和民族背景、健康素养水平各异的个体，以了解在反馈研究结果时如何最好地支持所有参与者。
