Mulhauser Kyler, Marotta Dario A, Gerstenecker Adam, Wilhelm Gabrielle, Myers Terina, Gammon Meredith, Vance David E, Nabors Burt, Fiveash John, Triebel Kristen
Department of Neurology, Division of Neuropsychology, University of Alabama at Birmingham, US.
O'Neal Comprehensive Cancer Center at UAB, Birmingham, Alabama, US.
Neurooncol Pract. 2020 Jul;7(4):439-445. doi: 10.1093/nop/npaa008. Epub 2020 Mar 9.
To evaluate the ability of individuals with metastatic cancer to provide informed consent to research participation, we used a structured vignette-based interview to measure 4 consenting standards across 3 participant groups.
Participants included 61 individuals diagnosed with brain metastasis, 41 individuals diagnosed with non-CNS metastasis, and 17 cognitively intact healthy controls. All groups were evaluated using the Capacity to Consent to Research Instrument (CCRI), a performance-based measure of research consent capacity. The ability to provide informed consent to participate in research was evaluated across 4 consent standards: and . Capacity performance ratings (intact, mild/moderate impairment, severe impairment) were identified based on control group performance.
Results revealed that the brain metastasis group performed significantly lower than healthy controls on the consent standard of , while both metastatic cancer groups performed below controls on the consent standard of . Both metastatic cancer groups performed similar to controls on the standards of and . Approximately 60% of the brain metastasis group, 54% of the non-CNS metastasis group, and 18% of healthy controls showed impaired research consent capacity.
Our findings, using a performance-based assessment, are consistent with other research indicating that the research consent process may be overly cumbersome and confusing. This, in turn, may lead to research consent impairment not only in patient groups but also in some healthy adults with intact cognitive ability.
为了评估转移性癌症患者对参与研究提供知情同意的能力，我们采用了基于结构化 vignette 的访谈来衡量 3 个参与者组的 4 个同意标准。
参与者包括 61 名被诊断为脑转移的个体、41 名被诊断为非中枢神经系统转移的个体以及 17 名认知功能完好的健康对照者。所有组均使用研究同意能力量表（CCRI）进行评估，这是一种基于表现的研究同意能力测量方法。通过 4 个同意标准评估参与研究的知情同意能力：以及。根据对照组的表现确定能力表现评级（完好、轻度/中度受损、严重受损）。
结果显示，脑转移组在同意标准上的表现显著低于健康对照组，而两个转移性癌症组在同意标准上的表现均低于对照组。两个转移性癌症组在和标准上的表现与对照组相似。脑转移组中约 60%、非中枢神经系统转移组中约 54%以及健康对照组中约 18%的人表现出研究同意能力受损。
我们基于表现的评估结果与其他研究一致，表明研究同意过程可能过于繁琐和令人困惑。这反过来可能不仅导致患者群体，也导致一些认知能力完好的健康成年人出现研究同意能力受损的情况。
