电话与当面传递种系癌症基因检测结果的随机非劣效性试验
Randomized Noninferiority Trial of Telephone vs In-Person Disclosure of Germline Cancer Genetic Test Results.
机构信息
Division of Hematology-Oncology, Department of Medicine, Department of Medical Ethics and Health Policy, and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Division of Hematology-Oncology and Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, and Center for Clinical Cancer Genetics and Global Health, The University of Chicago, Chicago, IL.
出版信息
J Natl Cancer Inst. 2018 Sep 1;110(9):985-993. doi: 10.1093/jnci/djy015.
BACKGROUND
Germline genetic testing is standard practice in oncology. Outcomes of telephone disclosure of a wide range of cancer genetic test results, including multigene panel testing (MGPT) are unknown.
METHODS
Patients undergoing cancer genetic testing were recruited to a multicenter, randomized, noninferiority trial (NCT01736345) comparing telephone disclosure (TD) of genetic test results with usual care, in-person disclosure (IPD) after tiered-binned in-person pretest counseling. Primary noninferiority outcomes included change in knowledge, state anxiety, and general anxiety. Secondary outcomes included cancer-specific distress, depression, uncertainty, satisfaction, and screening and risk-reducing surgery intentions. To declare noninferiority, we calculated the 98.3% one-sided confidence interval of the standardized effect; t tests were used for secondary subgroup analyses. Only noninferiority tests were one-sided, others were two-sided.
RESULTS
A total of 1178 patients enrolled in the study. Two hundred eight (17.7%) participants declined random assignment due to a preference for in-person disclosure; 473 participants were randomly assigned to TD and 497 to IPD; 291 (30.0%) had MGPT. TD was noninferior to IPD for general and state anxiety and all secondary outcomes immediately postdisclosure. TD did not meet the noninferiority threshold for knowledge in the primary analysis, but it did meet the threshold in the multiple imputation analysis. In secondary analyses, there were no statistically significant differences between arms in screening and risk-reducing surgery intentions, and no statistically significant differences in outcomes by arm among those who had MGPT. In subgroup analyses, patients with a positive result had statistically significantly greater decreases in general anxiety with telephone disclosure (TD -0.37 vs IPD +0.87, P = .02).
CONCLUSIONS
Even in the era of multigene panel testing, these data suggest that telephone disclosure of cancer genetic test results is as an alternative to in-person disclosure for interested patients after in-person pretest counseling with a genetic counselor.
背景
种系遗传检测是肿瘤学的标准实践。大范围癌症遗传检测结果的电话披露结果，包括多基因面板检测（MGPT）的结果，尚不清楚。
方法
招募正在进行癌症遗传检测的患者参加一项多中心、随机、非劣效性试验（NCT01736345），比较电话披露（TD）与常规护理、分层分组的个体咨询后个体咨询（IPD）对遗传检测结果的披露。主要非劣效性结局包括知识、状态焦虑和一般焦虑的变化。次要结局包括癌症特异性痛苦、抑郁、不确定性、满意度以及筛查和降低风险手术的意向。为了宣布非劣效性，我们计算了标准化效应的 98.3%单侧置信区间；使用 t 检验进行次要亚组分析。仅非劣效性检验为单侧，其他为双侧。
结果
共有 1178 名患者参加了该研究。由于偏好个体咨询，208 名（17.7%）参与者拒绝随机分组；473 名参与者被随机分配到 TD 组，497 名参与者被随机分配到 IPD 组；291 名（30.0%）患者进行了 MGPT。TD 在立即披露后的一般焦虑和状态焦虑以及所有次要结局方面均不劣于 IPD。TD 在主要分析中不符合知识的非劣效性标准，但在多重插补分析中符合标准。在次要分析中，两组在筛查和降低风险手术的意向方面没有统计学上的显著差异，在进行 MGPT 的患者中，两组的结局也没有统计学上的显著差异。在亚组分析中，阳性结果的患者在电话披露时，一般焦虑明显下降（TD-0.37 与 IPD+0.87，P=0.02）。
结论
即使在多基因面板检测时代，这些数据表明，在遗传咨询师进行个体咨询后，对感兴趣的患者进行电话披露癌症遗传检测结果，是个体咨询的替代方法。
Zotero 插件