Stakeholder assessment of the evidence for cancer genomic tests: insights from three case studies.
Stakeholder assessment of the evidence for cancer genomic tests: insights from three case studies.
复制标题
DOI：
10.1038/gim.2012.3
复制
发表时间：
2012-07
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
在现实世界环境中，没有足够的证据表明基因组测试的净效益和危害，这是基因组医学的翻译障碍。了解利益相关者对临床实践和覆盖决策的当前证据基础的评估应该是影响研究、政策和实践的关键一步。22名利益相关者参加了一次研讨会，探讨用于临床和覆盖决策的基因组测试的证据。利益攸关方在会议前和会议期间完成了一项调查。他们还讨论了他们是否会建议目前每种测试的临床应用。在基线上，对每种测试的临床有效性和临床实用性的信心水平各不相同，尽管该小组对EGFR突变和林奇综合征(LS)测试比对Oncotype DX更有信心。在讨论之后，调查结果反映出对Oncotype DX和EGFR检测的信心更低，但对LS没有信心。大多数利益相关者将考虑所有三种测试的临床应用，但条件是进行额外的研究或共享临床决策方法。利益相关者在不偏不倚的环境中的参与对于理解关于基因组医学证据阈值的各种观点是必要的。与会者建议使用各种方法来生成和合成证据。
Insufficient evidence on the net benefits and harms of genomic tests in real-world settings is a translational barrier for genomic medicine. Understanding stakeholders’ assessment of the current evidence base for clinical practice and coverage decisions should be a critical step to influence research, policy, and practice. Twenty-two stakeholders participated in a workshop exploring the evidence of genomic tests for clinical and coverage decision-making. Stakeholders completed a survey prior to and during the meeting. They also discussed if they would recommend for or against current clinical use of each test. At baseline, the level of confidence on the clinical validity and clinical utility of each test varied, although the group expressed greater confidence for EGFR mutation and Lynch Syndrome (LS) testing than for Oncotype DX. Following the discussion, survey results reflected even less confidence for Oncotype DX and EGFR testing, but not LS. The majority of stakeholders would consider clinical use for all three tests, but under the conditions of additional research or a shared clinical decision-making approach. Stakeholder engagement in unbiased settings is necessary to understand various perspectives about evidentiary thresholds in genomic medicine. Participants recommended the use of various methods for evidence generation and synthesis.
登录
查看更多内容
DOI：
10.1371/currents.rrn1249
发表时间：
2011-07-21
期刊：
PLoS currents
影响因子：
--
作者：
Ishibe, Naoko;Schully, Sheri;Ramsey, Scott David
通讯作者：
Ramsey, Scott David
影响因子：
45.3
作者：
Keedy, Vicki Leigh;Temin, Sarah;Giaccone, Giuseppe
通讯作者：
Giaccone, Giuseppe
影响因子：
1.7
作者：
Schully, S. D.;Benedicto, C. B.;Khoury, M. J.
通讯作者：
Khoury, M. J.
影响因子：
17.1
作者：
Clancy, Carolyn;Collins, Francis S.
通讯作者：
Collins, Francis S.
影响因子：
8.8
作者：
Veenstra, David L.;Roth, Joshua A.;Burke, Wylie
通讯作者：
Burke, Wylie