Lessons learned about harmonizing survey measures for the CSER consortium.
Lessons learned about harmonizing survey measures for the CSER consortium.
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汲取了有关CSER财团协调调查措施的经验教训。
DOI：
10.1017/cts.2020.41
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发表时间：
2020-04-24
影响因子：
2.6
通讯作者：
Lee SS
中科院分区：
文献类型：
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作者：
Goddard KAB;Angelo FAN;Ackerman SL;Berg JS;Biesecker BB;Danila MI;East KM;Hindorff LA;Horowitz CR;Hunter JE;Joseph G;Knight SJ;McGuire A;Muessig KR;Ou J;Outram S;Rahn EJ;Ramos MA;Rini C;Robinson JO;Smith HS;Waltz M;Lee SS
在临床护理中实施基因组规模测序具有重大挑战：该技术具有多种潜在结果，结果解释和交付需要多个医学专业的专业知识和协调，临床实用性可能不确定，并且可能存在超出个体参与者的更广泛的家庭或社会影响。跨学科联盟和协作团队科学已经做好了应对这些挑战的准备。然而，了解复杂的网络组织，制度，物理，环境，技术，以及其他政治和社会因素影响的有效性财团是研究不足。我们描述了我们的经验，临床测序证据生成研究（CSER）联盟，多机构翻译基因组学联盟。CSER联盟的一个关键方面是将特定于临床试验机构的措施与确定与临床效用相关的共识措施并置，并创建一套核心的协调措施。在这个协调过程中，我们试图最大限度地减少参与者的负担，适应项目特定的选择，并使用经过验证的措施，允许数据共享。确定平台以确保团队之间的快速沟通以及材料和数据的管理对于我们的协调工作至关重要。资助机构可以通过在提案准备阶段澄清跨项目的关键研究设计要素，并通过提供跨参与项目的数据共享框架来帮助联盟。总之，必须投入时间和资源，制定和实施协作做法，作为项目时间表开始时的准备工作，以提高研究联盟的效力。
Implementation of genome-scale sequencing in clinical care has significant challenges: the technology is highly dimensional with many kinds of potential results, results interpretation and delivery require expertise and coordination across multiple medical specialties, clinical utility may be uncertain, and there may be broader familial or societal implications beyond the individual participant. Transdisciplinary consortia and collaborative team science are well poised to address these challenges. However, understanding the complex web of organizational, institutional, physical, environmental, technologic, and other political and societal factors that influence the effectiveness of consortia is understudied. We describe our experience working in the Clinical Sequencing Evidence-Generating Research (CSER) consortium, a multi-institutional translational genomics consortium. A key aspect of the CSER consortium was the juxtaposition of site-specific measures with the need to identify consensus measures related to clinical utility and to create a core set of harmonized measures. During this harmonization process, we sought to minimize participant burden, accommodate project-specific choices, and use validated measures that allow data sharing. Identifying platforms to ensure swift communication between teams and management of materials and data were essential to our harmonization efforts. Funding agencies can help consortia by clarifying key study design elements across projects during the proposal preparation phase and by providing a framework for data sharing data across participating projects. In summary, time and resources must be devoted to developing and implementing collaborative practices as preparatory work at the beginning of project timelines to improve the effectiveness of research consortia.