From the Department of Pathology, University of North Carolina, Chapel Hill (Dr Gulley); the Department of Pathology, St Jude Medical Center, Fullerton, California (Dr Fitzgibbons); the College of American Pathologists, Northfield, Illinois (Ms Kennedy); the Department of Translational Medicine, Biogen Idec, Cambridge, Massachusetts (Dr Cosentino); the Department of Pathology, Vanderbilt Medical Center, Nashville, Tennessee (Dr Washington); the Department of Pathology, Duke Medical Center, Durham, North Carolina (Dr Dash); the Biorepositories and Biospecimens Research Branch, National Cancer Institute, National Institutes of Health, Rockville, Maryland (Dr Branton); the Department of Biospecimen Science, Van Andel Institute, Grand Rapids, Michigan (Dr Jewell); and the Department of Pathology, Spartanburg Regional Medical Center, Spartanburg, South Carolina (Dr Lapham).
Arch Pathol Lab Med. 2014 Apr;138(4):526-37. doi: 10.5858/arpa.2013-0250-CP. Epub 2013 Aug 12.
Biospecimens must have appropriate clinical annotation (data) to ensure optimal quality for both patient care and research. Clinical preanalytic variables are the focus of this study.
To define the essential preanalytic variables (data fields) that should be attached to every collected biospecimen and to provide a complete list of such variables, along with their relative importance, which can vary, depending on downstream use, institutional needs, and information technology capabilities.
The College of American Pathologists Diagnostic Intelligence and Health Information Technology Committee sponsored a Biorepository Working Group to develop a ranked list of the preanalytic variables for annotating biospecimens. Members of the working group were experts in anatomic, clinical, and molecular pathology; biobanking; medical informatics; and accreditation. Several members had experience with federal government programs, such as the National Cancer Institute's Biospecimens and Biorepository Branch and the National Cancer Institute's Community Cancer Center Program. Potential preanalytic variables were identified and ranked along with available supporting evidence, definitions, and potential negative effects if the variable was not attached to the biospecimen. Additional national and international stakeholders reviewed the draft manuscript.
The ranked listing of 170 preanalytic variables produced can be used as a guide for site-specific implementation into patient care and/or research biorepository processes. Conclusions.-In our collective experience, it is often difficult to choose which of the many preanalytic variables to attach to any specific set of biospecimens used for patient care and/or research. The provided ranked list should aid in the selection of preanalytic variables for a given biospecimen collection.
生物标本必须具有适当的临床注释（数据），以确保患者护理和研究的最佳质量。本研究关注临床分析前变量。
定义应附加到每个采集的生物标本的基本分析前变量（数据字段），并提供此类变量的完整列表，以及其相对重要性，这可能因下游用途、机构需求和信息技术能力而异。
美国病理学家学院诊断智能和健康信息技术委员会赞助了一个生物库工作组，以开发一个用于注释生物标本的分析前变量的排名列表。工作组的成员是解剖学、临床和分子病理学、生物库、医学信息学和认证方面的专家。一些成员具有联邦政府项目的经验，例如国家癌症研究所的生物标本和生物库分部以及国家癌症研究所的社区癌症中心计划。确定了潜在的分析前变量，并根据可用的支持证据、定义以及如果未将变量附加到生物标本上可能产生的潜在负面影响对其进行排名。其他国家和国际利益相关者审查了草稿手稿。
产生的 170 个分析前变量的排名列表可作为指导，用于特定于站点的实施，以纳入患者护理和/或研究生物库流程。结论-根据我们的集体经验，通常很难选择要将许多分析前变量中的哪一个附加到用于患者护理和/或研究的任何特定组生物标本上。提供的排名列表应有助于为给定的生物标本采集选择分析前变量。
