Core B: Biostatistics and Data Harmonization Shared Resource

摘要-核心B，生物统计学和数据协调共享资源 强大的生物统计学领导和专业知识是实现研究的科学完整性不可或缺的一部分 数据和分析结果，对于确保对潜在临床或公众的信心是不可或缺的 研究活动对健康的影响。核心B的首要目标是生物统计和数据协调 共享资源，监督和指导研究设计、数据管理和数据分析的方方面面 所有三个P01项目，因此每个项目的科学目标都是使用标准化、高效率的 高质量的数据集和最合适的统计方法。我们有一支强大的生物统计学家团队， 具有使用P01数据和人口的丰富经验的程序员/分析师和调查人员 资源。我们的资源包括与住院有关的加利福尼亚州和犹他州癌症登记处， 急诊和门诊手术数据；北卡罗来纳大学教堂山分校癌症信息和 人口健康资源；北加州凯撒永久医院和 南加州；以及关于人口子集的调查数据。不同的数据源提供了几个 清理、分析和解释方面的挑战，包括反向因果关系的可能性和各种 选择偏向的形式。核心提供的生物统计咨询将确保适当的应用 关于确定这种偏见的潜在程度的途径和解释这些偏见的方法。这个 核心的具体目标是： 1.全面领导、咨询和支持三个P01项目和 核心C，调查共享资源； 2.进行队列识别，以满足每个项目的每个目标的主题纳入标准 核心C中所述的调查； 3.统一和标准化跨数据来源和项目使用的变量定义； 4.构建并提供包含临床和管理数据的研究分析数据集 数据来源、癌症登记和患者调查； 5.使用适当的方法监督分析，以实现每个项目的目标，包括 在分析中考虑系统偏差、潜在混杂因素和抽样权重 调查数据。 为实现本P01的目标，集中的生物统计专门知识和服务将确保使用 在整个P01中列出了共同的概念和数据定义。该核心将确保数据是适当的 对于解决的问题，协调所有源数据系统以增强可比性，并分析 并用优势和局限性的知识来解释。这一战略将最大限度地发挥 P01调查结果，以告知和改善青少年和年轻成年癌症幸存者的医疗保健。

ABSTRACT – Core B, Biostatistics and Data Harmonization Shared Resource Strong biostatistical leadership and expertise are integral to achieving scientific integrity of research data and analytical results, and are indispensable for assuring confidence in the potential clinical or public health impact of research activities. The primary goal of Core B, the Biostatistics and Data Harmonization Shared Resource, is to oversee and guide all aspects of study design, data management and data analysis across all three P01 projects so the scientific aims of each project are addressed using standardized, high- quality datasets and the most appropriate statistical methods. We have a strong team of biostatisticians, programmer/analysts and investigators with extensive experience using the P01 data and population resources. Our resources include the California and Utah Cancer Registries linked to hospitalization, emergency and ambulatory surgery data; the University of North Carolina at Chapel Hill Cancer Information & Population Health Resource; the integrated healthcare systems of Kaiser Permanente Northern California and Southern California; and survey data on a population subset. The varying data sources present several challenges in cleaning, analysis and interpretation, including the potential for reverse causation and various forms of selection bias. Biostatistical consultation provided by the Core will ensure the appropriate application of approaches to determine the potential magnitude of such biases and methods to account for them. The specific aims of the Core are to: 1. Provide overall biostatistical leadership, consultation and support across all three P01 projects and Core C, the Survey Shared Resource; 2. Carry out cohort identification to meet the subject inclusion criteria for each aim of each project and for the survey described in Core C; 3. Harmonize and standardize variable definitions used across data sources and projects; 4. Construct and provide study analytic datasets that incorporate data from clinical and administration data sources, cancer registries, and patient surveys; 5. Oversee analyses using appropriate methods to achieve the aims of each project, including consideration of systematic biases, potential confounders, and sampling weights in the analysis of survey data. To carry out the objectives of this P01, centralized biostatistical expertise and services will ensure use of common concepts and data definitions throughout the P01. This Core will ensure that data are appropriate for the questions addressed, harmonized across source data systems to enhance comparability, and analyzed and interpreted with knowledge of strengths and limitations. This strategy will maximize the potential impact of P01 findings to inform and improve healthcare for adolescent and young adult cancer survivors.