Population Assessment of Tobacco and Health (PATH) Study [United States] Biomarker Restricted-Use Files

The Population Assessment of Tobacco and Health (PATH) Study is a collaboration between the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), and the Center for Tobacco Products (CTP), Food and Drug Administration (FDA). The study was launched in 2011 to inform the FDA's tobacco regulatory activities under the Family Smoking Prevention and Tobacco Control Act (TCA). For Wave 1 (baseline), the PATH Study sampled over 150,000 mailing addresses across the United States to create a national sample of tobacco users and non-users, yielding interviews with 45,971 adult and youth respondents. Each adult respondent, who completed the interview, was asked to provide up to three biospecimens. Providing biospecimens was voluntary and was not a condition of participation. Respondents were asked to report their use of all nicotine-containing products during the 3-day period prior to the time of any biospecimen collection (Nicotine Exposure Questions (NEQs)) to facilitate interpretation of biomarker results. Of the 32,320 respondents who completed the adult interview, 21,801 (67.4 percent) provided a urine specimen and 14,520 (44.9 percent) provided a blood specimen. A sample of 11,522 adults who provided sufficient urine for the planned analyses were selected from a diverse mix of six tobacco product use groups representing never, current, and recent former (within 12 months) users of tobacco products. 7,159 of the 11,522 adults also provided a blood specimen. All urine and blood specimens provided by these sampled adults were sent for laboratory analysis. Restricted-Use Biomarker Data Files (Biomarker RUF) consist of three different types of files: 2 Collection and NEQs for Urine (DS1001) and Blood (DS1101) 2 Biomarker Weight files including variables for use in variance estimation for Urine (DS1002) and Blood (DS1102) 7 Urine Panels (DS1003 to DS1009) and 1 Serum Panel (DS1103) containing biomarker assay results References to the collection of biospecimens will be specified by the collected specimen, i.e., urine and (whole) blood. However, references to biomarker analyses and analytes will be specified by the type of matrix (serum, plasma, or urine) used for the analysis.

《烟草与健康人口评估》（PATH）研究是由国家药物滥用研究所（NIDA）、国立卫生研究院（NIH）以及食品药品监督管理局（FDA）下属的烟草产品中心（CTP）共同发起的一项合作项目。该研究始于2011年，旨在为《家庭吸烟预防与烟草控制法案》（TCA）下FDA的烟草监管活动提供信息。在第一波次（基线调查）中，PATH研究对遍布美国的超过15万个邮寄地址进行了抽样，从而构建了一个全国性的烟草使用者与非使用者样本，并从中进行了45,971名成人和青少年的访谈。每位完成访谈的成人受访者被要求提供最多三个生物样本。提供生物样本是自愿的，并非参与条件。受访者被要求报告在采集任何生物样本前三天内所有含尼古丁产品的使用情况（尼古丁暴露问题，NEQs），以促进生物标志物结果的解读。在完成成人访谈的32,320名受访者中，有21,801名（占67.4%）提供了尿液样本，另有14,520名（占44.9%）提供了血液样本。从代表从未使用、当前使用和最近一年内戒烟者（12个月内）的六种烟草产品使用群体的多样化样本中，选择了11,522名提供充足尿液以供计划分析的人。其中7,159人也提供了血液样本。所有这些样本成人提供的尿液和血液样本均送至实验室进行分析。受限使用生物标志物数据文件（生物标志物RUF）包括三种不同类型的文件：尿液（DS1001）和血液（DS1101）的采集和NEQs；用于尿液（DS1002）和血液（DS1102）方差估计的生物标志物权重文件；尿液（DS1003至DS1009）和血清（DS1103）分析板，包含生物标志物检测结果。生物样本的收集将根据收集的样本类型进行说明，即尿液和（全血）。然而，生物标志物分析和分析物的说明将根据用于分析的基质类型（血清、血浆或尿液）进行指定。