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. 45,971 adults and youth constitute the first (baseline) wave, Wave 1, of data collected by this longitudinal cohort study. These 45,971 adults and youth along with 7,207 "shadow youth" (youth ages 9 to 11 sampled at Wave 1) make up the 53,178 participants that constitute the Wave 1 Cohort. Respondents are asked to complete an interview at each follow-up wave. Youth who turn 18 by the current wave of data collection are considered "aged-up adults" and are invited to complete the Adult Interview. Additionally, "shadow youth" are considered "aged-up youth" upon turning 12 years old, when they are asked to complete an interview after parental consent.At Wave 4, a probability sample of 14,098 adults, youth, and shadow youth ages 10 to 11 was selected from the civilian, noninstitutionalized population at the time of Wave 4. This sample was recruited from residential addresses not selected for Wave 1 in the same sampled PSUs and segments using similar within-household sampling procedures. This "replenishment sample" was combined for estimation and analysis purposes with Wave 4 adult and youth respondents from the Wave 1 Cohort who were in the civilian, noninstitutionalized population at the time of Wave 4. This combined set of Wave 4 participants, 52,731 participants in total, forms the Wave 4 Cohort.Please refer to the Restricted-Use Files User Guide that provides further details about children designated as "shadow youth" and the formation of the Wave 1 and Wave 4 Cohorts.Biospecimen Collection Each adult respondent, who completed the interview at Wave 1, was asked to provide at least two 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 at Wave 1, 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. This group constitutes the Wave 1 Biomarker Core. Of the 11,522 adults, 7,159 also provided a blood specimen. All urine and blood specimens provided by the Wave 1 Biomarker Core were sent for laboratory analysis.Each youth who completed the Wave 4 interview was asked to provide a urine specimen. Each Wave 4 shadow youth (ages 10 and 11 at Wave 4) who completed the Wave 5 youth interview was also asked to provide a urine specimen. Providing this urine biospecimen was voluntary and was not a condition of participation.Of the 14,798 respondents who completed the youth interview at Wave 4, 13,097 (88.5 percent) provided a urine specimen. A sample of 3,509 Wave 4 Cohort youth ages 12 to 17 who completed the Wave 4 youth interview and provided a sufficient amount of urine for the planned laboratory analyses was selected from a diverse mix of five tobacco product use and non-use groups. In addition, a sample of 528 Wave 4 shadow youth who completed a Wave 5 interview and provided a sufficient amount of urine for the planned laboratory analyses at Wave 5 was also selected. These 4,037 sampled youth and shadow youth constitute the Wave 4 Biomarker Core. All urine specimens provided by the Wave 4 Biomarker Core were sent for laboratory analysis.Biomarker Restricted Use Files Wave 1 Restricted-Use Biomarker Data Files (Biomarker RUF) consists of three different types of files for the Wave 1 Biomarker Core: 2

《烟草与健康人口评估》（PATH）研究乃由国家药物滥用研究所（NIDA）、国家卫生研究院（NIH）及食品药品监督管理局烟草产品中心（CTP）共同发起的协作项目。该研究于2011年启动，旨在为食品药品监督管理局在《家庭吸烟预防与烟草控制法案》（TCA）框架下进行的烟草监管活动提供信息支持。在第一波（基线）研究中，PATH研究从美国各地选取超过15万个邮寄地址，构建了烟草使用者与非使用者的全国样本，并对45,971名成年人与青少年受访者进行了访谈。这45,971名成年人与青少年构成了该纵向队列研究的第一波（基线）数据收集，即Wave 1。此外，包括7,207名“影子青少年”（在Wave 1中选取的9至11岁青少年）在内的53,178名参与者共同构成了Wave 1队列。受访者被要求在每个后续波次中完成访谈。至当前数据收集波次时年满18岁的青少年被视为“成年化青少年”，并受邀完成成人访谈。此外，“影子青少年”在年满12岁时被视为“成年化青少年”，需在家长同意后完成访谈。在Wave 4中，从Wave 4的民用、非机构化人口中选取了14,098名成年者、青少年及10至11岁的“影子青少年”作为概率样本。该样本来自未在Wave 1中选取的相同抽样辅助单位（PSU）和段落的居住地址，并采用类似的户内抽样程序进行招募。这一“补充样本”与Wave 1队列中在Wave 4时仍处于民用、非机构化人口中的Wave 4成年者和青少年受访者相结合，共计52,731名参与者，构成了Wave 4队列。请参考《受限使用文件用户指南》，以获取有关被指定为“影子青少年”的儿童以及Wave 1和Wave 4队列形成的详细信息。生物样本采集：在Wave 1中完成访谈的每位成年受访者均被要求提供至少两个生物样本。提供生物样本是自愿的，并非参与条件。受访者被要求在采集任何生物样本前的3天报告其所有含尼古丁产品的使用情况（尼古丁暴露问题（NEQs）），以协助解释生物标志物结果。在Wave 1中完成成人访谈的32,320名受访者中，有21,801名（67.4%）提供了尿液样本，14,520名（44.9%）提供了血液样本。从代表从未使用、当前使用及最近一年内（12个月内）戒烟的六种烟草产品使用组的多样化群体中，选取了11,522名提供充足尿液以供计划分析成年人作为样本。这11,522名成年人中，有7,159名也提供了血液样本。Wave 1生物标志物核心组中提供的所有尿液和血液样本均送往实验室进行分析。在Wave 4中完成访谈的每位青少年均被要求提供尿液样本。在Wave 4中完成Wave 5青少年访谈的每位Wave 4的10至11岁“影子青少年”也被要求提供尿液样本。提供这一尿液生物样本是自愿的，并非参与条件。在Wave 4中完成青少年访谈的14,798名受访者中，有13,097名（88.5%）提供了尿液样本。从完成Wave 4青少年访谈并提供了充足尿液以供计划实验室分析的12至17岁Wave 4队列青少年中，选取了3,509名作为样本，此外，还从在Wave 5中完成访谈并提供了充足尿液以供Wave 5计划实验室分析的528名Wave 4“影子青少年”中选取了样本。这些4,037名被选取的青少年和“影子青少年”构成了Wave 4生物标志物核心组。Wave 4生物标志物核心组提供的所有尿液样本均送往实验室进行分析。生物标志物受限使用文件：Wave 1生物标志物受限使用数据文件（Biomarker RUF）包括针对Wave 1生物标志物核心组的三种不同类型的文件：