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 people who use or do not use tobacco, 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 people who never used tobacco, currently use tobacco, and formerly used tobacco (within the last 12 months). 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

《烟草与健康人口评估》（PATH）研究是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）之间的合作项目。该研究始于2011年，旨在为美国食品药品监督管理局根据《家庭吸烟预防与烟草控制法》（TCA）进行的烟草监管活动提供信息。在第一波（基线）研究中，PATH研究从美国超过15万个邮寄地址中抽取样本，构建了一个全国范围内的烟草使用者与非使用者的样本库，从而对45,971名成人和青少年进行了访谈。这45,971名成人和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，还包括7,207名“影子青少年”（在Wave 1中抽取的9至11岁青少年），共同构成了53,178名Wave 1队列参与者。受访者被要求在每一波后续研究中完成访谈。在当前数据收集波次达到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12岁时也被视为“成年化青少年”，在获得家长同意后，他们需要完成访谈。在Wave 4中，从Wave 4时的平民、非机构化人群中随机抽取了14,098名成人、青少年和10至11岁的“影子青少年”作为样本。这个样本是从未在Wave 1中选中的相同抽样地区（PSUs）和段落的住宅地址中招募的，并采用了类似的户内抽样程序。这个“补充样本”与Wave 1队列中的Wave 4成人及青少年受访者合并，用于估计和分析，总共形成了52,731人的Wave 4队列。请参考《限制性使用文件用户指南》，其中提供了关于被指定为“影子青少年”的儿童以及Wave 1和Wave 4队列形成的相关详细信息。生物样本收集：在Wave 1中完成访谈的每位成人受访者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。受访者被要求报告在生物样本收集前的3天期间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分析。在32,320名完成Wave 1成人访谈的受访者中，21,801人（67.4%）提供了尿液样本，14,520人（44.9%）提供了血液样本。从代表从未使用烟草、目前使用烟草以及过去12个月内使用过烟草的六种烟草产品使用群体中，选取了11,522名提供足够尿液样本以供计划分析的人作为样本，这组人构成了Wave 1生物标志物核心。在11,522名受访者中，有7,159人也提供了血液样本。Wave 1生物标志物核心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受访者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10至11岁的“影子青少年”也被要求提供尿液样本。提供这种尿液生物样本是自愿的，并非参与条件。在14,798名完成Wave 4青少年访谈的受访者中，13,097人（88.5%）提供了尿液样本。从12至17岁的Wave 4队列青少年中，选取了3,509名完成Wave 4青少年访谈并提供足够尿液样本以供计划实验室分析的人作为样本。此外，还选取了528名在Wave 5中完成访谈并提供足够尿液样本以供计划实验室分析的Wave 4“影子青少年”。这4,037名样本青少年和“影子青少年”构成了Wave 4生物标志物核心。Wave 4生物标志物核心提供的所有尿液样本均送往实验室进行分析。生物标志物限制性使用文件：Wave 1限制性使用生物标志数据文件（生物标志物RUF）包括三种不同类型的...