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 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 Colle

《烟草与健康人口评估》（PATH）研究是由美国国家药物滥用研究所（NIDA）、美国国立卫生研究院（NIH）和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研究。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（基线）研究中，PATH研究从美国50个州超过15万个邮寄地址中抽取样本，构建了一个全国性的烟草使用者与非使用者样本库，并对45,971名成年人和青少年受访者进行了访谈。这45,971名成年人和青少年构成了纵向队列研究的第一次（基线）数据收集波次，即Wave 1。他们连同7,207名“影子青少年”（在Wave 1中抽取的9至11岁青少年）共同组成了53,178名Wave 1队列参与者。受访者被要求在每个后续波次完成访谈。在当前数据收集波次达到18岁的青少年被视为“成年化成人”，并被邀请完成成人访谈。此外，“影子青少年”在12岁时也被视为“成年化青少年”，在获得父母同意后，他们需要完成访谈。在Wave 4中，从Wave 4的平民、非机构化人口中随机抽取了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中选中的居住地址以及相同的抽样PSU和细分市场中，采用类似的户内抽样程序招募的。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《受限使用文件用户指南》，以获取有关“影子青少年”的指定及其在Wave 1和Wave 4队列形成方面的详细信息。生物样本收集：每位在Wave 1中完成访谈的成年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，且并非参与条件。受访者被要求报告在任何生物样本收集前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），以便利生物标志物结果的解释。在完成Wave 1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。从六个烟草产品使用组（从未使用者、当前使用者、近12个月内戒烟者）中选取了11,522名提供了足够尿液以供计划分析成年人的样本。这组构成了Wave 1生物标志物核心组。在11,522名成年人中，有7,159人也提供了血液样本。Wave 1生物标志物核心组提供的所有尿液和血液样本均送往实验室分析。每位完成Wave 4访谈的青少年被要求提供尿液样本。每位在Wave 4中完成Wave 5青少年访谈的10至11岁“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。在完成Wave 4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足够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名样本，以及从完成Wave 5访谈并在Wave 5中提供了足够尿液以供计划实验室分析的528名Wave 4“影子青少年”中选取了样本。这些抽样青少年和“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分析。生物标志物受限使用文件：Wave 1受限使用生物标志物数据文件（Biomarker RUF）包括Wave 1生物标志物核心组的三个不同类型的文件：