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. 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. Wave 1 Restricted-Use Biomarker Data Files (Biomarker RUF) consist of three different types of files: 2 Collection and NEQ files for Urine (DS1001) and Blood (DS1101) 2 Biomarker Weight files including variables for use in variance estimation for Urine (DS1021) and Blood (DS1121) 8 Urine Panels (DS1031 to DS1038), 4 Serum Panels (DS1131 to DS1134) and 1 Plasma Panel (DS1231) containing biomarker assay results. For Wave 2, urine biospecimens were requested from the Wave 1 Biomarker Core. Respondents were also asked to complete the NEQs prior to biospecimen collection. The Wave 2 Biomarker RUF consists of three different types of files: 1 Collection and NEQ file for Urine (DS2001) 2 Biomarker Weight files including variables for use in variance estimation for Urine (DS2021) and F2PG2a (DS2022) 8 Urine Panels (DS2031 to DS2038) containing biomarker assay results. For Wave 3, urine biospecimens were requested from the Wave 1 Biomarker Core. Respondents were also asked to complete the NEQs prior to biospecimen collection. The Wave 3 Biomarker RUF consists of three different types of files: 1 Collection and NEQ file for Urine (DS3001) 2 Biomarker Weight files including variables for use in variance estimation fo

《烟草与健康人口评估》（PATH）研究是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（FDA）下属的烟草产品中心（CTP）之间的合作项目。该研究于2011年启动，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）阶段，PATH研究从美国超过15万个邮寄地址中抽取样本，构建了一个全国性的烟草使用者与非使用者样本库，共对45,971名成年人和青少年进行了访谈。这45,971名成年人和青少年构成了纵向队列研究的首次（基线）数据收集波次，即第一波。他们连同7,207名“影子青少年”（在第一波中抽取的9至11岁青少年）共同组成了53,178名参与者的第一波队列。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‘成年化青少年’，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。在第四波中，从第四波时的民用、非机构化人口中，选取了14,098名成年人和青少年以及10至11岁的‘影子青少年’作为概率样本。此样本来自未被选中参与第一波同一抽样过程中的PSU和区段内的住宅地址，并采用类似的户内抽样程序进行招募。这个‘补充样本’与第四波成年人和青少年受访者结合，这些受访者来自第一波队列，并在第四波时属于民用、非机构化人口。这个结合的样本集，共计52,731名参与者，构成了第四波队列。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’的儿童以及第一波和第四波队列形成的进一步详细信息。在第一波中，每位完成访谈的成年受访者都被要求提供至少两种生物样本。提供生物样本是自愿的，并非参与条件之一。受访者被要求报告在采集任何生物样本前的三天内使用所有含尼古丁产品的情况（尼古丁暴露问题（NEQs）），以促进生物标志物结果的解读。在32,320名完成第一波成人访谈的受访者中，有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、当前使用和最近一年内戒烟（12个月内）的六种烟草产品使用组的多样化混合中，选取了11,522名提供足够尿液用于计划分析的成年人。这一群体构成了第一波生物标志物核心。在这11,522名成年人中，有7,159人也提供了血液样本。第一波受限使用生物标志物数据文件（Biomarker RUF）包括三种不同类型的文件：2个尿液（DS1001）和血液（DS1101）的采集和NEQs文件；2个包含用于尿液（DS1021）和血液（DS1121）方差估计变量的生物标志物权重文件；8个尿液分析板（DS1031至DS1038）、4个血清分析板（DS1131至DS1134）和1个血浆分析板（DS1231），其中包含生物标志物检测结果。对于第二波，从第一波生物标志物核心中请求尿液生物样本。受访者也被要求在采集生物样本前完成NEQs。第二波生物标志物RUF包括三种不同类型的文件：1个尿液（DS2001）的采集和NEQs文件；2个包含用于尿液（DS2021）和F2PG2a（DS2022）方差估计变量的生物标志物权重文件；8个尿液分析板（DS2031至DS2038），其中包含生物标志物检测结果。对于第三波，从第一波生物标志物核心中请求尿液生物样本。受访者也被要求在采集生物样本前完成NEQs。第三波生物标志物RUF包括三种不同类型的文件：1个尿液（DS3001）的采集和NEQs文件；2个包含用于尿液方差估计变量的生物标志物权重文件。