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 for Urine (DS3021 and DS3022); 6 Urine Panels (DS3032 to DS3037) containing biomarker assay results. Additional panel(s) will be added at a later date.; For Wave 4, urine biospecimens were requested from the Wave 1 Biomarker Core. Respondents were also asked to complete the NEQs prior to biospecimen collection. The Wave 4 Biomarker RUF consists of three different types of files: 1 Collection and NEQ file for Urine (DS4001); 2 Biomarker Weight files including variables for use in variance estimation for Urine (DS4021 and DS4022); 3 Urine Panels (DS4032, DS4033, DS4036) containing biomarker assay results. Additional panel(s) will be added at a later date.; 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（Population Assessment of Tobacco and Health，简称PATH）研究是由美国国家药物滥用研究所（National Institute on Drug Abuse，NIDA）、美国国立卫生研究院（National Institutes of Health，NIH）以及美国食品药品监督管理局（Food and Drug Administration，FDA）下属烟草产品中心（Center for Tobacco Products，CTP）联合开展的合作项目。该研究于2011年启动，旨在为美国FDA依据《家庭吸烟预防与烟草控制法（Family Smoking Prevention and Tobacco Control Act，TCA）》开展的烟草监管活动提供数据支撑。
在第一波（基线波，Wave 1）研究中，PATH研究抽样覆盖美国境内超过15万个邮寄地址，以构建全国范围内烟草使用者与非使用者的代表性样本，最终完成45971名成人与青少年受访者的访谈。这45971名成人与青少年构成了这项纵向队列研究的第一波（基线波，Wave 1）数据样本。该群体与7207名“影子青少年（shadow youth，即Wave 1中抽样的9至11岁青少年）”共同组成了Wave 1队列的53178名参与者。所有受访者需在每一次后续波次的研究中完成访谈。在当前数据收集波次年满18岁的青少年将被归类为“成年转化成人”，并受邀参与成人访谈。此外，“影子青少年”年满12岁后将被归类为“年龄达标青少年”，此时需在获得监护人知情同意后完成访谈。
在Wave 4研究中，研究人员从当时的民用非机构化人群中抽取了14098名成人、青少年以及10至11岁影子青少年组成概率抽样样本。该样本通过与Wave 1相同的初级抽样单元（Primary Sampling Units，PSUs）和抽样段，采用一致的户内抽样流程，从未被纳入Wave 1抽样的住宅地址中招募而来。为便于估算与分析，该“补充抽样样本”与Wave 1队列中在Wave 4研究期间属于民用非机构化人群的成人与青少年受访者进行合并。合并后的Wave 4参与者共计52731人，构成Wave 4队列。请参阅《受限使用文件用户指南（Restricted-Use Files User Guide）》以获取更多关于“影子青少年”分类以及Wave 1、Wave 4队列构建的细节。
每位完成Wave 1访谈的成人受访者需自愿提供至少两份生物样本，提供生物样本并非参与研究的强制条件。在采集任何生物样本前，受访者需报告其在采样前3天内使用的所有含尼古丁产品的情况（尼古丁暴露问卷，Nicotine Exposure Questions，NEQs），以辅助解读生物标志物检测结果。在完成Wave 1成人访谈的32320名受访者中，21801人（占比67.4%）提供了尿液样本，14520人（占比44.9%）提供了血液样本。研究人员从涵盖从未使用者、当前使用者以及近12个月内曾使用者在内的6类烟草产品使用群体中，筛选出11522名尿液样本量满足分析要求的成人，组成Wave 1生物标志物核心样本。在这11522名成人中，7159人同时提供了血液样本。Wave 1生物标志物核心样本提供的所有尿液与血液样本均被送往实验室进行分析。Wave 1生物标志物受限使用文件（Biomarker Restricted-Use Files，简称Biomarker RUF）包含三类文件：尿液（DS1001）与血液（DS1101）的采集信息及尼古丁暴露问卷文件共2份；用于尿液样本方差估算的生物标志物权重文件（DS1021）以及用于血液样本方差估算的生物标志物权重文件共2份；包含生物标志物检测结果的尿液检测组（DS1031至DS1038）共8份、血清检测组（DS1131至DS1134）共4份以及血浆检测组（DS1231）共1份。
针对Wave 2研究，研究人员向Wave 1生物标志物核心样本的参与者索要尿液生物样本，受访者同样需在样本采集前完成尼古丁暴露问卷。Wave 2生物标志物受限使用文件包含三类文件：尿液采集信息及尼古丁暴露问卷文件（DS2001）共1份；用于尿液样本方差估算的生物标志物权重文件（DS2021）以及用于F2PG2a的生物标志物权重文件（DS2022）共2份；包含生物标志物检测结果的尿液检测组（DS2031至DS2038）共8份。针对Wave 3研究，研究人员向Wave 1生物标志物核心样本的参与者索要尿液生物样本，受访者同样需在样本采集前完成尼古丁暴露问卷。Wave 3生物标志物受限使用文件包含三类文件：尿液采集信息及尼古丁暴露问卷文件（DS3001）共1份；用于尿液样本方差估算的生物标志物权重文件（DS3021与DS3022）共2份；包含生物标志物检测结果的尿液检测组（DS3032至DS3037）共6份，后续将新增更多检测组文件。针对Wave 4研究，研究人员向Wave 1生物标志物核心样本的参与者索要尿液生物样本，受访者同样需在样本采集前完成尼古丁暴露问卷。Wave 4生物标志物受限使用文件包含三类文件：尿液采集信息及尼古丁暴露问卷文件（DS4001）共1份；用于尿液样本方差估算的生物标志物权重文件（DS4021与DS4022）共2份；包含生物标志物检测结果的尿液检测组（DS4032、DS4033、DS4036）共3份，后续将新增更多检测组文件。
文中提及的生物样本采集将以采集物类型（即尿液与（全）血液）进行明确区分；而生物标志物分析与检测物则将以分析所用的基质类型（血清、血浆或尿液）进行明确标注。