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, 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）下属的烟草产品中心（Center for Tobacco Products, CTP）联合开展的研究项目。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案》（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）研究中，PATH研究在美国境内抽取了超过15万个邮寄地址，以构建全国范围内的烟草使用者与非使用者样本库，最终完成了45971名成年人与青少年受访者的访谈。这45971名成年人与青少年构成了该纵向队列研究的第一波（基线波，Wave 1）数据样本。这45971名参与者加上7207名“影子青少年（shadow youth）”（Wave 1抽样的9至11岁青少年），共同组成了第一波队列（Wave 1 Cohort）的53178名参与者。所有受访者需在每一次后续追踪波次中完成访谈。在当前数据收集波次年满18岁的青少年将被视为“成年转化者”，并受邀参与成人访谈。此外，“影子青少年”年满12岁后将被视为“青少年转化者”，在获得家长同意后需完成访谈。
在第四波研究中，研究人员从第四波研究开展时的民用非机构化人群中，抽取了包含成年人、青少年以及10至11岁影子青少年在内的14098名概率样本。该样本从与第一波研究相同的抽样初级抽样单元（Primary Sampling Units, PSUs）和区段中未被抽选为第一波样本的居住地址中招募，采用与第一波研究相似的户内抽样流程。该“补充样本”将与第四波研究中来自第一波队列且在第四波研究开展时属于民用非机构化人群的成年与青少年受访者合并，用于估算与分析。合并后的第四波研究参与者总计52731人，构成了第四波队列（Wave 4 Cohort）。请参考《受限使用数据文件用户指南（Restricted-Use Files User Guide）》以获取更多关于“影子青少年”的定义以及第一波、第四波队列构建的细节。
每一位完成第一波研究访谈的成年受访者需提供至少两份生物样本。提供生物样本属于自愿行为，并非参与研究的必要条件。研究人员要求受访者报告其在任意一次生物样本采集前3天内使用所有含尼古丁产品的情况（尼古丁暴露问卷（Nicotine Exposure Questions, NEQs）），以辅助生物标志物检测结果的解读。在完成第一波研究成人访谈的32320名受访者中，21801人（67.4%）提供了尿液样本，14520人（44.9%）提供了血液样本。研究人员从6个烟草产品使用群组（涵盖从未使用者、当前使用者以及近12个月内的近期戒烟者）中选取了11522名提供了满足分析需求尿液样本的成年人，该群组构成了第一波生物标志物核心样本（Wave 1 Biomarker Core）。在这11522名成年人中，有7159人同时提供了血液样本。第一波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。第一波受限使用生物标志物数据文件（Wave 1 Restricted-Use Biomarker Data Files, Biomarker RUF）包含三类文件：一是尿液（DS1001）与血液（DS1101）的采集信息及尼古丁暴露问卷文件；二是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（DS1121）；三是8份尿液检测面板（DS1031至DS1038）、4份血清检测面板（DS1131至DS1134）以及1份血浆检测面板（DS1231），上述文件包含生物标志物检测结果。
针对第二波研究，研究人员向第一波生物标志物核心样本的参与者索要尿液生物样本，同时要求受访者在样本采集前完成尼古丁暴露问卷。第二波受限使用生物标志物数据文件包含三类文件：一是尿液采集信息及尼古丁暴露问卷文件（DS2001）；二是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）；三是8份尿液检测面板（DS2031至DS2038），包含生物标志物检测结果。
针对第三波研究，研究人员向第一波生物标志物核心样本的参与者索要尿液生物样本，同时要求受访者在样本采集前完成尼古丁暴露问卷。第三波受限使用生物标志物数据文件包含三类文件：一是尿液采集信息及尼古丁暴露问卷文件（DS3001）；二是用于尿液样本方差估算的生物标志物权重文件（DS3021与DS3022）；三是6份尿液检测面板（DS3032至DS3037），包含生物标志物检测结果。后续将新增更多检测面板。
针对第四波研究，研究人员向第一波生物标志物核心样本的参与者索要尿液生物样本，同时要求受访者在样本采集前完成尼古丁暴露问卷。第四波受限使用生物标志物数据文件包含三类文件：一是尿液采集信息及尼古丁暴露问卷文件（DS4001）；二是用于尿液样本方差估算的生物标志物权重文件（DS4021与DS4022）；三是3份尿液检测面板（DS4032、DS4033、DS4036），包含生物标志物检测结果。后续将新增更多检测面板。
文中提及生物样本采集时，将以采集的样本类型（即尿液与（全）血液）进行说明。而提及生物标志物分析与分析物时，则将以分析所用的基质类型（血清、血浆或尿液）进行标注。