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. Each adult respondent, who completed the interview, 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, 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 NEQs 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 report on their use of all nicotine-containing products during a 3-day period prior to the time of any biospecimen collection (NEQs). Wave 2 Restricted-Use Biomarker Data Files (Biomarker RUF) consist of three different types of files: 1 Collection and NEQs files for Urine (DS2001) 1 Biomarker Weight file including variables for use in variance estimation for Urine (DS2021) 7 Urine Panels (DS2031 to DS2037) containing biomarker assay results. For Wave 3, urine biospecimens were requested from the Wave 1 Biomarker Core. Respondents were also asked to report on their use of all nicotine-containing products during a 3-day period prior to the time of any biospecimen collection (NEQs). Wave 3 Restricted-Use Biomarker Data Files (Biomarker RUF) consist of three different types of files: 1 Collection and NEQs files for Urine (DS3001) 2 Biomarker Weight files including variables for use in variance estimation for Urine (DS3021 and DS3022) 5 Urine Panels (DS3032, DS3033, DS3035, DS3036, DS3037) 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》（PATH）研究由药物滥用研究所（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）联合开展。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案》（TCA）所进行的烟草监管活动提供信息支持。在第一波次（基线）研究中，PATH研究从全美超过15万个邮寄地址中抽取样本，构建了全国范围内的烟草使用者与非使用者样本库，并对45,971名成年人与青少年受访者进行了访谈。每位完成访谈的成年受访者均被要求提供至少两份生物样本。提供生物样本为自愿行为，并非参与条件。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状况（尼古丁暴露问题，NEQs），以利于生物标志物结果的解读。在完成成年访谈的32,320名受访者中，21,801名（67.4%）提供了尿液样本，14,520名（44.9%）提供了血液样本。从代表从未使用、当前使用和最近一年内戒烟的六种烟草产品使用群体中，选取了11,522名提供充足尿液样本的成年人作为分析样本，该群体构成了第一波次生物标志物核心组。在11,522名成年人中，有7,159名也提供了血液样本。第一波次所有尿液和血液样本均送至实验室进行分析。第一波次限制性使用生物标志物数据文件（生物标志物RUF）包括三种不同类型的文件：尿液（DS1001）和血液（DS1101）的采集和NEQs文件；用于尿液（DS1021）和血液（DS1121）方差估计的生物标志物权重文件；尿液分析板（DS1031至DS1038），血清分析板（DS1131至DS1134）和血浆分析板（DS1231）包含生物标志物检测结果。对于第二波次，从第一波次生物标志物核心组请求尿液生物样本。受访者也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状况（NEQs）。第二波次限制性使用生物标志物数据文件（生物标志物RUF）包括三种不同类型的文件：尿液（DS2001）的采集和NEQs文件；用于尿液方差估计的生物标志物权重文件（DS2021）；包含生物标志物检测结果的尿液分析板（DS2031至DS2037）。对于第三波次，从第一波次生物标志物核心组请求尿液生物样本。受访者也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状况（NEQs）。第三波次限制性使用生物标志物数据文件（生物标志物RUF）包括三种不同类型的文件：尿液（DS3001）的采集和NEQs文件；用于尿液方差估计的两个生物标志物权重文件（DS3021和DS3022）；包含生物标志物检测结果的尿液分析板（DS3032、DS3033、DS3035、DS3036、DS3037），未来还将添加额外的分析板。生物样本的采集将根据采集的样本类型（尿液和（全血））进行说明。然而，对于生物标志物分析和分析物的说明将根据分析所用的基质类型（血清、血浆或尿液）进行指定。