Version Date: Mar 19, 2019 View help for published
Principal Investigator(s): View help for Principal Investigator(s)
United States Department of Health and Human Services. National Institutes of Health. National Institute on Drug Abuse;
United States Department of Health and Human Services. Food and Drug Administration. Center for Tobacco Products
Series:
https://doi.org/10.3886/ICPSR36840.v5
Version V5 (see more versions)
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Additional information about this collection can be found in Version History.
2019-03-19 Data and documentation for the Wave 2 urine collection and NEQ (DS2001), urine biomarker weights (DS2021), and seven urine panel assays (DS2031 to DS2037) have been added to the collection. Additionally, the master linkage file (DS0001) has been updated.
2019-02-01 Data and documentation for the Wave 1 VOCM urine panel (DS1009) and the master linkage file (DS0001) were updated for the collection.
2018-10-01 2018-09-28 Data and documentation for five panel assays (F2PGa, hsCRP, IL6, siCAM, and Fibro) was added to the collection. Additionally, data and documentation for the master linkage file was updated. The respondent's local time zones were converted to Eastern Time and the variable R01R_A_URINE_LASTURINATION was recalculated. One case was corrected for variable R01R_A_URINE_NEQ_TDIFF.
2018-05-01 The eight panel assay files were updated due to a modification in the derivation algorithm for the variables "R01R_A_XXXX_IMPFLAG". The text for this variable and that of "R01R_A_XXXX_RESULT_IMP" were updated to include a more detailed algorithm.
2018-02-15 The citation of this study may have changed due to the new version control system that has been implemented. The previous citation was:
2017-08-08 ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection:
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:
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:
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.
Export Citation:
None
Users are reminded that these data are to be used solely for statistical analysis and reporting of aggregated information, and not for the investigation of specific individuals or organizations.
Access to these data is restricted. Users interested in obtaining these data must complete a Restricted Data Use Agreement. Data are provided via ICPSR's Virtual Data Enclave (VDE). Apply for access to these data through the ICPSR VDE portal. Information and instructions are available within the data portal. For further assistance please reference the VDE Guide to learn about the application process, using the VDE, and how to request disclosure review of VDE output.
The Population Assessment of Tobacco and Health (PATH) Study is a longitudinal cohort study on tobacco use behavior, attitudes and beliefs, and tobacco-related health outcomes among an estimated 46,000 adults and youth in the United States. The study's primary objectives are to:
The study used a four-staged stratified sampling design to sample over 150,000 mailing addresses, yielding a Wave 1 (baseline) sample of 45,971 respondents (32,320 adults and 13,651 youth). Tobacco users and non-users, ages 12 years and older and in the civilian non-institutionalized household population were eligible for participation in the PATH Study.
Field interviewers invited each adult respondent to voluntarily provide biospecimens as part of the study. Respondents were invited to "self-collect" a urine sample. Consenting respondents received $25 for providing one or both samples. At Wave 1, adults consenting to provide a blood sample were scheduled for a blood draw appointment with a phlebotomist at the respondent's home. The respondent received $25 for their time during this activity. Specific details about specimen collection and storage are contained in Chapter 2 of the Biomarker Restricted-Use Files User Guide.
A four-stage stratified area probability sample design was used in the PATH Study, with a two-phase design for sampling adults at the final stage. At the first stage, a stratified sample of geographical primary sampling units (PSUs) was selected, in which a PSU is a county or group of counties. For the second stage, within each selected PSU, smaller geographical segments were formed and then a sample of these segments was drawn. At the third stage, the sampling frame consisted of the residential addresses located in these segments. The fourth stage selected adults and youth from the sampled households identified at these addresses, with varying sampling rates for adults by age, race, and tobacco use status. Adults were sampled in two phases - Phase 1 sampling used information provided in the household screener and Phase 2 sampling used information provided by the adult in the Phase 2 screener at the beginning of the adult instrument.
A stratified probability subsample of 11,522 adults who completed the Wave 1 adult interview and provided sufficient urine for the planned analyses (independently of whether they provided a blood specimen) was selected from a diverse mix of tobacco product users. This group constitutes the Wave 1 Biomarker Core. Of these 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. Please consult the Biomarker Restricted-Use Files User Guide for additional details about the subsampling.
Wave 2 was the first follow-up wave for participants in Wave 1. The target population for Wave 2 was the Wave 1 target population residing in the U.S. at Wave 2 with the exception of those who were incarcerated. Thus, Wave 1 respondents who later joined the military or entered a health care institution (e.g., nursing home) were members of the target population and eligible for Wave 2 data collection. At Wave 2, only Wave 1 respondents who died, resided outside the U.S., or were in a correctional facility were ineligible for a Wave 2 interview. The PATH Study completed 28,362 Adult Interviews in Wave 2. Those in the Wave 1 Biomarker Core were asked to provide urine, and of those who provided 9,012 qualified for analysis. See the Laboratory File Inventory for more details.
Adult (age 18 and older) never, current, and recent former (within 12 months) users of tobacco products in the civilian, non-institutionalized household population of the United States at the time of Wave 1 (September 12, 2013 - December 14, 2014).
In both the collection files for Urine (Wave 1: DS1001, Wave 2: DS2001) and Blood (Wave 1: DS1101, Wave 2: N/A), data are stored about recent nicotine exposure (NEQs). Specifically, respondents are asked about their use of seven types of tobacco products: cigarettes, e-cigarettes, cigars (traditional, cigarillos, filtered), pipes, hookah, smokeless tobacco (snus pouches and other forms of smokeless tobacco), and dissolvable tobacco. They are also asked about their use of nicotine replacement therapies (NRT) such as a patch, gum, inhaler, pill, etc., and prescription drugs used for smoking cessation. Each section contains the same basic four questions:
The Urine (Wave 1: DS1002, Wave 2: DS2021) and Blood (Wave 1: DS1102, Wave 2: N/A) Biomarker Weight files both contain:
Each Assay Panel for Urine (Wave 1: DS1003-DS1010, Wave 2: DS2031-DS2037), Serum (Wave 1: DS1103-DS1106, Wave 2: N/A), and Plasma (Wave 1: DS1201, Wave 2: N/A) contains the following information for each analyte included in the panel.
The following lists each chemical compound analyzed within each of the panel codebooks for Wave 1 and Wave 2.
A total of 32,320 adults completed an interview during Wave 1 of data collection. The collection rates of urine and blood provided by these 32,320 respondents were:
Not all adults who provided a blood sample provided a urine sample, and some adults refused to provide both of the requested specimens. Table 2 in the Biomarker Restricted-Use Files User Guide gives a breakdown of the various combinations of samples provided by the 32,320 adult respondents.
Among Wave 2 Adult Interview respondents, a subsample of continuing adults who provided urine at Wave 1 were asked to provide a urine specimen. Among the Wave 1 Biomarker Core, 9,996 completed a Wave 2 interview. The collection rate of urine specimens provided by the Wave 1 Biomarker Core at Wave 2 was 96.4 percent (a total of 9,640 collected). See the Laboratory File Inventory for more details.
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2019-03-19 Data and documentation for the Wave 2 urine collection and NEQ (DS2001), urine biomarker weights (DS2021), and seven urine panel assays (DS2031 to DS2037) have been added to the collection. Additionally, the master linkage file (DS0001) has been updated.
2019-02-01 Data and documentation for the Wave 1 VOCM urine panel (DS1009) and the master linkage file (DS0001) were updated for the collection.
2018-10-01 2018-09-28 Data and documentation for five panel assays (F2PGa, hsCRP, IL6, siCAM, and Fibro) was added to the collection. Additionally, data and documentation for the master linkage file was updated. The respondent's local time zones were converted to Eastern Time and the variable R01R_A_URINE_LASTURINATION was recalculated. One case was corrected for variable R01R_A_URINE_NEQ_TDIFF.
2018-05-01 The eight panel assay files were updated due to a modification in the derivation algorithm for the variables "R01R_A_XXXX_IMPFLAG". The text for this variable and that of "R01R_A_XXXX_RESULT_IMP" were updated to include a more detailed algorithm.
2018-02-15 The citation of this study may have changed due to the new version control system that has been implemented. The previous citation was:2017-08-08 ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection:
For Wave 1, there are two files containing weights for use in the analyses of biomarker data that reflect the complex PATH Study sample design. The final full-sample person-level weight for Urine is R0#_A_URINEPWGT and for Blood it is R0#_A_BLOODWGHT. Also, contained in these two files are 100 replicate weights and design variables (VARPSU and VARSTRAT) for use in variance estimation.
For Wave 2, there is one file containing longitudinal weights for use in the analyses including the Wave 2 urine biomarker data. The final full-sample person-level weight for Urine is R0#_A_URINEPWGT. Also, contained in this file are 100 replicate weights and design variables (VARPSU and VARSTRAT) for use in variance estimation.
Detailed information on how these variables were created, and how and why they should be used is provided in the Biomarker Restricted-Use Files User Guide. The weighting procedures adjust for oversampling of population groups and non-response. ICPSR strongly recommends that users read and understand this section before analyzing the data to ensure correct use of these variables.
Due to the subsampling of adults to determine the biospecimens sent for laboratory analysis, using the weights provided with the biomarker data makes the data nationally representative of tobacco users and nonusers in six tobacco product use groups only. These estimates can be described as representative of never, current, and recent former (within 12 months) users of tobacco products in the U.S. civilian, noninstitutionalized adult population at the time of Wave 1.
Weighted estimates of Wave 2 data are nationally representative of persons in the U.S. civilian, noninstitutionalized population at Wave 1 who lived in the United States (and were not incarcerated) at the time of Wave 2 and were adults at Wave 1 and at the time were never, current, or recent former (within 12 months) users of tobacco products. Weighted estimates of biomarker data after Wave 2 can be similarly described.
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