Version Date: Aug 8, 2017 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.v1
Version V1 (see more versions)
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Additional information about this collection can be found in Version History.
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 Wave 1 interviews with 45,971 adult and youth respondents.
Each adult interview respondent, who completed the interview, was asked to provide up to three biospecimens as part of the PATH Study. However, providing biospecimens was voluntary and was not a condition of participation. To help with interpretation of biomarker results, respondents were asked to report on their use of all nicotine-containing products during a 3-day period prior to the time of any biospecimen collection (Nicotine Exposure Questions or NEQs). Of the 32,320 respondents who completed the adult interview, 21,801 provided a urine specimen and 14,520 provided a blood specimen.
Buccal cells were collected for a limited time, from September 12, 2013, to May 18, 2014. There were 12,543 respondents who provided a buccal cell specimen. However, these specimens were not sent for laboratory analysis. There are no biomarker data files for buccal cells at this time, nor are there plans to create them.
The 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 medium (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.
Table 1 in the User Guide contains the list of available panel assays. The five assays listed below will be added at a later date to the PATH Study Biomarker Wave 1 RUF collection at a later date.
In accordance with the study's informed consent, information is suppressed for the individuals who withdraw from the PATH Study. Their information was recoded to a special missing value, designated as -97777.
The current release contains the restricted-use version of the Wave 1 data files. Wave 2 data files are tentatively planned to be released in 2018.
The questionnaires in this collection are updated versions of the fielded questionnaires that were annotated for analytic purposes.
Additional background information including answers to frequently asked questions for study participants and researchers can be found in the Researchers section of the PATH Study series page.
The User Guide provides an overview of the biomarker collection process. The user guide also covers such topics as biospecimen collection, subsampling of adults for biomarker analysis, weighting, and programming syntax to run common statistics and link the files. Researchers are encouraged to use the information in the User Guide for their publications, with the following citation:
The data for the PATH Study were collected and prepared by Westat. The contract number under which they performed their work is: HHSN271201100027C.
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. Taken directly from the PATH Study web site, 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, age 12 years and older in the civilian household population were eligible for participation in the PATH Study.
Field interviewers invited each adult respondent to voluntarily provide up to three biospecimens as part of the study. Respondents were invited to "self-collect" a urine and buccal cell sample. Consenting respondents received $25 for providing one or both samples. 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 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 sample of 11,522 adults who completed the Wave 1 adult interview and provided a sufficient amount of urine for the planned analyses (independently of whether they provided a blood specimen) was selected from a diverse mix of tobacco product users. All urine and blood specimens provided by these sampled adults were sent for laboratory analysis (7,159 of these 11,522 adults also provided a blood specimen). Please consult the User Guide for additional details about the sampling.
Adult (age 18 and older) users and non-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).
Urine Collection: Full-void urine specimens were self-collected by consenting participants in a 500 mL polypropylene container and given to the field interviewers following the completion of the interview. For more information, please see section 2 of the User Guide.
Blood Collection: A blood specimen was collected from consenting adults at a separate visit by a phlebotomist who visited the respondent's home at a time scheduled by the field interviewer. The phlebotomist collected six tubes of whole blood by venipuncture. For more information, please see section 2 of the User Guide.
Assay Methods: For information on assay methods please see the "Laboratory Procedures" document for each assay panel.
In both the Urine (DS1001) and Blood (DS1101) Collection and NEQ datasets the 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) used 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 (DS1002) and Blood (DS1102) Biomarker Weight files contain the same types of variables in both:
Each Assay Panel for Urine (DS1003-DS1009) and Serum (DS1103) contains the same types of variables for each analyte in the panel.
A total of 32,320 adults completed an interview during Wave 1 of data collection. The collection rate of biospecimens provided by these 32,320 respondents was:
A total of 6,950 adults (21.5 percent) provided all three samples. There were also 8,352 adults (25.8 percent) who refused to provide any of the three requested specimens. Table 3-1 in the User Guide provides a breakdown of the various combinations of samples provided by the 32,320 adult respondents.
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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:
There are two files containing weights for use in analyses of the 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. Detailed information on how these variables were created, and how and why they should be used is provided in the User Guide. One aspect to keep in mind is that the weighting procedures adjust for oversampling of certain population groups and non-response. ICPSR strongly recommends that researchers read and understand this section before analyzing the data so that these variables may be used in a correct manner.
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