Population Assessment of Tobacco and Health (PATH) Study [United States] Biomarker Restricted-Use Files (ICPSR 36840)

Version Date: Aug 8, 2017

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 ()

  • V22 [2024-07-17]
  • V21 [2024-06-14] unpublished
  • V20 [2023-12-15] unpublished
  • V19 [2023-03-22] unpublished
  • V18 [2022-12-16] unpublished
  • V16 [2022-05-11] unpublished
  • V15 [2021-12-16] unpublished
  • V14 [2021-07-15] unpublished
  • V13 [2021-06-03] unpublished
  • V11 [2020-08-17] unpublished
  • V10 [2020-06-22] unpublished
  • V9 [2020-03-19] unpublished
  • V8 [2020-03-05] unpublished
  • V7 [2020-03-05] unpublished
  • V6 [2019-11-05] unpublished
  • V5 [2019-03-19] unpublished
  • V4 [2019-02-01] unpublished
  • V3 [2018-09-28] unpublished
  • V2 [2018-05-01] unpublished
  • V1 [2017-08-08] unpublished

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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:

  • Checked for undocumented or out-of-range codes.

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Alternate Title

PATH Study Biomarker RUF

Summary

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:

  • 2 Collection and Nicotine Exposure Questions (NEQs) for Urine (DS1001) and Blood (DS1101)
  • 2 Biomarker Weight files including variables for use in variance estimation for Urine (DS1002) and Blood (DS1102)
  • 7 Urine Panels (DS1003 to DS1009) and 1 Serum Panel (DS1103) containing biomarker assay results

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.

Citation

United States Department of Health and Human Services. National Institutes of Health. National Institute on Drug Abuse, and United States Department of Health and Human Services. Food and Drug Administration. Center for Tobacco Products. Population Assessment of Tobacco and Health (PATH) Study [United States] Biomarker Restricted-Use Files. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2017-08-08. https://doi.org/10.3886/ICPSR36840.v1

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Funding

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.

Subject Terms

Geographic Coverage

Smallest Geographic Unit

None

Restrictions

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.

Distributor(s)

Inter-university Consortium for Political and Social Research
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Time Period(s)

2013 -- 2014 (Wave 1)

Date of Collection

2013-09 -- 2014-12 (Wave 1)

Data Collection Notes

  1. The PATH Study Data User Forum allows researchers using the PATH Study data (public-use and restricted-use files) to communicate with each other, including having an opportunity to ask and answer questions. Announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users will also be posted to the forum.
  2. Data are provided via ICPSR's Virtual Data Enclave (VDE) where researchers will work with data stored on secure ICPSR servers. Researchers will not possess actual physical copies of the data; however, upon review by ICPSR, they may request permission to access selected output outside the virtual environment. See the Access Notes to apply for access. Researchers are also encouraged to read the VDE Guide.
  3. Further information about the biospecimens collected at Wave 1 is available in the PATH Study Biomarker Restricted Use File User Guide. Researchers interested in accessing PATH Study biospecimens for biospecimen research should refer to the PATH Study Biospecimen Access Program page. This page provides instructions on applying for access, the schedule for reviewing applications, and frequently asked questions about the program.
  4. The Master Linkage file of the restricted-use questionnaire data will be expanded to match the Master Linkage file (DS0001) of the Biomarker RUF at a later date.
  5. The data files contain a person-level (PERSONID) variable to link participant IDs across files and across waves of data collection as more waves of biomarker data become available. The values in this variable are random and contain no direct or indirect personally identifiable information. Please review Chapter 5 in the User Guide for information and programming code on linking files. The files are sorted by the variable PERSONID.

  6. 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.

    • Urine - Oxidative stress biomarker (F2PG2a)
    • Serum - High-sensitivity C-reactive protein (hsCRP)
    • Serum - Interleukin 6 (IL6)
    • Serum - Intracellular adhesion molecule (sICAM)
    • Plasma - Fibrinogen activity (Clauss) (Fibro)
  7. Users are advised that most but not all of the information contained in the questionnaires is duplicated in the question text used in the codebooks. Some of the longer programming instructions were not incorporated into the question text. In these instances the question text includes a note that points to the questionnaire so that a user may read the full programming instructions for further clarity. Derived and imputed variables contain the algorithms used in the creation of these variables. Users are advised to refer to the User Guide and annotated questionnaires when reviewing the codebooks.

  8. 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.

  9. 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.

  10. The questionnaires in this collection are updated versions of the fielded questionnaires that were annotated for analytic purposes.

  11. 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.

  12. 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:

    • United States Department of Health and Human Services. National Institutes of Health. National Institute on Drug Abuse, and United States Department of Health and Human Services. Food and Drug Administration. Center for Tobacco Products. Population Assessment of Tobacco and Health (PATH) Study [United States] Biomarker Restricted-Use Files, User Guide. ICPSR36840-v1 Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2017-08-08. http://doi.org/10.3886/ICPSR36840.userguide

  13. The data for the PATH Study were collected and prepared by Westat. The contract number under which they performed their work is: HHSN271201100027C.

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Study Purpose

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:

  • Objective 1: Identify and explain between-person differences and within-person changes in tobacco-use patterns, including the rate and length of use by specific product type and brand, product/brand switching over time, uptake of new products, and dual- and poly-use of tobacco products (i.e., use of multiple products within the same time period, and switching between multiple products).
  • Objective 2: Identify between-person differences and within-person changes in risk perceptions regarding harmful and potentially harmful constituents, new and emerging tobacco products, filters and other design features of tobacco products, packaging, and labeling; and, identify other factors that may affect use, such as social influences and individual preferences.
  • Objective 3: Characterize the natural history of tobacco dependence, cessation, and relapse including readiness and self-efficacy to quit, motivations for quitting, the number and length of quit attempts, and the length of abstinence related to various tobacco products.
  • Objective 4: Update the comprehensive baseline and subsequent waves of data on tobacco-use behaviors and related health conditions (including markers of exposure and tobacco-related disease processes identified from the collection and analysis of biospecimens) to assess between-person differences and within-person changes over time in health conditions potentially related to tobacco use, particularly with use of new and different tobacco products, including modified-risk tobacco products. Each wave may also facilitate the selection of individuals by disease status, biomarker levels, or tobacco use status for participation in small-scale research studies (see Objective 8).
  • Objective 5: Assess associations between TCA-specific actions and tobacco-product use, risk perceptions and attitudes, use patterns, cessation outcomes, and tobacco-related intermediate endpoints (e.g., exposure and disease biomarker levels). Analyses will attempt to account for other potential factors, such as demographics, local tobacco-control policies, and social, familial, and economic factors, that may influence the observed patterns.
  • Objective 6: Assess between-person differences and within-person changes over time in attitudes, behaviors, exposures to tobacco products, and related biomarkers among and within population subgroups defined by racial-ethnic, gender, age, and risk factors (e.g., pregnancy or co-occurring substance use or mental health disorders).
  • Objective 7: To the extent to which sample sizes are sufficient, assess and compare samples of former and never users of tobacco products for between-person differences and within-person changes in relapse and uptake, risk perceptions, and indicators of tobacco exposure and disease processes.
  • Objective 8: Use the PATH Study's comprehensive baseline (i.e., Wave 1) and first follow-up wave (i.e., Wave 2) data on tobacco-use behaviors, attitudes, related health conditions (including markers of exposure, tobacco use-related disease processes identified from the collection and analysis of bio-specimens) as a potential basis to screen respondents for participation in small-scale research studies. Such studies would be submitted for approval to the Office of Management and Budget (OMB), for example, through one of the PATH Study's two generic clearances for cognitive testing or for methodological studies, or as an embedded study within a revision request, such as a request to conduct a small-scale research study during a follow-up wave of data and bio-specimen collection.

Study Design

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.

Sample

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.

Time Method

Longitudinal: Panel

Universe

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).

Unit(s) of Observation

individual

Data Source

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.

Data Type(s)

Mode of Data Collection

Description of Variables

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:

  • When the product was last used
  • What time of day the product was last used
  • Amount that was used in the past 2 days
  • Product used was the same brand that was mentioned during the original (main) interview (only asked when the NEQ is given in addition to the main questionnaire - e.g., at blood collection or >4 hrs after the main questionnaire)

The Urine (DS1002) and Blood (DS1102) Biomarker Weight files contain the same types of variables in both:

  • Complex design variables (stratum and cluster)
  • Overall person weight
  • 100 replicate weights

Each Assay Panel for Urine (DS1003-DS1009) and Serum (DS1103) contains the same types of variables for each analyte in the panel.

  • Laboratory variables (e.g., date of analysis, run number, etc.)
  • Imputed result value: The result value reported by the lab except results with values below the limit of detection (LOD) which are replaced with the LOD/(sqrt 2)
  • Imputation flag: Designates which result values were below LOD
  • Comment codes/text provide additional observations about the analyzed sample
  • Additional derived variables may also be included on some panels (e.g., total nicotine equivalents, etc.)

Response Rates

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:

  • Wave 1 urine specimen: 21,801; 67.4 percent
  • Wave 1 blood specimen: 14,520; 44.9 percent
  • Wave 1 buccal cell specimen: 12,543; 38.8 percent

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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Original Release Date

2017-08-08

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:

  • Checked for undocumented or out-of-range codes.
Hide

Weight

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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