Version Date: Jun 22, 2020 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.v10
Version V10 (see more versions)
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Additional information about this collection can be found in Version History.
2020-06-22 Data and documentation for the Master Linkage File and two additional Wave 3 Urine Panel Assays (DS3035 and DS3037) have been added to the collection.
2020-03-19 Data and documentation for the Master Linkage File has been updated.
2020-03-05 Data and documentation for the Wave 3 Urine Collection and NEQ (DS3001), two Wave 3 Urine Panel Weights (DS3021 and DS3022), and three Wave 3 Urine Panel Assays (DS3032, DS3033, and DS3036) have been added to the collection.
2019-11-05
Data and Documentation for the Wave 1 Urine Collection and NEQ (DS1001) and Wave 1 Blood Collection (DS1101) were updated to reflect withdrawn participants (indicated by Special Missing -97777). Documentation was updated for 508 compliance at this time.
Dataset and corresponding documentation number-schemes have changed for Wave 1.
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:
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:
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 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.
Data are provided via ICPSR's Virtual Data Enclave (VDE) where researchers work with data stored on secure ICPSR servers. Researchers cannot possess 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.
The data currently available are the Wave 1, Wave 2, and Wave 3 restricted-use biomarker data files. Additional Wave 3 restricted-use biomarker panel(s) are forthcoming in subsequent release(s).
Further information about the biospecimens collected at Wave 1, Wave 2, and Wave 3 is available in the PATH Study Biomarker Restricted-Use Files 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.
The Master Linkage file (DS0001) is also available from the restricted-use questionnaire data.
The data files contain a person-level (PERSONID) variable to link participant IDs across files (e.g., linking Wave 1 adult questionnaire data with Wave 1 biomarker data) and across waves (e.g., linking Wave 1 and Wave 2 biomarker data). The values in this variable are random and contain no direct or indirect personally identifiable information. Please review Chapter 5 in the Biomarker Restricted-Use Files User Guide for information and programming code on linking files. The files are sorted by the variable PERSONID.
The questionnaires in this collection have been annotated for analytic purposes. Users are advised that most but not all 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 for the user to read the full programming instructions in the corresponding section of the questionnaire. Derived and imputed variables contain the algorithms used in the creation of these variables. Users are advised to refer to the Biomarker Restricted-Use Files User Guide and annotated questionnaires when reviewing the codebooks.
In accordance with the study's informed consent, information is suppressed for individuals who withdraw from the PATH Study. Their information was recoded to a special missing value, designated as -97777.
The PATH Study's documentation is available for your use and may be reproduced in whole or in part without permission from NIH's National Institute on Drug Abuse or FDA's Center for Tobacco Products. Citation of the source is appreciated.
Additional background information including answers to frequently asked questions can be found in the Researchers section of the PATH Study series page.
The Biomarker Restricted-Use Files User Guide provides an overview of the biospecimen collection process. The User Guide also covers such topics as 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. 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. At Wave 2, the PATH Study completed 28,362 Adult Interviews, but only those in the Wave 1 Biomarker Core were asked to provide urine for lab analysis. Of those who provided urine samples, 9,012 were shipped for lab analysis. See the Laboratory File Inventory for more details.
Wave 3 was the second follow-up wave for participants in Wave 1. At Wave 3, the PATH Study completed 28,148 Adult Interviews, but only those in the Wave 1 Biomarker Core were asked to provide urine for lab analysis. Of those who provided urine samples, 8,643 were shipped for lab 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, Wave 3: DS3001) and Blood (Wave 1: DS1101, Wave 2: N/A, Wave 3: 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: DS1021, Wave 2: DS2021, Wave 3: DS3021 and DS3022) and Blood (Wave 1: DS1121, Wave 2: N/A, Wave 3: N/A) Biomarker Weight files both contain:
Each Assay Panel for Urine (Wave 1: DS1031-DS1038, Wave 2: DS2031-DS2037, Wave 3: DS3032, DS3033, DS3035, DS3036, and DS3037), Serum (Wave 1: DS1131-DS1134, Wave 2: N/A, Wave 3: N/A) and Plasma (Wave 1: DS1231, Wave 2: N/A, Wave 3: N/A) contains the following information for each analyte included in the panel.
See Appendix A of the Laboratory File Inventory for a list of chemical compounds analyzed within each of the panel codebooks for Wave 1, Wave 2, and Wave 3.
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.
Among Wave 3 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, 9,462 completed a Wave 3 interview. The collection rate of urine specimens provided by the Wave 1 Biomarker Core at Wave 3 was 97.5 percent (a total of 9,227 collected). See the Laboratory File Inventory for more details.
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2020-06-22 Data and documentation for the Master Linkage File and two additional Wave 3 Urine Panel Assays (DS3035 and DS3037) have been added to the collection.
2020-03-19 Data and documentation for the Master Linkage File has been updated.
2020-03-05 Data and documentation for the Wave 3 Urine Collection and NEQ (DS3001), two Wave 3 Urine Panel Weights (DS3021 and DS3022), and three Wave 3 Urine Panel Assays (DS3032, DS3033, and DS3036) have been added to the collection.
2019-11-05Data and Documentation for the Wave 1 Urine Collection and NEQ (DS1001) and Wave 1 Blood Collection (DS1101) were updated to reflect withdrawn participants (indicated by Special Missing -97777). Documentation was updated for 508 compliance at this time.
Dataset and corresponding documentation number-schemes have changed for Wave 1.
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.
For Wave 3, there are two files containing weights: the all-waves urine weights and the single-wave urine weights. The Wave 3 urine weights are for use in analyses including the Wave 3 urine biomarker data. The Wave 3 all-waves urine weights file contains weights for members of the Wave 1 Biomarker Core who completed the Wave 3 interview, provided a sufficient amount of urine for the planned analyses at Wave 3, and were also assigned a Wave 2 urine weight. The Wave 3 single-wave urine weights file contains weights for members of the Wave 1 Biomarker Core who completed the Wave 3 interview and provided a sufficient amount of urine for the planned analyses, regardless of their level of participation in the study at Wave 2. The Wave 3 all-waves weight is named R03_A_BC01A_URWGT. The Wave 3 single-wave weight is named R03_A_BC01S_URWGT. Each Wave 3 urine weights file also contains 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 adults in the U.S. civilian, noninstitutionalized population that were never, current, or recent former (within 12 months) users of tobacco products at Wave 1 and who lived in the United States (and were not incarcerated) at Wave 2.
Weighted estimates of Wave 3 data are nationally representative of adults in the U.S. civilian, noninstitutionalized population that were never, current, or recent former (within 12 months) users of tobacco products at Wave 1 and who lived in the United States (and were not incarcerated) at Wave 3.
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