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. 45,971 adults and youth constitute
the first (baseline) wave, Wave 1, of data collected by this longitudinal
cohort study. These 45,971 adults and youth along with 7,207 "shadow youth"
(youth ages 9 to 11 sampled at Wave 1) make up the 53,178 participants that
constitute the Wave 1
Cohort. Respondents are asked to complete an interview at each follow-up wave.
Youth who turn 18 by the current wave of data collection are considered
"aged-up adults" and are invited to complete the Adult Interview. Additionally,
"shadow youth" are considered "aged-up youth" upon turning 12 years old, when
they are asked to complete an interview after parental consent.At Wave
4, a probability sample of 14,098 adults, youth, and shadow youth ages 10 to 11
was selected from the civilian, noninstitutionalized population at the time of
Wave 4. This sample was recruited from
residential addresses not selected for Wave 1 in the same sampled PSUs and
segments using similar within-household sampling procedures. This
"replenishment sample" was combined for estimation and analysis purposes with
Wave 4 adult and youth respondents from the Wave 1 Cohort who were in the
civilian, noninstitutionalized population at the time of Wave 4. This combined
set of Wave 4 participants, 52,731 participants in total, forms the Wave 4
Cohort.Please refer to the Restricted-Use Files User Guide that provides
further details about children designated as "shadow youth" and the formation
of the Wave 1 and Wave 4 Cohorts.<strong>Biospecimen Collection</strong>
Each adult respondent, who completed the interview at Wave 1, 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 at Wave 1,
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.Each youth who completed the Wave 4 interview was
asked to provide a urine specimen. Each Wave 4 shadow youth (ages 10 and 11 at
Wave 4) who completed the Wave 5 youth interview was also asked to provide a
urine specimen. Providing this urine biospecimen was voluntary and was not a
condition of participation.Of the 14,798 respondents who completed the
youth interview at Wave 4, 13,097 (88.5 percent) provided a urine specimen. A
sample of 3,509 Wave 4 Cohort youth ages 12 to 17 who completed the Wave 4
youth interview and provided a sufficient amount of urine for the planned
laboratory analyses was selected from a diverse mix of five tobacco product use
and non-use groups. In addition, a sample of 528 Wave 4 shadow youth who
completed a Wave 5 interview and provided a sufficient amount of urine for the
planned laboratory analyses at Wave 5 was also selected. These 4,037 sampled youth
and shadow youth constitute the Wave 4 Biomarker Core. All urine specimens
provided by the Wave 4 Biomarker Core were sent for laboratory
analysis.<strong>Biomarker Restricted Use Files</strong>
Wave 1 Restricted-Use Biomarker Data Files (Biomarker RUF) consists of three
different types of files for the Wave 1 Biomarker Core:

2 Collection and NEQ 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 complete the NEQs prior to biospecimen
collection.
The Wave 2 Biomarker RUF consists of three different types of files:
1 Collection and NEQ file for Urine (DS2001)
2 Biomarker Weight files including variables for use in variance
estimation for Urine (DS2021) and F2PG2a (DS2022)
8 Urine Panels (DS2031 to DS2038) containing biomarker assay
results.

For Wave 3, urine biospecimens were requested from the Wave 1 Biomarker
Core. Respondents were also asked to complete the NEQs prior to biospecimen
collection.
The Wave 3 Biomarker RUF consists of three different types of files:

1 Collection and NEQ file for Urine (DS3001)
4 Biomarker Weight files including variables for use in variance
estimation for Urine (DS3021 and DS3022) and F2PG2a (DS3023 and DS3024).
7 Urine Panels (DS3032 to DS3038) containing biomarker assay
results.

For Wave 4, urine biospecimens were requested from the Wave 1 Biomarker Core
and all youth who completed the Wave 4 interview. Respondents were also
asked to complete the NEQs prior to biospecimen collection.
The Wave 4 Biomarker RUF consists of three
different types of files for each Biomarker Core:Wave 1 Biomarker Core:

1 Collection and NEQ file for Urine (DS4001)
4 Biomarker Weight files including variables for use in variance
estimation for Urine (DS4021 and DS4022) and F2PG2a (DS4023 and DS4024).
7 Urine Panels (DS4032, DS4033, DS4034, DS4035, DS4036, DS4037 and DS4038) containing
biomarker assay results.

Wave 4 Biomarker Core:
1 Collection and NEQ file for Youth Urine (DS4011)
1 Biomarker Weight files including variables for use in variance
estimation for Urine (DS4043)
6 Urine Panels (DS4051, DS4053, DS4054, DS4055, DS4056 and DS4057) containing
biomarker assay results. Additional panel(s) will be added at a later
date.

For Wave 5, urine biospecimens were requested from the Wave 1 Biomarker Core
and the Wave 4 Biomarker Core. Respondents were also asked to complete the NEQs
prior to biospecimen collection. Note that Wave 5 specimens from the Wave 4 Biomarker Core were sent for laboratory analysis prior to the Wave 4 specimens.
The Wave 5 Biomarker RUF consists of three different types of files for each
Biomarker Core:
Wave 1 Biomarker Core:

1 Collection and NEQ file for Urine (DS5001)
4 Biomarker Weight files including variables for use in variance
estimation for Urine (DS5021 and DS5022) and F2PG2a (DS5023 and DS5024)
6 Urine Panels (DS5032, DS5033, DS5035, DS5036, DS5037, and DS5038) containing biomarker
assay results.

Wave 4 Biomarker Core:

1 Collection and NEQ file for Youth Urine (DS5011)
1 Collection and NEQ file for Adult Urine (DS5001)
1 Biomarker Weight file including variables for use in variance estimation
for Urine (DS5042)
6 Urine Panels (DS5051, DS5053, DS5055, DS5056, DS5057, and DS5058) containing biomarker assay
results. Additional panel(s) will be added at a later date.

Note that the initial release of 3 Urine Panels and Biomarker weights for the Wave 4 Biomarker Core only included records for those among the 3,509 members who responded in Wave 5 and provided urine specimens in sufficient quantities for laboratory analyses. As of version 20, the Wave 5 biomarker data files and weights include data for all Wave 4 Biomarker Core members who provided urine specimens at Wave 5 in sufficient quantities for laboratory analyses, including the Wave 4 shadow youth who completed their first interview at Wave 5. This means that records were added to previously released urine panel data files (DS5051, DS5053, and DS5056) and biomarker weights (DS5042) to include data for the Wave 4 shadow youth (N=528) who completed their first interview at Wave 5. All panels released in version 20 and beyond will include records for the complete Wave 4 Biomarker Core. Also note that the Collection and NEQ file for Adult Urine (DS5001) includes data for both the Wave 1 Biomarker Core and Wave 4 Biomarker Core. Please refer to the PATH Study Biomarker Restricted-Use Files User Guide for additional information about the Wave 4 Biomarker Core.
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.