Supporting
Statement A
for
Population Assessment of
Tobacco and
Health (PATH) Study (NIDA) -
Third Wave of Data Collection
Submitted by:
Kevin P. Conway, Ph.D.
Deputy Director
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Blvd., Room 5185
Rockville, MD 20852
Phone: 301-443-8755
Email: [email protected]
Section Page
A. Justification 1
A.1 Circumstances Making Collection of Information Necessary 1
A.2 Purpose and Use of the Information Collection 4
A.3 Use of Information Technology and Burden Reduction 14
A.4 Efforts to Identify Duplication and Use of Similar Information 15
A.5 Impact on Small Businesses or Other Small Entities 18
A.6 Consequences of Collecting the Information Less Frequently 18
A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5 18
A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency 19
A.9 Explanation of Any Payment or Gift to Respondents 20
A.10 Assurances of Confidentiality Provided to Respondents 22
A.11 Justification for Sensitive Questions 26
A.12 Estimates of Annualized Burden Hours and Costs 31
A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers 34
A.14 Annualized Cost to the Federal Government 34
A.15 Explanation for Program Changes or Adjustments 35
A.16 Plans for Tabulation and Publication and Project Time Schedule 35
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate 38
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions 38
References 39
LIST OF ATTACHMENTS
(Appearance in Supporting Statement A)
Attachment 1. NIDA’s Data Collection Authority 1
Attachment 2. PATH Study Data Collection Instruments 6
Attachment 3. Crosswalk of PATH Study Objectives, Data Sources, Domains, and Analysis 6
Attachment 4. Sample Conceptual Models 7
Attachment 5. Summary of Proposed Changes to Instruments for Wave 3 9
Attachment 6. Additional Information on Biospecimens 11
Attachment 7. PATH Study Privacy Impact Assessments (PIA) 14
Attachment 8. Key Design Features of National Tobacco Surveys 15
Attachment 9. Follow-up, Retention, and Tracking Materials 18
Attachment 10. Public Comments to 60-Day Federal Register Notice 19
Attachment 11. List of Consultants 19
Attachment 12. Consent Materials 21
Attachment 13. Certificate of Confidentiality 23
Attachment 14. Assurance of Confidentiality 23
Attachment 15. IRB Approval Memo 24
Attachment 16. NIH Privacy Act Systems of Record Notice 24
Attachment 17. Procedures for Keeping Data Confidential 25
Attachment 18. ICPSR Data Use Agreement 26
Attachment 19. Field Data Collection Materials 29
Attachment 20. Sample Analysis Plans 36
The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA) and in partnership with the Food and Drug Administration (FDA), requests Office of Management and Budget (OMB) approval of a revision (OMB 0925-0664, expires 9/30/2016) for the Population Assessment of Tobacco and Health (PATH) Study to conduct the third wave (Wave 3) of data collection.
Under data collection authorization of Title 42 USC 285o (Attachment 1), NIDA is partnering with FDA to conduct the PATH Study through Westat, the prime contractor. Using computer-assisted interviews and collection of biospecimens, the PATH Study will collect baseline and follow-up information on tobacco-use patterns; trends in risk perceptions and attitudes regarding harmful constituents, and new and emerging tobacco products; tobacco initiation, cessation and relapse behaviors among youth aged 12 to 17 and adults aged 18 and older. These longitudinal data will allow the PATH Study to generate research hypotheses regarding relationships between tobacco exposure and use, health conditions, and the onset and progression of disease processes. The Wave 1 or baseline sample size is 45,971 (32,320 adults and 13,651 youth); the target Wave 2 sample size is 41,847 ( 29,287 adults and 12,560 youth), and the target Wave 3 sample size is 38,772 (27,224 adults and 11,548 youth). The population for this study is the civilian non-institutionalized population in the United States (U.S.). The PATH Study oversamples tobacco users, young adults, and African American adults; and it uses a “wide net” definition (as described in detail in Supporting Statement B) of a tobacco user to capture adults who have had experience with a range of different tobacco products and who may be at risk of progressing to more frequent use.
This revision request is for OMB approval of the PATH Study’s Wave 3 of data and biospecimen collection. The current plan is to follow the Wave 1 cohort for three years, which is over the duration of the current PATH Study contract. Additional waves are under consideration pending the availability of funding. Each wave is planned for 12 to 15 months, with the possibility of 1 or more months of overlap between the waves. Wave 3 data and biospecimen collection is scheduled to begin in the fall of 2015. NIDA will submit revision requests to OMB for each of the PATH Study’s waves of data collection. In addition, under the PATH Study's existing generic clearances for cognitive testing and methodological studies, NIDA may submit requests to conduct cognitive testing and methodological sub-studies, respectively, to inform potential changes to the Study's data collection instruments and protocol.
This revision request addresses the terms of clearance of OMB’s approval of the PATH Study’s Wave 2 (OMB 0925-0664, expires 9/30/2016). The terms of clearance require a full revision for OMB approval of the PATH Study’s Wave 3. In addition, prior to submitting the revision request for Wave 3 to OMB, the terms of clearance stipulate that NIDA and FDA should report to OMB on the: (1) response rates associated with the full Wave 1, including screening, interview completion, and biospecimen response; (2) Wave 2 retention and recruitment rates for the youth who age into the adult cohort and for the shadow youth who age into the youth cohort; (3) the results of nonresponse analysis and statistical approach for addressing non-response, as well as implications for the study going forward; and (4) the statistical approach to be applied to the biospecimen data to address potential nonresponse bias from lower consent and cooperation rates with this aspect of the study. OMB has reviewed and approved this interim report. (For additional information on the interim report, see Supporting Statement B, Section B.4.)
According to the 2014 Surgeon General’s report on smoking (U.S. Department of Health and Human Services, 2014), approximately 480,000 deaths in the U.S. each year are from cigarette use and second hand smoke exposure, and an estimated 16 million people alive today have at least one serious illness caused by smoking. Over one out of five high school students (22.9%) and nearly one out of fifteen middle school students (6.5%) were tobacco users in 2013 (CDC, 2014), and the majority of youth tobacco users report past use of more than one tobacco product (Apelberg et al., 2014). The 2013 National Survey on Drug Use and Health (NSDUH) reported "an estimated 66.9 million Americans aged 12 or older were current (past month) users of a tobacco product. This represents 25.5 percent of the population in that age range. Also, 55.8 million persons (21.3% of the population) were current cigarette smokers; 12.4 million (4.7%) smoked cigars; 8.8 million (3.4%) used smokeless tobacco; and 2.3 million (0.9%) smoked tobacco in pipes" (Substance Abuse and Mental Health Services Administration, 2014, p. 4). The NSDUH also estimated that about 5,700 persons became new cigarette smokers in the U.S. every day in 2013, and that about half (50.5%) of new cigarette smokers in 2013 initiated prior to age 18. According to the 2014 Monitoring the Future survey, daily cigarette smoking among 8th, 10th, and 12th graders has continued to decline. In 2014, daily cigarette smoking dropped to 1.4 percent among 8th graders, compared to 2.7 percent five years ago; among 10th graders, it dropped to 3.2 percent, compared to 6.3 percent five years ago; and among 12th graders, it dropped to 6.7 percent, down from 11.2 percent five years ago. Of concern, however, are the 2014 findings on the use of electronic cigarettes (e-cigarettes): past 30 day use of e-cigarettes by 8th graders was 8.7 percent; for 10th graders, it was 16.2 percent; and for 12th graders, it was 17.1 percent (Johnston et al., 2014).
On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (referred to herein as TCA) was signed into law. The TCA amended Section 201 of the Federal Food, Drug, and Cosmetic Act (FD&C) (21 U.S.C. 321) by inserting Chapter 9 (“Tobacco Products”), Section 901, which authorizes FDA to regulate tobacco-product standards; tobacco-product manufacturing practices, distribution, and marketing; the labeling of tobacco products, including health warnings on tobacco-product packages and in ads; tobacco-product constituents, ingredients, and additives, including requirements for testing and reporting of harmful or potentially harmful constituents (HPHC) by brand and sub-brand; and restrictions on access to tobacco products, advertising, and promotions among youth. To fulfill the mandates of the TCA, the FDA requires a solid evidence base to inform its regulatory decisions, their implementation, and subsequent assessments of their effectiveness, as well as to support its future regulatory decisions and actions.
The NIH, through NIDA, is partnering with FDA’s Center for Tobacco Products (CTP) in a large-scale collaboration to conduct the PATH Study. This national longitudinal study of tobacco use and health will enhance the evidence base available to the FDA by providing in-depth epidemiological, population-based data on the use of existing and emerging tobacco products; on attitudes and perceptions related to the use of different existing and emerging tobacco products; on tobacco-use cessation attempts, rates of relapse, and product switching, such as from one product to another perceived to be less risky; on biomarkers of tobacco exposure; and on indicators of tobacco-use-related health conditions and disease processes.
By virtue of its longitudinal cohort design, the PATH Study provides a unique opportunity to monitor and assess between-person differences and within-person changes over time in tobacco-product use and potentially-related health conditions. Cumulative data from the PATH Study on tobacco use behaviors, attitudes, exposures, and health in the United States can enrich the evidence base that informs FDA's regulatory actions under the TCA to reduce tobacco-related diseases, disabilities, and deaths.
The PATH Study’s mission is to gather and analyze national epidemiological and longitudinal data on tobacco use behaviors and health in the United States. Components of the study include conducting annual computer-assisted interviews on tobacco-product use behaviors with the national longitudinal cohort, which at the end of Wave 2 numbered approximately 41,847 current, former, and never tobacco product users ages 12 years and older. In addition, as in Wave 2, biospecimens (urine only or both urine and blood) are collected from PATH Study respondents to assess biological indicators of tobacco-related exposures and changes over time in measures of tobacco use-related harm. Specifically, the plans for Wave 3 are to: (a) request urine from a subsample of approximately 17,386 adults who initially provided urine at Wave 1 or Wave 2; and (b) request both urine and blood samples from aged-up 18 year olds, for whom Wave 3 is the baseline.
The PATH Study's longitudinal design allows for the recurring and sequential achievement of its eight key objectives, i.e., data from each wave will partially address each objective and provide a basis for comparisons with data collected in the succeeding waves. Data collected from Wave 3 will be helpful for informing potential future waves, for comparing data between waves, and for examining between-person differences and within-person changes over time. Thus, the PATH Study’s objectives are expected to be achieved iteratively and cumulatively over time; they are numbered here for convenience purposes only. The objectives are:
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 biospecimens) as a potential basis to screen respondents for participation in small-scale research studies. Such studies would be submitted for approval to 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 biospecimen collection.
The PATH Study will obtain completed interviews annually from a nationally representative sample of respondents 12 years of age and older. An adult extended interview will be administered to adults age 18 and older, a youth extended interview will be administered to youth ages 12 to 17 years, and a parent interview will be administered to parents of youth respondents. These instruments will also be tailored for those adults, youth, and parents of youth who age up to the PATH Study cohorts (i.e., a youth who turns 18, a shadow sample youth who turns 12 years old, and the parent of a shadow sample youth who turns 12). Biospecimen collection at Wave 3 will request urine from a subsample of approximately 17,386 adults who initially provided urine at Wave 1 or Wave 2. In addition, urine and blood will be collected from adults who responded to the youth interview at Wave 1 or Wave 2 and have subsequently aged up to the adult cohort and given consent for collections at Wave 3.
Table A-1 lists the PATH Study Wave 3 instruments and briefly describes the purpose and content of each. Attachment 2 includes the instruments; Attachment 3 provides the data sources, domains/questionnaire components, and analysis plan for each PATH Study Objective. Additional information on the instruments is summarized in the remainder of this section.
PATH Study instrument |
Data collected |
Adult – Extended Interview |
Tobacco use history for each tobacco product respondent uses; reasons for using each tobacco product; dependence on nicotine and tobacco products; interest in/experience with quitting; tobacco susceptibility (non-users); notice of/reactions to tobacco product packaging and health warnings; perceived risk and harm of tobacco products; media awareness and use; secondhand smoke exposure; social norms, peer and family influences; health effects; family history; exposure to advertising and promotion of tobacco; exposure to health promotion campaigns; other substance use; additional demographics; contact information. |
Adult – Age-up Interview |
Same as Adult – Extended Interview with additional questions that were removed for rotation from the re-contacted follow-up interview with adults who provided responses to those questions in a previous wave. |
Adult – Biospecimen Collection Forms |
Chemotherapy status, hemophilia or blood-clotting problems, time of last urination, time of last food intake, and time of last fluid intake. |
Adult – Tobacco Use Form |
Specific time of use and quantity used for 9 different tobacco products, nicotine replacement therapies, or prescription drugs for tobacco cessation. |
Parent Interview – Parent of Youth |
Respondent’s relationship to the child, education, and tobacco use status (if not ascertained elsewhere); household rules about tobacco; perception of child’s tobacco use; child’s curfew, school performance, school missed due to illness, health (height, weight, health effects, medications, emergency room visits); parents who live elsewhere; tobacco availability at home; detailed contact information if not ascertained elsewhere. |
Parent – Age-up Interview |
Same as Parent – Parent of Youth with additional questions that were removed for rotation from the re-contacted follow-up interview with the parent who provided responses to those questions about their youth participant in a previous wave. |
Youth – Extended Interview |
Tobacco use characteristics; tobacco use history for each tobacco product the respondent may use; tobacco susceptibility (non-users); reasons for using tobacco and specific tobacco products; dependence on nicotine and tobacco products; interest in/experience with quitting; notice of/reactions to tobacco product packaging and health warnings; perceived risk and harm of tobacco products; accessibility of tobacco; media awareness and use; secondhand smoke exposure; social norms, peer and family influences; health effects; exposure to advertising and promotion of tobacco; exposure to health promotion campaigns; other substance use; additional demographics. |
Youth – Age-up Interview |
Same as Youth – Extended Interview with additional questions that were removed for rotation from the re-contacted follow-up interview with youth who provided responses to those questions in a previous wave. |
Adult - Verification Interview |
Whether one or all of the participants still live at the most current home address, identification of another parent if the baseline parent is no longer living with a youth participant, and updated contact information on adult participants and parents. |
Adult – Validation Interview |
For adults who complete extended interviews, information that can be used to confirm the information recorded by field interviewers, and information on other aspects of interviewer performance. |
Adult, Youth – Follow-up/Tracking Participant Information Forms |
For adult and youth participants, detailed contact information for those who have moved between waves. For shadow sample youth, detailed contact information for youth who will be followed until age 12 when they will be invited to participate in the PATH Study. Forms for youth and shadow sample youth are completed by parents. |
The parent interview collects personal information about the parent of a sampled youth, some general characteristics of the youth’s household, information about the youth that can be obtained more accurately and reliably from the parent than from the youth, and contact information to support future data collection activities. This interview includes information about the youth respondent’s life that may be associated with tobacco use, such as parental supervision, parental risk perceptions of tobacco use, school performance, and tobacco use by youth. Additionally, parents of youth who age-up to the youth cohort will be asked to complete the Parent – Age-up Interview, which collects information about youth who have aged into the youth cohort. These interviews include new items (e.g., parental risk perceptions) and items from the original Wave 1 interview.
The core content of the adult and youth extended interviews is based on conceptual models of how and why tobacco regulations exert an influence on proximal and distal behavioral and health outcomes (see Attachment 4). The PATH Study’s adult and youth instruments include questions related to tobacco use history; tobacco warning labels; exposure to health promotion messaging and National campaigns by FDA, CDC, and others; product regulation; product characteristics (e.g., flavors, packaging, design); advertising and promotion; and tobacco product standards. Questions are included on the potential impacts of tobacco regulations on tobacco use behaviors, attitudes, biomarkers, and health, including tobacco product use, cessation, relapse, and initiation patterns and knowledge, attitudes, beliefs, and risk perceptions toward the use of tobacco products. Others are included to characterize the general population, including demographics; environmental factors and family and peer influences; general health; and health effects that may be associated with the use of tobacco products.
Existing national, cross-sectional surveillance surveys helped inform the contents of the PATH Study instruments. For example, many of the tobacco-related questions in the Tobacco Use Supplement to the Current Population Survey (TUS-CPS), in the National Youth Tobacco Survey (NYTS), and in the National Health Interview Survey (NHIS) were adapted to assess the full array of tobacco products of interest to the PATH Study, including the use of electronic nicotine delivery systems (ENDS), such as e-cigarettes. For example, the PATH Study’s question “Have you ever smoked tobacco in a hookah, even one or two puffs?” is based on a question from the NYTS (“Have you ever smoked a cigarette, even one or two puffs?”). Another example is the PATH Study’s question on past 12-month quitting of a tobacco product, which was drawn from the TUS-CPS. Nicotine dependence items in the PATH Study instrument were derived in part from the National Epidemiological Survey on Alcohol and Related Conditions (NESARC) survey.
Questions in the PATH Study about physical health endpoints were drawn from the National Health and Nutrition Examination Survey (NHANES), a national cross-sectional survey that includes tobacco-use questions in its instruments and collects biospecimens. Some of these items have been tailored to assess PATH Study-specific tobacco-related health conditions. For example, the NHANES item “In the past 12 months, have you been told by a doctor or other health professional that you had cancer?” has been modified for the PATH Study to “Have you ever been told by a doctor, dentist, or other health professional that you have pre-cancerous oral lesions?” Other health-related items in the PATH Study questionnaire are from standard screeners (i.e., the Global Appraisal of Individual Needs (GAIN) and the Patient-Oriented Outcomes Measurement Information System (PROMIS). For Wave 3, the PATH Study added questions for some new health conditions found to be causally related with smoking in the 2014 Surgeon General’s Report on the health consequences of smoking; for example, questions on macular degeneration and orofacial clefs were added.
The PATH Study questionnaires include items from other international, state, and privately funded tobacco surveillance systems, such as questions about tobacco regulation that are based on International Tobacco Consortium surveys; the cessation and nicotine replacement items from the Minnesota Adult Tobacco Survey; and the items on secondhand exposure from the Global Adult Tobacco Survey and Massachusetts Tobacco Survey.
The PATH Study Wave 1 and Wave 2 instruments were reviewed to ensure that they maximize the utility of the data collected by capturing changing use patterns and practices in the context of the changing tobacco-product marketplace and regulatory environment while also minimizing burden on respondents, avoiding duplication with existing Federal surveys, and complying with data standards of the U.S. Department of Health and Human Services (HHS). This review resulted in decisions to add, delete, and rotate various questions. In addition, cognitive testing was used to evaluate potential problems with existing questions, as well as to develop new questions (e.g., on the use of new tobacco products or on emerging tobacco product use patterns). Under the Generic Clearance for Cognitive Testing of Instrumentation and Materials for the PATH Study (OMB Control Number 0925-0663), 179 cognitive interviews were conducted to inform Wave 3 instrument development. These interviews included: 41 Spanish-language adult interviews, 108 English-language adult interviews, and 30 English-language youth (ages 12-17) interviews. The English-language interviews were conducted in St. Louis, MO, Pittsburgh, PA, Los Angeles, CA, and Tallahassee, FL; the Spanish-language interviews were conducted in Rockville, MD. The results from these interviews were used to inform recommendations for revisions of existing questions and to develop new questions on topics of interest. See Attachment 5 for details regarding content changes to the instruments from Wave 2 to Wave 3. In summary, these changes include:
Adult Questionnaire:
Moved questions from the tobacco use section into sections on specific products to improve the flow of the questions;
Added questions to assess (a) electronic nicotine products other than e-cigarettes; (b) nativity, years lived in the United States, and English proficiency; (c) modification of cigars to consume marijuana; (d) specifics on peer and family influences, family history of tobacco use, problematic alcohol use, and problematic drug use; (e) health, including follow-up items related to previously-reported health conditions; and
Deleted lower-priority questions, such as on reasons for using each tobacco product, use of coupons, and use of dissolvable tobacco, a product found to have very low prevalence of use.
Youth Questionnaire:
Added questions to assess (a) electronic nicotine products other than e-cigarettes; (b) nativity, years lived in the United States, and English proficiency; (c) use of roll-your-own cigarettes; (d) past 30-day purchases of tobacco products; (e) perceived harm of products; (f) peer and family influences; and (g) health, including follow-up items related to previously-reported health conditions; and
Deleted lower-priority questions, such as on the use of a product because of media influences or advertising , use of coupons, perceived harm of intermittent tobacco product use, and detailed questions on dissolvable tobacco, bidis and kreteks, all of which have been found to have very low levels in the prevalence of use.
Parent Questionnaire:
Added questions to assess (a) rules within the home on use of electronic nicotine products; (b) nativity, years lived in the United States, and English proficiency; (c) family history of tobacco use, problematic alcohol use, problematic drug use; and (d) perceived harm of tobacco products; and
Deleted lower-priority questions, such as those on the youth missing school and numbers of emergency room visits.
Over time, the PATH Study longitudinal cohort data will be used to develop and refine taxonomies of tobacco user subgroups, such as those who begin tobacco use by first using smokeless tobacco; those who switch among types of products, including new and emerging products, such as snus and e-cigarettes; those who use multiple types of tobacco products (e.g., combustible and non-combustible); and those who seek to reduce their health risks while continuing to use tobacco by, for example, switching to products perceived to be less risky (e.g., e-cigarettes). The PATH Study includes items on perceptions of health risks from smoking and use of other tobacco products. It also has items in the health outcomes section to assess current and former tobacco-product use among women reporting to be pregnant.
Some questions in the Wave 2 instruments have been deleted from the Wave 3 instruments because they refer to experiences that are unlikely to change from wave to wave. Conversely, some questions in the baseline instruments that were deleted in the Wave 2 instruments have been cycled back in to the Wave 3 instruments. These items will be asked in alternating year waves (e.g., at Wave 1, at Wave 3, and so on). This rotational approach is also used for items such as warning labels on cigarette packs (given that policies on warning labels have been stable in recent years and are unlikely to change between waves). Should these policies change, items will be added to questionnaires in future waves to capture respondents’ perceptions about the changes. However, respondents who age into a new cohort (e.g., shadow youth who age into the youth cohort (12 year olds) and youth who age into the adult cohort (18 year olds) will receive the Wave 1 version of the instrument in order to capture responses from the same questions initially asked of all participants in that age group.
While the PATH Study data are expected to produce cross-sectional prevalence estimates of health conditions by tobacco use subgroups, the Study's focus is on the examination of within-person changes and between-person differences in tobacco use behaviors and related health conditions within the cohort over time. In addition, as is characteristic of longitudinal cohort studies, the PATH Study may lose its representativeness over time, especially in the absence of cohort refreshment. However, in keeping with OMB's terms of clearance for the PATH Study's baseline and Wave 2, the PATH Study will always present its cross-sectional prevalence estimates relative to the prevalence estimates generated by HHS's ongoing, nationally-representative survey studies, such as the National Cancer Institute’s (NCI) TUS-CPS, the Substance Abuse and Mental Health Services Administration’s (SAMHSA) NSDUH, the Centers for Disease Control and Prevention’s (CDC) NHIS and NHANES, the CDC and FDA’s National Adult Tobacco Study (NATS), and the CDC and FDA’s National Youth Tobacco Survey (NYTS).
The PATH Study plans to collect biospecimens from consenting adult respondents (age 18 and older) over multiple waves of data collection to assess between-person differences and within-person changes in markers of tobacco exposure, and to detect and compare indicators of health status and disease processes associated with the use of tobacco products. These data will allow the PATH Study to identify and assess changes in the biomarkers that potentially correspond to changes in tobacco products by manufacturers, including changes resulting from a manufacturer’s response to new product standards or regulations enacted by FDA. The PATH Study’s longitudinal research design, combined with its detailed questionnaire and collection of biospecimens, is thus positioned to identify and assess changes in tobacco-use patterns, risk perceptions, attitudes, and exposures that inform, and potentially reflect, the tobacco-regulatory decisions and actions of the FDA under the TCA.
The rotational approach used for items in the PATH Study questionnaire is similarly applied to biospecimen collection. This approach allows the PATH Study to contain costs and minimize participant burden. Specifically, urine will be requested from a subsample of approximately 17,386 adults who initially provided urine at Wave 1 or Wave 2. Also, adult respondents who aged up to the adult cohort (i.e., completed a youth interview at Wave 2 but are 18 years old at Wave 3) will be asked to provide urine and blood at Wave 3. Biospecimens will be coded, de-identified, shipped, preserved, analyzed, and shared in accordance with rigorous provisions promulgated by the NIH on data access and security within the context of the privacy laws under which it operates (see Section A.10).
The biospecimens collected by the PATH Study allow for the examination of indicators of tobacco-related exposure and potential susceptibility to disease associated with the use of tobacco products. Urine provides the matrix by which many tobacco-exposure biomarkers are measured, including nicotine and nicotine metabolites, tobacco- specific nitrosamines, metals, and volatile organic compounds (VOCs). Blood collection will allow for the measurement of biomarkers that cannot be detected (or accurately measured) in urine samples. Examples include C-reactive protein (CRP) and interleukin 6 (IL-6) biomarkers of harm that will be measured in serum and plasma (respectively) isolated from blood samples. In addition to serum and plasma, blood samples will allow for nucleic acid isolations (DNA and RNA) for genetic and epigenetic analysis from the buffy coat and hemoglobin adducts (4-ABP hemoglobin) from red blood cells. (Attachment 6 provides a list of specific analytes and their preferred matrix.)
The Tobacco Use Form is administered at each follow-up visit in which biospecimens are collected, unless the adult extended interview is administered during the visit or the biospecimen collection occurs less than four hours after the completion of the adult extended interview. (The adult extended interview incorporates all of the questions from the Tobacco Use Form.) This form collects the time that the respondent last used any type of tobacco products, including other sources of nicotine, such as pharmaceutical smoking cessation medications. Its purpose is to inform and qualify the laboratory analyses of the biospecimens, which are sensitive to recent use of various tobacco and nicotine-containing products.
NIDA will use data collected by the PATH Study, in conjunction with the existing scientific literature, to enrich the knowledge base on the epidemiology and associated consequences of tobacco use in the United States.
The FDA will use PATH Study data to help inform its regulatory actions under the TCA. The PATH Study’s Wave 1, Wave 2, and Wave 3 data will provide cumulative longitudinal data over three years' time, from 2013 to 2016, to support analyses of between-person differences and within-person changes in tobacco use behaviors and health that are contemporaneous with FDA’s regulatory decisions and actions. Analyses include but are not limited to identifying key transitions in the course of nicotine dependence (from the earliest experiences of initiation, to daily use, poly-tobacco use, cessation attempts, and relapse) and assessing how these transitions are associated with tobacco use-related health conditions, the implementation of specific tobacco-related policies and programs, and changes in the tobacco product marketplace.
NIDA and FDA will use the data generated by the PATH Study to elucidate factors associated with: tobacco use behaviors among youth and adults; use patterns, attitudes, and beliefs regarding emerging tobacco products (e.g., snus and ENDS); and tobacco use-related health outcomes among key population subgroups, such as young adults. In addition, NIDA and FDA will examine the PATH Study's data on biomarkers of exposure to tobacco products and of tobacco use-related disease processes to understand the physiological changes associated with tobacco use and the natural course of nicotine dependence.
As NIDA’s principal partner in conducting the PATH Study, FDA plans to use the data to help inform its regulatory decisions and actions under the TCA. The TCA provides FDA authority to regulate the manufacture, distribution, and marketing of tobacco products in the United States to protect public health. The TCA mandates the regulation of tobacco products using a population health standard including users and non-users of tobacco products. FDA’s CTP aims to prevent Americans from starting to use tobacco, to encourage current users to quit, and to decrease the harms of tobacco product use. Information from the PATH Study is critical to facilitating this mission. Its nationally representative longitudinal cohort design will provide epidemiological, population-based data on tobacco use behaviors, attitudes, exposures, and health to help inform FDA’s regulatory decisions and actions under the TCA.
An important component of the PATH Study is the collection of biospecimens from respondents. NIDA supports FDA’s approach for analyzing some of the biospecimens, which is through an inter-agency agreement with the Centers for Disease Control and Prevention (CDC). Through this agreement, CDC’s Division of Laboratory Sciences will analyze a subset of the biospecimens collected in the PATH Study. NIDA and FDA may consider making arrangements with other Federal, as well as non-Federal, laboratories for other biospecimen analyses. Examples of specific analytes that biospecimens collected in the study will be tested for are included in Attachment 5.
NIDA and FDA intend to share the PATH Study's data with the scientific community as well as with other agencies within HHS whose missions are in service to the Nation’s health, such as the CDC. To this end, a public use dataset from each wave’s data will be made available to the public on-line, consistent with OMB’s Memorandum 13-13 (March 2013). The time period from completion of a wave to availability of a public use dataset is anticipated to be within 18 months. Data underlying all government-funded scientific publications will be made available to the public at the time of publication, to the greatest extent feasible and consistent with applicable laws. Such transparency is particularly important in the regulatory context (see the Office of Science and Technology’s Scientific Integrity Guidance, December 2010).
Restricted use datasets not suitable as public use files will be deposited into a repository for data sharing purposes with qualified researchers who apply to the PATH Study Data Access Committee and obtain a Data Use Certification. NIDA and FDA will collaborate in developing plans for the repository for the PATH Study data and biospecimens, as well as plans for data disclosure, sharing, and confidentiality for qualified researchers with interests in analyzing the PATH Study data.
Data sharing plans promulgated by the NIH dictate dissemination of appropriately de-identified data. After PATH Study data are stripped of personally identifiable information (PII) and subjected to disclosure limitation procedures, the data sets will be deposited in the National Addiction and HIV Data Archive Program (NAHDAP) at the University of Michigan’s Inter-University Consortium for Political and Social Research (ICPSR). Data from other NIDA-funded research projects, including research studies and surveys, are also routinely deposited in NAHDAP for public or restricted use.
The Privacy Impact Assessments (PIA) for the PATH Study Management System were promoted on July 6, 2012 (see Attachment 7). Appropriate technology will be used to keep respondent burden to a minimum.
Examples of information technology approaches to be used to minimize burden during the PATH Study data collection include:
Use of audio computer-assisted self-interviewing (ACASI) extended instruments (separate instruments for youth and adults) and a computer-assisted personal interviewing (CAPI) parent instrument to collect PATH Study data;
Use of flashcards or on-screen displays of lists and images to aid respondents with multiple response categories;
Arrangement of sections and questions in the PATH Study extended interviews that make sense to respondents and facilitate the efficient flow of administration from one topic area to another;
Elimination of questions that only need to be answered at the respondent’s baseline and use of responses from earlier waves, to efficiently route the respondent through an interview;
Use of data collectors who are bilingual in English and Spanish; and
Use of all instruments, consent forms, and other study documents in Spanish where English is not spoken or it is not the respondent’s preferred language for the interview.
Most of the PATH Study data will be gathered via computer-assisted questionnaires (i.e., CAPI or ACASI). The adult and youth questionnaires are designed with separate modules, and all but a few sections have lead-in questions that respondents can check for relevance in order to quickly skip out of non-relevant modules. This design was successfully used in Wave 1 of the PATH Study, and in the National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC) study (OMB # 0925-0628, expiration date 4/30/2014). Brief tests of the PATH Study instruments with fewer than 9 individuals indicated that the average adult or youth respondent answered questions in about one-third of the total number of sections in the adult or youth instrument, respectively. Further, within each instrument, about one-third of the associated questions were applicable to any particular respondent, leaving two-thirds inapplicable and, therefore, requiring no answer from either the adult or youth respondent taking the respective interview.
Tobacco-related data collections supported by the Federal government and reviewed by OMB seek to harmonize their efforts to assure they maximize the utility of data collected, minimize burden on participants, and comply with HHS standards. NIH and FDA coordinate with the Assistant Secretary for Planning and Evaluation (ASPE) at HHS, and with program leads on tobacco-related studies within NIH (e.g., NCI) and at HHS sister agencies (e.g., CDC, SAMHSA) to harmonize existing questions and reduce potential overlap or redundancy among tobacco-related data-collection efforts. From a feasibility perspective, requirements of the TCA give priority to the PATH Study for ensuring its collected research data are relevant to FDA’s regulatory mission regarding the manufacture, marketing, and distribution of tobacco products. Consequently, within the limits and authorities of the TCA, the PATH Study has flexibility to meet the data-collection needs of other HHS agencies, such as the CDC, by including questionnaire items and priority measures of shared interest. In their review of the draft revision request documents, the HHS program leads suggested minor changes to Supporting Statements A and B, which are reflected in the current documents; overall, their comments indicated support for the PATH Study’s proposed Wave 3 data and biospecimen collection.
The PATH Study design is intended for examining between-person differences and within-person changes in tobacco use behavior, exposure, and disease processes for a full range of new and emerging tobacco products. Its nationally representative prospective-cohort design was chosen for this purpose because it is the gold standard for generating epidemiological data on population trends and within-person changes in tobacco-use behaviors and tobacco-related knowledge, attitudes, perceptions, biomarkers of exposure and harm, and tobacco-related health conditions.
There are national surveillance surveys on tobacco use in the U.S. (see Attachment 8). Key features of the PATH Study distinguish it from tobacco-specific surveillance surveys, as described below.
Tobacco Surveys and the PATH Study. The PATH Study's unique features distinguish it from tobacco surveillance surveys, such as the TUS-CPS and NYTS. For example, the PATH Study, as a longitudinal cohort study, is designed for research purposes rather than to provide cross-sectional prevalence estimates. Its population-based behavioral and biospecimen data collection will support the generation and testing of research hypotheses over time, such as relationships between tobacco use-related risk perceptions, attitudes, behaviors, and associated markers of tobacco exposure and potential disease processes. As such, the PATH Study will provide a rich source of contemporary research data that, in conjunction with data from existing surveillance surveys, will help inform FDA's regulatory decision making and actions. For additional information on the PATH Study and on cross-sectional surveillance surveys on tobacco use, see Attachment 7.
In addition, as pointed out in A.2b, some items in the PATH Study questionnaires were selected because they harmonize with items in national surveys of tobacco use. For example, items for commonly-used tobacco products in the PATH Study have been adapted from the TUS-CPS. Some items in the PATH Study Youth Questionnaire have been adapted from the NYTS. A major difference between these studies and the PATH Study, however, is the PATH Study’s capacity to replace questionnaire items between data waves to collect time-sensitive data about new and emerging product-use behaviors; this is one of the priority objectives of the PATH Study, i.e., to identify and examine between-person differences and within-person changes over time relative to the use of new and emerging types and brands of tobacco products.
Longitudinal Design. The PATH Study’s longitudinal design gives it the capacity to generate data on between-person differences and within-person changes in tobacco-use behaviors, attitudes and risk perceptions, biomarkers of harm associated with tobacco use, and related health outcomes over the lifespan. This is important for understanding factors associated with the uptake of new products, in product switching, in poly tobacco use, and in cessation and relapse among the same individuals followed over time. By contrast, cross-sectional surveillance surveys such as NYTS and TUS-CPS are primarily designed to generate representative “snapshots” of the prevalence of given behaviors or conditions in the U.S. population at a specific point in time.
The PATH Study’s probability-based Wave 1 sample (n=45,971) is sufficiently large to generate data on between-person differences and within-person changes in use of the full range of tobacco products (especially of emerging products). Although as a longitudinal study the PATH Study may become less representative with time, especially in the absence of cohort refreshment, its data will provide an important resource for understanding attitudes and risk perceptions, biomarkers of exposure and harm associated with tobacco use, tobacco dependence, and tobacco use-related health outcomes over the lifespan of the cohort. It will also permit estimates for given subgroups, such as non-cigarette tobacco users, or by subgroup characteristics, such as by race, ethnicity, gender, pregnancy status, or co-occurring health disorder. Additionally, the PATH Study will oversample Blacks/African Americans to increase the sample size of menthol smokers1 for statistical analyses.
As a longitudinal cohort study, the PATH Study has the capability to follow youth as they age into young adulthood. This places the PATH Study in a position to assess between-person differences and within-person changes over the life course, from youth to adolescence, young adulthood, and adulthood, to understand contemporary trends in tobacco-use patterns, including onset and progression, cessation efforts and relapse, and successful cessation, all in the context of changes in the tobacco product marketplace, in marketing techniques and messages on different types and brands of tobacco products, and in FDA’s regulatory decisions and activities.
Focus on FDA Regulatory Issues. The PATH Study will take place in parallel with the rollout of tobacco product regulations by FDA as authorized by the TCA. Timely population-based data on between-person differences and within-person changes in tobacco-product use behaviors and health from the PATH Study will help to inform FDA’s regulatory decisions and actions, such as those related to tobacco product standards, requirements for warning labels, regulations on misleading brand descriptors, marketing, and health promotion messaging and public education campaigns. .
Scope of Data Collection. The PATH Study is distinguished by the breadth and depth of its coverage of tobacco use, tobacco products (e.g., cigarettes, cigars, pipes, smokeless, snus, hookah, and ENDS), and tobacco product brands and sub-brands. Data-collection methods, which include an image database of tobacco products, brands, and sub-brands, augment the specificity of the tobacco-use data, for example, by allowing the differentiation of traditional cigars, little filtered cigars, and cigarillos. In addition to respondent interview data, the PATH Study collected urine and blood samples from consenting adults during the entirety of Wave 12 to serve as the basis for examining and comparing biomarkers of exposure, including exposure to tobacco products, and tobacco brands and sub-brands. At Wave 3, a subsample of approximately 17,386 adults who initially provided urine at Wave 1 or Wave 2 will be asked to provide a urine sample. Also, adult respondents who aged up to the adult cohort at Wave 3 (i.e., completed a youth interview at Wave 1 but are 18 years old at Wave 3) will be asked to provide urine and blood. (At Wave 2, urine was collected from a subsample of adult respondents who provided a urine specimen at Wave 1, and urine and blood were collected from adult respondents who aged up to the adult cohort at Wave 2.) This multi-component data-collection protocol distinguishes the PATH Study’s capacity to generate cumulative, contemporaneous data to inform FDA's regulatory actions under the TCA.
No small businesses or other small entities will be involved in the PATH Study.
The longitudinal design of the PATH Study underscores the importance of maintaining its schedule of regular, annual waves of data collection with the same study respondents. The PATH Study will use follow-up, retention, and tracking materials (Attachment 9) to maintain contact with each respondent and to schedule regular, annual appointments with each respondent for their annual follow-up interviews. Less frequent data collection would impact the study’s ability to retain cohort respondents and achieve its annual and overall target response rates. This would have implications for the scientific quality and utility of study data, particularly data that would inform the development of new TCA-related policies and programs.
Not conducting the PATH Study as scheduled (or delaying its annual follow-up interviews of each cohort respondent) would significantly reduce FDA’s ability to capitalize on the strengths of the cohort study design to examine associations between enacted policies and tobacco use uptake, cessation, and relapse in the population. The dynamic environment of ever-changing policies and tobacco industry efforts requires annual data and biospecimen collection. For example, the PATH Study will subsample adults who initially provided urine at Wave 1 or Wave 2 to provide a urine sample again at Wave 3. This will allow the PATH Study to characterize and compare within-person changes and between-person differences in the urine analyte signatures of tobacco users and non-users at three points in time. Urine collection at Wave 3 will also allow for the examination of tobacco exposure biomarkers in new and emerging products that may not have been on the market at the time of the Wave 1 data collection. Data collected less frequently would be considerably less precise, and would significantly decrease the capacity of the study to meet the scientific needs of NIDA and FDA to establish a science framework that informs FDA’s efforts to protect the Nation’s public health.
This project fully complies with the guidelines of 5 CFR 1320.5.
The 60-day Federal Register Notice, required by 5 CFR 1320.8 (d) to solicit comments on the information collection prior to submission to the OMB, was published on February 11, 2015 in the Federal Register (Vol. 80, No. 28, pgs. 7619 – 7620). One comment was received, which was a letter in support of the collection of data for the PATH Study. The comment and NIDA’s response to it are included in Attachment 10.
Individuals from within NIH, FDA, and other units within HHS and numerous outside agencies, institutions, and universities were consulted from October 2011 to the present, and these consultations are ongoing. NIDA and FDA have now established within the project schedule the time needed to request and receive the feedback of program leads of tobacco-related studies at NCI, SAMHSA, and CDC on the draft and revised versions of the PATH Study questionnaires and other data collection materials. This has been an important process in the development of PATH Study data collection materials submitted under the revision request for Wave 3. NIDA and FDA, with program counterparts from sister HHS agencies, also participate in the HHS Tobacco Data Workgroup. Established in July 2014, the Data Workgroup meets on a quarterly basis under the auspices of the HHS’ ASPE to facilitate the coordination of HHS' tobacco-related data collection efforts and reduce potential redundancy and burden on the public. Other individuals with expertise in the fields of tobacco research, epidemiology, and longitudinal studies contribute on an ongoing basis as members of the PATH Study's Biological Workgroup, Questionnaire Workgroup, Ad Hoc Study Workgroup, and Sampling Workgroup, including researchers and methodologists from Roswell Park Cancer Institute, Legacy/The Schroeder Institute for Tobacco, University of California San Diego Moores Cancer Center, University of Waterloo, Dartmouth College, The Medical University of South Carolina, SRI International, and Westat. The names, affiliations, and phone numbers of non-Federal individual consultants are presented in Attachment 11.
The design of the PATH study involves significant burden to respondents, both in terms of interview time, multiple visits, and the provision of biospecimens. To assist in meeting the response rate goals of the PATH Study, multiple incentives were offered to respondents during the Wave 1 and Wave 2 data collections. Similar incentives are proposed to be offered as compensation for time and effort during Wave 3 (see Table A-2). Additional information on incentives in the PATH Study follows.
An incentive of $35 will be offered to adult respondents who complete the adult extended interview at the Wave 3 home visit. This $35 incentive payment is solely tied to a respondent’s participation in the extended interview, regardless of whether he or she consents to provide biospecimens.
At the Wave 3 home visit, an incentive of $25 will be offered to newly aged-up adult respondents (i.e., youth from Wave 1 who have turned 18 years old and have consented to participate in the PATH Study as an adult) who consent to provide a urine sample.
An incentive of $25 will be offered to an adult respondent who initially provided urine at Wave 1 or Wave 2, and also provides urine at Wave 3. Collecting the urine sample is contingent on the adult completing the Wave 3 extended interview.
An incentive of $25 will be offered to newly aged-up adult respondents (i.e., youth from Wave 1 who have turned 18 years old and have consented to participate in the PATH Study as an adult) and who consent to provide a blood sample.
An incentive of $10 is planned for parents who complete a parent interview.
An incentive of $25 is planned for youth who complete the youth extended interview.
Activity |
Incentive |
|
|
Adult Interview and Biospecimen Collection Adult Extended Interview |
$35 |
||
Biospecimen collection Visit #1 (urine – conducted by interviewer)
|
$25 |
|
|
Biospecimen collection Visit #2 (blood - conducted by health professional)
|
$25 |
|
|
Youth Interview |
$25 |
|
|
Parent Interview* |
$10 |
|
|
Contact Information Update** |
$10 |
|
|
* Parents receive $10 for each interview they complete for a youth, and may complete a total of 2 interviews for 2 youth to receive a maximum of $20. In households with multiple births, parents may complete a total of 4 interviews for 4 youth to receive a maximum of $40.
** An adult respondent will receive $5 for updating his/her contact information up to two times between data collection waves, for a total of $10. A youth respondent will receive $5 each time, up to two times, their parent updates the youth’s contact information, for a total of $10.
Use of separate incentives for completion of different components of a study was used in Waves 1 and 2 of the PATH Study, and has been used by other studies approved by OMB (e.g., NHANES (OMB # 0920-0950, expiration date 11/30/15).
To encourage retention of PATH Study respondents over time, an incentive will be offered to adult respondents who provide updates to their contact information in between data collection waves. Adults will receive $5 each time they update their contact information up to a total of $10 per year. Youth respondents will receive $5 each time their parent updates their contact information up to a total of $10 per year. Research supports the use of incentives such as this (i.e., between data collection waves), as they help to increase response rates and the amount of updated locator information received from respondents (McGonagle et al., 2011; Singer & Ye, 2013).
Incentives will be described in PATH Study materials, including the study consent document provided to each “new” respondent prior to the start of the PATH Study extended interview (see Attachment 12). These materials will clearly state that incentives will be offered as a thank you for completing each visit and associated tasks (the first adult visit for completing the adult extended interview and, separately, for consenting to and providing biospecimens; a second adult visit for consenting to and providing additional biospecimens; the parent interview; the extended youth interview; and for providing contact information for future follow-up by the PATH Study). Biospecimens will only be collected from adults who complete the PATH Study extended interview.
Thus, a new adult respondent at Wave 3 may receive up to $95 as a thank you for participating in the PATH Study: $35 for the Wave 3 extended interview, $25 for urine collection at the first Wave 3 home visit, $25 for blood collection at the second Wave 3 home visit, and an annual maximum of $10 for updating contact information. An adult who participated at Wave 1, including providing urine, may receive up to $70 as a thank you: $35 for the extended Wave 3 interview at the home visit, $25 if included in the core sample or supplement that provides another urine sample, and an annual maximum of $10 for updating contact information. Parents may receive up to $20 for completing parent interviews for a maximum of two youth ($10 as a thank you for completing each parent interview).3 A youth respondent may receive up to $35 for participating in the PATH Study: $25 for completing the youth extended interview, and a maximum of $10 for having their parent provide updated contact information.
The PATH Study proposes to pay some of the incentives by means of cash and others by means of debit cards. For the group of identified 9 to 11 year olds who are not yet enrolled in the PATH Study, the Study will send $5 in cash (up to two times between data collection waves) to the youth's parent when contact information is updated. Once an adult or youth participant is enrolled in the PATH Study, he/she receives a debit card. This debit card is then electronically loaded with the appropriate incentive amount, depending on the eligible activity. Each time the respondent completes an eligible activity (e.g., updates contact information), the PATH Study will transfer the correct funds to the debit card within approximately 3 business days. In addition to the monetary incentives, the Study plans to provide certificates of appreciation to youth, to acknowledge their participation in the Study; additional information on the certificates is provided in Supporting Statement B.
Concern for privacy plays a central role in the implementation of the PATH Study. Such protection is provided to respondents under the authority of 42 U.S.C. 241(d). The authority of 42 U.S.C. 241(d) has been delegated by the Secretary of HHS to NIH, of which NIDA is a part. Any person engaged in the research to which this section applies, and who desires authorization to withhold names and other identifying characteristics of individuals who are subject to such research from any person or authority not connected with the conduct of such research, may apply to the Office of the Director, NIDA for an authorization of confidentiality (also called a Certificate of Confidentiality or COC). Persons authorized by NIH to protect the privacy of research subjects may not be compelled in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings to identify them by name or other identifying characteristic. Because biospecimens are collected and some questions may be of a sensitive nature, the COC helps researchers avoid involuntary disclosure that could expose participants or their families to adverse economic, legal, psychological, and social consequences. The COC issued to the PATH Study on August 31, 2012, and amended on June 6, 2013, is included in Attachment 13.
Law governing Federal employees conducting this research study, 18 U.S.C. 1905 (which prohibits disclosure of individuals’ identifying information or confidential statistical data by Federal employees) is also relevant to the maintenance of confidentiality of data. In addition, all Study activities under this contract are conducted in compliance with 45 CFR Part 46, Protection of Human Subjects, HHSAR 352.270-4(b) (January 2006), the Privacy Act of 1974, and the Systems of Records Notice 09-25-0200 (regulations pertaining to confidentiality of data).
The PATH Study uses a range of procedures to protect respondents’ Personally Identifiable Information (PII) and the confidentiality of all data. All data collection staff are proficient in data security, confidentiality, and privacy issues and procedures. PATH Study field interviewers are required to sign a pledge of confidentiality (see Attachment 14) and to complete training on standards and ethics in research, including detailed content on topics such as confidentiality and informed consent.
The privacy of Study respondents is protected through field procedures that ensure interviews are not overheard by others in the home, and the use of ACASI, which uses headphones to increase comfort levels and encourage honesty in answering sensitive questions. In the field, data are collected on laptop computers that use advanced data encryption to protect confidentiality of data. Data from the laptops are transmitted securely and directly to the research data warehouse maintained by the prime contractor, reducing risks associated with unsecured electronic data collected on laptops or transported on removable media.
Data are identified by unique identification (ID) numbers assigned to each respondent. The ID numbers link the respondent’s extended interview responses with his or her own biospecimens. Crosswalks that match these numbers to PII are stored in secure, encrypted files accessible only to authorized staff whose roles on the Study necessitate access. NIDA does not have access to identifying information, and personal identifiers are not included in the data received by NIDA. The prime contractor transfers all data for the PATH Study and associated products and documents to NIDA at the time of compiling final data files and does not retain any records of the data. Procedures for the storage and disposition of data collected as part of the PATH Study are described in Section A.10b.
Prior to Wave 3 data collection, each PATH Study respondent will be informed of the Study sponsor, the purpose and uses of Study data, legal authorities, and the voluntary nature of his or her participation. “New” respondents (i.e., respondents who have “aged up” to the youth or adult cohorts) will be informed in writing that their information will be kept private to the extent permitted by law under the Privacy Act. Participation is voluntary; respondents may decline to answer particular questions without any consequence. An informed consent form, which includes descriptions of risks, benefits, and privacy protections, will be reviewed with each potential PATH Study respondent and will be signed by all those choosing to participate in the Study. Separate consent forms (see Attachment 12) and procedures have been developed for adults and youth. For youth, parental permission will be obtained in writing prior to seeking youth assent to participate in the PATH Study. There is also a separate consent form for adult biospecimen collection. Information in the consent documents is presented in language that is easily understood and covers many topics, including the (1) voluntary nature of the data collection; (2) purposes and uses of the data; (3) storage and use of the biospecimen samples; (4) privacy of the information; (5) whether study results or information are available to the respondent; (6) benefits/risks; and (7) contact information regarding questions about the PATH Study.
As noted previously in A.3, two PIAs for the PATH Study were promoted on July 6, 2012 (see Attachment 7). The PATH Study also received approval from the prime contractor’s Institutional Review Board (IRB) (Attachment 15).
Information collected in the PATH Study is covered by NIH Privacy Act SORN 09-25-0200, “Clinical, Basic, and Population-based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD” published in the Federal Register on September 26, 2002 (67 FR 60776) (Attachment 16). The NIH Privacy Act Officer has also reviewed the information contained herein and determined that the Privacy Act applies to the PATH Study data collection.
Compliance with the Privacy Act includes protections on identifying information residing in computer files. Data are maintained in separate, encrypted tables, with password protection and access limited to authorized personnel. The PATH Study complies with the Federal Information Processing Standards (FIPS PUB 41) and Computer Security Guidelines for Implementation of the Privacy Act of 1974, and FIPS PUB 73 (“Guidelines for Security of Computer Applications”). All staff members are required to complete regular trainings on information security, including the NIH training on data security. Authorized users access research data that are free of PII behind a secure data firewall that does not permit downloading or printing of data. In addition, no individual names or other identifiers are ever reported to NIDA, FDA, or other government agency.
Study data are identified and retrieved by a Study ID number only. Investigators cannot access PII. The majority of data collected in the Study are captured electronically, avoiding concerns of hard-copy storage of materials that contain PII. Hard-copy data forms are identified only by a Study ID number and stored in locked files at the contractor’s facilities. Datasets collected by the Study will be maintained until the completion of the Study or until they are no longer required for research purposes.
The prime contractor for the PATH Study is responsible for storing identifiers in a secure database environment in accordance with the security guidelines defined by the Federal Information Security Management Act (FISMA) and NIST Special Publication 800-53 for Moderate information system security. All systems and databases handling or storing PII and/or PHI (protected health information) are reviewed for FISMA compliance by the NIDA Chief Information Officer (CIO) and Information Systems Security Officer (ISSO), and cannot be operated in production mode until NIDA grants an Authority to Operate (ATO). FISMA moderate requirements govern the storage and maintenance of the PATH Study’s computerized data, none of which contain PII. Attachment 17 lists the procedures that are followed by the contractor to protect the privacy of Study data.
All contract staff members undergo background screening commensurate with their role on the Study and their access to Study data. Study staff are required to sign a pledge of confidentiality prior to beginning work (see Attachment 14) and to complete NIH Computer Security Awareness Training as well as Privacy Awareness Training. Access to PII is limited to a small number of immediate staff working on the Study. All records, including hard copies of informed consent and other documentation, are retained and disposed of under authority of the NIH Records Control Schedule contained in NIH Manual Chapter 1743, Appendix 1B “Keeping and Destroying Records” (HHS Records Management Manual, Appendix B-361) (see Attachment 16).
NIDA, FDA, and the prime contractor intend to make PATH Study data available through a public use dataset online, consistent with OMB’s Memorandum 13-13 (March 2013). The time period from completion of a wave to availability of a public use dataset is anticipated to be within 18 months. Data underlying all government-funded scientific publications will be made available to the public at the time of publication, to the greatest extent feasible and consistent with applicable laws. Such transparency is particularly important in the regulatory context (see the Office of Science and Technology’s Scientific Integrity Guidance, December 2010).
As described in Section A.2d, NIDA and FDA plan to develop restricted use files (RUFs) of the PATH Study data for deposit in the ICPSR’s NAHDAP, where data from other NIDA-funded research projects are routinely deposited for public or restricted use. Researchers interested in accessing the PATH Study RUFs will be required to apply to the PATH Study Data Access Committee (DAC), to be established by NIDA and the FDA. This committee will work with the data repository, such as ICPSR’s NAHDAP, to manage access to the data repository and track the progress of researchers who receive approval.
Upon receiving DAC approval, researchers will be required to submit a Data Use Agreement to the data repository (see example in Attachment 18) to gain access to the RUFs. These data files will include PATH Study questionnaire data and may include data from biospecimens; however, qualified researchers interested in accessing PATH Study biospecimens to conduct analyses will be required to apply to the PATH Study Biospecimen Access Committee (BAC). This committee will manage the sharing of biospecimens; instruct the PATH Study biospecimen repository subcontractor to ship specimens to approved labs/researchers; track the progress of researchers; and, if necessary, recall biospecimens.
As described in Section A.1, the cumulative data from the PATH Study on tobacco use behaviors, attitudes, exposures, and health in the United States will enrich the evidence base that informs FDA's regulatory actions under the TCA to reduce tobacco-related diseases, disabilities, and deaths. To meet this purpose, the PATH Study asks questions about tobacco use. Additionally, to meet its eight objectives (see Section A.2), the PATH Study’s instruments include questions on other sensitive topics, ranging from psychological problems and conditions, substance abuse, and income to sexual identity, orientation, and attraction. These questions relate directly to key outcomes or major correlates of tobacco use and health and are included in both the adult and youth instruments.
The mission of FDA’s CTP is to protect Americans from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products; and by educating the public, especially young people, about tobacco products and the dangers their use pose to themselves and others. The PATH Study supports this mission by collecting, analyzing, and reporting population-based data to enhance the evidence base that informs FDA’s regulatory activities.
Tobacco use questions constitute the core of the PATH Study. Most of the tobacco use items in its instruments are similar to or slight variations of items common to widely-used surveys on tobacco that have been approved by OMB. Answers to these questions provide the depth and breadth of data the PATH Study produces to enhance understanding of risk factors for tobacco use initiation, motivations for product-switching, the use of multiple tobacco products, and behaviors associated with quitting and relapse. Such questions are not generally considered sensitive when administered to adults.
Similar to the adult interview, the PATH Study youth interview contains questions that assess attitudes toward tobacco and tobacco use in great detail. These questions, especially when asked of underage children, may be considered sensitive by at least a portion of parents or youth. (As described in Section A.10, the PATH Study has implemented a range of procedures to protect youth’s privacy and ensure that he/she feels comfortable in answering the questions). The youth tobacco use questions are modeled on the CDC’s NYTS (OMB # 0920-0621, expiration date 1/31/2015); however, they have been expanded to cover a more diverse and specific array of tobacco products.
The PATH Study parent interview includes questions about the youth’s tobacco use and future tobacco use. These questions provide context for the youth responses as well as for understanding youth’s tobacco-use trajectories in future waves of data collection. Understanding trajectories and transitions among youth in tobacco use behaviors (e.g., onset, daily use, multiple product use, quitting attempts, relapse, and cessation) is essential to communicate effectively about tobacco products and the consequences of their use, as FDA is mandated by the TCA to do by educating young people.
Tobacco use is associated with an array of psychological problems and conditions, including depression and anxiety. Persons with mental health disorders have been found to use tobacco at higher rates and have more difficulty quitting tobacco use (Glasheen et al, 2014). Research has also shown that some mental disorders, such as anxiety disorders, are more predictive of onset to daily nicotine use, while others, such as mood disorders, are associated more strongly with the development of nicotine dependence (Swendsen et al., 2010).
Epidemiologic and clinical studies indicate that psychiatric disorders are important moderators of nicotine dependency severity (as measured by Fagerstrom Test of Nicotine Dependency or FTND scores, for example), withdrawal, craving, quitting, and responses to changes in cigarette pricing. As reported by Legacy (2012), “People with mental illnesses smoke at rates almost twice as high as the general population (41% versus 22.5%, respectively). Nearly half the cigarettes smoked in the United States (44-46%) are consumed by people with co-occurring psychiatric or addictive disorders.” Psychiatric disorders are associated with higher proportions of heavy smoking and lower likelihoods of cessation (Smith et al (2014). As noted by Hartz et al (2014), successful public health efforts to reduce smoking among persons 30 years of age and younger have been less effective among persons with psychiatric disorders. Moreover, remission from nicotine was moderated by comorbid psychiatric disorders and substance use disorders, findings that have been replicated in cross-sectional and longitudinal analyses. In summary, including these constructs in PATH Study instruments will facilitate understanding of how various program and policy changes may affect tobacco use behaviors in the population.
Since the early 1980s, national surveys of the general population have asked questions that deal with depression, anxiety, and related mood disorders. These include the National Institute of Mental Health’s Epidemiological Catchment Area Survey (ECA), fielded between 1981 and 1985, and its 1990-1992 and 2001-2002 National Comorbidity Surveys (NCSs); supplements to CDC’s NHIS in 1983, 1988, and 1991; the CDC’s Behavioral Risk Factor Surveillance System; and 15 national surveys conducted by the Alcohol Research Group with support by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). An analysis of all these surveys indicates that questions about psychological problems and conditions were not considered sensitive by respondents. Nonresponse for these questions was extremely low (i.e., less than 4.0%), comparable to questions not normally regarded as sensitive.
The PATH Study has developed a handout (see Attachment 19) that provides respondents with national help lines for problems with tobacco, alcohol, drug, and mental health issues. This handout will be provided to all interviewed persons who express an interest in getting help with one of these problems.
To assess potential associations between tobacco use and psychological problems and conditions, the PATH Study adult and youth interviews include items from the 5-minute Global Appraisal of Individual Needs Short Screener (GAIN SS). The GAIN SS includes a brief series of questions designed to identify respondents who have one or more behavior health disorders, including internalizing or externalizing psychiatric disorders and substance use disorders (Dennis et al., 2006).
Use of substances, including the use of alcohol and tobacco, frequently co-occurs. That is, substance abuse and substance use disorders are often found to be comorbid conditions. Results from numerous household surveys conducted since 1960 in the U.S. suggest that questions about substance use are generally not viewed as sensitive by respondents. Item nonresponse for such questions tends to be low (generally below 5.0%) as have been interview break-offs and refusals to these questions (below 1.0%). Examples of these surveys, all of which obtained OMB approval, include: SAMHSA’s NSDUH, conducted since the early 1980s (OMB # 0930-0110, expiration date 8/31/2017); the Bureau of Labor Statistics’ National Longitudinal Survey of Youth (NLSY), conducted periodically since 1973 (OMB # 1220-0109, expiration date 9/30/2016); and CDC’s NHANES (OMB # 0920-0950, expiration date 11/30/15).
The PATH Study adult and youth interviews include questions on substance use, including alcohol. The adult interview includes questions on use of substances during pregnancy. The parent interview and the adult interview also ask three items on family history of tobacco use and substance use problems, to provide context for factors associated with the trajectory to nicotine dependence among tobacco users. The items were adapted from the Family History Assessment Module (FHAM), a semi-structured diagnostic instrument based on the DSM-III to assess psychiatric and substance use disorders in the relatives of a respondent (Rice et al., 1995).
The PATH Study does not ask questions about salary, which is considered by many people to be sensitive. Instead, the adult and parent interviews include questions about household income. Collecting information about household income is important for analysis of nonresponse and potential cofactors. The wording of this item was adapted from NHANES so that it could be a self-administered item (rather than an interviewer-administered item); it includes household income categories that a respondent selects.
Research has shown that the prevalence of use of any tobacco product is much higher among gay, lesbian, or bisexual (LGBT) adults, compared with heterosexual adults (Agaku et.al., 2014) and with the total population in the U.S. (King et al., 2012). This finding has been attributed to, in part, tobacco product marketing toward the LGBT community (HHS, 2014) as well as to the higher levels of psychosocial stress, victimization, and stigma that LGBT individuals may experience in their daily lives (Ryan, et al., 2001). Pollard et al. (2011) found that, for females, a change from self-reported heterosexual attraction to lesbian or bisexual attraction was more predictive of higher smoking trajectories and differences in smoking patterns when compared with females who reported no change in sexual attraction.
To inform analysis of tobacco use behavior and related health conditions relative to gender identity and sexual orientation, the PATH Study adult interview includes two questions on each.. The sexual orientation question is similar to the question asked in Wave 1 from the NHIS 2013 (Miller, et al, 2011), except it omits a follow-up question to the “something else” response option. The gender identity question is based on the Massachusetts State Optional Module for the 2014 Behavioral Risk Factor Surveillance System (MA-BRFSS, 2014); it includes a follow up question for respondents who identify as transgender. The PATH Study youth interview includes the same two questions for youth ages 14 to 17 years of age. Items similar to these have been tested and used in the 2001 to 2009 school-based survey, the Youth Risk Behavior Surveillance System (YRBS), conducted among students in the same age group (14 to 17 years) in grades 9 to 12 (CDC, 2013).
The PATH Study includes one item on the respondent’s level of attraction to both sexes, asked of adults (R03_AM0021 in the adult interview) and of youth ages 12 to 17 years (R03_YM0021 in the youth interview). This item is from the National STD and Behavior Measurement Experiment (NSBME), as modified from the National Survey of Sexual Attitudes and Lifestyles (NATSAL); (Villarroel et al., 2008). It was selected and recommended for inclusion in the PhenX Toolkit by an NIH panel of experts for use in all studies that measure sexual attraction (Hamilton et al., 2011).
Table A-3 presents the estimated annualized burden hours for the Wave 3 data collection, the total of which is 54,434. Annualized cost to respondents associated with the PATH Study for the Wave 3 date collection is presented in Table A-4. Burden estimates are based on the results from the Wave 1 and Wave 2 data collections. These estimates include the time needed to read introductory text; provide consent (as appropriate); complete the entire interview and biospecimen collection (as appropriate); and, potentially, respond to the data quality validation interview. The reduction of 4,589 estimated burden hours between Wave 2 (59,023) and Wave 3 (54,434) is attributed to the following projections for Wave 3: (1) an 86 percent response rate for interviews with continuing adults, (2) an 87 percent response rate for interviews with aged-up adults, (3) a 91 percent response rate for interviews with continuing youth, and (4) an 89 percent response rate for interviews with aged-up youth.
The estimate for adult hourly wages is based on the national median hourly estimate for all occupations reported in the Bureau of Labor Statistics’ Occupational Employment Statistics, May 2014 National Occupational Employment and Wage Estimates United States. See http://www.bls.gov/oes/current/oes_nat.htm. The estimate for youth hourly wages is based on the federal minimum wage. See http://www.dol.gov/dol/topic/wages/minimumwage.htm.
Type of respondent
|
Estimated number of respondents |
Estimated number of responses per respondent |
Average burden per response(in hours) |
Estimated total annual burden hours requested |
|
25,444 |
1 |
1 |
25,444 |
|
2,046 |
1 |
4/60 |
136 |
|
1,780 |
1 |
68/60 |
2,017 |
|
1,780 |
1 |
5/60 |
148 |
|
13,805 |
1 |
10/60 |
2,301 |
|
765 |
1 |
18/60 |
230 |
|
14,570 |
1 |
5/60 |
1,214 |
|
27,224 |
2 |
8/60 |
7,260 |
|
9,625 |
1 |
35/60 |
5,615 |
|
1,923 |
1 |
3/60 |
96 |
|
1,923 |
1 |
45/60 |
1,442 |
|
9,818 |
1 |
16/60 |
2,618 |
|
2,161 |
1 |
5/60 |
180 |
|
1,961 |
1 |
19/60 |
621 |
|
35,564 |
1 |
2/60 |
1,185 |
|
3,579 |
1 |
4/60 |
239 |
|
11,548 |
2 |
8/60 |
3,079 |
|
2,282 |
2 |
8/60 |
609 |
Total |
|
|
|
54,434 |
* Estimated total number of adult extended interview respondents is 1,780 + 25,444 = 27,224.
** Estimated total number of youth extended interview respondents is 1,923 + 9,625 = 11,548.
Type of respondent
|
Estimated number of respondents |
Estimated number of responses per respondent |
Average burden per response(in hours) |
Estimated total annual burden hours requested |
Hourly wage rate |
Respondentcost |
|
25,444 |
1 |
1 |
25,444 |
$17.09 |
$434,838 |
|
2,046 |
1 |
4/60 |
136 |
$17.09 |
$2,324 |
|
1,780 |
1 |
68/60 |
2,017 |
$17.09 |
$34,471 |
|
1,780 |
1 |
5/60 |
148 |
$17.09 |
$2,529 |
|
13,805 |
1 |
10/60 |
2,301 |
$17.09 |
$39,324 |
|
765 |
1 |
18/60 |
230 |
$17.09 |
$3,931 |
|
14,570 |
1 |
5/60 |
1,214 |
$17.09 |
$20,747 |
|
27,224 |
2 |
8/60 |
7,260 |
$17.09 |
$124,073 |
|
9,625 |
1 |
35/60 |
5,615 |
$4.45 |
$24,987 |
|
1,923 |
1 |
3/60 |
96 |
$4.45 |
$427 |
|
1,923 |
1 |
45/60 |
1,442 |
$4.45 |
$6,417 |
|
9,818 |
1 |
16/60 |
2,618 |
$17.09 |
$44,742 |
|
2,161 |
1 |
5/60 |
180 |
$17.09 |
$3,076 |
|
1,961 |
2 |
19/60 |
621 |
$17.09 |
$10,613 |
|
35,564 |
1 |
2/60 |
1,185 |
$17.09 |
$20,252 |
|
3,579 |
1 |
4/60 |
239 |
$17.09 |
$4,085 |
|
11,548 |
2 |
8/60 |
3,079 |
$17.09 |
$52,620 |
|
2,282 |
2 |
8/60 |
609 |
$17.09 |
$10,408 |
Total |
|
|
|
|
|
$839,863 |
* Estimated total number of adult extended interview respondents is 1,780 + 25,444 = 27,224.
** Estimated total number of youth extended interview respondents is 1,923 + 9,625 = 11,548.
The PATH Study has no other annual cost burden to respondents or Record Keepers. This study has no capital, operation or maintenance costs.
This project is a multi-year, continuous activity, with interviews, biospecimen collection, and data processing occurring simultaneously. It is conducted by a contractor with oversight, management, scientific direction, and analyses by federal and contractor staff at NIH/NIDA, FDA, and CDC. The PATH Study contract is funded by FDA through an Interagency Agreement (IAA) with NIH/NIDA using tobacco user fees assessed under the authority of the TCA (PL 111-31, June 22, 2009). CDC’s laboratory oversight, management, and biospecimen analyses for the PATH Study are similarly funded by FDA through an IAA with CDC. Estimates in Table A-5 are presented as the annualized cost to the U.S. Government for this information collection.
Type of cost |
Contract |
Other |
Total |
Study Implementation, Data Collection and Processing, Operations |
$61,621,570 |
-- |
$61,621,570 |
NIH/NIDA and FDA Oversight, Monitoring, Scientific Direction, and Analyses |
$767,600 |
$1,408,240 |
$2,175,840 |
CDC Laboratory Oversight, Management, and Biospecimen Analyses |
$1,216,135 |
$1,477,379 |
$2,693,514 |
Total |
|
|
$66,490,924 |
This is a revision request (OMB 0925-0664, expires 9/30/2016) for the Population Assessment of Tobacco and Health (PATH) Study to conduct Wave 3 of data collection. There is a reduction of 4,589 estimated burden hours between Wave 2 (59,023) and Wave 3 (54,434). As noted in A.12, factors accounting for this reduction include the following: (1) an 86 percent response rate for interviews with continuing adults, (2) an 87 percent response rate for interviews with aged-up adults, (3) a 91 percent response rate for interviews with continuing youth, and (4) an 89 percent response rate for interviews with aged-up youth.
Plans for tabulation, statistical analysis, and publication of the PATH Study data are driven by its research design and major objectives presented in Section A.2 and by FDA regulatory science priorities. As a longitudinal cohort study, the PATH Study involves repeated observations on the same individuals to examine between-person differences and within-person changes over the same period of time. Benefits of the longitudinal research design include observing changes more accurately over time because the same persons are observed at multiple points over the same temporal order of events. The PATH Study Wave 3 data will be used for comparison purposes with the Wave 1 and Wave 2 data. The Wave 1 data provide a comprehensive assessment for the cohort that will serve as the “anchor” against which individuals will be compared to examine within-person changes over the follow-up waves. The Wave 2 data constitute the first annual follow up of the cohort, which can be compared to the data from Wave 1. In the same way, the Wave 3 data will provide the second follow up of respondents from Wave 1 and allow for analysis of within-person change over a 3-year period. The Wave 3 data will also provide an opportunity for the PATH Study to identify issues for small-scale research studies, such as through cognitive testing or methodological studies under its existing generic clearances or other types of research studies that focus on new and emerging tobacco-related issues and regulatory science priorities for FDA.
In addition, Wave 3 data will be used to inform the PATH Study’s major objectives, primarily by examining between-person differences in: (1) tobacco-use patterns, including 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 1); (2) risk perceptions regarding HPHC, new and emerging tobacco products, filters and other design features of tobacco products, packaging, and labeling, and other factors that may affect use, such as social influences and individual preferences (Objective 2); (3) tobacco use 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 various tobacco products (Objective 3); and (4) potential early markers of tobacco use exposures and related disease processes (Objective 4).
Planned analyses after completion of the Wave 3 data collection will focus on characterizing change in various outcomes relative to Wave 1 and examining correlates of that change. Of interest, for example, are rates of tobacco product uptake between waves and potential relationships between uptake and changes in risk perceptions. Additional interest focuses on inter-wave changes at the population level in tobacco use status (e.g., quitting, reducing consumption, or switching to one or more other products) relative to changes in health status indicators. Wave 1 data will be the basis for many of these analyses, although the longitudinal nature of the combined Wave 1, 2 and 3 data may also provide an opportunity for more in-depth analysis. (See Attachment 20 for detailed examples of some of the analyses planned after completion of the Wave 2 data collection.)
The PATH Study data will be used to 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 tobacco use-related disease processes. All such analyses will attempt to account for other potential factors that may influence these measures (e.g., demographics, local tobacco-control policies, and economic, social network, peer group, and family factors (Objectives 5 through 7). Major outcome variables represent dependent variables, while tobacco policy variables and major demographic and socioeconomic variables will serve as independent, confounding, mediating or moderator variables. Many of these analyses will include the use of logistic regression models; however, specific multivariate procedures will depend on: (1) basic characteristics of the outcome data (e.g., their continuous or discrete nature); (2) specific hypotheses or research questions being addressed; (3) whether the data meet underlying assumptions of the statistical model; and (4) sample size and power considerations for the specific multivariate analysis.
Additionally, as mentioned in Section A.2d, FDA has established a partnership with CDC to analyze a sub-set of PATH Study biospecimens. Examples of specific analytes for which some of the biospecimens will be tested are presented in Attachment 5. These analyses will allow the PATH Study to assess biomarkers of tobacco exposure as well as assess intermediate endpoints (i.e., markers of exposure and tobacco-related disease processes) and health outcomes.
The following table outlines the key activities and time schedules for the PATH Study Wave 3 data collection.
Activity |
Time schedule |
OMB approval of Wave 3 data collection Begin Wave 3 data collection |
August, 2015 2 Months after OMB approval |
Process and clean questionnaire data |
4 – 36 Months after OMB approval |
Data Analyses Publish preliminary study results/release public use data files for questionnaire data |
5 – 36 Months after OMB approval Within 18 Months after completion of data wave |
Publish preliminary study results/release public use data files for biospecimen data |
Within 18 months after completion of data wave |
There is no reason not to display the OMB expiration date for this data collection activity.
This data collection activity does not seek any exception to the certification statement associated with 5 CFR.1320.9, Certification for Paperwork Reduction Act Submissions.
References
Agaku, I., King, B., Husten, C., Bunnell, R., Ambrose, B., Hu, S., Holder-Hayes, E., & Day, H. (2014). Tobacco product use among adults — United States, 2012–2013. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6325a3.htm
Apelberg, B.J., Corey, C.G., Hoffman, A.C., et al. (2014). Symptoms of tobacco dependence among middle and high school tobacco users: Results from the 2012 National Youth Tobacco Survey, American Journal of Preventive Medicine, 47, S4-S14.
Arrazola, R. A.,. Neff, L.J., Kennedy, S.M., Holder-Hayes, E., & Jones, C.D. (2014). Tobacco use among middle and high school students – United States, 2013. Morbidity and Mortality Weekly Report, 63(45), 1021-1026.
Dennis, M.L., Chan, Y., & Funk, B.S. (2006). Development and validation of the GAIN Short Screener (GSS) for internalizing, externalizing, and substance use disorders and crime/violence problems among adolescents and adults. American Journal on Addictions, 15, 80-91.
Glasheen, C., Hedden, S.L., Forman-Hoffman, V.L., & Colpe, L.J. (2014). Cigarette smoking behaviors among adults with serious mental illness in a nationally representative sample. Annals of Epidemiology, 24, 776-780.
Hamilton, C.M., Strader, L.C., & Pratt, J.G., et al. (2011). The PhenX Toolkit: Get the most from your measures. American Journal of Epidemiology, 174(3), 253-60.
Hartz, S.M., Pato, C.N., Medeiros, H., Cavazos-Rehg, P., Sobell, J.L., Knowles, J.A., Bierut, L.J., & Pato, M.T. (2014). Comorbidity of severe psychotic disorders with measures of substance use. JAMA Psychiatry, 1, e1-e7.
Johnston, L.D., Miech, R.A., O'Malley, P. M., Bachman, J.G., & Schulenberg, J.E. (2014, December 16). National press release, “E-cigarettes surpass tobacco cigarettes among teens.” University of Michigan News Service, Ann Arbor, 16 pp.
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1 The 2010 rate of menthol cigarette use among Blacks/African Americans was approximately triple the rate among whites and five times the rate among Asians (SAMHSA, 2011).
2 During Wave 1, buccal cells also were collected from adult participants, but this collection was discontinued before the end of the wave. No buccal cells were collected during Wave 2; buccal cell collection is not planned for Wave 3.
3 In households with multiple births, parents may complete a total of 4 interviews for 4 youth to receive a maximum of $40.
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