2020 design and methods of the Population Assessment of Tobacco and Health (PATH) study during the COVID-19 pandemic.

The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative, longitudinal study of the US population on tobacco use and its effects on health, collecting data annually since 2013. The COVID-19 pandemic interrupted in-person survey data collections around the world. In the USA, this included a PATH Study data collection focused on youth (13-17) and young adults (18-19) as well as other US surveys on tobacco use. Given that it was necessary to pause data collection and considering that tobacco-use behaviours could be expected to change along with pandemic-related changes in the social environment, the original design for the 2020 PATH Study data collection for youth and young adults was modified. Also, the PATH Study Adult Telephone Survey was developed to address the need for adult tobacco use monitoring in this unprecedented time. This article describes the modifications made to the 2020 PATH Study design and protocol to provide nationally representative data for youth and adults after the onset of the COVID-19 pandemic as well as the implications of these modifications for researchers.

Update to the design and methods of the PATH Study, Wave 4 (2016-2017).

The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative study of the US population on tobacco use and its effects on health, with four waves of data collection between 2013 and 2017. Prior work described the methods of the first three waves. In this paper, we describe the methods of Wave 4, during which a replenishment sample was added to the ongoing cohort. We describe the design and estimation methods of the continuing Wave 1 cohort (with four waves of data) and the Wave 4 cohort (the new cohort created at Wave 4). We provide survey quality metrics, including response rates for both cohorts and a panel conditioning analysis, and guidance on understanding the target populations for both cohorts.

Longitudinal Uses of the Population Assessment of Tobacco and Health Study.

OBJECTIVES: The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative study of the US population on tobacco use and its effects on health, with 3 waves of data collection between 2013 and 2016. Prior work described the methods of the first wave. In this paper, we describe the methods of the subsequent 2 waves and provide recommendations for how to conduct longitudinal analyses of PATH Study data. METHODS: We use standard survey quality metrics to evaluate the results of the follow-up waves of the PATH Study. The recommendations and examples of longitudinal and cross-sectional analyses of PATH Study data follow a design-based statistical inference framework. RESULTS: The quality metrics indicate that the PATH Study sample of approximately 40,000 continuing respondents remains representative of its target population. Depending on the intended analysis, different survey weights may be appropriate. CONCLUSION: The PATH Study data are a valuable resource for regulatory scientists interested in longitudinal analysis of tobacco use and its effects on health. The availability of multiple sets of specialized survey weights enables researchers to target a wide range of tobacco-related analytic questions.

Design and methods of the Population Assessment of Tobacco and Health (PATH) Study.

BACKGROUND: This paper describes the methods and conceptual framework for Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study data collection. The National Institutes of Health, through the National Institute on Drug Abuse, is partnering with the Food and Drug Administration's (FDA) Center for Tobacco Products to conduct the PATH Study under a contract with Westat. METHODS: The PATH Study is a nationally representative, longitudinal cohort study of 45 971 adults and youth in the USA, aged 12 years and older. Wave 1 was conducted from 12 September 2013 to 15 December 2014 using Audio Computer-Assisted Self-Interviewing to collect information on tobacco-use patterns, risk perceptions and attitudes towards current and newly emerging tobacco products, tobacco initiation, cessation, relapse behaviours and health outcomes. The PATH Study's design allows for the longitudinal assessment of patterns of use of a spectrum of tobacco products, including initiation, cessation, relapse and transitions between products, as well as factors associated with use patterns. Additionally, the PATH Study collects biospecimens from consenting adults aged 18 years and older and measures biomarkers of exposure and potential harm related to tobacco use. CONCLUSIONS: The cumulative, population-based data generated over time by the PATH Study will contribute to the evidence base to inform FDA's regulatory mission under the Family Smoking Prevention and Tobacco Control Act and efforts to reduce the Nation's burden of tobacco-related death and disease.

The Influence of the VERB campaign on children's physical activity in 2002 to 2006.

OBJECTIVES: We evaluated physical activity outcomes for children exposed to VERB, a campaign to encourage physical activity in children, across campaign years 2002 to 2006. METHODS: We examined the associations between exposure to VERB and (1) physical activity sessions (free time and organized) and (2) psychosocial outcomes (outcome expectations, self-efficacy, and social influences) for 3 nationally representative cohorts of children. Outcomes among adolescents aged 13 to 17 years (cohort 1, baseline) and children aged 9 to 13 years from cohorts 2 and 3 were analyzed for dose-response effects. Propensity scoring was used to control for confounding influences. RESULTS: Awareness of VERB remained high across campaign years. In 2006, reports of children aged 10 to 13 years being active on the day before the survey increased significantly as exposure to the campaign increased. Psychosocial outcomes showed dose-response associations. Effects lessened as children aged out of the campaign target age range (cohort 1, baseline), but dose-response associations persisted in 2006 for outcome expectations and free-time physical activity. CONCLUSIONS: VERB positively influenced children's physical activity outcomes. Campaign effects persisted as children grew into their adolescent years.

Effects of the National Youth Anti-Drug Media Campaign on youths.

OBJECTIVES: We examined the cognitive and behavioral effects of the National Youth Anti-Drug Media Campaign on youths aged 12.5 to 18 years and report core evaluation results. METHODS: From September 1999 to June 2004, 3 nationally representative cohorts of US youths aged 9 to 18 years were surveyed at home 4 times. Sample size ranged from 8117 in the first to 5126 in the fourth round (65% first-round response rate, with 86%-93% of still eligible youths interviewed subsequently). Main outcomes were self-reported lifetime, past-year, and past-30-day marijuana use and related cognitions. RESULTS: Most analyses showed no effects from the campaign. At one round, however, more ad exposure predicted less intention to avoid marijuana use (gamma = -0.07; 95% confidence interval [CI] = -0.13, -0.01) and weaker antidrug social norms (gamma = -0.05; 95% CI = -0.08, -0.02) at the subsequent round. Exposure at round 3 predicted marijuana initiation at round 4 (gamma = 0.11; 95% CI = 0.00, 0.22). CONCLUSIONS: Through June 2004, the campaign is unlikely to have had favorable effects on youths and may have had delayed unfavorable effects. The evaluation challenges the usefulness of the campaign.

Methodology of the outcome evaluation of the VERB campaign.

This article summarizes the methods used in the outcome evaluation of the VERB campaign. The outcome evaluation was designed to measure the awareness and understanding of VERB among the target audience of children aged 9-13 years (tweens) and to determine the effect of VERB awareness on psychosocial and behavioral outcomes. Cohorts of tweens and parents were interviewed annually via a telephone survey (Youth Media Campaign Longitudinal Survey). The first cohort (baseline) was surveyed in 2002 prior to VERB advertising and was repeated annually through 2006. A second cohort was surveyed in 2004-2006. A third, cross-sectional sample was surveyed in 2006. Each cohort consisted of a nationally representative sample of tweens to enable generalizability to the nation as a whole. Propensity scoring was used to control for confounding influences. The outcomes were analyzed for dose-response effects (i.e., whether higher levels of awareness led to stronger effects) and overall awareness effects (i.e., the difference between tweens unaware of VERB and all tweens in the U.S.). Secular trends in tweens' physical activity during the life of the campaign were also examined. This article also discusses weighting and imputation, alternative analyses used to assess the adequacy of the propensity methods, and the challenges involved in media campaign evaluations.

Survey research methods in evaluation and case-control studies.

Survey research methods are widely used in two types of analytic studies: evaluation studies that measure the effects of interventions; and population-based case-control studies that investigate the effects of various risk factors on the presence of disease. This paper provides a broad overview of some design and analysis issues related to such studies, illustrated with examples. The lack of random assignment to treatment and control groups in many evaluation studies makes controlling for confounders critically important. Confounder control can be achieved by matching in the design and by various alternative methods in the analysis. One popular analytic method of controlling for confounders is propensity scoring, which bears a close resemblance to survey weighting. The use of population-based controls has become common in case-control studies. For reasons of cost, population-based controls are often identified by telephone surveys using random digit dialling (RDD) sampling methods. However, RDD surveys are now experiencing serious problems with response rates. A recent alternative approach is to select controls from frames such as driver license lists that contain valuable demographic information for use in matching. Methods of analysis developed in the survey sampling literature are applicable, at least to some degree, in the analyses of evaluation and population-based case-control studies. In particular, the effects of complex sample designs can be taken into account using survey sampling variance estimation methods. Several survey analysis software packages are available for carrying out the computations.

Variable selection and raking in propensity scoring.

This paper discusses some practical issues in applying propensity scoring in the context of endpoint analysis in a pre-/posttest longitudinal design with an ordinal measure of treatment intensity and a high-dimensional potential covariate space: how many covariates to include in propensity models; how to evaluate the adequacy of tentative propensity models; and how to tailor models to provide hypercontrol on a limited subset of covariates. These issues arose in the evaluation of a health communication program.