Impact of National Institutes of Health and Food and Drug Administration Tobacco Research Funding: A Bibliometrics Analyses.

INTRODUCTION: Conduct bibliometric analyses documenting the output of National Institutes of Health (NIH) tobacco-related and Food and Drug Administration (FDA) tobacco regulatory science (FDA-TRS) research portfolios. AIMS AND METHODS: PubMed identifiers for publications between 2015 and 2020 citing tobacco funding by NIH and/or FDA were imported into NIH iCite generating measures of productivity and influence, including number of citations, journal, relative citation ratios (RCR), and comparison of research influence across Web of Science (WoS) disciplines. Coauthorship and measures of centrality among and between NIH and FDA-supported investigators gauged collaboration. RESULTS: Between FY 2015 and 2020, 8160 publications cited funding from NIH tobacco-related grants, 1776 cited FDA-TRS grants and 496 cited Common funding (ie, both NIH and FDA-TRS funding). The proportion of publications citing NIH grants declined while those citing FDA-TRS or Common funding rose significantly. Publications citing Common funding showed the highest influence (mean RCR = 2.52). Publications citing FDA-TRS funding displayed higher median RCRs than publications citing NIH funding in most WoS categories. Higher translational progress was estimated over time for FDA-TRS and Common publications compared to NIH publications. Authors citing Common funding scored highest across all collaboration measures. CONCLUSIONS: This study demonstrates the high bibliometric output of tobacco research overall. The rise in publications citing FDA-TRS and Common likely reflects increased funding for TRS research. Higher RCRs across WoS subject categories and trends towards human translation among FDA-TRS and Common publications indicate focus on research to inform regulation. This analysis suggests that FDA support for TRS has expanded the field of tobacco control resulting in sustained productivity, influence, and collaboration. IMPLICATIONS: This paper is the first effort to better describe the impact of tobacco research resulting from the addition of FDA funding for TRS in the past decade. The analysis provides impetus for further investigation into the publication topics and their focus which would offer insight into the specific evidence generated on tobacco control and regulation.

Two weights make a wrong: Cluster randomized trials with variable cluster sizes and heterogeneous treatment effects.

In cluster randomized trials (CRTs), the hierarchical nesting of participants (level 1) within clusters (level 2) leads to two conceptual populations: clusters and participants. When cluster sizes vary and the goal is to generalize to a hypothetical population of clusters, the unit average treatment effect (UATE), which averages equally at the cluster level rather than equally at the participant level, is a common estimand of interest. From an analytic perspective, when a generalized estimating equations (GEE) framework is used to obtain averaged treatment effect estimates for CRTs with variable cluster sizes, it is natural to specify an inverse cluster size weighted analysis so that each cluster contributes equally and to adopt an exchangeable working correlation matrix to account for within-cluster correlation. However, such an approach essentially uses two distinct weights in the analysis (i.e. both cluster size weights and covariance weights) and, in this article, we caution that it will lead to biased and/or inefficient treatment effect estimates for the UATE estimand. That is, two weights "make a wrong" or lead to poor estimation characteristics. These findings are based on theoretical derivations, corroborated via a simulation study, and illustrated using data from a CRT of a colorectal cancer screening program. We show that, an analysis with both an independence working correlation matrix and weighting by inverse cluster size is the only approach that always provides valid results for estimation of the UATE in CRTs with variable cluster sizes.

NIH Tobacco Research and the Emergence of Tobacco Regulatory Science.

INTRODUCTION: This study explores how the emergence of FDA-funded Tobacco Regulatory Science (TRS) research complements and perhaps influenced the direction of tobacco research supported by NIH. AIMS AND METHODS: New NIH- and FDA-funded tobacco projects awarded in fiscal years (FY) 2011-2020 were identified using internal NIH databases of awarded grants. Project abstracts and research aims were coded by the authors to characterize research domains and tobacco products studied. RESULTS: Between FY 2011 and 2020, NIH funded 1032 and FDA funded 322 new tobacco projects. For the years and grant activity codes studied, the number of new NIH tobacco projects declined while FDA's increased; combined the number of new projects held steady. Much of NIH research included smoking combustibles (43.7%). The most common products in FDA research were cigarettes (74.8%) and e-cigarettes/ENDS (48.1%). Most NIH (58.6%) and FDA (67.7%) projects included research on the determinants of tobacco use. Another area of apparent overlap was health effects (29.5% NIH and 30.1% FDA). Projects unique to NIH included treatment interventions (33.3%), disease pathology/progression (17.8%) and neurobiology (18.9%). A minority of both NIH and FDA projects included populations particularly vulnerable to tobacco product use. CONCLUSIONS: In total, support for new tobacco research supported by NIH and FDA combined remained steady for the time period covered, though there was a concomitant decline in NIH tobacco projects with the increase in FDA-funded TRS projects for the activity codes studied. Despite the apparent overlap in some areas, both NIH and FDA support research that is unique to their respective missions. IMPLICATIONS: NIH continues to support tobacco research that falls within and outside of FDA's regulatory authorities. This research still is needed not only to bolster the evidence base for regulatory decisions at the national and state levels, but also to advance a comprehensive scientific agenda that can inform multiple levels of influence on tobacco control, use and addiction. It will be important to continue monitoring FDA-funded TRS and NIH-funded tobacco research portfolios to ensure that the level of support for and focus of the research is sufficient to address the burden of tobacco-related morbidity and mortality.

The iCook 4-H Study: Report on Physical Activity and Sedentary Time in Youth Participating in a Multicomponent Program Promoting Family Cooking, Eating, and Playing Together.

OBJECTIVE: To report physical activity and sedentary time outcomes of youth in iCook 4-H. STUDY DESIGN AND SETTING: iCook 4-H was a 5-state, randomized, control-treatment, family-based childhood obesity prevention intervention promoting cooking, eating, and playing together. PARTICIPANTS AND INTERVENTION: Youth aged 9-10 years and the main preparer of their meals participated in the 12-week program followed by monthly newsletters and biyearly booster sessions until 24 months. MAIN OUTCOME MEASURE(S): A total of 155 youth were fitted with an Actigraph GT3X+ accelerometer, which they wore for 7 days at baseline and 4, 12, and 24 months to measure mean daily minutes per hour of waking wear time for sedentary time (ST), light physical activity (PA) (LPA), moderate PA, vigorous PA, and moderate to vigorous PA. Self-reported PA was assessed using the Block Kids Physical Activity Screener and additional questions querying for the program goal of the frequency of family actively playing together. Linear mixed models were used to determine differences from baseline to 24 months. Significance was set at P ≤ .05. RESULTS: There was a significant (P < .05) group × time interaction for LPA (adjusted interaction B estimate, 95% confidence interval; 0.18 [0.05, 0.30]) and ST (-0.15 [-0.26, -0.04]); ST increased and LPA decreased in the treatment group. There were no differences in other accelerometer-derived PA measures, self-report Block Kids Physical Activity Screener measures, or frequency of family actively playing together at any time point. CONCLUSIONS AND IMPLICATIONS: iCook 4-H was a multicomponent program observing youth aged 9-10 years for 24 months that focused on enhancing cooking skills, mealtime behavior and conversation, and PA through daily family activities. Greater emphasis on developing PA skills, changing environmental factors, and increasing PA both in and after school may be needed.