Dataset Information

A review of tobacco regulatory science research on vulnerable populations.

ABSTRACT: In 2013 the U.S. Food and Drug Administration and National Institutes of Health established fourteen Tobacco Centers of Regulatory Science (TCORS) to advance scientific knowledge relevant to conducting evidence-based tobacco regulation. This report reviews TCORS-funded research with adult vulnerable populations. The literature search included a list of all TCORS-funded publications compiled by the TCORS coordinating center; all TCORS were requested to share publications not in the coordinating-center's list. Only TCORS-funded reports describing an empirical study with an adult vulnerable population published in a peer-reviewed journal between September 2013 and June 2018 were included. 71 reports met inclusion criteria; 39% (28/71) examined tobacco use among those with mental health and medical comorbidities, 34% (24/71) socioeconomic disadvantage, 31% (22/71) women of reproductive age, 30% (21/71) racial/ethnic minorities, 18% (13/71) rural residents, and 3% (2/71) each among active military/veterans and sexual/gender minorities. Regarding scientific domains, 63% (45/71) investigated behavior, 37% (26/71) addiction, 24% (17/71) health effects, 20% (14/71) impact analyses, 18% (13/71) toxicity, 8% (6/71) marketing influences, and 7% (5/71) communications. Totals exceed 100% because some reports addressed multiple populations/domains. TCORS funding has generated a substantial, multidisciplinary body of new scientific knowledge on tobacco use in adult vulnerable populations. However, considerable variability was noted in the amount of research conducted across the various vulnerable populations and scientific domains. Most notably, relatively few studies focused on active military/veterans or sexual/gender minorities, and the scientific domains of marketing influences and communications were conspicuously underrepresented. These are important knowledge gaps to address going forward.

SUBMITTER: Higgins ST

PROVIDER: S-EPMC6824984 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A review of tobacco regulatory science research on vulnerable populations.

Higgins Stephen T ST Kurti Allison N AN Palmer Marissa M Tidey Jennifer W JW Cepeda-Benito Antonio A Cooper Maria R MR Krebs Nicolle M NM Baezconde-Garbanati Lourdes L Hart Joy L JL Stanton Cassandra A CA

Preventive medicine 20190502

In 2013 the U.S. Food and Drug Administration and National Institutes of Health established fourteen Tobacco Centers of Regulatory Science (TCORS) to advance scientific knowledge relevant to conducting evidence-based tobacco regulation. This report reviews TCORS-funded research with adult vulnerable populations. The literature search included a list of all TCORS-funded publications compiled by the TCORS coordinating center; all TCORS were requested to share publications not in the coordinating-c ...[more]

PMID: 31054904

Similar Datasets

Project description:BACKGROUND:Children and patients with cognitive deficits may find it difficult to understand the implication of research. In the European Union (EU), clinical studies outside the EU directives concerning medicinal products or medical devices, i.e., "miscellaneous clinical studies", have no legally mandated timelines for institutional review boards' (IRB) decisions. GOAL:To evaluate the review process of IRBs for two different "miscellaneous" multicenter clinical research protocols involving vulnerable subjects (children and adult stroke patients). METHODS:Descriptive and comparative statistics. Protocol 1 is a prospective, multicenter, cross-sectional screening study of a symptomatic pediatric population at risk for Fabry disease involving genetic testing (NCT02152189). Protocol 2 is a prospective, multicenter, randomized, controlled, open-label, blinded endpoint post-market study to evaluate the effectiveness of stent retrievers (NCT02135926). After having obtained positive initial IRB votes at the main study site, both protocols were subsequently submitted to the remaining IRBs. RESULTS:Protocol 1 was submitted to 19 IRBs. No IRB objected to the study. Median time-to-final vote was 34 (IQR 10-65; range 0 to 130) days. Two IRBs accepted the coordinating center's IRB votes without re-evaluation. Changes to the informed consent documents were asked by 7/19 IRBs, amendments to the protocol by 2. Protocol 2 was submitted to 16 IRBs. Fifteen decisions were made. No IRB objected to the study. Median time-to final vote was 59 (IQR 10 to 65; range 0 to 128) days, which was not statistically significantly different compared with protocol 1 (Wilcoxon test). Two IRBs accepted a previous IRB decision and did not conduct an independent review. Eight/16 IRBs required changes to the informed consent documents; two IRBs recommended an amendment of the protocol. CONCLUSION:Both clinical research protocols involving vulnerable populations were well accepted. IRB workflows and decision times varied substantially. Some IRBs accepted a previous IRB decision without the necessity of another reevaluation process. Requested changes were focused on the informed consent documents. A more standardized approach across jurisdictions is desirable.

Project description:IntroductionCigars are a popular tobacco product of choice for youth and young adults. Despite growing interest in cigar research, there are gaps in the available literature limiting an ability to set evidence-based policies. Too small research samples, the heterogeneity of types of cigars when asking a single question about use, makes analyzing data difficult. Given the Food and Drug Administration's (FDA's) authority granted in 2016 to regulate cigars, and its popularity, data to better understand use and preference for cigars will help FDA set appropriate regulatory policies.MethodsWe harmonized cigar survey data previously collected by five independent tobacco regulatory science survey research projects. Data supplying participants included three Tobacco Centers of Regulatory Science, one Center for Tobacco Products grantee, and data from Population Assessment of Tobacco and Health (PATH) study's public use dataset.ResultsAnalyzing 92 data variables from across five studies, and applying a rigorous data harmonization protocol, we report findings on 24 key cigar use variables. The step by step protocol for harmonizing is presented. Selected findings showing strict reproducibility across all five studies reveal youth 17-19 years at highest risk for cigar initiation; relative reproducibility shows males more likely to try cigars than females but with significant differences in magnitude across studies; and areas of inconsistent reproducibility are revealed when evaluating brand preferences.ConclusionHarmonizing data from multiple sources fosters a broader view of the robustness and generalizability of survey data than that from a single source. These observations raise awareness to look for the highest degree of reproducibility among and across data sources to inform policy.ImplicationsHarmonizing data from discrete datasets provides insights into cigar initiation and use and is presented showing opportunities, challenges, and solutions. Comparing observational data from PATH and four independent research studies provides a best-practices approach and example of data synthesis for the tobacco research community. The dataset of five studies offers a look at the degree of confidence in analyzing harmonized survey results. Variable conclusions raise the need to strive for the highest degree of reproducibility, to best understand the behaviors of cigar users, and allow for the future development of the most effective interventions to alter tobacco use patterns.

Dataset Information

A review of tobacco regulatory science research on vulnerable populations.

Publications

A review of tobacco regulatory science research on vulnerable populations.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure