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Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity.
- Source :
-
Ethnicity & disease [Ethn Dis] 2019 Jan 17; Vol. 29 (1), pp. 23-30. Date of Electronic Publication: 2019 Jan 17 (Print Publication: 2019). - Publication Year :
- 2019
-
Abstract
- Objective: The exclusion criteria of tobacco cessation randomized clinical trials (RCTs) may have unintended consequences on inclusion and cessation disparities. We examined racial/ethnic differences in: a) exclusion from a group-based cessation RCT; and b) reasons for exclusion.<br />Design: Quasi-experimental. Inclusion criteria were self-identification as African American/Black, non-Hispanic White, or Hispanic (any race), adults, minimum five cigarettes/day or carbon monoxide reading of ≥ 8 parts per million (ppm), interest in quitting, and spoke/read English. Data were obtained from a parent trial, which is ongoing and will be completed in 2019. Analyses for our present study on participant screening and enrollment were conducted in 2018.<br />Main Outcome Measures: Study ineligibility, and reasons for exclusion (contraindications for nicotine patch use, serious mental illness [SMI, eg, bipolar disorder or schizophrenia], alcohol dependence or illicit drug use, current tobacco treatment, attendance barriers [eg, transportation], and other concerns [eg, aggressive, intoxicated, disruptive, visibly ill]).<br />Results: Of 1,206 individuals screened, 36% were ineligible. The most frequent reasons were SMI (28%), alcohol dependence or drug use (10%), and attendance barriers (7%). Ineligibility was greater among African Americans (42%) and Hispanics (37%), compared with Whites (24%; P<.001). Compared with African Americans and Hispanics, Whites were more likely to be excluded for single reasons, including attendance barriers, and medical conditions (P<.05). African Americans were more than twice as likely as Whites to be excluded for 3 or more reasons (12% vs 5% respectively, P<.05).<br />Conclusions: A notable proportion of smokers were ineligible for this RCT, with SMI as the greatest single cause. Racial/ethnic minorities were more likely to be excluded, with African Americans deemed ineligible for multiple reasons. Findings have implications for RCT generalizability, addressing tobacco disparities and health equity.<br />Competing Interests: Competing Interests: None declared.
- Subjects :
- Adolescent
Adult
Female
Florida epidemiology
Humans
Male
Middle Aged
Prevalence
Smoking Cessation statistics & numerical data
Tobacco Products statistics & numerical data
Tobacco Use Cessation Devices statistics & numerical data
Young Adult
Ethnicity
Patient Selection
Racial Groups
Smokers statistics & numerical data
Smoking Cessation ethnology
Subjects
Details
- Language :
- English
- ISSN :
- 1049-510X
- Volume :
- 29
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Ethnicity & disease
- Publication Type :
- Academic Journal
- Accession number :
- 30713413
- Full Text :
- https://doi.org/10.18865/ed.29.1.23