Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity

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. Quasi-experimental. Inclusion...

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Veröffentlicht in:Ethnicity & disease 2019, Vol.29 (1), p.23-30
Hauptverfasser: Hooper, Monica Webb, Asfar, Taghrid, Unrod, Marina, Dorsey, Asha, Correa, John B., Brandon, Karen O., Simmons, Vani N., Antoni, Michael A., Koru-Sengul, Tulay, Lee, David J., Brandon, Thomas H.
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container_issue 1
container_start_page 23
container_title Ethnicity & disease
container_volume 29
creator Hooper, Monica Webb
Asfar, Taghrid
Unrod, Marina
Dorsey, Asha
Correa, John B.
Brandon, Karen O.
Simmons, Vani N.
Antoni, Michael A.
Koru-Sengul, Tulay
Lee, David J.
Brandon, Thomas H.
description 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. 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. 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]). 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
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We examined racial/ethnic differences in: a) exclusion from a group-based cessation RCT; and b) reasons for exclusion. 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. 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]). 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&lt;.001). Compared with African Americans and Hispanics, Whites were more likely to be excluded for single reasons, including attendance barriers, and medical conditions (P&lt;.05). African Americans were more than twice as likely as Whites to be excluded for 3 or more reasons (12% vs 5% respectively, P&lt;.05). 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. 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disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hooper, Monica Webb</au><au>Asfar, Taghrid</au><au>Unrod, Marina</au><au>Dorsey, Asha</au><au>Correa, John B.</au><au>Brandon, Karen O.</au><au>Simmons, Vani N.</au><au>Antoni, Michael A.</au><au>Koru-Sengul, Tulay</au><au>Lee, David J.</au><au>Brandon, Thomas H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity</atitle><jtitle>Ethnicity &amp; disease</jtitle><addtitle>Ethn Dis</addtitle><date>2019</date><risdate>2019</risdate><volume>29</volume><issue>1</issue><spage>23</spage><epage>30</epage><pages>23-30</pages><issn>1049-510X</issn><eissn>1945-0826</eissn><abstract>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. 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. 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]). 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&lt;.001). Compared with African Americans and Hispanics, Whites were more likely to be excluded for single reasons, including attendance barriers, and medical conditions (P&lt;.05). African Americans were more than twice as likely as Whites to be excluded for 3 or more reasons (12% vs 5% respectively, P&lt;.05). 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. 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subjects Adolescent
Adult
Continental Population Groups
Ethnic Groups
Female
Florida - epidemiology
Humans
Male
Middle Aged
Original Report: Cancer
Patient Selection
Prevalence
Smokers - statistics & numerical data
Smoking Cessation - ethnology
Smoking Cessation - statistics & numerical data
Tobacco Products - statistics & numerical data
Tobacco Use Cessation Devices - statistics & numerical data
Young Adult
title Reasons for Exclusion from a Smoking Cessation Trial: An Analysis by Race/Ethnicity
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