Reasons for exclusion from a smoking cessation trial: An analysis by race/ethnicity

Monica Webb Hooper, Taghrid Asfar, Marina Unrod, Asha Dorsey, John B. Correa, Karen O. Brandon, Vani N. Simmons, Michael H Antoni, Tulay Sengul, David J Lee, Thomas H. Brandon

Research output: Contribution to journalArticle

1 Citation (Scopus)

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. 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. 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]). 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). 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.

Original languageEnglish (US)
Pages (from-to)23-30
Number of pages8
JournalEthnicity and Disease
Volume29
Issue number1
DOIs
StatePublished - Dec 1 2019

Fingerprint

Smoking Cessation
African Americans
Randomized Controlled Trials
Hispanic Americans
Alcoholism
Outcome Assessment (Health Care)
Tobacco Use Cessation
Tobacco Use Cessation Products
Tobacco Use
Street Drugs
Carbon Monoxide
Bipolar Disorder
Tobacco Products
Tobacco
Reading
Schizophrenia
Research Design
Pharmaceutical Preparations

Keywords

  • Disparities
  • Eligibility Criteria
  • Exclusion Criteria
  • Racial/Ethnic Differences
  • Randomized Clinical Trials
  • Tobacco Cessation

ASJC Scopus subject areas

  • Epidemiology

Cite this

Hooper, M. W., Asfar, T., Unrod, M., Dorsey, A., Correa, J. B., Brandon, K. O., ... Brandon, T. H. (2019). Reasons for exclusion from a smoking cessation trial: An analysis by race/ethnicity. Ethnicity and Disease, 29(1), 23-30. https://doi.org/10.18865/ed.29.1.23

Reasons for exclusion from a smoking cessation trial : An analysis by race/ethnicity. / Hooper, Monica Webb; Asfar, Taghrid; Unrod, Marina; Dorsey, Asha; Correa, John B.; Brandon, Karen O.; Simmons, Vani N.; Antoni, Michael H; Sengul, Tulay; Lee, David J; Brandon, Thomas H.

In: Ethnicity and Disease, Vol. 29, No. 1, 01.12.2019, p. 23-30.

Research output: Contribution to journalArticle

Hooper, MW, Asfar, T, Unrod, M, Dorsey, A, Correa, JB, Brandon, KO, Simmons, VN, Antoni, MH, Sengul, T, Lee, DJ & Brandon, TH 2019, 'Reasons for exclusion from a smoking cessation trial: An analysis by race/ethnicity', Ethnicity and Disease, vol. 29, no. 1, pp. 23-30. https://doi.org/10.18865/ed.29.1.23
Hooper MW, Asfar T, Unrod M, Dorsey A, Correa JB, Brandon KO et al. Reasons for exclusion from a smoking cessation trial: An analysis by race/ethnicity. Ethnicity and Disease. 2019 Dec 1;29(1):23-30. https://doi.org/10.18865/ed.29.1.23
Hooper, Monica Webb ; Asfar, Taghrid ; Unrod, Marina ; Dorsey, Asha ; Correa, John B. ; Brandon, Karen O. ; Simmons, Vani N. ; Antoni, Michael H ; Sengul, Tulay ; Lee, David J ; Brandon, Thomas H. / Reasons for exclusion from a smoking cessation trial : An analysis by race/ethnicity. In: Ethnicity and Disease. 2019 ; Vol. 29, No. 1. pp. 23-30.
@article{2f412db901ed48c0817c48941be32203,
title = "Reasons for exclusion from a smoking cessation trial: An analysis by race/ethnicity",
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. 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. 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]). 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). 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.",
keywords = "Disparities, Eligibility Criteria, Exclusion Criteria, Racial/Ethnic Differences, Randomized Clinical Trials, Tobacco Cessation",
author = "Hooper, {Monica Webb} and Taghrid Asfar and Marina Unrod and Asha Dorsey and Correa, {John B.} and Brandon, {Karen O.} and Simmons, {Vani N.} and Antoni, {Michael H} and Tulay Sengul and Lee, {David J} and Brandon, {Thomas H.}",
year = "2019",
month = "12",
day = "1",
doi = "10.18865/ed.29.1.23",
language = "English (US)",
volume = "29",
pages = "23--30",
journal = "Ethnicity and Disease",
issn = "1049-510X",
publisher = "ISHIB",
number = "1",

}

TY - JOUR

T1 - Reasons for exclusion from a smoking cessation trial

T2 - An analysis by race/ethnicity

AU - Hooper, Monica Webb

AU - Asfar, Taghrid

AU - Unrod, Marina

AU - Dorsey, Asha

AU - Correa, John B.

AU - Brandon, Karen O.

AU - Simmons, Vani N.

AU - Antoni, Michael H

AU - Sengul, Tulay

AU - Lee, David J

AU - Brandon, Thomas H.

PY - 2019/12/1

Y1 - 2019/12/1

N2 - 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. 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. 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]). 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). 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.

AB - 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. 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. 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]). 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). 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.

KW - Disparities

KW - Eligibility Criteria

KW - Exclusion Criteria

KW - Racial/Ethnic Differences

KW - Randomized Clinical Trials

KW - Tobacco Cessation

UR - http://www.scopus.com/inward/record.url?scp=85060775647&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85060775647&partnerID=8YFLogxK

U2 - 10.18865/ed.29.1.23

DO - 10.18865/ed.29.1.23

M3 - Article

C2 - 30713413

AN - SCOPUS:85060775647

VL - 29

SP - 23

EP - 30

JO - Ethnicity and Disease

JF - Ethnicity and Disease

SN - 1049-510X

IS - 1

ER -