Racial differences in eligibility and enrollment in a smoking cessation clinical trial

Abstract

Objective: The purpose of this study was to compare the recruitment, eligibility screening, and enrollment of African American and White smokers into an intensive smoking cessation intervention trial [The Chicago STOP Smoking Trial (C-STOP)].

Methods: We compared demographic, smoking, substance use, and medical/psychiatric screening data from the recruitment records of 1,189 non-Hispanic, African American and White smokers screened for eligibility in the last year of a randomized pharmacological and behavioral smoking cessation trial. The study took place at a large urban medical center and two satellite locations within the Chicago metropolitan area.

Results: Interest levels in the study were high among African American smokers, with twice as many African Americans as Whites contacting study staff for information and an initial screening. However, African Americans were nearly three times as likely not to be enrolled in the trial as Whites, because of higher ineligibility rates, failure to attend a screening session, and lower participation rates even among those meeting eligibility requirements.

Conclusions: Racial differences were observed nearly at all levels of enrollment determination. These critical barriers to inclusion of African Americans in smoking cessation research limit our understanding of treatment efficacy and ultimately the ability to reduce the health disparities in tobacco-related disease experienced by African Americans.

Figure 1

CONSORT diagram of eligibility determination in 1,189 non-Hispanic African American and White Smokers. Stages include telephone screening eligibility, attending the in-person screening, in-person screening eligibility, and electing to enroll in the trial among those deemed eligible. ¹due to rounding, % totals may not equal 100% in all cases