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.Ethn Dis. 2019;29(1):23-30; doi:10.18865/ed.29.1.23.

Achieving Equity in the Reach of Smoking Cessation Services Within the NCI Cancer Moonshot-Funded Cancer Center Cessation Initiative

“…Racial/ethnic minority populations experience a disproportionate burden of tobacco-related cancers, 13 have lower smoking abstinence rates, 14 and use cessation aids/pharmacotherapy at lower rates compared with white smokers. 15 Multilevel factors, including discrimination, stress, 16 exposure to environmental cues to smoke, 17 and less access to smoking cessation treatment, 18 play a role in these disparities. Disparities in access to cessation treatment may also exist as a function of age and gender.…”

Promoting inclusion in clinical trials—a rapid review of the literature and recommendations for action

“…It also means there is consequently a limited evidence base regarding health interventions in this population [ 33 ]. On the other hand, eligibility criteria may indirectly exclude some populations to a greater extent than others; for example, exclusion criterion may be more prevalent in some ethnic minority groups than in White Europeans, such as chronic diseases [ 34 ].…”

Inequity in smoking cessation clinical trials testing pharmacotherapies: exclusion of smokers with mental health disorders

“…This could be explained by the unique barrier that smokers with drug and alcohol use disorder face, in addition to commonly perceived barriers to smokers in the general population (eg, anxiety and weight gain), such as the belief that it will be harder to tolerate alcohol or drug craving without smoking 43. Another study investigating the reasons for exclusion from a smoking cessation RCT identified that self-reported diagnosis of SMIs was the primary reason for excluding 28% of the 1206 treatment-seeking smokers who expressed interest in participating in the trial 13. While people suffering from SMI continue to smoke at higher rates than the general population, care providers often do not address nicotine addiction in this population because of the common misbelief that treatment could worsen the patient’s mental illness or that the patient lacks the motivation to quit 44.…”

“…These include nicotine replacement therapies (NRTs), bupropion (an atypical antidepressant), varenicline or cytisine (nicotinic acetylcholine receptor (nAChR) partial agonist) and electronic cigarettes (e-cigarettes). Although data show that these treatments are both safe and effective in people with MHDs,10 11 this group of smokers is under-represented in smoking cessation research and in medical research more generally 12 13. Potential reasons why people with MHDs might be excluded from clinical trials include high rates of attrition, medication contraindications, low medication compliance and ethical and safety concerns 13–15…”

“…Although data show that these treatments are both safe and effective in people with MHDs,10 11 this group of smokers is under-represented in smoking cessation research and in medical research more generally 12 13. Potential reasons why people with MHDs might be excluded from clinical trials include high rates of attrition, medication contraindications, low medication compliance and ethical and safety concerns 13–15…”