Case Western Reserve University, Case Comprehensive Cancer Center.
University of Miami Miller School of Medicine, Department of Public Health Sciences and Sylvester Comprehensive Cancer Center.
Ethn Dis. 2019 Jan 17;29(1):23-30. doi: 10.18865/ed.29.1.23. eCollection 2019 Winter.
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<.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).
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.
戒烟随机临床试验（RCT）的排除标准可能对纳入和戒烟差异产生意想不到的后果。我们检查了种族/族裔差异：a）被排除在基于群体的戒烟 RCT 之外；b）被排除的原因。
准实验。纳入标准为自我认定为非裔美国人/黑人、非西班牙裔白人或西班牙裔（任何种族）、成年人、每天至少吸 5 支香烟或一氧化碳读数≥8ppm、有戒烟意愿、并且会说/读英语。数据来自一项正在进行的、将于 2019 年完成的母试验。我们目前对参与者筛选和招募的研究分析于 2018 年进行。
研究不合格和排除原因（尼古丁贴片使用禁忌症、严重精神疾病[例如，双相情感障碍或精神分裂症]、酒精依赖或非法药物使用、当前烟草治疗、出席障碍[例如，交通]和其他问题[例如，攻击性、醉酒、破坏性、明显疾病]）。
在筛查的 1206 人中，有 36%不合格。最常见的原因是 SMI（28%）、酒精依赖或药物使用（10%）和出席障碍（7%）。非裔美国人（42%）和西班牙裔（37%）的不合格率高于白人（24%；P<.001）。与非裔美国人和西班牙裔相比，白人更有可能因单一原因被排除在外，包括出席障碍和医疗条件（P<.05）。非裔美国人因 3 个或更多原因被排除的可能性是白人的两倍多（分别为 12%和 5%，P<.05）。
相当比例的吸烟者不符合这项 RCT 的条件，最大的单一原因是 SMI。少数民族更有可能被排除在外，非裔美国人因多种原因被认为不合格。这些发现对 RCT 的普遍性、解决烟草差异和健康公平性具有重要意义。
