Tobacco cessation in low- to middle-income countries: A scoping review of randomized controlled trials.

OBJECTIVE: The growing prevalence of tobacco use in low "to middle" income countries (LMICs) and the hurdles of conducting tobacco cessation in that context necessitates a focus on the scope of randomized controlled trials (RCTs) in LMICs to guide tobacco cessation in this environment. We conducted a scoping review to identify LMIC tobacco cessation RCTs. METHODS: Consistent with PRISMA-ScR guidelines and without language restrictions, we systematically searched peer-reviewed databases (MEDLINE, Embase, PsycINFO, articles published since inception, latest searches in March 2020) and gray literature (clinical trials registries, searches between September and December 2019). We searched for data on RCT type, outcome significance and intervention description. Inclusion: research conducted in LMICs; tobacco cessation; RCT. Exclusion: research conducted in high income countries; non-RCT; studies involving only those aged <18. Data was extracted from published reports. We generated narrative summaries of each LMIC's tobacco cessation RCT research environment. RESULTS: Of 8404 articles screened, we identified 92 studies. Tobacco cessation RCTs were recorded in 16 of 138 countries/territories in LMICs. Evidence was weak in quality and severely limited. Most RCTs were psychosocial, with limited behavioral and pharmacological variants. CONCLUSIONS: Tobacco control within LMICs is essential to reduce the tobacco mortality burden. Researchers should be cognizant that tobacco cessation in LMICs is still not an environment where best practice has been established. We suggest that developing solutions specific for LMICs is key to effective tobacco control in LMICs.

The scope of tobacco cessation randomized controlled trials in low- to middle-income countries: protocol for a scoping review.

BACKGROUND: Tobacco consumption is the leading cause of preventable death globally. The global mortality burden of tobacco use lies predominantly in low- to middle-income countries (LMICs). There is much evidence on the effectiveness of tobacco cessation RCTs in high-income nations. However, the evidence base in LMICs is far more limited. To effectively design randomized controlled trials (RCTs) that mitigate tobacco-related harms in LMICs, further understanding of RCTs in this environment will be helpful. We will provide quality evidence regarding the scope of tobacco cessation RCTs in LMICs. METHODS: A scoping review of tobacco cessation RCTs will be conducted. MEDLINE, Embase, PsycINFO, Global Health, Web of Science and Sociological Abstracts will be searched to capture current literature. We will review RCTs that have already been done on tobacco cessation in the LMICs. The key outcome will be tobacco cessation in adults. Examples of the key outcome include smoking abstinence and reduction of tobacco use. Study selection will conform to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines and study quality assessed with a modified version of the Cochrane Collaboration's instrument. DISCUSSION: As researchers attempt to minimize the harms from tobacco in LMICs, they need to be aware of scientific evidence to develop RCTs to achieve their aim. The review will complement the evidence base on tobacco cessation in LMICs.