Prevalence and Severity of Nicotine Dependence in India: A Systematic Review and Meta-Analysis Protocol

Background Despite the high prevalence on tobacco use in India, evidence on nicotine dependence and its severity across the demographic groups is limited. Therefore, this review aims to estimate the pooled prevalence and severity of nicotine dependence among tobacco users in India, stratified by age, gender, type of tobacco, and rural or urban setting. Methods The protocol has been prospectively registered in PROSPERO (ID: CRD420251133993) and adheres to the PRISMAP 2015 guidelines. Comprehensive literature searches will be conducted across Medline, Cochrane Library, Embase, Scopus, and grey literature sources. Eligible studies will include community based research reporting nicotine dependence assessed using the Fagerstrom Test for Nicotine Dependence (FTND) or FTNDST for smokeless tobacco. Two independent reviewers will carry out study selection, data extraction, and risk of bias assessment using the JBI checklist and the Newcastle Ottawa Scale. Pooled prevalence will be calculated using a random effects model, supplemented by subgroup analyses, sensitivity analyses, and meta regression. Publication bias will be assessed through Deviation from Expected Inverse Variance (DOI) plots for graphical asymmetry evaluation or by funnel plots, alongside the Luis Furuya Kanamori (LFK) index, where values within +-1 suggest no asymmetry, +-1 to +-2 indicate minor asymmetry, and >+-2 represent major asymmetry. The overall certainty of evidence will be appraised using the GRADE framework. Discussion By generating robust estimates of nicotine dependence and its severity among tobacco users in India, this review will address a significant evidence gap in the field. The findings will be valuable for policymakers, public health professionals, and clinicians, enabling them to design context specific tobacco control strategies, enhance cessation services, and develop targeted interventions. Such measures will contribute meaningfully to achieving Sustainable Development Goals 3 and 3.a, which aim to reduce premature mortality from non communicable diseases.