Cost-utility of cytisine for smoking cessation over and above behavioural support in people with newly diagnosed pulmonary tuberculosis: an economic evaluation of a multicentre randomised controlled trial.

OBJECTIVES: To assess the cost-effectiveness of cytisine over and above brief behavioural support (BS) for smoking cessation among patients who are newly diagnosed with pulmonary tuberculosis (TB) in low-income and middle-income countries. DESIGN: An incremental cost-utility analysis was undertaken alongside a 12-month, double-blind, two-arm, individually randomised controlled trial from a public/voluntary healthcare sector perspective with the primary endpoint at 6 months post randomisation. SETTING: Seventeen subdistrict hospitals in Bangladesh and 15 secondary care hospitals in Pakistan. PARTICIPANTS: Adults (aged ≥18 years in Bangladesh and ≥15 years in Pakistan) with pulmonary TB diagnosed within the last 4 weeks who smoked tobacco daily (n=2472). INTERVENTIONS: Two brief BS sessions with a trained TB health worker were offered to all participants. Participants in the intervention arm (n=1239) were given cytisine (25-day course) while those in the control arm (n=1233) were given placebo. No significant difference was found between arms in 6-month abstinence. PRIMARY AND SECONDARY OUTCOME MEASURES: Costs of cytisine and BS sessions were estimated based on research team records. TB treatment costs were estimated based on TB registry records. Additional smoking cessation and healthcare costs and EQ-5D-5L data were collected at baseline, 6-month and 12-month follow-ups. Costs were presented in purchasing power parity (PPP) adjusted US dollars (US$). Quality-adjusted life years (QALYs) were derived from the EQ-5D-5L. Incremental total costs and incremental QALYs were estimated using regressions adjusting for respective baseline values and other baseline covariates. Uncertainty was assessed using bootstrapping. RESULTS: Mean total costs were PPP US$57.74 (95% CI 49.40 to 83.36) higher in the cytisine arm than in the placebo arm while the mean QALYs were -0.001 (95% CI -0.004 to 0.002) lower over 6 months. The cytisine arm was dominated by the placebo arm. CONCLUSIONS: Cytisine plus BS for smoking cessation among patients with TB was not cost-effective compared with placebo plus BS. TRIAL REGISTRATION NUMBER: ISRCTN43811467.

Applying systems thinking to identify enablers and challenges to scale-up interventions for hypertension and diabetes in low-income and middle-income countries: protocol for a longitudinal mixed-methods study.

INTRODUCTION: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions. METHODS AND ANALYSIS: We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (TP), initiation of implementation (T0) and 1-year postinitiation (T1). We will extract project-related data from secondary documents at TP and conduct multistakeholder qualitative interviews to gather data at T0 and T1. We will undertake descriptive statistical analysis of TP data and analyse T0 and T1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks. ETHICS AND DISSEMINATION: The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.

The Impact of COVID-19 on Smoking Patterns in Pakistan: Findings From a Longitudinal Survey of Smokers.

INTRODUCTION: We investigated the influence of COVID-19 on smoking patterns in Pakistan. METHODS: In a longitudinal survey, we asked cigarette smokers in Pakistan about their smoking behaviors before and since COVID-19. Smokers were recruited before COVID-19 using two-stage random probability sampling. Since COVID-19, three subsequent waves were conducted over the telephone, asking additional questions on social determinants, mental health, and well-being. Based on the first two waves, we estimated the proportion of smokers who stopped, decreased, maintained, or increased smoking. We also explored any factors associated with the change in smoking patterns. In those who stopped smoking soon after COVID-19, we estimated the proportion relapsed in subsequent waves. We estimated all proportions based on complete-case analysis. RESULTS: We recruited 6014 smokers between September 2019 and February 2020; of these, 2087 (2062 reported smoking outcomes) were followed up in May 2020 after COVID-19. Since COVID-19, 14% (290/2062) smokers reported quitting. Among those who continued smoking: 68% (1210/1772) reduced, 14% (239/1772) maintained, and 18% (323/1772) increased cigarette consumption; 37% (351/938) reported at least one quit attempt; 41% (669/1619) were more motivated; while 21% (333/1619) were less motivated to quit. Changes in smoking patterns varied with nicotine dependence, motivation to quit, and financial stability since COVID-19. Among those reporting quitting soon after COVID-19, 39% (81/206) relapsed in the subsequent months (June-July 2020). CONCLUSIONS: There have been significant bidirectional changes in smoking patterns since COVID-19 in Pakistan. Although many people stopped, reduced, or tried quitting smoking, some increased smoking and some relapsed after quitting. IMPLICATIONS: We observed significant and complex changes in people's smoking patterns, which are likely to be attributable to the COVID-19 pandemic and replicated in similar events in the future. Assessing these changes is essential for most low- and middle-income countries like Pakistan, where the vast majority of tobacco users live, but cessation support is still rudimentary. If provided routinely, smoking cessation interventions can potentially support millions of highly motivated individuals in quitting successfully both in general and in global events like COVID-19, in particular.