The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial

Smoking cessation medications are effective but often underutilised because of costs and side effects. Cytisine is a plant-based smoking cessation medication with over 50 years of use in Central and Eastern Europe. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, direct comparison with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost-effectiveness of cytisine compared with varenicline.Two arm, parallel group, randomised, non-inferiority trial, with allocation concealment and blinded outcome assessment.Australian population-based study.Adult daily smokers (N=1266) interested in quitting will be recruited through advertisements and Quitline telephone-based cessation support services.Eligible participants will be randomised (1:1 ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10-12 minute sessions).Assessments will be undertaken by telephone at baseline, 4- and 7-months post-randomisation. Participants will also be contacted twice (two and four weeks post-randomisation) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up. We will also evaluate the relative safety and cost-effectiveness of cytisine compared with varenicline. Secondary outcomes will include self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview.If cytisine is as effective as varenicline, its lower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives worldwide

An empirical approach to selecting community-based alcohol interventions:combining research evidence, rural community views and professional opinion

<p>Abstract</p> <p>Background</p> <p>Given limited research evidence for community-based alcohol interventions, this study examines the intervention preferences of rural communities and alcohol professionals, and factors that influence their choices.</p> <p>Method</p> <p>Community preferences were identified by a survey of randomly selected individuals across 20 regional Australian communities. The preferences of alcohol professionals were identified by a survey of randomly selected members of the Australasian Professional Society on Alcohol and Other Drugs. To identify preferred interventions and the extent of support for them, a budget allocation exercise was embedded in both surveys, asking respondents to allocate a given budget to different interventions. Tobit regression models were estimated to identify the characteristics that explain differences in intervention preferences.</p> <p>Results</p> <p>Community respondents selected school programs most often (88.0%) and allocated it the largest proportion of funds, followed by promotion of safer drinking (71.3%), community programs (61.4%) and police enforcement of alcohol laws (60.4%). Professionals selected GP training most often (61.0%) and allocated it the largest proportion of funds, followed by school programs (36.6%), community programs (33.8%) and promotion of safer drinking (31.7%). Community views were susceptible to response bias. There were no significant predictors of professionals' preferences.</p> <p>Conclusions</p> <p>In the absence of sufficient research evidence for effective community-based alcohol interventions, rural communities and professionals both strongly support school programs, promotion of safer drinking and community programs. Rural communities also supported police enforcement of alcohol laws and professionals supported GP training. The impact of a combination of these strategies needs to be rigorously evaluated.</p

Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial

Background: In Australia, tobacco smoking rates have declined but inequalities remain with significantly higher smoking prevalence among low-socioeconomic populations. Clinical trial data suggest vaporized nicotine products (VNPs) aid smoking cessation. Most VNP trials have used refillable tank systems, but newer generation (pod) devices now comprise the largest market share yet have limited clinical trial evidence on safety and effectiveness. This study evaluates the effectiveness, safety and cost-effectiveness of VNPs (pod and tank device) compared with nicotine replacement therapy ([NRT]—gum or lozenge) for smoking cessation. Methods: This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment. The RCT is conducted at the National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia. Participants are people who smoke daily, are interested in quitting and receive a government pension or allowance (N = 1058). Participants will be randomized (1:1 ratio) to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavours; or NRT (gum or lozenge; 4 mg). All participants will receive daily text message behavioural support for 5 weeks. Assessments will be undertaken by telephone at baseline, with three follow-up calls (two check-in calls within the first month and final follow-up at 7 months post randomization) to ascertain smoking status, treatment adherence and adverse events. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated. Discussion: Further data are required to strengthen certainty of evidence for VNPs aiding smoking cessation, particularly for newer generation pod devices. To our knowledge, this trial is the first to offer choice of VNPs and no comparative effectiveness trial data exists for new pod devices. If effective, the findings can inform wider implementation of VNPs to aid smoking cessation in a priority group. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021. https://www.anzctr.org.a

Modelling the Costs and Outcomes of Changing Rates of Screening for Alcohol Misuse by GPs in the Australian Context

Aim: To assess the relative cost effectiveness of four strategies (academic detailing, computerised reminder systems, target payments and interactive continuing medical education) to increase the provision of screening and brief interventions by Australian GPs with the ultimate goal of decreasing risky alcohol consumption among their patients. Methods: This project used a modelling approach to combine information on the effectiveness and costs of four separate strategies to change GP behaviours to estimate their relative cost effectiveness. Results: The computerised reminder system and academic detailing appear most effective in achieving a decrease in the number of standard drinks consumed by risky drinkers. Conclusion: Regardless of the assumptions made, the targeted payment strategy appeared to be the least cost-effective method to achieve a decrease in risky alcohol consumption while the other three strategies appear reasonably comparable.Alcoholism, Cost-effectiveness, Diagnostic-Screening, General-practice, Health-economics, Medical-education, Pharmacoeconomics, Screening

Tailoring a family-based alcohol intervention for Aboriginal Australians, and the experiences and perceptions of health care providers trained in its delivery

Background: Aboriginal Australians experience a disproportionately high burden of alcohol-related harm compared to the general Australian population. Alcohol treatment approaches that simultaneously target individuals and families offer considerable potential to reduce these harms if they can be successfully tailored for routine delivery to Aboriginal Australians. The Community Reinforcement Approach (CRA) and Community Reinforcement and Family Training (CRAFT) are two related interventions that are consistent with Aboriginal Australians' notions of health and wellbeing. This paper aims to describe the process of tailoring CRA and CRAFT for delivery to Aboriginal Australians, explore the perceptions of health care providers participating in the tailoring process, and their experiences of participating in CRA and CRAFT counsellor certification. Methods. Data sources included notes recorded from eight working group meetings with 22 health care providers of a drug and alcohol treatment agency and Aboriginal Community Controlled Health Service (November 2009-February 2013), and transcripts of semi-structured interviews with seven health care providers participating in CRA and CRAFT counsellor certification (May 2012). Qualitative content analysis was used to categorise working group meeting notes and interview transcripts were into key themes. Results: Modifying technical language, reducing the number of treatment sessions, and including an option for treatment of clients in groups, were key recommendations by health care providers for improving the feasibility and applicability of delivering CRA and CRAFT to Aboriginal Australians. Health care providers perceived counsellor certification to be beneficial for developing their skills and confidence in delivering CRA and CRAFT, but identified time constraints and competing tasks as key challenges. Conclusions: The tailoring process resulted in Aboriginal Australian-specific CRA and CRAFT resources. The process also resulted in the training and certification of health care providers in CRA and CRAFT and the establishment of a local training and certification program

Prevalence and characteristics of patients with risky alcohol consumption presenting to emergency departments in rural Australia

This study measures the prevalence of problematic alcohol consumption in patients of EDs in rural areas of Australia, relative to the general population in the same rural communities. It also identifies the characteristics associated with risky drinking in rural ED patients. Surveys containing the Alcohol Use Disorders Identification Test (AUDIT) and questions corresponding to the 2001 Australian Alcohol Guidelines were completed by 1056 patients presenting to five EDs in rural areas of New South Wales, and 756 residents of the same five communities. Relative to the general community, ED patients were statistically significantly more likely to engage in risky alcohol consumption according to the AUDIT (39% vs 20%), alcohol consumption posing a high risk of short-term harm (26% vs 18%) and alcohol consumption posing a high risk of long-term harm (7% vs 3%). Although being aged under 40 years of age, being unmarried, not completing school and being assigned less urgent triage categories were associated with risky alcohol use among ED patients, rates of risky consumption were high across all patient subgroups. Risky drinking, across a number of measures, is overrepresented in patients of rural Australian EDs relative to the general community, and this type of consumption is not limited to certain subgroups of patients. There is a need for interventions that address both heavy single occasion drinking and excessive regular consumption in patients of rural Australian EDs, with universal interventions recommended rather than targeted programmes

Cost per incident of alcohol related crime in New South Wales

Introduction and Aims: The purpose of this paper is to provide a per incident of crime cost measure for New South Wales that is suitable for the use within cost-effectiveness studies of interventions aimed at reducing the burden of alcohol. This paper seeks to quantify the individual cost of an assault, property damage, sexual offence and disorderly conduct in New South Wales. Design and Methods: Costs regarding the criminal act, police involvement, prosecution in criminal courts and incarceration are estimated and then using a four-stage probability analysis, the expected cost per incident is calculated. Results: It is found that expected cost per incident for assault, sexual offence, property damage and disorderly conduct (in 2006 dollar values) is $3982,$5976, $1166 and$501 respectively. Discussion and Conclusions: A large total cost figure is a powerful policy motivator; however, for the purpose of economic analysis it is often more useful to estimate the per incident cost. This research furthers the existing research on cost of crime estimates and facilitates future cost-effectiveness and other economic analysis of interventions that reduce alcohol-related crime

Randomized controlled trial of mailed personalized feedback for risky drinkers in the emergency department : the impact on alcohol consumption, alcohol-related injuries, and repeat emergency department presentations

Background: Due to the difficulty encountered in disseminating resource-intensive emergency department (ED)-based brief alcohol interventions into real-world settings, this study evaluated the effect of a mailed personalized feedback intervention for problem drinking ED patients. At 6-week follow-up, this intervention was associated with a statistically significant reduction in alcohol consumption among patients with alcohol-involved ED presentations. This study aimed to evaluate the effects of this intervention over time. Methods: A randomized controlled trial was conducted among problem drinking ED patients, defined as those scoring 8 or more on the Alcohol Use Disorders Identification Test. Participants in the intervention group received mailed personalized feedback regarding their alcohol consumption. The control group received no feedback. Follow-up interviews were conducted over the phone, postal survey, or email survey 6 weeks and 6 months after baseline screening, and repeat ED presentations over 12-month follow-up were ascertained via linked ED records. Results: Six-month follow-up interviews were completed with 210 participants (69%), and linked ED records were obtained for 286 participants (94%). The intervention had no effect on alcohol consumption, while findings regarding alcohol-related injuries and repeat ED presentations remain inconclusive. Conclusions: Further research in which the receipt of feedback is improved and a booster intervention is provided is recommended