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"McRobbie, Hayden"
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A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy
2019
In a randomized trial involving 886 smokers, e-cigarettes were more effective than nicotine-replacement therapy with respect to the 1-year abstinence rate (18% vs. 10%). Throat or mouth irritation was more common in the e-cigarette group, and nausea was more common in the nicotine-replacement group.
Journal Article
Electronic cigarettes for smoking cessation: a randomised controlled trial
by
Laugesen, Murray
,
McRobbie, Hayden
,
Williman, Jonathan
in
Addictive behaviors
,
Adult
,
Adult and adolescent clinical studies
2013
Electronic cigarettes (e-cigarettes) can deliver nicotine and mitigate tobacco withdrawal and are used by many smokers to assist quit attempts. We investigated whether e-cigarettes are more effective than nicotine patches at helping smokers to quit.
We did this pragmatic randomised-controlled superiority trial in Auckland, New Zealand, between Sept 6, 2011, and July 5, 2013. Adult (≥18 years) smokers wanting to quit were randomised (with computerised block randomisation, block size nine, stratified by ethnicity [Māori; Pacific; or non-Māori, non-Pacific], sex [men or women], and level of nicotine dependence [>5 or ≤5 Fagerström test for nicotine dependence]) in a 4:4:1 ratio to 16 mg nicotine e-cigarettes, nicotine patches (21 mg patch, one daily), or placebo e-cigarettes (no nicotine), from 1 week before until 12 weeks after quit day, with low intensity behavioural support via voluntary telephone counselling. The primary outcome was biochemically verified continuous abstinence at 6 months (exhaled breath carbon monoxide measurement <10 ppm). Primary analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12610000866000.
657 people were randomised (289 to nicotine e-cigarettes, 295 to patches, and 73 to placebo e-cigarettes) and were included in the intention-to-treat analysis. At 6 months, verified abstinence was 7·3% (21 of 289) with nicotine e-cigarettes, 5·8% (17 of 295) with patches, and 4·1% (three of 73) with placebo e-cigarettes (risk difference for nicotine e-cigarette vs patches 1·51 [95% CI −2·49 to 5·51]; for nicotine e-cigarettes vs placebo e-cigarettes 3·16 [95% CI −2·29 to 8·61]). Achievement of abstinence was substantially lower than we anticipated for the power calculation, thus we had insufficient statistical power to conclude superiority of nicotine e-cigarettes to patches or to placebo e-cigarettes. We identified no significant differences in adverse events, with 137 events in the nicotine e-cigarettes group, 119 events in the patches group, and 36 events in the placebo e-cigarettes group. We noted no evidence of an association between adverse events and study product.
E-cigarettes, with or without nicotine, were modestly effective at helping smokers to quit, with similar achievement of abstinence as with nicotine patches, and few adverse events. Uncertainty exists about the place of e-cigarettes in tobacco control, and more research is urgently needed to clearly establish their overall benefits and harms at both individual and population levels.
Health Research Council of New Zealand.
Journal Article
Efficacy of cytisine in helping smokers quit: systematic review and meta-analysis
by
McRobbie, Hayden
,
Myers, Katie
,
Hajek, Peter
in
Alkaloids - pharmacology
,
Azocines - pharmacology
,
Humans
2013
Background A recent rigorous study has shown that cytisine, a low-cost drug, is effective for smoking cessation. A number of earlier studies exist, mostly from former communist countries where cytisine has been used since the 1960s. The key question now is whether there is sufficient evidence to warrant licensing cytisine or whether more work is needed. A systematic review was undertaken to assess the efficacy of cytisine in smoking cessation. Methods The Cochrane Library, CINAHL, Embase, Medline and PsycINFO databases were searched for relevant data. Data from controlled trials were entered into two separate meta-analyses. The first considered the strictest definition of outcome and longest follow-up from all available studies and the second pooled outcomes from studies with biochemically validated abstinence and follow-up of 6 months or longer. Results Eight controlled trials were identified. Seven trials provided extractable data and, when pooled (first meta-analysis), produced a risk ratio (RR) of 1.57 (95% CI 1.42 to 1.74). Data from two high-quality studies (second meta-analysis) produced a pooled RR of 3.29 (95% CI 1.84 to 5.90). Patients on cytisine reported more gastrointestinal symptoms than patients on placebo (RR=1.76, 95% CI 1.28 to 2.42). There was no difference in overall reports of adverse events and no specific safety concerns emerged. Conclusions Cytisine is an effective treatment for smoking cessation with efficacy comparable to that of other currently licensed treatments. Given its low cost and potential for public health benefit, expedited licensing of cytisine for smoking cessation is warranted.
Journal Article
Cytisine versus Nicotine for Smoking Cessation
by
Barnes, Joanne
,
Nosa, Vili
,
Glover, Marewa
in
Adult
,
Alkaloids - adverse effects
,
Alkaloids - therapeutic use
2014
In this trial involving smokers who called the New Zealand national quitline, cytisine (a partial agonist of the nicotinic acetylcholine receptor) was superior to nicotine-replacement therapy in helping smokers quit. Nausea and sleep disorders were more frequent with cytisine.
Cytisine is a plant-based alkaloid found in members of the Leguminosae family.
1
,
2
Like varenicline, cytisine is a partial agonist of nicotinic acetylcholine receptors (nAChRs), with an affinity for the α4β2 receptor subtype,
3
and a half-life of 4.8 hours.
4
Cytisine is a generic agent currently manufactured by Sopharma as Tabex and by Aflofarm Pharma as Desmoxan. It has been available both with and without prescription for smoking cessation since the 1960s, largely in Eastern Europe.
5
Four systematic reviews report cytisine to be superior to placebo for short-term and long-term abstinence.
6
–
9
When taken at the recommended dosage (1.5 to 9 . . .
Journal Article
A randomised controlled trial of the 5:2 diet
by
Peerbux, Sarrah
,
Myers Smith, Katie
,
McRobbie, Hayden
in
Biology and Life Sciences
,
Blood Pressure
,
Body Weight
2021
The 5:2 diet is a popular intermittent energy restriction method of weight management that awaits further evaluation. We compared the effects of one-off 5:2 instructions with the effects of one-off standard multicomponent weight-management advice; and also examined whether additional behavioural support enhances 5:2 adherence and efficacy compared to one-off instructions.
Three hundred adults with obesity were randomised to receive a Standard Brief Advice (SBA) covering diet and physical activity (N = 100); 5:2 self-help instructions (5:2SH) (N = 100); or 5:2SH plus six once-weekly group support sessions (N = 100). Participants were followed up for one year.
Adherence to 5:2SH was initially high (74% at 6 weeks), but it declined over time (31% at 6 months and 22% at one year). 5:2SH and SBA achieved similar weight-loss at six months (-1.8kg (SD = 3.5) vs -1.7kg (SD = 4.4); b = 0.23, 95%CI:-0.79-1.27, p = 0.7) and at one year (-1.9kg (SD = 4.9) vs -1.8kg (SD = 5.7), b = 0.20, 95%CI:-1.21-1.60, p = 0.79), with 18% vs 15% participants losing ≥5% of their body weight with 5:2SH and SBA, respectively at one year (RR = 0.83, 95%CI:0.44-1.54, p = 0.55). Both interventions received positive ratings, but 5:2SH ratings were significantly higher. 5:2SH had no negative effect on fat and fiber intake and physical activity compared to SBA. Compared to 5:2SH, 5:2G generated a greater weight loss at 6 weeks (-2.3kg vs -1.5kg; b = 0.74, 95%CI:1.37-0.11, p = 0.02), but by one year, the difference was no longer significant (-2.6kg vs -1.9kg, p = 0.37; ≥5% body weight loss 28% vs 18%, p = 0.10).
Simple 5:2 advice and multicomponent weight management advice generated similar modest results. The 5:2 diet did not undermine other health behaviours, and it received more favourable ratings. Adding initial group support enhanced 5:2 adherence and effects, but the impact diminished over time. Health professionals who provide brief weight management advice may consider including the 5:2 advice as an option.
ISRCTN registry (ISRCTN79408248).
Journal Article
Daily exposure to formaldehyde and acetaldehyde and potential health risk associated with use of high and low nicotine e-liquid concentrations
2020
Recent evidence suggests that e-cigarette users tend to change their puffing behaviors when using e-liquids with reduced nicotine concentrations by taking longer and more frequent puffs. Using puffing regimens modelled on puffing topography data from 19 experienced e-cigarette users who switched between 18 and 6 mg/mL e-liquids with and without power adjustments, differences in daily exposure to carbonyl compounds and estimated changes in cancer risk were assessed by production of aerosols generated using a smoking machine and analyzed using gas and liquid chromatography. Significant differences across conditions were found for formaldehyde and acetaldehyde (p < 0.01). Switching from a higher to a lower nicotine concentration was associated with greater exposure regardless of whether power settings were fixed or adjustable which is likely due to increased liquid consumption under lower nicotine concentration settings. Daily exposure for formaldehyde and acetaldehyde was higher for 17/19 participants when using low (6 mg/mL) compared with high (18 mg/mL) nicotine e-liquid concentration when power was fixed. When power adjustments were permitted, formaldehyde and acetaldehyde levels were higher respectively for 16/19 and 14/19 participants with the use of 6 compared with 18 mg/mL nicotine e-liquid.
Journal Article
Don’t Forget the Humble Text Message: 25 Years of Text Messaging in Health
by
Free, Caroline
,
Dobson, Rosie
,
Stowell, Melanie
in
Digital Health - economics
,
Digital Health - history
,
Health Promotion - economics
2024
Since the early studies exploring the use of SMS text messaging for health intervention, text messaging has played a pivotal role in the advancement of mobile health. As an intervention modality, text messaging has provided vital learnings for the design and delivery of interventions, particularly in low-resource settings. Despite the advances in technology over the last 25 years, text messaging is still being used in largely the same way to deliver health information, behavior change interventions, and support. The strong, consistent evidence for the benefits of this type of intervention has made text messaging a routine part of health interventions around the world. Key to its success is its simplicity, alongside the benefit of being arguably the most accessible form of consumer digital health intervention. Text message interventions are well suited for public health interventions due to their low cost, vast reach, frequent use, high read rates, and ability to be tailored and personalized. Furthermore, the nature of text messaging interventions makes them ideal for the delivery of multilingual, culturally tailored interventions, which is important in the context of increasing cultural diversity in many countries internationally. Indeed, studies assessing text message–based health interventions have shown them to be effective across sociodemographic and ethnic groups and have led to their adoption into national-level health promotion programs. With a growing focus on artificial intelligence, robotics, sensors, and other advances in digital health, there is an opportunity to integrate these technologies into text messaging programs. Simultaneously, it is essential that equity remains at the forefront for digital health researchers, developers, and implementers. Ensuring digital health solutions address inequities in health experienced across the world while taking action to maximize digital inclusion will ensure the true potential of digital health is realized. Text messaging has the potential to continue to play a pivotal role in the delivery of equitable digital health tools to communities around the world for many years to come. Further new technologies can build on the humble text message, leveraging its success to advance the field of digital health. This Viewpoint presents a retrospective of text messaging in health, drawing on the example of text message–based interventions for smoking cessation, and presents evidence for the continued relevance of this mobile health modality in 2025 and beyond.
Journal Article
Study protocol of the Our Futures Vaping Trial: a cluster randomised controlled trial of a school-based eHealth intervention to prevent e-cigarette use among adolescents
2023
Background
Effective and scalable prevention approaches are urgently needed to address the rapidly increasing rates of e-cigarette use among adolescents. School-based eHealth interventions can be an efficient, effective, and economical approach, yet there are none targeting e-cigarettes within Australia. This paper describes the protocol of the OurFutures Vaping Trial which aims to evaluate the efficacy and cost-effectiveness of the first school-based eHealth intervention targeting e-cigarettes in Australia.
Methods
A two-arm cluster randomised controlled trial will be conducted among Year 7 and 8 students (aged 12–14 years) in 42 secondary schools across New South Wales, Western Australia and Queensland, Australia. Using stratified block randomisation, schools will be assigned to either the
OurFutures Vaping Program
intervention group or an active control group (health education as usual). The intervention consists of four web-based cartoon lessons and accompanying activities delivered during health education over a four-week period. Whilst primarily focused on e-cigarette use, the program simultaneously addresses tobacco cigarette use. Students will complete online self-report surveys at baseline, post-intervention, 6-, 12-, 24-, and 36-months after baseline. The primary outcome is the uptake of e-cigarette use at 12-month follow-up. Secondary outcomes include the uptake of tobacco smoking, frequency/quantity of e-cigarettes use and tobacco smoking, intentions to use e-cigarettes/tobacco cigarettes, knowledge about e-cigarettes/tobacco cigarettes, motives and attitudes relating to e-cigarettes, self-efficacy to resist peer pressure and refuse e-cigarettes, mental health, quality of life, and resource utilisation. Generalized mixed effects regression will investigate whether receiving the intervention reduces the likelihood of primary and secondary outcomes. Cost-effectiveness and the effect on primary and secondary outcomes will also be examined over the longer-term.
Discussion
If effective, the intervention will be readily accessible to schools via the
OurFutures
platform and has the potential to make substantial health and economic impact. Without such intervention, young Australians will be the first generation to use nicotine at higher rates than previous generations, thereby undoing decades of effective tobacco control.
Trial registration
The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12623000022662; date registered: 10/01/2023).
Journal Article
Is opt-out enrolment acceptable for low-risk digital health services?
by
Evison, Karen
,
Whittaker, Robyn
,
McRobbie, Hayden
in
Cellular telephones
,
Childrens health
,
Coronaviruses
2022
Introduction: Digital health programmes not only complement existing services, but have the potential to reach populations that existing services are not reaching. Many of these services require people to opt-in to receive them, which presents significant barriers to access. An alternative is to make low-risk digital services opt-out, ensuring appropriate members of the target audience are signed up for a service unless they select to not receive it.Aim: This study aimed to investigate how changing enrolment in a low-risk digital health programme from opt-in to opt-out would impact on enrolment and dropout rates.Methods: This study involved the retrospective analysis of registration data from txtpēpi, a maternal and child health text-message programme. System-recorded data from enrolments during a 12-month period were obtained. In the first 6 months, users had to opt-in to the service (Period 1), but in the following 6 months, an opt-out process was implemented (Period 2).Results: There was a 77% increase in enrolments in Period 2 (n = 113) compared to Period 1 (n = 64) and no significant change in the proportion of enrolments of Māori between time periods (P = 0.508). There was no significant difference in withdrawal rates between time periods at either 2 weeks (5% vs 6%, P = 0.676) or 1 month (9% vs 9%, P = 0.907).Discussion: This study has shown switching from an opt-in to an opt-out option resulted in an increase in enrolments in an mHealth programme, but had no impact on withdrawals. This indicates that employing opt-out enrolment for low-risk evidence-based interventions is acceptable and a potential way to make these services more accessible.
Journal Article
A Theory-Based Video Messaging Mobile Phone Intervention for Smoking Cessation: Randomized Controlled Trial
2011
Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called \"STUB IT\") used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques.
The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation.
A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks.
The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated.
This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was sufficient positive feedback about the ease of use of this novel intervention, and the support obtained by observing the role model video messages, to warrant further investigation.
Australian New Zealand Clinical Trials Registry Number: ACTRN12606000476538; http://www.anzctr.org.au/trial_view.aspx?ID=81688 (Archived by WebCite at http://www.webcitation.org/5umMU4sZi).
Journal Article