Mild Traumatic Brain Injury Does Not Significantly Affect Midlife Cognitive Functioning Within the General Population: Findings From a Prospective Longitudinal Birth Cohort Study.

OBJECTIVE: To determine whether differences exist in mid-adulthood cognitive functioning in people with and without history of mild traumatic brain injury (mTBI). SETTING: Community-based study. PARTICIPANTS: People born between April 1, 1972, and March 31, 1973, recruited into the Dunedin Multidisciplinary Health and Development Longitudinal Study, who completed neuropsychological assessments in mid-adulthood. Participants who had experienced a moderate or severe TBI or mTBI in the past 12 months were excluded. DESIGN: Longitudinal, prospective, observational study. MAIN MEASURES: Data were collected on sociodemographic characteristics, medical history, childhood cognition (between 7 and 11 years), and alcohol and substance dependence (from 21 years of age). mTBI history was determined from accident and medical records (from birth to 45 years of age). Participants were classified as having 1 mTBI and more in their lifetime or no mTBI. The Wechsler Adult Intelligence Scale (WAIS-IV) and Trail Making Tests A and B (between 38 and 45 years of age) were used to assess cognitive functioning. T tests and effect sizes were used to identify any differences on cognitive functioning domains between the mTBI and no mTBI groups. Regression models explored the relative contribution of number of mTBIs and age of first mTBI and sociodemographic/lifestyle variables on cognitive functioning. RESULTS: Of the 885 participants, 518 (58.5%) had experienced at least 1 mTBI over their lifetime, with a mean number of 2.5 mTBIs. The mTBI group had significantly slower processing speed ( P < .01, d = 0.23) in mid-adulthood than the no TBI controls, with a medium effect size. However, the relationship no longer remained significant after controlling for childhood cognition, sociodemographic and lifestyle factors. No significant differences were observed for overall intelligence, verbal comprehension, perceptual reasoning, working memory, attention, or cognitive flexibility. Childhood cognition was not linked to likelihood of sustaining mTBI later in life. CONCLUSION: mTBI histories in the general population were not associated with lower cognitive functioning in mid-adulthood once sociodemographic and lifestyle factors were taken into account.

Effectiveness of nicotine salt vapes, cytisine, and a combination of these products, for smoking cessation in New Zealand: protocol for a three-arm, pragmatic, community-based randomised controlled trial.

BACKGROUND: Combining short-acting nicotine replacement therapy with varenicline increases smoking cessation rates compared with varenicline alone, but not all people tolerate these medications or find them helpful. We aim to investigate the therapeutic potential of an analogous combination, by evaluating the effectiveness, safety, and acceptability of combining nicotine salt e-cigarettes with cytisine, compared to nicotine salt e-cigarettes or cytisine only, on smoking abstinence at six months. METHODS: A pragmatic, community-based, investigator-blinded, randomised superiority trial design will be utilised. Eligible participants will be people who smoke daily (N = 800, 90% power) from throughout New Zealand, who are: aged ≥ 18 years, motivated to quit in the next two weeks, able to provide online consent, willing to use e-cigarettes and/or cytisine, and have daily access to a mobile phone. Recruitment will utilise multi-media advertising. Participants will be randomised (3:3:2 ratio) to 12 weeks of: 1) e-cigarettes (closed pod system, 3% nicotine salt, tobacco flavour) plus cytisine; 2) e-cigarettes alone, or 3) cytisine alone. All groups will receive a six-month, text-message-based behavioural support programme. The primary outcome is self-reported, biochemically verified, continuous abstinence at six months post-quit date. Secondary outcomes, measured at quit date, then one, three, six, and 12 months post-quit date, include self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes smoked per day, withdrawal and urge to smoke, time to (re)lapse, treatment use and compliance, treatment crossover, dual-use, use of other cessation products, change in e-cigarette products, continuation of product use, acceptability, change in health state, health-related quality of life, change in body mass index, adverse events, and cost per quitter. DISCUSSION: Pragmatic trials are of particular value as they reflect the 'real world' impact of interventions. The trial will provide some of the first evidence on the effectiveness of combining nicotine salt e-cigarettes with cytisine for smoking cessation, in a country with strong tobacco control policy. Findings will be incorporated into relevant systematic reviews, informing practice and policy. TRIAL REGISTRATION: NCT05311085 ClinicalTrials.gov. Registered 5th April, 2022.

A Model for Empowering Rural Solutions for Cervical Cancer Prevention (He Tapu Te Whare Tangata): Protocol for a Cluster Randomized Crossover Trial.

BACKGROUND: Maori are the Indigenous people of Aotearoa (New Zealand). Despite global acceptance that cervical cancer is almost entirely preventable through vaccination and screening, wahine Maori (Maori women) are more likely to have cervical cancer and 2.5 times more likely to die from it than non-Maori women. Rural Maori residents diagnosed with cervical cancer have worse outcomes than urban residents. Living in rural Aotearoa means experiencing barriers to appropriate and timely health care, resulting from distance, the lack of community resourcing, and low prioritization of rural needs by the health system and government. These barriers are compounded by the current screening processes and referral pathways that create delays at each step. Screening for high-risk human papillomavirus (hrHPV) and point-of-care (POC) testing are scientific advances used globally to prevent cervical cancer. OBJECTIVE: This study aims to compare acceptability, feasibility, timeliness, referral to, and attendance for colposcopy following hrHPV detection between a community-controlled pathway and standard care. METHODS: This is a cluster randomized crossover trial, with 2 primary care practices (study sites) as clusters. Each site was randomized to implement either pathway 1 or 2, with crossover occurring at 15 months. Pathway 1 (community-controlled pathway) comprises HPV self-testing, 1-hour POC results, face-to-face information, support, and immediate referral to colposcopy for women with a positive test result. Pathway 2 (standard care) comprises HPV self-testing, laboratory analysis, usual results giving, information, support, and standard referral pathways for women with a positive test result. The primary outcome is the proportion of women with hrHPV-positive results having a colposcopy within 20 working days of the HPV test (national performance indicator). Qualitative research will analyze successes and challenges of both pathways from the perspectives of governance groups, clinical staff, women, and their family. This information will directly inform the new National Cervical Screening Program. RESULTS: In the first 15-month period, 743 eligible HPV self-tests were performed: 370 in pathway 1 with POC testing and 373 in pathway 2 with laboratory testing. The positivity rate for hrHPV was 7.3% (54/743). Data collection for the second period, qualitative interviews, and analyses are ongoing. CONCLUSIONS: This Maori-centered study combines quantitative and qualitative research to compare 2 clinical pathways from detection of hrHPV to colposcopy. This protocol draws on rural community practices strengths, successfully engaging Maori from a whanau ora (family wellness) approach including kanohi ki te kanohi (face-to-face), kaiawhina (nonclinical community health workers), and multiple venues for interventions. It will inform the theory and practice of rural models of the use of innovative technology, addressing Maori cervical cancer inequities and facilitating Maori wellness. The findings are anticipated to be applicable to other Indigenous and rural people in high-income countries. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000553875; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000553875. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51643.

Te Ara Waiora-Implementing human papillomavirus (HPV) primary testing to prevent cervical cancer in Aotearoa New Zealand: A protocol for a non-inferiority trial.

BACKGROUND: Cervical cancer is caused by high-risk types of human papillomavirus (HPV). Testing for high-risk HPV is a more sensitive screening method than cervical cytology for detecting cervical changes that may lead to cancer. Consistent with recent evidence of efficacy and acceptability, Aotearoa New Zealand plans to introduce HPV testing as the primary approach to screening, replacing cervical cytology, from mid-2023. Any equitable cervical screening programme must be effective across a diverse population, including women that the current programme fails to reach, particularly Maori and those in rural areas. Currently, we do not know the best model for implementing an equitable HPV self-testing screening programme. METHODS: This implementation trial aims to assess whether a universal offer of HPV self-testing (offered to all people eligible for cervical screening) achieves non-inferior screening coverage (equal) to a universal offer of cervical cytology alone (the present programme). The study population is all people aged from 24.5 to 70 years due for cervical screening in a 12-month period (including those whose screening is overdue or who have never had screening). A range of quantitative and qualitative secondary outcomes will be explored, including barriers and facilitators across screening and diagnostic pathways. This study takes place in Te Tai Tokerau/Northland which covers a diverse range of urban and rural areas and has a large Indigenous Maori population. A total of fourteen practices will be involved. Seven practices will offer HPV self-testing universally to approximately 2800 women and will be compared to seven practices providing routine clinical care (offer of cervical cytology) to an approximately equal number of women. DISCUSSION: This trial will answer important questions about how to implement an equitable, high-quality, effective national programme offering HPV self-testing as the primary screening method for cervical cancer prevention. TRIAL REGISTRATION: Prospectively registered with the Australian New Zealand Clinical Trials Registry 07/12/2021: ACTRN12621001675819.

Effectiveness of a preschool asthma education programme, compared to usual care, on the frequency of acute asthma events: a community-based cluster randomised trial.

AIM: To determine whether an asthma intervention delivered within preschools can improve asthma outcomes in children aged 2-5 years with asthma or a high probability of asthma. METHODS: Between 2011 and 2013, we undertook a pragmatic, single-blind, cluster randomised trial in Auckland, New Zealand. We randomly assigned (1:1 ratio) preschools, and their children aged 2-5 years with asthma or a high probability of asthma, to receive an asthma intervention (a 12-month respiratory nurse-led asthma assessment using an evidence-based, web-based tool and a class-based asthma education programme for four months), or a control intervention (a class-based science education programme for four months). Both groups received standard asthma management by their primary care physician. The primary outcome was the proportion of children that had at least one unscheduled ("urgent") medical or ED attendance for asthma over 12 months. RESULTS: We randomised 171 preschools, 85 to the intervention (341 children) and 86 to the control (334 children). We found no difference in the primary outcome (intervention: 216/341, 63% vs control: 181/334, 54%: adjusted Odds Ratio=1.36, 95% Confidence Interval=0.95-1.94, p=0.095). However, compared with the control group, the intervention group had improved and sustained asthma control and fewer asthma symptoms over 12 months. CONCLUSIONS: Combining asthma education with a nurse-led, evidence-based asthma assessment and education intervention led to sustained improvements in asthma control in this preschool population, but its effect on acute events remains unclear.

Feasibility of Using Games to Improve Healthy Lifestyle Knowledge in Youth Aged 9-16 Years at Risk for Type 2 Diabetes: Pilot Randomized Controlled Trial.

BACKGROUND: Mobile games can be effective and motivating tools for promoting children's health. OBJECTIVE: We aimed to determine the comparative use of 2 prototype serious games for health and assess their effects on healthy lifestyle knowledge in youth aged 9-16 years at risk for type 2 diabetes (T2D). METHODS: A 3-arm parallel pilot randomized controlled trial was undertaken to determine the feasibility and preliminary effectiveness of 2 serious games. Feasibility aspects included recruitment, participant attitudes toward the games, the amount of time the participants played each game at home, and the effects of the games on healthy lifestyle and T2D knowledge. Participants were allocated to play Diabetic Jumper (n=7), Ari and Friends (n=8), or a control game (n=8). All participants completed healthy lifestyle and T2D knowledge questionnaires at baseline, immediately after game play, and 4 weeks after game play. Game attitudes and preferences were also assessed. The primary outcome was the use of the game (specifically, the number of minutes played over 4 weeks). RESULTS: In terms of feasibility, we were unable to recruit our target of 60 participants. In total, 23 participants were recruited. Participants generally viewed the games positively. There were no statistical differences in healthy lifestyle knowledge or diabetes knowledge over time or across games. Only 1 participant accessed the game for an extended period, playing the game for a total of 33 min over 4 weeks. CONCLUSIONS: It was not feasible to recruit the target sample for this trial. The 2 prototype serious games were unsuccessful at sustaining long-term game play outside a clinic environment. Based on positive participant attitudes toward the games, it is possible to use these games or similar games as short-term stimuli to engage young people with healthy lifestyle and diabetes knowledge in a clinic setting; however, future research is required to explore this area. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12619000380190; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377123.

Adapting an Evidence-Based e-Learning Cognitive Behavioral Therapy Program Into a Mobile App for People Experiencing Gambling-Related Problems: Formative Study.

BACKGROUND: Many people who experience harm and problems from gambling do not seek treatment from gambling treatment services because of personal and resource barriers. Mobile health (mHealth) interventions are widely used across diverse health care areas and populations. However, there are few in the gambling harm field, despite their potential as an additional modality for delivering treatment and support. OBJECTIVE: This study aims to understand the needs, preferences, and priorities of people experiencing gambling harms and who are potential end users of a cognitive behavioral therapy mHealth intervention to inform design, features, and functions. METHODS: Drawing on a mixed methods approach, we used creators and domain experts to review the GAMBLINGLESS web-based program and convert it into an mHealth prototype. Each module was reviewed against the original evidence base to maintain its intended fidelity and conceptual integrity. Early wireframes, design ideas (look, feel, and function), and content examples were developed to initiate discussions with end users. Using a cocreation process with a young adult, a Maori, and a Pasifika peoples group, all with experiences of problem or harmful gambling, we undertook 6 focus groups: 2 cycles per group. In each focus group, participants identified preferences, features, and functions for inclusion in the final design and content of the mHealth intervention. RESULTS: Over 3 months, the GAMBLINGLESS web-based intervention was reviewed and remapped from 4 modules to 6. This revised program is based on the principles underpinning the transtheoretical model, in which it is recognized that some end users will be more ready to change than others. Change is a process that unfolds over time, and a nonlinear progression is common. Different intervention pathways were identified to reflect the end users' stage of change. In all, 2 cycles of focus groups were then conducted, with 30 unique participants (13 Maori, 9 Pasifika, and 8 young adults) in the first session and 18 participants (7 Maori, 6 Pasifika, and 5 young adults) in the second session. Prototype examples demonstrably reflected the focus group discussions and ideas, and the features, functions, and designs of the Manaaki app were finalized. Attributes such as personalization, cultural relevance, and positive framing were identified as the key. Congruence of the final app attributes with the conceptual frameworks of the original program was also confirmed. CONCLUSIONS: Those who experience gambling harms may not seek help. Developing and demonstrating the effectiveness of new modalities to provide treatment and support are required. mHealth has the potential to deliver interventions directly to the end user. Weaving the underpinning theory and existing evidence of effective treatment with end-user input into the design and development of mHealth interventions does not guarantee success. However, it provides a foundation for framing the intervention's mechanism, context, and content, and arguably provides a greater chance of demonstrating effectiveness.

The Impact of COVID-19 on the Care of Patients With Noncommunicable Diseases in Low- and Middle-Income Countries: An Online Survey of Patient Perspectives.

We sought to gain insights into the impacts of COVID-19 and associated control measures on health and health care of patients from low- and middle-income countries with cardiovascular disease, diabetes, and mental health conditions, using an online survey during the COVID-19 pandemic. The most common concern for the 1487 patients who took part was contracting COVID-19 when they accessed health care. Of those infected with COVID-19, half said that their health had been worse since being infected. Collectively, most people reported an increase in feelings of stress and loneliness. The COVID-19 pandemic has led to a range of health care impacts on patients with noncommunicable diseases, including constraints on access to care and health effects, particularly mental well-being.

The impact of COVID-19 on the care of people living with noncommunicable diseases in low- and middle-income countries: an online survey of physicians and pharmacists in nine countries.

BACKGROUND: The global COVID-19 pandemic has disrupted healthcare worldwide. In low- and middle-income countries (LMICs), where people may have limited access to affordable quality care, the COVID-19 pandemic has the potential to have a particularly adverse impact on the health and healthcare of individuals with noncommunicable diseases (NCDs). A World Health Organization survey found that disruption of delivery of healthcare for NCDs was more significant in LMICs than in high-income countries. However, the study did not elicit insights into the day-to-day impacts of COVID-19 on healthcare by front-line healthcare workers (FLHCWs). AIM: To gain insights directly from FLHCWs working in countries with a high NCD burden, and thereby identify opportunities to improve the provision of healthcare during the current pandemic and in future healthcare emergencies. METHODS: We recruited selected frontline healthcare workers (general practitioners, pharmacists, and other medical specialists) from nine countries to complete an online survey (n = 1347). Survey questions focused on the impact of COVID-19 pandemic on clinical practice and NCDs; barriers to clinical care during the pandemic; and innovative responses to the many challenges presented by the pandemic. FINDINGS: The majority of FLHCWs responding to our survey reported that their care of patients had been impacted both adversely and positively by the public health measures imposed. Most FLHCs (95%) reported a deterioration in the mental health of their patients. CONCLUSIONS: Continuity of care for NCDs as part of pandemic preparedness is needed so that chronic conditions are not exacerbated by public health measures and the direct impacts of the pandemic.

Cytisine versus varenicline for smoking cessation in New Zealand indigenous Maori: a randomized controlled trial.

AIM: To determine whether cytisine was at least as effective as varenicline in supporting smoking abstinence for ≥ 6 months in New Zealand indigenous Maori or whanau (extended-family) of Maori, given the high smoking prevalence in this population. DESIGN: Pragmatic, open-label, randomized, community-based non-inferiority trial. SETTING: Bay of Plenty, Tokoroa and Lakes District Health Board regions of New Zealand. PARTICIPANTS: Adult daily smokers who identified as Maori or whanau of Maori, were motivated to quit in the next 2 weeks, were aged ≥ 18 years and were eligible for subsidized varenicline. Recruitment used multi-media advertising. INTERVENTIONS: A total of 679 people were randomly assigned (1 : 1) to receive a prescription for 12 weeks of cytisine or varenicline, plus low-intensity cessation behavioural support from the prescribing doctor and community stop-smoking services or a research assistant. Day 5 of treatment was the designated quit date. MEASUREMENTS: The primary outcome was carbon monoxide-verified continuous abstinence at 6 months, analysed as intention-to-treat (with multiple imputation for missing data). Secondary outcomes measured at 1, 3, 6 and 12 months post-quit date included: self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance and acceptability, nicotine withdrawal/urge to smoke and health-care utilization/health-related quality of life. FINDINGS: Verified continuous abstinence rates at 6 months post-quit date were 12.1% (41 of 337) for cytisine versus 7.9% (27 of 342) for varenicline [risk difference 4.29%, 95% confidence interval (CI) = -0.22 to 8.79; relative risk 1.55; 95% CI = 0.97-2.46]. Sensitivity analyses confirmed that the findings were robust. Self-reported adverse events over 6 months occurred significantly more frequently in the varenicline group (cytisine: 313 events in 111 participants; varenicline: 509 events in 138 participants, incidence rate ratio 0.56, 95% CI = 0.49-0.65, P < 0.001) compared with the cytisine group. Common adverse events were headache, nausea and difficulty sleeping. CONCLUSION: A randomized controlled trial found that cytisine was at least as effective as varenicline at supporting smoking abstinence in New Zealand indigenous Maori or whanau (extended-family) of Maori, with significantly fewer adverse events.

Adherence to home-based videogame treatment for amblyopia in children and adults.

Clinical relevance: Home-based videogame treatments are increasingly popular for amblyopia treatment. However, at-home treatments tend to be done in short sessions and with frequent disruptions, which may reduce the effectiveness of binocular visual stimulation. These treatment adherence patterns need to be accounted for when considering dose-response relationships and treatment effectiveness.Background: Home-based videogame treatments are increasingly being used for various sensory conditions, including amblyopia ('lazy eye'), but treatment adherence continues to limit success. To examine detailed behavioural patterns associated with home-based videogame treatment, we analysed in detail the videogame adherence data from the Binocular tReatment of Amblyopia with VideOgames (BRAVO) clinical trial (ACTRN12613001004752).Methods: Children (7-12 years), teenagers (13-17 years) and adults (≥ 18 years) with unilateral amblyopia were loaned iPod Touch devices with either an active treatment or placebo videogame and instructed to play for a total of 1-2 hours/day for six weeks at home. Objectively-recorded adherence data from device software were used to analyse adherence patterns such as session length, daily distribution of gameplay, use of the pause function, and differences between age groups. Objectively-recorded adherence was also compared to subjectively-reported adherence from paper-based diaries.Results: One hundred and five of the 115 randomised participants completed six weeks of videogame training. Average adherence was 65% (SD 37%) of the minimum hours prescribed. Game training was generally performed in short sessions (mean 21.5, SD 11.2 minutes), mostly in the evening, with frequent pauses (median every 4.1 minutes, IQR 6.1). Children played in significantly shorter sessions and paused more frequently than older age groups (p < 0.0001). Participants tended to over-report adherence in subjective diaries compared to objectively-recorded gameplay time.Conclusion: Adherence to home-based videogame treatment was characterised by short sessions interspersed with frequent pauses, suggesting regular disengagement. This complicates dose-response calculations and may interfere with the effectiveness of treatments like binocular treatments for amblyopia, which require sustained visual stimulation.

Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU).

INTRODUCTION: Compression is the mainstay of treatment for venous leg ulcers (VLUs) and there are few effective adjuvant treatments. There is only observational evidence supporting the use of hypochlorous acid (HOCl) as a topical wound solution on VLU and some limited randomised evidence for the effect of a prescribed regimen of exercise. METHODS AND ANALYSIS: The Factorial4VLU trial is a pragmatic, blinded, factorial randomised controlled trial, with 380 participants receiving either a prescribed exercise regimen compared with usual care and either active HOCl wound solution or placebo wound solution at each dressing change for up to 24 weeks. All participants will receive compression therapy. The primary outcome is the proportion of participants with healed VLU at 12 weeks after randomisation as adjudicated by blinded review of ulcer photographs. Secondary outcomes are proportion healed at 24 weeks, time to healing, estimated change in ulcer area, change in 2-Minute Walk Test, change in health-related quality of life, incidence of infection and incidence of all-cause adverse events. If either of the interventions shows a statistically significant positive difference on healing outcomes, cost-effectiveness will be modelled using a health service perspective. ETHICS AND DISSEMINATION: The Factorial4VLU trial received ethical approval from the Northern B Health and Disability Ethics Committee. We plan to publish the results within 1 year of trial completion and will include the results on the trial registration page. TRIAL REGISTRATION NUMBERS: Australia and New Zealand Clinical Trials Register (http://www.anzctr.org.au) (ACTRN12620000116921); Universal Trial Number (WHO) (U1111-1236-2997).

See How They Grow: Testing the feasibility of a mobile app to support parents' understanding of child growth charts.

BACKGROUND: Mobile devices provide new opportunities for the prevention of overweight and obesity in children. We aimed to co-create and test an app that offered comprehensible feedback to parents on their child's growth and delivered a suite of age-specific information about nutrition and activity. METHODS: A two-phased approach was used to co-create the digital growth tool-See How They Grow-and test its feasibility. Phase one used focus groups (parents and professionals such as paediatricians and midwives) and a national on-line survey to gather requirements and build the app. Phase two involved testing the app over 12-weeks, with parents or carers of children aged ≤ 2-years. All research activities were undertaken exclusively through the app, and participants were recruited using social media and hard copy materials given to patents at a child health visit. FINDINGS: Four focus groups and 101 responses to the national survey informed the features and functions to include in the final app. Two hundred and twenty-five participants downloaded the app, resulting in 208 eligible participants. Non-Maori/Non-Pacific (78%) and Maori (14%) had the highest downloads. Fifty-four per cent of participants were parents of children under 6-months. These participants were more likely to regularly use the app than those with children older than 6-months (64% vs 36%, P = 0.011). Over half of the participants entered three measures (n = 101, 48%). Of those that completed the follow-up survey (n = 101, 48%), 72 reported that the app helped them better understand how to interpret growth charts. CONCLUSION: The app was acceptable and with minor modifications, has the potential to be an effective tool to support parents understanding of growth trajectories for their children. A larger trial is needed to evaluate if the app can have a measurable impact on increasing knowledge and behaviour, and therefore on preventing childhood overweight and obesity.

Results of the 3 Pillars Study (3PS), a relationship-based programme targeting parent-child interactions, healthy lifestyle behaviours, and the home environment in parents of preschool-aged children: A pilot randomised controlled trial.

BACKGROUND: Early childhood is a critical period for the development of obesity, with new approaches to prevent obesity in this age group needed. We designed and piloted the 3 Pillars Study (3PS), a healthy lifestyle programme informed by attachment theory for parents of preschool-aged children. METHODS: A 2-arm, randomised controlled pilot study was conducted to assess the effectiveness of 3PS, a 6-week programme involving a half-day workshop plus 6-week access to a study website. The programme was designed to promote routines around healthy lifestyle behaviours, including sleep, limited screen use, and family meals, within the context of positive, reciprocal parent-child interactions. Parents (n = 54) of children aged 2-4 years who regularly exceeded screen use recommendations (≥1 hour per day), were randomised to the 3PS programme (n = 27) or a wait-list control group (n = 27). Child screen time at 6 weeks was the primary endpoint. Frequency of family meals, parent feeding practices, diet quality, sleep, Child Routine Inventory (to assess predictability of commonly occurring routines), and household chaos were also assessed. Study data were collected online at baseline, 6 weeks, and 12 weeks via REDCap. RESULTS: No group differences were observed for changes from baseline in screen time (primary endpoint), feeding behaviour scores, Child Routine Inventory scores, or total night time sleep duration at 6 and 12 weeks, although all measures improved in the hypothesised direction in the 3PS group. Compared with controls, the intervention group demonstrated significant improvements from baseline in household chaos scores (i.e. a reduction in chaos) and a number of measures of sleep outcomes, indicating improved sleep continuity. The programme was highly acceptable to parents. CONCLUSIONS AND RECOMMENDATIONS: A relational approach appears promising as a novel way to promote healthy lifestyle behaviours associated with the prevention of childhood obesity in children aged 2-4 years. A larger study is warranted.

Wool-derived keratin dressings versus usual care dressings for treatment of slow healing venous leg ulceration: a randomised controlled trial (Keratin4VLU).

OBJECTIVE: To determine the effect of a keratin dressing for treating slow-to-heal venous leg ulcers (VLU) on VLU healing. DESIGN: Pragmatic parallel group randomised controlled trial. SETTING: Community-dwelling participants. PARTICIPANTS: People aged 18 or more years with VLU (either present for more than 26 weeks or ulcer area larger than 5 cm2 or both). INTERVENTION: Wool-derived keratin dressing or usual care formulary of non-medicated dressings, on a background treatment with compression. PRIMARY AND SECONDARY OUTCOME MEASURES: Healing at 24 weeks based on blinded assessment of ulcer photographs. Other outcomes included time to complete healing, change in ulcer area to 24 weeks, change in health-related quality of life and incidence of adverse events. RESULTS: We screened 1068 patients with VLU and randomised 143 participants (51.1% of target recruitment), 71 to the keratin dressing group and 72 to the usual care group.The mean age was 66.1 years (SD 15.9) and 53 participants (37.1%) were women. There were no significant differences between the groups on the primary outcome (risk difference -6.4%, 95% CI -22.5% to 9.7%), change in ulcer area (-1.9 cm2, 95% CI -16.5 to 12.8 cm2), time to complete healing (HR 0.80, 95% CI 0.52 to 1.23) or the incidence of adverse events (incidence rate ratio 1.19, 95% CI 0.89 to 1.59) in the intention-to-treat analyses. However, the direction of effect on the primary outcome was reversed in a per protocol analysis specified a priori (risk difference 6.2%, 95% CI -12.4% to 24.9%). CONCLUSION: The effect of adding a keratin dressing to the treatment regimen for prognostically slow-to-heal VLU remains unclear. TRIAL REGISTRATION NUMBER: NCT02896725.

Manaaki - a cognitive behavioral therapy mobile health app to support people experiencing gambling problems: a randomized control trial protocol.

BACKGROUND: The low utilisation of current treatment services by people with gambling problems highlights the need to explore new modalities of delivering treatment interventions. This protocol presents the design of a pragmatic randomized control trial aimed at assessing the effectiveness and acceptability of cognitive behavioral therapy (CBT) delivered via a mobile app for people with self-reported gambling problems. METHODS: An innovative CBT mobile app, based on Deakin University's GAMBLINGLESS online program, has been adapted with end-users (Manaaki). Six intervention modules have been created. These are interwoven with visual themes to represent a journey of recovery and include attributes such as avatars, videos, and animations to support end-user engagement. An audio facility is used throughout the app to cater for different learning styles. Personalizing the app has been accomplished by using greetings in the participant's language and their name (e.g. Kia ora Tane) and by creating personalized feedback. A pragmatic, randomized control two-arm single-blind trial, will be conducted in New Zealand. We aim to recruit 284 individuals. Eligible participants are ≥18 years old, seeking help for their gambling, have access to a smartphone capable of downloading an app, able to understand the English language and are willing to provide follow-up information at scheduled time points. Allocation is 1:1, stratified by ethnicity, gender, and gambling symptom severity based on the Gambling Symptom Assessment Scale (G-SAS). The intervention group will receive the full mobile cognitive behavioural programme and the waitlist group will receive a simple app that counts down the time left before they have access to the full app and the links to the data collection tools. Data collection for both groups are: baseline, 4-, 8-, and 12-weeks post-randomisation. The primary outcome is a change in G-SAS scores. Secondary measures include changes in gambling urges, frequency, expenditure, and readiness to change. Indices of app engagement, utilisation and acceptability will be collected throughout the delivery of the intervention. DISCUSSION: If effective, this study will contribute to the improvement of health outcomes for people experiencing gambling problems and have great potential to reach population groups who do not readily engage with current treatment services. ETHICS APPROVAL: NZ Health and Disability Ethics Committee (Ref: 19/STH/204) TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry (ANZCTRN 12619001605189) Registered 1 November 2019.

Use of e-cigarettes and smoked tobacco in youth aged 14-15 years in New Zealand: findings from repeated cross-sectional studies (2014-19).

BACKGROUND: Media reports of a vaping epidemic among youth have raised concerns about the creation of a new generation of nicotine-dependent individuals who could graduate to cigarette smoking. We investigated the use of e-cigarettes and cigarettes in the youth of New Zealand from 2014 to 2019, with focus on daily use of these products as an indicator of potential dependence. METHODS: We analysed data from the Action for Smokefree 2025 Year-10 survey, an annual cross-sectional survey of tobacco use undertaken by almost half of all school students aged 14-15 years (21 504-31 021 students). The survey includes questions on whether students had ever smoked (even just a few puffs) and their current smoking behaviour (at least once a day, week, or month, or less often than once a month). In 2014, a question was added asking if students had ever tried an e-cigarette. Subsequent surveys asked about e-cigarette use at least once a day, week, or month, or less often than once a month. We compared the frequency of e-cigarette use with cigarette smoking by survey year, age, gender, ethnicity, and school decile (a proxy for socioeconomic status). We did χ2 analyses to compare categorical variables and Cochran-Armitage trend tests to assess changes over time. Multiple logistic regression was used to determine predictors of e-cigarette and cigarette use in 2019. FINDINGS: All measures of e-cigarette use increased and all measures of cigarette use decreased or remained static over time. Although the proportion of students who had ever tried e-cigarettes in 2019 (37·3%, 10 093 of 27 083), exceeded the proportion who had ever smoked (19·6%, 5375 of 27 354), daily use of products was low: e-cigarettes (3·1%, 832 of 26 532), cigarettes (2·1%, 575 of 27 212), both (0·6%, 159 of 27 633). In 2019, daily use of e-cigarettes was very low in never-smokers (0·8%, 175 of 21 385). Students who were Maori, Pacific, gender diverse, or from low-decile and mid-decile schools were more likely to be daily users of e-cigarettes or cigarettes, and males were more likely to be daily e-cigarette users, but less likely to smoke daily than females. INTERPRETATION: The overall decline in smoking over the past 6 years in New Zealand youth suggests that e-cigarettes might be displacing smoking. Ongoing monitoring will be important to determine whether the liberalisation of e-cigarette availability and marketing in New Zealand has any effect on long-term patterns of daily e-cigarette and cigarette use. FUNDING: New Zealand Ministry of Health.

Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial.

BACKGROUND: Combination nicotine replacement therapy shows additive cessation benefits. We aimed to find out the effectiveness of combining nicotine patches with an e-cigarette (with and without nicotine) on six-month smoking abstinence. METHODS: We did a pragmatic, three-arm, parallel-group trial in New Zealand in adult smokers who were e-cigarette naive and motivated to quit smoking. Participants were recruited from the general population using national media advertising. Participants were randomly assigned (1:4:4), with the use of stratified block randomisation, to receive 14 weeks (2 weeks before the agreed quit date) of 21 mg, 24h nicotine patches, patches plus an 18 mg/L nicotine e-cigarette, or patches plus a nicotine-free e-cigarette. We advised participants to use one patch daily, with e-cigarette use as and when necessary or desired. Participants and researchers were masked to e-liquid nicotine content. We offered 6 weeks of telephone-delivered behavioural support. The primary outcome was exhaled carbon monoxide (CO)-verified continuous smoking abstinence 6 months after the agreed quit date. Primary analysis was by intention to treat, with sensitivity analysis by per protocol, treatment adherence, varying CO cutoffs, and complete case analysis. This paper presents the main analyses and is registered with ClinicalTrials.gov, NCT02521662. FINDINGS: Between March 17, 2016 and Nov 30, 2017, 1124 people were assigned to nicotine patches (patches only group, n=125), patches plus a nicotine e-cigarette (patches plus nicotine e-cigarette group, n=500), or patches plus a nicotine-free e-cigarette (patches plus nicotine-free e-cigarette group, n=499). 62 (50%) of 125 participants in the patches only group withdrew or were lost to follow-up by 6 months compared with 161 (32%) of 500 in the patches plus nicotine e-cigarette group and 162 (33%) of 499 in the patches plus nicotine-free e-cigarette group. 35 (7%) participants in the patches plus nicotine e-cigarette group had CO-verified continuous abstinence at 6 months compared with 20 (4%) in the patches plus nicotine-free e-cigarette group (risk difference [RD] 2·99 [95% CI 0·17-5·81]), and three (2%) people in the patches only group (RD 4·60 [1·11-8·09]). 18 serious adverse events occurred in 16 people in the patches plus nicotine e-cigarette group compared with 27 events in 22 people in the patches plus nicotine-free e-cigarette group and four events in three people in the patches only group. In the patches plus nicotine e-cigarette group, two life-threatening serious adverse events were reported (two separate heart attacks in the one participant). In the patches plus nicotine-free e-cigarette group, one death occurred (accidental drug overdose) and one life-threatening serious adverse event (heart attack). No significant between-group differences were noted for serious adverse events, and none were treatment-related. INTERPRETATION: Combining reduced-harm nicotine products, such as nicotine patches with a nicotine e-cigarette, can lead to a modest improvement in smoking cessation over and above that obtained from using patches plus a nicotine-free e-cigarette (or patches alone), with no indication of any serious harm in the short-term. Future e-cigarette trials should focus on their use alone or in combination with usual smoking cessation support, given issues with differential loss to follow-up and withdrawal if a usual care group is used as a comparator. FUNDING: Health Research Council of New Zealand.

Measuring stroke and transient ischemic attack burden in New Zealand: Protocol for the fifth Auckland Regional Community Stroke Study (ARCOS V).

Aim: The goal of this paper is to provide a protocol for conducting a fifth population-based Auckland Regional Community Stroke study (ARCOS V) in New Zealand. Methods and Discussion: In this study, for the first time globally, (1) stroke and TIA burden will be determined using the currently used clinical and tissue-based definition of stroke, in addition to the WHO clinical classifications of stroke used in all previous ARCOS studies, as well as more advanced criteria recently suggested for an "ideal" population-based stroke incidence and outcomes study; and (2) age, sex, and ethnic-specific trends in stroke incidence and outcomes will be determined over the last four decades, including changes in the incidence of acute cerebrovascular events over the last decade. Furthermore, information at four time points over a 40-year period will allow the assessment of effects of recent changes such as implementation of the FAST campaign, ambulance pre-notification, and endovascular treatment. This will enable more accurate projections for health service planning and delivery. Conclusion: The methods of this study will provide a foundation for future similar population-based studies in other countries and populations.