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.

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.

Stroke Incidence by Major Pathological Type and Ischemic Subtypes in the Auckland Regional Community Stroke Studies: Changes Between 2002 and 2011.

BACKGROUND AND PURPOSE: Major pathological stroke types (ischemic stroke [IS], primary intracerebral hemorrhage [ICH], and subarachnoid hemorrhage) and IS subtypes, have differing risk factors, management, and prognosis. We report changes in major stroke types and IS subtypes incidence during 10 years using data from the ARCOS (Auckland Regional Community Stroke Study) III performed during 12 months in 2002 to 2003 and the fourth ARCOS study (ARCOS-IV) performed in 2011 to 2012. METHODS: ARCOS-III and ARCOS-IV were population-based registers of all new strokes in the greater Auckland region (population aged >15 years, 1 119 192). Strokes were classified into major pathological types (IS, ICH, subarachnoid hemorrhage, and undetermined type). Crude annual age-, sex-, and ethnic-specific stroke incidence with 95% confidence intervals was calculated. ISs were subclassified using TOAST (Trial of ORG 10172 in Acute Stroke Treatment) criteria into 5 etiologic groups. Rate ratios with 95% confidence intervals were calculated for differences in age-standardized rates between the 2 studies. RESULTS: In ARCOS-IV, there were 1329 (81%) ISs, 211 (13%) ICHs, 79 (5%) subarachnoid hemorrhages, and 24 (1%) undetermined type strokes. The proportional distribution of IS subtypes was 29% cardioembolism, 21% small-vessel occlusion, 15% large-artery atherosclerosis, 5% other determined etiology, and 31% undetermined type. Between 2002 and 2011, age-standardized incidence decreased for subarachnoid hemorrhage (rate ratios, 0.73; 95% confidence intervals, 0.54-0.99) and undetermined type (rate ratios, 0.14; 95% confidence intervals, 0.09-0.22). Rates were stable for IS and ICH. Among IS subtypes, large-artery atherosclerosis and small-vessel occlusion rates increased significantly. The frequency of all risk factors increased in IS. Ethnic differences were observed for both stroke subtype rates and their risk factor frequencies. CONCLUSIONS: A lack of change in IS and ICH incidence may reflect a trend toward increased incidence of younger strokes. Increased rates of large-artery atherosclerosis and small-vessel occlusion are associated with increased smoking and high blood pressure. Ethnic differences in the proportional distribution of pathological stroke subtypes suggest differential exposure and susceptibility to risk factors.

Impact of venous leg ulceration on health-related quality of life: A synthesis of data from randomized controlled trials compared to population norms.

Venous insufficiency is the most common cause of leg ulceration, but the impact of venous leg ulceration on health-related quality of life has not been adequately assessed. This study compared data from randomized controlled trials to population norms obtained from a large national population survey. We combined the baseline Short Form-36 (SF-36) version 1 data from two New Zealand randomized controlled trials that recruited participants with VLU and compared the pooled data to the population scores obtained from the New Zealand Health Survey using general linear regression to adjust for age, sex, and ethnicity differences between the cohorts. Baseline SF-36 scores obtained from 618 trial participants were compared to the SF-36 scores obtained from the 12,529 participants in the New Zealand Health Survey. Participants with VLU had significantly lower crude SF-36 scores across all eight SF-36 domains, but there was interaction between age and group. Adjusted mean differences for participants aged 65 years or younger were -25.8, -32.1, -21.2, -9.6, -7.6, -23.9, -21.5, and -9.3, respectively, for Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health whereas the adjusted mean differences for older participants were -15.7, -23.8, -13.8, -0.3 (nonsignificant), -4.6, -15.3, -21.2, and -6.6. This study is the first to compare a VLU population to norms from a general population survey and the first to show VLU interacts with age creating stronger impact in younger patients compared their age cohort. Younger patients may have need of more pastoral care as a consequence.

The effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation in people with mental illnesses and addictions: study protocol for a randomised-controlled trial.

BACKGROUND: Smoking rates are higher in New Zealand (NZ) adults with mental illnesses and alcohol and other drug (AOD) addictions, compared to the overall population. Quit attempts using "gold standard" smoking cessation treatments often fail in people with these conditions, so more flexible treatment regimens that adapt to a person's responsiveness to treatment are worth investigating. The STATUS trial aims to evaluate the effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation among varenicline non-responders in treatment for mental health illnesses and/or AOD addictions. METHODS: This is a pragmatic two-arm, open-label, randomised trial. Participants will be daily smokers using mental health and/or addiction services in Auckland, aged ≥18 years, motivated to quit smoking, and eligible to access varenicline through the NZ special authority process. After 2 weeks of using varenicline plus behavioural support, participants who have not reduced their daily smoking by ≥50% will be randomised (1:1) to either 10 weeks of continued varenicline use or 10 weeks of varenicline plus an 18 mg/mL nicotine e-cigarette. All participants will receive weekly withdrawal-orientated behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically-verified (exhaled carbon monoxide) continuous abstinence at 24 weeks post-randomisation. Secondary outcomes, measured at six, 12 and 24 weeks post-randomisation include: self-reported continuous abstinence, 7-day point prevalence abstinence, smoking reduction, time to relapse, cross-over, use of other smoking cessation support, serious adverse events, treatment adherence, compliance, acceptability, dual use, continuation of treatment use, mental illness symptoms and AOD use, health-related quality of life, and cost-analysis. A sample size of 338 will confer 80% power (p = 0.05) to detect a 15% absolute difference between the varenicline alone and varenicline plus e-cigarette groups. DISCUSSION: People with mental illness and/or AOD addictions are just as motivated as others to quit smoking, but are less likely to succeed. Adapting smoking cessation medication after a lack of responsiveness in the first 2 weeks of initial treatment in this priority population by adding a nicotine e-cigarette may be one way to increase long-term quit rates. TRIAL REGISTRATION: Australian NZ Clinical Trial Registry: ACTRN12616001355460 (29 September 2016).

Optical treatment of amblyopia in older children and adults is essential prior to enrolment in a clinical trial.

PURPOSE: Optical treatment alone can improve visual acuity (VA) in children with amblyopia, thus clinical trials investigating additional amblyopia therapies (such as patching or videogames) for children require a preceding optical treatment phase. Emerging therapies for adult patients are entering clinical trials. It is unknown whether optical treatment is effective for adults with amblyopia and whether an optical correction phase is required for trials involving adults. METHODS: We examined participants who underwent optical treatment in the Binocular Treatment for Amblyopia using Videogames (BRAVO) clinical trial (ANZCTR ID: ACTRN12613001004752). Participants were recruited in three age groups (7 to 12, 13 to 17, or ≥18 years), and had unilateral amblyopia due to anisometropia and/or strabismus, with amblyopic eye VA of 0.30-1.00 logMAR (6/12 to 6/60, 20/40 to 20/200). Corrective lenses were prescribed based on cycloplegic refraction to fully correct any anisometropia. VA was assessed using the electronic visual acuity testing algorithm (e-ETDRS) test and near stereoacuity was assessed using the Randot Preschool Test. Participants were assessed every four weeks up to 16 weeks, until either VA was stable or until amblyopic eye VA improved to better than 0.30 logMAR, rendering the participant ineligible for the trial. RESULTS: Eighty participants (mean age 24.6 years, range 7.6-55.5 years) completed four to 16 weeks of optical treatment. A small but statistically significant mean improvement in amblyopic eye VA of 0.05 logMAR was observed (S.D. 0.08 logMAR; paired t-test p < 0.0001). Twenty-five participants (31%) improved by ≥1 logMAR line and of these, seven (9%) improved by ≥2 logMAR lines. Stereoacuity improved in 15 participants (19%). Visual improvements were not associated with age, presence of strabismus, or prior occlusion treatment. Two adult participants withdrew due to intolerance to anisometropic correction. Sixteen out of 80 participants (20%) achieved better than 0.30 logMAR VA in the amblyopic eye after optical treatment. Nine of these participants attended additional follow-up and four (44%) showed further VA improvements. CONCLUSIONS: Improvements from optical treatment resulted in one-fifth of participants becoming ineligible for the main clinical trial. Studies investigating additional amblyopia therapies must include an appropriate optical treatment only phase and/or parallel treatment group regardless of patient age. Optical treatment of amblyopia in adult patients warrants further investigation.

Cytisine versus nicotine for smoking cessation.

BACKGROUND: Placebo-controlled trials indicate that cytisine, a partial agonist that binds the nicotinic acetylcholine receptor and is used for smoking cessation, almost doubles the chances of quitting at 6 months. We investigated whether cytisine was at least as effective as nicotine-replacement therapy in helping smokers to quit. METHODS: We conducted a pragmatic, open-label, noninferiority trial in New Zealand in which 1310 adult daily smokers who were motivated to quit and called the national quitline were randomly assigned in a 1:1 ratio to receive cytisine for 25 days or nicotine-replacement therapy for 8 weeks. Cytisine was provided by mail, free of charge, and nicotine-replacement therapy was provided through vouchers for low-cost patches along with gum or lozenges. Low-intensity, telephone-delivered behavioral support was provided to both groups through the quitline. The primary outcome was self-reported continuous abstinence at 1 month. RESULTS: At 1 month, continuous abstinence from smoking was reported for 40% of participants receiving cytisine (264 of 655) and 31% of participants receiving nicotine-replacement therapy (203 of 655), for a difference of 9.3 percentage points (95% confidence interval, 4.2 to 14.5). The effectiveness of cytisine for continuous abstinence was superior to that of nicotine-replacement therapy at 1 week, 2 months, and 6 months. In a prespecified subgroup analysis of the primary outcome, cytisine was superior to nicotine-replacement therapy among women and noninferior among men. Self-reported adverse events over 6 months occurred more frequently in the cytisine group (288 events among 204 participants) than in the group receiving nicotine-replacement therapy (174 events among 134 participants); adverse events were primarily nausea and vomiting and sleep disorders. CONCLUSIONS: When combined with brief behavioral support, cytisine was found to be superior to nicotine-replacement therapy in helping smokers quit smoking, but it was associated with a higher frequency of self-reported adverse events. (Funded by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12610000590066.).

MEMO: an mHealth intervention to prevent the onset of depression in adolescents: a double-blind, randomised, placebo-controlled trial.

BACKGROUND: Depression often starts in adolescence making it an ideal time to intervene. We developed a universal cognitive behavioural therapy-based programme (MEMO CBT) to be delivered via multimedia mobile phone messages for teens. METHODS: We conducted a prospective multicentre, randomised, placebo-controlled superiority trial in 15 high schools in Auckland, New Zealand, comparing MEMO CBT with a control programme [MEMO control] matched for intensity and type of message but with alternative content not targeting depression. The primary outcome was the change in score on the Children's Depression Rating Scale-Revised from baseline to 12 months. Secondary outcomes included the change in scores in the self-reported Reynold's Adolescent Depression Rating Scale-Second Edition, the Moods and Feelings Questionnaire, suicidal ideation using selected items from the Youth Risk Behaviour Survey, the Pediatric Quality of Life questionnaire, 12-month period prevalence of the diagnosis of depressive disorder using the Kiddie-Schedule for Affective Disorders and Schizophrenia, and students' ratings of their satisfaction with the programme. RESULTS: Eight hundred and fifty-five students (13-17 years old, mean 14.3 years) were randomly assigned to MEMO CBT (426) or to MEMO Control (429). Participants (68% female) had a mean CDRS-R at baseline of 21.5 (SD: 5). Overall 394 (93%) from the intervention group and 392 (91%) from the control group were followed up at 12 months. At the end of the intervention (approximately 9 weeks) the mean CDRS-R scores were 20.8 in the intervention group versus 20.4 in the control group, and at 12 months they were 22.4 versus 22.4 (p value for difference in change from baseline = 0.3). There was no obvious association between the amount of the intervention viewed by participants and outcomes. CONCLUSIONS: There was no evidence of benefit from the mobile phone CBT intervention compared with a control programme. Universal depression prevention remains a challenge.

Incidence of Transient Ischemic Attack in Auckland, New Zealand, in 2011 to 2012.

BACKGROUND AND PURPOSE: There have been few recent population-based studies reporting the incidence (first ever) and attack rates (incident and recurrent) of transient ischemic attack (TIA). METHODS: The fourth Auckland Regional Community Stroke study (ARCOS IV) used multiple overlapping case ascertainment methods to identify all hospitalized and nonhospitalized cases of TIA that occurred in people ≥16 years of age usually resident in Auckland (population ≥16 years of age is 1.12 million), during the 12 months from March 1, 2011. All first-ever and recurrent new TIAs (any new TIA 28 days after the index event) during the study period were recorded. RESULTS: There were 785 people with TIA (402 [51.2%] women, mean [SD] age 71.5 [13.8] years); 614 (78%) of European origin, 84 (11%) Maori/Pacific, and 75 (10%) Asian/Other. The annual incidence of TIA was 40 (95% confidence interval, 36-43), and attack rate was 63 (95% confidence interval, 59-68), per 100 000 people, age standardized to the World Health Organization world population. Approximately two thirds of people were known to be hypertensive or were being treated with blood pressure-lowering agents, half were taking antiplatelet agents and just under half were taking lipid-lowering therapy before the index TIA. Two hundred ten (27%) people were known to have atrial fibrillation at the time of the TIA, of whom only 61 (29%) were taking anticoagulant therapy, suggesting a failure to identify or treat atrial fibrillation. CONCLUSIONS: This study describes the burden of TIA in an era of aggressive primary and secondary vascular risk factor management. Education programs for medical practitioners and patients around the identification and management of atrial fibrillation are required.

Low-dose aspirin as an adjuvant treatment for venous leg ulceration: study protocol for a randomized controlled trial (Aspirin4VLU).

AIM: The aim of this study was to determine the effect of low-dose aspirin on venous leg ulcer healing when used in addition to compression. BACKGROUND: The mainstay of treatment for venous leg ulcers is compression therapy and there are few adjuvant treatments to accelerate healing. DESIGN: Pragmatic, community-based, double-blind, randomized trial. METHODS: Participants with venous leg ulcers will receive either 150 mg aspirin or placebo daily for up to 24 weeks. Participants will receive background treatment with compression therapy (system of choice guided by participant and/or clinical preference) delivered through district nursing services. The primary outcome will be time-to-healing. Secondary outcomes will include proportion healed at 24 weeks, change in ulcer area, change in health-related quality of life, adherence, efficacy of blinding and adverse events. The trial was funded in June 2014. DISCUSSION: The trial commenced in March 2015 and is successfully recruiting. The trial is one of three trials that will contribute to an individual participant data meta-analysis to be undertaken at the York Trials Centre. TRIAL REGISTRATION: Registered 5 June 2014 ClinicalTrials.gov NCT02158806. Protocol version 1·1, 14 April 2015.

Improving Adherence to Secondary Stroke Prevention Strategies Through Motivational Interviewing: Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Stroke recurrence rates are high (20%-25%) and have not declined over past 3 decades. This study tested effectiveness of motivational interviewing (MI) for reducing stroke recurrence, measured by improving adherence to recommended medication and lifestyle changes compared with usual care. METHODS: Single-blind, prospective phase III randomized controlled trial of 386 people with stroke assigned to either MI treatment (4 sessions at 28 days, 3, 6, and 9 months post stroke) or usual care; with outcomes assessed at 28 days, 3, 6, 9, and 12 months post stroke. Primary outcomes were change in systolic blood pressure and low-density lipoprotein cholesterol levels as indicators of adherence at 12 months. Secondary outcomes included self-reported adherence, new stroke, or coronary heart disease events (both fatal and nonfatal); quality of life (Short Form-36); and mood (Hospital Anxiety and Depression Scale). RESULTS: MI did not significantly change measures of blood pressure (mean difference in change, -0.2.35 [95% confidence interval, -6.16 to 1.47]) or cholesterol (mean difference in change, -0.0.12 [95% confidence interval, -0.30 to 0.06]). However, it had positive effects on self-reported medication adherence at 6 months (1.979; 95% confidence interval, 0.98-3.98; P=0.0557) and 9 months (4.295; 95% confidence interval, 1.56-11.84; P=0.0049) post stroke. Improvement across other measures was also observed, but the differences between MI and usual care groups were not statistically significant. CONCLUSIONS: MI improved self-reported medication adherence. All other effects were nonsignificant, though in the direction of a treatment effect. Further study is required to determine whether MI leads to improvement in other important areas of functioning (eg, caregiver burden). CLINICAL TRIAL REGISTRATION: URL: http://www.anzctr.org.au. Unique identifier: ACTRN-12610000715077.

Effect of a family-centered, secondhand smoke intervention to reduce respiratory illness in indigenous infants in Australia and New Zealand: a randomized controlled trial.

INTRODUCTION: Secondhand smoke (SHS) is a significant cause of acute respiratory illness (ARI) and 5 times more common in indigenous children. A single-blind randomized trial was undertaken to determine the efficacy of a family centered SHS intervention to reduce ARI in indigenous infants in Australia and New Zealand. METHODS: Indigenous mothers/infants from homes with ≥ 1 smoker were randomized to a SHS intervention involving 3 home visits in the first 3 months of the infants' lives (plus usual care) or usual care. The primary outcome was number of ARI-related visits to a health provider in the first year of life. Secondary outcomes, assessed at 4 and 12 months of age, included ARI hospitalization rates and mothers' report of infants' SHS exposure (validated by urinary cotinine/creatinine ratios [CCRs]), smoking restrictions, and smoking cessation. RESULTS: Two hundred and ninety-three mother/infant dyads were randomized and followed up. Three quarters of mothers smoked during pregnancy and two thirds were smoking at baseline (as were their partners), with no change for more than 12 months. Reported infant exposure to SHS was low (≥ 95% had smoke-free homes/cars). Infant CCRs were higher if one or both parents were smokers and if mothers breast fed their infants. There was no effect of the intervention on ARI events [471 intervention vs. 438 usual care (reference); incidence rate ratio = 1.10, 95% confidence intervals (CI) = 0.88-1.37, p = .40]. CONCLUSIONS: Despite reporting smoke-free homes/cars, mothers and their partners continue to smoke in the first year of infants' lives, exposing them to SHS. Emphasis needs to be placed on supporting parents to stop smoking preconception, during pregnancy, and postnatal.

Abrupt nicotine reduction as an endgame policy: a randomised trial.

OBJECTIVE: To determine if smokers unmotivated to quit reduce usual cigarette consumption when cigarettes priced according to nicotine content are made available. METHODS: Randomised, parallel-group, trial (ACTRN12612000914864) undertaken in Wakatipu/Central Otago, New Zealand. Dependent adult daily smokers unmotivated to quit were randomly allocated to an intervention group provided with 12 weeks supply of free very low nicotine content (VLNC) cigarettes, or to a control group, who were free to purchase their usual cigarette brand over the same period. The primary outcome was change from baseline in the daily mean number of usual cigarettes smoked over the previous week, measured at 12 weeks. Secondary outcomes at 6 and 12 weeks included cigarettes smoked per week (also measured at weeks 1-6 and 9), salivary cotinine, tobacco dependence, smoking satisfaction/craving, behavioural addiction to smoking, autonomy over smoking, motivation to stop, price at which participants would purchase VLNC cigarettes, quitting and adverse events. RESULTS: Thirty-three smokers were randomised (17 intervention, 16 control). A NZ$15 price differential (per pack of 20) based on nicotine content led to a halving in the mean number of cigarettes smoked per day over the previous week, a reduction in tobacco dependence and an increase in quitting. Intervention participants smoked a similar total number of cigarettes (usual plus VLNC) as those in the control group, exposing them to a similar level of toxicants. CONCLUSIONS: Smokers unmotivated to quit reduce their usual cigarette consumption (and thus nicotine exposure) when VLNC cigarettes are made available at a significantly reduced price.

Electronic cigarettes for smoking cessation: a randomised controlled trial.

BACKGROUND: 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. METHODS: 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 [Maori; Pacific; or non-Maori, 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: Health Research Council of New Zealand.

Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation.

BACKGROUND: Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study. DESIGN: Parallel group, 3-arm, randomised controlled trial. PARTICIPANTS: People aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking. INTERVENTION: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. PARTICIPANTS randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. PRIMARY OUTCOME: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. SAMPLE SIZE: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups. DISCUSSION: This trial will inform international debate and policy on the regulation and availability of e-cigarettes. If shown to be efficacious and safe, these devices could help many smokers as an alternative smoking cessation aid to standard nicotine products. TRIAL REGISTRATION: Australian NZ Clinical Trials Registry (ACTRN12610000866000).

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.

Neuropsychological profiles of 5-year ischemic stroke survivors by Oxfordshire stroke classification and hemisphere of lesion.

BACKGROUND AND PURPOSE: Although the neuropsychological literature typically examines stroke outcomes by hemisphere of lesion, the medical literature provides classifications more closely linked to circulatory distribution impacted by stroke. This article examined profiles of cognitive function by hemisphere and by Oxfordshire Community Stroke Project stroke classification. METHODS: This study included a sample of 315 5-year ischemic stroke survivors. Assessment included tests of verbal memory, visual memory, word finding/verbal fluency, abstract visual reasoning, executive functioning, and speed of processing. RESULTS: The sample produced scores within 1 standard deviation of the normative mean on tests of abstract visual reasoning, verbal memory, and visual recall. Impaired performances were observed for executive function and processing speed. Profile analysis revealed no significant differences in overall cognitive performance or in the profile of performance across measures by hemisphere of lesion. However, groups defined by Oxfordshire Community Stroke Project categories produced significantly different cognitive profiles. Post hoc analyses indicate those with posterior stroke performed best overall on all tests except the Stroop Dots trial, whereas those with total anterior stroke produced significantly worse scores on tasks requiring visual abstract reasoning (Block Design, Rey Figure Copy), word finding (Boston Naming Test), and processing speed (Stroop Dots, Trails A). CONCLUSIONS: Oxfordshire Community Stroke Project stroke subtypes identified significant differences between groups, suggesting this classification system is of greater use than hemisphere of lesion in predicting poststroke cognitive outcomes.

Prevalence and predictors of 6-month fatigue in patients with ischemic stroke: a population-based stroke incidence study in Auckland, New Zealand, 2002-2003.

BACKGROUND AND PURPOSE: Although persistent and significant fatigue affects the daily life of stroke survivors, there are no population-based studies examining the prevalence of fatigue in 6-month survivors of ischemic stroke and few studies of predictors of poststroke fatigue. METHODS: This article examined data from the Auckland Regional Community Stroke study conducted in Auckland, New Zealand, in 2002 to 2003. Presence of fatigue was evaluated at 6 months in 613 patients with ischemic stroke using a Short Form 36 Vitality Score (energy and fatigue) of ≤ 47. Multivariate logistic regression analysis was used to determine predictors of fatigue development 6 months poststroke. RESULTS: The prevalence of fatigue was 30% (28% in men and 33% in women). There was a clear association between increased prevalence of fatigue and advancing age. The only baseline variables independently associated with an increased risk of developing fatigue at 6 months poststroke were prestroke incontinence and being of New Zealand European ethnicity. Being independent and living alone at baseline were associated with significant reduction in the risk of being fatigued at 6 months poststroke. Severe depression at 6 months was significantly and independently associated with being fatigued. CONCLUSIONS: The prevalence of fatigue found in our study is at the lower level of range reported in other studies. The prevalence of fatigue increased with advancing age, as found in most previous studies. Because fatigue can have a negative impact on stroke recovery, particular attention needs to be paid to those who are older, incontinent before stroke, and those who report severe symptoms of depression at 6 months after stroke.