Association between freedom of movement and health of nursing home residents with dementia: an exploratory longitudinal study.

BACKGROUND: Locked doors remain a common feature of dementia units in nursing homes (NHs) worldwide, despite the growing body of knowledge on the negative effects of restricted freedom on residents. To date, no previous studies have explored the health effects of opening locked NH units, which would allow residents to move freely within the building and enclosed garden. This study examines the association between increased freedom of movement and the health of NH residents with dementia. METHODS: This longitudinal, pre-post study involved a natural experiment in which NH residents with dementia (N = 46) moved from a closed to a semi-open location. Data on dimensions of positive health were collected at baseline (T0; one month before the relocation), at one (T1), four (T2) and nine (T3) months after the relocation. Linear mixed models were used to examine changes in positive health over time. RESULTS: Cognition, quality of life and agitation scores improved significantly at T1 and T2 compared to the baseline, while mobility scores decreased. At T3, improvements in agitation and quality of life remained significant compared to the baseline. Activities of daily living (ADL) and depression scores were stable over time. CONCLUSIONS: Increasing freedom of movement for NH residents with dementia is associated with improved health outcomes, both immediately and over time. These findings add to the growing evidence supporting the benefits of freedom of movement for the overall health of NH residents with dementia.

Influence of Freedom of Movement on the Health of People With Dementia: A Systematic Review.

BACKGROUND AND OBJECTIVES: To protect residents with dementia from harm, nursing homes (NHs) often have closed-door policies. However, current research suggests a positive influence of freedom of movement, that is, the right to (decide to) independently move from one place to another, on the health of NH residents with dementia. This systematic review aims to collate, summarize, and synthesize the scientific evidence published to date on the influence of freedom of movement on health among NH residents with dementia. RESEARCH DESIGN AND METHODS: Multiple databases were searched up until March 2021. Peer-reviewed qualitative, quantitative, and mixed methods studies were included. Health was operationalized using the Positive Health framework, encompassing 6 dimensions: bodily functions, mental functions and perception, existential dimension, quality of life, social and societal participation, and daily functioning. The quality of included studies was assessed using the Mixed Methods Appraisal Tool. RESULTS: Sixteen studies were included of good to excellent quality. Compared to closed NHs, freedom of movement in semiopen and open NHs may have a positive influence on bodily functions, mental functions and perception, quality of life, and social and societal participation. The influence on daily functioning and on the existential dimension remains unclear. DISCUSSION AND IMPLICATIONS: Freedom of movement of NH residents with dementia is often studied as part of a larger context in which other factors may contribute to health benefits. More research is therefore needed to unravel the underlying mechanisms of the positive influence of freedom of movement on health.

Health impact of the first and second wave of COVID-19 and related restrictive measures among nursing home residents: a scoping review.

BACKGROUND AND OBJECTIVES: COVID-19 disproportionally affects older adults living in nursing homes. The purpose of this review was to explore and map the scientific literature on the health impact of COVID-19 and related restrictive measures during the first and second wave among nursing home residents. A specific focus was placed on health data collected among nursing home residents themselves. RESEARCH DESIGN AND METHODS: In this study, best practices for scoping reviews were followed. Five databases were systematically searched for peer-reviewed empirical studies published up until December 2020 in which data were collected among nursing home residents. Articles were categorized according to the type of health impact (physical, social and/or psychological) and study focus (impact of COVID-19 virus or related restrictive measures). Findings were presented using a narrative style. RESULTS: Of 60 included studies, 57 examined the physical impact of COVID-19. All of these focused on the direct impact of the COVID-19 virus. These studies often used an observational design and quantitative data collection methods, such as swab testing or reviewing health records. Only three studies examined the psychological impact of COVID-19 of which one study focused on the impact of COVID-19-related restrictive measures. Findings were contradictory; both decreased and improved psychological wellbeing was found during the pandemic compared with before. No studies were found that examined the impact on social wellbeing and one study examined other health-related outcomes, including preference changes of nursing home residents in Advanced Care planning following the pandemic. DISCUSSION AND IMPLICATIONS: Studies into the impact of the first and second wave of the COVID-19 pandemic among nursing home residents predominantly focused on the physical impact. Future studies into the psychological and social impact that collect data among residents themselves will provide more insight into their perspectives, such as lived experiences, wishes, needs and possibilities during later phases of the pandemic. These insights can inform policy makers and healthcare professionals in providing person-centered care during the remaining COVID-19 pandemic and in future crisis periods.

Exploring how residential care facilities can enhance the autonomy of people with dementia and improve informal care.

BACKGROUND AND OBJECTIVES: Residential care facilities (RCFs) strive to enhance autonomy for people with dementia and to enhance informal care provision, although this is difficult. This study explored how RCF staff can enhance autonomy and improve informal care by looking at the influence of interactions (contact and approachability between residents, staff members and informal caregivers) and the physical environment, including the use of technologies. RESEARCH DESIGN AND METHODS: A realist evaluation multiple-case study was conducted using document analyses, eight semi-structured interviews with staff members and relatives and 56 hours of observations of residents across two RCFs aiming to provide person-centred care. Realist logic of analysis was performed, involving Context-Mechanism-Outcome configurations. FINDINGS: The behaviour, attitudes and interactions of staff members with residents and informal caregivers appeared to contribute to the autonomy of people with dementia and enhance informal care provision. The physical environment of the RCFs and the use of technologies were less relevant to enhancing autonomy and informal care provision, although they can support staff members in providing person-centred care in daily practice. DISCUSSION AND IMPLICATIONS: The findings add to those of other studies regarding the importance of interaction between residents, staff members and informal caregivers. The findings provide insight for other RCFs on how successfully to enhance autonomy for their residents and to improve informal care provision, as well as, more broadly, how to implement person-centred care.

Dementia Enlightened?! A Systematic Literature Review of the Influence of Indoor Environmental Light on the Health of Older Persons with Dementia in Long-Term Care Facilities.

Light therapy for older persons with dementia is often administered with light boxes, even though indoor ambient light may more comfortably support the diverse lighting needs of this population. Our objective is to investigate the influence of indoor daylight and lighting on the health of older adults with dementia living in long-term care facilities. A systematic literature search was performed within PubMed, CINAHL, PsycINFO, Web of Science and Scopus databases. The included articles (n=37) were published from 1991 to 2020. These articles researched the influence of existing and changed indoor light conditions on health and resulted in seven categories of health outcomes. Although no conclusive evidence was found to support the ability of indoor light to decrease challenging behaviors or improve circadian rhythms, findings of two studies indicate that exposure to (very) cool light of moderate intensity diminished agitation. Promising effects of indoor light were to reduce depressive symptoms and facilitate spatial orientation. Furthermore, there were indications that indoor light improved one's quality of life. Despite interventions with dynamic lighting having yielded little evidence of its efficacy, its potential has been insufficiently researched among this study population. This review provides a clear and comprehensive description of the impact of diverse indoor light conditions on the health of older adults with dementia living in long-term care facilities. Variation was seen in terms of research methods, (the description of) light conditions, and participants' characteristics (types and severity of dementia), thus confounding the reliability of the findings. The authors recommend further research to corroborate the beneficial effects of indoor light on depression and to clarify its role in supporting everyday activities of this population. An implication for practice in long-term care facilities is raising the awareness of the increased lighting needs of aged residents.

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.

The Academic Collaborative Center Older Adults: A Description of Co-Creation between Science, Care Practice and Education with the Aim to Contribute to Person-Centered Care for Older Adults.

Long-term care for older adults is in transition. Organizations offering long-term care for older adults are expected to provide person-centered care (PCC) in a complex context, with older adults aging in place and participating in society for as long as possible, staff shortages and the slow adoption of technological solutions. To address these challenges, these organizations increasingly use scientific knowledge to evaluate and innovate long-term care. This paper describes how co-creation, in the sense of close, intensive, and equivalent collaboration between science, care practice, and education, is a key factor in the success of improving long-term care for older adults. Such co-creation is central in the Academic Collaborative Center (ACC) Older Adults of Tilburg University. In this ACC, Tilburg University has joined forces with ten organizations that provide care for older adults and CZ zorgkantoor to create both scientific knowledge and societal impact in order to improve the quality of person-centered care for older adults. In the Netherlands, a "zorgkantoor" arranges long-term (residential) care on behalf of the national government. A zorgkantoor makes agreements on cost and quality with care providers and helps people that are in need of care to decide what the best possible option in their situation is. The CZ zorgkantoor arranges the long-term (residential) care in the south and southwest of the Netherlands. This paper describes how we create scientific knowledge to contribute to the knowledge base of PCC for older adults by conducting social scientific research in which the perspectives of older adults are central. Subsequently, we show how we create societal impact by facilitating and stimulating the use of our scientific knowledge in daily care practice. In the closing section, our ambitions for the future are discussed.

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.

Using PROMs during routine medical consultations: The perspectives of people with Parkinson's disease and their health professionals.

BACKGROUND: The use of patient-reported outcomes measures (PROMs), such as quality of life or symptoms like pain or fatigue, is increasingly embraced within patient-centred care and shared decision making. OBJECTIVES: To investigate: (a) how patients and health professionals think about using PROMs during routine medical consultations; (b) for which purpose(s), patients and health professionals want to use PROMs during those consultations; and (c) how patients interpret PROMs information presented in various formats. People with Parkinson's disease and their health professionals served as case example. METHODS: We performed semi-structured interviews with patients (N = 13) and professionals (N = 7 neurologists; N = 7 physiotherapists). We also used a survey in which patients (N = 115) were shown six figures displaying different information types. Presentation formats of this information varied (line/bar graphs). Interpretation by patients, perceived usefulness of information, attitude towards using information during routine medical consultations and (hypothetical) decisions were assessed. FINDINGS: Patients and professionals were generally positive about using PROMs during medical consultations. Professionals stressed the opportunity to monitor changes in individual PROMs over time. Patients were primarily positive about aggregated PROMs to make treatment decisions. This information was also most often interpreted correctly, especially when presented through a line graph (90.1% correct). Professionals thought patients should take the initiative in discussing PROMs, whereas patients thought professionals should do so. CONCLUSION/DISCUSSION: When used in routine medical consultations, PROMs seem to have potential to support shared decision making and facilitate patient-professional communication. However, training seems needed for both patients and professionals to facilitate actual discussion and proper interpretation.

Factors associated with the identification of child mental health problems in primary care-a systematic review.

Background: Although common and often with long-lasting effects, child mental health problems (MHPs) are still under-recognized and under-treated. A better understanding of the factors associated with the identification of MHPs in primary care may improve the recognition of MHPs. Objectives: To review studies on factors associated with the identification of child MHPs in primary care. Methods: Six leading databases were systematically searched until 1 October 2018. Two independent researchers selected articles and extracted data on study characteristics and factors associated with MHP identification. Inclusion criteria were the investigation of factors associated with MHP identification by primary care professionals (PCPs) in children aged 0-18 years. Results: Of the 6215 articles identified, 26 were included. Prevalence rates of PCP-identified MHPs varied between 7 and 30%. PCPs identified 26-60% of children with an increased risk of MHPs as indicated by MHP assessment tools, but associated factors were investigated in relatively few studies. MHPs were more often identified in children with a family composition other than married parents, with worse mental health symptoms, prior MHPs, among boys in elementary school, when contact with PCPs was related to parental psychosocial concerns or routine health check-ups, when PCPs were recently trained in MHPs or when PCPs felt less burdened treating MHPs. Conclusion: MHP identification varied substantially between studies and PCPs and was related to several child, family and practice factors. Future studies should systematically investigate factors associated with MHP identification by PCPs and specifically in children with an increased risk of MHPs according to mental health assessment tools.

Effectiveness and safety of nicotine patches combined with e-cigarettes (with and without nicotine) for smoking cessation: study protocol for a randomised controlled trial.

INTRODUCTION: Evidence indicates e-cigarettes can help people quit smoking; however, more confirmatory trials are needed. To date, no trials have evaluated the effectiveness and safety of combining nicotine patches with e-cigarettes (with and without nicotine) for smoking cessation. METHODS AND ANALYSIS: This study is a pragmatic, three-arm, community-based, single-blind, randomised trial undertaken in New Zealand. Eligible participants are daily/non-daily smokers, aged ≥18 years, naive e-cigarette users and motivated to quit smoking in the next 2 weeks. Participants (n=1809), recruited using multi-media advertising, are randomised to 14 weeks of (1) 21 mg nicotine patches (n=201); (2) 21 mg nicotine patches+18 mg/mL nicotine e-cigarette (n=804); or (3) 21 mg nicotine patches+nicotine free e-cigarette (n=804). Participants receive weekly withdrawal-oriented behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically verified continuous abstinence (CA) at 6 months post quit-date. The primary comparison is nicotine patch + nicotine e-cigarette versus nicotine patch + nicotine free e-cigarette, and the secondary comparison is nicotine patch versus nicotine patch +nicotine e-cigarette (90% power, p=0.05, to detect an absolute difference in 6 month CA rates of 8% and 15% respectively). Secondary outcomes, collected by phone interview at quit date, then 1, 3, 6 and 12 months post-quit date, include self-reported CA, 7 day point prevalence abstinence, cigarettes per day (if smoking, or when smoking for non-daily smokers), time to relapse (if returned to smoking), belief in ability to quit, use of other cessation support, side effects/serious adverse events, treatment compliance, seeking additional support around e-cigarette use, daily use of both e-cigarettes and cigarettes, use of treatment past 14 weeks, views on treatment and recommendation to others, weight and cost-per-quitter. ETHICS AND DISSEMINATION: The Northern A Health and Disability Ethics Committee approved the trial. Findings will be disseminated through publication, conference/meeting presentations, and media. TRIAL REGISTRATION NUMBER: NCT02521662; Pre-results.

A co-designed mHealth programme to support healthy lifestyles in Maori and Pasifika peoples in New Zealand (OL@-OR@): a cluster-randomised controlled trial.

BACKGROUND: The OL@-OR@ mobile health programme was co-designed with Maori and Pasifika communities in New Zealand, to support healthy lifestyle behaviours. We aimed to determine whether use of the programme improved adherence to health-related guidelines among Maori and Pasifika communities in New Zealand compared with a control group on a waiting list for the programme. METHODS: The OL@-OR@ trial was a 12-week, two-arm, cluster-randomised controlled trial. A cluster was defined as any distinct location or setting in New Zealand where people with shared interests or contexts congregated, such as churches, sports clubs, and community groups. Members of a cluster were eligible to participate if they were aged 18 years or older, had regular access to a mobile device or computer, and had regular internet access. Clusters of Maori and of Pasifika (separately) were randomly assigned (1:1) to either the intervention or control condition. The intervention group received the OL@-OR@ mHealth programme (smartphone app and website). The control group received a control version of the app that only collected baseline and outcome data. The primary outcome was self-reported adherence to health-related guidelines, which were measured with a composite health behaviour score (of physical activity, smoking, alcohol intake, and fruit and vegetable intake) at 12 weeks. The secondary outcomes were self-reported adherence to health-related behaviour guidelines at 4 weeks; self-reported bodyweight at 12 weeks; and holistic health and wellbeing status at 12 weeks, in all enrolled individuals in eligible clusters; and user engagement with the app, in individuals allocated to the intervention. Adverse events were not collected. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12617001484336. FINDINGS: Between Jan 24 and Aug 14, 2018, we enrolled 337 Maori participants from 19 clusters and 389 Pasifika participants from 18 clusters (n=726 participants) in the intervention group and 320 Maori participants from 15 clusters and 405 Pasifika participants from 17 clusters (n=725 participants) in the control group. Of these participants, 227 (67%) Maori participants and 347 (89%) Pasifika participants (n=574 participants) in the intervention group and 281 (88%) Maori participants and 369 (91%) Pasifika participants (n=650 participants) in the control group completed the 12-week follow-up and were included in the final analysis. Relative to baseline, adherence to health-related behaviour guidelines increased at 12 weeks in both groups (315 [43%] of 726 participants at baseline to 329 [57%] of 574 participants in the intervention group; 331 [46%] of 725 participants to 369 [57%] of 650 participants in the control group); however, there was no significant difference between intervention and control groups in adherence at 12 weeks (odds ratio [OR] 1·13; 95% CI 0·84-1·52; p=0·42). Furthermore, the proportion of participants adhering to guidelines on physical activity (351 [61%] of 574 intervention group participants vs 407 [63%] of 650 control group participants; OR 1·03, 95% CI 0·73-1·45; p=0·88), smoking (434 [76%] participants vs 501 [77%] participants; 1·12, 0·67-1·87; p=0·66), alcohol consumption (518 [90%] participants vs 596 [92%] participants; 0·73, 0·37-1·44; p=0·36), and fruit and vegetable intake (194 [34%] participants vs 196 [30%] participants; 1·08, 0·79-1·49; p=0·64) did not differ between groups. We found no significant differences between the intervention and control groups in any secondary outcome. 147 (26%) intervention group participants engaged with the OL@-OR@ programme (ie, set at least one behaviour change goal online). INTERPRETATION: The OL@-OR@ mobile health programme did not improve adherence to health-related behaviour guidelines amongst Maori and Pasifika individuals. FUNDING: Healthier Lives He Oranga Hauora National Science Challenge.

Development of a framework with tools to support the selection and implementation of patient-reported outcome measures.

BACKGROUND: Patient reported outcomes (PROs) provide information on a patient's health status coming directly from the patient. Measuring PROs with patient reported outcome measures (PROMs) has gained wide interest in clinical practice for individual patient care, as well as in quality improvement, and for providing transparency of outcomes to stakeholders through public reporting. However, current knowledge of selecting and implementing PROMs for these purposes is scattered, and not readily available for clinicians and quality managers in healthcare organizations. The objective of this study is to develop a framework with tools to support the systematic selection, implementation and evaluation of PROs and PROMs in individual patient care, for quality improvement and public reporting. METHODS: We developed the framework in a national project in the Netherlands following a user-centered design. The development process of the framework contained five iterative components: (a) identification of existing tools, (b) identification of user requirements and designing steps for selection and implementation of PROs and PROMs, (c) discussing a prototype of the framework during a national workshop, (d) developing a web version, (e) pre-testing of the framework. A total of 40 users with different perspectives (clinicians, patient representatives, quality managers, purchasers, researchers) have been consulted. RESULTS: The final framework is presented as the PROM-cycle that consists of eight steps in four phases: (1) goal setting, (2) selecting PROs and PROMs, (3) developing and testing of quality indicator(s), (4) implementing and evaluating the PROM(s) and indicator(s). Users emphasized that the first step is the key element in which the why, for whom and setting of the PROM has to be defined. This information is decisive for the following steps. For each step the PROM-cycle provides guidance and tools, with instruments, checklists, methods, handbooks, and standards supporting the process. CONCLUSION: We developed a framework to support the selection and implementation of PROs and PROMs. Each step provides guidance and tools to support the process. The PROM-cycle and its tools are publicly available and can be used by clinicians, quality managers, patient representatives and other experts involved in using PROMS. Through periodic evaluation and updates, tools will be added for national and international use of the PROM-cycle.

Cytisine versus varenicline for smoking cessation for Maori (the indigenous people of New Zealand) and their extended family: protocol for a randomized non-inferiority trial.

BACKGROUND AND AIMS: Cytisine, a nicotinic acetylcholine receptor partial agonist (like varenicline) found in some plants, is a low-cost, effective smoking cessation medication that may appeal to Maori [the indigenous people of New Zealand (NZ)]. The RAUORA trial aims to determine the effectiveness, safety and cost-effectiveness of cytisine (Tabex® ) versus varenicline (Champix® ) for smoking cessation in Maori and the whanau (extended family) of Maori. DESIGN: Pragmatic, community-based, open-label randomized non-inferiority trial. SETTING: Lakes District Health Board region, NZ. PARTICIPANTS: Daily smokers (n = 2140) who self-identify as Maori or whanau of Maori, and are: aged ≥ 18 years, motivated to quit smoking in the next 2 weeks, eligible for subsidized varenicline, able to provide verbal consent and have daily access to a mobile phone/internet. Recruitment uses multi-media advertising. INTERVENTION AND COMPARATOR: Participants are randomized (1 : 1 ratio) to receive a prescription for 12 weeks of cytisine tablets [following the manufacturer's dosing regimen for 25 days, then one 1.5-mg tablet every 6 hours (two per day) until 12 weeks] or varenicline tablets (following the manufacturer's dosing regimen). Both groups receive brief stop-smoking advice from the prescribing doctor and withdrawal-orientated behavioural support via community-based stop-smoking counselling services (frequency, duration and mode of delivery tailored for participants) or a research assistant (six weekly 10-15-minute calls). Participants are advised to reduce their smoking over the first 4 days of treatment, with day 5 as their designated quit-date. MEASUREMENTS: The primary outcome is carbon monoxide-verified continuous abstinence at 6 months post-quit date. Secondary outcomes at 1, 3, 6 and 12 months post-quit date include: self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance, treatment acceptability, nicotine withdrawal/urge to smoke and health-care utilization/health-related quality of life. COMMENTS: This trial compares cytisine and varenicline when used by the indigenous people of NZ and their extended family for smoking cessation.

Using codesign to develop a culturally tailored, behavior change mHealth intervention for indigenous and other priority communities: A case study in New Zealand.

The obesity rate in New Zealand is one of the highest worldwide (31%), with highest rates among Maori (47%) and Pasifika (67%). Codesign was used to develop a culturally tailored, behavior change mHealth intervention for Maori and Pasifika in New Zealand. The purpose of this article is to provide an overview of the codesign methods and processes and describe how these were used to inform and build a theory-driven approach to the selection of behavioral determinants and change techniques. The codesign approach in this study was based on a partnership between Maori and Pasifika partners and an academic research team. This involved working with communities on opportunity identification, elucidation of needs and desires, knowledge generation, envisaging the mHealth tool, and prototype testing. Models of Maori and Pasifika holistic well-being and health promotion were the basis for identifying key content modules and were applied to relevant determinants of behavior change and theoretically based behavior change techniques from the Theoretical Domains Framework and Behavior Change Taxonomy, respectively. Three key content modules were identified: physical activity, family/whanau [extended family], and healthy eating. Other important themes included mental well-being/stress, connecting, motivation/support, and health literacy. Relevant behavioral determinants were selected, and 17 change techniques were mapped to these determinants. Community partners established that a smartphone app was the optimal vehicle for the intervention. Both Maori and Pasifika versions of the app were developed to ensure features and functionalities were culturally tailored and appealing to users. Codesign enabled and empowered users to tailor the intervention to their cultural needs. By using codesign and applying both ethnic-specific and Western theoretical frameworks of health and behavior change, the mHealth intervention is both evidence based and culturally tailored.

A Co-Designed, Culturally-Tailored mHealth Tool to Support Healthy Lifestyles in Maori and Pasifika Communities in New Zealand: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: New Zealand urgently requires scalable, effective, behavior change programs to support healthy lifestyles that are tailored to the needs and lived contexts of Maori and Pasifika communities. OBJECTIVE: The primary objective of this study is to determine the effects of a co-designed, culturally tailored, lifestyle support mHealth tool (the OL@-OR@ mobile phone app and website) on key risk factors and behaviors associated with an increased risk of noncommunicable disease (diet, physical activity, smoking, and alcohol consumption) compared with a control condition. METHODS: A 12-week, community-based, two-arm, cluster-randomized controlled trial will be conducted across New Zealand from January to December 2018. Participants (target N=1280; 64 clusters: 32 Maori, 32 Pasifika; 32 clusters per arm; 20 participants per cluster) will be individuals aged ≥18 years who identify with either Maori or Pasifika ethnicity, live in New Zealand, are interested in improving their health and wellbeing or making lifestyle changes, and have regular access to a mobile phone, tablet, laptop, or computer and to the internet. Clusters will be identified by community coordinators and randomly assigned (1:1 ratio) to either the full OL@-OR@ tool or a control version of the app (data collection only plus a weekly notification), stratified by geographic location (Auckland or Waikato) for Pasifika clusters and by region (rural, urban, or provincial) for Maori clusters. All participants will provide self-reported data at baseline and at 4- and 12-weeks postrandomization. The primary outcome is adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score at 12 weeks that assesses smoking behavior, fruit and vegetable intake, alcohol intake, and physical activity. Secondary outcomes include self-reported body weight, holistic health and wellbeing status, medication use, and recorded engagement with the OL@-OR@ tool. RESULTS: Trial recruitment opened in January 2018 and will close in July 2018. Trial findings are expected to be available early in 2019. CONCLUSIONS: Currently, there are no scalable, evidence-based tools to support Maori or Pasifika individuals who want to improve their eating habits, lose weight, or be more active. This wait-list controlled, cluster-randomized trial will assess the effectiveness of a co-designed, culturally tailored mHealth tool in supporting healthy lifestyles. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Register ACTRN12617001484336; http://www.ANZCTR.org.au/ACTRN12617001484336.aspx (Archived by WebCite at http://www.webcitation.org/71DX9BsJb). REGISTERED REPORT IDENTIFIER: RR1-10.2196/10789.

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).

Smokers' identity and quit advice in general practice: General practitioners need to focus more on female smokers.

OBJECTIVE: We examined smoker and non-smoker self-identities among smokers visiting their general practitioner (GP) for other reasons than smoking cessation counselling. We determined whether identity impacted on patients' appreciation of GP-initiated conversations about smoking and quit advice, and subsequent quit attempts, and examined the role of gender. METHODS: Secondary analyses of a cluster-randomised controlled trial in which baseline and 12-month follow-up data were collected among 527 daily (n=450) and non-daily smokers (n=77). RESULTS: Participants identified more with smoking than non-smoking. Participants with stronger non-smoker self-identities were more often female, appreciated the conversation about smoking more, were more likely to receive quit-advice and to have attempted to quit at 12-month follow-up. Participants with stronger smoker self-identities were also more often female, and appreciated the conversation more. Men with stronger non-smoker self-identities were more often asked about smoking and advised to quit, and appreciated the conversation more than women. CONCLUSION: Non-smoker identity was more important for receiving quit-advice, appreciation, and quit attempts than smoker identity. Future research needs to unravel why female smokers appreciated the conversation less than male smokers. PRACTICE IMPLICATIONS: We suggest to incorporate an identity-component in smoking cessation interventions. GPs should increase their focus on female patients who smoke.

Emergency department visits of young children and long-term exposure to neighbourhood smoke from household heating - The Growing Up in New Zealand child cohort study.

In developed countries, exposure to wood or coal smoke occurs predominantly from neighbourhood emissions arising from household heating. The effect of this exposure on child health is not well characterized. Within a birth cohort study in New Zealand we assessed healthcare events associated with exposure to neighbourhood smoke from household heating. Our outcome measure was non-accidental presentations to hospital emergency departments (ED) before age three years. We matched small area-level census information with the geocoded home locations to measure the density of household heating with wood or coal in the neighbourhood and applied a time-weighted average exposure method to account for residential mobility. We then used hierarchical multiple logistic regression to assess the independence of associations of this exposure with ED presentations adjusted for gender, ethnicity, birth weight, breastfeeding, immunizations, number of co-habiting smokers, wood or coal heating at home, bedroom mold, household- and area-level deprivation and rurality. The adjusted odds ratio of having a non-accidental ED visit was 1.07 [95%CI: 1.03-1.12] per wood or coal heating household per hectare. We found a linear dose-response relationship (p-value for trend = 0.024) between the quartiles of exposure (1st as reference) and the same outcome (odds ratio in 2nd to 4th quartiles: 1.14 [0.95-1.37], 1.28 [1.06-1.54], 1.32 [1.09-1.60]). Exposure to neighbourhoods with higher density of wood or coal smoke-producing households is associated with an increased odds of ED visits during early childhood. Policies that reduce smoke pollution from domestic heating by as little as one household per hectare using solid fuel burners could improve child health.