Integrating Trauma and Violence Informed Care in Primary Health Care Settings for First Nations Women Experiencing Violence: A Systematic Review.

It is imperative that access to primary health care services is equitable as health care practitioners are often the first responders to women who experience violence. This is of particular importance for First Nations women who disproportionately experience interpersonal and structural violence when compared to non-First Nations women, as well as the ongoing impact of colonization, racism, and intergenerational trauma. To understand how primary health care services can provide equitable and effective care for First Nations women, we explored how trauma and violence informed care is integrated in primary health care settings through the lens of an equity-oriented framework. A systematic search of electronic databases included Medline (via Ovid), Scopus, Informit, and PubMed and grey literature. Six studies were included in the review and we undertook a narrative synthesis using the equity-oriented framework to draw together the intersection of trauma and violence informed care with culturally safe and contextually tailored care. This review demonstrates how equity-oriented primary health care settings respond to the complex and multiple forms of violence and intergenerational trauma experienced by First Nations women and thus mitigate shame and stigma to encourage disclosure and help seeking. Key attributes include responding to women's individual contexts by centering family, engaging elders, encouraging community ownership, which is driven by a culturally competent workforce that builds trust, reduces retraumatization, and respects confidentiality. This review highlights the importance of strengthening and supporting the workforce, as well as embedding cultural safety within intersectoral partnerships and ensuring adequate resourcing and sustainability of initiatives.

Protocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS).

RATIONALE: To address unmet needs, electronic messages to support person-centered goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited. HYPOTHESIS: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomization. METHODS AND DESIGN: Multicenter, double-blind, randomized controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalized, goal-centered, and administrative electronic messages, while the control group only receive administrative messages. The trial includes a process evaluation, assessment of treatment fidelity, and an economic evaluation. Participants: Confirmed stroke (modified Rankin Score: 0-4), aged ≥18 years with internet/mobile phone access, discharged directly home from hospital. Randomization: 1:1 computer-generated, stratified by age and baseline disability. Outcomes assessments: Collected at 90 days and 12 months following randomization. OUTCOMES: Primary outcomes include hospital emergency presentations/admissions within 90 days of randomization. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months. Sample size: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of α = 0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n = 668 are obtained, with maximum sample capped at 1100. DISCUSSION: We will provide new evidence on the potential effectiveness, implementation, and cost-effectiveness of a tailored eHealth intervention for survivors of stroke.

Is urban green space associated with lower mental healthcare expenditure?

INTRODUCTION: While the evidence of mental health benefits from investing in green space accumulates, claims of reduced healthcare expenditure are rarely supported by evidence from analyses of actual healthcare data. Additionally, the question of 'who pays?' has been ignored. We addressed these gaps using person-level data in three Australian cities. METHODS: 55,339 participants with a mean follow-up time of 4.97 years in the Sax Institute's 45 and Up Study (wave 2, collected 2012-2015) were linked to fee-for-service records of antidepressant prescriptions and talking therapy subsidised by the Australian Government (including data on per unit fee, state subsidy, and individual co-payment). Total green space, tree canopy and open grass within 1.6 km road network distances were linked to each participant. Multilevel logistic, negative binomial, and generalised linear models with gamma distribution adjusted for demographic and socioeconomic confounders were used to assess association between each green space variable and prescribing/referral and costs of antidepressants and talking therapy. RESULTS: Prescription of at least one course of antidepressants occurred for 20.01% (n = 11,071). Referral for at least one session of talking therapy occurred in 8.95% (n = 4954). 13,482 participants (24.4%) had either a prescription or a referral. A 10% increase in green space was associated with higher levels of antidepressant prescribing (e.g. incident rate ratio (IRR) = 1.06, 95%CI = 1.04-1.08). Tree canopy was not associated with antidepressant prescribing or referrals for talking therapy. Open grass was associated with higher odds (OR = 1.17, 95%CI = 1.13-1.20) and counts (IRR = 1.05, 95%CI = 1.02-1.08) of antidepressant prescriptions. Open grass was also associated with lower odds (OR = 0.87, 95%CI = 0.82-0.92) and counts (IRR = 0.93, 95%CI = 0.90-0.96) of talking therapy referrals. Open grass was associated with higher total and mean per-person levels of expenditure on antidepressant prescriptions. CONCLUSION: Although green space supports mental health, these unexpected results provide pause for reflection on whether greening strategies will always result in purported reductions in mental healthcare expenditure.

"It's hard for me to tell my story" the experiences of Aboriginal and Torres Strait Islander male clients at a residential drug and alcohol rehabilitation centre using primary health care.

ISSUE ADDRESSED: Aboriginal males who use drug and alcohol may experience unique barriers accessing primary health care. This study explores the perceptions of Aboriginal males in treatment for drug and alcohol use around their experiences accessing primary health care, and barriers to access. METHODS: Twenty male Aboriginal clients at a fee-paying residential drug and alcohol rehabilitation centre completed semi-structured interviews about their primary health care experiences before their stay. Interpretative phenomenological analysis was used to inductively develop themes. RESULTS: About half the males had regular General Practitioners at a mainstream primary health care service or Aboriginal Medical Service. Positive experiences included having medical needs met or understanding the health information provided; and negative experiences included inefficient health service or system processes or experiencing cultural bias or racism. Barriers included limited access to appointments or to the same GP regularly, long wait times, lack of access to transport, worry or fear about their health or the visit or their complex lives taking priority. CONCLUSION: This research showed that the participants sought out health care and identified barriers to accessing care and potential improvements. SO WHAT?: Access to a regular General Practitioner, continuity of care and culturally appropriate and comprehensive communication techniques are important to facilitate access to primary health care by Aboriginal males. Efforts to enhance access may focus on inherent strengths within Aboriginal communities including focusing on relationships between clinicians and families, providing a welcoming environment and encouraging clients to bring a trusted family member to appointments.

Responses to the primary health care needs of Aboriginal and Torres Strait Islander women experiencing violence: A scoping review of policy and practice guidelines.

ISSUE ADDRESSED: It is demonstrated that primary health care (PHC) providers are sought out by women who experience violence. Given the disproportionate burden of violence experienced by Aboriginal and Torres Strait Islander women, it is essential there is equitable access to appropriate PHC services. This review aimed to analyse whether Australian PHC policy accounts for the complex needs of Aboriginal and Torres Strait Islander women experiencing violence and the importance of PHC providers responding to violence in culturally safe ways. METHODS: Using the Arskey and O'Malley framework, an iterative scoping review determined the policies for analysis. The selected policies were analysed against concepts identified as key components in responding to the needs of Aboriginal and Torres Strait Islander women experiencing violence. The key components are Family Violence, Violence against Aboriginal and Torres Strait Islander Women, Social Determinants of Aboriginal and Torres Strait Islander Health and Wellbeing, Cultural Safety, Holistic Health, Trauma, Patient-Centred Care and Trauma-and-Violence-Informed Care. RESULTS: Following a search of Australian government websites, seven policies were selected for analysis. Principally, no policy embedded or described best practice across all key components. CONCLUSION: The review demonstrates the need for a specific National framework supporting Aboriginal and Torres Strait Islander women who seek support from PHC services, as well as further policy analysis and review. SO WHAT?: Aboriginal and Torres Strait Islander women disproportionately experience more severe violence, with complex impact, than other Australian women. PHC policy and practice frameworks must account for this, together with the intersection of contemporary manifestations of colonialism and historical and intergenerational trauma.

Pilot randomised clinical trial of an eHealth, self-management support intervention (iVERVE) for stroke: feasibility assessment in survivors 12-24 months post-event.

BACKGROUND: Electronic communication is used in various populations to achieve health goals, but evidence in stroke is lacking. We pilot tested the feasibility and potential effectiveness of a novel personalised electronic self-management intervention to support person-centred goal attainment and secondary prevention after stroke. METHODS: A phase I, prospective, randomised controlled pilot trial (1:1 allocation) with assessor blinding, intention-to-treat analysis, and a process evaluation. Community-based survivors of stroke were recruited from participants in the Australian Stroke Clinical Registry (AuSCR) who had indicated their willingness to be contacted for research studies. Inclusion criteria include 1-2 years following hospital admission for stroke and living within 50 km of Monash University (Melbourne). Person-centred goals were set with facilitation by a clinician using a standardised template. The intervention group received electronic support messages aligned to their goals over 4 weeks. The control group received only 2-3 electronic administrative messages. Primary outcomes were study retention, goal attainment (assessed using Goal Attainment Scaling method) and satisfaction. Secondary outcomes were self-management (Health Education Impact Questionnaire: 8 domains), quality of life, mood and acceptability. RESULTS: Of 340 invitations sent from AuSCR, 73 responded, 68 were eligible and 57 (84%) completed the baseline assessment. At the goal-setting stage, 54/68 (79%) were randomised (median 16 months after stroke): 25 to intervention (median age 69 years; 40% female) and 29 to control (median age 68 years; 38% female). Forty-five (83%) participants completed the outcome follow-up assessment. At follow-up, goal attainment (mean GAS-T score ≥ 50) in the intervention group was achieved for goals related to function, participation and environment (control: environment only). Most intervention participants provided positive feedback and reported that the iVERVE messages were easy to understand (92%) and assisted them in achieving their goals (77%). We found preliminary evidence of non-significant improvements between the groups for most self-management domains (e.g. social integration and support: ß coefficient 0.34; 95% CI - 0.14 to 0.83) and several quality-of-life domains in favour of the intervention group. CONCLUSION: These findings support the need for further randomised effectiveness trials of the iVERVE program to be tested in people with new stroke. TRIAL REGISTRATION: ANZCTR, ACTRN12618001519246 . Registered on 11 September 2018-retrospectively registered.

Trauma and Violence Informed Care Through Decolonising Interagency Partnerships: A Complexity Case Study of Waminda's Model of Systemic Decolonisation.

Through the lens of complexity, we present a nested case study describing a decolonisation approach developed and implemented by Waminda South Coast Women's Health and Welfare Aboriginal Corporation. Using Indigenous research methods, this case study has unfolded across three phases: (1) Yarning interviews with the workforce from four partner health services (n = 24); (2) Yarning circle bringing together key informants from yarning interviews to verify and refine emerging themes (n = 14); (3) Semi-structured interviews with a facilitator of Waminda's Decolonisation Workshop (n = 1) and participants (n = 10). Synthesis of data has been undertaken in stages through collaborative framework and thematic analysis. Three overarching themes and eight sub-themes emerged that centred on enhancing the capabilities of the workforce and strengthening interagency partnerships through a more meaningful connection and shared decolonisation agenda that centres Aboriginal and Torres Strait Islander families and communities. Health and social services are complex systems that function within the context of colonisation. Waminda's innovative, model of interagency collaboration enhanced workforce capability through shared language and collective learning around colonisation, racism and Whiteness. This process generated individual, organisational and systemic decolonisation to disable power structures through trauma and violence informed approach to practice.

Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT.

BACKGROUND: Our Cochrane review of selective serotonin inhibitors for stroke recovery indicated that fluoxetine may improve functional recovery, but the trials were small and most were at high risk of bias. OBJECTIVES: The Fluoxetine Or Control Under Supervision (FOCUS) trial tested the hypothesis that fluoxetine improves recovery after stroke. DESIGN: The FOCUS trial was a pragmatic, multicentre, parallel-group, individually randomised, placebo-controlled trial. SETTING: This trial took place in 103 UK hospitals. PARTICIPANTS: Patients were eligible if they were aged ≥ 18 years, had a clinical stroke diagnosis, with focal neurological deficits, between 2 and 15 days after onset. INTERVENTIONS: Patients were randomly allocated 20 mg of fluoxetine once per day or the matching placebo for 6 months via a web-based system using a minimisation algorithm. MAIN OUTCOME MEASURES: The primary outcome was the modified Rankin Scale at 6 months. Patients, carers, health-care staff and the trial team were masked to treatment allocation. Outcome was assessed at 6 and 12 months after randomisation. Patients were analysed by their treatment allocation as specified in a published statistical analysis plan. RESULTS: Between 10 September 2012 and 31 March 2017, we recruited 3127 patients, 1564 of whom were allocated fluoxetine and 1563 of whom were allocated placebo. The modified Rankin Scale score at 6 months was available for 1553 out of 1564 (99.3%) of those allocated fluoxetine and 1553 out of 1563 (99.4%) of those allocated placebo. The distribution across modified Rankin Scale categories at 6 months was similar in the two groups (common odds ratio adjusted for minimisation variables 0.951, 95% confidence interval 0.839 to 1.079; p = 0.439). Compared with placebo, patients who were allocated fluoxetine were less likely to develop a new episode of depression by 6 months [210 (13.0%) vs. 269 (16.9%), difference -3.78%, 95% confidence interval -1.26% to -6.30%; p = 0.003], but had more bone fractures [45 (2.9%) vs. 23 (1.5%), difference 1.41%, 95% confidence interval 0.38% to 2.43%; p = 0.007]. There were no statistically significant differences in any other recorded events at 6 or 12 months. Health economic analyses showed no differences between groups in health-related quality of life, hospital bed usage or health-care costs. LIMITATIONS: Some non-adherence to trial medication, lack of face-to-face assessment of neurological status at follow-up and lack of formal psychiatric diagnosis during follow-up. CONCLUSIONS: 20 mg of fluoxetine daily for 6 months after acute stroke did not improve patients' functional outcome but decreased the occurrence of depression and increased the risk of fractures. These data inform decisions about using fluoxetine after stroke to improve functional outcome or to prevent or treat mood disorders. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) (Australasia/Vietnam) and Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke (EFFECTS) (Sweden) trials recruited an additional 2780 patients and will report their results in 2020. These three trials have an almost identical protocol, which was collaboratively developed. Our planned individual patient data meta-analysis will provide more precise estimates of the effects of fluoxetine after stroke and indicate whether or not effects vary depending on patients' characteristics and health-care setting. TRIAL REGISTRATION: Current Controlled Trials ISRCTN83290762. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 22. See the NIHR Journals Library website for further project information. The Stroke Association (reference TSA 2011101) funded the start-up phase.

Fluoxetine, sometimes referred to by the drug company name Prozac, has been used for many years to treat people who are depressed, including after a stroke. However, studies have suggested that treatment with fluoxetine started soon after a stroke might improve patients' physical recovery. The Fluoxetine Or Control Under Supervision (FOCUS) trial recruited 3127 volunteers who had had a stroke within the previous 2 weeks from 103 UK hospitals between 2012 and 2017. Participants were randomly allocated to take a 6-month course of fluoxetine or an identical placebo capsule containing no fluoxetine. They were followed up at 6 months and 12 months after recruitment. Patients completed questionnaires that indicated how much they had recovered, and also measured their mood, fatigue and quality of life. The results of the trial showed that the physical recovery of patients was very similar in both groups. This indicates that fluoxetine does not improve physical outcomes of stroke patients. However, participants receiving fluoxetine were less likely to develop depression after the stroke but once the fluoxetine was stopped these effects on mood disappeared. Unfortunately, patients on fluoxetine were slightly more likely to fall and fracture a bone than those on placebo. The FOCUS trial is the first of three large randomised controlled trials testing fluoxetine in stroke patients to be completed. The FOCUS trial results suggest that patients with stroke should not routinely be treated with fluoxetine. The other two trials will give us further information about the effects of fluoxetine after stroke and whether or not its effects differ between countries or ethnic groups.

'We're here to listen and help them as well': a qualitative study of staff and Indigenous patient perceptions about participating in social and emotional wellbeing research at primary healthcare services.

BACKGROUND: Research can inform culturally-appropriate care to strengthen social and emotional wellbeing (SEWB) among Aboriginal and Torres Strait Islander (hereafter, the term 'Indigenous Peoples' is respectfully used and refers to all Aboriginal and/or Torres Strait Islander Peoples of Australia). We acknowledge the cultural diversity of Australia's Indigenous First Peoples and they do not represent a homogenous group.) (hereafter Indigenous) Peoples. We explore the perspectives of primary healthcare staff and Indigenous patients about their willingness to and experiences participating in SEWB research. METHOD: Process evaluation using grounded theory approaches of Getting it Right: The validation study, a national validation designed Indigenous SEWB research project (N = 500). Primary healthcare staff (n = 36) and community members (n = 4) from nine of ten primary healthcare services involved with the research project completed qualitative semi-structured interviews. Interview data were triangulated with participant feedback (responses to structured questions and free-text feedback collected during Getting it Right), study administrative data (participant screening logs, communication logs, study protocol, deviation logs and ethics correspondence) and interviewer field notes. RESULTS: Three themes about staff, patient and community perspectives concerning research participation developed: (1) considering the needs, risk, preferences and impact of participation in research for staff, patients and community; (2) building staff confidence speaking to patients about research and SEWB problems and (3) patients speaking openly about their SEWB. Some staff described pressure to ensure patients had a positive experience with the research, to respond appropriately if patients became upset or SEWB problems were identified during interviews, or due to their dual role as community member and researcher. Patients and staff reported that patients were more likely to participate if they knew the staff outside of the service, especially staff with a shared cultural background, and they perceived SEWB as a community priority. Staff reported their skills speaking to patients about the research and SEWB improved during the research, which built their confidence. Contrary to staff preconceptions, staff and patients reported that many patients appreciated the opportunity to speak about their SEWB and contributing to research that may eventually enhance SEWB in their community. CONCLUSION: Our research project was considered acceptable by most staff and patients. The positive outcomes reported by staff and feedback from patients highlights the importance of providing opportunities for people to speak about their SEWB and for research-informed SEWB PHC care. TRIAL REGISTRATION: Getting it Right is registered on ANZCTR12614000705684 .

Process evaluation of the Getting it Right study and acceptability and feasibility of screening for depression with the aPHQ-9.

BACKGROUND: The Getting it Right study determined the validity, sensitivity, specificity and acceptability of the culturally adapted 9-item Patient Health Questionnaire (aPHQ-9) as a screening tool for depression in Aboriginal and Torres Strait Islander (hereafter referred to as Indigenous) people. In this process evaluation we aimed to explore staff perceptions about whether Getting it Right was conducted per protocol, and if the aPHQ-9 was considered an acceptable and feasible screening tool for depression in primary healthcare. This process evaluation will provide information for clinicians and policy makers about the experiences of staff and patients with Getting it Right and what they thought about using the aPHQ-9. METHODS: Process evaluation using grounded theory approaches. Semi-structured interviews with primary healthcare staff from services participating in Getting it Right were triangulated with feedback (free-text and elicited) from participants collected during the validation study and field notes. Data were thematically analysed according to the Getting it Right study protocol to identify the acceptability and feasibility of the aPHQ-9. RESULTS: Primary healthcare staff (n = 36) and community members (n = 4) from nine of the ten participating Getting it Right services and Indigenous participants (n = 500) from the ten services that took part. Most staff reported that the research was conducted according to the study protocol. Staff from two services reported sometimes recruiting opportunistically (rather than recruiting consecutive patients attending the service as outlined in the main study protocol), when they spoke to patients who they knew from previous interactions, because they perceived their previous relationship may increase the likelihood of patients participating. All Getting it Right participants responded to at least six of the seven feedback questions and 20% provided free-text feedback. Most staff said they would use the aPHQ-9 and most participants said that the questions were easy to understand (87%), the response categories made sense (89%) and that they felt comfortable answering the questions (91%). CONCLUSION: Getting it Right was predominantly conducted according to the study protocol. The aPHQ-9, the first culturally adapted, nationally validated, freely available depression screening tool for use by Indigenous people, appears to be acceptable and feasible to use. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ANZCTR12614000705684 , 03/07/2014.

Generating sustainable collective action: Models of community control and governance of alcohol supply in Indigenous minority populations.

Restrictions on the supply of alcohol are amongst the most effective and cost effective interventions to address harmful use. However, despite international human rights bodies recognising that self determination must be pre-eminent in efforts to improve Indigenous health, little is known about the role of Indigenous communities in designing and implementing alcohol controls as well as the degree to which government resourcing and/or regulation is utilised. This commentary explores Australian examples of the governance models used to ensure Indigenous participation and leadership when developing regulatory interventions for alcohol control within communities. We identify four models of Indigenous governance: alcohol control interventions that were community conceived and implemented, government-facilitated community-led, community coalitions backed by government intervention and government initiated community partnerships. Each model is underpinned by specific governance arrangements which incorporate rules and processes that determine authority, accountability and Indigenous participation in decision-making. The aim of this paper is to benchmark these models of governance along a spectrum of community engagement beginning with forms of non-participation and ending with full citizen control. In addition, we put forward recommendations for governments at all levels to facilitate culturally acceptable and robust models of Indigenous governance that have the potential to improve health and social outcomes.

The conduct of Australian Indigenous primary health care research focusing on social and emotional wellbeing: a systematic review.

Objectives and importance of study: Values and ethics: guidelines for ethical conduct in Aboriginal and Torres Strait Islander health research (Values and ethics) describes key values that should underpin Aboriginal and Torres Strait Islander (Indigenous)-focused health research. It is unclear how research teams address this document in primary health care research. We systematically review the primary health care literature focusing on Indigenous social and emotional wellbeing (SEWB) to identify how Values and ethics and community preferences for standards of behaviour (local protocols) are addressed during research. STUDY TYPE: Systematic review in accordance with PRISMA Guidelines and MOOSE Guidelines for Meta-Analyses and Systematic Reviews of Observational Studies. METHODS: We searched four databases and one Indigenous-specific website for qualitative, quantitative and mixed-method studies published since Values and ethics was implemented (2003). Included studies were conducted in primary health care services, focused on Indigenous SEWB and were conducted by research teams. Using standard data extraction forms, we identified actions taken (reported by authors or identified by us) relating to Values and ethics and local protocols. RESULTS: A total of 25 studies were included. Authors of two studies explicitly mentioned the Values and ethics document, but neither reported how their actions related to the document's values. In more than half the studies, we identified at least three actions relating to the values. Some actions related to multiple values, including use of culturally sensitive research processes and involving Indigenous representatives in the research team. Local protocols were rarely reported. CONCLUSION: Addressing Values and ethics appears to improve research projects. The academic community should focus on culturally sensitive research processes, relationship building and developing the Indigenous research workforce, to facilitate acceptable research that affects health outcomes. For Values and ethics to achieve its full impact and to improve learning between research teams, authors should be encouraged to report how the principles are addressed during research, including barriers and enablers that are encountered.

Return to driving after a diagnosis of epilepsy: A prospective registry study.

OBJECTIVE: To determine the frequency and predictors of return to driving within 1 year after a diagnosis of epilepsy. METHODS: SEISMIC (the Sydney Epilepsy Incidence Study to Measure Illness Consequences) was a prospective, multicenter, community-wide study of people of all ages with newly diagnosed epilepsy in Sydney, Australia. Demographic, socioeconomic, and clinical characteristics and driving status were obtained as soon as possible after baseline registration with a diagnosis of epilepsy. Multivariate logistic regression was used to determine predictors of return to driving at 12-month follow-up. RESULTS: Among 181 (76%) adult participants (≥18 years old) who reported driving before an epilepsy diagnosis, 152 provided information on driving at 12 months, of whom 118 (78%) had returned to driving. Driving for reasons of getting to work or place of education (odds ratio [OR] = 4.70, 95% confidence intervals [CI] = 1.87-11.86), no seizure recurrence (OR = 5.15, 95% CI = 2.07-12.82), and being on no or a single antiepileptic drug (OR = 4.54, 95% CI = 1.45-14.22) were associated with return to driving (C statistic = 0.79). More than half of participants with recurrent seizures were driving at follow-up. SIGNIFICANCE: Early return to driving after a diagnosis of epilepsy is related to work/social imperatives and control of seizures, but many people with recurrent seizures continue to drive. Further efforts are required to implement driving restriction policies and to provide transport options for people with epilepsy.

The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis.

BACKGROUND: Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials which aim to determine whether the routine administration of fluoxetine (20 mg daily) for six months after an acute stroke improves patients' functional outcome. METHODS/DESIGN: The core protocol for the three trials has been published (Mead et al., Trials 20:369, 2015). The trials include patients aged 18 years and older with a clinical diagnosis of stroke and persisting focal neurological deficits at randomisation 2-15 days after stroke onset. Patients are randomised centrally via each trials' web-based randomisation system using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for six months. The primary outcome measure is the modified Rankin scale (mRS) at six months. Secondary outcomes include: living circumstances; the Stroke Impact Scale; EuroQol (EQ5D-5 L); the vitality subscale of the 36-Item Short Form Health Survey (SF36); diagnosis of depression; adherence to medication; serious adverse events including death and recurrent stroke; and resource use at six and 12 months and the mRS at 12 months. DISCUSSION: Minor variations have been tailored to the national setting in the UK (FOCUS), Australia, New Zealand and Vietnam (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will provide the most precise estimate of the overall effect and establish whether any effects differ between trials or subgroups. This statistical analysis plan describes the core analyses for all three trials and that for the individual patient data meta-analysis. Recruitment and follow-up in the FOCUS trial is expected to be completed by the end of 2018. AFFINITY and EFFECTS are likely to complete follow-up in 2020. TRIAL REGISTRATION: FOCUS: ISRCTN , ISRCTN83290762 . Registered on 23 May 2012. EudraCT, 2011-005616-29. Registered on 3 February 2012. AFFINITY: Australian New Zealand Clinical Trials Registry, ACTRN12611000774921 . Registered on 22 July 2011. EFFECTS: ISRCTN , ISRCTN13020412 . Registered on 19 December 2014. Clinicaltrials.gov, NCT02683213 . Registered on 2 February 2016. EudraCT, 2011-006130-16 . Registered on 8 August 2014.

The quality of Australian Indigenous primary health care research focusing on social and emotional wellbeing: a systematic review.

Objectives and importance of the study: Primary health care research focused on Aboriginal and Torres Strait Islander (Indigenous) people is needed to ensure that key frontline services provide evidence based and culturally appropriate care. We systematically reviewed the published primary health care literature to identify research designs, processes and outcomes, and assess the scientific quality of research focused on social and emotional wellbeing. This will inform future research to improve evidence based, culturally appropriate primary health care. STUDY TYPE: Systematic review in accordance with PRISMA and MOOSE guidelines. METHODS: Four databases and one Indigenous-specific project website were searched for qualitative, quantitative and mixed-method published research. Studies that were conducted in primary health care services and focused on the social and emotional wellbeing of Indigenous people were included. Scientific quality was assessed using risk-of-bias assessment tools that were modified to meet our aims. We assessed community acceptance by identifying the involvement of community governance structures and representation during research development, conduct and reporting. Data were extracted using standard forms developed for this review. RESULTS: We included 32 articles, which reported on 25 studies. Qualitative and mixed methods were used in 18 studies. Twelve articles were judged as high or unclear risk of bias, four as moderate and five as low risk of bias. Another four studies were not able to be assessed as they did not align with the risk-of-bias tools. Of the five articles judged as low risk of bias, two also had high community acceptance and both of these were qualitative. One used a phenomenological approach and the other combined participatory action research with a social-ecological perspective and incorporated 'two-way learning' principles. Of the 16 studies where a primary outcome was identified, eight aimed to identify perceptions or experiences. The remaining studies assessed resources, or evaluated services, interventions, programs or policies. We were unable to identify primary outcomes in eight studies. CONCLUSION: Conducting Indigenous-focused primary health care research that is scientifically robust, culturally appropriate and produces community-level outcomes is challenging. We suggest that research teams use participatory, culturally sensitive approaches and collaborate closely to plan and implement high-quality research that incorporates local perspectives. Research should result in beneficial outcomes for the communities involved.

Process evaluation of a primary healthcare validation study of a culturally adapted depression screening tool for use by Aboriginal and Torres Strait Islander people: study protocol.

INTRODUCTION: Process evaluations are conducted alongside research projects to identify the context, impact and consequences of research, determine whether it was conducted per protocol and to understand how, why and for whom an intervention is effective. We present a process evaluation protocol for the Getting it Right research project, which aims to determine validity of a culturally adapted depression screening tool for use by Aboriginal and Torres Strait Islander people. In this process evaluation, we aim to: (1) explore the context, impact and consequences of conducting Getting It Right, (2) explore primary healthcare staff and community representatives' experiences with the research project, (3) determine if it was conducted per protocol and (4) explore experiences with the depression screening tool, including perceptions about how it could be implemented into practice (if found to be valid). We also describe the partnerships established to conduct this process evaluation and how the national Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research is met. METHODS AND ANALYSIS: Realist and grounded theory approaches are used. Qualitative data include semistructured interviews with primary healthcare staff and community representatives involved with Getting it Right. Iterative data collection and analysis will inform a coding framework. Interviews will continue until saturation of themes is reached, or all participants are considered. Data will be triangulated against administrative data and patient feedback. An Aboriginal and Torres Strait Islander Advisory Group guides this research. Researchers will be blinded from validation data outcomes for as long as is feasible. ETHICS AND DISSEMINATION: The University of Sydney Human Research Ethics Committee, Aboriginal Health and Medical Research Council of New South Wales and six state ethics committees have approved this research. Findings will be submitted to academic journals and presented at conferences. TRIAL REGISTRATION NUMBER: ACTRN12614000705684.

Disability income support design and mental illnesses: a review of Australia and Ontario.

AIM: Mental illnesses have many distinctive features that make determining eligibility for disability income support challenging - for example, their fluctuating nature, invisibility and lack of diagnostic clarity. How do policy makers deal with these features when designing disability income support? More specifically, how do mental illnesses come to be considered eligible disabilities, what tools are used to assess mental illnesses for eligibility, what challenges exist in this process, and what approaches are used to address these challenges? We aimed to determine what evidence is available to policy makers in Australia and Ontario, Canada, to answer these questions. METHODS: Ten electronic databases and grey literature in both jurisdictions were searched using key words, including disability income support, disability pension, mental illness, mental disability, addiction, depression and schizophrenia, for articles published between 1991 and June 2013. This yielded 1341 articles, of which 20 met the inclusion criteria and were critically appraised. RESULTS: Limited evidence is available on disability income support design and mental illnesses in the Australian and Ontarian settings. Most of the evidence is from the grey literature and draws on case law. Many documents reviewed argued that current policy in Australia and Ontario is frequently based on negative assumptions about mental illnesses rather than evidence (either peer reviewed or in the grey literature). Problems relating to mental illnesses largely relate to interpretation of the definition of mental illness rather than the definition itself. CONCLUSIONS: The review confirmed that mental illnesses present many challenges when designing disability income support and that academic as well as grey literature, especially case law, provides insight into these challenges. More research is needed to address these challenges, and more evidence could lead to policies for those with mental illnesses that are well informed and do not reinforce societal prejudices.

Global systematic review of Indigenous community-led legal interventions to control alcohol.

OBJECTIVES: The national and subnational governments of most developed nations have adopted cost-effective regulatory and legislative controls over alcohol supply and consumption with great success. However, there has been a lack of scrutiny of the effectiveness and appropriateness of these laws in shaping the health-related behaviours of Indigenous communities, who disproportionately experience alcohol-related harm. Further, such controls imposed unilaterally without Indigenous consultation have often been discriminatory and harmful in practice. SETTING, PARTICIPANTS AND OUTCOME MEASURES: In this systematic review of quantitative evaluations of Indigenous-led alcohol controls, we aim to investigate how regulatory responses have been developed and implemented by Indigenous communities worldwide, and evaluate their effectiveness in improving health and social outcomes. We included articles from electronic databases MEDLINE, EMBASE, CINAHL, PsycINFO and Web of Science from inception to December 2015. RESULTS: Our search yielded 1489 articles from which 18 met the inclusion criteria. Controls were implemented in rural and remote populations of high-income nations. Communities employed a range of regulatory options including alcohol rationing, prohibition of sale, importation or possession, restrictions on liquor sold, times of sale or mode of sale, Indigenous-controlled liquor licensing, sin tax and traditional forms of control. 11 studies reported interventions that were effective in reducing crime, injury deaths, injury, hospitalisations or lowering per capita consumption. In six studies interventions were found to be ineffective or harmful. The results were inconclusive in one. CONCLUSIONS: Indigenous-led policies that are developed or implemented by communities can be effective in improving health and social outcomes.