Confidence, practices and training needs of people working with Aboriginal and Torres Strait Islander LGBTIQ+ clients.

Aboriginal and Torres Strait Islander LGBTIQ+ peoples face an elevated risk for poor health and social-emotional wellbeing, suggesting that this patient group are likely to attend health and community services. However, the current practices of those who deliver care to Aboriginal and Torres Strait Islander LGBTIQ+ peoples are unknown. Utilising mixed methods (survey; n = 197; focus groups and interviews; n = 56), we explored the current practices, confidence, knowledge, and training needs for working with Aboriginal LGBTIQ+ clients among Western Australian health and community service workers. Participants were predominately from the mental health and social-emotional wellbeing care sector. One-third of survey participants indicated that it was likely Aboriginal LGBTIQ+ peoples accessed their service. On average, participants reported high confidence and knowledge in working with Aboriginal LGBTIQ+ clients. Qualitative data indicated that staff struggled to accommodate what they understood to be the needs of clients who were both Aboriginal and/or Torres Strait Islander and LGBTIQ+, despite a willingness to 'get it right'. Findings provide the first-ever snapshot of inclusive practices among health and social support workers in Western Australia.

Aboriginal and Queer Identity/ies in Western Australia: When There is a Need to Know in Therapeutic Settings.

A central question for the exploratory Aboriginal and LGBTQ+ researcher led project 'Breaking the Silence: Being Indigenous and identifying LGBTQ+' (Breaking the Silence) is how provision of genuinely inclusive service responses for Aboriginal and Torres Strait Islander people identifying as LGBTQ+ can be developed. This article presents the qualitative findings of this mixed-methods research project to show how organizational staff working in health, education and social support services in Western Australia consider the Aboriginal LGBTQ+ identity/experience. Analysis of the written, interview and focus group responses to a question about the relevance of LGBTQ+ identity show that these questions need to be considered and evaluated within diverse service cultures and philosophies of services. Staff views are diverse and organizational consensus on the relevance (or not) of LGBTQ+ identity needs to be the precursor before the development or consideration of changes to service delivery and models.

'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.

The health-related quality of life of Indigenous populations: a global systematic review.

PURPOSE: Indigenous conceptions of health have been shown to differ from that of their non-Indigenous counterparts. As a result, there remains uncertainty over the appropriateness and value of using existing health-related quality-of-life (HRQoL) instruments in Indigenous communities. The objective of this review was to identify studies that either measure the HRQoL of an Indigenous population or validated a measure used to elicit the HRQoL in an Indigenous population. METHODS: A systematic review of the published literature was conducted to (1) investigate the extent to which HRQoL instruments are used in Indigenous populations; (2) to identify which instruments have been validated in which populations; and (3) to identify which instruments have been tailored for use with Indigenous populations. RESULTS: Forty-one studies were included in the review. Only three of the 41 studies utilised Indigenous-specific instruments. The remainder (38 studies) utilised generic population or disease-specific instruments. Four studies found specific HRQoL instruments to be valid in these populations and 32 estimated the HRQoL of an Indigenous population. The limited examples of Indigenous-specific instruments highlighted the potential importance to the HRQoL of these populations of domains that lie outside of traditional measures including social and community domains as well as domains relating to culture, diet and land use on top of more traditional HRQoL domains. CONCLUSION: Ensuring that the HRQoL of Indigenous populations is being appropriately measured is vital to prioritising available resources to the most effective interventions. HRQoL instruments present an opportunity to directly elicit and incorporate Indigenous preferences and conceptions of health into these decisions. Further work is required in the field to ensure that this potential is realised.

Facilitators and barriers to implementation of a pragmatic clinical trial in Aboriginal health services.

OBJECTIVE: To identify facilitators and barriers to clinical trial implementation in Aboriginal health services. DESIGN: Indepth interview study with thematic analysis. SETTING: Six Aboriginal community-controlled health services and one government-run service involved in the Kanyini Guidelines Adherence with the Polypill (KGAP) study, a pragmatic randomised controlled trial that aimed to improve adherence to indicated drug treatments for people at high risk of cardiovascular disease. PARTICIPANTS: 32 health care providers and 21 Aboriginal and Torres Strait Islander patients. RESULTS: A fundamental enabler was that participants considered the research to be governed and endorsed by the local health service. That the research was perceived to address a health priority for communities was also highly motivating for both providers and patients. Enlisting the support of Aboriginal and Torres Strait Islander staff champions who were visible to the community as the main source of information about the trial was particularly important. The major implementation barrier for staff was balancing their service delivery roles with adherence to often highly demanding trial-related procedures. This was partially alleviated by the research team's provision of onsite support and attempts to make trial processes more streamlined. Although more intensive support was highly desired, there were usually insufficient resources to provide this. CONCLUSION: Despite strong community and health service support, major investments in time and resources are needed to ensure successful implementation and minimal disruption to already overstretched, routine services. Trial budgets will necessarily be inflated as a result. Funding agencies need to consider these additional resource demands when supporting trials of a similar nature.

Improving the pragmatic usefulness of the scoring matrix for the Consolidated Framework for Implementation Research (CFIR). A proposal for a more frequency-based approach: The CFIR-f.

The Consolidated Framework for Implementation Research (CFIR) is a well-established framework for systematically identifying key factors influencing the implementation of programs. To enhance the classification of existing CFIR definitions, as well as its +2/-2 scoring system, this study incorporated the views of relevant experts to: i) improve how themes are scored; and ii) utilise more information regarding the frequency with which themes are identified. This structured, frequency-based approach to the CFIR's scoring process has been trialled as the CFIR-frequency (CFIR-f). Researchers thematically analysed semi-structured interview data from four groups of policy and program experts (N = 24) delivering two family-based therapies in New South Wales (NSW), Australia. Themes identified by less than 50% were excluded from further analysis. Themes identified by 50% or more of expert participants in the four groups were classified as enablers or barriers using clearly defined criteria. Each theme was allocated a score according to how many experts identified it as an enabler or barrier, and then mapped back onto the latest adaptation of the CFIR comprising 67 constructs. The CFIR-f successfully determined three enablers of, and six barriers to, implementation. Enablers included the family-based therapy programs, therapist training and participant monitoring systems. Barriers included referral, data collection and staffing difficulties, NSW adaptation issues and the suitability and safety of the programs for Aboriginal families. The same enablers and barriers were identified using both the CFIR-f and the original scoring approach, and the identified themes were successfully mapped to almost all CFIR constructs (65/67). This paper proposes a more frequency-based approach to CFIR's scoring process (the CFIR-f). By specifically utilising the frequency with which these barriers and enablers are identified, the CFIR-f engenders a list of ranked themes that service providers and policymakers can use to inform their decisions about program modification and implementation.

Building a Nyoongar work practice model for Aboriginal youth mental health: prioritising trust, culture and spirit, and new ways of working.

Mainstream youth mental health services struggle to comprehend the connection between colonisation and service provision for Aboriginal young people. This is the consensus agreed by Aboriginal Elders from Perth, Western Australia and young Aboriginal leaders within their communities (Wright, Culbong, Crisp, Biedermann, & Lin (2019). 1-7). What is required is a more nuanced, culturally relevant approach to both an understanding of the impact of colonisation on mental health and help-seeking behaviour if they are to provide equitable access for Aboriginal young people.In this paper, we report on a three-year participatory action research (PAR) project conducted on Whadjuk Nyoongar country in Perth, Western Australia. An innovative model of care framework developed from the project and described in this paper, focuses on key components that both inform and assist service providers in improving service provision to Aboriginal young people. The model, depicted as a tree, symbolises strength and growth, with the 'roots' of the tree, holding trust, culture and spirit. This paper details a culturally-safe co-design process that was held and directed with Elders, in partnership with young people, youth mental health service staff and youth policy staff.

The impact of vicarious trauma on Aboriginal and/or Torres Strait Islander health researchers.

AIM: To describe and reflect on an Aboriginal researcher's experience of vicarious trauma arising from a qualitative study of Aboriginal and Torres Strait Islander women with chronic disease. METHODS: In-depth semistructured interviews with thematic analysis were undertaken to explore the psychosocial factors experienced by Aboriginal and Torres Strait Islander women as they managed their chronic disease. An 'Indigenous women's standpoint theory' approach was adopted to frame discussion. This approach gives strength and power to the voice of Aboriginal and Torres Strait Islander women and their diverse cultural lived experiences. The raw and often brutal realities this approach exposed had a triggering impact on the Aboriginal team member for whom these realities were familiar. Interviews were conducted with participants from four Aboriginal Medical Services from urban, rural and remote Australia. Analysis of the interviews, and reflection regarding the researcher's experiences, occurred within the context of a multidisciplinary team. Participant selection for the interview study was purposive. Seventy-two participants were selected for this study. The duration of the study was 2 years, and it was undertaken between March and December 2014, and finalised in December 2016. RESULTS: In exploring how Aboriginal and Torres Strait Islander women managed their own health and wellbeing, compelling stories of trauma, domestic violence and generational incarceration were shared with the researcher. Hearing and re-living some of these overwhelming experiences left her feeling isolated and distressed. These compelling stories contributed to her experience of vicarious trauma. CONCLUSION: When Aboriginal and Torres Strait Islander researchers conduct research in Indigenous communities, we should monitor, prepare for and provide appropriate care and support to researchers to address the potential for vicarious trauma. These considerations are paramount if we are to build the capacity of Indigenous and non-Indigenous researchers to conduct Indigenous health research.

What are the resourcing requirements for an Aboriginal and Torres Strait Islander primary health care research project?

OBJECTIVE AND IMPORTANCE: To explore the role of resourcing during an Aboriginal and Torres Strait Islander primary health care research project. STUDY TYPE: Process evaluation using grounded theory approaches of a national Aboriginal and Torres Strait Islander research project (N = 500) named Getting it Right: the validation study. METHODS: Qualitative semistructured interviews with 36 primary health care staff and 4 community members from 9 of 10 primary health care services involved in the research project. Interviews included questions about the resources needed to conduct the research project, including flexible reimbursement to participating services (allocated within services), human resources and reimbursement to research participants (vouchers). Qualitative data were triangulated with participant feedback, study administrative data and field notes kept by the interviewer. RESULTS: Three themes were identified: 1) the influence of reimbursement on participating services and the research project; 2) the influence of human resources on the research project at participating services; and 3) the consequences of offering vouchers to reimburse research participants. Reimbursement was allocated to research expenses (human resources and logistics) or non-research expenses (service operations, equipment and conference attendance costs). Most services opted to offer vouchers to compensate participants for their time, which staff considered was appropriate recognition of participants' contributions and facilitated recruitment. Some staff described some potential unintended negative consequences from offering vouchers, including creating a welfare mentality or creating problematic expectations. CONCLUSION: Primary health care research should have sufficient resourcing available, including human resource capacity, to achieve research targets. Research planning should include consideration of the existing commitments, priorities and human capacity needs of services and patients.

"Our culture, how it is to be us" - Listening to Aboriginal women about on Country urban birthing.

BACKGROUND: Birth on Country is often assumed as relevant to Aboriginal women in rural/remote locations and not usually associated with urban environments. In Western Australia, one third of the Aboriginal population live in the greater metropolitan area. We wanted to know Aboriginal women's experiences of on Country urban births. METHODS: Indigenous qualitative data collection and analysis methods were used to learn about Aboriginal women's stories of contemporary and past experiences of maternity care and cultural practices associated with Birth on Country. RESULTS: Aboriginal Birthing, Senior and Elder women consistently reported ongoing cultural practices associated with childbirth including knowledge sharing across generations and family support, observance of extended family present at the time of or shortly after birth, and how their cultural security was improved when Aboriginal staff were present. Also noted, were the inflexibility of health systems to meet their needs and midwives lack of cultural awareness and understanding of the importance of Aboriginal kinship. CONCLUSION: The Birthing on Noongar Boodjar project Aboriginal women's data represents four generations of women's stories, experiences and expressions of childbearing, which highlighted that maternity care changes across time have failed to acknowledge and support Aboriginal women's cultural needs during childbearing. In terms of on Country urban birth, the women collectively expressed a strong desire to maintain cultural practices associated with childbirth, including birthing close to home (on Country); having family acknowledged and included throughout the perinatal period; and, having access to Aboriginal midwives, nurses, doctors, and other health care workers to support their cultural security.

Cultural security in the perinatal period for Indigenous women in urban areas: a scoping review.

BACKGROUND: Culturally secure care is considered foundational for good perinatal outcomes for Indigenous women. It is unknown what literature reports on whether Indigenous women giving birth in urban areas receives appropriate cultural care. The aim of this scoping review was to examine and summarise relevant evidence which reports on culturally secure care for Indigenous women using urban maternity services at any time during the perinatal period. METHODS: Ten journal databases plus grey literature and theses databases were searched for relevant material dated 1986-2018. Articles were included if they were about Indigenous women from Australia, New Zealand, Canada or the USA; care was provided anytime during the perinatal period, in an urban area; and cultural security (or variations of this term) were used. RESULTS: 6856 titles and abstracts were screened, of these: 25 studies, 15 grey literature documents and 9 theses matched the search criteria. Studies were mostly qualitative (13/25) and from Australia (18/25). Studies showed women's access to and experiences of culturally secure maternity care in urban areas as variable. The grey literature originated from Australia (8/15); New Zealand (4/15); and Canada (3/15); while theses were from Canada (7/9) and Australia (2/9). CONCLUSION: The scoping review results showed substantial qualitative evidence on Indigenous women's experience during the perinatal period in urban areas. In-depth analysis of these studies is required to inform future practice and policy on what works and what needs improvement. Culturally secure midwifery care shows promising results.

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.

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.

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.

Australian Aboriginal and Torres Strait Islander-focused primary healthcare social and emotional wellbeing research: a systematic review protocol.

BACKGROUND: Research with a focus on Aboriginal and Torres Strait Islander Australian's (hereafter referred to as Indigenous(1)) needs is crucial to ensure culturally appropriate evidence-based strategies are developed to improve health. However, concerns surrounding this research exist, arising from some previous research lacking community consultation, resulting in little community benefit or infringing on important cultural values. Values and Ethics: Guidelines for Ethical conduct in Aboriginal and Torres Strait Islander Health Research (hereafter referred to as Values and Ethics), developed by The National Health and Medical Research Council of Australia in 2003, is the ethical standard for Indigenous-focused health research. Researchers must address its Values in research design and conduct. However, its impact on research processes is unclear. Local Protocols should also be considered. This review aims to systematically examine practices related to Values and Ethics, Local Protocols and the processes of conducting Indigenous-focused primary healthcare research in collaboration with external researchers. METHODS: The following electronic databases and grey literature will be searched (2003 to current): MEDLINE, EMBASE, CINAHL, Informit and HealthInfoNet--an Indigenous-specific research and program website. Indigenous-focused research will be included. Research must be conducted in one or more primary healthcare services, in collaboration with external researchers and with a focus on social and emotional well being. One reviewer will review titles and abstracts to remove obviously irrelevant research articles. Full-text research articles will be retrieved and independently examined by two reviewers. Data and quality assessment will be completed by one reviewer and verified by a second reviewer. Quality will be assessed using modified versions of established quality assessment tools. DISCUSSION: This review will provide information on research processes and the impact of Values and Ethics on Indigenous-focused primary healthcare research, informing communities and primary healthcare staff around research practices, and researchers and policy makers of strengths and weaknesses of practice. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015024994.

Implementing Kanyini GAP, a pragmatic randomised controlled trial in Australia: findings from a qualitative study.

BACKGROUND: Pragmatic randomised controlled trials (PRCTs) aim to assess intervention effectiveness by accounting for 'real life' implementation challenges in routine practice. The methodological challenges of PRCT implementation, particularly in primary care, are not well understood. The Kanyini Guidelines Adherence to Polypill study (Kanyini GAP) was a recent primary care PRCT involving multiple private general practices, Indigenous community controlled health services and private community pharmacies. Through the experiences of Kanyini GAP participants, and using data from study materials, this paper identifies the critical enablers and barriers to implementing a PRCT across diverse practice settings and makes recommendations for future PRCT implementation. METHODS: Qualitative data from 94 semi-structured interviews (47 healthcare providers (pharmacists, general practitioners, Aboriginal health workers; 47 patients) conducted for the process evaluation of Kanyini GAP was used. Data coded to 'trial impact', 'research motivation' and 'real world' were explored and triangulated with data extracted from study materials (e.g. Emails, memoranda of understanding and financial statements). RESULTS: PRCT implementation was facilitated by an extensive process of relationship building at the trial outset including building on existing relationships between core investigators and service providers. Health providers' and participants' altruism, increased professional satisfaction, collaboration, research capacity and opportunities for improved patient care enabled implementation. Inadequate research infrastructure, excessive administrative demands, insufficient numbers of adequately trained staff and the potential financial impact on private practice were considered implementation barriers. These were largely related to this being the first experience of trial involvement for many sites. The significant costs of addressing these barriers drew study resources from the task of achieving recruitment targets. CONCLUSIONS: Conducting PRCTs is crucial to generating credible evidence of intervention effectiveness in routine practice. PRCT implementation needs to account for the particular challenges of implementing collaborative research across diverse stakeholder organisations. Reliance on goodwill to participate is crucial at the outset. However, participation costs, particularly for organisations with little or no research experience, can be substantial and should be factored into PRCT funding models. Investment in a pool to fund infrastructure in the form of primary health research networks will offset some of these costs, enabling future studies to be implemented more cost-effectively. TRIAL REGISTRATION: ACTRN126080005833347.

Patients' and providers' perspectives of a polypill strategy to improve cardiovascular prevention in Australian primary health care: a qualitative study set within a pragmatic randomized, controlled trial.

BACKGROUND: This study explores health provider and patient attitudes toward the use of a cardiovascular polypill as a health service strategy to improve cardiovascular prevention. METHODS AND RESULTS: In-depth, semistructured interviews (n=94) were conducted with health providers and patients from Australian general practice, Aboriginal community-controlled and government-run Indigenous Health Services participating in a pragmatic randomized controlled trial evaluating a polypill-based strategy for high-risk primary and secondary cardiovascular disease prevention. Interview topics included polypill strategy acceptability, factors affecting adherence, and trial implementation. Transcribed interview data were analyzed thematically and interpretively. Polypill patients commented frequently on cost-savings, ease, and convenience of a daily-dosing pill. Most providers considered a polypill strategy to facilitate improved patient medication use. Indigenous Health Services providers and indigenous patients thought the strategy acceptable and beneficial for indigenous patients given the high disease burden. Providers noted the inflexibility of the fixed dose regimen, with dosages sometimes inappropriate for patients with complex management considerations. Future polypill formulations with varied strengths and classes of medications may overcome this barrier. Many providers suggested the polypill strategy, in its current formulations, might be more suited to high-risk primary prevention patients. CONCLUSIONS: The polypill strategy was generally acceptable to patients and providers in cardiovascular prevention. Limitations to provider acceptability of this particular polypill were revealed, as was a perception it might be more suitable for high-risk primary prevention patients, though future combinations could facilitate its use in secondary prevention. Participants suggested a polypill-based strategy as particularly appropriate for lowering the high cardiovascular burden in indigenous populations. CLINICAL TRIAL REGISTRATION: URL: http://www.anzctr.org.au. ANZCTRN: 12608000583347.