Evaluating clinical decision support software (CDSS): challenges for robust evidence generation.

OBJECTIVES: Computerized clinical decision support software (CDSS) are digital health technologies that have been traditionally categorized as medical devices. However, the evaluation frameworks for traditional medical devices are not well adapted to assess the value and safety of CDSS. In this study, we identified a range of challenges associated with CDSS evaluation as a medical device and investigated whether and how CDSS are evaluated in Australia. METHODS: Using a qualitative approach, we interviewed 11 professionals involved in the implementation and evaluation of digital health technologies at national and regional levels. Data were thematically analyzed using both data-driven (inductive) and theory-based (deductive) approaches. RESULTS: Our results suggest that current CDSS evaluations have an overly narrow perspective on the risks and benefits of CDSS due to an inability to capture the impact of the technology on the sociotechnical environment. By adopting a static view of the CDSS, these evaluation frameworks are unable to discern how rapidly evolving technologies and a dynamic clinical environment can impact CDSS performance. After software upgrades, CDSS can transition from providing information to specifying diagnoses and treatments. Therefore, it is not clear how CDSS can be monitored continuously when changes in the software can directly affect patient safety. CONCLUSION: Our findings emphasize the importance of taking a living health technology assessment approach to the evaluation of digital health technologies that evolve rapidly. There is a role for observational (real-world) evidence to understand the impact of changes to the technology and the sociotechnical environment on CDSS performance.

Efficacy of biologically-directed daylight therapy on sleep and circadian rhythm in Parkinson's disease: a randomised, double-blind, parallel-group, active-controlled, phase 2 clinical trial.

Background: New non-pharmacological treatments for improving non-motor symptoms in Parkinson's disease (PD) are urgently needed. Previous light therapies for modifying sleep behaviour lacked standardised protocols and were not personalised for an individual patient chronotype. We aimed to assess the efficacy of a biologically-directed light therapy in PD that targets retinal inputs to the circadian system on sleep, as well as other non-motor and motor functions. Methods: In this randomised, double-blind, parallel-group, active-controlled trial at the Queensland University of Technology, Australia, participants with mild to moderate PD were computer randomised (1:1) to receive one of two light therapies that had the same photometric luminance and visual appearance to allow blinding of investigators and participants to the intervention. One of these biologically-directed lights matched natural daylight (Day Mel), which is known to stimulate melanopsin cells. The light therapy of the other treatment arm of the study, specifically supplemented the stimulation of retinal melanopsin cells (Enhanced Mel), targeting deficits to the circadian system. Both lights were administered 30 min per day over 4-weeks and personalised to an individual patient's chronotype, while monitoring environmental light exposure with actigraphy. Co-primary endpoints were a change from baseline in mean sleep macrostructure (polysomnography, PSG) and an endocrine biomarker of circadian phase (dim light melatonin secretion onset, DLMO) at weeks 4 and 6. Participants data were analysed using an intention to treat principle. All endpoints were evaluated by applying a mixed model analysis. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12621000077864. Findings: Between February 4, 2021 and August 8, 2022, 144 participants with PD were consecutively screened, 60 enrolled and randomly assigned to a light intervention. There was no significant difference in co-primary outcomes between randomised groups overall or at any individual timepoint during follow-up. The mean (95% CI) for PSG, N3% was 24.15 (19.82-28.48) for Day Mel (n = 23) and 19.34 (15.20-23.47) for the Enhanced Mel group (n = 25) in week 4 (p = 0.12); and 21.13 (16.99-25.28) for Day Mel (n = 26) and 18.48 (14.34-22.62) for the Enhanced Mel group (n = 25) in week 6, (p = 0.37). The mean (95% CI) DLMO (decimal time) was 19.82 (19.20-20.44) for Day Mel (n = 22) and 19.44 (18.85-20.04) for the Enhanced Mel group (n = 24) in week 4 (p = 0.38); and 19.90 (19.27-20.53) for Day Mel (n = 23) and 19.04 (18.44-19.64) for the Enhanced Mel group (n = 25) in week 6 (p = 0.05). However, both the controlled daylight (Day Mel) and the enhanced melanopsin (Enhanced Mel) interventions demonstrated significant improvement in primary PSG sleep macrostructure. The restorative deep sleep phase (PSG, N3) significantly improved at week 6 in both groups [model-based mean difference to baseline (95% CI): -3.87 (-6.91 to -0.83), p = 0.04]. There was a phase-advance in DLMO in both groups which did not reach statistical significance between groups at any time-point. There were no safety concerns or severe adverse events related to the intervention. Interpretation: Both the controlled daylight and melanopsin booster light showed efficacy in improving measures of restorative deep sleep in people with mild to moderate PD. That there was no significant difference between the two intervention groups may be due to the early disease stage. The findings suggest that controlled indoor daylight that is personalised to the individuals' chronotype could be effective for improving sleep in early to moderate PD, and further studies evaluating controlled daylight interventions are now required utilising this standardised approach, including in advanced PD. Funding: The Michael J Fox Foundation for Parkinson's Research, Shake IT Up Australia, National Health and Medical Research Council, and Australian Research Council.

Challenges in the Evaluation of Emerging Highly Specialised Technologies: Is There a Role for Living HTA?

There is currently deep uncertainty about the clinical benefits and cost effectiveness of highly specialised technologies (HSTs), like gene and cell therapies. These treatments are novel, typically have high upfront costs, the patient populations are small and heterogenous, there is minimal information on their long-term safety and effectiveness, and data are limited and often of poor quality. With the increasing number of these technologies and their high cost burden on governments and health care providers, policy makers are currently walking a decision tightrope. On the one hand, an unfavourable funding decision could potentially limit patient access to life-saving treatments, while on the other, a favourable decision could result in unsustainable budget impacts and perhaps poorer patient health outcomes. Health technology assessment (HTA) is meant to determine the value of a health technology in order to promote an equitable, efficient, and high-quality health system. However, standard HTA processes have failed to mitigate the deep uncertainties associated with these technologies. In this paper, we propose a Living HTA framework to address these challenges. This framework includes a one-off process for making explicit the societal values associated with HSTs. These would inform the decision-making approach, data collection and the development of disease-specific reference models to be used by industry sponsors as the basis for their submissions for public funding. Coverage with an evidence development mechanism is also proposed by which data can be collected in real time to update the reference model on a rolling basis, thereby allowing re-assessment of the clinical and cost effectiveness of individual HSTs. The HTA would be 'live' until the results indicate there is sufficient certainty for the funding decision to be confirmed, the price changed or the funding removed.

Establishing a clinical ethics support service: lessons from the first 18 months of a new Australian service - a case study.

BACKGROUND: Although the importance of clinical ethics in contemporary clinical environments is established, development of formal clinical ethics services in the Australia health system has, to date, been ad hoc. This study was designed to systematically follow and reflect upon the first 18 months of activity by a newly established service, to examine key barriers and facilitators to establishing a new service in an Australian hospital setting. METHODS: HOW THE STUDY WAS PERFORMED AND STATISTICAL TESTS USED: A qualitative case study approach was utilised. The study gathered and analysed data using observations of service committee meetings, document analysis of agendas and minutes, and semi-structured interviews with committee members to generate semantic themes. By interpreting the thematic findings in reference to national capacity building resources, this study also aimed to provide practice-based reflections for other health agencies. RESULTS: THE MAIN FINDINGS: An overarching theme identified in the data was a strong commitment to supporting clinicians facing difficult patient care decisions and navigating difficult discussions with patients and families. Another key theme was the role of the new clinical ethics support service in providing clinicians with a pathway to raise system-wide issues with the organisation Executive. While there was strong clinical engagement, consumer and community participation remained a challenge, as did unresolved governance issues and a need for clearer policy relationship between the service and the organisation. Considering these themes in relation to the national capacity building resources, the study identifies three areas likely to require ongoing development and negotiation. These are: the role of the clinical ethics support service as a link between the workforce and the Executive; the incorporation of consumers and patients; and ethical reasoning. To improve the effectiveness of the service, it is necessary to increase clarity on the service's role at the governance and policy level, as well as develop strategies for engaging consumers, patients and families. Finally, the capacity of the service to reflect on complex cases may be enhanced through explicit discussions of various different ethical frameworks and ways of deliberating.

Protocol for isolation of melanopsin and rhodopsin in the human eye using silent substitution.

Melanopsin-mediated visual and non-visual functions are difficult to study in vivo. To isolate melanopsin responses, non-standard light stimulation instruments are required, with at least as many primaries as photoreceptor classes in the eye. In this protocol, we describe the physical light calibrations of the display instrumentation, control of stimulus artefacts, and correction of individual between-eye differences in human observers. The protocol achieves complete photoreceptor silent substitution in psychophysical, pupillometry, and electroretinographic experiments for probing melanopsin, rod, and cone function. For complete details on the use and execution of this protocol, please refer to Uprety et al. (2022).1.

Neglected impacts of patient decision-making associated with genetic testing.

We highlight non-health-related impacts associated with genetic testing (GT) and knowing one's genetic status so that health technology assessment (HTA) analysts and HTA audiences may more appropriately consider the pros and cons of GT. Whereas health-related impacts of GT (e.g., increased healthy behaviors and avoidance of harms of unnecessary treatment) are frequently assessed in HTA, some non-health-related impacts are less often considered and are more difficult to measure. This presents a challenge for accurately assessing whether a genetic test should be funded. In health systems where HTA understandably places emphasis on measurable clinical outcomes, there is a risk of creating a GT culture that is pro-testing without sufficient recognition of the burdens of GT. There is also a risk of not funding a genetic test that provides little clinical benefit but nonetheless may be seen by some as autonomy enhancing. The recent development of expanded HTA frameworks that include ethics analyses helps to address this gap in the evidence and bring awareness to non-health-related impacts of GT. The HTA analyst should be aware of these impacts, choose appropriate frameworks for assessing genetic tests, and use methods for evaluating impacts. A new reporting tool presented here may assist in such evaluations.

A public health framework for reducing stigma: the example of weight stigma.

We examine stigma and how it operates, then develop a novel framework to classify the range of positions that are conceptually possible regarding how stigma ought to be handled from a public health perspective. In the case of weight stigma, the possible positions range from encouraging the intentional use of weight stigma as an obesity prevention and reduction strategy to arguing not only that this is harmful but that weight stigma, independent of obesity, needs to be actively challenged and reduced. Using weight stigma as an illustrative example, we draw on prior theoretical work on stigma mechanisms and intervention strategies to develop a framework for improving the understanding, evaluation, and planning of anti-stigma interventions. This framework has the potential to help public health actors to map out how protest, contact, education, and regulation strategies can be used to reduce direct discrimination, structural discrimination, and internalized stigma (self-stigma).

Design and validation of a chart-based measure of the limits of spatial contrast sensitivity.

PURPOSE: Current chart-based tests of spatial contrast sensitivity (SCS) with fixed or narrow frequency ranges (≤18 cycles/°) cannot characterise the limits of spatial contrast vision. Here we present the design and validation of a chart-based measure of the spatial contrast envelope. METHODS: Following the principles of the standard visual acuity (Bailey-Lovie) and contrast sensitivity (Pelli-Robson) charts, a combined spatial-contrast and visual acuity chart was designed using a language-independent triangular symbol for a four-alternative forced-choice procedure plus chart rotation. Symbol frequencies ranged between 0.38 and 60 cycles/° spaced along 10 radial axes (0.55%-100% contrast). The chart was validated with reference to the Bailey-Lovie and Pelli-Robson charts; its reliability and sensitivity to changes in illumination, simulated cataract and blur was evaluated in healthy adults. RESULTS: The photopic SCS function could be measured in 5.5 ± 0.5 min; thresholding around the spatial contrast resolution limit reduced completion times to ~2 min. There was good agreement with high-contrast visual acuity (difference = 0.08 ± 0.02 logMAR) and contrast-sensitivity at 1.5 cycles/° (0.13 ± 0.06 logCS). Test-retest reliability was excellent at all spatial frequencies (ICC = 0.99). Mesopic illumination or simulated cataract caused a generalised SCS loss; myopic blur reduced high-frequency sensitivity. Spatial contrast sensitivity was independent of radial axis orientation (cardinal or oblique). CONCLUSIONS: The chart provides a time-efficient, reliable and inexpensive measure of SCS with applications in research and clinic for detecting subtle deficits in early stages of ocular and neurological conditions that often manifest at higher frequencies. It is sensitive to vision changes occurring in dim lighting and with simulated cataract and blur. The chart is available open-access for self-printing; contrast variation in print can be controlled through user calibration and/or establishing normative SCS functions using the theoretical values.

Methods for the health technology assessment of complex interventions: a protocol for a scoping review.

INTRODUCTION: In healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs. Previous research has established that the HTA of CIs requires multiple factors to be evaluated but there is no agreement on which factors ought always to be considered. There is equally little agreement on which forms of evidence ought to be collected or synthesised and how. We plan to perform a systematic scoping review in order to identify the range of evaluation criteria and types of evidence currently used in the HTA of CIs. METHOD AND ANALYSIS: This protocol was developed to guide the methodological framework for the conduct of a scoping review on health technology assessment (HTA) of complex interventions (CIs), using the Joanna Briggs Institute guidelines and the six-stage framework proposed by Arksey and O'Malley, in addition to more recent innovations in scoping review methodology. A grey literature search will supplement the primary searches of seven electronic databases for studies available in English between January 2000 and August 2020. Two reviewers will independently screen all search results for inclusion and data will be extracted using a customised data extraction or charting form. Any dispute will be resolved by consensus or through arbitration by a third author. The mnemonic Population, Concept and Context will be adopted to establish criteria for selecting relevant literature, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Review will be used for reporting the results. Several explanatory-descriptive methods will be used for analysing the extracted data including frequency and trend analyses as well as reflexive thematic coding and analysis.Mapping evidence on the HTA of CIs will allow us to gain a better understanding of both established and emerging practices, including the information types, requirements, values and parameters that are incorporated in the HTA of CIs. We also expect the findings of the scoping review to help identify research gaps that will guide future studies. As healthcare becomes more complex in its delivery, it is timely to determine how these complex interventions should be assessed so that policy decisions can be made about whether implementation and public funding is warranted. ETHICS AND DISSEMINATION: This scoping review will involve secondary analysis of already collected data, and thus, does not require ethics approval. The research findings will be submitted to peer-reviewed journals for publication and will also be disseminated at conferences and seminars.

The rationale and design of public involvement in health-funding decision making: focus groups with the Canadian public.

BACKGROUND: Worldwide, governments employ health technology assessment (HTA) in healthcare funding decision making. Requests to include public perspectives in this are increasing, with the idea being that the public can identify social values to guide policy development, increasing the transparency and accountability of government decision making. OBJECTIVE: To understand the perspectives of the Canadian public on the rationale and design of public involvement in HTA. DESIGN: A demographically representative sample of residents of a Canadian province was selected to take part in two sets of two focus groups (sixteen people for the first set and twenty for the second set). RESULTS: Participants were suspicious of the interests driving various stakeholders involved in HTA. They saw the public as uniquely impartial though also lacking knowledge about health technologies. Participants were also suspicious of personal biases and commended mechanisms to reduce their impact. Participants suggested various involvement methods, such as focus groups, citizens' juries and surveys, noting advantages and disadvantages belonging to each and commending a combination. DISCUSSION AND CONCLUSIONS: We identified a lack of public understanding of how decisions are made and distrust concerning whose interests and values are being considered. Public involvement was seen as a way of providing information to the public and ascertaining their views and values. Participants suggested that public involvement should employ a mixed-methods strategy to support informed debate and participation of a large number of people.

Understanding Canadian Health Technology Assessment through a systems lens.

OBJECTIVE: Governments around the world face challenges in maintaining sustainable, high-quality healthcare systems. Health Technology Assessment (HTA) is widely used as a method to assist in funding decisions. However, the scope and influence of HTA is still limited. We examined how policymakers can improve the usefulness of HTA. METHODS: We used Systems Thinking as a theoretical framework to examine HTA as a system. We purposely sampled stakeholders involved in Canadian HTA at a national or provincial level. We conducted 22 semi-structured interviews in September-December 2016. Data were analysed using NVivo10 and findings are presented as a concept map with explanatory text. FINDINGS: The HTA system is influenced by stakeholder interactions. Such interactions are, in turn, affected by stakeholders' worldviews and environmental factors. Stakeholders' worldviews includes individual's or groups' values and affect the exchange of information, and interpretation of events. External factors, such as changes to government structures, also affect the system. CONCLUSION: Most stakeholder groups are supportive of the system. However, participants identified a need for change, though the exact changes being recommended differed. Some interactions were praised (formal, inclusive collaborations to provide government with policy guidance on both broad and technology-specific matters), while other interactions were criticised (two-party alliances formed around purposes other than the common good, and lacklustre patient and industry engagement on the part of provincial government).

Assessing the quality of health research from an Indigenous perspective: the Aboriginal and Torres Strait Islander quality appraisal tool.

BACKGROUND: The lack of attention to Indigenous epistemologies and, more broadly, Indigenous values in primary research, is mirrored in the standardised critical appraisal tools used to guide evidence-based practice and systematic reviews and meta-syntheses. These critical appraisal tools offer no guidance on how validity or contextual relevance should be assessed for Indigenous populations and cultural contexts. Failure to tailor the research questions, design, analysis, dissemination and knowledge translation to capture understandings that are specific to Indigenous peoples results in research of limited acceptability and benefit and potentially harms Indigenous peoples. A specific Aboriginal and Torres Strait Islander Quality Appraisal Tool is needed to address this gap. METHOD: The Aboriginal and Torres Strait Islander Quality Appraisal Tool (QAT) was developed using a modified Nominal Group and Delphi Techniques and the tool's validity, reliability, and feasibility were assessed over three stages of independent piloting. National and international research guidelines were used as points of reference. Piloting of the Aboriginal and Torres Strait Islander QAT with Aboriginal and Torres Strait Islander and non-Indigenous experts led to refinement of the tool. RESULTS: The Aboriginal and Torres Strait Islander QAT consists of 14 questions that assess the quality of health research from an Aboriginal and Torres Strait Islander perspective. The questions encompass setting appropriate research questions; community engagement and consultation; research leadership and governance; community protocols; intellectual and cultural property rights; the collection and management of research material; Indigenous research paradigms; a strength-based approach to research; the translation of findings into policy and practice; benefits to participants and communities involved; and capacity strengthening and two-way learning. Outcomes from the assessment of the tool's validity, reliability, and feasibility were overall positive. CONCLUSION: This is the first tool to appraise research quality from the perspective of Indigenous peoples. Through the uptake of the Aboriginal and Torres Strait Islander QAT we hope to improve the quality and transparency of research with Aboriginal and Torres Strait Islander peoples, with the potential for greater improvements in Aboriginal and Torres Strait Islander health and wellbeing.

Breast Density Notification: An Australian Perspective.

Breast density, also known as mammographic density, refers to white and bright regions on a mammogram. Breast density can only be assessed by mammogram and is not related to how breasts look or feel. Therefore, women will only know their breast density if they are notified by the radiologist when they have a mammogram. Breast density affects a woman's breast cancer risk and the sensitivity of a screening mammogram to detect cancer. Currently, the position of BreastScreen Australia and the Royal Australian and New Zealand College of Radiologists is to not notify women if they have dense breasts. However, patient advocacy organisations are lobbying for policy change. Whether or not to notify women of their breast density is a complex issue and can be framed within the context of both public health ethics and clinical ethics. Central ethical themes associated with breast density notification are equitable care, patient autonomy in decision-making, trust in health professionals, duty of care by the physician, and uncertainties around evidence relating to measurement and clinical management pathways for women with dense breasts. Legal guidance on this issue must be gained from broad legal principles found in the law of negligence and the test of materiality. We conclude a rigid legal framework for breast density notification in Australia would not be appropriate. Instead, a policy framework should be developed through engagement with all stakeholders to understand and take account of multiple perspectives and the values at stake.

Prenatal genetic testing for cystic fibrosis: a systematic review of clinical effectiveness and an ethics review.

PURPOSE: We aimed to assess the clinical value of prenatal testing for cystic fibrosis (CF) and whether ethical considerations would affect endpoint selection. METHODS: To determine effectiveness, we conducted a systematic literature review whose protocol outlined search strategies across eight databases, study inclusion criteria, and prespecified literature screening, data extraction, and synthesis processes. We conducted a scoping search on ethical considerations. RESULTS: The genetic test showed good diagnostic performance. A change in clinical management was observed: termination of pregnancy (TOP) occurred in most cases where two pathogenic variants were identified in a fetus of carrier parents (158/167; 94.6%). The TOP rate was lower in pregnancies where CF was diagnosed after fetal echogenic bowel detection (~65%). TOP and caring for a child with CF were both associated with poor short-term parental psychological outcomes. Ethical analyses indicated that informed decisions should have been the main endpoint, rather than CF-affected births prevented. CONCLUSION: CF testing leads to fewer CF-affected births. It is difficult to assess whether this means the test is valuable, since patients may not value TOP primarily in terms of maternal or fetal health outcomes, psychological or otherwise. The value of testing should arguably be measured in terms of improving patient autonomy rather than health.

An Ethical Analysis of Coverage With Evidence Development.

Sometimes a government or other payer is called on to fund a new health technology even when the evidence leaves a lot of uncertainty. One option is for the payer to provisionally fund the technology and reduce uncertainty by developing evidence. This is called coverage with evidence development (CED). Only-in-research CED, when the payer funds the technology only for patients who participate in the evidence development, raises the sharpest ethical questions. Is the patient coerced or induced into participating? If so, under what circumstances, if any, is this ethically justified? Building on work by Miller and Pearson, we argue that patients have a right to funding for a technology only when the payer can be confident that the technology provides reasonable value for money. Technologies are candidates for CED precisely because serious questions remain about value for money, and therefore patients have no right to technologies under a CED arrangement. This is why CED induces rather than coerces. The separate question of whether the inducement is ethically justified remains. We argue that CED does pose risks to patients, and the worse these risks are, the harder it is to justify the inducement. Finally, we propose conditions under which the inducement could be ethically justified and means of avoiding inducement altogether. We draw on the Australian context, and so our conclusions apply most directly to comparable contexts, where the payer is a government that provides universal coverage with a regard for cost-effectiveness that is prominent and fairly clearly defined.

Constructions of alcohol consumption by non-problematised middle-aged drinkers: a qualitative systematic review.

BACKGROUND: Current research into alcohol consumption focuses predominantly on problematic drinkers and populations considered likely to engage in risky behaviours. Middle-aged drinkers are an under-researched group, despite emerging evidence that their regular drinking patterns may carry some risk. METHODS: We searched Scopus, Ovid Medline, and Ovid PsycInfo for peer-reviewed, English-language publications appearing prior to 31 December 2015 and relating to the construction of alcohol consumption by middle-aged non-problematised drinkers. Thirteen papers were included in our thematic analysis. RESULTS: Middle-aged non-problematised drinkers constructed their drinking practices by creating a narrative of normative drinking via discourses of gender, identity, play, and learning to drink. They also used drinking norms to construct their gender and identity. Health was not identified as a significant consideration for the population of interest when constructing alcohol consumption, except where drinking behaviours were likely to harm another. CONCLUSIONS: These results suggest that public health campaigns aimed at reducing alcohol consumption may be more effective if they focus on unacceptable drinking behaviours instead of personal health outcomes.

The development of funding recommendations for health technologies at the state level: A South Australian case study.

OBJECTIVES: State governments often face capped budgets that can restrict expenditure on health technologies and their evaluation, yet many technologies are introduced to practice through state-funded institutions such as hospitals, rather than through national evaluation mechanisms. This research aimed to identify the criteria, evidence, and standards used by South Australian committee members to recommend funding for high-cost health technologies. METHODS: We undertook 8 semi-structured interviews and 2 meeting observations with members of state-wide committees that have a mandate to consider the safety, effectiveness, and cost-effectiveness of high-cost health technologies. RESULTS: Safety and effectiveness were fundamental criteria for decision makers, who were also concerned with increasing consistency in care and equitable access to technologies. Committee members often consider evidence that is limited in quantity and quality; however, they perceive evaluations to be rigorous and sufficient for decision making. Precise standards for safety, effective, and cost-effectiveness could not be identified. CONCLUSIONS: Consideration of new technologies at the state level is grounded in the desire to improve health outcomes and equity of access for patients. High quality evidence is often limited. The impact funding decisions have on population health is unclear due to limited use of cost-effectiveness analysis and unclear cost-effectiveness standards.

What Indigenous Australian clients value about primary health care: a systematic review of qualitative evidence.

OBJECTIVE: To synthesise client perceptions of the unique characteristics and value of care provided in Aboriginal Community Controlled Health Organisations (ACCHOs) compared to mainstream/general practitioner services, and implications for improving access to quality, appropriate primary health care for Indigenous Australians. METHOD: Standardised systematic review methods with modification informed by ethical and methodological considerations in research involving Indigenous Australians. RESULTS: Perceived unique valued characteristics of ACCHOs were: 1) accessibility, facilitated by ACCHOs welcoming social spaces and additional services; 2) culturally safe care; and 3) appropriate care, responsive to holistic needs. CONCLUSION: Provider-client relationships characterised by shared understanding of clients' needs, Indigenous staff, and relationships between clients who share the same culture, are central to ACCHO clients' perceptions of ACCHOs' unique value. The client perceptions provide insights about how ACCHOs address socio-economic factors that contribute to high levels of chronic disease in Indigenous communities, why mainstream PHC provider care cannot substitute for ACCHO care, and how to improve accessibility and quality of care in mainstream providers. Implications for public health: To increase utilisation of PHC services in Indigenous Australian communities, and help close the gaps between the health status of Indigenous and non-Indigenous Australians, Indigenous community leaders and Australian governments should prioritise implementing effective initiatives to support quality health care provision by ACCHOs.