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Pharmacology Perspectives 3 April 2023 Open Access

“A wolf in sheep's clothing”: when so‐called placebo interventions are not what they seem

Not all placebo interventions control for the placebo effect, potentially producing misleading results Placebo‐controlled trials have traditionally been considered the gold standard when comparing the effect of an intervention with no intervention, as they allow the opportunity to differentiate between the therapeutic and placebo effects. However, the results are only valid if appropriate placebo controls are used; otherwise, the placebo control may be a “wolf in sheep's clothing”. The placebo effect is present in all experiences of interventions, with the magnitude of the effect potentially influenced by several factors.1 The observed summary measure of the primary outcome (eg, mean/median) in each treatment arm or intervention is thus a combination of the real therapeutic effect, the placebo effect, and the natural progression of the condition since treatment initiation (Box 1). The magnitude of each of these components may vary within both person and group. Placebo controls are intended to control for the placebo effect, but where the placebo effect is not equal across interventions, this is unlikely the case and the magnitude of the therapeutic effect remains unknown. To control for the placebo effect, a placebo control should have no specific therapeutic effect on outcomes of interest and be perceived as real and identical to the primary intervention.2 These placebo criteria are often not possible to achieve for all interventions (eg, lifestyle interventions). Despite this, several studies have compared such interventions with so‐called placebo controls that do not meet these criteria, potentially producing misleading results. In this Perspective, we discuss three possible problems with so‐called placebo controls that potentially result in failure to control for the placebo effect: the placebo control having a specific, therapeutic effect on outcomes of interest; the placebo control being distinguishable from the intervention of interest; and an emerging issue of open‐label placebos being used to supposedly control for the placebo effect. Specific therapeutic effects Placebo controls should have no specific therapeutic effect on outcomes of interest, to control for the placebo effect. However, there are several examples of so‐called placebo controls that contravene these criteria. For example, although saline injections are pharmacologically inert and, therefore, often thought of as having no specific effects, saline injections may improve symptoms3,4 and may have specific physical and chemical effects that could improve outcomes of interest,5 and hence do not necessarily control for the placebo effect. Importantly, the potential negative effects of so‐called placebo controls should also be considered. Recently, the REDUCE‐IT trial compared the effect of icosapent ethyl with a placebo control (a mineral oil) on cardiovascular disease, concluding that the drug improved cardiovascular outcomes.6 However, further analyses revealed that this difference was not likely due to the effectiveness of the icosapent ethyl but rather to the harm caused by the placebo control, which may have interacted with other medications being taken by the participants.7 It is thus crucial to ensure that the placebo control does not have specific therapeutic effects, even if pharmacologically inert, because such effects may lead to misinterpretation of the therapeutic effects of the drug being tested. Distinguishable from the intervention of interest A placebo control must be indistinguishable from the primary intervention. This point not only facilitates blinding of the participant (and potentially outcome assessors) thus reducing bias, but also allows for control of the magnitude of the placebo effect. There is a large body of evidence indicating that not all placebo interventions have the same effect, with the level of invasiveness, dosage and brand differentially affecting individual expectations around intervention outcomes.1 For example, a 2022 study compared an education and exercise program for people with knee osteoarthritis with a so‐called placebo control, where the placebo was a saline injection with arthrocentesis (where required) — two very distinct treatments.8 Having so‐called placebo controls that are distinguishable from the primary intervention does not necessarily control for the placebo effect because the magnitude of the placebo effect may differ from that of the primary intervention. Open‐label placebos A new suggested approach to allow for comparison of distinguishable interventions while apparently controlling for the placebo effect is the use of an open‐label placebo — an inert intervention where the participant is made aware of the inert status of the intervention. Open‐label placebos have gained increasing attention, with evidence indicating they are more effective than no treatment in some contexts.9,10,11 However, these findings do not indicate that open‐label placebos control for the placebo effect, and the manner in which they are delivered may also have an impact on the outcomes for the intervention group. An open‐label placebo was employed in the abovementioned study regarding knee osteoarthritis. In that study, all participants had the candidate interventions described, with statements that the saline injections were “inert, yet with potential beneficial effects that may compare to those of exercise and education” and that “investigators had no treatment preference,“8 presumably in an attempt to make the placebo effect comparable. However, both statements mean the intervention is no longer perceived to be real and may negatively affect the outcomes of the education and exercise intervention. It is critical to appreciate that the participants’ expectations, particularly when manipulated by investigators, may not only increase the expectations of benefits but also reduce them and, therefore, affect measured outcomes. For instance, in a recent study, the same active medication was provided to all participants, but one group was told they had the real medication (the truth) and the other group that they had an “active placebo” (deception), resulting in statistically significant differences in measured effect between the groups, despite the therapeutic effect per se being identical in both groups.12 In the same way, in the 2022 knee osteoarthritis trial, the explanations to participants regarding the potential comparative effectiveness of the saline injection versus the exercise and education intervention may have influenced the measured effect by manipulating the participants’ expectations.8 Open‐label placebos do not typically control for the placebo effect adequately, as the magnitude of the placebo effect is still likely to differ between groups as well as at the individual level. Implications and recommendations For interventions involving lifestyle and psychosocial components, we do not and cannot know the mean/median magnitude of the placebo effect for each group. Based on the 2022 trial,8 we provide two hypothetical scenarios (Box 2). For simplicity of comparison, each scenario assumes that the measured mean/median effect of the two interventions is equal. The identical outcome scores may lead one to conclude that combined education and exercise programs have no real therapeutic value. Where the placebo effect is adequately controlled (Box 2, A), this conclusion would be correct. However, where the placebo effect is not equal across the two groups (Box 2, B), this conclusion would be misleading; the education and exercise intervention in fact has a greater therapeutic effect. We have no way of knowing the true magnitude of the placebo effect and, therefore, we are unable to assess the real therapeutic effect of the intervention. As such, we cannot make assumptions about the appropriateness of these interventions as placebo controls. While placebo‐controlled trials may have value in differentiating the relative real and placebo effects of an intervention, we must accept that they are not possible for many interventions, including lifestyle and psychosocial interventions. It is not always possible to have a control intervention with no specific therapeutic effects that is perceived to be real and appears identical to the primary intervention, which are the requirements of a placebo control.2 Importantly, the impossibility of undertaking placebo‐controlled trials for some interventions does not diminish their potential role as part of the management of chronic conditions, nor the need for and value of pragmatic randomised controlled trials that compare such interventions with, for instance, usual treatment. Although these studies may be criticised for the potential benefits being driven by the placebo effect, we argue that the placebo effect is now an accepted part of any intervention. Indeed, prescribing placebos is common among medical professionals,13,14,15 despite knowing that the treatments they are administering have no therapeutic effect per se. The ethical implications of such practice are beyond the scope of this Perspective, but the practice highlights a willingness to accept that the placebo effect contributes to the effectiveness of therapies. If we remain focused on placebo‐controlled trials as the gold standard, researchers may feel pressured to conduct trials that are no longer consistent with an acceptance in current practice that placebo effects are an integral part of effective therapy and/or trials that might not necessarily control for the placebo effect. There must be a clear rationale for conducting placebo‐controlled trials, and the limitations of this approach for guiding a necessary evidence base for clinical practice should be acknowledged.16,17,18 We must accept that we cannot have appropriate placebo controls for many interventions, and that calling comparison interventions “placebo controls”, when they do not necessarily control for the placebo effect, is misleading and may result in inappropriate recommendations from health professionals as well as false perceptions of treatment effectiveness by the general public. We should focus on the best available evidence that may also be the best possible evidence, even if that evidence does not consist of placebo‐controlled trials. Box 1 – A hypothetical example comparing the difference in treatment outcome between three interventions: (1) no intervention, (2) a placebo intervention, and (3) an intervention of interest* * Where appropriate, placebo interventions have been used, assuming no impact of treatment on the placebo effect. Box 2 – Hypothetical examples comparing the pain reduction from saline injections with a combined education and exercise program, with both interventions having the same measured effect but different magnitudes of placebo effect* * (A) The placebo effect is adequately controlled. (B) The placebo effect is not equal across the two groups.

Jessica Stanhope · Amy Salter · Philip Weinstein

Mja2 51881
Health policy Perspective 3 April 2023 Open Access

Out‐of‐pocket fees for health care in Australia: implications for equity

Out‐of‐pocket fees create access barriers to health care, exacerbating health inequalities In Australia, 15% of all expenditure on health care comes directly from individuals in the form of out‐of‐pocket fees — this is almost double the amount contributed by private health insurers.1 There is concern that vulnerable groups — socio‐economically disadvantaged people and older Australians in particular, who also have higher health care needs — are spending larger proportions of their incomes on out‐of‐pocket fees for health care.2 A 2019 study identified that one in three low income households are spending more than 10% of their income on health care.3 This might create economic hardship, and individuals do forgo care,4 with one in four Australians without a health care condition and up to one in two with certain health conditions avoiding care because of the cost.4 Health care services in Australia are delivered through a mixture of public and private providers, with governments subsidising the costs of care but out‐of‐pocket fees remaining a significant component.5 Australia is not unique in this, with similar systems in New Zealand, Ireland, France, Germany, the Netherlands, and the United Kingdom. However, in Australia, out‐of‐pocket fees make up a larger proportion of overall health expenditure than in these other countries.6 The amount paid by households on health care in Australia was estimated to be $3200 in 2014,3 with out‐of‐pocket fees per health care service rising over time.7 The increasing out‐of‐pocket expenditure by patients is concerning in light of international experience in the United States, where there is a reliance on private or market‐based health care, and health care costs are the leading cause of bankruptcy.8 The level of out‐of‐pocket fees in Australia has ignited vigorous policy and academic debate.9,10,11 Varied viewpoints range from the impact of high fees on a patient's ability to access care4 and the equity implications of high fees,12 to the right of private providers to set their own fees in an open market and to recover costs of providing care.13 Out‐of‐pocket fees are also part of cost‐sharing measures between governments and patients, as a result of increasing government expenditure on health care and unprecedented levels of demand.1 This article examines the current provision of health care and out‐of‐pocket fees within Australia through a micro‐economic lens, identifying the access and equity implications of the dual public–private system, and considers potential systems‐level options for a way forward. Universal health care and private health insurance in Australia Under Australia's universal health care system, individuals can access care in public hospitals free of charge. Public hospitals are owned and operated by state governments. Outside of public hospitals, health care services are owned and operated by private providers on either a for‐profit or not‐for‐profit basis. The costs to individuals for accessing these services are partly subsidised by the federal government through Medicare. Medicare covers services such as consultations with general practitioners and specialists, and diagnostic tests and imaging. Australia also has numerous policy incentives and penalties to encourage Australians to take out private health insurance and access private hospitals, and thus private specialist health care. Private health insurance covers the hospital stay component in private hospitals. For the actual health services provided by private specialists within private hospitals, Medicare will pay a subsidy for the service, with an individual's private health insurance potentially paying for either the remainder of the charge, or patients themselves also having to pay. This will depend upon the coverage of each individual policy, and the amount charged by the provider of the service, with many private health insurance policies only providing reimbursement up to a certain amount. Only 44% of private hospital admissions had no out‐of‐pocket fees in the 2020–21 financial year;14 and in the same period only 34% of specialist attendances were bulk billed (meaning there was no out‐of‐pocket fee).7 The average out‐of‐pocket fee for out‐of‐hospital specialist and obstetric services was $98 and $303 per non‐bulk billed visit, respectively.7 Out‐of‐pocket fees are therefore a major feature of private specialist care. User fees and the role of the market in setting price Private health care services (ie, all services outside of public hospital services) are provided through the market. This means that the fee charged for services covers the cost of production (staff salaries, capital costs, and operation costs such as insurance) less any government subsidies. For providers operating on a for‐profit basis, it also includes a profit component, and the objective of such providers is profit maximisation. A recent report found that profits for private specialists increased by 11% between 2019–20 and 2020–21; profits for GPs increased by a smaller amount (2%).13 It is also notable that the average salary, before tax and after deducting practice costs, is around $400000 per year for specialists, and around $200000 per year for GPs.15 The ability of private providers of health care services to set their own fees, to cover operational costs and make profits, is a key feature of the Australian health care system. This is supported by the Australian Constitution, with government excluded from regulating fees that health care providers charge for their services.16 The fee charged, and the amount of profit, is therefore determined by an individual consumer's willingness to pay for the service. In the market, the higher the willingness to pay, the higher the service fee. This is problematic in health care as willingness to pay is constrained by ability to pay, with people at socio‐economic disadvantage — who generally have poorer health17 — having a lower ability to pay the higher prices often paid by those at socio‐economic advantage.18 Although the private market is subsidised through Medicare, patients are only reimbursed a fixed amount based on the Medicare schedule fee for each service. This schedule fee generally differs from the fees actually charged.7 The Medicare safety net reimburses patients at a higher amount (initially 85% for most out‐of‐hospital services, or 100% of GP services; increasing to 100% under the safety net) once they have reached a certain threshold of out‐of‐pocket expenditure in a year ($531.70 in March 2023). However, the disconnect between the schedule fee and the fees charged by providers still leaves patients vulnerable to open‐ended out‐of‐pocket fees (Box). The extended Medicare safety net applies when a higher threshold (in March 2023, $770 for people who have a concession card or family tax benefit, and $2414 for others) reimburses patients at 80% of out‐of‐pocket expenditure based on the actual provider fee; however, again this still leaves patients to pay a potentially high out‐of‐pocket amount. Implications for access to care With the market as the mechanism for the distribution of private care, only those with the ability to pay the market price will be able to access this care. To some extent, as a result of the dual private and public system in Australia, those who are unable to afford to pay or who are unwilling to pay the market price for private care may still be able to receive care through the public hospital system — with public hospitals providing care for all essential acute medical services, based upon urgency. However, this does not cover primary care, and waiting times in public hospitals for non‐urgent reasons might mean that people priced out of the private market are not able to achieve access. Using Queensland public hospital outpatient specialist clinics as an example, 20% of non‐urgent cardiac patients and 30% of non‐urgent respiratory patients wait more the 365 days to receive care.19 Market undermining equity Although people with higher incomes may have the ability to pay to access private specialist care, such user fees cannot themselves directly contribute to the promotion of equity. There is no direct transfer of out‐of‐pocket fees from people of higher socio‐economic status to those of lower socio‐economic status. Out‐of‐pocket fees, and by extension government subsidies, do nothing to directly subsidise access for people of lower socio‐economic status who are unable to pay market prices. This, combined with public subsidisation of private health insurance premiums ($6.2 billion per year)1 means that there is potentially a large transfer of public expenditure (Medicare subsidies for private specialist care, plus private health insurance subsidies) to wealthier people and away from lower socio‐economic status groups,20 who are more likely to be in need of care.17 Allowing the more affluent to exercise their higher ability to pay only contributes to higher inequality by allowing higher socio‐economic status groups to access care more frequently.21,22,23 Systems‐level options for change A potential option to reduce out‐of‐pocket fees and reduce affordability barriers is for the federal government to expand Medicare coverage to areas such as dental, and increase the subsidies paid through Medicare, by increasing Medicare Benefit Schedule fees. However, previous increases in Medicare rebates have not resulted in substantial out‐of‐pocket cost reductions.24 Increasing the volume of outpatient specialist care through public hospitals might be an additional option to improving equity. Although there is a skew towards higher socio‐economic status in access to Medicare services,21,22,23,25 public hospitals achieve greater equity in the provision of care than private hospitals.25,26 However, public hospitals play a vital role contributing to equity in health access once conditions arise; they do not cover primary and preventive care. The Pharmaceutical Benefits Scheme has also achieved equity in health care access.27 The Pharmaceutical Benefits Scheme differs from Medicare in that the federal government pays a set, agreed price to providers (pharmaceutical companies), and there is a maximum out‐of‐pocket price that consumers will pay for any medication. Introducing a low ceiling out‐of‐pocket fee under Medicare, whereby individuals never pay more than this amount for health care services and governments pay an agreed amount to providers, could produce more equitable access. Many other options for change have also been proposed, such as incentives for bulk‐billed private specialist services, promoting greater price transparency, and funding specific conditions in bundles of funding (rather than based on frequency of services).28,29,30 There is therefore a considerable suite of options for reform. Conclusion Out‐of‐pocket fees in Australia are already leading to patients avoiding care because of the cost. The US offers a salient reminder of the impacts of unaffordable health care. There are numerous options for reducing out‐of‐pocket fees and promoting affordability. Moving forward with active, bold reform should be a priority to ensure promotion of equity and truly universal health care in Australia. Box – Vulnerability of patients to high out‐of‐pocket fees even with the Medicare safety net* * Medicare schedule fee hypothetically set at $100 and actual provider fee hypothetically set at $130. These different amounts lead to patients being vulnerable to high out‐of‐pocket fees even with the Medicare safety net: $45 initially, or $30 with the Medicare safety net.

Emily J Callander

Mja2 51895
Rehabilitation Perspectives 3 April 2023 Open Access

The NDIS at ten years: designing an equitable scheme for the next decade

As the NDIS turns ten, we must make changes to improve scheme equity The National Disability Insurance Scheme (NDIS) was created to provide reasonable and necessary supports for people with disability under the age of 65 years to live an included and meaningful life on an equal basis with other Australians. The mechanism for this is individualised support plans underpinned by personal budgets that are spent on services purchased from a social care market. Former Prime Minister Julia Gillard announced the scheme in 2012 and the national roll‐out, which began in 2013, was achieved in July 2020.1 The NDIS is a very significant social policy innovation and its importance for people with disability in Australia cannot be underestimated. For many people with disability, the supports provided through the NDIS have been essential to living an included life. The scheme was funded in part by an increase in the Medicare Levy, against which there was little initial protest.2 However, providing these essential supports has been more costly than originally anticipated by the Productivity Commission.3 The NDIS is expected to cost $50 billion annually by 2024–2025,4 which is higher than the annual budget for either Medicare or defence. Attention to the scheme costs has been mounting, along with attendant fears about cost‐cutting to plans.5 This has caused mistrust, with fear over cost‐cutting to and by the NDIS a factor in community rejection of the now cancelled “independent assessments”.6 Even with expanding costs there remains significant concerns about equity within the scheme, with some groups still failing to receive the services that they need in comparison with others. To address these and other concerns, such as access, market and workforce, the federal government has initiated an independent review into the NDIS. Who is in? Who is out? There are over 535000 NDIS participants compared with almost 4.4 million people with disability in Australia, including 2.4 million aged under 65 years,7 which means the NDIS can only ever be part of the national disability support landscape. Yet in the early days of its implementation, it became the default disability system as other existing disability supports and approaches were defunded or removed. These supports included successful programs such as Partners in Recovery, which was defunded when most existing participants were not eligible for the NDIS.8,9 This has led to a situation where the NDIS is, as Bruce Bonyhady, the original Chair of the National Disability Insurance Agency, calls it, an “oasis in the desert”,10 with scheme participants receiving support to a much higher level than non‐participants. This situation makes people currently eligible desperate to retain NDIS supports and others desperate to become eligible.11 A Tier 2 scheme was originally envisioned to provide referrals and community assistance so that people not eligible for individual NDIS plans could receive support. However, the Tier 2 scheme has not been effective in delivering this.10 Current NDIS participants are overwhelmingly young (under 18 years) and male, which is driven by the large number of participants with autism and developmental delay.12,13 Participants with a primary autism diagnosis comprise 30.9% of scheme participants, followed by intellectual disability (20.2%) and psychosocial disability (9.1%). Eighty‐nine per cent of men aged over 18 years have applications for access approved compared with 80% of women.13 Just 37% of NDIS participants are women — substantially lower than the 49% of people with disability aged under 65 years who are women.14,13 This raises concerns that the intersectional influence of gender might drive disparities in access.15 Concerns about utilisation and support Concerns have been raised about scheme access and utilisation of approved plans (ie, percentage of budgeted supports used), which are lower in some participant groups compared with others, resulting in inequity of access to necessary supports.16 Although utilisation is not a perfect measure because it relies on planning processes that may in themselves be inequitable, it is clear that utilisation differs by disability type; for example, people with psychosocial disability have an average plan utilisation of 53% compared with 70% for those with autism.17 A major factor in the disparity in plan utilisation is due to the failure of markets to function where participant needs necessitate more specialised supports, which come at higher costs to providers, and in areas where there are poor economies of scale.18,19 Plan utilisation is higher for people in metropolitan than regional and remote areas (eg, only 11% plan utilisation for people with psychosocial disability in the Far West region of New South Wales).20 Interestingly, some populations that are traditionally underserved in health and social care receive good access to the NDIS, with culturally and linguistically diverse people with disability having higher than average plan spending and utilisation.17 This may be a function of rurality, with most of this population resident in metropolitan areas.17 Differences in use of plans, for some groups of people with disability compared with others, underline the fact that the scheme functions better for people with support needs that are relatively straightforward and can receive support from less specialised, more generic services and support workers. In an exploration of plan utilisation by people with psychosocial disability, a 2022 study found that utilisation of plans is affected by both individual and broader systemic conditions, including available workforce.21 Workforce planning to ensure more equitable access for people with more complex needs is therefore one part of the strategy for addressing this deficit.22 Much of the NDIS workforce do not have specialised qualifications in disability, which makes them an easier workforce to come by and a workforce that is therefore cheaper for services to employ compared with experienced or qualified workers (and with wage costs reduced, enables easier profits). This can mean that the quality of support is lower even for those with lower support needs because the workforce may have limited knowledge of disability and have low expectations of what people with disability want and need to do, for example, beyond assisted showers, walks around the neighbourhood, and some social conversation. Participants prefer experience specific to their needs.23 Relevant experience does not necessarily come from training but may come from lived experience of disability and disability support, with many people prioritising interpersonal skills over qualifications in disability.24 Without an experienced workforce, people with complex language and communication disability (including one of the authors of this article with deaf‐blindness), for instance, will not have their needs understood and so remain marginalised. There is a fear that ill‐informed service providers sometimes act as gatekeepers denying supports that people with disability, the true experts, know they need: “They need to be able to have walked in our shoes”.25 These workforce deficiencies are structural problems enabled by deficiencies in the market structure that accompanies the NDIS and must be addressed to provide equity for people with disability.26 Aboriginal and Torres Strait Islander people with disability There are also cultural barriers to equity in the operation of the NDIS, with lower levels of plan utilisation in Indigenous people with disability.17 There are a number or reasons for this, including the number of Indigenous people living outside of major cities (56.8% v 31.6% non‐Indigenous) and in remote areas (9.8% v 0.8%).17 NDIS planning processes are fraught with challenges for Indigenous people living in regional and remote areas. The process of providing evidence of disability often causes significant stress and trauma.27,28 The principle and process of providing evidence is situated in a deficit model, requiring people to prove the experience of disability as a burden. This model of disability is the antithesis of Indigenous cultural ways of experiencing disability where disability is interpreted as part of the diverse human experience as opposed to a limitation or impediment.27,28 The NDIS is also designed on Western‐centric assumptions that all people with disability exist at the same starting line: house, shelter, food, family support. Many Indigenous people with disability are homeless, living in poverty or in overcrowded houses.29,30,31 To address equity for this group there needs to be Indigenous‐controlled service providers who generate whole‐of‐life case management to help Indigenous people with disability who are living in disadvantage understand and access the scheme.32 What next? Inherent in these tensions is a concern that a scheme that should be agnostic to diagnosis and provide support based on individual needs does not work well for those with more complex needs or whose experiences do not fit mainstream ways of understanding or experiencing disability. The NDIS is one mechanism through which Australia fulfils its obligations under the United Nations Convention on the Rights of Persons with Disabilities.33 Under the UN Convention, rights should be equitable, so should not be better enjoyed by people with some types of disability or needs over others. Equity decisions should not be outsourced to a market where decisions of profit compete with decisions about equitable service access. In order to ensure equitable disability support, we need to consciously build a disability support system (including the NDIS) that i) ensures that decisions with equity consequences do not rely on the goodwill of service providers but are a product of market design, and ii) that provides a cohesive system structure that enables access to necessary services for people with disability sitting outside the NDIS (including people aged over 65 years). The National Disability Insurance Agency has significant existing powers to make decisions affecting scheme equity through scheme redesign to address underutilisation and, at a micro‐level, through decisions relating to individual participants. Key to realising equity is an adaptive approach to the design of social care markets where all parts of the market are not treated in the same way.26 This approach means that the areas of disability support that work best within a traditional market environment may continue to function in that way but with government directing markets in a proactive way to provide supports for people with complex or unique needs. This could include increased pricing for services for particular groups or locations or appointing providers to deliver services where markets do not emerge to provide services. We urgently need evidence for how this can be done successfully.34 It is critical that issues of equity for people with disability, both within and outside the NDIS, are brought to the fore in the current NDIS review. A failure to address inequity within the operation and design of disability support means that the NDIS will continue to perpetuate the disabling and ableist structures that marginalise people with disability in the Australian society.

Jennifer Smith‐Merry · John Gilroy · Annmaree Watharow

Mja2 51899

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