Government targets quality in proposed PIP overhaul

The AMA has expressed concern that a proposed major shake-up of the Practice Incentives Program is not being supported by increased investment in general practice.

The Health Department has unveiled plans to “refresh” the 18-year-old PIP system by slashing the number of incentive payment categories on offer, reducing the administrative burden on practices and intensifying the focus on quality.

Under the proposal, outlined in a discussion paper released by the Department, seven existing payments covering asthma, cervical screening, diabetes, aged care access, prescribing, Indigenous health and procedural GP incentives would be axed; four existing payments, covering rural loading, after hours services, teaching and e-health – would be maintained; and a new Quality Improvement Incentive payment would be introduced.

The AMA has welcomed the increased focus on quality, and is in consultation with the Department over the proposal to collapse the PIP payment categories.

But it voiced concern that the changes were not being supported by an increase in financial support for GPs, particularly given that many practices are being pushed to the financial brink by the Medicare rebate freeze and the prospect of cuts to pathology collection centre rents.

The Department has indicated that there will be no extra money injected in the PIP scheme.

It said the quality incentive payment would be used to “give general practices increased flexibility to improve their detection and management of a range of chronic conditions, and to focus on issues specific to their practice population”.

The push to overhaul the PIP system comes at the same time the Government is launching the initial stage of its Health Care Home model of care and undertaking a comprehensive review of the 5700 services listed on the MBS.

The Department said the initiatives together would “take the health system towards services that are aligned with contemporary practice”.

The case for changes to the PIP has been mounting in recent years, with a number of organisations including the Australian National Audit Office, the Organisation for Economic Co-operation and Development and the Grattan Institute all raising concerns that the system imposed an unduly heavy administrative burden on practices and was failing to keep up with evolving health needs and priorities.

The Department said the evidence showed that many existing incentives might be no longer appropriate, and that the more could be achieved by intensifying the focus on quality, including by making better use of data.

“Redesigning the PIP would enable it to move away from process-focused funding towards a simpler system that encourages quality improvement and innovation, and allows practices to see improvements in measures that are important to them,” it said.

Precisely how this could be achieved was up for consultation and debate, the Department added.

It suggested two options. One would be to merge all five PIP items (including the new Quality Improvement Incentive) into a single payment administered by the Department of Humans Services – essentially building on and adapting existing arrangements. Eligible practices would receive sign-on and quarterly payments, to be used to make quality improvements of their choosing.

Under the second option, the Department would no longer directly fund practices. Instead, practices would use PIP funds to engage third-party providers to support their quality improvement work.

Whatever the option chosen, practices would be required to regularly share data to map quality improvements, individually, locally and nationally.

The Government is inviting submissions on the proposed PIP overhaul. The deadline is 30 November.

The Department’s consultation paper can be downloaded here.

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Gene tests on ‘don’t do’ list

Medical experts have taken aim at ‘direct to consumer’ genetic testing services amid concerns that they are causing unnecessary expense and alarm.

Medical experts have warned that patients should not initiate genetic tests on their own, particularly for coeliac disease and for the genes MTHFR and APOE, which are, respectively, associated with levels of folate and susceptibility to Alzheimer’s disease.

The Gastroenterological Society of Australia has recommended against genetic tests for coeliac disease because the relevant gene is present in about a third of the population and “a positive result does not make coeliac disease a certainty”.

Similarly, Human Genetics Society of Australasia Clinical Professor Jack Goldblatt said variants of the MTHFR gene were “very common in the general population [and] having a variant in the gene does not generally cause health problems”.

Additionally, Professor Goldblatt said that although the APOE gene was considered a risk factor for Alzheimer’s, “having a test only shows a probability, so people undertaking [the test] can also risk being falsely reassured”.

“Unnecessary genetic testing can lead to further unnecessary investigations, worry, ethical, social and legal issues,” he said. “In particular, we caution people to not initiate testing on their own. Genetic tests are best performed in a clinical setting with the provision of personalised genetic counselling and professional interpretation of test results.”

The recommendations are among 20 made by the Gastroenterological Society of Australia (GESA), the Royal Australian and New Zealand College of Radiologists (RANZCR), the Human Genetics Society of Australasia and the Australasian Chapter of Sexual Health Medicine, as part of program being coordinating by the Choosing Wisely Australia campaign to improve the use of medical tests and treatments.

The advice includes cautioning women against self-medicating for thrush, improved use of radiation therapy to treat cancer, and careful use of colonoscopies.

Professor Anne Duggan from GESA said colonoscopies had a “small but not insignificant risk of complications”, and those undertaken for surveillance placed “a significant burden on endoscopy services”.

Professor Duggan said surveillance colonoscopies should be targeted “at those most likely to benefit, at the minimum frequency required to provide adequate protection against the development of cancer”.

The RANZCR said radiation treatment was “a powerful weapon” in the treatment of cancer, and half of those diagnosed with the disease would undergo radiation therapy.

But the College advised that such treatment should be provided within clinical decision-making guidelines, “where they exist”.

In particular, it has recommended sparing use of radiation to treat prostate cancer.

Dean of the College’s Faculty of Radiation Oncology, Dr Dion Forstner, radiation oncology might not be immediately required where prostate cancer is diagnosed.

“Patients with prostate cancer have options including radiation therapy and surgery, as well as monitoring without therapy in some cases,” Dr Forstner said.

The College also advised that while whole-breast radiation therapy decreased the local recurrence of breast cancer and improved survival rates, recent research had shown that shorter four-week courses of therapy could be equally effective “in specific patient populations”. It said patients and doctors should review such options.

The Chapter of Sexual Health Medicine made several recommendations, including advising against tests including herpes serology and ureaplasma in asymptomatic patients, and the use of serological tests to screen for chlamydia, because of frequent inaccuracy and the possibility of false-positive results.

In addition, it flagged concerns about the treatment of thrush.

Chapter President Dr Graham Neilsen said it was concerning that many women with recurrent and persistent yeast infections self-administered treatment, or were prescribed topical and oral anti-fungal treatments.

Dr Neilsen said it was important that patients had “good conversations” with clinicians about appropriate care.

“It is important to rule out other causes…such as genital herpes or bacterial vaginosis, so that other infection are not left untreated,” he said. “As well as the importance of ruling out other causes before commencing anti-fungal agents, inappropriate use of antifungal drugs can lead to increased fungal resistance.”

The 20 recommendations are the latest instalment in an ongoing program, coordinated by Choosing Wisely, in which 23 medical colleges and societies are working to improve the use of tests and treatments based on the latest evidence.

The process is separate from the Federal Government’s MBS Review, which is examining all 5000 items on the Medicare Benefits Schedule.

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AMA at the table on health insurance reforms

The Federal Government continues with its reforms to health care, shifting focus to the private health sector.

Health Minister Sussan Ley has recently established a Private Health Ministerial Advisory Committee (PHMAC) to develop recommendations across a range of policy areas relevant to private health.

The PHMAC follows on the work earlier in the year of an industry working group on reforms to the Prostheses List. The Prostheses List sets out the reimbursement amounts for thousands of prostheses used in the private health system.

The Minister has announced reductions in the benefit amounts for some prostheses to support a reduction in cost to private health insurers and a consequential reduction in private health insurance premiums for consumers.

The benefits for a small number of prostheses will be reduced from February 2017, including a:

10 per cent reduction across the cardiac devices category;
10 per cent reduction to the ophthalmic (intraocular lenses) category;
7.5 per cent reduction across the hip product category; and
7.5 per cent reduction across the knee product category.

In total, these reductions are expected to deliver savings of $86 million to health funds in the first year, and $394 million over five years. The Minister has also announced moves towards a more transparent pricing model with open disclosure.

The work of the PHMAC is now underway as the second part of the reforms.

The Committee’s terms of reference include a closer examination of private health insurance (PHI) product design with simplified consumer products; standard product categories; the role of exclusions and restrictions; appropriate excess levels; and the scope of services covered by PHI.

The Committee will also look at consumer information; premium setting; second tier default benefits; risk equalization; single billing; lifetime health cover; and providing better value for rural and remote consumers.

The first meeting of the PHMAC considered some early thinking from the private health insurers on product design and a potential ‘Gold/Silver/Bronze’ product classification model.

These are all important areas for review.

The AMA has a strong interest in the work of the Committee and its outcomes.

The AMA has a commitment to a viable private health sector and sees the work of the Committee as key to strengthening the sector and maintaining its relevance and attractiveness to patients into the future.

I am representing the AMA on the PHMAC, using a reference group of senior clinicians to provide advice in the lead in to each meeting.

The AMA will make available on its website the outcomes from each meeting (which are circulated for publication).

I welcome comment and input from members. The work of PHMAC will inform the shape of private health care funding for years to come. It is important that the AMA voice is heard.

Appropriateness of care: why so much variation

Broad descriptions of variation are a useful way of finding disparities, but to generate change they need to be carefully analysed and applied

The Supplement accompanying this issue of the MJA addresses variation in health care delivery as an important theme in ensuring appropriate care across the health system. While all would agree that health care should be provided as and where needed, and that only appropriate care should be delivered, difficulties arise when seeking consensus on what variation is “appropriate” and what should be done about it.

Complex systems are inherently variable. Indeed, a multitude of data shows variation in clinical practice but there is less consensus on its implications. For example, while one focus is high utilisation, there is also an issue with underutilisation, raising issues of equity. Aboriginal and Torres Strait Islander people receive fewer interventions for a range of major health conditions than non-Indigenous Australians; the age standardised rate of coronary procedures is 40% lower.1 Overall, the lowest quintile by socio-economic status of area of residence has 78.8 elective hospital admissions involving elective surgery per 1000 population compared with 91.5 for the highest quintile.2

Geographic variation is the focus of the recent Australian Atlas of Health Care Variation,3 summarised in the Supplement by Buchan and colleagues.4 The Atlas compares extreme high and low rates of interventions, using about 350 areas. An earlier report by the Australian Commission on Safety and Quality in Health Care (ACSQHC) and the Australian Institute of Health and Welfare calculated a systematic component of variation and provided a comprehensive picture covering 60 Medicare Locals, which were in place at that time.5

The two reports focus attention on variation, emphasising unwarranted variation, but crucially they do not define “unwarranted”. While presenting a high profile call for action, priority areas for action are not suggested.

In their Supplement article, DaSilva and Gray,6 noting English experience, point out that an atlas can be used to draw attention to variation, but engagement with clinical and health management leadership is essential for an effective response. Drawing on United States experience, they warn that the transformative promise of variation can disappoint without clinical and political commitment. The authors conclude that:

It is not sufficient to publish an Atlas of Variation … and expect it to have remarkable impact. An Atlas of Variation needs to be an integral part of a larger transformational change program.6

The limited available evidence indicates that public reporting alone has minimal impact on changing clinical practice.7 Change may also be facilitated by considering local factors.8 Atkinson and colleagues identified 13 factors required for system change, including microsystem capacity, credible evidence, engagement, peer support and integration into routine practice.9

In 2016, the Grattan Institute released an analysis of variation in preventable conditions across Victoria and Queensland.10 The report set the bar higher for addressing variation, noting the need for a time series when targeting action. The Institute found that 15% of areas exceeded their variation benchmark each year, but only 5% exceeded it for 3 successive years. It proposed identifying areas showing sustained variation and developing response strategies in consultation with all stakeholders.

Financial incentives are another approach. In the Supplement, Hall and van Gool report disappointing evidence that financial incentives improve quality, and note possible unintended effects through gaming or patient selection.11 Moreover, complex Australian health care financing arrangements make it difficult to share the economic benefits of reductions in practice variations among the various stakeholders. Caution is therefore necessary in considering financial incentives.

A weakness of variation data is that they are always explicable by specific variables, such as patient factors or legitimate process differences. One way to deal with this is to use variation data to identify where change may appear warranted, and then focus on the development of mutually agreed standards of best practice care. Contributions in the Supplement reflect the important work that the ACSQHC has undertaken in this regard: Chew and colleagues describe the process for developing clinical care standards in Australia;12 important examples are provided by Caplan and colleagues (cognitive impairment)13 and Turnidge and colleagues (antimicrobial stewardship).14 However, as noted above, these need to be incorporated into broader micro and macro change strategies.

Wilcox and McNeil argue that clinical registries can play a role in identifying quality interventions and clinical pathways, and indeed the ACSQHC has published guidelines for clinical registries.15 Registries are potentially a link between high level policy and practice variables of interest to a given clinical community. A strategy is now needed to link clinical registries with national hospital data collections, to better inform understanding of in-patient activity variation and performance.

In conclusion, broad descriptions of variation are a useful way of finding disparities, but will not of themselves generate change. To point the way to useful policy change, they need to be carefully analysed and applied.

Variation needs to be addressed as part of the broader quality and safety agenda, where political commitment has been hard won over the past 20 years. Regular, considered reporting of variation may assist, but is not in itself a magic bullet.

Restructuring primary health care in Australia

When appropriately resourced, medical homes can deliver the system-wide benefits of truly integrated primary care

For patients with chronic and complex conditions, optimal care involves a range of clinical skills other than those provided by doctors (eg, a social worker, a clinical nurse specialist or a home care team), some of which are generally not available through Medicare. Patients experience fracturing of their care — such as the need to obtain referrals to consult other health practitioners — and significant out-of-pocket expenses, on which Australians spent around $27.5 billion dollars in 2013–14.1

If both doctors and patients are dissatisfied2 with the current primary care system, what do we wish to offer in the future? Imperatives include a highly personalised service that improves the patient’s health literacy and capacity to better care for themselves and their dependants; continuity of care, important for early detection of problems before they become chronic and complex; the availability of in-house teams to provide most of the services required to efficiently manage chronic, complex illness; and care in a community setting for many patients who would currently be sent to hospital.

In the international setting, the evidence suggests that primary care delivered via the medical home model has been most successful in achieving the goal of truly integrated primary care.3,4 However, international experience demonstrates that the success of the model requires the availability of a specific supportive infrastructure.5,6

The medical home

A key factor in the success of this model involves patients identifying with a practice that assumes responsibility for the holistic care of patients. The voluntary enrolment by the patient in a practice of their choice and the psychology associated with it are also important.7 A sense of belonging to a facility where all health problems can be managed is reassuring and promotes adherence to the advice given.5 Medical homes foster a culture of partnership and expectation and those enrolled accept the obligation to deal with problems that might produce illness or compromise its management. Likewise, the medical team is responsible for helping their patients to avoid or manage health problems.8,9

The staff of a well resourced medical home might include doctors, nutritionists, a social worker, various nurse specialists, physiotherapists, occupational therapists and a dental hygienist. For example, in a new suburb with young families, the medical home might have paediatric nurse specialists and pregnancy management experts, but elsewhere with an older demographic, nurses with geriatric and palliative care expertise might be essential. The exact nature of a given team is determined by the needs of the patients enrolled in the practice. In other countries, the most successful medical homes use electronic health records and offer members electronic connectivity with their team. The Kaiser Permanente group in the United States has turned two million face-to-face consultations with a general practitioner into email-based consultations over the past 10 years to the satisfaction of all parties.10

Because of the continuity of care, which involves appropriately scheduled visits, the team is aware of patients whose health is fragile and who need care in their homes or other community setting. Outreach to such patients can markedly reduce deteriorations that might require hospital admission.5 An effective community intervention in the 3 weeks before patients require hospital care may reduce the number of preventable admissions, which are estimated to be about 600 000 per year in Australia.11 Electronic connectivity — using platforms such as email, Facebook or FaceTime with patients, their carers and local hospitals — is imperative for this model.12

Specialists may wish to affiliate with medical homes, but if international trends are followed, more specialists will visit or practice near medical homes creating what has been referred to as the “patient-centered medical neighbourhood”.13

The model focuses on mutual respect for the skills of different health professionals and a commitment to the central role of the patient with an emphasis on prevention.

After 2009, many countries (eg, the United Kingdom, US and New Zealand) using well resourced medical homes have reported reductions in hospital admissions of 20–24%.5,6

Introduction of the medical home model to Australia

The Australian government has recently announced plans to establish a trial of health care homes with the aim of “[providing] continuity of care, coordinated services and a team based approach according to the needs and wishes of the patient”.14 The trial of this model, for which the government is providing $21 million, is due to start in July 2017, and finish 2 years later. Few details have been provided, but the concept is far from the fully resourced medical homes, whose effectiveness is supported by a strong evidence base. The government’s model relies heavily on some services, such as allied health, being provided outside of the medical home by the 31 Primary Health Networks.

Clinical and consumer champions of the initiative, who have embraced the concept, have convinced others to try the model. Government support, but not imposition, is critical and was a feature of the successful development of integrated primary care in New Zealand.15 Persuasion not regulations are needed and the old will for some time co-exist with the new.

In Australia, the introduction of better integrated primary care delivered from well resourced medical homes as a taxpayer-funded service will require professional, community and political support. The Royal Australian College of General Practitioners,2 the Royal Australasian College of Physicians16 and the Australian Medical Association17 have endorsed the need for trials of the model in Australia. The opposition to the move from all Medicare payments being a fee-for-service has dissipated.17 The model is easily understood by consumers and enthusiastically embraced in many countries.12,18

Remuneration and structure

Remuneration for GPs will occur via a blended payment model, where the majority of income is derived from salaried or contractual arrangements, not fee-for-service payments. Since 2009 in New Zealand, 85% of the public have enrolled in a primary health care program and 85% of GPs are being remunerated via this model.19 Similar initiatives have occurred in the US since 2011, where in many areas, around 65% of GPs are being remunerated using a blended payment model.5,20

Looking at international trends and the history of provision of primary care by the private sector in Australia, we envisage that most medical homes will be independent, privately run organisations. Many of them may be established as companies limited by guarantee or as not-for-profit organisations.12 Consumer involvement will be enhanced by representation on the boards of such companies. Clinicians will be financially rewarded for keeping patients healthy. Through their efforts, the clinical team will build up a business that is valuable and their equity in the endeavour improves their overall financial wellbeing.12

Costing and funding

Pricing skills have been developed in Australia over the past decade to support activity-based funding for hospital care, where the hospital is funded for the casemix of patients it treats. Similar methodology will be needed as we develop new costing and payment systems for primary care services.

There is evidence that the medical home model of care can be adequately funded, with overall expenditure on health remaining in the range of 10–12% of the gross domestic product.21 Over time, the growth in the amount of funding required will be offset by the increased productivity of a healthier population.

A continuous effort to reduce health system-wide inefficiency will be equally important as we move to implement the new model of primary care. Ongoing work of agencies, such as the Agency for Clinical Innovation, to standardise optimal regimens for disease management must continue.22 Dissemination and uptake of these recommendations will reduce variations in clinical care and improve cost effectiveness. Savings will also come from reductions in rates of hospital admission and specialist visits.5,23

Experience from the implementation of this model, in Australia and internationally, will provide a constant stream of learnings that may lead to refinements of the outlined blueprint. However, there is an acceptance among countries in the Organisation for Economic Co-operation and Development that contemporary health systems need to emphasise and resource both prevention strategies and team management of chronic disease if health care is to be equitable and cost-effective.

Health care variation: time to act

Why are knee replacement rates in Australia over four times higher than they are in Israel? Or the rate for caesarean deliveries nearly twice as high as in Finland? These findings come from an Organisation for Economic Co-operation and Development report that highlighted substantial variation in the rates of several common health care interventions both across and within 13 countries.1 These types of geographic variations in health care use have been consistently demonstrated over long periods of time and for a vast range of clinical interventions.2–6

Variation in health care use across Australia has now been mapped in the recently published Australian atlas of healthcare variation, produced by the Australian Commission on Safety and Quality in Health Care (ACSQHC) and the National Health Performance Authority.7 Health care use by location of patient residence is mapped using standard geographic regions. Rates are standardised by age to adjust for age differences between different geographic populations. Data used to produce the Atlas have come from three datasets: the Admitted Patient Care National Minimum Data Set (APC NMDS), covering patients admitted to public and private hospitals; the Medicare Benefits Scheme (MBS) claims database (use of medical services, procedures and tests covered under this scheme); and the Pharmaceutical Benefits Scheme (PBS) claims database (use of subsidised prescription medicines). This is the first time that data from all these datasets have been used to explore variation across health care settings.

Information on dispensing of antimicrobials, use of diagnostic investigations, interventions for chronic disease, mental health interventions (including use of psychotropic medicines), opioid dispensing and use of surgical procedures are presented in the Atlas. For most hospital admissions, the data are from the 2012–13 financial year. MBS and PBS data are for 2013–14. In Australia, there is high overall use of some drugs, such as antimicrobials and antidepressants, and considerable variation in the rates of some interventions, even when outliers are excluded (Box). Marked regional variation is apparent in rates of surgical interventions such as hysterectomy, endometrial ablation and MBS-funded cataract surgery. There are differences between states in use of psychotropic medicines. The patterns of hospital admission for chronic conditions, with higher rates in rural and regional Australia, contrast with the patterns seen for many elective surgical admissions. Some interventions are used more in areas of higher socio-economic status or, like knee arthroscopy, are known from previous work to be provided mainly in private settings.2 There is no public/private breakdown provided in the Atlas — this would be a useful next step in order to explore the extent to which there are discrepancies in access because of people’s ability or willingness to pay for health care.

Reasons for observed variation

Some variation will reflect differences in need for health care because of differing disease prevalence or severity. Studies of variation aim to account for demographic differences in disease prevalence by standardising results for age and sex. Variation in disease severity is more difficult to adjust for at the population level or to determine using routinely collected health care data. The same limitation applies to risk factors for disease.

Some observed variation may be explained by differences in patient preferences for type of care; for example, choice of medical rather than surgical treatment or for “aggressive” rather than “conservative” management.

Variation may reflect problems with datasets such as incomplete capture of information or inconsistency in coding practices. It may also be random variation — a particularly important consideration when analysing small populations.

Use of health services is clearly related to their supply and accessibility.1,8 High intervention rates for some types of care may reflect poor access to alternatives. One reason for the marked variation in dispensing of psychotropic medicines noted in the Atlas may be a lack of access to alternative mental health care. Similarly, decreased access to community care among rural and remote populations may explain some of the higher rates of hospitalisation in these communities for chronic diseases examined in the Atlas. Less use of elective surgery may be due to lack of local service capability or the inability of patients to pay for private care. Methods for funding or reimbursing costs of health care can markedly influence service provision. Remuneration methods that reward greater volumes of procedures provide incentives to both individual health care providers and organisations for higher rates of servicing.

Clinical decisions are a key driver of health care variation. Practice patterns of individual doctors are influenced by their knowledge, skills, experiences and differences in beliefs about the benefits or harms of specific interventions.9 Even when robust evidence on effectiveness is widely disseminated and well publicised, practices that are at variance with the evidence may remain entrenched in some areas. The personal preference of surgeons for certain types of procedures, irrespective of published literature on effectiveness, can exert a marked effect on rates of use.10–13 Thousands of Australians aged 55 and over continue to have knee arthroscopy, with markedly different rates across the country, despite evidence that arthroscopy for treatment of uncomplicated degenerative disease is no better than placebo and potentially harmful.7,14–16 Practices known to be effective, such as foot care for people with diabetes, are not consistently employed.17 Such variation highlights problems with the way research on effectiveness is translated into routine practice.

Variation may also result from “indication creep” when a treatment shown to be beneficial within a narrow set of indications (eg, for younger patients with severe disease and few co-morbidities) becomes used in patients with a broader set of indications (eg, for people with less severe disease or older patients with multimorbidity) where there is little or no evidence of effectiveness.

While there is general agreement about the usefulness of operations such as total knee replacement in patients with severe osteoarthritis, there are controversies in the literature about how some patient characteristics affect operative outcomes. Doctors differ in their opinions about which patients will benefit most, leading to different patient selection and different practice patterns.13,18 While studies comparing the long term results of different treatment strategies for the same condition in “real world” patients are starting to be reported,19 the lack of use of routine measures of patient outcome, and the risk of confounding by selection bias, mean considerable uncertainty remains about the true effects on patients of these differences in practice.

Differential use of new therapies with uncertain or unproven benefit also drives variation. The need for a system for controlled introduction and evaluation of new surgical techniques and medical technologies in Australia has been recently highlighted.20

Warranted versus unwarranted variation

Substantial variation in health care use that cannot be explained by patient needs or preferences is often referred to as unwarranted variation.1 It may reflect both underuse of care of proven benefit, raising concerns about equity and the unrealised potential for better health, or overuse of care that is ineffective or likely to confer net harm, thus posing a needless threat to patients and an opportunity cost to a society with limited resources.

Identifying the rate of use of an intervention that is most appropriate within a defined patient population is a major challenge in studying warranted versus unwarranted variation. Routine data collection currently captures a large amount of information about what care is delivered in the health care system, and how long people wait to receive it, but very little about the indications for care and patient outcomes achieved as a result.

Patient-reported outcome measures are mandated for some types of surgery in the United Kingdom21 but are not routinely used in Australia. Linkage of data from different sources to follow up patient health status (while ensuring privacy protection) is another means of determining information on outcome, but while there are some state-based systems for record linkage — for example, in Western Australia data linkage has been undertaken for several decades22 — such linkage is not routine at the national level.

Accurate measurement of the outcomes for people who undergo common or costly interventions would help clarify which types of patients (outside of research settings) are most or least likely to benefit from care. It would also help determine the appropriate population rate of intervention use for specific clinical indications, and would allow for comparisons of variation in outcomes, in addition to variation in use, of interventions.

Defining benefit thresholds is also particularly important in avoiding the natural inclination to assume that, when confronted with a range of low or high use outliers, the mid-point or average value is necessarily the one that reflects the most appropriate rate of use.

Analysing variation

Datasets used to explore variation should satisfy certain requirements. Comprehensive population coverage provides confidence that any observed variation is not due to differential capture of information across geographic areas. Age, sex and residence of the person receiving care are required for standardisation and mapping. The geographical regions used to report variation must have a population of sufficient size to prevent identification of individual patients and health care providers.

The three datasets used for analysis (APC NMDS, MBS, PBS) were established for administration and reimbursement purposes and currently have some limitations when used to investigate geographic variations in health care use. MBS and PBS data do not contain diagnostic information or the reason for provision of the service. Information on most public hospital drug usage, private prescribing or over-the-counter sales is not captured by the PBS data, nor is information on some medicines dispensed by Aboriginal health services. Pathology testing data are only captured on the three most expensive tests ordered for each patient and, as with medicines, information on most of the tests provided free of charge to public patients in hospitals is not captured. The APC NMDS contains detailed diagnostic and procedural information on admissions to a public or private hospital in Australia, but does not include details of tests ordered or drugs prescribed.

As a result, some types of care provided in the system are not consistently captured by any of these three datasets. For example, it is not possible to obtain an accurate picture of variation in total use of magnetic resonance imaging across public and private sectors. The lack of standardised hospital admission policy means some observed variations may be due to differences in admission practices rather than differences in care provided.

Despite their limitations, these three datasets provide the best available information in Australia for identifying variations in health care use. They could be rendered even more useful if some of the issues noted were remedied. Linking individual-level data across these datasets, and with death registries and other clinical or population datasets (while ensuring patient confidentiality), would provide better information about outcomes. It would also help highlight areas where care could be improved; for example, whether there is variation in secondary preventive care for specific conditions after discharge from hospital.

Responses to evidence of variation

The aim of publishing data showing variation in health care is to prompt investigation into why variation is occurring and to ensure that patients receive appropriate care. Reasons for variation need to be examined at a local level using information about service provision that is not available nationally and data sources such as registries that contain clinically richer collections of information about patient care delivery and its outcomes. Within the Atlas, there are 67 recommendations for action. States and local health care organisations should review data and practices in their region, particularly where they are outliers. Some findings have been referred for review by national bodies such as the Pharmaceutical Benefits Advisory Committee; for example, the use of topical quinolones and access to amoxicillin-clavulanate on the PBS. For some items, review of the need for evidence-based guidelines or for new Clinical Care Standards23 is identified; for example, a clinical care standard for the management of osteoarthritic knee pain. Mandated adherence to the National Safety and Quality Health Service Standards24 provides a mechanism for increasing use of evidence-based practice. The Australian Health Practitioner Regulation Agency and national boards are asked by the Commission to consider what can be done to ensure registered health professionals have up-to-date knowledge of prescribing guidelines.

Some recommendations focus on improving patients’ understanding of their care options. Evidence suggests shared decision-making approaches enable people to better choose among different options with associated benefits in terms of better knowledge and more accurate expectations of the likely effects.25,26

Medical colleges and clinical groups may investigate and respond to the data in the Atlas in a variety of ways, including via guidelines, performance measures, audit and feedback and various behavioural incentives.27

Researchers have documented large and persistent variations in health care use, far beyond that explainable by patient need or preference, for many decades.28,29 Research into causes and consequences of variation has been less prolific and linking research to action on unwarranted variation has been problematic. The involvement of policy agencies and clinical organisations in the generation and use of the Australian Atlas offers the opportunity to link investigation of variation with policy levers and actions by health care organisations and clinical groups to reduce unwarranted variation.

Box –
Selected data items from the Australian atlas of healthcare variation7

Data item	Data source	Rate per 100 000 people*	Times difference^†	Times difference^† excluding outliers	No. of procedures performed/prescriptions dispensed

Fibre optic colonoscopy	MBS	146–4374	30.0	4.1	589 748
Computed tomography of the lumbar spine	MBS	209–2464	11.8	2.7	314 033
Knee arthroscopy (people aged ≥ 55 years)	APC	185–1319	7.1	4.2	33 682
Tonsillectomy (people aged ≤ 17 years)	APC	254–1640	6.5	3.0	38 575
Hysterectomy and endometrial ablation	APC	131–687	5.2	3.3	34 181
Antidepressant medicines, prescriptions dispensed (people aged 18–64 years)	PBS	14 981–175 380	11.7	2.8	14 933 534
ADHD medicines, prescriptions dispensed (people aged ≤ 17 years)	PBS	382–28 642	75.0	7.3	544 218
Anticholinesterase medicines, prescriptions dispensed (people aged ≥ 65 years)	PBS	1843–28 261	15.3	3.7	427 211
Opioid medicines, prescriptions dispensed	PBS	10 945–110 172	10.1	2.9	13 905 258
Diabetes-related lower limb amputations (people aged ≥ 18 years)	APC	8–91	11.4	2.5	4402

ADHD = attention deficit hyperactivity disorder. APC = Admitted Patient Care National Minimum Dataset (financial year 2012–13); includes public, private and day hospital admissions. MBS = Medical Benefits Schedule (financial year 2013–14). PBS = Pharmaceutical Benefits Schedule (financial year 2013–14). * Range across local areas: rates standardised based on the age structure of the Australian population in 2001; local area refers to Australian Bureau of Statistics standard geographic region known as Statistical Area Level 3 for all items except diabetes-related lower limb amputations, which was analysed at Statistical Area Level 4 because of confidentiality requirements given the low number of admissions. † The difference in rates between the areas with the lowest and highest rates for the specific procedure/medication.

Paying hospitals for quality: can we buy better care?

The idea of paying more for better quality care and paying less (or not at all) for poor quality care appears inherently sensible, and has motivated several attempts to introduce financial incentives for improving the quality of health care. These range from bonus payments to hospitals that meet specified clinical indicators for particular conditions (Queensland and Western Australia are currently implementing such schemes) or paying for structures that encourage quality (including higher payments for achieving accreditation), to penalties for poor quality, such as withholding payment for “never ever events” or shocking medical errors, such as wrong site surgery (as applied in the United Kingdom and by the United States Centers for Medicaid and Medicare Services).1,2 Activity-based funding for hospital care is widely used across the world, and quality payments are generally applied as adjustments to the case payments. Financial incentives that reward quality are also applied in primary care, but this article will focus on hospitals.

Two key questions must be considered when thinking about paying for quality. The first is whether the standard case payment is inadequate for providing quality care; that is, whether appropriate quality care, even when supplied efficiently, simply costs more than the case payment. The second is whether the use of rewards (and penalties) will encourage more appropriate or higher quality care. Any use of payments or other incentives obviously requires a clear definition of appropriate quality.

The first question involves the concern that quality could be actively constrained by not paying enough for care. There can be no sensible argument in support of paying too little to achieve appropriate quality; the question is whether it is likely to happen. In Australia, the casemix price paid through activity-based funding is based on the analysis of existing cost data supplied by public hospitals in all states and territories. Unless the present quality of care is significantly lower than appropriate, the national price will therefore reflect adequate care. This could change with technological advances or new evidence about clinical effectiveness. Incremental change is incorporated by regular revisions of casemix classifications and price. Even a major shock in terms of technological progress or additional evidence is likely to be focused on a particular case type, so that the impact on total hospital revenue would be marginal and corrected within a short period of time. While arbitrary cuts can be made by funders to the national price, these would not be a cost-based determination.

The second question is both more interesting and more challenging. Financial incentives that target health care use are generally effective, consistent with economic theory. It should follow that aligning incentives with quality improvement should enhance the quality of care. Evidence collected over the past decade has been disappointing in this respect,3,4 and more recent critiques are no more encouraging in terms of their finding improved health outcomes.5 One reason for these disappointing findings is that financial incentives are not precise, and there are wide differences in the characteristics and the contexts of the different programs. For example, incentives may be positive (extra payments) or negative (reducing or withholding payments). The incentives might apply at the hospital level, benefiting the hospital budget as a whole; at a clinical department level, benefiting the departmental budget; or be directed to individual clinicians, in cash or in kind. The size of the incentive ranges from token payments to substantial funding. This would make it difficult to generalise findings about outcomes, even if there were a series of rigorous evaluations. Any design or evaluation should therefore start by considering whether the financial incentive is well targeted and appropriate for the behaviour it is trying to change.

Financial incentives can be applied to hospital-level indicators that encompass all conditions, or be targeted at particular conditions. Targeting a particular condition is more precise, but loses the scope of the entire patient population. Even a high volume condition affects a small proportion of the patient population, so that a targeted program will achieve only a limited overall impact.

Incentives can be directed to reward either better outcomes or improved processes of care. While better health outcomes for patients are undoubtedly the desired end, good quality care does not guarantee a better outcome for the individual. Many factors other than the processes of care influence outcomes, and there is always an element of chance. Further, some outcomes may not be experienced until years after care has been delivered.

The economic principle underlying the design of payment schemes is that the funder should reward effort that promotes the interests of the funder. This requires that the hospital, department or clinician is rewarded for what they do and for how they manage factors within their control. Not surprisingly, most financial incentives are therefore applied to improving processes of care. However, to avoid losing sight of the desired better outcomes, evidence that improving the specified processes leads to better outcomes is generally required.

Establishing the evidence base is challenging. Hospitals are complex organisations and hospital care typically involves a variety of clinicians and diagnostic and treatment modalities. The links between incentive, process and health outcome depend on the actions and interactions of many different players.

As stated earlier, a performance payment alone does not achieve anything. Generally, a specific payment is grafted onto an existing payment scheme; and, unsurprisingly, what works in one context or in one organisational and funding model cannot necessarily be extrapolated to another. For example, whether funders and hospitals are operating in a competitive market or in a centrally controlled system will affect how a pay-for-performance model works. Additional payments grafted onto a population-funded model would be expected to have a different impact to paying the same reward as an adjustment of activity-based funding. Further, incentives are complex and encompass more than financial rewards. Professional status, striving for excellence, and effective leadership can each influence behaviour.6

Evidence of no benefit is not the same as no evidence of benefit. The first means that there is evidence that an intervention is not effective; the second that the necessary research has not been undertaken. Even without strong evidence of improved outcomes, some people would argue that rewarding good quality processes is, in itself, valuable because quality should be encouraged, and higher quality is more likely to improve than to harm outcomes. However, it is important to first ask whether there could be unintended consequences of payment schemes, and the answer is unequivocally: yes.

The initial effect of a payment incentive is to focus attention. Some reward payments are too small or too cumbersome for potential recipients to claim, making them ineffective. Where the incentive is sufficiently strong, the attention of management will be focused on how to maximise the rewards. While this will improve the measured processes of care, it will also draw attention away from other problems. It is difficult to establish what the opportunity cost will be, but improved performance in one aspect of care may come at the expense of foregone improvements, or even deteriorations, elsewhere.

Incentives can also have perverse effects by encouraging gaming. This can involve changing how treatment processes are counted, such as coding conditions as more complex case types; raising the threshold for recognising hospital-acquired conditions; re-defining a multidisciplinary case conference. This effect can be mitigated by monitoring and auditing processes. One of the more undesirable effects is patient selection: if there is a strong incentive to choose less complex patients, an unintended effect is that hospitals may favour easier cases, so that patients in greater need find it difficult to receive treatment. This is more challenging to monitor.

More significant is the problem of intrinsic and extrinsic motivation, which tends to be little discussed in this context. Intrinsic motivation is complex and powerful, and is vital in health care: care providers are motivated by doing their job well, caring for their patients, and gaining the respect of their peers. Extrinsic motivation relates to behaviour that is driven by external rewards; financial incentives are clearly an important form of extrinsic motivation. Not only do extrinsic motivators lose their effectiveness over time, however, they can “crowd out” or displace intrinsic motivation. As a result, the rewarded behaviour is likely to fade once the reward is removed, even among those who were doing the right thing before the incentive is introduced.7

Any discussion of financial incentives should also address the notion of purchasing health gains. This is not as simple as it first seems. Let us assume that the Australian social value, or willingness to pay for a degree of health gain as measured in quality-adjusted life-years (QALYs), is about $75 000 (a reasonable estimate based on Pharmaceutical Benefits Advisory Committee determinations8). It does not follow that the Australian health care system should spend $75 000 for every QALY gained; this would certainly not maximise the health outcomes achieved by its budget.9 Specific health gains are delivered at a range of prices; for example, if it cost $15 000 per QALY for a particular treatment, paying $75 000 represents an overpayment of $60 000, or a loss of 4 QALYs. Maximising health outcomes requires starting with the lowest cost per QALY, and adding more expensive treatments until the upper budgetary limit, or the maximum social willingness to pay for a QALY, is reached.

Translated into hospital funding, this means not paying the same price for each unit of health gain. It means paying the efficient price for each treatment for each case type, up to the maximum social willingness to pay. It requires an umpire to set the efficient price for a case type, and a different perspective for determining whether this represents value for money. According to this argument, the price paid should reflect the efficient cost of production, but the volume of cases should be managed separately. The efficient price is intended to provide the incentive for better cost control, particularly in high cost hospitals. It is aimed at improving technical efficiency; that is, maximising the output for a given input.

Finally, getting the incentives to be consistent with the desired ends is only part of the challenge. Managers, clinicians and others involved in health care may be offered the “right” incentives, but, if they lack the skills and tools to identify what and how to effect change, they are powerless to respond.10

Financial incentives used alone are a blunt instrument. Their effectiveness will depend on the size and design of the reward or penalty, and also on how they reinforce (or are inconsistent with) other signals in the operating environment. It is therefore not surprising that it is difficult to reach general conclusions about their usefulness. It is even more difficult to reach conclusions about their relative cost-effectiveness compared with alternative approaches. Further, financial incentives have an opportunity cost, diverting funds and attention from other problems. Given what is known and what is still uncertain, it would be unwise to rush into their widespread use as a strategy for improving the quality of health care in Australia. Instead, they should be applied cautiously, with careful consideration of design and context and of the potential for unintended effects, and with evaluation of outcomes.

Clinical quality registries have the potential to drive improvements in the appropriateness of care

The effectiveness of clinical quality registries (registries) to monitor and benchmark patient outcomes is well established.1–3 There is also compelling evidence for the ability of registry information to drive continuous improvements in patient outcomes and adherence to guideline-recommended care.2–5 Systematic and ongoing collection of standardised data on medical and surgical interventions allows the identification and analysis of clinical practice variation and its effect on patient outcomes. Registry data has credibility with clinicians, stimulating increased use of evidence-based clinical management, decreased variation in care and improved patient outcomes.2,4

Capturing a high proportion of a registry’s eligible patient population is critically important in minimising the selection bias associated with incomplete capture. A low capture rate renders the pool of results unrepresentative and ungeneralisable, thus weakening the power of a registry to inform policy determinations.3 Omissions of data within a single clinical unit create the potential for “manipulation” of included and excluded data, thus weakening the credibility of unit-level reports and their ability to drive change.

Current reporting in Australia

A small number of national registries in Australia now capture a high proportion of their eligible patient populations. These include the Australia and New Zealand Dialysis and Transplant Registry,6 the Australian Orthopaedic Association National Joint Replacement Registry,7 the adult and paediatric registries run by the Australian and New Zealand Intensive Care Society,8 the Australasian Rehabilitation Outcomes Centre9 and the Palliative Care Outcomes Collaboration.10

Examples of how these registries report on rates of appropriate or recommended care include reports from the Australia and New Zealand Dialysis and Transplant Registry, which show improvement in the preferred type of vascular access — arteriovenous fistula — for haemodialysis patients over the period 2008 to 2012 (Box 1).11

The extent of adherence to guideline-recommended care delivered in intensive care units (ICUs) across Australia is demonstrated by information provided by the Adult Patient Database8 of the Australian and New Zealand Intensive Care Society’s Centre for Outcome and Resource Evaluation. Box 2 shows the high proportion of ICU admissions for which the patient received guideline-recommended care for venous thromboembolism prophylaxis each year for 5 years.8

Data from the Australasian Rehabilitation Outcomes Centre (AROC) demonstrate improvements in a key process indicator — assessment of functional status — for rehabilitation care provided in Australian hospitals over the period from 2002, when the Centre opened, to 2015 (unpublished data provided by AROC, July 2016) (Box 3).

The Palliative Care Outcomes Collaboration (PCOC) collects data from palliative care services across Australia on the length of time palliative care patients spend in the unstable phase of illness. An unstable phase ends when a new plan of care is in place, has been reviewed, and no further changes are required. A patient is considered to have an acceptable outcome if they experience no more than 3 days of instability. Information reported by the PCOC shows a considerable improvement in palliative care services achieving this benchmark over the period 2010–2015 (unpublished data provided by PCOC, July 2016). For care provided in hospital, the proportion of patients spending no more than 3 days in the unstable phase increased from 57% in 2010 to 86% in 2015. Similarly, for patients receiving care at home, the proportion increased from 41% to 76% (Box 4).

Governments across Australia have developed a number of registries with a jurisdictional focus. The Victorian Department of Health and Human Services, in particular, has invested in a significant number of clinical quality registries. In some instances, substantial funding has been made available by other organisations such as the Victorian Transport Accident Commission, Medibank Private and the Movember Foundation. Some state-based registries such as the Victorian Cardiac Outcomes Registry and its counterparts in South Australia, Queensland and New South Wales are collaborating to develop nationally consistent datasets.

There remains, however, limited capacity across Australia to benchmark outcomes and assess the degree with which health care aligns with evidence-based practice in a number of high priority clinical domains. In 2011, Evans and colleagues conducted a national survey to determine the capacity of Australian clinical registries to accurately assess quality of care. Of 28 registries surveyed, the majority were found to require modifications to provide useful and reliable information for quality improvement purposes. Thirteen of the 28 registries (46%) recruited fewer than 80% of the eligible population. Twenty-three surveyed registries (82%) did not formally audit reliability of coding at the clinical level and five (18%) did not collect the information required for basic risk adjustment of outcome measures.12

In a 2010 systematic review of how medical registries provide information feedback to health care providers, van der Veer and colleagues confirmed findings from previous studies that process of care measures — such as adherence to guideline-recommended treatment or treatment modality, time to treatment, and use of secondary prevention medication — are more readily influenced by feedback than by outcome measures.13 However, national measurement of health care appropriateness (as measured by how closely care aligns with guidelines) in some important clinical domains such as acute coronary syndrome and stroke care has relied on intensive periods of clinical audit.14,15 This could be monitored more effectively using registries, which routinely collect a minimum dataset. Well constructed registries collect and report information on both the effectiveness of care (outcomes) and the appropriateness of care (process) on an ongoing basis, obviating the requirement for clinical audit.3,16,17

Some Australian registries are developing to the point where national auditing of clinical care will no longer be required in order to gain an accurate picture of national outcomes and patterns of care. The Australian Cardiac Outcomes Registry18 intends to develop its collection of outcomes data for patients with acute coronary syndrome along with processes of care data in line with the Guidelines for the management of acute coronary syndromes 2006.19 The recently launched Australian and New Zealand Hip Fracture Registry20 has commenced collecting data items on both effectiveness and appropriateness of care in line with the Australian and New Zealand guideline for hip fracture.21 The Australian Stroke Clinical Registry22,23 collects and reports information on the outcomes of care for stroke patients and information on processes of care in accordance with the Clinical guidelines for stroke management 2010.24 For example, Box 5 shows participating adult hospitals’ adherence to five guideline-recommended process of care indicators.

Registry reporting outside Australia

In the United Kingdom, the National Hip Fracture Database (NHFD) was developed as a collaboration between the British Orthopaedic Association (BOA) and the British Geriatrics Society (BGS). Data are collected on casemix, care processes and patient outcomes.25 Care is measured against six standards laid out in the 2007 Blue Book (clinical care standards) on the care of fragility fracture patients, including prompt admission to orthopaedic care; surgery within 48 hours and within normal working hours; nursing care aimed at minimising pressure ulcer incidence; routine access to orthogeriatric medical care; assessment and appropriate treatment to promote bone health; and falls assessment.26 In 2010, the NHFD registry became a ready-made data collection and reporting mechanism for measuring compliance with a set of clinical care standards incentivised by a best practice tariff.27 Box 6 shows the compliance with best practice for a number of clinical care standards using registry data.

The authors of the 2012 NHFD national report note:

clinical teams have used the synergy of audit, feedback and standards locally in clinical change or service development initiatives prompted and monitored by the NHFD, often with very substantial and quantifiable improvements. These include reduced mortality and reductions in length of stay, often arising from care pathway redesign and improved collaboration between surgeons, anaesthetists and ortho-geriatricians; and substantial efficiency savings that are in keeping with an important point made in the BOA/BGS Blue Book: “Looking after hip fracture patients well is cheaper than looking after them badly”.25

In the United States, the American Heart Association/American Stroke Association Stroke registry has been successful in measuring adherence to a number of agreed care processes, including deep vein thrombosis prophylaxis, antithrombotic therapy, discharge medication, dysphagia screening, stroke education, smoking cessation and assessment for rehabilitation.28 The registry has over two million patients enrolled from more than 2000 hospitals and links performance data with Medicare fee-for-service claims data. This has enabled the creation of 30-day and 1-year mortality prediction models, outcomes variation comparison across hospitals and the assessment of the impact of critical variables on outcomes of interest.28

Heart failure registries in the US collect data on clinical characteristics, patterns of hospital and outpatient care, as well as outcomes of patients admitted with this condition.4 Online tools are used to provide personally tailored feedback on performance and other quality measures against a national benchmark. Process of care improvement tools have been developed and made available in a toolkit, which includes evidence-based practice algorithms, critical pathways, standardised orders, discharge checklists, pocket cards, and chart stickers. The toolkit also includes algorithms and dosing guides for guideline-recommended therapies and a comprehensive set of patient education materials. Participation in heart failure registries in the US has been associated with substantial improvements in the use of guideline-recommended therapies for heart failure in both the inpatient and outpatient settings.4 Conformity with appropriateness measures has been shown to improve patient outcomes and disparities in care have been reduced or eliminated.4

Swedish registries have contributed to a vast amount of information used in health services research in that country.29 Many of the Swedish registries commenced operations over 20 years ago with government financial support and have been attentively maintained. Incentives are provided to hospitals complying with routine contributions to the registries. Required datasets are succinct, thereby minimising data entry burden. This has produced high participation rates which are closely representative of the eligible population. In return hospitals and clinicians are provided with high quality reports which are up to date and risk adjusted.30

Opportunities that registries provide

Well designed and managed clinical registries provide clinical information which is richer, more reliable and more credible than information generated from hospital administrative systems.31 Analyses based on clinical data are respected by clinicians and patients. A comparative review by Cohen in 2014 demonstrated that the Cardiac Care Network Registry in Ontario, Canada, provides relevant clinical details with greater accuracy when compared with administrative databases.32 Data from the registry were found to be more robust for informing best practice cardiac clinical care pathways and evidence-based cardiac procedures. Information provided by registries therefore enjoys a high level of trust by clinicians, health managers, governments, private hospital groups and funding bodies.

The use of registries to monitor health care quality and safety is supported by patients. Analyses show that as long as appropriate measures are taken to ensure data security and confidentiality, the majority of patients acknowledge the value of registries and the necessity to collect identifying data, and accept the requirement for registries to operate under opt-out consent with scope for linkage to other datasets.33

The purpose and scope of patient registries are expanding. Aside from the principal function of monitoring and benchmarking the appropriateness and effectiveness of clinical care, registries can provide the foundation for opportunities to undertake evidence-based health care reform. The potential for articulation with best practice pricing incentive schemes has been highlighted above. Registries also provide a way of generating an early warning of lowered outcomes and a means to share learnings from high performing units, such as those with lower infection rates. Examples of other opportunities provided by registries include clinician and facility performance assessment and credentialing; greater accountability and transparency through public reporting; performance-based reimbursement; value-based purchasing; the development of evidence-based practice guidelines; enhanced post-market surveillance of medical devices and pharmaceuticals; monitoring trends in utilisation and access to care; supporting cost-effectiveness studies; and the provision of infrastructure with which to conduct clinical trials and comparative effectiveness studies.5,29,34

Patient-reported outcome measures (PROMs) are increasingly being introduced into registries,35 providing a personal perspective on the expectations and impact of surgery. For example, the Victorian Severe Trauma Registry and the Victorian Prostate Cancer Registry both collect and report PROMs at a time of clinical stability. The Arthroplasty Clinical Outcomes Registry in NSW reports pre- and post-operative PROMs, and health-related quality of life, for primary and revision procedures (Box 7).36 In the UK, the National Health Service requires the routine measurement of PROMs for all patients undergoing total knee or hip arthroplasty (http://content.digital.nhs.uk/proms). In Sweden, almost all units performing total hip arthroplasty are administering PROMs before and after surgery.37 The respective registries in those countries collect and report such data.

There is increasing evidence that registries demonstrate good value for money, that is, improved health outcomes at lower cost.38–40 In 2012, Larsson and colleagues calculated that if the US had a registry for hip replacement surgery that encouraged reductions in surgical revision rates comparable with those attributed, in part, to the presence of the Swedish registry, the US might have avoided $2 billion of an expected $24 billion in total costs in 2015 for these surgeries.39

Barriers to effective reporting

Barriers to registry development are well documented.41–45 Adequate funding is a problem that registries share with many other health care initiatives. Funding aside, the principal barriers to the development of clinical quality registries in Australia are:

reluctance of some health care providers and organisations to supply source data;
poor interoperability between clinical information systems leading to unnecessary duplication of data entry;
limited availability of the skills (clinical, epidemiological, biostatistical) and resources (advanced and secure data systems) to run national registries; and
data governance burdens and constraints, including restrictions on the disclosure, collection, linkage and reporting of patient level data.

Notwithstanding successful efforts to develop new registries20 and improve established registries, these barriers persist for clinical groups and registry experts wishing to improve the quality of information and level of participation in registries in Australia.

Beyond the barriers

To address these barriers, the Australian Commission on Safety and Quality in Health Care worked with jurisdictional representatives and registry experts to develop a framework detailing national arrangements under which patient level data may be routinely and securely disclosed, collected, analysed and reported. The Framework for Australian clinical quality registries46 (endorsed by the Australian Health Ministers’ Advisory Council in March 2014) describes a mechanism by which government jurisdictions and private hospital groups can authorise and secure record-level data, within high priority clinical domains, to measure, monitor and report the appropriateness and effectiveness of health care. Application of the Framework to registries provides assurances to jurisdictions, private hospital groups, clinicians and patients, that registry data and the systems that hold those data have satisfied minimum security, technical and operating standards.

The establishment of a number of national clinical quality registries for high burden, high variance conditions or interventions is a cost-effective38–40 way of addressing Australia’s information gaps in order to effectively monitor the appropriateness and effectiveness of health care. The development of one national registry per clinical domain — rather than multiple state and territory-based registries all attempting to monitor similar indicators — has obvious efficiencies and is more likely to attract funding. Well designed registries are an increasingly important component of clinical practice47 and health system monitoring. The provision of timely, relevant and reliable feedback about patient care to clinicians drives improvements in health care quality. Improved reporting of registry information on the appropriateness of care is likely to improve adherence to evidence-based practice.

Box 1 –
Vascular access type at initial treatment, by time to referral for haemodialysis in Australia, 2008–2012

Source: reproduced with permission from ANZDATA Annual Report 2013, Ch 5: Haemodialysis, Fig 5.75.11

Box 2 –
Proportion of admissions in which venous thromboembolism prophylaxis was administered to eligible patients within 24 hours of admission to an intensive care unit, 2010–11 to 2014–15

Source: data provided by the Australian and New Zealand Intensive Care Society, July 2016.

Box 3 –
Proportion of patients assessed for functional status (activities of daily living) within three days of admission to a hospital rehabilitation ward, 2002–2015

Source: data provided by the Australasian Rehabilitation Outcomes Centre, Australian Health Services Research Institute, University of Wollongong, July 2016.

Box 4 –
Proportion of patients in the unstable phase with an effective care plan implemented in 3 days or less

Source: data provided by the Palliative Care Outcomes Collaboration, Australian Health Services Research Institute, University of Wollongong, July 2016.

Box 5 –
Hospital adherence to process indicators for stroke care

Hospital stroke care

All episodes

Ischaemic

TIA

Patients admitted to a stroke unit

5847/7608 (77%)

3904/4583 (85%)

992/1489 (67%)

Patients who received intravenous thrombolysis (tPA) of an ischaemic stroke

476/4583 (10%)

Patients discharged (not deceased while in hospital)

6744/7400 (91%)

4115/4481 (92%)

1470/1474 (99.7%)

Patient discharged on an antihypertensive (if not deceased while in hospital)

4661/6555 (71%)

3044/4027 (76%)

969/1440 (67%)

Patients who received a care plan at discharge (if discharged home or to RACF)

2046/3713 (55%)

1122/1996 (56%)

651/1289 (51%)

Source: Australian Stroke Clinical Registry Annual Report 2013, Table 7, p.29.22 na = not applicable. RACF = residential aged care facility. TIA = transient ischaemic attack. tPA = tissue plasminogen activator. Unknowns coded as no; inpatient death determined using National Death Index data.

Box 6 –
Compliance with best practice standards for hip fracture patients in the United Kingdom, 2009–2012

Source: prepared with permission from data in the National Hip Fracture Database National Report 2012 – Supplement, Table 1.25

Box 7 –
Pre- and post-operative patient-reported outcome measures (Oxford Hip Scores [OHS]) for hip arthroplasty — all hospitals, 2013

Source: reproduced with permission from Arthroplasty Clinical Outcomes Registry, 2013 Annual Report, Fig 7.1.36

Antimicrobial use in Australian hospitals: how much and how appropriate?

Antimicrobial agents play a central role in modern health care, especially in the hospital setting. Many of the modern advances in health care such as intensive care, neonatal care, cancer chemotherapy, complex surgery and prosthetic joint replacement depend on the ongoing effectiveness of antimicrobials. However, antimicrobial resistance (AMR) has emerged in the most common and important pathogens, and as resistances have accumulated, multiresistant strains have arisen. The impact of resistance and multiresistance is being felt worldwide.1

In Australian hospitals, some multiresistant organisms were epidemic and have now become endemic in many facilities, particularly those delivering tertiary and quaternary care. Much of this resistance is driven by hospital antimicrobial use. Because antimicrobials are necessary for providing safe care in hospitals, questions arise about what factors in antimicrobial use may be adjusted in order to deliver both low levels of resistance and low prevalence of multiresistant organisms. Factors to consider include relationships between volumes of antimicrobials used and AMR; patterns of use and AMR; and appropriateness of prescribing.

The Australian Commission on Safety and Quality in Health Care (the Commission) has produced a range of resources regarding antimicrobial stewardship, now considered to be the most effective tool in promoting rational antimicrobial use. Antimicrobial stewardship is a term that describes a suite of activities designed to maximise the rational use of antimicrobials and minimise the selection pressure for AMR. In 2011, the Commission released a blueprint for antimicrobial stewardship in Australian hospitals.2 In 2012, the Commission released the National Safety and Quality Health Service Standards (NSQHSS) for hospital accreditation. Within Standard 3: Preventing and controlling healthcare associated infections3 there is a requirement for hospitals to develop and implement an antimicrobial stewardship program, and regularly review its effectiveness (Standard 3.14). Subsequently, the Commission has developed a clinical care standard for antimicrobial stewardship, designed to provide a basic set of nine standards that prescribers of antimicrobials should follow.4

In 2013, the Commission also commenced the task of coordinating the development of a national surveillance system for antimicrobial resistance and antimicrobial use — the AURA (Antimicrobial Use and Resistance in Australia) project (http://www.safetyandquality.gov.au/national-priorities/amr-and-au-surveillance-project). Two key elements of the system are passive and targeted surveillance of antimicrobial use in hospitals. In this context, passive surveillance refers to the collation of data primarily collected for other purposes (such as pharmacy dispensing data), while targeted surveillance refers to data gathered for a specific purpose — for example, data on appropriateness of prescribing and compliance with guidelines.

The AURA project was in a good position to develop both of these types of surveillance by building upon existing initiatives. The National Antimicrobial Utilisation Surveillance Program (NAUSP), established in 2004 and funded by the Australian Government Department of Health, forms the basis of the passive antimicrobial surveillance. The program built on a South Australian initiative to incorporate data from other Australian states. Targeted surveillance is based on the National Antimicrobial Prescribing Survey (NAPS), a 2011 initiative of clinicians at Royal Melbourne Hospital to establish a national auditing tool for hospital stewardship teams to use in assessing appropriateness of prescribing in their own hospitals using published methodology.5 This has matured into an online tool that was rolled out nationally in 2013. Although both programs are built on voluntary participation (there are currently no mechanisms available to mandate participation), by 2014 NAUSP had 129 participants and NAPS had 248 participants.

Data sources and representativeness

The data presented here are from the 2014 NAUSP report6 and the 2013 and 2014 NAPS reports.7,8 All these results must be interpreted with caution, given the voluntary nature of participation in the programs.

We examined the representativeness of participation in both programs in 2014 using the data provided in the Australian Institute of Health and Welfare (AIHW) publication on hospital peer groups in November 2015, to which we added two hospital sites that had provided data in 2014 but did not appear on the AIHW list.9 Of the 748 public hospitals in Australia, the NAUSP program collected data from 14.8%, and the NAPS program collected data from 26.3%. The percentages from the 497 private hospitals were 3.6% and 10.3% respectively. The Northern Territory did not provide usable data to NAUSP in 2014. In addition, NAUSP did not collect data from children’s hospitals (see below). Participation was greatest from principal referral hospitals, and public and private acute hospitals in groups A and B of the AIHW peer group list; NAUSP collected data from 61.0% of 195 hospitals in these categories, while NAPS also collected 61.0%; of these 45.1% were in common. The majority of participants were from remoteness groups “major city” and “inner regional” (93.0% for NAUSP and 76.0% for NAPS), reflecting the availability of resources in larger/hospitals and centres. Overall, 92 hospitals contributed data to both programs in 2014. A more detailed analysis of representativeness is given in Supplementary Tables S1–S3 in the Appendix at mja.com.au. Information on the types of data collected in each program, including their limitations, is given in the volumes of use and appropriateness sections below. The imbalances created by voluntary participation are found in these tables.

Volumes of antibacterial use, including variations and trends

NAUSP collects data from public and private hospitals, excluding paediatric hospitals and paediatric wards. These exclusions are because there is no internationally agreed measure equivalent to that used for adults, namely defined daily doses (DDD) per 1000 occupied bed days (OBD). It reports on use of antibacterials, but not antifungals or antiviral agents, dispensed to adult, acute care inpatient wards and emergency departments. Data from psychiatric services, rehabilitation, dialysis and day surgery units are not included in order to align with international definitions of somatic care, and outpatient data are also not included. The data also exclude most topical formulations, as well as antimycobacterials (except rifampicin) and antimicrobials prepared as infuser packs. NAUSP undertakes data validation at the time of receipt, including outlier detection. All suspect data are queried with the relevant participant, and corrections made if errors are confirmed.

Across all Australian hospitals participating in calendar year 2014, the total aggregate use rate of systemic antimicrobials was 936 DDD/1000 OBD, ranging from a low of 330 to a high of 2040 DDD/1000 OBD — more than a sixfold difference. The overall rate compares with 597 DDD/1000 OBD in Sweden,10 747 DDD/1000 OBD in the Netherlands,11 and 944 DDD/1000 OBD in Denmark.12 These are the only countries currently publishing comparable data.

There were noticeable variations between states (Box 1), the highest rates being in Tasmania. The reasons for such variations are not clear. While there is likely to be less antimicrobial use in small states and territories due to lack of availability of highly complex interventions, this would not seem to account for the pattern observed. Higher use in Tas may have been related to statewide adoption of combination narrow spectrum antimicrobials for urinary and intra-abdominal infections (eg, amoxicillin + gentamicin + metronidazole = 10–12 DDD compared with ceftriaxone + metronidazole = 2 DDD). Imbalances in representativeness between states (see Supplementary Table S2 in the Appendix at mja.com.au) are also likely to have contributed to the variation, although even greater variation has been observed nationally between hospitals in the same peer group.13

There is also some variation in use related to hospital type. Using the new peer group classification of public hospitals promulgated by the AIHW,9 aggregate rates of usage in principal referral hospitals in 2014 were 927 DDD/1000 OBD (range, 544–1511), 985 DDD/1000 OBD in large public acute hospitals (range, 451–2050), and 872 DDD/1000 OBD in medium public acute hospitals (range, 504–1345). This variation was different to what might have been expected, given the assumption that principal referral hospitals would have the most complex patients and procedures and therefore require the highest antimicrobial use. This may also be a reflection of the presence of more mature stewardship programs in principal referral institutions.

Box 2 shows usage rates of the various classes of antimicrobials over the ten years to 2014. There has been a steady decline in total usage nationally since 2010. Some of this can be attributed to the increasing numbers of smaller institutions joining the program, but it is thought that at least some part of the reduction can be attributed to an increasing focus on antimicrobial stewardship. During the period from January to December 2014, the aggregate antibacterial usage rate for all participants (n = 129) was 936 DDD/1000 OBD (Box 2). Compared with a rate of 961 DDD/1000 OBD for the previous year (n = 113), this represents a 2.6% decrease. Excluding the new participants, the decrease was still 1.6%.

The most commonly prescribed antibacterials in Australia are shown in Box 3 as a percentage of all use or prescriptions. The differences in data collection methods between NAUSP and NAPS mean that there are differences in many of the percentages: NAUSP captures all use throughout the year and provides output as a percentage of total DDD/1000 OBD. NAPS output is cross-sectional data at a point in time or over a short time interval. Hence, agents such as cefazolin, which is prescribed frequently but often for very short durations, features prominently in NAPS, but less so in NAUSP. Of note is the significant proportion of use/prescriptions for ceftriaxone (4.5% in NAUSP and 9.1% in NAPS), an agent that many antimicrobial stewardship teams would consider should be reserved for specific indications and should only be prescribed with stewardship team approval.

Appropriateness of antimicrobial use, including variations

The principal aim of the NAPS tool is to provide data to antimicrobial stewardship teams on the rates of appropriate use and compliance to guidelines in their own hospitals. The stewardship teams are able to use the data to identify local issues and prioritise their stewardship activities. The utility of the online collection and storage of data allows individual teams to compare themselves with their peers, and provides the opportunity to gain better insight into national and regional rates. Participation is voluntary, but has been significantly boosted by the release of Standard 3.14 in the Commission’s hospital accreditation standards. Participation resource requirements are significantly lower than for NAUSP, because NAPS surveys are conducted annually, largely as a point prevalence survey to coincide with antimicrobial awareness week in November. The survey methods have been developed to support hospitals of all sizes and complexity, so that point prevalence surveys (single and repeated), period prevalence surveys, and random patient selection surveys are all available to hospitals. Benchmarking is only available for point prevalence and random selection surveys. The NAPS tool has been developed using published methods5 modelled on those developed and applied in Europe,14 and which are now being applied internationally.15,16

To ensure data validity, participants are required to follow a structured assessment guide. In addition, training is provided to all participants and phone advice is offered by the NAPS team for participants who have uncertainties or questions about specific prescriptions. To reduce the impact of lack of expertise in sites that do not have direct access to expert advice from infectious diseases physicians or microbiologists, remote support is provided by skilled antimicrobial stewardship personnel.17 The validity of this approach has been reinforced by the consistency of findings between the years 2013 and 2014 (Box 4). In 2014, 248 hospitals participated, including 197 public hospitals (26.3% of all public hospitals in Australia) and 51 private hospitals (10.3%). This was a 64% increase on the number of participants in the previous year. The most popular method, a whole-of-hospital point prevalence survey on a single day, was conducted by 42.3% of participants, followed by a whole-of-hospital repeated point prevalence survey (with the time between surveys varying from consecutive days to several months) by 28.6%. Together, these two methods accounted for 70.9% of hospitals but 79.9% of all prescriptions reviewed. The remaining 29.1% of hospitals chose to survey selected wards or specialties, collected a random sample, selected antimicrobials or indications, or used other methods. The total number of prescriptions reviewed by all hospitals was 19 994. The variation in data collection methods means that the data presented here should be considered at best indicative.

Box 4 shows the overall findings for the key indicators of appropriateness and compliance with guidelines, comparing results from 2014 with those found in 2013. For these indicators, all participants were provided with standard recommendations for assessing appropriateness, and the Therapeutic guidelines: antibiotic18 or locally developed guidelines/protocols were used to judge compliance. Best practice rates for some of these indicators were included. Among the results were:

Only 74% of prescriptions had an indication documented in the medical record (best practice, >95%). If prophylaxis indications were excluded, that figure rose to 79.2%.
The prescription was considered inappropriate in 24% of cases where a satisfactory assessment of the prescription could be made.
Non-compliance with guidelines was detected in 26% of cases where compliance was assessable.

In 2014, there were some differences between states in rates of appropriate prescribing, with the Australian Capital Territory having the lowest rate (68.2%) and Queensland the highest (79.2%). Similarly, rates of compliance with guidelines had differences across states, with ACT having the lowest 65.2% and Queensland the highest (72.5%). There was little variation in rates of appropriate prescribing across hospital peer groups, but there was a tendency for compliance with guidelines to be lower in smaller hospitals. Remoteness had little impact on either appropriateness or compliance with guidelines. Rates for both were slightly lower in private hospitals (75.1% and 65.2% respectively) compared with public hospitals (77.2% and 70.6% respectively).8

A notable finding was the frequency with which surgical antimicrobial prophylaxis was administered for more than 24 hours. For most surgical procedures where antimicrobial prophylaxis is warranted, a single dose of the agent at the time of skin or mucosal incision, or less than 1 hour before the procedure, is known to be adequate.18 In 2013, more than 40% of surgical prophylaxis courses lasted longer than 24 hours, falling to 36% in 2014. The findings of the 2014 survey also identified that surgical prophylaxis was not indicated at least 20% of the times that it was prescribed.

Antimicrobial agents that are often used as directed therapy, for instance flucloxacillin for staphylococcal infection, or antimicrobials prescribed as part of treatment protocols for cancer chemotherapy, tended to have high rates of appropriate use in 2014. For prescriptions that could be adequately assessed, five antimicrobials (cefalexin, amoxicillin–clavulanate, azithromycin, cefazolin and ceftriaxone) all had rates of inappropriate use above 30%, with that for cefalexin exceeding 40%.

Apart from surgical prophylaxis as discussed above, the other notable condition for which antimicrobials were frequently prescribed inappropriately in 2014 was infective exacerbations of chronic obstructive pulmonary disease, with a rate of appropriate prescribing of only 62%. For the latter condition, appropriate prescribing involves the use of oral amoxicillin or doxycycline, and not broader spectrum or intravenous antibacterials.

Possible areas for action and intervention

Despite the voluntary nature of participation in the NAUSP and NAPS, a picture of antimicrobial practices in Australian hospitals is now emerging from these datasets. Before the emergence of these programs, there was no information about antimicrobial use across Australia. The datasets indicate that there are major opportunities for improvement for antimicrobial stewardship programs, and provide strong evidence for their introduction in hospitals where stewardship systems have not yet become established,. Stewardship programs should focus on the implementation of the Antimicrobial Stewardship Clinical Care Standard,4 and also ensure that prescribers have access to treatment guidelines, especially the national Therapeutic guidelines: antibiotic.18

The most important benefits of NAUSP and NAPS are that they provide stewardship programs with the capacity to benchmark and identify issues peculiar to their own institution. This greatly assists in directing efforts to the areas of greatest need at the local level. Nevertheless, NAUSP has identified high rates of use across Australia (57% higher than Sweden for example), albeit with a trend downward. NAPS is the only published antimicrobial prescribing survey that includes appropriateness of use as a composite measure of prescribing quality. This is important because clinical guidelines cannot cover all aspects of empirical and directed therapy. Recent reports show that the number of hospitals participating in NAPS well exceeds those participating in point prevalence surveys in other countries.15,16 Further, NAPS has identified major areas for intervention, such as the appropriate use of surgical prophylaxis, and prescribing for infective exacerbations of chronic obstructive pulmonary disease. The Commission believes that surgical prophylaxis is worthy of a national approach and has contacted several peak bodies such as the Royal Australasian College of Surgeons to drive improvements in this area.

The adoption of the NSQHSS has provided a significant boost to participation in NAUSP and NAPS. Stewardship programs are now able to compare their performance with overall use and prescribing practices. The findings of these two programs are already generating benefits for the participants. However, participation is still voluntary. Ultimately, all hospitals will be required to generate data of this kind for accreditation against Standard 3 of the NSQHSS. Participation in these national programs will be a simple method for them to achieve this.

The voluntary nature of participation in these programs has necessarily created imbalances in participation between hospital types and jurisdictions. Participation requires time and effort from hospital pharmacists, including stewardship pharmacists, infectious diseases physicians, microbiologists and often infection control staff and other nursing staff. Hospitals vary greatly in their size, throughput and resources (see separation rate variation in Supplementary Table S1 in the Appendix at mja.com.au). In some circumstances, particularly in outer regional and remote areas, pharmacy services are delivered offsite, and the hospital does not have access to the data required for NAUSP participation. Nevertheless, the Commission will continue to promote participation in both programs for all hospitals because the principles of antimicrobial stewardship apply everywhere that antimicrobials are used.

Both NAUSP and NAPS have identified specific issues and gaps in their data collection. For NAUSP, the single most important issue is the measure used — DDD/1000 OBD. While this measure is suitable for international comparisons, there are a number of instances where the internationally agreed DDD does not concur with the most commonly prescribed daily dose in Australia. Another important issue is the lack of DDDs for children, leading to underreporting of total volumes of use in the paediatric population. Moreover, generating totals for antimicrobials does not reveal how many patients are exposed to antimicrobials during their stay. This is likely to be a more relevant measure of selection pressure for antimicrobial resistance. The NAPS data are also vulnerable to the level of expertise of the participants in assessing appropriateness of use and compliance with guidelines, although, as noted above, strenuous efforts are being made to overcome this problem. Ultimately, all participants will be trained and skilled to undertake these surveys. As the AURA project moves from establishment to maintenance, it will be necessary to fill in the gaps and solve the issues found in both programs, as well as to encourage both ongoing and increased participation.

The building of workforce capacity and competence to undertake antimicrobial stewardship is an essential requirement to meet the objectives of the National Antimicrobial Resistance Strategy.19 The evolution of pharmacy and clinical information systems, and the introduction of electronic medical records and electronic medicines management, will improve data capture and interpretation for NAUSP and NAPS significantly and will enhance the quality of data contributing to national surveillance of antimicrobial use.

Box 1 –
Total hospital antibacterial use by state (all NAUSP hospitals, all antibacterial classes), 2014*

DDD = defined daily doses. NAUSP = National Antimicrobial Utilisation Surveillance Program. OBD = occupied bed days. * Northern Territory did not provide usable data in 2014.

Box 2 –
Total hospital antibacterial use by year (all NAUSP hospitals, all antibacterial classes)

DDD = defined daily doses. NAUSP = National Antimicrobial Utilisation Surveillance Program. OBD = occupied bed days.

Box 3 –
Top ten antimicrobials in 2014 — proportion of total use (NAUSP) or prescriptions (NAPS)

NAPS = National Antimicrobial Prescribing Survey. NAUSP = National Antimicrobial Utilisation Surveillance Program.

Box 4 –
Results of key indicators in 2013 and 2014 for all participating hospitals8

Key indicator

% of total prescriptions

% change from 2013

2013

2014

Indication documented in medical notes (best practice, > 95%)

70.9

74.0

+ 3.1

Appropriateness

Appropriate (optimal and adequate)

70.8 (75.6)*

72.3 (75.9)*

+ 1.5

Inappropriate (suboptimal and inadequate)

22.9 (24.4)*

23.0 (24.1)*

+ 0.1

Not assessable

6.3

4.7

– 1.6

Compliance with guidelines

Compliant with Therapeutic guidelines: antibiotic18 or local guidelines

59.7 (72.2)^†

56.2 (73.7)^†

– 3.5

Non-compliant

23.0 (27.8)^†

24.3 (26.3)^†

+ 1.3

Directed therapy^‡

10.4

No guideline available

11.0

4.6

− 6.4

Not assessable

6.3

4.5

− 1.8

Surgical prophylaxis given for > 24 hours (best practice, < 5%)

41.8

35.9^§

− 5.9

na = not applicable * Figures without parentheses apply to all prescriptions. Figures in parentheses apply to prescriptions where appropriateness was assessable (12 001 prescriptions in 2013; 18 998 prescriptions in 2014); the denominator excludes antimicrobial prescriptions marked “Not assessable”. † Figures without parentheses apply to all prescriptions. Figures in parentheses apply to prescriptions where compliance was assessable (10 599 prescriptions in 2013; 15 899 prescriptions in 2014); the denominator excludes antimicrobial prescriptions marked “Directed therapy”, “Not available” or “Not assessable”. ‡ Introduced in the 2014 survey as a new classification category. § Where surgical prophylaxis was selected as the indication (2785 prescriptions).

Clinical care standards: appropriate care everywhere — acute coronary syndromes as an example

Australian practice data from clinical audits and other research have clearly shown that dissemination of high quality clinical practice guidelines is not enough to ensure everyone with a particular clinical condition receives appropriate care.1–3 Even for clinical conditions with established networks of care, such as acute coronary syndromes (ACS), variations in care persist, not all of which can be explained by patient needs or preferences. In this article, we explore the features and underlying principles of clinical care standards (looking at the example of ACS) and the improvements in delivery of appropriate care that a clinical care standard may help to make.

The National Health Reform Agreement signed by the Council of Australian Governments in 2011 (http://www.federalfinancialrelations.gov.au/content/npa/health/_archive/national-agreement.pdf) determined that clinical standards would be developed by the Australian Commission on Safety and Quality in Health Care (the Commission) to help ensure appropriateness of care for specific clinical conditions nationally. Clinical care standards are small sets of concise recommendations (quality statements) that focus on specific gaps in evidence-based practice for a clinical condition. Their aim is to drive delivery of appropriate care, reduce unwarranted variation and to promote shared decision making between patients, carers and clinicians.

What’s different about a clinical care standard?

Unlike a clinical practice guideline, a clinical care standard is not a comprehensive management guide. Instead, it targets areas of care where both divergence from evidence and the opportunity for improvement are greatest. In collaboration with a working group of clinicians, researchers, health care organisations and consumers, the Commission uses practice data to identify key areas for improvement, which become the focus of each quality statement.

Clinical care standards are developed using a process designed to optimise the uptake and reach of the care they describe. First, each topic requires the agreement of representatives of state and territory health departments. Second, before public consultation, the draft standard is considered by representatives from private and public health sectors. Third, each draft is released for broad public consultation, with feedback sought from all levels of the health system as well as from key organisations. Finally, before it is released, the standard is submitted to the Australian Health Ministers Advisory Council and then to Australian Health Ministers. This highly collaborative and consultative method of development not only assists in ensuring the relevance of the standard to the health care system but builds engagement of both clinical and policy decision makers at multiple levels within the system. In prompting review of existing initiatives, the standard acts as a focus for integrated whole-of-system efforts to improve the quality of care.

Putting patients at the centre of care is an integral part of clinical care standards and is ensured in several ways:

the quality statements are written from the patient’s perspective, describing the care that patients can expect to be offered by the health care system;
a consumer fact sheet accompanies each standard describing in lay terms what the quality statement means; and
the standards align understanding and expectations of patients, clinicians and health services about what good care is, how it should be delivered, and what needs to be put in place to ensure it happens.

Indicators are an important part of implementation support for each clinical care standard. Each standard has a set of indicators for local use by health services to monitor adherence and to identify areas for improvement. The National Stroke Foundation’s 2015 national audit recently showed how the process indicators from a standard can be used to track performance over time.2 The indicators can also be used by health services to show they are providing high quality evidence-based care, a requirement of the National Safety and Quality Health Service Standards.4 The indicators are not mandatory, as some services may have other measures in place to demonstrate they are delivering the care described within a standard.

Australia is the second country to develop national clinical standards. In 2009, the National Institute for Health and Care Excellence (NICE) established a program to develop quality standards across health care, public health and social care, for use in England. As of December 2015, NICE had developed over 100 quality standards. The Commission’s Clinical Care Standard program began in 2013. Standards on ACS, antimicrobial stewardship, acute stroke, delirium and hip fracture care have been released. Standards for osteoarthritis of the knee and heavy menstrual bleeding are under development.

Improving care for patients with acute coronary syndromes

The ACS Clinical Care Standard was developed to address substantial heterogeneity in the use of treatments known to reduce risk of cardiac events, which could not be explained by clinical complexity or patient needs.1 Research into the sources of this variation offers insights into potential targets for improving ACS care throughout Australia, and was used to inform the quality statements of the Standard (Box 1).

Practice-related factors

Translation of knowledge into practice has been identified as a major practice-related issue affecting quality of ACS care.6 In a 2009 survey, Australian clinicians reported high levels of agreement with, and adherence to, the existing (2006) ACS guidelines. However, these views correlated poorly with observed practice, with often striking overestimation by clinicians of their use of treatments recommended in the guidelines.6

Clinician misperception about patient risk of recurrent cardiovascular events and uncertainty about applying evidence for patients with complex clinical needs appear to be contributors to the variation. Cardiovascular risk stratification is a critical decision point in the appropriate provision of cardiac care. Compared with assessment using validated cardiovascular risk tools, clinical intuition more frequently overestimates the risk for low risk patients and underestimates that for high risk patients.7,8 Underappreciation of cardiovascular risk is worse for females with myocardial infarction (MI) than for males with MI and is associated with delays in providing invasive management, lower use of evidence-based drugs and an increase in the risk of late mortality.9

Even when risk is accurately estimated, challenges remain in applying the ACS evidence base among patients with complex clinical needs. Australian data show that patients with comorbidities are less likely to receive evidence-based treatments than patients at the same level of cardiovascular risk without comorbidities.10 Age and clinical comorbidities, such as prior cerebrovascular disease, lung disease and impaired renal function, elevate the risk of adverse events from invasive management (eg, reperfusion) and cardiovascular therapies (eg, antiplatelet drugs). However, the marked divergence in care for these patients suggests that intervention-related risks are not being objectively weighed up against treatment benefits (Box 2).10

Risk stratification and discussion of these risks and the benefits of coronary angiography for non-ST-segment-elevation ACS are the focus of quality statements 4 and 5 of the Standard (Box 1).

System factors

There are several important system-related contributors to ACS practice variation. The absence of systematic processes to improve the timely provision of reperfusion in ST-segment-elevation MI (STEMI) results in longer “door to balloon time” and is associated with increased rates of mortality and recurrent MI.11,12 In a survey of 35 hospitals examining implementation strategies for reducing time to reperfusion, those with at least one strategy delivered reperfusion on average 21 minutes faster than those without any strategy, and this was associated with a reduced rate of 12-month death or MI (12.8% v 22.1%, respectively; P = 0.006).12

The need for systematic processes to improve the timeliness and accuracy of diagnosis is highlighted in quality statements 1 and 2 of the Standard; quality statement 3 focuses on systems to support the timely provision of reperfusion (Box 1).

The vastness of Australia’s geography and the nation’s cultural diversity are both possible contributors to ACS practice variation and to patient outcomes. Mortality and complication rates due to MI are higher in rural and regional areas than in metropolitan areas;1,13 lack of access to clinical expertise and to timely invasive management for non-ST-segment-elevation ACS may contribute to variation in these areas of care.14 Variation in prescription of secondary prevention medications and lifestyle modifications, and in the engagement of patients to adhere to them, are likely to be particularly challenging gaps to address in the diverse demographic profile of modern Australia, yet they are important targets for well-designed interventions.

Quality statement 6 of the Standard focuses on use of an individualised care plan to improve the transition of care, including the ongoing need for secondary prevention measures (Box 1).

Impact of reducing variation

Attempts to estimate the impact of quality initiatives suggest there are substantial gains associated with making system-wide improvements to ACS care.15 Several observations are worth highlighting:

The gains to be had from rectifying omissions of care (eg, missed opportunities in timely reperfusion) far exceed the benefits to be gained from choices between therapies (eg, immediate fibrinolysis versus transfer for percutaneous coronary intervention in STEMI).
Improving the application of secondary prevention therapies is likely to have a much greater impact on late clinical outcomes than a focus on invasive management.
The incremental benefit of new treatments and strategies applied to patients who are already optimally treated is relatively small and is dwarfed by the gains to be had for all by small improvements in the delivery and reach of evidence-based care across the whole system.11,12

Economic evaluation of strategies to improve the quality of ACS care in Australia are limited. Yet the fact that half of all cardiovascular events occur in patients with prior documented coronary artery disease, and that the estimated yearly costs of MI to the Australian community is $1.14 billion dollars, suggests that even modest systems improvements in ACS care are likely to be highly efficient.16

Efforts to redesign the provision of care in various parts of Australia have been promising, showing meaningful improvements in patient outcomes. For example, several health networks have sought to move the identification of STEMI into the ambulance, through the transmission of initial echocardiographic data to the emergency department, ensuring patients are brought to hospitals with appropriate clinical teams and facilities, as well as shortening the time to response when these teams are on remote call.17,18

Similarly, clinical networks that provide remote clinical support combined with access to metropolitan-based invasive services have been shown to reduce heterogeneity in clinical care and improve short term outcomes for patients residing in rural areas.14

Complementary to these initiatives, approaches to secondary prevention that embrace the individuality of patient needs and tailor education and care to these have shown significant promise in improving adherence, as well as the achievement of risk factor targets known to lower overall risk of future cardiovascular events.19,20

The uptake of the ACS Clinical Care Standard is not yet known, and neither is that of the UK’s corresponding quality standard, also released in 2014. However, substantial improvements in the care and survival for older people with hip fracture in England have been attributed to initiatives underpinned by a national clinical standard, including a national registry to support audit and feedback, and a financial incentives program.21 In December 2014, NICE reported on the uptake of 28 published quality standards. While data were limited, uptake of care could be tracked over time for many quality standards using selected process indicators.22

What the ACS Clinical Care Standard adds

The ACS Clinical Care Standard is a significant step forward in supporting clinicians and health services to realise all of the gains promised by the ACS evidence base.23 It focuses on the areas of care that are known to be most associated with variation in outcome. It supports patient involvement in critical decisions that affect their care, refocuses clinicians on the priority areas of ensuring appropriate ACS care, and informs health services about the systems required to deliver evidence-based care. The revised ACS clinical practice guidelines released in August 2016 remain consistent with the ACS Clinical Care Standard and specifically support its use for quality improvement.24

Ensuring effective and equitable care of patients with ACS across Australia is complex. For the first time, a common vision for care of patients with ACS provides an opportunity for alignment and coordination of local, state and national efforts to improve consistency of care. In doing so, the ACS Clinical Care Standard may just represent the keystone for evidence translation in Australian ACS care.

Box 1 –
Acute Coronary Syndromes Clinical Care Standard5

1. A patient presenting with acute chest pain or other symptoms suggestive of an acute coronary syndrome receives care guided by a documented chest pain assessment pathway.

2. A patient with acute chest pain or other symptoms suggestive of an acute coronary syndrome receives a 12-lead electrocardiogram (ECG) and the results are analysed by a clinician experienced in interpreting an ECG within 10 minutes of the first emergency clinical contact.

3. A patient with an acute ST-segment-elevation myocardial infarction (STEMI), for whom emergency reperfusion is clinically appropriate, is offered timely percutaneous coronary intervention (PCI) or fibrinolysis in accordance with the time frames recommended in the current National Heart Foundation of Australia/Cardiac Society of Australia and New Zealand Guidelines for the management of acute coronary syndromes.In general, primary PCI is recommended if the time from first medical contact to balloon inflation is anticipated to be less than 90 minutes, otherwise the patient is offered fibrinolysis.

4. A patient with a non-ST-segment-elevation acute coronary syndrome (NSTEACS) is managed based on a documented, evidence-based assessment of their risk of an adverse event.

5. The role of coronary angiography with a view to timely and appropriate coronary revascularisation is discussed with a patient with a non-ST-segment-elevation acute coronary syndrome (NSTEACS) who is assessed to be at intermediate or high risk of an adverse cardiac event.

6. Before a patient with an acute coronary syndrome leaves the hospital, they are involved in the development of an individualised care plan. This plan identifies the lifestyle modifications and medicines needed to manage their risk factors, addresses their psychosocial needs and includes a referral to an appropriate cardiac rehabilitation or another secondary prevention program. This plan is provided to the patient and their general practitioner or ongoing clinical provider within 48 hours of discharge.

Box 2 –
Impact of cardiac risk and comorbid risk on the likelihood of angiography in acute coronary syndromes10