Perspectives

Opioid use is increasing, and not just for chronic conditions or cancer Global concern about the prescribing of opioid analgesic medications (particularly oxycodone) for chronic pain is growing. In this Journal in September 2011, Roxburgh and colleagues examined the rise of oxycodone and morphine prescribing and the harm associated with opioid use.1 In the accompanying editorial, Hall and Farrell argued that this suggests that most prescribing of opioids was for chronic non-malignant pain.2 We tested this assertion using general practitioner prescribing data linked to the problem under management, and examined the characteristics of the GPs who prescribed opioids and the patients who received these prescriptions. We analysed data from the Bettering the Evaluation and Care of Health (BEACH) program (detailed methods are described elsewhere3). For the period April 2010 to March 2011, we examined encounters at which opioids were either prescribed or supplied directly to patients. We then measured changes in opioid and oxycodone prescribing rates over the past decade and extrapolated these results to all Medicare GP service items claimed nationally.4 While Roxburgh and colleagues1 reported dispensing rates as measured by the Pharmaceutical Benefits Scheme (PBS), BEACH data measure GP prescription and supply actions. Using the international Anatomical Therapeutic Chemical classification,5 we defined opioids as “N02A” and oxycodone as “N02AA05”. We determined the statistical significance of differences by non-overlapping 95% CIs. In the 2010–11 BEACH data year, at least one opioid was prescribed or supplied at 4666 of the 95 839 encounters (4.9%) recorded from 892 GPs (93.1% of the 958 GPs who participated in that year). There were a total of 5350 opioids prescribed (5237; 97.9%) or supplied (113; 2.1%) by the GP at the 4666 encounters. From this point, we shall refer to them all as being prescribed. Compared with encounters at which no opioids were recorded, those at which an opioid was prescribed were four times more likely to be claimable through workers compensation (6.8%; 95% CI, 5.7%–7.8% v 1.7%; 95% CI, 1.5%–1.9%), and more likely to be long or prolonged consultations (10.0%; 95% CI, 8.8%–11.2% v 7.8%, 95% CI, 7.2%–8.4%). Opioids were prescribed at a rate of 3.7 per 100 problems managed, accounting for 5.8% of all medications prescribed or supplied by participating GPs. There was no significant difference in opioid prescribing rates for male and female patients. Opioid prescribing was rare for young patients, rose significantly for patients aged 25–44 years, peaked among 45–64-year-old patients and stayed almost as high in older age groups. Opioid prescribing was significantly less for patients new to the practice, possibly because of their younger age (results not shown) or GP reluctance to prescribe opioids at an initial consultation (Box 1). Commonwealth Health Care Card holders had a significantly higher rate of opioid prescribing than other patients; this rate was even higher than for patients aged 65 years and older, suggesting that age was not the only contributing factor. While the prescribing rate for opioids did not differ with the age group of the GP, male GPs prescribed significantly more opioids per 100 encounters than did females (Box 2), adding to previous research evidence showing that female GPs prescribe fewer medications than males.6 Malignant neoplasms accounted for only 3.5% of opioids prescribed, and chronic non-cancer conditions for a further 43.9%, so a significant proportion were prescribed for conditions classed as non-chronic.7 Almost 60% of prescriptions were for musculoskeletal problems. The higher prescribing rate by male GPs may reflect their higher management rate of musculoskeletal problems when compared with female GPs.6 Back problems accounted for over a quarter of all opioids prescribed and was the most common individual problem for which opioids were provided. About one in 10 opioids prescribed were for osteoarthritis, provided at almost one in five occasions of osteoarthritis management. Less than 7% of opioids prescribed were for generalised multisite pain, but 72.7% of generalised multisite pain managements had an opioid prescribed (Box 2). The most common opioids prescribed were combinations of paracetamol with at least 30 mg codeine (the minimum amount for classification as an opioid). Extrapolation suggests that there were over two million prescriptions for the year, nationally. The next most common opioid was oxycodone, followed by tramadol (Box 2). Over the past decade, the total prescribing rate for total analgesics remained steady4 but the prescribing rate for opioids rose from 3.8 per 100 encounters in 2000–01 to 5.6 per 100 in 2010–11; this was particularly the case for oxycodone (up from 0.3 prescriptions per 100 encounters to 1.5 per 100 over the period). Extrapolation suggests GP prescriptions for opioids almost doubled (from 3.83 million to 6.65 million), while the number of oxycodone prescriptions increased almost sevenfold (from 0.26 million to 1.73 million). These increases reflect both the increased prescribing rate and the increase in the number of GP visits claimed through Medicare in recent years. Our results show that Hall and Farrell were correct in their assertion that chronic non-malignant pain accounted for a far greater proportion of opioid prescriptions than did malignant neoplasms.2 However, we have also shown that a significant proportion of opioid prescriptions are for problems classified as non-chronic. The classification of a problem as non-chronic does not preclude it being chronic in some patients (although it is not usually chronic), nor does it preclude involvement of severe pain over an extended period. 1 Opioid prescribing at Australian general practice encounters by patient characteristics (based on weighted data) Patient characteristics Patients at opioid encounters Patient characteristic opioid prescribing rate per 100 encounters (95% CI) Total encounters 4666 5.6 (5.3–5.9) Sex (missing data, 44) Male 2572 (44.4%) 5.8 (5.4–6.3) Female 2050 (55.6%) 5.4 (5.0–5.7) Age group (missing data, 30) 0–14 years 6 (0.1%) 0.1 (0.0–0.1) 15–24 years 152 (3.3%) 2.0 (1.6–2.3) 25–44 years 1154 (24.9%) 6.1 (5.5–6.6) 45–64 years 1729 (37.3%) 7.7 (7.1–8.3) 65–74 years 734 (15.8%) 6.7 (6.1–7.3) ≥ 75 years 860 (18.6%) 6.5 (5.9–7.0) New patient to practice (missing data, 56) 213 (4.6%) 3.4 (2.8–4.0) Commonwealth concession card (missing data, 304) 2753 (63.1%) 8.2 (7.6–8.7) 2 Opioid prescriptions or supplies (n = 5350) at 4666 Australian general practice encounters (based on weighted data) A: Characteristics of general practitioners prescribing opioids GP characteristics Opioid prescriptions GP age- and sex-specific opioid prescribing rate per 100 encounters (95% CI) Sex (missing data, 0) Male 4150 (77.6%) 6.1 (5.7–6.6) Female 1200 (22.4%) 4.2 (3.8–4.7) Age group (missing data, 17) < 35 years 275 (5.2%) 6.1 (4.6–7.7) 35–44 years 889 (16.7%) 5.1 (4.4–5.7) 45–54 years 1686 (31.6%) 5.4 (4.9–5.9) ≥ 55 years 2482 (46.6%) 5.9 (5.4–6.4) B: Health problems managed with opioids Health problem Opioid prescriptions % of this problem treated with an opioid Back problem* 1449 (27.1%) 37.9% Osteoarthritis† 517 (9.7%) 18.4% Generalised multisite pain 351 (6.6%) 72.7% Fracture† 205 (3.8%) 20.3% Prescription—all† 198 (3.7%) 6.9% Malignant neoplasms—all‡ 187 (3.5%) 10.7% Sprain/strain† 147 (2.7%) 10.5% Migraine 108 (2.0%) 18.1% All musculoskeletal 3114 (58.2%) 17.3% Chronic non-cancer conditions§ 2350 (43.9%) 4.1% C: Main opioids prescribed or supplied Opioids Opioid prescriptions Estimated number nationally in 2010–11 Paracetamol/codeine (30 mg)¶ 1730 (32.3%) 2 130 000 Oxycodone 1406 (26.3%) 1 730 000 Tramadol 864 (16.2%) 1 060 000 Buprenorphine 427 (8.0%) 530 000 Morphine sulphate 371 (6.9%) 460 000 Fentanyl 252 (4.7%) 310 000 Dextropropoxyphene/paracetamol 180 (3.4%) 220 000 * Includes back symptom/complaint, low back symptom/complaint, back syndrome without radiating pain and back syndrome with radiating pain. † Includes multiple International Classification of Primary Care – Version 2 (ICPC-2) or ICPC-2 PLUS codes (see appendix 4 of Britt et al3). ‡ Includes all malignant neoplasms except of skin, for which only melanomas are included. § Chronic conditions are defined as in O’Halloran et al.7 ¶ Paracetamol and codeine combinations with less than 30 mg codeine are not classified as opioids.

Christopher M Harrison BPsych(Hons), MSocHlth · Janice Charles BA, MSc(Med) · Joan Henderson BAppSc(HIM)(Hons), PhD(Med) · Helena Britt BA, PhD

Knowing if a patient is Indigenous can be key to improving their care An article published in 2010 in the New England Journal of Medicine advocated the collection of data on the race and ethnic groups of patients by medical practices in the United States. This was part of an initiative to computerise medical records and broaden the collection of demographic data. The authors suggested that such data could be used to detect health disparities, optimise the effectiveness of quality improvement interventions, and generate more reliable data on quality of care and outreach to patients. According to the authors, the “most common and strongest objection” was that doctors (and other practice staff) believed that “knowing a patient’s race and ethnic group is, or should be, clinically irrelevant”.1 Doctors are motivated by quality of care,1 but in this US initiative, there is an incentive for the data collection in the form of additional reimbursement. In Australia, incentives have been introduced for doctors to improve the management of infectious and chronic disease among Indigenous Australians (eg, payment for additional immunisations for children, access to health assessments at an earlier age and programs to improve access to medicines).2,3 However, these incentives have generally had limited uptake.2,3 This has been attributed to a failure to collect information on whether or not patients are Indigenous. In 2009, using a combination of an analysis of the available literature and de-novo qualitative research, we examined strategies for improving the identification of Indigenous people in general practice in order to facilitate the uptake of new measures associated with the Closing the Gap objective.4 Three issues emerged from discussions with general practitioners that have important implications for improving the identification of Indigenous patients in general practice. First, there was a clear consensus that the poorer health status of Indigenous patients indicated a need to improve their medical care. Second, in order to convince clinicians and overcome resistance to identifying Indigenous patients, the relevance of identification to quality of care needs to be demonstrated. Third, the experienced clinicians interviewed for our report could not provide any examples demonstrating how identifying Indigenous patients had improved medical care. In part, this last issue seemed to arise from the way clinicians conceptualise quality of care. Campbell and colleagues proposed a model of quality of care with two dimensions — access and effectiveness.5 Access means availability, accessibility, affordability and acceptability while effectiveness is operationalised as the processes of interpersonal and clinical care. Interpersonal care relates to the interaction between health care providers and their patients. Clinical care relates to the technical aspects of care.5 This distinction is also reflected in guidelines developed in the US to address disparities in health.6 Our research indicated that one of the barriers preventing clinicians from making the link between identifying their Indigenous patients and and quality of care is that they tend to focus on effectiveness of care rather than access to care. For example, in focus groups, none of the clinicians talked about access to additional or modified health services as a reason for identifying Indigenous patients, even though this is a cornerstone in reducing health disparities.4 However, at case study sites, we found that clinicians who did associate identification with accessing specific services or applying different sets of clinical guidelines were more confident and willing to ask patients about their ethnicity. Focusing on awareness of health services specifically available to Indigenous people, the rationale underlying these services and the associated incentives resulted in significant increases in completed health assessment for Indigenous people.4 Making the link between the collection of identifying data with quality of care is also important from the perspective of the community. Consultation with the community has revealed that, while many community members were prepared to identify as Indigenous, they did not see this information as relevant to the quality of care they received.7 Understanding that they might directly benefit from information provision was seen as further incentive for patients to identify as Indigenous. Not surprisingly, displaying promotional material in practices (including Indigenous flags etc.) significantly improved Indigenous identification. Knowing a patient’s ethnicity can help orientate clinicians to a range of issues and health service options that they might not otherwise have considered. Ensuring that identification results in improved care requires that this information (like any other aspect of a patient’s social history) is considered a starting point for enquiry that reflects the clinical and interpersonal imperatives of any interaction. Increasing the willingness of doctors to enquire about ethnicity will require a doctor more easily making the link between knowing a patient’s ethnicity and his or her quality of care. While this will involve improving doctor and patient awareness, it will also require having systems in place that enable information about ethnicity to contribute explicitly to improved quality of care.

Margaret Kelaher BScPsych, PhD · Amy Parry BA, DipPH · Susan Day BA, PhD · Yin Paradies MMedStats, MPH, PhD · Ian Anderson MBBS, PhD

Social networking and search engine data confer real-time advantages The population-level pattern-based nature of epidemiological research makes it well suited for computational work in general, and for machine learning in particular. The social nature of disease spread makes recent trends in social media computing specifically amenable to epidemiological research, but can computational techniques be reliable indicators and predictors of communicable disease? Previous approaches to epidemiology have had to rely on self-report mechanisms (eg, online health surveillance at www.flutracking.net), or on reports from health care services, such as the United Kingdom Health Protection Agency (HPA), the United States Centers for Disease Control (CDC) and the European Centre for Disease Prevention and Control. The recent growth in the use of social media means that people now volunteer large amounts of information on a real-time and location-specific basis. Along with this, advances in computational intelligence in the form of machine-learning and data-mining techniques have proven useful in knowledge discovery and predictions in other domains. So, how best can we make use of and interpret that vast quantity of information? The information is of two main kinds: that provided by users (status updates and microblogging, such as on Facebook and Twitter); and requests for information using search engines such as Google and Yahoo. Patterns found in this information can be interpreted by applying machine-learning and data-mining techniques. Roughly speaking, machine learning and data mining are used to make predictions based on patterns learned from data and discovering patterns in data. In the words of Tom Mitchell, “A computer program is said to learn from experience E with respect to some class of tasks T and performance measure P, if its performance at tasks in T, as measured by P, improves with experience E”.1 Researchers from the University of Bristol in the UK have been using Twitter to investigate the possibility of tracking influenza spread. They collected about 160 000 tweets per day over 24 weeks from the 54 most populated areas in the UK, in which they sought, for example, reports of sore throat, fever or headache. Reports from the HPA (based on general practitioner consultations per 100 000 citizens resulting in influenza diagnoses) were used as the “gold standard” basis for disease activity when learning to predict influenza rates. Learning and discovering patterns resulted in the ability to predict HPA flu rates with about 90% accuracy.2 The University of Iowa used a similar approach, whereby public sentiment about pandemic (H1N1) 2009 influenza and actual disease activity was tracked using Twitter posts. Using about a million influenza-related tweets and the CDC’s reported data, machine learning was used to construct a predictive model. Even though the model does not predict disease activity, it was able to estimate activity in real-time, reflecting the data in the official CDC reports. The advantage is that “real-time” is typically 1–2 weeks ahead of CDC reports.3 People do not use use Twitter to discuss their health — many use search engines to research symptoms, treatments, spread of diseases, and so on. Google conducted an experiment on monitoring search queries related to influenza. An analysis of 5 years’ worth of log-files in combination with available CDC information was used to construct a regression model for influenza surveillance, which contains the top 45 search terms. This model was used to predict the spread of influenza in the 2007–2008 influenza season. As with the University of Iowa example, the system was able to consistently estimate the percentage of the population with influenza 1–2 weeks ahead of official CDC reports.4 I have highlighted just some of the emerging work on applying clever algorithms and large amounts of computational power to vast amounts of information generated by users of search engines and social media. Despite the impressive results, these approaches are not a panacea for epidemic surveillance. There are challenges, some shared with existing techniques and some that are unique. People discussing their health on Twitter are not representative of the general population, and Twitter use is not uniform across time and geography. Demographic data provided by traditional surveillance cannot (yet) be supplied by search queries. Additionally, it is difficult to separate discussion about epidemics from actual cases. Regardless of current shortcomings, these approaches will prove to be important parts of modern medicine.

Anders Kofod-Petersen DrScient

Veterinary pharmacologist Stephen Page believes that antibiotic use in animals benefits human and animal health While antibiotic use in livestock has the potential to cause harm to human health, the likelihood of harm arising from the use of antibiotics under current Australian practices is highly unlikely. There is ample independent evidence supporting the long history of appropriate use of antibiotics in Australian livestock. For example, the past six annual reports of the National Residue Survey contain the results of tests for the presence of up to 38 antibacterial agents in the edible tissues of cattle, pigs, poultry and sheep.1 Almost 400 000 assays were performed and compliance with Australian standards was at or above 99.99% for each of the four species tested. Given the high morbidity and mortality associated with many of the diseases of livestock (eg, necrotic enteritis and coccidiosis in poultry, bovine respiratory disease and mastitis in cattle, and post-weaning diarrhoea and porcine respiratory disease in pigs), prevention of infectious diseases is of fundamental importance. Judicious use of antibiotics in integrated animal health plans has an important role to play in protecting the health and welfare of animals and in contributing to the safety and quality of the food that is produced. Only 39 antibacterial agents are approved and available for use in Australian livestock, six of which are from classes with no human medical use counterpart. As an example of contemporary patterns of use, a recent survey of the use of antimicrobial agents in the Australian pig industry found most use was for control of infections with Lawsonia intracellularis, Mycoplasma hyopneumoniae and Escherichia coli and relied on sulfonamides, tetracyclines and penicillins2 — all drugs considered by the Expert Advisory Group on Antimicrobial Resistance to be of low importance to public health.3 What led the Australian Department of Health and Ageing to conclude that “Australia’s food supply is one of the safest and cleanest in the world”4? In 2008, Food Science Australia was commissioned to survey the presence of bacteria with antimicrobial resistance in samples of raw whole poultry, beef mince and pork chops collected from shops in Melbourne, Sydney, Brisbane and Perth. Among the isolates of Campylobacter jejuni, Salmonella and E. coli that were collected, no fluoroquinolone or ceftiofur resistance was identified. No Enterococcus faecium was isolated and all Enterococcus faecalis isolates were susceptible to ampicillin, penicillin and vancomycin; only one of 300 E. faecalis isolates was resistant to gentamicin. In contrast, Denmark, despite being recognised as having one of the most regulated and conservative approaches to the use of antibiotics in livestock, noted significant antibiotic resistance in their most recent antimicrobial resistance monitoring report: fluoroquinolone-resistant C. jejuni in 17% of broiler meat samples; high-level gentamicin resistance in E. faecalis from pork samples; vancomycin-resistant E. faecium in 47% of isolates from broiler chickens; extended-spectrum β-lactamase producing E. coli (ceftriaxone resistant) in 27% of broiler cloacal swabs and 9% of broiler meat samples; fluoroquinolone-resistant Salmonella enterica subspecies enterica serovar Enteritidis in 8% of sporadic cases of human salmonellosis; multiresistant Salmonella enterica subspecies enterica serovar Typhimurium definitive type 104 (DT104) in 7% of isolates from pigs; and ceftiofur-resistant E. coli in 1% of domestic pork and broiler meat samples.5 OzFoodNet (http://www.ozfoodnet.gov.au) was established by the Australian Government in 2000 to enhance surveillance of foodborne disease. It has published eight annual reports, which do not identify any cases of domestically acquired foodborne illness caused by infections with Salmonella, Campylobacter or Shiga toxin-producing E. coli complicated by antibiotic resistance of livestock origin. By contrast, a number of human cases of fluoroquinolone-resistant Campylobacter infection and S. Typhimurium DT104 infection have been described, but each originated from overseas (especially South-East Asia) or from imported food. Since 2001, the Australian Salmonella Reference Centre has tested more than 18 000 Salmonella isolates from cattle, pigs, sheep, chickens (broilers and layers), raw meat and eggs. No fluoroquinolone-resistant isolates were found and only nine isolates (most of which were submitted before 2004) were phenotypically resistant to cefotaxime at 1 g/mL. Australians should be reassured that food safety is the highest priority in livestock production. The Australian Veterinary Association is currently updating a series of guidelines for responsible use of antibiotics, the poultry industry is supporting leading edge research to develop a vaccine to prevent necrotic enteritis, and the pig industry has spent over $7 million on projects to refine and replace the use antibiotics and has committed to halving antibiotic use by 2018. Antibiotics used prudently and selectively can clearly benefit animal health and welfare, leading to overall human health benefits, not risks.

Stephen W Page BVSc(Hons), MVetClinStud, MAppSci(EnvTox)

Effective clinical practice is predicated on valid and relevant clinical science — a commodity in increasingly short supply. The pre-eminent place of clinical research has become tainted by methodological shortcomings, commercial influences and neglect of the needs of patients and clinicians. Researchers need to be more proactive in evaluating clinical interventions in terms of patient-important benefit, wide applicability and comparative effectiveness, and in adopting study designs and reporting standards that ensure accurate and transparent research outputs. Funders of research need to be more supportive of applied clinical research that rigorously evaluates effectiveness of new treatments and synthesises existing knowledge into clinically useful systematic reviews. Several strategies for improving the state of the science are possible but their implementation requires collective action of all those undertaking and reporting clinical research.

Ian A Scott FRACP, MHA, MEd · Paul P Glasziou FRACGP, PhD

Donor countries withdraw HIV funding just when compelling evidence on prevention emerges The global epidemic of HIV and AIDS started in sub-Saharan Africa, and there are now 23 million people in the region living with HIV, representing 68% of the world total. In December 2011, I participated in the 16th International Conference on HIV/AIDS and Sexually Transmitted Infections in Africa (ICASA), held in Addis Ababa, Ethiopia. The conference was full of good news about progress against HIV over the past few years, but there was also a great deal of concern about the ability to sustain the momentum. The 2011 Global HIV/AIDS Response progress report, released on 30 November, showed that the number of new HIV infections in sub-Saharan Africa declined from 2.2 million in 2001 to 1.9 million in 2010, and the number of AIDS-related deaths declined from 1.7 million in 2005 (the peak) to 1.2 million in 2010.1 The decline in AIDS deaths is mainly due to the increased availability of antiretroviral therapy (ART), and the main reason for the availability of ART in Africa is the United States President’s Emergency Plan for AIDS Relief (PEPFAR). President George W Bush established PEPFAR in 2003, and he was guest of honour at ICASA. The 5000 delegates gave him a standing ovation as he approached the podium to deliver his address. A major cause for optimism at ICASA was the recently published evidence that ART can effectively prevent transmission of HIV, a concept called “treatment as prevention”. Results from a randomised trial published in August 2011 showed that early initiation of ART for the HIV-positive partner in a serodiscordant couple reduced HIV transmission to the HIV-negative partner by 96%.2 Other studies published in 2011 have shown that use of ART by the HIV-negative partner reduces risk of HIV infection.3 This all bodes well for control of HIV in Africa — but only if there is adequate funding. Overshadowing ICASA was the spectre of cuts to foreign aid to Africa as a result of the global financial crisis. Just before ICASA, the Global Fund to Fight AIDS, Tuberculosis and Malaria announced that it was cancelling Round 11 of its funding. One of ICASA’s keynote speakers, Canada’s Stephen Lewis, was particularly scathing in his criticism of the Global Fund and its donor countries. Like previous speakers, he warned that a reduction in funding meant that people would die because of lack of access to ART. But Lewis went further. He said: “The decision on the part of the donor countries is unforgiveable ... It’s unconscionable, indefensible, outrageous. It’s murder, that’s what it is: murder.”4 While the Global Fund’s decision to cancel Round 11 was unexpected and shocking, there was, nevertheless, general recognition at ICASA that African countries need to become less dependent on donors in their efforts to control HIV and AIDS. Indeed, the theme of the conference was “Own, scale-up and sustain”. One of the advocacy groups at ICASA — these conferences tend to involve a nice mixture of scientists and activists — was lobbying hard for African governments to spend 15% of their budgets on health, as they had agreed to do in the Abuja Declaration as long ago as 2001.5 Led by its Minister of Health, Dr Tedros Adhanom Ghebreyesus, Ethiopia is one country that is taking a comprehensive approach to improving the health of its population. Dr Tedros has often been called the “world’s best health minister”. His major achievements include training and deployment of 38 000 health extension workers and an increase in medical school admissions from 250 students in 2005 to 2500 in 2012. At ICASA, he spoke of how he has used donor funding for HIV programs as a platform for strengthening the entire Ethiopian health system. There was only a handful of Australians at ICASA. I worked with HelpAge International, the World Health Organization and UNAIDS (the Joint United Nations Programme on HIV/AIDS) to convene a workshop on HIV in people aged 50 years and older, and Dr Daniel O’Brien from Geelong presented data from his work with Médecins sans Frontières on false positive results from rapid diagnostic tests for HIV. It’s a pity there weren’t more of us. Ethiopia holds a special place in Australia’s relationship with Africa. It is the site of the fistula hospital established by Australian Dr Catherine Hamlin and her husband, and also a new Australian Embassy that will soon start allocating significant funding for maternal and child health. ICASA shows that the next few years will be crucial to health in Africa. Australian doctors should contribute more to the continent with the highest burden of disease.

Robert G Cumming MB BS, MPH, PhD

Increased research in the area of complementary and alternative medicine (CAM) is urgently required, in addition to a balanced appraisal and communication of the state of evidence in the field. Current challenges for clinicians and the public in accepting purported CAM evidence concern potential selective publication of results, marked differences in product quality ...

Jerome Sarris PhD, MHSc

Ray Moynihan explores dilemmas over public access to records on professional misdemeanours These days, it seems technology starts to answer the questions it raises, even before we’ve had time to properly formulate them. As social media and sophisticated software force previously unimagined forms of transparency deep into the fabric of our lives, asking where to draw the line between professional privacy and the public right to know feels somehow old-fashioned. Yet, the answers will affect the future of health care, its massive workforce and the population at large. Australia’s new national register of over half a million health professionals now offers the possibility of searching someone’s entire track record with one click. The extent to which we embrace this new opportunity is the subject of an emerging debate that’s likely to generate a lot more attention. A powerful piece of investigative journalism from the new Global Mail outlet has laid out some of the groundwork for this debate, citing examples of past egregious conduct which fails to appear on practitioners’ current registration records.1 One case involved a nurse being repeatedly violent to nursing home residents; another featured a pharmacist moving large amounts of flunitrazepam, popularly known as a “date rape” drug; a third involved a doctor using cocaine with, and making sexual advances to, a receptionist and being convicted of criminal charges. As the Global Mail made clear, there is no legal requirement for past suspensions or reprimands — even for serious misdemeanours — to be part of the current registration record of a practitioner. What the new law does require is transparency about ongoing restrictions on a provider’s registration — which is, of itself, a major improvement on the old situation where many adverse findings were effectively secret. “The level of trust in regulators needs to be high”, says Joanna Flynn, chair of the Medical Board, one of the 14 boards that sit within the new Australian Health Practitioner Regulation Agency, in an interview. “If it looks as if we’re hiding anything it could diminish that trust.” She points out that the new register’s site also has links to external legal databases with previous decisions of courts and tribunals, though these can be difficult to track down. As to the question of whether everything in a practitioner’s track record should be easily available at the push of one button, “that’s for a wider debate”, Flynn told me. The new agency’s chief executive officer, Martin Fletcher, agrees. “I think there’s an important debate to have about transparency. There’s no right or wrong answer”, he said when I interviewed him, adding that the register is in place to protect the public, not punish practitioners. The clear tension here is between professionals wanting to protect their reputations and move on from past problems, and the public wanting to make the best decisions about who they want to care for them. “The debate is live, fraught and controversial”, said Ian Freckelton SC, a barrister and law professor at Monash University with long experience on health tribunals, in my interview with him. He says community expectations have changed significantly in the past decade, and there is a need to balance complex issues of privacy, rehabilitation, access to information and informed decision making by patients — which can be more complex still when involving a practitioner’s individual health condition. “This is something we’re just forming our views on.” There does seem to be an informal consensus about the need for a formal public consultation on the extent of transparency on the new national register. Should there be full one-click transparency of the entire track record, or should practitioners’ entries be cleared of problems they have demonstrably overcome? “We believe in rehabilitation”, said Merrilyn Walton, when I interviewed her. Her default position is full transparency, but with the opportunity for material to come off the registration record on a case-by-case basis. A former consumer watchdog and now board member for the new registration agency, she told me in her capacity as professor of patient safety at the University of Sydney that she’d like to see widespread public consultation: “We need to talk about this”. There seems little doubt we’ll soon be doing a lot more talking about the merits and limits of one-click transparency.

Ray N Moynihan BA

A window of opportunity for change The current health care reform process is remarkable for its lack of attention to private non-general practice (non-GP) specialist services. About 23 million ambulatory visits are made to non-GP specialists each year, and $1.6 billion of the Medicare budget flows to these services. For the patient, effective collaboration between his or her various health care providers is essential for safe, high-quality care. This is particularly so when the patient is consulting more than one non-GP specialist. An individual with type 2 diabetes, for example, might be seeing an endocrinologist, a nephrologist, a cardiologist and perhaps others, in addition to his or her general practitioner and allied health providers.1 The final report of the National Health and Hospitals Reform Commission (NHHRC) noted the key role of non-GP specialists in the shared management of care for patients with complex and chronic health needs, and recommended improving access to a more comprehensive and multidisciplinary range of primary health care and specialist services in the community through the establishment of Comprehensive Primary Health Care Centres and Services, available for extended hours.2 However, the current reforms are concerned almost exclusively with public hospital, general practice, community and primary care services. While GP Super Clinics may provide consulting facilities for visiting medical specialists, there are currently only 64 implemented or planned across Australia, and there is no formal requirement or policy incentive for functional integration between non-GP specialists and members of the primary health care team working in the same GP Super Clinic.3 So is there a problem? Potentially, yes. The vast majority of non-GP specialists in private practice are highly skilled, committed practitioners. Nevertheless, the lack of a comprehensive policy framework means that access to private specialist services is determined largely by market forces. This is most apparent in the geographical maldistribution of the medical workforce, with relatively few non-GP specialists choosing to work outside metropolitan areas. Moreover, almost no improvement in specialist–population ratios in remote and rural areas is expected over at least the next 8 years.4 Even in metropolitan areas, there is a tendency for private specialists to practice in affluent areas, limiting the choice available to patients in more deprived areas, whose mobility may be reduced by poverty or disability. And yet it is in socioeconomically deprived areas that patients are more likely to suffer multiple chronic diseases.5 It is striking that about 80% of general practice consultations but only 27% of non-GP specialist appointments for ambulatory care are bulk billed.6 The average gap between the fee charged by a non-GP specialist and the Medicare benefit received by a patient who is not bulk billed is $46.12. A recent Australian Bureau of Statistics (ABS) survey found that about 10% of Australians referred to a non-GP specialist delayed or did not keep the specialist appointment because of cost.7 Unlike in general practice, there are no Medicare incentives for non-GP specialists to bulk bill for most consultations. The Medicare Safety Net helps, but it is clear from the ABS data quoted above that up-front billing can exceed the cash reserves of many patients. A further potential problem with the lack of a policy framework for private non-GP specialist services is the risk of lapses in quality and safety. All medical practitioners in Australia are required to provide evidence of participation in continuing professional development at the time of annual registration but, unlike the accreditation process for general practices, there is no requirement for the quality review of non-GP private specialist practices, with the exception of imaging providers and laboratories. Lapses in the quality of non-GP specialist care are likely to be rare, although few rigorous data exist, but when they occur the implications can be disastrous.8 A more common threat to quality and safety may be lack of timely communication with the patient’s general practitioner following every consultation by another specialist.9 This can have major ramifications for a patient with complex care needs. There is very little point in a doctor seeing and advising a patient without communicating with the other health practitioners involved in his or her care. Radiologists, pathologists and non-medical health practitioners who provide Medicare-rebateable services following referral are required to supply a report to the referring doctor, and it seems reasonable for such reporting to be universally expected of all referred services. No systematic data exist, but general practitioners report frequent frustration at the lack of timely communication from other medical colleagues.10 These difficulties are further compounded by failure to implement the NHHRC’s recommendation of strategies to assist patients living with complex health problems to adopt a single general practice as their “health care home” responsible for continuity and coordination of care.2 So what is required to address these problems? Medicare Locals are currently being rolled out across Australia, replacing Divisions of General Practice, and will be required to work with local clinicians — including Lead Clinician Groups and presumably individual specialists — “to identify and remedy service gaps and breakdowns in service integration and coordination”.11 However, their ability to bring about change at regional level will be limited without a national policy framework that includes provisions relating to non-GP private specialist practice. General practitioners receive incentive payments for bulk-billing concession card holders and children. For reasons that are not clear, other specialists only receive bulk-billing incentives for telehealth consultations. A Medicare incentive for non-GP specialists to bulk bill consultations and other services for concession card holders and children would help to address the financial barrier faced by many patients. Such an incentive would also help redress the potential differential in revenue for specialist practices between affluent and deprived communities. A bulk-billing incentive would be more socially just than the current Extended Medicare Safety Net (EMSN) which, on the ABS evidence cited above, fails 10% of referred patients. A review published in 2011 found that some 53% of EMSN benefits were distributed to the 20% of the population living in Australia’s most socioeconomically advantaged areas, whereas the 20% living in the most disadvantaged areas received only 3.7% of benefits.12 Medicare rebates should be contingent on a report being provided for all referred medical services, not only pathology and imaging services. It will become easier to ensure that such reports are accessible to all treating health professionals once the impediments to a national personally controlled electronic health record are overcome. Incentives are required for all health practices, not just general practices, imaging providers and laboratories, to undergo regular accreditation. The present Australian health reform process provides a window of opportunity to develop and implement policy changes relating to private non-GP specialist practice, ensuring that the considerable public funding flowing to this sector of the health system achieves the most effective and equitable contribution to the nation’s health.

Tim P Usherwood MD, FRACGP, FRCP

“When you have seen one AHSC, you have seen just one AHSC” — Academic Health Sciences Centre, National Task Force Final Report1 Australia’s health system is struggling to meet demand and expectations. Demand is driven by an increasing burden of chronic non-infectious disease associated with ageing.2 Expectations of cutting-edge care for all are set by the public and by government.3 Meeting these demands and expectations will be possible only with substantial effort in research and education as part of health service delivery. Separation of funding for research and education from the delivery of patient care diminishes the opportunity for mutually enhancing integration, and for expenditure efficiencies.4,5 Recognising the importance of evidence-based clinical practice in quality and efficiency of health care delivery has been a driver for the creation of academic health sciences centres (AHSCs) in the United Kingdom6 and Canada.1 Australian commentary on AHSCs7 has emphasised an absence of government leadership in establishing AHSCs in Australia. It is critical to the success of AHSCs as a tool for optimal health care delivery that they are inclusive, and that they set performance benchmarks in service delivery, education and research, while neither aspiring to elitism, nor separating their activities from the provision of health care itself. In early 2010 and 2011, a group of Brisbane hospital, university and community health care practitioners, administrators, educators and researchers had several meetings to consider the feasibility of establishing an AHSC. They recognised that some integration of education and research with service delivery was already occurring. A successful example of this was a hospital-based research program that had led to the development of cervical cancer vaccines,8 which had led to development of research facilities. This and other similarly successful programs were facilitated by leadership from individuals; however, an environment that encouraged activity by all practitioners was seen as likely to result in better outcomes in education, research and service. The meetings concluded that providing such universal support would improve health care, and further noted that failure to combine the three domains could be wasteful. Several barriers to integration of education and research with service delivery were identified, which could be resolved by using a partnership model between local research institutions, public and private health care providers and educational facilities. Emphasising a partnership meant moving from a workplace focus to integrated management and service delivery structures across boundaries between primary and tertiary health care, and between education and research. The partnership model was chosen because governance was identified as key to realigning the purposes of hospital and academic institutions.9 Although it was hoped that merging many of the partners’ processes would occur with time, it was agreed that incremental changes in leadership and management structure could usefully start the process. These changes would be prioritised in terms of their potential to have a positive effect on health outcomes and resource efficiency. Developments in health and hospital reform and the release of a National Health and Medical Research Council position paper on designation of Advanced Health Research Centres in 2010, to which the group provided comments, helped launch the Diamantina Health Partners (DHP) in mid 2011 as an AHSC. This partnership brought together the University of Queensland (UQ) PA-Southside Clinical School, UQ Diamantina Institute, UQ general practitioner partners, research and teaching components of the Queensland University of Technology (QUT), the newly created Translational Research Institute (TRI), and health service delivery units from the Princess Alexandra and Mater Hospitals. The partnership is a functional (not legal) one, with relationships and governance determined by a signed memorandum of understanding (MOU). The MOU covers the following issues relating to governance: The DHP board is entrusted to explore options for the best organisational vehicle for the DHP (which in time may become a separate legal entity). Sufficient internal resources will be committed by the partners as appropriate to achieve outcomes, with each (except the TRI) making an initial financial contribution for the development of the DHP. Financial contributions may be varied by mutual agreement of the board. The initial financial commitments of the DHP are the costs of a senior administrative consultant and workshops for strategic developments. All income remains with the participating entities. The board is to formulate and control administrative and strategic development. Mission and visionThe major aim of the DHP is to integrate research, teaching and training with clinical service delivery, to enable internationally benchmarked, quality health care to be delivered in a timely and cost-effective manner. We recognise that complete integration is not realistic, but believe that mutually beneficial strategic decisions at university and hospital levels will facilitate achievement of the vision. Initially, we will align the strategic goals and plans of DHP stakeholders with expectations of patients using DHP services, for which we established six principles of development (Box 1). Planning coordination is pivotal to the success of the DHP, and we believe education of clinical staff in research will encourage critical evaluation and application of new ideas and therapies in clinical care — skills to improve hospital performance in key performance indicators relating to efficient use of health care infrastructure (Box 2). Staff discussions about conjoint appointments facilitating teaching, research and clinical services are underway between the partners. Current situationOne of our most pressing problems is engagement and representation in the DHP, which we are using our committee structure, reporting system, discussion groups and user groups to address. Early success in engagement is evident in collaboration on draft proposals and in facilitation of clinical research (by building clinical trial enrolments into performance indicators of service providers and departments). Engagement success is also seen in the teaching of medical, allied health and nursing students about clinical research methods, and by facilitating encounters between clinicians and basic researchers. Engagement is important from the strategic and survival perspectives of the DHP, and various strategies to benefit health and working environments are being planned. The ability to address new barriers is also crucial to success. Another issue is that although the DHP board needs to have strategies in the best interests of the DHP, some partner representations on the board will be necessary, at least initially. The long-term aim is to have the right mix of people and skills acting in the interests of the DHP. An appropriate policy for membership of the board and its committees is being developed, as is a structure for successful implementation of DHP strategy into practice. Clear governance lines between the board and the partners will be necessary. Lastly, board diversity needs to be considered. The increasing number of women who are clinical academic leaders in Queensland will help achieve a balance of sexes. Care must be taken not to change organisational structure unless changes are clearly linked to improving health outcomes. Areas under consideration include harmonisation of job descriptions and salaries between employment agencies, transparency of data and information technology services, and standardisation of intellectual property and commercialisation management. Setting research and policy priorities is underway. An evident failure to deliver the vision espoused in the original 2010 proposal for health reforms threatens the existence of AHSCs, as federal funding for research, education and health remain separated. It is expected that the DHP will be politically independent and the board will be accountable for policy delivery and efficient use of public funds. The outstanding issues to be resolved by the DHP board are engagement; structural and policy “levers” it can use to influence institutional strategies; and ensuring strong alignment between the DHP and its individual components. SummaryMany have asked “what is the benefit of the DHP over the current situation?” We believe that the responsiveness of research to community health needs and the balance of research and teaching outcomes in academic institutions can be improved, and stronger incentives to integrate research outcomes into clinical practice can be provided. The DHP is thus set up differently to a clinical research centre. The aim of our DHP is to improve health outcomes by means of coordinated excellence in teaching, research and clinical care. Technical efficiencies and excellence in care mean that financial efficiencies will occur. Joint clinical, research and teaching initiatives are underway, and plans are being developed to teach future clinical staff the science of clinician-directed, rational use of medical resources. These include pathology, imaging services, pharmaceuticals and patient referrals, assisted by published expert guidelines. There are significant administrative and personnel issues to surmount, but planning for integration has begun, and plans for turning research outcomes into clinical care plans are already emerging. 1 Six principles of development The Diamantina Health Partners (DHP) will work towards: 1. A joint governance structure promoting a coordinated effort towards better health care. The DHP governance structure is based on a partnership — a non-incorporated joint venture. This structure enables partners to honour obligations to other entities. Functional integration is supported through joint appointments and creation of joint activity streams. 2. Jointly determined key performance indicators (KPIs) in patient care, education and research. Traditional measures of research focused on publications and of teaching based on student assessment were felt not to provide an ability to measure relevant contributions to health outcomes or “quality”. 3. A jointly agreed strategy for improving health care, focused on health and wellbeing. 4. Administrative processes aimed at accelerating dissemination of research-based evidence into clinical practice. 5. Collaborative use of public resources with public accountability. Cost-effectiveness is part of DHP strategy. Collaborations that ensure the best use of public resources and public accountability are encouraged. Reporting towards KPIs that relate to measurable health improvements will be introduced. 6. Common drivers encouraging development and improvement of clinical innovation, training and health policy. Proven strengths on the DHP campuses will be used as exemplars for setting aims and employment standards at an international level. 2 Clinical issues that could be improved with better linked education and research Role of emergency department for multiple attenders and for people with chronic conditions Bottlenecks in internal medicine discharges and the primary–secondary health care interface Providing health care for areas of high medical need, such as bariatric surgery versus a proliferation of obesity clinics in tertiary hospitals Use of expensive pharmacotherapies that have not been proven to meet clinically relevant end points, and which may cause high rates of adverse drug events New research tools such as genomics for predictive management of disease or response to drug therapies, streamlined by information gained from health services research in a particular health district

Jennifer H Martin FRACP, PhD · David E Theile MB BS, FRACS · Ken K Y Ho MD, FRACP, FRCP(UK) · Ian H Frazer FRCPE, FRCPA, FAA

The challenge of removing what’s useless, harmful or cost-ineffective It’s easy to forget that the evidence-based approach to medicine is still relatively new, and that a substantial part of health care is not supported by gold-standard evaluation. New procedures, until very recently, have had no requirement for rigorous testing, unlike new drugs. Of the more than 5000 items on the Medicare Benefits Schedule (MBS) today, most “have never been comprehensively assessed for their safety, effectiveness and/or cost-effectiveness”.1 But now many more interventions will be exposed to the chill winds of evaluation. And those that don’t shape up could become targets for “disinvestment” — withdrawal of funding from existing treatments. Although not explicitly mentioned, disinvestment is part of the thinking behind recent developments in Canberra. Announced in the current Budget, a “comprehensive management framework” for Medicare strengthens assessment of new treatments, and introduces “rolling reviews” of existing interventions, to assess quality, safety and fee levels.2 Systematic methods will be developed to inform “appropriate amendment or removal of existing MBS items”. Judging by the progress of several “demonstration reviews”, clinicians nervous about threats to their livelihoods needn’t worry too much. Sensitive about perceptions of taking something away, the federal government is treading warily — using maximum engagement with affected specialties. For example, despite finding colonoscopy use had jumped an extraordinary 84% in just a decade, the review of this procedure gave it a big thumbs up.3 The most comprehensive review is the ongoing whole-of-specialty review of ophthalmology. A report has been produced by Adelaide Health Technology Assessment, at the University of Adelaide, advised by a clinical working group from the Royal Australian and New Zealand College of Ophthalmologists (RANZCO) — in close collaboration with the health department.4 The report suggests a number of minor changes, including tightening the patient pool for a handful of Medicare items, but little in it is controversial. Importantly, assessing costs was strictly excluded. A key challenge in reviewing the evidence behind all the tests and treatments used by ophthalmologists was actually finding the evidence. Sometimes there was little published literature, so reviewers relied on guidelines built on consensus rather than on solid evidence. And existing procedures tended to be treated more leniently in the review than new procedures seeking funding today. Alex Hunyor, a representative of RANZCO who is intimately involved in the review, says some treatments, particularly medicines, lend themselves to randomised controlled trials, whereas with surgery often “the evidence is not necessarily of the type we’d like it to be”. He adds that, in cases where technology is evolving quickly, “we can’t necessarily say, ‘here’s the hard evidence’”. A high-profile example of a procedure without hard evidence from another specialty area is vertebroplasty. After a long battle between proponents and critics, trials showing no meaningful benefit, and an independent review, the government’s Medical Services Advisory Committee recommended dropping the procedure — a powerful example of disinvestment.5 Three clinical advisers disagreed with the recommendation, but it was accepted. The procedure no longer carries a Medicare rebate. In the United States, the failure to similarly disinvest in vertebroplasty has become a case study in the difficulty of withdrawing support from well established procedures unsupported by good evidence.6 Even in the United Kingdom, where debate is well advanced, decisions to disinvest are often not implemented in practice. Not surprisingly, the term “disinvestment” is little loved, rather than being seen as a positive attempt to bring scientific accountability to health care funding. “We’re trying to work together to get better value for money” is how the process is described by Ian Larmour from the Southern Health network of hospitals in Victoria, which has generated considerable savings using “therapeutic equivalence” to seek lower-cost medicines.7 It’s vitally important that Medicare’s rolling reviews are as rigorous and independent as they can be, to bring much needed scientific scrutiny to medicine’s vast back catalogue. Outcomes would be more credible if the influence of vested interests in the process was diluted, and the effectiveness, safety and cost of existing treatments was assessed with the same rigour applied to new ones. A healthy dose of disinvestment — no matter how unpleasant the term — may be required for those treatments where the balance of benefits, costs and harms is unfavourable. It’s not unhealthy rationing, it’s rational health policy.

Ray N Moynihan BA

Despite significant recent public investment in mental health, do we really know what Australia is getting for its money? In response to repeated inquiries revealing a profound crisis in the provision of mental health care services,1 Australia has committed to spending around $8 billion of new money on mental health since 2006. Few would argue that this investment was long overdue, given the significant gap between the funding mental health receives ($5.8 billion2 out of $113 billion of total health expenditure in the 2008–09 financial year3) and the contribution of mental illness to the burden of disease (13%).4 However, proper accountability for this expenditure is crucial. Health care consumers, carers, service providers, funders and taxpayers all have a right to know that funding for mental health is being spent judiciously, is targeted at the areas of greatest need, and is delivering better outcomes for people with mental illness. Establishing this accountability is not easy. The complexity of state and federal Budget announcements (and re-announcements) are the modus operandi of governments and perpetuate an environment characterised by opacity rather than transparency. After decades of underfunding for mental health services, new funding is often simply welcomed without query as to provenance or policy. In this article, we review the recent wave of mental health funding decisions in Australia. While we want to see the level of funding increase, such increases must be evidence-based, effectively delivered and transparently monitored. Recent mental health fundingThe major contribution to recent funding for mental health has been through the Council of Australian Governments (COAG) National Action Plan (NAP) on Mental Health 2006–2011.5 This provided $5.5 billion, comprising $2.2 billion from the Australian Government and $3.3 billion from the states and territories. However, analysis of Medicare Benefits Schedule (MBS) item reports shows that the uncapped growth in the Better Access to Psychiatrists, Psychologists and General Practitioners through the MBS (Better Access) initiative alone accounted for $2.1 billion by September 2011. It is concerning that, for such a sizeable investment, there have only been two NAP progress reports published, the most recent being released in September 2009.6 A subsequent COAG agreement in 2010 included $1.6 billion to be spent on subacute care, with an unspecified proportion to be allocated to mental health. Lastly, there is the federal government’s 2011 Budget announcement of a “record” $2.2 billion investment in mental health, partly funded through changes made to curb government payments under the Better Access initiative. A large proportion of this package was to enable continued funding of existing programs like Better Access, but the Budget also continued the government’s extensive investment in largely untested semi- or non-professional coordination of services (the Personal Helpers and Mentors Program) and “flexible” packages of care. There are as yet no data to assess how this new funding is progressing. In total, this new spending represents a significant public investment in mental health and, as such, deserves scrutiny. COAG National Action Plan fundingThe $5.5 billion committed in the 2006–2011 COAG NAP was allocated across four agreed action areas. However, there were no agreed definitions as to what activities could or should occur within each action area, and jurisdictions had complete autonomy over how money would be spent and reported. Consequently, there were significant variations in the funding allocations between jurisdictions (Box).6 Fully two-thirds of all NAP funding was allocated to Action Area 2 — “integrating and improving the care system” — while only 5% was allocated to Action Area 4 — “increasing workforce capacity”.6 The bulk of Action Area 2 funds went to the Better Access initiative. Supported housing options, community participation and employment (Action Area 3) remained secondary elements of the NAP, accounting for 17% of total funding allocations. In New South Wales, more than half the spending in this area ($58 million) was on one program — the Housing and Accommodation Support Initiative. Victoria pledged to spend about $44 million on growing its psychosocial rehabilitation sector, but over a 5-year period (2006–2011) this would barely cover anticipated price pressures and wage increases, let alone service expansion. Increasing access to mental health care was clearly a key goal of the NAP, but the evidence for progress is equivocal. The second NAP progress report certainly shows substantial service growth over the period 1997–2007, largely accounted for by the growth in Medicare-funded (Better Access) services.7 It reported that the proportion of the Australian population receiving clinical care for mental illness under Medicare rose from 3.1% in 2006–07 to 4.8% in 2007–08.6 However, the same progress report also shows that the proportion of the population accessing state-run mental health services dropped from 1.6% to 1.5%. Further, the National Survey of Mental Health and Wellbeing conducted by the Australian Bureau of Statistics in 2007 showed that treatment rates for people with a mental illness were unchanged since 1997.8 If the spending effort in Action Area 2 has not led to a discernible increase in treatment rates, then what substantive impact is this increased investment in traditional services having on mental health care in Australia? One explanation might be that new funds and new services are struggling to reach new clients. The data for state-run mental health services in the second NAP progress report indicate that this is the case for state and territory services. The current debate regarding the effectiveness and reach of the Better Access initiative is significant in this regard.9,10 There is evidence suggesting that groups who were missing out on care before Better Access are still missing out. In 2008, 68% of people using the Better Access program were using it for the first time. In 2009, this figure had dropped to 57%.11 The NAP progress report does not provide reasons for the variation in spending priorities between jurisdictions. There is no context to explain why Western Australia should allocate nearly a quarter of its funding to Action Area 1, while Queensland spent almost nothing (Box). Similarly, WA spent four times as much as South Australia on Action Area 3, and the Australian Capital Territory allocated 20% of its effort to workforce development, to which Victoria committed less than 1%. It is conceivable that these jurisdictional variations may be based on local service deficiencies and are therefore warranted. However, if this is the case, it is not clear how such deficiencies were identified. The NAP progress report shows a patchwork of jurisdictional investments rather than a coordinated national effort to address the agreed priorities. In the absence of nationally consistent definitions and accounting processes, it is impossible to verify whether jurisdictions really did spend what they reported. 2010 COAG agreement funding for subacute careThe 2010 COAG agreement to spend $1.6 billion on creating 1300 subacute beds, some of which are to be allocated to mental health, is also without transparency and agreed guidelines. In making this commitment to subacute care, COAG echoed the 2009 final report of the National Health and Hospitals Reform Commission, which stated: We recommend that every hospital-based mental health service should be linked with a multi-disciplinary community-based sub-acute service that supports “stepped” prevention and recovery care.12 There has been no progress report on the implementation of the mental health aspect of this agreement, but from public announcements it is possible to once again discern major variations in jurisdictional approaches. Queensland is building community care units, while SA is opting for supported accommodation places with crisis respite support. NSW is allocating all its subacute funding to new beds on hospital campuses. This variation between jurisdictions is not surprising, as there is no agreement on what constitutes subacute mental care. The term “subacute” does not appear anywhere in the National Mental Health Policy 2008 and is mentioned only once in passing in the Fourth National Mental Health Plan. Alternatives to hospital admission for mental health care in Australia are few. An unpublished national snapshot survey of acute psychiatric wards across Australia in 2006 indicated that 43% of all acute beds were occupied by people who could be cared for in other settings if suitable services were available. The investment in subacute care offers critical opportunities to build new services nationwide. However, competing priorities and a lack of consistent implementation may mean this opportunity could be lost. ConclusionDespite these increased investments, mental health’s share of overall health spending is shrinking. For the period 2004–05 to 2008–09, total mental health spending in Australia increased by an average of 4.8% per annum,2 while total health spending rose by more than 5%.3 There have been some 44 inquiries into mental health in Australia since the 1890s — about one every 2 and a half years. Despite these inquiries, and dozens of plans and policies, spending between jurisdictions continues to be uncoordinated, lacking both accountability and a focus on patients’ needs. There is little evidence to show that new mental health investments are driving improved health outcomes. For people with mental illness, the spectrum, capacity and quality of services available depends on where they live, and the quality of care goes largely unassessed. For real accountability, the new National Mental Health Commission must begin with a robust plan to identify and close service gaps based on evidence-based models of care. This should be accompanied by a National Report Card that includes nationally validated data of the experience of care, quality of life, and rates of homelessness, education and employment for people with a mental illness. Without this, no one will know if mental health funding is well targeted or just well meant. Council of Australian Governments (COAG) National Action Plan (NAP) on Mental Health 2006–2011 funding allocations, by action area and jurisdiction6 Action area* Jurisdiction 1: Promotion, prevention and early intervention 2: Integrating and improving the care system 3: Participation in the community and employment† 4: Increasing workforce capacity Total NAP ($ million) Australian Government 164.2 (8.2%) 1329.8 (66.7%) 369.5 (18.5%) 129.9 (6.5%) 1993.4 New South Wales 121.7 (12.4%) 721.6 (73.6%) 113.8 (11.6%) 23.3 (2.4%) 980.3 Victoria 97.7 (15.2%) 432.1 (67.0%) 110.6 (17.2%) 4.4 (0.7%) 644.8 Queensland 16.3 (1.7%) 717.5 (73.0%) 168.4 (17.1%) 76.9 (7.8%) 983.3 Western Australia 106.8 (22.1%) 216 (44.6%) 139.6 (28.9%) 21.5 (4.4%) 483.9 South Australia 47.1 (16.3%) 215.1 (74.6%) 22.1 (7.7%) 4.2 (1.5%) 288.5 Tasmania 2.2 (3.8%) 36.6 (62.4%) 11.3 (19.3%) 8.6 (14.7%) 58.7 Australian Capital Territory 5.1 (12.3%) 20.1 (48.3%) 8.1 (19.5%) 8.3 (20.0%) 41.6 Northern Territory 1.3 (8.6%) 13 (86.1%) 0.8 (5.3%) 0 15.1 Total 562.3 (10.2%) 3701.8 (67.4%) 944.2 (17.2%) 277 (5.1%) 5490.1 * Figures shown for each action area are $ million (percentage of total COAG commitment). Percentages may not sum to 100% because of rounding. † Including accommodation.

Sebastian P Rosenberg MPubAdmin · John Mendoza BEd · Lesley Russell PhD

Non-surgical intervention has many benefits. A recent article published in the Journal1 was widely reported in the popular press, with statements such as the following being quoted: public health messages encouraging people to eat healthy food and to exercise are unlikely to have long-term impact on their weight....

Daniel J Green PhD · Andrew J Maiorana PhD

A High Court of Australia ruling has reinstated the need for patients to prove causation of injury. The tort (ie, civil wrong) of medical negligence has recently changed, to the advantage of doctors. By its judgment in the case of Tabet v Gett in 2010....

Neera Bhatia LLB(Hons), LLM · James Tibballs MD, MHlth&MedLaw, FCICM

Proactive recognition and response, pre-emptive management Despite improvements in medical therapy and improved outcomes, patients admitted to acute care hospitals may suffer clinical deterioration and potentially avoidable morbidity. Recent reports show that patients admitted to hospital suffer cardiac arrests at a rate between 0.66 and 11.2 per 1000 admissions,1,2 and the approximately 80% mortality rate due to in-hospital cardiac arrests has not changed since the description of cardiopulmonary resuscitation more than 50 years ago.3,4 In this article, we review the epidemiology of in-hospital cardiac arrests and the evolution of the medical emergency team (MET) model to prevent them. In addition, we outline lessons learned from the MET model and the development of a national approach for recognising and responding to deteriorating patients. Finally, we contend that another paradigm shift is required to further improve patient outcomes via a more proactive and pre-emptive approach that includes improved detection and recognition of deterioration as well as structured management of patients who are at high risk of deterioration. The old paradigm: cardiac arrestWith introduction of cardiac arrest teams and Code Blue calls around 1970 came the first ubiquitous hospital protocol for escalating the care for deteriorating patients.3 This system is activated when a patient is pulseless and apnoeic, has no recordable blood pressure and is unresponsive. However, several studies published between 1990 and 2002 reported that in-hospital cardiac arrests were not sudden or unexpected, but were preceded by instability that was sub-optimally responded to.5-7 Up to 84% of patients had abnormal vital signs or new problems before cardiac arrest,5-7 and most were in asystole or had pulseless electrical activity.8,9 The current paradigm: METsIn 1995, the first description of the MET as a model for responding to patient deterioration was published.10 METs are composed of an intensive care, general medicine or emergency medicine registrar, and a critical care nurse. The advent of the MET delivered a mechanism for escalation of care earlier in the course of clinical deterioration than cardiac arrest. Criteria for a MET call are based on deranged vital signs and altered conscious state.10,11 A “staff member worried” criterion is often included to empower ward staff to call for assistance and bypass the traditional hierarchical model of escalation. Such criteria provide semi-objective thresholds for when ward staff should escalate care for deteriorating patients, and provide an expected and structured institutional response. The MET call is usually activated using a public announcement and pagers, and the team is expected to arrive within about 5 minutes. This system is the first patient-centred, organisation-wide system to be implemented across hospitals throughout the world. Over the past 16 years,10 METs have been introduced in at least 100 Australian hospitals.12 Although evidence of the effectiveness of METs is controversial,13,14 the MET model is currently the prevailing paradigm for identification of deteriorating ward patients and rapid escalation of care for them. Research into the characteristics and outcomes of MET patients has provided epidemiological data on deteriorating ward patients. In a MET-naive hospital, it was reported that 4.5% of ward patients fulfilled MET criteria on two separate days.15 Studies of mature METs report that 2.6%–5.6% of patients hospitalised for more than 24 hours receive MET review.16 Thus, about one in 25 ward patients will experience clinically significant deterioration. Research into MET patients has also shown that vital sign measurement is inconsistent and often incomplete, deterioration is variably recognised, and staff do not always activate a MET call when patients fulfil the criteria.17 In addition, activation is often delayed, and this is associated with increased mortality.18,19 Two surveys of ward nurses suggest that there is underappreciation of the significance of physiological derangements associated with MET criteria.20,21 A number of studies have reported that patients subject to MET review have a mortality rate of about 25%22-25 — higher than the 11% in-hospital mortality rate of patients admitted to intensive care units (ICUs),26 and much higher than the 2.5% in-hospital mortality rate for overall hospital admissions.27 Finally, about one-third of MET calls involve end-of-life care issues.24,25,28 These often occur out of hours, when parent teams are not in the hospital. As the patients are acutely unwell, they are often unable to participate in discussions regarding their preferences for active treatment, or conservative or palliative care. Accordingly, these decisions are typically left up to covering doctors, the MET and family members, and often need to be made expeditiously. A new paradigm: proactive, pre-emptiveThe MET model has emphasised the tenet that early intervention improves outcome (Box 1). Thus, the mortality of patients subject to MET review (25%) is lower than that of cardiac arrest patients (80%) but higher than that for patients admitted to ICUs. However, the MET model is reactive, as it requires a patient to deteriorate before it can be activated. We contend that a new paradigm is needed to promote a more proactive approach to recognising and responding to deterioration, and to provide a pre-emptive, structured, standardised approach to managing patients who are known to be at risk of deterioration (Box 2). This paradigm shift is supported by the National consensus statement: essential elements for recognising and responding to clinical deterioration,29 which describes the clinical systems necessary to provide appropriate care to deteriorating patients and the organisational supports needed to ensure that these systems operate effectively (Box 3). Predicting risk and preventing deteriorationNot all patients admitted to hospital will suffer a complication, but some will suffer sudden and unexpected deterioration. Increasing evidence suggests that patients can be risk profiled at, or even before, hospital admission. A hospital outcome predictive equation (HOPE) was recently developed using six variables that are associated with increased risk of death: age, sex, diagnosis at admission, emergency admission, aged care resident and inter-hospital transfer.27 In surgical patients, most postoperative complications are medical.30 It remains to be determined whether hospital-wide strategies or models of medical comanagement can improve patient outcomes based on such risk profiling. Similar criticisms were levelled at the MET model of care almost 10 years ago.31 Advance care planningAdvance care planning is particularly important in the context of the ageing Australian population, increasing numbers of comorbidities in hospitalised patients, and increasing complexity and intensity of medical therapies. Patients need to receive therapies that are beneficial to them, and do not cause significant harm or discomfort, and their wishes and choices regarding such care must be considered. Experience with the MET model suggests that many deteriorating patients receive suboptimal end-of-life care planning, and that this planning is done emergently by the MET. Advance care planning should be conducted when a patient is cognitively intact and able to contribute meaningfully to discussions, so that their preferences are known when deterioration is detected. In a recent trial, an advance care planning program improved the rate at which patients received preferred care, improved patient and family satisfaction, and did not increase patient mortality.32 Detecting and recognising early deteriorationImproved detection of deterioration requires tailoring of vital signs measurement to a level commensurate with a patient’s diagnosis, acuity, proposed treatments and change in status with time.29 In some patients, this may include the use of continuous automatic electronic monitoring systems that record observations and alert staff when trigger points are reached.33 Research shows marked variation in the quality and ease of use of vital sign charts.34 Enhanced design of observation charts has been associated with improved documentation of vital sign sets and recognition of deterioration.35 Improving management and follow-up of early deteriorationImproved training in the recognition of and response to early deterioration is needed. A multifaceted approach to this type of intervention — involving a newly designed observation chart, a track-and-trigger system and an education package — has been shown to be associated with increased MET activation, reduced unplanned ICU admission and reduced in-hospital mortality.36 Optimising the outcomes of MET patientsAs delayed MET activation worsens patient outcomes,18,19 research is needed to better understand the decision-making processes of ward staff with regard to escalating care for deteriorating patients. Specifically, it is important to understand the circumstances under which staff call their parent unit, as opposed to requesting external assistance. Auditing the clinical causes of MET calls may assist in the development of strategies to improve the outcomes of patients who fulfil MET criteria. The concept of “MET syndromes” has been raised,37 and it has been shown that sepsis, heart failure, pulmonary oedema and arrhythmias (especially atrial fibrillation) may be associated with about 50% of MET calls.38 Implementing checklists, guidelines or bundles of care for common causes of MET review may help to standardise management and improve outcomes of patients after a MET call has been activated. A simulation-based training course for MET members has been shown to be associated with improved team performance, but the effect of such training on MET patient outcomes has not yet been tested.39 ConclusionIn the 50 years since the components of cardiopulmonary resuscitation were described, outcomes of in-hospital cardiac arrest have changed little. The failure of cardiac arrest teams to substantially improve outcomes, in conjunction with research showing that cardiac arrests are often preceded by signs of deterioration, facilitated a paradigm shift to encourage detection and escalation of care before the onset of circulatory arrest. Although the effectiveness of the MET approach continues to be debated, METs have highlighted the need for even earlier detection and escalation of care for deteriorating patients. Another paradigm shift is now needed to improve prediction, detection and recognition of deterioration, and to optimise subsequent escalation of care. 1 Criteria for escalation of care and rates of mortality at various phases of patient deterioration Hospital inpatient27 Abnormal vital signs15 MET call22-25 Cardiac arrest1-4 Event rates (per 1000 admissions) — 138 10–50 0.66–11.2 Criteria for escalation Heart rate (beats/min) — ≤ 50 or > 120 < 40 or > 130 0 Systolic blood pressure (mmHg) — < 100 < 90 or > 200 0 Respiratory rate (breaths/min) — ≤ 10 or > 28 < 8 or > 35 0 Other — — Fall in conscious state or urine output Unresponsive In-hospital mortality rate 2.5% 14.6% Approx 25% Approx 80% 2 Phases of patient deterioration and strategies that may improve outcomes at each phase MET = medical emergency team. ICU = intensive care unit. 3 Essential elements for the care of deteriorating patients29 Clinical processes Measurement and recording of observations Escalation protocols Rapid response systems Communication processes Organisational prerequisites Organisational supports Education Evaluation and monitoring Use of new technology

Daryl A Jones FRACP, FCICM, MD · Nicola J Dunbar BSc(Hons), PhD, MPS · Rinaldo Bellomo FRACP, FCICM, MD

When “should not” becomes “must not” — how mandatory compliance with guidelines can threaten professional independence There is a proliferation of rules and red tape at all levels of society. In New South Wales, for example, the Department of Health has been generating around 70–100 policy directives a year. Among other things, such directives tell obstetricians when and how to deliver babies — compliance is mandatory, under threat of disciplinary action and loss of indemnity cover. One of the most prominent recent directives, PD2010_045 (Maternity — towards normal birth in NSW), requires a reduction in caesarean section rates to 20% by 2015,1 a target that is illusory and possibly dangerous. Others are worse. Policy directive PD2007_024 (Maternity — timing of elective or pre-labour caesarean section) states: The risk of respiratory morbidity is increased in babies born by caesarean section before labour, but this risk decreases after 39 completed weeks. Therefore elective or pre-labour caesarean section must not routinely be carried out before 39 completed weeks. These findings are supported by recent studies.2 This text is taken almost verbatim from a guideline of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom3 and, at the time, accorded with the relevant Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) guideline on the timing of elective caesarean section, the wording of which has since been softened slightly.4 However, there is one very substantial difference: the “should not” of NICE and RANZCOG became a “must not”. The NICE guideline was produced by a committee of 16 members, two of whom were obstetricians. Nicholas Fisk, then chairman of the Royal College of Obstetricians and Gynaecologists (RCOG) Scientific Advisory Committee, strongly criticised the outcome and stated that the committee “selectively interpreted” the facts to suit its case.5 Timing of elective caesarean delivery is a complex issue. There are factors (mainly related to pulmonary maturity) suggesting delay until 39 weeks’ gestation, and others (mainly related to unexplained stillbirth6,7) supporting the traditional timing between 38 weeks and 38 weeks and 6 days. A large randomised controlled trial (RCT) or a carefully conducted observational study employing propensity scoring would be required to provide a solid evidence base. For the moment it remains a matter of opinion, and RCOG, NICE and RANZCOG can, and should, express expert opinion and review the available evidence. Guideline committees and their products make an important contribution to improving clinical practice, and the voluntary work of countless individuals in this regard should not be denigrated. However, the situation may be altered completely once bureaucrats become involved. Changing the “should” of a College guideline to a “must” in a NSW Health policy directive has major implications. PD2007_024 effectively forbids doctors in NSW public hospitals to schedule routine elective caesarean section before 39 weeks. Anyone doing so risks disciplinary action and may forfeit their indemnity cover. PD2007_024 is not currently supported by high-level evidence, and even if there were solid data from a large RCT or a meta-analysis, it would be inappropriate to stipulate “mandatory compliance”. Evidence-based medicine has great potential to improve patient care, but it is a tool to inform clinicians, not an excuse to switch off one’s brain. As recently argued in the case of mesh use in pelvic reconstructive surgery,8 guidelines derived from a large RCT (or a valid meta-analysis of appropriate trials) are of limited use as a guide to the care of an individual patient if that patient is far off the trial sample mean in predictors of outcome. The Term Breech Trial9 is an excellent example. If there is a very high likelihood of an uncomplicated birth for an individual woman (eg, fast progress, small baby, previous normal births), a clinician may want to ignore the findings of the Term Breech Trial when deciding how to advise her. The process of starting with some initial information (probabilities of events of interest) and combining it with data related to an individual case or circumstance has been mathematically formalised by statisticians as “Bayesian updating”.10-13 Information from a clinical guideline, prevalence study or meta-analysis provides the “prior probability”, the data related to the individual case at hand are embodied in the “likelihood”, and the application of Bayes’ theorem13,14 gives the updated “posterior probability” on which a decisionmaker can act. This implies that even the best evidence in literature and guidelines can provide only prior probabilities. It is our job to adapt these to the clinical management of the individual patient, generating posterior probabilities that have been updated by the relevant particulars of the patient and processed by clinical intuition and common sense. However, in a trend that is encouraged by guidelines and policy directives, clinicians increasingly omit this updating process. Once a document — a seminal paper, a guideline, a policy directive — is published, it is likely to be interpreted cautiously (ie, as widely as possible) because of the litigious, risk-averse nature of our society. We do not particularise to the individual patient because our work environment strongly discourages doing so. Finally, even if a guideline is produced after an optimally diligent process and published so rapidly that it is up to date at its launch, it still freezes current best practice. Inevitably, today’s best practice will be obsolete tomorrow. Practice guidelines therefore have the potential to slow down progress, and unthinking adherence to such documents is unlikely to deliver the best outcomes to the greatest number of individuals. The expert system of our brains, employed in the assessment and treatment of the individual patient — and using relevant prior information from evidence-based sources — is a potentially superior tool when compared with the replication of a course of action outlined in a document issued by a government agency or professional body. It is time to reassert our professional independence.

Hans Peter Dietz MD, PhD, FRANZCOG · Barrie J Stokes BSc, MMath

The formula for reform works, but is the next review already overdue? In 2008, we reported our review of the Sydney University graduate medical program.1,2 When the program was introduced 11 years previously, it was innovative, with emphasis on helping students to solve problems and to think critically about what they were learning rather than to memorise lists of facts. In 2005, the Australian Medical Council (AMC) reviewed the program and awarded the maximum 10-year accreditation. However, the AMC also suggested a number of actions, including reviewing the role of problem-based learning (PBL) in the final 2 years of the course, reviewing some areas of assessment, providing a renewal process that allowed for flexibility and innovation within the defined outcomes, and reviewing the complex system of committee structures. We made 730 recommendations in our 2007 review, incorporating the AMC’s suggestions and covering the provision of an initial scaffolding on which students could build knowledge, increased anatomy teaching and the creation of clear learning objectives. We now report on the impact of that review. The major changes implemented after the review are shown in Box 1. Eighty-five per cent of the recommendations have been implemented. Another 5% are currently being implemented; 2% are no longer relevant; and 8% have not been implemented (Box 2). The implementation of 85% of the changes was due to three main factors: the inclusive nature of the review process; the commitment of the dean; and the team chosen to implement the changes through a newly created Office of Medical Education. The first 9 weeks of the course became a foundation block that provides a scaffolding of basic facts and concepts on which students can build future knowledge. The foundation block provides learning activities and additional tutorial groups specifically for students from non-science backgrounds who initially find the course difficult. An additional Chair of Anatomy with specific responsibility for teaching was created, and the amount of anatomy teaching in the first 2 years of the course was increased from 50 to 170 hours. An additional appointment of an academic surgeon jointly for Surgery and Anatomy has enabled the return of whole-body dissection as a student elective.3 These new appointments have ensured that anatomy is now taught throughout the course. Students now have electronic access to detailed learning objectives and a core curriculum with clear links to the teaching program for each week. They engage more with medical librarians, critically evaluating information sources, developing and refining search strategies and learning database construction. A student guide provides a direct link for quick location of key databases and basic science resource materials. While PBL remains a core component of the medical program, clinical reasoning sessions, which have more clinical emphasis than the traditional PBL tutorial,4 have replaced PBL tutorials in the final 2 years. The artificial distinction that existed between the two clinical years has been removed so they have become fully integrated. The amount and sophistication of assessment has been increased. In formative assessments, students are able to see their progress in relation to that of other students. Grading, which was not in the original graduate program, now occurs in the last 2 years. The criteria for awarding honours on graduation have become more rigorous, with a higher standard and an increased emphasis on academic supervision. Students interested in pursuing a career in research may also do a concurrent Master of Philosophy degree, which requires intensive immersion in research during holidays and the elective term. Heads of disciplines have become more involved in curriculum matters. Academic staff from disciplines that were previously not well integrated into the curriculum now meet regularly, contribute more to teaching and have become more collegiate. This has re-engaged clinicians and reinvigorated some disciplines that previously had less involvement in the curriculum. The introduction of new material has depended on the leadership given by champions who have taken on these new areas. This was particularly applicable with regard to helping students to understand and critically review complementary and alternative medicine, to develop an awareness of the spiritual dimensions of health for some patients and to better understand the problems of people with a disability. Medical humanities has been strengthened; and the creation of the position of Associate Dean, International Health increased students’ exposure to a range of global health issues. Recommendations regarding the importance of Indigenous health throughout the course have resulted in some Aboriginal health care delivery concepts being incorporated into the teaching of communication skills. Students are now encouraged to become more involved with Aboriginal medical services. Student numbers are increasing (Box 3). The total number of students increased from 261 in 2007, to 299 in 2011, with international fee-paying students increasing from 34 to 66. Federal government funding arrangements have created the need for medical schools to take more international fee-paying students. However, a balance has to be struck between this need and the essential requirement to provide a high-quality program with good support and tutorial groups of an effective size. A medical curriculum cannot guarantee effective student learning and satisfaction if numbers increase without a commensurate increase in academic staff, support staff and upgraded facilities on campus and in clinical schools. This issue is not unique to Sydney Medical School. Medical student teaching is intensive, with emphasis on small group tutorials, one-to-one teaching and role modelling. Teaching cannot be separated from research, as research informs much of the teaching. However, adequate resources must be put into teaching so that it is supported just as research is supported. Areas in which changes to the University of Sydney graduate medical program still need to be made are shown in Box 4. Leadership is essential for creating and sustaining changes. Academic leadership has been a key factor in the implementation of the majority of changes recommended in this curriculum review. The leadership of the dean, the academic course coordinators and the associate deans of the clinical schools has been crucial in implementing the changes so far. The dean should be clearly in charge of the curriculum and the curriculum should be one of his or her obvious priorities. While day-to-day curriculum management is delegated, regular meetings between the dean and academic course coordinators to discuss key issues, rather than curriculum detail, are important. Where innovative recommendations have been implemented, there has been a clearly designated and committed leader for the new area. In some cases these leaders were recognised in advance, while in other cases leadership arose spontaneously. In contrast, recommendations that were not successfully implemented did not have a champion identified. Before introducing change to a medical curriculum, there should be wide consultation with students, faculty members, other teachers, professional bodies and community groups.5 In our experience, wide consultation with faculty members, listening to and incorporating their suggestions and giving them some responsibility for implementation effectively re-engaged them and were the crucial factors in successfully changing the curriculum. While the importance of factors such as leadership and wide consultation may seem obvious, we need to acknowledge their essential contribution to effective, sustained change. Attempts to change a medical curriculum without leadership at the highest level, identification of leaders for specific roles and wide, regular and frequent consultation are likely to be doomed to failure. It became clear when reviewing the curriculum in 2007 that 11 years is too long to wait. A medical curriculum is dynamic and needs to respond to changes in medicine, health regulations, educational thinking and society. More frequent review would ensure that the curriculum remains relevant and plays an integral part in shaping the future leaders in medical care. Medical education and health care delivery are not static, which is why curriculum revision must be a continuous process of renewal and response to change. 1 Key changes implemented after the 2007 review Simplified and strengthened governance Revised first 9-week foundation block Developed core curriculum with clear learning outcomes Increased basic science teaching Trebled anatomy teaching hours Increased written and clinical assessments Introduced grading in final 2 years Upgraded honours requirements Created more research opportunities Created optional concurrent MPhil degree Increased use of IT for teaching and assessment Added new areas to curriculum Increased emphasis on critical care and surgery teaching 2 Why some recommendations were not implemented Lack of funding Increased student numbers Difficulty in recruiting teachers Lack of effective collaboration with outside bodies 3 Local and overseas students admitted to Sydney Medical School, 2007–2011 No. of students Year Local International Total 2007 227 34 261 2008 226 36 262 2009 247 46 293 2010 222 53 275 2011 233 66 299 4 Areas of the University of Sydney graduate medical program still in need of change Refugee health Aboriginal health Equipping students for leadership Clinical teaching on ambulant and standardised patients Interprofessional learning Greater ownership by clinical teachers More involvement by recent graduates

Kerry J Goulston MD, FRACP · R Kim Oates MD, DSc, FRACP

Ray Moynihan explores the push for new powers and strong opposition to it If there was ever a case of market forces running ahead of regulators, it is corporatised medicine in Australia. Driven by medical entrepreneurs and merchant banks, the creation of giant health care empires has taken place with little public debate or political interest. While a new private industry is now successfully profiting from publicly funded Medicare, health authorities have so far found no meaningful mechanism to police the sector. “The business of medicine has been altered forever”, argues the former head of Medicare’s watchdog unit, “by the entry of corporatised medicine”.1 Testifying to a recent senate inquiry, Tony Webber, former Director of the Professional Services Review (PSR), said he’d like to see a revamped PSR scheme within Medicare given the power to “investigate scams and unacceptable corporate behaviour, of which I have seen significant examples”. Asked if any executive had been prosecuted, Webber told senators: “Sadly, no, because the legislation makes it very difficult to do so”.1 Responding to his concerns, the committee recommended strengthening the watchdog’s powers and government is currently considering its response. Evidence of corporate “scams”, says Webber, remains largely anecdotal and based on tip-offs which, while appearing credible, are currently unable to be followed-up. According to Webber, the problem is while companies are geared to make money, Medicare was never designed to pay the doctor and a nice corporate dividend as well — a theme he expands on elsewhere.2 One of the industry’s giants is Sonic Healthcare, owner of the Independent Practitioner Network with 140 medical centres and around 1000 GPs who produced “strong revenue growth” last year, contributing to Sonic’s overall profit of $295 million.3 The other giant is Primary Health Care Limited, running almost 90 centres, also contracting 1000 doctors, worth around $1.5 billion, and with profits of $80 million.4 Another player is Healthscope, bought recently by a consortium of global private equity firms. All three are “vertically integrated”, with medical centres, pathology laboratories and imaging facilities. There is no suggestion that these, or other particular corporations, or people associated with them, engage in or encourage any form of inappropriate behaviour. The man known for pioneering corporatisation of health care in Australia is Edmund Bateman, managing director of Primary Health Care Limited. The company describes itself as the “most profitable in this field” with a “formula” offering value to doctors and patients.4 In an extended interview with me recently, Bateman strongly rejected the need for enhanced watchdog powers, saying it was “based on the assumption that the corporation is responsible for the behaviour of the doctor”, which was “out of touch” with the reality. He said there’s also an assumption of “improper pressure” on doctors, but it doesn’t exist. “I can’t tell them what to do”, he told me, “if there is any pressure, it’s to practise better medicine”. While stressing that doctors signing contracts with Primary Health Care Limited retained clinical autonomy, in general, they also “undertake to support our services, where clinically appropriate” he said, adding doctors “tend to support the pathology in the building, out of convenience”. The idea of forcing corporations to contribute to paying the fines of doctors found to have practised inappropriately is also opposed by Bateman: “it’s human nature for people to try and blame other parties”, he says, “professionals in particular are responsible for their own behaviour”. Arguing it’s not “proper process”, he suggests that the entire PSR Scheme should be abandoned and any action against doctors happen via “normal legal process”. Asked about his own use of courts to take action against doctors contracted to his companies, and a newspaper report that there had been dozens of cases against practitioners in the past decade,5 Bateman declined to confirm a figure, saying that of the 1000 contracts with doctors only a “very small minority” ended in litigation, and that he is suing the newspaper involved. Questioned about suggestions that his centres had created and billed for “care plans” for patients who regularly saw doctors outside, he said that “sounds like sour grapes from someone who should have provided one before this”. Other corporate chiefs contacted declined to comment. In my view, one way to independently assess competing claims about corporate medicine might be to compare profiles of doctors working inside and outside corporate structures. While complex, with confounding factors, a sophisticated analysis could cast much-needed light here and build academic expertise in the field. As to recommendations for new powers to “pursue abuse” of the system,1 the government’s response is pending. Perhaps it may also be timely to reassess just how well the private-for-profit corporate structure sits with the spirit of a publicly funded universal health insurance scheme.

Ray Moynihan BA

Yes. Public health adviser David Roder and Cancer Council Australia CEO Ian Olver believe the reduction in breast cancer mortality in Australia reflects both treatment and screening effects All screening programs should be assessed for their benefits and risks, including the extent of overdiagnosis. Recently, Burton and colleagues concluded that almost 60% of the Australian decline in breast cancer mortality since 1991 could not be due to BreastScreen Australia (the free national mammographic program), attributing most of the decline to adjuvant hormonal and chemotherapy.1 Questions around attribution are not new. There has been no formal modelling in Australia, but modelling funded by the National Cancer Institute in the United States suggested that about half the US breast cancer mortality reduction may be due to adjuvant therapy and about half to screening.2 Age-standardised breast cancer mortality rates have decreased by about 29% among Australian women since the 1989–1991 period, when organised mammography screening (now known as BreastScreen) began.3 Compared with a linear projection of mortality increases in the 1980s, the observed rate in 2007 was about 38% lower.3 Observations on women outside the screening age range show that factors other than screening would have contributed to this decline, but there is also evidence for an important BreastScreen effect.3 Three evaluations of mammography screening of Australian women aged 50–69 years, including the formal BreastScreen Australia Evaluation Plan, indicated reductions in breast cancer mortality of between 30% and 47% from screening.3 This range is broadly consistent with trial evidence where a reduction of around 35% was estimated by an expert working group of the International Agency for Research on Cancer (IARC).4 A 25% reduction in breast cancer was estimated by Australian researchers from a meta-analysis of trial data for all ages.5 Collective results of 35 studies in other countries are similar to the IARC’s 35% reduction estimate,3,4 although individual study results varied from little or no benefit to reductions of up to 76%.3 With present participation rates in Australia’s BreastScreen program, a 35% reduction in breast cancer mortality in participants would correspond with an estimated 270 fewer breast cancer deaths a year in all Australian women aged 55–74 years. (Note that this allows for a time lag of 5 years in deaths.) Breast cancer incidence rates rose in Australia following the introduction of BreastScreen.3 The extent to which this reflected lead-time effects of screening, changes in pathology and other diagnostic practices, overdiagnosis, and real increases due to changes in underlying risk factors (eg, reproductive behaviour, body weight, alcohol consumption and use of hormone replacement therapy) is unknown. Increases in incidence were already occurring in the 1980s before BreastScreen introduction,3 but the contributions of increased use of private mammography and changes in risk factors during that period are not known. The increase in breast cancer mortality rates in the 1980s is suggestive of real increases in underlying incidence.3 There is concern that screening may result in detection of cancers that would never have caused symptoms or death in a woman’s lifetime (ie, overdiagnosis).3 There is no consensus on levels of overdiagnosis, with estimates worldwide varying from close to zero to over 30% of diagnosed cancers, irrespective of whether in-situ lesions were included.3 The estimates vary so widely that interpretation is difficult. Research is needed to better define levels of overdiagnosis and, ideally, to develop more effective means of determining at diagnosis the potential for screen-detected and other breast cancers to progress. In summary, it is likely that the reduction in breast cancer mortality in Australia reflects both treatment and screening effects. The relative contribution of each to the overall reduction is not clear, although there is evidence that both would be contributing substantially. Women should be informed of both the risks and the benefits of screening, including the uncertainty around overdiagnosis. However, present screening participation levels of 50–69-year-olds in BreastScreen would be consistent with a significant annual reduction in breast cancer mortality. Levels of overdiagnosis are uncertain and require better definition. Means of better predicting the likelihood of progression of untreated in-situ lesions and early invasive breast cancers to advanced disease are needed, and this need is likely to increase as more sensitive screening and diagnostic technologies are developed.

David M Roder PhD · Ian N Olver MD, PhD, FRACP