Health services administration

When will Australians be able to count on receiving health care that is safe? The Oxford English dictionary defines safety as “freedom from danger and risks”, and there is little doubt that the question of safety is foremost in the minds of many Australians on admission to our hospitals. These concerns were heightened when, 10 years ago, the Quality in Australian Health Care Study (QAHCS) revealed that admission to hospital was associated with a 16% risk of an adverse event, including permanent disability or death.1 In the years that followed, public concerns about hospital safety were reinforced by a series of sensational scandals involving patient care at the King Edward Memorial Hospital in Perth, Western Australia (1999),2 the Canberra Hospital in the Australian Capital Territory (2000),3 and Campbelltown and Camden Hospitals in New South Wales (2002).4 Not surprisingly, all these incidents had common characteristics:3 compromised patient safety not detected by sentinel event reporting; suboptimal clinical governance; health care professionals, who, frustrated by inaction after internal reporting of adverse events, brought the matter to the attention of politicians; and, finally, all incidents provoked one or more independent inquiries.3 There is little doubt that, pari passu with these scandals, the public’s trust in hospitals and doctors has taken a pounding, as has the perception of the profession’s ability to regulate itself. And now, in 2005, we have the Bundaberg Hospital scandal in Queensland. Not surprisingly, this incident shares most of the features of the preceding hospital scandals. But it is also different — it reaches into the hearts of the Medical Board of Queensland, Queensland Health and the Queensland Government. The Bundaberg Hospital incident might revolve around the performance of Dr Jayant Patel, but it is in fact a symptom of an affliction affecting health care Australia-wide. In 2003, Patel was appointed as a surgical medical officer at Bundaberg Hospital and subsequently promoted to Director of Surgery. Over the following 2 years, he operated on about 1000 patients, of whom 88 died and 14 suffered serious complications.5 A clinical review has since found that Patel directly contributed to the deaths of eight patients and “may have exhibited an unacceptable level of care in another eight patients who died”. The report noted that although “in the comfortable majority of cases examined, Dr Patel’s outcomes were acceptable . . . [he] lacked many of the attributes of a competent surgeon”.6 All this may not have happened had the 2003 registration of Patel by the Queensland Medical Board been more rigorous. An in-depth review would have uncovered that Patel was placed on probation for 3 years in 1983 for “gross negligence” in his practice at Rochester Hospital in New York State; that in 2000 the Oregon Board of Medical Examiners in the United States restricted the scope of his surgery; and, in 2001, under threat of having his licence revoked in New York State, he instead obtained permission to surrender his licence to practise.7 The subsequent questioning of Patel’s performance at Bundaberg Hospital did not emerge from a clinical governance system but from concerns of individual doctors and nurses about his surgical performance and prowess. It was a letter from the nursing staff about this matter which, when tabled in Queensland Parliament, resulted in the establishment of a Commission of Inquiry headed by Anthony Morris QC. In the meantime, Patel left the country unimpeded. Inquiries are established to ascertain the facts, to learn from the events, to provide a catharsis for stakeholders, to hold people and organisations accountable, to reassure the public that something is being done, and to serve the interests of governments.8 It was hoped that the Morris Inquiry with these tasks and terms of reference9 would have shed light on: Patel’s appointment to Bundaberg Hospital; the role of the Queensland Medical Board in assessing, registering and monitoring overseas-trained doctors deemed to be necessary for areas of need; the role of federal, state and territory governments and the clinical colleges in these processes; systems to ensure accountability and monitoring of appropriate performance of individuals and clinical services; and systems to receive, process and resolve complaints about clinical performance or services. Now, with the termination of the Inquiry on the grounds of perceived bias, the public and the profession will have to wait.10 But, despite this, answers to these issues will have to be unearthed. They are not only pertinent for Queensland — they have national implications. We have had report after report11-13 on quality and safety, and bodies devoted to safety and quality such as the Australian Council on Healthcare Standards, the Australian Council for Safety and Quality in Health Care, the National Institute of Clinical Studies and, more recently, the NSW Clinical Excellence Commission. And the list goes on. Yet we continue to suffer hospital scandals affecting lives and limbs, which, for all we know, are only the tip of the iceberg. Ten years after the QAHCS and 5 years after the establishment of the Australian Council for Safety and Quality in Health Care, we still have no nationally accepted framework for clinical governance to ensure the safety and quality of Australian health services or the means to comprehensively monitor these indices.14 Based on QAHCS outcomes, 25 patients die each day in our hospitals from preventable adverse events and another 22 suffer preventable permanent disability (Dr R M Wilson, Director, Northern Centre for Healthcare Improvement, Royal North Shore Hospital, St Leonards, NSW, personal communication, 2005). Whether, 10 years after QAHCS, being treated in Australian hospitals still results in the same number of preventable human tragedies, we simply do not know, and this ongoing vacuum is an indictment of our health ministers and organised medicine. The time has long passed for Australia’s political leaders to abandon their leisurely bureaucratic approach to quality and safety15 and to insist on fast-tracking a national program that ensures quality and safety for all Australians accessing health care. It can only be hoped that the Bundabueg Hospital scandal will prompt out political leaders to act more decisively. In tandem with the dismantled Morris Inquiry, there is a wide-ranging Inquiry into the health system in Queensland, instigated by the Queensland Premier in April this year. This Inquiry, driven by two eclectic working groups, both headed by Peter Forster, issued an interim report at the end of July which is not flattering of Queensland Health.16 It is depicted as a gigantic dysfunctional conglomerate with a corporate centre that is more concerned with performance indicators, revenue generation and cost control, than with people. It appears to be preoccupied with tortuous decision processes and ineffective workforce management systems, and with workforce planning that is not linked to service delivery. In short, its command-and-control ethos has resulted in a chasm between administration and front-line health services. In the field, Queensland Health’s focus on cost containment and revenue raising has caused concern, frustration and even anger among clinicians who “feel undervalued and marginalised from a system which does not allow them sufficient time to undertake teaching and research, where they face ever increasing patient loads . . . [and] have limited ability to influence the way the health system is run”.16 There is an even deeper reason for clinicians’ discontent — Queensland is an impoverished health care state! It has the lowest number of doctors per head of population in Australia and is critically dependent on overseas-trained doctors, who now account for nearly one in four doctors in Queensland.16 But there is more. Queensland’s average recurrent expenditure on health is the lowest in the nation, and in 2002–03 its recurrent expenditure on public hospitals was 20% below the national average, and this is despite the greater geographic dispersion of health care facilities in Queensland. And to top off this bleak picture, the remuneration of hospital-salaried medical staff is the second lowest in the country.16 These telling statistics might be trumpeted by politicians and bureaucrats as reflecting good fiscal management, or blamed on the politically convenient federal–state health divide. But others may see it as an inhumane and unnecessary capping of the health budget. Whatever the rhetoric, the impoverishment of the Queensland health system cannot be sheeted home to Queensland Health. It lies squarely with the Queensland Premier and it will be interesting to follow the Queensland Government’s response to the final report of the Forster Inquiry, which is due at the end of this month. But the response will not require rocket science. There is a dire need for Queensland Health to be dragged into the 21st century by a restructuring of its monolithic and disconnected organisation into more diverse and discrete health structures. These should be open, transparent and, most importantly, connected to local communities and to clinicians empowered to make decisions about health care delivery. Queensland could do no worse than to emulate the clinician-led ongoing reform of NSW hospitals.17 Queensland is also in dire need of a boost to its health budget. It also needs to consider attracting clinicians to work in Queensland hospitals — by making its recruitment and retention packages for salaried staff competitive with those of other states, and by providing incentives for clinicians to work in non-metropolitan areas. The reward system does not have to be all monetary. It could include innovations such as a program of continual professional development and refreshment of non-metropolitan doctors through regular periods of secondment to major metropolitan centres. An attitudinal change to the role of visiting medical officers in public hospitals might also help. Despite having more medical schools than any other Australian state or territory, Queensland will be dependent on overseas-trained doctors for some time to come.18 There is a risk of some of these doctors not being suited to the local culture and practice expectations, or not having the necessary skills.6 Their continuing professional and cultural development needs to be met by structured programs involving the clinical colleges, as well as regular monitoring and constructive feedback. It’s time to cease the apparent neglect of overseas-trained doctors, not only in Queensland but nationwide.19 In a recently released book, Patient safety: achieving a new standard of care, there is a simple statement: “Americans should be able to count on receiving health care that is safe.”20 So should all Australians, whether in provincial Queensland or elsewhere.

Martin B Van Der Weyden MD, FRACP, FRCPA

Objective: To assess the value of cusum analysis in hospital bed management.Design: Comparative analysis of medical patient flows, bed occupancy, and emergency department admission rates and access block over 2 years.Setting: Internal Medicine Services and Emergency Department in a teaching hospital.Interventions: Improvements in bed use and changes in the level of available beds.Main outcome measures: Average length of stay; percentage occupancy of available beds; number of patients waiting more than 8 hours for admission (access block); number of medical patients occupying beds in non-medical wards; and number of elective surgical admissions.Results: Cusum analysis provided a simple means of revealing important trends in patient flows that were not obvious in conventional time-series data. This prompted improvements in bed use that resulted in a decrease of 9500 occupied bed-days over a year. Unfortunately and unexpectedly, after some initial improvement, the levels of access block, medical ward congestion and elective surgical admissions all then deteriorated significantly. This was probably caused by excessive bed closures in response to the initial improvement in bed use.Conclusion: Cusum analysis is a useful technique for the early detection of significant changes in patient flows and bed use, and in determining the appropriate number of beds required for a given rate of patient flow.

Claire M Burns RN, BNursing · Cameron J Bennett MB BS, FRACP · Colin T Myers MB ChB, FACEM · Michael Ward MB BS, FRACP

In late 1995, a treatment program for renal disease and hypertension was introduced into a remote Aboriginal community. Over the next 3.5 years, mean blood pressure levels were markedly reduced, renal function stabilised, and rates of both renal and non-renal deaths declined significantly. In 1999–2000, responsibility for the program was passed to the community’s local Health Board, which subsequently faced deficiencies in clinical information systems and a shortfall in funding. After the handover, the intensity of the program declined, and compliance with medicines fell. Blood pressures in the treatment cohort increased, renal function deteriorated, and rates of deaths from natural causes subsequently rose. From 2002 to mid-2003, the adjusted risks of renal and non-renal deaths in the treatment cohort were three and 9.5 times the respective risks of people during the first 18 months of treatment in the systematic phase of the program. Sustained vigorous activity, both in treatment of people already identified and in community screening for treatment eligibility, is required to maintain good results in any chronic disease program. Adequate resources and well supported staff are essential, and constant evaluation is needed to follow outcomes and modify strategies as necessary.

Wendy E Hoy FRACP · Srinivas N Kondalsamy-Chennakesavan MB BS, MPH · Jennifer L Nicol BSc(Hons), MSc(Stats)

Present-day public hospitals are often lacking in humanity, costing more and doing less, and run by executive staff with minimal clinical knowledge The current obsession with finding and punishing “Dr Death”, as Patel has been called, instead of dealing with the system that sponsored him, seems likely to ensure that, when the dust has settled, the status quo will prevail. The Bundaberg Hospital scandal is a symptom, and more attention needs to be paid to the underlying causes. Work is performed within systems and its quality is determined by the quality of those systems. People generally do what the system requires. With all the media mayhem, we should not forget that many able people work for organisations like Queensland Health. I believe that the current problems in Australian hospital systems have their roots in the “reforms” of the 1980s: the development of corporate structures and managerialist management systems.4,5 Corporate structures devalue clinical involvement, alienate hospital communities, diminish humanity, and result in a burgeoning corpocracy. The managerialist approach produces staff and bed shortages, long waiting lists and excessive bed usage.6 It concentrates on business plans and targets, and negative short-term financial objectives, producing perverse economic activity; managers are rewarded for “quick fix” solutions. This can result in inaction and deferral of work. For example, there are concerns about waiting lists for surgery and delays with specialist referrals.3,6 The period since the 1980s has also seen considerable politicisation of public services in Australia.7,8 This can result in bias, inappropriate appointments and excessive use of secrecy and spin. Good systems are designed deliberately to produce high quality work.9 By eliminating waste, delay and the need to redo substandard work, they achieve long-term cost effectiveness. All good hospital departments have leaders who are clinically competent, but they must also be just, transparent, energetic and committed. They have the ability to transform their staff into effective teams. Team “ownership” results in people working to improve systems instead of merely using those systems to further their own ends. When I was a junior resident medical officer in Townsville Hospital in 1960, the hospital was of intense interest to the local community, and this “ownership” was a strong incentive to hospital staff. In addition, the Medical Superintendent was a competent and active general surgeon. The hospital made remarkably efficient use of the resources available to it. I don’t remember there being any waiting lists. Contrast this with present-day public hospitals — they are likely to be isolated from their communities, lacking in humanity, costing more and doing less,10 and run by executive staff with minimal clinical knowledge. There are other problems besetting Australian hospitals. For example, many have been slow to adopt safe systems. New intravenous device technology has been demonstrated to reduce the risk of needlestick injury.11 Many hospitals are yet to define and mandate best practice for the use of intravenous devices — the major source of hospital acquired bacteraemias.12 Although the immediate costs of such initiatives may be considerable, the treatment of a potentially preventable blood stream infection that endangers life can cost tens of thousands of dollars, and an injury with a contaminated needle may lead to chronic illness, substantial economic loss and potentially shortened life. In addition, hospital systems have not capitalised on the advantages of information technology. Communication and the dissemination of knowledge are vital in the complex dynamic systems that are modern hospitals, and this requires efficient communication systems.3 Yet, hospital IT departments can become corporate empires dedicated to the control of computer hardware and software — they often seem to do more to inhibit communication than to facilitate it. Although the Morris Inquiry was clearly essential, its base cost has been estimated at about $6 million.2 In addition, compensation of those who may have been injured, and repair of those injuries, is likely to entail a substantial financial burden. Ultimately, this money has to come from the pockets of taxpayers and the Queensland economy, and is therefore unavailable for treating patients or educating children. This is quite apart from the moral and personal costs involved, and the damage to staff morale when a job is either not done or done badly. So, what can be done? Unfortunately, the culture of the managerialist corpocracy is so deeply embedded in public administration in Australia that no quick answer seems likely. And, according to the late popular historian Barbara Tuchman, when something fails, it seems humans are inclined to believe that the solution lies in doing it twice as hard.13 One thing that could be done now is to make central offices behave like coaches rather than controllers and judges. Good coaches are able to mould effective teams, they are expert at dealing with poorly performing players, and they themselves are expendable if the team persistently underperforms. In addition, really good coaches think of the longer term. Politicians and senior staff in central offices need to relearn the motto of the schools some of them attended: “cui servire est regnare” — to serve is to rule. Quality is always positive; we can only ever do better by having better systems and by learning how to make better use of them. This requires careful systems analysis and systems optimisation.9 A fundamental requirement is trust, and this demands justice and transparency. However, if we are to improve the quality, safety and economy of hospitals in the long term, we need an “idea whose time has come”, to quote Victor Hugo (http://www.geocities.com/Paris/LeftBank/9640/otherq). Like Maynard Keynes, who found a way to end the Great Depression, we can only hope that succeeding generations will be able to see more clearly the reality of things as they are. To create an enduring and worthwhile hospital system, public administration has to move beyond corporate structures and managerialist management approaches.

Anthony P Morton MD, MS, MScAppl

It is time to focus on issues of roll-out and quality control “Hospital in the home” can mean different things in different countries and contexts. A Cochrane review defined it as “a service that provides active treatment . . . in the patient’s home of a condition that otherwise would require acute hospital in-patient care”.1 This definition includes services that substitute acute care by home-based management (admission avoidance) and those that support discharge with community-based post-acute care and rehabilitation (discharge support). The review found “insufficient evidence to support expansion or contraction” of home-based alternatives to inpatient hospital care.1 Two articles in this issue of the Journal contribute to the clinical evidence base for home care as an admission-avoidance service. There is a growing list of well-defined conditions that have been shown. . . to be manageable in home care. . . There is less consensus about whether treatment at home saves money. . . In a randomised controlled trial of an admission-avoidance hospital-in-the-home scheme in patients with mild to moderate community-acquired pneumonia, Richards et al (page 235) in New Zealand found no clinically important differences in time to discharge, duration of intravenous and oral antibiotic use or general functioning, but higher levels of satisfaction and lower costs for patients treated at home.2 In a retrospective case series of patients with pulmonary embolism in an admission-avoidance hospital-in-the-home scheme conducted in New South Wales, Ong et al (page 239) found outcomes similar to those in hospital cohorts, but acknowledged these results need to be confirmed in a trial.3 There is a growing list of well-defined conditions that have been shown in adequately powered trials or meta-analyses to be manageable in home care, provided either as a complete alternative to hospital admission or to support early discharge from inpatient care. These include cellulitis,4 chronic obstructive pulmonary disease5 and deep vein thrombosis.6 These findings should reassure clinicians who had concerns that similar overall outcomes in trials with a varied casemix may have masked important differences in outcomes for specific conditions. There is also consistent evidence from these studies that patients and carers prefer treatment at home. There is less consensus about whether treatment at home saves money, partly because of the difficulty of measuring costs realistically within a trial rather than a “real world” context,7 but also because costs are highly influenced by the health care system in which hospital in the home operates. A recent study from Victoria of 924 patients treated at home and matched hospital controls showed that home care was cheaper — especially if inpatient admission was completely avoided, in which case costs were 38% less.8 Costs also need to be considered as part of a whole system of health and social care provision. For example, it has been estimated that the Victorian hospital-in-the-home scheme provides the equivalent of more than 400 beds, and so has effectively provided care that would otherwise require the building and maintenance of a large metropolitan hospital.9 In contrast, in the United Kingdom, schemes are generally too small to have a detectable effect on hospital provision. If the evidence does support expansion of the scheme, clinicians and policymakers will need to know which key elements need to be replicated. Nearly all the evidence cited above relates to models with specific admission criteria, which include medical assessment by a specialist, generalist or both, either at home, in an accident and emergency department, or before transfer from inpatient care. Care is also supported by ongoing medical review, provided either in primary care or as hospital outreach. These schemes explicitly provide substitute, not additional, care and require detailed cooperation between the acute and community care providers. Interestingly, the development of hospital at home and other forms of intermediate care in the UK is going largely in the opposite direction. Since publication of the National service framework for older people in 2001,10 the emphasis has been on providing a wide range of schemes in response to local need, in part to prevent “avoidable admissions” (ie, those whose needs are primarily non-medical).11 Many schemes adopt low technology, and are nurse- or therapist-led, with admission rights extended to community nursing and social work teams.12 These developments have contributed to resistance, especially from physicians involved in the care of older people, who are concerned that inadequate assessment of geriatric clinical syndromes will disadvantage frail older people and reverse advances in clinical care made in the second half of the 20th century.13 These concerns are accompanied by fears held by general practitioners that they are neither equipped nor available to provide medical support to intermediate care. Although Richards et al point to the opportunities for involvement in home care schemes to increase the skills and experience of GPs,2 it seems only a minority of GPs in the UK will use the service if they have to assume medical responsibility. This proportion is likely to decline as most urban practices opt out of providing out-of-hours care.14 A national evaluation of intermediate care has recently been completed, but results have yet to be published. It seems likely that recent trial evidence will influence an updated Cochrane review, but problems appraising the evidence remain. Firstly, it may not be useful to combine data from intensive outreach interventions designed to substitute for inpatient hospital care (as seen in Australia and New Zealand) with more rehabilitative approaches designed to avoid unnecessary admissions and support discharge from inpatient hospital care. Furthermore, many of the advantages of hospital in the home, such as reducing risk of hospital-acquired infection and delirium and the social and psychological consequences of a hospital stay, occur only if admission is avoided, again suggesting that pooling data including supported discharge is not helpful. Finally, the Cochrane review will not include important evidence from large observational studies, which are more able than trials to detect uncommon complications and provide realistic estimates of cost. The articles by Richards et al and Ong et al add to the evidence for the effectiveness of a model of hospital in the home in which Australia and New Zealand are leading the world by providing services of sufficient scale to offer a real alternative to inpatient care. The evidence needed now goes beyond the remit of a Cochrane review, and should focus on issues of roll-out and quality control.

Andrew D Wilson MD, FRCGP · Stuart G Parker MD, FRCP

Objective: To determine whether community management of mild to moderate community-acquired pneumonia (CAP) is as effective and acceptable as standard hospital management of CAP.Design: Randomised controlled trial.Setting: Christchurch, New Zealand, primary and secondary care.Participants: 55 patients presenting or referred to the emergency department at Christchurch Hospital with mild to moderately severe pneumonia, assessed using a validated pneumonia severity assessment score, from July 2002 to October 2003.Interventions: Hospital treatment as usual or comprehensive care in the home delivered by primary care teams.Main outcome measures: Primary: days to discharge, days on intravenous (IV) antibiotics, patient-rated symptom scores. Secondary: health status measured using level of functioning at 2 and 6 weeks, patient satisfaction.Results: The median number of days to discharge was higher in the home care group (4 days; range, 1–14) than in the hospital groups (2 days; range, 0–10; P = 0.004). There was no difference in the number of days on IV antibiotics or on subsequent oral antibiotics. Patient-rated symptom scores at 2 and 6 weeks, median change in symptom severity from baseline to 6 weeks, and general functioning at 2 and 6 weeks did not differ between the groups. Patients in both groups were satisfied with their treatment, with a clear preference for community treatment (P < 0.001).Conclusions: Mild to moderately severe CAP can be managed effectively in the community by primary care teams. This model of comprehensive care at home can be implemented by primary care teams with suitable funding structures.

Dee A Richards MB ChB, DPH(Dist) · Les J Toop MD, MRCGP, FRNZCGP · Michael J Epton MRCP, FRACP, PhD · G Ian Town MB ChB, FRACP, DM · Robin D Dawson MB ChB, MRCGP, DCH · Michael C Hlavac MB ChB, FRACP · Graham R B McGeoch MB ChB, FRNZCGP · Simon M H Wynn-Thomas BM BS, MRCGP, FRNZCGP · Paul D Abernethy BA(Psych), RN · Anja M Werno MD, FRCPA

The obesity epidemic has been described as a catastrophic failure of government and public health authorities to devise and implement concerted, effective evidence-based action. To respond effectively to major public health challenges such as this, Australia needs a Ministry for the Public’s Health, with a budget and accountability to parliament separate from the Health Minister. This Ministry would be better able than current health departments to develop and implement health — rather than health care — policy, to build partnerships across tiers of government, and to present the health and economic arguments for disease prevention to state and federal treasuries. Such a Ministry has international precedents, with dedicated public health agencies created in Canada, Sweden and the United Kingdom, although it is, as yet, too early to gauge their effectiveness. The Ministry would be best placed within state and territory governments, as it is at this level that partnership building and whole-of-government cooperation would have the greatest impact.

Stephen J Corbett MPH, FAFPHM

Raymond W Cook Retired anaesthetist, PO Box 6135, O’Connor, ACT 2602. dcookATactonline.com.au To the Editor: A great deal has been said and written in recent years about inadequate numbers in the medical workforce. As a result, many scientific and political articles about the need to increase the number of medical students and how to train them for the workforce have been written.1,2 Yet there has been little discussion of how those already trained and in the workforce should be retained, or of the rate of attrition of those in the workforce. After 30 years as an anaesthetist, I can recall only one positive change in my conditions of work — the introduction of exhaust gas scavenging. All other changes have been negative: longer hours, greater stress (from multiple factors, such as increased complexity, day surgery and admission on day of surgery) and higher public expectations. My motives in suggesting the need for such research are purely selfish — having recently retired, and enjoying the lack of stress, I wish to be sure there is an adequate workforce in my old age.

Raymond W Cook

There is growing recognition in Australia of the importance of early childhood to later health and wellbeing, with developments such as the National Agenda for Early Childhood and the National Public Health Action Plan for Children. To sustain a policy agenda for children and improve long-term outcomes, we need timely, comprehensive and accurate indicators and data on child health, development and wellbeing. Building this evidence requires a national monitoring and surveillance system that involves more than aggregating or linking existing data. Steps to building a national system are: to agree on key indicators of child health, development and wellbeing for regular reporting, to research a comprehensive set of indicators for each domain and ascertain data gaps, and to ensure development and coordination of data relevant to policy-making.

Sharon R Goldfeld FRACP, PhD · Frank Oberklaid FRACP, MD

In the competition for official development assistance, health is losing out to governance and security Governance, law and justice were “big ticket” items in the 2005–06 Australian federal budget, reflecting the increasing focus on national security in Australia and elsewhere. Our current aid budget reflects this trend. Australian official development assistance (ODA) seeks “to advance Australia’s national interest by assisting developing countries to reduce poverty and achieve sustainable development”.1 According to AusAID, the agency responsible for the ODA program, poverty reduction remains central, reflecting Australia’s humanitarian values and its economic and security interests. The Australian Government has committed to a number of interrelated policy, program and partnership initiatives. In 2005–06, these initiatives seek to promote a closer partnership with Indonesia and engagement with fragile states, to stimulate broad-based economic growth, to strengthen efforts to promote better governance, to tackle transnational threats (notably HIV/AIDS), and to contribute to greater stability and security. A fair contribution?Australian contributions to ODA, now $2.49 billion a year, have been increasing over the past 5 years — a step in the right direction. Budget allocation has risen from 0.25% of gross national income (GNI) in 2001–02 to 0.28% in 2005–06. However, this gradual rise must be seen against the much larger decline over the past 30 years: in 1975–76, 0.45% of GNI was allocated to ODA, falling to 0.43% in 1985–86, 0.32% in 1995–96; and 0.28% in 2005–06.2 Current levels are well below the 0.42% committed, on average, in 2004 by nations belonging to the OECD (Organisation for Economic Co-operation and Development).3 This prompts questions about how Australia will achieve the ODA targets required to meet the United Nations’ Millenium Development Goals, to which we committed in 2000. If it is to do so, a timetable for achievement should be reiterated, with Australian ODA reaching 0.5% of GNI by 2009, nearly double the current level, and 0.7% by 2015.4,5 Without allocating considerably more resources, Australia will be substantially under target. Who benefits?Australia’s ODA is increasingly directed to near neighbours; around 42% is allocated to just three countries — Indonesia, Papua New Guinea and the Solomon Islands. The allocation to the whole continent of Africa, where poverty and conflict cut deepest,6 and where the impediments to achieving the Millenium Development Goals are greatest, stands at only 3% of Australia’s ODA. Support for other resource-constrained countries in South and East Asia is not much greater. Assistance to those in greatest need remains crucial if the benefits of greater equity, stability7 and control of infectious diseases,8 for example, are to be achieved. Attainment of the Millenium Development Goals needs better governance, but also increased and more effective aid for basic services in the poorest countries. One of the agreed indicators of effective aid targeting is the proportion going to countries classified as “Least Developed” by the UN’s Economic and Social Council. As little as 0.05% of Australia’s GNI goes to Least Developed Countries, one of the lowest rates of all OECD donors.9 A notable trend in Australia’s latest aid budget is the increased focus on governance, which now attracts 36% of ODA, squeezing out other commitments (Box). Almost half of this governance expenditure goes towards law and justice, with large tranches allocated to the Department of Defence and the Australian Federal Police for their activities overseas. This commitment to a “whole of government” approach has seen greater involvement of Australian experts with limited experience of developing countries, and inadvertently undermines the concentration of development expertise within AusAID itself. A healthy contribution?In 2005–06, Australia is devoting only 12% of ODA to health, substantially less than countries such as the United Kingdom (22%),10 and much the same proportion as in the past few years. Within this health allocation, an increasing share is devoted to multisectoral HIV/AIDS programs; their funding has increased from around $25 million in 2001–02 to around $70 million in 2005–06. While increased HIV/AIDS funding is necessary and welcome, commitment to non-HIV health-related expenditure has declined, in some cases markedly. Countries such as Laos, Cambodia and Vietnam no longer receive AusAID funds for health and, in the case of Laos, had primary health care funds cut precipitously. Health is significantly linked to poverty, but there are no short-cuts or easy solutions to re-establishing, reforming, and reshaping functional, efficient, and more equitable health systems. Basic health care requires sustained investment in human resources, infrastructure, community-level health promotion, and essential services for primary care, as well as attention to the social determinants of ill health. While supporting basic services is not the most glamorous issue, with neither the profile of HIV/AIDS nor the visibility of uniformed police and defence force personnel, these services remain the cornerstone to promoting health and to ensuring that communities can participate in, shape and control their own development. The Australian Council for International Development (ACFID), an independent association of Australian non-government overseas aid and development agencies, estimates that a fair Australian contribution to the global aid requirements for health would be around A$580 million, substantially above our current commitment of A$299 million.2 Keeping track of where ODA goesKeeping track of ODA is important. Otherwise, we cannot assess the range of activities underway and their outcomes. In recent years, the monitoring of ODA has been made more difficult because of the greater proportion devoted to governance and security, the control of funds by government departments other than AusAID, the failure to separate HIV/AIDS from general health sector reporting, and a reduction in detailed statistical presentation (eg, AusAID has not published a detailed listing of all funded projects since 2001). The level of funding allocated to Australian government departments exposes us to the criticism of “boomerang aid”. The ability to track and account for where funds have actually gone, the proportion tied to purchase of Australian products,11 and the share that goes into basic infrastructure and service delivery in the social sectors, or other forms of direct poverty reduction, should be enhanced. Aid effectiveness remains a key challenge.12-14 While there are no simple answers, numerous international organisations have made a commitment to promoting evidence-informed policy and allocating resources to learning lessons and reflecting on current practice, in partnership with academic and country-based experts.15 Australian commitment to this trend is to be encouraged. Will government follow the lead of a generous public?The response of the Australian community to the 2004 earthquake and tsunami in the Indian Ocean demonstrated popular concern for the needs of others. In fact, even before the tsunami, private contributions by Australians to aid and development were increasing by around 10% per year in real terms (from around $380 million in 2000 to $443 million in 2004, both figures in 2004–05 dollars [G Luke, Policy Adviser to Australian Council for International Development, personal communication, June 2005]), indicating strong interest and support for development cooperation. We need to tap into this public solidarity and ensure that ODA, despite its limitations, obtains more resources and attention. Increasing commitment to health and education will reinforce governance and security, but this is not why they should be supported. Health and education should attract funds because we care about other people,16 because we have a commitment to promoting human security in the region, and because we find it unacceptable that women die in childbirth because of lack of health services, that preventable diseases kill so many children before the age of 5, and that infectious and non-communicable diseases are decimating economies. Basic services require support, which cannot be provided within the existing aid envelope. The Australian Government White Paper on aid, currently being drafted and due in early 2006, is an opportunity to reinforce commitments to dramatically increase ODA and should place health firmly back on the agenda. The Australian public has demonstrated a willingness to contribute directly. Can we mobilise a matching political commitment? Australian official development assistance by sector* * From analyses of AusAID budgetary data (G Luke, Australian Council for International Development, personal communication). Funds not earmarked for a particular sector (either because they go to multisectoral initiatives, such as gender and environment, or to development banks and United Nations agencies) are excluded. †Expressed in 2004–05 Australian dollars.

Anthony B Zwi PhD, FAFPHM · Natalie J Grove BOccThy, MPH · Maria-Theresa Ho MHP, MD

Objective: To estimate the short-term benefits of a reduction in smoking on acute myocardial infarction (AMI) and stroke hospitalisations and costs.Design and setting: Epidemiological study which applied functions describing reductions over time in risk of AMI and stroke in people quitting smoking to hospitalisation rates and costs for Australia.Main outcome measures: The numbers of AMI and stroke hospitalisations in 35–64-year-olds and the associated costs that could have been avoided over a 7-year period from 2001–02 if smoking prevalence had decreased by 1% in the first year (Scenario 1) or by 1% per annum for 5 consecutive years (Scenario 2).Results: Under Scenario 1, almost 1000 hospitalisations for AMI and about 350 hospitalisations for stroke would have been avoided over 7 years, saving about $20.4 million in health care costs. Under Scenario 2, over 3000 AMI hospitalisations and over 1000 stroke hospitalisations would be avoided, and health care costs could be reduced by $61.6 million (2.75% of costs for AMI and stroke over the period).Conclusions: This study provides further support for the proposition that modest and achievable reductions in smoking rates can substantially improve health outcomes and reduce health care costs, even in the short term.

Susan F Hurley MPharm, MS(Biostatistics), PhD

The problem of surgical waiting lists requires multifactorial solutions The provision of public hospital services inevitably involves managing the demand for these services. This is usually achieved by rationing. Elective surgery is the easiest service for health administrators to manipulate to meet budget imperatives and to manage demand pressures, through controlling surgical waiting lists. In short, the pestle of demand grinds against the mortar of budget restriction in the management of elective surgical lists. Although health planners are able to accurately predict demand for surgical services, administrators often plan not to meet that demand because of budgetary restrictions. With effective management, the only day-of-surgery cancellations should be occasional patients with an acute change in their medical condition. In this issue of the Journal, Schofield and colleagues report on one aspect of demand management: the cancellation of operations on the day of surgery.1 This is almost unheard of in the private health-care sector, where the supply of surgical services is virtually uncapped. Schofield et al also shed some light on the reasons for these cancellations. In the tertiary-care hospital that was the focus of their investigations, the rate of on-the-day cancellations of surgery (11.9% overall, and 13.2% for weekday elective surgery) is a cause for concern. The Australian Council on Health Care Standards guideline is that the day-of-surgery cancellation rate should be low,2 which, in New South Wales, is interpreted to mean not exceeding 1.5%. In my own hospital, Nepean (also a tertiary-care hospital), it is about 3%. A higher rate of cancellations can be expected in hospitals where patients, such as those undergoing major general and cardiac surgery, depend postoperatively on a dedicated intensive-care bed. For these patients, Schofield et al found cancellation rates of 31.2% and 28.5%, respectively; these are higher than would usually be expected. As intensive-care beds are assigned in NSW as part of a statewide coordination service, the management of this problem requires involvement of agencies at a higher level than hospital administration. However, it is not clear why surgical services in the survey by Schofield et al, such as ear, nose and throat or plastic surgery (which should be largely independent of intensive-care and inpatient beds), had such high cancellation rates. The reasons for elective surgery cancellations revealed by Schofield and colleagues fell into five nearly even groups — lack of theatre time, lack of postoperative beds, cancellation by patient or carer, patient clinical change, and procedural reasons. As elective surgery is one of the most predictable aspects of hospital medicine, the great bulk of these cancellations could be avoided with better management systems. With effective management, the only day-of-surgery cancellations should be occasional patients with an acute change in their medical condition. Managing elective surgery more efficiently requires a well thought out management system with quarantining of resources to ensure patient flow. Such a system has recently been described by Ryan and colleagues — the 23-hour ward model.3 In this model, it is expected that the episode of care can be delivered within an envelope of 23 hours, during which time patients require only pain relief and monitoring in a supervised setting until fit for discharge. This model is quarantined from the rest of the hospital or area bed-base, either in a designated ward or a smaller hospital in the area. Patient care is protocol driven, and patients are not admitted unless they are on a clinical pathway. The protocol includes compulsory pre-admission and pre-anaesthetic assessment, careful construction of lists matching patients to available beds and operating-room slots, and a guarantee that elective procedures will not be cancelled. Patient flows are predetermined, with a staged recovery process. This model does not lead to significant increases in readmission rates, nor does it significantly affect community services.3 It is suitable for about 80% of patients requiring elective surgery. The NSW Surgical Service task force has recently recommended the adoption of this model, and the NSW Department of Health has advised all area health services to institute it. Adopting this model’s approach may also help patients who require stays of over 23 hours. A management process that links the predictable demand for elective surgery to operating sessions and beds can avoid cancellations and enable effective and predictable access for all patients. Waiting times are multifactorial and vary between areas, between hospitals in areas and between individual surgeons within hospitals.4 In addition to better management practices based on operational research,5 other solutions to the problem of waiting lists are needed. In elective orthopaedic surgery, there is a need for more resources for prostheses and a better system of prosthetic purchasing. In ear, nose and throat surgery, there is a need for more creative schemes to better utilise the few available specialists. Other solutions may involve contracting specific groups of patients to the private sector (the subject of a pilot study in NSW6) and developing whole new approaches, especially in the apparently insoluble area of intensive-care bed provision (eg, the surgical acute-care unit7). Currently, 1% of the NSW population is on a surgical waiting list, with similar figures in other states and territories. We have clear evidence of the harm that excessive waiting times cause patients.8 All available means must be used to solve this problem. Above all, there is a need to avoid the distress caused to patients by day-of-surgery cancellations.

Patrick C Cregan FRACS

Objective: To establish the rate of and reasons for cancellations of surgery on the scheduled day in an Australian hospital.Design: Prospective survey.Setting: Major metropolitan tertiary hospital, 13 May to 15 November 2002.Main outcome measures: Proportion of operations cancelled on the day of surgery, obtained each day from the operating theatre list and a separate list of additions and cancellations compiled on the day; reasons for cancellations from the cancellation list, extended or confirmed, as necessary, by questioning of bookings and ward staff, or members of the surgical team; estimated and actual duration of each operation and patient information from hospital clinical records.Results: 7913 theatre sessions were scheduled by 133 surgeons in the study period; 941 of these (11.9%) were cancelled on the day, including 724 of 5472 (13.2%) elective procedures on working weekdays. Main reasons for cancellation were: no theatre time due to over-run of previous surgery (18.7%); no postoperative bed (18.1%); cancelled by patient (17.5%); and change in patient clinical status (17.1%). Procedural reasons (including patient not ready, no surgeon, list error, administrative cause, and communication failure) totalled 21.0%. Ear, nose and throat surgery experienced the most cancellations (19.6%), followed by cardiothoracic surgery (15.8%).Conclusions: There were five major reasons of similar magnitude for on-the-day surgery cancellations. We estimated that 60% of cancellations of elective procedures were potentially avoidable. Change of one factor leading to cancellation (eg, provision of more postoperative beds) is not likely to lead to improvement unless the other major factors are also tackled.

William N Schofield MA, DipEdPsych · George L Rubin FAFPHM, FACR · Michael Piza BA(Hons), MPH · Ying Yin Lai MScApplStat · Doungkamol Sindhusake BA, MPH, PhD · Michael R Fearnside MS, FRACS · Peter L Klineberg FANZCA

We need to increase our investment to maintain and improve our position in the global knowledge economy Of all human endeavours, health and medical research arguably offers the greatest potential to improve human life. Research discoveries have extended and enhanced our lives, reduced the burden of many diseases in our society, and are changing the shape of health care. In an era of unparalleled promise offered by genomics, bioinformatics, stem-cell technology, biomedical devices, and therapeutic vaccines, the very nature of clinical practice could shift profoundly over the coming decades. There is, however, another very positive outcome of health and medical research — with the right support from government and industry, it could hold the key to Australia’s future prosperity in a global knowledge economy. The reality of this assertion is exemplified by the vibrant biotechnology and pharmaceutical industries so evident in the United States today. This powerhouse status is the outcome of political strategies put into place 25 years ago. The success of these strategies is reflected in a tenfold increase in the number of patents, royalty and licensing fees (amounting to one billion dollars US per year), strong links between academia and industry, and a fourfold increase in corporate research funding.1 Many overseas governments are now emulating this success by promoting the link between a country’s ability to foster and grow knowledge-based industries and its future economic prosperity. Developed countries, such as the US, Japan, Canada and the UK, are also implementing significantly resourced strategies to encourage citizens to become literate in science and technology, cultivate and attract the brightest minds, build infrastructure and capacity in basic sciences and research, develop commercial competence and grow new businesses. In April this year, the European Commission announced it would double its research budget to i70 billion over 7 years to bolster growth and competitiveness, catch up with American and Japanese spending on innovation, and transform the European Union (EU) into a knowledge-based economy.2 This spending is in addition to funds committed by the individual EU member states to support research within their own borders. The UK Medical Research Council (MRC), a taxpayer-funded organisation that supports and promotes biomedical research, lists among its goals “contributing to the wealth of the nation”. In the most recent financial year, the MRC spent nearly £450 million on research and earned about £15 million in licensing revenue. In Australia, the recommendations of the government’s 1999 Health and Medical Research Strategic Review (the “Wills Report”) were based on data showing that Australia had fallen behind other developed countries in its relative funding of health and medical research. The report found that additional investment would reap significant returns over the long term by improving the health of the Australian population, building the economy, and creating valuable jobs.3 Following its acceptance of the report, the government made an historic decision to increase National Health and Medical Research Council (NHMRC) funding over a 5-year period by injecting an additional $614 million, effectively doubling the annual NHMRC budget to about $412 million by 2005.4 State governments have focused on capturing the commercial potential of research outcomes and creating new business and industry. Initiatives like Queensland’s Smart State, BioMelbourne, BioInnovation SA and BioFirst NSW reflect the recognised importance and economic realities of catching the biotech wave. In December 2004, the Australian government released the report of the Investment Review of Health and Medical Research (the “Grant Report”) conducted by a committee of eminent experts from the commercial and research arenas.5 The government initiated this review to determine the impact of the additional investment made in response to the Wills Report and to revisit the Wills Report’s vision and assess if any changes of emphasis would be beneficial. Although it was carried out only 4 years after the government’s decision to accelerate the medical research investment cycle, the Grant Report’s independent assessment of the outcomes and returns generated by health and medical research showed that there had already been some successes, and that further commercial and health care benefits are likely in the near and long term. Two key success indicators are Australia’s comparatively high research productivity and quality, and the formation of 350 new businesses in the biomedical field from 1992 to 2003. Besides recommending continued strong growth in government funding to remain internationally competitive, the Grant Report also suggested that innovative new policies and incentives were needed to encourage greater private industry investment in research, targeting an increase in annual spending in Australia by multinational pharmaceutical and biotech companies from the current about $420 million6 to $1 billion. The Grant Report, completed in May 2004, was not released until December, and it has since slipped off the radar at this crucial time. If the Australian Government takes no further action, we could see Australia quickly drop away from the front-runners in biomedical research and innovation. Even flatline funding would be a reduction in real terms, and would see us fall further behind other countries as their investment and policy environments focus on optimising their leadership position. The Australian community supports increased health and medical research efforts. Research Australia’s annual health and medical research public opinion polls in 2003 and 2004 showed that most Australians wanted to see increased government and industry investment, and are prepared to contribute to that investment themselves.7 In fact, 47% of Australians said they would rather see surplus government funds invested in health and medical research than in tax cuts.8 Securing a strong, enduring, sustainable economic future for Australia requires a long-term view for building on the valuable investment to date. This will be achieved only by continued focus and leadership by national, state and territory governments in partnership with researchers, industry, and the community. Government commitment to the recommendations of the Grant Report would be a good first step towards showing this leadership.

Christine C Bennett MB BS, FRACP MPaed · Michael R Vitale PhD, MBA

Health services need state-of-the-art health information systems One could be forgiven for expecting that a nation that cracked the Enigma code, and, more recently, assigned all of its citizens a unique health service number, would possess an enviable health information system that made the planning, delivery and evaluation of medical services a seamless and simultaneously sophisticated exercise. But the United Kingdom is a nation where trains are regularly stopped by snow, leaves and even clouds — the latter apparently because clouds interfere with the onboard geographical positioning systems “talking” to geostationary satellites. The lack of interconnection and compatibility between health service computers is not unique to the UK. While the travails of the UK transportation industry regularly provoke tantrums in the tabloids, the state of the National Health Service’s computing systems is yet another test of the traditional grin-and-bear-it demeanour of the British public. In fairness, the NHS is not alone. But it is distinguished by the UK Government’s plan to inject £5 billion to “wire up” the nation’s health services properly. There are three issues that stalk health industry computing: fear on the part of health professionals (arising from ignorance about computer systems); outdated “hardware”; and lack of interconnection and systems compatibility. When faced with a computer for the first time, many otherwise confident, capable and experienced health professionals are genuinely afraid that a mistake on their part may damage the equipment. And their ignorance is profound — most medical students, for example, do not immediately grasp that entering an individual’s date of birth into an appropriate program allows the system to derive the person’s age. It is a fair bet that basic informatics, beyond searching databases of publications, is still missing from most undergraduate curricula for health professionals in Australia as well as in the UK. In the case of the NHS, after failure to train the “wetware”, the second strand of the Gordian knot is the hardware — there is not enough of it; a good deal of what is available is old and slow; and incompatibility is widespread. In the UK, many non-medical staff members working in community health do not have access to a computer. Their lack of access to email is increasingly a poor economic choice in the face of pay-by-the-minute telephone calls, and the difficulty in locating and coordinating many busy individuals. Difficulties can only mount as continuing care of patients with complex chronic diseases shifts out of hospitals. Recently, there has been a large investment in infrastructure for networking computers, although there remains a need for staff to become more proficient at using the network and demonstrating its value. The lack of interconnection and compatibility between health service computers is not unique to the UK. If one tries to compile a comprehensive register of patients with cancer managed by an Australian teaching hospital, it soon becomes evident that we too have the same informatics diseases. The common experience is that radiology, radiotherapy, histopathology, nuclear medicine, pharmacy and oncology all have different, mutually unintelligible systems, many of which cannot readily be searched for particular diagnoses or keywords. Furthermore, the medical record is still paperbound. In the UK, the persistence of separation between health and social services frequently means not only duplication of records — computers are meant to save time! — but physical duplication of terminals and keyboards. UK primary care, by contrast, is steadily converging on two dominant medical record packages, and an increasing proportion of practices are becoming “paper-frugal”. However, until very recently, the NHS insisted that a patient’s lifelong medical record could only be passed on in hard-copy format when that individual registered with a new practice. The advent of the DICOM (Digital Imaging and Communications in Medicine) standard for medical imaging is slowly stimulating alignment of certain hospital computer systems, but patients transferred as emergencies from local hospitals to teaching hospitals are still likely to have all their investigations repeated at the teaching hospital, as the results obtained at the first hospital can not be accessed electronically from the second. Again, time and money are wasted. Even if there were good, secure internet connections between the various parts of the NHS, finding the right record would still be a challenge, as most sites use their own numbering systems for patients and very few employ the NHS number. This is not a matter of overt, or even covert, resistance, because National Insurance (pension) numbers have to be produced and used regularly in the course of employment and taxation. Rather, there is no structural incentive for either patient or doctor to know or use a long, clumsy number; patients are not denied access to health services if they do not know their NHS number, and doctors do not suffer loss of income for failing to provide it. Consequently, the scope for exploiting the unique cradle-to-grave records — individuals’ NHS files — for planning and running health services better, or for epidemiological research, is surprisingly limited. Special projects in the Oxford region and in Dundee are two of the exceptions, but even the (now rather dated) Oxford Record Linkage Study omits information from primary care. However, collections such as the national General Practice Research Database are slowly becoming more user-friendly, even if they charge for access! Meanwhile, Accident and Emergency Departments, the scene of all the long trolley-waits beloved by the tabloids, remain a computing black hole. Most, but not all, have electronic systems, and what they collect and how they record it are institutionally idiosyncratic. An NHS with state-of-the-art health information systems! Cynics will believe it when they see it — it has all been promised before. Perhaps they’ll read about it while standing in their commuter trains, waiting for the clouds to clear.

Konrad Jamrozik DPhil, FAFPHM, MFPH · Richard F Heller MD, FRCP, FRACP, FAFPHM · David P Weller MPH, PhD, FRACGP, FAFPHM

Linsey S Hart,* Jane Vernon-Roberts† * AMC Liaison and Resource Officer, Postgraduate Medical Council South Australia, 71 Edward Street, Norwood, SA 5069. † Head of Clinical Studies, Royal Adelaide Hospital, Adelaide, SA. linseyATpmcsa.org.au To the Editor: McGrath’s article on integrating overseas-trained doctors (OTDs) into the Australian medical workforce noted that the areas of difficulty in this area have been well defined.1 McGrath challenged us to “get on with it”. We interpret this challenge to mean that there has been enough regurgitating and redefining of the problem, and it is time for some action. In South Australia, the difficulties of integrating overseas doctors into the workforce mirror those experienced by other states. The Department of Health Overseas Trained Doctor 2004 database listed 93 OTDs as eligible to work in SA. Seventy were employed. All of these doctors had only completed the Australian Medical Council (AMC) Multiple Choice Question (MCQ) examination. Since its inception in April 2003, the Postgraduate Medical Council of South Australia (PMCSA) AMC doctors subcommittee has worked to put in place a number of educational initiatives to support and assist OTDs to complete the Australian Medical Council Exams, and to advocate for their ongoing needs for better orientation to the workplace and protected education time at work. The programs initiated by the PMCSA are both Government-funded and self-funded. They are: culture and medical communication for doctors, MCQ tutorial program, ready for work program, hospital tutorials, objective structured clinical examination practice exam, clinical bridging program, and study groups. Examination results in 2004 for candidates undertaking the PMCSA programs bettered the national average. Of the 16 enrolled participants in the MCQ tutorial program, which ran from January to April 2004, nine sat the May AMC MCQ exam and seven deferred. Eight of the nine passed, giving a pass rate of 89% (AMC pass rate 56%; Australian Medical Council, personal communication). In the AMC clinical examinations, our candidates achieved an overall pass rate of 67%; 30 sat the exam, 20 passed and 10 were given a re-sit or a fail result. (AMC pass rate 59%; Examinations Officer Clinical, Australian Medical Council, personal communication). Twenty chose to defer after using the various programs and tutorials on offer to gauge their level of preparedness. These doctors are planning to undertake the exam in 2005. These programs constitute the South Australian Action Plan for OTD inclusion in the workforce. 2 All of these programs are available and appropriate for any OTD (permanent resident or temporary resident). To the best of our knowledge, no temporary resident wishing to work in “areas of need” has enrolled in our programs yet.

Linsey S Hart · Jane Vernon-Roberts

Barry P McGrath Professor of Medicine, Monash University; and Chair, Confederation of Postgraduate Medical Education Councils of Australia, Dandenong Hospital, Dandenong, VIC 3175. Barry.mcgrathATmed.monash.edu.au In reply: Hart and Vernon-Roberts outline the South Australian Action Plan by the Postgraduate Medical Council of South Australia Australian Medical Council (AMC) doctors subcommittee to support and assist overseas trained doctors (OTDs). Their worthy efforts are directed predominantly towards the many OTDs preparing for their AMC examinations, with associated bridging and “ready-for-work” programs to facilitate entry into the hospital medical workforce. However, the question that needs to be addressed, and which was the main thrust of my article,1 is why we don’t have a national coordinated approach to all elements of the pathway to integrating OTDs into the Australian health care system. This cannot be a largely political approach, as is the Australian Government’s Strengthening Medicare initiative, which is particularly weak in the areas of assessment for safe practice and support in training. A recent article has highlighted the need for a national approach to coordinated governance for postgraduate medical education in Australia and the unsatisfactory complexity of medical education and training systems in this country.2 This excellent article includes only very brief reference to OTDs, using the term “international medical graduates”, 2 which is becoming the more acceptable term and the one recognised by other countries. It does not address the many gaps and problems in the pathways for this group. The number of international medical graduates seeking employment and/or being actively recruited into the medical workforce in Australia each year is far greater than the number graduating from our own medical schools. Thus, there is a degree of urgency about the debate on postgraduate medical education in Australia. We need a national authoritative body, like the new United Kingdom Postgraduate Medical Education and Training Board.

Barry P McGrath

Unrealistic expectations may overshadow genuine advances and focus attention more on failures For many years, scientists and clinicians have sought to harness the power of genes for treating disease. The potential for gene therapy to cure otherwise untreatable conditions, and to offer a completely new strategy where conventional medicine has limited efficacy, has attracted huge interest and investment of time and money from both academic and commercial biotechnology sectors. The field of gene therapy has therefore grown rapidly. However, unrealistic expectation has overshadowed genuine advances and focused attention more on clinical failures and unnecessary mistakes. Only recently, federal law enforcement officials announced a substantial settlement with the University of Pennsylvania after the death of a patient in a gene therapy trial in 1999. Consequently, gene therapy has been viewed with suspicion, and the tight regulatory control on the conduct of clinical studies has to some extent restricted progress. But is the frequently cited accusation that gene therapy has failed to deliver in the clinical arena justified, or is it another manifestation of unrealistic expectation? At the start of the 1990s, the first clinical trials of gene therapy were attempted for an inherited severe combined immunodeficiency (SCID) caused by deficiency of the intracellular enzyme adenosine deaminase (ADA).1-4 In the absence of definitive treatment, SCID of any molecular type is usually fatal within the first year of life, although patients with ADA deficiency can be supported by administration of exogenous bovine enzyme. Even so, this is often only partially effective, and is extremely expensive. The rationale for the development of gene therapy for SCID therefore derives from the severity of the illness, the inadequacy of conventional therapy, and the considerable morbidity and mortality associated with stem-cell transplantation, particularly from a mismatched donor. Efficacy in these early studies was limited, but a decade further on, gene transfer technology and cell handling protocols had been refined sufficiently to produce real clinical benefit. Four recent studies have demonstrated highly effective gene therapy for the X-linked form of SCID (SCID-X1) and ADA deficiency, using retroviruses to deliver the therapeutic genes into haemopoietic stem cells ex vivo5-8 (also Gaspar and Thrasher, unpublished data). Bearing in mind the outcome and adverse effects of conventional therapy, these are remarkable results and the first clear indication that gene therapy can offer a cure for some human diseases. In a few patients, including one reported in this issue of the Journal (page 458),9 the treatment has failed, indicating that there is more to learn about the effective dose of corrected cells and the potential for host factors to influence immune cell development.10 Many different types of vector have been tested in laboratory experiments to deliver therapeutic genes, and their effectiveness is largely determined by the host and tissue type. For stable gene transfer to dividing cells, such as haemopoietic cells, the new genetic material has to be retained through cell division and passed on to daughter cells. Although retroviruses are highly effective for this, their dependence on chromosomal integration brings with it the risk of inadvertent gene activation or inactivation. Having initially achieved successful immunological reconstitution, three patients with SCID-X1 (out of a total of 18 SCID-X1 and seven ADA-deficient patients treated to date) developed T cell lymphoproliferative disease about 3 years after the gene therapy pro-cedure. 11 In two of these patients, the enhancer sequences in the retroviral vector, which are responsible for effective transgene expression, had activated the LMO-2 proto-oncogene. There are likely to be other factors that contributed to cell transformation, but they have not yet been defined. It is therefore unclear whether all patients are at significant risk, or whether this is restricted to a few with SCID-X1. All this makes decision-making by regulatory authorities very difficult, as it would be unfortunate to withdraw potentially life-saving therapy from patients who have few rational alternatives. It is also difficult for families faced with deciding whether to participate in a new therapy with proven curative potential but an element of uncertainty in the longer term. In light of the third adverse event reported earlier this year, regulatory authorities in both France and the United States have put ongoing SCID-X1 studies on hold, although the US Food and Drug Administration have preserved the potential to treat patients in whom allogeneic transplantation has failed. Having considered all options, UK authorities have allowed trials to continue as before, with case-by-case review. This response seems to offer the most flexibility, as patients in whom conventional therapy is judged to be of very high risk can continue to benefit from gene therapy. Importantly, it also empowers families to participate, with informed consent, in the decision-making process. The Australian position is outlined in this issue of the journal (page 441).12 Fortunately, it is likely that much can be done to improve efficiency and safety of current protocols, and these developments are expected to enter clinical trial quite soon. The design of vectors used for gene delivery is clearly important, and modifications are possible that limit the risks of mutagenesis, such as incorporation of DNA and RNA insulator sequences in integrating vectors; use of self-inactivating vectors in which the powerful viral enhancer sequences are deleted; or targeting of safe regions in the genome. Ultimately, the development of homologous recombination or gene repair to accurately correct genetic mutations, or the construction of mitotically stable extrachromosomal vectors, would obviate many of these problems, but current technologies are inefficient. The potential for gene therapy to treat human disease is clear, and the clinical evidence is beginning to emerge. The time between concept and delivery of therapeutic success is really no different from that of other significant medical advances, and the continuing occurrence of side effects associated with established approaches, such as organ and bone-marrow transplantation, should not be forgotten. Undoubtedly, similar strategies will be applied to other severe conditions, but also to a larger number of non-lethal conditions associated with significant disability. In this latter case, the risks of therapy have to be more clearly defined in biologically relevant model systems. The expectation that this exciting new therapeutic modality will produce major immediate effects in the absence of either predictable or unexpected adverse events is unrealistic. More than ever, human clinical trials are necessary to establish the efficacy of gene therapy and to inform future technological development.

Adrian J Thrasher

The NHMRC has set up the Gene and related Therapies Research Advisory Panel (GTRAP) to oversee gene therapy research The cornerstone of clinical research involving humans in Australia is the HREC (Human Research Ethics Committee). All studies must be approved by an HREC at the investigators’ institute(s). The demands on these committees are considerable, particularly when cutting-edge technology is involved. This was the situation in 1994 when the National Health and Medical Research Council (NHMRC) formed GTRAP (Gene and related Therapies Research Advisory Panel). The function of GTRAP was to provide the NHMRC, researchers, clinicians and HRECs with advice on medical, scientific and technical issues related to gene therapy,1 a novel form of treatment that had just been introduced in the United States. Its use in Australia — to treat severe combined immunodeficiency (SCID) — is described in this issue of the Journal (page 458).2 The NHMRC, through its Australian Health Ethics Committee, required that HRECs not give final approval for a gene therapy trial unless that trial had also been reviewed and approved by GTRAP. In Australia, gene therapy requires both local HREC and national GTRAP oversight. The reason for this was the novelty of the treatment, which does not involve traditional drugs or chemicals, but cells that have been genetically modified. Risks such as insertional mutagenesis, now tragically seen after gene therapy of SCID-X1, were known in the early 1990s to be possible. 3 Another concern was the unintentional involvement of germ cells, although the original targets for gene transfer were somatic cells. Genetic errors in somatic cells would harm the patient, but those in germ cells could be passed on to future generations. GTRAP works closely with the Therapeutic Goods Administration (Australia’s equivalent of the US Food and Drug Administration [FDA]), the Office of the Gene Technology Regulator and the Australian Health Ethics Committee through members in common. The “and related” component of GTRAP’s title reflects the growing use that will be made of cellular therapies in clinical practice. The NHMRC has recently expanded the GTRAP terms of reference to include cell therapies in the broader sense, given the future possibility that genetically engineered stem cells (or xenotransplants) will be trialled in clinical research. This move parallels the Therapeutic Goods Administration’s proposed new regulatory framework for tissues and emerging biological therapies.4 Because of the inherent uncertainty surrounding these novel therapies, GTRAP requires that all treated patients (or their families) be contactable should problems develop in the longer term. All studies require the sponsors or investigators to provide annual reports, notifications of adverse events, and a final report on completion of the study. GTRAP’s current position on trials of gene therapy for X-linked SCID or other therapy involving potential risk combinations (retroviral vectors and stem cell targets) is similar to that followed by the FDA, outlined in this issue of the Journal.5 For SCID-X1, this means that gene therapy can still be considered as an option if there are no alternative treatments, such as a suitable allogeneic bone marrow transplantation, or if such transplantation has failed. In the case of the potential risk combinations outlined above, gene therapy could continue after review of the risk–benefit analysis, ongoing monitoring which now would need to include 6-monthly integration-site analysis (analysis of the patient’s cells to detect any potential oncogenic events early), and inclusion in the patient information sheet and consent form the information that acute leukaemia has occurred in children as a complication of gene therapy. In Australia, the clinical investigator and sponsor of two ongoing gene therapy studies involving SCID-X12 and HIV, respectively, placed their studies on voluntary clinical hold when two cases of leukaemia were reported in children who had received gene therapy for SCID-X1. Since then, the SCID-X1 clinical study has remained on voluntary hold. The HIV study, which uses a retroviral vector targeted to haemopoietic stem cells, came off voluntary hold when reassessed by GTRAP. This reassessment included a review of the risk–benefit analysis, implementation of the additional monitoring requirement, and rewording of the consent documents, as described above. Following the report of a third leukaemia complication, the HIV study, which is also being conducted in the United States, has continued pending further advice from the FDA as well as GTRAP. At present, there are no additional scientific data available to GTRAP that would require a clinical hold on the HIV study, although the patient information sheet and consent forms must again be changed to reflect three, rather than two, leukaemia cases. More information on GTRAP (including a list of all gene therapy studies undertaken in Australia) can be found on the NHMRC website (www.nhmrc.gov.au/research/gtrap.htm).

Ronald JA Trent PhD, FRACP, FRCPA

Bernard M Bourke Vascular Surgeon, Gosford Hospital, 4/213 Albany Street North, Gosford, NSW 2250. Dr. BourkeATgvs.com.au To the Editor: Up and coming surgical registrar, Ken Wong, presents a revolutionary plan to allow him to look after surgical patients in the operating theatre.1 The use of the telephone for communication has merit, but he won’t feel so smug when he gets to the chapter entitled “The management of surgical patients in NSW public hospitals in winter”. There will be nowhere for Dr Wong to “hide” when he realises our operating theatres are, in fact, solar powered and that, when the sun goes down in winter, the theatres conk out. Surely now, with the statewide mergers of health services, there will be enough excess “committee people” to form a collaboration with the western NSW farmers so that the mice plague can be harnessed and trained to run on the cogs and at least provide lighting during power shortages. I’m sure my daughter could lend a few cats to chase the mice. In the absence of the provision of more hospital beds, the substitution of cat-and-mouse power for solar power is the best “winter strategy” I’ve heard in the last 10 years. This concept will feature in our next chapter, “How to train surgeons without patients or operating time”.

Bernard M Bourke

They reduce rates of restenosis but not mortality or infarction — so are they worth it? The development of drug-eluting coronary stents has proven to be a quantum advance in interventional cardiology, rivalling the impact of stenting itself. Drug-eluting coronary stents deliver effective local concentrations of antiproliferative drugs (thus avoiding systemic toxicities), without substantially modifying the technique of percutaneous coronary intervention (PCI). Two of the drugs used are sirolimus and paclitaxel. Sirolimus is an inhibitor of the G1-phase of the cell cycle, while paclitaxel inhibits microtubule formation, both of which are necessary for cell division. Thus, they inhibit the natural healing mechanisms — endothelial cell migration and extracellular matrix formation — that produce intimal hyperplasia, resulting in restenosis. Randomised clinical trials of patients with stents that elute these agents have demonstrated reduced angiographic restenosis rates when compared with patients with bare-metal stents.1,2 These individual trials are supported by a recent meta-analysis of 11 randomised clinical trials involving 5103 patients; this showed that, in patients with drug-eluting stents (compared with those receiving bare-metal stents), there was a significant reduction in the proportion of patients requiring target lesion revascularisation (Box).3 Thus, within the context of randomised trials, and when all other things are equal, drug-eluting stents are clearly superior in preventing restenosis, which is the most significant late morbidity associated with coronary intervention. But, not all things are equal — these stents come at an approximately threefold increase in economic cost. As a consequence of this cost differential, the benefits of this new technology need to be considered critically. While the meta-analysis confirmed that drug-eluting stents decrease rates of restenosis and target lesion revascularisation,3 there was no evidence that they reduced deaths and myocardial infarction rates. However, given the nature of the innovation, this would not be expected. Furthermore, from the patient’s perspective, the impact of drug-eluting stents on the more relevant endpoint of “any” coronary revascularisation (as opposed to “target lesion” revascularisation) has not been highlighted and will be eroded by the development of de novo disease in other areas of the coronary vasculature.6 Among cardiologists and patients, this technology has been embraced with substantial enthusiasm. Drug-eluting stents are now being implanted in patients in subgroups and with lesion types beyond those evaluated by randomised trials.7 Some clinicians have also proposed that multi-vessel PCI using drug-eluting stents provides a comparable alternative to coronary artery bypass grafting.8 This preference is best illustrated by the disparate rates of drug-eluting stent implantation in the private and public sectors, estimated at > 75% and < 25%, respectively, reflecting the difference in who is paying for this technology. Several issues make it difficult to compare the cost-effectiveness of the two types of stents. First, without a benefit in terms of mortality, assessment of cost-effectiveness by cost-per-life-year saved is precluded. To circumvent this issue, a published cost-effectiveness analysis from the SIRIUS trial of sirolimus-eluting stents in elective PCI used quality-adjusted life-year (QALY) data drawn from a trial of bare-metal stenting for reperfusion therapy after myocardial infarction.4 Whether these QALY data are applicable to the patients in the SIRIUS trial, and to Australian patients, is uncertain. Given the potential lack of generalisability of clinical trial data to clinical practice, the use of QALY data from patients treated within a different clinical context may lead to a cost-effectiveness extrapolation not relevant to our local context. The time has come for the Australian cardiology community to develop national systems that routinely assess the long-term clinical outcomes of all patients undergoing PCI and coronary artery bypass grafting. Such data should yield several benefits. First, actual local data on effectiveness are essential for locally relevant cost-effectiveness estimates. Second, data on specific patient and lesion subsets inadequately studied in randomised trials will allow us to apply this innovation to patients most likely to benefit from it.9 Such data are vital to the rational development of practice guidelines and reimbursement strategies for optimal patient outcomes and health care expenditure. Third, as with any emerging therapy or technology, routine evaluation of long-term safety remains a priority; this has been highlighted by the recent report of very late stent thrombosis associated with drug-eluting stents.10 Routine systems of evaluation would provide an effective infrastructure for surveillance of unexpected adverse events occurring after a new technology has been approved, and would be less reliant on physicians for recognition and reporting. Problems relating to the costs of data collection and the difficulties of risk adjustment remain to be solved before nationwide registries can be implemented. However, the clinical and economic consequences of inappropriate application of this and other technologies would exceed these costs, potentially by orders of magnitude. The resource burden associated with assessing implementation of a new technology should not be used as an argument against its conduct, but rather should encourage the incorporation of this activity into routine clinical practice and funding. It has been argued that, with time, the cost of drug-eluting stents will fall, clinical experience will grow, and the application of this technology to clinical practice will be optimised.11 Over the past 10 years, the cost of bare-metal stents has declined by approximately 60%. Yet, interventional practice remains heterogeneous, and outcomes remain uncertain. Registries designed to assess practice, outcomes and cost will offer essential objective data to inform rational choices — until the time when all things become equal. Summary of evidence related to drug-eluting stents A Bayesian meta-analysis* of 11 randomised controlled trials comparing drug-eluting stents with bare-metal stenting3 showed the former had: — No effect on mortality rates (odds ratio, 1.11; 95% credible interval*, 0.61–2.06)3 — No effect on rates of myocardial infarction (odds ratio, 0.92; 95% credible interval*, 0.66–1.25)3 — Substantially lower rates of target lesion revascularisation (odds ratio, 0.26; 95% credible interval*, 0.14–0.45)3 — Fewer major adverse cardiac events when death, myocardial infarction, and target vessel revascularisation are combined (odds ratio, 0.42; 95% credible interval*, 0.32–0.53)3 In a randomised comparison of sirolimus-eluting versus bare-metal stents in elective percutaneous coronary intervention, the incremental cost-effectiveness ratio was estimated to be US$27 540 per quality-adjusted life-year gained.4 This reflects the money that needs to be spent to gain a benefit of one quality-adjusted life-year with this technology. Up to 50% of patients undergoing percutaneous coronary intervention have characteristics that would have led to their exclusion from clinical trials of drug-eluting stents in the US Dynamic Registry, a comprehensive angioplasty registry sponsored by the National Heart, Lung and Blood Institute.5 * In a Bayesian meta-analysis, “credible interval” corresponds to confidence interval.

Derek PB Chew MB BS, MPH, FRACP

After 12 years of national mental health reform, major service gaps and poor experiences of care are common. The mental health community reports little progress in implementing its key priorities, such as expanded early-intervention programs, comanagement of people with mental health problems and related alcohol or substance misuse, and widening of the spectrum of acute care settings. We propose new national targets for reducing the social and economic costs of poor mental health; these include increased access to effective care, reduced suicide rates and improved rates of return to full social and economic participation. We detail specific service reforms designed to maximise the chance of achieving these targets, and prioritise youth health and integrated primary care programs. New independent and national reporting systems on the progress of mental health reform are urgently required.

Ian B Hickie MD, FRANZCP · Tracey A Davenport BA(Hons), GCM · Georgina M Luscombe BSc(Hons) · Grace L Groom DHSc · Patrick D McGorry FRANZCP

Roslyn G Poulos,* Anthony B Zwi† * Lecturer, † Professor and Head, School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW 2052. r.poulosATunsw.edu.au To the Editor: With increasing attention focused on the need for evidence-based policy making in recent years, researchers have come to the realisation that research has, in fact, little impact on policy making. The literature abounds with theories on how to improve the appropriate use of research evidence in policy decisions. Researchers must shoulder a large proportion of the responsibility, having spent too much energy generating evidence and insufficient time “translating” this knowledge into a useful product for decision makers.1 Further, the failure of the two communities to communicate has allowed researchers to follow their own agendas, rather than those of the potential users of their research.2 Improved two-way communication between researchers and policy makers may improve the uptake of research evidence.3 This is best achieved by supporting policy makers to utilise evidence and researchers to become more policy-sensitive. However, even when evidence has been “translated” and acknowledged, it is still subject to other forces. There are numerous barriers to evidence-based policy making, not the least of which is politics. For example, Stevenson recently highlighted the fact that young drivers are disproportionately represented in road trauma statistics.4 He presented data on a number of interventions that have successfully reduced fatal and injurious crashes involving young drivers. Similar data were presented by the NSW Government in its options paper on improving safety for young drivers, which was put out for community consultation in late 2004.5 So far, a policy decision has been made on only two out of 11 options. One decision, which prohibits provisional (P1) licence holders from driving high-performance cars, has, by the Government’s own admission, no supporting evidence of effectiveness.5 The other decision places a limit of one passenger for 12 months for drivers who lose their provisional (P1 or P2) licence. However, this decision is a variant of a strategy that is supported by evidence, and consequently may have little or no effect. Researchers need to be aware that social, electoral, ethical, cultural and economic factors have a powerful influence on policy.6 While the literature on evidence-based policy exhorts researchers and policy makers to work on bridging the gap between evidence and policy, the role of other key players (such as the public) has tended to be overlooked.7 As part of a National Health and Medical Research Council capacity-building grant in population health research, a consortium of academic institutions is working on enhancing the interface between injury research and policy and on promoting evidence-informed policy in injury prevention. (Members of the consortium are the NSW Injury Risk Management Research Centre, the School of Public Health and Community Medicine, and the Prince of Wales Medical Research Institute [all of the University of NSW]; and the Rehabilitation Studies Unit and George Institute for International Health [of the University of Sydney]). The role of the public as an audience with which researchers might profitably interact to improve dissemination and uptake of evidence will be explored, as will the role of health journalists in facilitating this.

Roslyn G Poulos · Anthony B Zwi

Kevin L Forbes Head, Years 3 & 4 MB BS Program, School of Medicine, University of Queensland, Mayne Medical School, Herston, QLD 4006. k.forbesATuq.edu.au To the Editor: The personal perspective on continuous improvement outlined by Kilham succinctly documents the concerns surrounding the application of management tools to the practice of medicine.1 As Kilham says, continuous improvement has been around for a long time and “flowed from a particular attitude . . . [that of] a mind open enough to recognise better ways of doing things, or ways of doing better things”.1 However, I would argue that even history-taking does need to continually improve to include various communication skills appropriate to individual patients. Continuous improvement in history-taking skills, to enable each patient to express their major concerns and to feel more in control of the consultation, has significantly reduced my feelings of frustration provoked by previous patients. Adherence to the strict script of history-taking taught to me in my undergraduate training seemed to provoke a rejection of the expert advice I was giving them. Management does need to understand the importance of recognising good work already done and the current high achievements of medical practitioners. On the other hand, even the busiest of clinicians should understand the professional advantage of participation in a project to further improve or develop new ways of solving their patients’ problems. There are multiple strategies needed for the effective “change from the existing entrenched structure and culture of patient care to one based on patient- centred, evidence-based care”.2 However, management certainly needs to support the busy clinicians during the project. It is also better to avoid jargon and the constant renaming of programs. I would argue that the learning principle underlying the range of continuous improvement programs is the same. That principle is to question, accept challenges, explain, justify and seek further information as a continuous process.3 One essential feature of continuous improvement (whatever it is called) is that the practitioner needs to participate in the selection of the project for continuous improvement and the objective outcome measures that will prove the change to be advantageous or not advantageous. It is also important to recognise that successful continuous improvement programs in one context do not necessarily translate to another context. I agree that management must accept the same standards and accountability demanded of clinicians. In addition, all clinicians should participate in continuous improvement projects as well as being assured that we currently practise medicine at a high standard.

Kevin L Forbes

We need a patient safety initiative that captures the imagination of politicians, professionals and the public Nearly 10 years have elapsed since the Journal published the ground-breaking Quality in Australian Health Care Study (QAHCS)1. With its disturbing findings, the study seared “patient safety” into the public’s psyche. The QAHCS methodology focused on the safety aspects of healthcare quality, without providing systematic data on other domains, such as access, efficiency and acceptability, and provided only some insight into effectiveness and appropriateness of care. The role of QAHCS was to estimate the size and nature of the problem of unsafe healthcare. . . . the absence of recent system-wide data on patient safety . . . makes a mockery of the tenets of continuous quality improvement. Now, 10 years on, most patients in our healthcare system do not suffer preventable harm, and receive good care. But it is still possible that up to 16% of hospitalised patients will suffer an adverse event: 50% of these events will be preventable and 10% of these preventable events will lead to permanent disability or death.1 Studies from the United Kingdom,2 Canada,3 Denmark,4 and France,5 using similar methodology to the QAHCS, indicate that Australian healthcare is no safer than that provided in these countries. The magnitude of the problem worldwide is reflected in the World Health Organization’s recent launch of the Patient Safety Alliance,6 which aims to improve patient safety in all 192 member nations. What has been achieved since the release of the QAHCS? In 2000, 5 years after the study’s release, the Australian Council for Safety and Quality in Health Care (ACSQHC) was formed to provide leadership in improving patient safety and quality through advice to all federal, state and territory health ministers. The ACSQHC has championed an extensive work program,7 including: developing an “open disclosure” standard for patients and their families when care processes go wrong; developing a national standard for credentialing and defining the scope of practice of medical practitioners; involving consumers in improving healthcare safety by producing the booklet Ten tips for safer health care: what everyone needs to know; establishing a national Centre for Research Excellence in Patient Safety; testing strategies to ensure safer medication use at the point of care by involving more than 100 healthcare facilities in the National Medication Safety Breakthrough Collaborative; introducing the “Ensuring correct patient, correct site, correct procedure protocol” to reduce “wrong site” or “wrong patient surgery” and launching a “high risk medication alert” on the use of concentrated potassium chloride solutions in hospitals. Furthermore, each state and territory has developed peak advisory bodies, and many elements of patient safety programs (eg, the reporting and investigation of serious incidents) have been incorporated into hospital practice in all states and territories. Professional bodies such as the Royal Australasian College of Physicians have strengthened activities for maintenance of their members’ professional standards,8 and hospitals and other healthcare facilities have formed committees and created departments to oversee patient safety activities. All this has involved considerable effort and resources. However, much of the investment has been in “top down” activities (in the form of policy or monitoring) rather than “bottom up” activities. This can result in a considerable gap between what patient safety strategies are supposed to have been implemented in the workplace and what strategies are actually in place. Instances of poor healthcare outcomes for individual patients, or adverse events involving particular hospitals, have rightly been highlighted in the media. The outcries reached deafening crescendos when perceived healthcare “scandals” in three Australian jurisdictions were revealed.9 This year, the NSW government’s Patient Safety and Clinical Quality Program released the “First report on incident management in the NSW public health system 2003–2004”10 452 incidents were reported that were regarded as “very high risk, can result in serious patient harm, and must be followed by immediate action . . .” This followed a similar report by the Victorian government in 2004.11 Ten years on can we confidently state that healthcare is safer for patients? Unfortunately, the answer is no. There is insufficient information at a state or national level to determine whether any or all of the efforts over the past 10 years have increased safety in our hospitals. It is regrettable that we have not measured the frequency of adverse events in Australia in a way that allows us to assess how we have fared since 1995; how we compare with other countries; and whether any of the initiatives described above have been effective in reducing patient harm. Given the truism we “manage what we measure”, the absence of recent system-wide data on patient safety seriously hinders our ability to manage the problem and make improvements. Its absence makes a mockery of the tenets of continuous quality improvement. We need a thorough understanding of the strengths and weaknesses of data derived from medical record audits, voluntary reporting systems, clinical indicators, and existing large datasets if we are to seriously tackle the size and nature of the problem, and determine whether a particular intervention or program has been successful in improving safety. This information gap is recognised in the 2005 national productivity report on government services.12 Despite all the developments in the last 10 years, and in the context of the current Australian Health Ministers’ review of the governance arrangements for safety and quality of healthcare,13 there are still four areas that require more action and greater urgency. Leadership — to provide clarity of vision and the will to change. As part of that leadership, we need an explicit and agreed goal, such as “to eliminate preventable patient harm from healthcare within 10 years”. A recent challenge from Don Berwick — the 100 000 lives campaign — is to avoid 100 000 preventable deaths in the United States between January 2005 and July 2006 and every year thereafter. The campaign aims to enlist thousands of hospitals across the US in a commitment to implement changes in care that have been proven to prevent avoidable deaths.14 Transparency — fears that open discussion will reduce patient trust in the healthcare system, leading to patients failing to present for care in a timely manner, seem to be unfounded.15 Measurement — to provide information about where to direct our improvement efforts and whether our interventions have been effective. Dependence on voluntary reporting systems will lead to a gross and inconsistent underestimate of the size of the problem. Improvement tools — there is a body of evidence on methodology for improvement projects at the local level, from the pioneering contributions of W Edwards Deming and Walter A Shewhart to the more recent Institute for Healthcare Improvement’s Breakthrough Collaborative methodology,16 which, through a collaborative learning model involving multiple organisations, helps health professionals to bring about breakthrough improvements in patient care outcomes. There has been a lack of appreciation that the use of tested methods increases the likelihood of success of a particular project. Hence, many efforts have not delivered their full potential, or discussion and learning have been prevented because successful efforts have not been publicised. The failure to successfully implement existing knowledge or policy is a worrying characteristic of healthcare systems,17 and demands greater rigour. Creating this capacity within our organisations is a major challenge to be addressed. The responsibility is on all of us — politicians, health administrators, clinicians and the public. Finally, the governance arrangements for transparency of performance of health service delivery, and the accountability for that performance at an individual, organisational, state and national level, need public negotiation and agreement. Currently, there seems to be an imbalance: much more attention is being paid to the accountability of individual healthcare providers than to improving healthcare safety at an organisational and whole-system level. Of equal importance is that the ACSQHC appears to have limited relevance to or influence on the daily lives of health professionals. It is sorely in need of an initiative that captures the imagination of politicians, professionals and the public.18 It could do no better than to emulate the US Institute of Medicine’s “Crossing the quality chasm” healthcare quality initiative19 by selecting a limited number of clinical conditions which have a high healthcare burden and resource use, and which clinicians agree are high priority. The task then is to apply the six aims for healthcare improvement to management of patients with these clinical conditions — their healthcare should be safe, effective, patient centred, timely, efficient, and equitable.18 Finally, the process must be driven from the bottom up. Alternatively, joining the Berwick challenge to save 100 000 lives by reducing unsafe healthcare could have a galvanising influence.14 The magnitude of the challenge of eliminating preventable patient harm is daunting, the progress slow, and the need for our efforts to be successful huge. A significant increase in resolve on the part of all Australians, regardless of their role in healthcare, is needed if we are to meet the challenge of eliminating preventable patient harm over the next 10 years.

Ross McL Wilson MB BS, FRACP, FJFICM · Martin B Van Der Weyden MD, FRACP, FRCPA