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Health services administration

Health services administration Task Transfer 3 July 2006 Free

Re-inventing medical work and training: a view from generation X

Medical career preferences are changing, with doctors working fewer hours and seeking “work–life balance”. There is an urgent need for creative workplace redesign if Australia is to have a sustainable health care system. Postgraduate medical education must adapt to changing medical roles. Curricula should be outcomes-based, should allow flexible delivery, and should consider future workforce needs.

Clare A Skinner MB BS, MPH, BA(Hons)

Emergency department frequent flyers: unnecessary load or a lifeline?

Caring for those who cannot or will not care for themselves In discussions and studies about access to health care — from prevention to inpatient management — the lower end of the socioeconomic spectrum rarely rates a mention. This sizeable subgroup, especially in cities but also in rural settings, is over-represented among people attending emergency departments.1 Frequent attenders to emergency departments are a heterogeneous group — a mix of patients with chronic medical, mental health, alcohol and drug problems, as well as other psychosocial issues.2,3 Individual patients often have a combination of some or all of the above problems. Interestingly, the frequency of attendance may change with time, although patients with psychiatric and substance misuse issues tend to be persistent heavy users.4 Despite the fact that they may be as sick as other, non-frequent attenders, frequent attenders are often perceived as time-consuming “illegitimate” users of emergency department resources.1 From the patient’s viewpoint, despite having good access to primary health care, the emergency department is seen as the most appropriate place to seek help because of a perceived need for urgent care.5 Rather than as a substitute, emergency departments are often used in conjunction with primary care services, with the emergency department providing appropriate higher level care.6,7 Some of the debate about the resourcing of very expensive 24-hour services, such as stressed emergency departments, focuses on “diverting” patients away or “streaming” them somewhere else (eg, general practice) after appropriate triage. Multidisciplinary teams (including allied health workers) that target high-risk patient subgroups — the elderly, patients with respiratory illnesses, patients with mental health problems — have been introduced in many hospitals to address the swamping of emergency services. But does all this actually make a difference? In this issue of the Journal, Phillips et al (page 602)8 evaluated the effect of multidisciplinary team case management on frequent attenders’ utilisation of an inner city emergency department in Melbourne, compared with their utilisation before case management (ie, the study population acted as their own historical controls). Emergency department utilisation and scores for housing stability, alcohol and drug use, and primary and community care engagement were determined. Perhaps surprisingly and paradoxically, despite intensive case management, Phillips et al found an increase in emergency department utilisation and overnight stays. A potential interpretation of this increased utilisation is that it may well reflect an increase in engagement of these patients, with the desired increased attention and improvement in their health. Furthermore, the study found that linkage with primary care and community services improved. Interestingly, in 2002, Moss et al, at another Melbourne inner city emergency department, found that a similar strategy produced a significant fall in hospital admissions.9 In an ideal world, there would be no debate about allocation of care teams to sick patients or the effectiveness of preventing health deterioration. Nor would certain groups of patients only be really visible once they have deteriorated — and then only mainly visible to certain parts of the health care system (eg, emergency departments, and community and mental health services). In health care, as elsewhere, planners can largely underestimate the need for, and the effect of, a new service where none previously existed. This would be easy to imagine when dealing with a marginalised, and at times psychosocially challenged, group of people. Quoting Malone: . . . reducing unwarranted or unwanted emergency services utilisation is not merely a matter of redirecting individuals to other medical care providers but is lodged within the larger and far more complex issue of how and where we as a society and as individuals care (or fail to care) for those who cannot or will not care for themselves in socially sanctioned ways . . .1 Research, measuring appropriate outcomes including accurate assessments of cost, has to be increased to allow resources to be rationally allocated.

Gordian W O Fulde FRACS, FRCS, FACEM · Martin Duffy MB BS, FACEM

Killing the messenger: should scientific journals be responsible for policing scientific fraud?

The responsibility lies with the scientific community Since, both in importance and in time, health precedes disease, so we ought to consider first how health may be preserved, and then how one may best cure disease. Galen, AD 130–200 The article on scientific misconduct by Gerber in this issue of the Journal calls for more vigilance on the part of editors and peer reviewers in exposing fraudulent research.1 A recent commentary in the New York Times also vigorously questions the merits of peer review and the role of scientific journals in light of recent disclosures of fraudulent research published in high level journals and asks for more credibility on the part of editors as science gatekeepers.2 All this begs the question: why do editors and scientific journals come into the spotlight each time there is a new and shocking discovery of scientific fraud? Are they really the guilty party for publishing fraudulent research articles? As articles in scientific journals are the main form of scientific communication and documentation of research,3 members of the public mostly see scientific fraud as a deficiency in the publication process and focus on “the messenger” rather than on the true causes of scientific fraud. Instead of considering how to preserve the “health” (ie, responsible conduct) of research,4 it is left to editors and peer reviewers to look for ways to treat the “disease”. Is this fair, especially in view of the fact that scientific journals have been instrumental in gathering evidence about fraudulent science3 and in detailing problems of peer review and publication?5 Their evidence, and the exposure of each new case of scientific fraud, increases the awareness that this issue must be very seriously and creatively considered by the whole research community — not only at the end stage of the research by those involved in the publication process. Although many say that fraud is a substantial problem and blame editors for downplaying its significance,1,2 when we look for evidence, the estimated prevalence of fraudulent articles in international journals is about 0.2% of published articles.3 The prevalence of fraudulent articles may be higher in smaller journals with little scientific impact,6 but their authors rarely get discovered because the articles are either not read or not cited by the wider scientific community. An important element of scientific misconduct is the personal responsibility of individual scientists who are involved in the research and whose names ultimately appear on the published article. The Hwang scandal clearly illustrates that, although all authors usually get the same or similar benefits from a published article, the authors are not the same in the face of scientific fraud: many are quick to accept praise and benefits flowing from a high-profile publication, but many also evade the responsibility we expect from all authors — responsibility for their published work.1 Even the International Committee of Medical Journal Editors (ICMJE) has pulled back from its strict requirement, in the 1988 revision of the Uniform requirements for manuscripts submitted to biomedical journals (URM), that “each author should have participated sufficiently in the work to take public responsibility for the content”.7 The requirement in the current edition of the URM8 is that “each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content”. The move away from requiring shared responsibility of all authors for the whole manuscript opened a loophole for authors of fraudulent articles to escape embarrassment and perhaps legal action, as they can always claim that they were not responsible for the questionable part of the research. This was the case with Professor Schatten and the University of Pittsburgh in the Hwang case.1 Schatten was an advisor in the research conducted by Hwang and colleagues. Although he was listed as a co-author on the offending articles, he, unlike Hwang, was found guilty of scientific misconduct rather than fraud. We believe that the change to the ICMJE authorship criteria was a wrong move by the editors who defined such criteria. Wouldn’t it be better and more natural for all authors of a manuscript to meticulously analyse data produced by their team and ensure the veracity of the evidence presented, rather than transferring this responsibility to editors and reviewers? In the absence of this process, it is not surprising to see strong criticism of journals, editors and the peer review process and to hear demands that key data for most manuscripts be made available to reviewers.1,2 Although this seems like a rational proposal, it would have to be counterbalanced by ensuring that the reviewers, who are often the authors’ competitors in the field, do not misuse their privileged access to the data. The process of scientific discovery is a human endeavour and, as such, is burdened by the imperfections of human nature and ability. In other words, a degree of dishonesty can and perhaps must be expected in this process. The system of entrusting money to someone (a scientist or group of scientists) to do research contains an inherent imperfection: there is no guarantee that the endeavour will succeed, because it aims towards the unknown. Consequently, the key principle of scientific research is relatively poorly founded trust. Having trust as the only safety mechanism leaves the research process open to the risk of failure — and fraud. Trust and honesty present one side of the equilibrium of scientific integrity, and have to be balanced against pressures for publication output. To use an analogy with the economic rationalisation for crime,9 scientific fraud can be considered as a rational act of balancing the expected utility of scientific promotion against the expected cost of punishment. If we want a fraud-free equilibrium, the scientific community must find ways to ensure that the costs of fraud and assisting in fraud are high while the cost of informing about fraud is low.10 That is why the problem of scientific fraud cannot ultimately be solved by better peer review or more stringent editorial processes.11 It requires active and preventive work by all those involved or affected, starting with the research and academic community itself.4,12

Ana Marušić MD, PhD · Matko Marušić MD, PhD

The Greater Metropolitan Clinical Taskforce: an Australian model for clinician governance

An innovative model for health planning has improved equity of access and outcomes Clinician frustration with marginalisation of their influence in the public hospitals and a growing mistrust of centralised bureaucracy reached boiling point in New South Wales in 1999. In response, the then Minister for Health established a program aimed at re-engaging clinicians in the governance of health services. One outcome of this engagement was the emergence of an entity, unique in the Australian context — the Greater Metropolitan Transition Taskforce (GMTT). At the core of this entity was clinician-led responsibility for the development of networks and plans for clinical services across a population of five million people. Two complimentary, independent reviews1,2 of the outcomes of the GMTT led to the permanent establishment of its successor, the Greater Metropolitan Clinical Taskforce (GMCT), in 2005, and the current search for a full-time clinician chief executive officer to carry it to the next phase. It is timely to review the achievements and outcomes of the GMTT (Box) and the relevance of these to future clinician involvement in health governance across Australia and, perhaps, beyond. At the heart of the GMTT experiment was the conviction that busy clinicians working under trying circumstances would, nonetheless, accept the challenge to join a collegial effort to network their services and accept responsibility for master planning for more equitable delivery of their particular specialty. The GMTT vision for clinician governance required doctors, nurses and allied health professionals in a particular specialty to meet and plan in a “first among equals” environment. Although many involved doctors knew their colleagues from scientific meetings, few had ever met to plan metropolitan-wide services and none had done this with nurses and allied health colleagues. An innovative aspect of the process was the appointment, as initial network chairs, of clinicians who did not belong to the discipline (eg, the cardiologists’ group was chaired by a gastrointestinal tract surgeon). After initial hesitancy, 17 designated networks formed and flourished. In 2002, the GMTT received $64 million from the NSW Government to deliver the 162 service improvements designed by the clinicians,3 on the condition that they function as metropolitan-wide networks. The money was necessary for change, but far from sufficient. Each network elected its chair and co-chairs. Critical to success, each was supported by clinician-managed infrastructure, including a senior network manager. Consumers were appointed as equal members to the executive committee of each network and to the GMTT committee, adding an important element of community scrutiny. The GMTT was strongly endorsed in an external review in 2003,1 and the activities of the GMCT have attracted interest from, and degrees of replication in, other states in Australia and in New Zealand. Internationally, there is growing interest in, and experience with, managed clinical networks as a means of counterbalancing some of the shortcomings of the current hierarchical systems of health service governance.4 The GMTT model and process were outlined in a commentary in the Lancet in 2004: “Turning the health system 90° down under”.5 In 2005, the networks were confirmed as the peak bodies advising NSW Health, the Director General of Health and the Minister for Health on all clinical matters relating to their field; this followed recommendations from a second external review (the Phelan review).2 Other essential ingredients of the success enjoyed by the taskforce include the commitment to meaningful consumer involvement and a continuing program aimed at increasing understanding and cooperation between “front line” clinicians and middle managers. Of particular importance have been partnerships with newly created organisations whose missions overlap with that of the GMCT: the Clinical Excellence Commission (CEC; a peak body established to improve quality and safety in health care in NSW), the Institute of Medical Education and Training (responsible for postgraduate training and a more equitable distribution of trainees) and the newly formed Cancer Institute NSW. The CEC in particular has valued the single point of entry to clinicians in a whole discipline that a GMCT network and program manager offers. Increasingly, the GMCT is working in concert with the Rural Health Taskforce to improve patient outcomes across NSW. Currently, more than 4000 clinicians are committed through the networks to the GMCT process and structure.6 They have used their networks to enhance equity of access, particularly in outer Sydney, with a range of new services from acute stroke units to interventional cardiology.6 There is good evidence that the stroke units have achieved significant improvements in the care of stroke patients. Similarly, the establishment of interventional cardiological procedures at several hospitals has led to a major improvement in the standard of care for patients presenting to those hospitals with acute coronary syndromes. Other clinicians have used their networks to eliminate waiting times for living related donor renal transplantation from 18 months to zero; to provide uniform clinical protocols across five million people (examples include web-published protocols for prioritisation and treatment for bone marrow transplantation7 and management of severe burns8); to attract substantial research funds from the National Health and Medical Research Council (NHMRC) and from the United Kingdom; and to implement data management programs they have designed. An important element of the success of the GMTT has been the process of peer review. A proposal that was generated within a specialty network did not progress unless it was supported by the medical, nursing and allied health peers within that network. Finally, to be adopted by the GMTT committee, the proposal had to be endorsed by peers from other specialties. This process added exceptional rigour to the resource allocation and ensured that it was not possible for specialists to make decisions that only benefited their own particular silo. For the future, is it better for a change agency such as the GMTT/GMCT to be inside or outside the tent? The GMTT was established as a ministerial advisory committee with regular and direct access to the Minister. This had the dual effect of energising the clinicians and alienating a sizeable section of the health bureaucracy. It created parallel processes — a circumstance that was considered necessary for change, but not viable in the long term. Following the Phelan review, it was agreed that the new GMCT should be integrated into the department, with dual reporting to the Director General and the Minister. This carries the opportunity for sustained influence, but the threat of demotivating some clinicians. Clinician vigilance will be required to ensure that the current genuine partnership with the bureaucracy is sustained. Time and achievements will tell. The next phase for the GMCT is challenging but exciting. Hospitals and their clinicians remain stressed by demands for services for which neither the dollars nor the available workforce are adequate. The GMCT must continue to expand its influence and reputation, develop further networks (orthopaedics, gastroenterology, respiratory medicine and urology are currently being targeted), and, most importantly, maintain the appropriate influence of clinicians on decision making. The challenge remains to ensure that the voices of those clinicians who are passionately committed to public hospital services are listened to as they should be. It has been a privilege to watch clinical colleagues respond so magnificently to the opportunities provided. This process for clinician governance merits recommendation to colleagues throughout Australia, where the benefits to patients and communities are likely to be the same. The Greater Metropolitan Transition Taskforce: achievements and outcomes For clinicians Involvement in making a difference for patients across greater metropolitan Sydney (five million people) Recognition of networks as peak advisory bodies for health service planning in their field Enhanced access for clinicians to Minister, Director General and Deputy Directors General of Health Dedicated infrastructure, including senior program manager and clinician-led data management Use of the networks for attracting research funds: Centres of Clinical Research Excellence, National Health and Medical Research Council (NHMRC) project grants, United Kingdom Medical Research Council trial funding Enhanced education and training, particularly for specialised nurses Enhanced communication and collegiality across professional and geographic boundaries For patients and communities Enhanced equity of access, particularly on the periphery of Sydney Greater equity of outcomes across the population Better clinical outcomes (eg, reduced morbidity and mortality [stroke network] and abolition of waiting times for living donor transplantation [renal network]) Representation on all clinical networks For government and Department of Health Better access to people who know where the solutions lie Safer, fairer and more cost-effective health care Assistance with identifying and addressing problems due to workforce shortages Details of the networks and their achievements can be viewed on http://www.health.nsw.gov.au/gmct.

Graeme J Stewart AM, PhD, FRACP, FRCPA · John M Dwyer AO, MB BS, PhD, FRACP · Kerry J Goulston AO, MB BS, MD, FRACP

Hospital in the home: a concept under question

The debate on its efficacy has been reignited Improvements in technology and greater acceptability have narrowed the gap between care in the hospital and care in the home. More patients with more diagnoses are receiving a greater diversity of hospital-type treatments at home than ever. However, the schism that once existed between hospital and home for treatment has opened up within the “hospital in the home” (HITH) movement over whether the concept works at all. In the early days, anecdotes suggested better outcomes at home, the only plausible mechanism being avoiding the risks of hospital. Then, it was easy to consider the high rate of adverse events in hospital and believe that HITH must reduce these. Because hospital-related adverse events are more common in older patients,1 it seemed plausible that older patients may have more to gain from HITH. However, the wide variety of adverse events hinted at difficulties in capturing the difference. It seemed even more obvious that replacing care in hospital with care at home must be cheaper. But critics thundered that HITH offered inferior care at greater cost.2 Both sides spoke without fear of contradiction because evidence was absent. But now there is evidence, and the debate has been reignited: Is HITH a true advance on in-hospital treatment with reduced complications, better health outcomes and greater patient satisfaction? Is it even cost-saving, or just a waste of money? On one side sits the Cochrane review, Hospital at home versus in-patient hospital care.3 This meta-analysis of 22 randomised controlled trials (RCTs) clearly concluded that there is no difference in outcomes and no cost savings! However, the review grudgingly accepts that patient satisfaction is greater with HITH than with hospital. The Cochrane process carefully sifted the trials to determine methodological rigour — whether the patients were adequately randomised, etc. Unfortunately, this sifting process did not include a criterion as to whether the basic experiment succeeded. One may assume that a review entitled Hospital at home versus in-patient hospital care would include only trials where patients in the control arm received their treatment in hospital, while those in the other arm received treatment entirely or almost entirely at home as a substitute for in-hospital care, with a curative intent. Studies of intensive palliative care at home should properly be called “hospice in the home”. Unfortunately, in one large study included in the Cochrane review, there was no statistically or clinically significant substitution for care in hospital by care at home. The study recruited older medical patients and the control group stayed in hospital 13.20 days while the group randomised to “HITH” was discharged 0.36 days earlier from hospital and then received an additional 9.04 days of “HITH” care at home.4 If the patients in the treatment group were not discharged from hospital earlier than the control group, that study does not meet the Cochrane review’s own definition of HITH, namely “treatment . . . that otherwise would require hospital in-patient care”, and should clearly have been excluded. Clouding by a study that did not meet HITH criteria was not the only impediment to discovering whether there was an improvement in health outcomes. Where outcomes were assessed, this was almost always done after discharge, often 3 or more months later. To be fair though, no one knew exactly what the difference in outcomes was, and so what “instrument” to use, at what time (during or after the admission) and how frequently to look for it, and in what patient group. On the other side, and providing the first inkling that there may be a difference, but that we had been looking at the wrong time, was an article published in this Journal. An RCT of 100 emergency department patients found a 20% decrease in the incidence of confusion in HITH.5 Three subsequent studies have now confirmed this. A trial (not an RCT) of surgical patients found less postoperative cognitive dysfunction at 7 days after day surgery compared with inpatient surgery.6 A United States multicentre trial (not an RCT) and an Australian single-centre RCT both showed significant decreases in delirium using the Confusion Assessment Method during the admission (to either hospital or HITH) for medical patients in HITH compared with hospitalised patients.7,8 The manifestation of this phenomenon in both medical and surgical patients demonstrates that the underlying diagnosis is not important, but the substitution of HITH care for in-hospital care is critical. Delirium is the “canary in the coalmine” of aged care — a transient early warning of increased mortality, nursing home placement and impaired physical and cognitive function. So, if delirium is reduced by HITH keeping patients out of hospital, you would expect to find reduced mortality and placement, and improved function, though a very large study or meta-analysis might be needed, because these events are less common than delirium. The Cochrane review, interestingly for a meta-analysis, does not combine all the data for mortality, and produces two solidly non-statistically significant results. But, if you combine all the Cochrane studies that measured mortality, excluding the palliative care studies (as Cochrane does) and the no-substitution study that should have been excluded, the odds ratio for mortality in HITH becomes a near-statistically significant 0.76 (95% CI 0.57–1.01; P = 0.0599)! The fact that it is not significant is probably a type II error. Interestingly, both groups in the Cochrane analysis, after removing the failed HITH trial, show an odds ratio of about 0.76 for mortality, indicating homogeneity. Even with borderline statistical significance, a one-quarter reduction in mortality from 17.8% to 13.4%, with a number needed to treat in HITH to prevent one death in 25, is clinically significant. Assessment for function in HITH studies shows two patterns. Studies where HITH substituted for hospital admission found that physical and cognitive function were improved.9,10 In studies in which patients are discharged early to HITH, the general focus on rehabilitation means that both groups attain comparable function. There are insufficient data on nursing home placement to draw conclusions. The problems with the financial analyses are similar, but simpler. Services where HITH is not a substitute for in-hospital care, but merely add-on care, are bound to be more expensive, no matter how sophisticated the economic analysis.4 Where HITH substitutes for in-hospital care, and the service works at reasonable capacity, HITH is cheaper than hospital.11 All the pieces are in place, though more evidence is needed to achieve statistical significance. The evidence clearly leads towards a conclusion that HITH offers better health outcomes and a reduction in costs.

Gideon A Caplan MB BS, FRACP

Should clinical software be regulated?

New Australian evaluation guidelines will help inform the debate It takes something like 10 years for a new compound to go from laboratory to clinical trial, and many more before a drug’s safety and efficacy are proven. Why isn’t clinical software — which might check for drug–drug interactions and dosage errors and generate alerts and recommendations to influence prescriber behaviour — treated as rigorously?1 Today, anybody with programming skill could create a rudimentary electronic prescribing package and put it directly onto the desktop of a general practitioner without regulatory approval. No doubt the stand-alone software in routine clinical use has undergone rigorous evaluation by its developers, but in most countries there is no specific regulation that requires this. Commercial vendors still sometimes sell prescribing systems with significant gaps in functionality.2 Some hospital prescribing systems are even sold devoid of the decision rules that will check for errors or guide prescribing. The expectation is that a hospital drug committee will have expertise in the development and maintenance of computational knowledge bases, an arcane and highly specialised skill set if there ever was one. Evidence mounts from systematic reviews that there is manifest benefit associated with clinical information technologies.3,4 However, case reports are appearing that indicate clinical software can sometimes cause harm.5 A new debate is building between those who demand that we rapidly introduce new information systems to improve the safety and quality of clinical practice and those whose view is that the evidence supporting its introduction is still wanting, and that, in some situations, there is a real possibility that it may do more harm than good.6 Much of the science on both sides in this debate is questionable. A widely reported article in 2005 identified 22 types of possible medication error risk associated with a clinical order-entry system.7 Clinical outcomes were not measured, and no attempt was made to explore whether these potential errors were the result of a badly designed system. Recently, Han et al reported that a hospital electronic prescribing system produced a statistically significant increase in mortality from about 3% to 7%.8 However, assigning the blame for this startling outcome solely to the software is problematic. Introduction of the software altered traditional work patterns and increased the complexity and time taken to prescribe. Yet the new system was implemented in less than a week — an extremely short time to introduce a complex new organisational process. On the technology proponents’ side, systematic reviews of decision support systems often try to infer which features are beneficial by lumping together widely dissimilar systems used in very different contexts.4 However, local and sociocultural variables strongly influence the uptake and efficacy of such systems,9 and these are rarely controlled for or quantified in studies, making it hard to interpret this type of systematic review. Further, citing lack of evidence for the value of different software features in a review, when the original studies were never designed to test for these features, does not say much. What should be done? The process guiding the development and testing of most medical treatments and biomedical instrumentation, including software embedded in or linked to clinical devices, is tightly regulated. In contrast, the development of stand-alone clinical software is not. In Australia, stand-alone decision-support computer programs, such as electronic prescribing systems, are not considered “therapeutic goods” and are not subject to regulation. Similarly, in the United States, software that relies on manual data input and that is not directly used in diagnosis or treatment is usually exempt from the premarket regulatory requirements of the Food and Drug Administration to demonstrate that the device is as safe and as effective as devices already on the market.10 Even if there were strict regulations for clinical software, defining either the process of system development or the knowledge within and behaviours of a system, there is no guarantee that software would be implemented or used safely. Information technology is only one component of health services.9 For the whole system to be safe, certification might have to include the skills of those using the software and the organisational processes within which the software is embedded. Consequently, the most appropriate model of governance over the safety and quality of clinical software is far from clear, and may involve elements of industry self-regulation, legislation and best practice guidance. These models are currently a matter of debate among organisations such as the International Organization for Standardization and the European Committee for Standardization. Locally, the National E-Health Transition Authority is developing basic technical standards for clinical software that should lead to more uniform and better engineered systems, and early work by the General Practice Computing Group examined the broader need for software accreditation. The United Kingdom’s National Programme for IT has moved further — establishing a safety team — and has embedded a safety management approach into its procurement processes. The Australian Health Information Council recently published national guidelines for the evaluation of electronic clinical decision support systems, to promote evaluation using rigorous and validated methodologies.11 The guidelines recognise that it is difficult to propose a single evaluation methodology that meets the diverse needs of both the software and clinical communities. Different user groups have different evaluation tasks and objectives. Even the choice of evaluation method is sometimes unclear, given the complexities of health services and the limited opportunities to carry out rigorously controlled trials. The guidelines outline approaches to testing the clinical effectiveness of decision support systems, their integration into existing work practices, user acceptability, and technical evaluations of the software and knowledge bases. Urgent debate is needed to move this agenda forward,12 and these guidelines should provide a platform to inform that debate. We can move quickly to develop appropriate models of governance for clinical software, or we can step back and let the courts decide, when legal cases of negligence occur. Some will argue that regulation inhibits innovation, but there are good examples of regulation driving technology innovation in other industries. The airline industry is often presented to us as a safety role model, but that industry was forced to change only after a string of catastrophic disasters. We can do much better by anticipating the potential risks of these technologies, rather than reacting to mishap. Over the next few years, despite people’s lives being saved or improved by these new systems, some hard lessons may be learned about their safe and effective use.

Enrico W Coiera MB BS, PhD · Johanna I Westbrook PhD, FACMI

The effect of multidisciplinary case management on selected outcomes for frequent attenders at an emergency department

Objective: To evaluate the effects of multidisciplinary case management (CM) on emergency department (ED) utilisation and psychosocial variables for frequent attenders at the ED.Design: Retrospective cohort analysis, with the study population as historical controls and data analysed 12 months before and after CM intervention in the period 1 January 2000 – 31 December 2004. Subgroup analyses were performed according to primary problem categories: general medical, drug and alcohol, and psychosocial.Setting: Inner urban tertiary hospital ED.Participants: Frequent ED attenders who received CM.Main outcome measures: ED attendances: length of stay, triage category, ambulance transport, disposition, attendances at the only two EDs nearby. Psychosocial factors: housing status, drug and alcohol use, and primary and community care engagement.Results: 60 CM patients attended the ED on 1387 occasions. Total attendances increased after CM for the whole group (610 v 777, P = 0.055). Mean average length of stay (minutes) of the total study population and each subgroup was unaffected by CM (297 v 300, P = 0.8). Admissions for ED overnight observation increased as a result of CM (P = 0.025). CM increased scores for housing stability (P = 0.007), primary care linkage (P = 0.003), and community care engagement (P < 0.001) for the whole group and variously within subgroups. Drug and alcohol use was unaffected by CM.Conclusion: ED-initiated, multidisciplinary CM appears to increase ED utilisation and have a positive effect on some psychosocial factors for frequent attenders. A trend towards increased ED attendance and utilisation with CM may have implications for policies that seek to divert frequent attenders away from hospitals.

Georgina Ann Phillips MB BS, FACEM · David S Brophy BA, BSW · Tracey J Weiland BBSc(Hons), PhD · Antony J Chenhall MB BS, FACEM · Andrew W Dent FACEM, FRCS, MPH

Health services research in Hungary

To the Editor: We read with great interest the editorial by Gruen and colleagues on the recent developments in health services research and the establishment of an EPOC (Effective Practice and Organisation of Care) satellite at the National Institute of Clinical Studies in Australia.1 Before the social and political changes in Central and Eastern Europe in the 1990s, policymakers in Hungary (population 10 million) and many other former socialist countries had little interest in the effectiveness of health service interventions.2 Important tools of health policy decision making were missing from the health care system. Over the past 16 years, efforts have been made in Hungary to strengthen the institutional background and tools of health policy decision making. We would like to highlight some milestones of this process. During the 1990s, Hungarian researchers were sent to foreign universities to receive formal training in subjects related to health services research. Later, academic institutions and departments were established (Health Services Management Training Centre at Semmelweis University [Budapest], School of Public Health at the University of Debrecen [eastern Hungary], Unit of Health Economics and Health Technology Assessment at Corvinus University [Budapest], and Department of Health Insurance and Health Policy at the University of Pécs [southern Hungary]). In 2004, the National Institute for Strategic Health Research was established to guide governmental health policy decision making by undertaking activities in four main areas: health informatics and information policy; health economics; health services and health system research; and health technology assessment and coverage policy. A key issue of Hungarian health policy was the introduction of the “fourth hurdle” (cost-effectiveness) into the decision-making process.3 In a first step towards achieving this, methodology standards were published by the Ministry of Health, which regulates the guidelines for conducting economic evaluation.4,5 During the development of health services research in Hungary, we carefully studied many aspects of the Australian experience, published in the international literature or presented at scientific meetings, including: coverage policy, drug pricing and reimbursement, health technology assessment, price/volume agreements, diagnosis-related groups, evidence-based guidelines, the National Health and Medical Research Council, the Pharmaceutical Benefits Advisory Committee and the Pharmaceutical Benefits Scheme, and performance measurement. Several of these (coverage policy, drug pricing and reimbursement, and diagnosis-related groups) had a significant effect on Hungarian health policy decision making. We found the main advantages of the Australian system, compared with other countries, to be the strong scientific and professional background (evidence-based medicine) and the transparency of decision making. Although we did not make any formal ranking of countries, the Australian experiences were evaluated as worthwhile for local application, together with those of the Netherlands, Sweden and the United Kingdom. Notwithstanding the considerable distance between Australia and Hungary, we look forward to reading about further developments in health services research and the Australian EPOC satellite, and hope that we can also benefit from your experience with the appropriate implementation of research findings throughout health policy decision making and into everyday medical practice.

Imre Boncz · Andor Sebestyén

The Research Quality Framework

To the Editor: Shewan and Coats1 are right to draw attention to the shortcomings of the Research Assessment Exercise (RAE) in the United Kingdom in relation to the formulation of the Research Quality Framework in Australia. The impact of the RAE on clinical academic medicine in the UK has been disastrous, and it will take years to recover. Driven by the imperatives of the RAE, gross distortions of the role of medical schools have occurred. Many major departments, particularly in the surgical disciplines, have been closed, irrespective of the service and teaching implications. Over the past 6 years, some 20% of clinical lecturer posts have been abolished.2 These are training-grade posts that inevitably make only a limited contribution to the RAE returns. However, these posts provide the seed corn for future academic staffing in clinical medicine. In academic pathology, 40% of all academic posts have been lost and there are now only 12 remaining lecturer posts in England and Wales. All these changes have occurred in the midst of a substantial increase in medical student numbers, when academic staff numbers should have been increased. Those responsible for funding tertiary education in the UK have consistently failed to understand that the role of clinical academic staff is to integrate the practice of medicine with research and teaching. This means that at least a third of their working hours will be taken up with clinical practice; therein lies the strength of clinical academic medicine. The RAE has effectively engendered a split in the roles of clinical academics and, by so doing, has seriously jeopardised the future existence of clinical academic medicine.3 The damage that this exercise in academic self-interest has caused has now been recognised at the highest political level, with a recommendation that the RAE be discontinued as from 2008.

E Malcolm Symonds

High-cost users of hospital beds in Western Australia

To the Editor: Now that Calver and colleagues have unequivocally established that “High costs appear to be needs-driven”,1 can we dispense with the Orwellian language used in this article? “High-cost users” can now become “high-needs patients”. The language in the article subtly reflects a view that is often adopted by senior non-clinical health service administrators, who are themselves usually in robust good health. This view is that people with high levels of health service need are merely rapacious consumers of rare health dollars, of which the administrators are guardians. For those of us providing services in primary (mostly ambulatory) care, life is complicated enough choosing between “patient”, “person with”, “client”, “consumer” or “punter”. Can we please avoid adding “user” to the already overcrowded lexicon of nominals used for patients? I am sure if we changed the terminology then those “high-cost users” would feel a bit more valued when they read this article.

Chris Holmwood

Action on climate change: no time to delay

Global warming is real, so what are we going to do about it, who will do it, and when? Climate change is now widely acknowledged as the greatest environmental threat that human civilisation faces.1 During 2005 there was a perceptible shift in scientific assessment of the consequences of increasing greenhouse gas accumulation in Earth’s atmosphere. Normally cautious climate scientists went on record with warnings that potentially unstoppable “runaway” climate change is now becoming a real risk. The faster than expected melting of Greenland ice, slowing of ocean currents, and possible reversal of terrestrial ecosystems (see Box) from carbon “sinks” to net sources of carbon dioxide emissions are prominent examples of non-linear change. Impacts of climate change on the biosphere are now clear, including melting of polar ice, shrinking of glaciers, and shifts in the biotic cycles and behaviours of birds, insects and plants. International assessments have sounded serious environmental alarms before, but the emerging evidence on climate change now brings an unprecedented urgency to policy debates. In the past year, public (and belatedly, political) discussion in Australia has moved on from questioning whether there is a human influence on climate change. The questions now being framed are what we should be doing about this, and who should be responsible? A 2°C limit to avoid dangerous climate changeLargely unchecked greenhouse gas emissions to date have already committed future societies to temperature increases. British Prime Minister, Tony Blair, commissioned a conference in Exeter in 2005 to answer the question “What level of greenhouse gases in the atmosphere is self-evidently too much?”.2 A limit in global mean surface temperature to 2°C above preindustrial times has since been recognised, in many ways, as a reasonably close marriage of pragmatism and science. Many small ecosystems in Australia are likely to be lost or severely damaged with temperature increases of 1–2°C (including the Great Barrier Reef, Kakadu, the Alpine zone, and the World Heritage rainforest area)3 as plants and animals are unable to adapt or migrate. Above 2°C, agricultural yields are predicted to fall, several billion people would experience increased water stress, additional hundreds of millions may go hungry, sea level rise may displace millions from coasts, and infectious disease risks multiply. Achieving a global average 2°C limit would result in slightly different temperature increases across Australia (lower than this in the south and greater warming towards the centre of the continent). Compared with the estimated future impacts of the current emissions trajectory, a 2°C limit would substantially reduce the annual heat-related mortality in Australia, as well as the southward extension of some mosquito-borne diseases.4 The immediate priority: reducing emissionsAchieving the widely proposed 2°C ceiling on global temperature increases means a rapid transition from fossil fuels to environmentally sound energy sources — within decades.5 Delays beyond that will necessitate far deeper and more rapid emission cuts to achieve this goal. The inertia of the socioeconomic system means that we cannot expect to be able to turn it around more quickly in future than we can now. Further, recent research by major Australian businesses (including BP Australia, Westpac, Insurance Australia Group, and Origin Energy) indicates there will be economic disadvantages if we delay. If early action is taken, a 60% reduction in Australian greenhouse gas emissions by 2050 is possible while still maintaining strong economic growth (with real gross domestic product [GDP] averaging 2.1% per year). Compared with this, postponing action to 2022 would result in lower real GDP growth of an average 0.2% per year, through to 2050.6,7 Climate change is a global problem that requires responses at multinational as well as national levels. The European Union plans to reduce its greenhouse gas emissions in line with a global 2°C target, and is investing in infrastructure, technologies and social policies. Sweden has announced a policy of non-reliance on oil by 2020.8 In contrast, climate change mitigation policy in Australia still lags behind Europe, and our government has not yet set a national greenhouse gas emissions reduction target beyond 2012. Procrastinating on reducing emissions means we are betting on future technological improvements to make the transition as seamless as possible. So far, there is no simple technological fix on the horizon to cure an overheating planet. The benefits of geosequestration (piping carbon dioxide emissions from power stations into storage wells), for example, have still to be proven in terms of efficacy, affordability and safety. It is far more likely that, as with preventive strategies for other major public health problems (such as smoking cessation or obesity reduction), we will need a “portfolio” approach to reducing emissions. While the full benefits from global greenhouse gas mitigation will only be experienced by future generations, the ancillary benefits of local emissions reduction policies would have immediate health benefits. For example, air pollution from motor vehicles caused an estimated 900–2000 early deaths in Australia in the year 2000, entailing direct costs of between $1.1 and $2.6 billion. A 50% reduction in vehicle-related emissions in the combined Sydney and Melbourne regions could avert 300–500 premature deaths per year from air pollution in those cities.4 Less car dependence (with a shift to public transport, walking and bike riding) would presumably also have substantial health and social benefits, through increased physical activity and social interaction. Adaptation measuresIt has been widely assumed that wealthy human societies will be able to buffer themselves from the more severe impacts of climate change, at least initially. However, events such as Hurricane Katrina and the European heatwave have shown that societies everywhere are vulnerable to extreme and unpredictable weather. In the late summer of 2003, an unprecedented heatwave in Northern Europe led to several tens of thousands of premature deaths.9 Elderly people were most vulnerable, as thermoregulatory ability usually decreases with age.10 The main contributing factor to this is reduced physical activity, leading to lower muscle strength, sweating capacity and cardiovascular reserve, and to lower cardiovascular stability. Drugs that affect body fluid balance, vasodilator activity and cardiac function are potentially harmful during extreme heat events. We know much more about the population-level risks that contribute to increased mortality during heatwaves. People in urban and suburban regions typically have far higher rates of mortality than rural regions. In France, many nursing homes were not air-conditioned, hospitals were understaffed, and families were holidaying (and hence unavailable to support elderly or mentally ill relatives) during what would usually have been a mild summer holiday period.11 Social isolation has also been linked to increased risk of death during heatwaves in the United States.12 The Australian Government has focused its policy development on identifying the risks and vulnerabilities of sectors to adapting to climate change.7 Health departments in several Australian states have commissioned studies of climate change adaptation needs: strategies, such as heatwave forecasting systems and associated directives for workplaces and nursing homes, and alerts for general practitioners, are now in the process of being developed. Details of adaptive strategies to reduce the impact of climate change will be local and context-dependent, although much can be generalised from experiences elsewhere. To support policy, we need more evidence about local conditions that modify heatwaves (such as the heat-island effect, household design to reduce heat retention, and social connectedness). We know that many bacteria (such as salmonellae) are sensitive to climatic conditions. It is less clear how the changing climate will interact with land use and social practices in a particular region to influence the vector, host (eg, domestic or native animal) and pathogen transmission routes for water-borne and food-borne diseases. We are beginning to understand the challenge that human-induced climate change poses for us, in terms of the likely impacts on humans. Anticipatory and precautionary adaptation is more effective and less costly than last-minute emergency adaptation or retrofitting.13 Even so, relying on incremental adaptation to lessen the evolving risks to health is as inappropriate as progressive multiplication of the number of defibrillator stations in a society undergoing an uptrend in coronary heart disease mortality. In the best traditions of public health, the focus must be on primary prevention — global greenhouse gas abatement. Individuals, families and communities should contribute to the collective effort, but the issue is so large in scale and so systemic in nature that only government-led mitigation can ensure that climate change is slowed and, hopefully, arrested. Glossary Ecosystem: A functional unit of interdependent organisms, together with their physical environment, linked together through nutrient cycling and energy flow. An ecosystem can be any size — a pond, field, forest, or Earth’s biosphere — but it always functions as a whole unit. Fossil fuels: Fuels such as coal, oil and gas made by the decomposition of ancient plant and animal remains which give off carbon dioxide when burned. Geosequestration: Sequestration is the storage of greenhouse gases from the atmosphere by plants or technological measures. Plants absorb carbon dioxide, release the oxygen and store the carbon in the soil. Geosequestration refers to the storage of carbon dioxide in underground reservoirs (such as old oil or gas wells). Greenhouse gases: Molecules (such as carbon dioxide and methane) that warm the atmosphere because they absorb some of the radiation that is emitted from the surface of Earth. Heat-island effect: Dark, dense materials (such as roof tiles or asphalt) absorb more heat from the sun than surrounding objects, and release the heat into houses and city areas in the evenings. In an urban heat island the temperature of a city can be 2–10°C higher than the surrounding rural area. The larger and more population-dense an urban area, the more pronounced is the heat-island effect. Landscape and housing design, vegetation, building spacing and paving materials all contribute to the heat-island effect.

Rosalie E Woodruff PhD, MPH · Anthony J McMichael FACOM, MB BS, PhD · Simon Hales MB BChir, MPH, PhD

Consumer choice and the National Bowel Cancer Screening Program

The opportunity for informed choice in screening is limited Commencing in mid 2006, the Australian Government will phase in a national bowel cancer screening program for men and women who turn 55 or 65 years of age, and for those who participated in the government’s pilot screening program, conducted from November 2002 to June 2004.1 Eligible people will be invited to complete an immunochemical faecal occult blood test (FOBT) in the privacy of their own home and mail it in for analysis.2 Consumers will not be offered a choice of screening test. The government came to this position after commissioning a review of the costs, benefits and harms of different screening options3 and evaluating the pilot screening program.1 The study by The Multicentre Australian Colorectal-neoplasia Screening (MACS) Group in this issue of the Journal (A comparison of colorectal neoplasia screening tests: a multicentre community-based study of the impact of consumer choice)4 suggests that participation in screening does not differ significantly between different screening tests that might be offered. The implication is that consumer choice can be taken out of the equation if maximising participation is the primary objective of screening. If consumer choice does not influence participation, then why not offer a range of screening tests? This invites two prior questions — to what extent should the Australian Government be concerned about consumer choice and participation, and what criteria should be applied to determining screening options? For decades, Australia has accepted the World Health Organization guidelines for evaluating the worth of screening. These guidelines, recently updated, state “. . . in screening there is an ethical responsibility to conduct programs that will be of overall benefit to those who are screened and will minimize harm and anxiety that will arise. It is not simply the offering of medical tests for people to accept or reject as they wish. This responsibility implies that if evidence is not available from valid studies on the effectiveness of screening, screening should not be offered.”5 Although one in six participants in the MACS Group trial participated in a screening strategy other than FOBT,4 neither flexible sigmoidoscopy, computed tomography colonography nor colonoscopy meet the WHO criteria for a screening test. As yet, there is no trial evidence that any of these tests reaches an acceptable ratio of population benefits to harms and costs that would warrant their inclusion in a national screening program. The results of the MACS Group trial raise important questions about whether participation in screening is an appropriate measure of success and whether participation itself is an adequate measure of consumer choice. The traditional view, one shared by the updated WHO guidelines, is that participation is a measure of success.5 All things being equal, the more people who are screened, the greater the reduction in bowel cancer mortality in the population. That line of reasoning is incontestable. What is contestable is whether people who participate in screening make an informed choice. The MACS Group suggest that the one reason why their participation rates (averaging 20.9% over all screen tests) were lower than the government pilot projects (45.4%)1 and other international programs is that the Group were required to “present the invitation as a clinical research project with due informed consent” (our emphasis). This, argues the MACS Group, may have contributed to a lower participation rate. They then suggest that a “guided choice” following formal clinical review might improve participation. The Australian Government should seriously consider providing a decision-support system that allows consumers to decide whether they want to take up the offer of screening, based on information of benefits, harms and the process of testing. This should include a guide to screening options. Not everyone will want or need a “guided choice”. Our previous study of consumer choice of FOBT screening found that a third of the target group opted for screening no matter what the ratio of harms to benefits, 55% took up the offer of a guided choice (weighing up the benefits and harms), and 12% chose outright not to be screened.6 Even if 30% of the target screening group take up the offer of a guided choice by a general practitioner, based on the 75% Medicare rebate for a level-B GP consultation, the cost per life-year saved (LYS) of biennial FOBT screening without a routine GP consultation would increase from about $13 5007 to $21 000 per LYS. If 70% of the target population opt for a GP visit, the cost per LYS is $31 300 — more than double the cost effectiveness ratio for a screening program without a routine visit to the GP. Even so, this figure is comparable to other cancer screening programs. The challenge is to develop an affordable decision-support system — one that is either self-directed or one that offers restricted access to an additional GP consultation. This applies equally to those aged under 55 years who will not be eligible for screening in the national program. Unless the national program actively engages the community, GPs and pharmacists in screening and diagnostic assessment of people with a positive FOBT, the opportunity for an informed choice and participation is limited. A key question for the National Bowel Cancer Screening Program is whether setting participation targets and using them to measure the success of screening is appropriate. Falling short of a 70% target participation rate shouldn’t be taken as a public health failure if it can be shown that consumers have had an opportunity to make an informed choice (alone or with their GP), using a decision-support system if they wish to do so. Informed consumers making smart choices about screening — now that would be a public health success.

Glenn P Salkeld GradDipHealthEcon, MPH, PhD · Jane M Young MPH, PhD, FAFPHM · Michael J Solomon MB BCh, MSc, FRACS

The incidence and cost of adverse events in Victorian hospitals 2003–04

Objectives: To determine the incidence of adverse events in patients admitted in the year 2003–04 to selected Victorian hospitals; to identify the main hospital-acquired diagnoses; and to estimate the cost of these complications to the Victorian and Australian health system.Design: The patient-level costing dataset for major Victorian public hospitals, 1 July 2003 – 30 June 2004, was analysed for adverse events by identifying C-prefixed diagnosis codes denoting complications, preventable or otherwise, arising during the course of hospital treatment. The in-hospital cost of adverse events was estimated using linear regression modelling, adjusting for age and comorbidity.Main outcome measures: Cost of each patient admission (“admitted episode”), length of stay and mortality.Results: During the designated timeframe, 979 834 admitted episodes were in the sample, of which 67 435 (6.88%) had at least one adverse event. Patients with adverse events stayed about 10 days longer and had over seven times the risk of in-hospital death than those without complications. After adjusting for age and comorbidity, the presence of an adverse event adds $6826 to the cost of each admitted episode. The total cost of adverse events in this dataset in 2003–04 was $460.311 million, representing 15.7% of the total expenditure on direct hospital costs, or an additional 18.6% of the total inpatient hospital budget.Conclusion: Adverse events are associated with significant costs. Administrative datasets are a cost-effective source of information that can be used for a range of clinical governance activities to prevent adverse events.

Jonathon P Ehsani MPH(Int) · Terri Jackson PhD · Stephen J Duckett PhD, DSc, FASSA

Health services administration For debate 5 June 2006 Free

Public reporting of hospital outcomes based on administrative data: risks and opportunities

In the wake of findings from the Bundaberg Hospital and Forster inquiries in Queensland, periodic public release of hospital performance reports has been recommended. A process for developing and releasing such reports is being established by Queensland Health, overseen by an independent expert panel. This recommendation presupposes that public reports based on routinely collected administrative data are accurate; that the public can access, correctly interpret and act upon report contents; that reports motivate hospital clinicians and managers to improve quality of care; and that there are no unintended adverse effects of public reporting. Available research suggests that primary data sources are often inaccurate and incomplete, that reports have low predictive value in detecting “outlier” hospitals, and that users experience difficulty in accessing and interpreting reports and tend to distrust their findings.

Ian A Scott FRACP, MHA, MEd · Michael Ward MB BS, FRACP

Health Workforce Innovation Conference

To the Editor: The report by Brooks and Ellis on the Health Workforce Innovation Conference held in November 2005 was, in my opinion, very misleading.1 I was one of about five doctors who attended this conference; the other 200 attendees were non-medical health care workers. It was fortuitous I attended — no invitation was extended to the Australian Society of Anaesthetists. Not only was the audience nearly exclusively composed of people dedicated to the introduction of non-doctors to replace doctors, but the presentations themselves included nobody expressing a contrary view. Such an unbalanced 2-day meeting therefore failed to truly examine medical task substitution. It failed to explore whether there truly is an inadequate number of doctors in Australia and whether the introduction of non-doctors to do medical work would actually save any money at all. In fact, the presentation by Sibbald indicated that nurse practitioners in the United Kingdom are no more cost effective: although they cost half as much, they take twice as long, so the overall cost is the same. The issue of the quality of Australian health care and how that quality would be affected by the introduction of non-doctors to do the doctoring was not addressed at all. There was also no examination of the consequences on the workforce of the rather illogical proposal to greatly expand the nurses’ scope of practice into medical work when there are already too few nurses in Australia. Such a proposal would surely only worsen the nursing workforce problem. Overall, the meeting was very disappointing, as it failed to approach the topic of medical task substitution in a balanced fashion, failed to justify why the proposal should be contemplated to begin with, failed to address whether there would be any improvement in health care delivery, failed to address whether there would be any reduction in health care costs, and absolutely failed to address how the proposed medical task substitution would not lead to an inevitable reduction in the quality of health care in Australia.

Gregory J Deacon

Health Workforce Innovation Conference

In reply: Deacon has unfortunately missed the whole point of the Health Workforce Innovation Conference. It was about innovation — new ways of doing things. It was also about health, not medicine — a concept that some doctors might find difficult to accept, but is actually the reality. Deacon seems to suggest that we still need to debate whether there is an “inadequate number of doctors in Australia” — surely most of us have moved on from there. One of the consequences of the “rather illogical proposal to greatly expand the nurses’ scope of practice” might be to retain nurses in the workforce. This, as most of us know, is a major issue. The Health Workforce Innovation Conference was not necessarily about saving costs; it was about producing a more effective health system and trying to provide for those who cannot access services because they are not available or there are long waiting lists for procedures that could well be done by other health professionals. A number of papers presented at the conference demonstrated that care could be provided by groups such as nurse practitioners or physician assistants without any reduction in quality, and it behoves Deacon (whom I assume is a believer in evidence-based practice) to present data to the contrary if he wishes to make those assertions. Deacon commented from the floor on a number of occasions, making the assertions that we would expect from an organisation which is dedicated to maintaining the status quo. I really think the time has come to move on.

Peter M Brooks

Health services administration Supplement 15 May 2006 Open Access

Key achievements of the Australian Council for Safety and Quality in Health Care

Supporting the workforceNational Standard for credentialling and defining the scope of clinical practice of medical practitioners (2004): The Council developed an agreed approach to credentialling and produced the National Standard. Support materials to assist in implementation were developed and distributed. National Patient Safety Education Framework (2005): The National Patient Safety Education Framework sets out the required skills, knowledge and behaviour in regard to patient safety. It recognises education as a foundation element for redesigning systems and facilitating a sustainable culture of safety and quality in health care. Already there is great interest in the Framework from universities and the vocational education and training sector, as well as international organisations. Measurement for improvementAgreed National List of Core Sentinel Events (2003): Sentinel events are adverse events that cause serious harm to patients. A national core set of sentinel events has been agreed with all jurisdictions, and a national report is being developed to measure and learn from events that cause death or serious harm to patients. Charting the safety and quality of health care in Australia (2005): This publication assembled data to provide health care providers, policy makers and consumers with a comprehensive overview of what is known about the safety and quality of the Australian health care system. Measurement for Improvement Toolkit (2005): This is a practical toolkit of ways to measure the safety and quality of clinical services. Patient Safety Risk Management Plans (2004): The Council worked with all jurisdictions to develop national specifications for incident reporting and management systems, including the use of root cause analysis. Each jurisdiction now has consistent incident management systems. Working with consumers10 tips for safer health care (2003): More than 100 000 copies of this booklet have been produced and distributed to help people understand health care safety and become more actively involved in their health care. It is also available in 15 community languages and is being widely distributed to patients at or before the time of admission. It has also been adopted by some private insurers. Open Disclosure Standard: a National Standard for open communication in public and private hospitals, following an adverse event in health care (2003): The Open Disclosure Standard was produced in 2003. It aims to encourage greater openness around adverse events, through acknowledging when things go wrong, and providing reassurance to patients and their carers that lessons learned will help prevent a recurrence of the event. Practice improvementsNational Strategy to Address Health Care Associated Infections (2003): Health care-associated infections are a leading cause of adverse events. There is national agreement on key definitions regarding health care-associated infections, as well as surveillance templates, and production of clinical guides for health professionals to reduce harm. High risk medication alerts (2003 and 2005): High risk medication alerts on intravenous potassium chloride (2003) and vincristine (2005) have been released, so that action is taken on known hazards with potentially catastrophic outcomes. Ensuring Correct Patient, Correct Site, Correct Procedure Protocol (2004): The Protocol was developed in 2004 to help prevent procedures being carried out on the wrong patient or body part, an event that can cause serious harm and distress to patients. This is an evidence-based tool that is being widely used by the Royal Australasian College of Surgeons, and in a wide variety of settings around Australia. Redesign and information technologyNational Inpatient Medication Chart (2004): The National Inpatient Medication Chart was developed in consultation with a wide group of stakeholders to reduce harm resulting from error in the prescribing, supply and administering of medications. All jurisdictions have participated in the pilot of the chart, which precedes a national roll-out of this initiative. Governance and investmentCentre for Research Excellence (2004): The Council has forged a partnership with the National Health and Medical Research Council to form a Centre of Research Excellence in Patient Safety, located at Monash University in Victoria. The Centre will provide the evidence base for sustainable and well researched improvements to the safety and quality of Australia’s health system. Australian Research Council Linkage Grant: The Council developed an industry partnership with ACT Health and the Australian National University, and was awarded an Australian Research Council Linkage Project Grant. This project aims to identify and develop promising regulatory strategies for improving safety and quality. The governance of health safety and quality discussion paper was published in July 2005 as the basis for the future directions of this project.

Health services administration Supplement 15 May 2006 Open Access

Shared meanings: preferred terms and definitions for safety and quality concepts

An early initiative of the Australian Council for Safety and Quality in Health Care (ACSQHC) was to set up a mechanism for reaching agreement on preferred terms and definitions for safety and quality concepts. The aim was to devise a language with common meanings to facilitate discussion and research.1 This need had been recognised before the Council was formed,2 and a group of international experts had been asked to comment on proposed terms and definitions (see Acknowledgements). The group was emailed proposals, along with alternative definitions from the literature, and asked their opinions and preferences, as well as any additional terms which should be considered. Their comments were circulated regularly among the group. When ACSQHC was formed, I was asked to coordinate a process to advance this “Shared meanings” project. We created a website, listing terms with their preferred and alternative definitions, sources and comments on the definitions.3 Visitors to the site were invited to submit suggestions. In all, 149 terms and their preferred definitions were posted, with a further 296 alternate definitions, and 63 sources of information (eg, there were 16 definitions for “error”, 14 for “adverse event”, and five for “adverse drug event”). It was decided to choose terms and definitions with meanings as close as possible to those in colloquial use, and not to use terms which are potentially ambiguous (eg, “accident”, “complication”, “medicament”); 19 terms posted were designated “not for further consideration”. A project group was then formed (see Acknowledgements), and a series of meetings held to decide on preferred terms and their definitions. The group decided to avoid long definitions with several “qualifiers”, but instead to start with simple, basic definitions, and then to “build” by defining the key terms used in these. It is therefore necessary to read the terms and their definitions in the sequence provided in Box 1; an alphabetically arranged list is given in Box 2. In October 2004, the World Alliance for Patient Safety was launched under the auspices of the World Health Organization (WHO), and one of its first initiatives was to develop a classification for patient safety.4 At a meeting in October 2005, the WHO invited me to propose an underlying information model for this classification. The WHO classification group is hosting a web-based Delphi process5 to seek submissions from member countries as to which concepts should populate the classification and to propose preferred terms in their various languages. The ACSQHC terms and definitions shown in Box 2 have gained considerable currency (eg, many are used by the National Patient Safety Agency in the United Kingdom), and will be submitted for consideration for this worldwide patient safety classification, which is planned to become a member of the WHO Family of International Classifications.6 1 Sequence in which to read the terms in Box 2 1 Incident 12 Injury 23 Side effect 34 Blame 2 Health care incident 13 Suffering 24 Error 35 Negligence 3 Health 14 Disability 25 Root cause analysis 36 Monitor 4 Health care 15 Adverse event 26 System failure 37 Benchmark 5 Event 16 Near miss 27 System improvement 38 Standard 6 Circumstance 17 Safety 28 Quality 39 Accreditation 7 Agent 18 Hazard 29 Quality of health care 40 Credentialling 8 Harm 19 Outcome 30 Risk 41 Iatrogenic 9 Complaint 20 Health care outcome 31 Risk management 42 Nosocomial 10 Loss 21 Preventable 32 Liability 43 Stakeholder 11 Disease 22 Adverse reaction 33 Accountable 2 List of preferred terms and definitions devised by the Australian Council for Safety and Quality in Health Care Introduction * An asterisk indicates that there are further terms within that definition which are also defined. For example, the term “incident*” contains the additional terms (in bold) “event”, “circumstance”, “harm”, “complaint” and “loss”, which are themselves defined. The definition for “harm*”, in turn, contains the terms “disease”, “injury”, “suffering” and “disability”, each of which is also defined. Alternative definitions, comments and sources of information are available from the author. Terms and definitions Accountable Being held responsible. Accreditation* Being granted recognition for meeting designated standards for structure, process and outcome. Adverse event* An incident in which harm resulted to a person receiving health care. Adverse reaction* An adverse event where the correct process was followed for the context in which the event occurred but unexpected and unpreventable harm resulted. (For example, an adverse drug reaction will be said to have occurred when the right drug was used for the correct indication in the right dose given by the right route, but the patient suffered unexpected and unpreventable harm. Adverse reactions can also result from some diagnostic tests, therapeutic interventions or devices.) Agent One who, or that which, acts to produce a change. Benchmark A criterion against which something is measured. Blame To hold at fault (implies culpability). Circumstance* All the factors connected with or influencing an event, agent or person/s. Complaint An expression of dissatisfaction with something. Credentialling* The process of assessing and conferring approval on a person’s suitability to provide a defined type of health care. (Can be synonymous with clinical privileging.) Disability* Any type of impairment of body structure or function, activity limitation and/or restriction of participation in society, associated with a past or present harm. Disease A physiological or psychological dysfunction. Error Unintentionally being wrong in conduct or judgement. Errors may occur by doing the wrong thing (commission) or by failing to do the right thing (omission). Event Something that happens to or with a person. Harm* Harm includes disease, injury, suffering, disability and death. Hazard* A circumstance or agent that can lead to harm, damage or loss. Health* A state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity. Health care* Services provided to individuals or communities to promote, maintain, monitor, or restore health. Health care is not limited to medical care and includes self-care. Health care incident* An event or circumstance during health care which could have, or did, result in unintended or unnecessary harm to a person and/or a complaint, loss or damage. Health care outcome* The health status of an individual, a group of people or a population which is wholly or partially attributable to an action, agent or circumstance. Iatrogenic* Arising from or associated with health care rather than an underlying disease or injury. Incident* An event or circumstance which could have resulted, or did result, in unintended or unnecessary harm to a person and/or a complaint, loss or damage. Injury* Damage to tissues caused by an agent or circumstance. Liability Responsibility for an action according to the law or in a legal sense. Loss Any negative consequence, including financial. Monitor To check, supervise, observe critically, or record the progress of an activity, action or system on a regular basis in order to identify and/or track change. Near miss* An incident that did not cause harm. Negligence (civil or criminal)* An incident causing harm, damage or loss as the result of doing something wrong or failing to provide a reasonable level of care in a circumstance in which one has a duty of care. Nosocomial Pertaining to or originating in a hospital (synonymous with “hospital-acquired”). Outcome* The status of an individual, a group of people or a population which is wholly or partially attributable to an action, agent or circumstance. Preventable* Accepted by the community as potentially avoidable in the particular set of circumstances. Quality (degree of)* The extent to which a service or product produces a desired outcome or outcomes. Quality of health care (degree of)* The extent to which a health care service or product produces a desired outcome or outcomes. Risk The chance of something happening that will have a negative impact. It is measured in terms of consequences and likelihood. Risk management* In health care, designing and implementing a program of activities to identify and avoid or minimise risks to patients, employees, visitors and the institution; to minimise financial losses (including legal liability) that might arise consequentially; and to transfer risk to others through payment of premiums (insurance). Root cause analysis* A systematic process whereby the factors which contributed to an incident are identified. Safety* Freedom from hazard. Side effect* An effect, other than that intended, produced by an agent (see also “adverse reaction”). Stakeholder Those people and organisations who may affect, be affected by, or perceive themselves to be affected by, a decision or activity. Standard Agreed attributes and processes designed to ensure that a product, service or method will perform consistently at a designated level. Suffering* Experiencing anything subjectively unpleasant. This may include pain, malaise, nausea, vomiting, loss, depression, agitation, alarm, fear or grief. System failure A fault, breakdown or dysfunction within an organisation’s operational methods, processes or infrastructure. System improvement* The result or outcome of the culture, processes and structures that are directed towards the prevention of system failure and the improvement in safety and quality

William B Runciman FANZCA, FJFICM, PhD

Health services administration Supplement 15 May 2006 Open Access

Sea change: public reporting and the safety and quality of the Australian health care system

The pursuit of demonstrable safety and quality in health care is an evolving process; there has been notable progress in measuring safety and quality in Australia. The first attempts to measure outcomes were in the field of anaesthesia, while national perinatal mortality reports have provided clinically useful information for many years. Nationwide reporting by the Quality in Australian Health Care Study (QAHCS) in 2005 triggered a more systemic approach to safety and quality. Systemic reporting has begun to emerge in anaesthesia and surgery, for implantable devices, perinatal services and sentinel events; in some jurisdictions, statewide incident data are now reported annually. While debate continues about the issue of individual clinician performance, the real issue is the effectiveness of any reporting system to bring about change in both safety and quality.

Clifford F Hughes AO, FRACS, FACS, FACC · Patricia Mackay FRCA, FANZCA

Health services administration Supplement 15 May 2006 Open Access

Health care safety and quality: where have we been and where are we going?

Health care will always be associated with risk, but the Australian Council for Safety and Quality in Health Care has achieved much in bringing health care safety and quality into public consciousness and beginning systemic change for improvement. Work is underway to develop safety and quality standards, and infrastructure and systems for measurement and evaluation; to increase workforce understanding of how to improve health care delivery; to increase consumer engagement in health care management; and to develop policy and understanding of the barriers to progress. With this foundation of reform, the future of the new Australian Commission on Safety and Quality in Health Care is promising, but it is up to us as health professionals and managers, with the help of the community, to improve the safety and quality of health care.

Bruce H Barraclough AO, FRACS, FACS · Jim Birch

Health services administration Supplement 15 May 2006 Open Access

Measurement of the safety and quality of health care

Measurement of safety and quality is fundamental to health care delivery. A variety of measures are needed to fully understand the system; quantitative and qualitative measures are both useful in different ways. Measures need to be valid, reliable, accurate, timely, collectable, meaningful, relevant and important to those who will use them. Clinicians value appropriate measures and respond to them.

Sarah Scobie BA, PhD · Richard Thomson MD, FRCP, FFPHM · John J McNeil PhD, FRACP, FFAPHM · Paddy A Phillips DPhil, FRACP, FACP

Health services administration Supplement 15 May 2006 Open Access

Designing safer health care through responsive regulation

Self-regulation by the health professions, while improving, is no longer enough; external drivers for safer health care include governments, funders and consumers. Enforced self-regulation is often more promising than a “command and control” strategy. Research evidence on the responsive regulatory pyramid and its options offers lessons for health care policy makers and managers. Start at the base of the regulatory pyramid — try persuasion first; move up the pyramid to secure compliance, and then be willing to move back down. Use existing capacities and structures, and if possible avoid new bureaucracies of control.

Judith Healy PhD · John Braithwaite BA, PhD

Health services administration Supplement 15 May 2006 Open Access

The development of the National Reporting and Learning System in England and Wales, 2001–2005

In 2001, the National Patient Safety Agency (NPSA) was created as part of a wider reform process to improve quality of care for patients in the National Health Services of England and Wales. The NPSA was charged with developing and implementing a national system for collecting and learning from reported patient safety incidents. Between 2003 and 2005, 303 447 incidents were reported from a wide range of health care settings. As a result, a range of interventions have been developed to improve safety. A number of lessons have been distilled from the experience of England and Wales, including that: clinical risk management system characteristics should be aligned with those of the national reporting system; and safety culture and information dissemination must be addressed at the same time as any new reporting system is implemented. These lessons should be of use to other countries implementing similar patient safety strategies.

Susan K Williams BA(Hons), IHM · Sue S Osborn BA(Hons), IHM

Health services administration Supplement 15 May 2006 Open Access

The WHO World Alliance for Patient Safety: towards the years of living less dangerously

Improving the safety of patient care is now a global issue. In 2004, the World Health Assembly supported the creation of the World Alliance for Patient Safety to coordinate, spread and accelerate improvements in patient safety internationally. Australia has been at the forefront of international work on patient safety and is working closely with the World Alliance. The World Alliance is taking forward work in six main action areas: Patients for Patient Safety; Reporting and Learning; Taxonomy; Solutions; Research; and Global Patient Safety Challenge. Despite differences in context, there are many common challenges for countries seeking to establish patient safety programs and initiatives. Looking forward, long-term action on patient safety must be built and sustained with the commitment of policy makers and the active engagement of health care professionals.

Sir Liam J Donaldson MD, FFPHM, FRCP · Martin G Fletcher BSocStud, BA(Hons), MMan

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