Health services administration

Objective: To quantify the barriers to practising as a rural consultant physician.Design: Cross-sectional postal survey.Participants: All 981 practising consultant physicians in Victoria, Australia, who were Fellows of the Royal Australasian College of Physicians in 1999; 52 (100%) of rural physicians and 634 (68.2%) of metropolitan physicians completed the survey.Main outcome measures: Demographic and practice characteristics; barriers to rural practice.Results: There were no rural female consultant physicians, and 35 of the 52 rural consultant physicians (67.3%) were born in a rural area. The most important perceived barriers to rural practice identified by both metropolitan and rural physicians were children's schooling (72.2%), spouse's occupation (65.7%), other issues related to children (66.7%) and difficulties getting back into metropolitan practice (45.7%). Among metropolitan physicians, barriers to rural practice differed by age, sex, place of birth and nationality. Returning to metropolitan practice, children and concern over procedures were more likely to be reported as barriers to rural practice among those aged 40 years or under, 41–50 years and 51 years and over, respectively.Conclusion: The major barriers to rural practice identified by physicians lie outside the health sector, and particularly concern a perceived need for wider opportunities in children's education and spouse employment.

David Simmons FRACP, MD · Les E Bolitho FRACP · Grant J Phelps FRACP · Rob Ziffer FRACP · Gary J Disher

Communication overload may well lead to errors, but this is yet to be firmly established Although stories of misunderstandings, ambiguity, amnesia and lack of cooperation abound, there have been few studies of communication between healthcare professionals. Recently, the topic has been given new impetus as communication problems have been identified as a major contributory factor to the occurrence of errors and adverse events.1 In this issue of the Journal, Coiera and colleagues (page 415) report a study of communication in two Australian emergency departments,2 extending earlier work carried out in the United Kingdom.3 The "communication load" was high, occupying about 80% of clinicians' time. As in other studies,4 almost a third of communications were interruptions, and about 10% of the time two or more conversations were occurring simultaneously (multitasking). Synchronous communication (face-to-face or telephone conversations) accounted for almost 90% of communications traffic. The authors argue that the combination of interruptions, multitasking, and sheer volume of information (much of it unwanted or irrelevant) may produce clinical errors by disrupting memory processes. Communication problems may take a number of different forms and it is important to distinguish between them, as both the contribution to error or adverse outcome and the appropriate remedy vary considerably. Communications may simply be omitted, as when a surgeon fails to inform the anaesthetist of a drug being administered, thus not preparing him or her for a fall in blood pressure. A common cause of omitted communication is an excessively deferential and hierarchical workplace social structure. The classic examples derive from copilots being reluctant to inform senior pilots of potentially dangerous situations.5,6 There is evidence that medical hierarchies and attitudes are even more entrenched than those in aviation.7 Communications may be ambiguous in a variety of ways. Semantic ambiguity occurs when the same phrase is correctly sent and received, but assigned different meanings by the parties. For example, in a child with a right forearm fracture of both the ulna and radius and a dislocation of the right elbow, a plan to reduce "both injuries" might refer to the two fractures, or to the forearm injury (taken as a whole) and the dislocation. Phonetic or lexical ambiguity (eg, aortic stenosis confused with atherosclerosis8) underlies the problem of sound-alike or look-alike drugs. And finally, message ambiguity can occur because the channel is noisy and the message received does not match the one transmitted. Emergency departments, in particular, are literally noisy channels, with high levels of ambient noise from patients, staff, telephones, alarms, pagers and equipment. Ironically, the natural response to noise interfering with communication is to speak more loudly, creating a positive-feedback loop and an ever-increasing din. Communication may also become problematic because the sheer volume of information overwhelms short-term memory, causing some of the information to be lost before processing is completed.9 In addition, the incoming information may be distracting, interrupting and disrupting complex procedures and decision-making. When levels of interruption are high, clinicians may react by ignoring pagers and messages, or waiting until they are paged twice before responding, to separate the trivial from the truly urgent, which, paradoxically, increases the volume of communications still further. A particularly interesting insight arising from previous studies by Coiera and colleagues is that, despite their own disinclination to be interrupted, clinicians often initiate communication or request information without any thought of the impact of their request on the other person.3,10 This is a form of suboptimisation, in which trying to increase one's own performance results in a net decrement in performance over the entire organisation. Solutions to communication difficulties are often couched in terms of training — "we must learn to communicate better". In a sense this will always be true, in that, ultimately, most improvements in communication will require a change in human behaviour. However, depending on the nature of the problem, the key intervention may be individual training, or involve technical aids, or be team oriented. Training of individuals might focus on giving precise information according to a standard format and considering the impact of the information on the other person. More thought might also be given to how clinicians could be trained to maintain focus and concentration in the face of multiple demands and a constantly changing environment; Technical aids might be simply the introduction of a white board in the emergency department, cutting down the need for multiple face-to-face interactions; and Team-based interventions might include restrictions on interruptions and face-to-face interactions (when information might be easily available in written form), or restrictions on communication and interruption at certain critical phases of procedures, analogous to the "sterile cockpit" rules prohibiting extraneous conversation during takeoff and landing. Human beings are immersed in a sea of communications for much of their waking life, and are well equipped for interpreting ambiguous messages when using information-rich channels such as face-to-face conversation. While communication overload may well lead to errors, this is yet to be firmly established and further studies of the nature of communication between clinicians may be needed first. It is important to realise that safety in high-risk environments relies heavily on continuous communication and rapid updating of information. The task for researchers is to begin to separate out the irrelevant and ambiguous communication from the necessary, if sometimes burdensome, flow of important information.11 Until this issue is clearer, any interventions to reduce communication overload should be implemented with caution. There is a risk that attempts to reduce the communication burden in healthcare by shifting it to progressively terser, more impoverished channels might inadvertently increase miscommunication, or result in even greater demand for synchronous communication. Coiera rightly points out in another article that the benefits of technical solutions may be limited unless they are well understood and carefully targeted.12 Observational studies of the many factors which affect human performance in complex environments have a long history, going back at least to World War II.7 However, in medicine, with a few notable exceptions,13 such studies have been infrequent. The approach taken by Coiera and colleagues2 to the understanding of error and adverse events is important in that it involves direct observation and study of work and workers "in the wild".14 While many valuable studies of error and adverse events have been conducted from records or other documents, it is clear that the full range of factors involved in the genesis of adverse events15 can never be captured completely by such methods. The fluidity and complexity of the clinical environment16 and the need to appreciate clinicians' decision making and cognitive load require studies in which interviews and verbal protocols are combined with observation or video recordings. These methods are not familiar to medicine, and will require collaboration with psychology and engineering.17 Future studies will also have to tackle the difficult topic of linking the details of communication to the occurrence of error or some more general aspect of clinical performance or outcome.

Charles A Vincent PhD · Robert L Wears MD, MS, FACEP

Objective: To measure communication loads on clinical staff in an acute clinical setting, and to describe the pattern of informal and formal communication events.Design: Observational study.Setting: Two emergency departments, one rural and one urban, in New South Wales hospitals, between June and July 1999.Participants: Twelve clinical staff members, comprising six nurses and six doctors.Main outcome measures: Time involved in communication; number of communication events, interruptions, and overlapping communications; choice of communication channel; purpose of communication.Results: 35 hours and 13 minutes were observed, and 1286 distinct communication events were identified, representing 36.5 events per person per hour (95% CI, 34.5–38.5). A third of communication events (30.6%) were classified as interruptions, giving a rate of 11.15 interruptions per hour for all subjects; 10% of communication time involved two or more concurrent conversations; and 12.7% of all events involved formal information sources such as patients' medical records. Face-to-face conversation accounted for 82%. While medical staff asked for information slightly less frequently than nursing staff (25.4% v 30.9%), they received information much less frequently (6.6% v 16.2%).Conclusion: Our results support the need for communication training in emergency departments and other similar workplaces. The combination of interruptions and multiple concurrent tasks may produce clinical errors by disrupting memory processes. About 90% of the information transactions observed involved interpersonal exchanges rather than interaction with formal information sources. This may put a low upper limit on the potential for improving information processes by introducing electronic medical records.

Enrico W Coiera PhD, FACMI · Rohan A Jayasuriya MPH, MBA, MD · Jennifer Hardy RN, CM, ICU(Cert), BSc, MHP Ed · Aiveen Bannan MB BS, DTM · Max E C Thorpe MD, FRACP

Decision making in health and medicine. Integrating evidence and values. M G Myriam Hunink, Paul P Glasziou, Joanna E Siegel et al. Cambridge: Cambridge University Press, 2001 (xvi + 388 pp). ISBN 0 521 77029 7. Like the practice of medicine itself, this book is not for the faint-hearted. Not because it is difficult to read or to understand, but because, unless you are already skilled in decision analysis, you will find it new, thought provoking and rigorous. The consequences of embracing its message are profound. Its fundamental premiss is that medicine (defined in its broadest sense to cover clinical medicine, population research, policy development and health management) is about uncertainty and the need to make decisions despite this uncertainty. For example, you have just diagnosed a 58-year-old man with atrial fibrillation. If you prescribe warfarin you can reduce his risk of embolic stroke by 70%, but this benefit comes at the price of an increased risk of haemorrhage, and the need for regular blood tests and avoidance of activities that increase his risk of injury. How do you weigh up the probabilities and incorporate into the decision your patient’s individual values about what is important to him? This book presents an approach and a handful of tools for making complex, value-laden decisions such as this. The approach, PROACTIVE, is adapted from a generic approach to decision making. As the authors say, one of its greatest strengths is that it requires you to make the decision-making process transparent. By carefully outlining your decision, viewing it from other perspectives and considering what the important objectives are, the best decision may become readily apparent without having to go any further. If you need to work quantitatively with probabilistic data, to make trade-offs between benefits and risks (or length of life versus quality of life, or costs versus benefits), and to incorporate people’s values and preferences, the book provides detailed guidance on the tools that are available. It takes the novice from a definition of a probability and a proportion all the way to advanced microsimulation modelling. Decision making in health and medicine updates the 1980 book Clinical decision analysis. It has a broader framework, and covers population health decision-making. It also includes more information on diagnostic testing, methods for measuring and incorporating quality-of-life measures and newer approaches to modelling. To support it, there is an accompanying CD with solutions to exercises, decision-analytical software, examples of decision-analytic models using the software, spreadsheets and references with abstracts. It is an extraordinarily ambitious book that achieves its aim. Alexandra L BarrattEpidemiologistUniversity of Sydney, NSW

Alexandra L Barratt

For most of the 20th century, Australia's Medical Colleges have played an important role in our healthcare system. The Colleges were founded to maintain and enhance professional standards in medicine's various disciplines. This was achieved through providing opportunities for the continuing medical education of College Fellows, by certifying that aspiring specialists could practise independently, and by encouraging research. The training role of Colleges was progressively developed, with evolution of training curricula, and through involvement in selection of trainees, appointment of supervisors and accreditation of hospitals and other healthcare providers as suitable sites for specialist training. Over the years, the Colleges have attained considerable professional and community respect. This respect has underpinned the freedom that Colleges enjoy and allowed for their participation in the medical profession's regime of self-regulation. However, this respect and standing could rapidly diminish if the Colleges do not jealously guard their independence, while acknowledging their accountability to society. In this, they should be concerned primarily with the knowledge, competence and performance of their Fellows and with ways to assist in the maintenance of these attributes. More recently, Colleges have sought to have the expertise of their Fellows contribute to community debates on the safety and quality of healthcare and broader health policy issues. This has been facilitated, in a number of instances, by the establishment of health policy units such as that of the Royal Australasian College of Physicians, which provides an evidence base for College views. For this expertise to be widely accepted, the Colleges must not be subject to external influences, nor have a major role in protecting their Fellows' financial and narrow professional interests. Our Colleges increasingly recognise that they must be actively involved with the community and other key organisations in the healthcare and educational systems and that their activities should be open to external scrutiny. The acceptance of this move to external scrutiny is demonstrated by the strong support of the Colleges for the Australian Medical Council (AMC) to become the accrediting body for specialist education and professional development programs. Already, trial accreditation of two Colleges (the Royal Australian and New Zealand College of Radiologists and the Royal Australasian College of Surgeons) has demonstrated the rigour and value of the process.1,2 Areas requiring improvement have been identified and the Colleges taking part have to report to the AMC on a regular basis on how these shortcomings are being addressed. Accreditation is helping the Colleges to ensure that they are meeting the expectations of their Fellows, trainees, providers of healthcare and consumers, and that they are publicly accountable. Hopefully, it will ensure that College trainees are not only skilled clinicians but also appreciate the issues associated with the delivery of safe, high-quality care in the Australian healthcare system. AMC accreditation is also providing a transparent pathway for other organisations to seek accreditation for training and professional development programs in competition with those of existing Colleges. No other country has developed such a robust external system of accreditation of specialist education and training, and the process is attracting considerable international interest. Our Colleges are also working closely with the AMC and Medical Boards to establish specialist medical registers in all States and Territories. Among other benefits, these registers will allow the community to more readily identify medical practitioners as recognised specialists. As part of this process, Colleges are contributing to the development of the criteria for regular re-registration and examining how these can reflect the maintenance of professional standards. Rightly, the community expects that all medical practitioners will maintain their competence and behave in a professionally appropriate way. While it may seem appropriate for Colleges to consider complaints that one of their Fellows has failed to meet these standards, Colleges in Australia do not have this role. Medical Boards, but not Colleges, have the statutory authority to investigate complaints against doctors and can give protection to the complainant. The legal position of Colleges in undertaking such investigations is far from certain. The appropriate role of the Colleges in such difficult matters should be to provide independent advice on standards to Medical Boards and other statutory bodies, and to provide assistance to the Board in the re-education and retraining of underperforming Fellows. The traditional discipline base of the Colleges may impede innovative developments in healthcare delivery. Increasingly, there is overlap and close collaboration in clinical activities (such as in radiation oncology and medical oncology) and there is a trend to bring together, in one service unit, physicians and surgeons dealing with the same body system. Strengthening the intercollegiate body (the Committee of Presidents of Medical Colleges), while maintaining individual College autonomy, may well assist this process by promoting multiple College training and professional development programs. This would seem preferable to formation of new Colleges, although the AMC now has a more robust and transparent process for these to be recognised. If Colleges are to continue to command the respect and confidence of the medical profession and society, they must not become financially or otherwise dependent on government or other organisations with a vested interest in their opinions and contributions to public debate. While it is understandable that Colleges, because of their unique expertise, may undertake some contractual work for governments or other organisations to assist in improvements to healthcare, this must be done with great caution. Colleges should ensure they are not influenced by the provider of the funds; furthermore, it would be extremely unwise to build up a significant College bureaucracy or facilities that are dependent on such external funding. Equally, Colleges should be extremely reluctant to become fundholders for government-sponsored training programs or to build up organisations dependent on such funding. Political decisions, as has recently happened with the training program for general practitioners, can place a College in a very difficult position. The threat of removal of such funding and the resulting impact on the financial viability of a College could temper criticism of the policies of government or other organisations. These issues have received considerable attention in North America and Europe. Pellegrino and Relman3 recently argued strongly that a professional organisation such as a Medical College can not become involved in protecting its members' financial welfare or other narrow professional interests: "It would be far better . . . for physicians to promote patients' interests on ethical and medical grounds as members of medical associations than to seek confrontation as union members. In our view, unions and truly professional associations are simply incompatible." These sentiments obviously have parallels in Australia. As the eminent ethicist Sullivan4 points out, true professionalism depends on the moral contract between the professional and society. It is only when the responsibility to patients and to the public interest is held to be paramount that members of the medical profession can expect society to accept self-regulation of the profession and to listen carefully to proffered opinions and advice. Colleges must continue to promote these principles to their Fellows and trainees, and Colleges and their Fellows must demonstrate to society their commitment to them.

Peter D Phelan MD FRACP

Evidence-based healthcare. How to make health policy and management decisions. 2nd ed. J A Muir Gray. Edinburgh: Churchill Livingstone, 2001 (xxxix + 444 pp). ISBN 0 443 06288 9. Muir Gray is an extraordinary man. He is Director of the Institute of Health Sciences at Oxford and the Project Director of the National Electronic Library for Health. He posits himself as the amanuensis of a very talented group of fellow travellers, and the benefits of his authorship are evident in the consistent style and integrity of argument presented in this book. Evidence-based healthcare is organised in three sections: finding and appraising evidence; developing the capacity for evidence-based decision making; and getting research into practice. It is written for those who make decisions about groups of patients in order to “improve the competence of health service decision makers and to strengthen the motivation of any health service decision maker to use scientific methods when making decisions”. Thus, it represents one man’s vision for evidence-based healthcare and is a source of illumination and support for would-be evidence-based decision-makers. It is clearly not aimed at novice clinicians attempting to familiarise themselves with the technical tasks of critical appraisal or electronic information-searching techniques. This is the companion volume to such instructional texts. This edition shows signs of “second edition spread”, having grown from 270 to 444 pages over four years. New chapters cover evidence-based public health, consultation, and introduce post-modernism to evidence-based health care. Anyone with an interest in getting health policy right, from a new Health Minister to a hospital CEO faced with the third reincarnation of a Health network, or a clinician unexpectedly elevated to the ranks of hospital management, could profitably delve into this text. It will help clinicians to appreciate a systems perspective and the requirements for successfully implementing change. Few will attempt to read it cover to cover. If there is to be a systematic approach to health services delivery in Australia it will be led by clinicians and managers who can appreciate and work through the issues which Muir Gray identifies and discusses with such clarity and insight. I know of no book like this and, having read it, I would like to know more of the author. Donald A CampbellDirector, Clinical Epidemiology and Health Services Evaluation Unit Royal Melbourne Hospital, VIC

Donald A Campbell

Australia has been experimenting with fundholding in primary care for nearly a decade. When the concept was floated in 1992,1-4 the debate was heavily influenced by the problems experienced in the United Kingdom with fundholding in general practice, including lack of measurement of improvement in quality of care.5 Fundholding still engenders disquiet because of its potential for a primary focus on cost savings, increased control of clinicians by management,6 and a reduction in quality of care7 and equity of access.8 Over the past five years, there have been 14 trials in Australia that included a fundholding model: nine General Coordinated Care Trials (GCCTs) (one of which comprised four subtrials) (Box 1);9-17 four Aboriginal and Torres Strait Islander Coordinated Care Trials (ATSI CCTs) (Box 2);18 and the Maitland After-Hours Care Trial (MAHT) (Box 3).19 Such trials are expected to continue, and the debate about the impact of fundholding on patient outcomes remains unresolved. It is therefore an appropriate time to review the Australian experience of fundholding in primary care. Here, we present the results, focusing on the question: Does the Australian experience of fundholding thus far provide evidence of improved patient health and well-being? Key conceptsFundholdingFor this article, fundholding is defined as a framework within which specified resources, agreed prospectively, are made available for a defined period, and from which a range of services are provided to a specific group of patients. It is a framework for funding a healthcare initiative rather than an initiative in itself. It overcomes the constraints that the existing funding structure and availability of funds impose on a healthcare initiative by introducing flexibility within an overarching healthcare system in relation to the fundholder(s), the funds pool (budget), and the economic benchmark. The fundholderThe fundholder is the organisation holding the funds. It may be established specifically for that purpose or be part of an existing regional body. Typically, the fundholder considers a broader range of patient management factors than would be possible under existing structures. The role and objectives of the fundholder are critical to the success or otherwise of fundholding. Compared with existing fundholders, a new fundholder may bring a very different perspective to the healthcare of a group of patients. The funds poolThe funds pool comprises the resources managed by the fundholder to support the services and infrastructure otherwise financed by more than one program or budget (eg, Medical Benefits Scheme [MBS], Home and Community Care [HACC], hospitals, and Pharmaceutical Benefits Scheme [PBS]). The economic benchmarkThe economic benchmark is the guide to "how much" ought to be contributed to the funds pool by the various financial stakeholders. In the Australian trials, the benchmark was usual care, or usual care plus a specified additional payment (eg, ATSI CCTs18 and MAHT19). It is also possible to base the economic benchmark on the resources required for a specified group of services (eg, in relation to a care protocol for a patient recently diagnosed with diabetes, or best-practice antenatal shared care).20 Review of the Australian experienceIn Australia, a dominant feature of fundholding discussions is that improved health and well-being of patients, rather than cost containment, should be guiding its implementation. Initiatives so far in Australia have included: care planning; care coordination; after-hours care; care for people with chronic and complex needs; hospital admission prevention or improved discharge programs; and Aboriginal community empowerment. All these initiatives were aimed at improving the care offered to the people enrolled. The GCCTs9 and ATSI CCTs18 were underpinned by care plans and evidence-based guidelines, and the MAHT by improved patient access and satisfaction.19 It is worth noting that care coordination was originally intended to be undertaken by a skilled professional, not necessarily a GP. The change in federal government in 1996 resulted in a decision by the new health minister that these trials should involve GPs in the care-coordination models, as they were the "central focus of primary health care" (see Chapter 5 — Care planning and coordination).9 ReviewIn reviewing the evidence for improved patient outcomes with fundholding, we consulted both published and unpublished reports of the trials, and also interviewed organisations and individuals involved in the trials themselves or in their evaluation as trial managers, trial sponsors, financial stakeholders or evaluators. Boxes 1, 2 and 3 summarise the trials — the healthcare initiative, the fundholding model, and the outcomes. Given the complexity of the trials, it was not possible to attribute any gains in patient outcomes directly to fundholding. Thus, our review distinguished between three types of outcomes: The outcomes of the initiative itself (eg, did improved coordination of care lead to improved patient health and well-being?); The effectiveness of fundholding's contribution to achieving these broader program initiatives (eg, did fund pooling contribute to improved coordination of care?); and The operational outcomes of fundholding (eg, was the program in operating surplus or loss at the end of an agreed period?). FindingsOur findings suggest that fundholding has a role in overcoming the constraints imposed on specific healthcare initiatives by the Australian healthcare system. However, the relationship between fundholding and patient health and well-being is largely dependent on the objectives and effectiveness of the overall initiative. Four main themes emerged with regard to evidence of the relationship between fundholding and patient outcomes: evidence of impact on patients, role of fundholders, institutional acceptance, and information systems. Evidence of impact on patientsThere was limited quantitative evidence of reduced morbidity and fewer admissions to hospital. Although it would be inappropriate to attribute health gains across each of the components of the coordinated care intervention (care plans, care planners and fundpooling), some important service provision changes were facilitated by fundholding, and, supported by the qualitative evidence, had significant implications for patient well-being. In the GCCTs, community service use increased for the trial clients in trials pooling these services. (Individuals enrolled in the trials were referred to as clients rather than patients.) There was also limited evidence of improvements in well-being, as assessed by SF36 (36 questions covering eight domains of mental and physical well-being),21 and some evidence of reduced hospital admissions and readmissions.9 In the MAHT, there was an increase in after-hours access to medical care.19 In the ATSI CCT, improved access to coordinated services,18 and a more coordinated approach for patients with complex needs, was accompanied by community empowerment and capacity building.18 Additional money (Commonwealth-equivalent MBS/PBS funding) led to significant improvements in the range and quantity of services available to the communities. Role of fundholdersThe types of organisations acting as fundholders varied across the trials. In the ATSI CCTs, community-controlled boards determined how the pooled funds would be used,18 and in MAHT the GP Division managed the funds.19 In the GCCTs, the fundholders included the Department of Human Services in one State, regional health services, and specifically constituted organisations.9 There is substantial evidence of the significant role the fundholder played in the GCCTs and ATSI CCTs. In the ATSI CCTs,18 the fundholders, mostly community representatives, replaced government organisations as key decision-makers for funds covering a broad range of services. The fundholder had three main responsibilities: the financial viability of the program (ensuring there was no operating loss); engaging stakeholders in the process (both providers and fundholders); and achieving the objectives of the overall initiative (eg, patients' health and well-being). A critical role for fundholders was balancing the trade-offs between additional services for patients and the program's financial position. The evidence from these 14 trials is that future fundholders will need training and skills to manage this difficult and critical task. The most appropriate fundholder organisation will depend on the nature of the initiative and the type of stakeholder engagement required. Institutional acceptanceStakeholders' willingness to engage in fundholding varied across the trials and stakeholders and was influenced by at least three factors. Shifts in resources — the pooling of financial stakeholders' resources in one budget leads to increased engagement across institutions in resource-allocation decisions, but shifts in resources away from a contributor's institution as a result of fundholding can reduce willingness to participate. Availability of savings — in most fundholding frameworks, providers of care are encouraged to make decisions leading to financial savings (efficiency gains). There is a greater likelihood of providers generating these efficiency gains if the savings remain available to the initiative. Workforce implications — ensuring that the workforce implications of changing the mix of patient services are considered requires broader institutional engagement than can be achieved through fundholding alone. In the ATSI CCTs, it was noted that, without additional workforce expansion and training, fund pooling alone would not bring sustainable health system change.18 The role of information systemsInformation technology (IT), in particular the timely availability of accurate data on patients' service use, care plans and associated expenditure, played a significant role in the effectiveness of fundholding in the GCCTs. These data included both historical data on service use by patients (used to estimate the size of the fund pool) and service use throughout the trials. Unless it was clear to fundholders which services were being used by the trial patients, it was difficult to monitor quality of care and ongoing financial trial viability. The data collection and information technology (IT) framework for monitoring the funds pool, establishing the economic benchmark and evaluating the trials, was time consuming and expensive. If fundholding is to successfully improve patient care, the most efficient fundholder is unlikely to reach these goals without excellent IT systems, and the second round of the GCCTs has recognised IT system development as a key requisite for effective care coordination and fundholding. Next stepsWe identified three necessary steps before fundholding can be adopted more widely: More formally evaluated trials of a greater range of initiatives focused on specific health and well-being outcomes; Improved prospective analysis of the likely effectiveness of fundholding on both a general and case-by-case basis; and Informing the broader health community. It is important that future trials, including the second round of CCTs and their evaluation, are designed to provide evidence of the impact on patient health and well-being and the role of fundholding in facilitating any such gains. Also needed are rigorous analyses of how a particular initiative could be improved by including a fundholding framework. Such analyses were completed by participants in the GCCTs and informed decisions about funding of the trial initiatives, the contributions to the funds pool, and the ongoing viability of fundholding. The simulations supporting the second round of CCTs are more accurate, as these trials have access to improved data sources and better estimates of costs per patient (capitation rates). Despite these improvements, the estimates of possible efficiency gains in coordinated care (eg, reductions in hospital admissions and MBS service use) seem too optimistic. Preliminary work on the application of such simulations has begun with Shared Care Obstetrics20 and GP fundholding.22 Evidence from other countries23,24 can inform the debate, but should be analysed from an Australian perspective. Informing the broader health community of the potential benefits and limitations of fundholding is important. Time and patience are needed for some clinicians and managers to change their perspective and embrace the concept.25 In MAHT, there was a need to foster relationships with existing providers (eg, emergency physicians) and manage the change in these relationships.19 In both the ATSI CCTs18 and the GCCTs,9 appropriate engagement of the community was crucial to develop transparent and accountable processes for allocating the funds and establishing relationships with service providers. 1: General Coordinated Care Trials (GCCTs)*9-18 The initiative The first round of GCCTs comprised nine trials between June 1997 and December 1999. The overall objective was to improve health and well-being through improved coordination of care and care planning. The intended target group was people with chronic illness and/or complex needs; however, people actually enrolled included those currently without such needs, but with historical or anticipated needs for greater care, particularly before and after hospital admissions. The trials involved 5580 control and 10 953 intervention clients (individuals enrolled in the trials were referred to as clients rather than patients) and a range of healthcare professionals providing, in addition to the usual services, care planning, care coordination and service coordination. The trials developed a range of models of care coordination, all of which involved a GP in developing the medical component of the care plan. Beyond this, the role of the GP varied across the models, with most trials employing care and service coordinators. Fundholding model The objectives of fundholding were: to remove those barriers patients and providers have in accessing appropriate services created by the program-based funding structure — referred to as "removing labels from dollars"; and to ensure savings generated by the efficiency gains of care coordination were used to fund services for clients or infrastructure for the initiative (eg, if care coordination reduced the need for a hospital admission, these savings were made available to the trial). The economic benchmark for the fund pool was usual care (ie, the dollar value of care patients were expected to access during the trial). The estimates of the funds pool for each trial were based on historical use (Medical Benefits Scheme [MBS], Pharmaceutical Benefits Scheme [PBS], community services and hospital inpatient costs), adjusted for the expected effects of ageing and increased illness severity and expected risk of hospitalisation. The range of services pooled varied, but always included MBS, PBS, and hospital inpatients. Some trials included Health and Community Care (HACC), Department of Veterans' Affairs and Royal District Nursing Service (RDNS). The fundholders varied across trials and included the Department of Human Services in one State, regional health services and specially constituted trial organisations. In two cases, Divisions of General Practice were fundholders for part of the overall budget relating to payments to GPs for care coordination services and strategies involving GPs. Outcomes Care coordination and care planning outcomes: There was general consumer satisfaction with care coordination services and care planning, and this tended to be higher for consumers who had a greater need for coordination of their services. The highest exit rate was from a trial that enrolled people with limited potential to benefit. No trial had a "meaningful" gain in health and well being as measured by the SF36, for intervention compared to control, although three subtrials showed small gains (see Chapter 11 — Client health and well-being).9 There was limited evidence of a reduction in hospital admissions, with reasonable evidence from only one trial with a randomised control (see Chapter 18 — Impact on service utilisation and expenditure).9 Trials that directed a substantial portion of their budgets to increased RDNS and HACC services to clients who could benefit from these reported that there was an improvement in client well-being. Fundholding as a contributor to the effectiveness of care planning and coordination: Fundholding allowed trials to fund strategies and infrastructure that would otherwise not have been possible. Clients' community service use increased for trials that pooled such services. At the conclusion of the GCCTs, there was limited evidence that there had been reduced use of hospitals, MBS and PBS. There was limited evidence that trials met the expectation that they could generate sufficient savings in some areas (eg, PBS and hospital admissions) to fund coordinated care activities and additional community services (see Chapter 16 — Financial and economic experience; and Chapter 18).9 (Some trials made savings in relation to specific programs [eg, PBS], but this was often because the initial contribution was an overestimate of expected use.) Fundholding as a funding model: The funds pool for each trial varied from $7.5 million to $28.4 million. This comprised infrastructure (range, 23%–42% of total) and service income. The variation across trials was a result of client numbers, their rates of leaving the trials, the range of services pooled, whether the enrolled clients were high or low users of services, and the extent to which infrastructure funding could be attracted from outside the core Commonwealth grants. Three trials did not have an operating loss, partly as a result of overestimates of usual care and the subsequent funds pool size, as well as infrastructure contributions. Funds pool estimates were generally poor (between plus or minus 25% from the best estimate of usual care). In a number of trials, it was very difficult to obtain an estimate of what the costs of care would have been in the absence of coordinated care. * Caveat: There were nine distinct trials (one of which contained four subtrials) and the generalisations made in this summary are not necessarily representative of the experience of each trial. For more details, see the local evaluations of each trial or the national evaluation.9-18 2: The Aboriginal and Torres Strait Islander Coordinated Care Trials (four trials) (ATSI CCTs)18 The initiative These trials were established to "achieve a more coordinated approach to the delivery of health care services to people with a diverse range of complex health needs".18 In contrast to the GCCTs, these trials had another series of aims related to community empowerment and capacity building, with the aim of improving the health status of Aboriginal communities. Fundholding model The four trials ran from 1997 to 1999. The actual trial sites are given below. Trial Clients Fund pool (in millions) Infrastructure and sponsorship funding (in millions) Katherine West (NT) 2012 $5.6 $1.1 Tiwi Islands (NT) 1818 $7.6 $1.4 Wilcannia (NSW) 780 $4.7 $1.5 Bunbury/Perth (WA) 1990 $5.6 $1.2 The fund pool included Commonwealth-equivalent MBS/PBS funding, existing local health services and, in some cases, hospital resources. Importantly, additional funds above usual care were provided in the form of Commonwealth-equivalent MBS/PBS funding. Each trial received $599.70 per client, either enrolled or in a specified community. This represented per capita (Australia-wide) use of MBS and PBS which was significantly greater than historical use in these regions. The fundholder varied from community-based boards to the Health Department of Western Australia and a local Health Service. The policies and strategies of the latter group were determined by a "community working group".18 Outcomes Care coordination and care planning outcomes: There was improvement in service access and flexibility (by the use of the funds pooling) and improved appropriateness of service provision (by the use of care coordination). Fundholding as a contributor to the effectiveness of care planning and coordination: There was development of the organisational structures required to implement fundholding; evidence that fundholding could be an effective mechanism for allocating "new" resources in the MBS/PBS equivalent funding; and improved individual and community empowerment. There was an opportunity to develop substantial infrastructure, including financial infrastructure and information systems. Fundholding as a funding model: All trials operated within their financial budget, and all had unexpended funds as a result of several factors, including the delay in recruiting program staff required to implement agreed strategies, and the cautious approach to expenditure adopted by the fundholders. MBS/PBS = Medical Benefits Scheme/Pharmaceutical Benefits Scheme 3: Maitland After Hours Primary Care Trial (MAHT)19 The initiative In response to an identified and quantified need for improved after-hours care in the Maitland area of the Hunter region, a comprehensive trial with four elements was established in October 1999. An after-hours triage service; A service provided by GPs (Maitland After Hours GP Service [MAGS]) in the Maitland Hospital Emergency Department A funded transport service; and A home visiting service. The two main needs met by MAGS were to ease the patient burden on the Maitland Hospital Emergency Department, and to lessen the difficulties faced by local GPs in meeting patients' after-hours care. A key element was organising the after-hours GP workforce more effectively. Fundholding model The trial involved pooling funding from two Commonwealth sources (Medical Benefits Scheme, Practice Incentive Payment [$457 000] and Commonwealth infrastructure funding [$279 000]) and the Maitland Hospital (staff, pathology, investigations, pharmaceuticals and consumables [$200 000]), making the total fund about $936 000. The economic benchmark was estimated usual after-hours care for the region across GP and Maitland Hospital Emergency Department services, with an additional contribution by the Commonwealth to fund the program's establishment. The fundholder was the Hunter Urban Division of General Practice, but the Board of Management for MAGS included Area Health Service personnel. Outcomes After-hours care service: Overall, the GPs and all stakeholders were very happy with the service and wanted it to continue. In all, 11 315 patients were seen at MAGS, 2093 telephone calls were handled and 103 home visits completed. There was a 61% decrease in Category 4 and 5 patients (the two least urgent triage categories) seen by the Emergency Department staff during the time MAGS was operating. From a survey in February – April 2000 of 81 users of the service (34% response rate), 79% rated the "overall quality of the service as excellent or very good (5% said it was fair/poor), 91% said they would return to the service for medical care, and 89% would recommend it to their family or friends". At a follow-up interview in August – September 2000 of 422 people who had used the service, 89% agreed they were able to get the care they wanted, 84% were happy with the doctor they saw and 35% felt they had to wait a long time. There were 12 formal complaints. Fundholding as a contributor to the effectiveness of an after-hours service: Fundholding provided an alternative model for paying GPs (salaried rather than fee-for-service); It provided the additional funding above usual-care costs to establish and maintain the alternative model; and It engaged stakeholders in the process of changed models of care, partly as a result of the transparency of the model in terms of its financial and patient-load impact on the various providers. Fundholding as a funding model: The model was financially viable (ie, within budget). Payments were timely and initial infrastructure funding was sufficient for startup. A key to successful implementation was that the Area Health Service remained committed to the trial and facilitated dealings with Maitland Hospital. This was important, as the reduction in patient load clearly had resource implications for Maitland, but the exact extent of the impact on Emergency Department resources was difficult to estimate, partly owing to the cost structure of emergency departments.

Justin J Beilby MB BS, MD · Brita Pekarsky BEc(Hons), DipHEc

The Australian Council for Safety and Quality in Health Care (ACSQHC) plans to publish data about the performance of the Australian healthcare system. It is probably inevitable that this kind of information, which is actively disseminated and reported in such a way as to encourage readers to draw comparisons, will be used in the near future by the media, the public and politicians to make public judgements about the relative performance of individual hospitals or even individual doctors or groups of doctors. Initiatives such as these will therefore be perceived as a threat by some health professionals and some organisations. Would this negative response be justified? What might be gained from public disclosure and how can the policy be implemented successfully? We believe that a negative response to public disclosure in Australia would be counterproductive. Greater openness in healthcare is inevitable. Information is freely available about most areas of modern life and many believe that healthcare is one of the last bastions of protectionism. When millions of dollars are spent on healthcare, those who pay have a right to know that the money is being spent effectively, and the publication of comparative data sends a strong message about the willingness of health professionals and organisations to be accountable. In addition, public disclosure appears to be an effective way of improving quality.1 There is a growing body of evidence that the current level of quality of care is unacceptable2,3 and that quality-improvement initiatives using confidential data have been largely ineffective at changing the behaviour of health professionals.4 When comparative data are released to the public, it appears to remind providers of the issues and refocuses them towards taking action.5 Arguments in support of the status quo — that the data are inadequate, the public won't understand them and the media will misuse them — are not sustainable if public disclosure is introduced properly. There are lessons that can be learnt from other countries to guide the process of disclosure in Australia. The United States has nearly 15 years' experience of publishing data in the form of "report cards", or "provider profiles". The initiative was launched by the federal government and the momentum has been maintained by a variety of public, private, commercial and not-for-profit organisations. Consumers and purchasers of healthcare were expected to play a key role by selecting high-performing providers, but recent evidence suggests that the providers themselves make greater use of the data than the service users.6 There are some notable examples of improvements in both the processes and outcomes of care associated with the publication of performance data.1 Public reporting in Europe is less well established than in the United States, but hospital "league tables" have been published in the Netherlands for several years, and the UK government plans to introduce incentives linked to a range of publicly reported performance criteria.7 What can we learn from the initiatives that have already been introduced? First, a backlash from some doctors, professional groups and institutions (particularly those seen to be performing badly) is predictable. Some criticisms were justified in the early days of report cards but lessons are being learnt. For example, we know that forcing new initiatives on reluctant professionals is not the most effective way of changing attitudes, and the introduction of report cards is more likely to be successful if doctors are encouraged to take a lead, particularly in selecting the performance measures. Bringing the media on board at an early stage to ensure fair and balanced coverage also helps. In addition, delaying publication for a short period to allow providers time to look at and act upon the data is a useful strategy. Second, it is important that those who publish the data show a commitment to investing in the process and progressively improving the quality of the data and the validity of comparisons arising from the data. However, it makes little sense to "wait for better data" — data will always be imperfect and, as one commentator stated, it is important not to let "perfect be the enemy of good".8 Experience suggests that the process of publication can in itself act as a catalyst for data improvement. Third, the utility of comparative data comes less from making absolute judgements about performance than from the discussion arising from using the data to benchmark performance. There is therefore a strong educational component to the effective use of comparative data, and resources are required to facilitate this process.6 Finally, it is important to be cognisant of the risks of publishing comparative data.9 The danger of institutions refusing to treat certain disadvantaged groups in order to improve their apparent performance is well recognised, although probably overstated,10 and can be reduced by careful adjustment of risk and casemix. A tendency to focus on what is being measured at the expense of other areas of practice can be minimised by publishing a wide range of quality indicators. The risk of "short-termism" — an inappropriate focus on annual reporting cycles — can be reduced by ensuring a balance between short-term targets and long-term strategic aims. A greater degree of public reporting of information about healthcare quality is an inevitable and desirable way forward. Practitioners and policymakers in Australia have an opportunity to ensure that the policy is implemented in a manner that is most likely to produce positive change.

Martin N Marshall MSc, MD, FRCGP · Robert H Brook MD, ScD

Objective: To assess the incidence and nature of postoperative serious adverse events (SAEs) among inpatients having surgery in a tertiary hospital, and to determine which subgroups of patients might be at greatest risk.Design: Prospective observational study from 1 December 1998 – 31 March 1999.Setting: Tertiary teaching hospital in Melbourne, Victoria.Subjects: 1125 subjects having inpatient surgery during the study period.Main outcome measures: Inhospital mortality, length of hospital stay, and SAEs (myocardial infarction, pulmonary embolism, acute pulmonary oedema, unscheduled tracheostomy, respiratory failure, cardiac arrest, stroke, severe sepsis, acute renal failure, and emergency admission to intensive care unit [ICU]).Results: There were 414 SAEs in 190 of the 1125 patients (16.9%); 80 patients died (7.1%). The most common adverse events were emergency admission to ICU (95), respiratory failure (52) and readmission to ICU (37). In patients without SAEs, mean duration of hospital stay was 18.4 days (95% CI, 15.4–21.4), while in those with SAEs it was 38.5 days (95% CI, 35.3–41.7) (P < 0.0001). SAEs, including deaths, were more common after unscheduled surgery and in patients over 75 years of age. The combination of these two factors carried a 20% mortality. There were no differences in the incidence of SAEs among the major surgical specialties.Conclusions: SAEs are common and result in high mortality, especially in older surgical inpatients and those having unscheduled surgery. These findings raise important issues of optimal perioperative management in tertiary hospitals.

Rinaldo Bellomo MD, FRACP · Donna Goldsmith RN · Sarah Russell RN, PhD · Shigehiko Uchino MD

Rapid and radical change in almost every facet of society has brought in its wake community anxiety, suspicion and hostility. Current examples in Australia include the impact of globalisation, the introduction of the goods and services tax, and the actions of the banks in phasing out local branches. Even the health industry faces increased levels of public scrutiny and criticism. A recent example has been the aged-care institutions, charged with providing suboptimal facilities and services.1 Hospitals, too, both in the private and public sector, have received embarrassing media attention — the organ-harvesting scandal in the United Kingdom being but one example.2 Surprisingly, while such public pressure has resulted in many large companies formulating corporate codes of ethics, few hospitals, with the exception of some with religious affiliations, have adopted such codes. This may be due in part to many hospital staff having their own professional codes of ethical behaviour. However, a hospital is more than the sum of its professional staff, and decision-making at a corporate level raises ethical issues. For example, ethical issues need to be taken into account in the allocation of scarce financial resources and the sometimes fierce interdepartmental battles for funding. The size of many hospital budgets brings them into the ambit of "big business" and, as such, boards must be sensitive to the bottom line of financial accountability. Currently, there is increasing pressure on all businesses, large and small, to establish their activities on a sustainable basis, incorporating "triple-bottom-line" accountability — decision-making must take into account not only financial outcomes but also human rights and the impact on the environment.3 Only when all these issues are addressed, it is argued, can legitimate and responsible decisions be made. The question might be asked, why bother with a code of ethics when hospitals are governed by highly prescriptive laws and regulations covering just about every aspect of their activities — from occupational health and safety to environmental protection to paternity leave — and where the threat of litigation hangs heavily over the system? The simple answer is that, to maintain and develop a reputation with customers and the community and create credibility and trust in a "brand" or image, any organisation must these days go beyond pure legal compliance with regulations and avoidance of litigation. This requires a willingness to communicate the values under which the organisation will operate, and to be judged against those values. This is particularly important for community service organisations such as hospitals and even medical practices. In a code of ethics, a hospital is stating the values to which it is committed and which, in seeking to achieve its objectives, it will never violate. In short, the end never justifies the means. Codes of conduct have been in use in the Australian medical world for many years (eg, the Central Sydney Area Health Service has had a code of conduct in operation since the early 1990s),4 and A statement of ethical principles for those who shape and give health care has been developed by the Tavistock Group (a group comprised mostly of UK and US healthcare professionals and ethicists).5 However, a recent initiative by the Austin and Repatriation Medical Centre (ARMC), a major metropolitan teaching hospital in Melbourne, is believed to be the first code of ethics adopted by a major non-religious public hospital in Australia. Codes of ethics and codes of conduct are often assumed to be synonymous, whereas they perform quite different, but complementary, roles. To quote Lagan: 6,7 A code of ethics sits alongside a code of conduct and together they provide the ground rules for day-to-day behaviour as well as guiding how decisions might be made in unanticipated situations. Typically a code of ethics spells out an organisation's values and principles; it both reflects and shapes the organisation's culture. It makes transparent the values framework by which management will manage the business and its employees and the core values that will underpin company policies. [On the other hand] a code of conduct is about what types of behaviour are acceptable in the workplace. It outlines the rules and measurements by which employees will be held accountable in observing the stated corporate values and principles. Like all tertiary teaching hospitals engaged in research, ARMC conforms with the ethical requirements of the National Health and Medical Research Council. It also has a Patient Care Ethics Committee that deals with such issues as patient autonomy, and limitation-of-treatment policies. In 1995, a decision was made by the then Liberal State Government that the ARMC would be privatised. This naturally caused considerable concern. A major factor in this concern was whether the new "owners" of the hospital would adhere to the hospital's perceived high level of ethical concern and care for its patients. These ethical standards were nowhere codified. Therefore, a committee that included professional staff from the hospital — doctors, nurses and allied health professionals — together with community representatives set about developing a corporate code of ethics, to which some 200 staff members subsequently contributed. The plan was to present the code to the prospective purchasers of the hospital and seek their acceptance of it. In the event, the decision to privatise the ARMC was reversed, but the code had aroused so much interest that the ARMC Board decided to adopt it. While staff contributions to the development of the ARMC Code of Ethics were substantial, its continued relevance depends on effective promulgation or it risks going the way of many similar well-meant projects. Firstly, the code must be displayed within the hospital in such a way that staff, patients and visitors are constantly reminded of its ethical standards. One American hospital, which has a code of ethics, has achieved this by placing framed copies of the code in critical positions, such as reception, outpatients, emergency and other departments. Secondly, staff intake programs must include a session on the importance of the code. Finally, publicity in the community is vital. Above all, a code of ethics must be a living document, and genuinely form the basis for the value system on which every person in the hospital operates, and is seen to operate — from the boardroom to the bedside to the boiler room. The challenge to every incorporated body in the medical field, big or small, is to formulate a code of ethics that demonstrates its adherence to fundamental human values in the face of rapidly changing circumstances. Reconciling the ethics of responsible financial accountability and best-practice medical care has, in recent times, caused difficulties for hospital boards. Hence, the need for a code of ethics which covers both business and medical practice, and whose standards are higher than the minimum required by law. It is not an easy task and will become even more difficult in the future, but, in the long run, it will save hospitals and the practice of medicine many potential difficulties and enhance their status in the community. It is particularly important that such a code be regularly updated to reflect, among other things, emerging ethical issues in patient care and treatment in end-of-life situations and in the rapidly developing fields of life science, such as gene technology. Corporate code of ethics The Austin & Repatriation Medical Centre (ARMC) has adopted this Corporate Code of Ethics as an expression of its commitment to the community that it will apply the highest ethical standards to all its activities Values The Austin & Repatriation Medical Centre upholds the following values as being self evident and having both intrinsic worth and universal application: The inherent dignity of each and every human being The autonomy of the individual The exercise of care and compassion The practice of justice, fairness, honesty and integrity The proper stewardship of resources The advancement of knowledge and learning The striving for excellence Principles These values will be guided by the following principles: 1. All individuals of whatever culture, class or belief will be treated with respect, including and especially those who are intellectually or physically impaired or disabled, incompetent or deceased. 2. All individuals, especially patients, have the right to make or be involved in decisions which affect their lives, and where applicable this right extends to include consultation with those who are close to the patients concerned. 3. The primary concern of the hospital will be the provision of compassionate care and treatment to its patients with every effort made to relieve suffering. 4. The principle of justice will be observed in the avoidance of all discriminatory practices and the provision of equal opportunity. 5. Organisational activity, including administration, will be conducted in a fair, open and collaborative manner. 6. Responsibility and accountability will be exercised in all decisions and actions at every level to ensure that the best use of resources is achieved. 7. The importance of research and teaching in every clinical discipline will be recognised and every effort made to ensure that all research is conducted at the highest scientific and ethical standards. 8. The hospital acknowledges that it shares both a natural and a cultural environment with a wider community and affirms its commitment to respect and nurture those environments. 9. The pursuit of excellence will be encouraged not only in clinical practice but in every field of activity with the aim of improving standards of service to the community. Practices In accordance with "best practice" policy of the hospital, the principles enunciated in this Corporate Code of Ethics will be implemented as follows. Principle 1. Respect The conduct of all staff will reflect a respect for the uniqueness of every individual regardless of disability, impairment or incompetence. Such respect will be accorded to patients not only when they are living but also when they are deceased. "End of life" decisions will be made with due regard to the patient's known wishes, the responses of the next of kin and the relevant hospital policies. Principle 2. Autonomy Patient participation in decisions relevant to their condition will be regarded as both important and valued. They will be provided with information relevant to their condition openly and honestly, encouraged to ask questions and, where clinically viable, given time to reflect and consult before responding. Whenever possible, information will be made available both orally and in written form and in the patient's customary language. Clinicians will explain clearly to patients the difference between procedures which are accepted practices and those which are related to research. In the latter case, ARMC research ethics policies will be strictly observed. Principle 3. Compassion Every effort will be made to relieve patients of unnecessary suffering as speedily and effectively as possible. Special efforts will be made to identify and respond to unarticulated fears and anxieties. Where possible the needs of next of kin and others closely related to the patient will be addressed with care and concern. Principle 4. Justice The hospital recognises that this principle applies to dealings with staff and "stakeholders" as well as with patients. All patients will be afforded best possible treatment and care appropriate to their medical condition. There will be no discrimination based on race, culture, religion, sex or position in society. Treatment will be determined according to need, likely benefit, and the responsible use of resources. Legislation related to discrimination, harassment and equal opportunity will be observed both in the spirit and the letter of the law. Grievance issues will be addressed speedily and fairly. Principle 5. Collaboration Mutuality of respect will be encouraged between those engaged in clinical treatment and patient care. The sharing of information and decision making will be practised in the best interest of the patients. Unnecessary duplication of examinations, investigations and patient interviews will be avoided. External agencies and individuals including ministers of religion who contribute to the patient's welfare will be afforded respect and assistance. Before any innovative or experimental procedures are undertaken they will be discussed with other health professionals engaged in the patient's care. Principle 6. Accountability Clear guidelines of responsibility for the care of patients will be established. Health care professionals will be encouraged to express concerns without fear of recrimination. The allocation of human, financial and technical resources will be in accord with the hospital's policies and the responsible spending of public monies. There will be a continuing review of resource allocation in the light of subsequent outcomes. Principle 7. Research and teaching All professions represented at the hospital will be encouraged to engage in high quality research both in clinical practice and academic study. All research conducted within or under the auspices of the hospital will be subjected to scrutiny as to its scientific value and validity and according to the high ethical standards which the hospital holds. As a teaching hospital it will endeavour to provide students of relevant disciplines with opportunities for clinical study at the highest standard. The hospital will encourage and support the conduct of forums, seminars and other methods of education designed to assist staff and the wider community to a better understanding and practice of health related issues. Principle 8. Environment The hospital acknowledges that it shares a common natural environment with the surrounding community and will ensure that any potential threat to this environment emanating from the hospital will be speedily and effectively identified and addressed. The hospital will support community initiatives for the preservation and enhancement of the natural environment. Recognising the multicultural character of the social environment in which it operates, the hospital will encourage community involvement in its activities. Principle 9. Excellence The hospital will promote the pursuit of excellence at every level of its activities. Continuous quality improvement programs will be regarded as fundamental to this process. The hospital will recognise and appropriately reward outstanding achievements on the part of individuals and departments. The hospital will strive for world leadership in its clinical, research, teaching and administrative practices.

Max M J Griffiths MBE, BA, BCom, BD · Ian T Dunlop MA(Cantab), FAICD, FAIMM

To the Editor: We strongly support the proposal1 that it is time to create a special grant category for curiosity-based research proposals. Having been in biomedical research for over 50 years, we have experienced a period when most research was curiosity based. We can thus compare with the present situation — research aiming for a rapid, practical and commercial outcome has become almost a necessity for survival because of the increasingly severe reduction in government funding for universities and research institutes. We would like to illustrate the value of curiosity-based research with a few Australian examples from our own fields. In 1946, one of us (F F) was working on the experimental epidemiology of the causative agent of infectious ectromelia of mice (related to vaccinia virus). A chance observation — that the mice which survived the infection developed a skin rash — led to further study of the virus as a model for smallpox, measles and chickenpox infections. Thus, unexpected discoveries were made about the way the virus spreads through the body during the incubation period of these diseases.2 In 1951, myxomatosis spread in rabbits in the Murray–Darling basin of south-eastern Australia. The virus was initially extremely virulent (99% fatal), but the rabbits slowly developed genetic resistance. One of us (F F) studied the virus for 15 years, and this work was acknowledged as the best example of the co-evolution of viral virulence and host resistance.3 In 1957, Macfarlane Burnet proposed the clonal selection theory of antibody formation — that individual B lymphocytes made antibody of a single specificity.4 This was one of the most original concepts ever proposed in biology and it took 10 years to be widely accepted. It has since led to the production of monoclonal antibodies, which are used as basic reagents in research and diagnostic laboratories, and are now being used in immunotherapy. In the 1970s, Peter Doherty and Rolf Zinkernagel studied the role of the newly discovered cytotoxic T cells (which could lyse virus-infected cells) to find out how T cells recognised the infected cells. They showed that killing was restricted by the major histocompatibility complex (MHC) and that its role was to signal "altered self" to the T cell.5 These studies led to the award of the Nobel Prize in 1996. Cytotoxic T cell activity has since been shown to be the main immune mechanism for controlling and clearing many intracellular infections. Induction of a strong cytotoxic T cell response is the mechanism of candidate vaccines currently being trialled against HIV-1. In the late 1960s, one of us (G A), together with Chris Parish, showed that a bacterial protein, flagellin, induced antibody tolerance over a wide dose range. Parish was the first to show the inverse relationship between antibody and cell-mediated immune responses, which led others to describe two classes of helper T lymphocytes.6 These have been shown to be important in the development of allergy in infants, and offer the opportunity for immunotherapy to reduce the later incidence of allergy. None of these research programs was initiated with a commercial goal in mind. Benjamin Franklin, when asked about the importance of some research, replied "Of what use is a baby?".

Gordon L Ada AO, DSc, FAA · Frank Fenner MB BS, MD

To the Editor: The article by Nelson et al1 estimates Pharmaceutical Benefits Scheme and Repatriation Pharmaceutical Benefits Scheme (PBS/RPBS) savings if hypertensive patients on monotherapy were prescribed the agents recommended in guidelines; however, the analysis contains algebraic errors and insufficient sensitivity analyses. The question of excessive costs through the use of expensive agents for which there is no evidence of increased benefit for most patients is an important one, but the estimates of extent of overuse should be methodologically sound. The three main concerns we have with the paper's estimates are as follows: The total number of patients on monotherapy in Box 3 of the article adds to 1.1 million, whereas elsewhere the authors state that 60% of all 1.2 million Australian patients treated for hypertension are on monotherapy, giving an estimate of 0.72 million. (These estimates of 60% and 1.2 million are not referenced in the article.) One reason for this discrepancy is that the authors have treated the sum of column 4 in Box 2 as patients, not patient-years of treatment (some patients are on dual or triple therapy), leading to a 40% overestimate of numbers of patients on monotherapy reported in Box 3. Utilisation of prescription drugs is recorded by PBS/RPBS only if the cost to patient is subsidised. Therefore, PBS/RPBS expenditure divided by total patient numbers (Box 2) underestimates consumer cost for diuretics and β-blockers, both of which cost less than the non-concessional co-payment. Of total PBS/RPBS scripts, 16% are for non-cardholders,2 and the cost per script to these patients is about three to four times the prevailing 1998 cardholder co-payment. As a rough estimate, total consumer cost for these agents may need to be doubled, and their omission is therefore material. Although non-concessional patients still have a saving, it is less than that estimated in the article. Sensitivity analysis should have been performed on the following critical assumptions: (1) proportion of use for hypertension for each class of drugs, (2) the number of unsubsidised users of diuretics and β-blockers, and (3) the proportion of patients on each agent who are on monotherapy. It is vital that the current scrutiny by all stakeholders of PBS/RPBS expenditure be informed by reasonable estimates of inappropriate utilisation. The contribution made by the authors in developing a technique to estimate appropriate use for this group of drugs is valuable. However, use of unreferenced estimates of key variables, insufficient application of sensitivity analyses, algebraic errors and inappropriately combining PBS with non-PBS data may cloud rather than shed light on this issue.

Ben D Ewald · Brita A Pekarsky

In reply: We thank Pekarsky and Ewald for their comments. It is difficult to estimate the percentage of patients on monotherapy from any source. We used data from IMS Health (http: //www.ims-global.com/) to determine the number of person-years of exposure to drugs prescribed with a principal indication of hypertension. Some of these drugs were prescribed as a sole agent if the script was for this single drug alone. Exposure for such agents was expressed as a percentage of the total exposure of this drug. For example, angiotensin-converting enzyme (ACE) inhibitors were sole agents in 63.9%. In the other 36.1%, the co-prescribed drugs may have been another antihypertensive drug or another type of drug altogether. Corresponding figures for calcium-channel blockers were 61.3%, for diuretics 53.6%, and for β-blockers 60.0%. As an approximation, we used the estimation that 60% of patients were likely to have been on monotherapy for hypertension. Adding the number on monotherapy for each drug gives an estimate of 1.2 million for the total population on monotherapy for hypertension. Therefore, the total number on drugs is likely to be greater than the 1.2 million as estimated in our article. However, the essential figure is that of 1.2 million for monotherapy, which we stand by. It is true that a minority of prescriptions (16%) are written for people without a concession card and that these are more likely to pay the full cost of a cheaper drug. Our economic perspective was that of the PBS/RPBS. Hence, consumer costs were only included where the government made a copayment. It is acknowledged in the Methods section that "with some drugs, the patient copayment covers the total cost; in these instances the Commonwealth makes no contribution to the cost and these prescriptions are not recorded in the PBS/RPBS data" (page 566). It is also stated in the Discussion that the PBS/RPBS captures "much more of the cost of the newer, more expensive agents than thiazide diuretics or β-blockers" (page 567). We chose to limit our sensitivity analysis to the key issue of redistribution of agents after initiation of monotherapy. The data we presented allow interested parties to conduct their own further sensitivity analyses, such as those suggested by Pekarsky and Ewald.

Mark R Nelson MFM, FRACGP · John J McNeil PhD, FRACP · Anna Peeters BSc(Hons), PhD · Henry Krum PhD, FRACP · Christopher M Reid MSc, PhD

To the Editor: On reviewing the results of the Wimmera clinical risk management program,1 we are prompted to ask whether the model can be generalised to a tertiary hospital. The program outlined by Wolff and colleagues is a good model for local quality improvement and provides a foundation for developing a model for tertiary hospitals. However, in considering its applicability to tertiary hospitals, a number of issues must be addressed. The number of separations and emergency department presentations at tertiary hospitals does not lend itself to review of all medical records. Such review is time- and resource-intensive and probably unrealistic in a tertiary setting. A sampling strategy might be more suitable, but would introduce the possibility of sampling error and missing adverse events. The availability of medical staff to review records is also limited, with clinicians often having public, private and teaching commitments. It would also not be feasible for a medical director to be involved regularly in the day-to-day tasks of the process. Nevertheless, these issues could be addressed by allocating the review process to a dedicated, trained team. Development of a review pathway would ensure participation of senior medical or management staff when necessary. The interface between tertiary hospitals and local general practitioners is broader and less defined than in rural areas, making the involvement of GPs difficult. The clinical mix and complexity of patients requiring tertiary care differ significantly from those at a rural base hospital, and restricting screening criteria for adverse events to eight items, as in the Wimmera program, would likely result in adverse events being missed. In addition, the clinical structure of tertiary hospitals is not uniform, and specific criteria may need to be developed to address the clinical specialties of the hospital. Lastly, in this era of cost containment in healthcare, Wolff et al did not address the cost of its clinical risk management program. While this is not a fault in the study, cost would be an essential consideration in generalising the program to a tertiary hospital. The model used in the Wimmera program has limitations when considering adaptability to tertiary hospitals, because of issues of scale and day-to-day practicalities. Further examination of the costs involved in ongoing operation of the program and a cost–benefit analysis are required. In addition, investigation is needed into feasible options that deliver useful results in a tertiary setting before a quality improvement model can be developed that is relevant, appropriate and cost-effective for tertiary hospitals.

Kathy M Brown · Humsha Naidoo · Arona E Offenberger

In reply: The model developed in the Wimmera hospital for clinical quality improvement has formed the basis for quality improvement systems in several regional and tertiary hospitals in Australia. The resources required to implement the model have been costed, and the Victorian Department of Human Services has allocated $4.8 million to establish clinical risk management programs based on the Wimmera model in every Victorian public hospital in 2001–2002.1 Whichever programs are implemented, some adverse events will be missed. However, not all medical records need to be reviewed, nor all adverse events found. Regular identification of some events provides significant opportunities to improve care. As clinician time is limited, some hospitals that have implemented the Wimmera model have paid clinicians with existing appointments for extra hours to participate in risk-management programs. Although feedback to general practitioners is logistically more difficult in a tertiary centre, it can still provide valuable information if limited to only a sample of inpatients. We agree that some departments in tertiary hospitals, because of their specialised nature, would need to develop additional screening criteria. The actual cost of running a clinical risk-management program based on the Wimmera model depends on how many components of the model are implemented, but in our experience should not exceed 0.5% of a hospital's total budget. Cost–benefit analyses are difficult to undertake, as some adverse events arise through underuse of available evidence, and additional resources would be needed for full implementation of the evidence (eg, giving prophylactic antibiotics immediately before surgery to prevent postoperative infection,2 or low molecular weight heparin postoperatively to prevent thromboembolism3). We believe that in any institution, whatever its size, the initiation of effective programs for clinical quality improvement needs both enthusiastic support from the highest level of management and champions at the "coalface" of patient care. If these two elements are present, adequate resources will often be found. However, providing resources without appropriate clinical and administrative support is unlikely to improve patient care.

Alan M Wolff · Jo Bourke · lan A Campbell · David W Leembruggen

To the Editor: In their recent article on the use of modelling in pharmacoeconomics to estimate the potential benefits, risks and costs of preventive drugs, Liew and colleagues highlighted important strengths and limitations of this technique.1 One limitation is that modelling is discretionary: different analysts elect different models and get different answers. We argue that modelling is the first step. The next step is testing the predictive validity of the model by systematically collecting cost and effectiveness data over a period of time. Then the predictions of the original analysis could be compared to what actually transpired. The goal of pharmacoeconomics is the most accurate estimation of costs and benefits. The more these variables are truly study outcomes (that is, experimental and not constrained by assumptions of the economic model), the more valid the process. This will help reduce model discretion, improve data quality and increase the likelihood that the experiment could be replicated independently, the acid test of validity. In reducing the discretion inherent in pharmacoeconomics, we can allay the concerns of those who have questioned its underlying theory2 and validity.3 If one does not know the benefit of a drug, one conducts a study. Equally, if one does not know the cost of a drug, one needs a study. This has been the impetus for randomisation in design of pharmacoeconomic studies, thereby decreasing reliance on economic modelling.4 Furthermore, there are well-tested methods for quantifying the uncertainty of estimates obtained with randomised studies. In contrast, economic modelling assesses the robustness of the model assumptions, as reflected in the estimate, using sensitivity analysis. However, this analysis cannot separate uncertainties attributable to the model assumptions, uncertainty inherent in the data put into the model, and uncertainty of outcome estimates. One is left with nostalgia for the simplicity of the null hypothesis. How can we move forward? To reduce reliance on modelling and to collect better data, we propose that Australia, with its "culture of evaluation",5 again take the lead by creating a new "conditional listing" category on the Pharmaceutical Benefits Scheme for all drugs, not just preventive therapy. This would be available for selected products with strong biological rationale but inadequate current evidence on cost-effectiveness. By necessity, these would include only high-volume/low-cost and low-volume/high-cost products, as high-volume/high-cost products are rarely developed, and low-volume/low-cost products are not problematic. The sellers would then collect prospective data to substantiate cost-effectiveness of the products or would have them delisted. This would be truly innovative and, like the Pharmaceutical Benefits Advisory Committee itself, a first for the Commonwealth. Certainly, no other jurisdiction is even considering this, let alone proposing systematic study. With better data, we would learn which models and model assumptions yield accurate predictions. Of course, many challenges and difficulties will need to be addressed regarding this proposal, but in our opinion none are insurmountable, and the benefits of a program of this type clearly exceed the risks.

Kent R Johnson · Marissa N Lassere

Australia is following North America, the United Kingdom and other developed countries in promoting the use of nurse-led telephone advice services. The core of these services is very similar — nurses follow computer-driven protocols to give advice about a wide range of problems, most of which relate to acute minor illness. In the UK, NHS Direct has been introduced by government to improve access to NHS services and NHS Direct advice is also available on the Internet.1 In this issue of the Journal , Turner and colleagues report for the first time the operation of a nurse-led telephone advice service in Australia, HealthDirect in Western Australia.2 The service has been widely used, with over 300 000 calls being received during the first two years of its operation. The 10 most frequently used guidelines of the service covered more than half of all calls to HealthDirect, and more than half of callers were advised to contact their general practitioners. As in other countries, most callers were young adults or parents calling on behalf of children. There is some concern that the increasing use of telephone advice may disadvantage elderly and ethnic people, who find it less easy to use the telephone. Healthcare planners are clearly interested in whether these new services will reduce the demand for existing healthcare services. Turner and colleagues found that HealthDirect has reduced telephone calls to hospital emergency departments. In the UK, a reduction in the number of calls handled by emergency department staff coincided with the introduction of NHS Direct,3 but there was no reduction in the numbers actually attending hospital emergency departments or using ambulance services.4,5 NHS Direct may, however, have stemmed the rise in demand for GP out-of-hours care. The main effect in the UK appears to have been to provide a new service that the public use, and initial evaluation suggests that satisfaction with the service is high.6 An ongoing evaluation will determine the relative extent to which HealthDirect substitutes for other contacts with health professionals or simply provides a new service. A key question is whether such services are safe. A report of the UK service identified three cases out of over 280 000 where the advice given might have resulted in an avoidable serious outcome.7 A randomised controlled trial of a computer-assisted nurse telephone consultation service found no increase in deaths or serious adverse events resulting from nurse telephone advice.8 It seems likely that, in terms of avoiding serious adverse events, nurse-led services are at least as safe as other forms of care. However, US studies of simulated patients have documented substantial variability and incorrect advice,9,10 and early evaluation of the computer programs in NHS Direct reported similar levels of variability.11 For example, the proportion of callers in the first three NHS Direct sites advised to seek immediate GP care varied nearly threefold between sites (from 10% to 29%), and there was agreement on management between sites for only 39% of 119 standardised evaluation calls. Further studies of safety and consistency of advice are clearly needed. These should include evaluating telephone advice given by both nurses and doctors. Indeed, doctors have expressed concern about safety of the increasing amount of advice which they themselves give over the telephone.12 There remains the question about the cost effectiveness of nurse-led telephone advice lines. The actual cost of calls to NHS Direct has been estimated at £15 (A$42.50) per call.7 However, as important as the actual cost is the impact of these services on overall demand for care. If the net impact is to provide additional services, we do not know whether this is the best way to spend extra healthcare resources. Further, we do not know whether telephone advice would best be given by doctors or nurses. In Denmark, doctors staff telephone advice lines, and are electronically linked to community pharmacies so that they can prescribe remotely for suitable patients.13 If the aim is to reduce demand for existing medical services, then it might be more cost effective to use doctors (who deal with minor illness more rapidly) than nurses in this type of service. Overall, nurse-led telephone advice lines should be welcomed cautiously. Patients use them, and they are probably safe, but we do not know if they will reduce demand for existing services, or if they will merely provide patients with additional, albeit valued, service.

Martin Roland

The Hippocratic Oath has been in a parlous state, especially in the past three decades, since the rise of contemporary bioethics. Ethicists, historians, feminists, and patients' rights activists have all, for one reason or another, disparaged it. The Oath has been called outmoded, an instrument of gender discrimination, a device for professional monopoly, out of tune with societal mores, and inadequate to meet the moral demands of modern medical practice. Critics seem to agree that the Oath must be revised, replaced by a new ethic or left to physician and patient to decide for themselves. I have dealt elsewhere with the substance of these critiques.1 Here, I wish to call to attention the curious fact that, as depreciation of the Oath has intensified, its use at commencement exercises has become virtually universal in US and Canadian medical schools.2 To be sure, with increasing usage, extensive alterations have been made to the content of the Oath. Yet, the idea of an oath persists, and indeed flourishes, almost in direct relationship to its depreciation. Clearly, medical students, faculty members and medical school deans see some lasting value in an oath at the end, and even at the beginning, of a medical education. One may ask, What is the value of so discredited an exercise? Why does it survive? Why should it survive? Should, or, given the choice, would, medical students refuse to take it? Is the idea of an oath, Hippocratic or otherwise, merely a shard of a shattered image, or is it a seed of hope against a dispiriting future? Its currently dubious state notwithstanding, there are several reasons why oath-taking persists and should persist: An oath is a solemn promise made on a solemn occasion at which medical graduates publicly declare their dedication to certain distinguishing moral commitments. This makes them de facto a moral community, a group of people united by a common ideal and together making up a single organism. Their common commitment is a reassurance to the public, a source of strength for those taking the oath and a promise that physicians will act in the interest of their patients. An oath sets the profession apart. It declares that those who take it are committed to something beyond self-interest. This is not commonly the case in a world where competition and self-interest are so strongly legitimised. Although this competitive element has already corroded the idea of a profession, there is enough awareness of the common bond of profession to provide a restraining force. An oath is also a reminder of the continuity of a profession whose roots are in antiquity. Although many medical practitioners in the past and present have violated the canons of the oath, physicians are loath to give up the ideal. They know intuitively that to do so would be to destroy the ideal and to lower the moral sights of a majority of physicians. Even those who argue strongly for the laissez faire approach to medical practice do so with the lame excuse that an oath is too "idealistic". An oath also has the seed of hope within it. Not that a golden age of the past will be resuscitated — there never has been a golden age of medical morality. But there have been times when physicians were more unequivocally committed than now to the good of those they serve. The pragmatists may call this impractical and unrealistic. But even pragmatists can not deny that there is something especially demanding, but, at the same time, satisfying, about caring for sick people. What this all adds up to is the innate recognition by conscientious physicians that they are engaged in something more than commerce, industry or mere contracts for service. They may justify their lapses in behaviour by saying that change is required by the times or that it is what society wants, and so on. But no true physician can, in good conscience, destroy the archetype of medicine as a noble profession. Yes, perhaps for many the medical oath is today a shard of a fractured ancient image. But enough of that image remains in the consciousness of the profession to remind us that to forget it entirely would be to make medicine a commercial, industrial or proletarian enterprise. We know instinctively what this would do to the care of the sick. That is why we still take oaths. Let us hope we always will.

Edmund D Pellegrino

Internationally, there has been mounting interest in call centres and their use of modern telecommunications and information technology for the purpose of medical triage.1 These initiatives originated mostly in the United States in response to the need to reduce escalating healthcare costs.2 However, they became widespread in the early 1990s as part of a broader strategy by many US healthcare organisations to implement demand-management strategies focused on improving consumer health knowledge and preventing unnecessary use of expensive health resources such as emergency departments.3 These services, staffed largely by registered nurses, often acted as a gatekeeper for access to emergency healthcare services and provided telephone triage, recommending appropriate levels of care supplemented by advice on self-care and information about provider availability. In countries with largely public healthcare systems, such as the United Kingdom and Canada, gatekeeper functions are performed mostly within existing primary care services. Thus, potential indirect benefits such as improvement in service access and availability (especially after-hours) have made telephone triage a rational and popular policy initiative. The largest whole-of-population approach to date has been NHS Direct in the United Kingdom. This service began in 1997 and currently 65% of the population of England has 24-hour access.1,4 In the United States 100 million people are estimated to have access to telephone triage, while in Ontario, Canada, the Ministry of Health and Long-Term Care has instituted a similar approach for a population of more than 10 million people. In 1996, the Department of Health in Western Australia (DoHWA) began negotiations with relevant stakeholders which culminated in the official launch of HealthDirect at the end of May 1999. This triage and health information service is provided by McKesson, a specialist in the delivery of health call centre services on behalf of the DoHWA. It operates from a dedicated call centre with 33 full-time-equivalent (FTE) operational staff (48 nurses) and is available to the whole of the State, 24 hours a day, seven days a week. Here, we document the activity of this centre over the first two years. The serviceTelephone triage is performed by nurses registered to practise in Western Australia. Recruitment is followed by several weeks of intensive training. Once nurses are taking calls it takes a further three to six months to build skills to a level commensurate with the expected triage standard performance criteria (Box 1) and key performance indicators (Box 2). During training and throughout the probationary period, nurses are provided with information about their individual performance related to these performance indicators. Monitoring and feedback continue throughout employment, focusing on the positives while identifying areas for improvement. Access to the triage service is by an extensively advertised, freecall 1800 number. The nurse asks for the caller's name and contact number, although the service accommodates the 6.4% of callers who wish to remain anonymous. After registering the caller, the nurse obtains sufficient history to assign a "primary symptom" from which the most appropriate clinical guideline is selected from the call centre Centramax decision-support software (proprietary software written in the US, but modified by a DoHWA-appointed group of Western Australian general practitioners to reflect Australian terminology and medical practice). After a series of responses to guideline-prompted questions, a disposition (one of 26 codified management recommendations; see Box 3) is reached and the caller advised to seek the recommended level of care. At their discretion nurses may override to a higher level, but there is no provision to downgrade dispositions. Training, continuing education and continuous quality managementTraining, quality assurance (QA) and quality improvement (QI) are overseen by three part-time medical directors (a general practitioner, consultant psychiatrist and emergency physician) and an emergency clinical nurse specialist employed by DoHWA. There is also a nurse responsible for training and continuing professional education (0.5 FTE), as well as two nurses (1.5 FTE) who undertake quality control and improvement. One per cent of call volume, about 25–30 randomly selected calls per week, are monitored for this purpose. This involves real-time monitoring as well as examining the case record. In some cases the nurse may also listen to a tape recording of the call, although taping is not routine and the tape is erased after review. These data are appraised against a set of guidelines developed by HealthDirect and enable the objective measurement of individual nurse performance as well as formalising feedback to DoHWA. QA is also complemented by fortnightly, formal coaching of all nurses by their team leader. Performance dataDuring the 24 months there were 315 784 inbound calls, of which 217 891 (69%) originated from the metropolitan 1800 number, 78 946 (25%) were transferred from metropolitan hospital switchboards and 18 947 (6%) originated in rural Western Australia (where the service was only available for the last 12 months). The abandonment rate was 6.8%, but 30% of such calls disconnected were connected for less than 20 seconds. Based on data for 2001, 75% of calls were answered within 20 seconds, with an overall average speed to answer of 53 seconds. The average call duration was nine minutes 47 seconds (range, 1 to > 60 minutes), including one minute 46 seconds of after-call documentation. These results accord with HealthDirect's telephone service standards. There were an average 13 158 inbound calls per month (range, 10 099–16 430; see Box 4a). Consistent with international data,5 there is a preponderance of calls relating to childhood illness and adults aged 21–30 years (Box 4b). Of interest is the absence of a significant demand peak from persons older than 60 years. This may reflect a greater level of comfort among younger adults using the telephone as a means of obtaining services and information. The number of calls increases after 6am and reaches a peak at 8am which is sustained until mid-afternoon. This is followed by a second peak in the early evening (Box 4c). A reduction in call volume ensues at about 10pm but 30–40 calls are answered between midnight and 6am. Predictably, concern over public health issues increases call numbers and at times may prove overwhelming. For example, this occurred in late June 1999 immediately following a well-publicised enterovirus outbreak, when an additional 700 calls were received during a 24-hour period. That day there were 1149 calls, with rates exceeding 100 calls per hour during several periods. The top six dispositions are listed in Box 3. HealthDirect advised 54% of adults and 78% of children to attend a general practitioner within four hours to one week. The remainder were given an immediate disposition to either a general practitioner or emergency department, or advised to call an ambulance. Six per cent of calls were referred to the Poisons Information Centre (PIC) and 0.24% to the Psychiatric Emergency Team. Transfers to Poisons Information involved a wide range of issues, including insect bites, accidental and deliberate ingestions and medication enquiries. The Centramax software6 used at the HealthDirect database consists of 550 guidelines, of which 149 are "activated" (appraised and modified for local use). Of these, the 10 most frequently used adult and paediatric guidelines (Box ) cover 51% of calls, while an additional 25 guidelines encompass 95% of all calls. In the absence of an appropriate guideline, the nurse follows an established procedure for assessing the urgency of symptoms and level of care needed. This type of assessment usually applied to low-acuity symptoms, for example chronic fatigue, and was used in 5.4% of calls. The frequency of the principal dispositions for both adults and children is shown in Box 3. These frequencies are similar to those reported by similar nurse triage services in the US and the UK that use non-algorithmic decision support software5 (Ian Lazarus, McKesson Call Center, Phoenix, 1998, personal communication). Since December 1999, 1479 1–2-hour QA assessments have been completed, a rate of 2–3 per month for each nurse. This included a monthly report card based on individual nurse performance on key indicators. Overall, 96% of appraisals scored a satisfactory or higher grade. DiscussionHealthDirect was instigated by DoHWA to provide symptomatic callers with advice on when and where they should seek medical attention. The numbers of calls (an average of 95 per 1000 for the 1.67 million WA population) is similar to that documented in other countries.7,8 The annual call centre budget of $4.5 million (including all programs) is less than $2.51 per capita and represents about 0.2% of the State health budget. This translates to about $20 per triage call. It must be stressed that HealthDirect advises most symptomatic callers to attend a healthcare provider, albeit in differing time frames. A homecare disposition was deliberately omitted initially in the interests of introducing a new service with maximum possible safety, but has now been included in some guidelines on the advice of the local medical review panel. In any case, there is evidence from a recent 72-hour call-back study conducted by Curtin University of Technology in WA (yet to be released) that a substantial number of callers given lower dispositions are satisfied with the telephone advice provided and do not attend a medical service. Therefore, the greater use of a homecare disposition could potentially reduce general practitioner consultations for minor complaints without compromising patient wellbeing. Although we have records of several patients, including seven with documented meningococcal infections who were offered and took advice to attend hospital immediately, there are insufficient data to rigorously address the issue of efficacy, or to benchmark performance against other forms of medical assessment. At present, there are only two specific outcomes supported by data. Firstly, the service appears to be popular. This accords with the experience of others,5,9,10 including in Australia, where research has "demonstrated enormous community support [for] emergency department telephone advice"11 which is "rated highly by the community and the compliance is strong".12 Secondly, telephone advice calls directed to the Perth metropolitan hospital emergency departments are now, to all intents and purposes, non-existent. Given that 50 000 emergency department attendances equate to 24 hours of non-stop telephone advice,11,12 HealthDirect has relieved emergency departments of a considerable burden. Currently, a 12-month independent evaluation of HealthDirect is being undertaken by Curtin University of Technology WA on behalf of DoHWA and the Commonwealth Department of Health and Aged Care. The results will also form part of a national after-hours primary medical care "trial", with similar studies being conducted in four other States. The main focus will be to determine the effectiveness of telephone triage as a demand- management and referral tool for the more efficient use of health services, particularly after-hour services. The approved study plan is comprehensive and employs several methods to gauge consumer compliance and satisfaction with advice given, health-provider acceptability with referrals, quality of clinical advice, impact on services, as well as financial aspects. The study will also measure the impact of HealthDirect on emergency department workload and ascertain the appropriateness of referrals. Although overseas data document that call centre nurses with GP backup do not increase mortality, morbidity, admission to hospital or emergency department attendance,7 as well as significantly reduce after-hours telephone calls to GPs,8 there is justified uncertainty about the role of telephone triage centres. Opinions include those which regard the service as no more than a "de facto general practice"13 or express the opinion that "a multinational or offshore managed care organisation" would be "in a very good position to slowly set up a monopoly by opening their own health centres and directing after hours, and in-hours patients . . . to their own facilities".14 Others argue that the impact of telephone triage on health services is unknown and assert that the high cost of such ventures would be better directed elsewhere. It bears repeating that only further research will provide sufficient data to decide these issues. Regardless, it is not the aim of telephone triage to diminish the role of general practitioners. Experience has shown that almost three-quarters of calls occur after normal practice hours, and indeed HealthDirect consistently receives calls every few days from one or more of the six Perth GP after-hours cooperative clinics advising they are unable to accept further referrals. The futureOver the next 12 months, given the policy direction articulated by both State and Federal governments, it is likely that an increasing proportion of the Australian population will have access to telephone-based triage and health information services. Further, the use of call centre infrastructure to provide services focused on improving access and outcomes for the mentally ill and those with chronic medical conditions is also likely to be trialled. Information documenting demand will be complemented by data measuring the ability of this type of service to favourably influence human behaviour and medical outcomes. It remains to be seen whether the inclusion of interactive options such as cardiac telemetry and spirometry is likely to prove beneficial and cost effective. Attractive as they may seem, novel inventions must transcend novelty. 1: Triage standard performance criteria Operational 24 hours, seven days a week Access for people with hearing impairment and from non-English-speaking backgrounds Call interaction documentation Advice supported by a clinical decision support system Patient confidentiality maintained Activity and performance reporting Ability to link with other services and transfer calls 80% of calls answered within the first 20 seconds Abandonment rate of 5% or less of calls Call time (talk time and after-call work time) 550 seconds 1% of calls monitored for quality assurance 2: Summary of key performance indicators Opening, closing, transfer, holding Establishing caller needs Rapport, conversation control Attentive listening Capturing relevant data Data entry accuracy Use of approved resources and information Primary assessment Interpretation of presenting problem Choice of guideline Determining first pertinent positive and disposition (see Box 3) Need to override disposition Provision of understandable solution Lack of bias Management of difficult calls 3: The six principal dispositions (of a total 26), and the percentages of adults and children assigned these dispositions in the 24 months Disposition Description Adult Paediatric RING 000 The caller needs to be transported to hospital immediately and may require medical attention in transit or before being transported to hospital 9.1% 2.7% EDIMMED The caller needs to attend an emergency department immediately 14.7% 11.8% URGCARE The caller needs to attend a doctor immediately. The provider (general practitioner, clinic or locum service, or emergency department) is determined by availability at the time of call 12.6% 4.9% SEEIN4 The caller needs to see a doctor soon and within four hours 16.6% 17.5% SEEGP1 The caller needs to make an appointment to see a GP either the same day, or the next day if they are calling in the evening. Callers are informed that they should see their GP earlier if their symptoms worsen 18.4% 17.5% SEEGP2 The caller should make an appointment to be seen by a GP when convenient within the same week. Callers are informed that they should see their GP earlier if their symptoms worsen 19.0% 42.6% 4: Call patterns over the 24 months 5: The 10 most frequently used adult and paediatric guidelines Adult Paediatric Abdominal pain Fever Headache Vomiting Chest pain Diarrhoea Vomiting Rashes, widespread Neurological deficits Cough Backpain Head trauma Rash Abdominal pain Dizziness Colds Abrasions/lacerations/bites/stings Rashes, localised Diarrhoea Headache

Valendar F Turner FRACS, FACEM · Peter J Bentley MB BS · Sharon A Hodgson MB ChB, FRANZCP · Peter J Collard BBus · Rosalia Drimatis BHealthSci (Nursing) · Catherine Rabune BSN, MHA · Andrew J Wilson MM FRANZCP

The research enterprise The Menzies Centre for Population Health Research A unique and supportive local population was a vital ingredient in the Centre's success Terence Dwyer MJA 2001; 175: 617-620 Early days: the Tasmanian Infant Health Survey and Sudden Infant Death Syndrome - The post-SIDS era: taking stock - New directions - Genomics - The future - References - Authors' details - - More articles on Psychiatry I ACCEPTED THE CHAIR IN COMMUNITY HEALTH at the University of Tasmania in 1985 with the intention of setting up a research centre that focused on epidemiological research into preventable causes of disease. While I did not know how the centre would be funded, I was certain that Tasmania would be a very competitive site for such research. Already, valuable epidemiological studies on iodine deficiency, hydatid disease and asthma had been conducted in the absence of significant research infrastructure.1 The "Island State" provided a perfect source population for unbiased selection of cases and comparison samples or controls. Further, the land area and population size (around 500 000 people) made follow-up of cohorts relatively easy. Thus, Tasmania had important advantages for the two major strategies used to search for environmental and lifestyle causes of disease — case-control and cohort studies. Funding from the Menzies Foundation came about through the input of three people — Basil Hetzel, then Chief of the Commonwealth Scientific and Industrial Research Organisation Division of Human Nutrition in Adelaide, who had a close association with the Menzies Foundation; Professor Ian Lewis, Dean of the Medical School at the University of Tasmania and a member of the Menzies Foundation Board; and Eric Wigglesworth, the Director of the Foundation. To determine the likely success of such a centre, the Foundation Board held a three-day workshop attended by representatives of State and Federal health departments and the World Health Organization, notable Australians in the field of public health, and distinguished British epidemiologist Sir Richard Doll. History of the Menzies Centre 1987 Workshop ("Towards a Centre for Population Health Research") in Hobart, Tasmania. 1988 Official opening in January. Collection of Tasmanian Infant Health Survey (TIHS) data began (prospective study on Sudden Infant Death Syndrome [SIDS]). 1990 Designated as a World Health Organisation Collaborating Centre for the Prevention of Cardiovascular Diseases. 1991 Provides prospective evidence confirming importance of prone sleeping position as a cause of SIDS (Lancet 1991; 337: 1244-1247). 1992 Evidence that SIDS death rate was falling after a national campaign on infant sleeping position. 1993 Research helps explain how prone position interacts with other factors to increase risk (N Engl J Med 1993; 329: 377-382). 1995 First follow-up of TIHS cohort searching for early life influences on childhood diseases. Shows that the major decline in SIDS deaths from 1991 onwards is the result of changes in infant sleeping position (JAMA 1995; 273: 783-789) 1997 Contract signed with AMRAD pharmaceutical company. Provides funding for Genetic Epidemiology Unit. 1997-2000 Follow-up of the Tasmanian Infant Health Survey cohort into childhood provides important evidence about early life determinants of risk for osteoporosis, blood pressure and asthma (J Clin Endocrinol Metab 1998; 83: 4274-4279; J Bone Miner Res 1999; 14: 146-151; BMJ 1999; 319: 1325-1329; Thorax 1999; 54: 664-669). 2000 Named "Tasmanian Icon" by State Premier. Core funding doubles. Key events Major scientific achievements. Subsequently, the Menzies Foundation Board decided to support the establishment of an epidemiology research centre, to be named the Menzies Centre for Population Health Research. The Foundation then met with the Tasmanian Premier and Minister for Health, who matched the Foundation's initial contribution of $100 000 per year. Early days: the Tasmanian Infant Health Survey and Sudden Infant Death Syndrome Before my departure from Sydney University, I had been reviewing the data on disease distribution in Tasmania. Sudden Infant Death Syndrome (SIDS), with an annual rate in Tasmania twice the national average, stood out. The head of neonatology at the Royal Hobart Hospital, Neville Newman, convinced me that this should be the subject of a major research effort. The cause had not been clearly identified, and epidemiological research had been limited. With helpful input from Geoffrey Berry, Professor of Biostatistics at Sydney University, we planned the first prospective cohort study on this condition. Preliminary work began just before the decision of the Menzies Foundation to support the establishment of the Centre. The epidemiology research group within the Medical School at the University of Tasmania consisted of one epidemiologist, the research fellow Trevor Beard, and limited support staff. Even with the extra $200 000 that the establishment of the new Centre brought, it would not have been realistic to work on a broad front. It was decided that we would focus most of our effort on the new SIDS research program. The next step was to build an appropriately skilled team. We advertised for another epidemiologist and a biostatistician, but it proved very difficult to attract qualified applicants. It seemed that Australian academics were either not interested in living in Tasmania, or were not confident their careers would flourish there. This problem was compensated for by a stroke of good luck when a young Tasmanian medical graduate, Anne-Louise Ponsonby, became our first postgraduate student, working on SIDS. She put an incredible amount of intelligently directed energy into the SIDS program, and together, with financial help from the Australian Rotary Health Research Fund, we were able to develop momentum in the project. In 1988, we initiated the first full data collection for the cohort study — a huge endeavour that involved measurements each year in 1500 infants and their mothers on three occasions in the first three months after birth. That we could get this work under way was pleasing, but we needed to find well-qualified biostatisticians. Given the previous lack of success with advertising in Australia, I decided to use our international network. Sir Richard Doll referred Michael Jones, a young Master of Science graduate from Oxford, who was recruited to our ranks, and then Laura Gibbons, from the University of Massachusetts, joined us. This relatively small and young team of investigators coordinated the conduct, data management and analysis of the SIDS program. They also assisted with less well resourced but developing areas in cancer and cardiovascular disease. In late 1990 evidence was accumulating from case-control studies that prone sleeping position might be a major cause of SIDS, but the research was retrospective, creating concerns that recall bias might explain the findings. We had the only prospective data in the world and were able to show that the association was equally strong prospectively, ruling out recall bias.2 A number of countries, including Australia, launched campaigns to encourage parents not to place babies on their stomachs in the cot, with astonishing results — the death rate from SIDS in Australia fell from 507 in 1990 to 139 in 1998, with similar falls in a number of other countries.3 While our work was not the only important contribution to the understanding of this major cause of SIDS, it provided an important piece of evidence needed for solving the puzzle. Later, in 1993, our team explained why prone sleeping position seemed to exert a different effect in winter than summer and a different effect across countries.4 Then, in 1995, we provided evidence that showed clearly that the fall in deaths could only be attributed to the changes in prevalence of prone sleeping position.5 This success will undoubtedly rank as one of the major contributions of the Centre in the years to come. It also established the organisation as one which, in its special location, could have a significant impact on international medical science. It was the much-needed platform that would underpin future recognition and opportunities. The post-SIDS era: taking stock The death rate from SIDS fell so rapidly after the prone sleeping position campaign that, by late 1991, it was clear there would eventually be insufficient cases occurring annually in Tasmania for epidemiological research (when we started the SIDS program, there had been an average of 27 cases a year for an extended period, and by 1998 there were only three). While this outcome was tremendously gratifying, it was clear that the research money to support our staff of now approximately 20 would dry up unless we repositioned our research program. This was confirmed by the National Health and Medical Research Council (NHMRC) Regional Grants Interview Committee's decision not to recommend refunding of our cohort study for 1992. We went from triumph to a period of considerable adversity. One of our first responses was to tell the Tasmanian public that we needed its financial and moral support. They responded generously. With a major public fundraising appeal, helped greatly by our Board and new Chairman John Tomlinson, and a timely decision by the United States National Institutes of Health, we were able to continue the study long enough to thoroughly evaluate the impact of the prone sleeping intervention campaign. In 1992, I took some time to review where we were going as an organisation and to think about where our future research opportunities might lie. I visited people like Richard Doll in Oxford, who had provided very helpful mentoring since 1987. I also had discussions with Ken Rothman (author of Modern epidemiology6), and Dimitris Trichopoulos at Harvard. These visits confirmed that, if we were to continue to conduct work of global significance, we would have to search even more thoroughly for gaps in knowledge that might be filled by an epidemiological approach. I was also convinced that we would need to develop stronger working relationships with basic scientists if we wished to use epidemiology to understand aetiology. These strategies were challenging, but all our team had learned a great deal from the SIDS research experience. While overseas, I also upgraded my skills in organisation and management by attending a management course in Salzburg, led by Peter Drucker, one of the world's most prominent management theorists. New directions The perspectives gained during my overseas visit were incorporated into planning from 1992 onwards. The major new strategy we decided on was to follow the Tasmanian Infant Health Survey (TIHS) cohort, now numbering 11 000 infants and children. The focus would be to search for links between early life exposures and later disease, using our extensive database of infant measurements that provided information on more than 450 variables measured during the first three months of life. One disease we looked at was asthma, an important disease for which preventable causes had not yet been identified and for which there was a shortage of good epidemiological data. This investigation would be coordinated by Anne-Louise Ponsonby, with help from David Couper, a biostatistician who had joined us from Seattle. We also increased our activity in research on the development in childhood of risk factors for cardiovascular disease and diabetes. Fitting into this theme was the new program started by a recent recruit from the Garvan Institute in Sydney, Graeme Jones (we were finally starting to see interest in work opportunities from well-qualified Australians outside Tasmania). He had a strong track record in osteoporosis in the elderly, and he used that background to focus on the impact of early-life factors on bone density in childhood. Fortuitously, interest in the "Barker hypothesis", which concerns the impact of fetal development on later disease, was gaining momentum. We were well placed to make an important contribution in this field, and our capacity was greatly enhanced by the addition of Ruth Morley, from the Institute of Child Health in London. Supplemented by smaller research efforts in cancer and adult cardiovascular disease, by 1994 we were able to see evidence that the research program was growing again. Between 1994 and 2000, the team was able to attract 17 new NHMRC grants from 38 applications submitted. This overall level of success was built on the tremendous preparedness of the Tasmanian public to be involved in the research. Response rates for case-control studies in this period were about 90% for cases and 80% for controls sampled from the electoral rolls, with comparable figures for cohort follow-up. In addition to our growing research effort we took on an important role in ensuring that knowledge was transferred to countries with less developed research capacity. The World Health Organization designated our institution as a Collaborating Centre for the Prevention of Cardiovascular Disease (CVD) a decade ago. That role has expanded steadily to the point where the Centre is assisting in studies on CVD in countries including Vietnam, Fiji and Samoa, where CVD and diabetes are producing an unexpectedly high disease burden. Genomics For the first seven years (1988-1995) the Centre focused solely on the environmental and lifestyle causes of disease. Meanwhile, others had been using the deep family pedigrees available in Tasmania to search for genetic causes of diseases following a Mendelian pattern of inheritance. Novel genes or linkages were discovered for several conditions, including multiple endocrine neoplasia and Huntington's disease. These successes were based on special features of Tasmania that are replicated in few other locations, namely (i) a population descended largely from identifiable founder families; (ii) comprehensive genealogical records; (iii) a modern healthcare system capable of identifying disease outcomes; (iv) a demonstrated capacity to involve the population in studies; and (v) organisational structures to facilitate the research. In 1995, David Mackey, a Tasmanian medical graduate and ophthalmologist at the Victorian Eye and Ear Hospital, approached us. He was undertaking important work in Tasmania on the more complex genetics of glaucoma. He wanted a base in Tasmania, and the Walter and Eliza Hall Institute, in Melbourne, was seeking a Tasmanian institution to manage new research and development syndicate funds to support his research. We accepted the role and our interest in the use of epidemiology to find genes for human diseases increased. Then, in 1996, the Australian pharmaceutical company AMRAD approached us about increasing its involvement in gene discovery in Tasmania through the Menzies Centre. We agreed, on the condition that the funding would be for a genetic unit that would employ people who could provide intellectual input to the work from a Tasmanian base. AMRAD signed a contract in 1997 for a five-year grant of $2.5 million, and, in 1998, we attracted Tasmanian molecular geneticist Michele Sale to coordinate the work. With financial and other help we were able to very quickly get projects under way in multiple sclerosis and osteoarthritis, and have continued to develop activity with Cerylid, a spin-off from AMRAD formed to operate its discovery arm. The genomics development has also led to an increase in postgraduate student training at the Centre, with five PhD students currently enrolled. The future During the past 12 months there have been several important developments for the Centre, driven by our very committed Board, chaired by Jean Trethewey, and strongly supported by the Dean of the Faculty of Health Science at the University of Tasmania, Allan Carmichael. The Tasmanian Government introduced an "Icons Program", which supports the Tasmanian Symphony Orchestra and our State cricket team. To this list Premier Jim Bacon added the Menzies Centre, with a commitment to provide $500 000 a year to help our organisation develop its capabilities. This, together with a large donation in 2000 from the United States-based Atlantic Philanthropies Inc, has placed us in a previously unimagined position to recruit more staff and drive our research program. To enable us to undertake these future developments with vigour, the University of Tasmania Council has established the Menzies Centre as an independent company limited by guarantee, remaining within the university structure. In 2002, the Centre will become the "Menzies Research Institute". Already, the Centre has grown to support a staff of 60. The new institute is likely to start 2002 with a budget of approximately $5 000 000 that will see staff numbers increase to more than 100, working on both environmental and genetic causes of disease. A major NHMRC grant of $2 290 000 over the next five years will enable us to study a cohort of Australians first measured as schoolchildren in 1985. They will be followed up for the emergence of adult disease, and it is anticipated this will provide the first direct evidence available on the impact of childhood lifestyle and biology on diseases such as coronary heart disease. A collaboration with similar cohorts in the US and Finland has already been established. A new director of the Cohort Studies Unit, Alison Venn, who has a strong background in this research strategy, has been recruited from the Centre for the Study of Mothers' and Children's Health at La Trobe University to coordinate developments. A large adult cohort study in Tasmania, with a focus on exposures that occur closer to the time of disease development, will also commence in 2002. Both studies will benefit from the input of a now-strong biostatistics group of three staff headed by one of our own PhD graduates, Leigh Blizzard. The level of genetic research activity will expand greatly. Tasmania presents opportunities as good as any in the world for gene discovery, and we intend to take up these opportunities. An increasing number of epidemiological studies at the Centre are focused on finding novel genes or validating candidate genes identified through animal or cell studies, or bioinformatic "data mining". This growth in activity reflects the recognition by commercial and government sources of the opportunities here, as well as the developing capacity of our genetic unit. Increasingly, our "environmental" epidemiologists and biostatisticians are developing their interests and skills in genetic research. This has not only led to the more rapid development of a critical mass for projects on gene discovery and validation, but has also opened up the possibility for in-depth investigation of gene-environment interaction. Projects with this focus are already under way in multiple sclerosis. There is great scope for us to contribute in an internationally significant way to the understanding of gene-environment interactions using Tasmania's unique population and our skill base. In the coming decade Australia will be relying more and more on its medical research institutes to maintain its competitive advantage in a knowledge-based global economy. We are confident that the new Menzies Research Institute will be making its contribution. References King H, editor. Epidemiology in Tasmania. Canberra: Brolga Press, 1987. Dwyer T, Ponsonby AL, Newman NM, Gibbons LE. Prospective cohort study of prone sleeping position and sudden infant death syndrome. Lancet 1991; 337: 1244-1247. Australian Bureau of Statistics. Deaths, Australia, 1990, 1998. Canberra: ABS, 1998. (Catalogue no. 3302.0/3303.0.) Ponsonby AL, Dwyer T, Gibbons LE, et al. Factors potentiating the risk of SIDS associated with the prone position. N Engl J Medicine 1993; 329: 377-382. Dwyer T, Ponsonby AL, Blizzard CL, et al. The contribution of changes in the prevalence of prone sleeping position to the decline in SIDS in Tasmania. JAMA 1995; 273: 783-789. Rothman K. Modern epidemiology. Boston: Little John and Co., 1986. Authors' details Menzies Centre for Population Health Research Terence Dwyer, MD, FAFPHM, Director. Reprints will not be available from the author. Correspondence: Professor T Dwyer, Menzies Centre for Population Health Research, 17 Liverpool Street, Hobart, 7000 TAS. t.dwyerATutas.edu.au Make a comment

Terence Dwyer

To benefit from the US experience of corporatisation, Australia must focus on the clinical advantages rather than the financial windfalls M Kevin Outterson MJA 2001; 175: 426-427 Clinical independence - Efficiency - Access to capital - The opportunity in Australia - References - Authors' details - - More articles on General practice and primary care From the annual reports of two publicly traded physician practice management corporations: . . . The Company enhances clinic operations by centralizing administrative functions and introducing management tools such as clinical guidelines, utilization review and outcomes measurement. The Company provides affiliated physicians with access to capital and advanced management information systems . . . The Company offers medical group practices and independent physicians a range of affiliation models. These affiliations are carried out by the acquisition of [practice] entities or practice assets, either for cash or through an equity exchange, or by affiliation on a contractual basis. In all instances, the Company enters into long-term practice management agreements that provide for the management of the affiliated physicians by the Company while assuring the clinical independence of the physicians. . . . As an integral element of these alliances, the Company utilizes sophisticated information systems to improve the operational efficiency of, and reduce the costs associated with, operating the Company's network and the practices of the affiliated physicians. . . .1 . . . [The Company] acquires and operates multi-specialty medical clinics . . . [Its] objective is to organize physicians into professionally managed networks that assist physicians in assuming increased responsibility for delivering cost-effective medical care, while attaining high-quality clinical outcomes and patient satisfaction. . . .2 As you may have guessed, these companies are not operating in Australia, although their plans may sound familiar. When these reports were written in 1997, the United States had 26 publicly traded physician practice management corporations.3 The two US public corporations described above employed 5650 physicians, with over 25 000 additional affiliated physicians. These two companies enjoyed peak stockmarket value in excess of US$6 billion. In the 10 months following December 1997, the 15 largest publicly traded physician practice management companies lost US$4.8 billion in stockmarket value.4 Today, MedPartners has utterly abandoned its physician division, while PhyCor is currently trading at less than 10 cents per share, down from a high of over US$37. Most other companies are either delisted or in bankruptcy. A few became dotcoms. Something went terribly wrong with corporatisation of physician practice management in the United States. Given the current developments in Australia,5 perhaps some lessons can be learned from the US experience. This article will briefly examine three claims that physician practice management corporations make to attract physicians to corporate practice: clinical independence, efficiency gains, and access to capital. Clinical independence Physicians selling to a corporate practice are promised clinical independence — that the allure of profits will not impair their clinical judgement. However, strong corporate pressures are brought to bear on referral patterns. If the practice owns a pathology or imaging centre, physicians are naturally inclined to use these facilities. For practices owned or affiliated with hospitals, the hospital benefits from inpatient admissions. Physicians owning equity in outpatient surgery centres likewise perform procedures in these centres. Primary care physicians employed by a multispecialty corporate practice may be encouraged to refer patients to specialists within the group. For example, one of MedPartners' large multispecialty clinics was the Summit Medical Group in New Jersey. After a concerted effort to redirect referrals, the use of outside specialists dropped from 30% to 18% of total referrals over a two-year period ending in 1996.6 Defenders of these practices make two points: (i) that existing independent practices are subject to the same financial pressures — a solo surgeon makes money by performing surgery, not by prescribing pharmaceuticals — and (ii) that quality is not compromised, even as referral patterns change.3 Given the poor quality of truly comparable data on outcomes of medical treatment in the United States, this quality assertion can not be proved.7 But, if one assumes that physicians were choosing high quality providers before, then why switch? If financial incentives under managed care can compromise quality,8 the same may be true under corporate ownership. The first argument is more difficult to counter. Physicians in independent practices have a direct financial incentive to see many patients and provide intensive and expensive treatments. This is a moral hazard for physicians, tempered by their ethical commitments to patients. The difference with corporations is the institutionalisation of ethical conflicts. Instead of answering to their own conscience, physicians in a large corporate practice must answer to a corporate superior, who will be analysing practice patterns. This could also be an advantage. If a corporate review using an evidence-based medicine system identifies physicians with inappropriate clinical practice patterns, then quality may improve in a corporate system.6 However, if the review is primarily with an eye to profitability, the opposite could result. Federal regulations in the United States discourage financial incentives for both referrals and some forms of cost cutting, unless the pool of physicians and patients involved is large enough to give the physician a negligible financial incentive with regard to any particular patient.9 The premise is that while a physician might subject a patient to unnecessary and potentially dangerous treatment for a $1000 financial reward, the same amount of money, spread over dozens of patients, will prove to be an inadequate incentive to overcome professional ethics. Efficiency Corporations were supposed to bring modern management practices to the cottage industry of physician practices. In retrospect, they added management layers as well as costs,4 where before there had been a single decision-maker. The cost of overheads was very difficult to control,10 particularly once corporate physicians became agitated and combative. Many corporate physicians chafed under what they called micromanagement. Nurse staffing levels, operating hours, and innumerable management details were modified to suit corporate objectives. Physician productivity also lagged behind expectations: the entrepreneurial energies of solo physicians were dissipated in the salaried corporate environment, particularly after receiving large payments for the sale of practices and goodwill.11 Some physicians who sold their practices to corporate entities in the late 1990s repurchased them at a fraction of the price a few years later. Others filed suit against their corporations, seeking damages for broken promises and a return to private practice.11 One article which is required reading for anyone considering involvement with a physician practice management corporation is The rise and fall of the physician practice management industry, by Professor Uwe E Reinhardt of Princeton University.4 He describes the "Ponzi schemes" and "pyramid scheme" (two fraudulent schemes which falsely lure an ever-increasing group of victims to invest money) which eventually characterised the US industry. The corporations chased unsustainable earnings per share growth, primarily through acquisitions, and neglected actual efficiency gains through "same store" growth (ie, increasing the size of each physician's practice).4 Optimists continue to point to the clinical efficiency of an integrated, multispecialty group practice, particularly if the practice maintains a single medical record. This practice model may offer the opportunity for quality and efficiency gains, but does not require corporate ownership. In the United States, many successful multispecialty group practices, such as the Mayo Clinic, are owned either by non-profit foundations or by physicians, without any equity investment of non-physicians. Access to capital Public companies by definition can access public capital markets that are closed to independent medical practices, and can deploy the capital to improve services. During the rapid growth phase of the American practice management sector, when company shares were trading at 40 times their earnings, promises of lavish clinical spending were easy to make and believe. When the bottom fell out of the market, the capital markets abandoned the sector quickly.11 Some clinics found their projects cancelled or delayed without warning. Capital spending decisions should be made for clinical reasons, with financial projections based on return on investment, not unrealistic multiples of projected earnings. The opportunity in Australia Australian corporations have the opportunity to improve quality and efficiency of care. Robust investment in clinical information systems and adoption of best business practices may be more likely in a corporate environment. However, so, too, will be ethical conflicts, short-term focus on profits, and opportunists who care little about healthcare. If Australia is to benefit from the US experience, then its focus must be on the long term and on the clinical advantages of consolidation rather than the US preoccupation with earnings growth and financial windfalls. References MedPartners, Inc. 1996 Annual report, Form 10-K, filed with the US Securities and Exchange Commission on 31 March, 1997. Available on Edgar at: <http://www.sec.gov/cgi-bin/srch-edgar> (accessed June 2001). Phycor, Inc. 1996 Annual report, Form 10-K, filed with the US Securities and Exchange Commission on 31 March, 1997. Available on Edgar at: <http://www.sec.gov/cgi-bin/srch-edgar> (accessed June 2001). Heller Financial. The physician practice management company. Alternative to the solo practice (winter 1998). Chicago: Heller Financial, 1998. Reinhardt UE. The rise and fall of the physician practice management industry. Health Affairs 2000; 19 (Jan/Feb): 42-55. Catchlove BR. GP corporatisation. The why and the wherefore. Med J Aust 2001; 175: 68-70. Robinson JC. Consolidation of medical groups into physician practice management organizations. JAMA 1998; 279: 144, 148. McGlynn EA. Six challenges in measuring the quality of health care. Health Affairs 1997; 16 (May/June): 7-21. Grumbach K, Osmond D, Vranizan K, et al. Primary care physicians' experience of financial incentives in managed-care systems. N Engl J Med 1998; 339: 1516-1521. Department of Health and Human Services, Health Care Financing Administration, Center for Health Plans and Providers, Medicare Managed Care Group. Physician Incentive Plan Regulations, 42 CFR. § 417.479 (2001). Baltimore, MD: DHHS, 2001. Moody's Investors Service. Not-for-profit health care: 1999. Outlook and medians. September 1999, pp 9-10. New York: Moody's Investors Service, 1999. Bank of America. Healthcare industry review and outlook: 1998 third quarter. October 1998, p 37, 34-40. New York: Bank of America, 1998. Authors' details Lauterpacht Research Centre for International Law, University of Cambridge, Cambridge, UK. M Kevin Outterson, BS, JD (Northwestern University), Visiting Scholar; and Partner, Baker, Donelson Bearman & Caldwell, Nashville, Tennessee, USA. Reprints will not be available from the author. Correspondence: Mr M Kevin Outterson, Lauterpacht Research Centre for International Law, University of Cambridge, 5 Cranmer Road, Cambridge, CB3 9BL, UK. kouttersonATbdbc.com Make a comment

MJA 2001; 175: 294-296 As editors of general medical journals, we recognise that the publication of clinical-research findings in respected peer-reviewed journals is the ultimate basis for most treatment decisions. Public discourse about this published evidence of efficacy and safety rests on the assumption that clinical-trials data have been gathered and are presented in an objective and dispassionate manner. This discourse is vital to the scientific practice of medicine because it shapes treatment decisions made by physicians, and drives public and private healthcare policy. We are concerned that the current intellectual environment in which some clinical research is conceived, study subjects are recruited, and the data analysed and reported (or not reported) may threaten this precious objectivity. Clinical trials are powerful tools; like all powerful tools, they must be used with care. They allow investigators to test biological hypotheses in living patients, and they have the potential to change the standards of care. The secondary economic impact of such changes can be substantial. Well-done trials, published in high-profile journals, may be used to market drugs and medical devices, potentially resulting in substantial financial gain for the sponsor. But powerful tools must be used carefully. Patients participate in clinical trials largely for altruistic reasons — that is, to advance the standard of care. In the light of that truth, the use of clinical trials primarily for marketing, in our view, makes a mockery of clinical investigation and is a misuse of a powerful tool. Until recently, academic, independent clinical investigators were key players in design, patient recruitment, and data interpretation in clinical trials. The intellectual and working home of these investigators, the academic medical centre, has been at the hub of this enterprise, and many institutions have developed complex infrastructures devoted to the design and conduct of clinical trials.1,2 The academic enterprise has been a critical part of the process that led to the introduction of many new treatments into medical practice and contributed to the quality, intellectual rigour, and impact of such clinical trials. But, as economic pressures mount, this may be a thing of the past. Many clinical trials are performed to facilitate regulatory approval of a device or drug rather than to test a specific novel scientific hypothesis. As trials have become more sophisticated and the margin of untreated disease harder to reach, there has been a great increase in the size of the trials and consequently in the costs of developing new drugs. It is estimated that the average cost of bringing a new drug to market in the United States is about $500 million.3 The pharmaceutical industry has recognised the need to control costs and has discovered that private non-academic research groups — that is, contract research organisations (CROs) — can do the job for less money and with fewer hassles than academic investigators. Over the past few years CROs have received the lion's share of clinical-trial revenues. For example, in 2000 in the United States, CROs received 60% of the research grants from pharmaceutical companies, as compared with only 40% for academic triallists.1 As CROs and academic medical centres compete head to head for the opportunity to enrol patients in clinical trials, corporate sponsors have been able to dictate the terms of participation in the trial, terms that are not always in the best interests of academic investigators, the study participants, or the advancement of science generally.4 Investigators may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation. These terms are draconian for self-respecting scientists, but many have accepted them because they know that, if they do not, the sponsor will find someone else who will. And, unfortunately, even when an investigator has had substantial input into trial design and data interpretation, the results of the finished trial may be buried rather than published if they are unfavourable to the sponsor's product. Such issues are not theoretical. There have been a number of recent public examples of such problems, and we suspect that many more go unreported.5,6 As editors, we strongly oppose contractual agreements that deny investigators the right to examine the data independently or to submit a manuscript for publication without first obtaining the consent of the sponsor. Such arrangements not only erode the fabric of intellectual enquiry that has fostered so much high-quality clinical research, but also make medical journals party to potential misrepresentation, since the published manuscript may not reveal the extent to which the authors were powerless to control the conduct of a study that bears their names. Because of our concern, we have recently revised and strengthened the section on publication ethics in the Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication, a document developed by the International Committee of Medical Journal Editors (ICMJE) and widely used by individual journals as the basis for editorial policy. The revised section is in the Box. (The entire uniform requirements document is currently undergoing revision; the revised version should be available at the beginning of 2002.) As part of the reporting requirements, we will routinely require authors to disclose details of their own and the sponsor's role in the study. Many of us will ask the responsible author to sign a statement indicating that he or she accepts full responsibility for the conduct of the trial, had access to the data, and controlled the decision to publish. We believe that a sponsor should have the right to review a manuscript for a defined period (eg, 30-60 days) before publication to allow for the filing of additional patent protection, if required. When the sponsor employs some of the authors, these authors' contributions and perspective should be reflected in the final paper, as are those of the other authors, but the sponsor must impose no impediment, direct or indirect, on the publication of the study's full results, including data perceived to be detrimental to the product. Although we most commonly associate this behaviour with pharmaceutical sponsors, research sponsored by governmental or other agencies may also fall victim to this form of censorship, especially if the results of such studies appear to contradict current policy. Authorship means both accountability and independence. A submitted manuscript is the intellectual property of its authors, not the study sponsor. We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication. We encourage investigators to use the revised ICMJE requirements on publication ethics to guide the negotiation of research contracts. Those contracts should give the researchers a substantial say in trial design, access to the raw data, responsibility for data analysis and interpretation, and the right to publish — the hallmarks of scholarly independence, and ultimately academic freedom. By enforcing adherence to these revised requirements, we can, as editors, assure our readers that the authors of an article have had a meaningful and truly independent role in the study that bears their names. The authors can then stand behind the published results, and so can we. International Committee of Medical Journal Editors (signatories to the revised statement) Frank Davidoff, MD, Editor Emeritus, Annals of Internal Medicine. Catherine D DeAngelis, MD, MPH, Editor, The Journal of the American Medical Association. Jeffrey M Drazen, MD, Editor-in-Chief, The New England Journal of Medicine. M Gary Nicholls, MD, Editor, The New Zealand Medical Journal. John Hoey, MD, Editor, Canadian Medical Association Journal. Liselotte HØjgaard, MD, DMSc, Editor-in-Chief, Ugeskrift for Læge (Journal of the Danish Medical Association). Richard Horton, FRCP, Editor, The Lancet. Sheldon Kotzin, Executive Editor, MEDLINE/Index Medicus. Magne Nylenna, MD, Editor-in-Chief, Tidsskrift for Den norske Lægeforening (Journal of the Norwegian Medical Association). A John P M Overbeke, MD, PhD, Executive Editor, Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine). Harold C Sox, MD, Editor, Annals of Internal Medicine. Martin B Van Der Weyden, FRACP, Editor, The Medical Journal of Australia. Michael S Wilkes, MD, PhD, Editor, wjm Western Journal of Medicine. Henderson L. More AMCs finding growth from reform. Centerwatch 2000; 7(6): 1, 10-13. Kowalczyk L. Harvard, other medical schools aim to give drug firms faster pace for trials. Boston Globe 2000; Jul 28, C4. Mathieu MP. Parexel's pharmaceutical R&D statistical sourcebook, 1998 edition. Waltham, Mass: Parexel International Corporation, 1999. Rennie D. Thyroid storm. JAMA 1997; 277: 1238-1243. Kahn JO, Cherng DW, Mayer K, et al, for the 806 Investigator Team. Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 106/L CD4 cell counts. A randomized controlled trial. JAMA 2000; 284: 2193-2202. Blumenthal D, Campbell EG, Anderson MS, et al. Withholding research results in academic life science: evidence from a national survey of faculty. JAMA 1997; 277: 1224-1228. Make a comment Publication ethics From the Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication (the full revised Uniform requirements will be published later) Conflict of interest Public trust in the peer review process and the credibility of published articles depend in part on how well conflict of interest is handled during writing, peer review, and editorial decision making. Conflict of interest exists when an author (or the author's institution), reviewer, or editor has financial or personal relationships with other persons or organisations that inappropriately influence (bias) his or her actions. The potential of such relationships to create bias varies from negligible to extremely great; the existence of such relationships does not necessarily represent true conflict of interest, therefore. (Relationships that do not bias judgement are sometimes known as dual commitments, competing interests, or competing loyalties.) The potential for conflict of interest can exist whether or not an individual believes that the relationship affects his or her scientific judgement. Financial relationships (such as employment, consultancies, stock ownership, honoraria, paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. Conflicts can occur for other reasons, however, such as personal and family relationships, academic competition, and intellectual passion. All participants in the peer review and publication process must disclose all relationships that could be viewed as presenting a potential conflict of interest. Disclosure of these relationships is particularly important in connection with editorials and review articles, because bias can be more difficult to detect in those publications than in reports of original research. Editors may use information disclosed in conflict of interest and financial interest statements as a basis for editorial decisions. Editors should publish this information if they believe it will be important to readers in judging the manuscript. Potential conflicts of interest related to individual authors' commitments When authors submit a manuscript, whether an article or a letter, they are responsible for disclosing all financial and personal relationships between themselves and others that might bias their work. To prevent ambiguity, authors must state explicitly whether potential conflicts do or do not exist. Authors should do so in the manuscript on a conflict of interest notification page that follows the title page, providing additional detail, if necessary, in the accompanying cover letter. Investigators should disclose potential conflicts to study participants, and should state in the manuscript whether they have done so. Editors also need to decide when to publish information disclosed by authors about potential conflicts. If doubt exists, it is best to err on the side of publication. Potential conflicts of interest related to project support Increasingly, biomedical studies receive funding from commercial firms, private foundations, and government. The conditions of this funding have the potential to bias and otherwise discredit the research. Scientists have an ethical obligation to submit creditable research results for publication. As the persons directly responsible for their work, researchers therefore should not enter into agreements that interfere with their access to the data or their ability to analyse the data independently, to prepare manuscripts, and to publish them. Authors should describe the role of the study sponsor(s), if any, in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the report for publication. If the supporting source had no such involvement, the authors should so state. Biases potentially introduced when sponsors are directly involved in research are analogous to methodological biases of other sorts; some journals therefore choose to include information about the sponsor's involvement in the methods section of the published paper. If a study is funded by an agency with a proprietary or financial interest in the outcome, editors may ask authors to sign a statement such as, "I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis". Editors should be encouraged to review copies of the protocol and/or contracts associated with project-specific studies before accepting such studies for publication. Editors may choose not to consider an article if a sponsor has asserted control over the authors' right to publish. Conflicts of interest related to commitments of editors, journal staff, or reviewers Editors should avoid selecting external peer reviewers with obvious potential conflicts of interest — for example, those who work in the same department or institution as any of the authors. Authors often provide editors with the names of persons they feel should not be asked to review a manuscript because of potential conflicts of interest, usually professional. When possible, authors should be asked to explain or justify their concerns; that information is important to editors in deciding whether to honour such requests. Reviewers must disclose to editors any conflicts of interest that could bias their opinions of the manuscript, and they should disqualify themselves from reviewing specific manuscripts if they believe such disqualification would be appropriate. As in the case of authors, silence on the part of reviewers concerning potential conflicts may mean either that such conflicts exist that they have failed to disclose or that conflicts do not exist. Reviewers must therefore also be asked to state explicitly whether conflicts do or do not exist. Reviewers must not use knowledge of the work, before its publication, to further their own interests. Editors who make final decisions about manuscripts must have no personal, professional, or financial involvement in any of the issues they might judge. Other members of the editorial staff, if they participate in editorial decisions, must provide editors with a current description of their financial interests (as they might relate to editorial judgements) and disqualify themselves from any decisions where they have a conflict of interest. Editorial staff must not use the information gained through working with manuscripts for private gain. Editors should avoid submitting to their own journal reports of original research to which they have contributed as authors. If they do so, they should recuse themselves from the editorial process and delegate editorial decisions on those manuscripts to other members of the editorial staff. Editors should publish regular disclosure statements about potential conflicts of interests related to the commitments of journal staff. Back to text

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Editorial Adult living donor liver transplantation: another Pandora's box? Important issues of safety and consent must be addressed MJA 2001; 175: 179-180 In 1990, the world's first successful living donor liver transplantation, from a mother to her child, was performed in Brisbane.1 Over the past three years, living donor liver transplantation has taken off in both the United States and Europe.2 In this issue of the Journal, House and colleagues from Western Australia report the first adult-to-adult living donor liver transplantation in Australia.3 This report is worthy of comment because it raises questions as to whether this procedure should be widely adopted in Australia, whether donor safety issues have been adequately addressed, and whether adult-to-adult living donor liver transplantation should be monitored and regulated in Australia. The upsurge of adult-to-adult living donor liver transplantation in the US and Europe reflects pressures from a mismatch between the demand for liver transplantation and the availability of cadaveric donor organs. In the US, there is a waiting list for liver transplantation of more than 14 000 patients, and a transplantation rate between 4000 and 5000 per year.4 The situation in the US is aggravated by an organ allocation system which gives priority to time on the waiting list for non-urgent cases: a patient entering the waiting list "late" is likely to receive a transplant only when there is deterioration to a more urgent category. In this system, deaths of patients while waiting for a transplant have dramatically increased over the past few years (in the US, about 1800 in 1999).4 The availability of living donor liver transplantation in an elective setting would presumably reduce or minimise these tragedies by increasing supply to match demand. This situation is not likely to apply in Australia because, although deaths on the waiting list have risen in the past few years, cases can be prioritised without the need to take time on the waiting list into consideration. Furthermore, in Australia, as in the US, patients with acute liver failure have a national priority listing that potentially minimises death while waiting for a suitable cadaveric donor. Nevertheless, the case report by House et al indicates that some of our liver transplantation units wish to introduce this procedure as an option. Hence, there is a need to address some important issues. What are the indications for adult-to-adult living donor liver transplantation? In Australia and New Zealand, it has been agreed to offer adult-to-adult living donor liver transplantation only to patients who have already fulfilled the criteria for a cadaveric donation. In the US and Europe, there is also general agreement on this, although some individual units feel that this is too restrictive and perform adult-to-adult living donor liver transplantation on patients who do not fulfil current criteria for liver transplantation, such as patients with large hepatocellular cancers or with acute alcoholic hepatitis. We believe that this is inappropriate; it is nonsensical to argue for the introduction of adult-to-adult living donor liver transplantation to address the supply-demand imbalance and simultaneously expand recipient criteria to increase demand. How are donors selected? Donor selection clearly requires an agreed formal informed consent process.5,6 The potential donor should be prepared by a team independent of the team advising and caring for the liver transplant recipient. Input from liaison psychiatrists is crucial. Any hint of coercion should lead to automatic exclusion, with the donor team having the final veto for progressing with adult-to-adult living donor liver transplantation. Potential donors should be selected using criteria that include psychological stability, appropriate vascular and biliary anatomy, age, and absence of underlying systemic or liver disease (eg, donation is contraindicated in an obese subject who is a smoker). A donor should be required to have a major emotional link to the recipient and should not be under any financial indebtedness to the recipient. A donor will usually, but not necessarily, be a close family member. A "cooling off" period after donor consent is also recommended. Size-matching of donor and recipient is crucial, since "shortchanging" of functioning hepatic mass in either may be fatal. In Australia, this would generally mean that the donation of an adult right hemiliver is required, although in Japan the left liver volume is often sufficient.7-9 What is the donor morbidity and mortality with adult-to-adult living donor liver transplantation? More than 1000 living donor liver transplantations have been performed worldwide with at least four deaths, although a report of only one has been published.4 Significant biliary complications have occurred in up to 5% of donors, and 2%-3% have required more than one surgical procedure. The donor is usually unable to work for 2-3 months, and 70% have persisting symptoms at six-month follow-up.10 Most living donor liver transplantations have been performed between adults and children, and those between adults include a large number of left liver grafts. This means that the true incidence of morbidity and mortality for right liver grafts remains unresolved. One would expect it to be higher for technical and other reasons related to hepatic mass. What are the outcomes for the recipient? The survival outcomes for recipients of adult-to-adult living donor liver transplantation are the same as with cadaveric donation, although biliary and vascular complications are increased.4 In the case reported by House et al, the patient met the listing criteria for liver transplantation and was on the urgent Australian and New Zealand list for the first available suitable cadaveric donation. The donor was prepared by an independent team in a process that took five days. The outcomes were favourable for both recipient and donor, although the follow-up of the donor is short and the recipient has already had significant biliary complications. However, the use of adult-to-adult living donor liver transplantation for fulminant hepatic failure requires comment. There is an Australasian priority listing for such patients. In the US, such a priority listing has usually obviated the need for adult-to-adult living donor liver transplantation.11 In Australia and New Zealand, waiting list deaths for fulminant hepatic failure are high, in the order of 30%. In Western Australia, the rate is 60%; the reason for this is unclear. Furthermore, in many patients with fulminant hepatic failure, for whom transplantation may be required within 24-72 hours of presentation, a donor consent "cooling off" period may not be possible. In the reported case, five days passed without a cadaveric donor, allowing such fears to be allayed. In many cases, this may not be so. In the US, it has been estimated that 600 transplantations per year may be possible with the widespread introduction of adult-to-adult living donor liver transplantation.4 If this figure is extrapolated to Australia and New Zealand, then between 20 and 30 cases can be expected each year. This amounts to only 1-15 cases in each Australian unit. Is this enough to justify widespread adoption of this procedure? Probably not. A recent commentary suggests that adult-to-adult living donor liver transplantation be restricted to "high case load" institutions,12 and states: The rapid proliferation of programmes that perform (liver) transplantation in adults with the use of grafts from living donors (most of those in the United States have performed fewer than 10 procedures each) is alarming for an innovative, nonstandardised operation that places two people, one of whom is healthy, at risk. It is clear there is a significant learning curve, with higher morbidity in donors and increased complications in recipients at units that have performed fewer than 50 adult-to-adult living donor liver transplantation procedures.4 Perhaps a single Australian centre should be established to do these procedures in the elective setting, although this may be logistically difficult to achieve. What is certainly achievable, however, is an agreed Australian and New Zealand protocol for donor and recipient selection, together with a central registry of transplantations performed. The Transplant Society of Australia and New Zealand is currently undertaking this process with the support of all liver transplantation units. The resulting protocol will be placed in the public arena for comment. Similarly, the Australian Safety and Efficacy Registry of New Interventional Procedures (Royal Australasian College of Surgeons) is undertaking a review of the need for adult-to-adult living donor liver transplantation in Australia. House and colleagues are to be recognised for their courage and ethical and technical skill in performing this procedure in a life-or-death situation. However, only time will tell whether this Pandora's box, containing within it all the issues of adult-to-adult living donor liver transplantation, should have stayed shut.13 Geoffrey W McCaughan A W Morrow Professor of Medicine, and Director Australian National Liver Transplantation Unit Royal Prince Alfred Hospital, Sydney, NSW Stephen V Lynch Associate Professor of Surgery, and Director, Queensland Liver Transplantation Unit Princess Alexandra Hospital, Brisbane, QLD Strong RW, Lynch SV, Ong TN, et al. Successful liver transplantation from a living donor to her son. N Engl J Med 1990; 322: 1505-1507. Renz JF, Busuttil RW. Adult-to-adult living-donor liver transplantation: a critical analysis. Sem Liver Dis 2000; 20: 411-424. House AK, Jeffrey GP, Edyvane KA, et al. Adult-to-adult living donor liver transplantation for fulminant hepatic failure. Med J Aust 2001; 175: 202-204. Proceedings of the 2nd international symposium dedicated to expand the donor pool. Rome. 26 August 2000. Tokyo: CD Toppon Medical Science, 2000. Abecassis M, Adams M, Adams P, et al. Consensus statement on the live organ donor. JAMA 2000; 284: 2919-2926. American Society of Transplant Surgeons' position paper on adult-to-adult living donor liver transplantation. Liver Transpl 2000; 6: 815-817. Yamaoka Y, Morimoto T, Inamoto T, et al. Safety of the donor in living-related liver transplantation — an analysis of 100 parental donors. Transplantation 1995; 59: 224-226. Marcos A. Right lobe living donor transplantation: a review. Liver Transpl 2000; 6: 3-20. Fan S, Lo C, Liu C, et al. Safety of donors in live donor liver transplantation using right lobe grafts. Arch Surg 2000; 135: 336-340. Trotter J, Talamantes M, McClure M, et al. Right hepatic lobe donation for living donor liver transplantation: impact on donor quality of life. Liver Transpl 2001; 7: 485-493. Hymar A, Durand B, Knaak M, et al. Sharing of livers for status I recipients in Region 7 — A good thing. Am J Transpl 2001; 1 Suppl I: 283 (A587). Cronin DC, Millis JM, Siegler M. Transplantation of liver grafts from living donors into adults — too much, too soon. N Engl J Med 2001; 344: 1633-1637. Strong RW. Whither living donor liver transplantation? Liver Transpl Surg 1999; 5: 536-538. Make a comment Readers may print a single copy for personal use. No further reproduction or distribution of the articles should proceed without the permission of the publisher. For permission, contact the Australasian Medical Publishing Company.

GP Corporatisation The why and the wherefore Barry R Catchlove MJA 2001; 175: 68-70 For editorial comment, see Van Der Weyden Abstract - What is corporatisation? - Why corporatisation now? - What do GPs think? - What are the consequences of corporatisation? - Alternative models? - References - Authors' Details - - More articles on General practice and primary care Abstract Through their clearly defined gatekeeper role, GPs have considerable market power to influence the flow of revenue associated with referrals and prescriptions. For this reason, and because the whole healthcare industry is going through a transition from a cottage industry to a more commercially sophisticated structure, corporatisation of general practice is on the increase. If properly and ethically run, corporatised general practices can provide high-quality, efficient primary care. There are four far-reaching, potential consequences of general practice corporatisation — an increase in healthcare spending; limitation of GPs' choice of practice environment; difficulty justifying GPs' legitimate fee increases; and de-skilling of GPs. Over the past two years there has been a huge upsurge in corporatisation of Australian general practice. It began in Perth, Western Australia, and is now spreading across metropolitan Australia. An estimated 2500 GPs (about 10% of those in practice) now work in practices owned by large corporations.1 What is corporatisation? Definitions of corporatisation vary, but all include the concept of changing the traditional ownership and practice structures to improve the profitability of general practice.2 In terms of what is happening now in Australian general practice, a working definition would comprise: A third party — doctor(s) or non-doctor(s) — acquires an interest in one or more general practices. Whatever the equity arrangements, GPs enter into a contract whereby they assign a proportion of their gross income in return for management of their practice, provision of support services, and a goodwill payment. The third party then gains access to the flow-on services of the practice (eg, pathology and radiology) and may benefit financially from the GPs' referrals. The practices are merged into a single medical centre, which is generally separately owned by the same third party. In Australia, corporatisation of medical services is not a new phenomenon. Large corporations own many private hospitals and most pathology and radiology services, and third parties, be they entrepreneurial doctors or people from outside healthcare, have been acquiring general practices for years. The current situation is therefore not unique, because: GPs are being offered previously unheard of goodwill payments. The rate of practice acquisitions has increased dramatically. Ownership of diagnostic services by corporate entities is now common. Specialists are now joining these corporate medical centres. The new corporate owners are often listed companies and may have "big name" investors, adding further to the high profile of the new structure. There is a clear intention to capitalise on the GPs' market power (in addition to achieving some economies of scale). Why corporatisation now? The interesting question is not why corporatisation is happening, but why it is happening now. After a review of corporatisation commissioned by the Commonwealth Department of Health and Aged Care in 2000,3 the answer to this question is still not entirely clear. As is often the case in the commercial world, there is no obvious trigger. It is worth recalling the 18th-century economist Adam Smith's famous remark about the "invisible hand of the market".4 However, two important and relevant issues, external to the medical profession, shed some light on the upsurge of corporatisation. Firstly, GPs have considerable market power, which, in this context, means the ability, through a clearly defined gatekeeper role, to influence the flow of revenue associated with referrals, prescriptions and suchlike. We know that for each dollar of Medicare revenue earned by a GP, another $1.60 is generated directly in diagnostic and specialist consultations. Based on the flow-on effects of one GP's initial decisions, it is estimated that 20 GPs' decisions could be responsible, directly and indirectly, for as much as $50 million of healthcare expenditure per annum.3 In the past, the cottage industry nature of general practice, with an average of fewer than two doctors per practice, made it difficult to exploit collective market power. Secondly, the whole healthcare industry is going through a transition from a cottage industry to a more commercially sophisticated structure. Ironically, this started in the public sector — public hospitals were grouped into areas, regions and networks. In the 1990s, it spread to the private sector with the involvement of large third party commercial organisations, the rationalisation of pathology then radiology services, and it is now having an impact on general practice. Even the charity hospitals have been forced into merging and forming corporatised structures. This process appears inevitable and unstoppable. What do GPs think? Despite widespread concerns being voiced within the profession and in the media, GPs currently involved in corporate-run practices are not complaining. At this early stage of corporatisation most appear happy. There is no evidence to suggest they are being pressured into overservicing or into directing patients to particular diagnostic services or specialists. GPs who previously owned practices have received a relatively large and unexpected goodwill payment. They are probably earning about the same as they did before corporatisation, but they have been freed from the administrative tasks of running their practice. In a business sense many would agree that GPs from inefficient and grossly undercapitalised practices needed to be dragged into the 21st century. If properly and ethically run, corporatised general practices can provide high quality, efficient primary care. On a more sober note, it must also be remembered that all these new entrants into corporatised general practice have only existed for a short time and therefore can only be judged on short-term performances. What are the consequences of corporatisation? At this stage, the real issues of corporatisation are not about the compromise of clinical autonomy (although there is no denying this could be a problem but not necessarily associated with corporatisation alone). I believe that, apart from some of the more obvious issues such as ownership of records and freedom to refer, there are four far-reaching, albeit subtle, consequences of corporatisation. Although corporatisation will get the blame, these four are in reality consequences of the inevitable changes associated with transforming healthcare from a cottage industry to a more rational, market-driven service sector. These include limitation of choice, increases in healthcare spending, difficulty justifying legitimate fee increases, and de-skilling of GPs. Limitation of choice There is a real risk that the corporate model will become so dominant that future GPs will have little choice about the sort of practice in which they wish to work. This is already happening to some extent in metropolitan Perth.5 For general practice to attract doctors, it needs to offer a range of alternative models from solo general practice right through to large corporate medical centres. The only way is to ensure viable alternatives offering equivalent benefits and advantages. Crucial to this is the creation of saleable goodwill. Increases in healthcare spending The real profitability in owning a general practice is not in the direct revenue, but in the "downstream" revenue, which is the product of GPs' gatekeeper role. The corporate groups believe that access is the key (not coercion). If a pathology collection centre or pharmacy is placed within the confines of a medical centre, then about 95% of the referrals can be assumed without any need to adopt overt pressure. The corporate practice benefits from ownership of diagnostic services, but, even if it doesn't (as is often the case for pharmacy and allied health services), it benefits from being able to demand premium rentals for floor space. Specialists who take consulting space in these medical centres may also be prepared to pay excessive rentals to gain access to a large number of GPs. The real concern is the subtle impact on referral rates, diagnostic and pharmaceutical expenditure. Take as a hypothetical example the presence of a full time dermatologist in a large medical centre (please forgive me for selecting a dermatologist, it could equally apply to other specialists). It is inevitable that many of the patients previously managed, and managed quite effectively, by GPs will now be referred. Again, access is key, with higher patient expectations, convenience, and perhaps even medicolegal concerns about not referring when the service is so readily available. Given the cost differential between GP and specialist consultations, both the referral rate and the cost per patient attendance will inevitably rise. If this situation is extrapolated to other possible diagnostic and specialist referrals, there is a potential for considerable increases in Medicare and Pharmaceutical Benefits Scheme spending. How will governments react to this? Very simply, they will encourage the already developing move to fund-holding, coordinated care, fund pooling — call it what you will. All these mean a move away from fee-for-service and towards managed-care models and the associated transfer of risk. If GPs control the budget, will government allow corporatised practices to share the savings, and if GPs have a vested interest in reducing referral rates what will be the impact on the downstream revenue? Could this undermine the viability of the corporate players already paying high prices for general practice acquisitions? Difficulty justifying legitimate fee increases Being owned by high profile, often publicly listed, successful corporate entities might decrease the ability of the medical profession to argue a case for legitimate fee increases. Imagine the situation — two large publicly listed corporate practices, perhaps partly owned by high profile entrepreneurs, announce record profits at the same time that representatives of general practice organisations are meeting with government to discuss increases in the fee schedule. De-skilling of GPs If every conceivable diagnostic test, specialist and ancillary service is available on site, and this results in increased referrals, then there is a likelihood that GPs will become nothing more than a postbox, and there is a real potential for de-skilling of GPs. A GP's clinical judgement will become largely unnecessary. Taking this situation to extremes, someone might eventually ask whether the GP's gatekeeper role is working and mightn't a much cheaper nurse practitioner fill the same role? Alternative models? What corporatisation has demonstrated is that there are more efficient ways to deliver primary healthcare. For those who acknowledge this, the challenge is to provide alternative models, drawing on the lessons of corporatisation. The KPMG report to the Commonwealth Department of Health and Aged Care asked some searching questions about the use of GP market power. Properly managed and with due regard to ethics, this market power can be used to improve care, reduce costs and improve the quality of practice. If GPs are prepared to responsibly manage their gatekeeper role, which often requires increased time and effort, they should be rewarded. GPs should be best suited to manage and control their market power. However, it is something of a truism that if you have such power and do not use it or control it then someone else will. Corporatisation in general practice is merely one aspect of the movement of health services from the cottage industry to a more rational and rationalised model. To argue a return to the good old days and the status quo would be attempting to do what King Canute proved was impossible — holding back the tide. References Corporate structure [news review]. Australian Doctor 2001; 27 April: 29-31. Australian Medical Association. General practice corporatisation. AMA scoping paper. Canberra: AMA, November 2000. Commonwealth Department of Health and Aged Care. Corporatisation of general practice: scoping paper. KPMG Consulting, May 2000. Smith A. An inquiry into the nature and causes of the wealth of nations. London: W Strahan, T Cadell, 1776. Kron J. Risky business. Australian Doctor 2001; 16 Feb; 45. Authors' Detials Barry R Catchlove, MB BS, FRACP, Director. No reprints will be available from the author. Correspondence: Dr Barry R Catchlove, Director, Padua Consulting Pty Ltd, Health Services Consulting, 11 Burton Street, Mosman, NSW 2088. bcatchloATbigpond.net.au Make a comment

Barry R Catchlove

Large initiatives are under way, but, as individual doctors, we can begin to identify the silent two-thirds majority who are too frightened to seek help MJA 2001; 174: 436-437 Urinary incontinence is a distressing and debilitating condition which will become more prevalent as our population ages. The personal suffering of those who find urine running down their legs is difficult to measure, but we know that quality of life is severely impaired. It is disturbing that only about a third of those affected actually seek medical help, because of lack of knowledge (on the part of the patient or the provider) about available treatments,1 as well as patients' embarrassment about revealing their "lack of control". For patients with urinary incontinence, the cost of buying pads and other appliances is a major burden. Indeed, some women are forced to reuse their commercial pads by opening them and restuffing them with toilet paper, or to dry their urine-soaked disposable pads on a heater for later use to reduce costs.2 The "cost" of a disease or condition is not adequately described by the dollars spent in the healthcare system. Nonetheless, in the current climate of economic healthcare rationalisation, it is still useful to calculate the measurable costs of a condition, as least to justify expenditure on this rather than upon some other medical problem. The cost of an illness comprises three components:3 "direct costs", which include personal costs (eg, pads and replacement of urine-soaked clothes), and treatment costs (met by patients and by several government subsidies); "indirect costs", which include lost productivity both in the home and in outside employment; and "intangible costs", which are most difficult to measure financially, but include psychological distress and impaired physical or mental health. The costs of urinary incontinence, for the sufferer and for the Australian healthcare system, have not been previously ascertained. The report by Doran and colleagues in this issue of the Journal4 represents the first attempt to estimate the direct costs of incontinence for all community-dwelling Australian women. Their calculations were made possible by two recent events. Firstly, the Women's Health Australia (WHA) project, a large, ongoing national longitudinal epidemiological survey, has made it possible to gain an accurate picture of the prevalence of incontinence in 41 724 young (18-23 years), middle-aged (45-50 years) and older (70-75 years) women.5 It also identified women who did and did not seek help. Secondly, an Australian group devised and validated a test instrument to measure the direct personal and treatment costs of incontinence in 100 community-dwelling women.2 Doran et al have extrapolated from the WHA prevalence data, using Australian Bureau of Statistics population figures, to deduce the total number of incontinent women in this country. They then used estimates from the second study to calculate the personal costs for all affected women, and added the treatment costs of those who sought help, to derive an annual cost for incontinence of $387 per incontinent woman, or $710 million (in 1998 prices). As the authors indicate, these figures do not include indirect or intangible costs. Equally important in terms of human suffering is the high prevalence of incontinence among Australian nursing home residents, and this also imposes a huge financial burden. One report found that urinary incontinence affected 77% of a sample of 1659 such residents, and that up to 25% of nursing staff time was spent dealing with urinary leakage.6 The long term care of each incontinent nursing home resident was estimated to cost $45 000 per annum, or $450 million a year (1991 prices). Many incontinent nursing home residents are not provided basic management, such as being taken to the toilet at regular intervals, owing to a lack of trained nurses in such facilities. Cost-effective strategies, such as applying continence pads instead of changing wet beds (with laundry savings of $40 per incontinent resident per month),7 are not routinely employed. So, what are we doing about the problem of incontinence and its great financial cost? There is hope on the horizon. The World Health Organization (WHO) has recently focused on the problem. At the first international WHO consultation on incontinence, in June 1998, a team of 24 committees (including five Australian clinicians and scientists) considered the best way to eradicate incontinence. The issue of cost, and our poor knowledge of the magnitude of the problem, was a major concern.3 The proceedings have been widely disseminated, and the second Consensus Meeting will be held in July 2001. The WHO concluded that incontinence should be considered a disease rather than a condition, in view of its debilitating effects upon health and wellbeing. In Australia, the Commonwealth Department of Health and Aged Care has recently provided $15 million over five years to fund a National Continence Management Strategy.8 Its expert advisory committee, which includes nurse continence advisors and representatives from general practice, urology, urogynaecology, colorectal surgery, physiotherapy and geriatric medicine, first met in September 1998. Funds are allocated to ensure more education of healthcare providers, wider dissemination of information about treatment to the public, and to develop a national management framework. As a first step, a Continence Helpline has been established (see Box). Three pilot projects about new ways to increase the uptake of continence treatment are under way in Perth, Wangaratta and the Hunter region. Recently, over one million dollars was allocated to testing innovative treatments. A project to measure all costs of incontinence for patients and for the tiers of funding subsidy is currently being assessed. The efforts of WHO and the Australian Government are laudable, but we must rise to the challenge of helping those with incontinence as individual doctors. By tactful enquiries of patients with known risk factors,9 we may begin to identify the silent two-thirds majority of affected patients who are frightened to seek help. By starting conservative treatment and, where appropriate, initiating a full investigation at an early stage, we can render help quickly before the problem has become entrenched, refractory and even more costly. Telephone number of the Continence Helpline: 1800 330 066 Back to text Kate H Moore Associate Professor of Obstetrics and Gynaecology Department of Urogynaecology, St George Hospital University of New South Wales, Sydney, NSW Holst K, Wilson PD. The prevalence of female urinary incontinence and reasons for not seeking treatment. N Z Med J 1988; 101: 756-758. Dowell CJ, Bryant CM, Moore KH, Simons AM. Calculating the direct costs of urinary incontinence: a new test instrument. Br J Urol 1999; 83: 596-606. Versi E, Defever M, Hu TW, et al. Socio-economic considerations in urinary incontinence. In: Abrams P, Khoury S, Wein A. Incontinence. Report of the World Health Organisation Consensus Conference. Plymouth, UK: Health Publications Ltd, 1999: 869-929. Doran CM, Chiarelli P, Cockburn J. Economic costs of urinary incontinence in community-dwelling Australian women. Med J Aust 2001; 74: 456-458. Chiarelli P, Brown W, McElduff P. Leaking urine: prevalence and associated factors in Australian women. Neurourol Urodynam 1999; 18: 567-577. Steel J, Fonda D. Minimising the cost of urinary incontinence in nursing homes. PharmacoEconomics 1995; 7: 191-197. Szonyi G, Pang S. Use of continence pads to reduce laundry costs in a nursing home. Aust Continence J 1998; 4: 34-37. Fonda D. National continence management strategy. Aust Continence J 1998; 4: 100-101. Millard RJ, Moore KH. Urinary incontinence: the cinderella subject. Med J Aust 1996; 165: 124-125. Make a comment

Kate H Moore