Health services administration

To the Editor: Telemedicine in eye care (teleophthalmology) is one of the established technologies in medicine, providing the means for undertaking sophisticated eye care and for maintaining contact with patients in rural and remote areas.1 Telemedicine in Australia has been primarily facilitated by government, against a background of complex funding arrangements and interwoven healthcare responsibilities (it is funded mostly by project grants and state government telehealth initiatives).2 This funding mechanism impedes the efficient use and integration of telemedicine services.2 The current healthcare environment demands a detailed economic evaluation to justify continuous funding for teleophthalmology. However, some of the economic benefits of teleophthalmology may not be directly visible in the healthcare system itself. Significant benefit may be obtained by, for example, savings in time and travel expenses, thereby contributing to society indirectly. Furthermore, the cost-effectiveness of a telemedicine service improves considerably when it is integrated with existing routine healthcare services.3 But organisational and attitudinal barriers and lack of funding have delayed such integration.4 These barriers relate to human resource allocation issues in an already overstressed healthcare system and the mindset of some critics who view telemedicine as a peripheral activity and a “novelty” area for technological enthusiasts. The cost-effectiveness of telemedicine will not be improved unless the perception that it is an “add on” is changed.4 The question of whether teleophthalmology should be integrated into routine services, with Medicare reimbursement, can be judged by four criteria:5 Is the technology sound? (ie, does it fulfil its purpose?) Is the program effective compared with existing care? Is the program cost-effective? Is the program practical? (ie, are there any significant problems associated with it?). On the basis of our own comprehensive evaluation of teleophthalmology in Western Australia,6 we believe that all four questions can be answered affirmatively, and that teleophthalmology would be most efficiently provided if integrated into existing healthcare services. Its inclusion in the Medicare Benefits Schedule would benefit many patients in remote and rural areas in Australia.

Sajeesh K R Kumar · Yogesan Kanagasingam · Ian J Constable

Objective: To determine trends in use of Australian acute hospital inpatient services by older patients.Design and data sources: Secondary analysis of hospital data from the Australian Institute of Health and Welfare in the period 1993–94 to 2001–02, with population data for this period from the Australian Bureau of Statistics.Outcome measures: Population-based rates of hospital separations and bed utilisation.Results: The Australian aged population (65 years and older) increased by 18% compared with total population growth of 10%, yet the proportion of hospital beds occupied by older patients remained stable at 47%. The most substantial changes were observed in the population aged 75 years and older, with separations increasing by 89%, length of stay reducing by 35% and bed utilisation increasing by 23%. However, rates of bed utilisation (in relation to population) declined among older groups (10% decline in per capita use in population 75 years and older), but increased in the younger population (1% increase in per capita use in people younger than 65 years).Conclusion: Important trends in use of inpatient services were identified in this study. These trends are contrary to common perception. Ageing of the Australian population was not associated with an increase in the proportion of hospital beds used by older patients.

Len C Gray PhD, FRACP · Margaret A Yeo MPH, BSc(Hons) · Stephen J Duckett PhD, FCHSE

Lionel L Wilson Principal, Qual-Med, 34B Kangaloon Road, Bowral, NSW 2576. Lwilson10ATbigpond.com To the Editor: Nisselle’s recent editorial on managing medical indemnity raises important issues.1 I would like to comment on some points. The quality movement, in the form of a system of hospital accreditation, actually began via the New South Wales Branch of the Australian Medical Association in the late 1960s. However, credentialling and the delineation of clinical privileges for medical staff are far from the norm that Nisselle claims. In fact, although some hospitals claim to be credentialling medical staff, in most instances this is little more than an exercise in tokenism and is quite incapable of contributing either to quality or to minimising risk. Nisselle also refers to the “safety movement”. While recognising current common usage, to talk of safety as separate from quality in healthcare is tautological. It is not credible to visualise a hospital that claims to provide quality care but tolerates unsafe practices of any description. Similarly, unsafe practices in a facility mean that quality care is not being achieved. In attempting to untangle the semantic problems occasioned by the term “risk management”, Nisselle merely compounds the problem that bedevils this subject. Of course, he is far from alone, and the medical literature further aggravates this confusion. I suggest the following definitions in the hope of introducing some clarity: Quality management: The management of all these issues, as Nisselle points out, is a big task. While the term “clinical governance” is currently in vogue, it means little, I believe, to most doctors. Managing quality is a complex task (as illustrated by Nisselle’s appropriate elephant analogy). So why not call it what it is? Managing quality is largely about avoiding patient harm. Risk management: The same definition should be used whether we are talking about an insurance company or a medical service. It is the minimisation of financial loss. In the case of healthcare, the risk is malpractice litigation directed at both doctors and hospitals. The techniques of risk management are very similar to those of quality management, and risk management is an intrinsic component of quality management.2 Risk management in healthcare is not simply about reducing error, any more than is quality management. It is this focus that leads to so much confusion. Quality assurance: This is the deliberate activity of ensuring that what was done and achieved is what should have been done and should have been achieved. It is another facet of the broader activity of quality management. The management of quality and avoidance of the risk of litigation is difficult enough. It would help if we did not all use the terminology to mean whatever we want it to mean.

Lionel L Wilson

Paul Nisselle Senior Advisor, Risk Management, Medical Defence Association of Victoria, PO Box 1059, Carlton, VIC 3053. nisselpATozemail.com.au In reply: Wilson highlights the confusing taxonomy of quality/risk in healthcare. My editorial distinguished prudential risk management (ensuring insurer solvency) from clinical risk management (reducing medical error).1 The term “clinical governance” combines quality improvement (ie, getting it right more often) and risk management (ie, getting it wrong less often). Wilson writes that “Managing quality is largely about avoiding patient harm”. But quality management is as much about finding more effective ways of doing things as it is about finding safer ones. Quality and safety are separate, albeit overlapping, concepts. Similarly, risk management is more than just “minimisation of financial loss”. Reducing the rate of head injuries by using seat belts has a human benefit, not just a financial one. One trade-off for the “Abbott reforms” to medical indemnity is a demand by government for a real commitment by both medical indemnity insurers and those insured to clinical risk management. Although we may disagree on the language, Wilson and I are in heated agreement on the need for a concerted, systemic approach to quality management. The medical indemnity insurers have a role to play that goes beyond just remaining solvent and keeping indemnity costs down!

Paul Nisselle

Kevin B Orr Surgeon, 3/22 Belgrave Street, Kogarah, NSW 2217. stgeorgedermATbigpond.com To the Editor: I report the case of an unexpected complication of a common cardiothoracic procedure which deserves the attention of the general medical community. An 82-year-old general practitioner required coronary artery bypass surgery. Although retired, he was fit enough to continue visiting patients in a number of nursing homes, and occasionally assisted at operations. His condition after the surgery was good for a few days, but deteriorated, with the development of dyspnoea, shortly before he was due to be transferred to a rehabilitation unit. Whether it was realised that his haemoblobin level had fallen from 150 g/L to 90 g/L over the days before surgery is not known. A blood count several days after surgery revealed a haemoglobin level of 100 g/L. This low level was attributed to insufficient transfusion during surgery. The patient was given two units of blood, which raised the haemoglobin level to 120 g/L. Although a repeat test on the day he was discharged to a rehabilitation unit showed the level was again 100 g/L, this result was not seen by a clinician before the transfer. On arrival at the rehabilitation unit, the patient was unable to complete the scheduled activities. He was breathless, returned to his room, almost fainted and had to be helped back into bed. Later that night, he had massive melaena and died. For some weeks leading up to the bypass surgery, the patient had suffered from dyspepsia and was “living on” antacid. He mentioned this to his general practitioner, who did not initiate any investigations or treatment. On the patient’s admission to hospital, the medical officer prescribed omeprazole, presumably in response to the history of dyspepsia. Whether this doctor was aware of a preoperative drop in haemoglobin level is not known. The most likely cause of this man’s death was a bleeding duodenal ulcer exacerbated by coagulation defects associated with major surgery (no autopsy was performed). Bleeding was initially slow but culminated in a fatal haemorrhage. The lesson from this case is that any suggestion of a serious concurrent illness should be thoroughly investigated before major surgery. In this case, a simple gastroscopy before the bypass surgery might have been lifesaving.

Kevin B Orr

Medical research in the UK is gripped by an anti-intellectual winter During the last British winter, a moderately well-off elderly couple in London somehow failed to pay their gas bill. After the routine warnings, the gas company turned off their supply. Interpreting the Data Protection Act of 1998 as prohibiting the divulgence of personal information to a third party without consent, the gas company failed to notify the local social services department that its former customers were now at risk. Eventually, one of the pensioners died quietly of hypothermia and the other of a cardiac event. Every piece of research . . . requires approval using a nationally standardised ethics form that potentially runs to 73 pages This true story highlights a national community that collectively has lost sight of reasonable balances between risk and benefit in regard to information and, by extension, the same equation as it applies to the systematic collection of data as it occurs in academic research. Somehow, the paediatric cardiac surgery scandal at Bristol Royal Infirmary and the murders committed by Shipman have, in the minds of tabloid editors and health bureaucrats, become conflated with the Alder Hey matter. The latter involved paediatric pathologists retaining tissue samples and body parts of deceased children “for research”, without obtaining the consent of their parents. A further ingredient is several infamous cases (mostly outside the United Kingdom) of research investigators being caught fabricating data. Throw in a typically prescriptive directive from the European Union regarding clinical trials of new drugs, and the results are a burgeoning “industry” regulating research, and paperwork that is multiplying faster than maggots in a dunghill. The UK Government has only added to the momentum. Its Research Management and Governance Framework obliges every National Health Service Trust, be it in primary care, a general hospital or the mental health services, to develop systems to ensure that it is aware of all research taking place on its “patch”, and that each project meets all relevant standards of ethical, intellectual, scientific and fiscal propriety. At first glance, this appears entirely reasonable, but the reality is that investigators now have to prepare and submit multiple copies not only of grant applications, and then ethics applications, but also of new forms for research governance. Every piece of research involving users or staff of health and social care services, or the data such organisations hold, requires approval using a nationally standardised ethics form that potentially runs to 73 pages. This also applies to research projects undertaken in these settings by students, including undergraduates. The disincentives to initiating research are clearly massive, and the burdens are becoming unsustainable, especially those on supervisors of trainees who need skills and experience in doing and interpreting research to practise their professions properly. In primary care, in particular, it may well be impossible for the responsible Trust to know which of its dozens of affiliated general practitioners are trying a new drug on a few patients at the behest of some larger or smaller pharmaceutical company, perhaps based at the other end of the country or even overseas. But if something goes wrong, it is the CEO of that Trust whose neck will be on the block. Should these individuals be lying awake worrying about that possibility? If we can disentangle Bristol and Shipman from research, because hopefully both were exceptional episodes of exceptionally bad clinical practice, then the truth is probably that the Alder Heys of this world are also rare and are likely becoming progressively rarer. Attitudes do change, and the kind of paternalism represented by the actions of the Alder Hey pathologists is generally on the wane. Indeed, several Australian jurisdictions revised their coroners acts about a decade before Alder Hey “broke”, because of a rising tide of concern that bodies had been released to grieving relatives with no indication that significant elements or even complete organs had been retained. The transition was not without pain, and pathology staff were obliged to brush up their skills for dealing with the living, but we fairly quickly reached a new level of respect for all of the parties in the forensic triangle. Certainly, Australian researchers were spared the chore faced by all British medical academics post-Alder Hey of having to account for every last histology slide up and down the country. In a highly competitive, publish-or-perish environment, the temptation to bend or break the rules of scientific and intellectual integrity may never be eliminated. And peer review is demonstrably not a foolproof defence against fraudsters. While instances of ingenious invention of interesting findings clearly do come along more frequently than transits of Venus, and therefore are more common than collisions of asteroids with the Earth, any scientifically literate member of an ethics committee will tell you that we face far greater problems in the shape of poorly designed and ethically and scientifically inadequate research protocols. At the very least, it takes the average medical student around 4 years to lose completely the capacity to describe any piece of research in terms that a potential lay participant can understand. Added to this is the problem posed by powerful computers that readily reanalyse any given set of data until at least one “statistically significant” (and therefore publishable) result emerges. Perhaps worst of all is the tendency for authoritative individuals and organisations to recommend clinical and public health policies that go well beyond the available evidence. In the UK, for example, the major diabetes charity has run a “missing million” campaign, advocating screening the population for undiagnosed diabetes. And all because rigorous controlled trials have shown that tight control of blood glucose level and blood pressure in people with clinically evident diabetes reduces vascular and renal complications.1,2 Research and its reputation are not without their problems, but breaches of the Data Protection Act, pathological paternalism, and the imminence of a cosmic collision are not chief among them. Greater clarity in thinking and improved scientific and ethical literacy in the population at large, in the community of investigators, and among policymakers and politicians would shorten the anti-intellectual winter now gripping much of medical research in the UK.

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

Objectives: To determine whether the quality of hospital inpatient care can be improved by using checklists and reminders in clinical pathways.Design: Comparison of key indicators before and after the introduction of clinical pathways incorporating daily checklists and reminders of best practice integrated into patient medical records.Setting and participants: The study, at Wimmera Base Hospital in Horsham, Victoria, included patients admitted between 1 January 1999 and 31 December 2002 with ST-elevation acute myocardial infarction (AMI) and patients admitted between 31 July 1999 and 31 December 2002 with stroke.Main outcome measures: Compliance with key process measures determined as best practice for each clinical pathway.Results: 116 patients with AMI and 123 patients with stroke were included in the study. ST-elevation AMI. After introducing the clinical pathway program, percentage-point increases for treatment compliance were 21.4% (95% CI, 7.3%–32.7%) for patients receiving aspirin in the emergency department; 42.7% (95% CI, 26.3%–59.0%) for eligible patients receiving β-blockers within 24 h of admission; 48.1% (95% CI, 31.4%–64.8%) for eligible patients being prescribed β-blockers on discharge; 43.7% (95% CI, 28.4%–59.1%) for patients having fasting lipid levels measured; and 41.2% (95% CI, 19.0%–63.5%) for eligible patients having lipid therapy. Stroke. After introducing the clinical pathway program, percentage-point increases for treatment compliance were 40.7% (95% CI, 21.0%–60.2%) for dysphagia screening within 24 h of admission; 55.4% (95% CI, 32.9%–77.9%) for patients with ischaemic stroke receiving aspirin or clopidogrel within 24 h of admission; and 52.4% (95% CI, 33.8%–70.9%) for patients having regular neurological observations during the first 48 h after a stroke. There was a fall of 1.0 percentage point (ie, a difference of –1% [95% CI, –4.7% to 10.0%]) in the proportion of patients having a computed tomography brain scan within 24 h of admission.Conclusion: Significant improvements in the quality of patient care can be achieved by incorporating checklists and reminders into clinical pathways.

Alan M Wolff FRACGP, MBA · Sally A Taylor BN, RM, MAM (Health) · Janette F McCabe BN, CritCareCert, MAM (Health)

Nat Lenzo Head, Department of Nuclear Medicine, Royal Perth Hospital, Wellington Street, Perth WA 6000, and Co-ordinator, WA PET/Cyclotron Service, Sir Charles Gairdner Hospital, Nedlands, WA 6009 nat.lenzoAThealth.wa.gov.au To the Editor: I read with interest the article by Ware et al1 and the response from Davies.2 Let me first commend Ware and his colleagues on an excellent piece of investigative journalism. For the readers’ information, there are about 200 operational positron emission tomography (PET) scanners in the United States, and the United Kingdom has recently committed to 50–60 PET scanners within the next 5–10 years.3 This is based on the vast amount of published evidence with respect to the benefit of PET for the diagnosis, staging and monitoring of a range of malignancies and other disorders. Despite more than 15 000 publications3 and the fact that some countries reimburse for many indications not covered in Australia (eg, breast cancer restaging, dementia assessment), our authorities request “Australian data” before allowing expansion of the Medicare benefit for PET in Australia. The issuing of only eight Medicare licences (ie, about 1 per 2.5 million population) also impedes access to what may be the most important imaging development of the past 20 years. What was not mentioned by Ware et al is the grossly inadequate amount paid for PET services under the Medicare Benefits Scheme in Australia. Currently, the reimbursement for a fluorodeoxyglucose PET scan in the US is about US$2000/scan. In Australia, the Medicare Benefits Scheme pays about $900. This makes our reimbursement one of the cheapest in the world. So cheap that it makes no economic sense for private entities to provide PET services in this country (note: isotope cost, about $350/patient; cost of PET set-up, $2.5–5 million). So the Commonwealth has no need to worry — it already has done much to slow the growth of clinical PET in Australia. Before Davies replies that we need “Australian data”, cost-effectiveness data, etc, before allowing new technology expansion, I ask: are Australian data so much better than those from our colleagues overseas? And what is the level of evidence for much of what we currently do and get paid for in clinical practice? For example, what is the rationale behind the reimbursement, without limit, of regular computed tomography scanning in the follow-up of patients with treated lymphoma? I direct readers to the articles by Guppy et al4 and Dryver et al5 to see what little benefit there is in this practice. Of course, these are British and Canadian studies, so surely they cannot be taken seriously.

Nat Lenzo

Robert E Ware,* Hilton W Francis,† Kenneth E Read‡ * Nuclear Medicine Physician, 49 Augusta Road, Lenah Valley, TAS 7008; † Rheumatologist, Hobart; ‡ Barrister, Malthouse Chambers, Hobart. robwareATtrump.net.au To the Editor: In light of our article examining the Australian Government’s review of positron emission tomography (PET),1 it is interesting to note that the accompanying official response is attributed to the Department of Health and Ageing (DOHA).2 When asked to clarify its role in the review of PET, DOHA had previously persuaded the Commonwealth Ombudsman that it had contributed only secretarial support to the process. With no accountability for policy decisions or the review itself, is it any wonder that DOHA’s response does not address the hard evidence that the politicians are “misusing” evidence-based medicine. The comment that “one of the concerns that has been raised about the PET reviews is that the government did not follow the views of individuals who were involved in the process” does not relate to our text. We are aware that individual opinion is considered very low-level evidence. Our argument is that the supporting committee made a decision that PET was safe, clinically effective and potentially cost-effective on the basis of the evidence it reviewed. The Medical Services Advisory Committee (MSAC) itself did not review any evidence, so, by changing the decision of its supporting committee, MSAC’s own opinion was substituted without any sound scientific basis. Therefore, the decision at a ministerial and government level to restrict Medicare funding for PET is purely a political decision, and must not be misrepresented as “evidence-based”. Indeed, the evidence suggests that the policy decision to restrict Medicare funding for PET prejudiced the objective analysis of the evidence by MSAC. The suggestion that “the government is funding the collection of data by service providers to improve the evidence base related to the use of PET in a wider range of indications” is misleading. To improve the level of evidence for PET would require, in the words of the permanent medical adviser to MSAC, “very large randomised trials, which are probably not feasible”. The current data collection is not a randomised trial. For many of the indications being examined, the validity of the PET findings and consequent management changes will not be assessed. There is no plan to evaluate cost-effectiveness. Therefore, the process is not going to improve the level of evidence for subsequent decision-making. Perhaps this is the outcome envisaged for 2006! The problem with the PET review was a fundamental disregard for the promised standards. The ongoing problem is that MSAC is not an appropriately legislated body (unlike the Pharmaceutical Benefits Advisory Committee). MSAC is secretive and its process and decision-making are difficult and costly to penetrate. Unless the structure, process and accountability of MSAC are changed, history is likely to repeat itself. The official response to our article only serves to heighten our concerns.

Robert E Ware · Hilton W Francis · Kenneth E Read

The New South Wales Medical Board has developed the Impaired Registrants Program to deal with impaired registrants (doctors and medical students) in a constructive and non-disciplinary manner; the program is now well established. The Program enables the Board to protect the public, while maintaining doctors in practice whenever possible. Disorders that commonly lead to referral of impaired doctors include alcohol and drug misuse, major depression, bipolar disorder, cognitive impairment and, less commonly, psychotic and personality disorders and anorexia nervosa. Pathways in the program are individualised according to the impact of the specific disorder, the registrant’s career stage, stage of involvement in the program, insight and motivation. Critical points in the program include entry, easing of conditions, breach of conditions, return to work after suspension, and exit from the program. Decision-making at these points takes into account the nature of the impairment, compliance, professional and personal support available and the registrant’s insight and motivation.

Kay A Wilhelm MD, FRANZCP · Alison M Reid MHA, FAFPHM

To the Editor: International medical graduates on temporary residency visas now make up a substantial proportion of the rural medical workforce. Anecdotal reports suggest that many make the transition to professional life in Australia reasonably well, in terms of both cultural adaptation and applying their professional skills, even though the level of educational assessment and support may vary considerably. However, there are some disturbing reports of a few such medical practitioners who perform poorly and are moved on, perhaps to another state. A survey conducted for Tropical Medical Training, the regional general practitioner training provider for North Queensland, found that international medical graduates were often the only doctors in some rural communities, and their lack of teaching confidence and connection to a medical school was a significant barrier to expanding medical student and registrar training in the region. 1 As part of a follow-up project that aims to identify the educational needs of international medical graduates in rural northern Queensland and design support programs for them, several organisations were approached to gain access to this group, rumoured to be perhaps 50–100 individuals. Because of the Privacy Act, the survey was to be distributed by one or more organisations that knew how to contact these doctors. However, no single organisation appeared to have an accurate database that included the target group. Queensland Health, a major employer of international medical graduates, had no central record. Divisions of General Practice stated that few international medical graduates joined them, and most were ineligible to join a college. The Queensland Rural Medical Support Agency probably had the largest database, but its accuracy cannot be verified. The lack of access to international medical graduates will place constraints on the research project (there is no denominator and response rates cannot be measured). However, the broader issue is that international medical graduates, at least in rural and remote communities, appear to have no single organisation monitoring their recruitment, educational qualifications and needs, or retention. They appear to be an almost invisible workforce. This somewhat chaotic situation cannot be in the best interests of either the workforce or the quality of Australian healthcare.

Richard B Hays

More than 170 clinicians from diverse healthcare backgrounds attended the National Institute of Clinical Studies (NICS) “Heart Failure Forum 2004: improving outcomes in chronic care”, held in Canberra, 7–8 June 2004. The purpose of the forum was to raise awareness of the growing burden of heart failure, engage with Australian and international experts in heart failure and chronic care management, and explore strategies for improving outcomes in chronic care. Successful models of careGeoffrey Tofler (Chair of the NICS Heart Failure Advisory Group and Professor of Preventive Cardiology, University of Sydney) set the scene by highlighting gaps in the current medical treatment of heart failure. These gaps are most notable in the use of evidence-based drug therapies, such as angiotensin-converting enzyme (ACE) inhibitors and β-blockers, that reduce symptoms and hospital admissions and improve survival.1 Chronic care expert Ed Wagner (Director, MacColl Institute for Healthcare Innovation, Group Health Cooperative, Seattle, Washington, US, and leader of the Robert Wood Johnson Foundation Improving Chronic Illness Care Program) argued that the current care system is not working adequately for either patients or healthcare professionals,2 and emphasised the importance of redesigning care systems around the needs of patients with chronic illnesses. He described the essential elements of the chronic care model (Box 1),3 and illustrated how the model, combined with the Institute of Healthcare Improvement collaborative improvement method, enabled over 1000 US healthcare organisations to improve quality of care for patients with asthma, diabetes and chronic heart failure.4 Peter Didsbury (Chairman, New Zealand Guidelines Group, and Deputy Head and Manager of Integration, ProCare Health Ltd, Wellington, NZ) reported increased prescribing of ACE inhibitors, β-blockers and spironolactones following multifaceted intervention strategies, such as improved access to echocardiography, rapid access to cardiology advice, funding for β-blocker titration, access to a cardiac nurse specialist and 24-hour telephone triage. The results of an unpublished randomised trial he conducted involving patients with chronic obstructive pulmonary disease led him to suggest that improving the effectiveness of patient adherence through more structured care processes (such as holistic assessments, education about the condition, lifestyle therapy, action plans and active follow-up) may have greater effect. The vital role played by nursing staff was highlighted by Simon Stewart (Chair, Cardiovascular Nursing, and Director of the Centre for Innovation in Health, University of South Australia). He presented evidence from a recent systematic review of randomised trials of multidisciplinary strategies for the management of patients with heart failure at high risk for admission. This review showed that programs that incorporate follow-up by a specialised multidisciplinary team (in either a clinic or a non-clinic setting) reduce mortality, heart failure hospitalisations and all-cause hospitalisations.5 Stewart emphasised the need for a more systematic implementation of specialist nurse-led, home-based, follow-up services after discharge for patients with heart failure. Such services are currently available to less than 10% of those needing them. Whether this form of care is applicable in rural and remote locations is not certain, according to Henry Krum (Director, NHMRC Centre of Clinical Research Excellence in Therapeutics, Monash University), who described the computerised, telephone-based patient support system (“Telewatch”) his research group is trialling in Australia. The system allows healthcare providers to closely monitor symptoms of patients with chronic heart failure and to track progress, respond to deterioration and make suggestions to improve overall management. Specific questions relate to diet, exercise, alcohol use, smoking, use of drugs for chronic heart failure, use of prescribed and over-the-counter medications unrelated to chronic heart failure, mood state and current coping. Results are expected by the end of 2005. The role of GPs in management of heart failureAlthough heart failure is a leading medical cause of hospital admissions in older people, Justin Beilby (Head, Department of General Practice, University of Adelaide) noted that patients with heart failure represent a low proportion of the total patients that each general practitioner treats. Of concern to GPs is the need to identify people with early heart failure, who would benefit from more aggressive intervention. This point was reinforced by Michael Feneley (Chair, Cardiac Society of Australia and New Zealand Echocardiography Working Group), who stressed that new shortness of breath with no other obvious cause is often a symptom of early heart failure and should trigger investigation. He believes echocardiography is the most useful investigation in confirming or ruling out heart failure and is critical for determining the underlying cause and guiding therapy.6 Mark Harris (Professor, General Practice, University of New South Wales) detailed the important role of Divisions of General Practice in providing support and feedback to practices in the collection and analysis of data and in the use of patient registries — key elements of proactive chronic care patient management. The forum heard from Judith Mackson (Prescribing Program Coordinator, National Prescribing Service [NPS]) that the NPS, the National Heart Foundation of Australia (NHFA) and the NICS have formed a collaboration to improve targeted elements of heart failure diagnosis and management in general practice. This joint program will deliver key messages on drug use for treating heart failure and will emphasise the importance of echocardiography to confirm the diagnosis and guide treatment. Current government initiatives in chronic careThe importance of adopting a more systematic approach to chronic care management in Australia was reinforced by Andrew Tonkin (Director, Health, Medical and Scientific Affairs, NHFA), who argued that the effective management of heart failure represents an excellent paradigm for improving the care of people with other chronic conditions. The value and cost-effectiveness of management programs that can support patients with heart failure in the home and community and prevent hospitalisation have been demonstrated. Programs and information systems for patients with heart failure, once established, could be easily adapted to the needs of other chronically ill patients. Jane Halton (Secretary, Australian Government Department of Health and Ageing) highlighted recent Budget initiatives. Funding is provided for 1600 more primary care nurses and a new Medicare Benefits Schedule item number linked to the Enhanced Primary Care multidisciplinary care plan for services provided by allied health professionals. Ms Halton outlined the government’s plans for a national chronic disease strategy, following development and consultations by the National Health Priority Action Council’s Chronic Disease Strategy Group. The forum heard about different state heart failure programs. Craig White (Deputy Chair, Victorian Hospital Admission Risk Prevention Program, and Executive Director, Clinical Services, Austin Health) and Kym Scanlon (Assistant Director, Chronic Care Program, NSW Health) presented figures showing encouraging reductions in hospital admissions for chronic heart failure since the commencement of statewide chronic care programs, such as the Victorian Hospital Admission Risk Prevention Program and the NSW Chronic and Complex Care Program.7,8 Clearly, more patients need to access these programs, with only an estimated 15% of eligible patients enrolled in Victoria (Andrea Driscoll, Deakin University). NSW Health is currently addressing implementation and spread of issues through a statewide chronic care collaboration that focuses on heart failure and chronic obstructive pulmonary disease. The change principles of the collaboration are based on the key elements of Wagner’s chronic care model, as well as policy components from the World Health Organization’s Innovative Care for Chronic Conditions Framework.9 Conclusion and the way forwardIn the concluding plenary session, Didsbury and Wagner suggested strategies that would facilitate implementation of the chronic care model in Australia. They emphasised the need to reward care planning, support efforts to encourage practice system change, and make patients a part of the planning. Using the patient journey as a framework, Geoffrey Tofler presented a matrix of key strategies and interventions that patients, clinicians and governments should consider to improve outcomes and quality of life for patients with heart failure (Box 2). The matrix indicates areas where best-practice models of care are known, such as cardiac nurse specialists for post-discharge heart failure patients, and areas where more research is needed, such as the best use of practice nurses in chronic diseases. Finally, the matrix suggests areas where enhanced government support is needed (such as in creating mechanisms for funding comprehensive care programs and in further funding for practice nurses). The range of participants at the forum reinforced the broad approach needed to improve outcomes in heart failure. Furthermore, strategies adopted successfully with heart failure could have major effects when extrapolated to other chronic conditions. The forum presentations and a more detailed report are available on the National Institute of Clinical Studies website (www.nicsl.com.au). 1 The chronic care model Source: Ed Wagner keynote address, NICS Heart Failure Forum 2004. Available at www.nicsl.com.au. For more information on the chronic care model, see reference 3. 2 Matrix of key strategies and interventions for a patient with heart failure Stage Prevention Early stage Acute exacerbation Ongoing care Palliative care Issues Identification of high-risk patients Recognition of early signs and symptoms, when and whom to refer for echocardiography Use and availability of echocardiography, particularly in rural areas Use of BNP in primary care to be further defined In-hospital initiation of appropriate therapy and discharge to community with management plan, including dose titration schedules Comorbidities, diagnostic issues, systematic patient education and support Need research on the education of practice nurses in chronic care management and effectiveness in improving patient outcomes Changing roles in general practice Need research on access to palliative care services and how to extend these to patients with heart failure Model Prevention and management of coronary artery disease and hypertension Consumer Education (NICS Online directory of quality information for patients with heart failure) Appropriate use of echocardiography in diagnosis and assessment of heart failure in primary care (NICS education module in preparation) Clinician-led quality improvement programs Heart failure nurse-led, home-based management programs (Alternatives include hospital-based rehabilitation, heart failure clinics) Chronic care management model Study and implement self-management models Targeted interventions aimed at implementing best practice management of heart failure in primary care (NICS, NPS and NHFA joint heart failure program) Need research on appropriate palliative care model and extrapolation of palliative care and nursing principles Consumer role Awareness of risk factors (SNAP) Awareness of early symptoms and precipitants, especially in high risk individuals Working in partnership with healthcare professionals Access to self-management education and support, particularly post-discharge Self-management education and support, ongoing monitoring, adherence to treatment Heart Failure Action plan Consider advance directives Access to self-management and support Provider role Identification and treatment of high-risk patients by GPs, cardiologists, general physicians Assessment of patients with early signs and symptoms by GPs Referrals to cardiologists or general physicians, where appropriate Emergency physicians, cardiologists, general physicians, geriatricians, cardiac nurses, hospital pharmacists GPs, practice nurses with training in chronic care and support from cardiac nurses, allied health, community nurses and pharmacists GPs, community nurses, palliative care teams Government role Heart failure health promotion campaign, and systems in place to support this Access to echocardiography, access to cardiologists Need heart failure prevalence study and minimum heart failure dataset Need initiatives for improved outcomes for cardiovascular disease in primary care Ongoing resourcing for cardiac nurse role in acute settings and post-discharge (state) Testing and implementation of chronic care model in general practice and system redesign issues (Commonwealth) Mechanism for funding comprehensive care programs More practice nurses Capacity building for quality improvement Extend palliative care entitlements to patients with heart failure (eg, access to medicines, oxygen and home nursing services) BNP = Brain natriuretic peptide. NICS = National Institute of Clinical Studies. NPS = National Prescribing Service. NHFA = National Heart Foundation of Australia. SNAP = Smoking, Nutrition, Alcohol, Physical activity.

Susan M Phillips DPhil · Janice M Davies PhD · Geoffrey H Tofler MB BS, MD

Rosalie C Viney,* Madeleine T King,† Elizabeth J Savage,‡ Jane P Hall§ * Senior Lecturer, † Lecturer, ‡ Senior Lecturer, § Professor, Centre for Health Economics Research and Evaluation, University of Technology Sydney, PO Box 123, Broadway, NSW 2007. Rosalie.vineyATchere.uts.edu.au To the Editor: Segal et al propose a new method — “transfer to utility” (TTU) — to convert clinical and quality-of-life (QOL) trial-based outcome measures to a common metric — quality-adjusted life-years (QALYs) — to compare the cost-effectiveness of different interventions.1 TTU uses regression to map clinical and QOL instruments to a “utility-equivalent scale” that aims to measure strength of preference for health outcomes. In their example, several instruments were administered to osteoarthritis patients. Australian Assessment of Quality of Life (AQoL) scores were regressed on SF-36 subscale scores and QALYs were generated from published SF-36 results by means of a conversion algorithm based on these parameter estimates. The approach is novel, but we question its validity. Utility and health-related quality of life (HRQOL) are fundamentally different concepts. HRQOL is a standardised multi-dimensional, ordinal measure of the individual’s perception of how disease and treatment affect physical, social and emotional functioning. Measuring utility requires a critical next step: capturing strength of preference for outcomes in a unidimensional interval scale. HRQOL and utility scales have very different interpretations. Any appearance of similarity is superficial. The algebra of scale conversion is easy, but conceptually problematic. TTU involves a complex trail of estimation and prediction. Ordinal SF-36 subscale scores are used as arguments in regression, imposing interval properties. Statistically valid interpretation of the resulting parameters requires dummy coding. The dependent variable is the AQoL score generated by applying the AQoL algorithm, developed in previous research using a different population2 to respondents’ surveys. The new algorithm from the TTU regression parameters is used to convert published trial-based average SF-36 subscale scores to AQoL scores. Misspecification errors are built into the predicted AQoL scores. Information about variability in outcomes and preferences in intermediate measures, and hence uncertainty around point estimates of predicted AQoL scores, is suppressed. How plausible are these results? Segal et al report an estimated “utility gain” 12 months after hip surgery of 0.304 (from 0.464 before surgery to 0.767 at 12 months).1 The interpretation is that an average patient undergoing hip surgery for osteoarthritis would be willing to forgo about 40% of their remaining life span for the quality-of-life improvement the surgery would provide. Apparently, sophisticated quantitative approaches cannot add information about factors not measured in trials. The validity of the approach stands or falls on appropriate statistical methods, data quality and interpretable results. TTU potentially introduces bias, suppresses information relevant to decision-making and may lead decision-makers to place undue trust in point estimates based on heroic assumptions.

Rosalie C Viney · Madeleine T King · Elizabeth J Savage · Jane P Hall

Leonie Segal,* Richard H Osborne,† Susan E Day‡ * Deputy Director, ‡ Research Fellow, Health Economics Unit, Monash University, PO Box 477, West Heidelberg, Melbourne, VIC 3081. † Senior Lecturer, Centre for Rheumatic Diseases, University of Melbourne, Melbourne, VIC. Leonie. SegalATbuseco.monash.edu.au In reply: The “transfer to utility” TTU technique was devised to compare disparate interventions, using published clinical trial literature, where utility data are not reported. While collection of utility data in clinical trials would be preferable, until this occurs routinely a means to translate reported quality-of-life scores into utility scores is highly useful. Other groups are also grappling with this.1 In developing the TTU weights, various sophisticated statistical techniques were explored. However, added complexity did not improve the estimates. Contrary to the suggestion by Viney and colleagues, the TTU estimates are highly plausible and were vetted by our reference panel of clinical experts. Taking the example Viney and colleagues cite, a 0.304 increase in utility score for hip replacement indicates a patient would, on average, be willing to forgo 30.4% of remaining life-years to obtain the benefits of surgery — not 40% as incorrectly stated by Viney et al. This is consistent with the large increase in well-being observed following hip replacement (in the seminal trial, SF-36 mean scores increased from 26.9 to 66.6 for physical function, 14.6 to 58.7 for role physical, and 32.9 to 72.8 for bodily pain). Whether the TTU introduces bias (a characteristic of other summative approaches to estimating health, such as the popular DALYs) is a matter for future research. Undoubtedly, all population-wide approaches suppress specific information, but the purpose of the priority-setting model supported by the TTU is not to provide information on individuals, but to compare management options to give clinicians and policymakers another way of understanding the comparative performance of disparate interventions.

Leonie Segal · Richard H Osborne · Susan E Day

Leonie Segal,* Richard H Osborne,† Susan E Day‡ * Deputy Director, ‡ Research Fellow, Health Economics Unit, Monash University, PO Box 477, West Heidelberg, Melbourne, VIC 3081. † Senior Lecturer, Centre for Rheumatic Diseases, University of Melbourne, Melbourne, VIC. Leonie. SegalATbuseco.monash.edu.au In reply: Our economic analysis of COX-2-specific inhibitors (CSIs) was part of a research program on priority setting. The application to osteoarthritis (OA) involved cost–utility analyses of 19 interventions (written up in a 195-page research report1), and was subject to peer review by an advisory panel including senior clinicians. The research drew on over 200 references, 23 on CSI, but a limit of 50 references for articles in the Medical Journal of Australia meant that full referencing was not possible. Evidence of efficacy in OA and adverse events (gastrointestinal and cardiac) are incorporated in our QALY estimates, the latter based primarily on the seminal CLASS trial (Celecoxib Long-term Arthritis Safety Study), and the United States Federal Drug Administration (FDA) analysis2-4 of this trial (summarised previously5). The FDA report concludes that for the primary endpoint specified in the study protocol — clinically significant upper gastrointestinal event (CSUGIE) — for the entire study period there was no significant difference in adverse events between the celecoxib arm and the combined diclofenac/ibuprofen arms (P = 0.45).2 Using the broader definition — combined CSUGIE and gastroduodenal ulcer (CSUGIE/GUD) — a significant difference is reported between combined non-specific non-steroidal anti-inflammatory drugs (NSAIDs) and celecoxib (P = 0.040), but not with diclofenac (P = 0.295).2 The FDA concluded that “celecoxib was not able to demonstrate it was statistically superior to diclofenac in terms of the clinically important UGI [upper gastrointestinal] endpoints and conditions defined in this study. The same is not true when comparisons are made to ibuprofen.”2 The dominance of non-specific NSAIDs reflects celecoxib priced at $32.13/month (for 200 mg/day) and diclofenac at $13.42/month (for 75 mg/day)6 and evidence of equivalence in management of OA and GI side effect profile. We agree this does not support a conclusion about class dominance. All NSAIDs and all CSIs are not the same. Celecoxib is listed on the Pharmaceutical Benefits Schedule, but, as submissions by companies to the Pharmaceutical Benefits Advisory Committee (PBAC) are confidential, the research team may not have had access to all relevant evidence. We would welcome access to such information from which to prepare revised estimates. Placing all submissions to the PBAC in the public domain, as now occurs with reports of the PBAC, would allow a more informed public debate on these matters and would be most welcome.

Leonie Segal · Richard H Osborne · Susan E Day

Harm-reduction approaches are more easily embedded in policy when drugs are legally regulated “Harm reduction” in relation to drugs refers to policies and practices intended primarily to reduce the health, social and economic costs of mood-altering drugs without necessarily restricting their consumption. The recognition of AIDS in 1981, and the subsequent realisation of the magnitude of the threat of HIV spread among and from injecting drug users, has given increasing prominence to harm-reduction approaches. The 15th International Conference on the Reduction of Drug Related Harm was held in Melbourne from 20 to 24 April 2004. This is the third time this conference has been held in Australia, an indication of Australia’s leadership position in this field for nearly two decades. The goal of the conference is to bring together people representing the diverse aspects of harm reduction, and the conference’s theme was “Minimising the harm: maximising the impact”. As a reflection of the growing strength of the harm-reduction movement worldwide, the conference attracted over 1100 delegates from more than 40 countries. Delegates included researchers, clinicians, policy makers, law-enforcement officers, politicians, past and present drug users and private industry representatives. Cross-sectoral and interdisciplinary discussions and networking were a major feature of the conference. The 875 papers presented (including 450 posters) covered a diverse range of topics (see Box) and encompassed a wide range of approaches, including sophisticated science, complex policy analysis and activism. Research methods varied from quantitative epidemiology, qualitative ethnography, randomised clinical trials to economic analyses. Round-table discussion and other interactive forums were common, and the conference included the first international festival of films about drugs and harm reduction. Legal drugs (alcohol and tobacco), which account for 4% of the global burden of illness, were the subject of only 10% of papers, compared with illicit drugs, which account for 0.8% of the global burden of illness, but to which almost 90% of papers were devoted. This reflects the reality that harm-reduction approaches are much more easily embedded in policy when drugs are legally regulated. Public health and human rightsPublic health was the major framework for many conference speakers, who saw harm-reduction approaches as essential for improving the health status of drug users and their communities. Other speakers emphasised the important links between human rights and public health. This aspect dominated many discussions of HIV prevention among injecting drug users in countries where this population is savagely discriminated against and driven underground, reducing substantially the effectiveness of health and social interventions. Harm-reduction tensionsA fertile debate centred on the relationship between harm reduction and demand reduction. For some speakers, preventing drug use sat uncomfortably with harm reduction, while many others saw no conflict in simultaneous efforts to reduce both demand and harm. The observation that “what works in drug policy is unpopular and what’s popular doesn’t work” struck a chord with delegates from many countries familiar with official denigration of evidence-based interventions, such as needle and syringe and methadone programs, and the zealous promotion of law-enforcement efforts to restrict drug supply, notwithstanding limited evidence of benefit. A second area of controversy is in the relationship between harm-reduction and law-enforcement approaches. An important paper by Peter Reuter (School of Public Affairs and Department of Criminology, University of Maryland, USA), a world expert on organised crime and the impact of drug policy, concluded that there was “no evidence to support law enforcement efforts” to curtail the availability of illicit drugs. Two senior Russian law-enforcement representatives demonstrated for delegates — somewhat unintentionally — the conflict around harm reduction within conservative law-enforcement ranks in Russia, and the difficulties of establishing effective drug policy and HIV prevention in environments where authorities rely almost entirely on harsh law-enforcement measures to control illicit drugs. The first representative called for tougher measures against drug traffickers, and said that, although Russia needed harm reduction, its introduction was impossible because it was illegal. His colleague counselled “methadone is a therapy of despair . . . like a death sentence”. Attending delegates strongly refuted the claims, with representatives from the Central Eastern European harm-reduction network pointing to the lawful establishment of needle and syringe programs in Russia. Other papers emphasised the now extensive research evidence supporting methadone maintenance and needle and syringe programs as highly effective harm-reduction strategies. For example, new data were presented at the conference based on evidence that needle and syringe programs in Australia had meant 25 000 fewer cases of HIV and saved up to $7 billion.1 Collateral damageCollateral damage from the “War against drugs” was a popular theme, with numerous illustrations of the severe counterproductive effects of current prohibition policies. Some speakers provided ample grounds for pessimism: thousands of drug users and traffickers mysteriously murdered in Thailand in recent years after a government-inspired campaign; five million new cases of HIV infection globally in 2003; widespread and active discrimination against illicit drug users; entrenched negative attitudes opposing harm reduction among some UN organisations and in some countries and regions; and an epidemic of incarceration of drug users in many countries. Ernie Drucker (Director, Division of Public Health and Policy Research, Montefiore Medical Center, Albert Einstein College of Medicine, New York City, USA) estimated that the introduction of the draconian Rockefeller drug laws in New York State in 1973, requiring harsh prison terms for the possession or sale of relatively small quantities of drugs, had resulted in more years of life lost than had the 2900 deaths in the attack on the World Trade Center on 11 September 2001. Positive progressSome speakers saw abundant grounds for optimism: the growing strength of the evidence base for harm reduction and rational drug policy; revolutionary recent shifts in attitudes in Central and Eastern Europe; the success of the recent decriminalisation of use and possession of all drugs in Portugal; the remarkable adoption and implementation of harm reduction in Iran; and the active involvement of law-enforcement participants in the conference, and their growing involvement in harm reduction worldwide. The scientific and policy aspects of the conference were balanced by more personal views: some speakers referred to immense personal loss from drugs, while others argued from their individual perspective for more humane attitudes towards drug users. Conference highlightsThe 2004 Annual National Rolleston Award is granted at each conference to an individual from the host country who has contributed outstandingly to harm reduction. The award perpetuates the memory of an influential English physician who, in 1926, supported the lawful provision of morphine or heroin to selected drug-dependent people if this would assist their leading “a fairly normal and useful life”. It was awarded to Mr Tony Trimingham, founder and coordinator of Family Drug Support, Sydney, for his work in support of families and friends of those affected by heroin-related deaths. There was a strong presence of Indigenous Australians and Indigenous culture throughout the conference. This reflected the enormous toll, initially from licit and more recently also from illicit, drugs on the health and wellbeing of Indigenous Australians. A presentation by Tony McCartney (Chair of the National Aboriginal Community Controlled Health Organisation) highlighted the ineffectiveness of policy, attracting considerable attention and concern from national and international delegates. However, numerous delegates praised many other aspects of Australia’s response to illicit drugs in recent decades. Another of the conference highlights was the annual Rolleston Oration. Former Australian Minister for Health, Neal Blewett (currently President of the Alcohol and Other Drugs Council of Australia), delivered the 2004 Oration. He presented a magisterial review of the almost two decades since he, as the responsible minister, oversaw the introduction of harm reduction in Australia in 1985. This shifted the emphasis of drug policy from intent to consequences, enabling the rapid introduction and vigorous expansion of measures that successfully controlled HIV infection among injecting drug users, and allowed policy makers to encompass legal as well as illegal drugs in a pragmatic policy framework. The current Indonesian Minister for Health, Dr Achmad Sujudi, made a strong call for the wide-scale introduction of harm-reduction measures in his country to stem the tide of HIV infection. Ms Marina Mahathir, President of the Malaysian AIDS Council, echoed this call, urging the adoption of effective and pragmatic, human-rights-based measures to combat AIDS in Asia. ConclusionJudging by the breadth and confidence of the discussions and presentations at the conference, harm reduction now seems to be leaving behind a phase of marginalisation and conflict and entering an era of mainstream acceptance and understanding. The conference disseminated new evidence of the effectiveness of harm-reduction approaches to drug problems, stimulated collaboration between participants from diverse backgrounds, gave new energy and confidence to harm-reduction practitioners from far and wide, and helped focus attention on how much more needs to be accomplished, especially in the global battle to contain the AIDS epidemic. Distribution of the topics of the verbal presentations at the 15th International Conference on the Reduction of Drug Related Harm.

Alison J Ritter PhD, MA(ClinPsych), MAPS · Alex D Wodak FRACP, FAFPHM, FChAM · J Nick Crofts MB BS, FAFPHM, MPH

Objective: To estimate Pharmaceutical Benefits Scheme (PBS) subsidies for drugs to treat smoking-related cardiovascular disease (CVD) in 2001–02, and over the period of the government’s Intergenerational Report (IGR), assuming current smoking prevalence rates and a 5% absolute reduction.Design and setting: An Australian epidemiological study, using prescribing data, aetiological fraction methodology, and IGR trends.Main outcome measures: Estimated smoking-related PBS subsidy costs in 2001–02 and predicted cumulative subsidies until 2041–42, under current and reduced smoking prevalence assumptions.Results: The PBS costs of smoking-related CVD in 2001–02 were $126 million, 9.77% of the cost of drugs for CVD and 2.96% of total PBS subsidies. The cumulative difference in these costs over the 40-year period with a 5% drop in smoking prevalence was predicted to be $4.5 billion, a 17% reduction. The saving would be $1.14 billion discounting future costs at 5% per year.Conclusions: Further investment in tobacco control interventions could curb the increasing cost of the PBS and contribute to government efforts to ensure the viability of Australia’s healthcare-financing programs. The net present value of a campaign to reduce smoking prevalence was estimated at $1 billion, with an internal rate of return of 33%.

Susan F Hurley MS, PhD · Michelle M Scollo BSc, GradDipCommHlth, CertHlthEcs · Sandra J Younie PostgradDipHealthEc · Dallas R English PhD · Maurice G Swanson BSc, MPH

The Australia–United States Free Trade Agreement (AUSFTA) contains major concessions to the US pharmaceutical industry that may undermine the egalitarian principles and operation of the Pharmaceutical Benefits Scheme (PBS) and substantially increase the costs of medicinal drugs to Australian consumers. AUSFTA’s approach to the PBS excessively emphasises the need to reward manufacturers of “innovative” new pharmaceuticals, instead of emphasising consumers’ need for equitable and ...

Ken J Harvey MB BS, FRCPA · Thomas A Faunce LLB(Hons), BMed, PhD · Buddhima Lokuge MB BS, MPH · Peter Drahos GDLP, LLM, PhD

Patients want doctors who are competent, respectful, honest and able to communicate with them. That is patient-centred professionalism. Professional self-regulation, as practised hitherto, has failed to achieve this for all patients. In the United Kingdom, a new way of looking at professional regulation has been developed — as a partnership between public and doctors. At its heart is a code of good practice, agreed between public and profession, in which doctors’ licence to practise is conditional on regularly demonstrating continuing compliance. That means revalidation–relicensure.

Donald H Irvine CBE, MD, FRCGP

Objective: To examine the trends in processes of diabetes care and in participant outcomes after an intervention in two remote regions of Australia.Design: Follow-up study over 3 years.Setting: Seven health centres in the Tiwi Islands and the Katherine West region of the Northern Territory.Participants: 137 Aboriginal people with type 2 diabetes.Intervention: Implementation of a multifaceted trial, including transfer of purchasing and planning responsibility to local health boards, the development and dissemination of clinical guidelines supported by electronic registers, recall and reminder systems and associated staff training, and audit and feedback.Main outcome measures: Trends in the proportion of Aboriginal people receiving services in accordance with clinical guidelines and in the proportion for whom specified levels of blood pressure and glycosylated haemoglobin (HbA1c) were achieved; health staff perceptions of barriers to effective service delivery.Results: An initial improvement in overall service levels from 40% to 49% was not fully sustained over the 3-year period. The overall proportion of services delivered varied from 22% to 64% between communities and over time. The proportion of participants whose most recent HbA1c level was less than 7% improved from 19% to 32%, but there was little change in blood pressure control. Perceived barriers to service delivery included discontinuities in staffing, lack of work-practice support and patients’ acceptance of services.Conclusions: Multifaceted interventions can improve quality of care in this environment, but achieving sustainable, high-quality care in a range of services and local conditions presents particular challenges. Developing and testing strategies for consistent and sustained improvement should be a priority for service providers and researchers.

Ross S Bailie MPhil(MCH), MD · Damin Si MMed · Samantha J Togni MA · Gary W Robinson PhD · Peter H N d’Abbs PhD

Despite it being confusing, inherently inequitable, and subject to excessive federal government control, Australia provides good healthcare My career has spanned three decades, two of these as a specialist oncologist, and I have been directly involved in delivering healthcare at a variety of levels on three continents. Over the years, I have been the sometimes innocent, but often active, participant in innumerable healthcare changes. Many resulted in outcome improvements. However, on balance, I believe there have been far too many changes in the organisation of the systems of care, not all of which have been for the better. Examples of this include internal markets being developed and then partially removed in the British National Health Service (NHS) because of inequalities in funding and access; and here, in Victoria, the governance structure affecting the Alfred Hospital where I worked changing four times from 1992–2003, returning eventually almost to the second-generation format. One of my blessings has been direct experience of working and observing in four diverse social and medical cultures: Edinburgh (somewhat pretentious and aloof), Houston, Texas (brash and pushy), Melbourne (relatively conservative) and Glasgow (friendly, but impoverished). My roles in healthcare have included scrubbing surgeons’ boots, in an era when the average length of stay after a myocardial infarction was four weeks and surgeons did not clean their own clogs. Highlights have been working with dedicated clinicians (doctors, nurses and other healthcare professionals), patients and others to deliver, improve, manage and otherwise organise patient-centred care. My personal philosophy of healthcare was moulded and refined by observing, as a child, a “Dr Finlay-type” family general practitioner in a fledgling NHS and by “salt of the earth” working-class parents. They raised me not in poverty, but in a Scots “but ’n ben” (a two-room house common to many families in postwar Britain) where there could be no savings or excess — and certainly no money for “choice” of education or healthcare. But then, in 1950s and 1960s Britain, there was no need for choice, as both were good and often excellent. That personal ethos has also been honed and influenced by mentors to whom I owe a great deal. They include teachers at Edinburgh Medical School, and in hospitals in Houston, Texas and, in the last decade, in Australia. Encountering Australia’s healthcare systemWith that background, for which I give thanks and make no apologies, I embarked in 1992 on the most exciting part of my career — emigration to Melbourne, Victoria. The difference at that time between the NHS — showing its age and beginning to reel from the dogmatic attacks of Mrs Thatcher — and Australia’s complex healthcare system was profound. For a start, Australia is not an offshoot of the “old country”. It is foreign. The light is different, and even the hospital buildings seemed brighter and lighter than the soot-begrimed heritage collection that still makes up much of the NHS estate. Of course, a close inspection of Australia’s younger hospitals reveals the inevitable flaws, cracks and problems. However, to be asked to direct a new radiation oncology centre, the William Buckland Radiotherapy Centre at The Alfred in Melbourne, kitted out with the best equipment of the times, and with space and an ambience to please both patients and staff, was an opportunity that had to be grasped and enjoyed. The challenge permitted me to show that a public hospital such as The Alfred in Melbourne could house a facility the equal in appearance and service quality to any private hospital. Somewhat curiously, there were some in the profession who disapproved. An initial impression of those early days was that some clinicians and many patients felt the public system was for the indigent; that facilities should reflect that; and that the process of care — public clinics, denial of any right to see a particular clinician — should also emphasise the difference. My background would not allow me to concede that. The team I was fortunate to gather and mentor at The Alfred proved over and over (if proof were needed) that quality care could be delivered in the public system and be the equal of that in the private system. It seemed to me, in 1992, that some clinicians believed they were still “honoraries”, donating their time and skills to those who could not afford to see them in private. Yet any observer would not take long to realise that that “private” system was underpinned and subsidised significantly by the federal health service’s Medicare system. The mysteries of MedicareMedicare confused me from Day 1. When, in early 1992, I innocently asked a committee of Victoria’s healthcare service managers and senior clinicians (who were intent on yet another review of radiotherapy services) to explain Medicare, I was regaled with laughter. Eleven years on, as I departed, it was patently clear that neither the press, nor television journalists, nor politicians of any hue, understand Medicare. Clinicians who bill the Medicare Benefits Schedule (MBS), however, do know it in infinite detail, because they need to. That media and politicians debate as though Medicare only applies to general practice is nonsensical. Argument centred on bulk billing belittles the complex and essential nature of the Australian “NHS”. Because Medicare is misunderstood by patients, media, politicians, government and public servants, healthcare managers at all levels have been able to play the game of cost shifting. It appears to be enjoyed by both federal and state officials and public servants and their ministers and shadow ministers. Add hospital managers to that equation and the situation is ripe for confusion and gamesmanship. Is it reasonable to manage a multibillion-dollar healthcare system on the basis of confusion and shifting costs, often in breach of the Act governing it? Healthcare professionals in Australia have to adapt to this confusing conspiracy. Usually this is done for the benefit of patients. Otherwise, the built-in inequity of the Australian systems would be more obvious to all, and hence presumably less acceptable. Such inequity is confusing to a newly arrived migrant, particularly one brought up to believe that healthcare should and can be delivered free at the point of care on the basis of need. In addition, is Australia not renowned for being classless and for mateship? The financial contribution of patients in Australia to their healthcare is significant and does not clearly and fairly take into account their ability to pay. It is also the secret part of the cost/payment equation. It is rarely quantified in easily available public information, although the Australian Institute of Health and Welfare and the Health Insurance Commission do publish reports on out-of-pocket costs for healthcare. Legislation over recent years to cajole citizens into private health insurance has increased that contribution. It can also be argued that the federal subsidy that supports private health insurance contributions compensates for this increased personal copayment. It appears that, politically, on both sides of the House, Medicare cannot be dismantled. Compulsion by carrots (the 30% subsidy on insurance premiums) and sticks (increased Medicare levy for those who refuse to be insured) gives money to the private insurers. It is to be hoped that the previously reported ludicrous use of subsidised private health insurance to fund lifestyle improvements (with compact discs and suchlike for the overly stressed) have ceased. The health insurance industry’s policies are, however, themselves overly complex and confusing and far from ideal, constrained as the insurers are by legislation as to what is insurable. Two systems, two tiersThe premium subsidy will rise relentlessly because premiums will rise relentlessly. That subsidy is not available to improve the public hospitals. With two health systems managed by the state and federal governments the process of healthcare management and improvement is not joined up. The result is two systems offering two tiers of care. To access the “top”, or private, tier a patient must generally pay — insurance, “gap” contribution, and over-gap charges. By exercising that much-vaunted “choice”, the patient who can elect and who can pay may not be choosing a better outcome. He or she may only be choosing a better place or a more convenient time. While these may be the drivers of such choice, those who cannot so choose should, in my view, not be penalised by needing to rely on underfunded services. There is, I believe, no inherent or ethical problem with exercising such a choice. The problems I had with the systems were the inbuilt unfairness of one arm of government manipulating the situation at so many levels. The federal government decides on the major subsidy to each state for, inter alia, healthcare. It also legislates over private health insurance — not only what can be covered, but also how the people may be persuaded to buy it. In addition, that same government manages a significant double subsidy for private healthcare — the insurance premium subsidy and MBS fees. One result is that those too poor to afford insurance or gap payments rely on a public system which has been progressively underfunded and too often denigrated. One proof of underfunding is the significant waiting times in the public system compared with those in the private system. The bright sideIn spite of these challenges and differences and inequities, the public sector, at least in cancer care in most of Victoria, was good. It was possible to deliver personal, patient-centred care of the highest quality and with the latest technology. It was pleasing to see patients return to a public hospital that had access to a new, but expensive, cytotoxic drug before that drug received a PBS subsidy. Of course, the reverse occurred when that subsidy was approved. It was sad when the public hospital budget ran dry and public patients had to scrimp and save for the same drug in the private sector. Fortunately, recent pilot changes to this unfair categorisation of and access to expensive drugs will address this inequity. The driver for this was pressure from oncologists, particularly in Victoria and its Cancer Council and the Victorian Cooperative Oncology Group, and it resulted in a pilot study that allowed some public hospitals like The Alfred to prescribe medication to outpatients and, on discharge, on the PBS. It was also a privilege to work closely with inspired and dedicated colleagues in the “private” sector who established patient-centred services with full support personnel and multidisciplinary-team care. Medicare could not fund that directly in the private sector. The public sector hospitals led the way and did fund, for example, breast care nurses. Enlightened practitioners in private practice followed suit at their own expense. Now, a year after returning to the real NHS, I recognise that the complex, blurry-edged, two-level system that is Australian healthcare delivers, one way or another, high-quality care to most patients. I still do not think it is equitable or totally fair, but, for the time being, the standard of care is better than much that is available in the UK. Perhaps it is because the UK system has fallen behind badly that, across Britain, there is an enormous critical reappraisal of the service at all levels. Modernisation agencies, targets, extra funding — even a cancer “czar” and “czarina” — have found their way into a creaking system. It seemed to me that, until very recently, Australia has been slow to ask questions beyond the large political issue of Medicare — bulk billing. Perhaps a glow of self-satisfaction tinged the healthcare community. There also seemed to be a reluctance to rock the boat of subsidised private medicine. Yet, in recent months there has been a healthy questioning in the medical community1,2 and medical press,3,4 matched by reasoned critiques in the press.5,6 Sadly, the federal government’s response is akin to Hollywood’s approach to the movies, and so we had “MedicarePlus” then “Strengthening Medicare” — or is it just Medicare II? At least the debate continues, if somewhat quietly. I hope that debate will not go silent once the new Medicare has been dragged through Parliament. The issues of equity, quality and cost of care have not yet been fully addressed. The Australian healthcare system is good. It offered me the opportunity to learn much, from both patients and colleagues. It allowed me to practise good medicine with a superb team in an excellent environment. This good system can still be improved for everyone, if the issues of intergovernmental argument over an unnecessarily duplex, but two-tiered, system could be resolved.

Alan Rodger FRCSEd, FRCR, FRANZCR, FAChPM

A more efficient system of governance is needed to safeguard individual privacy while allowing registries to operate for the public good The recent controversy about cancer registries and patient privacy in the United Kingdom highlights the need for more debate about the governance of medical registries.1 For 40 years, identified data from UK patients with cancer have been transmitted to cancer registries without the patients’ express knowledge or consent. Although many benefits have flowed from analysis of these data, societal conventions have now changed, and questions are being asked in the UK and other countries, including Australia, about the privacy issues involved in the governance of medical registries in particular2-4 and medical research in general.5,6 Medical registries were traditionally established by public health authorities to monitor trends in the incidence of conditions such as infectious diseases and cancer. However, registries have become increasingly important in monitoring outcomes after the implementation of disease-prevention and treatment programs. They are now vital to quality-improvement programs that assess the safety of new drugs and procedures, identify best clinical practice and compare healthcare systems. For example, the Australian Orthopaedic Association National Joint Replacement Register currently monitors the use and survivorship of artificial hip- and knee-replacement prostheses,7 while the Victorian State Trauma Registry (VSTR) was established largely to monitor the effects of changes to the state trauma system.8 For registries to be effective, they must include all eligible participants so as to avoid biases that would affect the applicability and generalisability of results, and they must collect patient-specific data so as to adjust outcomes for risk and management factors. Further, in the absence of a unique national identification number, registries require name-based identification if participants are to be contacted for follow-up, or if registry data are to be validated against those held in other databases. The need for identified data raises consent and privacy issues. Registries must be established and governed in compliance with both federal and state legislation on privacy. Current requirements of this legislation have necessitated the development of consent procedures that maintain the effectiveness of medical registries, while informing patients and protecting their personal medical information. However, obtaining patient consent before participation in broad-based registries is often impractical and results in poor enrolment rates.,4 A more practical approach is to inform participants of their registration but to allow them to opt out of the registry. This approach resulted in the loss of fewer than 0.5% of eligible participants from the VSTR (unpublished data). This both complies with privacy legislation and achieves enrolment levels sufficient to maintain the scientific integrity of registries. Privacy legislation also sets down the circumstances under which privacy principles may be waived. For example, a human research ethics committee (HREC) may determine that the public benefit in allowing access to identified data substantially outweighs individuals’ right to privacy. However, as broad-based registries collect identified data from many sources, they are currently required to seek approval from many individual HRECs. This process is both time consuming and expensive. Further, many local HRECs have insufficient resources or expertise to evaluate the scientific merit of epidemiological research or to interpret privacy legislation,4,8,9 and consequently may reject legitimate research proposals. Registries could be established by legislation that overrides privacy provisions, but this approach lacks flexibility. A more workable system is required for establishing and governing medical registries that both safeguards individual privacy and allows the registries to continue to provide the foundations for quality-improvement programs and epidemiological research. No general guidelines for establishing and governing registries have been published, either in Australia or overseas. However, the National Health and Medical Research Council (NHMRC) has produced guidelines for genetic registers,10 which complement the National Privacy Principles11 with respect to the collection, use and disclosure of sensitive information, data quality and security, and the use of unique identifiers. After further development by the NHMRC in conjunction with federal and state privacy commissions, this model might be applied to other medical registries. We also propose that the NHMRC acts as an accrediting authority for institutions maintaining medical registries. This would ensure that the institutions comply with privacy legislation, maintain independence from the agencies that directly manage participating patients’ healthcare, and have the personnel, facilities and funding to maintain the registry and achieve its purpose. Institutions could be encouraged to seek accreditation by linking it to ongoing funding for registries. Further, a centralised HREC with scientific, ethical and legal expertise might be better able than local HRECs to ensure that registries can achieve their public health aims while maintaining patient privacy. Such a centralised committee should include patient advocates, as well as experts in epidemiology, ethics and privacy law. It could also provide guidance to local HRECs, if current legislation requires that they make their own determination, to avoid unnecessary duplication of review processes. Good registry governance involves developing a structure that includes stakeholders in management of institutions that analyse personal medical information; has a management independent of the institutions that provide healthcare; provides a research environment that maximises scientific benefit to patients and the wider community; and receives adequate funding to ensure continuity of data collection and quality assurance. We hope that developing processes to ensure good registry governance will allay public concerns about privacy and allow registries to continue to underpin programs of healthcare quality improvement and epidemiological research.

Owen D Williamson GradDipClinEpi, FRACS · Peter A Cameron MD, FACEM · John J McNeil PhD, FRACP

Objective: To compare differences in functional outcomes between urban and rural patients with traumatic brain injury (TBI).Design: A longitudinal, prospective, multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program (BIRP) for New South Wales, with follow-up at 18 months after injury.Participants: 198 patients (147 urban, 51 rural) with severe TBI from the 11 participating rehabilitation units.Main outcome measures: Demographic and injury details collected prospectively using a standardised questionnaire, and measures from five validated instruments (Disability Rating Scale, Mayo–Portland Adaptability Inventory, Sydney Psychosocial Reintegration Scale, Medical Outcomes Study Short Form and the General Health Questionnaire – 28-item version) administered at follow-up to document functional, psychosocial, emotional and vocational outcomes.Results: Demographic details, injury severity, lengths of stay in intensive and acute care wards were similar for both rural and urban groups. There were no significant group differences in functional outcomes, including return to work, at follow-up.Conclusions: Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents, and suggest that the integrated network of inpatient, outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live.

Peter G Harradine MB BS, FAFRM (RACP) · Julie B Winstanley PhD, CStat · Robyn Tate MPsychol, PhD · Ian D Cameron MB BS, PhD · Ian J Baguley MB BS, FAFRM · Ross D Harris PhD, MA

Clive D Hadfield Gastroenterologist, 30 Megan Street, Cairns, QLD 4870. chadfieldATaustarnet.com.au To the Editor: In their recent study, Scott and colleagues demonstrated benefit from a program to standardise clinical management of cardiac conditions in Queensland hospitals.1 They found differences in the effect on “low-intensity intervention” hospitals compared with “high-intensity intervention” hospitals. The former were, by and large, district-type hospitals and the latter tertiary hospitals. The study found that about 50% more patients in the larger hospitals had assessments of left ventricular function. Three times as many patients in the larger hospitals accessed rehabilitation. Nearly three times as many patients in the smaller hospitals were readmitted with a diagnosis of acute coronary syndrome within 30 days, perhaps a surrogate for angiography rates, which were not reported differentially. It may be that the most urgent intervention required is “high-intensity” funding of district hospitals, so that they can achieve rates of echocardiography, rehabilitation and coronary angiography approaching those of tertiary hospitals. This intervention would need no further justification than that the population served by the district hospitals has paid its share for these treatments. Let us hope that the remaining comparative outcome data are published.

Clive D Hadfield

Ian A Scott,* Irene C Darwin,† Kathy H Harvey,‡ Andy B Duke,§ Nicholas D Buckmaster,¶ John Atherton,** Hazel E Harden,†† Michael Ward,‡‡ for the CHI Cardiac Collaborative * Director of Internal Medicine, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102; † Program Manager, ‡ Project Manager, § Senior Analyst, Collaborative for Healthcare Improvement, Queensland Health; ¶ Director of Medicine, Caboolture Hospital; ** Director of Cardiology, Royal Brisbane Hospital; †† Program Manager, Integrating Strategy and Performance, Queensland Health; ‡‡ Program Director, Queensland Health Skills Development Centre, Royal Brisbane Hospital. ian_scottAThealth.qld.gov.au In reply: We agree with Hadfield that optimising cardiac care may require extra resources targeted at increasing access of patients in regional Queensland to specific interventions, such as coronary angiography, cardiac rehabilitation and echocardiography, in addition to the quality-improvement strategies used within our collaborative. We contend that both approaches are necessary, and that the magnitude of improvement achieved by either will depend on the intensity with which they are applied. Indeed, the “high-intensity” quality-improvement hospitals in our study were defined on the basis of more funding being made available to undertake quality-improvement activities at those sites. We concede that some of the differences in quality indicators between “high-intensity” and “low-intensity” quality-improvement hospitals may be attributable to inequities in capital expenditure on service delivery that we did not measure. However, some of the differences may have also arisen from variation in systems for identifying and referring those patients who have most to gain from receiving the care targeted by our collaborative.

Ian A Scott · Irene C Darwin · Kathy H Harvey · Andy B Duke · Nicholas D Buckmaster · John Atherton · Hazel E Harden · Michael Ward