Volume 176 Issue 3

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

In Australia, 7.5% of the adult population has diabetes, and for every one person diagnosed with diabetes there is another undiagnosed.1 The prevalence of the most common form of diabetes, type 2, is increasing worldwide because of changing lifestyle, especially increasing weight caused by nutritional excess and decreasing physical activity. Many people with type 2 diabetes have cardiovascular and renal complications on diagnosis, and early detection of diabetes is an important strategy for reducing morbidity and premature mortality.2 The diagnostic test for diabetes is measurement of plasma glucose (PG) level. Although population PG is a continuum, PG levels diagnostic of diabetes identify a subgroup of the population at increased risk of diabetes-related complications. Risk data on these complications are based on the 2 h PG level during an oral glucose tolerance test (OGTT), with risk increasing significantly at a PG ≥ 11.1 mmol/L. It has long been recognised that this 2 h level does not equate to the fasting PG level of 7.8 mmol/L that has also been used to diagnose diabetes. Recently, both the American Diabetes Association (ADA)3 and the World Health Organization (WHO)4 lowered the diagnostic fasting PG level from 7.8 mmol/L to 7.0 mmol/L to more closely align it with a 2 h PG of 11.1 mmol/L. Despite this agreement, the ADA and WHO differ fundamentally on their recommended procedure for diagnosing diabetes, in particular the role of the OGTT in routine clinical practice. WHO continues to advocate routine use of the OGTT to maximise identification of people with increased risk of diabetes complications that may be reduced or prevented by treatment. In contrast, the ADA does not recommend routine use of the OGTT, as it believes that the new lower fasting PG level will detect most people with diabetes diagnosed by the OGTT. However, if an OGTT is performed, the ADA and WHO agree completely as to how the test should be done and interpreted. The study by Hilton and colleagues published in this issue of the Journal5 compares the prevalence of diabetes diagnosed using the ADA and WHO recommendations in a high-risk cohort from the Australian Diabetes Screening Study. It reports that about 50% fewer people are diagnosed with diabetes on the basis of the fasting PG alone (ADA recommendations) compared with the fasting and/or 2 h PG levels (WHO recommendations). Similar findings have come from other populations.6 As the ADA and WHO recommendations define different, although overlapping, cohorts, both of which are labelled with diabetes, the question arises as to when is diabetes really diabetes? There are several reasons why Australia, and indeed most of the world, has adopted the WHO recommendations.7 The diagnostic criteria for diabetes were derived from the increased risk of complications defined by the 2 h PG value, not the fasting PG.3 Clearly, the new lower fasting PG cut-off of 7.0 mmol/L does not equate to a 2 h PG of 11.1 mmol/L. Also, recent evidence confirms the importance of a raised 2 h PG as an independent risk factor for mortality and cardiovascular disease, even when the fasting PG is not raised.8,9 Therefore, failure to consider the 2 h PG ignores a subgroup at particular risk of macrovascular complications. In summary, diabetes is diagnosed by one of the following: symptoms of diabetes and a casual PG level ≥ 11.1 mmol/L; fasting PG level ≥ 7.0 mmol/L; or 2 h PG level during an OGTT ≥ 11.1 mmol/L. How should this information be used by general practitioners faced daily with many people at risk of undiagnosed type 2 diabetes? In Australia, soon-to-be-released evidence-based guidelines from the National Health and Medical Research Council advocate a staged approach for case detection of undiagnosed type 2 diabetes.6 A staged approach is similarly recommended by all national diabetes guidelines in other countries. The new Australian guidelines recommend risk assessment followed by measurement of fasting PG (Box). Those with a fasting PG < 5.5 mmol/L are considered unlikely to have diabetes but should be retested every three years, while those with a fasting PG ≥ 7.0 mmol/L are very likely to have diabetes, which should be confirmed by repeat fasting PG measurement. The remainder with an equivocal result (fasting PG, 5.5–6.9 mmol/L) should have an OGTT. Our analysis of population data from the AusDiab Study (Australian Diabetes, Obesity and Lifestyle Study) shows that, if the above recommendations were followed, about 25% of people who are at risk of undiagnosed diabetes and have a fasting PG measured would require an OGTT (unpublished analysis). The study by Hilton and colleagues confirms the important role of the OGTT in identifying people with diabetes, despite the inconvenience of the test.5 However, not all people with an equivocal PG result are in fact having an OGTT when indicated. Release and adoption of the new national guideline for case detection of undiagnosed type 2 diabetes should help correct this. Indications for measuring fasting plasma glucose levels Age 55 years or over. Age 45 years or over and one of the following: - obesity; - hypertension; - first degree relative with type 2 diabetes. Age 35 or over if Aboriginal or Torres Strait Islander. Age 35 or over if from a high-risk group from non-English-speaking background (Indian subcontinent, Pacific Islands, Chinese origin). Previous history of impaired glucose tolerance or impaired fasting glycaemia. Previous history of cardiovascular event. Women with previous history of gestational diabetes. Obese women with polycystic ovary syndrome.

Stephen Colagiuri FRACP

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

Objectives: To study the influence of different diagnostic criteria on the prevalence of diabetes mellitus and characteristics of those diagnosed.Design and setting: Retrospective analysis of data from the general-practice-based Australian Diabetes Screening Study (January 1994 to June 1995). Participants: 5911 people with no previous diagnosis of diabetes, two or more symptoms or risk factors for diabetes, a random venous plasma glucose (PG) level > 5.5 mmol/L and a subsequent oral glucose tolerance test (OGTT) result.Main outcome measure: Prevalence of undiagnosed diabetes based on each of three sets of criteria: 1997 criteria of the American Diabetes Association (ADA), 1996 two-step screening strategy of the Australian Diabetes Society (ADS) (modified according to ADA recommendations about lowered diagnostic fasting PG level), and 1999 definition of the World Health Organization (WHO).Results: Prevalence estimates for undiagnosed diabetes using the American (ADA), Australian (ADS) and WHO criteria (95% CI) were 9.4% (8.7%–10.1%), 16.0% (15.3%–16.7%) and 18.1% (17.1%–19.1%), respectively. People diagnosed with diabetes by fasting PG level (common to all sets of criteria) were more likely to be male and younger than those diagnosed only by 2 h glucose challenge PG level (Australian and WHO criteria only). The Australian (ADS) stepwise screening strategy detected 88% of those who met the WHO criteria for diabetes, including about three-quarters of those with isolated post-challenge hyperglycaemia.Conclusion: The WHO criteria (which include an OGTT result) are preferable to the American (ADA) criteria (which rely totally on fasting PG level), as the latter underestimated the prevalence of undiagnosed diabetes by almost a half. The Australian (ADS) strategy identified most of those diagnosed with diabetes by WHO criteria.

Deborah J Hilton MPH · Christopher M Reid MSc, PhD · Peter K O'Rourke PhD · Timothy A Welborn PhD, FRACP

Objective: To review the clinical management of young women with intellectual disabilities with menstrual and contraceptive concerns.Design: Prospective cohort study of all girls and young women with a significant intellectual disability and moderate to high support needs who presented at my gynaecology clinic for management of menstrual and contraception-related issues in the period 1990–1999.Setting: Gynaecology clinic at the Centre for Adolescent Health, Royal Children's Hospital, Melbourne, and my private consulting rooms.Outcome measures: The clinical management options considered most appropriate for these women, including advice, reassurance, medication (oral contraceptive pill, non-steroidal anti-inflammatory drugs, depo-medroxyprogesterone acetate, hormone replacement therapy) and surgical options.Results: For 2 of 107 young women, surgical approaches were required to manage their menstrual problems or contraception-related issues. For the remainder of the women, information, advice or medical management were sufficient.Conclusions: Management of the menstrual and contraceptive needs of young women with an intellectual disability is similar in most cases to the management of non-disabled women. Surgical management is required infrequently.

Sonia R Grover MD BS, FRANZCOG

Thoracic aorta injury secondary to blunt chest trauma accounts for 10% to 20% of fatalities from high-velocity accidents, and the subsequent mortality rate in untreated survivors is high.1 Standard management is based on prompt radiological diagnosis and surgical repair by thoracotomy, usually with partial left heart bypass. Despite technical advances, these procedures carry significant mortality and postoperative paraplegia rates (up to 30% and 10%, respectively),2 and severe traumatic comorbidity or coincidental chest disease in many patients makes their aortic injury inoperable. Endovascular stent-graft repair is emerging as an alternative for treating thoracic aortic injury, with a number of potential advantages.3,4 These include the ability to treat patients with contraindications to thoracotomy, and the potential to reduce neurological complications. However, clinical experience with this procedure is limited. The procedure involves deploying a self-expanding, fabric-covered metal stent from within the diseased vessel to exclude an aneurysmal segment, and is performed by means of a dedicated delivery system retrogradely inserted through the femoral artery. We report a case of immediate stent-graft repair of a traumatic false aneurysm of the thoracic aorta in a patient for whom thoracotomy was relatively contraindicated. We also review the published data and discuss technical issues. Clinical recordA 47-year-old professional motorcyclist was thrown from his bike against a rubber tyre wall at high speed. He did not lose consciousness, but immediately noticed low back pain and lower-limb tingling. His vital signs were stable, and he was transferred to the trauma unit with full spinal precautions. Subsequent evaluation showed a pulse rate of 65 beats per minute, blood pressure of 150/65 mmHg, 30 respirations per minute, and a Glasgow Coma Score of 15. He had absent left knee and ankle jerks, reduced light touch sensation in L2–S1 dermatomes on the left and L2–L3 on the right, with normal power and anal tone. Chest and spine radiographs showed an abnormal mediastinal contour consistent with haemorrhage, and a fracture-dislocation of the lumbar spine at the L2–L3 level. Computed tomography (CT) angiography showed thoracic aortic injury with intimal flap and false aneurysm of the proximal descending aorta. We felt that turning the patient to the lateral thoracotomy position for conventional surgical repair would risk further neurological deficit. Therefore, after discussing therapeutic options with the patient and his family, emergency endovascular stent-graft repair of the thoracic aortic injury was performed (see Box for technical details). CT angiography confirmed absence of extraluminal flow after the procedure. The patient subsequently underwent fixation of the lumbar spine injury using posterior rods, pedicle screws and bone graft. He made a complete neurological recovery. Three days after stent-graft insertion, he underwent video-assisted thoracoscopic evaluation of the left side of the chest for drainage of a large haemoserous pleural effusion. The thoracic aortic contour was normal, with minimal peri-aortic haematoma. Repeat CT angiography at six and 12 months confirmed thrombosis of the false aneurysm, with no complication related to the stent-graft repair, and the patient remains well 18 months after the injury. DiscussionA number of centres have published encouraging initial results for elective endovascular stent-graft repair of chronic thoracic aortic aneurysms, usually related to atherosclerosis or chronic dissection.4-7 The largest study, of more than 100 patients, reported an initial technical success rate (aneurysm thrombosis) of 85%, one-month mortality of 10% and morbidity of 30%, and two-year actuarial survival of 70%.4 Stent-graft repair has been used to treat established traumatic thoracic aortic aneurysms,8,9 but there are few reports of immediate stent-graft repair of thoracic aortic injury.10-12 This case demonstrates the feasibility of emergency endovascular stent-graft repair for thoracic aortic injury. Stent-graft repair is an option for patients who are unable to undergo thoracotomy because of associated injuries or pre-existing chest disease. The endovascular strategy may reduce early surgical morbidity. In particular, the minimal requirement for anticoagulation and avoiding aortic cross-clamping may lower the risks of cerebral haemorrhage and paraplegia.2 For our patient with coincidental spinal injury, stent-graft repair minimised the chance of neurological deterioration secondary to lateral positioning for thoracotomy. Continuing improvements in devices and delivery systems are likely to increase the familiarity, ease of use and availability of "off-the-shelf" thoracic aortic stent-graft systems. However, the role of emergency endovascular repair of thoracic aortic injuries requires further clarification. Medium-term follow-up data for endovascular repair of chronic thoracic aortic aneurysms suggest a small incidence of endoleak, delayed rupture and paraplegia,4,13 but very limited information is available for traumatic false aneurysms. In particular, the role of stent-graft repair in the context of intensive medical management of thoracic aortic injury needs to be defined.14 Stent-graft deployment technique The diameter of the isthmic (26 mm) and descending (24 mm) thoracic aorta and the longitudinal extent of intimal injury were determined from computed tomography, and an appropriately sized "off-the-shelf" stent-graft (Zenith, 28 mm diameter, 120 mm length, Cook Australia) was obtained. The procedure was performed with the patient in the supine position in the angiography suite under general anaesthesia, commencing eight hours after the accident. Diagnostic aortography via the right common femoral artery confirmed a transverse intimal tear 2 cm distal and opposite to the left subclavian artery origin (Figure a). Formal left common femoral arteriotomy was performed, followed by placement of the stent-graft device within its 24 F delivery system to the aortic arch over a stiff Lunderquist guide wire (Cook Australia). Precise proximal positioning of the device was aided by intermittent angiography of the left subclavian artery origin using a 4 F Omni-flush catheter (Angiodynamics, USA) inserted via the left brachial artery. (In this case there was sufficient length of normal isthmic aorta to achieve a seal with the proximal stent-graft without compromising the left subclavian artery origin. Where there is insufficient distance it may be necessary to position the stent-graft across the subclavian artery origin, and to perform left carotid to distal subclavian bypass at a later stage should ischaemic symptoms ensue.) The self-expanding stent-graft was deployed in stages to allow recoil of the Z-stent sections to accommodate the inner radius of curvature of the aortic arch. Optimal apposition of the proximal stent-graft was achieved with secondary dilatation ("moulding") using a compliant latex balloon (Cook Australia), resulting in successful exclusion of the false aneurysm, and patency of the subclavian artery (Figure b). The left common femoral arteriotomy was repaired.

Julian A Hanson · D Mark Brooks · Jai S Raman

A New South Wales Supreme Court jury has decided that environmental tobacco smoke (ETS) can cause or materially contribute to the development of laryngeal cancer. Evidence presented that ETS may cause or materially contribute to laryngeal cancer included the molecular genetics of tobacco-smoke-induced carcinogenesis, and two relevant epidemiological studies. The plaintiff's exposure to ETS was established indirectly, on the basis of occupational history involving work as a bar attendant in licensed premises. The jury's decision seems likely to encourage other "passive smoking" cases, and may result in measures to reduce occupational exposure to ETS.

Bernard W Stewart PhD, FRACP · Peter C B Semmler MA, QC

Medical practitioners and the pharmaceutical industry serve interests that sometimes overlap and sometimes conflict. There is strong evidence that associations between industry and doctors influence the behaviour of the latter in relation to both clinical decision making and the conduct of research. In view of the risk of compromising relationships with patients and the integrity of the research process, doctors must exercise care in their dealings with industry. The basic principles underlying the conduct of doctors with respect to pharmaceutical companies should be openness and transparency. Clearly articulated procedures should be developed to deal with specific issues such as travel subsidies, receipt of gifts, sponsorship of conferences and continuing education activities, and dualities of interest arising in clinical and research settings.

Paul A Komesaroff MA, PhD, FRACP · Ian H Kerridge MPhil, FRACP, FRCPA

Objective: To survey the use of declarations of ethical commitment made by graduating medical students in Australia and New Zealand.Methods: Information, obtained by email and telephone, from faculty officers of all faculties of medicine (or medicine and health sciences) in Australia and New Zealand.Results: Declarations are made by graduating medical students at seven of 12 Australasian faculties of medicine. To date, declarations have been based on the Declaration of Geneva or the Hippocratic Oath or have been formulated by academic staff or the students themselves. In six of the seven universities, declarations are made as part of a special declaration ceremony (usually combined with a prize-giving ceremony). One university includes a declaration as part of the official graduation ceremony.Discussion: We discuss the relative merits of a declaration selected for students by staff members and a declaration written anew by each group of graduating students.

Paul M McNeill MA, LLB, PhD · S Bruce Dowton MD, FACMG, FRACP

Amiodarone is used in the management of cardiac dysrhythmias. Accumulation of amiodarone in the thyroid gland may result in thyroid dysfunction, either hypothyroidism or thyrotoxicosis.1 Amiodarone-associated thyrotoxicosis (AAT) occurs in about 3% of patients.2 In some patients, cessation of amiodarone is not practical, as it may be the only effective anti-arrhythmic agent. Furthermore, cessation of amiodarone may be followed by a rebound rise in tri-iodothyronine, which worsens the thyrotoxic state.3,4 Even when amiodarone can be discontinued, AAT can take up to nine months to resolve. Medical management may be ineffective and can result in complications, or sometimes death.5 In these very difficult situations, surgery has an important role. In the past it was thought that the risk of thyroid storm and the risks associated with anaesthesia would preclude surgery. However, recent experience has demonstrated that surgery may be performed safely and successfully, as illustrated in the case reports summarised in Box 1. DiscussionThe patients all had severe cardiac disease and AAT refractory to medical treatment, yet general anaesthesia and total thyroidectomy were successful and uncomplicated in each case. All patients recovered rapidly and remain well and euthyroid on thyroxine replacement therapy. Patient 1 had a large multinodular goitre and the other four had normal-sized or slightly enlarged thyroid glands at the time of surgery. The histological findings in all cases showed a similar destructive thyroiditis (Box 2). Up to 1996 only 20 cases of AAT treated by surgery had been reported.3,4,6-10 However, in the past few years, a further 29 cases have been documented.5,11,12 Including the five cases described here, there have been 54 cases, of which 19 (35%) have been in Australia. Even allowing for possible publication bias, the results are exceptionally good, with no surgical mortality reported. It is standard practice to render thyrotoxic patients euthyroid preoperatively. This is not possible in AAT, yet postoperative thyroid storm appears to be an extremely rare event. Most patients are suitable for general anaesthesia, and local anaesthesia would probably be more stressful. There is discussion among anaesthetists as to the choice of anaesthetic agents, with some advocating total intravenous anaesthesia11,13 and others favouring inhalation anaesthesia.12 All authors agree that the medical management of patients with AAT is problematical and difficult.1,14 Apart from the doubtful success of medical treatment,5 it can be associated with prolonged illness and additional complications such as occurred in two of our patients, who had serious infections related to prednisone-induced immunosuppression that delayed the curative surgery. Thyroidectomy is the only treatment that reliably allows the continued use of amiodarone.15 Clinical decisions about apparent "unfitness for surgery" have sometimes been made without consulting an appropriate anaesthetist or endocrine surgeon. Despite the obvious difficulties with management of patients with AAT, anaesthesia and surgery may be performed safely and successfully. Consideration should be given to referring the patient for early surgery, particularly in cases where it would be advantageous to continue the amiodarone therapy and before complications of immunosuppression due to prednisone therapy have occurred. Lessons for practice are listed in Box 3. 1 : Summary of case reports for five patients with amiodarone-associated thyrotoxicosis who were treated successfully with total thyroidectomy Patient Age (years) Sex Clinical features Treatment preceding total thyroidectomy 1 82 F Toxic multinodular goitre treated with carbimazole for 20 years. Commenced amiodarone for atrial fibrillation and developed thyrotoxicosis after four months. Amiodarone discontinued, but patient remained thyrotoxic on propylthiouracil, prednisone and potassium perchlorate. 2 39 M Four operations for tetralogy of Fallot and on waiting list for cardiac transplantation. Recurrent ventricular tachycardia treated with amiodarone for three years. Automatic implanted cardiac defibrillator required for worsening ventricular tachycardia due to thyrotoxicosis. Amiodarone ceased, but patient remained thyrotoxic on carbimazole, prednisone, potassium perchlorate and lithium carbonate. 3 32 M Familial dilated cardiomyopathy with recurrent ventricular tachycardia treated with amiodarone for four years. Thyrotoxicosis for 18 months before referral; ejection fraction 24%. Amiodarone continued, and patient remained thyrotoxic on propylthiouracil, potassium perchlorate and lithium carbonate. 4 61 M Rheumatic heart disease with aortic valve replacement and congestive cardiac failure. Ventricular tachycardia and fibrillation treated with amiodarone for two years and also sinoatrial node ablation, pacemaker and warfarin. Thyrotoxicosis developed two months after amiodarone was discontinued. Thyrotoxicosis persisted on propylthiouracil, prednisone and lithium carbonate. 5 63 M Coronary artery bypass grafts and cardiac pacemaker. Atrial fibrillation treated for two years with amiodarone and warfarin. Thyrotoxicosis developed three months after amiodarone was discontinued. Thyrotoxicosis persisted on carbimazole and prednisolone. 2: Photomicrograph of thyroid in Patient 5 A: Destruction of follicles, with loss of follicular epithelial cells and macrophages in the colloid. B: Marked inflammatory cell infiltration. C: Fibroblasts creating fibrous tissue. Haematoxylin and eosin stain; original magnification x 350. Courtesy of Queensland Medical Laboratory. 3 : Lessons for practice Amiodarone (an iodine-containing drug used for the treatment of cardiac arrhythmias) may cause a destructive thyroiditis, resulting in long-lasting thyrotoxicosis refractory to medical management. Total thyroidectomy under general anaesthesia may be performed safely and successfully in patients with amiodarone-associated thyrotoxicosis.

Ian R Gough MD, FRACS · Jenny Gough MB BS

Clinical questionA general practitioner noted that the Australian immunisation handbook1 stated that "tepid sponging of children to reduce a fever of < 41°C is no longer routinely recommended, as there is no evidence to support the efficacy of this practice". He asked whether tepid sponging is effective in lowering a raised body temperature, and whether paracetamol might be more effective in reducing body temperature if combined with tepid sponging. Search questionThe request concerned all children with raised body temperatures below 41°C. The interventions of interest were (a) tepid sponging compared with paracetamol or (b) paracetamol alone compared with paracetamol combined with tepid sponging. The ideal study design to answer this question would be a controlled trial that allocated patients at random to either (a) tepid sponging or paracetamol administration or (b) to paracetamol administration alone or in combination with tepid sponging. SearchWe conducted a PubMed search using the terms "fever", "febrile" or "temperature" combined with forms of the word "sponge" (including sponging) to identify relevant articles. To limit retrieval to methodologically rigorous studies, we applied a search filter2 that identified articles about therapy using specific research designs. Because of the time constraints of the evidence retrieval service, only articles with English abstracts published after 1989 were considered in answering the question. Summary of findingsOur search identified several studies comparing the use of tepid sponging with antipyretic drugs to reduce the body temperature of febrile children. All but one study3 specified that the subjects included were experiencing fever with temperatures in the range below 41°C. (a) A randomised controlled trial (RCT) of tepid sponging compared with oral paracetamol (15 mg/kg) found sponging was more effective in reducing body temperature only during the first 30 minutes of treatment.4 Another RCT comparing sponging with a single dose of aspirin (15 mg/kg), paracetamol (15 mg/kg) or ibuprofen (8 mg/kg) found sponging was more effective than each of the three medications during the first 30 minutes of intervention.5 After 60 minutes, the effects of each medication became superior to sponging. (b) Three studies compared the effects of paracetamol alone or combined with sponging. An RCT comparing paracetamol and paracetamol plus a 15-minute tepid sponge bath found that sponge-bathed subjects cooled faster during the first hour, but there was no significant temperature difference between the groups over the two-hour study period.6 Another RCT comparing paracetamol alone against paracetamol with tepid sponging found a greater and more rapid fall in mean temperature in the sponge plus paracetamol group. In the paracetamol-only group, 95% (n = 38) still had a temperature of 38.5°C or greater at 60 minutes, compared with 42.9% (n = 15) of the sponge-and-paracetamol group.7 An earlier study found that paracetamol plus sponging produced the greatest temperature reduction when compared with sponging or paracetamol alone, the smallest temperature reduction occurring in the group receiving sponging alone.3 We concluded that tepid sponging appears to be more effective within the first 30 minutes of treatment and has an additive effect when combined with paracetamol. OutcomeThe report was submitted to the requesting doctor, who decided to continue recommending tepid sponging in combination with paracetamol treatment to reduce body temperature in febrile children.

Vivienne F Bernath · Jeremy N Anderson · Chris A Silagy

To the Editor: From 1 February to 30 June 2001, 277 602 prescriptions for the smoking cessation drug bupropion hydrochloride (Zyban, GlaxoSmithKline) were processed. The Health Insurance Commission approved 343 737 prescriptions for bupropion between 1 February and 30 June.1 Comparing this figure with the 277 602 processed scripts, some 66 135 (19.2%) scripts went unfilled. One reason for this may have been extensive publicity given to reports of deaths and numerous adverse reactions following bupropion use. The website of the Australian Drug Reactions Advisory Committee (ADRAC) reports that, as at 22 June, there had been 18 reports of deaths in patients aged from 30 years to 69 years who were using or who had recently stopped using bupropion.2 ADRAC summarised intelligence on these deaths thus: ... there were a variety of reported causes of death and not a single consistent mode of death. In addition to being smokers, several patients had other existing risk factors for unexpected death such as alcohol abuse, diabetes or cardiomyopathy. Eleven of the 18 patients had an alternative explanation for death that was at least as plausible as a possible effect of bupropion. In four reports, the available information was very limited and it was not possible to assess the cause of death. Further information is being sought on three cases to aid assessment of the cause of death.2 Smokers are at 3.1 times greater risk of dying (from any cause) than non-smokers and twice as likely to die from coronary disease and stroke.3 People with depression are three times as likely to be daily smokers4 and have double the suicide rate of non-smokers.5 In Australia, sudden coronary fatalities occur at a rate of about 450 per million people aged under 65,6 perhaps at a rate of 355 per million in non-smokers and about double that in smokers. In three months (the period of recommended bupropion use), one would expect 180 deaths per million smoker-users. Thus, among 277 602 Australian smokers, 50 might die during any given three-month period without any added risk from bupropion. This estimate helps to place the 18 fatalities reported to ADRAC in context. The 277 602 scripts represent about 9.5% of Australia's 2.9 million regular smokers. These people, their families and doctors deserve to have their anxieties about the risks of using bupropion addressed. We would urge the government to commission urgently a case–control study of morbidity and mortality among smokers and their relationships to use or non-use of bupropion.

Simon C Chapman · Konrad Jamrozik

To the Editor: I read with interest the article by Hender and colleagues recently published in the Journal.1 I agree with the authors' conclusion that there is presently insufficient evidence to suggest the widespread use of endoluminal treatment for carotid artery disease. However, there are a number of problems with the authors' interpretation of our recent article comparing the outcome of surgical and endoluminal treatment of symptomatic carotid stenosis.2 Firstly, the figures in the Box are completely misleading. The percentages of adverse outcome quoted for patients undergoing endoluminal treatment are those that were found for cases receiving endarterectomy, while the figures quoted for endarterectomy are the findings for endoluminal treatment. [A correction of this error was published in the 3/17 December 2001 issue of the Journal, page 672.] Hence, any reader simply looking at the Box would be left with the false conclusion that the outcome of endoluminal treatment is superior. Secondly, the authors refer to our article2 as a "meta-analysis". In our article we went to some trouble to explain that a meta-analysis was not possible, as only one small randomised trial had been published at that time. Instead, we had to use reports from single centres and we discussed the difficulties of comparing the results when patients had not been randomised. Thirdly, the results of the CAVATAS trial were published in June 2001.3 A surprising finding was that the perioperative stroke rate (defined as a neurological deficit lasting seven days or more) for patients undergoing either carotid angioplasty (with or without stenting) or conventional endarterectomy was the same (around 10%). In fact, the disabling stroke rate of around 6% after either endovascular treatment or endarterectomy was three times higher than that found in the North American randomised trial of endarterectomy.4 Finally, the authors refer to our patients undergoing carotid stenting, whereas the majority of the patients referred to in fact received angioplasty alone.

Jonathan Golledge

To the Editor: Carotid stenting is a new application of endovascular therapy. Its efficacy in preventing strokes is yet to be established, by contrast with the proven Level 1 evidence of benefit from carotid endarterectomy. The risks of implanting carotid stents at present appear greater than the risks of carotid endarterectomy. An overview of carotid endarterectomies in Australia is maintained by vascular surgeons, through audits such as the ongoing Melbourne Vascular Surgeons Association Audit and the New South Wales Carotid Endarterectomy Audit. The technique of carotid stenting, the stents themselves and the brain-protective devices used during the implanting of stents are expensive and still evolving. The long-term durability of stents is unknown. Australian vascular surgeons, neuroradiologists and neurologists are awaiting the outcome of two major international randomised trials of carotid stenting versus endarterectomy (the US Carotid Revascularization Endarterectomy versus Stent Trial and the European International Carotid Stenting Study). These seek Level 1 evidence of the comparative risks and success of the new stenting procedures in stroke prevention and aim to document the late outcome of stenting, particularly the incidence of restenosis, which is a significant problem in other arteries after stenting. While these definitive trials are in progress, vascular surgeons of the Royal Australasian College of Surgeons wish to add their note of caution to the reservations expressed in the NHMRC guidelines on stroke prevention1 and the recommendations of the Australian Association of Neurologists.2 A recent commentary by Spence and Eliasziw3 illustrates the disparate nature and the limitations of existing studies of carotid stenting. We consider carotid stenting is not yet appropriate for widespread use in Australia. Experienced endovascular and neurology teams should continue to evaluate the new procedure. Stenting of symptomatic carotid atheroma should only be conducted with the consent of patients who are fully informed about stenting's known hazards and unproven status and who understand that the established treatment is carotid endarterectomy.4 Clinicians should audit closely the immediate outcome and long-term complications of any carotid stenting they perform.

Peter L Field

To the Editor: Preparations containing isoflavone phytoestrogens are widely used as an alternative therapy for treating symptoms of the menopause. Although Australian government regulations strictly control the components of alternative therapies, adherence to the stated amounts of the components in alternative therapies is not routinely assessed. Isoflavones exist in two forms — aglycone (the free form) and glycosylated or glycone (the conjugated form) — the relative proportions of which vary between preparations. As glycosylation contributes considerably to the mass of isoflavone molecules, it is relevant to consider the total amount of potentially available isoflavone in alternative therapy preparations. Isoflavone-containing preparations which had a recommended daily dose on their labels were purchased at random from pharmacies around Sydney during September 1999. Where possible, products from more than one manufacturing batch were purchased and all products were well within their stated shelf life. The tablets, capsules or powder were removed from their packaging to conceal their identity and randomly allocated to numbered plastic bags by the hospital pharmacy department. The samples were then sent to PhytoChem Technologies Inc (Chelmsford, Mass, USA), an independent reference laboratory for the assay of isoflavones. There, isoflavones were extracted within four months of purchase (and before their stated use-by date) from 500 mg of each specimen after dissolution in 70% methanol. Glycosylated and free isoflavones were assayed in duplicate by gradient high-pressure liquid chromatography, with detection of isoflavones at 254 nm using a Waters 996 series photodiode detector with a limit of detection of 0.2 µg/mL. The identity of chromatogram peaks was confirmed by UV–V spectral analysis, and by comparison with standards. The mobile phase was acetonitrile, and adequate peak separation, linearity, accuracy and reproducibility were demonstrated. The total amount of available aglycone isoflavones in each sample was estimated (see Table). Only two products (Phytolife and Promensil) had total isoflavone contents close to the stated amount, and the content of the Phytolife product was variable. Estimated aglycone contents of preparations demonstrated that glycosylated isoflavones contributed substantially to the stated content of the product. A previous study of isoflavone-containing preparations marketed in the United States produced similar results to ours.1 Consumers may wish to consider not only whether an alternative therapy is of use, but also whether the product they purchase contains what they expect. Actual and stated isoflavone content of commercially available preparations Manufacturer Product No. of batches assayed Stated isoflavone content (mg) in recommended daily maximum dose of product Actual total isoflavone content per daily dose (mg) Estimated aglycone isoflavone content per daily dose (mg) Blackmores Phytolife one a day 5 40 41.02 ± 6.12 25.75 ± 6.04 Bioglan Soy powder plus 4 68 48.75 ± 1.42 30.44 ± 0.86 Earths Own Soy + calcium 1 68 42.52 25.67 Health Direction Femme phase 1 235 mg soy protein* 0.29 0.20 Herron Phyto source 1 22.5 16.27 9.93 Natural Nutrition Menopause 1 60 0.56 0.51 Natural Nutrition Phytobalance 3 90 58.12 ± 6.26 34.96 ± 3.79 Novogen Promensil 4 40 40.12 ± 1.98 38.38 ± 1.20 Pretorius Maxi soy plus red clover wild yam and calcium 4 68 50.36 ± 1.64 31.24 ± 1.13 Wagner Probiotics Femme soy plus with red clover 2 27 30.76 ± 0.12 19.65 ± 0.05 * Soy protein has a high isoflavone content. Values are the mean ± standard deviation. Total isoflavones = glycone plus aglycone. Estimated available aglycone isoflavones = weight of aglycone isoflavones plus weight of glycone isoflavones corrected for glycone content.

Jan B Howes · Laurence G Howes

To the Editor: The 50 g glucose challenge test (GCT) is widely recommended as a screening test for gestational diabetes (GD).1 The test consists of a 50 g oral glucose load given at any time of the day, followed one hour later by the measurement of the plasma glucose concentration.2 This test is recognised as imperfect for screening, as sensitivity and specificity are not 100%.2,3 It is known that glucose tolerance deteriorates in the afternoon,4 which raises the question of whether time of day influences the response to the 50 g GCT. At Royal North Shore Hospital, screening for GD is performed at the 26–28-week visit by means of the 50 g GCT. In 2000, screening for GD was introduced into a morning midwives antenatal clinic, whereas previously it had only been performed in the afternoon. The population attending the clinic at the 26–28-week visit includes many women receiving shared care, and is regarded as being at low obstetric risk. The Table shows the results of screening at the morning clinic compared with screening in the afternoon over the same time period. The two groups were identical in terms of age, weight, ethnicity, and family history of diabetes or past history of GD. The percentage of women with a positive screening test result during the morning clinic (17.0%) was significantly lower than that during the afternoon clinic (31.1%). Positive screening results were followed up with a diagnostic 75 g glucose tolerance test, and GD was diagnosed according to the Australian Diabetes in Pregnancy Society criteria.5 Women with a positive screening test result confirmed with a 75 g glucose tolerance test in the afternoon were less likely to have GD than those with a positive test in the morning (31.5% v 40.0%). Despite the fact that a smaller percentage of women who screened positive in the afternoon had GD, a greater percentage of the total number screened in the afternoon had GD than in the morning group. In this cohort, the difference (9.8% v 6.8%) was not significant (Table; P = 0.15). These results are consistent with the hypothesis that a 50 g GCT test performed in the afternoon results in a greater number of positive results, a greater number of women undergoing diagnostic testing and a greater number of women identified with GD. The morning GCT appears to increase specificity, with an associated decrease in sensitivity. These results need to be taken into consideration when designing or implementing a screening program. Screening for gestational diabetes (GD): the effect of screening time Time Morning (0930–1200) Afternoon (1205–1710) Number screened 176 470 Age in years (mean ± SD) 31.2 ± 4.7 31.7 ± 5.0 Weight (mean ± SD) 59.4 kg ± 10.5 kg 60.8 kg ± 12.9 kg Family history of diabetes 27 24 Past history of gestational diabetes 1 3 % White/Asian/Middle Eastern 62.6/28.0/9.0 67.5/25.9/5.8 Positive result, 50 g glucose challenge test 30 (17.0%) 146* (31.1%) Abnormal result, 75 g glucose tolerance test 12 (6.8%)† 46‡ (9.8%)† *P < 0.001, χ2. † % Of number screened. ‡ P = 0.15, χ2.

Aidan McElduff · Rosemary Hitchman

To the Editor: We have recently noticed changes in the incidence of invasive cervical carcinoma in the Gippsland Health Region and would like to know whether other regions have noticed similar demographic changes. During 24 months in 1999–2000, 19 women (median age, 59 years; range, 33–88 years) with squamous carcinoma were registered in our pathology practice. Based on information from the Victorian Cervical Cytology Register, almost half (10 women) had no previous cervical smear history whatsoever, while three had had smears, but at irregular intervals up to 14 years apart. The remaining six women had had regular Pap smears, with 1–3 negative smears preceding the diagnosis of cancer. Sixteen of the women had consulted their general practitioner for some other ailment before the cervical cancer was discovered (median interval, 14 months), but no cervical smear had been obtained. Of particular interest is the fact that six of the 19 patients are in their seventh decade or older, with a median age of 80 years (range, 79–88 years). The Victorian Department of Human Services reports that the cervical-smear participation rate for eligible women in the Gippsland region is 68%, a rate not much different from the other regions.1 The two-yearly participation rate for the 60–69-years age group is 56%, and, although no official figure is available for women in their seventh or eighth decades, it is likely to be considerably lower. The Cancer Epidemiology Centre has recorded that, over a 16-year period, the incidence of cervical carcinoma in Victorian women aged over 70 years fell by 50%, and simultaneously there has been a shift in the peak incidence from the 70–74-years age group to one a decade older (Vicky Thursfield, Information Manager, personal communication). Accordingly, we suspect that women over 70 years of age still have a significant incidence of invasive cervical carcinoma, but are not being offered cervical smears, even when the National Health and Medical Research Council guidelines indicate the necessity.

Nicholas J Mulvany · Norman R Sonenberg

To the Editor: In response to Leeder and Rychetnik's article,1 evidence-based medicine (EBM) also has significant potential to reduce the quality of patient care, with obvious ethical implications. I refer to two specific issues of concern. The first relates to the increased expectation that clinicians, and especially trainees, not only understand the role of EBM in clinical practice, but actively contribute to its underlying database. Indeed, some of the professional colleges (eg, the Faculty of the Australian and New Zealand College of Anaesthetists) now include formal projects (which are often, but not necessarily, clinical trials) in their final assessment of trainees.2 This is leading to increasing numbers of poorly designed trials that are unlikely to make useful contributions to the clinical database. These commonly take two forms: studies which lack sufficient power to confirm the absence of a true difference between groups,3,4 or studies which use a placebo when effective therapeutic alternatives exist.5 Yet such studies are frequently published in reputable, peer-reviewed journals.6 Both of these types of studies are unethical, and both impact adversely on patient care. Increasing the evidence base of clinical medicine is important, but our primary responsibility remains the maintenance of quality of care of all patients, especially those involved in clinical trials. Therefore, education of clinicians, and especially trainees, must emphasise the role and importance of statistics, epidemiology and study design in all areas of medicine to prevent unnecessary reductions in the quality of care of this subset of patients. The second concern relates to the increase in "quality improvement" projects that are rarely submitted to ethics committees for approval. These activities also contribute to the evidence base, primarily at a local level, but patients are usually unaware that they are involved in these projects, and that these activities may have significant quality-of-care implications for them. It is therefore important that internal hospital quality assurance activities undergo a similar level of scrutiny by ethics committees to that of clinical trials. Patients involved in any audit or project that has the potential to influence their care should be required to give informed consent. Only then can we reassure a patient that, while we are continually striving to improve the care we provide by developing the evidence base for clinical medicine, the care of each individual remains our primary concern.

Simon R Tomlinson · Kerry J Breen · Malcolm H Parker · Chris B Del Mar · Paul P Glasziou · Lucie Rychetnik and · Stephen R Leeder

Comment: Tomlinson raises two important ethical issues in clinical research. While there are several ethical issues which may arise in acquiring and applying evidence to clinical practice and health administration, as outlined previously by Kerridge et al1 and picked up well by Leeder and Rychetnik,2 it is misleading if Tomlinson wishes to imply that the two issues he has raised can be attributed to the evidence-based medicine (EBM) movement. His first issue could be summarised as "badly designed clinical research should be seen as unethical", for reasons which may include wasting scarce resources or placing participants at discomfort or risk when the likelihood of benefit is slight. He alleges that poorly designed studies are "frequently published in reputable peer-reviewed journals", a statement which would surprise most editors. Peer review prior to publication, and the earlier independent prospective scrutiny of research proposals by human research ethics committees (HRECs) (according to updated national guidelines published by the National Health and Medical Research Council [NHMRC] in 19993), are two processes designed to prevent this. Assessment of the quality of design and execution of clinical research protocols is to some extent subjective, so these processes will never be perfect. His second issue relates to the definition of quality improvement/assurance and clinical audit, and whether such studies should be regarded as clinical research, and thus subject to prospective ethical review by an HREC. His own conclusion "that internal hospital quality assurance activities should undergo a similar level of scrutiny by ethics committees" is not consistent with the NHMRC guidelines,3 which, in the context of outlining the difficulties in defining research, state (on page 6) "such lists risk including activity that would not normally be included, like quality assurance activities or audits". Nevertheless, there are definitional uncertainties. The Australian Health Ethics Committee (AHEC) of the NHMRC has recognised that clinicians, HRECs and their hospitals need clear advice on how quality assurance and audit activities, which may not need ethical review, are to be separated from clinical research, which does need review. We are not the only country considering this matter.4 AHEC has established a working party to prepare such advice. The working party includes members drawn from AHEC, HRECs, consumer groups, medical colleges and health administrators. Draft advice will be subject to wide stakeholder consultation. The working party commenced its task in November 2001 and its final report is expected by mid-2002.

Simon R Tomlinson · Kerry J Breen · Malcolm H Parker MB BS, MLitt · Chris B Del Mar MD, FRACGP, FAFPHM · Paul P Glasziou MB BS, PhD · Lucie Rychetnik MPH, PhD · Stephen R Leeder FRACP, FFPHM, FAFPHM

To the Editor: We consider that Leeder and Rychetnik make several mistakes in their exploration of the relationships between ethics and evidence-based medicine (EBM).1 We share some of their ethical concerns about the determinants of the research agenda — lack of consumer input, emphasis on the benefits of interventions rather than harms, and funding structures favouring commercially promising interventions or biased by the status of the methodology to be used. However, these are criticisms that relate to producing new research, not using available research. The definition of EBM used by Leeder and Rychetnik2 values evidence that is non-quantitative, and explicitly demands the inclusion of patient preferences in clinical decision-making. Evidence about effects comes from research, while evidence about concerns and values comes from individual patients. To incorporate a patient's pre-ferences in the consultation is crucial to ethical practice, but quite independent of any particular hierarchy of evidence. Similarly, in claiming that treatment may be denied those of low social utility if patient autonomy is not valued, they mistakenly confuse preference or value with the quality of the evidence. The sin of old-fashioned paternalism is falsely attributed to EBM. The suggestion that EBM can exclude the importance of patient narrative is also at odds with the authors' chosen definition, which emphasises the "identification and compassionate use of patients' predicaments, rights, and preferences". Next, they worry that EBM might be misused in public health policy by neglecting areas where evidence is difficult to obtain, offering mental illness as an example. In fact, mental health attracts considerable attention3 and funding as one of the Commonwealth's current priority health areas.4 It has also been an area of considerable activity in EBM, with the Cochrane Mental Health groups and the BMJ's evidence-based summary journal Evidence-Based Mental Health. It may be that EBM has done the opposite of their prediction by highlighting an area of "evidence need". We agree that patients require support when they confront ambiguity and uncertainty. Nevertheless, doctors are ethically and legally obliged5 to provide full disclosure. Patients should be given correct information — warts, uncertainty and all — as often as possible. To suggest that the time spent seeking evidence threatens other elements of clinical practice is misleading. Clinical practice requires judgement to balance all its competing demands. We suggest that, by increasing the efficiency of continuing education, EBM should actually release more time for other requirements. Leeder and Rychetnik also misinterpret the relation between EBM and the law. They suggest that some practitioners who consult evidence, but practise against published guidelines, may be compromised. The point of EBM is to find the best available evidence. If that is clinical experience, consensus or narrative, rather than quantitative data, then so be it. Similarly, it is wrong to imply that those who practise EBM may be sued because they fail "to try everything". EBM, which is simply the getting of the best available information, changes nothing in the formal relationship between clinical evidence and the legal standard of care. Moreover, we believe that, by fostering patient involvement in decision-making, EBM should help protect clinicians from medicolegal dispute. We are always at risk of using new tools overzealously. But the champions of EBM temper its promotion with words like "judgement", "incorporating patient preference" and "conscientiousness". EBM involves a sensible and systematic search for the best information to include in the decision-making process. Great care should be exercised in issuing warnings about how it might be misused, in case EBM becomes unfairly caricatured, which may reduce the motivation of health professionals to find and apply the best treatment.

Simon R Tomlinson

In reply: Much of the literature about evidence-based medicine (EBM) has focused on the science of generating evidence, or the technical process of critically appraising and interpreting evidence for individual patients. In our article1 we opted to discuss EBM as a social activity with inherent potential for multiple manifestations. To describe EBM as a social activity is to emphasise how its definition, interpretation and application, and the ethical implications of those factors, are dependent on societal values and priorities — be they explicit or implicit. Debate about what EBM means, or should mean, in the context of Australian policy and practice does not degrade or negate the clearly ethical practice of consulting the best available research when making clinical or policy decisions. We challenge the view of Parker et al that by identifying and discussing how the concepts or language associated with EBM could be misused or misappropriated we will somehow reduce the motivation of health professionals to find and apply the best treatments. Indeed, our proposition is quite the opposite. Few of today's readers of the MJA will be unfamiliar with the benefits of systematic reviews of the best available research in their clinical area, and few are likely to be dissuaded of that view by our article. Our exploration of the relationship between ethics and EBM does not "misinterpret" EBM, but, rather, purposefully describes scenarios or social consequences about which there may be ethical concerns. If we can articulate clearly what we do not want EBM to mean, and describe the processes and consequences that we would consider unethical, it can only strengthen the development of an ethical and acceptable notion of what we do want from evidence-based policy and practice.

Simon R Tomlinson

To the Editor: Chronic hepatitis C virus (HCV) infection affects almost 200 000 Australians.1 It is monitored clinically by serial liver function tests (LFTs) and HCV RNA detection by polymerase chain reaction (PCR). HCV RNA is a marker of chronic infection and levels reflect response to antiviral therapy. However, testing for the presence of HCV RNA is expensive and, under the current Medicare Benefits Schedule, is not available to people with HCV antibodies and abnormal LFTs unless they are undergoing antiviral therapy. Using an in-house PCR assay, it has been shown that abnormal LFTs largely predict the presence of HCV RNA.2 We aimed to confirm this finding using a more reproducible PCR assay (Roche Amplicor HCV test) and to further investigate the relationship between LFTs and HCV RNA. We studied 323 HCV antibody-positive patients seen at the Fairfield Infectious Diseases Hospital, Melbourne, between May 1995 and September 1996. The Victorian Infectious Diseases Reference Laboratory performed all PCR assays and LFTs on these patients. Approval for the use of de-identified data was obtained from the Ethics Committee of the Royal Melbourne Hospital Research Foundation. Normal serum alanine aminotransferase (ALT) levels from at least two tests over a period of at least six months were considered to demonstrate normal liver function. In order to determine improved predictors of the presence of HCV RNA, the proportion of patients who were HCV RNA-positive and had an initially normal ALT level and the proportion with a normal ALT level persisting over six months were examined for each 10-IU/mL subdivision within the normal ALT range (0–50 IU/mL). Of the 323 patients, 88% were aged between 20 and 49 years and 68% were men. At initial testing, 251 (78%) were HCV RNA-positive by PCR, 206 (64%) had an abnormal ALT result and 183 (57%) had both a positive PCR result and an abnormal ALT level. An abnormal ALT level predicted the detection of HCV RNA in 89% (183/206) of patients and in 82% (14/17) if an abnormal ALT result was found within six months of an initial normal result. Of the 117 patients with a normal initial ALT level, only 49 (42%) had a negative PCR result. However, an initial ALT level of ≤ 20 IU/mL was more likely to be associated with a negative PCR result than an initial normal ALT level > 20 IU/mL (78% v 23%, respectively; P < 0.001). The probability of a negative PCR result was highest if the initial ALT level was ≤ 20 IU/mL and remained normal for at least six months (see Box). We concluded that, while an abnormal ALT level in a patient with HCV antibody generally predicted the presence of HCV RNA, the absence of HCV RNA was best predicted by an initially low ALT level that remained within the normal range for at least six months. Proportion of patients with normal initial serum ALT level and persistently normal ALT level who were positive for HCV RNA by PCR, divided into 10-IU/mL subdivisions of the normal ALT range Initial ALT range (IU/mL) Number (%) PCR positive, all patients Number (%) PCR positive, patients with persistently normal ALT over six months ≤ 10 2/11 (18%) 2/3 (67%) 11–20 7/29 (24%) 0/11 (0) 21–30 18/30 (60%) 11/12 (92%) 31–40 23/27 (85%) 8/8 (100%) 41–50 18/20 (90%) 2/2 (100%) ALT = Alanine aminotransferase. HCV = Hepatitis C virus. PCR = Polymerase chain reaction.

Heath A Kelly · William J Maskill · William Sievert · D Scott Bowden

To the Editor: The letter "Prejudice against mental illness" in the 20 August issue of the Journal1 resonates with my own experiences when attempting to obtain income protection insurance. Many colleagues have a similar story. In 1994, I suffered an episode of major depression requiring hospitalisation. I was a first-year resident medical officer, had relocated to a different city, and had just moved out of home for the first time, at the age of 25. Subsequently, I have progressed well in my career, and will soon complete specialist training. I have dealt successfully with a number of substantial personal and career hurdles, including postgraduate examinations and training, difficult property transactions, engagement and subsequent break-up of the engagement, the death of a flatmate, and illness and personal difficulties within my family and close friends. I have invested considerable time and effort in cognitive–behavioural therapy, and changed many attitudes and behaviours contributing to the initial breakdown. Wary of the implications for insurance, I have been reluctant to have any contact with my psychiatrist. My last appointment was a courtesy visit two years ago, with another visit 12 months before that. I have continued to self-prescribe an antidepressant tablet in the belief that it is probably doing more good than harm. Without any reference to medical reports, an examination, or an appraisal of my achievements and performance, several experienced brokers have confirmed that my history prevents me from being able to obtain income protection insurance, even with an exclusion clause for mental health problems. The one insurer that will consider covering people with a history of depression, with such an exclusion clause, requires me to be off any treatment for 12 months. It is understandable that an income protection insurer would refuse cover for depression-related claims. However, I fail to see why I am denied the opportunity to purchase insurance against the myriad other accidents and illnesses that can befall anyone, irrespective of their history. It appears the underwriters' methods are based on actuarial data that are overly generalised, and undoubtedly many years out of date in terms of diagnosis and prognosis of mental illness. Ironically, private health insurers cannot refuse to cover any patient, regardless of pre-existing conditions. Such discrimination reflects endemic ignorance and prejudice about mental health and illness. It is time for a review of the criteria by which insurers may reject applications.

Name and address withheld

To the Editor: A whole issue of the Journal devoted to Death and Dying [19 November 2001 issue] and not a single obituary!

Paul B Harris MB BS FRACR

In reply: I am reminded of a line from the American poet Edwin Arlington Robinson: "I shall have more to say when I am dead." Nowadays, the opportunity to be the voice commemorating the life of a colleague through an obituary in the Journal seems to be of low priority for members of Australia's medical profession. The decade 1991–2000 saw the lowest number of obituaries published by the Journal in the five decades since 1951.1 We did not include an obituary in the "Death and Dying" issue because, fortunately or unfortunately, the obituary tray was empty.

Martin B Van Der Weyden

Curious connection A retrospective review of hospital patients with bacteraemia has found reduced mortality among those taking statins. The study, from the United States, involved 368 male veterans and two women with bacteraemic infections caused by aerobic gram- negative bacilli or Staphylococcus aureus. Although the 35 patients (9%) who were taking statins were more likely than those not taking statins to have diabetes, hypertension and coronary artery disease, they had significantly lower rates of death from any cause (6% v 28%; P = 0.002), and attributable to the infection (3% v 20%; P = 0.01). The authors suggest that this may result from the effects of statins on the inflammatory process. This interesting finding will need to be confirmed in a prospective study. Clinical Infect Dis 2001; 33: 1352-1357 Hidden weakness A large observational study conducted in the United States has found high rates of osteopenia and osteoporosis among otherwise healthy, post-menopausal women. Researchers in the NORA (National Osteoporosis Risk Assessment) study enrolled 200 160 postmenopausal women aged 50 years and over from 4236 primary care practices in 34 states. The women underwent peripheral bone densitometry or ultrasonography of heel, finger or forearm in their physician’s office, and self-reported any fractures at baseline and 12 months later. Using World Health Organization criteria, 39.6% had osteopenia and 7.2% had osteoporosis. Women with osteoporosis or osteopenia had significantly higher one-year fracture rates than women with normal bone densitometry values (rate ratios, 2.7 and 1.7, respectively). JAMA 2001; 286: 2815-2822 Infection alert An Australian team has identified a number of hospital-acquired computer virus infections. The team reported on 10 types of virus, differentiated clinically by the message they flash. For example, Pathology Department Virus (PDV) flashes the message “a fatal error has occurred”, Radiology Virus (RV) “scan repeatedly until broke” and Orthotics Virus (OV) “needs re-booting”. Arch Dis Child 2001; 85: 496-496 Sneezing season A new approach to the treatment of seasonal allergic rhinitis has been trialled in the United States. Omalizumab is an immune-based, targeted therapy which is administered by subcutaneous injection. In this double-blind randomised controlled trial, 536 patients with moderate to severe ragweed-induced seasonal rhinitis were randomly allocated to receive courses of 50, 150 or 300 mg of omalizumab, or placebo. Self-reported nasal symptoms and the use of “rescue” antihistamine were key outcome measures. Treatment effectiveness was globally rated as good or excellent by significantly more patients in the omalizumab groups than those receiving placebo (71% for 300 mg omalizumab, 60% for 150 mg omalizumab and 52% for 50 mg omalizumab v 41% for placebo). Nasal symptom severity scores were significantly lower in those receiving 300 mg of the drug than those receiving placebo. Patients in the 150 mg and 300 mg groups also used less rescue antihistamines than those in the placebo group. Pharmaceutical companies funded this research and played a major role in its design and conduct. Comparative trials will be needed to determine the role of omalizumab in the overall treatment of allergic rhinitis. JAMA 2001; 286: 2956-2967 At a cost The Victorian Infant Collaborative Study Group has recently reported on the neurosensory outcomes of a regional cohort of extremely low birth weight (ELBW) babies who are now teenagers. Between 1979 and 1980 there were 351 live births of infants weighing 500–999 g, all born before exogenous surfactant was available. At age 14 years, 88 (25%) had survived and 79 were assessed. More than half the subjects had some disability, which was classified as severe in 14%, moderate in 15% and mild in 25%. Forty-six percent of ELBW teenagers had no disability, compared with 83% of a group of normal birth weight controls. Impairments included eight cases of cerebral palsy, five of bilateral blindness and four of deafness requiring hearing aids. Sixteen subjects had IQs more than two standard deviations below the mean. Early-childhood assessments, from age 2 years, were highly predictive of disability at age 14 years, although there was a tendency to over-diagnose mild cerebral palsy. The authors note that the longer the period of follow-up of this cohort, the less the relevance to contemporary ELBW infants in newborn nurseries, as perinatal care and survival rates have improved dramatically in the interim. Arch Dis Child Fetal Neonatal Ed 2001; 85: F159-F164