Issues
Volume 180 Issue 3
From the editor’s desk
Marketing medicine
Just before Christmas 2003, I received the following email: “ Dear Martin,... Re: HEALTHY 25% DISCOUNT ON HEART SCAN FOR YOU AND YOUR EXECUTIVE TEAM. Give yourself and your executive team an early Christmas present this year or help them make a New Year's resolution that is easy to keep. Either way, our 25% discount on heart scan appointments before 31 January 2004 is a healthy gift. A heart scan is normally $415 including GST.” A prominent executive endorsed the offer, saying, “ I have had a heart scan and so has my wife. You owe it to yourself and your family.” It went on to give contact details of a company offering heart and body scanning. Such targeted marketing, long a tactic in the commercial world, is now on the march in medicine. The benefits of virtual colonoscopy and body scans are aggressively marketed to the “worried well”. Cures for sexual dysfunction or miraculous repair of visual defects enjoy similar paid publicity. Some would say, why not? It is the consumer's right to choose and buy in a free market! However, the growth in direct medical advertising has occurred without being widely debated in the community or within the profession. This is in stark contrast to the recent vigorous debate on direct advertising of pharmaceuticals to consumers. Some would argue that medical advertising is adequately controlled by legislation, such as the Trade Practices Act 1974, which prohibits misleading or deceptive advertising, unconscionable conduct and misrepresentation. But has medicine now been reduced to a trade bound by trade precepts? Has not the time come for our professional bodies to tackle direct medical advertising? National guidelines, developed and endorsed by our profession, are the least we should expect.
Martin B Van Der Weyden
In This Issue
A little bit country We know that if doctors or their partners come from the country, they're more likely to return to practise in the country. Many rural medical workforce initiatives have therefore centred on attracting country kids to the profession. In searching for other possible determinants of rural practice, Peach et al hit upon internship, which, in Victoria, can be undertaken in rural Ballarat as well as metropolitan areas. On (→ A case for more year-long internships outside metropolitan areas?) they report whether this taste of country life affects eventual place of practice. While this study calls to mind the proverbial (free range) chicken and egg, Wearne and Wakerman (→ Training our future rural medical workforce) believe it’s time we saw more of the rural internship — with a few provisos . . . (I can't get no) satisfaction These famous Rolling Stones lyrics would be apt for many people re-presenting with asthma to hospital emergency departments (EDs). Yet why do these patients re-present? In a study that most GPs and ED and respiratory physicians will find relevant, Goeman and colleagues (→ Back for more: a qualitative study of emergency department reattendance for asthma) explored people’s reasons for reattendance and identified potentially preventable ones. Purpuric perpetrator A previously healthy 46-year-old man presents with purpuric rash and polyarthritis. Ignoring the alliterative ailment exhibited by this columnist, what’s your diagnosis for the patient? Turn to (→ Palpable purpura, polyarthritis and abdominal pain) for more clues to this Diagnostic Dilemma, reported by Mukhopadhyay et al. The postemptive strike The facts of the case are these: a patient tells her doctor that her right fallopian tube and ovary were removed in an appendicectomy years ago. The doctor performs a left tubal ligation, noting that the right tube and ovary are not visible. Five years later, the woman gives birth to a healthy baby boy — the sterilisation had failed. Was the High Court right to uphold the decision that the child’s parents are entitled to the costs of raising him? Read Gerber’s article (→ Failed sterilisations and the unwanted child: a new medicolegal minefield?) and judge for yourself . . . Sudden death Devastating sudden deaths, compounded by their occurrence in the young, is the subject of a forensic review by Doolan and colleagues (→ Causes of sudden cardiac death in young Australians). They reviewed the autopsy reports of people who had died at age 35 years or younger from sudden cardiac death to determine the causes and incidence of these deaths. Worth the effort Keep up (or start) the good work in blood glucose control, say Davis and Colagiuri to patients with diabetes and their doctors, in an editorial on the UK Prospective Diabetes Study (→ The continuing legacy of the United Kingdom Prospective Diabetes Study). At an international meeting last year, early findings from 5 years' post-study monitoring of more than 3000 study participants were presented. Our editorialists conclude that early, aggressive blood glucose control certainly pays off. The wild wild Web In the uncharted territories of the Internet and its apparently infinite possibilities, St George and colleagues (→ Overseas-based online pharmacies: a source of supply for illicit drug users?) mark out a new frontier — online pharmacies as a source of drugs. They are motivated to write when a patient gives them a blow-by-blow account of how to get such drugs without a script. The editorial by Gijsbers and Whelan (→ E-drug deals: part of the Wild West world of e-commerce) raises several issues: how big a problem is illicit online drug supply, especially compared with other sources of illicit drugs or even with the supply of licit drugs (such as tobacco)? Mightn't the biggest villains in the county be our supermarkets and pubs? Sending in marshals with guns blazing is clearly not the answer. (Not) doing the Cam-Cam New South Wales was rocked by recent revelations of poor patient care at Campbelltown and Camden hospitals in December 2003, thanks to the persistence of whistleblowers and a Health Care Complaints Commission report. But let’s look beyond individual blame, says Van Der Weyden (→ The "Cam affair": an isolated incident or destined to be repeated?) in response to the ministerial actions since. MJA‘s greatest hits An article published by the MJA on polycystic ovaries has been our highest-rating article every year since its publication in 1998 (see www.mja.com.au/public/issues/nov16/kidson/kidson.html). But will the latest on polycystic ovaries in our Practice Essentials: Endocrinology series (→ Norman et al, 4: Polycystic ovary syndrome) knock Kidson’s original article off its perch? Time will tell . . . Another time ... another place... The hospitals [in Utopia] are . . . supplied with everything needed to cure the patients who are nursed with tender and watchful care. Highly skilled physicians are in constant attendance . . . Hardly anyone in the city . . . would not rather be treated . . . at the hospital than at home. Thomas More, Utopia. 1516
Editorials
The “Cam affair”: an isolated incident or destined to be repeated?
The problems of staff and funding shortages implicated in this affair may not be confined to the hospitals in question In December 2003, public confidence in New South Wales hospitals was severely shaken by the release of the Health Care Complaints Commission (HCCC) report on the “Cam affair”. 1,2 This had erupted from the allegations of four nurses who had voiced their concern, some 13 months earlier, over questionable patient care, disregard for quality and safety, and an indifferent administration at the Campbelltown and Camden hospitals of the Macarthur Health Service in Sydney’s southwest.3 The HCCC report detailed a raft of symptoms of a sick hospital and administration system, and outlined a blueprint to rid the health service of this sickness.4 It is hoped that something more substantial than yet another list of blameworthy individuals will emerge from the inquiry. The response by the NSW Minister for Health, Morris Iemma, was surgical and swift: two doctors were suspended and another nine were referred to the NSW Medical Board; disciplinary proceedings were commenced against four administrators; 19 deaths examined in the HCCC report were referred to the State Coroner; and the South West Area Health Board, ultimately responsible for the two hospitals, was dissolved.5 To this point, the minister’s actions had the right political resonance and were ostensibly defensible. But then came a decision at odds with the wisdom of focusing on the message, and not the messenger. The minister noted, “The report does detail in great length instances of clinical failure, deficiencies in management systems, and the failure to ensure appropriate supervision. But for an investigation that took 13 months to complete, the HCCC doesn’t go far enough in terms of finding anyone accountable for these failures [my emphasis].”5 He then dismissed the HCCC commissioner, Amanda Adrian. This baffling, and as yet unexplained, decision might reflect information to which the minister alone is privy, or simply poor advice from his minders. In any event, the commissioner went. To drive home the political focus on accountability, the minister announced yet another inquiry.5 Its brief is not only to retrace the HCCC investigation, but also to “make recommendations as to further actions against individuals, and to refer any matter or person for disciplinary action” and to “make recommendations on the regulatory and administrative arrangement of the HCCC.”5 It is hoped that something more substantial than yet another list of blameworthy individuals will emerge from the inquiry. To the casual observer, the Cam affair resembles the United Kingdom’s high profile Bristol case.6 Both were the result of whistleblowers’ altruism, and their frustration when their complaints about unacceptable patient care and safety fell on institutional deaf ears. In both, the whistleblowers (seven nurses in the Cam affair and an anaesthetist in the Bristol case) paid a high personal and professional price for their public stance. 4,7 In both, there were long initial investigations followed by other inquiries. 5,7 But there the similarity ends. The Bristol case revolved around issues of professional competence and self-regulation,6 whereas the Cam affair centres on, among other things, a mismatch between clinical capacity and clinical demand4 — a mismatch exacerbated by the chronic “poor country cousin” status of Sydney’s outer metropolitan hospitals compared with their “rich city cousins”, the established inner-city hospitals.8,9 But what to do? What are the pathways out of this situation? The HCCC remedial blueprint and the recommendations for change made by the Macarthur Expert Clinical Review Team led by Bruce Barraclough, Director of the NSW Institute of Clinical Excellence,10 have much in common. The Macarthur Expert Clinical Review Team, at the behest of the minister, examined the embattled hospitals in August 2003. Its recommendations include the need for: significant leadership in the clinical and administrative spheres; increased clinical service capacities in workforce and resources; involvement of academic institutions and clinical colleges to enhance the professional attractiveness of the hospitals for postgraduate training and senior staff; and an ethos that encourages open reporting, review and remediation of problems — an ethos that is patient and safety centred. These conventional approaches to troubled healthcare systems are laudable, but the Cam affair also provides opportunities to explore innovative approaches that might be transferable to our troubled hospitals in other jurisdictions. These include: confronting the “silo” mentality of our hospitals by appointing staff, not to specific hospitals, but to health areas, so that expertise and services are available area-wide according to need (there is a pressing need to develop more flexible service capacity within healthcare services); developing clinical services on the basis of area-wide need rather than political or academic opportunism; establishing a tertiary care teaching hospital at the hub of the health area, with real and transparent service or training links with the area’s other hospitals; and developing indicators, or clinical “Plimsoll lines”, which signal higher risks to proper patient care and required quality and safety. At a global level, politicians need to be made more individually aware of, and accountable for, health services. This may be achieved by: dismantling the highly centralised and adversarial HCCC and replacing it with local-area health ombudsmen, accountable to an independent panel comprising the area’s state and federal politicians along with community and health-discipline representatives (such a system would be far more responsive to local difficulties and more in tune with concepts of accountability and quality); and increasing the proportion of bipartisan local, state or federal politicians serving on area health boards, along with limited-tenure members selected for professional prowess rather than political patronage. But change and innovation alone will not allay a real anxiety about whether the Cam affair was an isolated incident or is destined to be replayed elsewhere. The unstoppable demand for hospital services during a medical and nursing workforce crisis, compounded by inadequate hospital funding,11 suggests that the latter is more likely. The community, through its politicians, has a confronting choice: either reinvigorate our hospital services by increasing the number of doctors and nurses and attend to our hospitals’ waning capacity and infrastructure through adequate funding, or await the next Cam affair. Ironically, the Macarthur Health Service’s quality policy statement throughout this affair outlined a commitment to the principles of customer focus, strong leadership, striving for best practice, evidence of outcomes, and a culture of improving.12 But the Cam affair illustrates that, for our hospitals, there is more to quality than rhetoric.
Martin B Van Der Weyden MD, FRACP, FRCPA
Training our future rural medical workforce
We need to provide appropriate, high-quality training in and for rural areas Australia’s medical workforce is distributed unevenly — in rural and remote areas, where people have the highest morbidity and mortality rates, there is reduced access to medical services. 1,2 Not only is there a maldistribution adversely affecting rural and remote areas, but the work of rural and remote general practitioners is more complex than that in metropolitan areas.3 Thus, we need to provide appropriate medical training for these environments, and strategies to increase the rural workforce. In recent years a suite of initiatives has been introduced to encourage more doctors to choose careers in the bush.4 These range from visits to rural high schools promoting medicine as a career, to undergraduate scholarship schemes, through to regionalised general practice training. Rural Australian Medical Undergraduate Scholarships are offered to students from rural areas, and the John Flynn Scholarships are open to all students who express an interest in future rural practice. Both of these foster relationships with rural areas and practitioners. All general practice registrars are now required to work for at least 6 months in a rural area, and there are financial incentives to train in rural areas. Finally, substantial academic infrastructure, in the form of university departments of rural health and rural clinical schools, has been funded.5 Will these initiatives have an impact on rural and remote workforce shortages? Current evidence suggests that rural doctors are more likely to have come from a rural background, to have a partner or spouse with a rural background, to have wanted a career as a general practitioner, and to have undertaken undergraduate and postgraduate training in rural areas. 6-8 Doctors who spend more than half their postgraduate training period in rural areas are over 10 times more likely to practise in a rural area.9 Most of the initiatives to encourage rural practice have been aimed at medical students, or at doctors after rather than before registration. Historically, most internships have been completed in metropolitan hospitals. The health system needs high technology centres, but are they an appropriate place to apprentice practitioners in their pre-differentiated stage? In this issue of the Journal, Peach et al (page 106)10 present the results of a study on the eventual place of work of doctors who completed their internships in a regional hospital in Victoria. These doctors were more likely to work as general practitioners in regional Victoria than their contemporaries who completed internships in metropolitan hospitals. Peach et al argue that more internships should be available in regional areas. This retrospective, case–controlled study shows an association between regional internships and regional careers, but, as the authors acknowledge, this does not prove causation. Were those who worked in regional Ballarat a self-selected group, already with an interest in life outside the city? Only a prospective study can explore why choices were made, and what aspect of the internship promoted the choice of a career in rural medicine. Was it the social network the doctor made? or the content of medicine in rural areas, with common acute presentations to hospital rather than rare conditions (providing confidence in diagnosis and reducing the “fear” factor of on-call in comparative isolation)? or was it the context, with close relationships with a community making the doctor feel involved and included? There has always been a tension in postgraduate medical education between providing workforce and furthering the education of doctors in training. Studies have shown that sending general practice registrars to areas of workforce need does not always guarantee a good learning experience, and may generate a desire to rush back to the city at the earliest opportunity. A study in central Australia suggests that, without adequate supervision, the significant learning opportunities available in rural areas are not fully utilised.11 Moreover, the National Female Rural General Practitioners Research Project12 noted that, while increasing numbers of women are choosing rural general practice, many female general practice registrars in rural areas planned to return to metropolitan areas once they had completed their training. To solve the rural and remote workforce shortages, we need to provide appropriate, high-quality training in rural areas and specifically for rural areas. The absolute numbers of medical students with a rural background are still low, so any mechanisms that encourage students from urban backgrounds to work in rural and remote areas are important. However, the intern year needs to provide, in a protected environment, the practical knowledge and skills necessary for a safe standard of medical practice. We need to be sure that regional areas can provide this environment — accredited education, support, assessment, and suitable working conditions.13-15 Do we need further evaluative research, as suggested by Peach et al? Yes, we need a prospective cohort study, taking into account the planned Committee of Deans of Australian Medical Schools (CDAMS) Rural Programs Evaluation Project, to examine the impact of both undergraduate and postgraduate rural initiatives on career directions.16 Should we wait for another 5 or 10 years for the results of this research? No, Australians in rural and remote areas cannot wait. We now have sufficient evidence to be confident that rural and remote training has an impact on subsequent choice of rural practice, and we know what constitutes an effective training post. Armed with these two pieces of information, we can proceed with increasing the numbers of regional internships. The distribution of internships should better reflect the health needs across Australia.
Susan M Wearne MMedSc, FRACGP, GCTEd · John Wakerman MTH, FAFPHM, FACRRM
E-drug deals: part of the Wild West world of e-commerce
Cyberdrugs will only take off if there is a significant price advantage over that on the black market The Wild West is a prominent metaphor for the new challenges and opportunities the Internet brings. The adventurous welcome the challenge, the cautious fear the hazards. The Internet has opened up a whole new area of information exchange and free trade. The information exchange makes it difficult for totalitarian regimes to easily control their citizens’ access to information, and Internet share trading makes governments more cautious about their fiscal policies. Free traders welcome the level playing field, for they see restricted markets opening up, and efficiencies based on market forces.1 The Internet cuts out the “middle man”. However, there are downsides, as anyone harassed by SPAM mail will know. Multinationals can more easily extend their sphere of influence, the pornography trade flourishes, as does the trade in music and illicit CDs, which boldly flouts copyright laws. Internet trading of pharmaceuticals challenges the tradition that pharmaceutical drugs should only be prescribed by health professionals and dispensed by pharmacists who have seen the person face-to-face. In June 1999, the American Medical Association formally adopted the position that appropriate medical care can only result from face-to-face consultations.2 Likewise, members of the US Food and Drug Administration are expressing a caveat emptor (“let the buyer beware”) about e-pharmaceuticals,3 because of problems with the quality of cyberpharmacies and the qualifications of cyberpharmacists.4 To what extent does society get involved in individuals’ free choice, especially in the context of drug use? Is free trade better than social control? Social safeguards are set both to protect the ignorant and to restrain the wilful, although critics will argue that the medical and pharmacy professions are simply protecting their eroding turf. With drugs of dependence, those involved in misuse would prefer to cut out the “middle man”, and make their own deals. In addition, they are quite prepared to use substances of poor quality and uncertain potency. Should the profession try to stop this? And, if so, how? Social controls of the supply of drugs of dependence vary for different drugs. Thus, society is tightening its control over tobacco advertising and distribution, relaxing controls over alcohol, and clamping down on illicit drugs. Decisions for each drug class are decided somewhat arbitrarily — partly they relate to the severity of the perceived problems arising from use of the drug and partly to the feasibility of control measures. The underlying assumption is that society should exercise some control over drug dealers who seek to exploit those vulnerable to drug addiction, but, in each case — whether tobacco, alcohol or illicit drugs — some uneasy compromises are necessary. These compromises change over time, depending in part on ideological and political forces, as well as on the science of drug-related harm. What is the size of the cyberpharmacy problem in relation to addictive drugs? Is the single case of online purchasing of drugs for misuse described by St George and colleagues in this issue of the Journal (page 118)5 an exception, or the start of a new and dangerous trend? We need more data, but we can make some observations. Licit drugs present a far greater problem than illicit drugs. Most drug-related deaths in our society are a result of diseases caused by tobacco. Tobacco accounts for over 80% of drug-related deaths and 79% of years of life lost. 6 When the cardioprotective effects of alcohol are factored into the equation, the impact of alcohol is on a par with those of the illicit drugs. Yet, alcohol as a licit drug is freely available in our local supermarkets. Are not tobacco and alcohol a higher priority? The illicit use of licit drugs — prescription opioids and benzodiazepines — is more difficult to study. In particular, the impact of sedatives, including benzodiazepines, is difficult to quantify, as their main impact is their contribution to opiate deaths in polydrug overdoses. How big a problem, compared with other sources, is the cybersourcing of licit drugs for illicit use? As general practitioners have become more aware of the need to restrict benzodiazepine prescribing, a black market has developed. There is also a growing market in black-market prescription opiates, like MS Contin (Mundipharma) and Kapenol (GlaxoSmithKline). Thus, there is a ready market for people keen to buy these drugs. Cyberdrugs will only take off if there is a significant price advantage over that on the black market. Data are hard to obtain, but we suspect that, until it becomes harder for users to obtain benzodiazepines from lax prescribers or on the black market, the purchase of cyberdrugs will be regarded as too slow and too expensive. What should we now do? We need more data, and cases like that described by St George et al help to alert health professionals in the field to this new drug source. The suggestions put forward by St George and colleagues have merit, but, without more data, their alarm may be premature. In the past, drug control on the supply side, especially of illicit drugs, has produced disappointing results.7 In the meantime, we believe more effort is needed to control the damage caused by tobacco, alcohol and opiates.
Alan J Gijsbers FRACP, FAChAM · Gregory Whelan MD, FRACP, FAFPHM, FAChAM
The continuing legacy of the United Kingdom Prospective Diabetes Study
Five years after the completion of the study, some of its benefits have been maintained The United Kingdom Prospective Diabetes Study (UKPDS) provided definitive evidence for the benefit of intensive management of blood glucose level and blood pressure in people with type 2 diabetes.1,2 When the main findings of the UKPDS were published in 1998, a year after the study had closed, several questions arose. How much would the UKPDS findings influence usual care? Would the vascular benefits of intensive therapy be sustained? Would the status of borderline or unexpected results change with longer observation? 1: Key findings of 5-year post-study monitoring after the United Kingdom Prospective Diabetes Study1,2 Diabetes control (assessed by haemoglobin A1c levels) in patients treated either conventionally or with intensive pharmacotherapy converged The effect of intensive blood glucose control on diabetes end-points was maintained The reduced risk of a fatal or non-fatal myocardial infarction became statistically significant The benefit of metformin treatment in overweight people was maintained The increased risk of all-cause and diabetes-related mortality with combination sulfonylurea and metformin therapy was no longer evident Blood pressure levels converged in the conventionally and intensively treated groups, but the beneficial effects of aggressive antihypertensive therapy were only maintained for microvascular complications To answer these questions, post-study monitoring was initiated after completion of the UKPDS. All patients stopped protocol-driven management but were asked to participate in further regular assessment. The 5-year post-study monitoring period ran from September 1997 to September 2002. Some early results were presented at the International Diabetes Federation Scientific Meeting in Paris in August 2003. The Chief Investigator, Professor Rury Holman, stressed the preliminary nature of the data, and foreshadowed full peer-reviewed publication in 2004. Nevertheless, given the impact of the UKPDS since 1998, the data were of great interest to many delegates present. In the UKPDS, 3867 patients newly diagnosed with type 2 diabetes were randomly allocated to receive either conventional diet-based blood glucose control therapy or intensive pharmacotherapy, primarily with sulfonylurea or insulin (with a target fasting plasma glucose level of < 6.0 mmol/L). Of the original cohort, 489 died during the study period and 76 were lost to follow-up. Thus, 3302 patients (85.4%) entered post-study monitoring. Endpoint data were collected for all of these patients. More detailed results were available for the 1696 (51.4%) patients who were followed up in UKPDS clinics. Regardless of whether or not the patients elected to continue attending UKPDS clinics after the study had finished, management was left to the discretion of the treating physician. The median haemoglobin A1c (HbA1c) values in the two therapy groups were close to 7% at the start of the UKPDS; they diverged during the first year of the study, then rose in parallel, with a separation approaching 1%.1 After the end of the UKPDS, the median HbA1c levels in the conventional therapy group plateaued at about 8.5%, while those in the intensive therapy group continued to rise. By the end of 3 years of post-study monitoring, the curves had converged. Over the next 2 years, the median HbA1c level fell progressively in both groups by about 1%. Only a quarter of patients had achieved the target HbA1c level of < 7.0% by the end of post-study monitoring, even though most were receiving insulin treatment at the time. The post-UKPDS changes in median HbA1c level mirror those found after the end of the equivalent type 1 diabetes study, the Diabetes Control and Complications Trial.3 The convergence during the first 3 years of post-study monitoring probably reflects a combination of patient reluctance to maintain intensive therapy (in view of the risks of hypoglycaemia and weight gain), set against increasing acceptance of lower glycaemic targets by patients and their doctors in the conventionally managed group. The subsequent downward trend suggests that incorporation of UKPDS-based recommendations into usual care was increasing, but the availability of new therapies, including thiazolidinediones, may have contributed. When analysed on an intention-to-treat basis, post-study monitoring data confirmed that participation in the intensive blood glucose lowering policy group was associated with a significantly lower rate of any diabetes-related endpoint (eg, myocardial infarction, stroke, renal failure, retinopathy, death from hyper- or hypoglycaemia) and of microvascular complications 5 years after the UKPDS had finished. This sustained effect has been termed “metabolic imprinting”.3 Although there were no group-specific differences in all-cause mortality and diabetes-related deaths during the UKPDS, intensive therapy during the study period was associated with a lower risk of diabetes-related death during post-study monitoring. The benefit of intensive therapy on fatal or non-fatal myocardial infarction — borderline in the UKPDS — was still weak by the end of post-study monitoring, but had become statistically significant. During the UKPDS, metformin therapy in overweight patients substantially reduced the risk of any diabetes-related endpoint, all-cause mortality, diabetes-related deaths and myocardial infarction compared with conventional therapy.4 During post-study monitoring, these risk reductions were attenuated but remained significant. There were unexpected increases in all-cause mortality (relative risk, 1.60; 95% CI, 1.02–2.52) and diabetes-related deaths (relative risk, 1.96; 95% CI, 1.02–3.75) in patients taking combination sulfonylurea plus metformin compared with sulfonylurea monotherapy in the UKPDS.4 This was considered a chance finding resulting from the low number of deaths in the latter group. These differences were no longer evident at the end of post-study monitoring. In the UKPDS, a subset of 1148 hypertensive patients were randomly allocated to tight blood pressure control (target, < 150/85 mmHg) or less tight control (target, < 180/105 mmHg).2 Of these, 884 were available for post-study monitoring, of whom 522 continued to attend UKPDS clinics. The pattern of change in systolic and diastolic blood pressure was similar to the pattern of change in HbA1c levels during post-study monitoring, with convergence between groups during the first 3 years and progressive reduction over the next 2 years. Despite a doubling of the percentage of patients taking three or more antihypertensive medications during the post-study period, only one in six patients had achieved a systolic blood pressure of < 130 mmHg and a diastolic blood pressure of < 80 mmHg at the end of this time. Compared with event rates in the less tightly controlled patients at the end of the UKPDS, there were impressive reductions in any diabetes-related endpoint, diabetes-related deaths, stroke and microvascular disease among patients subject to tight blood pressure control.2 By the end of post-study monitoring, the relative risk reductions in the first three of these categories were no longer statistically significant. For microvascular disease, a significant but attenuated risk reduction remained in the tight-control group. The UKPDS design was complex, and analysis of post-study monitoring data will be further complicated by the fact that clinical management was non-uniform after completion of the UKPDS. Nevertheless, it appears that the microvascular benefit of tight glycaemic control is maintained after resumption of usual care. This was also seen in the Diabetes Control and Complications Trial,3 and argues for early and aggressive blood glucose management strategies. Concerns about the safety of combination metformin–sulfonylurea therapy appear to have been allayed, and the macrovascular benefits of metformin in overweight patients are supported by the data presented in Paris. Disappointingly, it appears that the effects of aggressive antihypertensive therapy may wane relatively quickly. Formal analysis of post-study monitoring data is eagerly awaited, but, until then, there is reason to believe that the legacy of the UKPDS continues.
Timothy M E Davis FRACP · Stephen Colagiuri FRACP
Research
A case for more year-long internships outside metropolitan areas?
Objective: To determine whether medical graduates who spent their intern year at a non-metropolitan hospital were more likely to practise outside metropolitan areas on completion of training than were interns in metropolitan hospitals.Design: Retrospective follow-up of doctors who held year-long internships at a non-metropolitan hospital and interns from metropolitan hospitals.Setting: Ballarat Base Hospital (BBH) (Rural, Remote and Metropolitan Area [RRMA] rural zone) and hospitals in Melbourne and Geelong (RRMA metropolitan zone).Participants: 57/63 (90%) Victorian medical graduates completing internships at BBH between 1989 and 1997 and 126/126 (100%) sex-matched metropolitan interns, chosen at random.Main outcome measures: Practice location in 2002.Results: More BBH interns were practising as GPs outside metropolitan areas (44%) than metropolitan interns (13%) (difference, 31%; 95% CI, 17%–45%). The proportion of interns in specialist practice outside metropolitan areas was small for both groups — zero and 3%, respectively (difference, − 3%; 95% CI, − 6% to 0). None of the specialist training posts held by interns were outside metropolitan areas. Of BBH interns entering general practice, 41% (95% CI, 24%–58%) did so in the local health region.Conclusions: Regional interns are a good source of non-metropolitan GPs, especially locally. Prospective studies to determine the precise influence of regional internships on eventual practice location, and whether more such posts would lead to more graduates entering non-metropolitan practice, would be worthwhile.
Hedley G Peach PhD, FFPH · Maxine Trembath · Bernie Fensling BSc, MB BS
Causes of sudden cardiac death in young Australians
Objectives: To determine the causes of sudden cardiac death in people aged 35 years or younger.Design and setting: A review of all autopsies performed between 1 January 1994 and 31 December 2002 at a major Sydney forensic medicine department serving an area with over 2 million people.Main outcome measures: Incidence of various types of cardiac disease causing sudden death in those aged ≤ 35 years; proportion of deaths in which no cause was found at autopsy.Results: There were 10 199 autopsies performed during the study period. Of these, 2986 (29.2%) deaths occurred in people aged ≤ 35 years; 193 were classified as sudden cardiac deaths. The cause of sudden death in this group was not established in 60 (31%), and was presumed to be due to primary arrhythmogenic disorders. Coronary artery disease occurred in 46 (24%), hypertrophic cardiomyopathy/unexplained left ventricular hypertrophy in 29 (15%), and myocarditis in 23 (12%).Conclusions: Unexplained deaths, presumed to result from sudden primary arrhythmogenic causes, occur in young Australians with structurally normal hearts. That underlying disease-causing genetic defects may be involved has clinical implications for family members.
Alessandra Doolan BMedSc · Christopher Semsarian MB BS, PhD, FRACP · Neil Langlois MB BChir, MD, FRCPA
Back for more: a qualitative study of emergency department reattendance for asthma
Objective: To explore the reasons why individuals recurrently present with asthma to hospital emergency departments.Design: A predominantly qualitative study in which participants were interviewed in-depth about their asthma. Data on medication use, respiratory health and asthma knowledge were also collected, and asthma severity was determined from medical records.Setting: A tertiary teaching hospital and a suburban hospital emergency department (ED) from 1 March to 30 April 2000, and a rural hospital ED from 1 July to 31 August 2000.Participants: The participation rate was 32% of an initial 195 ED attendees (183 of whom were eligible) aged 18–70 years: 32 had presented to an ED for asthma care on more than one occasion over the preceding 12 months (reattendees), and 29 were non-reattendees.Results: Two-thirds (22/32) of reattendees had chronic severe asthma and presentation to ED was deemed appropriate for 18 of these, indicated by recurrent severe asthma attacks despite seeking prior medical intervention. Reasons for re-presentation identified in a third of all reattendees included poor asthma knowledge, and financial and other barriers to medication use.Conclusions: We identified potentially preventable issues in about a third of patients (most of whom had mild to moderate asthma) who recurrently presented to EDs for treatment. The remainder of the participants sought emergency asthma treatment appropriately after failing to respond to medical care, and this was frequently in accordance with their asthma management plans.
Dianne P Goeman MA, GradDipSoc · Francis C K Thien MD, FRACP · Jo A Douglass MD, FRACP · Rosalie A Aroni PhD · Michael J Abramson PhD, FRACP · Susan M Sawyer MD, FRACP · Kay Stewart PhD, BPharm(Hons)
For debate
Overseas-based online pharmacies: a source of supply for illicit drug users?
Overseas-based online pharmacies dispense prescription medications without a prescription, thus creating an alternative source of pharmaceuticals for people using illicit drugs. Health professionals need to be aware of this new drug source, which may change the rates and patterns of illicit drug use in Australia. Because of the nature of the Internet, this issue needs to be dealt with at both an international and a national level. The provision of health-related services through the Internet is fast becoming a reality. Online pharmacies are an extension of this service.1 There have been reservations about privacy as well as the quality of the information available from these health sites, but we have recently become aware of a more disconcerting issue: obtaining potentially addictive prescription medication through the Internet. Online pharmacies, such as those based in Mexico and Asia, will dispense prescription medications without a prescription, including commonly misused pharmaceutical drugs (eg, diazepam, oxycodone, temazepam and anabolic steroids). In 1998, results of the National Drug Strategy Household Survey indicated that 46% of Australians have used an illicit drug at some time. Analgesics were identified as second only to marijuana as the most widely used illicit drugs.2 When compared with the total Australian population, the group with the highest proportion of current users of any illicit drug was young people aged 14–29 years, and in the period 1995–1998 recent illicit drug use by teenagers rose.3 Although illicit drug use is not exclusively a youth issue, young people are competent users of the Internet, with 75% of 18–24 year olds accessing the Internet in 2000, compared with only 9% of those over 65 years.4 Example of drug misuse via the InternetA 20-year-old patient was referred for management of anxiety and polydrug misuse. The patient related that anyone could be a misuser and pusher of drugs without relying on illicit suppliers of such drugs or “doctor shopping”. A click of a mouse could supply whatever drug a patient wanted from online pharmacy services available 24 hours a day. These sites are easy to use and often require little more than a credit card number to gain access to a wide range of prescription drugs, such as diazepam, alprazolam, temazepam, methylphenidate, morphine and codeine. The patient had a 2-year history of using large amounts of zolpidem, temazepam, alprazolam and diazepam with alcohol, as well as regular use of marijuana. These medications were originally obtained by doctor shopping for prescriptions. However, while researching these medications on the Internet, our patient discovered the online pharmacies that dispensed prescription medication without a script. Zolpidem, oxycodone and methylphenidate were all ordered by the patient from online pharmacies based in Mexico and Thailand. He “surfed” the Internet for the site with the cheapest drugs and found one that sold 100 zolpidem, his drug of choice, for US$70.00, with a delivery charge of US$5.50. He was able to order quantities of 100, 200 or 500 tablets. It took 2 weeks for the discreetly packaged drugs to arrive at the patient’s door. The patient volunteered this information during therapy for drug addiction and was quick to see the negative implications. After a period of counselling about the causes of medication misuse, he was motivated to cease further ordering and willing to undergo drug detoxification. Further investigationsWe accessed many of the sites used by the patient to obtain medications. Online pharmacies are subject to the laws of the country in which they are based. Those in Australia require a valid Australian prescription before prescription medication will be dispensed (Peter Waterman, Media Spokesperson, Pharmacy Guild of Australia, personal communication). However, in some countries, such as Mexico, many prescription medications can be purchased over the counter, and they can be sold over the Internet without prescription. Of 33 surveyed pharmacy websites in the United States most (88%) require a prescription before medication will be dispensed,5 and the remaining sites either dispense prescription medication without a prescription, or accept scripts by fax or email. This may mean that one script could be recycled through many of these online pharmacies. Other overseas sites offered to provide consumers with a prescription after an online or phone consultation. Some sites charge a membership fee before medications like morphine and oxycodone can be obtained. There are also sites that provide, for a fee, a directory of online and land-based pharmacies that dispense prescription medications without prescription. Many sites boast of proven methods for getting packages past customs, and some offer to re-ship medication if a seizure notification from customs can be produced. The Therapeutic Goods Administration (TGA) in Australia, the government organisation responsible for controlling and regulating importation and manufacture of medications, prohibits the importation of prescription medications without a permit or prescription. The medications must be for personal use only and cannot be on-sold, but this is difficult to police. Importers can bring up to 3 months’ supply of medications into the country per importation.6 These regulations can only be enforced if the contents of packages are discovered, and it seems that some packages do slip through. We have written to and discussed these issues with the following people: Managing Director of Australia Post; Chief Executive Officer of the Australian Customs Service; Drug Intelligence Network (Australian Federal Police); Crime Stoppers (New South Wales Police); and Local police. We could not determine what actions these authorities were pursuing in regard to this issue. Australia Post does not have the authority to open postal articles because of privacy issues (Sal Perna, Group Manager, Australia Post, personal communication). Customs informed us that their surveillance capacity has been increased over the past 2 years to meet the challenges posed by Internet purchases of medications and other restricted goods. Customs also regularly prosecutes those who attempt to import prohibited goods without permits. At present all international mail and 70% of air cargo arriving in Australia is examined either physically or by x-ray (J H Jeffery, Acting Chief Executive Officer, Australian Customs Service, personal communication). DiscussionThe use of the Internet as an alternative source of supply of prescription medications for people using illicit drugs is unlikely to overtake the street market or doctor shopping for scripts as a means of obtaining illicit drugs; in 1999–2000 the Health Insurance Commission identified over 9000 “doctor shoppers” (defined as people who had attended 15 or more different general practitioners in 1 year).7 However, the extent of the current use of the Internet as a source of drug supply is unclear. Although medications can be ordered from home, without contacting medical practitioners or pharmacists, ordering drugs over the Internet is still expensive and entails a 2-week wait for the medications. However, it may have the potential to encourage people who would not purchase drugs on the street or “doctor shop” to purchase drugs over the Internet. The purchase of medication from offshore pharmacies also raises the issue of the quality of the medication. Drugs manufactured in Mexico are not as closely regulated as they are in Australia or the US, and are not subject to the same quality standards. This increases the potential for increased rates of addiction and accidental overdose. Although the Internet may not be the major source of supply for illicit drug users, restricting access to Schedule 4 and 8 drugs through this channel can do no harm. This is where Customs plays an important role. The decrease in the availability of heroin in Australia caused by the 2001 “heroin drought” led to a marked fall in the number of heroin-related deaths, but did not necessarily lead to a decrease in rates of illicit drug use.8 Many heroin users simply substituted pharmaceutical drugs for heroin. Thus, restricting supply is not the answer to the complex problems posed by drug misuse. Prescription medications are still widely available on the Australian black market and through doctor shopping. However, restricting Internet access to these drugs may help to prevent the creation of new users. Another factor to take into account is that, if drug users are no longer presenting to GPs to acquire scripts, it may be difficult to determine their past drug use histories, as the use of online pharmacies to acquire prescription medication is unrecorded. Because of the nature of the Internet, problems with online pharmacies need to be dealt with at an international and national level. Customs plays a vital role at a national level and has informed us that they and the Australian Government are aware of and are addressing the issue (J H Jeffery, personal communication). We also suggest that the Australian Government could initiate discussions with the countries where these pharmacies are based, perhaps encouraging them to tighten controls. At a local level, doctors and other professionals working with people who misuse drugs, and especially with young people, should be educated about drug availability on the Internet. All those working with these people should be made aware that the avenues for acquiring drugs are changing, and they should continue to provide support through education and harm-minimisation strategies. We realise that it will be impossible to completely stamp out Internet availability of illicit drugs. However, a concerted and concentrated campaign by all involved parties will ensure the vast majority are denied access to such drugs through the Internet.
Bernard N St George MB BS, FRANZCP · Joseph R Emmanuel MRCGP, DRCOG · Kate L Middleton
Diagnostic dilemmas
Palpable purpura, polyarthritis and abdominal pain
We report a patient who presented with a purpuric rash and polyarthritis, but IgA deposits were not found in the skin. Abdominal pain and renal disease first emerged 1 and 2 weeks, respectively, after presentation, to reveal the classic tetrad of Henoch–Schönlein purpura. Our patient emphasises the need for careful follow-up in patients with cutaneous vasculitis, as they may develop systemic manifestations, of which renal involvement, particularly, may be asymptomatic. Henoch–Schönlein purpura (HSP) is the most common vasculitis in children, but is uncommon in adults. It is characterised by a tetrad of purpuric rash, arthritis, gastrointestinal involvement and nephritis. The hallmark of the disease is IgA deposition in small vessels of the skin and kidney. The disease is often preceded by an upper respiratory tract infection, but drugs have also been implicated in the pathogenesis. Clinical recordA 46-year-old previously healthy man developed upper respiratory tract symptoms (rhinitis and postnasal drip) and, on the second day, took one dose of naproxen to alleviate his symptoms. Later that evening he developed a rash over both his legs that gradually spread to his arms and trunk. Over the next 2 days, he experienced marked swelling of multiple joints, including both ankles, wrists, knees and elbows. Physical examination revealed an erythematous, palpable purpuric rash all over the body, most pronounced on the legs. This was accompanied by swelling, warmth and redness of the joints mentioned above. In the emergency room, he was given 60 mg of prednisone for 2 days. There was no improvement in the patient’s condition and he was admitted for investigations. Laboratory tests revealed a normal total leukocyte count, haematocrit and platelet count. The erythrocyte sedimentation rate was 11 mm in the first hour. All metabolic parameters were within normal limits. Urinalysis did not show an active sediment or proteinuria. The results of tests for hepatitis B surface antigen, hepatitis B core antibody (IgM) and hepatitis C antibody were negative. Likewise, the results of tests for HIV, rapid plasma reagin (for syphilis), anti-nuclear antibody, anti-double-stranded DNA antibody, rheumatoid factor, cytoplasmic antineutrophil cytoplasmic antibody, perinuclear antineutrophil cytoplasmic antibody and antistreptolysin-O titre were all negative. Complement components C3 and C4 levels were 1.39 g/L (reference range [RR], 0.88–2.01 g/L) and 0.46 g/L (RR, 0.16–0.47 g/L), respectively. Antibody test results for parvovirus, mycoplasma and coxsackievirus were also negative. There was no evidence of cryoglobulinaemia. A skin biopsy was consistent with leukocytoclastic vasculitis, but no IgA or immune complex deposits were found (Box, Figure A). A week after the rash, the patient developed severe colicky abdominal pain, nausea, vomiting and features of subacute intestinal obstruction with melaena. An upper gastrointestinal endoscopy revealed severe erosive oesophagitis. An abdominal computed tomography scan revealed thickening of the bowel wall, with dilated loops suggestive of small-bowel obstruction. In view of the abdominal symptoms, mesenteric and renal angiograms were performed to rule out microscopic polyangiitis, which may rarely involve medium-sized arteries. The angiograms did not show any evidence of arteritis. A provisional diagnosis of pauci-immune small-vessel vasculitis was made. Intravenous methylprednisolone was started at a dose of 125 mg twice a day. After 2 days of this therapy the patient developed haematuria and proteinuria (2 weeks after the onset of the initial rash). Urinalysis revealed a moderate amount of red cells, with proteinuria of 1.6 g/day. Blood urea nitrogen and serum creatinine levels remained normal. Renal biopsy showed focal proliferative glomerulonephritis with segmental necrosis (Box, Figure B). Electron microscopy revealed dense immune complex deposits with IgA and fibrinogen deposition. The presence of a small vessel vasculitis with IgA deposition was consistent with HSP. Intravenous methylprednisolone pulse therapy was started at 1 g/day for three consecutive days, followed by one dose of intravenous cyclophosphamide (1 g/m2). The patient’s abdominal symptoms, arthritis and rash resolved. He was discharged home, taking oral prednisolone 80 mg/day and ramipril 5 mg/day. The dose of prednisolone was gradually tapered over 4 months to a small maintenance dose of 10 mg/day. The patient is being followed up, with regular urinalysis and renal function tests. His proteinuria has decreased to 0.17 g/day over 4 months. DiscussionOur patient presented with a purpuric rash and polyarthritis, but IgA deposits were not found on skin biopsy. A review of the literature shows that skin biopsies in HSP can be negative for IgA in up to 25% of cases.1 A rash followed by polyarthritis occurs in up to 61% of adults with HSP.2 Our patient went on to develop gastrointestinal involvement in the form of subacute intestinal obstruction. Obstruction, intussusception and perforation of the gastrointestinal tract are rare in HSP,3 although many patients have other gastrointestinal symptoms — colicky abdominal pain, nausea, vomiting, diarrhoea, haematemesis and melaena. The final component of the tetrad in our patient was renal involvement in the form of proteinuria. Our patient illustrates that HSP may be difficult to diagnose because the various components of the tetrad evolve over time. There are a wide range of differential diagnoses in a patient with a rash accompanied by polyarthritis — including meningococcaemia, Lyme disease, streptococcal infection, gonorrhoea, syphilis, rheumatic fever, viral infections, allergic/hypersensitivity vasculitis and small vessel vasculitis. IgA deposits on skin biopsy help to narrow the diagnosis in favour of HSP, but the absence of this finding does not rule out HSP. In our patient the crucial findings were gastrointestinal and renal involvement, with renal IgA deposition. Therefore, patients with a vasculitic rash and polyarthritis should be carefully followed up so that involvement of other organs can be detected early. In addition to vigilant monitoring of symptoms, regular urinalysis is invaluable. Kidney biopsy should be performed at the first indication of renal involvement.4 HSP nephritis of adults carries a high long-term risk of renal dysfunction. 2,5 In the absence of randomised controlled trials testing the benefit of immunosuppressive treatment in adults with HSP, there is no consensus on this issue. Pillebout et al followed up 250 adults with HSP and concluded that age > 50 years, proteinuria > 1 g/day, macroscopic haematuria, glomerular sclerosis and glomerular necrosis were significant prognostic factors for eventual development of severe renal failure.2 That study also stated that proteinuria of > 1 g/day and focal proliferative glomerulonephritis conferred respective relative risks of 2 and 9 for the eventual development of renal failure. By these parameters, our patient had a significant risk of developing severe renal failure. Moreover, he developed renal involvement while taking methylprednisolone; hence, we chose to treat him aggressively with immunosuppressive therapy. A preceding upper respiratory tract infection is seen in up to a third of patients with HSP. Although an association with naproxen is less likely, it cannot be ruled out. Various drugs have been linked to the development of HSP,6 and naproxen has previously been reported to cause cutaneous vasculitis,7 renal damage7 and polyarthritis.8 Our case emphasises the need for careful follow-up in patients with cutaneous vasculitis with polyarthritis, and the need for a renal biopsy at the first sign of renal involvement. Finally, we raise the possible role of naproxen as a trigger in this disorder. Microscopic examination of skin and renal biopsies A: Skin biopsy showing leukocytoclastic vasculitis (arrows) (haematoxylin–eosin stain; original magnification × 40). B: Renal biopsy showing focal proliferative glomerulonephritis with segmental necrosis (arrows) (haematoxylin–eosin stain; original magnification × 40).
Surabhi Mukhopadhyay MD · Soha Mousa MD · Biby R George MD · Andras Perl MD, PhD
Medicine and the law
Failed sterilisations and the unwanted child: a new medicolegal minefield?
A recent High Court decision has held that parents are entitled, in addition to the usual costs arising from a failed sterilisation, to the reasonable costs of raising a healthy child. In the recent case of Melchior v Cattanach and State of Queensland, a majority in the Queensland Court of Appeal1 and in the High Court2 upheld the finding by the trial judge (Holmes J) that a doctor must pay for all the reasonable costs of raising Jordan Melchior, a healthy boy born as a result of a failed sterilisation. The defendant doctor’s negligence was said to consist of an unreasonable reliance on the history he was given by the plaintiff that her right fallopian tube had been removed, together with her right ovary, during an appendicectomy some 15 years earlier. In fact, the right tube was present and patent. (The doctor’s postoperative notes, after performing a left tubal ligation, stated “Good view small bowel associated with right adnexal area — extensive adhesions. No right tube or ovary visible. Consistent with patient’s history of right salpingo-oophorectomy.” We now know that the right fallopian tube was obscured from view by the bowel adhesions.) Holmes J doubted “that the history [the doctor] obtained could be described in any more than a superficial sense, although he clearly perceived it as so. A little more probing may well have revealed its dubious quality.” Her Honour concluded that, in the circumstances, it was incumbent on the doctor to advise the patient that a procedure (namely, a hysterosalpingogram) was available for detecting whether a functioning fallopian tube was present. I believe that the finding of negligence was highly dubious. It was certainly received less than enthusiastically by the Court of Appeal. In the judgment handed down by the Court of Appeal,1 the sole reference to the issue of negligence was by Thomas J, who stated, “With some hesitation I have taken the view that the view taken by the learned trial judge was open, although it is not a view that her Honour was bound to take or that I think I would have taken.” The significance of the case therefore turns on the controversial award of damages for the cost of raising Jordan up to the age of 18 years. Throughout the case presented at the trial and on appeal (and, indeed, in similar cases in the United Kingdom and the United States) the damages (ie, the cost of raising a child conceived as a result of a failed sterilisation) were labelled as flowing from a “wrongful birth” (ie, a birth that would not have happened except for the defendant’s alleged negligence). That description obscures the reality, namely that Jordan is, in the eyes of the law, an unwanted child whose parents chose to keep him — and sue — rather than mitigate their “loss” by placing the unwanted child for adoption. Has the law any place in the area of human reproduction? In posing that question in the High Court appeal,2 Chief Justice Gleeson, albeit in the minority, answered this question as follows: In deciding whether, in contemplation of the law, the creation of [the parent–child relationship] is actionable damage, it is material to note that it is unlikely that the parties to the relationship, or the community, would regard it as being primarily financial in nature. It is a human relationship, regarded by domestic law and by international standards as fundamental to society. To seek to assign an economic value to the relationship, either positive or negative, in the ordinary case, is neither reasonable nor possible. Without going into the extensive and complex reasoning of each of the judges involved in the case, I will attempt to summarise the views of the majority in the High Court (McHugh, Gummow, Kirby and Callinan JJ), and will briefly discuss the decisions of the dissenting judges (Gleeson CJ, Hayne and Heydon JJ).2 Of the majority, Kirby J (whose views were largely shared by the other judges of the majority) reviewed the relevant law in depth, both in Australia and in the United States, the United Kingdom, Canada, New Zealand and South Africa, as well as the approaches of the civil law in some European countries. His Honour noted that in the United States only a small number of states allow full recovery for the ordinary costs of raising a healthy child born after a failed sterilisation or a failure to adequately warn of potential failure. He further noted that in the United Kingdom the law on the subject had recently veered sharply against awarding damages of the kind at issue in Melchior v Cattanach. In a House of Lords decision, McFarlane v Tayside Health Board,3 their Lordships were unanimous in concluding that the parents of a healthy child, born in consequence of alleged medical malpractice, were not entitled to recover from the doctor the cost of reasonable maintenance of the child during his or her minority. (The word healthy is highlighted here, for reasons that will be discussed below.) Kirby J observed that the common law does not exist in a vacuum and that it had to respond to the ever-increasing claims by disappointed parents who had undergone sterilisation operations — in preference to using contraceptive devices — only to discover that the operations had failed and that they were burdened by an unwanted child and by short-term and long-term losses: What commenced as a relatively small number of cases is now a substantial and growing body of decisional law, not only in common law countries but also in countries with a civil law system.2 In what Kirby J described as an attempt to “stem the tide of such claims”, Jupp J, in the UK case Udale v Bloomsbury Area Health Authority,4 awarded the mother, over and above an amount for pain and suffering and loss of earnings during pregnancy, a small amount for the disturbance of family finances caused by the unexpected conception. However, Jupp J firmly rejected the mother’s claim for the cost of raising the child up to the age of 16, such a claim being regarded as “contrary to public policy, being disruptive of family life and inconsistent with the sanctity of human life”.2 Kirby J continued: As more such cases came before the courts differing views soon emerged. The approach of Jupp J was not followed in a number of the English cases that ensued, including Emeh v Kensington and Chelsea and Westminster Area Health Authority,5 Thake v Maurice6 and Benarr v Kettering Health Authority.7 In those cases, the judges rejected the argument that public policy prevented recovery of damages for the cost of child-rearing [and asserted that] the normal legal principles of recovery of damages would apply. A person injured through the negligence of another could recover damages on the compensatory principle for all losses that were reasonably foreseeable to the tortfeasor [(wrongdoer)] at the time of the wrong. Such losses included . . . the basic costs of child-rearing.”2 It is important to note here that the three cases cited by Kirby J were all first-instance cases whose arguments were soundly rejected by a unanimous House of Lords in McFarlane v Tayside Health Board,3 the first occasion the issue was taken on appeal to the House of Lords. The majority in the High Court having firmly rejected the “English” view (ie, that damages for the cost of child-rearing should not be claimable), their Honours thus gave their imprimatur to earlier Australian cases dealing with an unwanted child, the most significant decision being CES v Superclinics (Australia) Pty Ltd.8 That case was an instance of repeated negligent misdiagnosis of the plaintiff’s pregnancy, thus depriving the mother of the chance to procure a lawful abortion which, she claimed, she would have undergone. On appeal to the New South Wales Court of Appeal (of which Kirby J was then President), the three judges were divided in their opinion. Although Kirby P and Priestley JA both upheld the appeal, they did not agree on the extent of damages the unmarried parents of the unplanned child could recover. Kirby P would have allowed full recovery for the upbringing of the unwanted child. Priestley JA believed that the parents should be entitled to damages relating to the pregnancy and the period shortly afterwards, but not to damages that were too remote or unforeseeable. He argued that . . . after a very short interval, the parents could have surrendered the child for adoption. The mother’s decision to keep the child was her own choice. After that decision was made, the defendant was not legally responsible for the parents’ financial costs of rearing the child. (Restated by Kirby J in the High Court case.2) In his dissenting view in the CES appeal case,8 Meagher JA stated that the parents’ claim was “utterly offensive” and that “there should be rejoicing that the hospital’s mistake bestowed the gift of life upon the child”. He concluded that no damages for rearing the child could be recovered. In Cattanach v Melchior, Kirby J (now a member of the High Court) noted somewhat dismissively, in relation to Meagher JA’s decision in the CES appeal, that “lying deep in many of the judicial opinions are perceptions of moral or ethical factors, illustrated by recourse to Biblical citations.”2 Given such divergent views, Kirby J stated in the High Court that, when sitting in the Court of Appeal, he had reluctantly agreed with Priestley JA, whose views expressed “the highest denominator of the majority”, in order to “provide guidance . . . to trial courts generally”.2 He restated his own view in the High Court: The application of the general rule, requiring the tortfeasor to pay the victims of the wrong for the reasonably foreseeable consequences of any proved negligence, obliges the inclusion in the recoverable damages of a sum for the costs of child-rearing. Clearly such costs are within the ambit of the compensable principle required by “corrective justice”.2 I suggest that the major difference between the majority and minority views in Cattanach v Melchior2 turns, in the main, on whether the law should distinguish between claims of negligence brought by parents who bear a child with a disability and parents who bear a healthy child after a failed sterilisation. Kirby J adopted the view that this differentiation . . . is arbitrary, and therefore unacceptable as a statement of the common law. In Australia, even the description of such parents as “afflicted with a handicapped child” would be offensive to most such parents and contrary to their attitudes about themselves, their child and others.2 The three minority High Court judges, on the other hand, upheld the defendants’ argument that the birth of a normal, healthy child should not be regarded as a legal harm or wrong for which damages may be awarded: [The contrary arguments] are unsound because they take insufficient account of the law’s assumptions about some key values in family life as reflected in the unenacted and enacted law. They also take insufficient account of the type of litigation that is likely to take place if recovery of rearing costs is permitted.2 Against that background, it is interesting to briefly review the speeches of the House of Lords in McFarlane v Tayside Health Board.3 Three of their Lordships (Lords Slynn, Steyn and Hope) characterised the costs of bringing up the child as “pure economic loss”. In denying the claim, these Law Lords identified the relevant question as being “whether the doctor had owed the patient a duty to take reasonable care in giving advice which was a duty that protected the patient’s economic interest”. Lord Slynn concluded that there was no duty of any kind, because the doctor had not assumed a responsibility for the expense of rearing the child. Lord Steyn invoked notions of “corrective” and “distributive” justice, concluding that “commuters on the Underground” would not accept that to impose such a liability would be a “just distribution of the burden and losses among members of the society”. Lord Hope expressly invoked the tripartite test of what is “fair, just and reasonable” — commonly used in the United Kingdom to ascertain the existence of a duty of care — to conclude that “the cost of bringing up the child should not be recoverable while, at the same time, denying that the cost of maintenance had been shown to exceed the value of parenthood”. (Quoted from Hayne J in the High Court case.2) Lord Millett adopted the same view voiced by Meagher JA in the CES case,8 namely that “the law must take the birth of a normal, healthy baby to be a blessing, not a detriment”, adding that, although a mixed blessing, “society must regard the balance as beneficial” and that it would be “subversive of the mores of society for parents to enjoy the advantages of parenthood while transferring to others the responsibility which it entails”.3 It is beyond the scope of this article to examine in detail the views of the High Court judges on the role of “choice” — ie, the exercise of the parents’ choice whether to keep Jordan or place him for adoption, thus exploring the “mitigation” principle enshrined in the law of torts. Neither is it appropriate to discuss at length the role public policy plays in the development of the common law, or, indeed, whether human life can be assigned a monetary value. Suffice it to say that a bare majority agreed that the primary judge was correct in concluding that Dr Cattanach’s “negligence” was the causative — and reasonably foreseeable — factor in the parents incurring the cost of raising Jordan up to the age of 18 years, being an economic loss of a kind for which the defendants were liable. The possibility that Jordan may eventually discover that he was born unwanted produced some caustic observations from some members of the minority. Heydon J noted: Since there is a question whether a rule of law exists which permits parents to recover from negligent defendants the cost of rearing children, it is relevant to consider the consequences of the rule. The rule under consideration would encourage parents both to exaggerate and to denigrate their children’s aptitudes. The rule would encourage parents to search for characteristics of the children which might call for future expenditures with a view to recover monetary compensation to meet those possible expenditures.2 In perhaps the most biting indictment of this “rule”, Heydon J quoted Meagher JA’s warning in the CES case:8 Having given birth to a healthy child in August 1987, the parents claimed at a court hearing in December 1993 that the child, then over six years old, was unwelcome, a misfortune, perhaps a disaster, certainly a head of damages. For all I know the child was in court to witness her mother’s rejection of her. Perhaps, on the other hand, the plaintiff had the taste to keep her child out of court. Even if that be so, it does not mean that the unfortunate infant will never know that her mother has publicly declared her to be unwanted. When she is at school some âme charitable — perhaps the mother of one of her “friends” — can be trusted to direct her attention to the point. That a court of law should sanction such an action seems to me improper to the point of obscenity. In contrast, none of the majority in the High Court dealt with the issue of the potential effect on the child of discovering that he was unwanted and the subject of legal proceedings. I believe the case of Cattanach v Melchior was one in which an unfortunate factual finding, at first instance, gathered its own momentum, allowing judicial adventurism to triumph, the majority accepting a result that other judges regarded as an “obscenity”. The civil law has always shown more caution in imposing tortious liability for negligent acts affecting purely financial interests than it applied to negligent acts causing damage to person or property. At common law, the death of a human being is still a damnum sine injuria (ie, a loss for which the law provides no remedy).9 It required Acts of Parliament in all common law countries to allow specified dependants to sue for damages if death was the result of a negligent act. Why should “legal remedies consequent upon the birth of a healthy child, which all of us regard as a good thing”3 be left to the personal views of common law judges? In the words of Gleeson CJ, quoting from Brennan J in another Australian case,10 “The accepted approach in this country is that the law should develop novel categories incrementally and by analogy with established categories.”2 The majority in the High Court case clearly did not heed that “accepted approach”.
Paul Gerber LLB DJur
EBM: Trials on trial
Should smokers be referred to a smoking-cessation clinic before undergoing elective surgery?
QuestionCan smokers be assisted in giving up smoking before elective surgery and does this reduce complications? Trial detailsDesign: Randomised controlled trial of preoperative smoking intervention in patients undergoing hip and knee replacement surgery. Setting: Three university-affiliated hospitals in Denmark. Patients: 62 women and 46 men aged 30–85 years, scheduled for surgery in 6–8 weeks. A further 12 patients were recruited to the trial, but were not included in the analysis because their operations had been postponed or cancelled. Median (range) of smoking exposure was 15 (3–30) cigarettes per day. Interventions: Weekly counselling with a project nurse and the option of nicotine replacement therapy. The first meeting included a questionnaire to measure nicotine dependence and a personalised nicotine substitution schedule was devised. The patients were strongly encouraged to stop smoking completely, or to at least reduce their tobacco consumption by at least 50%. At all subsequent meetings, tobacco consumption was recorded and patients were advised on how to manage immediate withdrawal symptoms and how to keep weight gain to a minimum. Main outcome measures: Frequency of postoperative complications. Main results: The overall complication rate was 18% in the intervention group and 52% in controls (P = 0.0003). These included wound-related complications (5% v 31%; P = 0.001), cardiovascular complications (0 v 10%; P = 0.08), and secondary surgery (4% v 15%; P = 0.07). The median length of stay was 11 days (range, 7–55 days) in the intervention group and 13 days (range, 8–65 days) in the control group (P = 0.41). Overall relative risk reduction was 65% and the number needed to treat (NNT) to avoid any complication was 3 (95% CI, 2–6). In addition, the NNT to avoid wound infection was 4 and the NNT to avoid secondary surgery was 9. Conclusion: A smoking intervention program before surgery can help smokers quit and is associated with a reduction in postoperative complications. CommentaryRationale for the trialSmoking increases the risk of complications in patients undergoing surgery, and it is usual practice to recommend stopping smoking for at least 6 weeks beforehand. 1-3 About 25% of all patients who undergo surgery are current smokers. Studies of the adverse effects of smoking in surgical patients have mostly focused on cardiopulmonary risk reduction, but recent studies identify an association with wound infection. 4,5 Trial methodsThe trial was very well conducted and interpreted, but some aspects deserve closer scrutiny. The intervention period was 6–8 weeks before and 10 days after the operation. In Australia, many patients undergoing elective surgery have their operations booked within a few weeks, and so may not have an opportunity to participate in such a program. A shorter intervention program may not be effective, which raises the question of whether surgery ought to be delayed to allow such a program to be instituted. The intervention program included many components: counselling with a project nurse, additional information and support for patients, smoking cessation or reduction, and use of nicotine replacement therapy. Each could have contributed to the reduction in complications. Nicotine substitution products were provided without charge. If smokers were asked to pay, they may be less willing to participate. In this study, 46 patients (of 166) refused to participate. Patients who refused may have been heavier smokers, and could have been more at risk of complications, despite a short-term change in smoking behaviour. This could affect the generalisability of the results. The study population was restricted to orthopaedic patients. It is yet to be determined if this intervention can be effective in patients undergoing procedures associated with a higher risk of pulmonary complications, such as abdominal or thoracic surgery. Patients in the control group received standard care, with little or no information about the risk of tobacco smoking or smoking cessation counselling. Some readers may believe that this does not represent contemporary Australian practice, but most smokers do not quit in any case.4 Twelve patients were excluded from the analysis because of cancellation or postponement of surgery. An additional analysis of the entire intention-to-treat population could be expected to reduce the estimated risk reduction and increase the number needed to treat (NNT). New informationSmoking cessation or at least 50% smoking reduction occurred far more frequently in the smoking intervention group — 36 patients, compared with four in the control group, stopped smoking. This study found an impressive reduction in the rate of postoperative wound complications among patients who underwent the smoking intervention program. Implications for clinical practiceThis trial identified a simple and effective intervention that reduces wound complications after orthopaedic surgery. The study was unable to show an impact on postoperative pulmonary morbidity, but this may have been because orthopaedic procedures are associated with a relatively low risk of pulmonary complications. Other information suggests that extrapolating these findings to patients undergoing other types of surgery might be beneficial. 1-6 The extent of the risk reduction attributable to smoking cessation is consistent with Australian data for smokers having other types of surgery on a day-stay basis.4 This effect is substantial, and highlights a need to identify smoking status before elective surgery to enable an effective intervention to be offered. The known risks of smoking and the benefits of stopping smoking should be made clear to patients. Are doctors doing enough to stop their patients smoking? There are reports of successful smoking intervention programs targeting hospital patients.7 There has been considerable success in reducing coronary heart disease risk factor levels and improving general health status, including reduced anxiety and depression, in patients awaiting coronary artery bypass graft surgery.7 Nicotine replacement and bupropion therapy can be useful adjuncts.8 Community smoking intervention programs are cost-effective, especially when absenteeism, premature disability and death are taken into consideration.9 Additional cost savings could be expected if such programs were used for patients requiring elective surgery, in view of the marked additional costs of increased need for intensive care and treating complications.
Paul S Myles MD, FRARCSI, FANZCA
Making sense of trial results: outcomes and estimation
The format in which the results of randomised controlled trials (RCTs) are presented can have a major impact on how they are interpreted, and the extent to which they will be adopted into clinical practice. A key element in the reporting of RCTs is the measurement scale on which outcomes are assessed. Scales which are presented as large whole numbers tend to attract the interest of clinicians and patients, independent of the reliability of the estimates.1,2 Enough information needs to be presented to allow clinicians to convert the size of the reported benefit into a format which allows easy comparison with other relevant trial results, including the range of certainty of the benefit (Box 1).3 As outcomes may be measured and collected in a variety of ways, it is essential that there is prior agreement on how any benefit or detriment of the intervention will be reported. Measurement of outcome efficacyFour critical measures of outcomes contribute to the interpretation of the benefits (or otherwise) of specific interventions: Observed effect of the intervention, which should reflect both the magnitude and direction of the effect, and be indicated as differences (between means or medians, proportions), ratios of quantities measuring association (odds, risk, hazards) or ratios of quantities measuring effect (variances or correlations). Other specialised measures (such as the “location” effect) also occur in certain statistical analyses such as the Wilcoxon rank sum test.4 Precision of the estimate of effect is usually called the standard error (SE), and provides a measure of how accurately this estimate measures the true intervention effect. In general the SE is proportional to the sample size — the larger the sample size the smaller the SE. The calculated SE of the effect takes into account the inherent variability (as measured by the standard deviation, SD) in the measured outcome in each of the comparison groups. Confidence interval for the true effect,5 which provides a range of feasible values within which the true effect may lie. The popularity of the 95% CI relates to the use of the 5% level of significance for testing whether the effect is likely to have occurred by chance alone. Confidence intervals are commonly two-sided, reflecting a two-sided hypothesis test (ie, compared with the control, the intervention can have either a benefit or detriment). A generic expression for a two-sided 95% CI is 95% CI = (effect – 1.96 × SE) to (effect + 1.96 × SE), where 1.96 is obtained from the standard normal distribution and relates to the 95% level chosen. P value, a statistical measure of the “strength” of the observed effects. Small P values suggest strong evidence of a real effect, while large ones suggest weak evidence. The conventional “cut point”, 0.05, sometimes referred to as the level of significance, is that value below which it is commonly deemed there is sufficient evidence to declare that the effect of the intervention is truly beneficial or detrimental. Thus a P value of 0.05 reflects a likelihood of 5% that the observed effect might have occurred by chance alone. However, statistical significance does not necessarily imply clinically meaningful differences, making it critical that the magnitude of the effect be accompanied by confidence intervals. Presentation of outcomesDifferent formats for presenting results can make comparisons with other studies confusing (see Box 2). Whichever format is chosen, sufficient information must be provided to allow readers to convert from one format to another. The most popular format is to present results as relative risk reductions (Box 2, Trial B). When the four trials in Box 2 were presented to clinicians, more than 70% considered the active treatments in Trials B and D worth using in clinical practice, while less than 20% considered the treatments in Trials A and C worthwhile. In fact, the “trials” were the same study and treatment.6 Even though the reliability of the statements in Box 2 cannot be determined without either a confidence interval or a P value, confidence intervals are rarely requested. Essential information to enable calculation of the results in all of these formats should be provided to readers. For studies of clinical events, this would include the numbers experiencing the event (numerators) in each group and the numbers at risk (denominators/group size) in each group (Box 3). From this, the proportion of participants in each group experiencing an event (risk) can be calculated, as well as the difference in proportions (absolute risk difference). A confidence interval around this difference and a P value can then be calculated. The relative risk reduction is then simply the risk difference divided by the risk in the control arm. The reciprocal of the absolute risk difference gives the number needed to treat (NNT),7 which is the expected number of patients who need to receive the intervention to see clinical benefit in one patient. A confidence interval for the NNT can be calculated by simply using the reciprocal of the confidence interval of the absolute risk difference. Interpretation of resultsGraphical presentation of results can give a clearer indication of effect sizes and clinical and statistical significance than presenting the results in a table, particularly when reporting treatment effect on multiple outcomes or in subgroups.8 Box 4 shows various scenarios demonstrating effect size and direction, confidence intervals (reliability) and the strength of the evidence (P value). The smallest useful clinical benefit underpins the interpretation of the treatment effect, and this is usually determined by expert clinical discussion before the study is undertaken. Cost and known side effects, as well as comparison with alternative treatment options, need to be considered when determining smallest useful clinical benefit. Box 4(a) shows a statistically significant benefit with a narrow confidence interval (confidence interval boundary does not cross the “no effect” [one] line) and a small P value. However, this effect is not large enough to achieve a clinically meaningful result and would not be considered important enough to change clinical practice, as the lower limit of plausible-effect magnitude falls above the smallest clinically useful benefit. Box 4(b) shows an effect which is both clinically and statistically significant (small P value). The magnitude surpasses the limit for a clinically useful benefit and, even though the confidence interval is wide, the minimum plausible effect is just beyond (more extreme than) the smallest useful benefit. Box 4(c) illustrates a null effect. This result is associated with a large P value and confidence intervals which cross the no-effect line. This is a reliably null result, with a zero-effect estimate, a narrow confidence interval and large P value. Box 4(d) is statistically non-significant and shows an inconclusive clinical effect. The true effect may well be beneficial, but the wide confidence interval is consistent with a broad range of possible effect sizes, suggesting the sample size for the study may have been too small (study lacks statistical power).9 Box 4(e) also shows an inconclusive result — both clinically and statistically. The very wide confidence interval indicates that the estimate of effect is unreliable. DiscussionSelecting the scale of measurement for the outcome is essential in study design, as this will be a critical factor in deciding the appropriate sample size.9 Some outcomes have a natural scale (eg, binary, ordinal), while others may lend themselves to reclassification. Thus, variables like blood pressure or cholesterol level may be easier to interpret when classified as high or low rather than being compared on their natural (continuous) measurement scale. The SE of the measured effect on outcome provides an estimate of the precision of the observed effect, while confidence intervals give a range of the plausible values in which the true effect may lie. Confidence intervals can also be used to aid in clinical decision making and to create clinical-significance curves and risk–benefit contours.5 Estimates of NNT provide a simple translation of the study results which can be directly applied to clinical practice. If these issues are considered, carefully planned and prospectively declared, the generalisability and validity of the final results will be enhanced. A checklist for good reporting of results is given in Box 5. 1: CONSORT checklist of items to include when reporting a trial3 Selection and topic Item no. Descriptor Outcomes and estimation 17 For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (eg, 95% CI). 2: Challenges in comparing trial results Four treatments were tested against placebo in clinical trials for about 5 years. In no trial were there major side effects of the treatments. The results were reported as follows: Trial A 91.8% in the group allocated to the active treatment survived, compared with 88.5% in the placebo group. Trial B Patients allocated to the active treatment had a 30% reduction in the risk of death. Trial C Mortality was reduced by 3.4% in the group allocated to the active treatment. Trial D One death was avoided for every 30 patients treated. On the basis of these reports, and assuming all treatment costs are modest, which treatments would seem reasonable to introduce into your clinical practice? 3: The calculation of different effect measures in a placebo-controlled trial Treatment group (N = 1000) Control group (N = 1000) Number of events 60 100 Group risk (proportion with event) 60/1000 = 6% 100/1000 = 10% Absolute risk difference 10% - 6% = 4% Relative risk reduction 4%/10% = 40% Relative risk/risk ratio (treatment v control) 6%/10% = 0.6 95% CI for risk difference and P value 1.6%–6.4% reduction, 2P < 0.001 Number needed to treat and 95% CI 1/4% = 25; 1/0.064; 1/0.016 = 15.6–62.5 The “odds” of an event (and odds ratio) are commonly used instead of risk and risk ratio in reporting clinical trial results; odds are easily calculated as the number with an event divided by the number without an event. In this example, the odds of having an event are 6.4% for the treatment group and 11.1% for the control group, giving an odds ratio of 0.57 (95% CI, 0.41–0.80; 2P = 0.001). 4: Graphical representations of benefit from treatment 5: Checklist: ideal reporting of trial results Number of events expected in the control population, and the effect size assumed for the sample size calculation Numbers of events observed and numbers at risk in each comparator group separately The absolute risk reduction/difference for each event type Relative risk or odds ratio for treatment effect 95% confidence interval for either absolute risk reduction or relative risk (or odds ratio) 2-sided P value for determining statistical significance of either absolute risk reduction or relative risk (or odds ratio) Number needed to treat (NNT) and 95% CI and/or number needed to harm (NNH) and 95% CI The minimum clinically worthwhile benefit of the intervention
Rachel L O'Connell BMath, MMedStat · Val J Gebski BA, MStat · Anthony C Keech MScEpid, FRACP
MJA Practice Essentials — Endocrinology
4: Polycystic ovary syndrome
Polycystic ovary syndrome (PCOS) is a common condition characterised by menstrual abnormalities and clinical or biochemical features of hyperandrogenism. Features of PCOS may manifest at any age, ranging from childhood (premature puberty), teenage years (hirsutism, menstrual abnormalities), early adulthood and middle life (infertility, glucose intolerance) to later life (diabetes mellitus and cardiovascular disease). While pelvic ultrasound examination is useful, many women without PCOS have polycystic ovaries; ultrasound evidence is not necessary for the diagnosis. Testing for glucose intolerance and hyperlipidaemia is wise, especially in obese women, as diabetes mellitus is common in PCOS. Lifestyle changes as recommended in diabetes are fundamental for treatment; addition of insulin-sensitising agents (eg, metformin) may be valuable in circumstances such as anovulatory infertility. Infertility can be treated successfully in most women by diet and exercise, clomiphene citrate with or without metformin, ovarian drilling, or ovulation induction with gonadotrophins; in-vitro fertilisation should be avoided unless there are other indications.
Robert J Norman MD, FRANZCOG, FRCPA · Ruijin Wu MD, PhD · Marcin T Stankiewicz MRANZCOG
Letters
Multicentre research: negotiating the ethics approval obstacle course
Lynne M Roberts,* Lucy Bowyer,† Caroline S Homer,‡ Mark A Brown§ * Research Midwife [corresponding author], † Senior Lecturer in Obstetrics (University of New South Wales), ‡ Midwifery Consultant, Department of Women’s and Children’s Health, St George Hospital, Research Building, St George Hospital, Kensington Street, Kogarah, Sydney, NSW 2217; § Professor of Medicine (University of New South Wales), Department of Renal Medicine, St George Hospital. RobertslyATsesahs.nsw.gov.au To the Editor: The obstacles presented by Human Research Ethics Committees (HRECs) have caused a significant delay in commencing a valuable research project. We are currently conducting a multicentre study investigating the outcomes of hypertensive pregnancies in a cohort of 1620 women. It is a retrospective review of medical records and does not entail any participation of the women. Ethics approval was sought and gained from the New South Wales Health Department and one other NSW area health service (AHS) involved in the study. The bulk of the medical records (85%) are held by this AHS and a smaller proportion by eight other AHSs in NSW. Despite these prior approvals, the process of gaining ethics approval from the eight AHSs was fraught with obstacles at every stage. After 8 months’ work, we have received approval from the HREC of each of the AHSs. Our experience has revealed many inconsistencies in the requirements of the HRECs in the different AHSs, as summarised in the Box 1. These inconsistencies highlight discordances with the guidelines to support researchers and HRECs drawn up by the National Health and Medical Research Council (NHMRC). The NHMRC’s National Statement on Ethical Conduct in Research Involving Humans1 clearly outlines that, once approval has been gained from one HREC, other sites should accept that approval. Unfortunately, it seems that the HRECs involved in giving approval for our study did not follow the guidelines relating to multicentre projects. Other researchers have reported similar problems. 2-4 Breen and Hacker2 suggest that HRECs are slow to adopt a simplified review process because this interferes with traditional practices of each committee making its own assessment. It is indisputable that ethics considerations are a vital component when undertaking human research. It is also crucial to have a reliable and trustworthy process that evaluates research proposals in order to protect participants from physical and psychological harm. However, it has taken the research midwife (who is on a 1-year non-renewable grant) 8 months to secure ethical approval at all sites. This process is cumbersome and counterintuitive to the principles and guidelines for multicentre research in this country. 1: Summary, by area health service (AHS, coded S to Z), of different requirements for gaining ethics approval for a multicentre study Area health service S T U V W X Y Z No. of pages of application form 19 20 19 20 12 23 2 11 No. of copies of form required 1 1 17 15 20 16 1 14 No. of hospitals in AHS covered by approval 2 2 4 1 3 5 3 5 Approval covered private hospitals in AHS also na na Yes No No na No na No. of contacts made (phone/letter/email) to gain approval 20 15 20 15 20 30 10 20 Time taken to gain approval 3 months 5 months 4.5 months 8 weeks 6 weeks 6 weeks 1 week 3 weeks Special requests during approval process A F A, B, C, E A A, D A G, H Approved after first submission Yes No No Yes Yes Yes Yes Yes na = not applicable. A = Asked for local researcher to be a contact person for the study. B = Charged a $33 fee to submit application. C = Requested scientific protocol with references. D = Requested budget form. E = Reviewed by scientific advisory committee before human research ethics committee (HREC). F = Requested consent and subject information forms. G = University HREC’s approval as well as approval of area health service HREC required. H = Final approval required from chief executive officer of major hospital in that AHS.
Lynne M Roberts · Lucy Bowyer · Caroline S Homer · Mark A Brown
Surveillance for Barrett’s oesophagus: if you do it, do it properly
Gautam Ramnath,* Peter Bampton† * Gastroenterology Registrar, † Head of Endoscopy, Department of Gastroenterology and Hepatology, Flinders Medical Centre, Bedford Park, SA 5042. peter.bamptonATflinders.edu.au To the Editor: Reflux oesophagitis is an increasingly common medical condition, and up to 10% of all patients with reflux oesophagitis have associated columnar-lined oesophagus, or Barrett’s oesophagus (Box 1).1 This is associated with an increased risk of adenocarcinoma in Australian data of 1 in 176 patient-years.2 Current surveillance guidelines for Barrett’s oesophagus recommend second-yearly endoscopy with quadrantic biopsies at 2–3 cm,3,4 although recent reviews have suggested that the time interval can be extended.1 No prospective study has demonstrated that screening for Barrett’s oesophagus improves survival in the screened population. All the evidence is based on retrospective reviews. If, however, screening is to be of benefit, then adequate tissue sampling is required, otherwise the screening test provides false reassurance and is a poor use of endoscopy resources. We retrospectively audited the endoscopies performed for Barrett’s oesophagus (with intestinal metaplasia) surveillance at our institution over 5 years (1996–2001). In this period, 253 endoscopies were performed as surveillance procedures for Barrett’s oesophagus. We reviewed the endoscopy and histopathology reports to determine whether an adequate number of biopsies had been taken. We found that quadrantic biopsies (defined as four biopsies per 2 cm or less) at every 2–3 cm were performed in 27 of 72 (38%) short-segment, 27 of 150 (25%) long-segment (3–10 cm), and 1 of 13 (8%) extensive (> 10 cm) Barrett’s oesophagus. An acceptable number of biopsies were taken from 40% of patients. The number of biopsies taken per centimetre of Barrett’s oesophagus was inversely proportional to the length of Barrett’s oesophagus. The median interval between surveillance procedures was 12 months. In most surveillance procedures (137/217; 63%) the endoscopy was performed following medical review in the outpatient department rather than because of planned call-back, although in only a few cases did it appear to be due to alarm symptoms such as dysphagia or weight loss. There was little consistency in recommendations among the medical staff. Only one cancer was identified through surveillance in this period, with another presenting in a patient previously on the call-back system who had been lost to follow-up. Three high-grade dysplasias were found. Our retrospective audit revealed that the endoscopists were not following biopsy guidelines, and revealed significant variances in practice. Previously, we found a similar picture with post-polypectomy surveillance; with re-education and development of a prospective review of all cases, we have been able to greatly improve this aspect of practice.5 We were surprised at the result of our audit, and invite other endoscopy units to perform a similar audit of their own practice. It has encouraged us to develop a process similar to the one we have adopted to improve post-polypectomy surveillance. This should improve our practice and enable more efficient utilisation of the endoscopy facility. 1: Barrett’s oesophagus
Gautam Ramnath · Peter Bampton
Lessons from early large-scale adoption of celecoxib and rofecoxib by Australian general practitioners
Mark R Nelson NHMRC Research Fellow, Department of Epidemiology and Preventive Medicine, Monash University, Commercial Road, Prahran, VIC 3181. mark.nelsonATmed.monash.edu.au To the Editor: The lessons from the introduction of COX-2-selective non-steroidal anti-inflammatory drugs (NSAIDs), related by Kerr et al,1 have a corollary in the introduction of angiotensin-II-receptor antagonists 2 years previously. Both cases involved common conditions (osteoarthritis and hypertension), with extensive prescribing of newly developed and marketed agents, which blocked an enzyme further down the cascade of reactions to avoid adverse outcomes — the gastrointestinal upset and bleeding associated with non-selective NSAIDs, and the cough and angioedema caused by angiotensin-converting enzyme inhibitors. In both conditions, off-patent, low-cost alternative drug therapies were available — paracetamol and acetylsalicylic acid, and thiazide diuretics and β-blockers, respectively. My quantitative investigation of general practitioners’ perceptions of newer versus older antihypertensive agents suggested that they thought newer agents were more efficacious, and were safer in the short term and long term, but were more expensive.2 These beliefs were held despite the lack of long-term safety data. Younger doctors were more likely to hold these beliefs. It is possible that the experience of using older medications permitted older doctors to maintain a healthy scepticism towards the marketing claims of medical representatives. It may be interesting for Kerr and colleagues to look at the demographics of GPs in the General Practice Research Network to see if these findings hold true for this cohort.
Mark R Nelson
Effect of computerised prescribing on use of antibiotics
Ian D Coombes,* Danielle A Stowasser,† Charles A Mitchell,‡ Paul Varghese§ * Leader, Adverse Drug Event Prevention Project, Queensland Health Medication Management Services, ‡ Associate Professor of Medicine, § Director of Geriatric Medicine, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102; †Manager, Queensland Health Medication Management Services, Royal Brisbane Hospital, Brisbane, QLD. Ian_coombesAThealth.qld.gov.au To the Editor: We would like to add our perspective to the discussion on computerised prescribing.1 Electronic prescribing with appropriate decision support is recognised by the Medication Safety Taskforce of the Australian Council for Safety and Quality in Health Care as a key initiative to prevent patient harm.2 Such systems reduce the opportunity for prescribing errors and improve patient safety.3 The widely espoused benefit of the clarity and legibility associated with electronic prescribing appears to have led many to assume that electronic prescribing is an essential component of medication safety systems whether or not it includes a decision support system. In fact, electronic prescribing without decision support has been associated with an increase in the incidence of error4 and inappropriate use of medications.1 A computer-generated discharge summary was developed at a tertiary referral teaching hospital in Brisbane. With this system, a discharge prescription was generated using information entered from the database by the medical officer. As part of standard practice, a pharmacist reviews all discharge prescriptions and compares them with the inpatient medication chart, discussing any apparent errors with the medical officer. We conducted an audit of 200 consecutive medical discharge prescriptions (100 generated by computer and 100 handwritten) in mid-2001. The errors detected are summarised in the Box. The same medical staff were responsible for both types of prescriptions. Significantly more errors in prescribing were noted for the computer-generated prescriptions than for the handwritten scripts (P < 0.001). The proportion of errors with potential for harm was similar in both groups. Three specific types of error occurred more frequently with electronic prescribing. We can speculate that dosing errors occurred when previous discharges were copied and the previous dose was continued, duration errors occurred as a result of a computer default to 10 days’ therapy, and the continuation of drugs not required for discharge resulted from copying previous medication records and not reviewing the current drugs prescribed. This uncontrolled observational audit demonstrated that electronic prescribing without decision support in busy medical wards can significantly increase the risk of patient harm when compared with the handwritten system. The discharge prescription component of this system was withdrawn on the basis of this audit, and the paper-based system reinstituted until a safer alternative becomes available. 1: Comparison of error rates with electronic and handwritten discharge prescribing systems Examples of prescribing errors Computer Handwritten Number of prescriptions 100 100 Number of drugs 700 605 Omissions Warfarin and irbesartan omitted 12 16 Duplications Spironolactone and atorvastatin duplicated 2 0 Dosing errors Prednisolone 50 mg in the morning for 10 days ordered: should have been reducing by 10 mg every second day 25 5 Drug errors Diltiazem oral 60 mg three times a day ordered: should have been diltiazem slow release 180 mg in the morning 4 4 Drug name unclear Fluticasone inhaler: no strength 6 0 Duration error Antibiotics intended for 3 or 5 days: ordered for 10 days (default quantity) 13 1 Drug not required on discharge Frusemide 80 mg twice daily was continued: the drug had been stopped during admission 15 4 Route error Glyceryl trinitrate 5 mg oral ordered: patch was the intended form of drug 3 0 Frequency error Carvedilol ordered for mornings: had been twice daily in hospital 1 0 Total number of errors 81 30 Error rate per item 11.6% 5.0%
Ian D Coombes · Danielle A Stowasser · Charles A Mitchell · Paul Varghese
Palliative care: new guidelines for psychosocial care
Jane Turner,* Brian McAvoy,† Karen Luxford,‡ Jane Fletcher§ * Senior Lecturer, Department of Psychiatry, University of Queensland, Herston, QLD; † Deputy Director, § Senior Project Officer, National Cancer Control Initiative, Carlton, VIC; ‡ Program Director, National Breast Cancer Centre, Camperdown, NSW. jane.turnerATuq.edu.au To the Editor: The Supplement on palliative care (15 Sep 2003) provided a welcome overview of this critical area of clinical practice. 1 Many of the articles emphasised the generalist nature of palliative care and the importance of multidisciplinary care and teamwork. Recently published guidelines2 now provide evidence-based information on psychosocial aspects of care for health professionals working in the field, as well as surgeons, radiation oncologists, medical oncologists, general practitioners, nurses, social workers, psychologists, psychiatrists, physiotherapists and occupational therapists. These are the world’s first comprehensive, evidence-based guidelines on the social, psychological and economic impacts of cancer and how these can be better prevented, managed and treated by health professionals. They cover the whole spectrum of cancer care, from diagnosis through to treatment and palliation. The guidelines are based on comprehensive and systematic reviews of the international research literature and an extensive consultative process to ensure their clinical relevance. Developed by the National Breast Cancer Centre and the National Cancer Control Initiative (NCCI) and funded by the Federal Government, the guidelines were approved by the National Health and Medical Research Council (NHMRC) in April 2003. The guidelines cover the most commonly occurring cancers: colorectal, breast, gynaecological, head-and-neck, lung, pancreatic, prostate and urogenital cancers, and melanoma and non-Hodgkin’s lymphoma. Recommendations for clinical practice are rated according to NHMRC levels of evidence.3 Four main areas are addressed by the guidelines: understanding the challenges of cancer and how people react; provision of care by the treatment team to all patients with cancer; referral for specialised care; issues requiring special consideration — culture, age, geography and sexual orientation. The guidelines were developed to assist health professionals in supporting adult cancer patients. This includes providing information and choice to patients, helping them deal with procedures and treatments, providing emotional and social support, ensuring continuity of care, and dealing with specific concerns that may arise, including anxiety and depression. The guidelines can be accessed at the NCCI’s website (www.ncci.org.au), or hard copies can be obtained from the National Breast Cancer Centre.
Jane Turner · Brian McAvoy · Karen Luxford · Jane Fletcher
Tissue plasminogen activator (tPA) for acute ischaemic stroke: why so much has been made of so little
David J Blacker Neurologist and Stroke Physician, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, WA 6009. davidblackermdAThotmail.com To the Editor: I respect the opinion of Hoffman1 and others who have recently expressed concerns about the use of tissue plasminogen activator (tPA) in patients with ischaemic stroke. However, it is critical that these views do not dampen the enthusiasm for better stroke treatments. The Therapeutic Goods Administration recently approved tPA for ischaemic stroke patients with symptoms of less than 3 hours’ duration. This approval has catalysed collaboration between stroke units around Australia and may provide benefits to patients who do not receive tPA, by improving clinical pathways, as well as a more coordinated approach to treatment. Internationally acclaimed Australian stroke experts have already rebutted the arguments of opponents of the National Institute of Neurological Disorders and Stroke (NINDS) trial, 2,3 and an independent reanalysis of the NINDS data showed tPA to be more effective than originally reported.4 It is time to stop bickering about the NINDS trial5 and move forward, by focusing on a collaborative effort between emergency departments and stroke teams. In the near future, there will surely be better data on new-generation thrombolytics and other agents; all will operate on similar “time is brain” protocols, as did the NINDS trial. Obviously, more data would be useful, but when clinicians are faced with patients with acute stroke today they must give the patients and their families the facts about tPA, regardless of their personal opinion. These are best expressed in terms of the absolute risk reduction for disability seen in the NINDs trial. It is interesting to note the widespread discomfort with the 6.4% risk of intracerebral haemorrhage (half of which were fatal) in this trial of a “medical” therapy. Surgeons quote similar morbidity and mortality risks every day to patients undergoing procedures such as coronary artery bypass grafting. Additionally, many surgical procedures became established on much less solid evidence than the NINDs trial, and yet there is no outcry. For example, many thousands of carotid endarterectomies were performed before the publication of controlled-trial data. In properly selected patients in expert hands, we now have a treatment that works. Its risks should not be underestimated, but should also be placed into context when compared with other powerful therapies for serious illnesses. Patients presenting with acute ischaemic stroke in Australia today have the chance to benefit from tPA, but future patients will benefit even more, partly because of the process that is being undertaken to institute pathways for using this drug.
David J Blacker
Tissue plasminogen activator (tPA) for acute ischaemic stroke: why so much has been made of so little
Jerome R Hoffman Professor of Medicine and Emergency Medicine, UCLA School of Medicine, Los Angeles, California, USA. jrhATucla.edu In reply: I agree with Blacker that enthusiasm generated by thrombolytic therapy could lead to benefit for stroke patients, independent of whether the therapy is actually useful, or even whether they receive it. However, I believe there are better ways to encourage rational stroke care. I also acknowledge that some experts believe thrombolysis is proven to be beneficial if used in accordance with NINDS (National Institute of Neurological Disorders and Stroke) guidelines. Others believe the question is not yet settled and are concerned that widespread adoption of the guidelines will lead to more harm than good. It is one thing to enthuse about possible benefits of a treatment, particularly for a devastating disease for which we have traditionally had little to offer. It is entirely different to embrace this therapy, even though it may be harmful overall, simply out of this frustration. I disagree with Blacker that the best way to inform patients about thrombolysis is “in terms of the absolute risk reduction for disability seen in the NINDS trial”. Regardless of concerns about the trial itself, it is always foolhardy to accept data from one small study as “the truth”. Many other trials have found far worse results — it would be equally inappropriate to base all estimates on their worst outcomes. Finally, there is strong evidence that, even if NINDS-like “success” could be achieved under optimal circumstances, routine use in the community might well lead to overall harm. I am also cautious about Blacker’s comparison of thrombolysis and some surgical procedures in terms of adverse effect rates. No single adverse effect rate is or is not acceptable for all interventions — a 90% rate of intracerebral haemorrhage could be acceptable in a disease with 100% mortality, while a 2% rate would be completely unacceptable in a disease with no long-term morbidity. Furthermore, the adoption of many surgical interventions in the absence of persuasive evidence does not justify repeating this mistake. Of course we must routinely make decisions without definitive evidence, based on our best estimates of benefits and harms. We should never take such decisions lightly, and should in general embrace the precautionary principle, which tells us not to adopt new therapies without reasonable evidence of their safety (especially when any benefit is likely to be extremely small). Although some advocates support thrombolysis based on current knowledge, my reading of available evidence is far less sanguine. That is why I continue to argue that this treatment should not be introduced into routine practice until far better evidence of its benefit outweighing its harm becomes available. Given the possibility that this treatment will harm stroke patients overall, and the likelihood that any potential benefit is very limited for the stroke population as a whole, I ask once again, why is so much being made of so little?
Jerome R Hoffman
Heart failure: how can we prevent the epidemic?
Matthew T Naughton,* Darren R Mansfield,* David M Kaye,† Peter Bergin,† Meroula Richardson† * Respiratory Physician, † Cardiologist, Alfred Hospital, PO Box 315, Prahran, VIC 3181. m.naughtonATalfred.org.au To the Editor: We were surprised that Campbell’s recent article on heart failure1 made no mention of sleep apnoea. This is despite the fact that about 50% of heart failure patients have sleep apnoea (either central or obstructive) and that quite a large body of literature now supports a causative relationship between obstructive sleep apnoea and congestive heart failure, supported by recent authoritative reviews. 2-4 Canine studies have shown that, in the absence of any other variable, obstructive sleep apnoea results in left ventricular systolic and diastolic dysfunction. Importantly, the impact of continuous positive airway pressure (CPAP) in acute cardiogenic pulmonary oedema and subacute pulmonary oedema (central sleep apnoea) and heart failure in the setting of obstructive sleep apnoea are not mentioned. Identification and treatment of sleep apnoea in people with heart failure is supported by a trial we have recently conducted in which significant improvements in quality of life and objective markers of cardiac function were seen in patients treated with nasal CPAP.5
Matthew T Naughton · Darren R Mansfield · David M Kaye · Peter Bergin · Meroula Richardson
Heart failure: how can we prevent the epidemic?
Duncan J Campbell Senior Research Fellow, St Vincent's Institute of Medical Research, 41 Victoria Parade, Fitzroy, VIC 3065. J. CampbellATmedicine.unimelb.edu.au In reply: I am grateful to Naughton and colleagues for their contribution to the debate about how we might prevent the epidemic of heart failure. I agree that both obstructive and central sleep apnoea are frequently associated with heart failure and that treatment of sleep apnoea can improve cardiac function. However, as indicated by its title, my article focused on how we might prevent heart failure. Central sleep apnoea in heart failure is usually the consequence of the heart failure.1 Heart failure may contribute to obstructive sleep apnoea as well,2 and obstructive sleep apnoea may, in turn, be an important contributor to heart failure pathogenesis. Epidemiological evidence links obesity with hypertension and obstructive sleep apnoea.3 Significant sleep apnoea is present in about 40% of obese people, and about 70% of people with obstructive sleep apnoea are obese.3 Obesity and obstructive sleep apnoea may each contribute to one another, and both may contribute to hypertension. The need to prevent obstructive sleep apnoea is an argument for more effective prevention of obesity. In addition to reducing its metabolic consequences, preventing obesity is likely to reduce the incidence of hypertension and obstructive sleep apnoea, and to thereby decrease the incidence of heart failure. For people with obstructive sleep apnoea not caused by obesity, alternative strategies will be required to prevent and treat the sleep apnoea and thus prevent its consequences.
Duncan J Campbell
Pet owners and risk factors in cardiovascular disease
Balakrishnan R Nair,* Brendan Flynn† * Director, † Medical Registrar, Division of Geriatric Medicine, John Hunter Hospital, New Lambton, NSW 2291. knairATmail.newcastle.edu.au To the Editor: We refer to the recent article by Parslow and Jorm1 and the editorial by Headey2 on the link between pet ownership and health outcomes. There is no evidence that pet ownership per se confers cardiovascular benefits. Indeed, the findings of the study were that pet owners were more likely to smoke, had a higher diastolic blood pressure and a higher body mass index than the non-pet owners. The editorial points out that, based on sociological studies, it is likely that pet ownership does have a positive effect on health, but the medical data demonstrating how this is achieved are lacking.2 Might there be other negative effects of pet ownership on health outcomes? A patient under our care recently demonstrated the potential risks involved in pet companionship for elderly people. An 81-year-old woman who was living independently was admitted after a fall caused by tripping over her delightful Himalayan Persian cat. Her presenting symptom was severe back pain exacerbated by weight bearing. However, no bony abnormality was identified. She had difficulty mobilising initially, and the outcome of her fall was significant morbidity with some loss of her previous mobility, even on discharge. She stayed in hospital for 12 days. A follow-up phone call revealed that the patient was still experiencing difficulty mobilising some 2 weeks after discharge. This case raises the possibility that the risks may outweigh the benefits of pet ownership in elderly people who are already at risk of falls. A MEDLINE search, using the terms elderly, trauma, cat, pet and fall (and combinations of these), did not reveal any relevant literature. A recent case report highlighted other cardiovascular issues relating to cat ownership.3 It described a patient who had recurrent episodes of syncope whenever her cat slept on the right side of her neck. The underlying mechanism was carotid sinus hypersensitivity. She required a single-lead ventricular pacemaker and for the cat to lie on her left side. Anecdotal evidence from colleagues highlighted the danger of “dogs taking elderly patients for walks”, resulting in rotator cuff injuries. Additionally, older patients with peripheral vascular disease and fragile skin have presented with non-healing ulcers from dog scratches. Pet ownership for the purpose of modifying cardiovascular risk factors would seem to be unwise in this population. However, the benefits of companionship and the pleasure derived from pets may outweigh the risk of falls for many elderly patients. Should we be doing more “cat scans” or “pet scans” in older patients?
Balakrishnan R Nair · Brendan Flynn
Pet owners and risk factors in cardiovascular disease
Michael McDonnell General Practitioner, and owner (with his wife) of Daisy and Cashew, 1/4 Mylne Street, Toowoomba, QLD 4350. To the Editor: Having read the article by Parslow and Jorm,1 I dashed to my surgery — praise the Lord, my diastolic blood pressure was 70 mmHg. So, I raced home again and reassured our labradors that they would not have to be shot. Let’s leave elderly pet owners and their blood pressures alone. Pet ownership is all about companionship, friendship, trust, care for your friend — the really important things in life — not your diastolic blood pressure!
Michael McDonnell
Obituary
Walter Monz MB BS(Hons)
Walter Monz was born in Boonah, in south-east Queensland, on 8 July 1914. He was educated at Brisbane Boys Grammar School, where he won a prestigious science prize. After completing the first year of the basic sciences course at the University of Queensland, he proceeded to the University of Sydney, where he graduated MB BS with Honours in 1939. (There was no medical school in Brisbane at the time.) Walter worked at the Brisbane General Hospital (now the Royal Brisbane Hospital) from 1940 to 1942, when he joined the Royal Australian Army Medical Corps. He was based on Thursday Island, where he worked at the 106th Australian Casualty Clearing Station of the Australian Imperial Force. He was also the Medical Officer to the Japanese prisoner-of-war camp on Thursday Island. Following demobilisation in 1945, Walter became a general practitioner in Goomeri, in south-east Queensland. In 1950, he set up a solo general practice in the Brisbane suburb of Yeronga, where he remained for the next 50 years, until severe osteoporosis forced him to retire in 2000. Walter was a Foundation Member of the Thoracic Society of Queensland (1945) and the Royal Australian College of General Practitioners (RACGP) (1958). He was also a life-long member of the Queensland Branch of the British Medical Association (later a branch of the Australian Medical Association). Walter was a skilled photographer and had a great interest and expertise in the area of audiovisual aids as an integral part of the Continuing Medical Education program. In 1968, he was elected Chairman of the Audio-Visual Aids Sub-Committee of the Medical Education Standing Committee of the Queensland Faculty of the RACGP. He was subsequently elected to the Queensland Faculty Board, and remained a Board member until 1986. Walter was a quiet, gentle, unassuming, and very private person. He died on 29 January 2003, aged 88 years, after a fall. He is survived by his daughters Pamela and Deirdre. Walter made generous bequests to the Queensland Faculty of the RACGP and St Andrew’s Lutheran Church on Wickham Terrace, Brisbane, with which his family had a long association. John A Comerford
John A Comerford
Book reviews
Ambitious guide to diagnostic tests
Pocket guide to diagnostic tests. Australian edition. Robert Dunstan, Diana Nicol, Stephen J McPhee, et al (editors). Sydney: McGraw-Hill, 2003 (viii + 488 pp). ISBN 0 074 710362. The concept of a pocket guide to assist clinicians in their choice of diagnostic tests is an excellent one — unfortunately, here, the authors have set themselves too ambitious a task. If they had limited themselves to common laboratory tests for common diseases they would have fulfilled their intent. This edition is described as "especially adapted for the Australasian market", but the adaptation is not comprehensive and the manual remains very North American in its perspective. In addition, where costs are mentioned, it is unclear whether they are quoting Australian dollars, and whether the costs are based on test performance or cost to the patient. The quantity and quality of the information varies widely. The chapter on basic principles and interpretation of test results provides sections on patient preparation, specimen collection and interfering factors, which are extremely useful. However, the section on reference intervals mars this chapter, as these are often population and method specific, and those in the book should only be used as a guide. Much of the remaining information is too detailed and technical to be of real use to busy clinicians. Many of the "common bedside laboratory procedures" described are not easily performed at the bedside. For example, the Gram stain for microbiological assessments and Wright stain for examination of the peripheral blood require considerable expertise both in performance and interpretation. At the same time, some common procedures which could be conducted under these circumstances, such as measuring blood glucose, cholesterol and haemoglobin levels, are not mentioned. Some instructions are clearly wrong — tubes should not be filled "completely", but rather to the specified level; and glass tubes are no longer used when measuring arterial blood gases. Also, no mention was made of evacuated blood sample containers, which are in almost universal use in Australia. Similarly, many of the examples of "commonly used laboratory tests" described in chapter three are not "common", and to label them as such is misleading and may lead to overordering. Several of the references in the "Comments" column in this chapter are too old to be useful, with some dating as far back as 1967, and many being from the 1980s. All references to blood banking quote the 13th edition of the Technical manual of the American blood banks, whereas the 14th edition is the current benchmark. Calculations for low-density lipoprotein (LDL) cholesterol are only given for conventional units, not for SI units, and the glucose tolerance test uses United States protocols and not World Health Organization or Australian guidelines. While there are many drawbacks in the chapter, many of the tests, together with interpretation and comments, are well presented and could be useful for reference purposes. The excellent introduction to therapeutic drug monitoring is clearly set out with all the requisite information, including half-life and requirements for dosage adjustment. There is microbiological information about "clinically important diseases", but again some very uncommon situations are described. The categorisation by body area is commendable and useful. The authors do make some helpful introductory comments relating to medical imaging in chapter six; however, this chapter is quite inadequate, with insufficient information to be of real value. For instance, indications for CT scan of the brain are restricted to intracranial or subdural haemorrhage, and there is no mention of space-occupying lesions, thrombotic events or hydrocephalus. There is no apparent correlation between chapters, as abdominal imaging makes no reference to imaging for diverticulitis, which is recommended in the microbiology chapter. The chapter on basic electrocardiography is more comprehensive and, overall, is useful. It could be the basis for an excellent small pocket guide in its own right. The final chapter provides algorithms, nomograms and tables and is a mixture of useful and less useful facts, figures, interpretations and recommendations. The layout is complicated and difficult to negotiate. In summary, this book cannot be recommended as a quick, reliable and easily portable reference for investigating clinical problems in the Australian setting. Eva RaikHaematologist Royal North Shore Hospital, St Leonards, NSW
Eva Raik
Special health care for gays and lesbians: a queer idea?
Caring for lesbian and gay people: a clinical guide. Allan Peterkin, Cathy Risdon. Toronto: University of Toronto Press, 2003 (xii + 378 pp). ISBN 0 8020 4857 9. One of the unintended consequences of the gay liberation movement of the seventies and beyond has been the myth that lesbians and gays are "bullet-proof". Evelyn Hooker's1 work from the 1950s is often misinterpreted to suggest that lesbians and gays are so mentally and physically robust that the effects of childhood parental disapproval, adolescent social exclusion and a lifetime of discrimination and victimisation just "bounce off". This was meant to leave us just as healthy as members of the advantaged mainstream. The notion of the "pink dollar" — which implies that all gay men (and, to a lesser extent, lesbians), despite widespread discrimination at work, are rich urban professionals with expensive cars — is another facet of this mythology. Peterkin is a psychiatrist and Risdon a family physician (an unfortunate term alienating to many gays and lesbians). They are part of a welcome movement that is dismantling this myth and recognising that lesbian, gay, bisexual and transgendered people, like members of other persecuted groups, may require special consideration in redressing the health consequences of social disadvantage. Their book is clinically practical, well researched and a reliable guidebook for the primary health care practitioner. It is inclusive of the issues of people who are multiply disadvantaged, although it betrays its North American origins in the section focusing specifically on the concerns of gay and lesbian Native Americans. This is only partially applicable to the care of gay Indigenous Australians. Bisexuals might find the book's title exclusive. The authors could also be criticised for uncritically accepting an "identity" view of sexual diversity that ignores the last 20 years of academic writing on "queer theory", and the social construction of homosexuality. Its main purpose, however, is a desktop guide for clinicians, which it does very well. Gary D RogersDirector, Health in Human Diversity Unit Department of General Practice University of Adelaide, SA 1. Dr Evelyn Hooker was an American psychiatrist who published the first empirical research to challenge the then prevailing psychiatric assumption that homosexuality was a mental illness. Her groundbreaking work ultimately led to the removal of "homosexuality" from the Diagnostic and Statistical Manual of Mental Disorders.
Gary D Rogers
Columns
In Other Journals
Wakley winners For the first time, two essayists have shared The Lancet’s Wakley Prize. The prize, named for Dr Thomas Wakley who founded The Lancet in 1823, is given annually for the best essay on a clinical topic of international health importance. Writing from the Antipodes, Dr Amanda Kvalsvig wrote of how being a deaf doctor has helped her determine how to (and how not to) respond to people with disabilities — without assumption or blithe reassurance, but rather by letting them "tell how it is". Remembering time spent in the Andes, Dr J Jaime Miranda recounted the stories of three patients battling tuberculosis. He asked: is it acceptable for money (or the lack of it) to draw the line between life and death? Lancet 2003; 362: 2038, 2079-2082. Arrests at the dentist’s Australian researchers say that if a patient has a cardiac arrest while in the dentist’s chair, the dentist should administer CPR with the patient lying flat in the dental chair rather than move them onto the floor. Their small study compared the effectiveness of CPR performed by three health professionals on a resuscitation mannikin lying supine on a dental chair with CPR on the mannikin when lying on the floor nearby; two types of chairs in three different settings were involved. CPR was effective in both positions; study participants reported that CPR was easier to perform with the mannikin in the chair (especially in a cramped setting). Aust Dent J 2003; 48: 244-247 Long-life partnerships The Swiss HIV Cohort Study Group has reported that in patients with HIV receiving highly active antiretroviral therapy (HAART) those with a stable partner have a slower rate of disease progression to AIDS or death. Conversely, HIV-positive patients without a stable partner may be expected to progress more rapidly through clinical latency. The link between partnership status and disease progression was shown at all stages of disease, from early to advanced. BMJ 2004; 328: 15-18 The first time Compared with previous generations, today’s young Australians are not only younger at the time of their first experience of sexual intercourse they are also more likely to use contraception, including condoms. This augurs well for their future health and social wellbeing, say Boyle and colleagues. They surveyed nearly 1800 people across Australia aged 18-59 years, asking about early heterosexual experiences. Among other findings, women in the youngest age group were more likely than women in the oldest age group to have had first sex with a non-steady partner (about 30% compared with 15%). Both women and men were now much less likely to have had sex for the first time with a marriage partner (23% v 3% for women and 12% v 1% for men). Int J STD AIDS 2003; 14: 745-752 Chest pain belief challenged Do you share the common belief that acute chest pain relieved by glyceryl trinitrate is probably due to active coronary artery disease? US researchers would have us dispel this notion: in a study of 459 patients admitted with chest pain who received 400 mg of spray or sublingual nitroglycerin, relief from pain at 5 minutes after the first dose of this treatment did not predict active coronary artery disease.1 Further, at 4 months after admission, clinical outcomes were similar whether or not patients had responded to glyceryl trinitrate. Although an editorialist agreed that nitrate responsiveness is not helpful in diagnosing the cause of acute chest pain, he maintained that it has a place in diagnosing chronic stable chest pain.2 1. Ann Intern Med 2003; 139: 979-986 2. Ann Intern Med 2003; 139: 1036-1037 Doctoring nursery rhymes In recent years, some traditional fairy tales have come under fire for being politically incorrect. Now, Canadian authors have raised concerns about the medically inaccurate, or at least inadequate, nature of nursery rhymes. Giles and Shea critically appraised six rhymes in which head injury was mentioned, including "Humpty Dumpty", "Jack and Jill" and "Ring around the Rosie". All fell far short of best practice in terms of responding to injury appropriately, seeking a medical opinion, giving a clear history and using precise medical terminology. For example, the authors questioned whether "all the king’s horses and all the king’s men" were capable of launching an appropriate medical intervention after Mr Dumpty’s unfortunate accident. In an attempt to remedy this "sad situation", the authors present a new, medically sound nursery rhyme about Little Johnny’s head injury, featuring a neurosurgeon, no less! CMAJ 2003; 169: 1294-1296 — Dr Ann Gregory, MJA
Ann Gregory
Managing allegations of scientific misconduct and fraud: lessons from the “Hall affair”
Martin B Van Der Weyden MD, FRACP, FRCPA
Health and foreign policy: moving forward with greater focus
Anthony B Zwi MB BCh, P hD, FFPHM · John Wyn Owen CB, MA(Camb) · Alan Ingram MA, PhD
Globalisation: what is it and how does it affect health?
Kelley Lee MPA, MA, DPhil
The specialist consumer
Martin B Van Der Weyden
Doing better with cancer in adolescents and young adults
Catherine H Cole FRACP, FRCPA
Metformin and serious adverse effects
Janelle C Nisbet MB BS · Joanna M Sturtevant BPharm, BSc · Johannes B Prins PhD, FRACP