Volume 188 Issue 8

How to safeguard academic integrity when working with Australian governments A recent study revealed that Australian governments regularly suppress embarrassing information by hindering public health research or publication of its findings (Box 1).1 The results resonate with concerns raised in the Report of the independent audit into the state of free speech in Australia.2 Two issues of immediate relevance to Journal readers are the protection of academic independence, and the crucial role of objective evidence in improving outcomes of the Australian health system. Editors of medical journals have rightly opposed contracts with sponsors (such as pharmaceutical companies) that deny researchers the rights to work independently and publish results without the sponsor’s consent.3 While emphasis has been placed on funding support, the same objections apply to conditions imposed by government agencies for data access and representation on research teams. Public health and health services researchers are too often presented with pro-forma contracts for data access or commissioned research funding, on a “take it or leave it” basis, with contractual terms that give the agency a right of veto over publications. Strong institutional guidance is needed to clarify that such contracts can lead to severe publication bias, as evidenced by the Australian suppression study1 and overseas research.4 These contracts are therefore anathema to academic independence. The Australian Code for the Responsible Conduct of Research5 is inconsistent on this point and should be amended in line with the position of the International Committee of Medical Journal Editors (ICMJE).1,3 Incorporating this view is important, because results of public health and health services research are published in a wide range of non-medical and technical media, in addition to medical journals. This is not to say that academic researchers should never undertake research that is strictly for internal use within a government agency. From the outset, research should be either for internal or public consumption; it should not be for public consumption only when the results place the government in a favourable light. The latter creates a conspiracy that will eventually erode the public’s trust in the integrity of researchers and their employing academic institutions. An ethical approach, consistent with the standpoint of the ICMJE, would be to allow government agencies the right to comment on a draft report within a defined period of 30–60 days.3 This will often enhance the quality of the final report by unearthing additional facts that can affect interpretation. It also provides the government agency with a head start on an appropriate response. This would be a constructive process, given that the purpose of public health research is usually for the public to benefit from better informed government decisions. Smith-Merry and colleagues have bemoaned the impediments to a flourishing research culture in Australian health policy circles.6 Moves now afoot through the National Collaborative Research Infrastructure Strategy7 to develop population health and clinical data linkage stand to strengthen the evidence base for a more informed national health policy debate. However, the development of better national health information platforms will fall short of expectations unless careful attention is paid to the rules of engagement between government departments (as the main sources of health data) and researchers (as the major users).1 Key areas where interventions are needed to safeguard academic integrity are shown in Box 2. The challenges ahead will be familiar to leaders of the medical profession who have struggled to introduce adverse incident reporting and other quality assurance programs, with admirable, even if incomplete, degrees of success. The champions of clinical quality and safety have faced up to the suppression of health information at a more local level and have overcome the barriers of cynicism, fear and the cycle of blame.8,9 Analogous tensions exist when researchers work with governments, although a fear of tortious liability is then paralleled by concerns that government agencies and their ministers will be pilloried in the media when a researcher exposes a new health problem. What can we learn from successful clinical quality assurance programs that will reduce the desire of governments to suppress health information and increase their commitment to evidence-based decision making? The answer lies in a complex, gradual, yet not unattainable “culture change”. The existing culture of governmental health decision making needs to change, and there are three steps involved. The first step is to realise that the amount of independent academic research has no net effect on the quantity of bad press that the health system receives. There is an endless supply of anecdotal material for headline stories on the “health care crisis”, which will continue regardless of whether or not public health and health services researchers are suppressed. The second step is to appreciate that there is political mileage (the equivalent of a clinical profession’s credibility) to be gained by supporting ideals and principles that are morally strong — academic independence, a commitment to truth and honesty, and a desire to learn and improve. The third step — the threshold step — is to implement lasting changes to the culture through strong leadership. Unlike the avoidance of publication bias, culture change requires more than adherence to a code of practice. It is also the product of communicating and doggedly enacting a compelling vision. This is most easily achieved when led from the top. Prime Minister Rudd has promised new freedom-of-information laws and a “pro-disclosure” attitude among government and public service staff.10 Senator Carr, Minister for Innovation, Industry, Science and Research, has taken steps to strengthen the independence of the Australian Research Council because “research is not a political plaything to be toyed with at the whim of the Government”.11 These are encouraging signs. The proof of leadership is now to turn the rhetoric into reality, so that an open culture becomes the established norm. 1 Key results of A survey of suppression of public health information by Australian governments1 A national survey of 302 public health academics at 17 Australian universities was conducted in August 2006. They reported 142 witnessed suppression events, including 85 separate instances where 64 respondents (21%) had their own research affected. Suppression took place where a government agency that provided data or commissioned the research put conditions on the release of the results, or where government employees were part of the research team and were restricted in what they could do. Governments most commonly suppressed research by sanitising the results or by delaying or prohibiting the publication of results (66% of events), but no part of the research process was unaffected. In 48% of cases, the affected researchers believed their work was targeted for suppression because it drew attention to failings in health services. Another 26% of cases related to the health status of a vulnerable group (such as Indigenous Australians, refugees or people with mental illness), while in a further 11% the research had pointed to an environmental harm. In 87% of instances, the government agency succeeded, leaving the public uninformed or giving it a false impression. 2 Interventions to safeguard academic integrity when working with governments Public awareness of the issue and its importance Guidelines for managing conflict of interest in the public service Guidelines for avoiding result-dependent publication in academia Mandatory statements by authors that works have not been subject to a right of veto by government Agreements between government and academic bodies that support researcher independence Independent mechanisms to resolve complaints about suppression of health research Best-practice models of synergistic partnerships between government and academic bodies Organisational values that avoid blame and welcome constructive criticism Inclusion of oversight of government–researcher relations in the role of institutional ethics committees Publicly reported surveillance systems to monitor suppression events

C D’Arcy J Holman MB BS, PhD, FAFPHM

The problems are already well known; what we need are solutions and health care reform The New South Wales Government has announced another investigation into the health care system. This latest inquiry was triggered by the Deputy State Coroner, Carl Milovanovich, who called for a “full and open inquiry into the delivery of health services in NSW”.1 The stimulus for this call was his review of the case of 16-year-old Vanessa Anderson, who died after being admitted to Sydney’s Royal North Shore Hospital. Although mooted to be broader in scope, this inquiry swiftly follows an external review2 and a parliamentary inquiry3 into another patient mishap at the same hospital. In this issue of the Journal, Joseph and Hunyor, two of the Royal North Shore Hospital clinicians who gave evidence at the parliamentary inquiry, provide a first-hand account of the inquiry process and argue the case for clinicians’ active involvement in health care reform (→ The Royal North Shore Hospital inquiry: an analysis of the recommendations and the implications for quality and safety in Australian public hospitals).4 This most recent examination of the health system is yet another in a series of investigations in NSW, reaching back to the Chelmsford Inquiry into deep-sleep treatment between 1988 and 1990,5 and, more recently, to the reviews into Camden and Campbelltown Hospitals, where, earlier this decade, aggrieved whistleblowers asserted that the quality of care was poor.6 That grievance was subject to a Health Care Complaints Commission inquiry,7 the Walker Special Commission of Inquiry8 and several Independent Commission Against Corruption investigations.9 This multiplying effect suggests that inquiries seem to have a way of taking on a life of their own. In the Anderson case, the coroner found that the young woman’s death was due to the depressant effects of opiate medications, which led to respiratory failure. These medications were given as a result of a combination of factors at the hospital, including a lack of communication, poor management, staff inexperience, and poor record-keeping.10 Will another inquiry identify additional systemic problems of which we are not already aware? The answer, the evidence suggests, is no. Our research shows that patient safety inquiries across the world consistently identify the same recurring problems as the cause of iatrogenia: health care below promulgated standards; lack of quality-monitoring processes; patients, family members and concerned staff being ignored and excluded; whistleblowers being vilified; and persistent deficiencies in teamwork, systems and communication.11 If the problems are well known, what is the actual purpose of another inquiry? Peay, reviewing the role of inquiries after homicides committed by psychiatric patients, found that inquiries generally serve four functions: learning, discipline, catharsis and reassurance.12 The learning function incorporates understanding the determinants of problems, as well as learning about solutions. The catharsis and reassurance elements appear self-evident. Announcing an inquiry serves as a way of regaining public confidence that the issue will be investigated in an open manner, and that witnesses, including patients, the community and staff, might be considered as important stakeholders, not only in compiling the evidence but in any activities leading to reform, or even healing, of the health system. As for discipline, inquiries of the type recently announced are generally more concerned with establishing broad principles of system reform than with disciplining individuals, which is most often left to the courts and professional bodies.12 In theory, the discipline function of an inquiry is intended to ensure that the government and relevant department are held accountable not only for inquiry processes, but for implementing recommendations. In practice, however, implementing recommendations is not necessarily a straightforward task that will result in the desired outcome. Two fundamental questions need to be considered before naïvely assuming the government will implement inquiry recommendations. First, is it possible and appropriate to implement the recommendations? Taking the commonly cited issue of deficiencies in teamwork as an example, how does one begin to break down barriers to the way people work together? Who is primarily responsible for addressing deficiencies in teamwork: universities, governments, hospitals or professional groups? Second, what evidence is there to say that implementing the recommendations will improve the quality of patient care? The answer to this invariably requires significant research, thought and expertise. As soon as this latest inquiry was announced, the state Liberal Opposition argued on the front page of the Sydney Morning Herald for a Royal (rather than Special) Commission, as this, it was asserted, would have greater powers to “overhaul” the system.1 There is no doubt that an inquiry can result in an overhauling. The Walker Inquiry was at least partially responsible for the restructuring of the whole NSW Health system, which took years to accomplish and is still not “bedded down”. However, in the aftermath of that restructuring, there is no clear evidence that the number of errors is decreasing across the NSW Health system, nor that restructuring health systems will contribute to a reduction in errors13 — nor that inquiries will, either. The latest inquiry will provide a space for the witnessing of the experiences of patients and staff. It has already begun to fill the newspapers and nightly news slots with interest stories. It will also seek to identify systemic and institutional issues affecting the delivery of health care in NSW.14 Explaining why things went wrong seems to be the underlying purpose of inquiries. Identifying solutions to these problems and undertaking health care reform that results in improved quality of patient care — in other words, actively learning from what occurred — is a separate and undoubtedly more difficult issue. Too often, these fundamentally important tasks are left untouched by the ever-growing number of inquiries.

Joanne F Travaglia MEd · Jane E Lloyd BAppSc, MPH · Jeffrey Braithwaite PhD

Naltrexone implants have not been subject to the usual rigorous scrutiny required for new devices in Australia, but are widely used through the Special Access Scheme In this issue of the Journal, Lintzeris and colleagues report eight patients with naltrexone implants who developed serious medical complications considered to be related to the implant (→ Unplanned admissions to two Sydney public hospitals after naltrexone implants).1 Intuitively, naltrexone is an attractive treatment for opioid dependence, as it is inexpensive, long-acting and generally well tolerated, and blocks the actions of heroin when taken orally. However, empirical support for naltrexone has been unimpressive,2-4 with research showing that poor adherence to treatment limits its effectiveness. An Australian study found that, while patients who adhered to treatment did well, only 2% were still taking the drug 3 months after conventional inpatient detoxification.5 Naltrexone was registered by the Therapeutic Goods Administration (TGA) in 1998 as “an aid in the maintenance of previously opiate-dependent patients who have ceased the use of opioids”.6 However, the Pharmaceutical Benefits Advisory Committee twice rejected applications for the inclusion of naltrexone in the Pharmaceutical Benefits Scheme as a treatment for opioid dependence on the grounds of lack of evidence of efficacy. Controversy over efficacy was followed by growing doubts about naltrexone’s safety. Intermittent naltrexone consumption lowers opioid tolerance, thereby increasing the risk of heroin overdose. An Australian study found the death rate for those leaving naltrexone treatment was eight times that recorded among participants leaving treatment with agonists such as methadone or buprenorphine.7 As the weakness of the case for oral naltrexone became clearer, a range of interventions were developed to overcome the inherent problems of treatment initiation and poor adherence. The publication in 1997 of an article entitled “I woke up . . . cured of heroin” in a popular Australian magazine8 sparked intense community and political interest in the initiation of naltrexone treatment during general anaesthesia or heavy sedation, followed by oral administration. This was said to be a novel, dramatically effective treatment for heroin dependence. However, subsequent evaluation showed that these approaches increased the cost of oral naltrexone without increasing efficacy.9 More recently, depot injections10 and implants of naltrexone have become the focus of public and political hope. In this historical context, it is concerning that the recent research on naltrexone implants in Australia has not followed usual scientific processes. In particular, naltrexone implants have not been subject to the usual rigorous scrutiny required for new drug products seeking registration in this country. Nevertheless, they are available through the TGA Special Access Scheme; there is no requirement for TGA approval for access to unapproved goods in Australia for Category A patients under this Scheme, and no apparent requirement for collection of efficacy or safety data. Supporters of the naltrexone implant have argued that heroin injectors meet the criteria for Category A patients under the Scheme as “persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment”.11 Most Category A patients have malignant conditions or rare life-threatening diseases. The annual mortality of heroin injectors is in the order of 1%12 — almost 15 times higher than expected for persons of the same age and sex with no history of heroin use, but hardly in the range generally considered appropriate for the Special Access Scheme. But the inclusion of naltrexone implants in the Scheme and their widespread use (reportedly by more than 1500 individuals) means the product has achieved a substantial market while not undergoing the rigorous evaluation usually applied to drugs before registration. Some of the implants used in Australia are produced locally, while others are manufactured overseas. There are doubts about the quality of manufacture, as well as deficiencies in the safety and efficacy data. As far as we are aware, no major national drug regulatory authority has licensed naltrexone implants for management of opioid misuse. However, a depot injection of naltrexone has been approved by the Food and Drug Administration in the United States, but only for alcohol, not opioid, dependence.10 Although the effectiveness, safety and cost-effectiveness of methadone and buprenorphine treatments for heroin dependence are supported by substantial and compelling evidence, a greater range of pharmacological treatments suited to the broad range of individual patients is required. A recent randomised controlled study of depot naltrexone for the treatment of opioid dependence had encouraging results.13 The strong theoretical rationale for the usefulness of naltrexone in treating heroin dependence justifies further rigorous investigations. However, the uncontrolled use of unregistered products of uncertain quality hampers the development of proper clinical trials. Since the thalidomide disaster in the 1960s, all new medications introduced into Australia have been regarded as ineffective and unsafe until proven otherwise. Constant vigilance is required to ensure that only new medications and devices of proven effectiveness and safety are permitted widespread use. The disturbing suggestions of mortality and morbidity from unregistered naltrexone implants make a strong case for an independent review to determine whether this treatment is sufficiently safe for such widespread use. This review should also assess whether the TGA Special Access Scheme has been used to circumvent the requirement for rigorous assessment of the quality, safety and efficacy of naltrexone implants. This assessment is the cornerstone of a drug regulatory system designed to protect the public from ineffective and unsafe medicines. The TGA has the power under the Therapeutic Goods Act 1989 (Cwlth) (s. 31A(2) and s. 41JD) to seek clarification of the Category A classification of patients, and should do so urgently regarding access to unapproved naltrexone products in Australia.

Alex D Wodak FRACP · Robert Ali FAChAM · David Henry FRCP(Edin) · Lloyd Sansom AO, PhD

Objective: To describe hospital presentations related to the use of naltrexone implants, an unlicensed product used in Australia for treating heroin dependence.Design: Retrospective case file audit.Setting: Two Sydney teaching hospitals.Patients: Identified through referrals to Drug and Alcohol Consultation–Liaison services over a 12-month period, August 2006 to July 2007.Main outcome measures: Diagnosis, management and duration of admission.Results: Twelve cases were identified: eight were definitely or probably related to naltrexone implants or the implantation procedure (rapid detoxification). Of these, six patients had severe opiate withdrawal and dehydration, with an average hospital stay of 2.3 days. One patient had an infection at the implant site, and one an underlying anxiety disorder requiring psychiatric admission. Three patients had analgesia complications, and one had unrelated cardiac arrhythmia.Conclusions: These severe adverse events challenge the notion that naltrexone implants are a safe procedure and suggest a need for careful case selection and clinical management, and for closer regulatory monitoring to protect this marginalised and vulnerable population.

Nicholas Lintzeris MB BS, PhD · Soung Lee BN · Lucinda Scopelliti BN · James Mabbutt BN, MPH · Paul S Haber MB BS, PhD

Objective: To determine the incidence of lactic acidosis in community-based patients with type 2 diabetes, with special reference to metformin therapy.Design: Substudy within a longitudinal observational study, the Fremantle Diabetes Study (FDS).Participants and setting: 1279 patients from a postcode-defined population of 120 097 people in Western Australia.Main outcome measures: Confirmed hospitalisation with lactic acidosis identified through the WA Data Linkage System during two periods: (1) from study entry, between 1993 and 1996, and study close in November 2001; and (2) from study entry to 30 June 2006.Results: At entry, 33.3% of patients were metformin-treated, and 23.1% of these had one or more contraindications to metformin (55.1% and 38.0%, respectively, after 5 years’ follow-up). Five confirmed cases of lactic acidosis were identified during 12 466 patient-years of observation; all had at least one other potential cause, such as cardiogenic shock or renal failure. From study entry to close, the incidence was 0/100 000 patient-years in both metformin-treated and non-metformin-treated patients. Between study entry and 30 June 2006, incidence was 57/100 000 patient-years (95% CI, 12–168) in metformin-treated patients and 28/100 000 patient-years (95% CI, 3–100) in the non-metformin-treated group, an incidence rate difference of – 30 (– 105 to 46) (P = 0.4).Conclusion: The incidence of lactic acidosis in patients with type 2 diabetes is low but increases with age and duration of diabetes, as cardiovascular and renal causes become more prevalent. Metformin does not increase the risk of lactic acidosis, even when other recognised precipitants are present.

Niklaus Kamber MD · Wendy A Davis MPH, PhD · David G Bruce MD, FRACP · Timothy M E Davis MRCP, DPhil, FRACP

Objective: To compare attitudes and practices of Australian medical practitioners, by specialty, to a range of medical decisions at the end of life.Design, setting and participants: As part of an international study, in 2003, a structured questionnaire was mailed to 2964 medical practitioners drawn from membership registers of Australian and Australasian professional colleges. Data from 1478 questionnaires were statistically analysed using validated instruments.Main outcome measures: Practitioners’ willingness to comply with requests from patients and/or their relatives for symptom relief which might also hasten death; provision of terminal sedation and euthanasia, or willingness to provide these on their own initiative.Results: Respondents reported being much more willing to comply with a patient’s request for increasing symptom relief, even at risk of hastening death, than for terminal sedation. Over a quarter of respondents would provide terminal sedation to competent patients on their own initiative. A small number of respondents would intentionally hasten death. There were significant differences by specialty for all three actions. Oncologists, palliative care physicians and geriatricians were least likely to actively hasten death, and more likely to act unilaterally to relieve symptoms as a medical necessity.Conclusions: Perceptions about the causation of death and aspects of medical culture appear to influence physicians’ attitudes towards medical decisions at the end of life. Our findings have implications for medical education, interprofessional communication and discussion between the medical profession and the community.

Malcolm H Parker MLitt, LLM, FACLM · Colleen M Cartwright PhD, MPH, BSocWk(Hons) · Gail M Williams PhD, MSc, MSc(Epidem)

Objective: To determine agreement between diagnoses and management plans made during an initial videoconference appointment and subsequent face-to-face consultations in paediatric ear, nose and throat (ENT) surgery.Design and setting and participants: A paediatric ENT clinic servicing patients from Bundaberg, Queensland, was conducted through the Centre for Online Health at the Royal Children’s Hospital (RCH) in Brisbane. Between January 2004 and February 2006, 152 consultations with 97 patients were carried out. We retrospectively audited patients’ charts to compare the diagnosis and management plan formulated at the initial videoconference and the eventual diagnosis and surgical management after face-to-face consultation. The clinical outcomes for children who were not recommended for surgery at the RCH were ascertained by telephone survey.Main outcome measures: Agreement between videoconference and face-to-face consultation findings.Results: Of the 97 patients, 75 were recommended for surgical management at the RCH. The remaining patients were either referred back to their general practitioner (9), followed up by the regional paediatrician (10) or lost to follow-up (3). At the conclusion of the study, seven patients were still awaiting surgery and were excluded. Among the 68 patients seen via videoconference and in person, the recorded diagnosis was the same in 99% of cases (67). Surgical management decisions were the same in 93% of cases (63). Telephone follow-up with paediatricians and GPs confirmed that there were no missed diagnoses or ongoing ENT-related problems in the 19 patients referred back to their care.Conclusions: Decisions about ENT surgical interventions for children assessed during videoconference clinics are in close agreement with decisions made by the same surgeon at face-to-face consultation. The way is open to employ telemedicine more widely for pre-admission ENT assessment. However, as in any telemedicine work, widespread application requires care.

Anthony C Smith MEd, BN, PhD · Samuel Dowthwaite BBiomedSc, MB BS · Julie Agnew MB BS(Hons), FRACS · Richard Wootton PhD, DSc

In 1997, the University of Sydney replaced its undergraduate medical course with a new 4-year graduate medical program. The course was reaccredited by the Australian Medical Council (AMC) in 2005. Suggestions for further development by the AMC led to a comprehensive review of the course, commencing in July 2006. This article describes the review process and outlines key recommendations that came out of the review that have been or are being implemented.

Kerry J Goulston MD, FRACP · R Kim Oates MD, DSc, FRACP

The need for consistency in assessing international medical graduates for work in Australia led the Council of Australian Governments, in 2006, to direct health ministers to implement a nationally consistent approach. An Implementation Committee was established in late 2006 to oversee the development of the new assessment process; the first steps were completed by July 2007 and further development will occur over the next 12 months. The pre-existing Australian Medical Council (AMC) examination pathway will continue to be available, and there will be two additional pathways for non-specialists. The pre-existing pathway for specialists is being revised. Elements that are being introduced include: standardised pre-employment assessment, including an off-shore screening examination; assessment of competence against a standardised position description and, if necessary, a structured clinical interview by an AMC-accredited provider before obtaining limited registration; orientation to the job, the Australian health care system and to communication and cultural issues; standardised supervision and supervisory reporting; a requirement for compulsory continuing professional development for reregistration; workplace-based assessment; assessment by an AMC-accredited provider before gaining full registration; and consistency of assessment for specialists by specialist colleges. Some elements have been operating in some jurisdictions from July 2007, and there is a commitment to full implementation in participating jurisdictions by July 2008.

on behalf of the Implementation and Technical Committees, under the auspices of the Australian Health Ministers’ Advisory Council

In October 2007, the New South Wales Parliament appointed a Joint Select Committee to inquire into the quality of patient care at Royal North Shore Hospital (RNSH). The inquiry was initiated in response to the publicity and complaints surrounding a patient who had a miscarriage in the toilets of the RNSH emergency department waiting area. The Committee held four public hearings and received 103 submissions. It handed down 45 recommendations in its report on 20 December 2007. There has been criticism from clinicians and others that the recommendations are too general and will not effect significant change for the severe systemic problems affecting the hospital. This article represents the view of some of the clinicians who work at RNSH, and who gave evidence at the inquiry, on the recommendations and some possible solutions for the health system in general.

Anthony P Joseph MB BS, FACEM, MRCP · Stephen N Hunyor MB BS, FRACP, MD

Objective: To investigate current use of Australian snake antivenoms and the frequency and severity of immediate-type hypersensitivity reactions.Design: Nested prospective cohort study as part of the Australian Snakebite Project.Patients and setting: Patients receiving snake antivenom in Australian hospitals between 1 January 2002 and 30 November 2007.Main outcome measures: The use of CSL Limited antivenom; frequency and severity of hypersensitivity reactions to antivenom; premedication and treatment of these reactions.Results: Snake antivenom was administered to 195 patients, mostly for venom-induced consumption coagulopathy (145 patients, 74%), followed by non-specific systemic effects (12%), neurotoxicity (5%) and myotoxicity (4%). Antivenom was given to nine patients (5%) without evidence of envenoming or who were bitten by a species of snake for which antivenom is not required. The commonest antivenoms used were brown snake (46%), tiger snake (30%) and polyvalent (11%). The median dose was four vials (interquartile range, 2–5 vials), and 24 patients received two different types of antivenom. Immediate-type hypersensitivity reactions occurred in 48 patients (25%); 21 satisfied our definition of anaphylaxis, with 11 moderate and 10 severe cases, including nine in which patients were hypotensive. The remaining 27 reactions were mild (skin only). Adrenaline was used in 26 cases with good effect. The frequency of reactions to tiger snake (41%) and polyvalent (41%) antivenoms was higher than that to brown snake antivenom (10%). Hypersensitivity reactions occurred in 11 of 40 patients receiving any form of premedication (28%) and in 2 of 11 given adrenaline for premedication (18%) versus 20 of 86 not receiving premedication (23%).Conclusions: Antivenom was used appropriately, and most commonly for coagulopathy. Hypersensitivity reactions were common, but most were not severe. The discretionary use of premedication was not associated with any reduction in reactions.

Geoffrey K Isbister BSc, FACEM, MD · Simon G Brown MB BS, FACEM, PhD · Ellen MacDonald · Julian White MB BS, MD · Bart J Currie MB BS, FRACP

There is a heavy burden of disease associated with family violence, discrimination, bullying and social exclusion. These important causes of suffering and loss of productivity all relate to a very fundamental feature of human existence and civil(ised) societies — the way we treat each other. We can, and do, make each other sick. Reducing the resultant human and economic costs has major implications for the way we distribute opportunity, wealth and amenity. These, in turn, have implications for the way we protect and empower minority groups, and for legislation, education and the availability of, and access to, services.

Rob Moodie FRACGP, FAFPHM, MPH

Eight children suffered drowning or near-drowning in Sydney pools over an 11-day period in January 2007. Four received basic life support (BLS) within 5 minutes of immersion and survived with good functional neurological outcomes. The other four were not discovered for ≥ 5 minutes and all died. This cluster serves as a reminder that timely effective bystander BLS is crucial to survival and good clinical outcomes in near-drowning episodes. Clinical recordDuring an 11-day period in January 2007, eight children presented to several emergency departments in the Sydney metropolitan region after a drowning or near-drowning event. While these incidents are known to be more common in summer, it is relatively uncommon to have such a cluster of cases occurring within a short period of time. We retrospectively obtained information on these patients from clinical documentation of the hospitals involved, including ambulance run-sheets, hospital medical records, and coroner’s reports. Details of the patients are shown in Box 1. Seven of the children were from western Sydney, while the other child presented to a hospital in North Sydney. Six were girls and two were boys, with ages ranging from 1.5 to 6 years. In all cases, the children had not been adequately supervised. In seven cases, the approximate period of time for which the child had been unaccounted could be determined from the records. This time ranged from about 1 minute to 20 minutes. Seven of the events occurred in backyard residential swimming pools and the other in a public pool. Three episodes occurred while children were visiting relatives; these children all drowned. Four children had a period unaccounted for of < 5 minutes. Timely effective basic life support (BLS) (defined as adequate ventilation and/or chest compression administered within 5 minutes of non-breathing1) was performed on each of these children by either their parent or a bystander. One patient regained consciousness and BLS was ceased. All four children survived without any neurological deficits. Of the other four children, three had a period unaccounted for of ≥ 5 minutes and one for an unknown time, estimated by the paramedics at the scene to be about 10–20 minutes. BLS was attempted on only one of these four patients. Two of these children died in the emergency department, and the other two had intensive care support withdrawn due to brain death. DiscussionOver the past 10 years, there has been a significant reduction in the number of drowning and near-drowning events in children.2 Several factors have contributed to this decrease, including community education programs alerting parents to the importance of supervising their children; legislation to place fences around backyard swimming pools, and efforts to teach effective BLS in the community.3-5 However, evidence is lacking of good compliance with these preventive measures, particularly backyard pool fencing,6 highlighting the need to continually stress water safety messages to parents. In addition, a recent paradigm shift in resuscitation guidelines, coupled with differences in interpretation of the new guidelines by various resuscitation authorities, has led to confusion among lay rescuers and clouded the key messages that should be delivered to the public.7,8 It is recommended that the guidelines published by the Australian Resuscitation Council should be followed (Box 2).7 Of the eight patients reported here, four received timely effective bystander BLS and had a good clinical outcome. For the other four children, BLS was attempted late or not at all. It is possible that the prognosis of these four children would not have been good even with BLS, given their probable long duration of immersion. Even for children with a period unaccounted for of < 5 minutes, the likelihood of neurological damage increases if effective BLS is not provided immediately. Hence, timely effective BLS is not just crucial for survival but also important for a better clinical outcome. There are avenues for lay people to be trained in BLS, but doing so often requires considerable motivation, as there is a monetary and time burden involved, and retraining is required as guidelines change and skill levels deteriorate. Although community attitudes toward BLS are positive, theoretical knowledge of BLS is poor.9 At our emergency department, when parents are asked about their willingness and ability to perform BLS should their child need it, few respond positively. We believe that a more uniform community effort is required to ensure this vital link in the chain of survival, when the primary prevention measures of supervision and fencing fail. This effort could include universal provision of BLS training in workplaces and in high schools. 1 Details of eight children involved in drowning or near-drowning events in Sydney, January 2007 Patient no. Age (months) Incident location Time unaccounted for (min)* Time to BLS after retrieval Who gave BLS Outcome† 1 49 Relative’s home 20 na na Died in PICU 2 23 Own home < 5 Immediate Medical doctor‡ Survived 3 47 Own home 2–3 Immediate Mother Survived 4 26 Relative’s home 20 Immediate Father Died in PICU 5 17 Relative’s home 5–10 na na Died in ED 6 42 Own home 1–1.5 Immediate Father Survived 7 29 Public pool < 5 Immediate Bystander Survived 8 72 Own home 10–20 na na Died in ED BLS = basic life support. ED = emergency department. na = not applicable because BLS not given. PICU = paediatric intensive care unit. * Best estimate of the period of time the child was unaccounted for (ie, possible duration of immersion). † All children who survived had no neurological deficit. ‡ Present at the time of the event. 2 Basic life support flow chart*7 CPR = cardiopulmonary resuscitation. * Reproduced with permission of the Australian Resuscitation Council.

Jeanette Marchant MB ChB, DCH, MRCPCH · Nicholas G Cheng MB BS, DCH, FRACP · Lawrence T Lam MAppPsy, MPH, PhD · Fiona E Fahy RN, RM, MN(Perioperative) · S V Soundappan MB BS, MS(General Surgery), MCh(Paediatric Surgery) · Danny T Cass MB BS, PhD, FRACS · Gary J Browne MD, FRACP, FACEM

A recent study of a thrombolysis protocol for patients with acute stroke, and an accompanying editorial, prompted debate about the safety and efficacy of tissue plasminogen activator in stroke, and the data supporting its use for this indication. (MJA 2007; 187: 567-570 and 548-549) HTML PDF James C Hurley — Med J Aust 2008; 188 (8): 488. HTML PDF Gino J Toncich — Med J Aust 2008; 188 (8): 489. HTML PDF Daniel M Fatovich — Med J Aust 2008; 188 (8): 489. HTML PDF Julia J Batmanian, Meeyin Lam, Caitlin Matthews, Andrew Finckh, Martin Duffy, Robert Wright, Bruce J Brew and Romesh Markus — Med J Aust 2008; 188 (8): 489-490. HTML PDF Stephen M Davis, Peter J Hand and Geoffrey A Donnan — Med J Aust 2008; 188 (8): 490.

To the Editor: The recent report on the use of a stroke thrombolysis protocol by Batmanian and colleagues1 raises many issues. The most recent guidelines regarding thrombolytic therapy for ischaemic stroke recommend that “If thrombolytic therapy is to be used . . . consultation with a neurologist or stroke physician is essential before instigating therapy. Strict adherence to the inclusion and exclusion criteria is important . . .”2 Hence, I find the integral role of a neurologist in Batmanian and colleagues’ protocol reassuring. However, consent to therapy in this setting is not simple. In the protocol, they informed the patient and/or next of kin about the risks and benefits of thrombolysis, but did they seek informed consent? The benefits of thrombolytic therapy are controversial, and equipoise exists. Reflecting this, a multicentre trial3 is underway that includes patients who meet the eligibility criteria of Batmanian et al’s protocol. The evidence cited by Batmanian and colleagues in support of thrombolysis was based on small randomised trials published more than a decade ago.4 Further, the summary results of the meta-analysis they cited are associated with significant heterogeneity and lose statistical significance with the inclusion of additional results from observational studies5 (Box). Moreover, the more recently published audits and the analysis that led to the number-needed-to-treat estimate cited by Batmanian et al were based on comparisons with a reference group dominated by the placebo group of the NINDS (National Institute of Neurological Disorders and Stroke) trial.6 This trial has been criticised for likely faulty randomisation resulting in baseline disparities unfavourable to the placebo recipients. These projections of benefit based on comparisons with a small and non-representative placebo group from a trial published over a decade ago are misleading. A calculation of numbers needed to treat based on such limited evidence, particularly for a soft endpoint such as assessment of disability, is hazardous and potentially misleading.7 There are other important issues associated with this therapy that need to be resolved. For example: Are mortality rates increased in groups receiving tissue plasminogen activator therapy in non-teaching hospitals?;8 Is this therapy safe in older people?; and finally, does this therapy not have the proven mortality risk associated with streptokinase in randomised trials in patients with stroke?4 Thrombolysis for stroke requires more evidence from randomised trials, not more protocols. Trials including older people are especially needed, given the age-dependent mortality risk associated with this therapy. Odds ratios for fatal outcome from published cohorts of patients receiving tissue plasminogen activator therapy within 3 hours of onset of acute ischaemic stroke The addition of two recent observational cohorts, the German Stroke Register and the Cleveland experience, to the meta-analysis of six controlled trials as reported in Wardlaw et al4 increases the summary odds ratio from 0.97 (95% CI, 0.69–1.36) to 1.21 (95% CI, 0.93–1.57). (Figure reproduced from Hurley5 with permission from Wiley-Blackwell Publishing Ltd.) ATLANTIS = Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke. ECASS = European–Australasian Cooperative Acute Stroke Study. NINDS = National Institute of Neurological Disorders and Stroke.

James C Hurley

To the Editor: The assertion of Davis and Batmanian and their colleagues that thrombolytic treatment for ischaemic stroke is reasonably safe and highly effective1,2 is not supported by the primary randomised trials of its use.3 Is tissue plasminogen activator (tPA) safe? It remains undisputed that none of the trials for thrombolysis in stroke have shown any mortality benefit.4 All of the trials have shown increases in symptomatic intracranial haemorrhage; in the NINDS trial, the increase was from 0.6% in the placebo arms to 6.4% in the treatment arms — a 1000% relative increase — and 45% of those with symptomatic bleeds died.5 Presumably, any mortality benefit from opening blocked arteries is lost because of the increased mortality from intracranial bleeding. Therefore, the drug is not safe. Is tPA effective? Thrombolysis for acute myocardial infarction was assessed in tens of thousands of patients in many independent studies, with virtually all showing clear mortality benefit. By comparison, the stroke thrombolysis literature is full of negative studies, with only one positive result. The NINDS trial4 stands alone as the only randomised controlled trial (RCT) providing positive evidence for thrombolysis for stroke. Ignoring criticisms of its interpretations and methodology, of which there are many, it had fewer than 600 patients and its results have not been reproduced independently. Breaches of protocol continue to be published. Batmanian and colleagues gave patients tPA after 180 minutes despite all the evidence saying this has no benefit, justifying it by saying the decision had been made at 170 minutes.2 Davis and colleagues1 based their claims of safety and efficacy on registries, subgroup analyses, meta-analyses, and expert panels all based on the same single RCT — the NINDS trial.4 This is low-grade evidence for a potentially lethal therapy. It is time a major RCT was done to repeat the NINDS trial and finally determine whether its result was a statistical anomaly or a real effect. There is no shortage of stroke patients — Batmanian et al found that 14% of patients were eligible for this therapy.2 The paucity of evidence for thrombolysis for stroke does not justify rushing patients to stroke centres, bypassing perfectly good hospitals in the hope of finding some of the 3% of patients eligible for treatment, of whom one in eight (0.38% of all stroke patients) would theoretically have a better neurological symptom score if given thrombolysis.6,7 I feel that it is a waste of time and effort, and a danger to patients, to focus all resources on supplying a potentially lethal therapy that is often incorrectly used and provides a marginal benefit.

Gino J Toncich

To the Editor: I found it ironic to read the recent editorial by Davis and colleagues endorsing the use of tissue plasminogen activator (tPA) therapy for stroke patients.1 The irony relates to the fact that a week later I attended the annual scientific meeting of the Australasian College for Emergency Medicine, where data were presented (Hoffman J. New information on the use of tPA in acute ischaemic stroke. 24th Annual Scientific Meeting of the Australasian College for Emergency Medicine; 2007 Nov 25–30; Gold Coast, Qld) that cast strong doubt on the conclusions derived from the NINDS trial.2 There are further objections to the claim that the value of tPA has been adequately proven,3 none of which are remotely addressed by the editorial. As an emergency physician, this dichotomy of opinion is frustrating. There is obviously conflicting evidence, which usually means that data are insufficient. Hence, until more research is completed, especially clinical trials that replicate the original NINDS study, the claim of Davis et al that tPA is “highly effective, reasonably safe and grossly underused”1 is inappropriate.

Daniel M Fatovich

In reply: We welcome the opportunity to respond to issues raised by Hurley and Toncich. Australian, United States and European stroke guidelines based on level 1, grade A evidence recommend intravenous recombinant tissue plasminogen activator (IV-rtPA) for patients with acute ischaemic stroke (AIS) who meet specific inclusion criteria and present within 3 hours of AIS onset.1,2 Recombinant tPA is approved for this indication by the Therapeutic Goods Administration. We obtained informed consent before thrombolysis, but recognise that this is challenging because of the urgent need to initiate treatment, rather than doubts regarding benefit. A Cochrane systematic review of eight randomised controlled trials (RCTs), which together comprised 2955 patients, concluded that IV-rtPA within 3 hours of AIS onset was more effective in reducing death or dependency (odds ratio [OR], 0.66; 95% CI, 0.53–0.83), with no statistically significant adverse effect on death (OR, 1.13; 95% CI, 0.86–1.48).3 The Third International Stroke Trial (IST-3), which Hurley cites to support his view that sub-3-hour stroke thrombolysis remains controversial, was in fact designed to address different issues: efficacy of rtPA given 3–6 hours after symptom onset and to those aged over 80 years, as well as imaging predictors of response. We believe Hurley’s figure from his own letter is an incorrect attempt at meta-analysis. He combines data from RCTs and selected observational studies (excluding the Safe Implementation of Thrombolysis in Stroke Monitoring Study [SITS-MOST] of 6483 patients4), a method subject to selection bias. Although the original Cleveland study (as cited by Hurley) showed high rates of intracranial haemorrhage, 50% of patients in the study were not treated according to the protocol. The incidence of intracranial haemorrhage was subsequently reduced to the expected level following implementation of a quality improvement program to ensure strict adherence to protocols.5 Hurley suggests that projections of IV-rtPA benefits are misleading because of baseline imbalances in the NINDS trial. These concerns were addressed by reanalysis of the data by an independent committee commissioned by NINDS,6 which not only reconfirmed the original results but suggested an even greater benefit for AIS patients receiving IV-rtPA. We believe Hurley’s statement that mortality rates are increased when stroke thrombolysis occurs in non-teaching hospitals is unsubstantiated. In the study cited, mortality rates were similar to those observed in RCTs of IV-rtPa, with no difference between teaching and non-teaching hospitals.7 Indeed, large registries in Europe (where 50% of centres had little or no prior experience)4 and in Canada8 report efficacy rates following thrombolysis similar to those from RCTs with lower rates of intracranial haemorrhage and mortality. In our view, IV-rtPA within 3 hours of AIS does not require more RCT evidence. Due to therapeutic inertia, only a small proportion of eligible stroke patients receive this therapy. Comprehensive acute stroke protocols in the emergency department in partnership with stroke clinicians could improve delivery of this highly effective treatment.

Julia J Batmanian · Meeyin Lam · Caitlin Matthews · Andrew Finckh · Martin Duffy · Robert Wright · Bruce J Brew · Romesh Markus

In reply: Stroke experts around the world consider that the evidence for thrombolysis with tissue plasminogen activator (tPA) within 3 hours is overwhelming. Licensing authorities such as the Therapeutic Goods Administration in Australia and the Food and Drug Administration in the United States have approved use of tPA after rigorous, independent analysis of all the available data. However, it seems that a minority of sceptical emergency physicians remains, who will probably never be convinced. Further trials in the sub-3-hour time window are unlikely to receive ethical approval. The focus of stroke research has now moved on. Current targets include expansion of the time window and alternative approaches to recanalisation such as intra-arterial thrombolysis and clot retrieval. Hurley states that there was a baseline imbalance in the pivotal NINDS trial in favour of tPA. We think this old chestnut was laid to rest by an independent reanalysis of the NINDS data.1 The quoted Cochrane review included all thrombolytic agents (such as the now-abandoned streptokinase),2 whereas meta-analyses restricted to tPA alone are unequivocally positive.3 The figure presented by Hurley is misleading, combining both randomised controlled trials and selected population registries — yet excluding SITS-MOST, an observational study of 6483 patients.4 Both Toncich and Fatovich criticise the trial evidence. This contrasts not only with the virtually universal expert opinion of stroke clinicians, but also with the opinion of many emergency physicians.5,6 Indeed, the INSTINCT (Increasing Stroke Treatment through Interactive behavioral Change Tactics) trial aims to identify local barriers to the use of tPA in emergency departments, with the goal to increase appropriate use of tPA in acute ischaemic stroke.5 Finally, stroke physicians do not need to be neurologists. We consider that most general physicians, and indeed emergency physicians, should acquire the core skills to deliver intravenous tPA in acute ischaemic stroke. Would anyone familiar with modern stroke medicine deny tPA to an otherwise well 65-year-old with hemiparesis who presents 90 minutes after symptom onset? It is critical that all eligible patients in Australia are offered this licensed therapy.1-6

Stephen M Davis · Peter J Hand · Geoffrey A Donnan

To the Editor: There are two fundamental flaws in the case for reform of youth mental health services outlined recently by McGorry and colleagues.1,2 They argued that 18 years is an unnatural and inappropriate transition point between adolescent and adult services, and that Child and Adolescent Mental Health Services (CAMHSs) are somehow inherently ill equipped to deal with serious mental illness. McGorry has long advocated a “youth model” catering for adolescents and young adults together. I believe this would be a disaster, particularly for adolescents. Adolescents and young adults need very different models of care, because of the differing degrees of responsibility and autonomy they can handle, the legal and moral responsibilities of families, carers, schools and health professionals, and the effectiveness of treatments. McGorry’s well deserved reputation and influence mean there is a real risk his opinions will be accepted as fact, especially as the opposing view is seldom heard. People aged under 18 years (on average) are not expected, or permitted, to take full responsibility for their lives or their mistakes. Legally, they cannot vote, drink or buy cigarettes. They are generally still at school and living in the family home. Those aged under 16 years are not automatically entitled to grant or withhold consent to treatment. Families thus have a central role in the management of illness in adolescents, in a way that is neither possible nor appropriate for adult patients. Adolescent inpatient units need to be highly structured environments where adults would be out of place, with school-like rules, and careful control of group process and peer interactions. Otherwise, there is bullying, sexual exploitation, epidemics of self-harm, and the kind of competitive rebelliousness that leads to riots and fires. In adult units, adolescents are unacceptably vulnerable, not only from exploitative older patients, but from a lack of boundaries to their own behaviour. McGorry made several perplexingly dismissive comments about CAMHSs. Two cannot go unanswered: that CAMHSs “struggle operationally and clinically with . . . mood, psychotic, substance use, and borderline personality disorders”;1 and that “the capacity to skilfully and safely manage highly disturbed behaviour, and the more sophisticated psychopharmacological skills, are often lacking in . . . CAMHSs”.1 The disorders described are, in fact, “bread-and-butter” work for CAMHSs. Further, there is powerful anecdotal evidence that CAMHSs manage them better, not worse, than others. Examination of data held by the Victorian Department of Human Services and the Office of the Chief Psychiatrist on seclusion (sole confinement) rates, consumer satisfaction and suicide rates will bear this out. Child psychiatrists all train as adult psychiatrists first and, in my experience, do not lack psychopharmaceutical sophistication. It is hard to see what adolescents and their families have to gain from being incorporated into young adult services, nor why 30-year-olds should be excluded from specialist early psychosis services. We need greater integration between the current tiers of service, and a more flexible approach to transition between them, not another separate tier of service.

David A Sholl

In reply: Sholl asserts that our case for reform of youth mental health services is based largely on personal opinion. In fact, as detailed in the Journal supplement,1 it is based on hard epidemiological facts, the latest developmental perspectives and a growing evidence base. Consequently, it has been widely supported by young people, families, governments and the community. The youth model ensures that developmental approaches appropriate to all stages of the process of transition from childhood to adulthood continue until the young person is genuinely independent. To design a health system around the transition age of 18 years, based on legal and educational precedents, is outmoded. Many more young people now pursue postsecondary education and are financially and socially dependent on their families well into young adulthood.2 The youth mental health paradigm involves families in a developmentally appropriate way from puberty to the mid-20s, and also recognises the increasing value of peer relationships. The key difference is that young people have increasing choice about the level and pattern of family engagement. Similarly, brain development continues actively up until the mid-20s. We believe Sholl has misunderstood the fundamental issue of youth mental health reform. It is not a binary choice between current child–adolescent and adult service models. A new stream of care is required to respond to these “transition age youth” or “emerging adults”, as they were recently termed.2 This stream borrows many of the features of adolescent psychiatry and extends these to around 25 years of age, complementing them with new evidence-based approaches, which have been difficult to create and nurture within a constrained and under-resourced Child and Adolescent Mental Health Services system. This step is crucial for the “graduates” of state care, who have appalling outcomes when care is withdrawn at 18 years (even though they can vote).3 We have successfully developed and provided such an adolescent–young adult service to a quarter of Melbourne for over a decade. Recently, we extended this to Sydney. The real-world impact of this approach has helped greatly to convince the community, including federal and state government leaders, of its wider value. We want to see genuine reform, restructure and substantial investment in a new stream of care. How well this links, not only with existing child and adult specialist systems, but equally importantly with other key systems — notably education and employment, primary care, housing, justice and drug and alcohol services — will be critical to its success.

Patrick D McGorry · Ian B Hickie · Anthony F Jorm · Rosemary Purcell

To the Editor: Singh and Castle recently commented on the assumptions made in relation to the National Mental Health Policy.1 One such assumption was that the cost of the community care service model could be constrained by limiting services to the “severely” mentally ill. The authors went on to describe the realities associated with making this and other assumptions on current mental health care delivery. Many public wards have become the province of treatment-resistant consumers with limited insight who do not welcome the interventions provided by mental health workers. It may be that this type of inpatient population is influencing medical students’ views of psychiatry and contributing to low numbers in psychiatry training across the country. Students’ perceptions that psychiatry is a difficult and pressured work environment have been reported.2 Public services for consumers who have mental illnesses that do not involve psychosis are under severe pressure in the current paradigm. Despite the availability of effective treatments, anxiety and depressive disorders remain the principal cause of the disability produced by mental disorders, and half the people with such a disorder do not seek help, not realising how well they can become.3 However, the public system appears to be retreating from providing services for such patients. There seems to be a view that all Australians with anxiety and depression can be treated in private practice or by general practitioners. Does targeting low-prevalence disorders for treatment represent an acknowledgement by those in government of the power of mental health stigma? Is there misguided thinking that spending money on patients with psychotic disorders will keep mental illness and violence off the streets? Doctors have an obligation to inform those in power that effective treatments need to be made available to the broadest range of Australians, not just those who are obviously mentally ill. The difficulty of retaining psychiatrists in the public sector has been noted in many countries.4 Health services need to provide variety in the work of clinicians to keep them within the public sector — a diet of chronic psychosis tends not to attract or sustain staff. I believe fostering specialist units dealing with high-prevalence disorders like anxiety and depression, and high-morbidity conditions like eating disorders, would encourage the training of new staff, contribute to research, and strengthen the future of psychiatry. Revitalising public treatment services for high-prevalence psychiatric disorders could provide both symptom relief and a return to productivity for many thousands of Australians, and a more sustaining work environment for mental health clinicians. It is time for our governments to hear the call to provide mental health care for the many, not just the few.

James D Hundertmark

To the Editor: A 20-year-old sub-elite Australian Rules football player presented with pain and tenderness in the lower third of the sternum. He had been involved in a moderate body collision with an opposing player about 3 weeks before presentation, and had continued to train and play despite sternal discomfort. He described no other symptoms. On examination, there was no obvious sternal deformity. There was mild to moderate tenderness over the lower third of the sternum, and minimal sternal discomfort on lateral chest compression. Chest auscultation was clear. Plain chest and sternal x-rays were normal. A technetium-99m HDP bone scan showed increased tracer uptake in the lower sternum, consistent with an undisplaced oblique sternal fracture (Box). Management of the player’s injury and his fitness to train and play were discussed informally with medical and paramedical practitioners. Their opinions ranged from an immediate return to competition to 12 weeks of complete rest. After discussions within the player’s club, he was placed on a training regimen that avoided all upper body clashes and stresses, and he was rested from match play. He was regularly reassessed for symptoms and made an uneventful return to full competition 6 weeks after his initial injury. He remained asymptomatic and competitive for the remainder of the season and at 1-year review. The usual cause of sternal fracture is blunt anterior chest trauma, with about 90% of sternal fractures caused by trauma resulting from the forces associated with motor vehicle accidents.1 Sternal fracture is rarely encountered in Australian Rules football and such a case has not previously been described in the literature. The Australian Football League Injury Report database revealed only four cases of sternal fracture over the period 1992–2006, accounting for a total of 18 missed games (range, 1–11 games) (John Orchard, Conjoint Senior Lecturer, Sports Medicine Program, University of New South Wales, personal communication, May 2007). Patients suspected of suffering a sternal fracture should be investigated with appropriate chest x-rays. If these are inconclusive, it is now suggested the patient should be further investigated with sternal ultrasound, which has recently been demonstrated to be superior to bone scan in identifying sternal fractures,2 and without the associated radiation exposure. Patients with an acute suspected sternal fracture should also undergo electrocardiography. If the electrocardiogram is normal and there is no evidence of intrathoracic injury on radiological investigation, the patient can safely be discharged.3 Chest pain is the predominant persisting symptom after sternal fracture.4 Conservative management with rest, analgesia and/or anti-inflammatories, and, if required, appropriate padding and taping5 should result in full recovery and an uneventful return to competition. Bone delay views from dynamic localised technetium-99m HDP bone scan There is a band of low to moderate tracer uptake running in a slightly oblique line across the lower sternum (arrow), suggesting a sternal fracture.

Robert J Douglas

To the Editor: According to a recent article in the Journal, the pervasive nature of under-age drinking underscores the need to develop prevention strategies to delay the onset of alcohol use and its adverse consequences.1 In the United States, school-based prevention programs have played a prominent role in the alcohol-use prevention scene. Drug Abuse Resistance Education (DARE), the most widely recognised school-based alcohol-use prevention effort, is an elementary school curriculum that focuses on the adverse effects of substances of misuse, and the development of skills to resist peer pressure to use. Despite its nationwide appeal, attempts to empirically evaluate the efficacy of DARE have failed to yield positive results.2 Subsequently, Mothers Against Drunk Driving developed a school-based alcohol-use prevention program called “Protecting You/Protecting Me” (PY/PM). PY/PM centres on instructing children about central nervous system development and the importance of protecting developing brains from substances of misuse. PY/PM appears to be effective in enhancing knowledge of alcohol toxicity and changing attitudes toward binge drinking,3 but its efficacy in decreasing alcohol use remains to be established. Although the efficacy of school-based alcohol-use prevention strategies has been the subject of controversy, such programs have proliferated. School-based multicomponent approaches have also emerged. Project Northland integrated school, neighbourhood, and family components in an effort to decrease alcohol use.4 Project Northland consisted of classroom curricula, extracurricular activities, and parental involvement. Twenty-four school districts were randomly allocated to receive some or all of the prevention package or a control. At the end of 3 years, significantly fewer students in the intervention school districts reported the onset of alcohol use than students in control districts. Efforts to disentangle the impact of its various components show differential effects. While the classroom curricula proved moderately effective, the strongest effects in decreasing drinking were seen for those who participated in the extracurricular activities and parent program components.4 The robust benefits noted from the parent program in Project Northland parallel effects of some other studies suggesting the utility of family-based approaches to alcohol-use prevention. In one study, the Iowa Strengthening Families Program significantly delayed the initiation of alcohol use.4 This program, which is geared towards optimising parenting skills, showed persistence of positive effects on alcohol outcomes 4 years after the intervention.4 These data suggest that parenting and family skills training may play a part in school-based alcohol-use prevention packages. Further evaluation of these programs in other countries is necessary, and may help to reduce the widespread adverse effects of early alcohol use among children.

Vania Modesto-Lowe · Nancy M Petry · Melissa McCartney

To the Editor: We read with interest the recent editorial and articles on health technology assessment.1-4 We are pleased that the Journal highlighted this important policy process that attempts to ensure that technologies that improve health gain or health care are supported and those that do not contribute to an improved outcome are not supported. The description of HealthPACT in the editorial1 is not quite accurate in that HealthPACT is a subcommittee of the Medical Services Advisory Committee (MSAC). Its funding comes through MSAC with some supplementation from the Australian Health Ministers’ Advisory Committee. The techniques of early detection and horizon scanning have been developed, and the results of this work are available to the health community of Australia, be it jurisdictional, public, private or specialised. In particular, if promising health care technologies are identified through this process, they are referred to MSAC for a full health technology assessment, thus ensuring that appropriate technologies are identified as early as possible in the technology cycle and are assessed by MSAC for introduction into the health care system. This horizon-scanning activity does not currently involve drugs or vaccines, and the Australian health care system could benefit from this process, just as the National Institute for Health and Clinical Excellence in the United Kingdom and the Canadian Agency for Drugs and Technologies in Health undertake comprehensive horizon scanning. With respect to conflicts of interest, MSAC is very specific at all levels of its operation. At the commencement of every advisory panel and MSAC meeting, the Chair requests declaration of conflicts of interest. These are recorded in the minutes and appropriate decisions are made on the participation of the person declaring a conflict based on an assessment of the issue. This is formal and explicit, and is on the public record. It is important to state this, as the article by Petherick and colleagues implies that MSAC does not record conflicts of interest.4 In fact, MSAC places great importance on declaration of conflicts of interest.

Brendon J Kearney · Stephen L Blamey

To the Editor: I wish Professor Carr the very best in his attempt to eliminate the somewhat confusing term “Barrett’s oesophagus” from the literature.1 Changing well entrenched medical nomenclature is difficult, however. I tried to do this with “microscopic colitis” 10 years ago2 but was not successful. After all, I argued, we do not speak of “microscopic bronchitis” or “microscopic salpingitis” — so why should we have the term microscopic colitis? It is nonetheless pleasing to note that the definition of microscopic colitis has tightened up over the past 10 years,3 and I think this may be a more realistic aim for Professor Carr with the term Barrett’s oesophagus. Admittedly, the two entities are not perfectly analogous, as, unlike microscopic colitis, Barrett’s oesophagus is classically associated with abnormally coloured mucosa. However, in both entities, the endoscopist usually takes biopsies from endoscopically flat mucosa, specifically looking for the disease in question. I am not sure I can see myself in 10 years’ time looking down someone’s oesophagus and saying, “I think there may be some columnar metaplasia down there. I wonder if there is some intestinal metaplasia as well?” Maybe this would be a good conversation opener in the halls of the pathology department, but certainly not in the endoscopy suite! I think I will still be saying, “That looks like Barrett’s, but we will need to take biopsies to make sure”.

Andrew A Thomson

In reply: I thank Dr Thomson for his kind comments. I sympathise with his attempts to eliminate the term “microscopic colitis”1,2 and would happily join him in this campaign. I agree it is important to tighten up the definitions of ambiguous terms. For example, “indeterminate colitis” is another term that continues to be used in different ways, despite attempts to clarify its definition.3 However, in the case of Barrett’s oesophagus, there are precise definitions, but they are mutually exclusive. The British Society of Gastroenterology uses one definition (not requiring goblet cells), whereas other national bodies use another definition (requiring the demonstration of goblet cells histologically).4 Therefore, when an endoscopist says “That looks like Barrett’s”, he or she could be saying either that the mucosa appears glandular or that a pathologist will find goblet cells in it. The two are not the same and we should not confuse them. I believe we should not use “Barrett’s oesophagus” because it is defined differently by different people; confusion regarding the site of a particular biopsy can cause it to be applied inappropriately; and we have existing terminology that does the job. I accept that a few lone voices are not going to change well entrenched terminology. However, we can hope that the national and international bodies that construct guidelines in this area will take heed, accept the challenge and deal with the problem.

Norman J Carr

A 16-year-old boy with a 3-month history of intermittent postural headaches presented with sudden worsening headache after a game of soccer. The results of a neurological examination were unremarkable. Magnetic resonance imaging showed elongation of the midbrain, bilateral frontoparietal subdural haematomas (Figure, A), and a collection of fluid within the soft tissues overlying the lumbar spine (Figure, B). The cerebrospinal fluid (CSF) opening pressure on lumbar puncture was low (60 mmHg). Spontaneous intracranial hypotension was diagnosed, and the response to conservative treatment was good. Intracranial hypotension is a syndrome characterised by postural headaches and CSF hypovolaemia. Most cases are secondary to a tear in the dura mater following lumbar puncture, with a resultant slow CSF leak and gradual volume depletion. It can also occur secondary to severe dehydration, and, occasionally, no cause is identified, when it is termed “spontaneous”.1 In this case, there was no history of lumbar puncture, and CSF accumulation within the lumbar soft tissues was presumed to be secondary to a spontaneous dural tear in this region. Intracranial hypotension has characteristic imaging features, which include elongation of the midbrain, linear enhancement of the pachymeninges and subdural effusions.2 Patients are predisposed to subdural haemorrhage after minor trauma as a result of “stretching” of the dural veins. Intracranial hypotension is commonly misdiagnosed as migraine, meningitis or a psychogenic disorder.1 Most cases resolve spontaneously, but intractable headaches may be successfully treated with steroids, epidural blood patches or surgery.1 A: Axial T1-weighted magnetic resonance image showing elongation of the midbrain and bilateral subdural haematomas (arrows). B: Sagittal T2-weighted fat-saturated magnetic resonance image showing high-signal cerebrospinal fluid accumulation within the soft tissues of the lower back (arrow).

Edward Hoey · Guneesh Dadayal · Sashidhar Yeluri · Neetu Kumar · Kshitij Mankad

Thomas Stapleton, an internationally renowned advocate for improved child health, died on 15 November 2007, aged 87 years. Tom was born in Lynton, United Kingdom, on 1 February 1920. He was educated at the King’s School in Canterbury and at University College, Oxford, graduating in medicine in 1943. After doing war service with the Royal Army Medical Corps, Tom pursued postgraduate studies at the Boston Children’s Hospital in the United States. He later returned to England to work at St Mary’s Hospital in London, where he was involved in studies of childhood electrolyte abnormalities, particularly hypernatraemia. This was a stimulating time in his career, working with a very active group of paediatricians, many of whom became leaders in their fields in the UK, the US and Australia. In 1960, Tom succeeded Sir Lorimer Dods as Professor of Paediatrics at the University of Sydney and at the Royal Alexandra Hospital for Children. He became very active in international child health and was very influential in this field through his appointments as Secretary-General (1965–1974) and Treasurer (1974–1977) of the International Paediatric Association (IPA). The IPA includes about 140 national paediatric societies and has about 500 000 paediatrician members. Through the IPA and his extensive international travels and contacts, he was able to advocate strongly for better health and the related needs of children worldwide, particularly in developing countries. He had access to many powerful political and policy leaders around the world, including rulers such as Mao Zedong and Indira Ghandi. He frequently visited the People’s Republic of China and was a keen Sinophile. Tom spoke strongly over many years for Australia and its paediatricians to be hosts to the triennial International Congress of Pediatrics. Despite physical frailty, he attended the most recent Congress in Athens in late August 2007 and strenuously supported Australia’s formal bid. He was delighted with Australia’s success in being chosen to host the Congress in Melbourne in 2013. After retiring from the University of Sydney, Tom returned to England. Over the years, he was a generous host and enjoyed having many of his old friends and other guests stay at his charming cottage in rural Buckinghamshire. He also provided many Chinese and Russian postgraduate students with board and lodging during their studies. He died at home peacefully in his sleep.

Michael S Gracey

Handbook of advanced cancer care. Raphael Catane, Nathan Cherny, Marianne Kloke, et al, editors. Oxford: Taylor & Francis, 2006 (ix + 278 pp). ISBN 978 0 415 37530 6. As it discusses issues that lie at the interface of oncology and palliative care in this country, the Handbook of advanced cancer care is more useful than its title might suggest. It will be valuable not only to specialists but also to nurses, general practitioners and doctors in training. The book was commissioned by the European Society for Medical Oncology and describes many situations that would be familiar to Australian cancer specialists. The treatments too are familiar and readily available. Overall, the text is pleasingly comprehensive for a small book, up to date and practical. The authors begin by making the important point that even in advanced cancer, specific anticancer treatments (chemotherapy, radiotherapy) can be the best way of improving quality of life, and in some far advanced cases can even still be curative: think, for example, of disseminated germ cell tumours. In addition to the expected topics (such as pain, constipation, and hypercalcaemia), there are useful entries concerning fungating wounds, hiccups, sweating and pressure sores. Modern drugs such as buprenorphine are included. For this older oncologist, it was comforting to read that ‘‘[o]lder patients in overall good health are able to tolerate chemotherapy as well as their younger counterparts...”. This is a statement that might not have been made a few years ago. There are useful chapters about communication for the health professional, the place of psycho-oncology, and how to handle bereavement. In the latter chapter, I particularly endorse the advice that medical practitioners should routinely indicate to the relatives that they are available for a visit after the patient’s death to discuss “leftover” questions. There is limited repetition — Tables 1.1 and 7.1 are identical and Tables 1.2 and 7.2 virtually so. Although the idea of providing algorithms is useful for clinical practice, the deep colours chosen for the various boxes make it difficult to read the text within. There is a description of massive terminal haemoptysis but not of catastrophic terminal haematemesis. Perhaps the most serious shortcoming, though, is that the chapter on pain glosses over the need to make a diagnosis of its cause before considering symptomatic treatment options. In summary, this is a useful, concise handbook which would soon be well thumbed if made available on the oncology and palliative care wards. In days gone by, it would have fit neatly into the pocket of a white coat, but who wears those any more?

Raymond M Lowenthal

Palliative care: core skills and clinical competencies. Linda L Emanuel, S Lawrence Librach, editors. Philadelphia: Saunders, 2007 (xxi + 705 pp). ISBN 978 1 4160 2597 9. What can we learn from Americans about palliative care? “Not much!” you might say, especially when this book’s foreword — by Balfour Mount — is largely devoted to the legacy left by British pioneers like Saunders and Kearney. But palliative care is rapidly taking off in the United States, as the many new textbooks from there attest. So is this one worth reading? While some contributors are well known (Mount, Emanuel, Bruera, Buckman, Meier, Fainsinger), most will be unfamiliar to Australian readers. Pitched at the student/trainee level, or the non-specialist provider, it has a very practical orientation (eg, Buckman’s “SPIKES” protocol for breaking bad news, and a six-step protocol for eliciting the goals of therapy), providing insight into the emerging North American approach to palliative care. These methods might not go down well here, but they serve as a useful teaching resource. Being a soft-covered handbook comprised of 40 short chapters, divided into four sections, Palliative care represents good value for money. Section one, “Core skills”, takes up the first half of the book, and a large part of that is on symptom control. All chapters are written to a template, making it reader-friendly, each one concluding with “Pearls”, “Pitfalls” and a short summary. References are limited to 20 per chapter, but there are also useful resources lists (Internet and non-Internet). Symptom control chapters broadly cover their subjects and the therapeutics are up to date. For example, ketamine is mentioned in Fainsinger’s pain chapter, but dealt with in 35 words. Most common problems faced in modern palliative care practice are covered, including chapters on advanced care planning and handling euthanasia requests. But there is nothing on prognostication, an important omission. While the North American focus can grate, the chapters giving the US perspectives on suffering, legal and ethical issues, the economic burden of illness, and reimbursement for physicians make for interesting reading for Australian palliative care practitioners interested in the future directions of their specialty.

Paul A Glare

Transsexual and other disorders of gender identity: a practical guide to management. James Barrett, editor. Oxford: Radcliffe Publishing, 2007 (298 pp). ISBN 978 185775 719 4. This is an outstanding book, fulfilling a marked need. Barrett, principal author and editor, is a consultant psychiatrist and lead clinician at the Charing Cross Hospital Gender Identity Clinic in London. He draws on 20 years’ clinical experience; his writing and presentation are clear and most helpful. The book concentrates on the major aspects of the health care of transgender men and women, including the role of the psychiatrist and the contributions made by other medical specialists, speech therapists, and surgeons. That the general practitioner’s role in patient care was not given emphasis surprised me. GPs are often in the best position to provide continuity of patient care and coordination of the various specialist consultations. For the male-to-female transsexual, a masculine voice may be the major obstacle to the person being accepted in the desired sex role. Two chapters describe what can be achieved by speech training and laryngeal surgery. Feminisation of the male body or masculinisation of the female body is one of the most urgent requests that transgender patients have at their first consultation. Once their diagnosis of transsexualisation has been established, they will require lifelong hormone therapy. The chapter on this subject is essential reading. It is a masterly dissertation on all of the principles of hormonal treatment and the various regimes and modes of administration. Side effects of such therapy and their management are also discussed. Discussions of surgical treatments deal with breast augmentation or reduction, removal of penis and testicles, vaginoplasty, vulvoplasty, and phalloplasty. All are excellent chapters, but that on phalloplasty deserves special mention because it deals with a difficult and complex subject in an enlightening manner. In all of these chapters, postoperative care and complications are adequately discussed, along with limitations of the various surgical procedures. The legal issues of gender change are included in a chapter that addresses marriage, the family, employment, pensions and privacy. Even transsexuals in the military services, various religious traditions and their teachings about gender change, and fertility issues affecting transsexuals are considered in the concluding chapters of the book. The editor and authors have definitely produced a practical text on gender identity disorders for everyday clinical use. I strongly recommend it to all health care professionals involved in the care and management of patients with issues of gender identity. Educators in medicine and the health sciences should consider recommending this book for their undergraduate students. It can truly be said that this book is a clinical gem.

William A W Walters

Uterine artery Doppler Uterine artery Doppler ultrasonography appears to be a useful predictor of pre-eclampsia and intrauterine growth restriction, but is more accurate in predicting the former, according to a systematic review. Researchers identified 74 studies of pre-eclampsia and 61 studies of intrauterine growth restriction — a total of over 120 000 patients. When performed in the second trimester of pregnancy, uterine artery Doppler was found to be more accurate than in the first trimester. Pulsatility index, a measure of systolic and diastolic uterine artery blood flow, was the most useful of the Doppler indices for predicting pre-eclampsia. CMAJ 2008; 178: 701-711 Rhinosinusitis — to treat or not to treat . . . Common clinical signs and symptoms of rhinosinusitis do not necessarily help decide which patients will benefit from antibiotic therapy, according to the results of a recent meta-analysis. Researchers set out to assess if common clinical signs and symptoms of rhinosinusitis can distinguish between viral and bacterial forms, and thus identify those patients who would benefit from antibiotics. Signs and symptoms studied included duration and severity of symptoms, purulent nasal or pharyngeal discharge, facial pain, and the presence of pyrexia. Data from nine randomised controlled trials involving over 2500 adults with rhinosinusitis were analysed. The number needed to treat (NNT) with antibiotics to cure one additional patient with the disease was 15 people. Those with a purulent pharyngeal discharge took longer to cure, and this sign had some prognostic value, but eight patients with this sign still needed to be treated before one additional patient benefited (NNT = 8). The authors conclude that common clinical signs and symptoms of rhinosinusitis did not seem to be able to identify the subgroup of patients who would benefit from antibiotic treatment. Antibiotics appear not to be justified even if symptoms are present for longer than 7-10 days. Only symptoms suggesting the presence of a serious complication warrant immediate antibiotic treatment. Lancet 2008; 371: 908-914 How old are your lungs? Telling smokers their “lung age” can significantly improve the probability that they will quit smoking, say British researchers. All 561 participants underwent spirometric assessment of lung function. They were then randomly assigned to two groups; the intervention group received their results in terms of “lung age” (the age of the average healthy individual who would perform similar to them on spirometry). The control group participants were given a raw figure for forced expiratory volume in 1 second (FEV1). Cessation of smoking was the main outcome measure, and was verified using salivary cotinine testing after 12 months. The verified quit rate in the intervention group at 12 months was 13.6% compared with 6.4% in the control group. Interestingly, whether the lung age was normal or not did not affect the quit rate. The authors comment that the reasons people decide to quit smoking remain complex, but that this intervention appears promising and cost-effective. BMJ Online; 6 March 2008 Autism — what do we mean? The diagnosis of autism is increasingly common, but the classification of autism and related disorders remains disputed and unclear, prompting Australian researchers to investigate the diagnostic labelling of autism spectrum disorders. They claim that current classification systems may allow children to satisfy the criteria for both autism and Asperger syndrome, leading to questions about the validity of each diagnostic label. The study included 348 children with one or more criteria for an autistic disorder according to the Diagnostic and statistical manual of mental disorders - 4th Edition (DSM-IV). Clinicians were asked to give a diagnostic label and complete the DSM-IV for each child. The agreement between diagnostic label and DSM-IV classifications was 97% for autism, but very low (27%) for Asperger syndrome and pervasive developmental disorder. The authors comment that although the use of the term “autism spectrum disorder” is widespread, the lack of specific current diagnostic criteria associated with the term may create problems in interpreting the child’s profile and needs. J Paediatr Child Health 2008; 44: 108-113 Beware thromboembolism in pregnancy The leading causes of maternal death in Australia are related to venous thromboembolism (VTE). Although infrequent, the mortality and morbidity associated with VTE are significant. In a retrospective study based in Victoria, Australian researchers analysed the records of women with confirmed VTE during pregnancy or the postpartum period. Identified risk factors were age over 30 years, obesity, a previous history of thromboembolism, and caesarean section. The overall rate of VTE was 1.14 per 1000 deliveries, with most cases occurring in the first trimester of pregnancy. The authors comment that the focus on prevention of VTE should shift to pregnancy, and not be confined to the postpartum period. Aust N Z J Obstet Gynaecol 2008; 48: 44-49

Tanya Grassi

Med J Aust 2008; 188 (8 Suppl).