Issues
Volume 191 Issue 5
From the editor’s desk
Confronting conflict of interest
Recently, a French medical organisation initiated legal action against nine doctors for failing to disclose their relationships with drug and other medical industries. At the same time, federal legislators in the United States are moving to enforce mandatory disclosure of industry gifts and payments to doctors on a public website. Indeed, Senator Chuck Grassley of the Senate Committee on Finance is in open conflict with US medical schools over their non-disclosure of drug-firm gifts and payments to faculty members, and is threatening to withhold federal funds. Such developments are testament to an accelerating campaign to confront conflict of interest. Earlier this year, the US Institute of Medicine (IOM) released a comprehensive report on conflict of interest, covering medical research, education and practice, as well as individual and institutional circumstances. The report advanced wide-ranging recommendations for the handling of conflict of interest in order to “protect the integrity of professional judgment and to preserve public trust”. Closer to home, the National Health and Medical Research Council (NHMRC) is currently reviewing its policy on conflict of interest. It is perhaps surprising that a profession which prides itself on ethical performance should continue to be plagued by lack of transparency in this one area. But history repeatedly attests to the lure of financial advantage. The IOM has thus recommended that Congress enact legislation requiring companies and their foundations to publicly report payments and gifts made to both individuals and institutions, whether they be physicians or non-physicians prescribing drugs or using medical devices, biomedical researchers, professional societies, continuing medical education providers, or specific patient advocacy groups. Sadly, our approach to conflict of interest is hopelessly fragmented. The time has come for rhetoric to give way to binding recommendations based on the US model. To make this happen, we need committed leadership and a national organisation with clout.
Martin B Van Der Weyden
In This Issue
Beyond mandatory reporting Mandatory reporting of child abuse has been enacted throughout Australia. Now, the onus is on all health professionals to provide mandatory responding, as no child protection agency can cope with all the referrals it receives, says Winterton. At a general practice level, this response may involve reviewing the patient on a number of occasions in order to obtain a clearer picture, and being in contact with the local child protection agency and other health care providers. It is only by responding appropriately, case by case, that we will be able to facilitate better outcomes for these children (→ Child protection and the health professional: mandatory responding is our duty). Science and the sole In reflexology, a popular complementary modality, particular areas (usually on the sole of the foot) are thought to correspond to one particular organ or organ system; massage of these sole areas is purported to be of therapeutic benefit. However, a UK expert reports that the best evidence available does not demonstrate convincingly that reflexology is an effective treatment for any medical condition. In a systematic review, Ernst identified 18 randomised controlled trials (RCTs) that had applied reflexology for any one of a wide range of conditions, including asthma, cancer and multiple sclerosis. Overall, the methodological quality of the trials was often poor, and their sample sizes were generally small. Although five RCTs did yield positive results, most of the higher-quality trials did not (→ Is reflexology an effective intervention? A systematic review of randomised controlled trials). Your money or your life? People are choosing not to obtain genetic information because of concerns that the results could affect future (and renewable) insurance policies, according to Keogh and colleagues. They found that a much higher proportion of participants in the Victorian Colorectal Cancer Family Study (49% versus 19%) declined genetic testing for a germline mutation in the mismatch repair (MMR) genes after information about this possible implication of genetic testing was included in updated consent forms. People who carry a germline MMR gene mutation are at greatly increased risk of colorectal cancer, especially at a young age; screening and early identification of carriers could be a highly cost-effective way to reduce our burden of the disease. Keogh and colleagues say that, unless addressed, the Australian insurance industry’s current position on genetic information could lead to damaging clinical and public health consequences (→ Is uptake of genetic testing for colorectal cancer influenced by knowledge of insurance implications?). Planning strategy A recently announced National Perinatal Depression Plan, with a budget of over $80 million, is to be implemented across Australia over the next 5 years. However, in For Debate, Yelland and colleagues question whether we have sufficient evidence to roll out the Plan. In particular, there is scant evidence of effectiveness for the first of three goals — routine screening for depression during pregnancy and a follow-up check at 2 months after birth — when currently available screening tools are used. The authors say new approaches to assessing and managing perinatal psychosocial issues need to be developed and evaluated before a universal population-based screening program is rolled out (→ A national approach to perinatal mental health in Australia: exercising caution in the roll-out of a public health initiative). The snake and the staff? “Twisted together like the snake and staff, doctors and drug companies have become entangled in a web of interactions as controversial as they are ubiquitous”, said Moynihan in the BMJ. Mitchell refers to the perspectives of Moynihan and others in a viewpoint about the relationship between members of the medical profession and the pharmaceutical industry. Mitchell believes that to ask the medical community to divorce itself completely from industry, as others have argued, would be unrealistic. Instead, he calls for integrity and transparency in such relationships (→ Winds of change: growing demands for transparency in the relationship between doctors and the pharmaceutical industry). A new dawn for health reform The dark clouds of our current global financial crisis may well have a silver lining. Lewis and Leeder point out that it is now fiscally impossible to extend the failed natural experiment of the past decade — of “spending”, rather than thinking, our way to try to achieve health care excellence. Pointing out that financial abundance neither eliminated fundamental problems in health care delivery nor reduced health disparities, Lewis and Leeder say that it is finally dawning on governments that improved health care quality costs less. Further, that the health systems that do best are attuned to users, rather than providers, of services (→ Why health reform?). Another time . . . another place It is a poor government that does not realize that the prolonged life, health, and happiness of its people are its greatest asset. Charles Horace Mayo, 1919
Ann Gregory
Editorials
From medical school to medical practice: a national tracking system to underpin planning for a sustainable medical workforce in Australasia
To provide the ongoing robust evidence needed for workforce planning, a national longitudinal study will itself need to be sustained into the future Globally, medical workforce shortages and maldistribution are major impediments to providing accessible, sustainable and safe health care.1,2 Strategic medical workforce planning is essential for resolving this problem. This requires up-to-date, robust data to predict future trends and, most importantly, give sound insights into the underlying determinants of workforce patterns and choices for workforce participation. Many countries have sought to develop appropriate medical workforce data collection mechanisms for tracking practitioners from graduation through employment, with varying degrees of success.3,4 Rural medical workforce shortages have been the impetus for several of these collections. Experience from these highlights the importance of comprehensive, systematic and ongoing quantitative data collection, and the value of establishing a minimum data collection system from the outset of a medical education program.5-9 In Australia and New Zealand, a small number of cross-sectional workforce studies have been undertaken in the past.10 A major limitation in using the disparate research outcomes of these to inform policy directions is the lack of connection between studies of students, current practitioners and past practitioners. Evaluations of government health workforce initiatives in Australia and New Zealand further emphasise the need for a uniform data collection methodology as the basis for tracking the progress of students throughout their training program and beyond.11-13 All of these approaches highlight the fundamental problem — a series of cross-sectional studies and evaluations “stitched together” to answer workforce questions will always provide less robust evidence than a well conducted, purpose-built, ongoing study. Sound medical workforce planning requires longitudinal data. Responding to this need, Medical Deans Australia and New Zealand (MDANZ) established the Medical Schools Outcomes Database (MSOD) and Longitudinal Tracking Project in 2005. This project collects reliable demographic and educational data about medical students across all Australian and New Zealand medical schools. To date, data have been collected on at least 11 200 medical students in Australia over 5 years of their training. Using an agreed national minimum dataset based on consistent definitions, the project targets critical times of medical career decision making — at the commencement of, and exit from, medical school; during the intern year; and during postgraduate training. Demographic information and data on vocational and practice location intentions are collected from surveys of students commencing medical school. Data obtained directly from the medical schools provide information on the nature of the students’ education and clinical experiences; for example, the length and nature of rural exposure, or membership of rural health clubs. Exit surveys of students again collect demographic data, vocational and practice location intentions, data on factors influencing career choices, and future contact details. Initial results from the MSOD show that length of residence in a rural area, generalist practice intention, and financially supported study (but not a bonded arrangement) are the strongest predictors of intention to take up rural medical practice. In addition, changing trends towards intended take-up of specialties are apparent — for example, a steadily increasing proportion of students intending to take up general practice was apparent between 2006 and 2008.14 In short, excellent data now exist to benchmark the impact of medical education and training activities. Success for this project requires more than a strong interest in evaluative medical education research. Other important catalysts have included champions (leading medical education researchers and medical school deans), resources (national funding provided by the Australian Government), a mandate (national auspicing by MDANZ to ensure comprehensive collection of relevant data), and timing (eg, to assess the impact and effectiveness of specific Rural Undergraduate Support and Coordination program funding designed to increase the numbers of students taking up rural practice). Importantly, the process for establishing the MSOD drew on international expertise to identify possible pitfalls and to help realise its potential. Professor Howard Rabinowitz, a rural workforce expert in the United States who played a leading role in a medical school longitudinal study in Pennsylvania, was engaged in an advisory capacity at the outset and continues to have an ongoing role. The MSOD will allow both short- and long-term monitoring and reporting on outcomes of medical education programs, and will inform national workforce policy implementation. It can contribute to evaluating the effectiveness of federally funded medical education initiatives in achieving improved medical workforce recruitment and retention. It complements activities of bodies such as the National Health Workforce Taskforce (NHWT), state and territory medical boards in Australia, and the Medical Council of New Zealand. It has the potential to link with data collected by the NHWT and other similar groups to track graduates after they leave medical school. This will allow further exploration of factors influencing career choice and destination, and continued data collection on the location and types of their clinical experience. Linking the MSOD with the forthcoming national medical registration system has the potential to identify specialty, practice location and changes in patterns of medical practice. In addition, the MSOD project offers a facility for conducting targeted substudies of specific policy or research questions, not unlike other well known longitudinal studies such as the 45 and Up Study.15 The project has access to 100% of the relevant student doctor population, and to date has achieved a student participation rate of around 95%, providing a high-quality sampling frame on which to base any empirical study. MDANZ considers MSOD an essential resource and is fully committed to its success — but is this sufficient to ensure its sustainability? Given the tyranny of distance, the process of bringing diverse groups together has required fostering trust and collegiality among all players around a shared project goal, in order to minimise competition and apprehension. Moreover, longitudinal studies have a long lead time before results become apparent, and convincing funders that outputs will justify the time and resources needed requires good ongoing communication and strong partnership arrangements. The Australian Government Department of Health and Ageing has provided crucial financial support that has produced a solid foundation without which the MSOD project would not have progressed. Several factors have been built into the project with a view to ensuring its sustainability. The database has not been produced by any one individual, university or workforce organisation. Instead, a collective approach that reflects all parties as equal partners is led by the MDANZ steering and management group. The process is underpinned by project officers who liaise with stakeholders. Project objectives, processes and desired outcomes are shared by all parties, and stakeholders are regularly engaged in full and open discussion of any likely sticking points, including ethics, ownership of data, roles and responsibilities. Agreed principles (such as simplicity, necessity, consistency, objectivity, sufficiency and relevance) guide the data collection process and support the intended outcomes. While all medical schools share a belief that the total good is more valuable than the sum of the parts, there is ample opportunity within the MSOD and Longitudinal Tracking Project to conduct rigorous substudies, either by individual medical schools or in partnership with others. Sound medical workforce policy decisions and reforms cannot be made in the absence of quality longitudinal data. The MSOD project is unique, well established and running effectively. With the continued and sustained commitment of MDANZ and the Department of Health and Ageing, the full potential of this resource as a valuable platform for informing a more coordinated approach to medical workforce planning will be realised.
John S Humphreys BA(Hons), DipEd, PhD · David Prideaux BA(Hons), MEd, PhD · Justin J Beilby MB BS, MD, FRACGP · Nicholas J Glasgow MB ChB, MD, FRACGP
Child protection and the health professional: mandatory responding is our duty
Don’t just report, respond — inaction injures children Every Australian state has enacted mandatory reporting of child abuse. Child abuse is a ubiquitous problem affecting at least one in 13 children, and among Indigenous Australians, this rate is higher.1 The most important comorbidities for child abuse — poverty, domestic violence, mental ill health and substance misuse2 — are seen by all health professionals on a daily basis. Mandatory reporting of child abuse aims to achieve better outcomes for children and families where abuse is thought to have occurred or has occurred. It arose in the United States out of the correctly perceived need to allow health workers to report concerns about child abuse to statutory child protection agencies without fear of subsequent litigation for breach of confidentiality. The assumption is that the child protection agency will pick up the baton and protect the child. Current research clearly indicates that this is not the case.3 The recent Wood Inquiry into the New South Wales child protection agency (Department of Community Services) has outlined the perils of this false expectation; no child protection agency can cope with all the referrals that it receives.4 Mandatory reporting is not essential to good child protection. However, good communication between agencies and practitioners is essential; when this fails, disaster strikes. There are, sadly, many examples of these failures in Australia (where the case of Daniel Valerio is one of the best known5) and overseas (eg, the cases of Victoria Climbié6 and Baby P7). Management of child abuse does require mandatory responding. There is an obligation on each and every one of us who work in the community as a health professional to respond, and this must involve more than completing a mandatory reporting form. If we are to make a difference to children’s lives, all health professionals must respond when they suspect child abuse. The difficulty for all of us is that, unlike in other areas of medical practice, few patients are either willing or able to outline their suffering in a standard consultation. On many occasions, the parent deliberately sets out to mislead the practitioner in situations where child protection issues exist. This may be done maliciously, out of pride, or out of fear of prosecution. Thus health professionals need to have an index of suspicion, and then act on that suspicion in a way that does not jeopardise further the safety of the child. This suspicion is often outside the comfort zone of many health care practitioners. Of reports made to statutory agencies, substantiation rates vary from 2.4 to 9.3 per 1000 reports.1 Substantiation is not a cure for the child in question; all it does is confirm that the original concerns were correct and that the child needs help. The vast bulk of cases are unable to be substantiated, and this may result in the protection agencies feeling that such cases are no longer a priority; this potentially endangers children even further. The onus is thus on health practitioners, you and me, to respond.8 How can we do this? Responding can take many forms, depending on what is needed. It must never be assumed that someone else will fix it. If a particular case requires major social intervention, and if statutory agencies have not acted or have acted inappropriately, phone/write/fax/email them and alert them to your concerns. On occasion it may entail being more tenacious than you are used to being. If the issue is the mental ill health of a parent or child, ensure that the parent gets help either from you or from someone else. This may require repeated contact with mental health agencies. Mental Health Care Plans are very useful in this setting. Child abuse is a criminal matter that puts children at risk. In such cases, ensure that police are involved and are taking appropriate action. If there are medical matters affecting a parent’s ability to parent, these need to be addressed. If you are in doubt about what you see when a child presents, arrange for the child to be admitted and for the protection issues to be investigated while the child is safe. At a general practice level, responding appropriately in child protection cases may involve reviewing the patient on a number of occasions in order to obtain a clearer picture, and being in contact with your local child protection agency and other health care providers. Doctors often falsely believe that they can do better alone than by involving child protection services.9 Every capital city in Australia has at least one child protection unit at their children’s hospital, from where advice can be obtained. There is often a moral and legal fear that reporting may do more harm than good for the child and his or her family. A groundless report can cause anguish; however, inaction injures many more children than the odd report that should not have occurred. With Australia-wide mandatory reporting, the onus is now on us to provide mandatory responding. Only by responding in an appropriate manner, case by case, will we be able to facilitate better outcomes for children and, in turn, for society at large. Mandatory responding at the individual level and as a public health issue is the universal panacea for child abuse; mandatory reporting is only one tool in that response.
Peter M Winterton BA, MB BS, FRACGP
Translational research and rational therapy: structural barriers in Australia
“Second-generation” clinical trials are refining the use of toxic and expensive drugs, but “silo” regulatory and funding structures prevent Australia participating The development of drugs aimed at new molecular targets exemplifies the power of translational research — “bench to bedside” translation of biomolecular science into clinical practice — to offer both significant clinical outcomes and the opportunity for commercial benefit. Classic examples are the monoclonal antibody trastuzumab for HER-2 receptor-positive breast cancer and the “designer” small-molecule inhibitor imatinib for BCR/ABL-positive chronic myeloid leukaemia.1,2 However, in Australia, there are structural constraints on funding for translational clinical research that prevent us participating fully in its clinical and financial benefits. To understand these constraints, we need to examine the roles of the various regulatory and funding bodies in Australia — the Pharmaceutical Benefits Scheme (PBS), Medical Services Advisory Committee (MSAC), Medicare, and the National Health and Medical Research Council (NHMRC). We also need to consider their different attitudes to “primary” and “second-generation” clinical trials. Pharmaceutical companies devise clinical trial strategies to register their drugs as rapidly as possible. These “primary” trials are conducted by large groups and provide high statistical power;3 the resulting data form the basis for drug marketing and reimbursement in Australia by the PBS. In contrast, “second-generation” trials apply new pathological and radiological technologies to refine treatment schedules and identify patient subgroups in whom new drugs have optimal clinical and cost-effectiveness. Second-generation trials have the potential both to improve clinical outcomes and to reduce costs. In Europe, second-generation studies refining dosage and patient subgroups are emerging through government-funded cooperative trial groups. Such studies require integrated funding of imaging, molecular analysis and pharmaceutics. This is currently not possible in Australia, reflecting “silo”-like structural barriers that prevent the PBS, MSAC and Medicare commissioning research. These regulatory bodies are unable to look beyond primary marketing data submitted by industry. They are unable to commission evaluation of the integration of diagnostic and therapeutic modalities. The optimal indications, schedules and duration of use of expensive pharmaceuticals cannot be effectively investigated in Australia — our superb collaborative clinical trial organisations are structurally limited to first-generation industry-funded studies, unless they can obtain funding through competitive grant systems that are neither pragmatically nor economically orientated. Two examples of second-generation trials that Australian groups have not accessed, reflecting the inability of the regulatory silos to fund such activity, are: Trastuzumab in HER-2 receptor-positive early breast cancer.4 Based on initial trials, current therapy is a 1-year course of the monoclonal antibody trastuzumab, at a cost to the PBS of about $50 000 per course. Separate European groups are currently investigating 3-month and 6-month versus 12-month courses with potential for dramatic cost savings and reduction in toxicity. Oxaliplatin in stage II colorectal cancer.5 Current therapy includes a 6-month course of this expensive and toxic drug at an overall cost of about $20 000. European groups are comparing 3-month versus 6-month courses, which could increase cost effectiveness and reduce toxicity. An application by an Australian group to the NHMRC to fund participation in this cost-neutral study was not ranked highly enough based on “lack of innovation” (Professor J Zalcberg, Peter MacCallum Cancer Institute, Melbourne, VIC, personal communication). A solution to the disconnection between regulation and funding could be to develop relationships between the PBS, MSAC, Medicare and others to address funding of the translation of new diagnostic and therapeutic technologies into practice. The treatment of cancer is an ideal model for this, given its interdependence on imaging, molecular pathology and targeted therapeutics.6 The stakes are high. In the 2005–06 financial year, the PBS cost7 Australia more than $6 billion, and its cost is increasing rapidly. The current Health Technology Assessment review to examine Therapeutic Goods Administration and MSAC procedures may solve some of these problems; it has noted the need to coordinate Pharmaceutical Benefits Advisory Committee and MSAC recommendations.8 One solution could be the creation of an “Emerging Technology Assessment Group”, representing the PBS, MSAC, Medicare, NHMRC and the cooperative clinical trials groups, supported by health economics input. This group could recognise emerging issues and commission appropriate second-generation trials. These would almost certainly be associated with international groups using the European model. These trials would be cost-neutral, reflecting reduced drug usage in the experimental arms. There may even be a place for a “health dollar offset trading scheme” (analogous to carbon emissions trading schemes) between the PBS, MSAC and Medicare. The second-generation trials would represent a new form of postmarketing surveillance, with the emphasis moving from assessing toxicity to optimising clinical and cost outcomes through the application of technology to translate into rational therapeutics. We should not adopt the simplistic solution of using NHMRC funding for these trials, as this would exacerbate the cost-transfer silo problem. The scheme should also recognise the need for Australian Health Care Agreements to appropriately support clinical research and infrastructure funding in teaching hospitals.
Richard M Fox MB BS, PhD, FRACP
Research
An expert-supported monitoring system for patients with chronic obstructive pulmonary disease in general practice: results of a cluster randomised controlled trial
Objective: To investigate the long-term effectiveness of a general practice monitoring system with respiratory expert recommendations for general practitioners’ management of patients with chronic obstructive pulmonary disease (COPD), compared with usual care. Design, settings and participants: A multicentre randomised controlled trial of patients with COPD, clustered by general practices; 200 participants were recruited to maintain at least 75 participants per group for analysis. The trial took place from July 2005 to February 2008 in the south-western region of the Netherlands.Intervention: Ongoing half-yearly monitoring of COPD patients with respiratory expert recommendations for the GP was compared with usual care.Main outcome measures: Primary outcome — Chronic Respiratory Questionnaire (CRQ) score; secondary outcomes — CRQ domain scores, generic health-related quality of life (Short-Form 12 and EuroQol-5D), breathlessness (Modified Medical Research Council score), exacerbations, and decline in forced expiratory volume in 1 second. A detailed process evaluation was performed along with the trial.Results: Data from 170 participants were analysed. Based on repeated measurement analyses, the additional gain in CRQ score during follow-up was 0.004 points for monitoring compared with usual care (95% CI, − 0.172 to 0.180). Also, no important differences between monitoring and the usual care group were found for secondary outcomes. Half the monitoring visits resulted in disease management recommendations by a respiratory expert, and 46% of these recommendations were implemented by the GPs. Patient adherence to lifestyle recommendations was low.Conclusion: An expert-supported monitoring system for patients with COPD was not clinically effective. As patients had a pre-existing entry in the monitoring system, the population may be well regulated, with reduced room for improvement.Trial registration: www.clinicaltrials.gov NCT00542061.
Lisette van den Bemt MSc · Tjard R J Schermer PhD · Ivo J M Smeele MD, PhD · Leandra J M Boonman-de Winter MSc · Ton van Boxem MD, PhD · Joke Denis · Joke G Grootens-Stekelenburg · Richard P T M Grol PhD · Chris van Weel MD, FRCGP, FRACGP
Is uptake of genetic testing for colorectal cancer influenced by knowledge of insurance implications?
Objective: To assess whether knowledge of insurance implications influenced uptake of genetic testing by participants in a research study of the causes of colorectal cancer.Design, setting and participants: Analysis of uptake of genetic testing by participants in the population-based Victorian Colorectal Cancer Family Study during two periods: from 1999 to 2003, when participants were not informed of any potential effect of genetic testing conducted during the study on their eligibility for new insurance policies; and from 2003 to 2006, when the protocol was changed to provide participants with information on the potential effect of genetic testing on insurance eligibility.Main outcome measure: Uptake of genetic testing for germline mutations in DNA mismatch repair (MMR) genes at a family cancer clinic.Results: The proportion of participants who declined genetic testing among those informed of insurance implications was more than double the proportion among those without this knowledge (29/59 [49%] v 9/47 [19%]; P = 0.002). This difference could not be explained statistically by adjusting for measured putative predictors.Conclusion: Identification of people with a mutation in an MMR gene has clinical importance, and such screening may be a cost-effective way to reduce the burden of colorectal cancer in the community. If people are choosing not to obtain genetic information because of how it will affect their eligibility for insurance, reforms to existing insurance practices are indicated.
Louise A Keogh BSc, MA, PhD · Christine M van Vliet BSc, MB BS, MPH · David M Studdert LLB, ScD · Judith A Maskiell BSc(Nursing), GradDip(BusMgt) · Finlay A Macrae FRACP, FRCP, MD · D James St John MB BS, MD, FRCP · Clara L Gaff BSc, FHGSA(GenCounsel), PhD · Mary Anne Young GradDip(FamilyTherapy), FHGSA(GenCounsel), MHSc(GenCouns) · Melissa C Southey BSc, PhD, GradDipLaw · Graham G Giles BSc, MSc, PhD · Doreen A Rosenthal BA, PhD · John L Hopper BSc, MSc, PhD · Mark A Jenkins BSc, PhD
Adequacy of consent documentation in a specialty surgical unit: time for community debate?
Objective: To determine the adequacy of consent documentation related to descriptions of intended procedures, associated risks and treatment alternatives, and to analyse trends in the adequacy of consent documentation in a specialty surgical unit.Design, patients and setting: Retrospective reviews of consent forms for all patients on the Urology Unit waiting list of the Repatriation General Hospital, Adelaide on three occasions. Reviews were undertaken during 2005, 2007 and 2008, with a minimum of 12 months between reviews.Results: 1280 consent documents were evaluated. No trend in the studied criteria of adequacy of documentation was observed during the study period. Overall, 18.5% of consent forms described procedures using plain language. In 15.3% of consent forms, a significant component of the procedure was described using only an acronym, without further explanation. In 6.6% of consent forms, procedure descriptions contained only acronyms, abbreviations or technical terminology, with no plain language word. The purpose of the operation was conveyed in 10.1% of consent forms. Relevant risks were provided in 4.1%. Any indication of the magnitude of procedural risks was provided in only four of 1280 forms. No consent form provided information about alternative treatments.Conclusions: We believe these findings are broadly representative of current hospital practice and that the community should consider whether an acronym or technical terminology is appropriate for documenting consent. If not, can minimum practice standards be defined, and should any emerging recommendations be mandated?
Mark T Siddins MB BS(Hons), MS, FRACS(Urol) · Elizabeth M Klinken BM BS, BSc · Lee R Vocale BM BS, BSc
Systematic review
Is reflexology an effective intervention? A systematic review of randomised controlled trials
Objective: To evaluate the evidence for and against the effectiveness of reflexology for treating any medical condition.Data sources: Six electronic databases were searched from their inception to February 2009 to identify all relevant randomised controlled trials (RCTs). No language restrictions were applied.Study selection and data extraction: RCTs of reflexology delivered by trained reflexologists to patients with specific medical conditions. Condition studied, study design and controls, primary outcome measures, follow-up, and main results were extracted.Data synthesis: 18 RCTs met all the inclusion criteria. The studies examined a range of conditions: anovulation, asthma, back pain, dementia, diabetes, cancer, foot oedema in pregnancy, headache, irritable bowel syndrome, menopause, multiple sclerosis, the postoperative state and premenstrual syndrome. There were > 1 studies for asthma, the postoperative state, cancer palliation and multiple sclerosis. Five RCTs yielded positive results. Methodological quality was evaluated using the Jadad scale. The methodological quality was often poor, and sample sizes were generally low. Most higher-quality trials did not generate positive findings.Conclusion: The best evidence available to date does not demonstrate convincingly that reflexology is an effective treatment for any medical condition.
Edzard Ernst MD, PhD, FMedSci
Pandemic (H1N1) 2009
The community’s attitude towards swine flu and pandemic influenza
Objective: Design, setting and participants: Cross-sectional survey of Sydney residents during WHO Phase 5 of pandemic (H1N1) 2009. Members of the public were approached in shopping and pedestrian malls in seven areas of Sydney between 2 May and 29 May 2009 to undertake the survey. The survey was also made available by email.Main outcome measures: Perceived personal risk and seriousness of the disease, opinion on the government and health authorities’ response, feelings about quarantine and infection control methods, and potential compliance with antiviral prophylaxis.Results: Of 620 respondents, 596 (96%) were aware of pandemic (H1N1) 2009, but 44% (273/620) felt they did not have enough information about the situation. More than a third (38%; 235/620) ranked their risk of catching influenza during a pandemic as low. When asked how they felt pandemic influenza would affect their health if they were infected, only a third (33%; 206/620) said “very seriously”. Just over half of the respondents (58%; 360/620) believed the pandemic would be over within a year. Respondents rated quarantine and vaccination with a pandemic vaccine as more effective than hand hygiene for the prevention of pandemic influenza.Conclusions: Emphasising the efficacy of recommended actions (such as hand hygiene), risks from the disease and the possible duration of the outbreak may help to promote compliance with official advice.
Holly Seale BSc, PhD · Mary-Louise McLaws DipTropPH, MPH, PhD · Anita E Heywood BSc, MPH · Kirsten F Ward BHthSci(Public Health) · Chris P Lowbridge RN, BAppSci, MPH · Debbie Van · Jan Gralton BSc · C Raina MacIntyre MB BS, PhD, FRACP
Health care reform
Why health reform?
Traditional health care is fragmented, marred by quality and safety defects, with a failure to provide evidence-based care, and huge and unjustifiable variations in practice. There is abundant evidence that traditional means of delivering health care are obsolete. Concerns are deepening about persistent and widening gaps in health status that health care cannot overcome. Increased spending on health care has never definitively solved the problems of access, quality, or equity. Non-medical determinants of health indicate that the solutions to health problems lie mainly outside health care. The current financial crisis may create the urgency and courage to both eliminate the fundamental problems in health care delivery and reduce health disparities.
Steven J Lewis MA · Stephen R Leeder MD, PhD, FRACP
Viewpoint
Winds of change: growing demands for transparency in the relationship between doctors and the pharmaceutical industry
The relationship between medicine and the pharmaceutical industry in the United States is undergoing rapid and momentous change; US Senator Grassley has alleged inadequate disclosure of earnings from industry and lack of acknowledgement of conflicts of interest by leading academics. This article is based on the premise that it is not the relationship per se that is the problem, but rather how that relationship is enacted. The influential 2008 report of the Association of American Medical Colleges (AAMC) has provided detailed recommendations on appropriate interactions between academic physicians and industry (eg, proscribing receipt of gifts including travel support, and proscribing speaking at industry-sponsored educational programs). Contrary to expectations, there has been widespread acceptance of such guidelines. In Australia, details of all industry-sponsored educational events are now listed on the Medicines Australia website. Australian doctors have no alternative but to drastically improve the transparency of their interactions with industry, both in terms of the remuneration received and disclosure of potential conflicts of interest. Australian universities should seriously consider developing recommendations similar to those of the AAMC.
Philip B Mitchell MD, FRANZCP, FRCPsych
For debate
A national approach to perinatal mental health in Australia: exercising caution in the roll-out of a public health initiative
Perinatal depression is an important public health issue, with major consequences for the mother, child and family. Perinatal depression is often associated with anxiety and other mental health and psychosocial issues. The National Perinatal Depression Plan (NPDP) proposes routine screening during pregnancy and after birth, follow-up support for women assessed to be at risk of or experiencing depression, and training for health professionals. Identifying women at risk of or experiencing perinatal depression is difficult, and there is no standard tool used by all hospitals to assess women’s emotional health and psychosocial comorbidities. The NPDP provides an opportunity to develop and evaluate new approaches to assessing perinatal depression and a range of psychosocial issues, and to test strategies for supporting women and their families before and after birth.
Jane S Yelland BAppSc, PhD · Georgina A Sutherland BAppSci(Hons), PhD · Jan L Wiebe BHlthEd, MWomHlth · Stephanie J Brown BA(Hons), PhD
Research enterprise
A case study evaluation of ethics review systems for multicentre clinical trials
Objective: To evaluate the difference in time taken for ethics and site governance approval for multicentre clinical trials using two different systems of ethics review.Design: We evaluated the times to final ethics and governance approval for two international, multicentre clinical trials of treatment for metastatic colorectal cancer: the MAX trial, using a non-centralised ethics review system, and the CO.20 trial, using the new New South Wales centralised ethics review system.Main outcome measure: Time from trial submission to overall study approval.Results: The median time taken to obtain ethics approval for the MAX trial at 16 NSW sites was 100 days (range, 36–161 days). The median time to obtain central ethics approval for the CO.20 trial at 14 NSW sites was 77 days, with an additional 60 days (range 20–79 days) required to obtain site-specific research governance approval.Conclusions: Any difference in time to approval between the review systems was outweighed by the overall time taken. However, the time spent by both the coordinating centre and local sites in collation, submission and correspondence was greatly reduced, and the centralised process allowed for standardised documentation at all study sites.
Sian C Hicks BSc(Hons), PhD · Rebecca E James BA/BSc, GradDipEd, MScMed · Nicole Wong RN, BN, BSc(Hons) · Niall C Tebbutt BM BCh, PhD, FRACP · Kate Wilson BA, MPH
Diagnostic dilemmas
Acute psychiatric illness in a young woman: an unusual form of encephalitis
A 21-year-old woman was admitted to hospital with a diagnosis of acute psychotic mania, but developed, over approximately 6 weeks, seizures, delirium, catatonia, movement disorder and autonomic dysfunction. She was found to have antibodies to N-methyl-d-aspartate (NMDA) NR1–NR2 receptors in both serum and cerebrospinal fluid, consistent with anti-NMDA-receptor encephalitis, a severe, potentially lethal but treatment-responsive encephalitis often associated with ovarian tumour. With aggressive immunotherapy and bilateral oophorectomy, she recovered over a period of 14 months from her initial presentation. No ovarian tumour was identified. (MJA 2009; 191: 284-286) Clinical recordA 21-year-old Indigenous woman was admitted to hospital with an acute change in mental state over the preceding 24 hours. She had become agitated, was pressured in speech and singing constantly. In the weeks before presentation, family members had noted increasingly disorganised behaviour and altered sleep patterns. The patient’s family history included schizophrenia in a second-degree relative. The patient had used marijuana at least weekly for several years, but had no history of alcohol misuse. She had completed tertiary studies in the previous 18 months. On psychiatric evaluation, the patient was markedly manic, with pressure of speech, elevation of mood, disinhibited behaviour, insomnia and constant loud singing. She showed delusions of special powers, such as the ability to predict the future. There were no features of delirium at this time. A provisional diagnosis of psychotic mania was made, and treatment commenced with olanzapine and sodium valproate. Olanzapine was titrated to 10 mg twice daily and sodium valproate to 1 g twice daily over several days. Persistent profound disinhibition was partly alleviated with low doses of chlorpromazine. Intramuscular midazolam was used in the early stages for agitation but later withdrawn. A low-grade fever was noted, and treatment was begun for a microbiologically proven urinary tract infection. Ten days after admission, a 2-minute generalised tonic–clonic seizure was witnessed. This was thought most likely to be a consequence of withdrawal of midazolam and concurrent urinary tract infection. A computed tomography (CT) scan of the brain appeared normal. An electroencephalogram (EEG) was not performed because of the patient’s inability to comply with the procedure. Over the subsequent 2 weeks, she was noted to have features of delirium with agitation. A further seizure was witnessed on Day 28 of admission, with subsequent fluctuation between delirium with aggressive outbursts and signs consistent with catatonic stupor, including waxy flexibility, posturing, staring, mutism and stereotyped behaviour. The patient lost considerable weight. Magnetic resonance imaging (MRI) of the brain revealed two small foci of T2 hyperintensity in the right frontal lobe of uncertain significance. Cerebrospinal fluid (CSF) protein and glucose levels were within reference ranges, as were CSF cell counts. CSF culture showed no growth, and polymerase chain reaction tests of CSF for herpes simplex virus were negative. Oligoclonal bands were detected in both CSF and serum. The full blood count showed macrocytosis. Serum levels of vitamin B12, folate and thyroid antibodies, results of thyroid function tests and biochemical parameters were within reference limits, and the autoimmune profile was normal (including antinuclear, extractable nuclear antigen, antineutrophil cytoplasmic, double-stranded DNA, lupus anticoagulant and cardiolipin antibodies, and complement levels). Serological tests gave negative results for syphilis, HIV and hepatitis. On Day 44 of admission, the patient developed a low-grade fever, increased rigidity and an elevated serum level of creatine kinase (1459 U/L; reference range, 0–175 U/L), suggestive of neuroleptic malignant syndrome. Olanzapine was withdrawn, and a course of electroconvulsive therapy (ECT) commenced. After the first and only ECT treatment, fever recurred and the patient continued to display features of catatonic stupor. Four days later, she had a right-sided focal motor seizure with secondary generalisation. Endotracheal intubation and artificial ventilation were required for safe management; brain imaging repeated at this time was unchanged. An EEG showed diffuse 3 Hz delta slowing, indicative of diffuse cerebral dysfunction. Anti-epileptic therapy was escalated over several days, with the addition of levetiracetam (1500 mg twice daily), topiramate (50 mg twice daily) and phenobarbitone (30 mg three times daily). On Day 45, paroxysms of rigidity with arching of the back associated with orobuccal stereotypies and rapid eye movements were noted. Fever persisted and continuous buccolingual dyskinesia evolved, with “rabbit-like” movements of the lips and nose and involuntary stereotyped repetitive rolling movements of the tongue. The abnormal movements did not occur, or appear consistent, with seizure activity. Over the next 5 days, the clinical picture alternated between rigidity, with buccolingual dyskinesia and posturing, and periods of profound agitation, when the patient would scream uncontrollably and climb out of bed. Two further generalised tonic–clonic seizures occurred, and the score on the Glasgow Coma Scale fluctuated between 4 and 6. Infectious or autoimmune encephalitis had been considered as possible diagnoses, along with non-convulsive status epilepticus and inherited or acquired metabolic disorders. Paraneoplastic immune-mediated encephalitis was postulated and, while serum and CSF samples were sent for analysis, empirical treatment with intravenous immunoglobulin was commenced on Day 53 of admission. An intravenous dose of immunoglobulin 0.4 g/kg daily was given for 5 days. It was chosen as the first-line immunotherapy to avoid the possible psychiatric side effects of high-dose corticosteroids confusing the clinical response. Blood samples were analysed for antibodies, including anti-Hu, anti-Yo, anti-Ri, anti-CV2, anti-Ma and amphiphysin, all of which were negative. The search for an underlying malignancy ensued, particularly ovarian teratoma because of its association with anti-N-methyl-d-aspartate (NMDA)-receptor encephalitis. No malignancy was found despite extensive investigations, including CT, transabdominal and transvaginal ultrasonic scanning, MRI of the pelvis and whole-body fluorodeoxyglucose positron emission tomography. Despite modest improvements after the initiation of intravenous immunoglobulin, the patient’s condition further deteriorated, and a trial of intravenous methylprednisolone 1 g daily for 5 days was given. Over the following 2 weeks, the patient’s body was less rigid, she began using single words to express needs and was able to follow simple commands. However, her behaviour remained markedly abnormal, with singing and mumbling to herself and persistent buccolingual dyskinesia. During this period of modest improvement, the results of paraneoplastic antibody testing confirmed the presence of antibodies to NMDA NR1–NR2 receptors in both serum and CSF. (This testing was performed by J D at the University of Pennsylvania, Philadelphia.) Given the limited response to intravenous immunoglobulin and methylprednisolone, plasmapheresis was commenced but failed to have a significant effect on recovery. The patient remained significantly disabled after 9 weeks of immunotherapy, including a repeat pulse of 5 days of intravenous methylprednisolone given 6 weeks after the first dose. In view of the known strong association of anti-NMDA-receptor encephalitis with ovarian teratoma, and evidence that tumour removal expedites recovery, the possibility of oophorectomy was discussed in detail by members of the neurology, psychiatry, intensive care and gynaecology teams, together with the patient’s legal guardian. Although investigations did not yield evidence of a tumour, the strong association coupled with the possibility of microscopic disease led to the decision to perform a laparotomy and bilateral oophorectomy on Day 120 of admission. No ovarian tumour was identified microscopically. There was no evidence of mediastinal teratoma on imaging. Immunomodulation was maintained with the introduction of rituximab. These interventions were accompanied by rapid improvements in the patient’s rigidity and buccolingual dyskinesia. Given concurrent management with surgery and immunotherapy, it is not possible to determine the relative effect of each intervention on the patient’s recovery. The patient’s behaviour and communication improved gradually over a period of 9 months, and neuropsychological testing 14 months after her initial presentation showed her cognitive performance to be in the high–average range across domains. DiscussionAnti-NMDA-receptor encephalitis is an immune-mediated encephalitis that predominantly affects young women and has a strong association with underlying ovarian teratoma. It usually presents in the second to fifth decade of life,1 with a median age of onset of 23 years.2 Cases occurring in children and male patients have been identified.2-5 The incidence is unknown. Before the detailed description of four cases in 2005, only five cases had been reported in the English literature.6 A hundred cases have now been clinically characterised, suggesting that this disorder has been under-recognised in the past.2 The clinical syndrome (Box) begins with a prodromal illness of fever, headache or viral-like symptoms,3 followed by an acute- to subacute-onset psychiatric illness.1 Our patient presented with all the criteria, as listed by the Diagnostic and statistical manual of mental disorders, fourth edition, of a manic phase of bipolar illness,7 illustrating how difficult it may be to diagnose this illness at presentation. Short-term memory loss or seizures, alone or in combination with psychiatric manifestations, occur less commonly.2 The psychiatric presentation is typically followed by seizures. A state of unresponsiveness evolves with the patient appearing mute and akinetic. Akinesia may alternate with agitation.2 Autonomic instability is common at this stage,1 and mechanical ventilation is often required.2,3 Hyperkinetic movement disorder is characteristic, specifically orobuccal dyskinesia,2 as seen in our patient. About 60% of patients have an underlying tumour, usually a cystic ovarian teratoma.2,3 The teratoma can be benign or malignant. The neurological syndrome precedes the diagnosis of tumour in most cases.1,2 CSF lymphocytic pleocytosis is characteristic,1,2 with elevated CSF protein levels and oligoclonal bands seen in some cases. MRI findings often lack changes localised to the mesial temporal lobes as seen in other forms of paraneoplastic limbic encephalitis. Small punctate T2 hyperintensities in the frontal and parietal cortex, meningeal enhancement or a normal appearance on imaging have all been reported. Only 55% of patients in the recent case series had MRI abnormalities in one or several brain regions.2 An EEG classically shows diffuse delta activity. Investigations for viral, bacteriological and fungal pathogens, and for systemic autoimmunity, thyroid autoimmunity and classic antineuronal antibodies are negative. All cases show antibodies to the NMDA receptor.1 This receptor is made up of a heteromer containing two of each of the NR1 and NR2 subunits. The main epitope targeted by antibodies is the extracellular domain of the NR1 subunit.2 Antibodies reduce the number of cell surface NMDA receptors in cell cultures, and this effect can be reversed by antibody removal.2 In the clinical context, improvement is associated with a decrease in serum antibody levels.2 Recommended management is removal of the tumour and aggressive immunotherapy. Options include corticosteroids, plasma exchange, intravenous immunoglobulin, rituximab, cyclophosphamide and azathioprine. If one type of immunotherapy is ineffective, the condition may respond to another type. Tumour removal expedites recovery and reduces relapses.2,3,8,9 The relative effect of tumour removal versus immunotherapy is difficult to discern as these interventions are usually carried out simultaneously. Recovery is typically slow and may take many months. In the case series of 100 patients, 75% recovered or had mild deficits, the most common being signs of frontal lobe dysfunction and sleep disturbance.2 A characteristic feature of patients who recover from anti-NMDA-receptor encephalitis is persisting amnesia for the entire period of illness.2 Interestingly, detection of an ovarian teratoma is a good prognostic factor as the tumour is most often curable. Relapse is more common in patients with undetected or recurrent tumour.2 Anti-NMDA-receptor encephalitis is a severe, potentially lethal but treatment-responsive encephalitis, often associated with benign tumour. It provides an autoimmune model of movement, psychiatric and cognitive disorders. Practitioners across the disciplines need to be aware of this recently recognised entity to ensure effective treatment and favourable outcomes. Clinical features of anti-N-methyl-d-aspartate-receptor encephalitis Prodromal illness Fever; headache; viral-like symptoms Psychiatric symptoms at presentation Personality and behavioural changes; agitation; paranoid delusions; hallucinations; mania; catatonia Seizures Complex partial and/or generalised seizures Movement disorder Orobuccal dyskinesia; choreoathetosis; ballistic movements; dystonic posturing; rhythmic abdominal contractions; opisthotonus-like postures; catatonia Reduced level of responsiveness Akinesia alternating with agitation; paradoxical responses, including visual tracking Autonomic dysfunction Hyper/hypothermia; tachy/bradyarrhythmia; hyper/hypotension; central hypoventilation often requiring endotracheal intubation and mechanical ventilation
Kaitlyn L Parratt MB BS(Hons), FRACP · Martin Allan MB ChB · Simon J G Lewis MB BCh, MRCP, MD · Josep Dalmau MD, PhD · Gabor M Halmagyi MB BS, MD, FRACP · Judith M Spies MB BS, PhD, FRACP
Letters
Australia’s influenza containment plan and the swine flu epidemic in Victoria
To the Editor: Grayson and Johnson’s editorial of 17 June1 and Eizenberg’s viewpoint article of 1 July2 both betray blind spots regarding Victoria’s laboratory response to pandemic influenza (H1N1) 2009 (“swine flu”) and the role of the Victorian Infectious Diseases Reference Laboratory (VIDRL). Grayson and Johnson incorrectly suggest that Victoria’s swine flu infection case definition represented a barrier to laboratory testing and detection of disease spread. Between 18 April 2009 (when the second case was identified in the United States) and 18 May 2009 (when the first case was identified in Victoria), VIDRL tested more than 500 specimens for respiratory viruses. All 16 influenza viruses detected were seasonal influenza strains. Swine flu testing was appropriately reserved for cases with a high pre-test probability of being positive, and even in this at-risk population, no positive cases were detected. The same authors highlight VIDRL’s prominent role in public hospital testing for viral diseases, but mistakenly conflate this with public health laboratory support of infectious disease outbreaks, as if concentration of diagnostic virology at VIDRL were a matter of policy. VIDRL’s diagnostic service is available to Victorian health care institutions for as long as they elect to refer specimens. There is no barrier to decentralising this capacity through access to appropriate new technology and scientific expertise. Nevertheless, centralisation of laboratory capability with optimised specimen transport and reporting offers an arguably more efficient model, and is widely used for this reason. On the other hand, VIDRL’s public health role in supporting the Victorian Department of Human Services’ (DHS’s) outbreak response capability represents a deliberate centralisation of capacity — for good reasons. Public health laboratory testing needs enormous surge capacity — on 1 June 2009, for example, we processed 1004 specimens requiring 1401 swine flu polymerase chain reaction (PCR) tests in a laboratory normally doing 100 respiratory tests daily. Public health laboratories also require expertise to develop, validate and perform essential tests during the early high-pressure phase of an outbreak, while also working closely with the DHS to manage the large patient data flows that underpin public health actions. There is nothing visionary about frittering away this crucial response capacity by devolving responsibility to a series of small nodes, each below critical mass. Both Grayson and Johnson and Eizenberg make misleading generalisations about test turnaround times and refer to non-existent backlogs. On 1 June, the most demanding day of the swine flu outbreak, the mean turnaround time for the 1401 PCR tests performed was 24 hours, with 90% of samples being tested within 32 hours of receipt. There are several reasons outside VIDRL’s control why occasional delays might have occurred. Firstly, transport from point of collection to VIDRL was often slow (1–3 days, with few if any public hospitals achieving faster times). Secondly, more than 10% of samples arrived with missing or incorrect information regarding addresses for reports. Eizenberg should note the high number of general practitioners completing a private pathology provider’s request form but sending the specimen directly to VIDRL, causing delay while results went to the apparent referring laboratory. More than 200 specimens arrived with no request forms at all. Finally, many organisations had no mechanism in place for receipt of large numbers of test results late in the evening, when VIDRL was continuing to work. With Victoria’s move to the “Sustain” phase of the pandemic influenza plan on 3 June, test capacity was directed to defined clinically at-risk patients.3 Many hundreds of samples not meeting the criteria for testing continued to arrive each day. Between 5 and 16 June, these were stored but not tested, and an immediate report went to the sender saying so, and explaining why. Although the capacity to test approved samples was never under threat, stocks of key PCR reagents were transiently sufficiently limited in Australia to preclude testing of samples classified as not meriting a laboratory test in the first place. It may be this scenario that Eizenberg tries inaccurately to describe. It is disappointing to be drawn into exchanging correspondence in these pages rather than having a constructive debriefing together at the end of this outbreak. No criticism by us of laboratory colleagues is intended, as we know there is a shared sense of the logistic challenges with which we have grappled, and can improve together. However, the record still needs to be put straight for a small number of physicians with a more limited grasp of the issues.
Michael G Catton · Julian D Druce · Chris J Birch
A pandemic problem with public transport
To the Editor: The increasing overcrowding on public transport, particularly trains, in many Australian cities makes for considerable discomfort. As the problem deteriorates, concerns about attributable illness and even death have been raised.1 Overcrowding on public transport also contributes to the spread of respiratory diseases such as influenza (pandemic or otherwise).2 The risk of contracting influenza is greatest for people who are within 1 m of an infectious person, through exposure to respiratory droplets, particularly for periods of more than 15 minutes.3,4 Seasonal influenza, which infects millions of Australians annually — resulting in an estimated 2000 deaths and 10 000 hospitalisations5 — is a major health concern. As a resident of Melbourne and regular train commuter, personal observation supports recent claims of severe overcrowding,1 with the average number of people sitting or standing within 1 m of another person on Melbourne trains during peak periods having increased markedly over the past few years. If an average peak commuter is now placed within 1 m of 10 people for a prolonged period twice a day (a conservative estimate), at least 100 infectious influenza contacts potentially occur each week. With annual attack rates for seasonal influenza of 5%–10%,5 the likelihood of contracting infection while crammed into under-resourced train networks is significant. In the context of an influenza pandemic, with higher attack rates, the risk is even greater. Substantial community resources have appropriately been invested in pandemic planning and mitigation strategies. Perhaps we should devote some of these resources to public transport services to reduce overcrowding. Our national pandemic plan advises that A very simple way of reducing the chances of being infected or passing on infection is to stand or sit back from other people in public or in the workplace. Where possible, you should try to maintain a distance of at least a metre, which is about a large step.4 Such advice is impossible to follow on peak-period train services, certainly in Melbourne. Investment in train services to reduce the spread of infections would not only help delay the onset of the next influenza pandemic, but would also reduce seasonal influenza and other respiratory virus transmission. Furthermore, it could avert injuries and illness due to crushing and overheating/dehydration, and could conceivably reduce the road toll by taking cars off roads during peak hours. Few pandemic influenza planning investments could deliver such diverse public health dividends while we ride out the latest influenza pandemic and await the inevitable next one.
Benjamin C Cowie
First clinical case of a locally acquired carbapenem-resistant VIM-1 metallo-β-lactamase in Pseudomonas aeruginosa in Australia
To the Editor: Nosocomial infections caused by Pseudomonas aeruginosa often prove difficult to treat because of their resistance to multiple drugs. Carbapenems play a pivotal role in the management of severe multidrug-resistant gram-negative Enterobacteriaceae and P. aeruginosa infections. However, reports in Australia of carbapenem resistance due to production of a variety of carbapenemases, including metallo-β-lactamases (MBLs), have been increasing alarmingly.1,2 We wish to report the first clinical case of a VIM-1-producing MBL in Sydney. To our knowledge, this is the first reported locally acquired case of a P. aeruginosa strain producing acquired VIM-1 MBL in Australia. The patient was an 81-year-old man with chronic rheumatoid arthritis, managed with prednisone. He had a prosthetic knee infection that was first diagnosed in 1997 and, because of multiple recurrences, had been managed with oral moxifloxacin since 2003. The patient had not travelled outside the Sydney area since before his knee surgery. He was hospitalised in November 2005, when he underwent repair of a colovesical fistula. Carbapenem-resistant P. aeruginosa was isolated repeatedly from both urine and sputum cultures from December 2005 until February 2008, when further testing was performed using newly available molecular real-time polymerase chain reaction (PCR) technology with VIM generic and specific primers and DNA sequencing. This testing detected a VIM-1 gene. The P. aeruginosa isolates were routinely screened for antibiotic susceptibility. Multiresistance to numerous antibiotic classes was detected, with high minimum inhibitory concentrations for meropenem, gentamicin, ciprofloxacin, ceftazidime, cefepime, piperacillin–tazobactam, and ticarcillin–clavulanic acid. The isolates were susceptible to polymyxin B and aztreonam, and had intermediate resistance to amikacin. Multiresistant P. aeruginosa is a therapeutic challenge when managing patients with such infections.3 In the context of facilities such as large burns units or intensive care units, the presence of plasmid-transmissible carbapenem resistance within the gram-negative bacterial population has serious infection control implications. Until novel molecular real-time PCR methods became available, the underlying mechanism of carbapenem resistance in these organisms could not be adequately delineated. The increasing availability of such molecular technology and its routine application in the diagnostic laboratory will support appropriate antibiotic prescribing practices and enhance infection control measures in the hospital setting. Identification of a plasmid-mediated carbapenem-resistant strain is a concern in our hospital and throughout Australia, as outbreaks of VIM-1 resistance have been reported in Europe and the United States.4 As demonstrated by our isolates, such strains have a broad spectrum of hydrolytic activity against amino-, carboxyl- and ureido-penicillins, cephalosporins, cephamycins and carbapenems, but not monobactams. Our isolate was susceptible only to polymyxin and aztreonam.
John Merlino · Harold W Stokes · Elaine Y-L Cheong · Thomas Gottlieb
Melioidosis in south-eastern Queensland
To the Editor: A 79-year-old man from Gatton, 80 km west of Brisbane (Box 1), presented in July 2008 with an extensive area of cellulitis on the right knee surrounding a central ulcer 2 cm in diameter (Box 2). Gram staining of swabs taken from the ulcer showed polymorphs and gram-negative bacilli. An oxidase-positive, gentamicin-resistant, gram-negative bacillus was cultured. It had the biochemical profile and characteristic colonial morphology of Burkholderia pseudomallei, the causative organism of melioidosis. The identity of the organism was confirmed by polymerase chain reaction. Blood and urine cultures were negative, and a chest x-ray was normal. The patient was treated with intravenous ceftazidime 2 g four times a day for 10 days, as well as oral cotrimoxazole 320/1600 mg twice a day for 6 months. The infection appeared to be localised, and the patient made a successful recovery. Melioidosis can have a wide spectrum of clinical manifestations.1 Skin and soft tissue infections, as seen in our patient, may lead to fulminating systemic infections if treatment is inadequate.1 There were also several factors that predisposed our patient to melioidosis, including type 2 diabetes, renal impairment, and concurrent steroid treatment (for persistent sinusitis). The patient had a history of recent local exposure to floodwaters and soil: he had spent several hours kneeling in wet mud repairing a burst water pipe. Within a few days, an abrasion on the knee had developed into the presenting lesion. The patient denied visiting any areas where tropical melioidosis was endemic. In Australia, melioidosis is generally considered endemic in areas north of 20°S. In subtropical Australia, below 20°S, sporadic endemic infections in domestic animals and humans have occurred in south-eastern Queensland2-6 and south-western Western Australia.7 Three fatal human cases have been reported from the Brisbane River valley (two in 1996, near a reservoir 20 km north of Gatton;4 one in 1999, 5 km from Ipswich city centre5). All three patients were exposed to floodwaters, two had infected skin lesions, and all three progressed to fulminating pneumonia. All three also had alcohol-associated pathology, a recognised comorbidity.1 There were also two less well documented (but apparently local) human cases from the Brisbane region in 19676 and 1974.4 Recent molecular typing of five strains of B. pseudomallei isolated from south-eastern Queensland showed them to be genetically distinct from each other and from isolates obtained from tropical Australia, suggesting that this subtropical focus is most likely a natural phenomenon from ancient times.5 The reticulated water supply to our patient’s house was sourced from the Wivenhoe Dam. The source of the bacteria was most likely the local soil, which is of a heavy clay type suitable for this organism. The Brisbane River valley appears to be a subtropical endemic area for melioidosis, and further sporadic cases can be expected. 1 Location of melioidosis cases reported in Queensland 2 Area of cellulitis around a central ulcer on the patient’s right knee
Roger W Guard · Peter J Morero · Win Yi · Maureen J Mackay
Severe Queensland tick typhus complicated by diabetes in south-eastern Queensland
To the Editor: Rickettsia australis is the causative organism of Queensland tick typhus, also known as Australian spotted fever. It is an obligate, intracellular organism that invades endothelial cells, causing vasculitis.1,2 Its transmission to humans is via Ixodes tick species, which can occur along the east coast of Australia, but predominantly occur in the north-east.3 R. australis was previously thought to have a low complication rate; however, severe sequelae such as multiorgan failure, severe pneumonia and digital necrosis have emerged in recent years.1 A 54-year-old woman with type 1 diabetes presented to a rural hospital in Queensland with a 1-week history of vomiting, diarrhoea, rigors, and fevers to 39.4°C. Her blood sugar level on arrival was 31 mmol/L (reference range [RR], 3.0–7.8 mmol/L) and diabetic ketoacidosis was diagnosed. Despite initial treatment, her condition continued to decline, and she was transferred to a tertiary referral centre. Her condition deteriorated into multiorgan failure, requiring ventilation and inotropic support. Triple antibiotic therapy comprising ciprofloxacin, meropenem and doxycycline was initiated. Results of blood cultures for anaerobic and aerobic bacteria and a vasculitic screen were negative. The patient underwent serial chest x-rays, which demonstrated a resolving left lower lobe collapse/consolidation and a right-sided pleural effusion. Paired sera from Day 1 and Day 11 of admission to the tertiary hospital were tested in parallel for antibodies to R. australis. A rise in R. australis antibody titre, from 256 to 1024 (RR, < 32), supported a diagnosis of rickettsial disease. Serum from Day 1 was negative for antibodies to Mycoplasma, Leptospira, and Brucella species. A family conference later suggested that the patient may have been bitten by an insect; however, no suspicious lesion was identified. Her treatment was changed to intravenous doxycycline monotherapy, and slow improvement was noted. Two days after admission, the patient developed widespread bullae and dermal necrosis with large areas of affected dermis sloughing off (Box), as well as digital and proximal foot ischaemia. A skin biopsy showed changes consistent with septic vasculitis. The patient was reviewed by a dermatologist, who concluded that it was unlikely to be from a drug reaction. Thirty-six days after admission, she underwent bilateral below-knee amputations. Formalisation of the stumps was delayed to ensure viable tissue for coverage. Necrotic areas of her lower limbs and arms were also debrided and grafted, and seven of her fingers were amputated at the level of the proximal interphalangeal joint. The patient was discharged to a smaller centre for ongoing rehabilitation and support. This case highlights the possible severity of R. australis infection, which can be complicated by septic shock, coagulopathy, multiorgan failure and digital gangrene. In addition, diabetes and the resultant ketoacidosis contributed to a compromised host and an unusually severe clinical course. Bullae and dermal necrosis on the legs of a patient with severe rickettsial disease
Theo F Birch · Michael Muller
Glycaemic control in patients with type 1 diabetes after provision of public hospital-funded insulin pumps
To the Editor: In Australia, patients with type 1 diabetes and private health insurance are eligible for rebates on the purchase price of insulin pumps if deemed necessary for treatment. In contrast, hospital-funded or donated pumps are often used by non-insured patients. Hospitals may provide pumps to certain patients for various reasons — for example, to pregnant women (to improve their glycaemic control), to patients who want to try the pump to determine their preference or their ability to use it, or to patients waiting for private health insurance cover to be activated. Patient selection is important, as insulin pumps are cost-effective only if they reduce levels of glycated haemoglobin (HbA1c) and the frequency of hypoglycaemia1 — although quality of life may also be an important benefit. We conducted a study to compare outcomes for patients with public hospital-funded pumps (Group A) with outcomes for those with private health insurance-funded pumps (Group B). All pump starts between June 2000 and January 2008 at Fremantle Hospital and Rockingham General Hospital in Western Australia were assessed. HbA1c levels before and 6 months after pump initiation were recorded. Diabetes-related hospital admissions over a 1-year period before and a 1-year period after pump commencement were recorded using hospital software (TOPAS KEA! 340, version 5.106) that tracked admissions to all hospitals within the greater metropolitan area of Perth. Patients were excluded from our study if they had type 2 diabetes; had commenced pump use at a different hospital; had moved during the study period to a region not captured on the database; or had used a pump for less than a year (this last exclusion criterion was to ensure that admission rates for the subsequent 12 months were representative of the influence of pump therapy). We identified 109 patients (32 in Group A, 77 in Group B). There were no significant differences between the two groups in age, diabetes duration, initial HbA1c levels (9.2% v 8.7%; P = 0.29) or sex, although the proportion of females was higher in both groups (65.6% and 70.1%, respectively). Patients in Group A had more hospital admissions than those in Group B before and after commencement of pump therapy (0.7 v 0.2 admissions/year before [P = 0.02]; 0.7 v 0.2 admissions/year after [P = 0.04]). After commencing pump therapy, HbA1c levels fell significantly in Group B patients (8.7% v 8.0%; P < 0.005) but not in Group A patients (9.2% v 8.9%; P = 0.17). The mean interval between pump initiation and follow-up HbA1c readings was similar in both groups (10.3 months [Group A] v 10.8 months [Group B]; P = 0.70). There was no significant difference in diabetes-related admissions before and after commencement of pump therapy in either group.
Ken Y Thong · P Gerry Fegan · Bu B Yeap
Access block: it’s all about available beds
To the Editor: I have read with interest your recent series of articles on access block.1-3 While access block is clearly bad for patients, it is a measure that is focused on emergency departments and not patients. Access block only measures the first part of the process of admission to hospital. Surely, the best measure of access into a hospital is not the rapidity with which patients get out of the emergency department but how long before patients get into the ward that is most suited for their care. At my hospital, patients are shuffled out of the emergency department into a variety of “holding pens”. By this I mean wards (often temporary) whose sole purpose is to act as an overflow area while the patient is waiting to obtain a bed in the home ward of the medical or surgical unit that is looking after the patient. The purpose is to allow the emergency department to function better, but also to allow the hospital to look good from an “access block” point of view. This is hardly optimal patient care. A recent survey at my institution of 136 medical patients at high risk of delirium showed that over 43% had three or more ward moves during their admission, and 60% had three or more bed moves. No wonder they become confused. Patients who are moved to holding pens have intrinsic disadvantages to their care. They are often seen late in the day by medical teams; the medical and nursing teams are not used to working together; allied health professionals may change from ward to ward, and holding pens often have no allied health staff; patient’s belongings, pathology and radiology requests get lost in the transition to different wards; patient meals can be substandard in holding pens (because they are ordered at short notice); and there are multiple handovers between many different groups of nurses. Medications are missed. So, hospitals should not be allowed to play games with this metric. The time for patients to get into the home ward (or the most appropriate ward) of the admitting medical or surgical team needs to be part of the equation.
Charles P Denaro
Interventions to circumvent intensive care access block: a retrospective 2-year study across metropolitan Melbourne
To the Editor: Duke and colleagues recently reported the excess mortality and extra bed-days caused by intensive care access block in metropolitan Melbourne.1 Access block is an important patient safety issue, and we report here additional data that support their results. The Australasian Clinical Indicator Report: 2001–2007, published by the Australian Council on Healthcare Standards (ACHS), reported that the national rate of intensive care access block was 5.9% in 2007, a statistically significant (P < 0.001) increase from 5.3% in 2001.2 There were large differences between states, with higher rates in Victoria in 2006 and 2007. In 2007, the rate of cancellation or postponement of elective major surgery due to lack of intensive care beds was 3.1%, and the rate of interhospital transfer was 1.3%.2 Other rates reported were: the rate of discharge from the intensive care unit delayed more then 12 hours (16.6%) and the rate of after-hours (between 18:00 and 06:00) discharge (17.5%).2 The Victorian rate of after-hours discharge from the intensive care unit, calculated from seven participating hospitals in 2007 (21.6%),2 is comparable with the rate of after-hours step-down to a low-acuity ward found in Duke et al’s study — 18.6% for the period July 2004 to June 2006.1 The ACHS Clinical Indicator Program provides national and peer-group benchmarking to health services participating in its accreditation program, the Evaluation and Quality Improvement Program (EQuIP). Through its annual Clinical Indicator Report, the data are analysed and allow identification of unsatisfactory rates and wide variations in practice. Such national data can help health policymakers identify areas for potential improvement in the standards of health care delivery, particularly in areas where indicators address access. Duke and colleagues’ salient article illustrates the importance of such data being utilised for this purpose.
Helen E Stark · Chris N Maxwell · Robert W Gibberd
Access block can be managed
To the Editor: Cameron and colleagues are to be congratulated on their article outlining strategies that do and do not help improve the access of emergency medical patients to public hospital ward beds.1 The authors fail to mention one strategy that is particularly relevant to rural hospitals, namely, referring privately insured medical patients who present to emergency departments directly to tertiary medical services at private hospitals. This strategy has the dual benefit of providing a hospital bed for a patient in a rural emergency department who requires hospital admission, and relieving some of the external pressures on metropolitan tertiary referral public hospitals to provide beds. Traditionally, private health insurance has been thought of as providing patients with the ability to obtain treatment from the doctor and hospital of their choice. Increasingly, private health insurance is giving patients the ability to choose between staying on an emergency department trolley and being able to access a hospital bed in a timely manner. It is worth noting that privately insured patients who require services that are not provided at our hospital (such as interventional cardiology, neurosurgery, cardiothoracic surgery and faciomaxillary surgery) can sometimes access a bed in a private hospital about 500 km away sooner than we can find them a bed in our hospital prior to transfer to a tertiary public hospital. A significant impediment to this process for some privately insured patients is the inability of private hospitals to perform insurance fund checks out-of-hours. While most private health insurance funds provide internet authorisations and confirmations of a patient’s insurance status to private hospitals, some do not. In one case, this meant the wife of a patient with unstable angina pectoris had to provide a cash guarantee of $28 000 on a Sunday so that her husband could have an angiogram the next day. Even though they had “top-level” private health insurance cover, the private hospital could not confirm their insurance status and obtain an authorisation from their health insurance fund on a weekend. Patients with private health insurance should be able to use the benefits of their insurance 24 hours a day, 7 days a week. Private health insurance funds that do not provide 24-hour authorisations to private hospitals for hospital admission should state this limitation clearly in their insurance product as a part of their statutory product disclosure statements. Such disclosure would provide relevant information to consumers to enable them to make an informed choice about their private health insurer.
Antony Nocera
Should the Pharmaceutical Benefits Advisory Committee extend the range of free nicotine replacement therapies available for Aboriginal and Torres Strait Islander people?
To the Editor: In March 2008, nicotine patches (15 mg per 16 hours) were authority-listed for Aboriginal and Torres Strait Islander people by the Pharmaceutical Benefits Advisory Committee (PBAC) as part of efforts to improve access to medications.1,2 Although timely and welcome, the decision to list only 15 mg patches should be revisited, as it is not consistent with current smoking cessation clinical guidelines.3-5 Neither is it consistent with evidence from a 2008 tobacco survey that we conducted in remote Aboriginal communities in Arnhem Land, Northern Territory. Clinical guidelines advise that smokers will require more intensive support to quit smoking if they: (i) demonstrate a high level of dependency; (ii) have had more than one short quit attempt; (iii) still smoke or experience cravings when using nicotine replacement therapy (NRT); and/or (iv) are frequently exposed to other smokers.3,4 This support includes appropriate medication and counselling, which are more effective in combination.5 Under-dosing is a common problem, given that NRT products deliver nicotine plasma levels well below that delivered by a cigarette.3 Higher-dose NRT products (eg, 4 mg gum) or combination nicotine therapies (eg, patches with gums) are effective for highly dependent smokers.3,5 In the Arnhem Land survey, we interviewed 397 people (aged ≥ 16 years) about tobacco. Of these, 77% were current smokers. Among the current smokers, 17% were attempting to quit or had tried to quit, and 58% were contemplating quitting. Dependency was common, with 55% of smokers reporting they smoked first thing in the morning or during the night. With many dependent smokers, high rates of smoking and widespread “cue” exposure, there is a high need for intensive quit support. We also interviewed 24 smokers interested in quitting who were offered 21 mg patches, and 4 mg and 2 mg gums and lozenges. All used the gums; four combined gum with 21 mg patches, with one of these initially trying lozenges. Modest increases in periods of abstinence and reduction in daily consumption were documented in the 11 participants followed up so far. This evidence, albeit limited, challenges the PBAC rationale for listing patches but not gums for Aboriginal and Torres Strait Islander people, namely: “this population eschews oral aids for smoking cessation”.1 Some Aboriginal and Torres Strait Islander smokers wanting to quit may benefit from combination NRT or gums alone. A wider range of NRT products including gums should therefore be considered by the PBAC.
Jan A Robertson · David J MacLaren · Alan R Clough
Poor outcomes among gastrostomy-fed patients in the community
To the Editor: The article by Calver and colleagues on the use of gastrostomy tubes in older Western Australians raises important issues regarding decision making for gastrostomy tube insertion and ongoing care of gastrostomy-fed patients. Calver et al report a high incidence of readmissions within 1 year for gastrostomy tube replacement or gastrostomy-related complication (25%) and a high 1-year mortality rate (54%)1 Extrapolation of New South Wales data suggests that about 11 000 Australians rely on gastrostomy feeding at home as their sole source of nutrition and hydration.2 In NSW, about 2300 gastrostomy and jejunostomy procedures are performed each year in public health care facilities, for which about 60% of patients are discharged home. Of these patients, 40% require tube feeding for 2 or more years, and 11% for 5 or more years. In the financial year 2004–05, there were about 700 reported presentations to emergency departments of patients requiring percutaneous endoscopic gastrostomy tube replacement or experiencing tube-associated feeding complications (eg, stoma site infection, tube blockage, buried bumper syndrome, and diarrhoea related to tube feeding); 15% of these presentations resulted in ward admission.2 Many complications can be prevented or treated effectively in the community, provided that patients, carers and health professionals are adequately trained and supported, and that formula, consumables and equipment are affordable. Of particular concern are situations where patients who have multiple comorbidities and disabilities and who cannot advocate for themselves are discharged to nursing homes and group homes. The NSW Ombudsman reported the deaths of two people in 2006 as a result of poor management of their gastrostomy tube feeding and recommended that minimum care standards be introduced.3 Enteral nutrition is an orphan therapy, with no single professional group taking ownership of it. Hospitals release their responsibility when they discharge a patient, as the patient is no longer admitted, and there are limited community services to take over care. Patients are left to fend for themselves, resulting in poor outcomes. How a patient will manage tube feeding at home should be an important part of the decision-making process that occurs before a tube is inserted, rather than an afterthought. As the use of therapies that can be performed at home increases (eg, dialysis and enteral nutrition), there needs to be increased investment in community-based health services to support patients in caring for themselves at home. This will bring social and economic benefits to both patients and the health care system.
William H Watt · Kate A Needham · Peter L Talbot · Janet P Bell · Glen J Pang
Anxiety and depression among long-term survivors of cancer in Australia: results of a population-based survey
To the Editor: We applaud the attempt by Boyes and colleagues to ascertain the level of psychological distress experienced by patients over the years following diagnosis with cancer, through a retrospective, cross-sectional survey of New South Wales cancer registrants.1 However, we believe several methodological limitations ought to reduce the confidence with which the authors drew their conclusions. The authors’ comment that “life after cancer is not all doom and gloom” was, perhaps, intended to be a little facetious. From a scientific point of view, however, such a statement is also very difficult to ever disprove — of course it isn’t all doom and gloom. Further, the authors’ assertion that psychosocial wellbeing several years after cancer diagnosis is comparable with that of the general population cannot be substantiated by studies conducted by this method. As the survey was cross-sectional, we have no information about the level of distress experienced during the years since diagnosis. A longitudinal design is now de rigueur in this field for this reason. Certainly, clinical experience shows us that many patients actually do experience “doom and gloom” often, indeed, arising from “insidious and relentless disease” — this group may not, however, be well represented by a cancer registry survey sampling 5 years after diagnosis. Selection bias is a major problem. Of the sample of 2029 eligible, randomly selected people, 655 (32%) were deemed ineligible, with one of the exclusion criteria being not “mentally capable of participating”. Could this sizable subgroup have included those who were distressed? Also, of the eligible sample of 1374, 366 (27%) declined to participate. What were the reasons for refusal? Were some too distressed to participate? In summary, how were the 37% who did not participate in the study faring 5 years after diagnosis? The Hospital Anxiety and Depression Scale (HADS), used by Boyes et al to detect psychological distress in early-stage breast cancer, under-reports distress when recommended cut-off scores are used, compared with a structured clinical interview validated to provide Diagnostic and statistical manual of mental disorders, fourth edition (DSM-IV2) diagnoses.3 In other words, the HADS is known to lack sensitivity and positive predictive power in the cancer setting. Other cancer researchers found the same.4,5 Further, measuring distress only in terms of anxiety and depression 5 years into the adjustment process fails to capture the quality of continuing distress and the degree to which traumatic growth and other forms of meaning-based adjustment have been achieved. The limitations of the HADS should have been better acknowledged.
Jeremy W Couper · Anthony W Love · Annabel C Pollard · Sidney Bloch
Anxiety and depression among long-term survivors of cancer in Australia: results of a population-based survey
In reply: We thank Couper and colleagues for their interest in our article,1 but reiterate that we focused on anxiety and depression experienced by long-term cancer survivors, specifically at 5–6 years after diagnosis. We agree that longitudinal studies are vital for understanding the level of psychological distress experienced during the years since diagnosis, and as discussed in our article, we are currently undertaking a longitudinal study with a diversity of cancer patients to assess a comprehensive range of physical, psychological, social and lifestyle effects of cancer. Although opinions on the performance of the Hospital Anxiety and Depression Scale (HADS) vary, it is one of the most popular measures of psychological distress, and has been used extensively across the cancer continuum.2 A recent review of the validity of the HADS concluded that it performs well in screening for caseness of anxiety disorders and depression in a range of patient populations, including patients with cancer, and in the general population.3 We acknowledge that our study had the strengths and limitations normally associated with recruiting through a population-based cancer registry.4 Nevertheless, our results are consistent with a growing body of evidence indicating that most cancer survivors are doing well 5 or more years after diagnosis.5 We believe our conclusions are justified.
Allison W Boyes · Afaf Girgis · Alison C Zucca · Christophe Lecathelinais
Bicycling injuries and mortality in Victoria, 2001–2006
To the Editor: Sikic and colleagues state that the 1990 legislation making helmets compulsory for bicyclists in Victoria was associated with a decrease in non-fatal head injuries and fatalities.1 However, of the three citations given to support this statement (references 8–10 in Sikic et al),1 one is a study performed before the helmet law was introduced, another is an editorial, and the third makes the common error of attributing to helmet use the effects of economic recession and road safety campaigns. These together reduced all road deaths in Australia by about a third.2 Careful analysis takes account of such factors. Western Australia and New Zealand offer good datasets of injuries to cyclists and control groups through the period of increasing helmet use and enforcement: neither dataset shows evidence that mass helmet use reduced the occurrence of serious head injuries to cyclists.3 With fewer serious crashes, there were fewer serious head injuries, and a general reduction in severity of injury in road accidents for all road users. These observations make it hard to accept that cycle helmets reliably confer significant protection. Sikic et al further state that “Wearing an approved safety helmet substantially reduces the risk of serious head injury in cyclists who fall or are involved in collisions with motor vehicles”,1 citing case–control studies. Such studies are known to have serious weaknesses when applied to voluntary behaviour in a socially disparate population.4,5 Risk assessments do not justify helmet laws for cyclists alone. Analysis of Australian Government data (1988–1990) showed that cyclists faced a lower risk of death per hour than car occupants (0.41 v 0.46 fatalities per million hours of use).6 Wider risk assessment based on European data confirms that cycling risks are in the same range as for walking and driving.7 Sikic et al ask for further research to identify factors other than helmet wearing that contribute to preventing cycling injuries. One important factor is already well known: an increase in cyclists on the roads means less risk per cyclist.8 Considerable experience is now available to show that mass helmet use has not been effective in preventing serious head injuries in cycling populations.3 Enforced helmet laws in Australia may deter people from cycling9 and getting the major health benefits of moderate exercise.10
Malcolm J Wardlaw
Bicycling injuries and mortality in Victoria, 2001–2006
In reply: The main conclusion of our population-based study1 was that a consistent increase in bicycle-related injuries occurred over the study period. Our study was not designed to analyse the effect of helmet wearing. The potential benefits of helmet wearing were identified in the discussion as a means of reducing the increasing burden of injury. There has been opposition to legislation enforcing helmet wearing in Australia.2 The response to this opposition has been adequately addressed by Canadian researchers.3,4 In addition, a number of Cochrane systematic reviews have arrived at different conclusions to Wardlaw.5,6 Although there are no randomised controlled trials, the weight of evidence would suggest that wearing helmets reduces head injuries in the bicycle-riding population and the imposition is worth the inconvenience to bicycle riders.
Antonina A Mikocka-Walus · Francis T McDermott · Peter A Cameron
Snapshot
Three synchronous tumours identified by FDG-PET/CT
A 65-year-old woman underwent integrated fluorodeoxyglucose positron emission tomography and computed tomography (FDG-PET/CT [Philips GXL, Philips Medical Systems, Milpitas, Calif, USA]) to stage a newly diagnosed squamous cell carcinoma of the tongue (Figure, A). The scan revealed two additional, unexpected synchronous tumours, one in the left axilla (B) and the other in the sigmoid colon (C). The patient underwent subtotal glossectomy, after which further investigations confirmed a node-positive neuroendocrine carcinoma of the left breast and a dysplastic colonic tubulovillous adenoma. The detection of three synchronous tumours of different aetiology in the one patient on PET is rare. Previous cases of synchronous tumours detected on PET involved tumours of the head and neck, upper gastrointestinal tract and lungs, thought to be related to shared risk factors, such as smoking.1
Paul M Leong · Michael Lin · Allan R Fowler
Corrections
Retirement intentions of general practitioners aged 45–65 years
Incorrect data in Box 1: In the article “Retirement intentions of general practitioners aged 45–65 years” in the 20 July 2009 issue of the Journal (Med J Aust 2009; 191: 75-77), in Box 1, the number (%) of “Nursing home or hostel visits” should be 114 (64%), not 52 (29%). The html and pdf versions of the article published online were corrected on 6 August 2009
Thomas D Brett · Diane Arnold-Reed · Diane A Hince · Ian K Wood · Robert G Moorhead
Improving general practice consultations for older people with asthma: a cluster randomised control trial
Omission of funding details: In the In Clinical Practice article “Improving general practice consultations for older people with asthma: a cluster randomised control trial” in the 20 July 2009 issue of the Journal (Med J Aust 2009; 191: 113-117), funding details provided by the authors were inadvertently omitted. These details, which should have appeared in the acknowledgements, are as follows: This intervention study was funded by an Asthma Targeted Intervention Grant provided by the Australian Government Department of Health and Ageing; the Australian Government has not reviewed this material and does not represent or guarantee that its contents are correct. We also acknowledge the support of the Cooperative Research Centre for Asthma and Airways. The html and pdf versions of the article published online were corrected on 10 August 2009.
Dianne P Goeman · Lena A Sanci · Simon L Scharf · Michael Bailey · Robyn E O’Hehir · Christine R Jenkins · Jo A Douglass
Evolution of a house: Darwin’s link to Pambula
Incorrect author affiliation: In the letter “Evolution of a house: Darwin’s link to Pambula” in the 3 August 2009 issue of the Journal (Med J Aust 2009; 191: 192), George D Repin was incorrectly described as Honorary Director of the Centre for Continuing Medical Education at the University of New South Wales, Sydney. The author is a retired Health Services Consultant. The html and pdf versions of the article published online were corrected on 6 August 2009.
George D Repin
Columns
In Other Journals
Melanoma and moles are in the genes Australian researchers have been involved in two recent genome-wide association studies, the results of which have identified genetic loci linked with the development of cutaneous naevi and malignant melanoma.1,2 In the study focusing on melanocytic naevi, strong associations were found between two genetic loci (MTAP and PLA2G6) and the number of melanocytic naevi in the individual.1 MTAP is found adjacent to the familial melanoma susceptibility locus. Variants in both the MTAP and PLA2G6 loci were also associated with melanoma risk. The authors comment that understanding how these loci influence the development of naevi may lead to a better understanding of the development of malignant melanoma. In the other genome-wide study, three genetic loci have been found to be associated with a high melanoma risk.2 Two of the loci are closely linked to genes related to pigmentation, freckling and sun sensitivity. The researchers note that further work is required to determine if these associations function through melanoma-associated phenotypes, or if they have an independent association with melanoma risk. 1. Nat Genet 2009; 41: 915-919 2. Nat Genet 2009; 41: 920-925 Ask the patient Patient-reported outcomes (PROs) are commonly used in research involving large numbers of participants, such as clinical trials, but they can be very useful at the individual level, say the authors of a commentary about including such tools in clinical practice. PROs can be used as screening questionnaires, with follow-up in the management of conditions such as depression, and in cancer management as a tool to provide feedback to the clinician about treatment and quality of life. The authors comment that, as well as being useful to facilitate communication between clinician and patient, PROs can improve patients’ recall of health-related incidents and help identify problems which they might not otherwise have raised. Lancet 2009; 374: 369-370 Solvent exposure and lymphoma Frequent and heavy exposure to degreasing work, which uses organic solvents, may be associated with an increased risk of non-Hodgkin lymphoma (NHL), say the authors of a US study. In a large, population-based case-control study of NHL, researchers collected information about solvent exposure and used the resulting detailed data to search for a relationship between risk of NHL and such tasks as degreasing, painting, stripping paint, gluing and staining. An apparent increased risk for NHL was observed in subjects performing a large number of degreasing jobs that placed them in the highest category of maximal degreasing frequency (more than 520 hours per year). Other solvent-related tasks did not seem to be associated with NHL. The authors acknowledge limitations of the study, including the small numbers of participants highly exposed to solvent-related tasks. Despite this, they suggest that research needs to be done to determine the effect of degreasing agents on lymphomagenesis. Occup Environ Med 2009; 66: 557-560 Chlamydia in men — a quick test A new, rapid urine test for chlamydia in men using first-void urine has shown promising results in a UK evaluation trial. The study, which involved over 1200 men, compared the sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test with a traditional polymerase chain reaction assay. The new test performed well on all criteria, having a combined overall sensitivity and specificity of 82.6% and 98.5%, respectively. The authors comment that test results are available within 1 hour, allowing for immediate treatment and contact tracing, and that first-void urine is a preferable collection method to urethral swabbing for many men. They also point out that the test could be used as a screening tool in areas where infection with Chlamydia trachomatis is highly prevalent or access to nucleic acid amplification testing is limited. BMJ 2009; 339: b2655 Twin towers — the health legacy Almost 8 years after the terrorist attacks on the World Trade Center on 11 September 2001, a longitudinal cohort study has been published highlighting some of the ongoing health effects in those who were involved. The World Trade Center Health Registry includes information on over 70 000 rescue and recovery workers, residents, office workers and passers-by who were affected by the event. Two surveys, completed in 2003-2004 and 2006-2007, reported new asthma diagnoses in 10.2% of adults post-event, with asthma risk highest among rescue and recovery workers exposed to the heavy dust cloud associated with the event. Participants also completed a post-traumatic stress disorder (PTSD) checklist; of those with no PTSD history, nearly a quarter reported symptoms at either survey and nearly 10% had symptoms at both surveys. The authors recommend short-and long-term interventions for mental and physical health following future disasters. JAMA 2009; 302: 298-305
Tanya Grassi
Rostering hospital staff
Martin B Van Der Weyden
In This Issue
Ann Gregory
Maximising the effectiveness and cost-effectiveness of cardiovascular disease prevention in the general population
Andrew M Tonkin MD, FRACP, FCSANZ · Andrew N Boyden MPH, FRACGP · Stephen Colagiuri FRACP
Improving the management of chronic non-malignant pain and reducing problems associated with prescription opioids
Alex D Wodak FRACP, FAChAM, FAFPHM · Milton L Cohen MD, FRACP, FFPMANZCA · Malcolm D H Dobbin PhD, FAFPHM, MPH · Richard A Hallinan BMed, FAChAM · Mary Osborn MPubHlth
Dismembering GPs
Martin B Van Der Weyden
In This Issue
Ann Gregory
Critical importance of effective supervision in postgraduate medical education
Kevin D Forsyth MD, PhD, FRACP
Asthma in older adults: a holistic, person-centred and problem-oriented approach
Guy B Marks PhD, FRACP · Leanne M Poulos BMedSc(Hons), MPH(Hons) · Christine R Jenkins MD, FRACP · Peter G Gibson MB BS, FRACP